TISSUE EXPANDERS AND METHODS OF USE

• US 20110152913A1
• Filed: 12/20/2010
• Published: 06/23/2011
• Est. Priority Date: 09/21/2004
• Status: Active Grant

• Current Assignee: Oxford Special Assets LLC
• Original Assignee: AIRX Bioscience LLC
• Inventors: Jones, Christopher S., Purdy, Craig A., Mintz, David S., Han, Ryan S., Jacobs, Daniel, Payne, F. Mark, Shalon, Tadmor
• Granted Patent: US 10,792,121 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Tissue expanders and their methods of use.

Claims

1. A tissue expansion system, comprising:

an implantable device adapted to be implanted within a patient, wherein the implantable device has an anterior portion, a posterior portion, an inferior portion, and a superior portion, and wherein the implantable device comprises a communication component secured in the superior and anterior portions; and

an external device adapted to be disposed external to the patient to wirelessly communicate with the communication component to control the expansion of the implantable device.

2. The system of claim 1 wherein the implantable device comprises an inner layer defining an expandable chamber, wherein the inner layers comprises a preformed shape that defines the anterior, posterior, inferior, and superior portions, and wherein the communication component is secured to the superior and anterior portions of the inner layer.

3. The system of claim 1 wherein the inner layer comprises an inelastic material.

4. The system of claim 1 wherein the inner layer has a preformed general breast configuration defining the anterior, posterior, inferior, and superior portions, and wherein the communication component is secured to the anterior and superior portions of the general breast configuration.

5. The system of claim 4 wherein the general breast configuration has a lower pole and an upper pole, wherein the upper pole is disposed in the superior portion, wherein the lower power has a thickness greater than a thickness of the upper pole, and wherein the communication component is secured within the upper pole.

6. The system of claim 1 further comprising a fluid reservoir within an inner chamber of the implantable device, wherein the communication component and the fluid reservoir are in communication, and wherein the external device is adapted to wirelessly communicate with the communication component to controllably release fluid from the fluid reservoir into the inner chamber.

7. The system of claim 1 wherein the communication component comprises an antenna.

8. A method of expanding tissue, comprising:

an implantable device implanted with a patient, the implantable device comprising an expandable chamber, a fluid reservoir, and a communication component;

positioning a remote controller proximate the bodily region in which the implantable device is implanted; and

actuating the remote controller to expand a lower pole of the expandable chamber to have a greater projection than an upper pole of the expandable chamber

9. The method of claim 8 wherein expanding the lower pole expands tissue adjacent the lower pole, and expanding the upper pole expands tissue adjacent the upper pole, and wherein expanding the lower pole to have a greater projection than the upper pole comprises expanding the tissue adjacent the lower pole to a greater extent than the tissue adjacent the upper pole.

10. The method of claim 8 wherein the expandable chamber has a preformed configuration in which the lower pole has a projection that is greater than a projection of the upper pole, and wherein actuating the remote controller expands the expandable chamber towards the preformed configuration.

11. The method of claim 8 wherein actuating the remote controller expands the expandable chamber towards a general breast configuration.

12. The method of claim 8 wherein the implantable device comprises anterior, posterior, superior, and inferior portions, and wherein positioning the remote controller proximate the bodily region in which the implantable device is implanted comprises positioning the remote controller adjacent the superior and anterior portions.

13. A breast implant, comprising:

a self-contained implantable device adapted to be implanted within breast tissue of a patient, wherein the implantable device has a substantially inelastic portion having a general breast configuration.

14. The implant of claim 13 wherein the substantially inelastic portion comprises at least the curved portions of the general breast configuration.

15. The implant of claim 14 wherein the substantially inelastic portion additional comprises a generally flat posterior portion of the breast configuration.

16. The implant of claim 15 wherein the anterior and posterior portions are two different components secured together.

17. The implant of claim 13 wherein the substantially inelastic portion at least partially defines an inner chamber in which a fluid is contained.

18. The implant of claim 17 wherein the substantially inelastic portion completely defines an inner chamber in which a fluid is contained

19. The implant of claim 17 wherein the fluid is saline.

20. The implant of claim 17 wherein the fluid is a gas.

21. The implant of claim 17 wherein the implant further comprises a gas reservoir disposed completely within the inner chamber.

22. The implant of claim 21 wherein the implant further comprises a communication component disposed completely within the inner chamber adapted to wirelessly communicate with a device external to the patient.

23. The implant of claim 22 wherein the external device is adapted to be actuated to control the release of gas from the gas reservoir into the inner chamber to expand the inner chamber.

