System for implanting a cross-linked polysaccharide fiber and methods of forming and inserting the fiber

• US 6,139,520 A
• Filed: 08/28/1997
• Issued: 10/31/2000
• Est. Priority Date: 08/17/1994
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Kamath, Kalpana, Sahatjian, Ronald, McCrory, Jennifer, Luscher, Patrik
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/919,107
• Time in Patent Office: 1,160 Days
• Field of Search: 604/1, 604/2, 604/11, 604/13, 604/15, 604/57, 604/59, 604/60, 604/82, 604/83, 604/84, 604/85, 604/187, 604/257, 604/264, 604/365, 604/367, 222/80, 222/129, 222/135, 222/136, 222/145.1, 623/1, 623/12, 606/1, 606/213, 128/898
• US Class Current: 604/60
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

Systems and methods are disclosed for implanting and forming both a polysaccharide fiber and an implant formed of the fiber. In one system, a liquid including polysaccharide and a liquid including a cross linking agent are mixed in a cannula to form a cross linked polysaccharide fiber in the cannula. In another system, a carrier fluid delivers a previously manufactured fiber through a cannula. A cutter is optionally provided on the cannula to sever the fiber after a sufficient length of fiber is implanted. The disclosed methods include a method of forming a polysaccharide fiber in the cannula while the cannula is inserted in a body, and a method of making a cross linked polysaccharide fiber for loading in a delivery system.

Claims

1. An implant system comprising:

a first reservoir containing a first liquid including polysaccharide;

a second reservoir containing a second liquid including an ionic cross linking agent; and

a cannula including

a first lumen in fluid communication with the first liquid in the first reservoir,

a second lumen in fluid communication with the second liquid in the second reservoir,

a distal end portion wherein the first and second lumens fluidly communicate with one another to mix the first and second liquids and thereby form a cross linked elongate fiber, and

an opening in the distal end portion allowing passage of the cross linked fiber therethrough.

2. The implant system of claim 1, wherein the distal end portion of the cannula includes a cutter for severing the fiber.

3. The implant system of claim 2, wherein the cutter includes a loop shaped portion for surrounding the fiber and an actuator extending from the loop shaped portion, the loop shaped portion severing the fiber in response to movement of the actuator.

4. The implant system of claim 2, wherein the cutter includes a compliant slit valve, the slit valve opening in response to increased pressure in the distal end portion to allow for passage of the fiber from the cannula and closing in response to reduced pressure in the distal end portion to sever the fiber.

5. The implant system of claim 1, wherein the first liquid includes alginate.

6. The implant system of claim 1, wherein at least one of the first liquid and the second liquid includes chitosan.

7. The implant system of claim 1, wherein the first liquid includes sodium alginate.

8. The implant system of claim 1, wherein the second liquid includes calcium.

9. The implant system of claim 1, wherein at least one of the first and second liquids includes one of the group consisting of a precipitating material for forming a matrix capable of holding the fiber together and an adhesive for adhering portions of the cross linked fiber to one another.

10. The implant system of claim 1, wherein the system further comprises a syringe having a first barrel forming the first reservoir and a second barrel forming the second reservoir.

11. The implant system of claim 10, wherein the syringe further comprises a first plunger in the first barrel and a second plunger in the second barrel, the first and second plungers being coupled together to move simultaneously.

12. The implant system of claim 1, wherein the cannula is a flexible catheter.

13. The implant system of claim 1, wherein the cannula is a catheter including a first tubular portion having a distal end and a second tubular portion having a distal end extending beyond the distal end of the first tubular portion, the first tubular portion being in the second tubular portion, the first lumen being in the first tubular portion and the second lumen being between an outer surface of the first tubular member and an inner surface of the second tubular member.

14. The implant system of claim 1, wherein at least one of the first and second liquids includes a radiopaque substance.

15. The implant system of claim 14, wherein the radiopaque substance includes at least one of tantalum, tungsten, barium sulfate, and titanium dioxide.

16. The implant system of claim 1, wherein at least one of the first and second liquids includes a drug.

17. The implant system of claim 16, wherein the drug is chosen from at least one of alcohol and thrombogenic substances.

18. The implant system of claim 1, wherein at least one of the first and second liquids includes a drug, and wherein the drug is capable of being released over time from the fiber.

19. A method of forming an implant in a body, comprising:

introducing a cannula into the body, the cannula including a first lumen, a second lumen, and an opening in a distal end portion of the cannula;

passing a first liquid through the first lumen, the first liquid including polysaccharide;

passing a second liquid through the second lumen, the second liquid including an ionic cross linking agent;

mixing the first and second liquids in the cannula to form a flexible cross linked fiber;

moving the fiber through the opening in the cannula; and

contacting the fiber against body tissue to allow the fiber to bend and to form the implant in the body.

20. The method of claim 19, further comprising separating a portion of the fiber from the cannula.

21. The method of claim 20, wherein the separating includes cutting the fiber by passing a loop of material through the fiber.

22. The method of claim 20, further comprising passing the fiber through a slit valve on the cannula and wherein the separating includes cutting the fiber by closing the slit valve to cut the fiber.

23. The method of claim 20, wherein the cannula includes a first tubular portion having the first lumen and a second tubular portion having the second lumen, and wherein the separating includes moving the first tubular portion with respect to the second tubular portion to push the fiber through the opening in the cannula.

24. The method of claim 19, wherein the first liquid includes alginate.

25. The method of claim 19, wherein at least one of the first liquid and the second liquid includes chitosan.

26. The method of claim 19, wherein the first liquid includes sodium alginate.

27. The method of claim 19, wherein the second liquid includes calcium chloride.

28. The method of claim 19, wherein at least one of the first and second liquids includes an adhesive, and wherein the method further comprises adhering portions of the cross linked fiber to one another.

29. The method of claim 19, wherein at least one of the first and second liquids includes a precipitating material, and wherein the method further comprises holding the fiber together with a matrix formed from the precipitating material.

30. The method of claim 19, further comprising ejecting the first liquid from a first barrel of a syringe and ejecting the second liquid from a second barrel of the syringe.

31. The method of claim 19, wherein the cannula is a catheter including a first tubular portion having a distal end and a second tubular portion having a distal end extending beyond the distal end of the first tubular portion, the first tubular portion being in the second tubular portion, the first lumen being in the first tubular portion and the second lumen being between an outer surface of the first tubular member and an inner surface of the second tubular member, and wherein the method further comprises mixing the first and second liquids in the distal end of the second tubular portion.

32. The method of claim 19, further comprising adding a radiopaque substance to at least one of the first and second liquids.

33. The method of claim 19, further comprising adding a drug to at least one of the first and second liquids.

34. The method of claim 33, wherein the drug is chosen from at least one of alcohol and thrombogenic substances.

35. The method of claim 19, further comprising delivering the fiber into a blood vessel to at least partially occlude the blood vessel.

36. The method of claim 19, further comprising delivering the fiber into a blood vessel leading to an aneurysm to limit blood flow to the aneurysm.

37. The method of claim 19, further comprises delivering the fiber into a blood vessel leading to an arteriovenous malformation to limit blood flow to the arteriovenous malformation.

38. The method of claim 19, further comprising adding a drug to at least one of the first and second liquids, wherein the drug is released over time from the fiber.