Post-biopsy cavity treatment implants and methods

• US 7,534,452 B2
• Filed: 01/22/2008
• Issued: 05/19/2009
• Est. Priority Date: 10/16/2003
• Status: Expired due to Fees

• Current Assignee: Encapsule Medical, LLC
• Original Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Inventors: Chernomorsky, Simon, Vetter, James W., Chernomorsky, Ary S.
• Primary Examiner(s): Henley, III; Raymond J
• Application Number:
  US12/018,170
• Publication Number:
  US 20080114329A1
• Time in Patent Office: 483 Days
• Field of Search: 424/600, 424/1.37, 424/9.3
• US Class Current: 424/600
• 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 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 49/04 X-ray contrast preparations
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like

Abstract

A method of treating a cavity created by a percutaneous excisional procedure carried out through an incision includes steps of providing a post-procedure cavity implant, the post-procedure cavity implant including: a radiopaque element; a core portion coupled to the radiopaque element, the core portion including a first porous matrix defining a first controlled pore architecture, and a shell portion coupled to the core portion, the shell portion including a second porous matrix defining a second controlled pore architecture that is different from the first controlled pore architecture; implanting the post-procedure cavity implant into the cavity, and closing the incision.

Claims

1. A method of treating a cavity created by a percutaneous excisional procedure carried out through an incision, comprising the steps of:

providing a post-procedure cavity implant, the post-procedure cavity implant including;

a radiopaque element;

a core portion coupled to the radiopaque element, the core portion including a first porous matrix defining a first controlled pore architecture, and

a shell portion coupled to the core portion, the shell portion including a second porous matrix defining a second controlled pore architecture that is different from the first controlled pore architecture;

implanting the post-procedure cavity implant into the cavity, and

closing the incision.

2. The method of claim 1, wherein the providing step is carried out with the core portion surrounding the radiopaque element.

3. The method of claim 1, wherein the providing step is carried out with the shell portion surrounding the core portion.

4. The method of claim 1, wherein the providing step is carried out with the core portion surrounding the radiopaque element and the shell portion surrounding the core portion.

5. The method of claim 1, wherein the providing step is carried out with the shell portion swelling faster than the core portion when the implant is placed in a biological fluid environment.

6. The method of claim 1, wherein the providing step is carried out with the shell portion swelling to a greater extent than the core portion when the implant is placed in a biological fluid environment.

7. The method of claim 1, wherein the providing step is carried out with the first controlled pore architecture differing from the second controlled pore architecture with respect to at least one of:

pore density, pore shape, pore orientation and pore dimensions.

8. The method of claim 1, wherein the providing step is carried out with the radiopaque element including a portion having a paramagnetic property.

9. The method of claim 1, wherein the providing step is carried out with at least one of the core and shell portions including a dye disposed therein.

10. The method of claim 1, wherein the providing step is carried out with at least one of the core and shell portions including a pigment disposed therein.

11. The method of claim 1, wherein the providing step is carried out with at least one of the core and shell portions including a contrast medium disposed therein.

12. The method of claim 1, wherein the providing step is carried out with at least one of the core and shell portions including a therapeutic agent disposed therein.

13. The method of claim 1, wherein the providing step is carried out with at least one of the core and shell portions being biodegradable.

14. The method of claim 1, wherein the providing step is carried out with at least the shell portion including collagen.

15. The method of claim 1, wherein the providing step is carried out with the core portion including at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a polyglyconate, a polyanhydride, PEG, cellulose, a gelatin, a lipid, a polysaccharide, a starch and a polyorthoester.

16. The method of claim 1, wherein the providing step is carried out with the core and shell portions being configured so as to form a laminar structure.

17. The method of claim 1, wherein the providing step is carried out with at least one of the core and shell portions being echogenic.

18. The method of claim 1, wherein the providing step is carried out with at least the shell portion including a plurality of fibers.

