Medical device with adjustable tissue ingrowth cuff

• US 8,979,806 B2
• Filed: 10/07/2010
• Issued: 03/17/2015
• Est. Priority Date: 07/27/2001
• Status: Active Grant

• Current Assignee: Mark A. Saab
• Original Assignee: Mark A. Saab
• Inventors: Saab, Mark A.
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/924,869
• Publication Number:
  US 20110125129A1
• Time in Patent Office: 1,622 Days
• Field of Search: 604175-180, 604288-28804, 604/533, 604/539
• US Class Current: 604/175
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0282 with implanted tubes connected to the port
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• 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

Abstract

Methods and apparatus are disclosed for making and using adjustable epidermal tissue ingrowth cuff and catheter assemblies for transcutaneous placement to provide periodic or continuous external access for medical purposes to an interior body region of a patent who requires such medical treatment over an extended period of time.

Claims

1. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin surface, through the epidermis, and into a living body, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising a hub top side with a hub top side upper face that faces the skin surface when the hub component is implanted and a hub top side lower face that faces away from the skin surface, a hub sidewall extending from the hub top side to a location beyond the hub top side lower face in a direction away from the skin surface, and a hub passageway extending between a passageway inlet at the hub top side upper face and a passageway outlet at the hub sidewall, and also wherein a longitudinal axis of the hub passageway at the hub top side is oriented transversely relative to a longitudinal axis of the hub passageway at the hub sidewall;

(b) a transcutaneous hub tube mated with the hub passageway when said hub component is implanted such that a proximal hub tube end extends above the skin surface, a transcutaneous hub tube portion extends between the skin surface and the hub passageway at least to the hub top side lower face, and the transcutaneous hub tube terminates before reaching the passageway outlet, and a transcutaneous conduit runs seriatim from outside the body, through the hub tube and said hub passageway, and into the body interior; and

,

(c) porous tissue ingrowth surfaces along the hub top side upper face and also along the outside of at least a section of the proximal hub tube end and the transcutaneous portion of the hub tube such that porous tissue ingrowth surface extends along the hub tube from above the skin surface at least to the hub top side lower face and terminates before reaching the passageway outlet.

2. An apparatus according to claim 1 further wherein said hub component and hub tube consist essentially of a material which is compatible with the epidermis.

3. An apparatus according to claim 1 wherein a distal end of the transcutaneous conduit is connected with the proximal end of an implanted subcutaneous conduit to extend the access channel to more remote regions of the body.

4. An apparatus according to claim 1 wherein said porous surfaces comprise surface pores ranging in size between about 20-2000 microns.

5. An apparatus according to claim 1 further wherein said porous tissue ingrowth surfaces consist essentially of polyester.

6. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin surface, through the epidermis, and into a living body, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising a hub top side with a hub top side upper face that faces the skin surface when the hub component is implanted and a hub top side lower face that faces away from the skin surface, a hub sidewall extending from the hub top side to a location beyond the hub top side lower face in a direction away from the skin surface, and a hub passageway extending between a passageway inlet at the hub top side upper face and a passageway outlet at the hub sidewall, and also wherein a longitudinal axis of the hub passageway at the hub top side is oriented transversely relative to a longitudinal axis of the hub passageway at the hub sidewall;

(b) a transcutaneous hub tube mated with the hub passageway when said hub component is implanted such that a proximal hub tube end extends above the skin surface, a transcutaneous hub tube portion extends between the skin surface and the hub passageway at least to the hub top side lower face, the transcutaneous hub tube terminates before reaching the passageway outlet, and the passageway outlet abuts or comprises a collar element that extends from inside the hub passageway through the hub sidewall, and a transcutaneous conduit runs seriatim from outside the body, through the hub tube, the hub passageway and the collar element, and into the body interior; and

,

(c) porous tissue ingrowth surfaces along the hub top side upper face and also along the outside of at least a section of the proximal hub tube end and the transcutaneous portion of the hub tube such that porous tissue ingrowth surface extends along the hub tube from above the skin surface to below the hub top side lower face and terminates before reaching the passageway outlet.

7. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin surface, through the epidermis, and into a living body where the channel or a transcutaneous conduit comprising the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising a hub top side with a hub top side upper face that faces the skin surface when the hub component is implanted and a hub top side lower face that faces away from the skin surface, a hub sidewall extending from the hub top side to a location beyond the hub top side lower face in a direction away from the skin surface, and a hub passageway extending between a passageway inlet at the hub top side upper face and a passageway outlet at the hub sidewall, and also wherein a longitudinal axis of the hub passageway at the hub top side is oriented transversely relative to a longitudinal axis of the hub passageway at the hub sidewall;

(b) a transcutaneous hub tube mated with the hub passageway when said hub component is implanted such that a proximal hub tube end projects above the skin surface, a transcutaneous hub tube portion extends between the skin surface and the hub passageway at least to the hub top side lower face, the transcutaneous hub tube terminates before reaching the passageway outlet, and a transcutaneous conduit runs seriatim from outside the body, through the hub tube and hub passageway; and

,

(c) a hub connector fitting at the distal end of said transcutaneous conduit to provide a connection to the proximal end of an implanted subcutaneous catheter, wherein said hub connector fitting comprises a threaded collar that may be tightened to better secure the conduit to the hub component in graduated tightening increments at the juncture between the distal end of the transcutaneous conduit and the proximal end of the subcutaneous catheter; and

(d) porous tissue ingrowth surfaces along the hub top side upper face and also along the outside of at least a section of the proximal hub tube end and the transcutaneous portion of the hub tube such that porous tissue ingrowth surface extends along the hub tube from above the skin surface to below the hub top side lower face and terminates before reaching the passageway outlet.

8. An apparatus according to claim 7 wherein the collar is sized to fit concentrically around a hub outlet connector, said collar having internal threads at its proximal end sized to engage and mate with external threads of the hub outlet connector, such that rotation of the collar tightens the connection between the hub component and the conduit in graduated tightening increments.

9. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin surface, through the epidermis, and into a living body where the channel or a transcutaneous conduit comprising the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising a hub top side with a hub top side upper face that faces the skin surface when the hub component is implanted and a hub top side lower face that faces away from the skin surface, a hub sidewall extending from the hub top side to a location beyond the hub top side lower face in a direction away from the skin surface, and a hub passageway extending between a passageway inlet at the hub top side upper face and a passageway outlet at the hub sidewall;

(b) a transcutaneous hub tube mated with the hub passageway when said hub component is implanted such that a proximal hub tube end projects above the skin surface, a transcutaneous hub tube portion extends between the skin surface and the hub passageway at least to the hub top side lower face, the transcutaneous hub tube terminates before reaching the passageway outlet, and a transcutaneous conduit runs seriatim from outside the body, along a first axis into the portion of the hub tube that is mated with the proximal end of the hub passageway, through said tube and hub passageway, and out of the distal end of said hub passageway along a second axis that is oriented transversely relative to the first axis;

(c) a fitting external to the hub passageway that maintains the hub tube in place relative to the hub component; and

,

(d) porous tissue ingrowth surfaces along the hub top side upper face and also along the outside of at least a section of the proximal hub tube end and the transcutaneous portion of the hub tube such that porous tissue ingrowth surface extends along the hub tube from above the skin surface at least to the hub top side lower face and terminates before reaching the passageway outlet.

10. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin surface, through the epidermis, and into a living body where a transcutaneous conduit that runs through the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising a hub top side with a substantially flat hub top side upper face that faces the skin surface when the hub component is implanted and a hub top side lower face that faces away from the skin surface, a hub sidewall extending from the hub top side to a location beyond the hub top side lower face in a direction away from the skin surface, and a hub passageway extending between a passageway inlet at the substantially flat hub top side upper face and a passageway outlet at the hub sidewall;

(b) a transcutaneous hub tube mated with the hub passageway when the hub component is implanted such that a proximal hub tube end projects above the skin surface, a transcutaneous hub tube portion extends between the skin surface and the hub passageway at least to the hub top side lower face, the transcutaneous hub tube terminates before reaching the passageway outlet, and a transcutaneous conduit runs seriatim from outside the body, through the hub tube and hub passageway;

(c) a fitting external to the hub passageway that securely fixes the hub tube in place relative to the hub component for the duration of the long-term use; and

,

(d) porous tissue ingrowth surfaces along the substantially flat hub top side upper face surrounding an entrance to the hub passageway and also along the outside of at least a section of the proximal hub tube end and the transcutaneous portion of the hub tube such that porous tissue ingrowth surface extends along the hub tube from above the skin surface to a location below the hub top side upper face and terminates before reaching the passageway outlet.

