WO2000038572A1 - Chronically implantable blood vessel cuff with sensor - Google Patents
Chronically implantable blood vessel cuff with sensor Download PDFInfo
- Publication number
- WO2000038572A1 WO2000038572A1 PCT/US1999/029785 US9929785W WO0038572A1 WO 2000038572 A1 WO2000038572 A1 WO 2000038572A1 US 9929785 W US9929785 W US 9929785W WO 0038572 A1 WO0038572 A1 WO 0038572A1
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- Prior art keywords
- sensor
- set forth
- medical device
- implantable medical
- fixture
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6876—Blood vessel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/021—Measuring pressure in heart or blood vessels
- A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6879—Means for maintaining contact with the body
- A61B5/6884—Clamps or clips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0031—Implanted circuitry
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
- A61B5/414—Evaluating particular organs or parts of the immune or lymphatic systems
- A61B5/418—Evaluating particular organs or parts of the immune or lymphatic systems lymph vessels, ducts or nodes
Definitions
- This invention relates to the field of implantable monitoring devices and is partially suitable for long term monitoring of physiologic parameters including most particularly blood pressure from small arteries.
- External devices include those described in US patent No. 3,926,179, and three which describe a watch mounted external device, US patent No. 4,802,488;
- a device to enable the continuous chronic monitoring of patient blood pressure automatically and at low cost.
- To provide such a device without the requirement for vascular access and which could safely monitor the left side of the vascular system as well as the venous system would be of no small additional benefit.
- Such devices as are described herein can be applied to monitoring patients with hypertension without cumbersome discrete point analysis over long terms with many hospital or clinic visits. Dosage accuracy can be enhanced with continuous long term monitoring of blood pressure for administration of hypertensive medications.
- the applicability of this invention is not limited to sensing blood pressure however. It should be recognized right from the start that the invention described herein can be used to obviate the use of many sensors which otherwise would require implantation into an active artery or vein system.
- a profile of patient status during activities of daily living and over prolonged intervals can accurately depict the patient's true hemodynamic health status over months of use.
- Such automatic monitoring circumvents patient compliance and operator compliance issues which are problematic in the use of external devices.
- the fixture with sensors concepts described herein can be applied to peripheral, internal and neurologic blood and other fluid pressures, flow and so forth.
- Carotid arterial blood pressure, pulmonary venous blood pressure and cerebral ventricular pressure associated with hydrocephalous are just three examples.
- the device could be used to monitor the formation of transudate and exhudate fluids, such as in conditions of subcutaneous edema.
- the device can of course be useful as a research tool, and may find many uses in veterinary medicine and monitoring.
- Fig. 1 is a perspective view of a preferred embodiment.
- Fig. 2 is a perspective of another preferred embodiment of the invention.
- Fig. 3 is a cut away view of Fig.2.
- Fig. 4 is a cut away view of the upper portion of the embodiment illustrated in Fig. 2 taken at line 4-4 of Fig.2.
- Fig. 5 is a frontal view of the embodiment described with respect to Fig.
- Fig. 6 is a top view of the device of Fig. 2 .
- Fig. 7 is a sectional view taken at line A A of Fig. 5.
- Fig. 8 is a sectional of Fig. 6 taken at line BB.
- Fig. 9 is a side view of one embodiment of the sensor fixture in accord with the invention.
- Fig. 10. is a back view of the fixture of Fig. 4.
- Fig. 1 la is a side view of another embodiment of the invention surrounding an arteriole artery or other blood vessel which is pinched off to fit into an inventive fixture in accord with a preferred embodiment.
- Fig. lib. is another side view of the fixture and blood vessel of Fig. 11 with the normal flow restored.
- Fig. 12 is an illustration of am implantable medical device for monitoring data produced by the inventive fixture connected to it by a lead.
- Fig. 13 is a view facing an inner sensor laden surface of the tunnel or passageway space for containing a living body's blood vessel as it may be constructed in accord with a preferred embodiment of the invention.
- Fig. 14 illustrates a sensor array having an emitting element, a receiving element and their position within the inventive fixture relative to a blood vessel.
- Figs. 15 a-e are illustrations of arterial blood vessel locations suitable fore use with one preferred embodiment of the invention.
- Fig. 16A is a perspective view of a preferred embodiment fixture configuration and connection to a lead.
