WO1993016640A1 - Vorrichtung zur führung einer punktionseinrichtung und deren verwendung mit einem handgerät zum auffinden von gefässen - Google Patents
Vorrichtung zur führung einer punktionseinrichtung und deren verwendung mit einem handgerät zum auffinden von gefässen Download PDFInfo
- Publication number
- WO1993016640A1 WO1993016640A1 PCT/EP1993/000453 EP9300453W WO9316640A1 WO 1993016640 A1 WO1993016640 A1 WO 1993016640A1 EP 9300453 W EP9300453 W EP 9300453W WO 9316640 A1 WO9316640 A1 WO 9316640A1
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- WO
- WIPO (PCT)
- Prior art keywords
- ultrasound
- guide
- syringe
- detector
- cannula
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
- A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/06—Measuring blood flow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4887—Locating particular structures in or on the body
- A61B5/489—Blood vessels
Definitions
- the present invention relates to a guide device for a puncture device, such as a syringe or a catheter, according to the preamble of claim 1.
- a puncture device such as a syringe or a catheter
- Such a device is known from EP 0 467 291 A1 discussed below.
- Devices which are used for examining arteries or veins, for example to determine vascular diseases or vasoconstrictions. These devices work on the basis of sonography, ie with ultrasound with frequencies in the range of> 20 kHz. With the aid of a transducer, ultrasound waves are sent to parts of the body and the reflections are measured. In this way, boundary layers in the tissue and also vessels such as arteries and veins can be examined. In the blood it is mainly the erythrocytes that reflect the ' sound waves. Part of the incident energy is scattered back towards the transducer and is available for evaluation.
- sonography of veins allows the determination of the direction of flow, flow velocity, depth of the vein, number of pulses, but also the diagnosis of various venous diseases and examinations of the nature of the tissue (density), as well as indirectly the determination of blood pressure.
- DE-OS 19 27 868 describes a device for the precise and rapid location of blood vessels and for the accurate insertion of an injection cannula into these vessels.
- This device has an ultrasound system directly in the area of the movement axis of the injection cannula on the skin surface or near the tip of the cannula.
- This consists of at least one locating transducer held on a carrier part and connected to a high-frequency transmitter and a Doppler device.
- a coupling piece lying against the skin surface and conducting the ultrasound can be connected upstream of the locating vibrator.
- the locating oscillator can be arranged in the interior of the injection cannula, next to the axis of movement of the injection cannula or the axis of movement of the injection cannula.
- the locating vibrator or part of its carrier part can be provided with a guide for the injection cannula into the vessels after the locating has taken place.
- a prerequisite for the correct functioning of this known device is that the location system and the injection cannula are spatially assigned to one another in such a way that they are operatively connected to the skin surface at the moment of the puncturing process.
- the injection cannula Before an injection it is therefore absolutely necessary to use both the injection cannula as well as to sterilize the locating transducer or the upstream coupler. During the injection, the locating vibrator inevitably also becomes contaminated, so that it has to be sterilized for reuse.
- DE-OS-21 48 700 which is an additional application to the above patent application, describes this device in combination with a depth measuring device.
- This depth measuring device works according to the pulse transit time principle and enables the detection of the vessel depth and the penetration depth of the cannula.
- a path scale is to be provided in the area of the front end of the injection cannula, which can be read in relation to the locating vibration transmitter.
- the devices described above have the disadvantage that the user needs both hands when operating. After the location has been carried out, the carrier part must be held with one hand, while the injection cannula is guided with the other hand through the guide bore in the carrier part in the direction of the located vessel.
- REPLACEMENT LEAF is very complex and has the disadvantage that the coupling gel located in the area of the puncture site can get into the tissue or the vessel with the injection needle. In addition, the location vibrator cannot be separated from the cannula.
- DE-OS-24 18 426 describes a device for simplified puncture of arteries and veins with the Doppler ultrasound probe.
- This device consists of a needle guide attachment with a first bore for receiving the Doppler ultrasound probe and a notch provided on one side for guiding a puncture needle.
- the direction of ultrasound forms a plane with the direction of puncture and the intersection of the two directions lies in the depth of the vessel in the tissue.
- the guidance of the injection needle is imprecise due to the short contact surface of the needle guide attachment and requires two-handed operation by the user.
- the devices described above have the disadvantage in common that both the actual syringe and the probe and the receiver must be sterilized or sterile packed before use. On the one hand, this is expensive and, on the other hand, the electrical components such as the locating vibration transmitter can be damaged during sterilization.
- DE-Al-39 09 140 proposes a syringe for Doppler sonographically assisted puncturing, in which the transmitter and the receiver are arranged in the plunger of a commercially available syringe. It is further proposed to inject a small amount of a physiological saline solution in the syringe in order to achieve a direct coupling of the ultrasound to the soft parts surrounding the sought-after vessel.
- the piston In this known device, the piston must be sterilized after each use and in a sterile disposable sleeve
- REPLACEMENT LEAF be packed.
- the needle is inserted through the skin into the area of the vessel to be localized in order to couple the ultrasound waves in order to find particularly deep-lying vessels.
- DE-AS 29 06 474 describes an ultrasound transducer probe which has a carrier with a support surface to be placed on the body surface of a patient, a plurality of ultrasound transducer elements arranged in a row on the support surface, and a cable for connecting the individual transducer elements an electrical transmitter / receiver section of an ultrasound diagnostic device and a cannula guide block that can be removed from the carrier.
- a cannula guide slot is formed in the cannula guide block with a wide opening on the upper cannula inlet side and with a taper in the direction of the support surface.
- In the cannula guide block there is also a slot which is essentially perpendicular to the guide slot for guiding the cannula out of the carrier and out of the cannula guide block.
