Systems and devices for soft tissue augmentation

• US 7,244,270 B2
• Filed: 09/16/2004
• Issued: 07/17/2007
• Est. Priority Date: 09/16/2004
• Status: Expired due to Fees

• Current Assignee: Evera Medical, Inc.
• Original Assignee: Evera Medical
• Inventors: Lesh, Michael D.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/942,728
• Publication Number:
  US 20060058735A1
• Time in Patent Office: 1,034 Days
• Field of Search: 623 111- 125, 623/23.72, 604/272, 604/239
• US Class Current: 623/1.11
• 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 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Medical devices, systems and kits for filling tissue are disclosed. The device has a first configuration wherein the device can pass through a small catheter or needle placed in the tissue to be filled and a second configuration in which the device is expandable to a predetermined or customizable shape. In one application, the device is adapted to be placed into the skin to reduce facial wrinkles or augment facial features such as the lips. Kits and systems include multiple device sizes, filler tubes, and filler media.

Claims

1. A tissue augmentation device, comprising:

an elongate, flexible body, having a proximal end and a distal end;

at least a first port on the proximal end, for accessing the interior of the body;

a valve for closing the port; and

a suture extending from the distal end.

2. A tissue augmentation device as in claim 1, further comprising a needle on the suture.

3. A tissue augmentation device as in claim 1, wherein the body comprises a tubular sleeve.

4. A tissue augmentation device as in claim 1, wherein the body comprises a sleeve with a flattened cross section.

5. A tissue augmentation device as in claim 1, wherein the body comprises a sleeve composed of two sheets of material bound together along their periphery.

6. A tissue augmentation device as in claim 1, wherein the body comprises two concentric tubular layers.

7. A tissue augmentation device as in claim 1, further comprising a second port for accessing the interior of the body.

8. A tissue augmentation device as in claim 1, further comprising at least two compartments within the flexible body.

9. A kit, for augmenting tissue, comprising:

at least one elongate, flexible body, which is transformable from a first configuration for implantation to a second configuration for augmentation;

a valve on the body;

at least one suture attached to the body;

a filler tube for permitting access to the interior of the body; and

a filler, for transforming the body from the first configuration to the second configuration.

10. A kit as in claim 9, wherein the body comprises a tubular sleeve.

11. A kit as in claim 9, wherein the body comprises a plurality of internal compartments.

12. A kit as in claim 9, comprising at least a second suture attached to the body.

13. A kit as in claim 9, wherein the filler comprises a liquid.

14. A kit as in claim 9, wherein the filler is polymerizable in situ.

15. A kit as in claim 9, further comprising a syringe for injecting the filler into the filler tube.

16. A kit, for augmenting tissue, comprising:

a plurality of elongate, flexible bodies, each of which is transformable from a first configuration for implantation to a second configuration for augmentation, provided in a plurality of sizes and shapes.

at least one suture attached to each body;

a filler tube for permitting access to the interior of the body; and

at least two different fillers, for transforming the body from the first configuration to the second configuration.

17. A kit as in claim 16, wherein the fillers have different viscosities.

18. A kit as in claim 16, wherein the fillers have different durometers.

19. A kit, for augmenting tissue, comprising:

at least one elongate, flexible body, which is transformable from a first configuration for implantation to a second configuration for augmentation;

at least a first and a second suture attached to the body;

a filler tube for permitting access to the interior of the body; and

a filler, for transforming the body from the first configuration to the second configuration.

20. A kit as in claim 19, wherein the body comprises a tubular sleeve.

21. A kit as in claim 19, wherein the body comprises a plurality of internal compartments.

22. A kit as in claim 19, wherein the body comprises a valve.

23. A kit as in claim 19, wherein the filler comprises a liquid.

24. A kit as in claim 19, wherein the filler is polymerizable in situ.

25. A kit as in claim 19, further comprising a syringe for injecting the filler into the filler tube.

26. A kit, for augmenting tissue, comprising:

at least one elongate, flexible body, which is transformable from a first configuration for implantation to a second configuration for augmentation;

at least one suture attached to the body;

a filler tube for permitting access to the interior of the body; and

a filler, for transforming the body from the first configuration to the second configuration;

wherein the filler is polymerizable in situ.

27. A kit as in claim 26, wherein the body comprises a tubular sleeve.

28. A kit as in claim 26, wherein the body comprises a plurality of internal compartments.

29. A kit as in claim 26, wherein the body comprises a valve.

30. A kit as in claim 26, comprising at least a second suture attached to the body.

31. A kit as in claim 26, wherein the filler comprises a liquid.

32. A kit as in claim 26, further comprising a syringe for injecting the filler into the filler tube.