- Fig. 16B is a side view of the top portion of the device illustrated in Fig. 16 A.
- Fig. 16C is a facing view of the top portion of the device of Fig. 16A.
- Fig. 17 is a side view of a preferred embodiment similar to that of Fig. 16A.
- Fig. 18 is a cross sectional view of a cable or lead in accord with a preferred embodiment of the invention.
- Fig. 19 is a cross sectional view of an alternative embodiment of the inventive fixture.
- Fig. 20 is a perspective view of another preferred embodiment of the invention.
- Figs. 20A-E are cross sectional slices of the interior surface of the internal space, tunnel, or passageway for containing blood vessels in accord with a preferred embodiment of the invention, each is taken from section lines A-E as illustrated on Fig. 20.
- Fig. 21 is a perspective view of another preferred embodiment.
- Figs. 22 and 23 are partially sectioned perspective views of two preferred embodiments.
- Fig. 24 is an exploded perspective view of a preferred embodiment of the invention, illustrating one manner of connecting two components in accord with the inventive concepts described herein.
- Fig. 25 is an assembled structure of the exploded view of Fig. 24.
- Fig 26 is a side view of one form of the upper part of the fixture in accord with a preferred embodiment.
- Figs. 27 A, 27B and 27C are a facing view, and two secitional views of the device of Fig. 26.
- the sensor system consists of a side-sensing chronically-implantable absolute pressure sensor incorporated into the inventive structure.
- This sensor may be similar or identical to the one described in US patent No. 5,564,434.
- US patent No. 5,564,434 To avoid unneeded prolixity, the just above mentioned and all subsequently mentioned patents are incorporated herein in their entireties by this reference sentence, and this sentence is operative to so incorporate all such mentioned patents at each such mention without the need of repeated recitation of this statement or its equivalent at the location of such mention.
- the pressure sensor is packaged inside or in close and operative association with a clamp type structure which we often refer to as a fixture which holds an artery against the sensor diaphragm or against the pressure transferring medium (such as silicone or medical grade adhesive) capable of accurately transferring or transporting pressure from the artery side wall to the sensor diaphragm.
- the shape of the artery channel through the fixture's clamp-like structure is such that it slightly deforms the artery to provide a flattening of the artery (in cross section) in the region where it passes over the sensor diaphragm or the silicone adhesive between the sensor diaphragm and the artery.
- This flattening of the artery causes pressure interior to the artery to be supported by the sensor structure rather than the artery wall structure. This causes the arterial pressure to be passed through the artery wall to be detected by the pressure sensor.
- This effect can be enhanced by varying the shape of the tunnel or channel through which the vessel is placed as described in some detail below.
- Calibration can be effected if required once the device is in place which may account for variations in wall thickness or other features of the vessels or for other reasons known in the pressure sensor art.
- Another feature of the clamp structure is on the opposite side (in this preferred embodiment) from the pressure diaphragm. What can be described as a slit is provided along the length of the clamp structure, this slit being substantially narrower than the diameter of the artery.
- the artery is inserted into the clamp by squeezing the artery (or clamping it off upstream) and passing it's collapsed form through the slit and than releasing the artery and allowing it to spring out to conform to the shape of the insides of the clamp's channel.
- the pressure inside the artery will tend to keep the artery confined within the clamp channel without the need of any additional fastening hardware, thus reducing the likelihood of complications.
- the artery can further be secured within the fixture (which we sometimes call an artery cuff) by forming the access slit in a serpentine shape, that is having a curved cut through which the filled vessel cannot easily slip out, once it has become secured within the fixture.
- this invention allows for the measuring for pressure within a artery or other vessel (like a vein) through a vessel wall by causing a flattening of the vessel at the point of sensing. It teaches the method of inserting and retaining a vessel within the clamp's structure to hold the vessel against the pressure sensor. It provides a second pressure sensor on the backside of the arterial pressure sensor this second sensor not being in contact of the vessel which can be used to measure ambient pressure for calculation of "gage" pressure. This invention provides for chronic measurement for arterial pressure through the arterial wall without needing to contact the inside of the blood vessel.
- sensors for sensing other physiologic parameters could either supplement the pressure sensor or replace it as described elsewhere in more detail.
