Artificial sphincter

• US 4,210,132 A
• Filed: 07/26/1978
• Issued: 07/01/1980
• Est. Priority Date: 07/26/1978
• Status: Expired due to Term

• Current Assignee: The Kendall Company (Colgate-Palmolive Company)
• Original Assignee: The Kendall Company (Colgate-Palmolive Company)
• Inventors: Perlin, Alfred R.
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US05/928,203
• Time in Patent Office: 706 Days
• Field of Search: 128/283, 128/DIG. 25, 3/1, 3/1.1, 428/900
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0018 magnetic
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An artificial sphincter for closure of a channel in a patient'"'"'s body communicating with an opening adjacent the outside of the patient'"'"'s body. The sphincter comprises, a generally annular member containing a first material for placement around the channel of the patient'"'"'s body, and a plug having elongated flexible sidewalls of an elastic material for placement within the annular member in the body channel. The plug contains a particulate second material positioned in a region within the annular member when the plug is located in the patient'"'"'s body. At least one of the first and second materials comprises a permanent magnetic material, while the other of the first and second materials comprises a material substantially susceptible to the one magnetic material. The sphincter has an applicator for selective placement and removal of the plug relative the channel in the patient'"'"'s body.

Claims

1. An artificial sphincter for closure of a channel in a patient'"'"'s body communicating with an opening adjacent the outside of the patient'"'"'s body, comprising:

a generally annular member containing a first material for placement at least partially around the channel of the patient'"'"'s body;

a plug having elongated flexible sidewalls of an elastic material for placement within said annular member in the body channel with the plug sidewalls flexing toward walls of said channel in a closure position of the plug, said plug containing a particulate second material positioned in a region within the annular member when said plug is located in said closure position, at least one of said first and second materials comprising a permanent magnetic material, and the other of said first and second materials comprising a material substantially susceptible to said one magnetic material; and

applicator means for selectively placing said plug in said closure position and for selectively removing the plug from the body channel comprising means for modifying the transverse dimensions of the plug sidewalls relative to the body channel.

2. The sphincter of claim 1 wherein said annular member extends around an intestine of the patient defining said channel adjacent said opening.

3. The sphincter of claim 1 wherein said annular member is located intermediate an outer end of an intestine and the skin of the patient'"'"'s body.

4. The sphincter of claim 1 wherein the length of said plug sidewalls is substantially greater than the length of said annular member.

5. The sphincter of claim 1 wherein said first material comprises said one magnetic material.

6. The sphincter of claim 5 wherein said first material is axially magnetized.

7. The sphincter of claim 5 wherein said first material is radially magnetized.

8. The sphincter of claim 5 wherein said first material comprises a plurality of spaced annular magnets.

9. The sphincter of claim 1 including an elongated closed end sleeve of flexible protective material covering said sidewalls and a distal end of said plug.

10. The sphincter of claim 1 wherein said plug sidewalls at least partially define a chamber in the plug, and in which said second particulate material is suspended in a liquid in said chamber.

11. The sphincter of claim 10 wherein said plug includes valve means communicating with said chamber, and in which the applicator means comprises pump means connectable to said valve means for selectively filling the chamber with the liquid and second material, and aspirating the liquid and second material from the chamber.

12. The sphincter of claim 11 wherein the pump means comprises a syringe.

13. The sphincter of claim 1 wherein said second material comprises a magnetic material.

14. The sphincter of claim 1 wherein said second material comprises a ferromagnetic material.

15. The sphincter of claim 1 wherein said plug includes a proximal outwardly directed annular rim for placement over the outside of the patient'"'"'s body adjacent said opening.

16. The sphincter of claim 1 wherein said plug has an elongated central passageway closed by a distal end of the plug, said passageway communicating with an aperture at a proximal end of the plug.

17. The sphincter of claim 16 wherein the applicator means comprises an elongated magnetized rod for placement in the passageway of the plug.

18. The sphincter of claim 17 including means for releasably attaching a distal end of the rod to the distal end of the plug in said passageway.

19. The sphincter of claim 16 wherein the applicator means comprises an elongated rod having a length greater than the length of said passageway, said rod being received in the passageway with a distal end of the rod bearing against the distal end of the plug to stretch said plug sidewalls away from the walls of the body channel.

20. The sphincter of claim 1 wherein said second material is contained within said plug sidewalls.

21. The sphincter of claim 1 wherein the plug sidewalls include circumferential regions of reduced thickness for increased flexibility in said regions.

22. The sphincter of claim 1 wherein said plug includes a generally annular flexible flap extending in a distal direction adjacent a distal end of the plug, said flap being placed at a location distal the annular member in the body channel in the closure position of the plug.

