Device for closing a septal defect

• US 5,634,936 A
• Filed: 02/06/1995
• Issued: 06/03/1997
• Est. Priority Date: 02/06/1995
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Holman, Thomas J., Buscemi, Paul J., Palme, Donald F. II, Linden, Bradley
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEONARDO, MARK
• Application Number:
  US08/383,824
• Time in Patent Office: 848 Days
• Field of Search: 606/213, 606/215, 606/153, 606/191, 604/15, 604/60, 604/93, 604/101, 604/53, 604/919
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 85/02 containing phosphorus

Abstract

A device for closing off a septal defect including a polymeric self-hardening material in a specific conformation which is delivered by a catheter device to the area of defect either directly on the cardiac tissue or into a balloon which spans both surfaces of the defect, and hardened in-situ by change in pH or ionic concentration, organic solvents, by permeation of a secondary material capable of precipitation, or by exposure to heat, light or laser energy. In blood, the device may be hardened through photopolymerization or a cooperative effect of coagulation, precipitation or ionization. The device can be made of biodegradable material impregnated with growth factors, mitogenic factors or other determinants which can improve tissue growth such that tissue ingrowth can occur over a period of time. The catheter itself may be an ultrasonic imaging catheter.

Claims

1. An apparatus for permanently closing off a septal defect, the apparatus comprising:

a. a plug comprising a polymeric material which is cured or hardened in situ, said plug being unitary in construction and having a first end and a second end, the plug being directly introduced into the area of a septal defect;

b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug;

c. means for releasably securing the plug to the catheter;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect, released from the catheter and cured or hardened in situ, whereby the hardened plug remains, plugging the defect.

2. The apparatus of claim 1 wherein the plug is made of a bioabsorbable polymeric material that reacts to heat, light, alterations in pH or chemical reactants.

3. The apparatus of claim 2 wherein the polymeric material includes growth factors and other mitogenic agents.

4. The apparatus of claim 1 wherein the catheter includes a balloon at its second end, said balloon being unitary in construction and having a specific conformation which is adapted to fit securely into the defect upon being positioned therein and substantially close it, and the plug comprises a sleeve which encases the balloon.

5. The apparatus of claim 4 wherein the plug is released from the catheter by deflation of the balloon.

6. The apparatus of claim 1 wherein the plug comprises a polymeric material which is relatively soft and compliant in a first state, the plug being of a specific configuration which is adapted to fit securely into the defect upon being positioned therein and substantially close it, said polymeric material being capable of being cured and changed to a hardened second state in-situ, whereby the defect is permanently closed by said plug of cured polymeric material.

16. The apparatus of claim 3 wherein the balloon is made of biodegradable polymeric material.

7. An apparatus for closing off a septal defect, the apparatus comprising:

a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect; and

b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug, said catheter including a corkscrew at its second end whereby the plug is releasably secured thereto;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.

8. An apparatus for closing off a septal defect, the apparatus comprising:

a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect;

b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug, said catheter further comprising a threaded protrusion at its second end adapted to mate with a threaded bore located at the first end of the plug, whereby the plug is releasably secured to the catheter;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.

9. An apparatus for closing off a septal defect, the apparatus comprising:

a. a plug having a first end and a second end, said plug comprising a balloon filled with polymeric foam, the plug being directly introduced into the area of a septal defect;

b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug;

c. means for releasably securing the plug to the catheter;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.

10. The apparatus of claim 9 wherein the catheter includes a fluid delivery lumen by means of which the polymeric foam is hardened after delivery to the area of defect.

11. The apparatus of claim 9 wherein the balloon is made of bioabsorbable material.

12. The apparatus of claim 9 wherein the balloon and polymeric material include growth factors and other mitogenic agents.

13. An apparatus for closing off a septal defect, the apparatus comprising:

a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect, said plug further comprising;

i. a dual-lobed balloon made of polymeric material; and

ii. a liquid solution which is introduced into the balloon at an elevated temperature and hardens into a gel upon cooling in-situ to body temperature;

b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug;

c. means for releasably securing the plug to the catheter;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.

14. The apparatus of claim 13 wherein the liquid solution introduced into the balloon comprises a water soluble composition selected from the group consisting of gelatin, collagen, albumin, agar and mixtures thereof.

15. The apparatus of claim 14 wherein the composition further includes bioactive components selected from the group consisting of collagen, albumin, β

Fibroblastic Growth Factor, angiogenic factors. RGD adhesion sequences, antibiotics and mixtures thereof.

17. The apparatus of claim 13 wherein the balloon is made of non-biodegradable, biocompatible polymeric material.

18. The apparatus of claim 13 wherein the balloon and liquid solution include growth factors and other mitogenic agents.

19. An apparatus for closing off a septal defect, the apparatus comprising;

a. a catheter having a first end and a second end, the catheter including at its second end a balloon having a specific conformation adapted to fit securely into the defect upon being positioned therein and substantially close it,

b. a plug having a first end and a second end, the plug comprising a sleeve which encases the balloon, said catheter being adapted to carry and release the plug, said plug being directly introduced into the area of a septal defect, said sleeve further being made of a deformable polymeric material, said sleeve being permanently deformed by the balloon within the defect in the shape of a plug, leaving the defect substantially plugged after deflation and removal of the balloon;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.