19. The method of claim 1, wherein the providing step is carried out with at least one of the core and shell portions including an internal reservoir configured to contain at least one of a dye, a pigment and a therapeutic agent.

20. The method of claim 19, wherein the providing step is carried out with the internal reservoir being configured to deliver the at least one of dye, pigment and therapeutic agent through elution when the implant is placed in a biological fluid environment.

21. The method of claim 19, wherein the providing step is carried out with the internal reservoir being configured to deliver the at least one of dye, pigment and therapeutic agent at a first rate when the reservoir is breached and at a second rate that is lower than the first rate when the reservoir is not breached.

22. The method of claim 1, wherein the providing step is carried out with the shell portion being configured to swell to a greater degree than the core portion when the implant is placed in the biological fluid environment.

23. The method of claim 1, wherein the providing step is carried out with the shell portion including collagen and wherein the providing step is carried out with a crosslinking density of the shell portion is controlled through adding a selected amount of a bifunctional reagent to the collagen.

24. The method of claim 23, wherein the providing step is carried out with the bifunctional reagent including at least one of an aldehyde and a cyanamide.

25. The method of claim 24, wherein the providing step is carried out with the aldehyde including a glutaraldehyde.

26. The method of claim 1, wherein the providing step is carried out with the shell portion including collagen and wherein the providing step is carried out with a crosslinking density of the shell portion is controlled by an application of energy to the collagen.

27. The method of claim 26, wherein the providing step is carried out with the application of energy including at least one of dehydrothermal processing, exposure to UV light and radiation.

28. The method of claim 1, wherein the providing step is carried out with the shell portion including collagen and wherein the providing step is carried out with a crosslinking density of the shell portion being controlled by a combination of dehydrothermal processing and exposure to cyanamide.

29. The method of claim 1, wherein the providing step is carried out with the implant, in a state prior to being placed in a biological fluid environment, being generally wedge-shaped.

30. The method of claim 1, wherein the providing step is carried out with the implant, in a state prior to being placed in a biological fluid environment, having a shape of a disk that has been folded multiple times.

31. The method of claim 1, wherein the providing step is carried out with the implant, in a state prior to being placed in a biological fluid environment, having a rectangular shape.

32. The method of claim 1, wherein the providing step is carried out with the shell portion defining a center portion and a peripheral portion and wherein the providing step is carried out with the peripheral portion defines a plurality of independently movable free ends.

33. The method of claim 1, wherein the providing step is carried out with at least one of the core portion and the shell portion including a radioactive material.

34. The method of claim 9, wherein the dye is radioactive.

35. The method of claim 10, wherein the pigment is radioactive.

36. A method of treating a cavity created by an excisional procedure, comprising the steps of:

selecting a first biodegradation rate range;

selecting a second biodegradation rate range that is different from the first biodegradation rate range;

providing a post-procedure cavity implant, the post-procedure cavity implant including;

a radiopaque element;

a core portion coupled to the radiopaque element, the core portion being configured to biodegrade at a first effective rate within the first biodegradation rate range, and

a shell portion coupled to the core portion, the shell portion being configured to biodegrade at a second effective rate within the second biodegradation rate range, and

implanting the post-procedure cavity implant within the cavity.

37. The method of claim 36, wherein the providing step is carried out with the core portion surrounding the radiopaque element.

38. The method of claim 36, wherein the providing step is carried out with the shell portion surrounding the core portion.

39. The method of claim 36, wherein the providing step is carried out with the core portion surrounding the radiopaque element and the shell portion surrounding the core portion.

40. The method of claim 36, wherein the providing step is carried out with the shell portion swelling faster than the core portion when the implant is placed in a biological fluid environment.

41. The method of claim 36, wherein the providing step is carried out with the shell portion swelling to a greater extent than the core portion when the implant is placed in a biological fluid environment.

42. The method of claim 36, wherein the providing step is carried out with the first controlled pore architecture differing from the second controlled pore architecture with respect to at least one of:

pore density, pore shape, pore orientation and pore dimensions.

