APPARATUS AND METHODS FOR TISSUE ANCHORING OF MEDICAL DEVICES

• US 20160166279A1
• Filed: 12/09/2015
• Published: 06/16/2016
• Est. Priority Date: 12/11/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Journot, Brice J., Oster, Daniel C.
• Granted Patent: US 10,112,042 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61N 1/00 Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An apparatus for tissue anchoring of a medical device includes a retention member and an elastic member secured between ends of the retention member. The retention member, being transformable along a longitudinal axis of the apparatus, is held by a spring bias of the elastic member in a first, gripping state; and, when opposing forces compress the elastic member, the retention member is transformed to a second, open state. In the first state, a lumen defined by a sidewall of the retention member has a diameter to forms a interference fit around a body of the device, and the ends of the retention member are spaced apart by a first distance; in the second state, the ends are spaced closer together than in the first state, and the diameter of the lumen is enlarged to allow movement of the apparatus along a length of the device body.

Claims

1. An apparatus for tissue anchoring of an elongate medical device body, the apparatus comprising:

a retention member including a tubular sidewall that extends from a first end of the retention member to a second end of the retention member and defines a lumen of the retention member, the lumen extending along a longitudinal axis of the apparatus from a first opening thereof to a second opening thereof, and the retention member being transformable along the longitudinal axis from a first, gripping state to a second, open state, and vice versa, the first state being that at which the lumen has a first diameter and the first and second ends of the tubular sidewall are spaced apart by a first distance, and the second state being that at which the lumen has a second diameter and the first and second ends of the tubular sidewall are spaced apart by a second distance, the first diameter being smaller than the second diameter, and the first distance being greater than the second distance;

an elastic member secured between the first and second ends of the retention member, the elastic member being spring biased to push the first and second ends apart from one another, thereby holding the retention member in the first, gripping state;

a pair of force interface members, a first of the pair of interface members being coupled to the retention member in proximity to the first end thereof, a second of the pair of interface members being coupled to the retention member in proximity to the second end thereof, and the interface members being configured to receive opposing forces that compress the elastic member, against the spring bias thereof, and thereby transform the retention member to the second, open state; and

a tissue fixation member directed outward from the retention member, when the retention member is in the first, gripping state;

wherein the apparatus is positionable along a length of the medical device body when the retention member is in the second, open state, and grips the medical device body when the retention member is in the first, gripping state.

2. The apparatus of claim 1, wherein the tubular sidewall of the retention member comprises a plurality of strands braided together.

3. The apparatus of claim 1, wherein the retention member further comprises a liner extending within the tubular sidewall and around the lumen.

4. The apparatus of claim 1, wherein the elastic member comprises a coiled spring mounted around the tubular sidewall of the retention member, outside the lumen.

5. The apparatus of claim 1, wherein the elastic member comprises a leaf spring element mounted alongside the tubular sidewall of the retention member, outside the lumen.

6. The apparatus of claim 1, wherein the tissue fixation member comprises a flexible tine element coupled in proximity to one of the first and second ends of the tubular sidewall of the retention member.

7. The apparatus of claim 1, further comprising an outer sheath extending between the force interface members and around the elastic member.

8. The apparatus of claim 7, further comprising a deployment member extending alongside the outer sheath and being free to slide relative to the sheath, and wherein:

the deployment member includes an end secured to the first force interface member and an outward protruding ramp member spaced apart, along the longitudinal axis, from the secured end; and

the tissue fixation member comprises a deployable tine or barb element, the tine or barb element including a fixed end and a free end, the fixed end coupled to the second force interface member, and the free end configured to engage with the ramp member of the deployment member; and

when the opposing forces that compress the elastic member are released, the ramp member of the deployment member forces the free end of the tine or barb element outward from the longitudinal axis to engage tissue.

9. The apparatus of claim 7, further comprising a pair of deployment members extending alongside the outer sheath and being free to slide relative to the outer sheath, and wherein:

each deployment member includes an end secured to a corresponding force interface member, and an outward protruding tab spaced apart, along the longitudinal axis, from the secured end, the tabs of the pair of deployment members being located closer together, along the longitudinal axis, when the retention member is in the first, gripping state, than when the retention member is in the second, open state; and

the tissue fixation member comprises an expandable element mounted around the pair of deployment members and between the outward protruding tabs thereof, the expandable element having a relatively low profile, when the retention member is in the second, open state, and the expandable element having a larger, fixation profile, when the retention member is in the first, gripping state, being compressed by the outward protruding tabs of the deployment members.

10. The apparatus of claim 1, wherein:

the tissue fixation member comprises a pair of deployable tine or barb elements and a separable coupling, each deployable tine or barb element including a fixed end and a free end, and the separable coupling engaging and thereby holding the free ends of the pair of deployable tine or barb elements together so that the pair of elements are in an un-deployed state;

each force interface member includes a junction that joins the fixed end of the corresponding tine or barb element to the interface member, so that the opposing forces that compress the elastic member, against the spring bias thereof, are applied through each junction by the holding together of the free ends of the pair of deployable tine or barb elements by the separable coupling; and

when the separable coupling for the pair of deployable tine or barb elements is detached, the free ends of the pair of deployable tine or barb elements are deployed and the opposing forces are released to allow the retention member to transform to the first, gripping state.

11. The apparatus of claim 1, further comprising at least one removable band secured around the pair of force interface members to apply the opposing forces that compress the elastic member.

