Method for using deformable medical implant

• US 9,302,088 B2
• Filed: 11/26/2013
• Issued: 04/05/2016
• 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): HAYMAN, IMANI N
• Application Number:
  US14/090,246
• Publication Number:
  US 20140088545A1
• Time in Patent Office: 861 Days
• US Class Current: 1/1
• 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. A method for removing a subcutaneously implanted port, designed for anchoring a transcutaneous treatment component when in use, from a subcutaneous implantation site, the method comprising the steps of:

(a) removing the transcutaneous treatment component from the port at a transcutaneous skin opening adjacent the port, wherein the port comprises;

(i) a device body portion having a passageway therethrough comprising a passageway entrance and a support wall for receiving the transcutaneous treatment component and for subcutaneously routing the transcutaneous treatment component to a location distal of the implantation site, the device body portion being produced from a deformable material and having an assembled area footprint; and

(ii) one or more frangible lines formed within the device body portion, a 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 a patient through the transcutaneous skin opening;

(b) inserting a retrieval implement through the transcutaneous skin opening;

(c) grasping the device body portion with the retrieval implement at or near one of the frangible lines;

(d) applying a force sufficient to fracture the one or more frangible lines thereby sectioning the device body portion into the one or more device body pieces sized in at least one dimension for removal through the transcutaneous skin opening; and

(e) pulling the one or more device body pieces through the transcutaneous skin opening.

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

3. The method of claim 1, further comprising a step before step (a) of creating the transcutaneous skin opening sized to remove the transcutaneous treatment component.

4. The method of claim 1 wherein the device body portion has a tissue ingrowth skirt disposed on a surface of the device body portion around a circumference of the passageway entrance for promoting tissue ingrowth at least around the circumference of the passageway entrance and the portion of the transcutaneous treatment component that passes through the passageway entrance.

5. The method of claim 4 wherein steps (d) and (e) are carried out while leaving the tissue ingrowth skirt within the physiology of the patient.

6. The method of claim 1 wherein the transcutaneous skin opening is also a point of entry where the transcutaneous treatment component enters the patient.

7. The method of claim 1 wherein the transcutaneous skin opening is an incision adjacent to the device body portion.

8. The method of claim 1 wherein the transcutaneous skin opening is longer along a long axis of the opening than in any other direction, and the opening along the long axis is no more than 50 percent of the longest dimension of the device body portion.

9. The method of claim 1 wherein the one or more frangible lines extend in a continuous path between the support wall and an outer perimeter of the device body portion.

10. The method of claim 9 wherein the continuous path forms a spiral along the device body.

11. The method of claim 1 wherein the one or more frangible lines form one or more frangible line paths across a major plane of the device body portion extending between two points on an outer perimeter of the device and thereby defining two or more device segments.

12. The method of claim 11 wherein the one or more frangible line paths are non-intersecting.

13. The method of claim 11 wherein the one or more frangible line paths intersect.

14. The method of claim 1 wherein the device body portion is dome shaped.

15. The method of claim 1 wherein the one or more frangible lines form one or more closed circuitous paths in a major plane of the device body portion thereby sectioning the device body portion into two or more stacked sections.

16. The method of claim 1 wherein the device body portion further comprises 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 the patient through the transcutaneous skin opening 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.

17. The method of claim 1 wherein the device body portion is generally disc shaped.

18. The method 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.

19. The method of claim 18 wherein the device body portion further comprises a device gripping element disposed on one or more of the two or more nested device segments 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 the patient through the transcutaneous skin opening 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.

20. The method of claim 1 wherein each frangible line of the one or more frangible lines comprises a pulling end and a terminal end.

21. The method of claim 20 wherein the device body portion further comprises a device gripping element disposed at the pulling end of a frangible line of the one or more frangible lines and extending within the assembled area footprint of the device body portion.

22. The method of claim 20 wherein the device body portion further comprises an access point adjacent the pulling end of a frangible line of the one or more frangible lines for accessing the pulling end to initiate a tear along one or more of the frangible lines.

23. The method of claim 22 wherein the access point is at a section of the device body portion that is thinner than the remainder of the device body portion.

24. The method of claim 20 wherein the device body portion further comprises a notch adjacent the pulling end of a frangible line of the one or more frangible lines for assisting in propagating the fracture along the frangible line.

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

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

27. The method according to claim 1, wherein a frangible line of the one or more frangible lines 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.

28. The method according to claim 1, wherein the device body portion has 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 or bioabsorbable so that the physiology of the patient dissolves and clears the tissue ingrowth skirt.

