Percutaneous access device

• US 5,906,596 A
• Filed: 12/27/1996
• Issued: 05/25/1999
• Est. Priority Date: 11/26/1996
• Status: Expired due to Term

• Current Assignee: Primo Medical Group, Inc.
• Original Assignee: STD Manufacturing Limited
• Inventors: Tallarida, Steven J.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/774,923
• Time in Patent Office: 879 Days
• Field of Search: 604/49, 604/51, 604/52, 604/93, 604/174, 604/175, 604/890.1, 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 2039/0282 with implanted tubes connected to the port
• 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

A subcutaneous access port for surgical implantation in the body of a mammal, such access port comprising a body portion defining a chamber with an open face, the body portion having attached thereto a biocompatible mesh material, whereby the subcutaneous access port may be fixed within the body by suturing or surgical stapling through the biocompatible mesh material.

Claims

1. A medical device for surgical implantation in the body of a mammal which does not require alignment for suturing/stapling through a preformed opening, said device having attached thereto and projecting outwardly from an access port a single layer of biocompatible mesh material, wherein said mesh material contains pores of sufficient size over the entirety of said biocompatible mesh material'"'"'s surface to allow suturing or stapling through any portion of said mesh material, whereby said device may be fixed within a body via suturing or surgical stapling through said biocompatible mesh material.

2. A percutaneous/subcutaneous access port for surgical implantation in the body of a mammal which does not require alignment for suturing/stapling through a preformed opening, such access port comprising a body portion defining a chamber with an open face, said body portion having attached thereto a biocompatible mesh material wherein said biocompatible mesh material consists essentially of a single layer of mesh material having a surface with pores therethrough wherein said pores are of sufficient size and are present over the entirety of said biocompatible mesh material'"'"'s surface to allow suturing or stapling through any portion of said mesh material, whereby said subcutaneous access port may be fixed within a body via suturing or surgical stapling through said biocompatible mesh material.

3. The access port of claim 2, wherein said biocompatible mesh material is selected from the group consisting of synthetic polymeric fiber material, perforated film, and stainless steel.

4. The access port of claim 3 wherein said biocompatible mesh material comprises a synthetic polymeric fiber material selected from the croup consisting of polypropylene and poly(tetrafluoroethylene).

5. The access port of claim 3, wherein the biocompatible mesh material comprises a perforated film selected from the group consisting of polytetrafluoroethylene, stainless steel and titanium.

6. The access port of claim 2, wherein said biocompatible mesh material is attached to said access port by an adhesive.

7. The access port of claim 6, wherein the adhesive is a biocompatible adhesive.

8. The access port of claim 7 wherein the adhesive is a silicon adhesive.

9. The access port of claim 2, wherein said access port comprises metallic material.

10. The port of claim 2, wherein said biocompatible mesh material is disk-shaped and has a thickness in the range of about 0.005 to 0.060 inches, and a diameter in the range of about 0.10 to 4.0 inches.

11. The access port of claim 2, wherein the biocompatible mesh material has a pore size in the range of 1×

10^-6 to 0.250 inches.

12. The access port of claim 2, wherein said access port comprises a non-metallic material.

13. The access port of claim 12 wherein said non-metallic access port comprises a plastic or elastomeric material.

14. A percutaneous/subcutaneous access port for surgical implantation in the body of a mammal, such access port comprising a body portion defining an upper cap portion containing a chamber with an open face, said body portion having a lower port section and attached thereto a biocompatible mesh material wherein said mesh material contains pores of sufficient size to allow suturing or stapling through any portion of said mesh material, whereby said subcutaneous access port may be fixed within a body via suturing or surgical stapling through said biocompatible mesh material and wherein said access port further contains a crimper on said access port between said upper cap and said lower port for crimping attachment of said biocompatible mesh material.

15. A percutaneous/subcutaneous access port for surgical implantation in the body of a mammal which does not require alignment for suturing/stapling through a preformed opening, such access port comprising a body portion defining a chamber with an open face, said body portion including a single layer of a non-porous biocompatible material attached to said body portion which substantially precludes the downgrowth of epidermal cells and which is sufficiently flexible whereby said subcutaneous access port may be fixed within a body via suturing or surgical stapling through any portion of said biocompatible material.

16. The percutaneous/subcutaneous access port of claim 15, wherein said non-porous biocompatible material comprises polymer film material or metallic film.

17. The percutaneous/subcutaneous access port of claim 16, wherein the biocompatible material comprises a polymer film material selected from the group consisting of a polysiloxane, a polytetrafluoroethylene, a polyester, a nylon, a polyolefin and a polyurethane.

