CN103889318B - The apparatus and method of one or more physiological parameters of non-invasive measurement experimenter - Google Patents
The apparatus and method of one or more physiological parameters of non-invasive measurement experimenter Download PDFInfo
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Abstract
The invention discloses the apparatus and method of the improvement of relevant one or more physiologys (such as the hematodinamics) parameter of a kind of noninvasive detection biological tissue.In one embodiment, assembly of the invention can automatically and precisely place and maintain sensor (such as measuring the pressure transducer of pressure) relative to the physiological structure of experimenter.This device is removably coupled to master device by sensor and constitutes, and described master device is for positioning sensor during measuring.Meanwhile, the method that the invention also discloses location alignment device and induction apparatus, and the method operating this device.
Description
Priority and related application
The application advocates the same subject application of the U.S. Patent Application No. 13/098,344 proposed on April 29th, 2011, its
All the elements are all introduced the foreign aid in this.The application relates to US publication the 2009/0131806th, and its theme is that " Noninvasive is surveyed
The apparatus and method of amount patient's arteriotony ", filing date on October 9th, 2008, and that this US publication is advocated is excellent
First power is the U.S. Provisional Patent Application 60/998,632 of same theme filed in 12 days October in 2007, and their all the elements are equal
Introduced the foreign aid in this.The application also with following U.S. Patent application about: United States Patent (USP) filed in device day July 19 in 2006 is open
No. 2008/0021334, its theme is " apparatus and method that noninvasive measures hemodynamic parameter "；January 20 in 2006
United States Patent (USP) filed in discloses No. 2006/0184051, and its theme is the " dress of noninvasive measurement hemodynamic parameter
Put and method "；United States Patent (USP) filed in 18 days Augusts in 2004 discloses No. 2005/0080345, and its theme is that " noninvasive is surveyed
The apparatus and method of amount hemodynamic parameter ", and it to be United States Patent (USP) filed in 11 days October in 2002 disclose the 10/th
269, No. 801 part continuation applications with theme patent, all these earlier applications are all introduced the foreign aid in this.
Copyright
Partial content disclosed in text of the present invention relates to the protection of copyright.In copyrighter does not oppose it
Hold and replicated by patent text or patent disclosure.For occurring in the middle of patent document and the record of Patent Office, but still retain
The proprietary rights of its copyright.
Technical field
The invention mainly relates to for monitoring physiology and the method and apparatus of fluid system relevant parameter, in one aspect
It is specifically related to non-intruding monitor organism medium-sized artery blood pressure and other hemodynamic parameter.
Background technology
In medical science field, pursue all the time a kind of can the high-acruracy survey of physiologic parameters of living subject
Method.Wherein, in this field, Noninvasive continuous blood pressure measuring and/or other hemodynamic parameter are particularly important.If energy
Enough utilize this kind of measurement technology, nursing staff then can repeat and continuous precise measure the parameter (such as blood pressure) of experimenter,
Such as, blood pressure is continued, high-precision display be must obligato Surgical Operating Room to so there is no need to by setting
Parameter uses invasive arterypuncture conduit (A-line as everyone knows).
So far, in order to non-intrusion type monitors the waveform of subject artery's blood pressure, have several known in the technology used, i.e. listen
Examine measurement method, vibration measurement method, tonometry etc..Stethoscopic technique and vibration measurement method are all the inflated types of use standard
Bundle arm, pushes down the brachial artery of experimenter.Tension measurement techniques is by monitoring the specific Ke Shi slowly exitted and produce by cuff
Sound, judges contraction pressure and the diastolic pressure of experimenter.On the other hand, vibration measurement technique is by measuring reality during bundle arm venting
Above-mentioned blood pressure, and the mean blood pressure of this experimenter are measured in pressure change.For any technology, it is required for halved tie in turn
Arm inflation and abandoning, thus can not measured pressure value constantly, and the actual blood pressure waveform of experimenter can not be repeated.Therefore,
Real continuously blood pressure during heart beating being monitored can not be realized by these technology.
Closed bundle arm instrument described briefly above is when measuring the blood pressure of experimenter, to a certain extent for for a long time
Some effect of trend.But, these instruments are the most invalid for the sensing of the blood pressure in the short time, and this point exists
Including surgical operation etc. most important in medical application.
At medical domain, it is also well-known that angiosthenia measures technology.Theoretical according to angiosthenia, there is abundant bone
Pressure in the shallow artery (such as radial artery) that bone supports may be by accurate recording in the pressing scanning that a transmural pressure is 0
Get off.Term " flattens " process referring to change the pressure putting on tremulous pulse.One pressure flattened on scanning Digital arteries is swept
When retouching beginning, tremulous pulse is shortened into the shape of " Os Canitis " by overvoltage, and therefore pressure pulse will not be recorded.Scan at this
End, this tremulous pulse is in the state of insufficient compression, and therefore the pressure pulse of minimum amplitude is recorded.At this in scanning, logical
Cross and think that having this arteries tension force of period pressing parallel with this tonometer surface occurs.Herein, arterial pressure is vertical
In surface, it is unique stress of being detected of tonometer.At this pressure, it is assumed that maximum the peak-to-peak amplitude (" large pluse obtained
Dynamic ") pressure correspond to 0 transmural pressure.
A kind of prior-art devices for pressure measurement technology, has the rigid array of a micro pressure sensor,
It can be applied to the outside organization of peripheral arterial such as radial artery.Each sensor can the direct machinery under perception destination organization
Pressure, and the size of each sensor only covers the sub-fraction of the following tremulous pulse of tissue.Array attaches in tissue, makes
Being positioned at the tremulous pulse planarization of downside, the pressure change of the endarterial eartbeat interval of result is sent at least certain biography by tissue
Sensor.The array arrangement of different sensors, no matter in what kind of position of experimenter's tissue, can guarantee to configure on tremulous pulse
There is sensor.But, this blood pressure is in respect of several defects.First, discretized sensor array moves with covering the most anatomically
The continuous-profile of the object tissue of arteries and veins is not fitted.This is always to cause the accurate not reason of sensor signal.It addition,
As this laminating is likely to result in tissue injury and nerve injury, it is also possible to limit blood flow and flow to distal tissues.
Other prior art is placed horizontally on tremulous pulse accurately also by by single pressure measurement sensor, from
And make sensor change perfect adaptation with endarterial pressure.But, sensor can be placed in geometry meaning by such a system
" geometric center " in justice, is not the most the optimum position with signal combination, due to the movement of tested organism when additionally measuring, many
Also need in the case of number frequently correct again or reorientate.Additionally, the most unnatural when the method configures in the early stage or configures afterwards,
(put then by pen or other labelling work with Fingers location after the appropriate location that nursing staff places a sensor at object
Tool) it is marked, the most again sensor is positioned on the position of labelling.It addition, some prior aries depend on additional biography
Sense component positions described sensor.When using extra device, cost and step that some are extra can be increased.
It addition, pressure-measuring system of the prior art, generally for the direction of pressure transducer on measured object
Very sensitive.Specifically, if the angle between pressure transducer and tremulous pulse deviates from " most preferably " angle of incidence, then this system
Accuracy also will degradation.And this is a critically important Consideration, because it is difficult to ensure that device and tremulous pulse when measuring for twice
Between can accurately keep identical angle.In the method for above-mentioned prior art, its shortcoming is to keep certain with tremulous pulse
Angular relationship (it doesn't matter with transverse direction position).Because as a rule, its location mechanism is not in view of object
Anatomical features, such as the curvature on wrist surface.
Another defect of the non-invasive blood kinetic measurement technology of prior art, is the place of the parts being connected with device
Reason problem.In particular it is desired that device may: (i) with measure object (one or more) directly or indirectly contact, thus
Device is caused to be contaminated in which way；(ii) need to adjust or proofread and can use on object；(iii) normal
Use and also can lose the quasi-heart, it is therefore desirable to re-calibrate process (not simple untapped replacement parts, but correction
With assembly)；Or (iv) uses 1 time or limited can going out of use afterwards for several times.In the case of prior art, particular elements is not
Easily be replaced, this feature (it is replaceable for being i.e. designed without part design), but or replaceable cost high or replace
Change difficulty.It is preferably that some relevant parts of non-invasive blood kinetic measurement device can single use be also easily
And the cost of replacement is relatively low.
Further drawback of the prior art relates to carry out experimenter repeatedly in different time and/or different positions
Hemodynamic measurement.Such as, need in the first and second positions to measure blood pressure (such as, operating room and the rehabilitation of hospital
Room), prior art there is certain situation following can occur: (i) uses invasive conduit (A-line)；(ii) will be at blood pressure measurement
System moves between all positions；Or () is after first measures position releasing and the connection of object, moves, then at second
Put and be connected with the second blood pressure measuring system.
The injury relevant to invasive conduit is well-known.The skin that such as can puncture experimenter (is attended by infection
Risk) and experimenter can be made uncomfortable.
Blood pressure monitoring system is moved integrally and is also practically impossible to, because the volume of system is too big, and will be in advance by prison
View apparatus is fixed on ad-hoc location.
Also, after being not intended to disconnect, reconnect with experimenter, because sensor or device are placed to patient again
Body on time, need to re-calibrate, it addition, 2 measurements carried out at diverse location, be actually difficult to mutually directly compare.
Specifically, due to by sensor and support device after the 1st position is physically removed, new sensor is placed to the 2nd
Experimenter's tissue of position, the connection between the sensor laid for twice and its lower vascellum laterale is likely to different.Therefore,
The change of connection, correction, sensor parameters and correlative factor can be caused, such that make endovascular pressure identical, it is also possible to
The situation that twice measured value can be caused different occurs.Its result, reduces repeatability and the confidence level of twice measured value.
It addition, in the prior art, sensor generally by external electrical connecting portion or " cable ", is electrically connected in cause
Dynamic device or other master device.Owing to such attachment means causes the cost of system and complexity to be enhanced further.
Based on above reason, needing a kind of apparatus and method being modified, it can high accuracy, continuously and non-intrusive
Property ground measure and the biology relevant parameter (such as, relevant to hematodinamics parameter) of experimenter.If there being this be modified
Apparatus and method, it is generally desirable to can be quickly and accurately to sensor (one or more) (such as, pressure measurement sensor, super
Sonic transducer) carry out initial setting, and can also carry out reliable according to the physiological condition of different patients and environmental condition and can weigh
Multiple setting.Such device also includes low cost and disposable unit.
(such as, automatically return additionally, such apparatus and method substantially can also be automatically adjusted for patient and calibrate
“0”).But also account for easily using.
Summary of the invention
The invention provides the apparatus and method of a kind of improvement, it can noninvasive and continuously monitoring is intravital includes
The hematodinamics features such as arteriotony, thus meet the demand.
A first aspect of the present invention, discloses the carriage assembly used in physiologic parameter monitoring device.In a kind of example
Property embodiment in, carriage assembly includes: substantially keep the support of shape, and it contains at least 1 opening, for receive extremely
The active surface of few 1 sensor；And at least 1 coupling component, for sensing device being coupled to described carriage assembly,
Described device has sensor；And 1 substantial transparent membrane, it is adjacent to described support and substantially passes through described
Opening.
A second aspect of the present invention, discloses a kind of physiological parameter detecting device.In a kind of exemplary embodiment,
Described device includes: an alignment members, and it has optical alignment guiding piece and sensor screen barrier layer；Sensor；And relatively
The master device that described sensor is constituted is configured in described barrier layer.Described alignment members is i.e. given up after being configured to single use
Abandoning and replaceable form, described sensor is configured to be used for multiple times.
