Heart anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions

• US 10,575,953 B2
• Filed: 08/29/2014
• Issued: 03/03/2020
• Est. Priority Date: 08/30/2013
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Van Bladel, Kevin, Annest, Lon, Heflin, Ernest, Mata, Gilbert, Crainich, Lawrence, LaRose, Brian
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): Wei, Charles M
• Application Number:
  US14/473,556
• Publication Number:
  US 20150066139A1
• Time in Patent Office: 2,013 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

According to one embodiment, a heart anchor tensioning device includes a main body and an elongate shaft. A tension member or tether may be inserted through a lumen of the elongate shaft to allow the shaft to be advanced over the tension member and within a body while the main body is positioned outside of the body. The device also includes an anchor coupling mechanism that is configured to engage a heart anchor and move the heart anchor into engagement with a first wall of the heart. The anchor coupling mechanism is able to lock the heart anchor to inhibit proximal movement of the heart anchor along the tension member. The device further includes a tension indicating mechanism that provides an indication of a force being applied to the heart anchor by the device.

Claims

1. A heart anchor positioning device comprising:

a device body;

an elongate shaft having a proximal end that is coupled with the device body and a distal end and a lumen extending between the proximal end and the distal end, wherein a tension member is insertable through the lumen to enable the device to be advanced over the tension member so that the distal end is insertable within a body adjacent the heart while the device body is positioned outside of the body;

an anchor coupling mechanism positioned at the distal end of the elongate shaft, the anchor coupling mechanism being configured to engage a heart anchor to move the heart anchor distally along the tension member and into engagement with a first wall of the heart to urge the first wall toward a second wall of the heart, the anchor coupling mechanism being configured to lock the heart anchor to inhibit proximal movement of the heart anchor along the tension member, the anchor coupling mechanism being further configured to apply a pulling force to unlock the heart anchor to enable proximal movement of the heart anchor; and

a tension indicating mechanism that is configured to indicate a force being applied to the heart anchor by the device.

2. The device of claim 1, wherein the device body includes a locking mechanism that is actuatable by a user to lock the heart anchor to inhibit proximal movement of the heart anchor along the tension member and to unlock the heart anchor to allow proximal and distal movement of the heart anchor along the tension member.

3. The device of claim 2, wherein the anchor coupling mechanism further comprises a pair of hooks, the pair of hooks being axially moveable relative to a pin disposed at the distal end of the elongate shaft, wherein proximal movement of the pair of hooks relative to the pin engages the pin with a cam component of the heart anchor to unlock the heart anchor.

4. The device of claim 1, wherein the tension indicating mechanism is operable in a first mode and a second mode, wherein in the first mode the tension indicating mechanism allows the device to engage the heart anchor to urge the first wall toward the second wall without indicating the force being applied by the device, and wherein in the second mode the tension indicating mechanism indicates the force being applied to the heart anchor by the device.

5. The device of claim 4, wherein the tension indicating mechanism includes a secondary body that is disposed within the device body, wherein the elongate shaft is coupled to the secondary body, wherein in the first mode the elongate shaft is stationary relative to the device body as the force is applied to the heart anchor by the device, and wherein in the second mode the elongate shaft is moveable axially relative to the device body as the force is applied to the heart anchor by the device.

6. The device of claim 5, wherein the secondary body is configured to engage a spring component positioned within the device body that allows the secondary body to move axially within the device body in the second mode, and wherein the device body includes a button component that is actuatable by a user to lock the secondary body relative to the device body to inhibit proximal movement of the secondary body within the device body.

7. The device of claim 6, wherein the secondary body further comprises indicia that indicates the force being applied to the heart anchor by the device as the secondary body is moved axially relative to the device body.

