CN1222840A - Method and apparatus for sampling and analyzing body fluid - Google Patents

Abstract

Body fluid is sampled by causing a syringe (26) mounted in a housing (12) to be displaced towards a skin surface. The syringe (26) remains in the resulting incision while the surrounding body tissue is stimulated by a stimulator ring (70) to urge body fluid towards the incision. Simultaneously, the syringe (26) is moved relative to the incision to keep the incision open.

Description

The method and apparatus of bodily fluid sampling

Invention field

Acquisition blood and other bodily fluid sampling have been the present invention relates to, for the apparatus and method of wearing out of analyzing or handle usefulness.

Background of invention

Many medical procedures in using at present need minute quantity, the blood sample in 5 to 50 microlitre scopes.On selected position, as point to adopt and wear out or piercing method is collected 1 or 2 liquid of bleeding, it with adopt venotomy to extract a venae vasorum blood to compare, concerning patient, spend more reasonable and suffered wound still less.Along with the domestic chemical examination, as the appearance of self check blood glucose, need a kind of simple program, can in any facility, finish by the needs laboratory personnel.

Normally used lancet generally has a rigid body and a sterile needle that goes out from a distal process.Lancet can be used for skin puncture, can collect blood sample from the opening that is produced thus.Blood is delivered to assay device or collecting device.The most common is that blood supply there generally is good from the finger blood sampling.But the neural density in this district makes many patients feel tangible pain.Sometimes can be at other position, as ear-lobe and extremity up-sampling, to enter not too sensitive part.But these positions are difficult for the blood sample that provides good, and are difficult to blood is directly delivered to assay device.

On finite table area (as finger), repeat to wear out and to form scleroma.This will increase the blood drawing difficulty and increase pain.

In order to reduce worry, many spring charging devices have been developed to skin puncture and corresponding pain.Below two parts of patents represented in the exploitation eighties, be used for the device on the domestic diagnostic assay product.

The U.S. Patent number 4,503,856 of Cornell etc. has been described a spring-loaded lancet syringe.This reusable device docks with tractable lancet.The lancet frame may be locked on the release location.When releasing device of user contact, a spring makes lancet with the high speed skin puncture, withdraws from then.In order to reduce and the corresponding pain of acupuncture, speed is very important.

The U.S. Patent number 4,517,978 of Levin etc. has been described a blood sampling device.This device also is spring-loaded, and has adopted the tractable lancet of standard.This design can be easily and accurately to finger locating, thereby be easy to determine the site of puncture.After the lancet skin puncture, the spring of resilience falls back on the interior home of device lancet.

In communal facility, often wish to collect sampling from patient, controllably sampling is delivered in the assay device then.For example, some system for detecting blood sugar need be in the assay device that blood sample is delivered to assay apparatus is connected.At this moment, patients fingers directly is put in the assay device can causes the danger that obtains infecting from previous patient blood.For this system, particularly in hospital facility, wear out a patient skin usually, by capillarity sample collection in a small-sized suction pipe, then the sampling deliver to the assay device from suction pipe.

The U.S. Patent number 4,920,977 of Haynes has been described the blood collection device that adopts lancet and small-sized collecting pipe.This device is combined into single assembly to lancet and collection container.Wearing out and collecting is two actions that separate, if but wish to collect before use sampling, this device is a convenience and tractable single assembly.Similar device is published in the U.S. Patent number 4,924,879 of the U.S. Patent number 4,360,016 of Sarrine and O ' Brien.

The U.S. Patent number 4,850,973 and 4,858,607 of Jordan etc. discloses a kind of composite set, and it can alternately be used as the injection device and the device of wearing out that has tractable solid lancet of syringe type according to not isostructure.

The U.S. Patent number 5,318,584 of Lange etc. has been described a blood and has been worn out device, the blood drawing when being used to diagnose.A rotation/slip transmission system, the pain when wearing out with minimizing have been adopted in this invention.User can be easily and is accurately regulated paracentesis depth.