29. A method for removing from a subcutaneous implantation site in a patient a subcutaneously implanted medical device, designed for anchoring an elongated transcutaneous treatment component that, in use, extends from outside skin of the patient, through a transcutaneous skin opening sized to just accommodate the treatment component at a point of entry into the patient, through the implanted medical device positioned at an implantation site, and then to a desired internal location in the patient distal of the implanted medical device, the device comprising:

a) a device body portion having a passageway therethrough comprising a passageway entrance and a 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 patient and applying force results in fracturing the frangible line along the continuous path enabling removal of the device body portion from the patient through a transcutaneous skin opening defining an area of less than thirty percent of the assembled area footprint;

wherein the method comprises using the at least one device gripping element to fracture the frangible line causing in situ disassembly of the device body portion, and thereafter removing the disassembled device body portion from the implantation site.

30. A method for removing from a subcutaneous body implantation site in a patient an implanted subcutaneous medical device comprising a device body portion as follows:

a) said device body portion comprises at least two transverse wall sections that are transverse relative to one another, the two transverse wall sections together defining a device interior region, further wherein the 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 one or more frangible lines causes in situ disassembly of the device body portion into one or more removably-sized device body pieces that are sized in at least one dimension for removal from the subcutaneous implantation site in the patient through a minimally-sized removal incision in the skin of the patient that is smaller than a dimension of the device body portion along any axis prior to disassembly of the device body portion;

wherein the method comprises fracturing the device body portion along the one or more frangible lines into the removably-sized device body pieces and removing the device body pieces from the implantation site.

31. The method according to claim 30 wherein the device body pieces are sized for removal through a removal incision in the skin of the patient that defines an area of less than thirty percent of the area footprint of the assembled device body portion.

32. The method according to claim 30, wherein a frangible line of the one or more frangible lines 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 of the one or more frangible lines produces a long, thin ribbon of material that unravels in situ and can be removed from the implantation site through the removal incision.

33. The method according to claim 30, wherein the device body portion has a tissue ingrowth skirt disposed along a wall section of the device body portion around the point of entry of the transcutaneous treatment component, and said skirt either entirely remains in place under the dermal layer adjacent the implantation site when the device body portion is disassembled and removed, or said skirt is biodegradable or bioabsorbable so that the physiology of the patient dissolves and clears the tissue ingrowth skirt.

34. The method according to claim 30 wherein the removal incision is longer along a long axis of the incision than in any other direction, and the incision along the long axis is no more than 50 percent of the longest dimension of the device body portion.

35. The method according to claim 30 wherein the device body portion is dome shaped.

36. The method according to claim 30 wherein the device body portion further comprises 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 the patient through the removal incision or accessed through an 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 one or more frangible line(s).

37. The method according to claim 30 wherein the device body portion is generally disc shaped.

38. The method according to claim 30 wherein the one or more frangible lines are non-intersecting.

39. The method according to claim 30 wherein at least two of the one or more frangible lines intersect.

40. The method according to claim 30 wherein each frangible line of the one or more frangible lines comprises a pulling end and a terminal end.

41. The method according to claim 40 wherein the device body portion further comprises a device gripping element disposed at the pulling end of a frangible line of the one or more frangible lines and extending into the device interior region.

42. The method according to claim 40 wherein the device body portion further comprises an access point adjacent the pulling end of a frangible line of the one or more frangible lines for accessing the pulling end to initiate a tear along the frangible line.

43. The method according to claim 42 wherein the access point is at a section of the device body portion that is thinner than the remainder of the device body portion.

44. The method according to claim 40 wherein the device body portion further comprises a notch adjacent the pulling end of a frangible line of the one or more frangible lines for assisting in propagating a tear along the frangible line.

45. method for removing from an implantation site in a patient an implanted subcutaneous medical device with a passageway therethrough for accommodating an elongated transcutaneous treatment component that, in use, extends from outside the body of the patient, through a skin opening having a first size, into and through the medical device positioned at the implantation site, and then to an internal body location, the medical device comprising:

a device body portion that is longer along a device-portion long axis than in any other direction and has one or more frangible lines formed within the device body portion, whereby, at the completion of an extended period in use in the patient'"'"'s body, the device body portion can be disassembled in situ along the frangible line(s) into removably-sized device body pieces that are sized or dimensioned for removal from the implantation site through a skin opening having a second size that is smaller than a length of the device body portion along the device-portion long axis;

wherein the method comprises fracturing the device body portion along the frangible lines into the removably-sized device body pieces and removing the device body pieces from the implantation site through the skin opening having the second size.

46. The method according to claim 45, wherein the device body portion has a tissue ingrowth skirt disposed along a wall of the device body portion adjacent the skin opening, and said skirt either entirely remains in place under the skin at the implantation site when the device body portion is disassembled and removed, or said skirt is biodegradable or bioabsorbable so that the physiology of the patient dissolves and clears the tissue ingrowth skirt.