WO2009069045A1 - Dispositif implantable de délivrance d'une substance thérapeutique - Google Patents

Dispositif implantable de délivrance d'une substance thérapeutique Download PDF

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Publication number
WO2009069045A1
WO2009069045A1 PCT/IB2008/054879 IB2008054879W WO2009069045A1 WO 2009069045 A1 WO2009069045 A1 WO 2009069045A1 IB 2008054879 W IB2008054879 W IB 2008054879W WO 2009069045 A1 WO2009069045 A1 WO 2009069045A1
Authority
WO
WIPO (PCT)
Prior art keywords
therapeutic substance
reservoir
delivery device
substance delivery
pump
Prior art date
Application number
PCT/IB2008/054879
Other languages
English (en)
Inventor
Ventzeslav P. Iordanov
Arnold Aalders
Gerardus L. M. Jansen
Original Assignee
Koninklijke Philips Electronics N.V.
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 Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Publication of WO2009069045A1 publication Critical patent/WO2009069045A1/fr

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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
    • 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
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14216—Reciprocating piston type
    • 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
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • A61M2205/106—General characteristics of the apparatus with powered movement mechanisms reciprocating

Definitions

  • Implantable therapeutic substance delivery device
  • the present invention pertains to an implantable therapeutic substance delivery device comprising a therapeutic substance reservoir and a pump for controllable release of the therapeutic substance, e.g. for medical or veterinary treatment.
  • therapeutic substance refers to medicines, drugs, placebos, non-medicinal substances, contrast agents, gases, fluids, liquids, radiological agents, imaging or medical markers, sensors for monitoring the person's vitals, etc..
  • the medical device industry produces a wide variety of electronic and mechanical devices for treating patient medical conditions such as therapeutic substance delivery devices.
  • Such devices can be configured to be surgically implanted or connected externally to the patient receding treatment. Clinicians can use such devices alone or in combination with other therapies or surgery.
  • Implantable drug delivery pumps can be used to treat conditions such as pain, spasticity, cancer, and a wide variety of other medical conditions.
  • An implantable therapeutic substance delivery device can be implanted by a clinician into a patient at a location appropriate for the therapy that interferes as little as practicable with patient activity such as subcutaneous in the lower abdomen.
  • a drug delivery catheter can be connected to the drug pump outlet and implanted to infuse the drug or other therapeutic substance at a programmed infusion rate and predetermined location to treat the medical condition.
  • Reliable and accurate operation of the delivery device is important because both inadequate and unintended therapeutic substance delivery can create patient complications.
  • Many drug pumps are configured, so the pump can be replenished with drug through a refill port or septum while the pump is implanted, so the period the pump can be implanted may not be limited by drug capacity.
  • the period the pump can be implanted is often limited by factors such as battery consumption, corrosive damage, and mechanical wear. The relative large size of some implantable drug pumps can limit locations where the device can be implanted in a patient.
  • Implantable drug delivery devices can use a variety of pumping mechanism such as a piston pump, rotary vane pump, osmotic pump, Micro Electro Mechanical Systems (MEMS) pump, diaphragm pump, peristaltic pump, and solenoid piston pump to infuse a drug into a patient.
  • pumping mechanism such as a piston pump, rotary vane pump, osmotic pump, Micro Electro Mechanical Systems (MEMS) pump, diaphragm pump, peristaltic pump, and solenoid piston pump to infuse a drug into a patient.
  • MEMS Micro Electro Mechanical Systems
  • diaphragm pump diaphragm pump
  • peristaltic pump peristaltic pump
  • solenoid piston pump solenoid piston pump
  • an implantable therapeutic substance delivery device comprising a therapeutic substance reservoir and a pump configured to pump a drug from the reservoir to an outlet, the pump comprising an inlet suction side and a discharge side leading to the outlet; wherein the inlet suction side of the pump is positioned within the therapeutic substance reservoir.
  • the reservoir of the therapeutic substance delivery device can for instance wholly or partly be confined by a flexible wall or membrane.
  • the flexible wall can be used to cope with pressure fall and can for example be the wall of a pressurized gas reservoir.
