WO1985002123A1 - Appareil et procede pour transferer un liquide d'un recipient de stockage externe a un dispositif medical implante - Google Patents

Appareil et procede pour transferer un liquide d'un recipient de stockage externe a un dispositif medical implante Download PDF

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Publication number
WO1985002123A1
WO1985002123A1 PCT/US1984/001836 US8401836W WO8502123A1 WO 1985002123 A1 WO1985002123 A1 WO 1985002123A1 US 8401836 W US8401836 W US 8401836W WO 8502123 A1 WO8502123 A1 WO 8502123A1
Authority
WO
WIPO (PCT)
Prior art keywords
reservoir
pressure
fluid
septum
ambient pressure
Prior art date
Application number
PCT/US1984/001836
Other languages
English (en)
Inventor
Peter C. Lord
Original Assignee
Pacesetter Systems, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pacesetter Systems, Inc. filed Critical Pacesetter Systems, Inc.
Publication of WO1985002123A1 publication Critical patent/WO1985002123A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3507—Communication with implanted devices, e.g. external control
    • A61M2205/3523—Communication with implanted devices, e.g. external control using telemetric means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/04—Tools for specific apparatus
    • A61M2209/045—Tools for specific apparatus for filling, e.g. for filling reservoirs

Definitions

  • the invention relates to implantable* medical devices and, more specifically, to an i plantable drug pump and an associated external filling system.
  • Implantable drug pumps having a drug-containing reservoir in which the pressure is less than the ambient pressure are known in the art.
  • such an implantable drug pump is disclosed in U.S. Patent 4,373,527 to R. E. Fischell.
  • the purpose of a reduced-pressure reservoir is to prevent a drug contained within the reservoir from flowing outwardly into a user's body should a leak occur. Because the pressure within the reservoir is less than the ambient pressure, fluid will flow from the body into the reservoir whenever a leak occurs, thereby elimi ⁇ nating the risk of traumatic effects associated with an excess amount of the drug being inserted into a user's body.
  • Such drug pumps are usually filled with an external syringe-type device where pressure exerted by the syringe forces drug into the reservoir via a hypodermic needle.
  • a hypodermic needle is usually incor ⁇ rectly positioned with respect to an appropriate recepticle in the implanted drug pump, an excessive amount of concentrated drug could be injected into the user's body.
  • Various systems have been devised to eliminate this problem.
  • One system utilizes two needles and relies on an electrical continuity check to determine if the needles are located properly.
  • some prior art systems utilize sophisticated electronics to terminate filling when the reservoir is fill.
  • the present invention eliminates the need for these complicated, expensive and potentially unreliable systems by providing a simple and reliable apparatus and method for refilling an implantable drug pump having a drug storage reservoir which is maintained at a pressure lower than the ambient pres ⁇ sure external to the user's body.
  • the apparatus provided by the invention is completely passive, and allows fluid flow from the syringe to the implanted drug pump only when the needle is correctly posi ⁇ tioned within the " drug pump. *
  • the invention provides an apparatus and method for transferring liquid, the apparatus including an implantable medical device having a first reservoir means, an externally located liquid storage means for storing a liquid at an ambient pressure, a pressure reducing means for providing a pressure within the first reservoir means that is less than the ambient pressure, and a fluid communication means for provi ⁇ ding fluid communications between the liquid storage means and the first reservoir means whereby fluid at the ambient pressure can flow from the liquid storage means to the first reservoir means.
  • the invention provides an apparatus which includes an implantable drug pump having a fluid storage means which is maintained at a pressure less than that of the ambient pressure external to the implanted drug pump.
  • the liquid storage means can be a syringe- type device located externally with respect to a user's body, the syringe-type device including a liquid storage means and a hypodermic needle in fluid communication with the liquid storage means.
  • the liquid storage means is formed of a flexible material exposed to the ambient pressure.
  • the needle is inserted through the user's skin and into the pump so that an orifice near the tip of the needle is exposed to the less than ambient pressure within the implantable drug pump reservoir.
  • the ambient pressure external to the reservoir forces liquid from the syringe into the reservoir without any external pressure being applied by the user. Liquid will automatically cease .flowing when the reservoir is full.