- temperature could be sensed and used for various purposes such as was described for rate control in pacing in US patent No. 5,005,574 or 4,803,987 ( incorporated herein by this reference), or temperature could be used as just another physiologic sense to monitor for therapeutic, research, drug titration and other medical purposes.
- Other sensors could provide additional data for similar medical uses like optical sensors for oximetry or pulse oximetry and even partial pressure of oxygen can be measured and stored or used for various purposes. An example of a sensor that could be used for this is described in a patent incorporated herein by reference; US Patent No.
- a device 10 illustrates a preferred embodiment of the invention.
- the device 10 is constructed of an outer shell 11 continuous with the inner surface 15. It is essentially a tubular shape having a slit 14 therein extending along the length. The length is indicated by arrows 13 and the slit opening has two opposing surfaces 16 and 17 which are narrow relative to a deeper passage P which forms the main portion of the tunnel through the device 10 beneath the slit 14.
- the sensors will be housed within the area between the passage P and the outer surface 11 indicated here by arrows 12.
- the surface 15 will be modified to accept the active end of any sensors employed, for operational effectiveness. Alternatively other areas of the surface of the tunnel passage P's walls may be used.
- the device may be built of metal or plastic which is tolerated for long term implantation into a living body.
- Implantable medical devices are commonly constructed of titanium currently; and ceramic, plastic, and silicone are among other commonly used materials for implanted medical devices. Any biocompatitable material maybe used. Our first embodiments tested were constructed of titanium.
- Fig. 2 illustrates another preferred embodiment of the invention.
- the device 20 has a passage there through, extending from the sides with openings 21 to area
- the device 20 has a slit 22 with two opposing surfaces 23 and 24. These are rounded into the external shape of the device 20 and continuous with the external surface 25 and 26 as well as with the substantially flat internal surface 27.
- the active diaphragm surface 1 is in this embodiment the functional equivalent or similar to the diaphragm 54 of the 5,564,434 patent referred to above. Any deflection of this diaphragm 1 will register a change in pressure by the pressure sensor. As with any sensor, this will produce a signal that has a value which can be stored, telemetered out, or used directly to affect the operation of an implantable medical device. The same is true with all the sensors in all the embodiments.
- the aperture defined by wall 28 extends up to the surface 27a of device 20a.
- This aperture will be filled in by medical adhesive in the preferred embodiment to transmit pressure directly from the blood vessel, (an arteriole in the preferred embodiment).
- the blood vessel will be captured within the clamping structure 20a lying along surface 27a.
- the diaphragm in the case of the pressure sensor, or other active surface of any other sensor
- Fig. 3 device may be illustrated more simply with reference to the cross section in Fig. 4 in which the sensor structure 41 is shown attached to the medical adhesive or pressure transfer medium Ps, through which the arterial pressure Pa, will be transmitted through the flattened arterial wall lying against the pressure transmission medium.
- the arms 42 and 43 provide the clamping structure that holds the artery in place for the sensor measurement to be made.
- these arms 42 may be covered with light reflective surfaces, or alternatively may also contain sensors instead of or in addition to the surface 27a.
- the artery or other vessel wall 44 may bulge into the gap between arms 42 and 43.
- the absolute size of the implanted sensor device can be adjusted to any specification so as to fit around the particular arterial, artery, vein, venuole, or other vessel through the wall of which one desires to make physiological measurements.
- numerals indicate the size in centimeters of a preferred embodiment fixture similar to that shown in cross section in Fig. 3.
- the inventive fixture 90 is shown in side view.
- the line 95 indicates the location of the flat surface and the line 96 indicates the location of the base of the slit or opposite to the flat surface. Taken together they define one diameter of the tunnel passageway that runs through the fixture and in which the vessel should rest when in use.
- a depression 91 is seen from this view.
- This depression is formed in the titanium block from which the fixture is formed in order to make the opening between the pressure sensor diaphragm on the surface coextensive with line 95.
- the outer edge of the generally flat, sensor bearing surface of the clamp's passageway can be seen at 107.
- the space 106 is the slit through the opposite side of said passageway. Openings 102 andlOl are the stop and entry ends for the pressure sensor which will be inserted into the fixture 100 to make the completed device.
- Fig. 11a and l ib illustrate the preferred method for having a body vessel (preferably a blood vessel) become surrounded and held by the clamp device, that is, the fixture, of this invention.
