Devices and methods of visualizing and determining depth of penetration in cardiac tissue

• US 10,058,321 B2
• Filed: 03/04/2016
• Issued: 08/28/2018
• Est. Priority Date: 03/05/2015
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Ancora Heart, Inc.
• Inventors: Sampson, Russel, Adam, Charles, Nguyen, Son, Baron, David Scott
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): GABR, MOHAMED GAMIL
• Application Number:
  US15/061,748
• Publication Number:
  US 20160256149A1
• Time in Patent Office: 907 Days
• Field of Search: 606142
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0493 Protective devices for suturing, i.e. for protecting the patient's organs or the operator
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for

Abstract

Disclosed herein are devices and methods for assessing the surface of a target cardiac tissue and for delivering a tissue anchor to cardiac tissue at a preselected depth within the myocardium in a beating heart procedure. In one variation, an anchor delivery device comprises an elongate body, a tissue anchor disposed within a first longitudinal lumen of the elongate body, and a tissue depth indicator slidable within a second longitudinal lumen of the elongate body. The tissue depth indicator has a first configuration that indicates the boundary of the surface of the target tissue and a second configuration that indicates when the distal tip of the elongate body has been advanced to a preselected depth into the target tissue. In some variations, a tissue depth indicator may also be configured to resist or limit the penetration of the delivery device into tissue after a preselected depth has been reached.

Claims

1. A tissue anchor delivery device comprising:

an elongate body having a longitudinal axis and comprising a proximal end, a distal end, a first longitudinal lumen that terminates at a first distal opening located at the distal end of the elongate body, and a second longitudinal lumen that terminates at a second distal opening located proximal to the distal end of the elongate body, wherein a longitudinal distance between the first distal opening and the second distal opening corresponds to a pre-selected tissue anchor delivery depth;

a tissue anchor coupled to a tether disposed in the first longitudinal lumen and configured to exit the first distal opening when deployed into tissue, wherein the tether is coupled to an eyelet of the tissue anchor; and

a tissue depth indicator extendable from the second distal opening

wherein a distal portion of the tissue depth indicator extends out from the second distal opening and comprises a first configuration wherein the distal portion extends toward the distal end of the elongate body and a second configuration wherein the distal portion extends away from the distal end of the elongate body, and wherein the tissue depth indicator is configured to transition from the first configuration to the second configuration after the distal end of the elongate body has penetrated a tissue surface at the pre-selected anchor delivery depth, and

wherein the tissue depth indicator comprises a radiopaque indicator wire having a proximal portion, and wherein the distal portion of the indicator wire is more compliant than the proximal portion.

2. The delivery device of claim 1, wherein the distal portion has a length from about 1 cm to about 5 cm.

3. The delivery device of claim 2, wherein the distal portion has a length of about 3 cm.

4. The delivery device of claim 1, wherein the distal portion of the tissue depth indicator extends beyond the distal end of the elongate body.

5. The delivery device of claim 1, wherein in the first configuration, the distal portion of the indicator wire forms an obtuse angle with respect to the second longitudinal lumen, and in the second configuration, the distal portion of the indicator wire forms an acute angle with respect to the second longitudinal lumen.

6. The delivery device of claim 1, wherein in the first configuration, sliding the tissue depth indicator within the second longitudinal lumen varies the length of the distal portion of the indicator that exits the second longitudinal lumen.

7. The delivery device of claim 6, wherein the obtuse angle is about 120 degrees and the acute angle is about 80 degrees.

8. The delivery device of claim 1, wherein in the first configuration, sliding the tissue depth indicator within the second longitudinal lumen varies the length of the distal portion of the indicator that exits the second longitudinal lumen.

9. The delivery device of claim 1, wherein at least the distal portion of the indicator wire is radiopaque.

10. The delivery device of claim 1, wherein the proximal portion of the indicator wire has a first stiffness and the distal portion of the indicator wire has a second stiffness, wherein the second stiffness is about 5% to about 50% of the first stiffness.

11. The delivery device of claim 1, wherein the first longitudinal lumen is distinct from the second longitudinal lumen.

12. The delivery device of claim 11, wherein the first longitudinal lumen and the second longitudinal lumen are separated by a wall.

13. The delivery device of claim 1, further comprising a push member slidably disposed within the first longitudinal lumen and configured to contact and distally advance the tissue anchor, and a stop structure located within the first longitudinal lumen and configured to restrict sliding the push member past a selected location along the first longitudinal lumen.

14. The delivery device of claim 1, wherein the distal portion of the tissue depth indicator extends along a longitudinal length of the elongate body between the first distal opening and the second distal opening in the first configuration, and the tissue depth indicator deflects away from the longitudinal length of the elongate body in the second configuration.