Medical device with induction triggered anchors and system for deployment of the same

• US 10,575,972 B2
• Filed: 04/28/2017
• Issued: 03/03/2020
• Est. Priority Date: 04/28/2017
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Kim, Woong
• Primary Examiner(s): Herbermann, Erich G
• Application Number:
  US15/581,980
• Publication Number:
  US 20180311055A1
• Time in Patent Office: 1,040 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0038 electromagnetically

Abstract

A medical device, deployment systems and methods of use thereof are provided. The medical device includes at least one anchor element coupled to a device body. The anchor element has a first configuration disposed about an anchor axis and configured to pierce a body tissue wall. In a second configuration, the anchor elements have an enlarged shape, and in response to a temperature rise in the anchor element, the pierced body tissue wall is drawn closer to the device body. The anchor element maintains alignment substantially with the anchor axis to inhibit tearing of the pierced body tissue wall by the anchor element. The system may include balloons for targeting the radial pressure of the anchor elements into the body vessel wall. The anchor elements may be made of shape memory materials capable of localized heating due to an induction device.

Claims

1. A medical device disposed about a longitudinal axis, comprising:

a device body comprising a stent frame structure;

at least one anchor element comprising a thermal activatable material, the at least one anchor element comprising a base and an anchor tip at an end opposite from the base, wherein the base is coupled to the stent frame structure; and

wherein the at least one anchor element is adjustable between;

a first configuration, where the at least one anchor element is disposed about an anchor axis substantially perpendicular to the longitudinal axis and the anchor tip is configured to pierce completely through a body tissue wall; and

in response to a temperature rise in the at least one anchor element, a second configuration, wherein, a portion of the at least one anchor element is configured to press against an exterior of a pierced body tissue wall to press the pierced body tissue wall closer to the device body, and the at least one anchor element within the body tissue wall is configured to maintain alignment substantially with the anchor axis to inhibit tearing of the pierced body tissue wall by the at least one anchor element.

2. The medical device of claim 1, wherein in the first configuration the at least one anchor element includes an elongated shape and the anchor tip is positioned extending outwardly from the device body.

3. The medical device of claim 2, wherein the at least one anchor element includes a wire member having a first profile perpendicular to the anchor axis in the first configuration, and in the second configuration the wire member is shaped to define a second profile perpendicular to the anchor axis that is greater than the first profile.

4. The medical device of claim 1, wherein the anchor tip is positioned relatively closer to the device body in the second configuration than in the first configuration.

5. The medical device of claim 4, wherein an end of the at least one anchor element spaced from the base and outside of the pierced body tissue wall is shaped having a coiled or looped configuration in the second configuration.

6. The medical device of claim 1, wherein the at least one anchor element, in response to the temperature rise, is pivotable about the base within 15 degrees of the anchor axis.

7. The medical device of claim 1, wherein the at least one anchor element comprises a plurality of anchor elements disposed along a discrete region of the device body.

8. The medical device of claim 1, wherein the at least one anchor element comprises a plurality of anchor elements disposed circumferentially along the device body.

9. The medical device of claim 1, wherein the thermal activatable material includes a shape memory material.

10. The medical device of claim 1, wherein the stent frame structure comprises an expandable stent support ring structure, and wherein the at least one anchor element is securely fixed to the expandable stent support ring structure.

11. A delivery system for deployment of a prosthesis within a body vessel, comprising:

an outer sheath coaxially disposed over an inner cannula, the outer sheath and the inner cannula defining a retention region; and

the prosthesis including a prosthesis body resiliently movable between a radially compressed configuration and a radially expanded configuration, and a plurality of thermal activatable anchor elements, each of the plurality of thermal activatable anchor elements having a base and an anchor tip at an end opposite from the base, wherein the base is coupled along the prosthesis body;

the plurality of thermal activatable anchor elements including;

a delivery configuration when the prosthesis is in the radially compressed configuration, wherein the prosthesis is disposed along the retention region and retained in the radially compressed configuration by the outer sheath;

a first deployed configuration wherein, with retraction of the outer sheath, the prosthesis is movable to the radially expanded configuration and the plurality of thermal activatable anchor elements are resiliently movable from the delivery configuration to pierce completely through a body tissue wall of the body vessel, and a second deployed configuration wherein, in response to an increase in temperature of the plurality of thermal activatable anchor elements in the first deployed configuration, the plurality of thermal activatable anchor elements are movable to press portions of the plurality of thermal activatable anchor elements extending through a pierced body vessel wall against an exterior of the body vessel to bring the prosthesis body and the pierced body tissue wall relatively closer to one another.

12. The delivery system of claim 11, further comprising at least one inflatable balloon at a proximal end of the inner cannula, wherein the at least one inflatable balloon is positionable within the prosthesis in the radially expanded configuration, wherein in response to expansion of the at least one inflatable balloon, a piercing pressure of the plurality of thermal activatable anchor elements in the first deployed configuration is increasable.

13. The delivery system of claim 12, wherein the at least one inflatable balloon includes a first inflatable balloon and a second inflatable balloon disposed in a longitudinal side-by-side relationship at the proximal end of the inner cannula, the system further comprising an inflation reservoir divided into a first chamber and a second chamber by a piston, the first chamber in fluid communication with the first inflatable balloon and the second chamber in fluid communication with the second inflatable balloon, wherein movement of the piston within the inflation reservoir selectively increases or decreases fluid volumes of the respective first and second chambers such that a cross-sectional area of expansion of the corresponding first and second inflatable balloons are selectively and independently increased or decreased.

14. The delivery system of claim 11, wherein each of the plurality of thermal activatable anchor elements in the first deployed configuration is disposed about an anchor axis, and wherein, in response to said temperature rise and movement to the second deployed configuration, each of the plurality of thermal activatable anchor elements maintains alignment substantially with the anchor axis to inhibit tearing of the pierced body tissue wall.

15. A medical device disposed about a longitudinal axis, comprising:

a device body comprising a stent frame structure;

at least one anchor element comprising a thermal activatable material, the at least one anchor element comprising a base and an anchor tip at an end opposite from the base, wherein the base is coupled to the stent frame structure; and

wherein the at least one anchor element is adjustable between;

a first configuration, where the at least one anchor element is disposed about an anchor axis substantially perpendicular to the longitudinal axis and the anchor tip is configured to pierce completely through a body tissue wall; and

in response to a temperature rise in the at least one anchor element, a second configuration where the at least one anchor element is configured to;

at a first portion of the at least one anchor element adjacent the base and extending through the body tissue wall, maintain alignment substantially with the anchor axis to inhibit tearing of a pierced body tissue wall by the at least one anchor element; and

at a second portion of the at least one anchor element extending outside the body tissue wall and adjacent the anchor tip, press against an exterior of the body tissue wall to bring the prosthesis body and the pierced body tissue wall relatively closer to one another.

16. The medical device of claim 15, wherein the anchor tip is positioned relatively closer to the device body in the second configuration than in the first configuration.

17. The medical device of claim 15, wherein the second portion of the at least one anchor element is shaped having a coiled or looped configuration in the second configuration.

18. The medical device of claim 15, wherein the at least one anchor element, in response to the temperature rise, is pivotable about the base within 15 degrees of the anchor axis.