Delivery catheter system with micro and macro movement control

• US 9,144,494 B2
• Filed: 05/11/2012
• Issued: 09/29/2015
• Est. Priority Date: 05/12/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Murray, Robert, Upadhyaya, Sameer, Casley, Mark, MacAulay, Patrick, Masud, Ak, Cassidy, Paul, Clarke, David
• Primary Examiner(s): Miles, Jonathan W
• Application Number:
  US13/469,670
• Publication Number:
  US 20120310332A1
• Time in Patent Office: 1,236 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/2.11, 606/108
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 prosthetic valve delivery system that is improved in controllability by way of a proximal handle system. Such a handle system of the present invention advantageously permits a controlled fine or micro movement or adjustment of a distal sheath for uncovering a plunger that is to be loaded with a prosthetic valve for deployment thereof. The delivery system of the present invention permits a trigger-release for a gross or macro movement to the sheath relative to the plunger. Also, the control handle of the delivery system is shaped and contoured for ease in manipulation of the micro-control actuator.

Claims

1. A delivery system for percutaneous delivery of an expandable prosthetic heart valve, as such a prosthetic heart valve is to be collapsed and loaded onto a distal deployment portion of the delivery system, the delivery system comprising:

an elongate catheter portion that extends from a proximal end to a distal end and that includes a first shaft with an axial lumen and a second shaft within the lumen of the first shaft;

a deployment portion at a distal end of the delivery system that is operatively connected with the catheter portion and comprises a plunger attached to the second shaft of the catheter portion and a sheath connected with the first shaft of the catheter portion, wherein relative movement between the first and second shafts also provides relative movement between the plunger and the sheath so that a valve supporting portion of the plunger can be effectively covered and uncovered by the sheath;

a control handle portion at a proximal end of the delivery system and comprising a micro-control actuator that is operatively connected to the first shaft and is configured to advance and retract along a screw shaft that is operatively connected with the second shaft so that translation of the micro-control actuator along the screw shaft by rotation of the micro-control actuator translates the sheath relative to the plunger in a controlled micro-adjustment manner, wherein the micro-control actuator is releasable from the screw shaft so that the micro-control actuator can be translated along the screw shaft without rotation of the micro-control actuator in a controlled macro-adjustment manner; and

a tip retractor disposed proximal of the control handle portion and releasably attached to the screw shaft, wherein the second shaft is connected to the tip retractor, wherein the tip retractor includes a first configuration wherein the tip retractor is attached to the screw shaft such that the second shaft does not move relative to the screw shaft and a second configuration wherein the tip retractor is released from the screw shaft such that the tip retractor, the second shaft and the plunger can be moved relative to the screw shaft.

2. The delivery system of claim 1, further comprising a front grip of the control handle portion that is fixed with the screw shaft, wherein with the tip retractor in the first configuration, the second shaft, the screw shaft, and the front grip are part of a stationary portion of the delivery system, wherein a relatively movable portion of the delivery system is movable with respect to the stationary portion, and wherein the relatively movable portion comprises the micro-control actuator and the first shaft.

3. The delivery system of claim 1, wherein the first shaft is connected to the micro-control actuator by way of a T-shaft that is movable within a passage of the screw shaft.

4. The delivery system of claim 3, wherein the screw shaft includes at least one slot along which a tab portion of the T-shaft is slidable and for limiting a range of movement of the T-shaft, and thus the first shaft and the sheath, relative to the screw shaft, and thus the second shaft and the plunger.

5. The delivery system of claim 1, further comprising a threaded insert assembly that is provided internally between the micro-control actuator and a threaded portion of the screw shaft, the threaded insert assembly comprising an inner sleeve having at least one movable element that further is provided with a threaded portion to be engagable and disengagable with the threaded portion of the screw shaft, so that when the threaded portion of the movable element of the inner sleeve is disengaged from the threaded portion of the screw shaft, macro-adjustment of the sheath to the plunger can be performed.

