Dissolvable subcutaneous catheter cover

• US 6,939,328 B2
• Filed: 02/26/2003
• Issued: 09/06/2005
• Est. Priority Date: 02/27/2002
• Status: Active Grant

• Current Assignee: Medical Components, Inc.
• Original Assignee: Medical Components, Inc.
• Inventors: Raulerson, J. Daniel
• Primary Examiner(s): Thanh, LoAn H.
• Application Number:
  US10/374,834
• Publication Number:
  US 20030163145A1
• Time in Patent Office: 923 Days
• Field of Search: 604/93.01, 604/96.01, 604/103.05, 604/171, 604/263, 604/268, 604/523, 604533-536, 604285-287, 604/915, 604/104, 604/175, 606/192, 606/195, 606/108, 606/154, 606/194
• US Class Current: 604/175
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

A subcutaneous cover for insertion within a body of a user is disclosed. The cover is adapted to extend over at least a portion of a medical device disposed within the body of the user, and wherein the cover is dissolvable in the body of the user. Further, a method of subcutaneously inserting the cover into the body is also disclosed.

Claims

1. A catheter assembly for insertion within a body of a user comprising a catheter having an ingrowth device and a subcutaneous cover comprising a cover including a first open end and a second open end, wherein the cover is sized to allow the catheter to extend through both the first and second open ends when the catheter is disposed within the body of the user, wherein the cover comprises a generally funnel-shaped body, and wherein the cover is dissolvable within the body of the user.

2. The subcutaneous cover according to claim 1, wherein the catheter assembly is constructed from polyalkylene glycol.

3. The subcutaneous cover according to claim 2, wherein the catheter assembly is further constructed from at least one of an ester and a carbonate group.

4. The subcutaneous cover according to claim 3, wherein the catheter assembly has a molecular weight of at least about 30,000 Daltons.

5. The subcutaneous cover according to claim 1, wherein the ingrowth device is a clamshell cuff.

6. The catheter assembly according to claim 1, further comprising a longitudinal side opening extending from the first open end to the second open end.

7. The catheter assembly according to claim 6, wherein the longitudinal side opening is closable with sutures.

8. The catheter assembly according to claim 7, wherein the sutures are dissolvable within the body of the user.

9. The catheter assembly according to claim 6, further comprising a plurality of interlocking members, wherein the longitudinal side opening is closable by interlocking the plurality of interlocking members.

10. A medical device assembly comprising a clamshell cuff and a cover formed over the clamshell cuff, wherein the cover includes a first open end and a second open end, wherein the cover is shaped to facilitate insertion of the cover and the clamshell cuff into a subcutaneous area of a body of a user, and wherein the cover is dissolvable within the body of the user.

11. The medical device assembly according to claim 10, wherein the medical device assembly is a catheter assembly.

12. The medical device assembly according to claim 10, wherein the cover is initially formed over the clamshell cuff in one of a liquid, gelatinous and semi-solid form.

13. The medical device assembly according to claim 10, wherein the cover is constructed from polyalkylene glycol.

14. The medical device assembly according to claim 13, wherein the subcutaneous cover is further constructed from at least one of an ester and a carbonate group.

15. The subcutaneous cover according to claim 14, wherein the cover has a molecular weight of at least about 30,000 Daltons.

16. A method of subcutaneously inserting a medical device assembly into a body of a user, wherein the medical device assembly comprises a protruding portion, wherein the method comprises:

forming a subcutaneous tunnel in the body of the user;

disposing a cover over the protruding portion, wherein the cover is dissolvable within the body of the user;

inserting the medical device assembly, the protruding portion, and the cover into the subcutaneous tunnel, wherein at least the protruding portion and the cover remain in the subcutaneous tunnel; and

allowing the cover to dissolve within the subcutaneous tunnel.

17. The method according to claim 16, wherein the protruding portion comprises an ingrowth cuff, and the method further comprises, after allowing the cover to dissolve within the subcutaneous tunnel, allowing the body of the user to grow around the ingrowth cuff.

18. The method according to claims 16, wherein disposing the cover over the protruding portion comprises inserting the medical device assembly into the cover.

19. The method according to claim 16, wherein disposing the cover over the protruding portion comprises applying at least one of a liquid, gelatinous, and semi-solid compound over the protruding portion and allowing the at least one of the liquid, gelatinous, and semi-solid compound to solidify around the protruding portion prior to inserting the medical device.