A third aspect of the present invention, discloses the measuring method of in vivo more than a kind physiologic parameters.Exemplary in one
Embodiment in, described method includes: at least 1 support element is configured at experimenter；The master device of induction apparatus will be connected
Coupling with described support element, described coupling comprises the active surface of at least 1 described sensor is configured at described framework
In the opening of part；Use described master device that described sensor component automatically configures the monitoring position in defined, and calibrate biography
Sensor component；Use the parameter that described sensor component measures more than 1 of object.Described measurement is to be carried out by thin film, institute
State thin film and substantially prevent the skin surface of object and contacting of sensor.
A fourth aspect of the present invention, discloses a kind of measuring method obtaining live body parameter.In a kind of exemplary enforcement
In mode, described method includes: configuring support member on the physiological structure of experimenter, described support member contains thin film；?
On live body, configuration has the master device of sensor, and communicates with described support member, makes described sensor substantially press close to
Described thin film；Described sensor is used to be got parms measurement by thin film.
A fifth aspect of the present invention, disclose the physiological structure with experimenter (physiology) be coupled and constitute
Hold component.In a kind of exemplary embodiment, support member substantially places induction apparatus relative to experimenter, its bag
Include: pliability support, described pliability support substantially with the mating shapes of physiological structure；1st component；And at least 1
Divide and have sticking 2nd component.Described 1st component is substantially clipped in the folder between described support element and described 2nd component
Core structure；The glued portion of described 2nd component is for described support member being connected with described physiological structure removedly.
A sixth aspect of the present invention, discloses one and utilizes a kind of reusable sensor and disposable sensing
The method measuring hemodynamic parameter of device support.
A seventh aspect of the present invention, discloses a kind of reusable sensor with removable protection overcoat.
A eighth aspect of the present invention, discloses a kind of disposable support element, and it has protective film, and being used for will
The skin of object separates with reusable sensor.
In the following description of the present invention and description taken in conjunction with the accompanying drawings, these and other features of the invention will become aobvious
And be clear to.
Accompanying drawing explanation
The underside perspective view of a kind of embodiment of the hemodynamic evaluation device of Fig. 1: the present invention, it is shown that sensor
Assembly is coupled to the top of actuator.
Fig. 2: for the perspective view of a kind of embodiment of the sensor cluster of Fig. 1 shown device.
Fig. 2 a: the schematic diagram of a kind of embodiment of fully enclosed sensor attachment portion assembly.
The schematic diagram of the sensor attachment portion of a kind of embodiment of sensor attachment portion assembly shown in Fig. 2 b: Fig. 2 a.
Fig. 2 c: the sensor that embedded in pressure transducer and storage device (such as EEPROM) on a printed circuit connects
A kind of schematic diagram of the sensor attachment portion of the embodiment of parts.
The sensor attachment portion of a kind of embodiment, pressure transducer and the EEPROM of Fig. 2 d: sensor attachment portion assembly
Schematic diagram, described sensor attachment portion assembly embeds on a printed circuit and be positioned in connecting portion shell.
The schematic diagram of a kind of embodiment of Fig. 2 e: sensor attachment portion assembly, described sensor attachment portion assembly is placed
Enclose in connecting portion shell and by top package parts.
Fig. 2 f: embed the schematic diagram of a kind of embodiment of the sensor attachment portion assembly of pliability support.
Fig. 2 g: the sensor attachment portion assembly being arranged on foam-back and the schematic diagram of a kind of embodiment of support.
Fig. 2 h: the support discarded of other embodiment of the present invention and the perspective exploded view of associated components.
The perspective exploded view of the sensor component assembly of the repeatable utilization of Fig. 2 i: other embodiment of the present invention.
The underside perspective view of a kind of embodiment of Fig. 3: actuator means, it is shown that connector and sensor mounting portion.
The actuator intercoupled in Fig. 3 a: Fig. 3 and the sectional view of sensor cluster.
The actuator intercoupled in Fig. 3 b: Fig. 3 and the exploded view of sensor cluster.
Fig. 3 c: the sectional view of a kind of embodiment of the sensor cluster being coupled with the mounting portion of actuator.
Fig. 4: use the theoretical flow chart of a kind of embodiment of the method for the hemodynamic evaluation device of the present invention.
The another embodiment of Fig. 5: the inventive method theoretical flow chart, specifically use Fig. 2 h-2i blood
The flow chart of kinetic assay device.
Fig. 6: for by the schematic diagram of a kind of embodiment of the visual acuity aid of alignment bracket on object.
Detailed description of the invention
Illustrating hereinafter with reference to accompanying drawing, wherein similarity sign represents identical part.
It should be noted that and the description of the present invention essentially describes radial artery (the i.e. wrist or front with artificial object
Arm) the evaluation method and device of hemodynamic parameter of blood circulation, but present invention is equally applicable to human body other
The monitoring of similar parameters in the monitoring of the similar parameters of blood vessel and other position, and other homoiothermic animal.All such repair
Changing or alternate embodiments is all easy to be readily appreciated by one skilled in the art and implement, this is considered to belong to the right of the present invention
Within claimed range.
Terminology used herein " hemodynamic parameter " refers to the parameter that the blood circulation of experimenter is relevant, such as, wrap
Include pressure (such as diastolic pressure, shrinking pressure, pulse or its meansigma methods)；Blood flowing kinetic energy, flow velocity, density, temporal frequency point
Cloth, narrow existence, blood oxygen concentration, pulse cycle and any artefact of the pressure waveform line pipe with experimenter.
It addition, term " pressure measxurement ", " sphygomanometer " and " pressure measurement method " etc. used in this specification, broadly
Refer to by placing sensor on the surface of skin in mode communicatedly, although with contact skin but and non-direct contact (the most logical
Overcoupling medium or other interface), noninvasive measures one or more hemodynamic parameters such as such as pressure.
Terminology used herein " press-stretched " and " pressing " etc. refer to tissue, blood vessel and other physiological feature of experimenter
Pressure (relative to non-pressurized state) such as tendon or muscle.Equally, flatten " scanning " and refer to that flattening level change (such as increases, subtracts
Or combinations thereof) one or more cycles of time.Terminology used herein " flattens " and generally refers to linear (certain speed)
Shift in position, but can also be other arbitrary form, include but not limited to that (i) continuous print is non-linear (such as, right
Number) press over time be increased or decreased；(ii) the discontinuous or continuously linear of segmentation or non-linear pressure；(iii) hand over
The compression replaced and lax；(iv) sine or triangle wave function；(v) random motion (such as " random walk ")；Or (vi) definitiveness
Distribution.All these forms is considered to be contained by above-mentioned term.
Term used herein " integrated circuit (IC) " refer to any kind of any integrated horizontal component (include but not
It is limited to ULSI, VLSI and LSI), unrelated with technique or material (including but not limited to Si, SiGe, CMOS and GaA).IC can wrap
Include: such as means of storage (such as DRAM, SRAM, DDRAM, EEPROM/ flash memory, ROM), digital processing unit, SoC component, FPGA,
ASIC, ADC, DAC, transceiver, Memory Controller Hub and other device, and their combination in any.
Term used herein " memorizer " include any type of integrated circuit or other storage device, including but do not limit
In ROM, PROM, EEPROM, DRAM, SDRAM, DDR/2SDRAM, EDO/FPMS, RLDRAM, SRAM, " flash memory " memorizer
(such as NAND/NOR) and PSRAM.
General introduction
At a basic sides, device that the present invention comprises and correlation technique, be by accurate and repeatable (optionally)
Ground configures one or more sensors in the physiological tissue of experimenter, utilizes sensor measurement physiologic parameters.Such as, as follows
As face illustrates in more detail, the present invention is by accurately pressure sensor assembly, it is possible to effectively from the radial artery of people
The most also blood pressure or other parameter are measured in noninvasive ground.But, the sensor (such as ultrasound wave, optics etc.) of any kind can
Be used singly or in combination for the present invention, including the device as described in documents below and correlation technique: on October 7th, 2004 Shen
Please still examine United States Patent (USP) 10/961,460, its theme be " for noninvasive measure blood pressure kinetic parameter tight
Gather type apparatus and method "；United States Patent (USP) 09/815,982 filed in March 22 calendar year 2001, its theme is " to comment for noninvasive
Valency is the method and apparatus of hemodynamic parameter including vessel position "；And theme is the " circulation organism experimenter
The method and apparatus of evaluating blood kinetic parameter in system " U.S. Patent Application No. 09/815,080 and U.S. of authorizing special
The patent of profit number 7,048,691, its all the elements are all inherited and introduce the foreign aid in this.
In a kind of exemplary embodiment, aforesaid pressure transducer is connected to actuator, and described actuator leads to
Cross carriage assembly and be worn on the radial artery region of experimenter.After this actuator is connected with sensor, according to any quantity controlling party
The position of horizontal (or near centre of body weight direction, depending on requiring) and the pressing of downside tissue of sensor are controlled, such as by case
Seeing United States Patent (USP) 10/211,115 in a review filed in 1 day August in 2002 of this assignee, its theme is " to be used for controlling non-
The method and apparatus of invasive parameter measurement ", the grant number of this patent is U.S. Patent No. 6,974, No. 419；And 2002 2
United States Patent (USP) 10/072,508 filed in the moon 5, its theme is " to utilize parameter noninvasive to measure the side of hemodynamic parameter
Method and device ", the grant number of this patent is U.S. Patent No. 6,730, No. 038, and they are the most intactly introduced the foreign aid in this.It addition,
The present invention can be also used for sensor independent of flattening the system of mechanism, and the various combinations of aforesaid feature and sensor.
The advantage of actuator is that his " displacement " drives, and is thus independent on executing stressed measurement result, and only has with displacement
Close.This technical scheme, owing to eliminating pressure transducer and relevant signal processing, greatly simplifies actuator (and female
System) the operation of structure, and also make actuator and system the most durable.
Assembly of the invention still a further advantage is that the sensor cluster being able to maintain that for receiving subject physiologic's structure
With the most firmly coupling between support element, thus by flexibility (compliance) almost all of in cancellation element
Further increase the accuracy of system.
On the other hand, sensor energy automatic zero set it is in place of the present invention is better than prior art.Due to can automatic zero set,
Thus just can place sensor attachment portion assembly without increasing other component, therefore can effectively place sensor.
In the illustrative embodiments of the present invention, also a key character is to be sensed by circuit direct-assembling
On device such that it is able to be simply assembled, operate and correct.
Other key character of the present invention also includes: (i) is easy and simple to handle in various different operating environments；(ii) measure
Repeatable；(iii) some parts can single use.By use sensor put and device operating aspect new construction and
New technique, and sufficiently modularized design and the various restrictions under considering the clinical setting of typical case's (and atypia), thus
Achieve these features.
On the other hand, the present invention can be dismantled by its female device by offer one and holding is positioned over tested in transit
Sensor cluster on person, thus overcome defect of the prior art, this contributes in medical institutions (such as hospital) different
Place uses same sensor, carries out the measurement with high performance reproducibility, is retouched just as in another part application of assignee
State that (U.S. Patent Application No. 11/336 filed in 20 days January in 2006, No. 222, it is entitled, and " noninvasive is measured blood and moved
The apparatus and method of mechanics parameter "), its content is described herein by reference and is cited completely.Hereinafter, above and other to the present invention
Feature is described in detail.
The present invention on the other hand, uses the device with sensor to obtain the measurement to hemodynamic parameter, described
Sensor detects one or more parameters by sealer barrier layer or thin film from experimenter.In a kind of variation, sensor quilt
It is designed as can being used for multiple times (the most recycling), and support member and thin barrier film can use (as disposably made by limited number of time
With).Discardable support element is positioned over the surface of subjects skin together with barrier, so can be by sensor component and skin
Isolate and be protected.Such structure can ensure that the surface of sensor is cleaned the most very much, is subject to even multiple
Examination person after using also is.Owing to sensor couples with actuator devices, adjustable sensor high accuracy placement on experimenter (with
Different dimension).