6. The delivery system of claim 5, further comprising an outer sleeve as part of the threaded insert assembly that is slidable relative to the inner sleeve and that is connected with a trigger, wherein in a first position of the outer sleeve relative to the inner sleeve, the threaded portion of the movable element is in threaded engagement with the threaded portion of the screw shaft for micro-adjustment.

7. The delivery system of claim 6, wherein in a second position of the outer sleeve relative to the inner sleeve, the movable element is moved such that the threaded portion of the movable element of the inner sleeve is disengaged from the threaded portion of the screw shaft for macro-adjustment.

8. The delivery system of claim 7, further comprising a spring element for biasing the outer sleeve to the first position relative to the inner sleeve.

9. A delivery system for percutaneous delivery of an expandable prosthetic heart valve, as such a prosthetic heart valve is to be collapsed and loaded onto a distal deployment portion of the delivery system, the delivery system comprising:

an elongate catheter portion that extends from a proximal end to a distal end and that includes a first shaft with an axial lumen and a second shaft within the lumen of the first shaft;

a deployment portion at a distal end of the delivery system that is operatively connected with the catheter portion and comprises a plunger attached to the second shaft of the catheter portion and a sheath connected with the first shaft of the catheter portion, wherein relative movement between the first and second shafts also provides relative movement between the plunger and the sheath so that a valve supporting portion of the plunger can be effectively covered and uncovered by the sheath;

a control handle portion at a proximal end of the delivery system and comprising a micro-control actuator that is operatively connected to the sheath for moving the sheath relative to the plunger by rotation of the micro-control actuator about a screw shaft in a controlled micro-adjustment manner, wherein the micro-control actuator includes a releasable trigger for permitting linear movement of the micro-control actuator along the screw shaft and thus movement of the sheath without rotation of the micro-control actuator in a controlled macro-adjustment manner; and

a tip retractor disposed proximal of the control handle portion and releasably attached to the screw shaft, wherein the second shaft is connected to the tip retractor, wherein the tip retractor includes a first configuration wherein the tip retractor is attached to the screw shaft such that the second shaft does not move relative to the screw shaft and a second configuration wherein the tip retractor is released from the screw shaft such that the tip retractor, the second shaft and the plunger can be moved relative to the screw shaft.

10. The delivery system of claim 9, further comprising a front grip of the control handle portion that is fixed with the screw shaft, wherein with the tip retractor in the first configuration, the second shaft, the screw shaft, the front grip and the plunger are part of a stationary portion of the delivery system, wherein a relatively movable portion of the delivery system is movable with respect to the stationary portion, and wherein the relatively movable portion comprises the micro-control actuator and the first shaft.

11. The delivery system of claim 9, wherein the first shaft is connected to the micro-control actuator by way of a T-shaft that is movable within a passage of the screw shaft.

12. The delivery system of claim 11, wherein the screw shaft includes at least one slot along which a tab portion of the T-shaft is slidable and for limiting a range of movement of the T-shaft, and thus the first shaft and the sheath, relative to the screw shaft, and thus the second shaft and the plunger.

13. The delivery system of claim 9, further comprising a threaded insert assembly that is provided internally between the micro-control actuator and a threaded portion of the screw shaft, the threaded insert assembly comprising an inner sleeve having at least one movable element that further is provided with a threaded portion to be engagable and disengagable with the threaded portion of the screw shaft, so that when the threaded portion of the movable element of the inner sleeve is disengaged from the threaded portion of the screw shaft, macro-adjustment of the sheath to the plunger can be performed.

14. The delivery system of claim 13, wherein the threaded insert assembly includes an outer sleeve that is slidable relative to the inner sleeve and that is connected with the trigger, wherein in a first position of the outer sleeve relative to the inner sleeve, the threaded portion of the movable elements is in threaded engagement with the threaded portion of the screw shaft for micro-adjustment.

