Cardiac tissue penetrating devices, methods, and systems for treatment of congestive heart failure and other conditions

• US 10,314,498 B2
• Filed: 05/20/2014
• Issued: 06/11/2019
• Est. Priority Date: 05/24/2013
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Van Bladel, Kevin, Moshe, Meir, Annest, Lon
• Primary Examiner(s): Dorna, Carrie R
• Application Number:
  US14/282,849
• Publication Number:
  US 20140350417A1
• Time in Patent Office: 1,848 Days
• CPC Class Codes: A61B 1/0058 using shape-memory elements
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall

Abstract

According to one embodiment, a tissue penetrating device includes an elongate shaft having a proximal end, a distal end, and a lumen extending there between. A first needle is disposed within the lumen of the elongate shaft and is extendable therefrom between a first configuration and a second configuration. In the first configuration, the first needle is disposed within the elongate shaft'"'"'s lumen and is substantially aligned with an axis of the lumen. In the second configuration, the first needle extends distally of the elongate shaft'"'"'s distal end and bends away from the lumen'"'"'s axis. A second needle is disposed within a lumen of the first needle and is extendable therefrom when the first needle is positioned in the first configuration and when the first needle is positioned in the second configuration. The second needle may be extended from the first needle to penetrate tissue of a patient.

Claims

1. A tissue penetrating device comprising:

an elongate shaft having a proximal end and a distal end and a lumen extending between the proximal end and the distal end, wherein the proximal end is positionable outside of a patient'"'"'s body and the distal end is positionable within the patient'"'"'s body;

a first needle disposed within the lumen of the elongate shaft and extendable distally of the elongate shaft'"'"'s distal end between a first orientation and a second orientation, the first needle having a proximal end and a distal end with a lumen extending between the proximal end and the distal end, wherein in the first orientation the first needle is disposed within the elongate shaft'"'"'s lumen and is substantially aligned with an axis of the elongate shaft'"'"'s lumen, and wherein in the second orientation the first needle is extended distally of the elongate shaft'"'"'s distal end and bends away from the axis of the lumen; and

a second needle disposed within the first needle'"'"'s lumen, the second needle being extendable distally from a distal tip of the first needle when the first needle is positioned in the first orientation and being extendable distally from the distal tip of the first needle when the first needle is positioned in the second orientation so as to penetrate tissue of a patient, the second needle being retractable within the lumen of the first needle subsequent to penetration of the tissue so that the second needle is fully disposed within the first needle'"'"'s lumen;

wherein when the second needle is extended distally of the distal tip of the first needle, a distal end of the second needle is coaxially aligned with the distal tip of the first needle;

wherein the first needle is made of a flexible shape-memory material having a preconfigured bend or curve such that the first needle bends or curves from the first orientation to the second orientation as the first needle is extended distally of the elongate shaft'"'"'s distal end; and

wherein the second needle comprises a proximal end and an open distal end with a lumen extending between the proximal end and the open distal end such that a guidewire is insertable through the lumen and through the open distal end of the second needle.

2. The tissue penetrating device of claim 1, wherein the second needle is configured to measure or monitor fluid pressure within the patient'"'"'s body.

3. The tissue penetrating device of claim 2, wherein the fluid pressure is measured or monitored so as to determine a location within a heart chamber of the patient.

4. The tissue penetrating device of claim 1, further comprising a tool body positioned at the proximal end of the elongate shaft, the tool body being configured to be grasped by a physician to enable the physician to extend the first needle and the second needle to penetrate the patient'"'"'s tissue.

5. The tissue penetrating device of claim 4, wherein the tool body comprises a first trigger member that is slidable axially along the tool body to extend and retract the first needle relative to the elongate shaft'"'"'s distal end.

6. The tissue penetrating device of claim 5, wherein the tool body further comprises a second trigger member that is operable independent of the first trigger member, the second trigger member being slidable axially along the tool body to extend and retract the second needle relative to the first needle.

7. The tissue penetrating device of claim 4, wherein the tool body comprises a spring trigger mechanism that causes the first needle or the second needle to rapidly deploy distally upon actuation of the spring trigger mechanism.

8. The tissue penetrating device of claim 1, wherein the distal end of the elongate shaft comprises a locking mechanism that is couplable with an attachment device that is removably attachable to the patient'"'"'s tissue.

9. The tissue penetrating device of claim 1, wherein when in the second orientation the first needle is bendable away from the axis of the lumen by between 45 and 210 degrees.

10. The tissue penetrating device of claim 1, wherein the distal end of the first needle or second needle comprises a pressure transducer or is configured to monitor fluid pressure.