  • the pump can for instance comprise a piston having its end operatively moveable in a piston chamber between a retracted position and an actuated position, wherein the piston chamber is positioned in the reservoir and operatively connected to the reservoir outlet.
  • the piston can for example run through an opening in the flexible reservoir wall, the opening having a perimeter connected to the piston in a leak tight manner.
  • the membrane moves jointly with the piston. This way the piston can pass through the reservoir wall without the risk of leakage.
  • the reservoir outlet can be provided with a pressure valve, such as a ball check valve, having a bias element, such as a coil spring, biasing the valve ball away from the outlet.
  • a bellows can be connected to the inlet side of the pressure valve, the bellows comprising an inlet and wherein the pump comprises an actuator to actuate the bellows.
  • the inlet of the bellows can be provided with an inlet pressure valve. When the bellows is pressed together, the outlet valve is pushed open while the inlet valve is closed off. When the bellows is opened again, the inlet valve opens due to the low pressure in the bellows and therapeutic substance flows into the bellows.
  • the pressure valves can for example be serially arranged ball check valves having their valve balls biased away from the reservoir outlet.
  • the pressure valve at the inlet side of the bellows can comprise an inlet element connected to a flexible reservoir wall connected to an actuator. This makes it possible to actuate the bellows via the flexible reservoir wall using driving means located outside the reservoir.
  • the actuator can for instance be an electro -magnetic actuator - such as a reluctance-type or Lorentz-type actuator - or a pneumatic, osmotic, electro-osmotic, thermal actuator driver or an actuator based on a rotating motor or any other suitable type of actuator.
  • the implantable therapeutic substance delivery device can be programmed or controlled to deliver or dispense a medicament according to a dispensing timing pattern while traversing through the gastrointestinal tract.
  • the device can include control and timing circuitry for controlling the opening and closing of a valve or hatch according to the desired dispensing timing pattern for dispensing a medicament stored within the device.
  • the implantable device can be controlled by a wireless remote control means, e.g. radiographically.
  • Fig. IA shows a front view of a therapeutic substance delivery device according to the present invention
  • Fig. IB shows a longitudinal cross section of the device of Fig. IA
  • Fig. 1C shows in detail the suction and discharge side of the pump of the device of Fig. IA;
  • Fig. 2A shows schematically in cross section a pump and drug reservoir of a therapeutic substance delivery device according to the present invention
  • Fig. 2B shows the device of Fig. 2A with actuated piston
  • Fig. 3 shows a drug reservoir of an alternative embodiment of a therapeutic substance delivery device according to the present invention.
  • Figs. IA and IB show an exemplary embodiment of a therapeutic substance delivery device 1 according to the present invention.
  • the device 1 comprises a housing 2 encasing a reservoir 3, a power source 4, electronic control circuitry 5, an actuator driver 6 and a pump 7, shown in more detail in Fig. 1C.
  • the housing 2 has rounded outer ends 21 to prevent sharp shape transitions and edges, which may irritate or damage surrounding tissue.
  • the housing 2 is provided with a refill port 22 and an outlet 23 in one of the rounded end sections 21.
  • a flexible membrane 31 isolates a pressurized gas part 32 of the interior of housing 2 from a compressible reservoir section 33 which is in open connection with a non- compressible reservoir section 34.
  • the power source 4, control circuitry 5 and actuator driver 6 are located between the compressible section 33 and non-compressible section 34.
  • a second flexible membrane 35 isolates a second pressurized gas part 36 between the compressible reservoir 33 and a surface of the power source 4. Via the flexible membranes 31, 35 the pressurized gas maintains a pressure within the reservoir when therapeutic substance is discharged.
  • the power source 4 is a battery, which provides power to the actuator driver 6 and control circuitry 5.
  • the battery can be a thin film lithium battery photo lithium, silver oxide, lithium coin cells, zinc air cells, alkaline, or any other suitable type of battery.
  • the electronic control circuitry 4 serves to control actuator driver 6 and the pump 7.
  • the electronic control circuitry 4 is capable of receiving and transmitting data and can be programmed prior to implantation or after implantation, e.g. via a wireless link.
  • Fig. 1C shows the end section of the pump 7 which comprises a piston 71 slideably engaged in a piston chamber 72 having an open end 73 receiving the piston 71 and an outlet end 74, where it is provided with a ball check valve 75 comprising an annular ridge
