Valvuloplasty device

• US 9,827,096 B2
• Filed: 01/26/2016
• Issued: 11/28/2017
• Est. Priority Date: 02/23/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Weber, Jan, Flanagan, Aiden
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US15/006,177
• Publication Number:
  US 20160135949A1
• Time in Patent Office: 672 Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves

Abstract

The disclosure pertains to valvuloplasty devices which include a first outer shaft, a second inner shaft, a plurality of elongate members disposed therebetween and adapted to be expanded radially by relative motion between the first outer shaft and second inner shaft and a circumferential member disposed about the central portions of the plurality of elongate members, wherein the circumferential member is urged by radial expansion of the plurality of elongate members to contact the valve to be treated thereby effecting a valvuloplasty and methods of use therefor.

Claims

1. A method of performing a valvuloplasty, comprising:

inserting a valvuloplasty device intravascularly into a patient,

said valvuloplasty device comprising;

an outer shaft;

an inner shaft;

a plurality of elongate members disposed between the distal end of the outer shaft and the distal end of the inner shaft and affixed thereto;

and a circumferential member affixed to the plurality of elongate members and disposed between the distal end of the outer shaft and the distal end of the inner shaft;

advancing the valvuloplasty device to a position within a valve to be treated;

reducing a distance between the distal end of the outer shaft and the distal end of the inner shaft thereby causing a central portion of the plurality of elongate members disposed between the distal end of the outer shaft and the distal end of the inner shaft to expand to a radially expanded configuration and press the circumferential member against the valve to be treated thereby performing a valvuloplasty;

increasing the distance between the distal end of the outer shaft and the distal end of the inner shaft thereby causing the central portion of the plurality of elongate members disposed between the distal end of the outer shaft and the distal end of the inner shaft to contract radially;

removing the valvuloplasty device from the patient intact in a radially contracted configuration in which the distal end of the inner shaft extends distally beyond the distal end of the outer shaft and the plurality of elongate members disposed between and operably connected to the inner shaft and the outer shaft are generally parallel to a longitudinal axis of the inner shaft.

2. The method of claim 1, wherein the valvuloplasty device includes one or more cutting edges extending radially outward therefrom and the step of reducing the distance between the distal end of the outer shaft and the distal end of the inner shaft causes the central portion of the plurality of elongate members disposed between the distal end of the outer shaft and the distal end of the inner shaft to expand radially outward and causes the one or more cutting edges extending radially outward to cut the valve to be treated.

3. The method of claim 1, wherein the valvuloplasty device includes a first population of elongate members and a second population of elongate members,

wherein the first population of elongate members differs from the second population of elongate members with regard to lengths of the members of the respective populations of elongate members.

4. The method of claim 1, wherein the valvuloplasty device includes a first population of elongate members and a second population of elongate members,

wherein the first population of elongate members differs from the second population of elongate members with regard to the stiffness of the elongate members of the respective populations.

5. The method of claim 1, wherein the valvuloplasty device includes elongate members which vary in cross-sectional area along their length.

6. The method of claim 1, wherein the valvuloplasty device includes elongate members which vary in cross-sectional shape along their length.

7. The method of claim 1, wherein the valvuloplasty device includes elongate members which vary with regard to a mechanical property along their length.

8. The method of claim 1, wherein the plurality of elongate members are uniformly distributed circumferentially in the radially expanded configuration.

9. The method of claim 1, wherein the plurality of elongate members are non-uniformly distributed circumferentially in the radially expanded configuration.

10. The method of claim 1, wherein the radially expanded configuration includes a longitudinal taper.

11. The method of claim 1, wherein the circumferential member is textured on its radially outermost surface.

12. The method of claim 1, wherein the valvuloplasty device includes a drug coating on at least a portion of its surface.

13. The method of claim 1, wherein the valvuloplasty device includes a one-way valve.

14. The method of claim 1, wherein the valvuloplasty device includes a one or more radiopaque elements.