  • the invention provides a completely passive apparatus for transferring liquid from the external storage device to the implanted reservoir without risk of the hypodermic needle being incorrectly positioned and liquid being forced from the external storage means directly into the user's body.
  • the invention also provides a unique mechanical valve that can be utilized with both a negative pres ⁇ sure and positive pressure liquid storage reservoir in an implanted medical device.
  • two volumes are provided in the implantable drug pump, one volume containing a liquid having a vapor pressure lower than the ambient pressure external to the user's body, and the second volume defining a drug-containing reservoir.
  • the two volumes share a common flexible wall.
  • the reservoir is maintained at a pressure less than the ambient pressure because of the reduced pressure in the other volume.
  • the reservoir is in fluid commu ⁇ nication with an injection chamber containing a novel mechanical valve.
  • the injection chamber is adapted to receive the end of the external hypodermic needle through a pierceable septum.
  • the pressure at an orifice near the end of the needle is less than the pressure external to the user's body.
  • fluid drug will flow from the external drug-containing storage container into the injection chamber and then
  • the invention provides an entirely passive apparatus and method for filling the reser ⁇ voir of the implanted medical device.
  • Figure 1 is a perspective view of an implantable drug pump provided by the invention
  • Figure 2 is a cross-sectional view taken along line 2-2 of Figure 1;
  • FIG. 3 is a perspective view of an embodiment of the valve means provided by the invention.
  • Figure 4 is the cross-sectional view of a syringe to be provided by the invention.
  • Figure 5 is a cross-sectional view of a further embodiment of a syringe provided by the invention. Detailed Description
  • an apparatus for trans ⁇ ferring liquid from an external storage device or syringe to an implanted drug pump having a liquid storage reservoir is disclosed.
  • the implantable drug pump is configured so that liquid in the storage reservoir within the drug pump is maintained at a pressure below that of the ambient pressure external to a user's body.
  • the syringe is configured so that liquid contained therein is subjected to the ambient pressure.
  • a hollow hypodermic needle having an exit aperture near its tip is in fluid communication with liquid contained within the syringe so that liquid will flow through the exit aperture whenever it is subjected to a pressure less than that of the ambient pressure.
  • the implantable drug pump includes a pierceable septum through which the end of the hypo ⁇ dermic needle can be inserted.
  • the storage reservoir in the drug pump when not full is subjected to a pressure less that ambient pressure, fluid will flow from the syringe via the hypodermic needle into the storage reservoir so long as this pressure dif ⁇ ferential exists.
  • the storage reservoir itself includes a movable diaphragm, one side of which pro ⁇ vides part of the storage reservoir surface.
  • a fluid material having a vapor pressure at body temperature less than the ambient pressure is present in a volume on the other side of the diaphragm, this lower pressure tending to reduce the pressure within the reservoir to a pressure less than the ambient pressure.
  • a unique valving scheme is disclosed in which a valve is opened by insertion of the needle through a septum, and is closed when the needle is removed from the septum.
  • an implantable drug pump 10 having a dispensing conduit 12 through which a drug 14 can be injected into a user's body.
  • An annular depression 16 is provided in one side of the drug pump 10 to appropriately guide a hypodermic needle for refilling a reservoir contained within the implantable drug pump 10.
  • a syringe 20 is shown having a hollow conduit or hypodermic needle 22 which has an orifice or exit aperture 24 located on the side of the needle 22 adjacent to the needle tip 26.
  • any fluid flowing through the hollow conduit or needle 22 will exit through the orifice 24.
  • the pressure adjacent to the orifice 24 is less than the ambient pressure of the fluid in the syringe 20, fluid will flow from the syringe 20 through the orifice 24.
  • the implantable drug pump 10 in Figure 2 is shown positioned below the skin 28 of the user.
  • the drug pump 10 includes a pump 30 which draws fluid from a drug storage reservoir 32 and provides it to the dispensing conduit 12.
  • Control electronics 34 are provided for controlling the pump 30 in accordance with either preprogrammed or telemetered program information which is stored within the control electronics 34.
  • a flexible diaphragm 36 is pro ⁇ vided, the diaphragm 36 being configured to form an annular bellows 38 around its periphery. The bellows 38 allows the diaphragm 36 to extend down ⁇ wardly in the direction of the arrow 40 so as to enlarge the volume of the storage reservoir 32.
  • a bellows 38 is shown, other means for allo ⁇ wing the diaphragm to extend downwardly could be utilized.