  • the slit 79 between the piston and the inner surface of the piston chamber forms an suction inlet side of the pump 7 located within the non-compressible reservoir 34.
  • FIG. 2A and 2B An alternative embodiment of a therapeutic substance delivery device according to the invention is schematically shown in Figs. 2A and 2B.
  • the device 201 comprises a pump 207 and a drug reservoir 203 with an outlet 223. Opposite the outlet 223 the reservoir 203 is confined by a flexible membrane 231.
  • the pump 207 comprises a piston 271 passing through the flexible membrane 231 in a leak tight manner. Its end located within the drug reservoir 203 is slideable engaged in a piston chamber 272 having an open end 273 receiving the piston 271 and an outlet end 274, where it is provided with a ball check valve 275 comprising an annular ridge 276 on the inner surface of the piston chamber 272, a ball 277 with a diameter larger than the inner diameter of the annular ridge 276, and a coil spring between the ball and the outlet, pressing the ball 277 onto the annular ridge 276.
  • the piston part outside the reservoir 203 runs slideable through a stator 280 with an electromagnetic coil 281 coaxially disposed around the piston 271. At its outer end, the piston 271 comprises a sole plate 282.
  • a pressure coil 283 is positioned between the sole plate 282 and a shoulder 284 forcing the two apart.
  • a change in the direction of the electric current through the coil 281 changes the magnetic flux generated by the coil 281 inducing a translation force to the piston 271. This way, the piston 271 is moved between a retracted position, as shown in Fig. 2A, and an actuated position, as shown in Fig. 2B.
  • a low pressure is created within the piston chamber 272 by retracting the piston 271, evacuating therapeutic substance from the reservoir 203 into the piston chamber via the annular slit 278 between the piston 271 and the piston chamber wall. During this time, the ball 277 is pressed onto annular ridge 276 by the spring coil 275, closing off the piston chamber 272.
  • FIG. 3 shows a perspective view on a cross section of a therapeutic substance reservoir 303 of a further alternative embodiment of a therapeutic substance delivery device 301 according to the present invention.
  • the reservoir 303 comprises an outlet 323. Opposite the outlet 323 the reservoir is confined by a flexible wall 331.
  • the membrane 331 is linked to an actuator (not shown) located outside the reservoir 303 which can move the flexible membrane 331 between a retracted position and an actuated position.
  • a pump section comprising a cylindrical suction inlet part 390 with lateral suction inlet openings 379.
  • the cylindrical suction inlet part 390 is attached to the center part of the flexible membrane 331.
  • the end of the cylindrical part 390 is in line with and operatively connected to a first ball check valve 391 comprising an outer cylinder 392, an annular ridge 393 on the inner surface of the cylinder 392, a ball 394 with a diameter being larger than the inner diameter of the annular ridge 393, an inner cylinder 395 defining an outlet channel at a distance from the ball 394, the inner cylinder 395 having a shouldered end 396 fitting within the inner diameter of the outer cylinder 392, and a coil spring 397 between the ball 394 and the shouldered end part 396 of the inner cylinder 395 forcing these apart.
  • the second ball check valve 375 also comprises an outer cylinder 372, an annular ridge 376 on the inner surface of the cylinder 372, a ball 377 with a diameter being larger than the inner diameter of the annular ridge 376, an inner cylinder 379 defining an outlet channel at a distance from the ball 377.
  • the inner cylinder 379 has a shouldered end 399 fitting within the inner diameter of the outer cylinder 372, and a coil spring 378 between the ball 377 and the shouldered end part 399 of the inner cylinder which resiliently forces these apart.
  • the bellows 398 When the flexible membrane 331 is pushed inwardly into the reservoir 303, the bellows 398 is compressed and the pressure within the bellows 398 increases. Due to the increased pressure in the bellows 398, the ball 377 of the second ball check valve 375 is pushed away from its seat on the corresponding annular ridge 376 and therapeutic substance is squeezed to flow from the bellows 398 along the ball 377 of the valve 375 into outlet channel in inner cylinder 379 to the outlet 323. As a result, the pressure in the bellows 398 returns to a normal level and the ball 377 of the second valve 375 turns back to its seat on the annular ridge 376. When the flexible membrane 331 is pulled back, the bellows 398 is stretched to create a vacuum.
  • the resulting pressure difference between the low pressure in the bellows 398 and the higher pressure in the drug reservoir 303 pushes the ball 394 of the first ball check valve 391 from its seat on the annular ridge 393, and therapeutic substance can flow from the reservoir 303 into the bellows 398 via the first ball check valve 391.

