Distal Torque Component, Delivery System and Method of Using Same

• US 20190321207A1
• Filed: 06/06/2019
• Published: 10/24/2019
• Est. Priority Date: 10/31/2017
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Bahar, Nico, Garcia, Eduardo Alejandro, Rush, Scott L.
• Granted Patent: US 11,376,145 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/9662 the middle portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A delivery system and method for implanting a stent graft prostheses includes and employs a torque component at a distal end of the stent graft prosthesis, whereby following advancement of the stent graft to a surgical site in a constrained or partially constrained configuration, torque is applied to the torque component and, consequently, to the stent graft to rotationally align the stent graft about a longitudinal axis of the stent graft, followed by deployment of the stent graft in correct rotational alignment, and subsequent retraction of the delivery device from the deployed stent graft and the subject. The torque component includes a pushrod and at least two arms.

Claims

1. A delivery system for implanting a stent graft, comprising:

a) a longitudinal body defining a longitudinal axis and having a proximal handle and a distal handle;

b) a guidewire catheter having a proximal end and a distal end, and extending from the distal handle of the longitudinal body;

c) a stent graft extending about the guidewire catheter, the stent graft including

i) a luminal graft component, and

ii) a plurality of radial stents distributed longitudinally along the luminal graft component, at least one of the stents having struts that are joined to define proximal and distal apices;

d) a radial constraint at a stent graft extending about the guidewire catheter;

e) a torque component, including

i) a pushrod extending about the guidewire catheter and distally from the proximal handle, and

ii) at least two arms disposed radially about and extending distally from the pushrod, each arm being moveable from a constricted state to an expanded state, whereby the torque component exhibits radial expansion, and whereby application of torque force to the torque component by rotation of the proximal handle about the longitudinal axis causes the stent graft to rotate about the longitudinal axis.

2. The delivery system of claim 1, further including a hub linking the pushrod to the at least two arms.

3. The delivery system of claim 2, wherein at least a portion of the arms are articulated.

4. The delivery system of claim 1, wherein the arms are self-expanding from the constricted state to the expanded state.

5. The delivery system of claim 1, wherein each of the at least two arms, when viewed at an angle normal to the longitudinal axis of the longitudinal body, has a curvilinear shape in the expanded state.

6. The delivery system of claim 1, wherein the radial constraint includes at least one of a thread and wire combination, and a flexible sheath extending about the stent graft, whereby the stent graft can be released from constraint by withdrawing the wire from the thread or the flexible sheath from the stent graft.

7. The delivery system of claim 6, wherein the radial constraint includes both the thread and wire combination, and the flexible sheath extending about the stent graft, whereby the stent graft can be released from constraint by removing the flexible sheath in one stage, and the wire can be withdrawn from the thread in another stage.

8. The delivery system of claim 1, wherein at least one of the arms defines an opening at a distal end, wherein the stent graft defines an opening, and further including a suture secured to the opening and extending through the opening, extends from the opening, and further including a wire extending from the longitudinal body and through the suture to secure the stent graft to the arm, whereby retraction of the wire toward the handle releases the stent graft from the arm.

9. The delivery system of claim 1, further including an apex capture catheter extending distally from the distal end of the longitudinal body and about the guidewire catheter, the apex capture catheter being moveable between a first position and a second position, and an apex capture device having a distal capture component at a distal end of the catheter, and a proximal capture component at a distal end of the apex capture catheter, wherein the distal capture component and the proximal capture component together define an interior space that captures a proximal stent of the stent graft when the apex capture catheter is in the second position.

10. The delivery system of claim 1, wherein the radial constraint includes an introducer sheath extending about and radially constricting the torque component and the stent graft, the introducer sheath extending distally from the longitudinally body and being retractable from the stent graft and at least a portion of the torque component by at least one of retraction of the introducer sheath and advancement of the pushrod and guidewire catheter.

11. The delivery system of claim 1, further including a nose cone at the distal end of the guidewire catheter.

12. The delivery system of claim 1, wherein each arm has a cross section that has radial height less than a width at the cross section along at least a portion of a length of the at least one arm.

13. The delivery system of claim 1, wherein two arms are fixed to a distal end of the pushrod at a proximal end of each arm.

14. The delivery system of claim 13, wherein each of the two arms are evenly spaced relative to each other about the longitudinal axis of the pushrod.

15. The delivery system of claim 1, wherein three arms are fixed to a distal end of the pushrod at a proximal end of each arm.

16. The delivery system of claim 15, wherein each of the three arms are evenly spaced relative to each other about the longitudinal axis of the pushrod.

17. The delivery system of claim 1, wherein four arms are fixed to the distal end of the hub at the proximal end of each arm.

18. The delivery system of claim 17, wherein each of the four arms are evenly spaced relative to each other about the longitudinal axis of the longitudinal body.

19. The delivery system of claim 1, further including a stent graft having a proximal end, and a distal end extending about the arms, wherein the stent graft is radially constrained by the radial constraint.

20. The delivery system of claim 19, wherein the stent graft includes a suture that secures at least a portion of the arms from rotational movement relative to the stent graft, whereby the torque component is substantially prevented from rotating within the stent graft before deployment.