  • a somewhat corrugated diaph ⁇ ragm could be utilized which is formed of a flexible, impervious material such as titanium foil.
  • a liquid 42 is positioned in the volume 43 defined by the flexible diaphragm 36 and the case of the drug pump 10, the liquid 42 having a vapor pressure at the body temperature of the user which is less than the ambient pressure external to the user.
  • the liquid 42 will tend to reduce the pressure within the volume 43 and the reservoir 32 to a value less than the ambient pressure external to the drug pump 10.
  • the pressure within the reservoir 32 will be such as to tend to draw any liquid at ambient pressure into the reservoir 32.
  • Freon 113 is a satisfactory liquid 42 to use.
  • Other Freon materials and solvent" mixtures will be readily apparent to those familiar in the art. There are many other techniques which could be utilized to reduce the pressure with the storage reservoir 32.
  • the bottom.of the flexible diaphragm could be connected to the inner surface of the drug pump case by a spring under tension, the spring being located where the arrow 40 is located.
  • the volume 43 could be subjecting to a partial vacuum during manufacture, thereby exerting a downward pressure on the flexible diaphragm in the direction of the arrow 40.
  • the annular depression 16 is formed of a hardened ceramic material 46, although it could also be the same material utilized for the case of the drug pump 10.
  • the annular depression 16 is in the form of an inver- - ted truncated cone, the narrow portion of which is defined by a pierceable septum 48 which can be formed of any of a number of well-known, body-inert septum materials of the type which tend to be self-sealing subsequent to removal of a hypodermic needle.
  • an injection chamber 50 is formed by a hollow cylindrical struc ⁇ ture 52, the bottom portion of which rests on a sup ⁇ port platform 54, the lower surface of which defines the upper surface of the reservoir 32.
  • the pierce- able septum 48 is supported by the upper portion of the hollow cylindrical structure 52, and is in sealing contact with the hardened ceramic material 46.
  • the portion of the pierceable septum 48 which is exposed to the ambient pressure in the user's body defines a perforation area 56 through which the end portion of the needle 22 can enter the injection chamber 50.
  • a valve is also provided which includes a circular plate 58 having an annular ridge 60 around the periphery of its upper surface.
  • the circular plate 58 is guided by the cylindrical structure 52 as it is displaced.
  • the annular ridge 60 is provided to make sealing contact with the lower surface of the pierceable septum 48 due to the action of a spring 62 which is chosen to exert a pressure against the bottom of the circular plate 58 which would prevent fluid at an " ambient pressure from flowing through the septum 48 and into the injection chamber 50 should be septum 48 become ruptured.
  • An aperture 64 is provi- ded in the wall of the hollow cylindrical structure 52 so that fluid can flow therethrough and through an interconnecting conduit 66 into the -reservoir 32.
  • the aperture 64 can be fitted with a suitable filter 68 to prevent material greater than a certain size from flowing out of the injection chamber 50 into the reservoir 32.
  • the hollow cylindrical structure 52 could be formed of a ceramic filter material, thereby eliminating the need for a separate filter.
  • An aperture 70 is provided for fluid with- drawal from the reservoir 32 by the pump 30.
  • the annular ridge 60 becomes self-sealing in that pressure on the lower surface of the circular plate 58 will be greater than the ambient pressure on the upper surface of the plate 58, thereby forcing the ridge 60 into the sep ⁇ tum 48. If the implanted drug pump reservoir is maintained at a pressure lower than the ambient pressure, the spring 62 is chosen so that it will overcome the higher ambient pressure on the upper surface of the plate 58 and force the annular ridge 60 into sealing contact with the septum 48.
  • valve disclosed herein provides a positive mechanical apparatus for
  • a container 76 for containing a drug to be dispensed is formed of a flexible material 78 which is attached to a needle 22 having an orifice 24 at a side portion close to the needle tip 26.
  • a movable piston 82 is provided should it be necessary to force liquid from the liquid container 76.
  • Orifices 84 and 84' are provided to insure that the pressure surrounding the container 76 is an ambient pressure.
  • the movable piston 82* can be removed from the syringe case 86 and a new container 76 and associated needle 22 can be inserted.
  • the piston 82 can be utilized to force fluid within the container 76 through the orifice 24, it should be understood that the purpose of this is only to estab ⁇ lish that there can be flow through the orifice 24 and to check fluid in the container 78.
  • fluid will flow automatically from the container 76 into the reser ⁇ voir 32 without any external pressure applied by the movable piston 82 and will automatically stop when the reservoir 32 is full.