Hematodinamics measurement apparatus
A kind of illustrative embodiments of the hematodinamics measurement apparatus 100 of the present invention is described referring now to Fig. 1.
This embodiment generally comprises 1 actuator 300, and it couples with sensor cluster 200.Described actuator 300 may select
Ground is wrist fastener shape as depicted, and controls the movement of the sensor/pressing component 210 of sensor cluster 200.Described
Sensor cluster 200 includes 1 pliability support 204 with foam-back 206.Following Fig. 2-2g will be the most detailed
Thin description sensor cluster 200.
In the illustrated embodiment, this structure preferably by use material (such as the plastic mo(u)lding of low cost) at a low price and
Design feature is made and this is discarded structure.But, in some specific purposes (such as, it is intended to recycle), also
The material of good endurance can be selected.
With prior art a great difference, in the above-mentioned embodiment in hemodynamic parameter measurement apparatus, not
Have and include alignment device (such as pad (paddle)) common in the embodiment of prior art.On the contrary, the present invention's is exemplary
Embodiment employs automatic zero set, makes just to make without external device (ED) sensor component be directed at by this zeroing technology.
Therefore, sensor component can automatically be positioned on the optimum position of experimenter's tissue.
In a kind of variation of the present invention, support (frame) 204 includes arrow, and these arrows are used for and are drawn in patient
Line alignment on arm (such as, is manuallyd locate the anatomical structure of experimenter in optimum position by nursing staff, is tremulous pulse place
Position).Clinician passes through palpation, and sets out arteries and veins with pen labelling on skin, draws a line at tremulous pulse.Then, he/her
By line drawn on skin, by the 2 of cradle top arrow alignment.
Fig. 2 shows the illustrative embodiments of sensor cluster 200.As it can be seen, sensor cluster 200 generally comprises
Sensor attachment portion assembly 202 (being described in more detail in following Fig. 2 a-2e), described sensor attachment portion assembly is with soft
Tough support element 204 couples (being described in more detail in following Fig. 2 f), and the latter also includes a foam-back 206
(having a detailed description in following Fig. 2 g).
In one embodiment, sensor cluster 200 also includes label or other jacket layer (covering) 208, its
In (i) its cover described foam end, otherwise expose binding agent；And (ii) shows correct putting to user in wrist
Put.Because at the end that edge is support of label, so the pliability of foam improves, thus adding the comfortable of wrist
Degree.Label as shown, uses top surface to be coated with the foam of binding agent so that it is can be bonded in removedly on support, when
So it can be understood as effect same the most also can be reached.
The sensor attachment portion assembly 202 that Fig. 2 a shows, it includes that sensor attachment portion 218 is arranged on sensor/pressure
On flat component 210.Sensor attachment portion assembly 202 also includes an integrated electricity of EEPROM (EEPROM)
Road (component 248 in Fig. 2 c), one or more pressure sensor components (such as, transducer, strain bundle device, piezoelectricity or pressure drag
Device etc.), the grip assembly 214 of 1 multilamellar.These components of sensor attachment portion assembly 202 will be retouched in Fig. 2 b-2e further
State and with discussion.
The effect of sensor/pressing component 210 is under the active force of actuator 300, applies to circumvascular tissue
Pressure, thus press to blood vessel wall with customer service blood vessel wall or Zernike annular polynomial.This pressing component 210 is by special structure, it is possible to
Alleviating the impact transmitting loss, this to alleviate transmission loss structure simple, repeatable and reliability is high, the most such impact
I () is negligible or (ii) compensates as the part of piezometry.
Sensor attachment portion assembly 202 farther includes sensor attachment portion 218, and it is more detailed that it can be seen in figure 2b
Carefully.
Fig. 2 b describes sensor attachment portion 218.Described sensor attachment portion include multiple wire (such as wire 220 or
Alternative flat rubber belting, conductive trace etc.).Around the wire side generally along taper substantially or conical bovine or block 224
Extending, other profile or shape (such as, conical, trapezoidal, hemispherical, hexagon etc.) are also taken into account.The shape used
Contribute to connecting portion being directed to socket and not being stuck or misplace.Wire 220 is by a series of protuberances (ridge) 222 edge
The inboard portion of taper bobbin 224, thus keep electric isolution state each other.The composition of these wires 220 is, when described biography
When sensor connecting portion assembly 202 couples with the depressed part 308 of actuation part 300, wire 220 and the electricity of depressed part (recess) 308
Contact (electrical contact) 312 constitutes electrical communication.The exemplary reality of sensor attachment portion 218 as shown in Figure 2 b
Execute in mode, show further multiple conductor terminal 226.8 conductor terminals 226 as shown in figure embodiment, also may be used
To be interpreted as in the present invention using such terminal of any number.By making big such multiple exposed leading
Line 220, the electric connection part corresponding with actuator of can making to greatest extent as described below keeps good contact.
In embodiment as depicted, 2 in the middle of 8 wires are exposed from the side of assembly, and remaining 6 are revealed from other place
Go out, thus obtain mechanical stability when mounted.
The overall cone-shaped of the top section of sensor attachment portion 218, promotes sensor cluster 200 and relevant cause
Frictional engagement between dynamic device acceptance division (actuator receptacle) 304, this is only exemplary.Therefore, actuator connects
Receipts portion 304 (seeing Fig. 3 and following relevant discussion) is the most contrary with the top section of sensor attachment portion 218, i.e.
Actuator acceptance division 304, at least profile and bracket flange (frame lip) 282 with sensor attachment portion 218 (below will
Discuss) couple on the whole.Depressed part (indention) 212 is arranged on the top surface of the bottom of described sensor component, thus
It is made to coincide with top.The top of described sensor attachment portion 218 is regarded as " public " component, corresponding actuator acceptance division
304 is " female " component.The generally square shape of the pedestal of sensor attachment portion 218, is conducive to controlling sensor attachment portion
218 relative to the rotation under torsional load effect of the described actuator acceptance division 304.The cooperation of component 218 and 304 allows to activate
Device 300 and sensor cluster 200 are under flattening (normally) size, it is possible to high rigidity and non-flexible connect, and therefore can effectively disappear
Except as a result of which the error that rises of the hematodinamics measured value that causes.Anastomotic structures for bracket flange 282 will be
It is discussed below.
As shown in Figure 2 c, sensor attachment portion assembly 202 also includes printed circuit board (PCB) 240, and it arranges connecting portion
218.The printed circuit board (PCB) 240 that the tab (tab) 228 of sensor attachment portion 218 is easily installed on sensor attachment portion 218, it
Be incorporated in (not shown) in circuit board 240 tab groove.
Being configured to when sensor attachment portion 218 is connected on printed circuit board (PCB) 240 of sensor attachment portion conductor terminal 226
Time, conductor terminal 216 electric contact 244 with sensor attachment portion terminal on printed circuit board (PCB) 240 is directed at.Connect by such
Touch, from sensor transmissions information (not shown), naturally it is also possible to use other method.
It addition, as shown in Figure 2 c, sensor attachment portion assembly 202 also includes sensor component, and it is accommodated in sensor and connects
In the lower sensor shell 246 of the lower section in portion 218.Some receives feature, and cantilever units is for by solid for lower floor's casing component 246
Other layer due to sensor attachment portion assembly 202.In another embodiment, this sensor has 4 prominent lead-in wires, and
Form " lower limb " and be soldered to the opposite side of circuit board.This part also adheres on plate, rigidly fixed to guarantee.
Shown annular feature is that described blow vent highlights from described pressure transducer (246).This vent is a circle
Cylinder, by this plate so that the pressure in sensor becomes measurement component.1 is all had effectively in every side of pressure diaphragm
Blow vent, side contacts with skin silicone rubber gel UNICOM, opposite side and the air communication in environment.
Described sensor component (not shown) is positioned at the inside of lower sensor shell 246, thus sensor can contact and be subject to
The skin of examination person.Then biasing member 216 forms " pocket " of substantially elliptical profile and is suitable for accommodating described sensor component.
Additionally, in figure 2 c, Electrically Erasable Read Only Memory (EEPROM) chip 248 or other storage device quilt
It is arranged in printed circuit board (PCB) 240.The chip terminal 250 of EEPROM is arranged to, when eeprom chip 248 is arranged on printing electricity
Time in the middle of road plate 240, terminal 250 is placed on the electric contact 252 of the EEPROM terminal with circuit board 240 and contacts.
Shown annular feature 242 is that a blow vent highlights from pressure transducer 246.This blow vent is a cylinder
Project through circuit board, so that pressure mould on a sensor is a kind of metering device.Equal in every side of pressure diaphragm
There is 1 effective blow vent, side contacts with skin silicone rubber gel UNICOM, opposite side and the air communication in environment.
This makes this device will not read the difference of the atmospheric pressure at differing heights.
In view of in assembly described above, sensor attachment portion assembly 202 in this embodiment is suitable to comprise must
The circuit wanted and sensor electronics, so that assembly 202 is worked as with described actuator 300 in the situation not using other device
Under, it is possible to from described sensor component (one or more) (such as, pressure transducer, not shown) to actuator 300 transmitting telecommunication
Number.In this fashion, by according to sensor cluster 200 in the electrical connection of actuator 300, assembly can detect immediately and
Monitoring pressure, and need not form other electrical or mechanical connection.Therefore, in the above-described embodiment, it is possible to effective and easy
In operatively determining and monitoring hemodynamic pressure continuously.
Fig. 2 d shows the exemplary multilayer package component of the chip 248 comprising EEPROM and sensor attachment portion 218
The configuration of the printed circuit board (PCB) 240 around 214.Multilayered shell casing component 214 is particularly useful to maintain and protect printed circuit board (PCB)
240 and component.Therefore, the surface of casing component 214 essentially forms containing a depressed part to adapt to printed circuit board (PCB)
240.And then, the surface of described casing component 214 also includes a projection 260, and it is directed at the indenture 254 of described printed circuit board (PCB)
(Fig. 2 c) it should be noted that each layer of this multilayer shell component 214 includes multiple projection and complementary depressed part, so that
Each layer can combine in the way of unique, therefore can need not bonding and just can combine, also can be as required
Use other mechanism.It addition, the most this bonding or other mechanism can also be omitted.It is appreciated that other is by casing component
The mode kept together is also applied for the present invention.It addition, single layer enclosure component can be used for replacing described in the invention
Multiple structure.In a kind of mode of texturing, this assembly can also be made can " pallet " of separated plate.Described connecting portion and
EEPROM is soldered to the side of the mold of this arrangement or plate, then be coupled by sensor, and weld the opposite side of every block of cutter plate.
Once separate, be formed for the assembly as shown in 2c.Described housing includes that 1 shell and lid are for being maintained at plate in the middle of shell.
Make by ABS plastic on exemplary lid, and be positioned over connecting portion, be then fused to shell, the most effectively fix
Connecting portion, plate and sensor.Also have other to constitute to include lid with ultrasonic welding in shell, or otherwise make lid and
Encasement couples.
The placement of the end layer of the multilayer package component 214 of Fig. 2 e example.This layer of casing component 214 also includes multiple coupling
Closing 212a, 212b, 212c of indenture, they are applicable to be connected to the connecting portion assembly 202 of described sensor the actuating of parent
Device 300 (having more detailed corresponding description in Fig. 3-3c).May be appreciated the quantity of upper different structure and bindiny mechanism all
May be used for coupling sensor attachment portion assembly 202 with actuator 300.