Landscapes

  • 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

L'invention concerne un dispositif implantable de délivrance d'une substance thérapeutique (1, 201, 301) comprenant un réservoir de substance thérapeutique (3, 203, 303) et une pompe (7, 207, 307) conçue pour pomper un médicament depuis le réservoir vers une sortie. La pompe comprend un côté de succion d'entrée (79, 278, 378) placé à l'intérieur du réservoir. Le réservoir est au moins en partie enclos par une ou plusieurs parois flexibles (31, 231, 331).
PCT/IB2008/054879 2007-11-27 2008-11-20 Dispositif implantable de délivrance d'une substance thérapeutique WO2009069045A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP07121590 2007-11-27
EP07121590.9 2007-11-27

Publications (1)

Publication Number Publication Date
WO2009069045A1 true WO2009069045A1 (fr) 2009-06-04

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2008/054879 WO2009069045A1 (fr) 2007-11-27 2008-11-20 Dispositif implantable de délivrance d'une substance thérapeutique

Country Status (1)

Country Link
WO (1) WO2009069045A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012145343A2 (fr) * 2011-04-18 2012-10-26 Kuvio, Inc. Dispositif d'administration de médicament avec chambres compressibles pour fluide

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996000095A1 (fr) * 1994-06-23 1996-01-04 Minimed Inc. Pompe de perfusion de medicaments a siege de soupape en fluoropolymere
EP0791369A1 (fr) * 1996-02-22 1997-08-27 Siemens-Elema AB Pompe
WO2002083208A2 (fr) * 2001-04-10 2002-10-24 Medtronic, Inc. Pompe a solenoide avec aimant permanent pour dispositif implantable d'administration de substance therapeutique

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996000095A1 (fr) * 1994-06-23 1996-01-04 Minimed Inc. Pompe de perfusion de medicaments a siege de soupape en fluoropolymere
EP0791369A1 (fr) * 1996-02-22 1997-08-27 Siemens-Elema AB Pompe
WO2002083208A2 (fr) * 2001-04-10 2002-10-24 Medtronic, Inc. Pompe a solenoide avec aimant permanent pour dispositif implantable d'administration de substance therapeutique

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012145343A2 (fr) * 2011-04-18 2012-10-26 Kuvio, Inc. Dispositif d'administration de médicament avec chambres compressibles pour fluide
WO2012145343A3 (fr) * 2011-04-18 2013-01-17 Kuvio, Inc. Dispositif d'administration de médicament avec chambres compressibles pour fluide

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