- This ultrasonic transducer probe is intended to ensure that the guide surface for a sterilized cannula to be inserted into a body is sterile.
- the carrier and the cannula guide block that can be used therein are designed separately. Before use, only the guide slot part (cannula guide block) is suitably sterilized, or a single-use unit that has been packaged in aseptic or sterile condition is used. The wearer, who himself never comes into direct contact with the cannula, can e.g. be disinfected in alcohol.
- DE-OS 25 53 404 describes a surgical device with a detector device for ultrasound, in which an ultrasound transducer or a group of ultrasound transducers are used, which are connected to an evaluation device for localizing a body point to be punctured.
- the ultrasonic transducer elements are arranged at the front end of a housing, on which a puncturing device is also adjustable by means of a holder.
- a rubber-filled bladder can be arranged in the region of the front of the transducer, which is suitable for the transmission of the ultrasound.
- the coupling gel usually used can be omitted.
- This known device has the disadvantage that the entire arrangement must be sterilized for use under sterile conditions.
- EP 0 467 291 AI describes a needle guide arrangement which can be placed on an ultrasound image converter by means of a spring clip. A sterile protective cover is pulled over the head end of the transducer, which is held in place by the spring clip. Before use, an acoustic coupling gel is first applied to the transducer surface, the sterile protective cover is pulled over the transducer and the needle guide is placed on the transducer. A coupling gel is then applied to the outside of the protective cover on the transducer surface.
- This known device has the disadvantage that the sterile protective cover is designed in the manner of a bag which is pulled over the head end of the transducer, wrinkles being able to form in the region of the end face of the transducer.
- a coupling gel is used between the transducer surface of the transducer and the sterile protective sheath, wherein when the protective sheath is pulled over, air bubbles can be enclosed in the coupling gel, which prevent the passage of ultrasonic waves.
- the protective sheath Coupling gel with the injection needle reached the puncture site.
- this device consists of several individual parts, which makes it difficult to mount on the converter.
- CH 676 787 A5 describes a puncturing device for puncturing blood vessels, consisting of a housing with a displaceable holder for a syringe arranged on one side and a tubular support for a probe head of a transmitter / receiver arrangement of an ultrasound system arranged on an opposite side.
- the housing contains the electrical circuit necessary for the function of an ultrasound system with all operating elements, the energy supply and acoustic signal transmitters.
- the probe head is held by the support via a plug connection, so that it can be replaced at any time with another head, for example with other ultrasonic vibrators.
- the probe head has a longitudinal slot in which the needle of the syringe is mounted practically without contact, but is guided in the direction of the needle axis when the movable holder is moved.
- the front of the housing can be coated with a potting compound that serves as an acoustic coupling compound for ultrasound.
- the casting compound On its flat back, the casting compound is delimited by two flat ultrasonic vibrators, one of which acts as a transmitter and the other as a receiver.
- the transducers are electrically connected to the plugs on the bottom of the probe head.
- the sealing compound In order to focus the ultrasound waves, the sealing compound can be designed either as a convex lens or as a concave lens. These lenses can consist of polymers, for example of araldite, a silicone or a rubber.
- This known puncturing device has the disadvantage that the entire arrangement must be sterilized for use under sterile conditions. Sterilization is time consuming dig and causes costs for material and personnel. In the meantime, the device is not available.
- the present invention is based on the object of providing a device with which vessels, in particular veins, located below the skin surface can be reliably located using an ultrasound detector device and with the aid of which a puncture device such as a syringe or a catheter can be securely inserted into the device
- a puncture device such as a syringe or a catheter can be securely inserted into the device
- the vessel to be punctured can be guided, sterile conditions being maintained during the puncturing process.
- the guide device enables the housing with the detector device accommodated therein to be handled together with the overlying puncturing device when it is operated with one hand.
- First the point ons acquired on the housing such that the front end of the puncturing device does not protrude beyond the front end of the housing.
- the guide device is placed on the body parts in question with a gel pad arranged at the front end of the housing and the position and direction of the guide device is changed until the detector device finds a suitable one Position for a point reports.
- the puncturing device such as a syringe or a catheter, is displaced along the guide surface in the direction of the vessel to be punctured.
- the device according to the invention has the advantage that the detector device does not come into direct contact with the body part to be punctured. Instead, the detector device is completely surrounded by a housing, and the gel cushion for ultrasound coupling is located between the detector and the body part to be punctured. This has the advantage that in order to maintain sterile conditions at the part of the body to be punctured, only the gel cushion, and possibly additionally the housing, must be sterile.
- the housing is designed as a plug-on body which can be detachably placed on the detector device.
- the gel pad is located at the front end of the plug-on body.
- This plug-on body thus fulfills an adapter function, i.e. different puncture devices can be used in connection with a generally usable detector device.
- different plug-on bodies which are each adapted to the size and shape of a specific puncture device to be used, can advantageously be used in conjunction with the universally usable detector device.
- the push-on body with the gel cushion arranged thereon is preferably designed as a disposable part. This has the advantage that in each case, for example, a sterile packaged push-on body with the gel pad arranged thereon is used for a single puncture procedure, which ensures sterility at the puncture site.
- the plug-on body is preferably open at its rear end and the detector device is pushed into the cavity through this opening to such an extent that coupling is achieved and ultrasonic waves emitted by the detector device are transmitted to the body site to be examined and the return signals essentially without damping can be received.
- the gel cushion is preferably attached to the front end of the housing by means of gluing or welding.
- the gel pad is optionally connected over a large area to the front end wall of the housing or along a region adjacent to the outline of an opening at the front end.
- a dimensionally stable gel pad is particularly preferably used, which is made from a material that is permeable to ultrasound waves.
