Non-intravascular infusion access device

• US 6,042,561 A
• Filed: 10/22/1997
• Issued: 03/28/2000
• Est. Priority Date: 10/22/1997
• Status: Expired due to Fees

• Current Assignee: AAT Catheter Technologies, LLC
• Original Assignee: ASH Medical Systems Incorporated
• Inventors: Janle, Elsa M., Ash, Stephen R.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Finkel, Sharon
• Application Number:
  US08/956,001
• Time in Patent Office: 888 Days
• Field of Search: 604/93, 604/19, 604/29, 604/27, 604/28, 604/30, 604/51-53, 604/118, 604/264, 604/158, 604/161, 604/174, 604/175, 604/280, 604/890.1, 604/891.1
• US Class Current: 604/93.01
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• 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 non-intravascular infusion access device and method for long-term continuous infusion of drugs. The infusion access device includes a porous membrane made of a material which is biocompatible for long-term patency inside the body. The porous membrane is connected to a conducting tubing which exits from the body and is connected to a drug infusion system. At the exit site is a cuff of porous material. The cuff serves to anchor the access device in position as the surrounding body tissue grows back around the cuff. There are also two small suture retainers for stabilizing the position of the access device relative until tissue ingrowth occurs in and around the cuff.

Claims

1. A non-intravascular infusion access device for long-term continuous infusion of a therapeutic agent into the body, comprising:

an elongate tubular porous membrane having a closed end and an open end, said membrane made of a substantially nonexpandable biocompatible material suitable for implantation within a non-intravascular location inside the body and having pores sized to allow the passage of the therapeutic agent through said membrane while preventing the passage of a member selected from the group consisting of bacteria and viruses;

a conducting tubing having first and second open ends, said conducting tubing sized to permit infusion therethrough of a fluid containing the therapeutic agent, said open end of said tubular porous membrane attached to and in fluid communication with said first open end of said tubing whereby fluid infused through said conducting tubing is caused to flow through said porous membrane;

an infusion delivery system including a fluid source containing the therapeutic agent; and

a means for connecting the second open end of said conducting tubing to the infusion delivery system.

2. The non-intravascular infusion access device of claim 1 and further comprising:

a porous cuff extending around said conducting tubing, said cuff being formed of a material compatible with body tissues thereby promoting tissue ingrowth therein when said cuff is implanted within the body.

3. The non-intravascular infusion access device of claim 2 and further comprising a suture retainer means extending from said conducting tubing and adapted to secure the position of said membrane inside the body until the position of said cuff is secured by tissue ingrowth.

4. The non-intravascular infusion access device of claim 3 wherein said suture retainer means includes a pair of ovular shaped suture retainers spaced apart along and protruding from the exterior surface of the conducting tube.

5. The non-intravascular infusion access device of claim 1 wherein the maximum diameter size of the pores in said porous membrane is in the range of about 0.2 to about 1 micron.

6. The non-intravascular infusion access device of claim 1 wherein said porous membrane has pores sized to pass insulin molecules having a molecular weight of up to about 50,000 daltons.

7. The non-intravascular infusion access device of claim 1 wherein said porous membrane has an outer surface area which is greater than the cross-sectional area of said first open end of said conducting tubing.

8. The non-intravascular infusion access device of clam 1 wherein said porous membrane is formed of a copolymer of polyacrylonitrile and polyvinyl chloride.

9. A kit for providing long-term continuous infusion of a therapeutic agent into a non-intravascular body location, comprising:

(a) an elongate tubular porous membrane having a closed end and an open end, said membrane made of a substantially nonexpandable biocompatible material suitable for implantation within a non-intravascular location inside the body and having pores sized to allow the passage of the therapeutic agent through said membrane while preventing the passage of a member selected from the group consisting of bacteria and viruses;

(b) a conducting tubing having one end connected in fluid communication with said open end of said porous membrane and sized to permit infusion therethrough of a fluid containing the therapeutic agent;

(c) an infusion system including a fluid source containing the therapeutic agent configured for connection to said conducting tubing opposite said one end; and

(d) an introducer having a passageway sized to slidably receive therethrough at least that portion of said non-intravascular infusion access device including said porous membrane.

10. The kit of claim 9 and further comprising:

a porous cuff extending around said conducting tubing and made from a body compatible material promoting tissue ingrowth.

11. An infusion access device for long-term continuous infusion of insulin into a subcutaneous space within the body, comprising:

an elongate tubular porous membrane having a closed distal and open proximal end, said porous membrane formed of a material compatible for implantation within a subcutaneous body space and having pores sized to allow the passage of insulin through said membrane;

a conducting tubing having one end connected to the proximal open end of said porous membrane in fluid communication therethrough, said conducting tubing sized to permit infusion therethrough of a fluid containing the therapeutic agent; and

an adaptor connecting said proximal open end of said conducting tubing to an insulin infusion system.

12. A method for continuous long-term infusion of a therapeutic agent into the body, comprising the acts of:

providing an infusion access device including an elongate tubular porous membrane and a fluid conducting tube;

implanting said porous membrane into a non-intravascular body location;

connecting said infusion access device to an externally located fluid source containing a therapeutic agent whereby the source is in fluid communication with the fluid conducting tube; and

infusing a fluid containing the therapeutic agent from said fluid source through said porous membrane;

wherein the elongate tubular porous membrane has a closed end and an open end, said membrane made of a substantially nonexpandable biocompatible material suitable for implantation within a non-intravascular location inside the body and having pores sized to allow the passage of the therapeutic agent through said membrane while preventing the passage of a member selected from the group consisting of bacteria and viruses; and

wherein the conducting tubing has first and second open ends, said conducting tubing sized to permit infusion therethrough of a fluid containing the therapeutic agent, said open end of said tubular porous membrane attached to and in fluid communication with said first open end of said tubing whereby fluid infused through said conducting tubing is caused to flow through said porous membrane.

13. The method of claim 12 wherein said implanting is accomplished by using a hollow introducer needle sized to receive therein said porous membrane and said method further comprises:

positioning the porous membrane within said hollow introducer needle;

advancing said hollow introducer needle into a subcutaneous body location; and

withdrawing said needle from the body after said porous membrane is desirably positioned within the subcutaneous body location.

14. The method of claim 13 and further comprising:

securing the position of said infusion access device relative to the body.

15. The method of claim 14 wherein said securing is accomplished by applying a skin suture around said conducting tube.

16. The method of claim 15 wherein said infusion access device includes a cuff positioned around said conducting tube and said securing is further accomplished by implanting said cuff into body tissues and allowing ingrowth of said tissues into said cuff.