The U.S. Patent number 5,368,047 of Suzuki etc., the U.S. Patent number 5,320,607 of the U.S. Patent number 4,654,513 of Dombrowski and Ishibashi etc. has all been described the suction-type hemostix.When after the skin puncture, when the lancet maintaining body withdraws from, these devices are being worn out generation suction effect between position and the device end.Extracting from the site of puncture before suitably sampling or user withdraw from from device, helping the sealing of end around the site of puncture around a pad of device end.

The U.S. Patent number 5,217,480 of the U.S. Patent number 4,637,403 of Garcia etc. and Haber etc. discloses wearing out and blood collection device of combination, and they adopt a thin film to set up the vacuum at the position of being wound.

The U.S. Patent number 5,582,184 of Erickson etc. has been described the device collecting and measure body fluid.This system has adopted coaxial injectors and the capillary tube that is placed in the separating element.Separating element has limited the paracentesis depth of syringe, and in syringe is stayed skin the bodily tissue around the time compression syringe, to improve interstitial fluid mobile to syringe.A suction apparatus is extracted out by syringe holder body fluid, and enters capillary tube.

For the chemical examination of single usefulness, as domestic cholesterol chemical examination, and use for the public place, also developed the device of single usefulness, to eliminate the cross infection of many patients when using.The U.S. Patent number 4,869,249 of Crossman etc. and the U.S. Patent number 5,402,798 of Swierczek also disclose the device of wearing out of tractable single usefulness.

As the alternative of invading sampling, U.S. Patent number 5,421,816; 5,445,611 and 5,458,140 disclose the ultransonic pump-absorb action of employing, directly extrude interstitial fluid from original (nothing is worn out) skin.But the liquid measure that obtains with this method is very limited.

Above-mentioned disclosed patent all is combined in here as a reference.

Even done many improvement, wear out the pain that causes many patients are still an important problem.For millions of diabeticss, the needs of blood sampling and also be a main obstacles to the fear of corresponding pain, because pain, they can not suitably detect their blood glucose.In addition, to obtain blood sample more general to other diagnostic application with wearing out, and the device that needs a kind of still less pain, minimum intrusion improves these level of application, and make these technology obtain more accepting.

So, the purpose of this invention is to provide a kind of apparatus and method, to obtain the sampling of body fluid by skin, in fact it does not have pain and few the intrusion.

Therefore, another object of the present invention provides a lancet device of eliminating above-mentioned shortcoming.

Another object of the present invention provides a kind of method, and it can obtain the sampling of blood or interstitial fluid according to the position of sampling and the degree of depth that is punctured.Although do not utilize the commodity of interstitial fluid (ISF) device at present, can initiatively manage to be based upon the analyte among the ISF, as glucose, with the comparison of whole blood.If be easy to get very much ISF, and set up above-mentioned relation, preferably ISF as a kind of sampling, because it does not have erythrocytic interference or regulates the needs of hematocrit.

Another object of the present invention provides a kind of method, and it extracts a small amount of but adjustable sampling, and as suitable, an assay device is 3 microlitres, and another assay device is 8 microlitres.

Another object of the present invention provides a kind of method, collect the sampling extracted thus, and can easily offer assay device, and no matter the position at health up-sampling position there.This method helps the control of infecting, and many patients do not contact with single assay apparatus; Only delivering in the assay apparatus with the sampling apparatus of tractable contact patients part.In addition, in fact the easy processing section of assay device can be connected with sampler, makes directly to sample in assay device in sampling period.Then, if suitable, can read assay device in assay apparatus, or can be combined in assay system in the sampler, assay device can be patient direct result displayed is provided.

Another object of the present invention provides a kind of minimum sampling apparatus of invading, and comprises a reusable sampler and tractable sample collection device.

Abstract of invention

The present invention can reach above-mentioned and other purpose, an one aspect relates to the method for blood sampling, the step that comprises is: the shell front end is placed on the skin surface, push ahead a hollow piercing element, cut out an otch at skin surface, and push a circle bodily tissue around the otch so that when body fluid is pressed to otch, unfold otch around.Simultaneously, piercing element moves into otch, keeps otch to open.Then piercing element is produced a suction effect, from the otch extracting bodily fluid, and enter with pipe that piercing element is communicated with in.