- a material that is permeable to ultrasound waves.
- Such a material is described, for example, in EP-A-0 211 482. It is a hydrogel with a water content of more than 90% by weight.
- This gel pad is fitted in an opening at the front end of the housing.
- the gel cushion is kept mechanically, preferably with the aid of grooves in the gel cushion and edges at the opening. Other mechanical attachments Graduations are also possible.
- the ultrasound head of the detector device touches the back of the gel pad directly (ie without a housing wall located in between).
- the gel cushion is used to produce an optimal coupling between the ultrasound head and the body part to be examined.
- the detector device can be locked in its end position in the housing by means of grooves on the detector device and corresponding edges on the housing.
- the gel pad is formed from a thin film and a coupling gel accommodated therein and has a high conductivity for ultrasound.
- the guide device can advantageously be placed at different angles on the body site to be punctured, ensuring that there is a connection between the detector device and the body site to be examined that conducts the ultrasound waves.
- the gel cushion lies over a large area on the body part to be examined and can adapt to any unevenness and the inclined position of the guide device.
- the front surface has an angle of 30-60 (45 °) to the axis of the ultrasound and thereby facilitates the oblique entry of the ultrasound into the tissue, which is necessary for determining the Doppler effect.
- the guide surface is formed by an elongated groove or a channel, the size and shape of which is adapted to the puncturing device.
- the width and depth of the groove is selected so that the puncture device at least partially protrudes into the groove and is guided laterally by the latter.
- the puncturing device is preferably a syringe with a cannula, a syringe body and a syringe plunger, and the syringe body is guided so as to be displaceable on the guide surface.
- a support preferably with a V-shaped Eir r.erbung provided in which the Ka ⁇ Nuele the syringe versc 4 is guided Abbar. This has the advantage that both de? ⁇ syringe body and the cannula are supported in the lateral direction.
- the height of the support, the dimensions of the elongated groove and the relative position to one another are preferably matched to the type and size of the syringe to be used in such a way that both the syringe body and the cannula lie against the respective guide surfaces. This enables precise guidance of an individual design of a syringe type, e.g. the central or off-center arrangement of the cannula in relation to the bottom surface of the syringe body.
- the groove described for guiding the syringe can be replaced by two webs which allow the syringe handle to move freely (which generally has a larger diameter than the syringe body).
- the two webs can also be used to guide a slide in which the syringe body is clamped. This slide would serve to allow the use of syringes of different sizes with a slip-on cover of a constant type. Only the adapter sled would have to be chosen accordingly.
- the syringe body is simply placed directly on the guide formed by the webs. The length of the webs is chosen so that the advancement of the syringe is not hindered by its protruding edge.
- the length of the webs is less than the length of the syringe body.
- a needle guide in the form of a slot is provided at the front end of the housing.
- the slot is preferably formed by two pivotable flaps arranged at a distance from one another. These flaps can be pivoted, for example, by means of a film hinge similar to a salon door, so that, if necessary, the neck of a cannula can also be passed through the slot in order to achieve the greatest possible depth of penetration of the cannula.
- the push-on body preferably has an elongated shape and tapers in cross section in the front region in the direction of the front end.
- the two side surfaces are preferably inclined obliquely to the center and the underside extends obliquely upwards.
- the side surface with the guide surface formed therein runs in one plane.
- the upper side surface, the underside and the oblique side surfaces delimit an opening at the front end of the housing, which opening is preferably arranged at an angle of 50-85 ° to the axial direction of the puncturing device.
- the side surfaces or the underside preferably form an angle of approximately 25 ° or approximately 16 ° with respect to the axial direction of the puncture device.
- the underside is flat and the guide for the puncture device used (e.g. Syringe) at an angle of 10-20 degrees to the longitudinal axis of the device.
- the puncturing cannula enters the effective area of the ultrasound shortly after perforation of the skin.
- the shape of the sheath is designed so that it can be easily gripped with one hand and the puncture device is fixed on the guide. For more complicated measures (eg venous catheter placement), once the vein has been found, the device can simply fall down to have space for the necessary manipulations.
- the material of the cover consists of a translucent plastic (preferably polypropylene) which enables an unobstructed view of the display of the internal evaluation device.
- the shell is adapted in size and shape to the detector device and completely surrounds it. Furthermore, a flap is arranged on the back of the cover, with which the back of the detector device is also covered sterile.
- the closure flap is articulated by means of a double hinge in the area of the upper edge on the back of the casing. With the help of this double hinge, the closure flap can be opened completely and opened up to the top of the casing. For the complete sealing of the interior of the casing, the closure flap has a circumferential edge which engages with a corresponding projection on the back of the casing in the closed state. On the side opposite the double hinge there is a tab for reopening the flap.
- the flap can optionally also be arranged on the underside and / or articulated by means of a single hinge.
- the plug-on body has an extendable tubular sleeve at the rear end, which is extended beyond the rear end of the detector device, for example to protect wire connections with an external data processing device can.
- This hose cover is designed, for example, in the form of an expandable bellows.
- the guide device is used with a hand-held device for locating vessels.
- This has a specially adapted ultrasonic measuring device.
- the external dimensions of the ultrasonic measuring device are preferably essentially adapted to the cavity in the guide device. Because of its small size and light weight, this combination enables one-handed use.
- the ultrasonic measuring device has at least one transducer, which preferably serves as both a transmitter and a receiver.
- the transducer is optionally arranged so that the ultrasonic waves are transmitted essentially in the same direction in which the puncturing device is aligned axially.
- the transducer is preferably arranged directly under the guide surface for the puncturing device.
- the geometry of the transducer is designed in such a way that the ultrasonic lobe has a largely homogeneous cross section of approximately 2 x 8 mm in the area between the skin surface and 40 to 50 mm depth.
