Partially implantable medical devices and methods

• US 9,370,618 B2
• Filed: 02/21/2009
• Issued: 06/21/2016
• Est. Priority Date: 02/21/2009
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: IncuMED, LLC
• Inventors: Mann, Alfred E., He, Tom Xiaohai
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): PENG, LAUREN MICHELE
• Application Number:
  US12/390,425
• Publication Number:
  US 20100217239A1
• Time in Patent Office: 2,677 Days
• Field of Search: 60428801-28804, 604/890.1, 604/891.1
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

Apparatus having a percutaneous cartridge port with an exterior having a porous region configured to promote soft tissue ingrowth and an implantable operative portion, including a fluid transfer device, operably connected to the percutaneous cartridge port, and methods that may be associated with an apparatus having a percutaneous cartridge port.

Claims

1. An apparatus for use with a dermis and a fluid cartridge, the apparatus comprising:

a percutaneous cartridge port including a tubular wall, with an open and unobstructed first longitudinal end, a second longitudinal end, and an exterior, an end wall at the second longitudinal end, a resilient needle-puncturable septum at the end wall, and a porous region on the exterior of the tubular wall configured to promote soft tissue ingrowth, the porous region being located on the tubular wall such that a fluid cartridge located within the percutaneous cartridge port and at least partially within dermis that is ingrown into the porous region can be removed from the dermis by way of the open and unobstructed first longitudinal end and independently of the apparatus; and

an implantable operative portion, including a pump, operably connected to the percutaneous cartridge port.

2. An apparatus as claimed in claim 1, wherein the porous region comprises a layer of a fiber mesh.

3. An apparatus as claimed in claim 2, wherein the fiber mesh comprises biocompatible metal fibers and/or biocompatible polymer fibers.

4. An apparatus as claimed in claim 1, wherein the porous region defines a porosity of about 60 to 95% and includes pores that are about 50 to 200 microns in size.

5. An apparatus as claimed in claim 1, wherein

the septum comprises a removable septum that may be removed and/or replaced by moving the removable septum through the end wall and the open and unobstructed first longitudinal end of the tubular wall while the percutaneous cartridge port remains within the dermis.

6. An apparatus as claimed in claim 5, wherein the end wall of the percutaneous cartridge port includes a septum aperture configured to receive the removable septum and a retainer having a locked state where the retainer abuts the end wall and prevents removal of the removable septum from the septum aperture, and an unlocked state where the retainer does not prevent removal of the removable septum from the septum aperture.

7. An apparatus as claimed in claim 6, wherein

the percutaneous cartridge port defines an interior;

and

the retainer defines a lumen that extends from the interior of the percutaneous cartridge port to the removable septum when the removable septum is within the septum aperture and the retainer is in the locked state.

8. An apparatus as claimed in claim 6, wherein removable septum includes a seal member and a retainer engagement member.

9. An apparatus as claimed in claim 1, further comprising:

a battery case configured to receive a battery and associated with the percutaneous cartridge port end wall such that a battery may be removed and/or replaced by moving the battery through the end wall where the resilient needle-puncturable septum is located and the open and unobstructed first longitudinal end of the tubular wall while the percutaneous cartridge port remains within the dermis.

10. An apparatus as claimed in claim 9, wherein the percutaneous cartridge port includes a retainer having a locked state where the retainer prevents battery removal, and an unlocked state where the retainer does not prevent battery removal.

11. An apparatus as claimed in claim 1, further comprising:

a battery contact associated with the percutaneous cartridge port.

12. An apparatus as claimed in claim 1, further comprising:

an implantable operative portion housing in which the pump is located; and

a removable delivery tube that extends outwardly from the implantable operative portion housing, is operably connected to the pump, and is associated with the percutaneous cartridge port such that it may be removed and/or replaced by moving the removable delivery tube through the end wall where the resilient needle-puncturable septum is located and the open and unobstructed first longitudinal end of the tubular wall while the percutaneous cartridge port remains within the dermis.

13. An apparatus as claimed in claim 12, wherein the percutaneous cartridge port includes a retainer having a locked state where the retainer prevents removal of the delivery tube, and an unlocked state where the retainer does not prevent removal of the delivery tube.