21. The delivery system of claim 1, wherein the at least two arms each independently have a length in a range of between about one inch and about five inches.

22. The delivery system of claim 1, further including a stent graft, wherein the stent graft includes a stent component and a graft component.

23. The delivery system of claim 22, wherein the arms of the torque component extend outside the stent graft.

24. The delivery system of claim 22, wherein the stent graft defines at least one opening, and wherein at least one of the arms of the torque component extends through the opening.

25. The delivery system of claim 24, wherein the at least one of the arms of the torque component extends distally from inside the stent graft through the opening to outside the stent graft.

26. The delivery system of claim 25, wherein at least one of the arms of the torque component extends distally from outside the stent graft through the opening to inside the stent graft.

27. The delivery system of claim 26, wherein at least one of the arms of the torque component extend distally through two openings in the stent graft.

28. The delivery system of claim 22, wherein the stent graft includes at least one stent component secured within the graft component of the stent graft, and wherein at least one of the arms of the torque component extends between the stent component and the graft component.

29. The delivery system of claim 22, wherein at least one stent component is secured outside the graft component and wherein at least one of the arms of the torque component extends between the stent component and the graft component.

30. The delivery system of claim 1, wherein the longitudinal body includes a handle body extending from the proximal handle to the distal handle, wherein the proximal handle is fixed to the pushrod and can rotate about the handle body to thereby rotate the torque component.

31. The delivery system of claim 30, further including a track at the longitudinal body, and an introducer sheath extending about and constraining the torque component and the stent graft, the introducer sheath extending distally from the track being retractable from the stent graft and the torque component by retraction of the introducer sheath, and a lead screw nut extending about the handle body and threadably engaged with the track, whereby the track and the introducer sheath can be retracted by rotation of the lead screw nut about the longitudinal body, or by retraction of the lead screw nut longitudinally along the handle body.

32. A delivery system for implanting a stent graft, comprising:

a) a proximal handle;

b) a guidewire catheter extending from the proximal handle, and having a proximal end at the proximal handle and a distal end;

c) a nose cone fixed at the distal end of the guidewire catheter;

d) a stent graft extending about the guidewire catheter, the stent graft including,

i) a luminal graft component having an outside surface, an inside surface, a proximal open end, a distal open end, and defining a lumen, and

ii) a plurality of stents extending longitudinally along the luminal wall;

e) a radial constraint that radially constrains the stent graft, extending about the guidewire catheter, wherein the release of the radial constraint allows radial expansion of the stent graft to the thereby at least partially deploy the stent graft; and

f) a torque component extending about the guidewire catheter, the torque component

including

i) a pushrod extending about the guidewire catheter and distally from the proximal handle, and

ii) at least two arms disposed radially about and extending distally from the pushrod, each arm being moveable from a constricted state to an expanded state, whereby the torque component exhibits radial expansion, and whereby application of torque force to the torque component by rotation of the proximal handle about the longitudinal axis causes the stent graft to rotate about the longitudinal axis.

33. A method of implanting a stent graft at an aneurysm site of a subject, comprising the steps of:

a) directing a stent graft to an aneurysm site of the subject, the stent graft being held in a constricted position by a radial constraint, and extending circumferentially about a guidewire catheter that extends distally from a distal handle of a longitudinal body of a delivery device and is within the stent graft, the stent graft having a proximal end and a distal end, and wherein the distal end of the stent graft is rotationally fixed relative to a torque component, the torque component including a pushrod extending about the guidewire catheter and at least two arms and extending distally and radially from the pushrod, each arm being moveable from a constricted state to an expanded state, whereby the torque component exhibits radial expansion;

b) rotating a proximal handle of the longitudinal body to thereby rotate the pushrod and rotationally align the stent graft within the aneurysm site;

c) retracting the radial constraint, thereby releasing the stent graft at the aneurysm site; and

d) retracting the guidewire catheter and the torque component from the subject, thereby implanting the stent graft at the aneurysm site of the subject.

34. A method of implanting a stent graft at an aneurysm site of a subject, comprising the steps of:

a) advancing a stent graft that is maintained in a constricted state by a radial constraint to an aneurysm site;

b) rotationally aligning the stent graft by rotation of the stent graft with at least partial assistance of a torque component at a distal end of the stent graft; and

c) removing the radial constraint from the stent graft, thereby implanting the stent graft at the aneurysm site.