23. The sphincter of claim 22 wherein at least a portion of said second material is located within said flap.

24. The sphincter of claim 1 wherein said annular member defines a relatively smooth inner surface.

25. The sphincter of claim 1 wherein said annular member defines a plurality of inner circumferential recesses.

26. The sphincter of claim 1 wherein a distal end of the plug has an elongated central recess.

27. An artificial sphincter for closure of a channel in a patient'"'"'s body communicating with an opening adjacent the outside of the patient'"'"'s body, comprising:

a generally annular member containing a first material for placement at least partially around the channel of the patient'"'"'s body;

a plug of elastic material having an elongated flexible annular outer wall for facing walls of the body channel, a closed distal end, and an annular inner wall defining an elongated central passageway extending between an opening adjacent a proximal end of the plug and said distal end, said inner and outer walls at least partially defining an elongated chamber in the plug having a length greater than the length of said annular member, said plug containing a fluid and a particulate second material in said chamber, with at least one of said first and second materials comprising a permanent magnetic material, and with the other of said first and second materials comprising a material substantially susceptible to said one magnetic material, said first and second materials causing flexation of said outer wall toward the walls of the body channel in a first closure configuration of the plug; and

applicator means for selective placement and removal of the plug comprising means for placing the outer wall of the plug in a second configuration with said outer wall in reduced transverse dimensions relative to the walls of said channel.

28. The sphincter of claim 27 wherein said applicator means comprises an applicator member having an elongated rod with a length greater than the length of said passageway, and a handle connected to the rod adjacent a proximal end of the applicator member, with a distal end of the rod bearing upon the distal end of the plug to stretch the plug walls and move the plug from said first configuration to said second configuration during placement and removal of the plug.

29. The sphincter of claim 28 including a retaining member having a channel to receive said rod, a retaining portion adjacent a proximal end of the retaining member, and including means for releasably attaching the retaining member to said plug with the channel of the retaining member aligned with the passageway of the plug, and with said retaining portion located proximal the plug, whereby the rod of the applicator member may be passed through said retaining member channel into said passageway with the retaining member attached to the plug, and the spacing between said handle and retaining portion may be reduced to apply pressure by the distal end of the rod and stretch the plug.

30. The sphincter of claim 29 wherein the attaching means comprises cooperating threads on the distal end of the retaining member and the proximal end of the plug.

31. The sphincter of claim 29 wherein said handle of the applicator member and the retaining portion of the retaining member comprise outwardly directed proximal rims.

32. The sphincter of claim 27 wherein said applicator means comprises an elongated rod for insertion into said passageway, said rod including magnet means to attract said second material in the plug cavity.

33. An artificial sphincter for closure of a channel in a patient'"'"'s body communicating with an opening adjacent the outside of the patient'"'"'s body, comprising:

a generally annular member containing a first material for placement at least partially around the channel of the patient'"'"'s body;

a plug of elastic material having a flexible annular outer wall for facing walls of the body channel, a closed distal end, and a chamber with a length greater than the length of said annular member, and valve means communicating with said chamber; and

pump means for selectively filling the chamber through the valve means with a medium and for selectively withdrawing the medium from the chamber, said medium comprising a liquid and a particulate second material, with at least one of said first and second materials comprising a permanent magnetic material, and with the other of said first and second materials comprising a material substantially susceptible to said one magnetic material.

34. An artificial sphincter for closure of a channel in a patient'"'"'s body communicating with an opening adjacent the outside of the patient'"'"'s body, comprising:

a generally annular member containing a first material for placement at least partially around the channel of the patient'"'"'s body;

a plug of elastic material having an elongated outer wall for facing the walls of the body channel, said outer wall having a length greater than the length of said annular member and defining a central passageway communicating with an opening adjacent a proximal end of the plug, said plug having a distal wall extending from said outer wall and closing a distal end of the passageway, and a particulate second material dispersed in a region of said outer wall having a length greater than the length of said annular member, at least one of said first and second materials comprising a permanent magnetic material, and the other of said first and second materials comprising a material substantially susceptible to said one magnetic material; and

applicator means for reducing the transverse dimensions of the outer wall to permit placement and removal of said plug.

35. The sphincter of claim 34 wherein the applicator means comprises an elongated rod receivable in said passageway and having a length greater than the length of the passageway, said rod having a distal end for engaging against said distal wall to stretch the plug during placement and removal.

36. The sphincter of claim 34 wherein the applicator means comprises an elongated rod receivable in the passageway and having magnet means to attract said second material in said outer wall.