11. The tissue penetrating device of claim 1, wherein the elongate shaft comprises a catheter.

12. A method of penetrating tissue of a patient, the method comprising:

providing a tissue penetrating device comprising;

an elongate shaft having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end;

a first needle disposed within the lumen of the elongate shaft and extendable distally of the elongate shaft'"'"'s distal end between a first orientation and a second orientation, the first needle having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; and

a second needle disposed within the first needle'"'"'s lumen and extendable therefrom;

advancing the first needle distally of the elongate shaft'"'"'s distal end so as to position the first needle'"'"'s distal end adjacent the patient'"'"'s tissue, wherein the first needle bends away from an axis of the elongate shaft'"'"'s lumen as the first needle extends distally of the elongate shaft'"'"'s distal end;

advancing the second needle distally of a distal tip of the first needle so as to penetrate the patient'"'"'s tissue with the second needle; and

advancing the first needle over the second needle and through the patient'"'"'s tissue so that the second needle is retracted and fully disposed within the first needle'"'"'s lumen;

wherein when the second needle is extended distally of the distal tip of the first needle, a distal end of the second needle is coaxially aligned with the distal tip of the first needle; and

wherein the first needle is made of a flexible shape-memory material having a preconfigured bend or curve such that the first needle bends or curves from the first orientation to the second orientation as the first needle is extended distally of the elongate shaft'"'"'s distal end; and

wherein in the second orientation, the first needle has a straight section that extends from the elongate shaft'"'"'s distal end and that is axially aligned with the elongate shaft and a curved section that extends between the straight section and the distal end of the first needle.

13. The method of claim 12, wherein the second needle comprises a proximal end, a distal end, and a lumen extending between the proximal end, and wherein the method further comprises inserting a guidewire through the lumen of the second needle and into the patient'"'"'s body.

14. The method of claim 12, wherein advancing the first needle comprises actuating a first trigger mechanism of a tool body, the tool body being positioned at the proximal end of the elongate shaft and being configured to be operated by a physician.

15. The method of claim 14, wherein advancing the second needle comprises actuating a second trigger mechanism of the tool body, the second trigger mechanism being operable independent of the first trigger mechanism.

16. The method of claim 15, wherein the first trigger mechanism or the second trigger mechanism comprises a spring trigger mechanism that causes the first needle or the second needle to deploy rapidly upon actuation of the spring trigger mechanism.

17. The method of claim 12, wherein the elongate shaft comprises a catheter.

18. A method of penetrating cardiac tissue for treatment of congestive heart failure, the method comprising:

positioning a distal end of an elongate shaft adjacent an external wall of a patient'"'"'s heart while a proximal end of the elongate shaft is positioned outside of the patient'"'"'s body;

advancing a needle distally of a distal end of the elongate shaft and through the external wall, the needle being disposed centrally within a lumen of a sleeve;

advancing the sleeve distally of the distal end of the elongate shaft and over the needle through the external wall so that the needle is retracted and fully disposed within the lumen of the sleeve, the sleeve being initially disposed within a lumen of the elongate shaft and coaxially aligned with the needle prior to advancement of the sleeve through the external wall;

advancing the sleeve distally of the external wall to position the sleeve and needle adjacent a septal wall of the patient'"'"'s heart, wherein the sleeve is advanced adjacent the septal wall with the needle fully disposed within the lumen of the sleeve, and wherein the sleeve comprises a flexible shape-memory material having a preconfigured bend or curve such that the sleeve curves away from an axis of the elongate shaft'"'"'s lumen as the sleeve is advanced distally of the distal end of the elongate shaft and distally of the external wall; and

advancing the needle distally of a distal tip of the sleeve and through the septal wall of the patient'"'"'s heart;

wherein when the needle is advanced distally of the distal tip of the sleeve, a distal end of the needle is coaxially aligned with the distal tip of the sleeve; and

wherein when the sleeve is fully advanced distally of the distal end of the elongate shaft, the sleeve has a straight section that extends from the elongate shaft'"'"'s distal end and that is axially aligned with the elongate shaft'"'"'s lumen and a curved section that extends between the straight section and the distal tip of the sleeve.

19. The method of claim 18, further comprising:

inserting a guidewire through a lumen of the needle and through the external wall and septal wall so that the guidewire is positioned within a chamber of the heart; and

joining the guidewire with a snare that is inserted within the chamber of the heart along a path different than the guidewire, wherein joining the guidewire and the snare couples a path of the guidewire and the snare.

20. The method of claim 19, further comprising advancing a first anchor and an elongate tension member into the chamber along the joined paths, wherein the first anchor is positioned distally of the septal wall and wherein the tension member extends from distally of the septal wall, through the external wall and septal wall, and outside the patient'"'"'s body.

21. The method of claim 20, further comprising:

coupling a second anchor to the tension member;

advancing the second anchor along the tension member to a position proximate the external wall; and

applying tension between the first anchor and the second anchor so that the anchors urge the septal wall and external wall to engage.

22. The method of claim 18, wherein the sleeve comprises an outer needle that is slidable over the needle and disposed within the elongate shaft'"'"'s lumen.

23. The method of claim 18, further comprising sensing a pressure with a distal end of the needle or sleeve.

24. The method of claim 18, wherein the elongate shaft comprises a catheter.