Conical crimper

• US 10,010,412 B2
• Filed: 07/25/2012
• Issued: 07/03/2018
• Est. Priority Date: 07/27/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taft, Rob, Oba, Travis Zenyo
• Primary Examiner(s): Wilson, Lee D
• Application Number:
  US13/558,053
• Publication Number:
  US 20130030418A1
• Time in Patent Office: 2,169 Days
• Field of Search: 292835
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2/9525 using a funnel
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

Embodiments of crimping devices for crimping stented prosthetic valves and other medical devices from a larger, expanded diameter to a smaller, crimped diameter are disclosed. Some crimping devices utilize a conical surface extending out-of-plane from the direction of crimping, where motion of the conical surface in the out-of-plane direction causes in-plane radially crimping. Other crimping devices comprise a funnel-shaped rigid body having a tapered inner lumen that compresses a medical device moving therethrough. Some funnel-shaped embodiments have slotted sides that allow portions of the medical device to project therethrough. Other funnel-shaped embodiments are used with a tubular sock to pull the medical device through the tapered lumen. Other crimping devices utilize rotating rollers that compress a medical device while the medical device spins between the rollers.

Claims

1. A crimping device comprising:

an annular outer frame comprising a first axial end portion, a second axial end portion, and a central opening that defines a central axis extending through the central opening;

an inner frame extending through the central opening of the outer frame, the inner frame comprising a first axial end portion, a second axial end portion, and a plurality of jaw guides extending between the first axial end portion and the second axial end portion, wherein a radial distance from the central axis to the jaw guides increases moving axially along the inner frame from the first axial end portion toward the second axial end portion, and wherein the inner frame defines first and second openings at opposite ends of the inner frame and a central lumen extending axially through the inner frame from the first opening to the second opening and centered on the central axis; and

a plurality of jaws operatively coupled to the inner frame and the outer frame, each jaw positioned within a respective jaw guide of the inner frame,

wherein relative axial motion between the outer frame and the inner frame causes radial motion of the jaws for crimping a prosthetic device positioned within the central lumen of the inner frame,

wherein the crimping device is configured to be axially movable relative to a delivery catheter such that at least a portion of the delivery catheter can be inserted through the central lumen of the inner frame and can extend axially beyond the first and the second axial end portions of the outer and the inner frames, and

wherein at least one of the jaw guides of the inner frame comprises a closed slot having a first stop surface disposed adjacent the first axial end portion of the inner frame and a second stop surface disposed adjacent the second axial end portion of the inner frame, and wherein the jaws are operatively coupled to the inner frame such that the jaws are axially movable within the slot between the first and the second stop surfaces.

2. The crimping device of claim 1, wherein a radial position of the jaws varies as a function of an axial position of the inner frame relative to the outer frame.

3. The crimping device of claim 1, wherein relative axial motion between the outer frame and the inner frame causes engagement portions of the jaws to slide along the jaw guides.

4. The crimping device of claim 1, wherein inner portions of the jaws define an iris between said inner portions of said jaws and relative axial motion between the outer frame and the inner frame causes the iris to change in radial size.

5. The crimping device of claim 4, wherein the iris is fully contracted when the first axial end portion of the inner frame is adjacent to the jaws, and the iris is fully dilated when the second axial end portion of the inner frame is adjacent to the jaws.

6. The crimping device of claim 1, wherein a radial position of the jaws is based on the radial distance from the central axis to the jaw guides at an axial position where the jaws are engaged with the jaw guides.

7. The crimping device of claim 1, wherein relative axial motion between the outer frame and the inner frame causes the jaws to move radially in unison.

8. The crimping device of claim 1, wherein the crimping device is configured to transfer an axial force imparted on the inner frame into a radial compressive force imparted from inner portions of the jaws to a prosthetic device positioned between the jaws, wherein the axial force is proportional to the radial compressive force.

9. The crimping device of claim 8, wherein a mechanical advantage of the crimping device is a function of a slope of the jaw guides, the slope being a ratio of change in radial dimension to change in axial dimension.

10. The crimping device of claim 1, wherein the inner frame comprises a generally frustoconical shape.

11. The crimping device of claim 1, wherein the inner frame comprises an annular wall that extends angularly around the central opening of the inner frame and the jaw guides comprise respective closed slots extending radially through the wall.

12. The crimping device of claim 11, wherein an engagement portion of each jaw comprises a neck positioned within a respective one of the slots of the inner frame, the slots being narrower in angular width than portions of the jaws immediately adjacent to the neck.

13. The crimping device of claim 1, wherein the outer frame comprises a plurality of radially extending jaw support holes spaced angularly around the outer frame, an outer portion of each of the jaws being positioned at least partially within a respective one of the jaw support holes such that the jaws can move radially relative to the outer frame but are restricted from axial or angular motion relative to the outer frame.

14. The crimping device of claim 13, wherein relative axial motion between the outer frame and the inner frame causes the outer portions of the jaws to slide axially within the jaw support holes.

15. The crimping device of claim 1, in combination with a delivery catheter having an inflatable balloon positioned in the inner frame so that the prosthetic device can be crimped directly onto the balloon.

16. An assembly comprising:

a prosthetic device comprising a plastically-expandable metal frame;

a delivery catheter having an inflatable balloon portion; and

a crimping device comprising;

an annular outer frame comprising a first axial end portion, a second axial end portion, and a central opening that defines a central axis extending through the central opening,

an inner frame extending through the central opening of the outer frame, the inner frame comprising a first axial end portion, a second axial end portion, and a plurality of jaw guides extending between the first axial end portion and the second axial end portion, wherein a radial distance from the central axis to the jaw guides increases moving axially along the inner frame from the first axial end portion toward the second axial end portion, wherein the inner frame defines first and second openings at opposite ends of the inner frame and a lumen extending axially through the inner frame from the first opening to the second opening and centered on the central axis, and

a plurality of jaws operatively coupled to the inner frame and the outer frame, each jaw positioned within a respective jaw guide of the inner frame,

wherein the prosthetic device and the inflatable balloon portion of the delivery catheter are positioned in the lumen of the inner frame, and relative axial motion between the outer frame and the inner frame causes the jaws to move radially inwardly and crimp the prosthetic device onto the inflatable balloon portion,

wherein the crimping device is movable along a length of the delivery catheter such that at least a portion of the delivery catheter extends through the first and the second axial end portions of the outer frame and extends through the first and second axial end portions of the inner frame, and

wherein at least one of the jaw guides of the inner frame comprises a closed slot having a first stop surface disposed adjacent the first axial end portion of the inner frame and a second stop surface disposed adjacent the second axial end portion of the inner frame, and wherein the jaws are operatively coupled to the inner frame such that the jaws are axially movable within the slots between the first and the second stop surfaces.