Referring again to shown in Fig. 2 a, the biasing member 216 of sensor attachment portion assembly 202 surrounds multilayer package component 214
Outer/bottom margin part and the part (not shown) that will contact with subjects skin of pressure sensor components.In one
In embodiment, biasing member 216 is to be completely formed by silicone base encapsulating material.Such as the sensor in the embodiment of Fig. 2 a even
Connect parts 202, use encapsulating material to make biasing member 216 at least 2 different advantages.Firstly, since producing ring
Border is difficult to process smaller size of foam, thus use encapsulating material simplify manufacture.Second, the end of biasing member 216
Edge, portion has individual radius or other intermediate form to mold the profile formed, thus is pressed in skin at sensor attachment portion assembly 202
Upper laterally or time nearside moves, reduce the shear inference on skin.It is noted that it addition, in the drawings other " single "
Encapsulating material can also be optionally by two or more independent or coupling component formed products.
It is also understood that in other embodiment of sensor cluster 200, other scheme can be used for the present invention, than
If do not used sensor attachment portion assembly 202 as flattening component.Such as, it may include be connected to flatten the actuator of component (not
Illustrate), individually or go coupling with pressure, it is possible to use other sensor.Although sensor is exemplary as flattening component
Ground uses significant economy and a little, but is not the essential condition of the enforcement present invention.Therefore, the present invention is not with any
Form is carried out example and is limited, even described sensor is as flattening mechanism (such as sensor attachment portion assembly 202).
In present embodiment, biasing member 216 includes silicone rubber based compound, and it is for the active face of pressure transducer
(and selected portion of casing component), effect is active face to be connected with the skin of experimenter, it is also possible to be used alone it
Its some material or be connected with additional medium (gel of type as known in the art or liquid) are used together and are preferred.This
Outward, in some embodiments, it is also possible on biasing member, be coated with last layer as required there is the material example of low-friction coefficient
Such as material Teflon TeflonTMDeng.
It addition, biasing member it is not absolutely required to the material structure of homogenizing, but can biasing member as required
Function uses mixing material.This includes mixing material, mixed with performance required for providing of the material etc. of silicon, it is also possible to according to need
Coating material to be selected etc..Based on present disclosure, those skilled in the art can also select other material countless.
In the exemplary embodiment, after described sensor (not shown) being positioned in described shell 214, described
Around sensor component and sensor (not shown) cast encapsulant (such as organo-silicon compound) and formed.As such, it is possible to protect
Card encapsulant can be completely covered sensor, and fills up all spaces.In effect, biasing member 216 is at sensor (not shown)
Mold around, therefore, it is possible to the appropriate direct-coupling ensured between encapsulant and the active surface of sensor.The sensing of Fig. 2 a
The structure of device and pressing component is also only exemplary, and the present invention can also use other sensor construction (as single or multiple
Sensor, homogeneous or heterogeneous sensor (that is, combining identical or other type of sensor), and/or use different geometry
The biasing member of shape).
Fig. 2 f shows that sensor/pressing component 210 and connecting portion assembly 202 are slidably mounted on a pliable and tough framework
In part 204.This illustrative embodiments generally includes 1 single support element 204, itself and 2 frameworks of prior art
The structure of part distinguishes.This method advantageously simplify the structure of device, and also provide and reduce manufacturing cost chance,
Also add nursing staff or simplicity time experimenter uses simultaneously.
Single-side stand component 204 includes the most flat (not yet bending), a thin profile.(that is, the flattening of this scheme
Material with slimming) there is the remarkable advantage being better than prior art, comprise the concordance of physiological make-up with monitored target
And the goodness of fit.Single-side stand component can be formed by polypropylene or polyethylene mold, and other material and suppleness can be used for this
Bright.
This assignee is also found by experiment, places the sensors on relative to wrist and the position of forearm farther side, permissible
Obtain more consistent systematic function and higher precision.Therefore, in the embodiment shown in Fig. 2 f, the support 204 of device, its
The surface area of the part of support 204 significantly diminishes, when being placed in human experimenter and being upper, at the radial side (radial of device
Side) extend.Utilize shape and the minimum position allowing support to be placed on farther side in this region, avoid thenar simultaneously
Protuberance (thenar eminence, the palm muscle parts below thumb).It should be noted, however, that in order to allow the shape of support
Shape is more suitable for the radius of experimenter's wrist, can select the pliability of support 204 further.Therefore, before for comfortableness and
Support selected by suitability and the feature of sensor, also can improve the degree of accuracy of acquired measured value.
Fig. 2 f also show the illustrative embodiments of support 204, shows miniature patch " by labelling to user
Figure " the pasted position on physiological structure is described.Such as, the one end at support element 204 is marked with " ulnar side (ulnar
Side) " 270, it is the poster on support element 204, it is also possible to completed by other approach, such as label, drawing/labelling etc.
This function.The meaning of this labelling be tell for, the ulnar side of support element should be positioned over the ulnar side of patient forearm.Institute
It is useful for stating the incision design in embodiment, and this lettering is more apparent than alternate manner for the user of device,
And be not easy to be deleted or abrasion.Correct place after, for by the support 204 of changeable shape around the wrist of experimenter,
Use binding agent to be positioned over the contact side (skin) of support, then remove screening glass and expose contact portion.
Fig. 2 f also show one group of rib frame (rib) or protuberance (riser) 272, these rib framves 272 tilt because they with
The character pair (such as groove) that actuator 300 is showed matches.In embodiment shown in Fig. 2 f, relative in prior art
Utilize composite construction to adapt to the inner side of actuator groove or outside, effectively simplify the design of alignment device support 204 and become
Type.Rib frame 272 also includes 1 Embedded Division (intrusion) or opening (aperture) 274 at each outer surface, and it corresponds to
Sensor attachment portion assembly 202.Embedded Division 274 is for receiving draw ring (tab) 322 and the actuator 300 of complementation, so that causing
Dynamic device is placed (i.e. coupling) with described sensor attachment portion assembly 200, and can not significantly rotate.Shown embodiment party
In formula, the rotation of 10 ° can be allowed according to the shape of the arm of different experimenters.Once device has been rotated out this limit,
Groove side can have counteracting force to the coupling feature on actuator, and forces riding, causes support to depart from from actuator.Will
Actuator is installed to support, it is necessary to press down on support by actuator simply, and the most whole support is as a buckle
Pin actuator.
This feature can ensure that actuator is simple, firm, be connected on sensor cluster 200 incessantly.
As shown in figure 2f, sensor attachment portion assembly being connected to support element 204 in illustrative embodiments is use 1
Individual pliable and tough and resilient snakelike suspension ring (suspension loop) 276 and the suspension arm (suspending arm) being associated
278 complete.
Suspension ring 276 are installed on the circumference of multilayer package component 214, and this ring is substantially around sensor attachment portion group
Part 202 also coincide with the groove of formation on the neighboring of sensor component 210, it is possible to use other configuration.As it can be seen,
The part of these suspension ring 276 forms the structure not contacted with casing component 214 described before.When actuator and sensor cluster
During 200 coupling, the arched door (arch) 280 that these parts are formed, for receiving the latch (pin) in actuator acceptance division 304
314.But, other method can be used for auxiliary and is maintained in the middle of actuator acceptance division 304 by sensor attachment portion assembly 202,
Also effect same can be obtained.
In said embodiment, end-rings additionally aids the elliptical ring feature ring of suspension ring around sensor multilayer module
Groove.They allow ring extend and assemble.
Suspension arm 278 is rigidly connected to support element 204 by integral injection molding, bonding or other method, and soft
Toughness it is connected to suspension ring 276.Suspension arm 278 provides enough " slackness " in the present embodiment, makes support element 204 He
Sensor component 210 can in support 204 transversely can estimate mobile (can also be other degree of freedom) so that activate
Device 300 is when performing the automatic zero set of location algorithm and sensor, relative to Radial artery movable sensor component 210.This
Bright also allow for proximally direction and moving freely flattening direction or vascular pressure direction.It addition, suspension arm 278 also can be arranged
For enough slacknesses, thus the nearside of described sensor component 210 can be made to move by actuator 300, and sensor
Component rotates (i.e. sensor cluster " can be gone off course " rotation around its vertical axis) on an x-y plane.The technology people of mechanical field
Member is easy to use other method to realize this function.
In the embodiment shown, it is also noted that suspension ring 276 and relevant suspension arm 278 can be by sensor component
210 (including the most significant active surface of this assembly) were maintained at the completely isolated or unsettled position above skin.This is favourable
In operator or system, when unexpected deviation occurs, adjust sensor and pressure transducer, such as calibration sensor
Time.
Exemplary clearing algorithm includes various feature, checks as resting state, the output of wherein said sensor including (i)
It is stable, (such as, is affected by sensor heating or other temperature, although be not necessarily invariable, but change is
Single), when sensor contacts to skin, this phenomenon no longer occurs；And/or (ii) sensor is reversed actuator with
And " rocking " flattens position, if during to guarantee that pressure is constant, sensor the most really have left skin.Can be by these 2 kinds of methods
All have a try.
Fig. 2 f also show exemplary bracket flange (lip) 282.Bracket flange 282 is along the central authorities of support element 204
The periphery of peristome and formed.Bracket flange 282 is designed to perfect with actuator acceptance division 304 chimeric, thus keeps sensing
The state that device assembly 200 contacts with actuator 300.Described edge also adds on direction just with coupling of actuator at support
Property.Described edge is interfered also by the reverse side at sensor, thus inhibits actuator to install from rear.
Therefore, actuator acceptance division 304 as described below, comprises 1 " ditch " in order to receive described prominent bracket flange
282.The structure reason more more preferable than prior art of the bracket flange 282 in example, during especially with this structure, it is possible to simple
Sensor cluster 200 is connected on actuator 300 with settling at one go.There is also other more preferable automatically imported method, from
And reduce unmatched probability to greatest extent.
Referring now to Fig. 2 g, the foam-back of support element 204 (foam backing) 206 installed above is carried out in detail
Describe in detail bright.Described foam-back 206 includes suitable foams and adhesive surface, and this adhesive surface is mountable to structure
The contact surface of part 204.This foam-back forms profile and the shape of uniqueness, tested to adapt to the biology of difformity and size
Person.
As it has been described above, compared with the embodiment of prior art, the most radial position of support element 204
Put and minimized.As it has been described above, the shape of foam-back 206 is can persistently to accommodate thenar eminence (" thumb flesh
Meat ") shape.Therefore, not only do not interfere with the arrangement of sensor cluster 200, also comply with the nature of subject physiologic's structure
Protuberance and depression.
It is positioned at the binding agent on the bottom surface of compatible foam-back 206, when support element 204 is positioned at the upper of subjects skin
Fang Shi, it will be adjacent to skin, and it is slightly distorted suitable with the surface profile of skin.Described binding agent to be selected to surely
Determine that (especially under experimenter produces the potential wet condition that perspiration etc. causes) of durable bond, also to ensure and be subject to
Examination person is affine and easily removes.But, moreover it is possible to use other method can maintain the support element 204 physiology relative to experimenter
The constant position of structure, such as, include nylon tape, adhesive tape, be directly used in by binding agent below direct component 204 itself.?
In another embodiment, using sensible heat or photosensitive timbering material, these materials are transmutability pliable and tough at the beginning, but sense
After hot, photosensitive or other similar process process, essentially become rigidity.
Known such cheap removable coverlay (such as one side has wax or coating) in adhesive field,
Can be used for being arranged on inside or the side of support element 204, before using, cover binding agent (not shown).User can be simple
After coverlay is peeled off on ground, support element 204 is positioned over desired physiologic site, can be as required by support element 204
Deformation makes it match with the physiological structure of experimenter.Bond sufficiently strong, and the pliability of support is also enough, for a framework
The random variation of part can ensure persistently to fit as discussed above.