- the cross section can vary in the range from 1 to 2.5 x 5 to 10 mm. This enables the axis of rotation of the detector device to be aligned with the course of the vein. The reflected signal is greatest when the large axis of the elliptical ultrasound beam is parallel to the vessel.
- two transducers are arranged below the guide groove, the one being arranged essentially parallel to the axial direction of the puncturing device and the second obliquely to the axial direction of the puncturing device.
- the alignment of the two lines of action of the two transducers is preferably chosen so that they are in the depth of the vessel to be punctured have a certain distance. This enables a very precise localization of the position or the course of the vessel to be punctured.
- the structure of the head is designed in such a way that the ultrasonic beam emanating from it has an elliptical diameter rather than a circular one.
- the large diameter of the ellipse will be perpendicular to the longitudinal axis of the device.
- the design of the ultrasound beam as an ellipse has the effect that additional information about the course of the vein sought is obtained. If the long axis of the ellipse is aligned parallel to the course of the vein, then a larger proportion of the ultrasound beam hits the center of the vessel. As a result, among other things, the intensity of the reflected ultrasound component increases with the greatest frequency shift. This is intended to increase the target accuracy, since it enables the device to be aligned with the course of the vessel.
- the puncture axis and the axis of the ultrasound cone intersect at an angle of 10-20 degrees. This and the fanning out of the ultrasound cone in the longitudinal axis compensate for the parallax error, the puncture axis lies predominantly in the area of the sound cone.
- the detector device has two transducers (two receiver crystals) and a transmitter.
- the axes of the main sensitivity of the two receiving transducers are either parallel to one another at a small distance (5 to 10 mm) or slightly divergent.
- a comparative measurement of the received signals can determine whether the detector device is aligned parallel to the course of the vessel.
- the ultrasonic lobes are about 2 mm wide and about 5 mm long.
- the axis of the direction of action of the ultrasound head is inclined by 10 to 20 °, preferably 15-17 °, against the axis of the puncturing device. This angle is if necessary, to adapt to the nature of the puncture device.
- the ultrasonic measuring device works on the basis of sonography, i.e. with ultrasound in the range from 1 to 30 MHz, particularly preferably 6 MHz to 10 MHz.
- sonography i.e. with ultrasound in the range from 1 to 30 MHz, particularly preferably 6 MHz to 10 MHz.
- sound waves are introduced into the parts of the body to be examined and the reflected parts are measured and evaluated.
- the depth of a vessel located under the skin surface can be determined from the running time of the reflected portion.
- the ultrasound Doppler effect is particularly preferably used to identify the vessels.
- arteries and veins in particular can be clearly distinguished from one another, so that unintentional puncturing of an artery can be avoided.
- a continuous ultrasound signal with a frequency of 8 MHz is emitted to locate a vein.
- the part of the ultrasound reflected by the flowing blood experiences a frequency shift in accordance with the flow direction and flow speed of the blood. This frequency shift can be represented acoustically or optically.
- the transducer is optionally connected to a transmitter via a transceiver.
- the transmitter works either in continuous mode or in pulse mode. In continuous operation, the Doppler shift is preferably measured, while the pulse operation is preferably used for the depth measurement, with runtime measurements being carried out for this purpose.
- the transmitter preferably has a pulse shaper, at the output of which, for example, an RF pulse with a Gaussian distribution is generated.
- a pulse shaper at the output of which, for example, an RF pulse with a Gaussian distribution is generated.
- the transmitter has a pulse shaper which amplitude-modulates the high-frequency oscillation with a defined envelope.
- Appropriate shaping of the envelope curve gives the transmission pulse a narrow frequency spectrum with still acceptable deformation in the time domain.
- a possible curve shape is the Gauss curve.
- the ultrasound measuring device has an evaluation device which can optionally be designed as an analog receiver or digital receiver using the low-frequency method or using the high-frequency method.
- a signal conditioning of the signal received by the transducer is preferably carried out by means of a low-noise preamplifier, possibly a downstream bandpass filter, the center frequency of which corresponds to the transmission frequency, and a further amplifier with preferably fixed, predefinable amplification of the order of magnitude from +60 to + 0 dB.
- a receiver protection in the form of an amplitude limiter device is preferably provided at the input.
- the reception signal of a mixer device e.g. fed to a ring mixer, which mixes this with a reference signal from a local oscillator and generates a low-frequency signal.
- the low-frequency signal is filtered out by means of a cut-off frequency corresponding to a low-pass filter.
- the output signal of the low pass is displayed after a control and amplifier stage, e.g. output through a loudspeaker.
- the output signal of the low-pass filter is converted analogously / digitally before or after the control and amplifier stage and evaluated and evaluated in a signal processor after frequency shift and / or transit time. finally the result is displayed.
- the frequency spectrum of the received signal is preferably examined. This can be done either by an FFT or by multiple bandpass filtering.
- the frequency maximum and the intensity of the received signal are displayed by means of a chain of optical signal transmitters (eg LED). Starting from a largely laminar flow in veins, the highest flow velocity in the middle of a vessel is to be expected.
- the data obtained are examined by means of a "fuzzy logic" for typical patterns for centrally sonicated veins and the probability of a hit is displayed.
- the received signal is converted directly to analog / digital and evaluated and displayed using a signal processor with DMA logic (direct memory access) or FIFO.
- DMA logic direct memory access
- the embodiment as an analog ultrasonic Doppler receiver is the cheapest solution for an electronic evaluation system. An estimate of the Doppler maximum is possible and thus suitable for determining the position of a vessel. However, the embodiment as a digital receiver using the high-frequency method offers the most diverse possibilities with regard to the evaluation of the received signal and thus also for more precise localization.