- a clamp 92 can be used to prevent the continuing flow of blood through a vessel 91 thereby producing a collapsed vessel 93.
- This collapsed vessel can easily be slid through the slit at the top of device 90 so that it rests within the passageway as shown.
- the clamp 92 is removed (see Fig. lib).
- the blood can flow through the vessel 91b thus clamping the vessel into the passageway in the clamp part 94 of device 90b.
- Additional physical features may be connected to the clamp device such as wings 95 or suture holes (not shown) which could be sewed onto tissue within the body to further stabilize the device, although when used with arterial vessels we have found no need for such further stabilization.
- a clip may be fit over the top of the slit to help ensure that the vessel cannot escape the clamp.
- a clip is illustrated on Fig. 1 as clip 4, having flat stabilizing ends to keep it from rotating around the fixture 10, and the fixture 10 should have bumps or ridges 5 and 6 to keep the clip from sliding, or some other detent and ridge or other mechanical arrangement could be used to ensure the clip 4 does not slide once in place.
- an implantable medical device 81 is illustrated having a body 87 containing a power source and appropriate electronics for powering and reading out data from the sensors in the device 85.
- Device 85 is connected to the inventive structure by a lead 83 in the preferred embodiment.
- This lead may be similar in construction to leads currently used in pacemakers and cardio defibrillators and the like in that they contain a conductor for bringing electric power to and from the sensor device in the clamp 85.
- the device may contain its own power supply circuitry, communications circuitry and so forth as desired. Presently it is most preferred that only the sensor (s) and some electronics associated with processing the transducer signals for such sensor(s) be contained in a sensor capsule of the inventive device.
- Fig. 13 the lower surface of the passage 100 is shown separated from the device. The direction of blood flow is indicted by the arrows.
- two sensor areas 101 and 102 are provided to allow for differential readings upstream and down stream.
- a heater preferably a resistive heater
- a measurement of the temperature of the blood can then be taken at location 101 and 102 or at least at 102 and a determination made from these measurements relating to the viscosity of the blood itself or the speed of passage through the distance through the passage way between 101 or 101a and 102.
- This can be done using principles defined in US patent No. 5,486,107 to Bonne et al hereby incorporated in its entirety by this reference hereto, which describes the use of specific heat and thermal conductivity to determine characteristics of a gas flowing past a sensor array.
- Doppler sensors or ultrasound transducers may be used as were used in 5,409,009 patent cited above and incorporated herein by reference for determining flow or other physiologic parameters, using this or similar sensor array patterns or even located at a single point as is the pressure transducer of the first disclosed embodiment.
- the internal passageway 110 of an inventive clamp device may have an infra red sending and receiving array 111 and 112 mounted into the wall thereof so that the light L can penetrate the vascular wall VW and provide measurements for indications for the percentage of oxygen's satiation of the blood passing through the passageway 110.
- these sensor locations can be adjusted to be on opposite sides of the fixture and the vessel, for example at points 113 and 114. Further, such configurations can be useful for impedance sensing to measure flow rate, viscosity and the like or for employing Doppler transducers for similar measurements.
- a feedback loop can be created using the measurements taken by sensors in the clamp device to deliver therapy to a living body into which the clamp device has been implanted.
- a fast acting blood pressure medication maybe monitored on a moment by moment basis throughout a patients daily activities by the use of such a clamp device associated with measurement circuitry and possibly processing circuitry and memory circuits implanted therewith.
- Data from the fixture device sensors can be used to modify programs for generating electrical pulses to stimulate nerves and to adjust pacing rate by coordination with an implantable pulse generator that has leads directing electrical energy to the appropriate bodily tissue.
- Fig. 15 a illustrates an arm having three highlighted locations for preferable mounting of the inventive blood pressure fixture in accord with this invention.
- the Axially Artery provides another apt location in Fig. 15 b.
- the Inguinal, and Femoral arteries as well as the posterior Tibial artery in Figs 15 c and d, respectively provide additional useful locations as do the Radial Ulnar and Superficial Palmar arteries shown in Fig. 15 e.
- Each of these locations provides particularly useful information and a combination of locations can be used so as to provide for a systemic or overall reading or to indicate that there is an imbalance in a given area or across the system.