As it has been described above, the significant difference between prior art and the above-mentioned exemplary embodiment of described sensor cluster 200
It is that the present invention lacks " pad " component.Prior art Intermediate gasket element is raw relative to experimenter for being placed on by sensor cluster
The ideal position of reason structure.But, in the present invention, user manually places sensor cluster and is replaced by automatic zero set process.
In this embodiment, automatic zero set advantageously simplify the operation to device, and due to there is no need to manufacture pad, also without
Need to assemble it etc., thus reduce manufacturing cost.Tremulous pulse or other vessel position it is directed between 2 parallel lines of backing plate
(such as, be directed at the longitudinal axis of tremulous pulse target location between 2 parallel line marks), the present invention has only to user will dress
The line of the arrow mark on bracket edge Yu tremulous pulse, in the physiological location of experimenter, is in line just by placement location.It addition,
The linear edge of support can place be directed at, and is end and the original position of palm of wrist herein with " disconnected wrist ".The shape of foam
The shape of thumb out can also be imitated.Therefore, the present invention is very easy to the use of nursing staff or experimenter.
In said embodiment, the shape of the sensor being essentially ellipse is conducive to the edge making support 204 to lean on
The centrage of nearly device, so that support 204 can accommodate thenar eminence.At the size sensor that laterally/middle direction is reduced
Support can be allowed less with profile (other embodiment relative to described herein), and between decreasing edge to nearby/
The impact of tendon at a distance.
It addition, by making sensor diminish in all directions, can reduce the surface area being pressed against on skin, result the most just can subtract
Major general's sensor press against skin to its internal pressure passed on.By reducing required strength, pressing/detent mechanism can be made to do
Less, thus reduce required electric power (variation for " self reliance type " or battery-driven is important).
Another advantage of less oval sensing element 210 is, owing to shortening, as above in the length of laterally/nearside
Stating (laterally/proximal direction) sensor and reduce the sensor impact on tendon in the mobile moment, therefore sensor can be at skin table
Face is evenly to move with smooth method.
So enable in particular to improve and laterally exploring the performance during detection.It addition, the sensor 210 of Fig. 2-2g is oval
Shape, makes the sensor attachment portion assembly 202 surface in continuous bend, thus reduces the impact of shearing effect, is conducive to
Movement laterally and on axis of centres direction.Specifically, " angle " of oval variation is on the one hand eliminated, it is possible to make direction
Change and omnibearing movement are the most smooth, add and are connected with the side wall assemblies bent or cross-sectional profiles, when sensor exists
When tissue surface makees certain rotation, percussion, driftage (or contrary, when the profile of skin or surface are irregular especially), disappear
Adverse effect tissue produced except sensor cluster.
In another embodiment, described device can be used can to obtain the measurement of hemodynamic parameter, described device
Including: can be used for multiple times or reusable sensor component (with reference to Fig. 2 i, discuss the most again)；Limited number of time use (such as 1
Secondary) discardable support element (with reference to Fig. 2 h, discuss the most again).Manufacture the relevant cost of described sensor component, the farthest
Cost higher than other component.Therefore, use such structure, make the operation of this device more meet cost benefit, it is only necessary to purchase
Buy the support element that the word for each experimenter or patient uses, and it is same to reuse (optionally) with multiple patients
One sensor.By using barrier film or thin film, make sensor avoid directly to contact the surface of subjects skin, thus protection or every
From sensor so that it is can be reused.
Support and sensor are approximately similar to above-mentioned a lot of aspects on allomeric function and structure, but, will be situated between below
Continue and distinguish part.
With reference to Fig. 2 h, it is shown that a kind of illustrative embodiments discarding support 500.As it can be seen, support can be discarded
500 include: support element 502, support pads 510, barrier film or thin film 514, membrane liner 520.
Sensor bracket component 502 includes compatible or pliable and tough and resilient by polyethylene formation polymer shaping
Body, it is possible to use other material and elastic grade.As it has been described above, the design of the specific bent shapes of this support, it is suitable for
The inboard portion of the wrist of most people, and above-mentioned level of elasticity can allow support 500 deform so that its global shape with
The wrist radius of destination object matches.Or, also to be designed to the support framework 500 of different size and shape, to meet not
With configuration and/or the needs of different object size.And then, support can also be shaped to the asymmetry that one end is bigger than the other end
Shape, thus easily grasp when using or taking away, moreover it is possible to improve the comfort level of object, and obtain interpolation label or the position of figure
Put.
Support element 502 can also comprise one or more containing sections to meet the organism of various different user
Tissue.These containing sections are not only the problem meeting match objects, but also beneficially support (also sensor) is thick
Alignment.Such as, in a kind of variation, support element 502 includes deformation or breach, forms deformation in radial side part or lacks
Mouthful, it is thus possible to storage bulbous projection.But, owing to using pliability and the timbering material of elasticity, support 502 can be made necessarily
Deformation, the most also can match from the physiological function position of different objects.In this respect, it is possible to use propping up of " unified size "
Frame 502, thus simplify production and stock etc..But it is also possible to use custom-made support element (such as, adult's is big
Size, the small size etc. of child).
Additionally, can be directed at marking by bulbous projection in use, this will describe in detail in Figure 5.
Sensor stand 502 in Fig. 2 h includes that the opening 524 that can receive one or more sensor component (below will
Can discuss).The described opening 524 of the support of example, is sized to the sensor that accommodates in the opening can be the most mobile
(the most horizontal or close size).So, it is allowed to support 502 is placed on the less accurate position of tissue of experimenter,
Because sensor can laterally or relocated in size by master device (such as actuator), with realize sensor with
The Best Coupling of blood vessel.
Sensor bracket component 502 includes: one or more features 504,506, is used for fixing master device and (such as activates
Device).In the embodiment shown, form one group of rib frame (rib) or protuberance (riser) 504 in support 502, be so used for receiving
Receive and there is the storage function (such as cavity) of actuator 300.Protuberance 504 is formed from the teeth outwards has groove or opening 526.Activate
Device 300 is coupled in the opening 526 of the sensor bracket component 502 of discardable support 500 and (can be found in this specification about cause
The description of dynamic device 300).Support 500 also assures that actuator and sensor structure with couple (by the opening 526) of actuator 300
The positive relative localization of part and anti-rotation.
Although this coupling has interfered significantly with the rotation of actuator and/or support, but can also such as be subject to according to difference
The change of the shape of examination person's forearm, be designed to by a small margin is rotatable.If being rotated out the amplitude of defined, support will be from actuating
Device comes off.Described in mode performed as described above, described actuator be by a kind of buckle by actuator (by master device, as
Fastener) install by support downwards.
Support 500 in Fig. 2 h also includes the flange 506 formed along opening 524.Bracket flange 506 and actuator 300
Characteristic of correspondence (such as actuator acceptance division 304) matches, so that carriage assembly 500 keeps contacting with actuator 300.?
In a kind of embodiment, the structure of flange 506 is the out of position (such as, reverse side) preventing actuator from putting into support, this
Can be realized by the asymmetric etc. of known such as keying, shape.
Sensor stand 502 can also include statement 508 or other visual indicia, is used for helping operator or experimenter's energy
Enough it is quickly assembled on the tram of forearm.In the illustrated embodiment, " ulnar side (ulnar side) " is a kind of identification.Separately
Outer or instead, it is possible to that be given is " radial side (radial side) ".Statement 508 can be printed to the surface of support 502,
Can also cut out or molding from the body of support 502, be attached to the upper side position etc. of support 502.Other word, position can also be used
Put, indicate, figure or feature etc. are for user operation and place, moreover it is possible to use arrow, coloud coding, figure/picture, scheme especially
Case, braille etc..
In another embodiment, sensor stand 502 can also include outward extending part, it is possible to upwards clasps cause
Dynamic device 300 or master device, so can support with the offer that couples of support 500 actuator/master device further.
The support pads 510 of the embodiment in Fig. 2 h is attached at the downside of sensor stand component 502.Support pads
510 are made up of the most pliable and the toughest polymer, such as polyethylene, if needing to use other material or pliable and tough journey
Degree, even includes the material of non-flexible.The support pads 510 used in embodiments of the present invention, is in order to by support element
500 liners when being positioned over subjects skin surface or cushion pad, it will of course be understood that this liner is nonessential in the present invention
's.The shape of described support pads 510 can accommodate the sensor stand 502 of common shape and above-mentioned opening 524.
In another embodiment, support pads includes 1 layer or multilayer material, and it is injected or coating is to support 502
Bottom side, or penetrate in the middle of timbering material (itself not being i.e. an independent component).
Dividing plate (diaphragm) or thin film (membrane) 514 parts of the support element 500 in described embodiment are attached
The bottom surface at support element 502.Described thin film is optionally included with 1 layer or multilamellar mounting portion (placement
portion)518.Mounting portion 518 ensures that thin film is attached to support pads (frame liner) 510 round opening.Thin film 514
Transparent part 516 pass through or cover the bottom side (side i.e. contacted) of opening 524 with subjects skin surface, and when sensing
When device is received in the middle of the opening 524 of support 502, between subjects skin surface and sensor, form barrier.Transparent part
516 are substantially made up of transparent thin material, the most transparent polyester polymers or polyethylene, and it is placed through opening described
Mouth is also tauted, in order to do not hinder the movement of sensor.Tightening of transparent part 516 is the end by along described foam spacer 510
The placement of the mounting portion 518 of film provides.The particular stiffness that the thickness of thin film 514 and physical parameter may select in a reality is (hard
Gu) and thickness parameter.Such as, hardness can be between 10-55 Shore A, and hot strength can be between 2.0-8.0 pounds per inch, thickness
Scope can be 0.001-0.010 inch.However, it is also possible to understand based on the special physiological parameters evaluated, can be selected for applying class
Type and/or the type of sensor.
Thin film 514 can coat lubricant side (at least in open area), such as a kind of solid, liquid or powder
Lubricant, so be conducive to sensor relative to the top of film surface (lubrication portion) horizontal/move about.As previously noted
Arrive, the approximate ellipsoidal of sensor element or the shape (and substantially " justifying " angle) of ellipse, facilitate similar further
Mobile, and do not retrain or " jerking movement ", the most then constraint or jerking movement can occur.
Barrier film or thin film 514 are included in well the binding agent 528 on the downside of it, are placed on the skin of experimenter so that propping up,
(binding agent by thin film) and be adhered on skin, and support can suitably deform, thus with the surface profile of skin
Match.Binding agent be advantageously selected for the firm and combination of anti-moisture (such as antiperspirant), but be intended to readily wash off and to tested
Person is without significant discomfort.Its mode can also be used to ensure support element 500 and to be positioned over the position that experimenter organizes, example constantly
As included nylon tape, binder etc., can be used alone or and use.
Known this low price is removable in adhesive field emulsion sheet (backing sheet) or liner
(liner) 520 (such as, wax or coating in side) can be used in illustrated embodiment, is used for the binding agent before covering use
528, torn before using.In use, user can tear simply by the note (thereon) 522 that draws above
Fall emulsion sheet 520, thus support element 500 is placed on appointment position, subjects skin surface, and pressing makes it be attached to lightly
The surface of subjects skin, can make support element deformation (so be beneficial to binding agent according to the profile of experimenter's tissue on demand
More regions contact skin).