8. A method for securing heart anchors of a heart implant device, the method comprising:

providing the heart anchor positioning device of claim 1;

positioning the heart anchor in engagement with the first wall of the heart, the heart anchor being slidably coupled with the tension member so that the heart anchor may slide proximally and distally along a length of the tension member;

positioning a second anchor in engagement with the second wall of the heart, the second anchor being coupled with the tension member;

advancing the elongate shaft of the heart anchor positioning device over the tension member so that the distal end of the elongate shaft engages the heart anchor while the device body of the heart anchor positioning device is positioned outside of the body;

applying a desired anchor force between the tension member and the heart anchor via the heart anchor positioning device so that the second anchor provides a force urging the second wall toward the first wall and the heart anchor provides a force urging the first wall toward the second wall, wherein the heart anchor positioning device provides an indication of the anchor force applied to the heart anchor by the heart anchor positioning device; and

actuating a locking mechanism of the heart anchor positioning device to secure the heart anchor to the tension member to restrict proximal movement of the heart anchor along the tension member.

9. The method of claim 8, wherein actuating the locking mechanism of the heart anchor positioning device reconfigures the heart anchor from a variable force mode that allows the heart anchor to slide proximally and distally along the tension member to a set force mode that restricts proximal movement of the heart anchor along the tension member.

10. The method of claim 9, wherein actuating the locking mechanism of the heart anchor positioning device moves the anchor coupling mechanism axially relative to a pin positioned on the distal end of the elongate shaft of the heart anchor positioning device, wherein movement of the anchor coupling mechanism relative to the pin engages the pin with a cam component of the heart anchor.

11. The method of claim 8, further comprising:

advancing the heart anchor distally along the tension member with the heart anchor positioning device in a first mode of operation, the first mode of operation allowing the heart anchor positioning device to engage the heart anchor to urge the first wall toward the second wall without indicating the anchor force being applied by the heart anchor positioning device; and

applying the desired anchor force to the heart anchor with the heart anchor positioning device in a second mode of operation, the second mode of operation allowing the heart anchor positioning device to provide the indication of the anchor force applied to the heart anchor by the heart anchor positioning device.

12. The method of claim 11, further comprising actuating a mode button of the device body of the heart anchor positioning device to switch the heart anchor positioning device from the first mode of operation to the second mode of operation.

13. The method of claim 8, wherein the applied anchor force comprises a Ventricular Contractile Force (VCF) and an additional force comprises a force of between about 2N and about 6N.

14. The method of claim 8, wherein the applied anchor force comprises a Ventricular Contractile Force (VCF) and an additional force comprises a force of between about 3N and about 4N.

15. A system for securing heart anchors of a heart implant device comprising:

the heart anchor positioning device of claim 1;

the tension member having a first end and a second end;

the heart anchor slidably couplable with the tension member, the heart anchor having a variable force mode that allows the heart anchor to axially slide proximally and distally along the tension member and also having a set force mode that inhibits proximal movement of the heart anchor along the tension member, the heart anchor being configured for anchoring engagement with the second wall of the heart; and

a second anchor coupled with the tension member at the first end, the second anchor being configured for anchoring engagement with the first wall of the heart;

wherein the heart anchor positioning device is configured to switch the heart anchor from the variable force mode to the set force mode and vice versa.

16. The system of claim 15, wherein the heart anchor positioning device is operable in a first mode that allows the heart anchor positioning device to engage the heart anchor and apply an anchor force without providing an indication of the anchor force, and the heart anchor positioning device is operable in a second mode that allows the heart anchor positioning device to provide the indication of the anchor force applied to the heart anchor by the heart anchor positioning device.

17. The system of claim 15, further comprising:

a tissue penetrating device having an elongate shaft and a lumen extending between a proximal end and a distal end of the elongate shaft;

a first needle disposed within the lumen of the elongate shaft and extendable therefrom between a first configuration, in which the first needle is substantially aligned with an axis of the lumen, and a second configuration, in which the first needle curves away from the axis of the lumen; and

a second needle disposed within a lumen of the first needle and extendable therefrom to penetrate the first wall or second wall of the heart.

18. The system of claim 15, further comprising a cannula or trocar through which the elongate shaft of the heart anchor positioning device is inserted to engage a distal end of the heart anchor positioning device with the heart anchor while the device body of the heart anchor positioning device remains positioned outside the body.

19. The system of claim 18, wherein the tension member is inserted through the lumen of the elongate shaft to allow the heart anchor positioning device to advance over the tension member through the cannula or trocar.