Another aspect of the present invention relates to the sampling apparatus of a bodily fluid sampling.Device comprises a shell and a piercing element frame that is contained in the shell and has a hollow piercing element.A pipe is communicated with piercing element.Be contained in the shell drive mechanism syringe frame forward, on skin, cut out an otch, and the piercing element head stayed in the otch.An exciting agency that is contained on the shell pushes a circle bodily tissue around the otch, makes when body fluid is pressed to otch, unfold otch around.The syringe travel mechanism that is contained on the shell makes the piercing element end move with respect to otch, so that when exciting agency is pressed into body fluid, keeps otch to open.The sucker mechanism that is contained on the shell is set up the suction effect in pipe, body fluid is extracted out by piercing element, and entered in the pipe.

A further aspect of the invention relates to obtain by skin the device of bodily fluid sampling, comprises a shell, and it has the hollow piercing element that a skin puncture is used.Be contained in first spring element pushing piercing element in the shell, make it outstanding, be enough to cut out percutaneous otch from the shell front end.Barrier element has been determined the maximum paracentesis depth of piercing element.Second spring that is contained in the shell partly retreats piercing element, keeps the front end of piercing element to stay in the otch simultaneously.A pipe is communicated with the rear end of piercing element.Sucker mechanism has been set up the suction effect in the pipe, by piercing element body fluid is sucked.

The accompanying drawing summary

From below in conjunction with the accompanying drawing detailed description of the preferred embodiment, objects and advantages of the present invention will become clearly, and same numbers is represented identical part among the figure, wherein:

Fig. 1 is the longitudinal sectional drawing of sampling apparatus of the present invention;

Fig. 2 is the view similar in appearance to Fig. 1, and the expression syringe triggers, and the situation after skin surface forms an otch;

Fig. 3 is the view similar in appearance to Fig. 2, and expression has started sucker mechanism, by the situation after the syringe suction body fluid;

Fig. 3 A is the profile of being got along 3A-3A line among Fig. 3;

Fig. 4 is syringe of the present invention vertical reciprocal sketch in otch;

Fig. 5 is syringe of the present invention horizontal reciprocal sketch in otch;

Fig. 6 is the sketch of syringe of the present invention with oval direction vibration;

Fig. 7 is the sketch that syringe of the present invention rotates in otch;

Fig. 8 is that sampling apparatus inferior segment of the present invention has been made the longitudinal sectional drawing of revising, and a syringe is in fallback state;

Fig. 9 is the view similar in appearance to Fig. 8, and expression is forward after the pushing syringe;

Figure 10 is the side view of syringe of the present invention lower end, has the barrier element that is fixed on the syringe;

Figure 11 is the profile of being got along the 11-11 line along among Figure 10.

The preferred embodiment of the present invention describes in detail

Described body fluid sampling device 10 at Fig. 1 to 3, it comprises a cylindrical shell 12.Being screwed onto in shell 12 upper ends is a fixed cover 14, forms upper and lower groove 16,18 in the cover.The female thread that is connected with external screw thread baffle ring 20 in upper groove 16 has, but the baffle ring opposite shell is adjusted to selected upright position.

What can do longitudinal sliding motion in fixed cover 14 is a hollow drive rod 22.What be screwed onto drive rod 22 lower ends is a syringe frame 24.What be contained in frame 24 lower ends is a syringe 26 that comprises vertical capillary channel 28 types (referring to Fig. 4).The preferably relative syringe central shaft of this passage is made lateral offset.Any suitable hollow piercing element can be used for replacing syringe, for example pin or sharp sleeve pipe.

The upper end of syringe is communicated with sampling tube 30, and the upper end of pipe cooperates with the following recess 32 that forms on drive rod 22.

Thereon, between the lower end, drive rod 22 has one and radially enlarges district 33, wherein forms a cannelure of outwards opening 34, its size can be held the pin 36 of first trigger 38.