18. The percutaneous/subcutaneous access port of claim 16, wherein the biocompatible material comprises a metallic film selected from the group consisting of stainless steel and titanium and has a thickness of about 0.0001-0.020 inches.

19. The percutaneous/subcutaneous access port of claim 16, wherein the biocompatible material comprises a metallic film selected from the group consisting of a stainless steel and titanium and has a thickness of about 0.002-0.010 inches.

20. The percutaneous/subcutaneous access port of claim 16, wherein the biocompatible material comprises a metallic film selected from the group consisting of a stainless steel and titanium and has a thickness of about 0.002-0.005 inches.

21. A percutaneous/subcutaneous access port for surgical implantation in the body of a mammal, such access port comprising a body portion defining a chamber with an open face, said body portion having attached thereto a biocompatible mesh material, whereby said subcutaneous access port may be fixed within a body via suturing or surgical stapling through said biocompatible mesh material, wherein said access port further contains a crimper on said access port for crimping attachment of said biocompatible mesh material.

22. The access port of claim 21, wherein said biocompatible mesh material is selected from the group consisting of synthetic polymeric fiber material, perforated film, and stainless steel.

23. The access port of claim 22, wherein said biocompatible mesh material comprises a synthetic polymer fiber material selected from the group consisting of polypropylene and poly(tetrafluoroethylene).

24. The access port of claim 22, wherein the biocompatible mesh material comprises a perforated film selected from the group consisting of polytetrafluoroethylene, stainless steel, and titanium.

25. The access port of claim 21, wherein said biocompatible mesh material is attached to said access port by an adhesive.

26. The access port of claim 25, wherein the adhesive is a biocompatible adhesive.

27. The access port of claim 26, wherein the adhesive is a silicon adhesive.

28. The access port of claim 21, wherein said access port comprises metallic material.

29. The access port of claim 21, wherein said access port comprises a non-metallic material.

30. The port of claim 21, wherein said biocompatible mesh material is disk-shaped and has a thickness in the range of about 0.005 to 0.060 inches, and a diameter in the range of about 0.10 to 4.0 inches.

31. The access port of claim 21, wherein the biocompatible mesh material has a pore size in the range of 1×

10^-6 to 0.250 inches.

32. The access port of claim 21, wherein said access port comprises a non-metallic material.

33. The access port of claim 32, wherein said non-metallic access port comprises a plastic or elastomeric material.

34. A percutaneous/subcutaneous access port for surgical implantation in the body of a mammal, such access port comprising a body portion defining a chamber with an open face, said body portion having attached thereto a non-porous biocompatible material, whereby said subcutaneous access port may be fixed within a body via suturing or surgical stapling through said biocompatible material, wherein said non-porous biocompatible material comprises a biocompatible polymer film material or a biocompatible metallic film selected from the group consisting of stainless steel and titanium having a thickness of about 0.002-0.010 inches.

35. The percutaneous/subcutaneous access port of claim 34, wherein the biocompatible material comprises a polymer film material selected from the group consisting of a polysiloxane, a polytetrafluoroethylene, a polyester, a nylon, a polyolefin, and a polyurethane.

36. A percutaneous/subcutaneous access port for surgical implantation in the body of a mammal, such access port comprising a body portion defining a chamber with an open face, said body portion having attached thereto a non-porous biocompatible material, whereby said subcutaneous access port may be fixed within a body via suturing or surgical stapling through said biocompatible material, wherein said non-porous biocompatible material comprises a biocompatible polymer film material or a biocompatible metallic film selected from the group consisting of stainless steel and titanium having a thickness of about 0.002-0.005 inches.

37. The percutaneous/subcutaneous access port of claim 36, wherein the biocompatible material comprises a polymer film material selected from the group consisting of a polysiloxane, a polytetrafluoroethylene, a polyester, a nylon, a polyolefin and a polyurethane.

38. A method of providing repeated access to a preselected site within a patient by an external filament such as an external catheter, needle, wire or optional fiber, comprising the steps of:

providing a percutaneous/subcutaneous access port, said port comprising a body portion defining a chamber with an open face, said body portion having attached thereto a biocompatible mesh material, wherein said biocompatible mesh material consists essentially of a single layer of mesh material having a surface with pores therethrough, wherein said pores are of sufficient size and are present over the entirety of said biocompatible mesh material'"'"'s surface to allow suturing or stapling through any portion of said mesh material,

making an incision in a patient'"'"'s skin, and locating said access port at a desired location and affixing said access port at said desired location via suturing or stapling through said mesh material, and

closing the incision.