  • a standard syringe and needle with a low force plunger could be utilized for filling the reservoir.
  • a further embodiment of the syringe 20 can be seen in Figure 5.
  • a syringe-like device 88 is shown, the device 88 serving the purpose of the syringe 20 without use of a movable piston.
  • a case 90 holds a container 92 for holding a drug to be dispensed.
  • the walls of the container are formed of a flexible material as in the Figure 4 embodiment.
  • a needle 94 in fluid communication with the volume defined by the container 92 has an orifice 96 through which drug contained within the container 92 can flow.
  • the orifice 96 is located near the needle tip 98 and is located on the side of the needle 94.
  • the top of the container 92 is formed by a pierceable septum 100 for filling the container 92, and is rein ⁇ forced by an annular, rubber-like material 102 defi ⁇ ning the upper portion of the container 92. As fluid is removed from the container 92, the container will tend to shrink in volume as shown by the dotted lines 104. A pressure relief orifice 106 is provided to ensure that the pressure surrounding the container 92 is the ambient pressure.
  • the needle 22 is forced through the pierceable septum 48 until its tip 26 is in touching contact with the circular plate 58. Further pressure on the syringe case 86 "will force the annular ridge 60 of the circular plate 58 away from the lower surface of the pierceable septum 48 by depressing the spring 62. When the spring 62 has been sufficiently depressed, the orifice 24 will be within the injection chamber 50.
  • fluid will flow from the container 78 through the orifice 24 into the injection chamber 50, and through the aperture 64 and filter 68 into the interconnecting conduit 66. From the interconnec ⁇ ting conduit 66, fluid will flow into the reservoir 32 until such time as its volume is no longer expan ⁇ dable by the action of the liquid 42. When fluid stops flowing from the container 78, the needle 22 can be removed, the reservoir 32 now being refilled.
  • the liquid 42 is chose to have a vapor pressure at body temperature less than the ambient pressure, the pressure of the fluid within the reser ⁇ voir 32 will tend to be less than the pressure of the fluid surrounding the implantable drug pump 10. Thus, if a leak should occur, for example, within the pierceable septum 48, the liquid contained within the reservoir 32 will remain in the reservoir 32 and the flow of any liquid would be from the user's body into the implantable drug pump 10 only if there was damage to the septum and valve rather than from the implant ⁇ able drug pump 10 into the user's body.
  • a device according to the inven ⁇ tion provides a safety factor to a user heretofore unknown by provi ⁇ ding the user with a completely passive method of filling an implanted drug pump reservoir.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Pompe à médicament implantable (10) comportant un réservoir de stockage de fluide (32) et une seringue (20) située à l'extérieur pour transférer le fluide de la seringue (20) au réservoir (32). Plus spécifiquement, une pompe à médicament implantée (10) comporte un réservoir de médicament (32) et un volume (43), le réservoir (32) et le volume (43) possédant une paroi commune déterminée par un diaphragme flexible (36). Le volume (43) contient un liquide (42) dont la pression de vapeur à la température du corps est inférieure à celle de la pression ambiante entourant la seringue externe (20), si bien que la pression du réservoir (32) tend à être inférieure à la pression ambiante. La seringue (20) comporte une aiguille (22) possédant un orifice (24) situé près de son extrémité (26). La seringue (20) contient également un récipient (76) à base d'un matériau flexible (78) en communication de fluide avec l'orifice (24). Une chambre d'injection (50) est en communication de fluide avec le réservoir (32). Pendant l'utilisation, l'aiguille (22) est forcée de traverser un septum perçable (48) dans la pompe à médicament (10), si bien que l'orifice (24) est en communication de fluide avec le réservoir (32). Comme la pression ambiante entourant le récipient (76) est supérieure à la pression régnant à l'intérieur de la chambre d'injection (50) et du réservoir (32), le fluide s'écoulera du récipient (76) au réservoir (32) sans qu'il y ait besoin d'appliquer une pression supplémentaire au récipient (76). Une vanne unique répondant à l'aiguille (22) perçant le septum (48) est également prévue. La présente invention décrit ainsi un appareil entièrement passif au sein duquel un médicament ne peut être transféré d'un récipient externe à un dispositif implanté que lorsqu'une aiguille en communication de fluide avec le récipient est positionnée correctement par rapport au dispositif implanté.
PCT/US1984/001836 1983-11-09 1984-11-09 Appareil et procede pour transferer un liquide d'un recipient de stockage externe a un dispositif medical implante WO1985002123A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US55007983A 1983-11-09 1983-11-09
US550,079 1983-11-09

