TOOL AND METHOD FOR COMPRESSING A STENTED PROSTHESIS

• US 20170333228A1
• Filed: 05/17/2016
• Published: 11/23/2017
• Est. Priority Date: 05/17/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Orth, Geoffrey, Bruner, Kenny, Tran, Don, Mendelson, Jill, Keogh, James R.
• Granted Patent: US 10,292,844 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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: B21D 39/04 of tubes with tubes; of tubes with rods crimped pipe joints as such F16L13/14
• CPC Class Codes: B21D 39/06 of tubes in openings, e.g. rolling-in
• CPC Class Codes: B25B 27/14 for assembling objects other than by press fit or detaching same
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall
• CPC Class Codes: Y10T 29/53987 Tube, sleeve or ferrule
• CPC Class Codes: Y10T 29/53996 by deforming

Abstract

A tool for compressing a stented prosthesis. The tool includes first and second sets of rollers. The first set includes a plurality of rollers arranged to define a first working region having a first working diameter. The second set includes a plurality of rollers arranged to define a second working region having a second working diameter. The sets of rollers are arranged such that the working regions are axially aligned. The first working diameter is greater than the second working diameter. A stented prosthesis traversing the first working region and then the second working region is forced to a compressed state. In some embodiments, the tool includes one or more intermediate sets of rollers between the first and second sets of rollers, with each of the intermediate sets of rollers defining a working region having a working diameter. The respective working diameters progressively decrease in a downstream direction.

Claims

1. A tool for compressing a stented prosthesis, the device comprising:

a first set of rollers including a plurality of rollers arranged to collectively define a first working region having a first working diameter; and

a second set of rollers including a plurality of rollers arranged to collectively define a second working region having a second working diameter;

wherein the first set of rollers is arranged relative to the second set of rollers such that the first and second working regions are axially aligned;

and further wherein the first working diameter is greater than the second working diameter.

2. The tool of claim 1, wherein the tool defines an entrance side opposite an exit side and a downstream direction from the entrance side to the exit side, and further wherein the second roller set is located downstream of the first roller set.

3. The tool of claim 2, wherein the tool is configured to receive a stented prosthesis at the entrance side and compress the stented prosthesis as the stented prosthesis is directed toward the exit side.

4. The tool of claim 3, wherein the tool is configured to exert a compressive force onto an inserted stented prosthesis along the first working region and the second working region, and further wherein the second set of rollers is configured to exert an elevated compressive force as compared to a compressive force exerted by the first set of rollers.

5. The tool of claim 1, wherein the rollers of the first set of rollers are substantially identical, and further wherein the rollers of the second set of rollers are substantially identical.

6. The tool of claim 1, wherein each of the rollers of the first and second sets of rollers includes an engagement segment and opposing first and second flange segments projecting from opposite sides of the engagement segment, a diameter of the engagement segment being less than a diameter of the flange segments, and further wherein the engagement segment has a height defined as a linear distance between the opposing flange segments, and even further wherein the height of the engagement segment of each of the rollers of the first set of rollers is greater than the height of the engagement segment of each of the rollers of the second set of rollers.

7. The tool of claim 6, wherein the engagement segment of each of the rollers of the first and second sets of rollers defines a concave shape in extension between the corresponding opposing flange segments.

8. The tool of claim 1, wherein the first set of rollers includes first and second rollers, and further wherein the device is configured such that a transverse spacing between the first and second rollers is adjustable.

9. The tool of claim 1, wherein at least one roller of the first set of rollers is spring loaded.

10. The tool of claim 1, further comprising a housing rotatably maintaining the rollers of each of the first and second sets of rollers, the housing including opposing, first and second walls, and further wherein the housing is configured such that the first wall is removably connected to the first and second sets of rollers.

11. The tool of claim 1, further comprising:

an actuator; and

a gear system linking the actuator to the rollers of each of the first and second sets of rollers;

wherein the tool is configured such that user-prompted movement of the actuator causes rotation of the rollers of each of the first and second sets of rollers.

12. The tool of claim 1, further comprising:

a third set of rollers including a plurality of rollers arranged to collectively define a third working region having a third working diameter;

wherein the third working region is axially aligned with the first and second working regions;

and further wherein the second working diameter is greater than the third working diameter.

13. The tool of claim 12, wherein the third set of rollers is located downstream of the second set of rollers, opposite the first set of rollers.

14. The tool of claim 12, further comprising:

a fourth set of rollers including a plurality of rollers arranged to collectively define a fourth working region having a fourth working diameter;

wherein the fourth working region is axially aligned with the first-third working regions;

and further wherein the third working diameter is greater than the fourth working diameter.

15. A method of compressing a stented prosthesis, the method comprising:

receiving a stented prosthesis in a first state defining a maximum outer diameter;

inserting the stented prosthesis in the first state into a tool, the tool comprising;

a first set of rollers including a plurality of rollers arranged to collectively define a first working region having a first working diameter,

a second set of rollers including a plurality of rollers arranged to collectively define a second working region having a second working diameter,

wherein the first set of rollers is arranged relative to the second set of rollers such that the first and second working regions are axially aligned,

and further wherein the first working diameter is greater than the second working diameter; and

directing the stented prosthesis successively through the first set of rollers followed by the second set of rollers to compress the stented prosthesis to a second state having a maximum outer diameter less than the maximum outer diameter of the first state.

16. The method of claim 15, wherein the step of directing includes exerting an increasing compressive force on to the stented prosthesis as the stented prosthesis is progressively directed through the device.

17. The method of claim 15, wherein after the step of directing, the method further comprising:

manipulating the tool to release the stented prosthesis.

18. The method of claim 15, wherein the stented prosthesis is a stented prosthetic heart valve.

19. The method of claim 15, wherein after the step of directing, the method further comprising:

loading the stented prosthesis in the second state onto a delivery system.

20. The method of claim 19, wherein the stented prosthesis is a stented prosthetic heart valve, the delivery system is a transcatheter delivery system, and the step of loading includes the transcatheter delivery system maintaining the stented prosthetic heart valve in the second state.