Method of treating a patient using a retrievable transcatheter prosthetic heart valve

• US 10,449,040 B2
• Filed: 10/19/2016
• Issued: 10/22/2019
• Est. Priority Date: 05/05/2004
• Status: Active Grant

• Current Assignee: Speyside Medical, LLC
• Original Assignee: Speyside Medical, LLC
• Inventors: Lashinski, Randall T., Bishop, Gordon B.
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/297,282
• Publication Number:
  US 20170079784A1
• Time in Patent Office: 1,098 Days
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/068 : Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30672 : temporary
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0021 : differing in coefficient of friction
• CPC Class Codes: A61F 2250/0059 : temporary
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

A method for replacing a patient'"'"'s native heart valve includes delivering a prosthetic valve at the cardiovascular site from a collapsed delivery configuration to an expanded configuration, testing a performance characteristic of the prosthetic valve, at least partially reversing the deployment of the prosthetic valve, repositioning the prosthetic valve, and re-deploying the prosthetic valve.

Claims

1. A method of implanting a prosthetic valve within a heart, the method comprising:

translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart, the inflatable structure including a distal ring and a proximal ring;

inflating the distal ring distal to the native valve; and

inflating the proximal ring proximal to the native valve after inflating the distal ring.

2. The method of claim 1 further comprising:

proximally retracting the prosthetic valve to seat the distal ring of the inflatable structure against a distally facing portion of the native valve.

3. The method of claim 1 further comprising:

inflating the distal ring; and

independently inflating the proximal ring.

4. The method of claim 1 further comprising:

stapling or suturing the prosthetic valve to an adjacent anatomical structure.

5. The method of claim 1 further comprising:

advancing a removal catheter over an inflation tube in fluid communication with the inflatable structure;

deflating the inflatable structure;

retracting the prosthetic valve into the removal catheter; and

withdrawing the prosthetic valve and the removal catheter from the patient.

6. The method of claim 1 further comprising:

positioning a temporary valve in series fluid flow with the native valve;

deploying the prosthetic valve upstream of the temporary valve; and

removing the temporary valve.

7. A method of treating a patient, comprising:

translumenally advancing a prosthetic valve to a position proximate a native valve of the heart; and

deploying the prosthetic valve at the native valve from a collapsed delivery configuration to an expanded configuration, a distal end of the prosthetic valve being expanded prior to a proximal end of the prosthetic valve being expanded;

testing a performance characteristic of the prosthetic valve;

at least partially reversing the deployment of the prosthetic valve;

repositioning the prosthetic valve; and

re-deploying the prosthetic valve,

wherein the prosthetic valve does not include an interlocking locking mechanism, and

wherein the prosthetic valve prevents the flow of blood through the valve in a first direction and allows the flow of blood through the prosthetic valve in a second direction during the expansion of the prosthetic valve, after expanding the distal end of the prosthetic valve, and prior to expanding the proximal end of the prosthetic valve.

8. The method of claim 7, wherein the prosthetic valve is expanded to the expanded configuration using an inflation media.

9. The method of claim 7, wherein the prosthetic valve has a non-cylindrical profile in the expanded configuration.

10. The method of claim 7, wherein a proximal portion of the prosthetic valve extends further radially outwardly than a central portion of the prosthetic valve.