- a perspective view of a fixture 130 A has a cable 136Tinking a pressure sensor, (not visible here)connected at a linking junction 137 to the fixture 130A. It is recognized that not all vessels to which the fixture will be used to surround will be of the same size and consequently, the inventive device will be made available in multiple sizes. The surgeon will select the appropriate sized fixture for the vessel and snap the pressure sensor into the one selected, either before or after the blood vessel is surrounded by the passageway in the fixture.
- the fixtures can be constructed of hylon or similar suitable biocompatible plastic, such as may be used in connector blocks for pacemakers or other implantable medical devices with electrical leads currently, or of ceramics or metals that may be acceptable.
- a block of medical adhesive will have been formed in the well 134 prior to the surgeon connecting the pressure sensor into the fixture 130A.
- the opening at 133 is what is left after wire electric discharge machining.
- Fig. 16A Details in the construction of the device of Fig. 16A can be more clearly seen with reference to Figs. 16B and 16C.
- Fig. 16B The structure 130s is the same as the top portion of the device 137a.
- a titanium block that has been electric discharged machined to produce the outer configuration shown in these Figs. 16A-C, including the tunnel like passage way 195 having the base 135 and a slit 134 at the top.
- the electric discharge machining first produces the slopped sides (if desired for the final design,) and then produces the tunnel like through passage way 195 and the slit 134.
- the rectangular passageway 133 must be machined very carefully because this step produces the pressure diaphragm itself.
- the lower surface of the pressure diaphragm which will be inside the pressure capsule is illustrated at line 139 in both figures 16B and 16C.
- a circuit board CB containing the sensor package 139a will be inserted in the area 133a machined from the area of the block opposite the slit 134.
- the preferred thickness of the diaphragm formed by the lower surface of the hole provided at 133 and the upper surface provided in area 133a should be on the order of approximately 0.001 inches.
- the cable 136 may be preferably manufactured with two conductors as illustrated in cross section 180 in Fig 18, with one center wire 181 surrounded by a cabled or wound wire 183 spaced apart from each other by silicone or medical adhesive or other biocompatible and preferably non-conductive material in layer 182.
- a sheath layer 184 surrounds the outer conductor.
- a current pacing lead construction with two coiled metal conductors would suffice as well, and many variations are possible, including merely twisted pair wires, straight conductors and the like.
- a coaxial configuration is preferred only because a less noisy signal will be obtained with such a structure.
- fiber-optic communications channels and their uses with sensors become better able to handle the stresses of implant by technological innovation, such cables may also be employed, and perhaps preferred.
- a side view of a structure like that of Fig. 16 is shown in cross section 140.
- the connecting cable 143 provides signal and power to what in the preferred embodiment is a titanium capsule 141 having two sensors at deformable membranes or plates 146 and 147, one at 147 being useful as a reference sensor.
- a reference sensor is used for any sensor, common mode noise can easily be canceled as is known in most sensor art fields.
- a value close to gage pressure can be obtained, as well as the differential represented by the value of the blood pressure signal. Accordingly, with such an embodiment we can cancel the effects of atmospheric pressure fluctuation as would be done in this art.
- the sensor under plate 146 would sense the blood affected pressure through a window of preferably something that will transmit a regular approximation of the blood pressure in the vessel above it, such as cured medical adhesive, and the ambient or atmospheric pressure will be sensed above the plate 147, which faces an area of stable body tissue or is blocked off from it.
- a pressure sensor could be mounted within a capsule implanted in a more stable area of the body for use as the reference sensor.
- the sensor capsule 141 is fixedly mounted or formed into the fixture surrounding it which from this cross section is seen to be mainly comprised of the passageway supporting section 142 through which the vessel will be mounted when in operation and the retaining portion 148.
- a dotted section is shown at 149 which could be formed of the same hard plastic that preferably forms sections 148 and 147, which if perforated to allow fluid access to the window 144 will provide a good environment for reference pressure measurements.
- the outline of such a reference sensor is illustrated at 227, and the perforations at 228.
- An alternative embodiment 190 is viewed cut across the tunnel shaped passageway 195 into which the vessel would be mounted in Fig. 19.
- the slit or opening 192 is near the flat internal surface 191, which indicates that the inventors considered the relative location to be non-critical. That is, it is not believed that the opening and the flat surface must be on opposite sides to perform sufficiently well to function. In fact, if one does not use a pressure sensor, it may not be necessary to flatten one side or even a part of one side of the inner surface of the tunnel like passageway.
