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

• US 10,531,972 B2
• Filed: 08/23/2016
• Issued: 01/14/2020
• 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): Shi, Katherine M
• Application Number:
  US15/244,157
• Publication Number:
  US 20170027725A1
• Time in Patent Office: 1,239 Days
• Field of Search: 606 1, 606108, 623 111, 623 112, 623 211, 60490501, 604 9504, 604528
• 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 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;

a cable having a first end coupled to a proximal portion of the sheath and a second end coupled to a storage drum of the inner shaft assembly, wherein 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 around the storage drum and retract the sheath; and

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.

2. The delivery system of claim 1, wherein release of the actuator causes the actuator to rotate in the second direction, thereby causing the 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 one-way clutch.

4. The delivery system of claim 1, wherein the inner shaft assembly includes an inner shaft component, 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.

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

6. The delivery system of claim 4, wherein the storage drum includes a non-circular track formed thereon for gathering the cable at a variable rate.

7. The delivery system of claim 4, 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, wherein the storage drum is disposed at a first end of the housing and the access wheel is disposed at a second end of the housing.

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

a handle having a housing;

a sheath extending from within the housing;

a clutching mechanism housed within the housing, the clutching mechanism including an actuator, an inner shaft assembly, and a one-way clutch disposed between actuator and the inner shaft assembly, wherein the 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;

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 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 to allow the prosthesis to expand to an deployed configuration; and

a locking mechanism configured to transfer the actuator between a storage configuration in which the actuator is substantially flush with an outer surface of the housing and an operational configuration in which the actuator is spaced outwardly from the outer surface of the housing.

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

12. The delivery system of claim 11, wherein the inner shaft assembly includes 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, wherein the bearing prevents the transmitting one-way clutch and storage drum from rotating in the second direction.

13. The delivery system of claim 10, wherein the locking mechanism includes a slider with a first recess and a second recess and a spring including a first arm, a second arm, and a hinge between the first and second arms, wherein the second arm of the spring is coupled to the actuator, wherein in the storage configuration a first rod at a first end of the first arm opposite the hinge is disposed in the first recess of the slider, and wherein in the operational configuration the slider is moved such that the first rod at the first end of the first arm is disposed in the second recess of the slider.

14. The delivery system of claim 13, wherein the slider further includes a tab that fits into an aperture of the actuator to hold actuator in the storage configuration.

15. The delivery system of claim 10,

wherein the actuator includes a lever having a first arm, a second arm, and a hinge between the first arm and the second arm,

wherein the locking mechanism includes an extension tab which extends from within the housing through a slot so as to be accessible and operable from an exterior of the housing,

wherein the locking mechanism includes a curved slot formed therethrough having a first socket and a second socket opposite the first socket,

wherein a first rod of the first arm opposite the hinge is configured to slide within the slot of the locking mechanism,

wherein a clip at a first end of the second arm opposite the hinge is coupled to an outer shaft disposed around the clutching mechanism,

wherein in the storage configuration the extension tab is in a first location such that the first rod of the first arm is disposed within the first socket of the slot and the lever is substantially flush with the outer surface of housing, and

wherein in the operational configuration, the extension tab is moved to a second location such that the first rod of the first arm is disposed in the second socket and the lever is spaced apart from the outer surface of the housing.

16. 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,

an actuator accessible from an exterior of the housing,

an outer shaft coupled to the actuator such that rotation of the actuator in a first direction causes rotation of the outer shaft in the first direction and rotation of the actuator in a second direction causes rotation of the outer shaft in the second direction opposite the first direction,

an inner shaft disposed concentrically within the outer shaft, the inner shaft having a first portion and a second portion,

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

a storage drum disposed concentrically around the second portion of the inner shaft, wherein the storage drum is coupled to the second portion of the inner shaft such that rotation of the first portion of the inner shaft causes rotation of the second portion of the inner shaft and rotation of the second portion of the inner shaft causes rotation of the storage drum, wherein the storage drum is coupled to the second portion of the inner shaft via mating non-circular surfaces between the storage drum and the second portion of the inner shaft; 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, and wherein release of the actuator causes the outer shaft to rotate in the second direction but does not cause the storage drum to rotate.

17. The delivery system of claim 16, wherein the storage drum includes a non-circular track formed thereon for gathering the cable at a variable rate.

18. The delivery system of claim 16, 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.

19. The delivery system of claim 16, 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.

20. The delivery system of claim 19, wherein the first angle is between 10 and 20 degrees and the second angle is between 40 and 50 degrees.