Delivery system having a single handed deployment handle for a retractable outer sheath

• US 9,445,928 B2
• Filed: 05/30/2013
• Issued: 09/20/2016
• Est. Priority Date: 05/30/2013
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Argentine, Jeffery
• Primary Examiner(s): Aleman, Sarah W
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US13/906,079
• Publication Number:
  US 20140358156A1
• Time in Patent Office: 1,209 Days
• Field of Search: 606/1, 606/108, 623/1.11, 623/1.12, 623/2.11, 604/95.01, 604/95.04, 604/528
• US Class Current: 1/1
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A delivery system for delivering a prosthesis, the delivery system including a housing, a sheath extending from within the housing, a clutching mechanism housed within the housing, and a cable. The clutching mechanism includes a one-way clutch that transmits a torque from an actuator to an inner shaft assembly when the actuator is rotated in a first direction and does not transmit a torque from the actuator to the inner shaft assembly when the actuator is rotated in a second opposing direction. The actuator is accessible from an exterior of the housing. The cable has a first end coupled to a proximal portion of the sheath and a second end coupled to the inner shaft assembly, and actuation of the actuator causes the actuator to rotate in the first direction, thereby causing the inner shaft assembly to wind up a portion of cable and retract the sheath.

Claims

1. A delivery system for delivering a prosthesis, the delivery system comprising:

a housing;

a sheath extending from within the housing;

a clutching mechanism housed within the housing, the clutching mechanism including a first one-way clutch that transmits a torque from an actuator to an inner shaft assembly when the actuator is rotated in a first direction and does not transmit a torque from the actuator to the inner shaft assembly when the actuator is rotated in a second opposing direction, wherein the actuator is accessible from an exterior of the housing, wherein the inner shaft assembly includes,

an inner shaft component,

a storage drum, the storage drum being concentrically disposed around a first portion of the inner shaft component and the first one-way clutch being concentrically disposed around a second portion of the inner shaft component,

a second one-way clutch, and

a bearing that is coupled to the housing and extends into or over the second one-way clutch, wherein the bearing prevents the second one-way clutch and the storage drum from rotating in the second direction; and

a cable having a first end coupled to a proximal portion of the sheath and a second end coupled to the storage drum, wherein actuation of the actuator causes the actuator to rotate in the first direction, thereby causing the storage drum to wind up a portion of cable and retract the sheath.

2. The delivery system of claim 1, wherein release of the actuator causes the actuator to rotate in the second direction, thereby causing the first one-way clutch to freely spin over the inner shaft assembly.

3. The delivery system of claim 1, wherein the actuator includes a lever and an outer shaft component concentrically disposed over the first one-way clutch.

4. The delivery system of claim 1, wherein the storage drum is coupled to the inner shaft component via mating non-circular surfaces between the storage drum and a portion of the inner shaft component.

5. The delivery system of claim 1, wherein the storage drum includes a non-circular track formed thereon for gathering the cable at a variable rate.

6. The delivery system of claim 1, further comprising an access wheel within the housing, wherein an intermediate portion of the cable is wound around the access wheel, and wherein the housing includes a window formed through the housing, the window being located adjacent to the access wheel.

7. The delivery system of claim 1, wherein the actuator includes a lever that rotates a first angle and causes the storage drum to rotate a second angle, wherein the second angle is greater than the first angle.

8. The delivery system of claim 7, wherein the first angle is between 10 and 20 degrees and the second angle is between 40 and 50 degrees.

9. The delivery system of claim 1, further comprising

a self-expanding prosthesis disposed at a distal end of the delivery system, wherein a distal end of the sheath constrains the prosthesis in a compressed configuration, wherein winding up a portion of cable retracts the sheath to allow the prosthesis to expand to a deployed configuration.

10. A delivery system for delivering a prosthesis, the delivery system comprising:

a housing;

a sheath extending from within the housing;

a clutching mechanism housed within the housing, the clutching mechanism including a one-way clutch that transmits a torque from a first actuator to an inner shaft assembly when the first actuator is rotated in a first direction and does not transmit a torque from the first actuator to the inner shaft assembly when the first actuator is rotated in a second opposing direction, wherein the first actuator is accessible from an exterior of the housing;

a cable having a first end coupled to a proximal portion of the sheath and a second end coupled to the inner shaft assembly, wherein actuation of the first actuator causes the first actuator to rotate in the first direction, thereby causing the inner shaft assembly to wind up a portion of cable and retract the sheath; and

a spring disposed within the housing and extending between the first actuator and a second actuator accessible from the exterior of the housing, the spring moveable from a loaded locked position in which a first end of the spring is secured within a first recess of the second actuator to an open unlocked position in which a second end of the spring pushes the first actuator radially away from the housing.

11. The delivery system of claim 10, wherein the inner shaft assembly includes an inner shaft component and a storage drum, the storage drum being concentrically disposed around a first portion of the inner shaft component and the one-way clutch being concentrically disposed around a second portion of the inner shaft component.

12. The delivery system of claim 11, wherein the inner shaft assembly further includes a second one-way clutch and a bearing that is coupled to the housing and extends into or over the second one-way clutch, wherein the bearing prevents the second one-way clutch and storage drum from rotating in the second direction.

13. The delivery system of claim 10, wherein the first actuator includes a lever and the second actuator includes a slider and movement of the slider moves the spring from the loaded locked position to the open unlocked position.

14. The delivery system of claim 10, wherein release of the first actuator causes the first actuator to rotate in the second direction, thereby causing the one-way clutch to freely spin over the inner shaft assembly.

15. The delivery system of claim 10, wherein the first actuator includes a lever and an outer shaft component concentrically disposed over the one-way clutch.

16. A delivery system for delivering a prosthesis, the delivery system comprising:

a housing;

a sheath extending from within the housing;

an actuator accessible from an exterior of the housing;

an inner shaft assembly disposed within the housing, the inner shaft assembly including an inner shaft component, a transmitting one-way clutch, a storage drum concentrically disposed around or within the transmitting one-way clutch, and a bearing coupled to the housing and extending into or over the transmitting one-way clutch;

a driving one-way clutch disposed between the actuator and a first portion of the inner shaft component of the inner shaft assembly, wherein the driving one-way clutch transmits a torque from the actuator to the inner shaft assembly when the actuator is rotated in a first direction and does not transmit a torque from the actuator to the inner shaft assembly when the actuator is rotated in a second opposing direction; and

a cable having a first end coupled to a proximal portion of the sheath and a second end coupled to the storage drum of the inner shaft assembly, wherein actuation of the actuator causes the actuator to rotate in the first direction, thereby causing the storage drum to wind up a portion of cable and retract the sheath, and release of the actuator causes the actuator to rotate in the second direction, wherein the bearing prevents the transmitting one-way clutch and storage drum from rotating in the second direction.

17. The delivery system of claim 16, wherein release of the actuator causes the driving one-way clutch to freely spin over the inner shaft assembly.

18. The delivery system of claim 16, wherein release of the actuator results in no movement of the cable or sheath.

19. The delivery system of claim 16, wherein the transmitting one-way clutch is concentrically disposed over a second portion of the inner shaft component and over a first portion of the bearing.

20. The delivery system of claim 19, wherein the transmitting one-way clutch is concentrically disposed over a portion of the storage drum and within the bearing.