- an acoustic and / or visual display is used to indicate the suitable position and position of the guide device for the desired puncture.
- Separate displays can be present for the display of the vessel type on the one hand and / or the display of the vessel length, ie the vessel course and its depth.
- the frequency of the local oscillator is preferably equal to that Transmission frequency selected so that the received RF carrier can not generate a disturbing acoustic beat.
- LED light indicators
- the light chain shows the maximum of the measured Doppler shift due to the number of illuminated elements. This can be coupled with a "peak-hold" mechanism for better visibility.
- the intensity of the lighting can also provide information about the intensity of the received signal.
- the light-emitting diodes preferably protrude above the upper side of the detector device.
- corresponding protrusions protruding outwards are provided in the casing, which at the same time serve to fix the casing in an axially correct position on the detector device.
- medically trained personnel such as doctors or nurses, can reliably determine the position of a vessel to be punctured under the skin surface and can safely localize even veins (non-palpable veins) that are deep below the skin surface and the Guide the puncture device such as a syringe or a catheter reliably to the vessel and puncture it with it.
- the device according to the invention facilitates the manual puncture of various veins, such as "jugular vein”, “femoral vein”, “brachiocephalic vein”.
- various veins such as "jugular vein”, “femoral vein”, “brachiocephalic vein”.
- the above-mentioned list is only an example. Other veins can also be localized and then punctured.
- the device according to the invention can be used particularly advantageously for people whose veins are difficult to recognize are like babies, children and especially obese (obese) people. It is suitable for distinguishing veins with good and low patency, like veins already frequently used for puncture, in which the blood flow is reduced as a result of adhesions (obliterations).
- the device according to the invention offers the possibility of differentiating different vessels, such as distinguishing a vein from an artery. This is of great advantage if, for example, a medicament is to be injected into a vein, but under no circumstances should it enter an artery.
- the present device can also be used advantageously in the field of veterinary medicine.
- the casing or housing according to the invention is packed airtight after manufacture and ' sterilized, for example by means of ethylene dioxide.
- This has the advantage that the gel pad consisting of up to 98% water is protected from drying out and is therefore usable for a long time.
- This airtight packaging is provided with a marked tear-open point, for example a perforation, so that it can be opened easily.
- the tear-open point is preferably located at the rear end of the sheath, ie the end opposite the gel pad.
- the detector device can be inserted into the casing through the opening at the tear-open point and the casing can then be removed from the packaging and the closure flap on the back can be closed. This ensures sterile conditions.
- the housing of the detector device is preferably welded completely watertight so that it can be placed in a disinfectant for cleaning. Charging the in Batteries present in the detector device are made inductively by means of radio frequency coupling.
- 1, 2, and 3 each show a perspective view (on a reduced scale), a side view and a
- REPLACEMENT LEAF 17 is a schematic side view of the embodiment of FIG. 9 in use.
- FIG. 22 shows two schematic half-sections of the side view of FIG. 20 along lines A-A and B-B,
- FIG. 23 is partial views of FIG. 20 with the flap open, the flap partially closed and the flap completely closed
- 29, 30, 31, 32 and 33 each show a view from below, a top view, side view, half rear view (left half) and half front view (right half) and a sectional view of FIG. 31 along the line AA, one detector device according to the invention,
- 34 shows a block diagram of a transmitter for an ultrasound measuring device
- 35 shows a first embodiment of an evaluation device for an ultrasound measuring device
- FIG. 36 shows a second embodiment of an evaluation device for an ultrasound measuring device
- 37 shows a third embodiment of an evaluation device for an ultrasound measuring device.
- the guide device according to the invention shown in FIGS. 1, 2 and 3 is designed in the form of a plug-on body 40 which can be placed on a detector device.
- a detector device can have, for example, the shape of the detector device shown in FIGS. 5 to 7.
- This plug-on body has a cavity 41, the shape and size of which is adapted to the detector device and, as can be seen, for example, from FIGS. 8 and 9, covers the front part of the detector device.
- the plug-on body 40 has a groove or channel 43 on its upper side 42 and has two adjoining inclined surfaces 44, 45 and two lateral inclined surfaces 46 in the front lower region (cf. also FIGS. 11 and 12).
- a gel pad 60 is provided at the front end 48 of the plug-on body 40.
- the gel pad is preferably removable. It ensures a low-reflection transition from ultrasound waves of the detector device to the relevant body location and in the opposite direction.
- a support 50 extends from the upper edge 42 and has a guide 52 for a cannula of a puncture device.
- the detector device according to the invention shown in FIGS. 4, 5, 6 and 7 has a substantially cuboid housing 10 which completely accommodates an ultrasound measuring device.
- a groove 13 for receiving a syringe body of a syringe (not shown) is formed on its upper side 12.
- the housing 10 has an end face 18 at the front end on, which is substantially perpendicular to the axial direction of the groove 13.
- first display devices 115a with, for example, two LEDs " and second display devices 115b with, for example, seven LEDs are arranged on the top 11 of the housing.
- the first optical display device serves, for example, to display the type of vessel, while the second display shows, for example, the intensity of the reflected signal or the position and depth of the vessel to be punctured.
- the detector device is preferably provided with a rechargeable battery, which can be used e.g. can be connected to a suitable power supply unit via contacts 70 at the rear end.
- FIGS. 8, 9 and 10 the plug-on body from FIG. 1 is plugged onto the detector device shown in FIG. 4.
- a new sterile plug-on body is preferably attached before each puncture.
- the plug-on body is pushed over the front end of the detector device until the end face 18 of the detector device lies against the gel cushion 60 of the plug-on body 40.
