IMPLANTABLE DEVICE WITH BRIDGE

• US 20140276141A1
• Filed: 03/14/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: MicroTech Medical Technologies Ltd.
• Original Assignee: MicroTech Medical Technologies Ltd.
• Inventors: DLUGACH, Yekaterina, AGIAN, Nadav
• Granted Patent: US 10,238,339 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49908 Joining by deforming

Abstract

This invention relates to an implantable device for a physiologic sensor, comprising an implantable expandable anchor, a bridge on which the sensor is secured, as well as an optional adapting ring. The invention also relates to a method of monitoring bodily functions using the anchor and sensor. The anchor is compressed and the bridge assumes an elongated shape during delivery to a target lumen. Upon deployment at the target site, the anchor expands and the bridge bows into the interior lumen of the expanded anchor, distancing the sensor from the vessel wall. This invention also relates to a method of manufacturing said device and a method of implanting a sensor.

Claims

1. An implantable device comprising:

an anchor having a plurality of serpentine rings defining a lumen along a longitudinal axis, and having a compressed and expanded configuration, and

a bridge attached to said anchor, wherein said bridge has a first end and a second end, said bridge is substantially aligned with the longitudinal axis of the anchor when said anchor is in the compressed configuration, and said bridge protrudes into said lumen when said anchor is in the expanded configuration.

2. The implantable device of claim 1, wherein adjacent serpentine rings of said anchor define a plurality of cells.

3. The implantable device of claim 1, wherein said plurality of serpentine rings are longitudinally spaced along the length of the anchor and each serpentine member comprises a plurality of peaks and valleys.

4. The implantable device of claim 2, wherein the adjacent serpentine rings are connected between a peak of a first serpentine ring and a valley of a second serpentine ring.

5. The implantable device of claim 3, wherein said first end of the bridge is attached to a peak of a first serpentine ring, and said second end of the bridge is attached to a valley of a second serpentine ring.

6. The implantable device of claim 5, wherein the distance between said peak of said first serpentine ring and said valley of said second serpentine ring is greater in the compressed configuration than in the expanded configuration.

7. The implantable device of claim 2, wherein a cell on the anchor has two vertices on opposite ends of said cell, and said ends of the bridge are attached to said vertices.

8. The implantable device of claim 7, wherein the distance between said vertices is greater in the compressed configuration than in the expanded configuration.

9. The implantable device of claim 1, wherein the bridge is attached to the anchor by welding, soldering, brazing, or through adhesives.

10. The implantable device of claim 1, wherein the bridge and the anchor are formed as a single unit.

11. The implantable device of claim 1, wherein the bridge comprises a plate.

12. The implantable device of claim 11, wherein a sensor is attached to said plate.

13. The implantable device of claim 12, further comprising an adapting ring configured for attaching said sensor to said plate.

14. The implantable device of claim 13, wherein the bottom end of the adapting ring is secured to the plate by a locking tab, welding, soldering, brazing, or adhesives.

15. The implantable device of claim 13, wherein the top surface of the sensor is recessed within the adapting ring.

16. The implantable device of claim 13, wherein the adapting ring comprises an opening configured for a protrusion of the sensor.

17. The implantable device of claim 12, wherein the sensor is configured to measure fluid pressure.

18. The implantable device of claim 12, wherein the sensor is coated with polyethylene glycol.

19. The implantable device of claim 1, wherein the bridge is substantially straight.

20. The implantable device of claim 1, wherein the bridge contains a plurality of loops.

21. The implantable device of claim 1, further comprising an angiographic marker attached to the bridge.

22. The implantable device of claim 1, wherein said anchor can return to the compressed configuration after partial expansion.

23. The implantable device of claim 11, wherein a sensor is embedded within said plate.

24. The implantable device of claim 12, wherein said sensor is an encapsulated sensor.

25. The implantable device of claim 1, wherein the anchor is self-expandable.

26. A method of making an implantable device comprising an expandable anchor, a bridge and a sensor, whereby the expandable anchor has a compressed and expanded configuration, said anchor having a longitudinal axis and forming an anchor wall, said bridge is aligned with the longitudinal axis of the anchor and aligned with the anchor wall when said anchor is in the compressed configuration, and said bridge protrudes into said lumen when said anchor is in the expanded configuration, comprising the steps of:

(a) manufacturing the anchor and the bridge as a single unit;

(b) assembling the anchor and bridge on a mandrel having a diameter of the desired expanded anchor and a divot

(c) positioning the bridge over the divot

(d) heat treating the anchor and the bridge a thermomechanically preset shape, and

(e) assembling of the sensor onto the bridge.