Thin film 514 in illustrated embodiment includes aligning guide or device (not shown), and this contributes to user/operation
The person location to support element 500.In one embodiment, this aligning guide includes that the essence being arranged on thin film 614 is transparent
Line shape in part 516 or symbol (such as lettering or imparting).Line shape can a lot of shapes, as " line ", 2 or a plurality of
Parallel lines, 1 point, a series of concentric ring (" target ") etc..Once it is determined that specifically monitored position is (such as by user/operation
Person, uses finger or other technology, finds a suitable pulse point on the zone line surface of experimenter, then should with labelling
Position etc.), tear emulsion sheet 520, by opening 524, the line shape on thin film 514 is directed at the pulse point of institute labelling.So
After, adhesive surface 528 is simply pressed against the surface of subjects skin by user/operator, thus is fixed on by support 500
Specify position.As noted earlier, the placement of support 500 need not very accurately (thus enable the system to stable not operated
The impact of the change in the error of person and operation) because the master device (actuator) in (i) exemplary includes blood vessel
Maintain algorithm/program, and (ii) support 502 includes the opening of enough size, to ensure the horizontal of sensor or nearside
Mobile, for correcting the inaccuracy of this placement.
It addition, other place can also arrange line, such as in the part of support element 502 (such as, as a part
It is shaped, it is also possible to can also remove after placement), it is also possible to it is to be placed in support element as stickup or removable cover layer
The top of 502.But, in another embodiment, a kind of the most removable or pad of movement, may be mounted to support
Head and shoulder 500 is used for being directed at, and is moved or remove after support is connected with actuator and sensor.
Referring now to Fig. 2 i, it is shown that the reusable sensor structure in a kind of illustrative embodiments of the present invention
Part 600.As discussed above, sensor component 600 can be in addition to sensing, additionally it is possible to as flattening component, for causing
The tissue around relevant blood vessel under dynamic device 300 scope flattens, and pressure passes to blood vessel wall to overcome blood vessel wall or hoop
Stress.In a kind of variation, as it has been described above, design flattens component 600 is used for the special impact eliminating and transmitting loss.At another
In embodiment, sensor 600 is not used as flattening component, but uses and individually flatten component (with pressure in a variation
Or the decoupled conjunction of other sensor).
As it can be seen, this sensor component 600 generally includes: sensor attachment portion component 612, lower sensor shell
608, upper sensor component 626, a part for sensor component 600 is sealed in the middle of silicone seal layer 602.It is noted that
Be term used herein " top " and " bottom " is relative concept purely, such as in the embodiment of Fig. 2 i, pass
Sensor component 600 is shown that dromic reversion, and this does not has any restriction to the present invention.But, implement at another
In mode, one or more surfaces (active surface the most therein) of sensor are not enclosed.
Sensor 600 in described embodiment in overall profile ovalize or oval shape (as Fig. 2-2g retouches
State).The size of sensor 600 is optional, thus between need not reorientate in the case of, sensor 600 is relative
The opening of support 500 has bigger horizontal/nearside to move.Equally, the overall dimensions of support 600 and shape, it is possible to as required
It is adjusted, can be less.The further advantage of the sensor 600 of global shape ovalize is as discussed above, the suitableeest
The sensor 600 of the repeatable utilization discussed in Fig. 2 i.
Silicone seal layer 602 includes the sealing 606 that silicones supports, and it at least surrounds the end of sensor component 600
Portion's shell 608 part, in one embodiment, forms its biasing member.Use various as biasing member of encapsulant
Advantage, as discussed in Fig. 2-2g, is applied equally to reusable sensor 600 discussed in this article.
Sealant 602 also includes the part 604 covering sensor (such as pressure transducer) active surface.Coating active table
The encapsulant in face, as the encapsulant wrapping up whole sensor, is the encapsulant based on silicones equally.It addition,
Cover this surface is thinner layer, or simply need not any material.Active surface material 604 can be directly exposing especially
The active surface of sensor can be protected.In embodiments of the present invention, the active surface 604 of described sealing directly and props up
The thin layer 514 of frame member interacts, and transmits signal by this thin film and diaphragm seal to the active surface of sensor.
The lower case 608 of the sensor component 600 of example is the sensor attachment portion 612 described in embodiment
Plastic housing.Lower case generally comprises at least 1 opening 624, and the lower part of its storage connecting portion component 612 (and exposes biography
The active surface of sensor), it is possible to make the shell of the active surface active surface layer 604 by sealant 602 stretch out.
Lower case 608 also includes removable device baffle plate (retainer) 610, its have with upper case as work
With, the removable device 618 worked in coordination with between maintaining between upper case and lower case is specifying position.Pass through upper case
A series of shrinkage pools 628 on 626, link together upper case and lower case, and described shrinkage pool is used to reception and is positioned at flat
Compatible feature (not shown) on platform 610.In a kind of variation, removable device includes 1 pliable and tough ring (such as polymer
Or rubber), it has individual draw ring to be easily grasped by a user.Can be by ring 620 can be removed in removing device 618, it is possible to from actuating
Sensor 600 is removed in device/master device.
As shown in fig. 2i, sensor attachment portion component 612 generally comprises sensor electronics and terminal 616, and it is arranged
For cone structure substantially.It addition, coupled structure 614 is arranged on the surface of sensor attachment portion 612, so can ensure that sensor
Connecting portion 612 is received (such as passing through frictional fit) safely by the acceptance division of actuator 300.The overall shape of sensor attachment portion
Shape is taper substantially, and its various advantages are described in the embodiment of Fig. 2-2g.
Sensor attachment portion component 612 also includes multiple wire 616 (such as tinsel or alternative flat rubber belting, conductive trace
Deng), it extends along the side of conical shell.Wire is connected for telecommunication with the electrical contact 312 of actuator 300.Although no
Display, but it is understood that connecting portion component 612 is mounted on a printed circuit so that described wire 616 and electricity thereon
Contact matches.The feature that the connecting portion component 612 of Fig. 2 i example is comprised has been discussed when compareing Fig. 2 b-2c, its effect
It is mechanical stability and strengthens telecommunication.
As it has been described above, the connecting portion component 612 of sensor 600 is by Electrically Erasable Read Only Memory (EEPROM)
Integrated circuit constitutes (being similar to the component 248 in above-mentioned Fig. 2 c).Electrically Erasable Read Only Memory (EEPROM) core
Sheet or other circuit devcie or assembly can be arranged on the printed circuit board.
Described sensor attachment portion component 612 also includes that one or more sensing elements, such as pressure transducer (do not show
Go out).The setting of one or more sensing elements described, the thin film having good positioning with support element 500 when sensor cluster 600 is connected
(on the skin of experimenter), the measurement of hemodynamic parameter can be carried out by thin film and sealing.
The acceptance division (being such as connected to the 2nd component 304 of actuator 300) of described actuator includes and sensor attachment portion
The shape that component 612 essence is complementary.Once fixing in actuator, connection is high degree of rigidity, makes the sensor 600 can not be relative
Actuator and move.
In one embodiment, described sensor is arranged to limited life-span (such as access times) or natural law.Its
Life cycle or access times determine based on minute of use.Such as, if life cycle is stored as 10800 minutes,
Eeprom memory can calculate remaining the number of minutes.This numerical value is in use to be calculated by master device.This side
Method can realize being used for multiple times of sensor, but not can exceed that its projected life, (this may result in performance or the damage of assembly itself
Consumption).
In one embodiment, described sensor is programmed with limited life-span (such as, access times) or natural law.
Life cycle or access times are specially by successively decreasing according to using minute storage lifecycle value to determine.Such as, Life Cycle
Phase can be to use to be stored in as number residue minute.This value is in use to be successively decreased by host apparatus.This method
Sensor is allowed to be used for multiple times, but less than its projected life.In a variant, sensor is programmed to holding of permission
Such as, continuous use or measurement, (until exceeding threshold value the use time of 10800 minutes or 180 hours, use from for the first time and open
Beginning successively decreases, and only calculates master device and measures the time of blood pressure) then can terminate to use.This is conducive to making nursing staff complete tested
The measurement of person, but not can exceed that.Once time-out in service life, sensor will again can not use, and master device would not allow for
The surplus value of EEPROM is the sensor of 0.
In one embodiment, the master device of the present invention can also be configured to allow write standard or correction
According to, such as height and weight index (BMI), it, in United States Patent (USP) 6 commonly owned with Gallant et al., has note in 730,038
Carrying, the issue date of this patent is on May 4th, 2004, the entitled " side of use parameter non-invasive measurement hemodynamic parameter
Method and device ", its entirety is introduced the foreign aid in this.As such, it is possible to use the different physiological parameter of same sensor parameter (as height,
Body weight, wrist girth etc.).
See Fig. 3-3c, describe a kind of illustrative embodiments of the actuator 300 of the present invention.Described herein
Actuator 300 is designed to and the position of regulation sensor component 210 mobile at arc direction and lateral (laterally), so
And, it is understood that it can be modified for providing more or less of degree of freedom (such as including that nearside adjusts).Therefore, with
Under embodiment be merely exemplary.
Fig. 3 shows the bottom surface of the actuator 300 in a kind of embodiment.The bottom surface of actuator includes being arranged on load
Put the various connecting elements in portion 302 and receive device.When sensor component 210 (and assembly 200) couples with actuator 300
Time, the space that receiving device (such as actuator acceptance division 304, connection dish 310 and connecting portion depression 308) provides can receive sensing
The part of device connecting portion assembly 202.Coupling mechanism, such as bracket flange receiver wall 320 and complementary draw ring 322, and activate
Device receives ring and can ensure that the connection between actuator 300 and sensor attachment portion assembly 202.Rubber bellows 318 also make reception
Portion moves relative to the remainder of actuator, and around the opening sealing of described acceptance division, places liquid or the entrance of dust.
These features will discuss in detail below one by one.Will be consequently realised that also have other coupled modes to make actuator 300 and sensor structure
Part 210 and assembly 200 couple, it is possible to use described coupling devices or receive device or do not use, it would however also be possible to employ with this
Bright consistent mode.
Exemplary mounting portion 302 also includes the attachment feature 306 of multiple plate, by it, mounting portion is fixed on actuator
The lower section of 300.In the embodiment of fig. 3, the mounting characteristic of plate includes, containing screwed hole, mounting portion being fixed to by tightening
On actuator 300 body.It is appreciated that also other method and technology can be used for mounting portion 302 is fixed on actuator 300
Body, such as bonding, snap close or similar techniques.
In the exemplary embodiment, the downside of actuator 300 is provided with an actuator acceptance division 304.Actuator receives
Portion 304 is the recess in actuator mounting portion 302, and it is suitable to receive sensor cluster 200.Actuator acceptance division 304 includes
Multiple internal ring, connection dish 310 and bracket flange receiver wall 320.
Connection dish 310 is suitable to receive the part of sensor attachment portion assembly 202, and promotes to be of coupled connections.Therefore, connection dish
310 comprise semiaxis carrier ring 316, and it substantially complies with the individual features of described sensor attachment portion assembly 202, and contributes to guaranteeing
The location of described actuator 300, especially controls actuator 300 in the horizontal or transverse load of nearside and rotation.Connection dish 310
Also including multiple contact pin 314, it is installed to the arch portion 280 of suspension ring 276.As it was previously stated, when actuator 300 is embedded in biography
During sensor assembly 200, contact pin 314 will be received in opening by suspension ring arch portion 280 laminating.
Connecting portion groove 306 is positioned on the connection dish 310 of actuator acceptance division 304.Connecting portion groove 306 is particularly suited for connecing
Receive vertebral body sensor attachment portion 218.Therefore, it is by the recess of a vertebral body shape.This adapter groove 306 is further adapted for when even
Connect portion's groove 306 and time sensor attachment portion 218 couples, it is possible to maintain on sensor attachment portion 218 with multiple wires 220
Electrical connection.Telecommunication is realized on adapter groove 306 by being placed into by electrical contact 308, therefore, it is possible to transmitting telecommunication number.