- a syringe 20 is inserted into the groove 43 on the upper side 42 of the plug-on body 40, the cannula 22 pointing forward and being supported and guided by the support 50 while it is still in motion the syringe plunger 26 protrudes beyond the rear end of the plug-on body 40.
- FIGS. 11, 12 and 13 show a second embodiment of a guide device according to the invention in the form of a plug-on body, which essentially corresponds to the first embodiment but has an extendable protective cover 54 at the rear end.
- the protective cover 54 is
- REPLACEMENT LEAF thereby insertable and extractable like an accordion, and serves to protect and for sterile sheathing of the detector device and, if necessary, of wire connections to an external device.
- FIGS. 14, 15 and 16 This second embodiment of a plug-on body according to the invention with a syringe 20 lying thereon is shown in FIGS. 14, 15 and 16. As can be seen in particular from FIG. 15, the plug-on body is plugged onto a detector device 10 according to FIG. 4.
- FIG. 17 shows a combination of a detector device and attached plug-on body 40, the front end of which lies against a skin surface 2.
- the ultrasonic measuring device of the detector device has a first transducer 92 and a second transducer 94, the first transducer 92 being directed essentially parallel to the upper side 41 of the plug-on body 40, while the second transducer 94 is inclined at an angle thereto, in the drawing is directed upwards.
- the transducers 92, 94 are connected to a transmitter 80 and an evaluation device 100, 200, 300, the result of which in turn is output to the display device 115, 215, 315.
- the arrangement of the transducers 92, 94 with respect to one another is selected such that their lines of action pass through the gel cushion 60 and the skin surface 2 and meet the vessel 4 to be located at a distance from one another.
- FIGS. 18 to 25 Another preferred embodiment of a guide device according to the invention, which is also referred to above as the casing, is shown in different views in FIGS. 18 to 25.
- Figures 26 to 28 show views of the gel pad used in this embodiment.
- This sleeve 400 serves to receive a detector device 500, as shown in FIGS. 29 to 33.
- the cover 400 has a gel pad 460 at the front end and at the rear end a flap 470.
- the flap 470 is attached by means of a double hinge 473 (cf. FIGS. 19, 20, 23-25) and can be pivoted on the upper side in the region of the rear end.
- a latching lug 472 On the side of the flap opposite the double hinge there is a latching lug 472 which can be brought into engagement with a groove 471 running on the underside of the casing 400 parallel to the rear edge. On the underside of the casing, three handle ulcers 490 are also indicated.
- the guide device for a puncture device such as a syringe body (not shown), is formed by two upright webs 431, 432 in this embodiment. These webs 431, 432 start at the front end of the sheath 400, run parallel to one another and are adapted in terms of their height, their length and their distance from one another to a puncture device to be guided.
- a needle guiding device 450 is disposed, .alpha..sub.i e TO E- guide the cannula is a syringe.
- this needle guiding device 450 projects obliquely upwards and forwards in the direction of the front edge of the sheath 400. As shown in FIG.
- the needle guide device consists of a left and right side part 451, 455, which form a slot 453 in the middle, the width of which corresponds to the diameter of a cannula.
- the side parts 451 and 455 each have a wing part 452, 453 which is arranged pivotably in the region of the slot and which can be pivoted in the manner of a saloon door, as a result of which the slot 453 is widened.
- an opening (hole) with an edge 485 is provided at the front end 480 of the casing 400.
- the one-piece gel cushion 460 is arranged at the front end thereof, which partially protrudes forwards and upwards through the opening in the front end.
- the front 461 of the gel pad is substantially parallel to the front edge of the sheath. The pre the side 461 comes into contact with the body part to be examined.
- the opposite back 462 of the gel cushion serves as a contact surface for a transducer 590 of a detector device 500 (see FIGS. 29 to 33).
- the gel cushion 460 has a circumferential notch line 466 into which the circumferential edge 493 of the opening engages.
- This mechanical intervention holds the gel pad 460 in place at the front end of the sheath 400.
- the gel pad completely fills the front space of the casing 400 and has an elevation 463 in the region of the front end. This causes a large-area contact with the body area to be examined and undisturbed radiation of the ultrasound.
- FIGS 23, 24 and 25 show the flap 470 in different open positions.
- the flap is pivoted upwards and the detector device 500 can be inserted or removed through the opening at the rear end.
- the latch 472 is in engagement with the groove 471.
- the double hinge 473 has additionally been pivoted in, as a result of which the flap 470 completely closes the rear opening of the casing 400.
- the detector device 500 (cf. FIGS. 29 to 33) is adapted in size and shape to the interior of the casing 400.
- the transducer 590 Arranged at the front end is the transducer 590, which protrudes slightly from the housing of the detector device 500.
- Illuminated displays 515a and 515b are arranged on the top of the detector device and protrude upwards.
- An indentation 520 is provided on the rear side, into which a plunger coil can be inserted for charging rechargeable batteries provided in the detector device 500.
- a switch 570 is also arranged on the top of the detector device. This switch is used to switch on the detector device and is also in the case 400 inserted detector device can be actuated by pressure on the corresponding wall point of the casing 400.
- FIG. 32 shows the rear view with the recess 520 on the one half and the front view with the transducer 590 on the other half.
- FIG. 33 shows a section along line A-A of the side view of FIG. 31.
- the embodiment described above has the advantage that the detector device 500 is completely enclosed by the sheath 400.
- the transducer 590 touches the back 462 of the gel pad over a large area, which is used for a good coupling of the ultrasound to the body site to be examined.
- the examples described above show hand-held devices that can be operated with one hand.