20. The apparatus of claim 19 wherein the balloon is dumbbell shaped.

21. The apparatus of claim 19 wherein the polymeric material includes growth factors and other mitogenic agents.

22. The apparatus of claim 19 wherein the polymeric material is made of a bioabsorbable material tilt reacts to heat, light, alterations in pH, or organic solvents.

23. The apparatus of claim 19 wherein the polymeric material reacts to electromagnetic energy, infrared light, visible light or ultraviolet light.

24. An apparatus for closing off a septal defect, the apparatus comprising:

a. a catheter having a first end and a second end, said catheter including at its second end a balloon having a specific conformation adapted to fit securely into the defect upon being positioned therein and substantially close it;

b. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect, the catheter being adapted to carry and release the plug, the plug comprising a deformable sleeve-like mesh of a bioabsorbable polymeric material, the mesh contacting the surrounding surface area of the septal defect when the balloon is inserted therein and inflated, said sleeve-like mesh encasing the balloon for delivery thereof, whereby the sleeve-like mesh may be delivered to the defect and permanently deployed by the balloon, leaving a mesh across the defect after deflation and removal of the balloon.

25. The apparatus of claim 24 wherein the balloon is bell shaped.

26. The apparatus of claim 24 wherein the polymeric material includes growth factors and other mitogenic agents.

27. The apparatus of claim 24 wherein the sleeve-like mesh is delivered to an area of defect through a catheter and secured to the area surrounding the detect by physical or chemical means.

28. The apparatus of claim 24 wherein the polymeric material is made of a bioabsorbable material that reacts to head, light, alterations in pH, or organic solvents.

29. The apparatus of claim 24 wherein the mesh is made of PET.

30. The apparatus of claim 24 wherein the mesh is made of PTFE.

31. The apparatus of claim 24 wherein the mesh is comprised of a material selected from the group consisting of caprolactone, polylactic acid and mixtures thereof.

32. The apparatus of claim 24 wherein the mesh further includes a bioactive material selected from the group consisting or fibronectin, vitronectin, collagen, fibrin and mixtures thereof.

33. The apparatus of claim 32 wherein the bioactive material is in fibrous form and is woven into the meshwork as a member of a composite fiber.

34. The apparatus of claim 32 wherein the bioactive material is deposited onto the surface of the fibers by chemical means.

38. The apparatus of claim 31 wherein the catheter includes a fluid delivering lumen by means of which the polymeric foam is hardened after delivery to the area of defect by infusion through the catheter of a solution of a different pH than the solution in which the apparatus was presoaked.

35. An apparatus for closing off a septal defect, the apparatus comprising:

a. a plug having a first end and a second end, said plug comprising a compressible polymeric foam made of a bioabsorbable material that reacts to heat, light, alterations in pH or chemical reactants, the plug being directly introduced into the area of a septal defect;

b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug;

c. means for releasably securing the plug to the catheter;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.

36. The apparatus of claim 35 wherein the polymeric material includes growth factors and other mitogenic agents.

37. The apparatus of claim 36 wherein the polymeric foam is presoaked in an organic or aqueous solution of a specific pH to retain its compressibility.

39. The apparatus of claim 37 wherein the polymeric material is presoaked in an organic solution, and the catheter includes a fluid delivering Iumen by means of which the polymeric foam is hardened after delivery to the area of defect by the removal of the organic solution by dilution.

40. The apparatus of claim 35 wherein the polymeric foam is hardened by the permeation therein or a second material which precipitates with a change in pH.

41. The apparatus of claim 40 wherein the second material is a gel.

42. The apparatus of claim 40 wherein the second material is a solution.

43. The apparatus of claim 40 wherein the alteration of the first state is effected in the presence of blood through a cooperative effect of coagulation, precipitation or ionization.

44. An apparatus for closing off a septal defect, the apparatus comprising:

a. a plug having a first end and a second end, said plug being made of a bioabsorbable polymeric material that reacts to light and is hardened by photopolymerization, the plug being directly introduced into the area of a septal defect;

b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug;

c. means for releasably securing the plug to the catheter;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.

45. An apparatus for permanently closing off a septal defect, the apparatus comprising:

a. a plug comprising a polymeric material which is cured or hardened in situ, said plug being unitary in construction and having a first end and a second end, the plug being directly introduced into the area of a septal defect;

b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug;

c. means for releasably securing the plug to the catheter;

whereby the plug is delivered to the defect area by the catheter, placed in the septal defect, released from the catheter and cured or hardened in situ, whereby the hardened plug remains, plugging the defect.

46. The apparatus of claim 45 wherein the catheter includes a balloon at its second end, said balloon being unitary in construction and having a specific conformation which is adapted to fit securely into the defect upon being positioned therein and substantially close it, and the plug comprises a sleeve which encases the balloon.