Deformable medical implant

• US 8,617,116 B2
• Filed: 03/27/2009
• Issued: 12/31/2013
• Est. Priority Date: 03/27/2009
• Status: Active Grant

• Current Assignee: Marvao Medical Devices, Ltd.
• Original Assignee: Marvao Medical Devices, Ltd.
• Inventors: Davey, Christopher
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US12/412,464
• Publication Number:
  US 20100249712A1
• Time in Patent Office: 1,740 Days
• Field of Search: 604174-176, 60428801-28804, 604/513, 604/891.1
• US Class Current: 604/175
• 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 2039/0279 for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 2039/0291 method or device for implanting it in the body
• 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

The present invention comprises an implantable subcutaneous port for anchoring a transcutaneous treatment component. The implantable subcutaneous port comprises a body portion and one or more frangible lines formed within the body portion. The body portion is adapted for receiving the transcutaneous treatment component beneath the point of entry into the physiology of a patient and routing the transcutaneous treatment component. The body portion is produced from a deformable material and has an area footprint and defines a support wall through which the transcutaneous treatment component enters the body portion. Fracturing the one or more frangible lines formed within the body portion enables removal of the body portion from the physiology of a patient through a transcutaneous opening defining an area of less than thirty percent of the area footprint of the body portion.

Claims

1. An implantable subcutaneous medical device for anchoring an elongated transcutaneous treatment component that, in use, extends from outside a patient'"'"'s skin, through a transcutaneous skin opening sized to just accommodate the treatment component at a point of entry into the physiology of a patient, through the implanted medical device positioned at an implantation site, and then to a desired internal location in the patient'"'"'s body distal of the implanted medical device, the device comprising:

a) a device body portion having a passageway therethrough comprising a passageway entrance and support wall for receiving the transcutaneous treatment component beneath the point of entry and for subcutaneously routing the transcutaneous treatment component to the desired internal location, the device body portion being produced from a deformable material and having an assembled area footprint; and

,

b) one or more frangible lines formed within the device body portion, the fracture of which enables in situ disassembly of the device body portion into one or more device body pieces sized in at least one dimension for removal from the physiology of the patient through the transcutaneous skin opening.

2. The medical device of claim 1 wherein the support wall is annular.

3. The medical device of claim 1 further comprising a tissue ingrowth skirt disposed on a surface of the device body portion about the passageway entrance for promoting tissue ingrowth at least about the passageway entrance and the portion of the transcutaneous treatment component that passes through the passageway entrance.

4. The medical device of claim 1 wherein the longest dimension of the transcutaneous skin opening is no more than 50 percent of the longest dimension of the major plane of the device body portion.

5. The medical device of claim 1 wherein the one or more frangible lines form a continuous path extending between the support wall and an outer perimeter of the device body portion.

6. The medical device of claim 5 wherein the continuous path forms a spiral along the device body portion.

7. The medical device of claim 1 wherein the device body portion is dome shaped.

8. The medical device of claim 7 wherein the one or more frangible lines form one or more closed circuitous frangible line paths in a major plane of the device body portion thereby defining two or more stacked device segments.

9. The medical device of claim 1 further comprising a device gripping element disposed on a wall of the device and extending within the assembled area footprint of the device body portion, whereby the device gripping element can be accessed from a point external to the physiology of a patient through the transcutaneous skin opening and/or the passageway after removal of the transcutaneous treatment component such that applying force to the device gripping element results in fracturing the one or more frangible lines.

10. The medical device of claim 1 wherein the device body portion is generally disc shaped.

11. The medical device of claim 1 wherein the one or more frangible lines form one or more closed circuitous frangible line paths in a major plane of the device body portion thereby defining two or more nested device segments.

12. The medical device of claim 1 wherein the one or more frangible lines form one or more frangible line paths across major planes of the device body portion, extending between two points on the outer perimeter of the device thereby defining two or more device segments.

13. The medical device of claim 12 wherein the one or more frangible line paths are non-intersecting.

14. The medical device of claim 12 wherein the one or more frangible line paths intersect.

15. The medical device of claim 1 wherein each frangible line comprises a pulling end and a terminal end.

16. The medical device of claim 15 further comprising a device gripping element disposed at the pulling end of a frangible line and extending within the assembled area footprint of the device body portion.

17. The medical device of claim 15 further comprising an access point adjacent the pulling end of a frangible line for accessing the pulling end to initiate a tear along one or more of the frangible lines.

18. The medical device of claim 17 wherein the access point is a relatively thinner section of the device body portion.

19. The medical device of claim 15 further comprising a notch adjacent the pulling end of a frangible line for assisting in propagating a fracture along the frangible line.

20. A medical device according to claim 1 wherein the device pieces are sized for removal through a transcutaneous skin opening that is smaller than the size of an incision required for implanting the assembled device body portion.

21. A medical device according to claim 1 wherein the device pieces are sized for removal through a transcutaneous skin opening that defines an area of less than thirty percent of the assembled area footprint of the assembled device body portion.

22. A medical device according to claim 1, wherein a frangible line formed within the device body portion forms a continuous spiral path extending between the passageway support wall and an outer perimeter of the device body portion such that fracturing the frangible line produces a long, thin ribbon of material that unravels in situ and can be removed from the implantation site through the transcutaneous skin opening.