27. The method of claim 26, further comprising the step (f) of crimping the implantable device onto a delivery catheter.

28. The method of claim 26, whereby the sensor is attached to the bridge by an adapting ring in step (e).

29. The method of claim 26, whereby an angiographic marker is inserted between the sensor and the bridge.

30. The method of claim 26, where the anchor and bridge are formed from a flat sheet of metal.

31. The method of claim 26, where the anchor and bridge are formed from a planar sheet of metal.

32. The method of claim 26, where the anchor and bridge are formed from a tube.

33. The method of claim 26, wherein in step (c) the bridge is pushed into said divot on said mandrel.

34. The method of claim 26, whereby the heat treatment of step (d) comprise applying heat at 600±

3°

C. for approximately 25-40 minutes.

35. The method of claim 26, whereby the heat treatment of step (d) comprises applying heat at 320±

3°

C. for approximately 70 to 85 minutes.

36. A method of making an implantable device comprising an expandable anchor, a bridge and a sensor, whereby the expandable anchor has a compressed and expanded configuration, said anchor having a longitudinal axis and forming an anchor wall, said bridge is aligned with the longitudinal axis of the anchor and aligned with the anchor wall when said anchor is in the compressed configuration, and said bridge protrudes into said lumen when said anchor is in the expanded configuration, comprising the steps of:

(a) manufacturing the anchor;

(b) manufacturing the bridge;

(c) heat treating the anchor and the bridge;

(d) attaching the bridge to the anchor; and

(e) assembling the sensor to the bridge.

37. The method of claim 36, further comprising the step (f) crimping the implantable device onto a delivery catheter.

38. The method of claim 36, where step (d) is performed prior to step (c).

39. The method of claim 36, where step (e) is performed prior to step (d).

40. The method of claim 36, whereby the sensor is assembled to the bridge by an adapting ring in step (e).

41. The method of claim 36, whereby an angiographic marker is inserted between the sensor and the bridge.

42. The method of claim 36, where the anchor and bridge are formed from a flat sheet of metal.

43. The method of claim 36, where the anchor and bridge are formed from a tube.

44. The method of claim 36, whereby step (c) comprises securing said anchor onto a mandrel.

45. The method of claim 36, whereby the heat treatment of step (c) comprise applying heat at 600±

3°

C. for approximately 25-40 minutes.

46. The method of claim 36, whereby the heat treatment of step (c) comprises applying heat at 320±

3°

C. for approximately 70 to 85 minutes.

47. The method of claim 36, whereby in step (c) the heat treatment of the anchor is performed separately from the heat treatment of the bridge.

48. The method of claim 36, whereby said anchor is placed onto a jig having an indented area after heat treatment and prior to step (d).

49. The method of claim 48, where the bridge and sensor is placed within said indented area of said jig.

50. A method of implanting a sensor comprising:

(a) preparing a device comprising an expandable anchor, a bridge and a sensor, whereby the expandable anchor has a compressed and expanded configuration, said anchor having a longitudinal axis and forming an anchor wall, said bridge is aligned with the longitudinal axis of the anchor and aligned with the anchor wall when said anchor is in the compressed configuration, and said bridge protrudes into said lumen when said anchor is in the expanded configuration;

(b) delivering the device to a lumen;

(c) expanding the anchor, causing the bridge to protrude into said lumen; and

(d) causing said sensor to protrude into said lumen.

51. A system for implanting a sensor comprising:

(a) a delivery catheter; and

(b) an implantable device mounted on said delivery catheter comprising an expandable anchor, a bridge and a sensor, whereby the expandable anchor has a compressed and expanded configuration, said anchor having a longitudinal axis and forming an anchor wall, said bridge is aligned with the longitudinal axis of the anchor and aligned with the anchor wall when said anchor is in the compressed configuration, and said bridge protrudes into said lumen when said anchor is in the expanded configuration.