Hybrid device for surgical aortic repair configured for adaptability of organs of various anatomical characteristics and method of using the same

• US 10,624,770 B2
• Filed: 07/10/2019
• Issued: 04/21/2020
• Est. Priority Date: 01/11/2015
• Status: Active Grant

• Current Assignee: Ascyrus Medical, LLC (Cryolife Incorporated)
• Original Assignee: Ascyrus Medical, LLC (Cryolife Incorporated)
• Inventors: Shahriari, Ali, Leopold, Eric
• Primary Examiner(s): Ho, Tan-Uyen T
• Assistant Examiner(s): Igboko, Chima U
• Application Number:
  US16/507,168
• Publication Number:
  US 20190328558A1
• Time in Patent Office: 286 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An assembly including a deployment device for deploying a stent device into an aorta of a patient is provided. The deployment device includes a rod translatable within an aorta of a patient and a first release wire configured for releasing one or more radially constraining members, wherein the radially constraining members are configured to constrain a diameter of the stent device. The stent device is at least partially permeable and engaged with the deployment device in an initial configuration, wherein a diameter and a length of the stent device in a deployed configuration can be altered by axial translation of the rod and releasing one or more of the radially constraining members by translation of the first release wire.

Claims

1. An assembly comprising:

a deployment device comprising;

a rod translatable within an aorta of a patient and having an operator end and a distal end;

one or more radially constraining members;

a first release wire configured for releasing the one or more radially constraining members, and

a stent device comprising;

a distal portion for being engageably received in the aortic arch of the patient and extending beyond the left subclavian artery when implanted;

a stent portion fluidly engaged with the distal portion, wherein the stent portion comprises an uncovered, braided stent member,

wherein the stent portion is configured to span a portion of the aortic arch to which the brachiocephalic trunk, left common carotid artery, and left subclavian artery attach when implanted in the aortic arch such that blood flows through the uncovered, braided stent member into the brachiocephalic trunk, left common carotid artery, and left subclavian artery;

a proximal portion fluidly engaged with the stent portion,

wherein the stent device is configured to be engaged with the deployment device so as to be deployed within the aorta of the patient in a deployed configuration while allowing a diameter and a length of the stent device to be varied to conform to that of the patient'"'"'s aortic anatomy;

wherein the stent device includes a collar engaged with the proximal portion, the collar configured for being selectively engaged with the aorta and being formed of a graft material,

wherein the stent device is engaged with the deployment device in an initial configuration, wherein the one or more radially constraining members are configured to constrain a diameter of the stent device, and

wherein the diameter and the length of the stent device in the deployed configuration can be altered by axial translation of the rod and releasing the one or more of the radially constraining members by translation of the first release wire, wherein the one or more radially constraining members comprise at least one slip joint and wrap around the stent portion at spaced-apart portions along a length of the stent portion extending from about a proximal end to about a distal end of the stent portion.

2. The assembly according to claim 1, wherein the deployment device includes a handle assembly for providing axial translation of the rod and defines a first outlet from which the first release wire extends, wherein the first release wire is configured for releasing the one or more radially constraining members, and includes a first cap selectively receivable by the first outlet, wherein the first release wire is engaged with the first cap.

3. The assembly according to claim 2, wherein the deployment device defines a second outlet from which a second release wire extends, wherein the second release wire is configured for releasing additional one or more radially constraining members.

4. The assembly according to claim 3, wherein the one or more radially constraining members are configured to release a first segment of the stent device, and the additional one or more radially constraining members are configured to release a second segment of the stent device.

5. The assembly according to claim 3, wherein the deployment device defines a third outlet through which a guidewire extends, wherein the rod defines a tip on the distal end that has an initially non-linear arrangement, and wherein advancement of the guidewire through the tip causes the tip to define a linear arrangement.

6. The assembly according to claim 5, further defining a stop member on the distal end of the rod for prohibiting movement of the stent device therebeyond.

7. The assembly according to claim 1, wherein the stent portion is a braided stent member and/or an uncovered, gridded pattern.

8. The assembly according to claim 1, wherein the stent device includes a biodegradable scaffold for engaging an anatomical feature of a patient.

9. The assembly according to claim 1, further comprising:

a proximal graft section engaged to the proximal portion of the stent device;

a distal graft section engaged to the distal portion of the stent device;

or

both the proximal graft section and the distal graft section,

wherein the proximal graft section, the distal graft section, or both are supported internally or externally by a metallic frame.

10. The assembly according to claim 1, wherein the one or more radially constraining members include at least one slip joint.