Being slidingly mounted in the sampling tube 30 is the plunger 40 that has soft 42, and it is close to (hermetically) inner surface at pipe 30.The upper end of plunger 40 is fixed to the lower end of pull bar 46, and pull bar can slide in the centre bore of drive rod 22.

What be screwed to drive rod 22 upper ends is installation sleeve 48, and second trigger 50 that can laterally slide wherein has been installed.Form a centre bore 52 on second trigger 50, it is bigger than the external diameter of pull bar 46.Pull bar 46 has recess 54, but the associated side of its size accommodation hole 52.

Driving spring 56 is the spiral compression spring form, acts on to enlarge between district 33 and the fixed cover 14.Leaning against on the fixed cover 14 is a contraction spring 58, is the spiral compression spring form.Act on and enlarge being and sucking spring 60 between district 33 and plunger 40 tops, be the spiral compression spring form.

Being installed on the syringe frame 24 is a piezoelectric transducer 66, and it is electrically connected on the battery 68.Piezoelectric transducer is conventional oscillating mode, can produce vibration in the direction of any hope.The lower end of piezoelectric transducer 66 contacts with syringe, so that syringe vibration, as vibrating along vertical (vertically), horizontal or oval the mode combination of oscillation crosswise (vertical and).

What be contained in shell 12 lower ends is an exciting cover 70.Cover has the following ring surface 72 of a truncated cone shape, and is screwed in the stock 74.Along stock 74 diametric(al) opposite ends outstanding be pin 76, they are contained in the perpendicular grooves 78 relevant on the shell 12 slidably.

What be contained in the relative both sides of shell 12 diameters rotationally is a pair of identical driven wheel 80 (also can referring to Fig. 3 A).What form in each gear 80 inner surface is that 82, one corresponding pins 76 of cam path are charged into wherein.Be contained in above the driven wheel, around the shell central longitudinal axis be a ring gear 84, it is driven by the output pinion 86 of electro-motor 88.The downside of ring gear 84 forms tooth, with the tooth engagement that forms on driven wheel 80 outer rims.So the rotation of pinion 86 is passed to driven wheel 80, driven wheel is rotated.The following of the eccentric grove 82 of driven wheel rotated and to be made pin 76, thereby makes and stock 74 be in vertical reciprocating motion with the exciting cover.

The operation of sampling apparatus 10 now is described.In order to be ready to this device, by user installation sleeve 48 is upwards drawn, up to the oblique angle in the expansion district 33 of drive rod 22 face along laterally extrapolated first trigger.Punctual when 38 pairs on groove 34 that enlarges the district and first trigger of pushing the outside to, by the spring (not shown) first trigger is inwardly pushed away, pin 36 insertion grooves 34, be in SBR (Fig. 1) to keep drive rod 22.Simultaneously, from relaxed state compressible drive spring 56, syringe frame 24 is elevated with syringe 26.Limited pull bar 46 positions by second trigger 50, made suction spring 60 be in compressive state.

The lower end 72 of shell 12 leans against on the skin surface S, preferably on the body part that lacks than the finger tip teleneuron.Forearm may be suitable position.With respect to the spring of bias voltage, extract the driving spring 56 that trigger 38 discharges drive rod 22 and compression then.The result is that drive rod 22, syringe frame 24 and syringe 26 all are driven to down, make syringe pass through skin surface S and cut an otch I, as shown in Figure 2.When drive rod 22 moved downward, installation sleeve 48 cooperated with the upper end of contraction spring 58, leaned against then on the baffle ring 20, had limited the degree of depth of otch thus and had compressed contraction spring 58 slightly.Contraction spring 58 moves up drive rod 22 slightly then, but is not enough to take out from otch I fully syringe 26.Then, manually or automatically starter 88, with thrusting of response syringe, exciting cover 70 are in vertical reciprocating motion.Therefore, lower surface 72 repeats circle skin and the bodily tissue of extrusion ring around otch.Each extruding of this circle make the otch projection and unfold otch around, the body fluid of blood or interstitial fluid and so on is outwards pushed by otch I, together the U.S. serial of the nearest submission of Zhuan Ranging--and--also be described in (agent's summary 018176-039 and 018176-060).In order to collect in (in order to be connected on following sampling) on the otch to the body fluid that inwardly pushes away, syringe 26 is done quite slow vibration by piezoelectric transducer 66, opens to keep otch.As previously described, direction of vibration can be determined by the special orientation of pick off 66.In one embodiment, direction of vibration is vertical or vertical (Fig. 5); In another embodiment, vibration is horizontal (Fig. 6); In also having an embodiment, vibration be laterally and vertical to combination, promptly general elliptical vibration (Fig. 7).