35. A delivery system for implanting a stent graft, comprising:

a) a proximal handle;

b) a guidewire catheter extending from the proximal handle, and having a proximal end at the proximal handle and a distal end;

c) a nose cone fixed at the distal end of the guidewire catheter;

d) a stent graft extending about the guidewire catheter, the stent graft including,

i) a luminal graft component having an outside surface, an inside surface, a proximal open end, a distal open end, and defining a lumen, and

ii) a plurality of stents extending longitudinally along the luminal graft component;

e) a radial constraint at the stent graft, the radial constraint including at least one ligature traversing at least a portion of the struts of the stents of the stent graft, the ligature including ends that, when linked, at least partially radially constrict the stents;

f) a wire extending longitudinally along the luminal graft component and linking the ligature ends, thereby radially constricting at least a portion of the stents of the stent graft, whereby retraction of the wire from the ends of the at least one ligature releases the radial constriction by the at least one ligature; and

g) a torque component extending about the guidewire catheter, the torque component, including

i) a pushrod extending about the guidewire catheter and distally from the proximal handle, and

ii) at least two arms disposed radially about and extending distally from the pushrod, each arm being moveable from a constricted state to an expanded state, whereby the torque component exhibits radial expansion, and whereby application of torque force to the torque component by rotation of the proximal handle about the longitudinal axis causes the stent graft to rotate about the longitudinal axis.

36. A delivery system for implanting a stent graft, comprising:

a) a proximal handle;

b) a guidewire catheter extending from the proximal handle, and having a proximal end at the proximal handle and a distal end;

c) a nose cone fixed at the distal end of the guidewire catheter;

d) a stent graft extending about the guidewire catheter, the stent graft including,

i) a luminal graft component having an outside surface, an inside surface, a proximal open end, a distal open end, and defining a lumen,

ii) a plurality of stents extending longitudinally along the luminal graft component; and

iii) a bare stent at the proximal open end of the luminal graft component, the bare stent including struts defining proximal and distal apices, wherein the bare stent is fixed to the luminal graft component at the distal apices of the bare stent;

e) a radial constraint at the stent graft, the radial constraint including at least one ligature traversing at least a portion of the struts of the stents of the stent graft, the ligature including ends that, when linked, at least partially radially constrict the stents;

f) a wire extending longitudinally along the luminal graft component and linking the ligature ends, thereby radially constricting at least a portion of the stents of the stent graft, whereby retraction of the wire from the ends of the at least one ligature releases the radial constriction by the at least one ligature;

g) an apex capture device at the distal end of the guidewire catheter, the apex capture device releasably capturing the proximal apices of the bare stent; and

h) a torque component extending about the guidewire catheter, the torque component including

i) a pushrod extending about the guidewire catheter and distally from the proximal handle, and

ii) at least two arms disposed radially about and extending distally from the pushrod, each arm being moveable from a constricted state to an expanded state, whereby the torque component exhibits radial expansion, and whereby application of torque force to the torque component by rotation of the proximal handle about the longitudinal axis causes the stent graft to rotate about the longitudinal axis.

37. A method of implanting a stent graft at an aneurysm of a subject, comprising the steps of:

a) directing a stent graft to an aneurysm of the subject, the stent graft including a luminal graft component and a plurality of radial stents distributed longitudinally along the luminal graft component, at least one of the stents having struts that are joined to define proximal and distal apices, the stent graft being held in a constrained position by a radial constraint, the radial constraint including at least one ligature traversing at least a portion of the struts of the stents of the stent graft, the ligature including ends that, when linked, at least partially radially constrict the stents, the radial constraint also including a wire extending longitudinally along the luminal graft component and linking the ligature ends and thereby radially constricting at least a portion of the stents of the stent graft, whereby retraction of the wire from the ends of the at least one ligature releases the radial constriction by the at least one ligature; and

extending circumferentially about a guidewire catheter that extends distally from a distal handle of a longitudinal body of a delivery device and is within the stent graft, the stent graft having a proximal end and a distal end, and wherein the distal end of the stent graft is rotationally fixed relative to a torque component fixed to a pushrod that extends proximally from and circumferentially about the guidewire catheter and within the stent graft;

b) rotating a proximal handle of the longitudinal body to thereby rotate the pushrod and rotationally align the stent graft within the aneurysm site;

c) retracting the radial constraint, thereby releasing the stent graft at the aneurysm site; and

d) retracting the guidewire catheter and the torque component from the subject, thereby implanting the stent graft at the aneurysm site of the subject.

38. A delivery system for implanting a stent graft, comprising:

a) a longitudinal body defining a longitudinal axis and having a proximal handle and a distal handle;

b) a guidewire catheter having a proximal end and a distal end, and extending from the distal handle of the longitudinal body;

c) a stent graft extending about the guidewire catheter, the stent graft including

i) a luminal graft component having an outside surface, an inside surface, a proximal surface, a proximal open end, a distal open end, and defining a lumen, and,

ii) a plurality of stents extending longitudinally along the luminal graft component;

d) a radial constraint at a stent graft, the radial constraint including,

i) a control rod extending longitudinally along the luminal graft component, and

ii) at least one ligature traversing at least one of the stents controllably and releasably fixed to the control rod, whereby control of the ligature at the control rod radially constricts the traversed stent; and

e) a torque component, including

i) a pushrod extending about the guidewire catheter and distally from the proximal handle, and

ii) at least two arms disposed radially about and extending distally from the pushrod, each arm being moveable from a constricted state to an expanded state, whereby the torque component exhibits radial expansion, and whereby application of torque force to the torque component by rotation of the proximal handle about the longitudinal axis causes the stent graft to rotate about the longitudinal axis.