15. The delivery system of claim 14, wherein in a second position of the outer sleeve relative to the inner sleeve, the movable element is moved such that the threaded portion of the movable element of the inner sleeve is disengaged from the threaded portion of the screw shaft for macro-adjustment.

16. The delivery system of claim 15, further comprising a spring element for biasing the outer sleeve to the first position relative to the inner sleeve.

17. A delivery system for percutaneous delivery of an expandable prosthetic heart valve, as such a prosthetic heart valve is to be collapsed and loaded onto a distal deployment portion of the delivery system, the delivery system comprising:

an elongate catheter portion that extends from a proximal end to a distal end and that includes a first shaft with an axial lumen and a second shaft within the lumen of the first shaft;

a deployment portion at a distal end of the delivery system that is operatively connected with catheter portion and comprises a plunger attached to the second shaft of the catheter portion and a sheath connected with the first shaft of the catheter portion, wherein relative movement between the first and second shafts also provides relative movement between the plunger and the sheath so that a valve supporting portion of the plunger can be effectively covered and uncovered by the sheath;

a control handle portion at a proximal end of the delivery system and comprising a micro-control actuator that is operatively connected to the sheath for moving the sheath relative to the plunger by rotation of the micro-control actuator over a screw shaft in a controlled micro-adjustment manner, wherein a front grip is positioned distally adjacent to the micro-control actuator and a carriage is positioned proximally adjacent to the micro-control actuator, and further wherein the front grip, the micro-control actuator, and the carriage are positionable in a linear arrangement next to one another and defining a smooth contoured side profile with at least the front grip and the micro-control actuator including surface curvatures providing at least an outward bulge to the front grip and an inward curve to the micro-control actuator; and

a tip retractor disposed proximal of the control handle portion and releasably attached to the screw shaft, wherein the second shaft is connected to the tip retractor, wherein the tip retractor includes a first configuration wherein the tip retractor is attached to the screw shaft such that the second shaft does not move relative to the screw shaft and a second configuration wherein the tip retractor is released from the screw shaft such that the tip retractor, the second shaft and the plunger can be moved relative to the screw shaft.

18. The delivery system of claim 17, wherein the front grip is fixed with the screw shaft, wherein with the tip retractor in the first configuration, the second shaft, the screw shaft, the front grip and the plunger are is thus part of a stationary portion of the delivery system, wherein a relatively movable portion of the delivery system is movable with respect to the stationary portion, and wherein the relatively movable portion comprises the micro-control actuator and the first shaft.

19. The delivery system of claim 17, wherein the first shaft is connected to the micro-control actuator by way of a T-shaft that is movable within a passage of the screw shaft.

20. The delivery system of claim 19, wherein the screw shaft includes at least one slot along which a tab portion of the T-shaft is slidable and for limiting a range of movement of the T-shaft, and thus the first shaft and the sheath, relative to the screw shaft, and thus the second shaft and the plunger.

21. The delivery system of claim 17, further comprising a threaded insert assembly that is provided internally between the micro-control actuator and a threaded portion of the screw shaft, the threaded insert assembly comprising an inner sleeve having at least one movable element that further is provided with a threaded portion to be engagable and disengagable with the threaded portion of the screw shaft, so that when the threaded portion of the movable element of the inner sleeve is disengaged from the threaded portion of the screw shaft, macro-adjustment of the sheath to the plunger can be performed.

22. The delivery system of claim 21, wherein the threaded insert assembly includes an outer sleeve that is slidable relative to the inner sleeve and that is connected with a trigger, wherein in a first position of the outer sleeve relative to the inner sleeve, the threaded portion of the movable element is in threaded engagement with the threaded portion of the screw shaft for micro-adjustment.

23. The delivery system of claim 22, wherein in a second position of the outer sleeve relative to the inner sleeve, the movable element is moved such that the threaded portion of the movable element of the inner sleeve from the threaded portion of the screw shaft for macro-adjustment.

24. The delivery system of claim 23, further comprising a spring element for biasing the outer sleeve to the first position relative to the inner sleeve.