Anchor elements, medical devices including one or more anchor elements and related assemblies and methods

• US 10,226,620 B2
• Filed: 11/25/2014
• Issued: 03/12/2019
• 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
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US15/039,027
• Publication Number:
  US 20170165478A1
• Time in Patent Office: 1,568 Days
• Field of Search: 607116
• 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 two engagement portions;

at least one lobe section positioned between the at least two engagement portion, the 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, the at least one lobe comprising a first end and a second end each being coupled to one respective engagement portion of the at least two engagement portions, the at least one lobe having a middle section positioned between the first end and the second end along the longitudinal axis, the middle section configured to define a laterally outermost portion of the at least one lobe, taken in direction transverse to the longitudinal axis, when the at least one anchor element is in the deployed state, the first end and the second end being separated by the middle portion when the at least one anchor element is in an initial state in a direction along the longitudinal axis; 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, the at least one lobe portion being defined by at least one slot in the at least one lobe section extending from an outer surface of the at least one anchor element to the lumen; and

an anchor deployment device comprising;

a first cannula configured to receive the at least one anchor element thereon and to receive a portion of the medical device therein, wherein the first cannula is separate from the medical device to which the at least anchor device is to be secured; and

a second cannula having configured to have 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 one of the at least two engagement portions of the at least one anchor element toward another of the at least two engagement portions in order to position the at least one anchor element in the deployed state while the at least one anchor element is positioned on the first cannula; and

force the at least one anchor element in the deployed state off of the first cannula in order to secure the anchor deployment device to the at least a portion of the medical device that is positioned within a subject, wherein the anchor deployment device is configured to be removed from the subject and the medical device after the at least one anchor device has been secured, and wherein neither the anchor deployment device nor the first cannula is configured to be secured in the subject by the at least one anchor element.

2. The anchor element assembly of claim 1, wherein:

in a first locking position, the anchor deployment device is adapted to substantially prohibit movement of the first cannula relative to the second cannula in order to secure the anchor deployment device from unwanted movement of the first cannula relative to the second cannula when the anchor deployment device is being moved and positioned along the medical device; and

in a second locking position, the anchor deployment device is adapted to substantially prohibit movement of the medical device relative to the first cannula in order to move the first cannula relative to the second cannula to enable the second cannula to force the at least one anchor element into the deployed state and onto the medical device.

3. The anchor element assembly of claim 1, 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 a 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 a portion of a first cannula configured to receive the at least one anchor element thereon 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 portion of the first cannula.

7. The anchor element assembly of claim 1, 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, and wherein the first cannula is configured to receive the at least a portion of the medical device within a lumen formed within the first cannula.

9. The anchor element assembly of claim 1, 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 the 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 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.

18. 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.

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

positioning at least a portion of the medical device in a subject;

positioning a lumen of at least one anchor element around a first portion of an anchor deployment device that is separate from and movable relative to the medical device;

deploying at least two protrusions 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 within the subject with a second portion of the anchor deployment device while to the at least one anchor element remains positioned around the first portion of the anchor deployment device, each of the at least two protrusions defined by a middle portion the at least one anchor element that defines the lumen when the at least one anchor element is in an initial state and defines a laterally outermost portion of the at least one anchor element when the at least one anchor element is in a deployed state; and

securing the at least a portion of the medical device within the lumen of the at least one anchor element by forcing the at least one anchor element off of the first portion of the anchor deployment device in the deployed state with the second portion of the anchor deployment device.

20. The method according to claim 19, further comprising:

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.