12. A kit comprising an apparatus for tissue anchoring of an elongate medical device body, and an associated tool configured to engage with the apparatus and thereby facilitate positioning of the apparatus along a length of the device body, and wherein the apparatus comprises:

a retention member including a tubular sidewall that extends from a first end of the retention member to a second end of the retention member and defines a lumen of the retention member, the lumen extending along a longitudinal axis of the apparatus from a first opening thereof to a second opening thereof, and the retention member being transformable along the longitudinal axis from a first, gripping state to a second, open state, and vice versa, the first state being that at which the lumen has a first diameter and the first and second ends of the tubular sidewall are spaced apart by a first distance, and the second state being that at which the lumen has a second diameter and the first and second ends of the tubular sidewall are spaced apart by a second distance, the first diameter being smaller than the second diameter, and the first distance being greater than the second distance;

an elastic member secured between the first and second ends of the retention member, the elastic member being spring biased to push the first and second ends apart from one another, thereby holding the retention member in the first, gripping state;

a pair of force interface members, a first of the pair of interface members being coupled to the retention member in proximity to the first end thereof, a second of the pair of interface members being coupled to the retention member in proximity to the second end thereof, and the interface members being configured to receive opposing forces that compress the elastic member, against the spring bias thereof, and thereby transform the retention member to the second, open state; and

a tissue fixation member directed outward from the retention member, when the retention member is in the first, gripping state;

wherein, when the tool engages the apparatus force interface members, the apparatus, with the retention member thereof in the second, open state, is positionable along the length of the device body; and

when the tool is released from engagement with the apparatus force interface members, the apparatus, with the retention member thereof in the first, gripping state, grips the medical device body.

13. The kit of claim 12, wherein the tubular sidewall of the apparatus retention member comprises a plurality of strands braided together.

14. The kit of claim 12, wherein the apparatus retention member further comprises a liner extending within the tubular sidewall and around the lumen.

15. The kit of claim 12, wherein the apparatus elastic member comprises a coiled spring mounted around the tubular sidewall of the apparatus retention member, outside the lumen.

16. The kit of claim 12, wherein the elastic member comprises a leaf spring element mounted alongside the tubular sidewall of the apparatus retention member, outside the lumen of the retention member.

17. The kit of claim 12, wherein the apparatus tissue fixation member comprises a flexible tine element coupled in proximity to one of the first and second ends of the tubular sidewall of the apparatus retention member.

18. The kit of claim 12, wherein the apparatus further comprises an outer sheath extending between the apparatus force interface members and around the apparatus elastic member.

19. The kit of claim 18, wherein:

the apparatus further comprises a deployment member extending alongside the outer sheath of the apparatus and being free to slide relative to the sheath;

the deployment member includes an end secured to the first force interface member of the apparatus and an outward protruding ramp member spaced apart, along the longitudinal axis of the apparatus, from the secured end;

the tissue fixation member of the apparatus comprises a deployable tine or barb element, the tine or barb element including a fixed end and a free end, the fixed end coupled to the second force interface member of the apparatus, and the free end configured to engage with the ramp member of the deployment member; and

when the opposing forces that compress the elastic member of the apparatus are released, the ramp member of the deployment member forces the free end of the tine or barb element outward from the longitudinal axis to engage tissue.

20. The kit of claim 18, wherein:

the apparatus further comprises a pair of deployment members extending alongside the outer sheath of the apparatus and being free to slide relative to the outer sheath;

each deployment member includes an end secured to a corresponding force interface member of the apparatus, and an outward protruding tab spaced apart, along the longitudinal axis, from the secured end, the tabs of the pair of deployment members being located closer together, along the longitudinal axis of the apparatus, when the retention member of the apparatus is in the first, gripping state, than when the retention member is in the second, open state; and

the tissue fixation member of the apparatus comprises an expandable element mounted around the pair of deployment members and between the outward protruding tabs thereof, the expandable element having a relatively low profile, when the retention member is in the second, open state, and the expandable element having a larger, fixation profile, when the retention member is in the first, gripping state, being compressed by the outward protruding tabs of the deployment members.

21. A method for securing an anchoring apparatus around an elongate body of a medical device, the method comprising:

applying opposing forces to compress an elastic member of the apparatus against a spring bias of the elastic member and thereby transform the apparatus from a first state to a second state, the elastic member being secured between first and second ends of the apparatus, the first state being that at which a lumen of the apparatus has a first diameter and the first and second ends are spaced apart by a first distance, and the second state being that at which the lumen has a second diameter and the first and second ends are spaced apart by a second distance, the first diameter being smaller than the second diameter, and the first distance being greater than the second distance;

inserting the body of the device through the lumen of the apparatus while applying the opposing forces; and

releasing the opposing forces to allow the apparatus to transform back to the first state, at which the apparatus grips the device body.

22. The method of claim 21, wherein:

applying the opposing forces comprises engaging a forceps-like tool with a pair of force interface members of the apparatus, a first force interface member of the pair being located at the first end of the apparatus, and a second force interface member of the pair being located at the second end of the apparatus; and

releasing the opposing forces comprises dis-engaging the forceps-like tool from the pair of force interface members of the apparatus.

23. The method of claim 21, wherein:

applying the opposing forces comprises forming a separable coupling to attach together free ends of a pair of deployable tine or barb elements of the apparatus, a first tine or barb element of the pair being joined to the apparatus in proximity to the first end thereof, and a second tine or barb element of the pair being joined to the apparatus in proximity to the second end thereof; and

releasing the opposing forces comprises detaching the separable coupling.

24. The method of claim 21, wherein:

applying the opposing forces comprises securing a removable band to a pair of force interface members of the apparatus, a first force interface member of the pair being located at the first end of the apparatus, and a second force interface member of the pair being located at the second end of the apparatus; and

releasing the opposing forces comprises removing the removable band.