Publications (1)

Publication Number Publication Date
WO1985002123A1 true WO1985002123A1 (fr) 1985-05-23

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Country Link
EP (1) EP0160698A1 (fr)
AU (1) AU3615184A (fr)
WO (1) WO1985002123A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0258777A1 (fr) * 1986-08-25 1988-03-09 Cordis Europa N.V. Dispositif implantable pour délivrer une substance liquide médicamenteuse
WO1996031246A1 (fr) * 1995-04-05 1996-10-10 Therex Corporation Systeme de perfusion medicamenteuse implantable avec dispositif d'injection de securite
EP1839695A1 (fr) * 2006-03-31 2007-10-03 Debiotech S.A. Dispositif d'injection d'un liquide à usage médical
DE102008002396A1 (de) * 2008-06-12 2009-12-17 Biotronik Vi Patent Ag Implantierbares Wirkstoffreservoir und Vorrichtung mit einem implantierbaren Wirkstoffreservoir
CN114377242A (zh) * 2020-10-02 2022-04-22 贺利氏医疗有限公司 用于局部释放活性成分的植入件

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2999500A (en) * 1954-05-22 1961-09-12 Schurer Friedrich Container for taking and storing of biological fluids
US4344435A (en) * 1978-12-15 1982-08-17 Aubin Norbert T Method and surgically implantable apparatus for providing fluid communication with the interior of the body
US4360019A (en) * 1979-02-28 1982-11-23 Andros Incorporated Implantable infusion device
US4373527A (en) * 1979-04-27 1983-02-15 The Johns Hopkins University Implantable, programmable medication infusion system

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2999500A (en) * 1954-05-22 1961-09-12 Schurer Friedrich Container for taking and storing of biological fluids
US4344435A (en) * 1978-12-15 1982-08-17 Aubin Norbert T Method and surgically implantable apparatus for providing fluid communication with the interior of the body
US4360019A (en) * 1979-02-28 1982-11-23 Andros Incorporated Implantable infusion device
US4373527A (en) * 1979-04-27 1983-02-15 The Johns Hopkins University Implantable, programmable medication infusion system
US4373527B1 (en) * 1979-04-27 1995-06-27 Univ Johns Hopkins Implantable programmable medication infusion system

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0258777A1 (fr) * 1986-08-25 1988-03-09 Cordis Europa N.V. Dispositif implantable pour délivrer une substance liquide médicamenteuse
WO1996031246A1 (fr) * 1995-04-05 1996-10-10 Therex Corporation Systeme de perfusion medicamenteuse implantable avec dispositif d'injection de securite
EP1839695A1 (fr) * 2006-03-31 2007-10-03 Debiotech S.A. Dispositif d'injection d'un liquide à usage médical
WO2007113708A1 (fr) * 2006-03-31 2007-10-11 Debiotech S.A. Dispositif medical d'injection de liquide
AU2007232227B2 (en) * 2006-03-31 2011-05-19 Debiotech S.A. Medical liquid injection device
US8298183B2 (en) 2006-03-31 2012-10-30 Debiotech S.A. Medical liquid injection device
DE102008002396A1 (de) * 2008-06-12 2009-12-17 Biotronik Vi Patent Ag Implantierbares Wirkstoffreservoir und Vorrichtung mit einem implantierbaren Wirkstoffreservoir
US8167854B2 (en) 2008-06-12 2012-05-01 Biotronik Vi Patent Ag Implantable drug reservoir and device having an implantable drug reservoir
CN114377242A (zh) * 2020-10-02 2022-04-22 贺利氏医疗有限公司 用于局部释放活性成分的植入件
US12102784B2 (en) 2020-10-02 2024-10-01 Heraeus Medical Gmbh Implant for local active ingredient release

Also Published As

Publication number Publication date
EP0160698A1 (fr) 1985-11-13
AU3615184A (en) 1985-06-03

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