IP Library Granted Patent US 12,303,412
Granted Patent B2
US 12,303,412 · App. 18/232,900 · Granted May 20, 2025

Orientable implantable device and method

Inventor: Daniel Ezra Walzman (Teaneck, NJ)
A61F2/954A61B17/00234A61B17/12113A61B17/12118A61F2/856A61F2/90A61F2/95A61F2/9517A61F2/958A61F2/966A61B2017/00292A61B17/0057A61B2017/1205A61B17/12172A61B2090/3966A61F2002/061A61F2002/823A61F2002/9534A61F2002/9583A61F2230/0004A61F2230/0017A61F2230/0023A61F2250/0023A61F2250/0024A61F2250/0098A61M2025/0008A61M25/0097
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Quick Facts
Patent No.
US 12,303,412
App. No.
18/232,900
Granted
May 20, 2025
Kind
B2
Abstract

An intravascular system having a first catheter having a first non-circular transverse cross-sectional configuration and a first delivery device configured for insertion into the lumen of the catheter. The first delivery device includes an implantable medical device and an elongated member supporting the first medical device such that the first elongated member and the first medical device are movable through the lumen of the first catheter. The first elongated member has a second non-circular transverse cross-sectional configuration corresponding to the first non-circular transverse cross-sectional configuration to thereby inhibit rotation of the first elongated member within the catheter and control orientation of the first medical device relative to the catheter.

Claims (68)

1. An intravascular system for treating a blood vessel comprising:

an elongated member defining a first lumen and a second lumen;

a first stent having a fenestration;

a second medical device configured for insertion into the second lumen to access a side branch of the blood vessel through a side hole and through the fenestration in the first stent;

wherein the second medical device includes a pusher, and the second lumen of the elongated member defines a non-circular transverse cross-sectional configuration and an outer surface of the pusher defines a non-circular transverse cross-sectional configuration corresponding to the non-circular transverse cross-sectional configuration of the second lumen so as to inhibit rotation of the pusher within the second lumen to thereby control orientation of the pusher relative to the elongated member.

2. The intravascular system of claim 1 , further comprising at least one circumferential marker along at least one of the lumens of the elongated member, second medical device, or pusher to mark corresponding rotational position.

3. An intravascular system for treating a blood vessel comprising:

a first medical device including:

an elongated member defining:

a first lumen extending from a proximal hole to a distal hole; and

a second lumen extending in generally parallel relation to the first lumen at least in a portion of the second lumen, the second lumen extending from near the proximal hole to a side-hole located proximally of the distal hole;

a first inflatable member supported by the elongated member and including a first fenestration; and

a first stent supported by the first inflatable member, the first stent configured to be deployed upon inflation of the first inflatable member, wherein the first stent includes a second fenestration; and

a second medical device configured for insertion into the second lumen to access a side branch or a side lesion of the blood vessel through the side-hole, through the first fenestration in the first inflatable member, and through the second fenestration in the first stent; and

wherein the second lumen defines a non-circular transverse cross-sectional configuration and an outer surface of the second medical device defines a non-circular transverse cross-sectional configuration so as to inhibit rotation of the second medical device.

4. The intravascular system of claim 3 , wherein the proximal hole is at a proximal end of the elongated member for an over-the-wire configuration.

5. The intravascular system of claim 3 , wherein the proximal hole is spaced from a proximalmost end of the elongated member for a rapid-exchange configuration.

6. The intravascular system of claim 3 , wherein the second medical device includes:

a body configured for connection to the first medical device and passage through the second lumen of the first medical device;

a wire configured for passage through the second lumen through the first and second fenestrations and into the side branch or the side lesion, wherein a distal hole of the second medical device can be advanced from the second lumen, through the side-hole, first and second fenestrations, and into the side branch or the side lesion over the wire.

7. The intravascular system of claim 3 , wherein the second medical device includes: a second stent supported on a pusher such that the pusher and the second stent are insertable into the side branch or the side lesion of the blood vessel through the first medical device via the second lumen and the side hole.

8. The intravascular system of claim 7 , wherein the second stent is expandable in the side branch of the blood vessel.

9. The intravascular system of claim 3 , wherein the non-circular transverse cross-sectional configuration of the second medical device corresponds to the non-circular transverse cross-sectional configuration of the second lumen.

10. The intravascular system of claim 3 , wherein the first stent has a variable porosity along a length.

11. The intravascular system of claim 3 , wherein the second medical device is a sac configured for placement in an outpouching.

12. The intravascular system of claim 3 , wherein the second medical device includes a second stent configured to be deployed after the first stent has been deployed and the elongated member removed.