Be appreciated that if syringe does not move, because the effect of the colloid albumen in the skin, immobilized syringe may cause the closure of otch in otch in otch, thereby body fluid can not collect on the otch.

Being enough to make after competent body fluid is pooled to very short time on the otch, manually boot second trigger 50, to discharge pull bar 46, make spring 60 in pipe 30, raise plunger 40.This produces the suction effect under pipe 30 inner plunger 40, syringe 26 suction (Fig. 3) are passed through in the sampling 90 of body fluid.

Then, can remove this device from skin, and suitable chemical examination place is delivered in sampling.

As the reciprocating alternative of syringe, when syringe is arranged in otch I, can be syringe around self central shaft rotation.To this, rotation syringe 92 as shown in Figure 7 can be used in the device 10 ' shown in Fig. 8 and 9.This installs the 10 ' device similar in appearance to Fig. 1 to 3, but has increased transmitting gear 94, and it is driven by the pinion 95 of second motor 96.Gear 94 has comprised a recess of upwards opening 98, and its size is the lower end 100 of containing pipe 30 closely, and syringe 92 is placed in the pipe.Therefore, when syringe frame 24 ' was driven towards skin, pipe 30 inferior segment 100 entered recess 98, set up manage 30 and gear 94 between frictional fit (referring to Fig. 9).Follow rotation pinion 95, make gear 94, pipe 30 and syringe 92, rotate around the axis that conforms to syringe 92 central shafts all with respect to frame 24 '.Syringe 92 comprises the tip 102 of a half cone form.When syringe when self axle rotates, half cone section 102 cuts out conical depression 104 in otch, and when exciting cover 70 moves back and forth, keeps otch to open.

A block can be housed on so far described any syringe substitute baffle ring 20.This block 110 is connected the back shown in Figure 10 and 11 with syringe 92.Block 110 comprises a dish that is fixed on the syringe.When dish contacted with skin surface, syringe no longer entered skin.Baffle ring 20 also can be used for the open and close otch, to promote compiling of body fluid.

Be appreciated that it is minimum that the pain that the present invention can make user stand is reduced to, because the sampling of body fluid can be provided at the body part that lacks than finger tip district teleneuron.When making the motion of syringe counteropening, because the bodily tissue around the exciting otch can make body fluid be pooled on the otch, provide competent sampling thus, suck and enter in the collecting pipe by syringe.Therefore, can utilize the not too responsive body part of pain is originated as body fluid.

Be essentially annular skin contact though illustrated exciting spare 70 has, promptly relative and central shaft is symmetric surface, and exciting spare 70 can be replaced with has ellipse or polygon end face, and Ji Ya bodily tissue circle can have corresponding shape thus.

Though having described the present invention in conjunction with the preferred embodiments, those skilled in the art are appreciated that, not specifically describedly as yet replenish, revise, substitute and deletion can make, and the spirit and scope of the invention that does not deviate from claims and limited.

Claims (22)

1. the method for bodily fluid sampling comprises the steps:

A) front end of shell is placed on the skin surface;

B) push ahead hollow piercing element, cut out a otch by skin surface;

C) push a circle bodily tissue around the otch, so as the body fluid pushing is unfolded during to otch otch around;

D) in step C, piercing element is moved in the otch, open to keep otch;

E) piercing element is applied the suction effect, extracts body fluid out from otch, and enter with pipe that syringe is communicated with in.

