ANCHOR ELEMENTS, MEDICAL DEVICES INCLUDING ONE OR MORE ANCHOR ELEMENTS AND RELATED ASSEMBLIES AND METHODS

• US 20170165478A1
• Filed: 11/25/2014
• Published: 06/15/2017
• Est. Priority Date: 11/25/2013
• Status: Active Grant

• Current Assignee: Custom Medical Applications, Inc.
• Original Assignee: Custom Medical Applications, Inc.
• Inventors: Racz, N. Sandor, Shoemake, James
• Granted Patent: US 10,226,620 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 5/6882 Anchoring means
• 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 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

Anchor elements include at least one protrusion configured to extend transversely from a longitudinal axis of the anchor element when the anchor element is in a deployed state. Anchor element assemblies and medical device assemblies may include such anchor elements. Methods of anchoring a medical device within a subject include securing at least a portion of the medical device within a lumen of at least one anchor element and deploying at least one protrusion of the at least one anchor element.

Claims

1. An anchor element assembly comprising:

at least one anchor element having a longitudinal axis, the at least one anchor element comprising;

at least one lobe section comprising at least one lobe configured to extend transversely from the longitudinal axis of the at least one anchor element when the at least one anchor element is in a deployed state; and

a lumen formed within the at least one anchor element configured to receive at least a portion of a medical device in the lumen; and

an anchor deployment device comprising at least one cannula configured to receive the at least one anchor element on the at least one cannula, the anchor deployment device configured to secure the anchor deployment device to the at least a portion of the medical device.

2. The anchor element assembly of claim 1, wherein the at least one cannula of the anchor deployment device comprises:

a first cannula configured to receive the at least one anchor element thereon; and

a second cannula having at least a portion of the first cannula received therein, wherein the first cannula is movable relative to the second cannula, and wherein the second cannula is configured to force the at least one anchor element off of the first cannula in order to secure the anchor deployment device to the at least a portion of the medical device.

3. The anchor element assembly of claim 2, wherein the first cannula is coupled to a hub movably received within a portion of the anchor deployment device such that movement of the hub translates the first cannula relative to the second cannula.

4. The anchor element assembly of claim 3, wherein the anchor deployment device further comprises a securing member configured to secure the hub to the anchor deployment device to prevent movement of the hub and the first cannula relative to the second cannula.

5. The anchor element assembly of claim 1, wherein the anchor deployment device further comprises a locking mechanism configured to secure the medical device to the anchor deployment device.

6. The anchor element assembly of claim 5, wherein the anchor deployment device further comprises a pivoting handle having the locking mechanism on a first side of the pivoting handle and the securing member on a second side of the pivoting handle, wherein, in a first position of the pivoting handle, the locking mechanism is configured to be engaged with the medical device and disengaged from the hub and, in a second position of the pivoting handle, the locking mechanism is configured to be disengaged from the medical device and engaged with the hub.

7. The anchor element assembly of claim 2, wherein an outer dimension of the first cannula of the anchor deployment device is greater than an inner dimension of the at least one anchor element, the first cannula configured to at least partially enlarge the lumen of the at least one anchor element in order to deploy the at least one anchor element over the at least a portion of the medical device.

8. The anchor element assembly of claim 3, wherein an inner dimension of the first cannula of the anchor deployment device is greater than an outer dimension of the at least a portion of the medical device, the first cannula configured to receive at least a portion of the medical device within a lumen formed within the first cannula.

9. The anchor element assembly of claim 2, wherein the anchor deployment device comprises a handle for moving the first cannula along the second cannula.

10. The anchor element assembly of claim 1, wherein the anchor deployment device is configured to at least partially move the at least one anchor element from an initial state where the at least one lobe section of the at least one anchor element is substantially parallel to the longitudinal axis of the at least one anchor element to the deployed state where the at least one lobe of the at least one lobe section extends transversely from the longitudinal axis of the at least one anchor element.

11. The anchor element assembly of claim 1, wherein the lumen of the at least one anchor element is configured to contract around the at least a portion of the medical device in order to secure the at least one anchor element to the at least a portion of the medical device.

12. The anchor element assembly of claim 11, wherein the at least one anchor element is configured to be secured to the at least a portion of the medical device via mechanical interference without the use of an adhesive or a fastener.

13. The anchor element assembly of claim 1, wherein the at least one lobe of the at least one anchor element comprises at least two lobes.

14. The anchor element assembly of any one of claim 1, wherein the at least one lobe section of the at least one anchor element comprises at least two lobe sections spaced along the longitudinal axis of the at least one anchor element, each lobe section of the at least two lobe sections comprising at least two lobes.

15. The anchor element assembly of claim 14, wherein the at least two lobes of a first lobe section of the at least two lobe sections are offset about the longitudinal axis of the at least one anchor element from the at least two lobes of a second lobe section of the at least two lobe sections.

16. The anchor element assembly of claim 1, wherein the anchor deployment device is configured to secure the at least one anchor element over the at least a portion of the medical device while the at least a portion of the medical device is positioned within a subject.

17. The anchor element assembly of claim 1, wherein an outer dimension of the at least one cannula of the anchor deployment device is greater than an inner dimension of the at least one anchor element, the at least one cannula configured to at least partially enlarge the lumen of the at least one anchor element in order to deploy the at least one anchor element over the at least a portion of the medical device.

27. A medical device assembly comprising:

a medical device configured to have at least a portion thereof positioned within subcutaneous tissue of a subject; and

the anchor element assembly of claim 1 configured to secure the portion of the medical device within the subject.

18. An anchor element comprising:

at least one protrusion section comprising at least two circumferentially-spaced protrusions configured to extend transversely from a longitudinal axis of the anchor element when the anchor element is in a deployed state; and

a lumen formed within the at least one anchor element configured to receive at least a portion of a medical device in the lumen, wherein the anchor element is configured to be secured over the at least a portion of the medical device while the at least a portion of the medical device is positioned within a subject.

19-21. -21. (canceled)

22. A method of anchoring a medical device, the method comprising:

positioning at least a portion of the medical device;

securing the at least a portion of the medical device within a lumen of the at least one anchor element; and

deploying at least one protrusion of the at least one anchor element to extend transversely from a longitudinal axis of the at least one anchor element while the at least a portion of the medical device is positioned.

25. The method according to claim 22, further comprising:

placing the at least one anchor element with an anchor deployment device;

enlarging the lumen of the at least one anchor element with the anchor deployment device; and

forcing the at least one anchor element off of the anchor deployment device to constrict the lumen of the at least one anchor element about the at least a portion of the medical device.

23-24. -24. (canceled)

26. (canceled)