13. An intravascular system for treating a blood vessel comprising:

a first medical device including:

an elongated member defining:

a first lumen extending from a proximal hole to a distal hole; and

a second lumen extending in generally parallel relation to the first lumen at least in a portion of the second lumen, the second lumen extending from near the proximal hole to a side-hole located proximally of the distal hole;

a first inflatable member supported by the elongated member and including a first fenestration; and

a first stent supported by the first inflatable member, the first stent configured to be deployed upon inflation of the first inflatable member, wherein the first stent includes a second fenestration; and

a second medical device configured for insertion into the second lumen to access a side branch of the blood vessel through the side-hole, through the first fenestration in the first inflatable member, and through the second fenestration in the first stent;

wherein the first lumen has a noncircular shape and at least one marker corresponding to a position of the side-hole.

14. An intravascular system for treating a blood vessel comprising:

a first medical device including:

an elongated member defining:

a first lumen extending from a proximal hole to a distal hole; and

a second lumen extending in generally parallel relation to the first lumen at least in a portion of the second lumen, the second lumen extending from near the proximal hole to a side-hole located proximally of the distal hole;

a first inflatable member supported by the elongated member and including a first fenestration; and

a first stent supported by the first inflatable member, the first stent configured to be deployed upon inflation of the first inflatable member, wherein the first stent includes a second fenestration; and

a second medical device configured for insertion into the second lumen to access a side branch of the blood vessel through the side-hole, through the first fenestration in the first inflatable member, and through the second fenestration in the first stent;

wherein the second medical device is configured as a guidewire, the guidewire being insertable into the side branch of the blood vessel through the side-hole in the first medical device, the guidewire having a non-circular outer shape along at least a portion of its length, and the guidewire has at least one marker to define a circumferential position.

15. The intravascular system of claim 14 , wherein the guidewire further comprises at least one segment comprising at least two wires wherein the at least two wires are configured such that when detached a detachment zone will splay and apply pressure to side walls of the vessel, and thereby help anchor the guidewire in place, and minimize longitudinal movements and rotation.

16. An intravascular system for treating a blood vessel comprising:

a first medical device including:

an elongated member defining:

a first lumen extending from a proximal hole to a distal hole; and

a second lumen extending in generally parallel relation to the first lumen at least in a portion of the second lumen, the second lumen extending from near the proximal hole to a side-hole located proximally of the distal hole;

a first inflatable member supported by the elongated member and including a first fenestration; and

a first stent supported by the first inflatable member, the first stent configured to be deployed upon inflation of the first inflatable member, wherein the first stent includes a second fenestration; and

a second medical device configured for insertion into the second lumen to access a side branch of the blood vessel through the side-hole, through the first fenestration in the first inflatable member, and through the second fenestration in the first stent;

a guidewire;

wherein the second medical device is configured as a balloon catheter, the balloon catheter including:

a body;

a second inflatable member supported by the body and a second stent configured to be supported by the second inflatable member, the second stent configured to be deployed upon inflation of the second inflatable member; and

wherein the body of the balloon catheter defines a lumen configured to receive the guidewire such that the balloon catheter is insertable into the side branch of the blood vessel over the guidewire;

wherein the lumen of the balloon catheter defines a non-circular transverse cross-sectional configuration, and an outer surface of a majority of the guidewire, including a proximal end configured to be outside the patient's body, defines a non-circular transverse cross-sectional configuration to thereby inhibit rotation of the guidewire within the lumen of the balloon catheter and at least one marker on at least one of the lumen of the balloon catheter or outer surface of the guidewire to mark a particular circumferential rotational position.

17. An intravascular system for treating a blood vessel comprising:

a first medical device including:

an elongated member defining:

a first lumen extending from a proximal hole to a distal hole; and

a second lumen extending in generally parallel relation to the first lumen at least in a portion of the second lumen, the second lumen extending from near the proximal hole to a side-hole located proximally of the distal hole;

a first inflatable member supported by the elongated member and including a first fenestration; and

a first stent supported by the first inflatable member, the first stent configured to be deployed upon inflation of the first inflatable member, wherein the first stent includes a second fenestration; and

a second medical device configured for insertion into the second lumen to access a side branch of the blood vessel through the side-hole, through the first fenestration in the first inflatable member, and through the second fenestration in the first stent;

wherein an outer diameter of the second medical device is substantially similar to the second lumen of the first medical device to thereby inhibit rotation of the second medical device and a second stent and control orientation of the second stent relative to the vascular anatomy and the first medical device, and at least one rotational marker on at least one of the lumens or outer surfaces to mark a particular circumferential rotational position.

Continuity (8)
Continuation 17515756 · Nov 1, 2021
Continuation In Part 17246853 · May 3, 2021
Continuation In Part 16888813 · May 31, 2020
Continuation 16852488 · Apr 19, 2020
Provisional Application 63109387 · Nov 4, 2020
Provisional Application 62921574 · Jun 25, 2019
Provisional Application 62921378 · Jun 12, 2019
Related Publication 20250049597A1 · Feb 13, 2025
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