2. according to the process of claim 1 wherein, step C comprises makes an exciting ring pulse to skin, and ring has the front end face around otch, and contacts with skin surface.

3. according to the method for claim 2, wherein, step D comprises that to make piercing element reciprocating.

4. according to the method for claim 2, wherein, step D comprises makes piercing element rotate around its central shaft.

5. according to the process of claim 1 wherein, step D comprises that to make piercing element reciprocating along the direction of parallel its central shaft.

6. according to the process of claim 1 wherein, step D comprises that to make piercing element reciprocating along the direction of vertical its central shaft.

7. according to the process of claim 1 wherein, step D comprises makes piercing element vibrate along general oval direction.

8. according to the method for claim 2, wherein, step C comprises that the direction that makes exciting ring edge be parallel to the piercing element central shaft is reciprocating.

9. according to the process of claim 1 wherein, steps A comprises shell is placed on the skin surface of body part beyond the finger.

10. the sampling apparatus of a bodily fluid sampling comprises:

A shell;

A piercing element frame that is contained in the shell and has a hollow piercing element;

A sample collection pipe that is communicated with piercing element;

A driving mechanism that is contained in the shell, its injector-actuated frame cut out an otch forward on skin, and the piercing element end is stayed in the otch;

An exciting agency that is contained on the shell, it pushes a circle bodily tissue around the otch, makes when body fluid is pressed to otch, unfold otch around;

A travel mechanism that is contained on the shell, it makes the piercing element end move with respect to otch, so that when exciting agency is pressed into body fluid, keeps otch to open;

A sucker mechanism that is contained on the shell, it sets up the suction effect in pipe, body fluid is extracted out by piercing element, and entered in the pipe.

11. according to the sampling apparatus of claim 10, wherein, exciting agency comprises a cover, it have one around piercing element, towards preceding end face, and reciprocator, it makes cover along reciprocating with the direction of piercing element central axes.

12. according to the sampling apparatus of claim 10, wherein, motion comprises that one makes piercing element around mechanism that its central shaft rotates.

13. according to the sampling apparatus of claim 12, wherein, the inferior segment of piercing element is a half cone section shape.

14. according to the sampling apparatus of claim 10, wherein, motion comprises that makes the reciprocating mechanism of piercing element.

15. according to the sampling apparatus of claim 14, wherein, motion comprises that one makes piercing element along the reciprocating mechanism of parallel its central axis direction.

16. according to the sampling apparatus of claim 14, wherein, motion comprises that one makes piercing element along the vertical reciprocating mechanism of its central axis direction.

17. according to the sampling apparatus of claim 14, wherein, motion comprises a mechanism that makes piercing element do vibration by general oval route.

18. the sampling apparatus according to claim 10 also comprises: be contained in the adjusting block on the shell, it has limited the degree of depth of piercing element insertion skin.

19. according to the sampling apparatus of claim 10, wherein, fix a block on the piercing element, its restriction piercing element inserts the degree of depth of skin.

20. one is obtained the device of bodily fluid sampling by skin, comprising:

An outer casing member, it has the hollow piercing element that a skin puncture is used;

First spring element that is contained in the shell, it pushes piercing element, makes piercing element outstanding from the shell front end, is enough to cut out a percutaneous otch;

A barrier element, it has determined the maximum paracentesis depth of piercing element;

Second spring that is contained in the shell, it partly retreats piercing element, keeps the front end of piercing element to stay in the otch simultaneously;

A pipe that is communicated with the rear end of piercing element; And

A sucker mechanism, it has set up the suction effect in the pipe, by piercing element body fluid is sucked.

21. the sampling apparatus according to claim 20 also comprises an exciting agency, it pushes a circle skin and a bodily tissue around the otch, makes when body fluid is pressed to otch, unfold otch around;

22. the sampling apparatus according to claim 21 also comprises travel mechanism one by one, it makes piercing element move with respect to otch, so that when the exciting element is pressed to otch to body fluid, keeps otch to open.

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