IMPLANT

Abstract

An implant comprising a shell, a core within the shell, and a conductive layer between the core and the shell; wherein the implant additionally comprises a sensor for detecting a change in one or more electrical properties of the conductive layer. A kit for use in detection of rupture an implant comprising the implant, a method of detecting rupture and a method of manufacture of an implant

Claims

1. An implant comprising a shell, a core within the shell, and a conductive layer between the core and the shell; wherein the implant additionally comprises a sensor for detecting a change in one or more electrical properties of the conductive layer.

2. An implant according to claim 1, wherein the core comprises a gel-fill biomaterial.

3. An implant according to claim 2, wherein the gel-fill biomaterial is selected from silicone, saline or a combination thereof.

4. (canceled)

5. An implant according to claim 1, wherein the conductive layer is adhered to the shell and comprises a coating on an innermost surface of the shell.

6. (canceled)

7. (canceled)

8. An implant according to claim 1, wherein the conductive layer substantially covers the innermost surface of the shell.

9. An implant according to claim 1, wherein the conductive layer partially covers the innermost surface of the shell and wherein the conductive layer comprises at least one conductive strip; and further comprising conductive strips embedded within the shell, wherein the further conductive strips are radially aligned with the conductive strip of the conductive layer.

10. (canceled)

11. An implant according to claim 1, wherein the conductive layer comprises conducting material which is a nanoparticulate selected from gold, silver, copper, graphite or a combination thereof.

12.-13. (canceled)

14. An implant according to claim 1, wherein the conductive layer is in electrical communication with the sensor.

15. An implant according to claim 14, wherein the conductive layer is connected to the sensor, wherein connection of the sensor to the conductive layer is either direct or via a tether.

16. (canceled)

17. An implant according to claim 1, wherein the sensor is powered by induction charging.

18. An implant according to claim 1, wherein the electrical property is electrical impedance and/or alternating current across the conductive layer.

19.-20. (canceled)

21. An implant according to claim 1, wherein the implant further comprises a temperature and/or pressure sensor.

22. A kit for use in detection of rupture an implant comprising: an implant according to claim 1; and a receiving device; wherein the receiving device is configured to communicate with the implant.

23. A kit according to claim 22, wherein the receiving device is hand-held, wherein the conductive layer and/or sensor is configured to receive power from the hand-held receiving device and wherein the receiving device is configured to generate a small alternating current across the conductive layer and/or the sensor.

24. A kit according to claim 22, wherein the receiving device is a passive energy source.

25. A kit according to any of claim 22, wherein communication of the receiving device with the implant comprises a request for data from the sensor, the receipt of information from a sensor within the implant, and optionally requests for correlation of data.

26. A kit according to any of claim 22, wherein communication of the receiving device with the implant comprises powering of the implant, wherein the conductive layer and/or sensor is configured to receive power from the hand-held receiving device.

27.-33. (canceled)

34. A method of detecting rupture of an implant comprising using the kit of claim 22 in the steps of: (i) placement of the receiving device within communication distance of the implant; (ii) measuring an electrical property of the conductive layer of the implant; (iii) transmittal of the measurement to the receiving device.

35.-41. (canceled)

42. A method of manufacture of an implant according to claim 1, comprising the steps of: (i) forming an implant shell; (ii) providing a conductive layer; (iii) providing a sensor; (iv) filling the implant; and (v) sealing the implant.

43. A method according to claim 42, comprising providing the conductive layer as a coating in an inner surface of the shell wherein the conductive layer is adhered to the inner surface of the shell using a layer of uncured silicone.

44.-47. (canceled)

Description

[0082] In order that the invention may be more readily understood, it will be described further with reference to the figures and to the specific examples hereinafter.

[0083] FIG. 1 is a schematic representation of a breast implant of the invention comprising a sensor directly attached to a conductive layer;

[0084] FIG. 2 is a schematic representation of a breast implant comprising a conductive coating;

[0085] FIG. 3 is a schematic representation of a breast implant comprising a conductive coating and a tethered sensor;

[0086] FIG. 4 is schematic representation of a breast implant comprising conducting strips; and

[0087] FIG. 5 is a schematic representation of a gluteal implant of the invention comprising conducting strips.

[0088] FIGS. 1 to 3 show implant 5 comprising a core 10, a shell 15 and a sensor 20. In addition, a conductive layer 25 is present, between the core 10 and the shell 15. In FIG. 1, the conductive layer 25 is loose between a silicone core 10 and the shell 15, the conductive layer 25 being formed of a silver nanoparticulate film. The sensor 20 is directly attached to the conductive layer 25 on a side of the layer 30 adjacent to the core 10. In FIGS. 2 and 3 the conductive layer 25 comprises a coating on an inner surface 35 of the shell 15. FIG. 3 illustrates the sensor 20 attached to the conductive layer 25 via a tether 40.

[0089] FIGS. 4 and 5 show an implant 5 comprising a core 10, a shell 15 and a sensor 20. In addition, connected circumferential conducting strips 35 attached to the inner shell surface are present between the core 10 and the shell 15. The sensor 20 is directly attached to the inner surface of the shell 15, adjacent to the core 10.

[0090] It would be appreciated that the apparatus and methods of the invention are capable of being implemented in a variety of ways, only a few of which have been illustrated and described above.