24. The implant of claim 13 wherein the general breast configuration includes an inferior portion and a superior portion, and wherein the inferior portion has a maximum projection dimension that is greater than a maximum projection dimension of the superior portion.

25. A tissue expansion system, comprising:

an implantable device comprising an expandable compartment and a gas source, wherein the gas source is secured within the expandable compartment but is not rigidly fixed relative to the expandable compartment to allow for relative movement between the gas source and the expandable compartment after the implantable component is positioned within a patient; and

an external device adapted to control the release of gas from the gas source into the expandable compartment from a location external to the patient.

26. The system of claim 25 wherein the implantable device comprises a gas source retention element, at least a portion of which is fixidly secured to the expandable compartment, and wherein the gas source is secured to the expandable component using the gas source retention element.

27. The system of claim 26 wherein the gas source retention element is a film layer, at least a portion of which is fixidly secured to the expandable compartment, and wherein the gas source is secured within the film layer.

28. The system of claim 26 wherein at least a portion of the gas source retention element is fixed to a posterior portion of the expandable compartment.

29. The system of claim 26 wherein the gas source retention element and the gas source form a hammock design.

30. A tissue expansion system, comprising:

an implantable device comprising a fluid source and an expandable chamber;

an external controller adapted to wirelessly communicate with the implantable device to control the release of fluid from the fluid source into the expandable chamber to expand the expandable chamber; and

a processing component adapted to compare the number of times fluid has been released from the fluid source within a given period of time with a maximum number of times fluid is allowed to be released from the fluid source within the given period of time.

31. The system of claim 30 wherein the processing component is disposed within the external controller.

32. The system of claim 30 wherein the processing component is further adapted to prevent the release of fluid from the fluid source if the number of times fluid has been released from the fluid source within the given period of time is greater than or equal to the maximum number of times that fluid is allowed to be released from the fluid source within the given period of time.

33. The system of claim 32 wherein the processing component is adapted to prevent the fluid source from releasing fluid more than 3 times within about a 24 hour period.

34. The system of claim 32 wherein the processing component is adapted to prevent the fluid source from releasing fluid more than once about every 3 hours.

35. The system of claim 30 wherein the external controller is adapted to communicate with the implantable device upon actuation of the external controller to control the release of fluid from the fluid source, and wherein the processing component is adapted to compare the number of times the external controller has been actuated within a given period of time with a maximum number of times the external controller can be actuated within the given period of time.

36. The system of claim 30 wherein the fluid source is a compressed gas source.

37. A tissue expansion system, comprising:

an implantable device comprising a gas source and an expandable chamber;

an external controller adapted to wirelessly communicate with the implantable device to control the release of fluid from the fluid source into the expandable chamber to expand the expandable chamber; and

a processing component adapted to compare the volume of fluid that has been released from the fluid source within a given period of time with a maximum volume of fluid that is allowed to be released from the fluid source within the given period of time.

38. The system of claim 37 wherein the processing component is disposed within the external controller.

39. The system of claim 37 wherein the processing component is further adapted to prevent the release of fluid from the fluid source if the volume of fluid that has been released from the fluid source within the given period of time is greater than or equal to the maximum volume of fluid that is allowed to be released from the fluid source within the given period of time.

40. The system of claim 37 wherein the processing component is adapted to prevent the fluid source from releasing more than about 30 mL of fluid within about 24 hours.

41. The system of claim 37 wherein the fluid source is a compressed gas source.

42. A tissue expansion system, comprising:

an implantable device comprising a fluid source and an expandable chamber;

an external controller adapted to wirelessly communicate with the implantable device in response to actuation of the external controller to control the release of fluid from the fluid source into the expandable chamber to expand the expandable chamber; and

a processing component adapted to prevent more than a maximum volume of fluid from being released from the fluid source upon a single actuation of the external controller.

43. The system of claim 42 wherein the processing component is disposed within the external controller.

44. The system of claim 42 wherein the processing component is adapted to prevent more than about 10 mL, of fluid from being released upon a single actuation of the external controller.

45. The system of claim 42 wherein a memory components logs an event if more than the maximum volume of fluid is released from the fluid source upon a single actuation of the external controller.

46. A tissue expansion system, comprising:

an implantable device comprising a fluid source and an expandable chamber;

an external controller adapted to wirelessly communicate with the implantable device to control the release of fluid from the fluid source into the expandable chamber to expand the expandable chamber; and

a processing component adapted to compare the total volume of fluid released from the fluid source into the expandable chamber with a maximum fill volume for the implantable device.