- the guide device or sheath is held together with the puncture device like a syringe with one hand, the vessel to be punctured is sought, the puncture is carried out and then the guide device is separated from the puncture device. That is, as soon as the puncture has taken place, the guide device and the syringe 20 can be separated from one another in a simple manner.
- Plastic is preferably used on the plug body. in the
- a sound transmission area a material which is permeable to ultrasonic waves, preferably a hydrogel based on polyacrylate, is used.
- the material of the plug-on body is preferably also translucent, so that the display devices 115a and 115b underneath can be seen in the embodiment shown in FIGS. 8 and 14, respectively.
- the display devices can be arranged in an area that is not covered by the plug-on body.
- Acoustic signal transmitters can also be used as a display.
- the device for determining the direction of flow (differentiation between artery and vein) and depth of the vessel to be punctured can be provided with an optical display and for determining the flow rate with an acoustic or an optical scale.
- the ultrasound transmitter shown in FIG. 34 comprises an oscillator 81, which preferably operates at a frequency of 8 MHz, an isolating amplifier 82 connected to the output of the oscillator, the output signal of which is passed to a pulse former 83, the output signal of which in turn is passed to two transducers 92, 94 via a power amplifier 84 and a transceiver 96.
- the ultrasound transmitter also has a control device 85 which can switch the oscillator 81, the isolating amplifier 82 and the power amplifier 84 on and off via a first output U A1 . Via a second exit .
- the envelope controller of the pulse shaper 83 is carried out U A2 of the control device 85.
- the continuous operation or the pulse operation of the transmitter can be selected via a first input U E1 of the control device 85.
- a second input U E2 of the control device 85 is used to trigger a pulse.
- Ultrasonic waves are introduced into the areas of the body to be examined and the reflected portions are received by the transducers.
- the received signal is passed via the transmission / reception switch 96 to an evaluation device 100, 200, 300 (FIGS. 35, 36 and 37).
- the crossover can be designed very easily or even be omitted entirely.
- the received signal is first passed to a limiter device 101, 201, 301
- REPLACEMENT tet which protects the following components from overstressing.
- a low-noise preamplifier 102, 202, 302 the output signal of which is passed via a bandpass filter 103, 203, 303 to an amplifier 104, 304 (cf. FIGS. 35 and 37).
- the bandpass preferably has a center frequency which corresponds to the transmission frequency, for example 8 MHz, and a bandwidth of 20 KHz, for example.
- the amplifier 304 is preferably designed as a logarithmic amplifier or as an amplifier with a fading control, since it is very easy to achieve the required reception dynamics.
- the output signal of the amplifier 104 or the bandpass filter 203 is applied to a mixer 106, 206, which also receives a reference signal from a local oscillator 105, 205.
- the output signal of the mixer is fed via a broadband termination for impedance matching 107, 207 to a low-pass filter 108, 208 directly or via a low-noise amplifier 204.
- the reference signal of the local oscillator 105 has a frequency of 7.99 MHz that can be tuned if necessary.
- the low-pass filter has a cut-off frequency of slightly less than 10 kHz, which essentially corresponds to the difference frequency of the input signal (8 MHz) and the reference signal (7.99 MHz).
- the output signal of the low-pass filter 108 is passed to a loudspeaker 115 via a voltage divider 109 and an LF amplifier 110.
- This purely analog evaluation device provides an inexpensive solution which is suitable for estimating the Doppler maximum and thus for locating vessels located under the skin surface.
- the frequency of the reference signal of the local oscillator 205 is preferably 7.95 MHz and the low-pass filter has a cut-off frequency of 40 kHz.
- the output signal of the low pass 208 is passed via a limiter 209, a low pass 210 and a driver circuit 211 to an analog / digital converter 212 (16 bits).
- the limiter serves to protect the ADC from destruction and from temporary malfunction when the area is exceeded.
- the low-pass filter directly in front of the ADC removes harmonics which arise due to the limitation and which would be folded back into the fundamental wave range by the scanning process.
- a sampling clock generated by a clock generator 216, with which the input signal is sampled, is applied to the analog / digital converter 212.
- the output signal of the analog / digital converter 212 is sent to a signal processor .213, the result of which is output on a display 215.
- the preamplified and band-limited received signal is applied directly to an analog / digital converter 308 via a limiter with low-pass filter 305 and a driver circuit 306.
- a clock generator 307 supplies a sampling clock to the analog / digital converter 308 with which the received signal is sampled.
- the sampling clock has a frequency of 20 MHz, while the received signal has a frequency of 8 MHz.
- the output signal of the analog / digital converter 308 (20 M words / s) is sent to a signal processor 309, preferably with DMA logic (direct memory access).
- the result of the calculations of the signal processor 309 is output on a display 315.
- the display is preferably carried out on a graphic display as in a notebook PC.
- the option is
- REPLACEMENT LEAF Evaluation device arranged separately from the guide device and both are connected to one another via signal connections such as lines or light guides.
- a portable, electronic device with which medically trained personnel can easily position e.g. of a vein under the surface of the skin and even veins deep below the surface of the skin can be safely punctured with a syringe or a venous catheter.
- the device can be operated with one hand and enables observation by means of ultrasound, direct contact between the detector and the ultrasound head being avoided with the patient's body and the user, so that the detector, including the ultrasound head, is not used before use must be sterilized.