11. An apparatus according to claim 10 further wherein said hub tube and hub component consist essentially of a material which is compatible with the epidermis and promotes tissue ingrowth.

12. An apparatus according to claim 10 further wherein porous tissue ingrowth surface along the outside of said hub tube extends below the hub top side lower face.

13. A medical apparatus for establishing a long-term body access channel sealed along its length and extending from a proximal location outside the skin surface, through the epidermis, and into a living body where the channel is or can be subcutaneously connected to the proximal end of an implanted subcutaneous catheter, said apparatus comprising:

(a) a hub component designed to be implanted subcutaneously, said hub component comprising a two-level hub top side with upper and recessed levels and also with a hub top side upper face that faces the skin surface when the hub component is implanted and a hub top side lower face that faces away from the skin surface, a hub sidewall extending from the hub top side in a direction away from the skin surface, a first hub connector fitting projecting outwardly from the recessed level of said hub top side and having a barbed end, and a hub passageway extending through the barbed end connector fitting and the hub to the hub sidewall;

(b) a transcutaneous hub tube mated with the hub connector fitting when said hub component is implanted such that a proximal hub tube end projects above the skin surface, a transcutaneous hub tube portion extends between the skin surface and the recessed level of the hub top side, and a transcutaneous conduit runs seriatim from outside the body, through the epidermis, through said hub tube, and into the body interior, wherein the conduit section housed inside the hub tube is sized to engage the barbed end of the first hub connector fitting when the hub tube is mated with the hub connector fitting; and

,

(c) porous tissue ingrowth surfaces along at least the upper level of the hub top side upper face and also along the outside of at least a section of the proximal hub tube end and the transcutaneous portion of the hub tube such that porous tissue ingrowth surface extends along the hub tube from above the skin surface to the recessed level of the hub top side.

14. An apparatus according to claim 13 further comprising a second hub connector fitting projecting outwardly from the hub sidewall and having a barbed end.

15. An apparatus according to claim 14 further comprising an implanted subcutaneous catheter having a proximal end sized to engage the barbed end of the second hub connector fitting.

16. A medical port for establishing a body access channel that extends from a location outside the body, through the skin surface, and into a living body, wherein the port comprises:

a hub component designed to be implanted subcutaneously such that there is a first hub face oriented generally toward the skin surface, the opposite side of the first hub face is a second hub face oriented generally away from the skin surface, and a hub side face extends from the second hub face in a direction away from the skin surface;

a hub passageway connects the first hub face and the hub side face and a longitudinal axis of the hub passageway at the first hub face is oriented transversely relative to a longitudinal axis of the hub passageway at the hub side face;

a conduit mated with the hub passageway when the hub component is implanted establishes a sealed channel that extends from outside the body, through the skin surface and into the hub passageway; and

, there is a porous tissue ingrowth surface along the first hub face and also a porous tissue ingrowth surface along a portion of the outer surface of the conduit that begins in the hub passageway and extends between the second hub face and a location above the skin surface so as to establish a substantially continuous porous tissue ingrowth surface from the second hub face to above the skin surface.

17. A medical port according to claim 16 further wherein the porous tissue ingrowth surfaces along the outer surface of the conduit extends from below the second hub face to a location above the skin surface.

18. A medical port according to claim 16 further wherein the hub component consists essentially of a material that is biocompatible.

19. A medical port according to claim 16 wherein the porous tissue ingrowth surfaces comprise surface pores ranging in size between about 20-2,000 microns.

20. A medical port according to claim 16 further wherein the hub component and the conduit comprise an inert material.

21. A medical port according to claim 16 further wherein at least a surface of the medical port is treated to reduce the formation of thrombus.

22. A medical port according to claim 16 further wherein at least a surface of the medical port is treated to control microorganisms.

