Methods and apparatus for intraluminal deposition of hydrogels

• US 6,152,943 A
• Filed: 08/14/1998
• Issued: 11/28/2000
• Est. Priority Date: 08/14/1998
• Status: Expired due to Term

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Sawhney, Amarpreet S.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/133,950
• Time in Patent Office: 837 Days
• Field of Search: 606/193, 606/194, 606/192, 604/523, 604/280, 604/284, 604/43, 604/96, 604/102, 128/898
• US Class Current: 606/193
• 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 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 6/225 transcervical
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2210/1425 Uterine tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/005 : for contrast media

Abstract

Methods and apparatus of forming hydrogel systems in situ are provided using a delivery system configured to deliver two or more fluent prepolymer solutions without premature crosslinking. The delivery system comprises separate first and second lumens coupling first and second inlet ports and first and second outlet ports, respectively, and may include a balloon, flexible distal region, mixing chamber or steerable distal end. Multi-component hydrogel systems suitable for use with the inventive methods and apparatus are also described.

Claims

1. A method for occluding or coating a space within a body or tissue lumen comprising:

providing a delivery system comprising a catheter having proximal and distal ends, first and second inlet ports disposed at the proximal end, first and second outlet ports disposed at the distal end, a first lumen coupling the first inlet port to the first outlet port, and a second lumen coupling the second inlet port to the second outlet port, the catheter configured to inject first and second fluent prepolymer solutions that crosslink when mixed, the first and second lumens configured so that the premature crosslinking of the first and second prepolymer solutions does not occur within the catheter;

positioning the distal end of the delivery system at a desired location in the space;

providing first and second fluent prepolymers;

injecting the first and second fluent prepolymers via the delivery system into the space;

crosslinking the first and second prepolymer solutions to form a hydrogel in situ in the space; and

withdrawing the delivery system from the space.

2. The method of claim 1 wherein a distal region of the catheter comprises a balloon, the method further comprising inflating the balloon to anchor the distal region of the catheter in place.

3. The method of claim 2 wherein flushing the space with a fluid comprises flushing the space with a radiocontrast agent.

4. The method of claim 1 wherein a distal region of the catheter further comprises a mixing chamber, injecting the first and second fluent prepolymers via the delivery system into the space further comprises injecting the first and second fluent prepolymers into the mixing chamber to initiate crosslinking, and crosslinking the first and second prepolymer solutions to form a hydrogel in situ in the space further comprises completing crosslinking of the first and second prepolymer solutions.

5. The method of claim 1 further comprising, prior to injecting the first and second fluent prepolymers via the delivery system into the space, flushing the space with a fluid.

6. The method of claim 1 wherein the delivery system further comprises a molding member disposed near the distal end, the method further comprising molding the first and second fluent prepolymer solutions using the molding member.

7. The method of claim 1 further comprising:

providing a stent; and

deploying the stent in a body lumen to partially define the space.

8. The method of claim 7 wherein the delivery system further comprises means for deflecting the distal end of the catheter away from a longitudinal axis and wherein positioning the distal end of the delivery system at a desired location in the space comprises:

deflecting the distal end of the catheter away from the longitudinal axis of the catheter; and

urging the distal end of the catheter so that the distal tip passes through a wall of the stent and into the space.

9. The method of claim 1 wherein providing first and second fluent prepolymers comprises providing first and second fluent prepolymers wherein at least one of the first and second fluent prepolymers contains a dissolved or dispersed therapeutic compound.

10. The method of claim 1 wherein positioning the distal end of the delivery system at a desired location in the space comprises:

transluminally inserting a guide wire into the space; and

advancing the delivery system along the guidewire to dispose the distal end within the space.

11. The method of claim 10 further comprising removing the guide wire from the delivery system.

12. The method of claim 1 wherein injecting first and second fluent prepolymer solutions comprises injecting first and second prepolymer solutions simultaneously.

13. The method of claim 1 wherein crosslinking the first and second prepolymer solutions comprises mixing the first and second prepolymer solutions.

14. The method of claim 13 wherein crosslinking the first and second prepolymer solutions further comprises warming the first and second prepolymer solutions to physiological temperature.

