Systems for deploying an expandable cardiac shunt

• US 10,039,905 B1
• Filed: 10/27/2016
• Issued: 08/07/2018
• Est. Priority Date: 10/07/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taft, Robert C., Karapetian, Emil, Hernandez, Cristobal R.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/335,891
• Time in Patent Office: 649 Days
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0113 : Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 25/0194 : Tunnelling catheters
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/06 : Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 27/002 : Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 27/008 : pre-shaped, for use in the urethral or ureteral tract

Abstract

Disclosed are cardiac shunts and method of delivery, and in particular, to a shunt to reduce elevated left atrial pressure (LAP). The methods include forming a puncture hole between the left atrium and the coronary sinus, widening the puncture hole, and placing an expandable shunt within the widened puncture hole. A first catheter having a side-extending needle may be used to form a puncture into the left atrium. A second catheter extends along a guidewire and an expandable shunt with distal and proximal flanges is expelled therefrom into the puncture. The shunt defines a blood flow passage therethrough that permits shunting of blood from the left atrium to the coronary sinus when the LAP is elevated. The shunt is desirable formed of a super-elastic material and manipulated with control rods. The shunt defines a tilted flow tube that facilitates collapse into the catheter.

Claims

1. A system for deploying an expandable shunt into a puncture wound in a tissue wall to maintain an opening therebetween, the wall defining a reference plane, comprising:

the expandable shunt comprising, in an expanded state;

a central flow tube defining a central axis therethrough;

distal flanges attached to a first axial end of the central flow tube; and

proximal flanges attached to a second axial end of the central flow tube opposite the first end;

a delivery catheter having a proximal handle, an outer sheath surrounding an inner sheath, the shunt being mounted in a collapsed configuration on the inner sheath with the outer sheath surrounding and maintaining the shunt in a collapsed state with the proximal flanges oriented toward the handle, and a pair of actuating rods extending from the handle distally through the inner sheath each of which engages one of the proximal flanges of the shunt, the actuating rods being linearly slidable within the inner sheath;

a puncture catheter having a proximal handle, an elongated flexible body having a distal tip, a guidewire lumen extending through the body from the handle to the distal tip, and a needle lumen extending through the body from the handle to a side port located near the distal tip; and

an elongated puncture sheath having a lumen and an elongated needle having a sharp tip sized to fit through the puncture sheath lumen such that the sharp tip projects therefrom, the puncture sheath being sized to pass through the needle lumen of the puncture catheter and project out of the side port to form a puncture in a tissue wall.

2. The system of claim 1, further including an expandable member sized to pass through the needle lumen and project out of the side port into the puncture, the expandable member being radially expandable to widen the puncture.

3. The system of claim 1, wherein in the shunt there are two distal flanges formed by struts and extending away from one another in opposite longitudinal directions, and there are two proximal flanges formed by struts and extending away from one another in opposite longitudinal directions and in the same directions as the distal flanges, wherein each proximal flange parallels one of the distal flanges to form a clamping pair of flanges with a gap therebetween sized to clamp onto the tissue wall.

4. The system of claim 3, wherein each clamping pair of flanges includes flanges of different lengths.

5. The system of claim 3, wherein when the shunt expands a first flange in each clamping pair of flanges rotates outward more than 90°

and a second flange in the same clamping pair of flanges rotates outward less than 90°

.

6. The system of claim 1, wherein in the shunt the central flow tube is defined by an opposed pair of lateral side walls formed by struts extending between an opposed pair of end walls formed by struts, the central flow tube defining a central axis therethrough angled from a reference axis extending perpendicular through the reference plane.

7. The system of claim 5, wherein the shunt is mounted in its collapsed configuration within a recess near a distal end of the inner sheath with the central axis therethrough coinciding with a longitudinal axis of the inner sheath at the recess.

8. The system of claim 1, further including an expandable anchoring member located on the flexible body opposite the side port.

9. The system of claim 8, further including a pair of radiopaque markers located distal and proximal to the expandable anchoring member on the side port side of the flexible body.

10. The system of claim 1, wherein the puncture catheter proximal handle includes an advancer for displacing the puncture sheath and a locking nut that fixes the puncture sheath relative to the handle.

11. A system for deploying an expandable shunt into a puncture wound in a tissue wall to maintain an opening therebetween, the wall defining a reference plane, comprising:

the expandable shunt comprising, in an expanded state;

a central flow tube defining a central axis therethrough;

distal flanges attached to a first axial end of the central flow tube; and

proximal flanges attached to a second axial end of the central flow tube opposite the first end;

a delivery catheter having a proximal handle, an outer sheath surrounding an inner sheath, the shunt being mounted in a collapsed configuration on the inner sheath with the outer sheath surrounding and maintaining the shunt in a collapsed state with the proximal flanges oriented toward the handle, and a pair of actuating rods extending from the handle distally through the inner sheath each of which engages one of the proximal flanges of the shunt, the actuating rods being linearly slidable within the inner sheath;

a puncture catheter having a proximal handle, an elongated flexible body having a distal tip, a guidewire lumen extending through the body from the handle to the distal tip, and a needle lumen extending through the body from the handle to a side port located near the distal tip, the puncture catheter further including an expandable anchoring member located on the flexible body opposite the side port; and

an elongated puncture sheath sized to pass through the needle lumen of the puncture catheter and project out of the side port to form a puncture in a tissue wall.

12. The system of claim 11, wherein the elongated puncture sheath has a lumen and an elongated needle having a sharp tip sized to fit through the puncture sheath lumen such that the sharp tip projects therefrom.

13. The system of claim 11, further including an expandable member sized to pass through the needle lumen and project out of the side port into the puncture, the expandable member being radially expandable to widen the puncture.

14. The system of claim 11, wherein in the shunt there are two distal flanges formed by struts and extending away from one another in opposite longitudinal directions, and there are two proximal flanges formed by struts and extending away from one another in opposite longitudinal directions and in the same directions as the distal flanges, wherein each proximal flange parallels one of the distal flanges to form a clamping pair of flanges with a gap therebetween sized to clamp onto the tissue wall.

15. The system of claim 13, wherein each clamping pair of flanges includes flanges of different lengths.

16. The system of claim 13, wherein when the shunt expands a first flange in each clamping pair of flanges rotates outward more than 90°

and a second flange in the same clamping pair of flanges rotates outward less than 90°

.

17. The system of claim 11, wherein in the shunt the central flow tube is defined by an opposed pair of lateral side walls formed by struts extending between an opposed pair of end walls formed by struts, the central flow tube defining a central axis therethrough angled from a reference axis extending perpendicular through the reference plane.

18. The system of claim 15, wherein the shunt is mounted in its collapsed configuration within a recess near a distal end of the inner sheath with the central axis therethrough coinciding with a longitudinal axis of the inner sheath at the recess.

19. The system of claim 11, further including a pair of radiopaque markers located distal and proximal to the expandable anchoring member on the side port side of the flexible body.

20. The system of claim 11, further including an elongated puncture sheath having a lumen and an elongated needle having a sharp tip sized to fit through the puncture sheath lumen such that the sharp tip projects therefrom, the puncture sheath being sized to pass through the needle lumen and project out of the side port to form a puncture in a tissue wall, wherein the puncture catheter proximal handle includes an advancer for displacing the puncture sheath and a locking nut that fixes the puncture sheath relative to the handle.