Hole-closure device

• US 9,414,823 B2
• Filed: 03/07/2013
• Issued: 08/16/2016
• Est. Priority Date: 04/25/2012
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Ben Hamou, Eli, Tuval, Yossi
• Primary Examiner(s): Severson, Ryan J
• Assistant Examiner(s): KNAUSS, CHRISTIAN D
• Application Number:
  US13/788,054
• Publication Number:
  US 20130289619A1
• Time in Patent Office: 1,258 Days
• Field of Search: 606/151, 606/153, 606/155, 606/157, 606/213, 606/215, 606/216
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

Medical devices for closing a hole or holes in a subject'"'"'s body, such as those related to transapical procedures, are disclosed. The medical devices can include a force-providing portion and a tissue-attachment portion. The medical devices can be configured for multiple positions including at least a constrained position and an unconstrained position. In some embodiments, the medical device may be used on a delivery device or delivery tool. In some embodiments, the force-providing portion can pivot radially outward and the tissue-attachment portion can become more constrained, and the hole can be at least partially closed. In some embodiments, the tissue-attachment portion can include a plurality of pins that assume a hook shape.

Claims

1. An apparatus for closing a hole in a subject, the apparatus comprising:

a hole-closure device, the hole-closure device being configured to define a constrained configuration when the hole-closure device is disposed within a delivery device, and a substantially unconstrained configuration when the delivery device has been retracted with respect to the hole-closure device, the hole-closure device comprising;

a tissue-attachment portion comprising a plurality of pins disposed around and in parallel with a longitudinal axis of the hole-closure device, the plurality of pins being configured to achieve a distally-facing first, constrained configuration when covered by the delivery device and a second, unconstrained configuration for attachment to the subject when the delivery device has been retracted from covering the tissue-attachment portion, wherein the plurality of pins further define a lumen of the tissue-attachment portion, and

a force-providing portion proximate the tissue-attachment portion, the force-providing portion being configured to achieve a first, constrained configuration when covered by the delivery device and a second, unconstrained configuration when the delivery device has been retracted from covering a proximal end of the force-providing portion, wherein when the proximal end of the force-providing portion is uncovered by the delivery device the force-providing portion is adapted to undergo a transition in shape to simultaneously pivot radially-outwardly and to at least partially constrict the lumen of the tissue-attachment portion by moving the plurality of pins toward the longitudinal axis of the hole-closure device.

2. The apparatus according to claim 1, wherein the force-providing portion is configured to assume a planar shape by pivoting radially-outwardly.

3. The apparatus according to claim 1, wherein the force-providing portion is configured to assume a frustoconical shape by pivoting radially-outwardly.

4. The apparatus according to claim 1, wherein the plurality of pins comprises more than three pins.

5. The apparatus according to claim 1, wherein the plurality of pins comprises less than twenty pins.

6. The apparatus according to claim 1, wherein each of the plurality of pins when in the distally-facing first configuration has a length of 2 mm to 15 mm.

7. The apparatus according to claim 1, wherein the force-providing portion is configured to assume a shape that defines a circular cross-section when in the first, constrained configuration.

8. The apparatus according to claim 1, wherein the force-providing portion is configured to prevent the hole-closure device from migrating when the hole-closure device is attached to the subject.

9. The apparatus according to claim 1, wherein when the tissue-attachment portion is in the second, unconstrained configuration each of the plurality of pins is configured to assume a hook shape by curving radially outwardly in response to retraction of the delivery device.

10. The apparatus according to claim 9, wherein when each of the plurality of pins is in the hooked shape, a length from a distal end of each pin to a center of a curved portion of each pin is between 25 percent and 50 percent of a total length of each pin.

11. The apparatus according to claim 1, wherein when the tissue-attachment portion is in the second, unconstrained configuration each of the plurality of pins is configured to assume a straight shape in response to retraction of the delivery device.

12. The apparatus according to claim 1, wherein the plurality of pins comprises more than three pins,

wherein when the tissue-attachment portion is in the second, unconstrained configuration each of the plurality of pins is configured to assume a hook shape by curving radially outwardly in response to retraction of the delivery device,

wherein the force-providing portion is configured to assume a shape that defines a circular cross-section when in the first, constrained configuration when covered by the delivery device,

wherein the force-providing portion is configured to assume a planar shape by pivoting radially-outwardly when the delivery device is retracted from covering the force-providing portion of the hole-closure device, and

wherein the lumen of the tissue-attachment portion constricts when the force-providing portion assumes the planar shape.

13. An apparatus for closing a hole and for use with a delivery device and a sheath, the apparatus comprising:

a hole-closure device, the hole-closure device defining a tissue-attachment portion, and a force-providing portion proximate to the tissue-attachment portion,

the hole-closure device being configured to define a constrained configuration when the hole-closure device is disposed on the delivery device and covered by the sheath, and an unconstrained configuration when the delivery device has been removed from the hole-closure device and the hole-closure device is not covered by the sheath,

the tissue-attachment portion of the hole-closure device being configured to be attached to tissue that surrounds the hole within the subject, and

the force-providing portion being configured to simultaneously pivot radially-outwardly and to constrict a lumen of the tissue-attachment portion by the sheath being removed from covering a proximal end of the force-providing portion, wherein the force-providing portion assumes a substantially planar shape and constricts the lumen of the tissue-attachment portion to thereby cause tissue that surrounds the hole to move inwardly to a center of the hole.