This acceptance division also has " u "-shaped for installing receptor from reverse side.
Fig. 3 further describes bracket flange receiver wall 320, and it is arranged on actuator acceptance division 304.Bracket flange connects
Receive wall 320 and substantially comply with the character pair of support element 204, with the position of fixing actuator 300.Especially, bracket flange
There is groove, thus when actuator 300 couples with sensor cluster 200 on receiver wall 320, the rib frame of support element 204 and
Protuberance 272 can be matched.Bracket flange receiver wall 320 also includes the draw ring 322 of correspondence, is designed at rib frame 272
On snap in match invasion design 274 such that it is able to allow actuator 300 can load appropriate location (such as with sensor group
Part 200 couples) and can not rotate.Also there is in terms of the side of receiver wall the shape for preventing from loading actuator from reverse side
Design.
Fig. 1 and Fig. 3 a-3c describes the exemplary coupling of actuator 300 and sensor cluster 200.In optimal Fig. 1
Described, can use different coupling mechanisms (as mentioned above) that actuator 300 and sensor cluster 200 are coupled into the assembly of entirety
(but being prone to split).
With reference to Fig. 3 a-3c, in said embodiment, the top of sensor attachment portion assembly 202 is substantially due to vertebral body
The sensor attachment portion 218 of shape and in elongated vertebral body shape.Equally, the connecting portion groove 308 being connected to actuator 300 is actual
On be the shape that sensor attachment portion assembly 202 is contrary, be i.e. typically effectively matched with sensor attachment portion assembly 202, and have
Nearly exactly correction and memory function.Therefore, the part of the sensor attachment portion assembly 202 received by actuator 300 is recognized
For being " public " component, acceptance division groove 308 is " female " component simultaneously.The substrate of sensor attachment portion 218 is essentially square, this
Contribute under torsional load, control the rotation about connecting portion assembly of the connecting portion groove.218 and 308 liang of components be coupled at pressure
Making actuator and sensor cluster on Ping is the strongest rigidity and non-compliant connection, thus effectively eliminates and produce owing to complying with
The raw error that hematodinamics is measured.Such design also includes having between coupling unit enough tolerances, consequently facilitating
By sensor cluster 200 decoupled conjunction from actuator 300.The bending of similar suspension arm 278 provides enough intensity, can hinder
Only sensor attachment portion assembly 202 separates from its female member sensor assembly 200, can also allow movable within simultaneously, pass
The structure of sensor assembly 200, under any circumstance, sensor attachment portion assembly 202 can be before bend arm 278 enough bends
Depart from from the actuator 300 that it couples.
It will be noted that, in the case of there is differential seat angle in itself in the elongate tapered of coupling component, it is also possible to couple 2
Parts, say, that at the top of sensor attachment portion assembly 202, it is possible at transverse plane (i.e. X-Y) from corresponding actuator
The connecting portion groove of 300 moves, and/or sensor cluster 200 can rotate by opposing actuator 300 in the case of coupling
Or erect.This feature increases the simplicity of clinical manipulation, such device can be certain between intolerant of sensor and actuator
Differential seat angle is not (because the actuator arm (not shown) of such as actuator 300 has and sensor cluster 200 and sensor component
210 perfect alignment).
It is also understood that, although way of example describes elongated substantial taper, but can also successfully make
Use other shape and size.Such as, this device can be complementary cone or frusto-conically shaped portion.Another embodiment
In, it is also possible to use and be essentially spherical shape.Other also includes using multiple " dome " and/or alignment characteristics, the 1st and
2 components exchange (for mother, the 2nd component is male to the i.e. the 1st component), or use electronic sensor to help two components alignments.
In a kind of embodiment of the hematodinamics measurement apparatus 100 of the present invention, this device can pass through integrated finger
Order reports to the performance (with couple state and the sufficient quantity of sensor cluster detection of electrons of actuator 300) of sensor cluster.Can
In order to any known instruction design of electronic applications, such as, difference is indicated to make it with the flicker of one or more monochromatic LEDs
State (includes not flashing), can also be used with different flash pattern, sequence, time as operator for diagnosing problem, moreover it is possible to
Use multiple LED, fluorescent tube.This device can also optionally include circuit board, its can the parameter of calculation pressure sensor, thus
Judge whether to set up with sensor and EEPROM to be connected.This device can also be designed in EEPROM information of finding and judge
Whether set up intended connection.
Fig. 3 a is the profile that actuator 300 is coupled to sensor cluster 200.It is specifically described connecting portion groove 308
The electrical connection of middle sensor attachment portion assembly and wire connect.
Broken away views shown in Fig. 2 b further describes the essence between sensor attachment portion assembly 202 and mounting portion 302
Close coupling.Show between bracket flange 282 (support element 204 of sensor cluster 200) and bracket flange receiver wall 320
Coupling.But, this coupling more detailed description sees Fig. 3 c.
As it has been described above, Fig. 3 c is the snap close mechanism between bracket flange 282 and receiver wall 320.As shown in Figure 3, activate
The polycrystalline substance of device includes 2 protuberances or wall 320 and complementary draw ring 322.As shown in figure 2f, the structure of sensor cluster 200
Including multiple rib framves or protuberance 272 and corresponding Embedded Division 274.As it can be seen, the draw ring 322 of actuator 300 and sensor group
The Embedded Division 274 of part 200 matches.The groove of support ribs side actually tipped in by padlock in mounting disc, and (component allocated into by component 322
274).As it is shown on figure 3, the polycrystalline substance of actuator includes 2 protuberances or wall 320 and complementary draw ring 322.As shown in figure 2f,
The structure of sensor cluster 200 includes bracket flange 282.Bracket flange does not has and any part snap close in actuator, but place
Lower section at actuator.Bracket flange also makes support be positioned at this region, thus improves padlock on the downside of actuator and catch support
Steadiness.
The internals of actuator 300 is not shown here, but is that the U.S. referred to during assignee common examines is special
Profit 10/961,460, the filing date of this patent day header October 7 in 2004 is that " noninvasive measures blood pressure kinetic parameter
Compact device and method ", its content is completely introduced the foreign aid in this.These generally include, but are not limited to motor basic module and phase
Close the coupling of sensor driver, and substrate (such as PCB) assembly.
It is also understood that for, the actuator mechanism in illustrative embodiments can also make sensor attachment portion assembly respectively
Individual side moves up separation, i.e. pressing, horizontal and nearside.Specifically, actuator mechanism allows shifting the most in different directions
Dynamic, it is also contemplated that the efficiency of the space/weight of high compact and actuator.A kind of example actuator mechanism also minimizes
Component (including motor) in actuator, thus decrease power consumption, and decrease during measuring by actuator
The pressure influence passed to.
Method
Referring now to Fig. 4, describe the tremulous pulse that sensor is positioned experimenter the conventional method immediately measuring blood pressure
400.Although description below is the pressure transducer (such as silicon strain bundle device) of piezometry for measure blood pressure, should
Method is equally applicable to other kinds of sensor and the other parts of subject physiologic's structure, and the mankind or other.
As shown in Figure 4, the illustrative embodiments of method 400 generally comprises: first, it is determined that the position of physiological make-up, and
Place the device in (step 402) above.
Then, carry out configuring (step 404) relative to labelling by sensor.Specifically, in this step of method, make
Coverlay is removed by user or clinician, exposes the binding agent of foam-back 206, is then bonded in by support element 204 and is subject to
On the skin of examination person, thus the pulse point that alignment is interested always known from experience by sensor attachment portion assembly 202.Sensor is once placed
Automatic zero set (such as, the nulling algorithm by previously described) is said on the physiological structure of experimenter, and can also be according to described
Similar algorithm automatically adjust placement and location at horizontal and/or nearside, thus avoid and be manually accurately positioned.Exemplary at this
In embodiment, support element 204 and sensor attachment portion assembly 202 " are assembled " or are packed in advance, and user only needs to beat
Open packaging, remove sensor cluster 200 (including installing sensor attachment portion assembly 202), and from binding agent, remove coverlay,
And support element 204 positioned as described above.
According to step 406, actuator 300 is coupled with sensor securely.In another embodiment, a kind of optional
Wrister first put on by experimenter, thus add the stability in subject physiologic's structure.Then, by actuator
300 install on sensor cluster 200 and wrister.As it has been described above, in one embodiment, when actuator 300 couples exactly
Indicator for displaying will be had time on sensor cluster 200.
In a step 408, device " resets " and optionally calibrates.
Finally, in step 410, after pick up calibration, (step) measures blood pressure or other parameter of experimenter.
Specifically, the binding agent on support element 204 and foam-back 206 and selectable wrister can be in the phases of measurement
Between maintain sensor position in subject physiologic's structure.Even if these coordinate ensure that removes actuator from sensor
300, also can guarantee that sensor element 210 is totally positioned at the tip position of experimenter's pulse point.One remarkable advantage of the present invention
It is, actuator 300 (and the other parts of hemodynamic monitoring device 100, including wrister) can be with experimenter
Remove, leave sensor cluster 200 and sensor element 210 in situ.Actuator 300 can be removed as required,
Than if desired for transfer experimenter, device must stay origin-location, or device 100 must be moved by monitored experimenter
Remove and enter next process (such as postoperative cleaning, by the health upset etc. of experimenter).Sensor component 210 can the most constant
Reason on experimenter's pulse point is that it passes through suspension ring 276 and is firmly connected on support element 204.
Therefore, when being desirable for sensor and again monitoring experimenter, actuator 300 (or another is appointed
Similar installation) fastener be installed in use with experimenter.User/nursing staff has only to fastener near activating
Device 300 is also connected with sensor component 210 (and sensor cluster 200), and sensor cluster takes off coupling at the first actuator
After, still together with support element 204 in situ.As it has been described above, this actuator automatic clear, therefore, there is no need to any
Alignment device or other technology carry out " starting anew " alignment sensor, thus have saved time and cost.Because same sensing
Device is used in the active position of same experimenter, the therefore movable more useful clinical effectiveness of this feature, thus above-mentioned 1st time and
The difference that 2nd time is measured will differ from the manual measurement of measurement apparatus 100 and is lowered.
It should further be understood that be, although when measuring for above-mentioned 2 times, sensor of the invention assembly 200 and method allow
In-order de-coupling-movement-again coupling is repeated several times, without the accuracy measured is had any significantly affecting.
Although the method for the discovery before assignee also have the biggest a little, including easy to use, low cost etc., but also
These steps can be made different combinations (and different devices).Such as, manufacturer may provide a kind of each component
External member, and allow user assemble.
In other alternate embodiments, " labelling " can use with support Colaesce.Such as, labelling potentially includes tangible mark
Note or visual indicia (such as plastics mask), or light source (such as LED, electric filament lamp or other low energy laser lamp) is projected
On the pulse point of experimenter.The advantage of the latter is to need not remove labelling, thus is simply rested on by sensor cluster 200
On pulse point, therefore in the case of there is no Physical Interference or illeffects, interdict light beam.
Optionally use sound wave or ultrasonic labelling (mark based on the physical parameter perceived from experimenter such as pressure
Note).Such as searching algorithm sensor or array can be used to be accurately positioned pulse point, as in the co-applications of the feelings of assignee
As Suo Miaoshu, find optimal lateral position.This search method can obtain desired closing on size, moreover it is possible to uses one
Individual with driving the actuator of motor and larger sized support.
Obviously, basic methods () is at anchor point labelling；() places sensor in mark position；And (iii) will sense
Device is placed on desired point of proximity, and those skilled in the art can also use other combination and structure according to the disclosure of invention
Become.The content that the present invention is discussed does not constitutes any restriction to this method.