- Also illustrated in Fig 19, is the potential for maintaining all electronics, power sources telemetry, memory and other processing circuitry in direct contact with the sleeve or tunnel like passageway which will surround the vessel.
- Fig 19 this is shown with an adjoining housing area 193, which can be of any convenient shape. It is expected that in most preferred uses, the smallness of the sensor fixture will be of paramount importance, so such circuitry will at least for the near future be mounted in a housing separated by a conductor containing lead from the fixture. For some applications a fiber-optic cable may be preferred or may supplement the electrical conductors.
- a sensor fixture could be mounted around the radial artery or vein with a pressure sensor mounted in the fixture, and a conductor bearing lead tunneled through the arm to an implantable pulse generator in the patient's chest.
- This sensor would provide feedback regarding changes in the pressure within the patient's body at the extremity and this measurement set could be used to modify stimulation pulses sent by the pulse generator mounted in the chest t, for example, by sending pulses of greater intensity or duration to the carotid sinus through another electrical medical lead connected to stimulate at that location.
- data in the sensor measurements provided by sensors mounted in the fixture can provide the basis for adaptive closed loop programs that provide changes in heart pacing stimulation or drug delivery from implanted drug pumps.
- the fixtures could be mounted to any body vessel including but not limited to bile ducts, pancreatic ducts, seminal vesicles, lymph vessels or any of the tubes involved in the Kidney function or the excretion of urine downstream therefrom, in short, on any vessel through which a fluid may flow, so as to take measurements of that fluid.
- the squeezing off of the body vessel provides for a smaller outer diameter that can fit through the opening or slit in the fixture, and then the vessel upon release will fill or overfill the internal diameter of the tunnel shaped passageway becoming thereby fixed thereto so that repeatable reliable long term measurements can be taken by a sensor structure mounted into the internal surface.
- a thin lead 204 can be connected to an end of the pressures sensor capsule 202 if desired.
- This lead 204 may be much thinner than a cardiac pacing lead (for example) since no coiling would be required for a conductor in such a lead.
- Optical communication could of course take place over an optical fiber (in lead 204) if the circumstances of the device suggests such a design would be preferred.
- use of not connected telemetric pathways for communications with the implantable device are an option and such communications with implantable medical devices has been known for some time.
- the fixture for holding the blood vessel 205 again is shown to contain a tunnel or passageway 201 having a slit 203 along one side of it between the arms 205a and 205b of the fixtures body 205.
- the internal diameter of the tunnel space 201 is taken in views of the sections A-E, illustrated in an abbreviated form in figures 20A-20E.
- the slit width dA-dE does not vary substantially in this preferred embodiment, even though the internal configuration of the tunnel does.
- Each of the internal diameters taken from the view lines A-E of Fig., 20 can be described as two rough semi circles, concave sides facing but spaced apart the length of a relatively flat line on the bottom which joins the semi circles 210-214, this flat area, in the preferred embodiments, being a cross sectional of the preferred substantially flat area in which the sensor(s) are most efficaciously placed.
- the opening is nearly round where in the middle it is quite oblong and again round at the other side.
- the tunnel or interior space designed in this manner provides some resistance to length wise slippage of the fixture along the length of the vessel it's meant to surround as well as reducing the ability of the vessel to come out through the slit. It is also believed to enhance the sensing of pressure.
- a convolved, curved or serpentine slit design is shown in slit 225 on device 220.
- the pressure sensor capsule body 221 is again mounted to the fixture 223 but in this design, the lead 222 is built integrity with pressure capsule 221.
- This holding fixture 238 and pressure capsule 231 can be designed as an integrated device or assembled in the operating room by the surgeon to form device 230. As in the device illustrated in Fig. 20, an attachment mechanism for attaching the lead to the pressure capsule 231 is also illustrated at
- the device can be a 2 or 3 piece combination, that is, a capsule and lead joined to a fixture, or a capsule joined to the lead and the fixture separately.
- a pressure transmissible substance 235 preferably medical adhesive although other similar substances can be used
- an actual pressure diaphragm surface should mate smoothly with the interior surface 237 of the device
- Surround structure or tub 234 can be formed integrally with either the sensor and or pressure capsule 231 or with the material 233 of which the fixture is made, depending on whether it is easier to manufacture with the surround 234 holding the fixture to the pressure sensor capsule 231 or to the fixture 238.