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- Surgery (AREA)
- Medical Informatics (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Pathology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
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Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP93904027A EP0627894A1 (de) | 1992-02-27 | 1993-02-26 | Vorrichtung zur führung einer punktionseinrichtung und deren kombination mit einem handgerät zum auffinden von gefässen |
JP5514546A JPH07504101A (ja) | 1992-02-27 | 1993-02-26 | 穿刺器具の案内装置及びその血管探当て用携帯器具における使用 |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US84249292A | 1992-02-27 | 1992-02-27 | |
US07/842,492 | 1992-02-27 | ||
DE19924206065 DE4206065C2 (de) | 1992-02-27 | 1992-02-27 | Medizinische Trägervorrichtung für eine Gefäßpunktionseinrichtung |
DEP4206065.6 | 1992-02-27 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1993016640A1 true WO1993016640A1 (de) | 1993-09-02 |
Family
ID=25912265
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP1993/000453 WO1993016640A1 (de) | 1992-02-27 | 1993-02-26 | Vorrichtung zur führung einer punktionseinrichtung und deren verwendung mit einem handgerät zum auffinden von gefässen |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP0627894A1 (de) |
JP (1) | JPH07504101A (de) |
AU (1) | AU3499493A (de) |
CA (1) | CA2129015A1 (de) |
WO (1) | WO1993016640A1 (de) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1996015446A1 (en) * | 1994-11-09 | 1996-05-23 | Commonwealth Scientific And Industrial Research Organisation | Particle property measurement |
WO2003007820A2 (en) * | 2001-07-18 | 2003-01-30 | Cardiosonix Ltd. | An ultrasonic transducer probe and a measurement device utilizing the same |
US8199189B2 (en) | 2006-04-07 | 2012-06-12 | Novarix Ltd. | Vein navigation device |
WO2021040619A1 (en) * | 2019-08-23 | 2021-03-04 | Medulla Pro Technology Pte. Ltd. | Apparatus, system and method for facilitating ultrasound medical imaging |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP5274740B2 (ja) * | 1999-09-08 | 2013-08-28 | グレイゼル,ジョセフ | ハンドルアセンブリ |
JP4581750B2 (ja) * | 2005-03-04 | 2010-11-17 | 株式会社ジェイ・エム・エス | カテーテル挿入用シース |
US8478386B2 (en) * | 2006-01-10 | 2013-07-02 | Accuvein Inc. | Practitioner-mounted micro vein enhancer |
CN104739370A (zh) * | 2013-12-31 | 2015-07-01 | 环达电脑(上海)有限公司 | 具有血管识别定位功能的电子装置及其方法 |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0104618A2 (de) * | 1982-09-24 | 1984-04-04 | Advanced Technology Laboratories, Inc. | Keimfreie Schutzhülle für ein Ultraschall-Abtastgerät |
US4877033A (en) * | 1988-05-04 | 1989-10-31 | Seitz Jr H Michael | Disposable needle guide and examination sheath for transvaginal ultrasound procedures |
CH676787A5 (en) * | 1989-08-30 | 1991-03-15 | Sulzer Ag | Puncture needle device for blood vessel - uses ultrasonic transceiver enclosing needle for accurate location of blood vessel |
EP0467291A1 (de) * | 1990-07-17 | 1992-01-22 | Acuson Corporation | Nadelführung zur Befestigung auf einem Abbildungsultraschallwandler |
EP0516582A1 (de) * | 1991-05-27 | 1992-12-02 | SULZER Medizinaltechnik AG | Punktiergerät für Blutgefässe |
-
1993
- 1993-02-26 EP EP93904027A patent/EP0627894A1/de not_active Ceased
- 1993-02-26 WO PCT/EP1993/000453 patent/WO1993016640A1/de not_active Application Discontinuation
- 1993-02-26 CA CA 2129015 patent/CA2129015A1/en not_active Abandoned
- 1993-02-26 AU AU34994/93A patent/AU3499493A/en not_active Abandoned
- 1993-02-26 JP JP5514546A patent/JPH07504101A/ja active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0104618A2 (de) * | 1982-09-24 | 1984-04-04 | Advanced Technology Laboratories, Inc. | Keimfreie Schutzhülle für ein Ultraschall-Abtastgerät |
US4877033A (en) * | 1988-05-04 | 1989-10-31 | Seitz Jr H Michael | Disposable needle guide and examination sheath for transvaginal ultrasound procedures |
CH676787A5 (en) * | 1989-08-30 | 1991-03-15 | Sulzer Ag | Puncture needle device for blood vessel - uses ultrasonic transceiver enclosing needle for accurate location of blood vessel |
EP0467291A1 (de) * | 1990-07-17 | 1992-01-22 | Acuson Corporation | Nadelführung zur Befestigung auf einem Abbildungsultraschallwandler |
EP0516582A1 (de) * | 1991-05-27 | 1992-12-02 | SULZER Medizinaltechnik AG | Punktiergerät für Blutgefässe |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1996015446A1 (en) * | 1994-11-09 | 1996-05-23 | Commonwealth Scientific And Industrial Research Organisation | Particle property measurement |
US5952560A (en) * | 1994-11-09 | 1999-09-14 | Commonwealth Scientific And Industrial Research Organisation | Particle property measurement |
WO2003007820A2 (en) * | 2001-07-18 | 2003-01-30 | Cardiosonix Ltd. | An ultrasonic transducer probe and a measurement device utilizing the same |
WO2003007820A3 (en) * | 2001-07-18 | 2003-05-15 | Cardiosonix Ltd | An ultrasonic transducer probe and a measurement device utilizing the same |
US8199189B2 (en) | 2006-04-07 | 2012-06-12 | Novarix Ltd. | Vein navigation device |
WO2021040619A1 (en) * | 2019-08-23 | 2021-03-04 | Medulla Pro Technology Pte. Ltd. | Apparatus, system and method for facilitating ultrasound medical imaging |
Also Published As
Publication number | Publication date |
---|---|
EP0627894A1 (de) | 1994-12-14 |
JPH07504101A (ja) | 1995-05-11 |
AU3499493A (en) | 1993-09-13 |
CA2129015A1 (en) | 1993-09-02 |
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