14. An apparatus as claimed in claim 1, further comprising:

an implantable operative portion housing;

wherein the pump is located within the implantable operative portion housing.

15. An apparatus as claimed in claim 14, wherein the percutaneous cartridge port is mounted on the implantable operative portion housing.

16. An apparatus as claimed in claim 14, wherein the percutaneous cartridge port is not mounted on the implantable operative portion housing.

17. An apparatus for use with a dermis, comprising:

means for percutaneously receiving and holding a fluid cartridge and resilient needle-puncturable septum such that at least a portion of the cartridge is within the dermis and the fluid cartridge can be removed from the dermis independently of the apparatus and without removal of the resilient needle-puncturable septum;

porous material configured to promote dermis ingrowth carried on an exterior of the means for percutaneously receiving and holding a fluid cartridge; and

an implantable operative portion that is operably connected to the means for percutaneously receiving and holding a fluid cartridge.

18. An apparatus as claimed in claim 17, wherein the porous material comprises a layer of a fiber mesh.

19. An apparatus as claimed in claim 17, further comprising:

a battery case associated with the means for percutaneously receiving and holding a fluid cartridge.

20. An apparatus, comprising:

a housing member defining an interior surface, an interior volume and an opening with a size and a shape;

a fluid transfer device, that does not include a reservoir, including

an electromagnet within an electromagnet case that defines an exterior surface and a case outer perimeter,

a fluid housing, that is not the housing member, mounted to the electromagnet case, defining a fluid housing outer perimeter, and having fluid lumens, a fluid inlet and a fluid outlet,

an armature movable within the fluid housing,

a piston mounted to the armature and movable within the fluid housing, and

a barrier between the electromagnet and the armature;

a housing cover, defining a cover outer perimeter that is greater than the case outer perimeter and the fluid housing outer perimeter and a size and a shape corresponding to the housing member opening, that is carried by the fluid transfer device such that at least a portion of the housing cover is located outside the fluid transfer device, is secured to the housing member at the opening, and includes a first side that faces the interior volume and a second side opposite the first side;

the fluid transfer device defining first and second longitudinal ends and the housing cover being located between the longitudinal ends such that the electromagnet and the electromagnet case are located within the housing member interior volume, the fluid housing is located outside the housing member interior volume with the entire fluid inlet, and the entire fluid outlet is located on the same side of the cover; and

a controller located within the housing member interior volume between the interior surface of the housing member and the exterior surface of the electromagnet case.

21. An apparatus as claimed in claim 20, wherein the housing member comprises a metal housing member, the apparatus further comprising:

a plastic housing member in which the fluid transfer device fluid housing is located.

22. An apparatus as claimed in claim 20, wherein the fluid transfer device defines a longitudinal axis and the cover is oriented transverse to the longitudinal axis.

23. An apparatus as claimed in claim 22, wherein the cover is oriented substantially perpendicular to the longitudinal axis.

24. An apparatus as claimed in claim 20, further comprising:

a circuit board and at least one capacitor located within the housing member interior volume.

25. An apparatus as claimed in claim 24, further comprising:

a multi-pin electrical feed-through carried by the housing cover.

26. An apparatus as claimed in claim 20, wherein

the fluid transfer device includes a first exterior ring and a second exterior ring that is secured to the first exterior ring;

and

the cover is carried by the first exterior ring.

27. An apparatus as claimed in claim 26, wherein the first and second exterior rings are welded to one another.

28. An apparatus as claimed in claim 26, wherein

the first exterior ring is secured to the fluid housing;

the second exterior ring is secured to the electromagnet case; and

the barrier is between the first and second exterior rings.

29. An apparatus as claimed in claim 28, wherein

the cover is welded to the housing member;

and

the first and second exterior rings are welded to one another.

30. An apparatus as claimed in claim 20, wherein there is no reservoir within the housing member interior volume.

31. An apparatus as claimed in claim 20, further comprising:

a reservoir located outside the housing member interior volume and operably connected to the fluid transfer device.

32. An apparatus as claimed in claim 20, wherein

the fluid transfer device fluid inlet is connected to a tube through which fluid flows to the fluid transfer device fluid inlet;

and

the entire fluid transfer device fluid inlet and the entire fluid transfer outlet are located in spaced relation to the housing cover.