- the inventive device 240 is again shown to be built of two main parts; the fixture 248 and the capsule in which the sensors are located 241.
- a pressure sensor diaphragm 246 is built below the upper surface of the mating tub 247 which will be filled with pressure transmissive substance in the preferred embodiment.
- the fixture 248 can simply be snapped over the mating tub 247 to employ a ridge of the same material as fixture 248 (not shown) which will mate with the detent 248 in the mating tub 247.
- pressure capsules like 241 are made of a metal like titanium, for this design it would be easiest to form the mating tub 247 with its mating detents 248 on the surface of that metal capsule.
- the next step would be to fill the tub with medical adhesive or other suitable pressure transmissive medium, wait for the pressure transmissive medium to cure, sterilize the whole thing and provide it to a physician or surgeon with a set of sized fixtures like that illustrated at 248.
- a kit could be provided so that the right sized fixture 248 could be picked from a kit of a range of such fixtures to mate with a single sterilized and prepared pressure capsule and lead combination.
- an oxygen sensor requiring that its sensor be touching the vessel would omit the steps of providing a pressure transmissive medium, and an impedance sensor may simply provide electrical connections to the fixture which may itself have electrodes mounted strategically around the tunnel formed by the fixture to contact the vessel most appropriately.
- Fig. 24 shows the combination 250 of the pressure capsule 252 having the mating tub 257 filled with pressure transmissible substance 247a which can come from one sterile package. Selecting the correctly sized fixture 251 and pressing it over the sensor package 252 will provide a reassuring snap to the physician when the internal ridges or ridge mate with the detent 253 and produce the device of Fig. 25, 260.
- Other mechanical links which may be well known in the art can be substituted for a ridge with mating detent. Bumps and detents, set screws and glue describe just a few of these.
- Fig. 26 and Figs. 27A-C are a facing view looking into the tunnel 264. It should be noted that this part of the device structure when assembled will hold the pressure capsule or other sensor housing at location 263 where the fixture curves inward toward the central passageway or tunnel 264. It can be noted that the upper portion of the tunnel 266 can be seen narrowing past this entry way which is nearly round at perimeter 265 from this view. Note also that the sidewall 262 corresponds to sidewall 262 on Fig. 26.
- a perimeter 265 of the tunnel can be seen as quite elliptical in shape and the curve of the slit 261 can be seen to have substantially moved in its location in Fig. 27B, the facing view taken at line B.
- a clip similar to that illustrated in Fig. 1 may be used to further insure that no blood vessel may escape the tunnel passageway 264.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP99968484A EP1139866B1 (en) | 1998-12-28 | 1999-12-15 | Chronically implantable blood vessel cuff with sensor |
AU25892/00A AU2589200A (en) | 1998-12-28 | 1999-12-15 | Chronically implantable blood vessel cuff with sensor |
DE69940355T DE69940355D1 (en) | 1998-12-28 | 1999-12-15 | PERMANENTLY IMPLANTABLE BLOOD VESSEL WITH TRANSDUCER |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/221,059 US6106477A (en) | 1998-12-28 | 1998-12-28 | Chronically implantable blood vessel cuff with sensor |
US09/221,059 | 1998-12-28 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2000038572A1 true WO2000038572A1 (en) | 2000-07-06 |
WO2000038572A9 WO2000038572A9 (en) | 2002-08-29 |
Family
ID=22826160
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/029785 WO2000038572A1 (en) | 1998-12-28 | 1999-12-15 | Chronically implantable blood vessel cuff with sensor |
Country Status (5)
Country | Link |
---|---|
US (1) | US6106477A (en) |
EP (1) | EP1139866B1 (en) |
AU (1) | AU2589200A (en) |
DE (1) | DE69940355D1 (en) |
WO (1) | WO2000038572A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
DE69940355D1 (en) | 2009-03-12 |
AU2589200A (en) | 2000-07-31 |
EP1139866A1 (en) | 2001-10-10 |
WO2000038572A9 (en) | 2002-08-29 |
EP1139866B1 (en) | 2009-01-21 |
US6106477A (en) | 2000-08-22 |
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