As noted above, one of remarkable advantage of the present invention is its motility, and it is hard that the present invention is not used
Part/firmware/software is fettered, but can be applicable to different platforms or systematic survey blood pressure kinetics or other physiology ginseng
Number.Such as, the inventive method and device substantially adapt with following patent content: U.S. that on May 20th, 2003 proposes
State's patent application 10/393,660, its entitled " method and apparatus controlling noninvasive parametric measurement "；In October, 2002
The U.S. Patent application 10/269,801 proposed for 11st, it is entitled, and " noninvasive measures the method for hemodynamic parameter
And device "；The U.S. Patent application 10/920,990 that on August 18th, 2004 proposes, it is entitled, and " noninvasive measures blood
The method and apparatus of kinetic parameter "；The U.S. Patent application 11/336,222 that on January 20th, 2006 proposes, it is entitled
" apparatus and method of noninvasive mensuration hemodynamic parameter "；The U.S. Patent application 6 that on April 29th, 2003 proposes,
554, No. 774, its entitled " method and apparatus of evaluating blood kinetic parameter in experimenter's live body ", assignee above-mentioned often
The content of individual application is the most all introduced the foreign aid in this.
Referring now to Fig. 5, description is the method 700 of the device using Fig. 2 h and Fig. 2 i.In the operation side that this is exemplary
In case, the support 500 that the recycling sensor 600 in Fig. 2 i is used for utilizing with limited number of time in Fig. 2 h is connected.
First, according to step 702, previously a kind of clamping plate described in application are selectively used for experimenter.Clamping plate
Use especially can improve the stable arrangement (such as fastener) of master device, and user can be more comfortable.
Secondly, according to step 704, the measurement point of selected living subject.Such as, user may utilize common vision skill
Art is found and is measured point, and uses specially designed device (such as stethoscope), or is felt such as radial artery by finger.This point
It is labeled or is write down (step 706), and using alignment device by this impact point (step 708) of rack alignment.
In a kind of variation, the other user of impact point is by the surface line-plotting institute labelling subjects skin.Line
Intermediate point just corresponding bulbous projection.Fig. 6 describes exemplary vision auxiliary (such as thin film), is used for being directed at support element.
As it can be seen, line includes 2 lines, with the markers align being marked on patients wrist, the line in wrist will be aligned at line
2 parallel lines between.Therefore this feature is conducive to the alignment of medial/lateral.
2nd feature of the vision auxiliary shown in Fig. 6 has article curve for instructing user that support is positioned over wrist
Correct direction.In one embodiment, phrase " bulbous projection (styloid) " is printed on vision aided location, also has and supplements
Phrase " ulnar side (ulnar side) " is also printed on above, is imprinted in one embodiment on support.In this case, make
User will not the placement of being fallen turnback.
In a kind of variation, the curve of printing can substantially bulbous projection with the radius of experimenter be directed at.Support
Edge is directed at close/tip at the disconnected wrist of experimenter.Generally speaking, when the edge of support is directed at the disconnected wrist of experimenter,
The width of frame can make the midpoint (being also sensor) of 2 parallel lines be directed at the bulbous projection of radius as much as possible.But,
The change of the size and dimension of experimenter's wrist can simply change this alignment.
Once being directed at, according to step 710, support 500 (by the binding agent side of thin layer 514) is fixed in experimenter.
The film portion 514 of support 500, by the active surface 630 of sensor device, separates with the skin surface of experimenter.
According to step 712, then sensor cluster 600 is loaded into master device or actuator (if being not ready).This
Sample makes circuit/terminal 616 keep being connected with the inner member of the acceptance division of actuator 300.Sensor component 600 is by aforesaid
Friction/fastener coordinates or other suitable component, is maintained in actuator.The master device prepared (i.e. contains reusable
The actuator of sensor cluster 600) be then placed to the position on support 500, then by foregoing protuberance
504, recess 526 and flange 506 carry out clamping plate (step 714).
When master device is placed into the fixed position on support, the active surface of sensor cluster 630 is adjacent or passes through thin
Film 516 is connected (such as, the position on the upper radial artery of subjects skin) with impact point.Sensor is then by the actuating of master device
Device passes thin film (such as flattening the tissue of experimenter, and/or the movement of transducer transversely/nearside), thus places the sensors on
Hematodinamics or the relevant data (step 716) of other parameter of experimenter is collected in appropriate position.In a kind of variation,
Finder can also be write such that it is able to drive actuator electrical equipment in master device, according to the data received from sensor, right
Sensor carries out stereoscopic localized.
When user has collected data, and support 500 removes from experimenter sets and processes perfect.Sensor element 600 meeting
Remain in the middle of actuator, or remove by removing ring 620.A kind of actuator protection set vision needs to be used for protecting sensing
The active surface 630 of device, thus sensor component 600 can continue to stay in actuator.By such mode, when to same
When one experimenter or other experimenters carry out follow-up hemodynamic parameter mensuration, sensor 600 can be in actuator
It is reused.
According to the invention, it is further possible to use other various variant embodiment of described method.Especially, some steps
It is selectable, it is possible to optionally perform or delete.Be similar to, other step (such as, data sampling, process, filter, calibrate,
Mathematical analysis etc.) can also be added in the middle of above-mentioned embodiment.It addition, the order of these steps can also change, or
Optionally parallel execution (series connection).Therefore, described embodiment is exemplary, and the scope of the method for the invention can be more
Wide.
Although above description as listed by various embodiments disclose the novel features of the present invention, but
Form and device or during for details various disappearances, replace and deform, before without departing from spirit of the invention
Put, those skilled in the art be will be apparent from.It is the preferred forms of the present invention as previously mentioned.These describe
To not limit the invention.The scope of the present invention will determine with reference to claim.
Claims (17)
1. a physiological parameter detecting device, including:
Conformal support, is configured couple to the forearm of patient, and described conformal support includes that alignment members, described alignment members include
Vision alignment guide and sensor screen barrier layer, described support includes opening, and described sensor screen barrier layer passes described opening；
Master component, including actuator devices, described actuator devices is configured to couple with sensor, and described master component is removedly
It is coupled to described support, and described sensor is arranged by the described master component being coupled to described support and described sensing
Device barrier layer communicates；And
Apparatus for removing, including being configured to the device that contributes to removing described master component from described conformal support, described in remove and cause
Described actuator and described sensor is removed from described support and the described sensor screen barrier layer of contact；
Wherein, described sensor screen barrier layer is configured to allow to detect one or more physiological parameters by described barrier layer；With
And
Wherein said vision alignment guide is configured to contribute to the blood vessel of relative living subject and places described support and described biography
Sensor.
2. device as claimed in claim 1, it is characterised in that described sensor screen barrier layer includes vision alignment guide.
3. device as claimed in claim 1, it is characterised in that make with lubricator to promote that described sensor is relative to described sensing
The motion of device barrier layer.
4. device as claimed in claim 3, it is characterised in that described lubricant includes powder.
5. device as claimed in claim 1, it is characterised in that described support is discarded after using 1 time.
6. device as claimed in claim 1, it is characterised in that described sensor includes that electrical interface, described electrical interface are configured to
When described sensor is coupled to described actuator devices, described sensor can directly with described actuator devices telecommunication.
7. being configured to detect a device for one or more physiological parameter from living subject, described device includes:
Conformal support, is configured to going out of use after a patient, and described conformal support includes having sensor barrier
The alignment members of layer, described sensor screen barrier layer includes that thin film, described thin film are configured to allow by described sensor screen barrier layer
Detecting one or more physiological parameters from the skin surface of living subject, described sensor screen barrier layer is neighbouring by least two
The region couples of described conformal carrier openings is to described conformal support；
Reused sensor, is configured for more than one patient；And
Master device, is configured to accommodate described reused sensor, and described master device is removably coupled to described conformal
Support, and be configured to be relatively close to described sensor screen barrier layer described reused sensor is set；
Wherein, described master device from described conformal support remove include the apparatus for removing by described master device by described can be many
The sensor of secondary use separates from described conformal support, remove described in whole described in reused sensor persistently connect
Receive described master device.
8. device as claimed in claim 7, it is characterised in that described alignment members includes disposable binding agent table
Face, described disposable adhesive surface is configured for being attached to alignment members the skin of described living subject.
9. device as claimed in claim 7, it is characterised in that described reused sensor includes draw ring, described in draw
Ring is configured to when user draws described draw ring, it is possible to make described reused sensor remove from described master device.
10. device as claimed in claim 7, it is characterised in that described master device includes fastener shape device, and described fastener shape fills
Put and be configured to when deployed, around the wrist of described living subject.
11. devices as claimed in claim 10, it is characterised in that also include being configured to be applied on described living subject's arm
Support device；
Wherein said fastener shape device is configured couple to described support device.
12. devices as claimed in claim 11, it is characterised in that described support device includes clamping plate.
13. devices as claimed in claim 7, wherein:
Described master device, with its coupling and described reused sensor, be further configured to be coupled to the 2nd live body
The 2nd conformal support of experimenter, and
Described reused sensor is further configured to obtain the one or more life of described 2nd living subject
The measurement of reason parameter.
The method of 14. 1 kinds of one or more physiological parameters measuring living subject, described method includes:
Configuring at least one support element on described living subject, at least one support element described includes opening and thin
Film, described thin film extends across described opening, and at least one support element described be configured to single use after go out of use；
Master device is coupled at least one support element described, and described master device includes actuator, the configuration of described actuator with
Sensor component couples, and described sensor component is configured to be used for multiple patient, and described master device is configured to coupling removedly
Closing at least one support element described, described coupling step includes being configured at the active surface of at least one described sensor
The described opening of at least one support element described, and it is not coupled at least one support element described；
Use described master device that described sensor component is positioned regulation monitoring position automatically, and calibrate described sensor structure
Part；
Described sensor component is used to measure the one or more physiological parameter of described experimenter；And
When completing described measuring process, by apparatus for removing, remove with described sensor from the described support element of coupling
The described master device of component, described sensor component is coupling in described master device；
Wherein, described measuring process is to be performed by described thin film, and described thin film stops described sensor component to contact described work
The surface of body subjects skin.
15. methods as claimed in claim 14, it is characterised in that use described master device to be automatically positioned described sensor group
The step of part farther includes to place relative to described sensor on described living subject, automatic to described sensor component
Reset.
16. methods as claimed in claim 14, it is characterised in that also include being coupled in described sensor component described main dress
Putting, described coupling step is included between described master device and described sensing member and concurrently forms electrical connection and be mechanically connected.
17. methods as claimed in claim 14, it is characterised in that also include:
Connection is had the described master device of described sensor component, is coupled on the 2nd support element of the 2nd living subject；
Obtain the measurement of the one or more physiological parameter of the 2nd living subject.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13/098344 | 2011-04-29 | ||
| US13/098,344 US9655530B2 (en) | 2011-04-29 | 2011-04-29 | Apparatus and methods for non-invasively measuring physiologic parameters of one or more subjects |
| PCT/US2012/035677 WO2012149485A2 (en) | 2011-04-29 | 2012-04-27 | Apparatus and methods for non-invasively measuring physiologic parameters of one or more subjects |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103889318A CN103889318A (en) | 2014-06-25 |
| CN103889318B true CN103889318B (en) | 2016-11-30 |
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Effective date of registration: 20180201 Address after: State Road 105 west of weft two road on the north side of Shangqiu City Industrial Zone Henan province Suiyang District agglomeration Patentee after: Zhejiang Shanshi Biological Medical Instrument (Shangqiu) Co., Ltd. Address before: The United States of California Santiago, No. 5825, building 100, Oberlin Avenue, 92121 Patentee before: Tensys Medical Inc. |