15. The method of claim 13 wherein crosslinking the first and second prepolymer solutions comprises crosslinking the first and second prepolymer solutions by a physical crosslinking process.

16. The method of claim 1 wherein crosslinking the first and second prepolymer solutions further comprises reacting the first and second prepolymer solutions with a body fluid to form a coagulum.

17. The method of claim 1 wherein crosslinking the first and second prepolymer solutions further comprises forming the hydrogel at less than equilibrium hydration, the method further comprising increasing the hydration of the hydrogel to anchor the hydrogel.

18. A method for occluding an opening within body tissue comprising:

providing a catheter comprising proximal and distal ends, first and second inlet ports disposed at the proximal end, first and second outlet ports disposed at the distal end, a first lumen coupling the first inlet port to the first outlet port, and a second lumen coupling the second inlet port to the second outlet port, the catheter configured to inject first and second fluent solutions that crosslink when mixed;

positioning the distal end of the catheter at a desired location in the opening;

providing first and second synthetic fluent solutions;

injecting the first and second synthetic fluent solutions via the catheter into the opening;

crosslinking the first and second synthetic fluent solutions to form a hydrogel in situ in the opening; and

withdrawing the catheter from the opening.

19. The method of claim 18 wherein a distal region of the catheter comprises a balloon, the method further comprising inflating the balloon to anchor the distal region of the catheter in place.

20. The method of claim 18 wherein a distal region of the catheter further comprises a mixing chamber, injecting the first and second synthetic fluent solutions via the catheter into the opening further comprises injecting the solutions into the mixing chamber to initiate crosslinking, and crosslinking the first and second synthetic fluent solutions to form a hydrogel in situ in the opening further comprises completing crosslinking of the solutions.

21. The method of claim 18 further comprising, prior to injecting the first and second synthetic fluent solutions via the catheter into the opening, flushing the opening with a fluid.

22. The method of claim 21 wherein flushing the opening with a fluid comprises flushing the opening with a radiocontrast agent.

23. The method of claim 18 wherein the catheter further comprises a molding member disposed near the distal end, the method further comprising molding the first and second synthetic fluent solutions using the molding member.

24. The method of claim 18 further comprising:

providing a stent; and

deploying the stent in a body lumen to partially define the opening.

25. The method of claim 24 wherein the catheter further comprises means for deflecting the distal end of the catheter away from a longitudinal axis and wherein positioning the distal end of the catheter at a desired location in the opening comprises:

deflecting the distal end of the catheter away from the longitudinal axis of the remainder of the catheter; and

urging the distal end of the catheter so that the distal tip passes through a wall of the stent and into the opening.

26. The method of claim 18 wherein providing first and second fluent solutions comprises providing first and second synthetic fluent solutions wherein at least one of the first and second synthetic fluent solutions contains a dissolved or dispersed therapeutic compound.

27. The method of claim 18 wherein positioning the distal end of the catheter at a desired location in the opening comprises:

transluminally inserting a guide wire into the opening; and

advancing the catheter along the guidewire to dispose the distal end within the opening.

28. The method of claim 27 further comprising removing the guide wire from the catheter.

29. The method of claim 18 wherein injecting first and second synthetic fluent solutions comprises injecting first and second fluent synthetic solutions simultaneously.

30. The method of claim 18 wherein crosslinking the first and second fluent synthetic solutions comprises mixing the first and second synthetic fluent solutions.

31. The method of claim 30 wherein crosslinking the first and second synthetic fluent solutions further comprises warming the first and second synthetic fluent solutions to physiological temperature.

32. The method of claim 30 wherein crosslinking the first and second synthetic fluent solutions comprises crosslinking the first and second synthetic fluent solutions by a physical crosslinking process.

33. The method of claim 18 wherein crosslinking the first and second synthetic fluent solutions further comprises reacting the first and second synthetic fluent solutions with a body fluid to form a coagulum.

34. The method of claim 18 wherein crosslinking the first and second synthetic fluent solutions further comprises forming the hydrogel at less than equilibrium hydration, the method further comprising increasing the hydration of the hydrogel to anchor the hydrogel.