23. A medical apparatus for establishing a long term body access channel extending from a location outside the skin surface, through the epidermis, and into a living body, said apparatus comprising:

(a) a subcutaneous member comprising an upper wall with a top face that faces the skin surface when the subcutaneous member is implanted and a bottom face that faces away from the skin surface, a sidewall that extends from the bottom face to a location beyond the bottom face, and a passageway through the subcutaneous member starting at the top face and extending to the sidewall wherein a longitudinal axis of the passageway at the top face is oriented transversely relative to a longitudinal axis of the passageway at the sidewall, and a top face porous tissue ingrowth surface at least along a portion of said top face adjacent the passageway;

(b) a transcutaneous conduit mated with said passageway when the subcutaneous member is implanted such that a proximal end projects above the skin surface thereby establishing a transcutaneous access channel extending from outside the skin surface into the body interior region; and

,

(c) a conduit porous tissue ingrowth surface at least along a portion of the outer surface of the transcutaneous conduit that begins in the passageway and extends transcutaneously from beneath the top face of the upper wall, through the skin, to a point above the external skin surface when said subcutaneous member is implanted.

24. A medical apparatus according to claim 23 further wherein said subcutaneous member comprises a structure sized, shaped, and subcutaneously positioned to minimize movement of the porous tissue ingrowth surfaces while allowing the orientation of the conduit to be changed from a path generally parallel to the skin surface where the conduit is distal of the subcutaneous member to a path that intersects the skin surface when the conduit is proximal of the subcutaneous member.

25. A medical apparatus according to claim 24 wherein the structure includes a fitting proximal of the subcutaneous member that restricts movement of the mated transcutaneous conduit.

26. A medical apparatus according to claim 24 wherein the structure includes a fitting distal of the subcutaneous member that restricts movement of the mated transcutaneous conduit.

27. A medical apparatus according to claim 23 further wherein the porous tissue ingrowth surfaces along the outer surface of the transcutaneous conduit extends from beneath the bottom face of the upper wall to a point above the external skin surface.

28. A medical apparatus according to claim 23 further wherein said subcutaneous member consists essentially of a material that is compatible with living dermal tissue.

29. A medical apparatus according to claim 23 further wherein said subcutaneous member consists essentially of a material that is compatible with living non-dermal tissue.

30. A medical apparatus for establishing a long term body access channel extending from a location outside the skin surface, through the epidermis, and into a living body, said apparatus comprising:

(a) a subcutaneous member comprising an upper wall with a top face that faces the skin surface when the subcutaneous member is implanted and a bottom face that faces away from the skin surface, a sidewall that extends from the bottom face to a location beyond the bottom face, and a passageway through the subcutaneous member starting at the top face and extending to the sidewall wherein a longitudinal axis of the passageway at the top face is oriented transversely relative to a longitudinal axis of the passageway at the sidewall, and a top face porous tissue ingrowth surface at least along a portion of said top face adjacent the passageway;

(b) a transcutaneous conduit mated with said passageway such that, when the subcutaneous member is implanted, a proximal conduit end projects above the skin surface whereby a transcutaneous access channel extends from outside the skin surface into the body interior region, and a distal conduit end is adapted with a connection fitting that selectively enables the access channel to be extended into more remote regions of a living body by the connection of a second conduit component; and

,

(c) a conduit porous tissue ingrowth surface at least along a portion of the outer surface of the transcutaneous conduit that begins in the passageway and extends transcutaneously from beneath the top face of the upper wall, through the skin, to a point above the external skin surface when said subcutaneous member is implanted.

31. A medical apparatus according to claim 30 further wherein said subcutaneous member comprises a structure sized, shaped, and subcutaneously positioned to minimize movement of the porous tissue ingrowth surfaces while allowing the orientation of the conduit to be changed from a path generally parallel to the skin where the conduit is distal of the subcutaneous member to a path that intersects the skin surface when the conduit is proximal of the subcutaneous member.

32. A medical apparatus according to claim 30 further wherein said porous tissue ingrowth surfaces along the outer surface of said transcutaneous conduit extends from beneath the bottom face of the upper wall to a point above the external skin surface.

33. A medical apparatus according to claim 30 further wherein said subcutaneous member consists essentially of a material that is compatible with living dermal tissue.

34. A medical apparatus according to claim 30 further wherein said subcutaneous member consists essentially of a material that is compatible with living non-dermal tissue.