23. A medical device according to claim 1, wherein the device further comprises a tissue ingrowth skirt disposed along a surface of the device body portion around the point of entry of the transcutaneous treatment component, which skirt either entirely remains in place under the dermal layer adjacent the implantation site when the device body portion is disassembled and removed, or which skirt is biodegradable and/or bioabsorbable so that the physiology of the patient dissolves and clears the tissue ingrowth skirt.

24. An implantable subcutaneous medical device for anchoring an elongated transcutaneous treatment component that, in use, extends from outside a patient'"'"'s skin, through a transcutaneous skin opening sized to just accommodate the treatment component at a point of entry into the physiology of a patient, through the implanted medical device positioned at an implantation site, and then to a desired internal location in the patient'"'"'s body distal of the implanted medical device, the device comprising:

a) a device body portion having a passageway therethrough comprising a passageway entrance and support wall for receiving the transcutaneous treatment component beneath the point of entry and for subcutaneously routing the transcutaneous treatment component to the desired internal location, the device body portion being produced from a deformable material and having an assembled area footprint;

b) at least a frangible line extending along a continuous path between an outer perimeter of the device body portion and the annular support wall; and

c) at least one device gripping element disposed on the device body portion at a point adjacent to the frangible line,

whereby gripping the gripping element from a point external to the body of a patient and applying force results in fracturing the frangible line along the continuous path enabling removal of the device body portion from the body of the patient through a transcutaneous skin opening defining an area of less than thirty percent of the assembled area footprint.

25. An implantable subcutaneous medical device comprising a device body portion as follows:

a) said device body portion comprises at least two wall sections transverse relative to one another, the wall sections together defining a device interior region, further wherein two transverse wall sections include apertures extending through the wall sections into the device interior region such that an elongated transcutaneous treatment component can be passed through the aperture of one wall section, through the device interior region, and out through the aperture of the other wall section; and

,

b) said device body portion further comprises one or more frangible lines formed within the device body portion such that fracturing the device body portion along the frangible lines causes in situ disassembly of the device body portion into one or more device pieces sized in at least one dimension for removal from a subcutaneous implantation site in a patient through a minimally-sized removal incision in the patient'"'"'s skin that is smaller than a dimension of the device body portion along any axis prior to disassembly of the device body portion.

26. The medical device of claim 25 wherein the device pieces are sized for removal through a removal incision in a patient'"'"'s skin that defines an area of less than thirty percent of the area footprint of the assembled device body portion.

27. A medical device according to claim 25, wherein a frangible line formed within the device body portion forms a continuous spiral path extending between the aperture of a wall section and the wall section having the other aperture such that fracturing the frangible line produces a long, thin ribbon of material that unravels in situ and can be removed from the implantation site through the removal incision.

28. A medical device according to claim 25, wherein the device further comprises a tissue ingrowth skirt disposed along a wall section of the device body portion around the point of entry of the transcutaneous treatment component, which skirt either entirely remains in place under the dermal layer adjacent the implantation site when the device body portion is disassembled and removed, or which skirt is biodegradable and/or bioabsorbable so that the physiology of the patient dissolves and clears the tissue ingrowth skirt.

29. The medical device of claim 25 wherein the longest dimension of the removal incision is no more than 50 percent of the longest dimension of the major plane of the device body portion.

30. The medical device of claim 25 wherein the device body portion is dome shaped.

31. The medical device of claim 25 further comprising a device gripping element disposed on a wall section and extending into the device interior region, whereby the device gripping element can be accessed from a point external to the physiology of a patient through the removal incision and/or the aperture of a wall section after removal of the transcutaneous treatment component such that applying force to the device gripping element results in fracturing the frangible line(s).

32. The medical device of claim 25 wherein the device body portion is generally disc shaped.

33. The medical device of claim 25 wherein the frangible lines are non-intersecting.

34. The medical device of claim 25 wherein at least two of the frangible lines intersect.

35. The medical device of claim 25 wherein each frangible line comprises a pulling end and a terminal end.

36. The medical device of claim 35 further comprising a device gripping element disposed at the pulling end of a frangible line and extending into the device interior region.

37. The medical device of claim 35 further comprising an access point adjacent the pulling end of a frangible line for accessing the pulling end to initiate a tear along the frangible line.

38. The medical device of claim 37 wherein the access point is a relatively thinner section of the device body portion.

39. The medical device of claim 35 further comprising a notch adjacent the pulling end of a frangible line for assisting in propagating a tear along the frangible line.

40. An implantable subcutaneous medical device with a passageway therethrough for accommodating an elongated transcutaneous treatment component that, in use, extends from outside a patient'"'"'s body, through a skin opening, into and through the medical device positioned at an implantation site, and then to an internal body location, the medical device comprising:

a device body portion and one or more frangible lines formed within the device body portion, whereby, at the completion of an extended period in use in a patient'"'"'s body, the device body portion can be disassembled in situ along the frangible line(s) into device pieces that are sized and/or dimensioned for removal from the implantation site through a skin opening that is smaller than the size of an incision originally needed for implanting the medical device.

41. A medical device according to claim 40, wherein the device further comprises a tissue ingrowth skirt disposed along a wall of the device body portion adjacent the skin opening, which skirt either entirely remains in place under the skin at the implantation site when the device body portion is disassembled and removed, or which skirt is biodegradable and/or bioabsorbable so that the physiology of the patient dissolves and clears the tissue ingrowth skirt.