47. The system of claim 46 wherein the fluid source is a gas source.

48. The system of claim 46 wherein the processing component is disposed within the external controller.

49. The system of claim 46 wherein the processing component is further adapted to prevent the release of fluid from the fluid source if the total volume of fluid that has been released from the fluid source is greater than or equal to the maximum fill volume for the implantable device.

50. The system of claim 49 wherein the processing assembly is adapted to prevent the release of fluid from the fluid source if a total of about 350 mL to about 1040 mL, of fluid has been released from the fluid source.

51. A tissue expansion system, comprising:

an implantable device comprising a fluid source and an expandable chamber;

an external controller adapted to wirelessly communicate with the implantable device to control the release of fluid from the fluid source into the expandable chamber to expand the expandable chamber; and

a processing component adapted to compare a total volume of fluid released from the fluid source into the expandable chamber with a maximum fill volume for the implantable component, wherein the processing component is adapted to automatically adjust the total volume of fluid released from the gas source into the expandable chamber to account for a volume of fluid that has permeated out of the expandable chamber.

52. The system of claim 51 wherein fluid source is a compressed carbon dioxide (CO2) reservoir, and the processing component is adapted to automatically adjust the total volume of carbon dioxide released from the carbon dioxide reservoir into the expandable chamber to account for a volume of carbon dioxide that has permeated out of the expandable chamber.

53. The system of claim 51 wherein the processing component is adapted to automatically cause the release of fluid from the fluid source to compensate for the volume of fluid that has permeated out of the expander chamber.

54. A tissue expansion system, comprising:

an implantable device comprising a gas source, an expandable chamber, and a pressure relief valve adapted to release gas from the expandable chamber; and

an external controller adapted to communicate with the implantable device to control the release of gas from the gas source into the expandable chamber to expand the expandable chamber.

55. The system of claim 54 wherein the external controller comprises an actuator that is adapted to open the relief valve upon actuation thereof to release gas from the expandable chamber.

56. The system of claim 55 wherein the external controller comprises a second actuator that is adapted to be actuated by control the release of gas from the gas source.

57. The system of claim 54 wherein the implantable device comprises a pressure sensor adapted to sense when the pressure within the expandable chamber exceeds a maximum allowable pressure, and wherein the pressure relief valve is adapted to automatically open to release a volume of gas from the expandable chamber.

58. The system of claim 54 wherein the external controller comprises a pressure sensor adapted to sense when the pressure within the expandable component exceeds a maximum allowable pressure.

59. The system of claim 54 wherein the pressure relief valve comprises a first magnetic component, and wherein the system further comprises relief valve actuator comprising a second magnetic component, wherein the second magnetic component is adapted to interact with the first magnetic component to open the relief valve and release gas from the expandable chamber.

60. A tissue expansion system, comprising:

an implantable device comprising a fluid source, an expandable chamber, and an intrinsic port, wherein the fluid source is in fluid communication with the expandable chamber; and

an external controller adapted to wirelessly communicate with the implantable device to control the release of fluid from the fluid source into the expandable chamber to expand the expandable chamber,

wherein the intrinsic port is adapted to allow a removal device to be inserted therethrough to remove fluid from the expandable chamber.

61. The system of claim 60 wherein the removal device is a needle, and the intrinsic port is adapted to re-seal after the needle is inserted therethrough to remove fluid from the expandable chamber.

62. The system of claim 61 wherein the intrinsic port is adapted to allow the implantable device to be re-filled with a second fluid after the fluid is released from the expandable chamber.

63. The system of claim 62 wherein the second fluid is saline.

64. The system of claim 61 wherein the external controller is adapted to wirelessly communicate with the implantable device to control the release of fluid from the fluid source after the removal of the fluid from the expandable chamber.

65. The system of claim 60 wherein the implantable device further comprises a communication component, and wherein the intrinsic fill port is disposed adjacent the communication component.

66. The system of claim 60 wherein the implantable device comprises an outer shell and an inner bag, wherein the intrinsic port is formed in the outer shell.

67. The system of claim 60 wherein the implantable device comprises an outer shell and an inner bag, wherein the intrinsic port is disposed within the inner bag.

68. A method of removing fluid from an implant, comprising:

removing a gas from a self-contained implant positioned within breast tissue, wherein removing the fluid comprises advancing a needle through an intrinsic port within the self-contained implant and removing fluid through the needle; and

after a radiation therapy has been performed on the patient, re-filling the self-contained implant with a second fluid.

69. The method of claim 68 wherein the second fluid is saline.

70. The method of claim 68 wherein re-filling the self-contained implant with a second fluid comprises positioning a needle through the intrinsic port and advancing the second fluid through the needle and into the implant.