Soft tissue depth-finding tool

• US 9,693,865 B2
• Filed: 09/13/2016
• Issued: 07/04/2017
• Est. Priority Date: 01/09/2013
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Gilmore, Michael, Murphy, Charlotte, Tobis, Idan
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US15/264,250
• Publication Number:
  US 20170000611A1
• Time in Patent Office: 294 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 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 2/2478 Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

Apparatus is provided that includes a tissue anchor, which (a) includes a helical tissue-coupling element which has a distal tissue-penetrating tip at a distal end of the tissue anchor, and is configured to be advanced into soft tissue, and (b) is shaped so as to define a longitudinal channel extending to the distal end of the tissue anchor. The apparatus further includes (a) a depth-finding tool, which includes a radiopaque bead, which is shaped so as to define a hole therethrough, and which is positioned within and axially moveable along the channel so as to serve as a marker indicating a depth of penetration of the tissue-coupling element into the soft tissue, and (b) and a shaft that is removably positioned within the channel, such that the shaft passes through the hole of the bead, and such that the bead is axially moveable along the shaft and along the channel.

Claims

1. Apparatus comprising:

a tissue anchor, which (a) comprises a helical tissue-coupling element which has a distal tissue-penetrating tip at a distal end of the tissue anchor, and which is configured to be advanced into soft tissue, and (b) is shaped so as to define a longitudinal channel extending from a proximal end of the anchor to the distal end of the tissue anchor; and

a depth-finding tool, which comprises;

a radiopaque bead, which is shaped so as to define a hole therethrough, and which is positioned within the channel and is axially moveable along the channel so as to serve as a marker indicating a depth of penetration of the tissue-coupling element into the soft tissue; and

a shaft that is removably positioned within the channel, such that the shaft passes through the hole of the radiopaque bead, and such that the radiopaque bead is axially moveable along the shaft and along the channel.

2. The apparatus according to claim 1, wherein the helical tissue-coupling element is shaped so as to define a distal stopper that prevents the radiopaque bead from exiting from the distal end of the tissue anchor.

3. The apparatus according to claim 1, wherein the depth-finding tool further comprises a wire, which is at least partially disposed within the channel, and which couples the radiopaque bead to the a proximal portion of the tissue anchor, thereby preventing the radiopaque bead from exiting the distal end of the tissue anchor.

4. The apparatus according to claim 1, wherein a distal tip of the shaft is sharp.

5. A method comprising:

providing a tissue anchor, which (a) includes a helical tissue-coupling element which has a distal tissue-penetrating tip at a distal end of the tissue anchor, and which is configured to be advanced into soft tissue, and (b) is shaped so as to define a longitudinal channel extending from a proximal end of the anchor to the distal end of the tissue anchor;

providing a depth-finding tool, which includes (a) a radiopaque bead, which is shaped so as to define a hole therethrough, and is axially moveable along the channel so as to serve as a marker indicating a depth of penetration of the tissue- coupling element into the soft tissue, and (b) a shaft that is removably positioned within the channel, such that the shaft passes through the hole of the radiopaque bead, and such that the radiopaque bead is axially moveable along the shaft and along the channel;

advancing the helical tissue-coupling element into the soft tissue, such that the radiopaque bead comes into contact with and remains at a surface of the soft tissue so as to serve as a marker indicating the depth of penetration of the tissue- coupling element into the soft tissue; and

proximally withdrawing the shaft from the channel, leaving the radiopaque bead in the channel.

6. The method according to claim 5, further comprising:

viewing the radiopaque bead and a proximal portion of the soft tissue anchor using imaging; and

assessing the depth of penetration of the helical tissue-coupling element into the soft tissue by estimating a distance between the radiopaque bead and the proximal portion of the tissue anchor.

7. The method according to claim 5, wherein proximally withdrawing the shaft from the channel comprises proximally withdrawing the shaft from the channel after finishing advancing the helical tissue-coupling element into the soft tissue.

8. The method according to claim 5, wherein a distal tip of the shaft is sharp, and wherein the method further comprises, before advancing the helical tissue- coupling element into the soft tissue, inserting the sharp distal tip of the shaft into the soft tissue slightly, in order to prevent sliding of the depth-finding tool and the anchor on a surface of the soft tissue before advancing the anchor into the tissue.

9. The method according to claim 5, wherein a distal tip of the shaft is sharp, and wherein the method further comprises advancing the shaft into the soft tissue while advancing the helical tissue-coupling element into the soft tissue.

10. The method according to claim 5, wherein the helical tissue-coupling element is shaped so as to define a distal stopper that prevents the radiopaque bead from exiting from the distal end of the tissue anchor.

11. The method according to claim 5, wherein the depth-finding tool further includes a wire, which is at least partially disposed within the channel, and which couples the radiopaque bead to the a proximal portion of the tissue anchor, thereby preventing the radiopaque bead from exiting the distal end of the tissue anchor.