43. The method of claim 36, wherein the providing step is carried out with the radiopaque element including a portion having a paramagnetic property.

44. The method of claim 36, wherein the providing step is carried out with at least one of the core and shell portions including a dye disposed therein.

45. The method of claim 36, wherein the providing step is carried out with at least one of the core and shell portions including a pigment disposed therein.

46. The method of claim 36, wherein the providing step is carried out with at least one of the core and shell portions including a contrast medium disposed therein.

47. The method of claim 36, wherein the providing step is carried out with at least one of the core and shell portions including a therapeutic agent disposed therein.

48. The method of claim 36, wherein the providing step is carried out with at least one of the core and shell portions being biodegradable.

49. The method of claim 36, wherein the providing step is carried out with at least the shell portion including collagen.

50. The method of claim 36, wherein the providing step is carried out with the core portion including at least one of a polylactide (PLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a polyglyconate, a polyanhydride, PEG, cellulose, a gelatin, a lipid, a polysaccharide, a starch and a polyorthoester.

51. The method of claim 36, wherein the providing step is carried out with the core and shell portions being configured so as to form a laminar structure.

52. The method of claim 36, wherein the providing step is carried out with at least one of the core and shell portions being echogenic.

53. The method of claim 36, wherein the providing step is carried out with at least the shell portion including a plurality of fibers.

54. The method of claim 36, wherein the providing step is carried out with at least one of the core and shell portions including an internal reservoir configured to contain at least one of a dye, a pigment and a therapeutic agent.

55. The method of claim 54, wherein the providing step is carried out with the internal reservoir being configured to deliver the at least one of dye, pigment and therapeutic agent through elution when the implant is placed in a biological fluid environment.

56. The method of claim 54, wherein the providing step is carried out with the internal reservoir being configured to deliver the at least one of dye, pigment and therapeutic agent at a first rate when the reservoir is breached and at a second rate that is lower than the first rate when the reservoir is not breached.

57. The method of claim 36, wherein the providing step is carried out with the shell portion being configured to swell to a greater degree than the core portion when the implant is placed in the biological fluid environment.

58. The method of claim 36, wherein the providing step is carried out with the shell portion including collagen and wherein the providing step is carried out with a crosslinking density of the shell portion is controlled through adding a selected amount of a bifunctional reagent to the collagen.

59. The method of claim 54, wherein the providing step is carried out with the bifunctional reagent including at least one of an aldehyde and a cyanamide.

60. The method of claim 59, wherein the providing step is carried out with the aldehyde including a glutaraldehyde.

61. The method of claim 36, wherein the providing step is carried out with the shell portion including collagen and wherein the providing step is carried out with a crosslinking density of the shell portion is controlled by an application of energy to the collagen.

62. The method of claim 61, wherein the providing step is carried out with the application of energy including at least one of dehydrothermal processing, exposure to UV light and radiation.

63. The method of claim 36, wherein the providing step is carried out with the shell portion including collagen and wherein the providing step is carried out with a crosslinking density of the shell portion being controlled by a combination of dehydrothermal processing and exposure to cyanamide.

64. The method of claim 36, wherein the providing step is carried out with the implant, in a state prior to being placed in a biological fluid environment, being generally wedge-shaped.

65. The method of claim 36, wherein the providing step is carried out with the implant, in a state prior to being placed in a biological fluid environment, having a shape of a disk that has been folded multiple times.

66. The method of claim 36, wherein the providing step is carried out with the implant, in a state prior to being placed in a biological fluid environment, having a rectangular shape.

67. The method of claim 36, wherein the providing step is carried out with the shell portion defining a center portion and a peripheral portion and wherein the providing step is carried out with the peripheral portion defines a plurality of independently movable free ends.

68. The method of claim 36, wherein the providing step is carried out with at least one of the core portion and the shell portion including a radioactive material.

69. The method of claim 40, wherein the dye is radioactive.

70. The method of claim 41, wherein the pigment is radioactive.