Implantable device delivery system handle and method of use

• US 8,535,366 B2
• Filed: 01/07/2005
• Issued: 09/17/2013
• Est. Priority Date: 01/08/2004
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Mangiardi, Eric, Borg, Ulf, Reynolds, Jason
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US10/585,430
• Publication Number:
  US 20090118740A1
• Time in Patent Office: 3,175 Days
• Field of Search: 623/1.23, 623/1.11, 623/1.12, 606/194, 606/198, 606/108
• US Class Current: 623/1.11
• 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

The present invention, in an exemplary embodiment, provides a delivery system and novel handle configuration for the delivery system that facilitates repeatable placement of implantable devices. In particular, in optical embodiments, the handle allows for the reversible coupling of scopes directly to the handle to enhance physician control during placement. The delivery system also allows for one-handed manipulation as finger action can be used to engage and disengage the scope as well as actuate the extent of implantable device deployment. Exemplary delivery systems are flexible, durable and/or assure proper installation of one or more implantable devices in a single procedure. Moreover, the preferred embodiments of the delivery system provides for the reloading of the delivery device with additional implantable devices for additional interventional procedures, resulting in a substantially reusable delivery device.

Claims

1. A stent deployment device for allowing a user to deploy a stent in an anatomical lumen of a patient, the stent deployment device comprising:

a support member configured to abut against a palm of a hand of the user;

a longitudinally extending outer tubular member having distal and proximal ends along a longitudinal axis, the distal end configured to receive the stent such that the stent is slidably disposed in the outer tubular member;

a longitudinally extending inner tubular member having distal and proximal ends, the distal end of the inner tubular member comprising a tip, the inner tubular member coupled with the support member and at least a portion of the inner tubular member disposed within the outer tubular member such that the inner tubular member is longitudinally and axially displaceable relative to the outer tubular member; and

a deployment mechanism coupled with the outer tubular member and configured to allow staged release of the stent, the deployment mechanism comprising

a graspable first release member to at least partially move the outer tubular member proximally and longitudinally relative to the inner tubular member, and

a graspable second release member positioned proximal to the first release member and operably connected to the first release member to move the outer tubular member proximally and longitudinally relative to the inner tubular member,

wherein the first release member is slidable along the longitudinal axis and has a first flange extending transverse to the longitudinal axis, and the second release member is slidable along the longitudinal axis and has a second flange extending transverse to the longitudinal axis, and

wherein the first release member and the second release member are configured to be serially retracted to provide staged release of the stent such that slidably retracting the second release member moves the first release member and the outer tubular member proximally and longitudinally relative to the inner tubular member from a first position to a second position to partially deploy the stent, and wherein subsequent sliding retraction of the first release member moves the outer tubular member proximally and longitudinally relative to the inner tubular member from the second position to a third position to fully deploy the stent.

2. The stent deployment device as recited in claim 1, further comprising a safety member for preventing movement of the first release member and the outer tubular member toward the support member beyond a predetermined position of the outer tubular member relative to the inner tubular member.

3. The stent deployment device as recited in claim 2, wherein movement of the first release member from the first position to the predetermined position exposes at least a portion of the stent.

4. The stent deployment device as recited in claim 3, wherein the portion of the stent exposed is from about 5% to about 95% of the length of the stent.

5. The stent deployment device as recited in claim 2, wherein the safety member comprises a removable tab disposed between the support member and the outer tubular member.

6. The stent deployment device as recited in claim 1, further comprising an elongated viewing device having a proximal end and distal end, the viewing device slidably disposed in the outer tubular member such that the proximal end of the viewing device extends outwardly of the proximal end of the outer tubular member.

7. The stent deployment device as recited in claim 6, further comprising means for releasably securing the viewing device with respect to the outer tubular member.

8. The stent deployment device as recited in claim 7, wherein the viewing device securing means is associated with the support member.

9. The stent deployment device as recited in claim 8, wherein the viewing device securing means comprises a clamp head threadably received in the support member.

27. The stent deployment device as recited in claim 1, wherein the deployment mechanism is operable without initially disengaging a safety mechanism.

10. A stent delivery system for use in an anatomical lumen of a patient, the stent delivery system comprising:

a support member configured to abut against a palm of a hand of the user;

a longitudinally extending outer tubular member having distal and proximal ends along a longitudinal axis, the distal end configured to receive the stent such that the stent is slidably disposed in the outer tubular member;

a longitudinally extending inner tubular member having distal and proximal ends, the distal end of the inner tubular member comprising a tip, the inner tubular member coupled with the support member and at least a portion of the inner tubular member disposed within the outer tubular member such that the inner tubular member is longitudinally and axially displaceable relative to the outer tubular member;

a stent having a proximal end and a distal end and slidably disposed within a distal portion of the outer tubular member and around a distal portion of the inner tubular member; and

a deployment mechanism coupled with the outer tubular member and configured to allow staged release of the stent, the deployment mechanism comprising

a graspable first release member to at least partially move the outer tubular member proximally and longitudinally relative to the inner tubular member, and

a graspable second release member positioned proximal to the first release member and operably connected to the first release member to move the outer tubular member proximally and longitudinally relative to the inner tubular member,

wherein the first release member is slidable along the longitudinal axis and has a first flange extending transverse to the longitudinal axis, and the second release member is slidable along the longitudinal axis and has a second flange extending transverse to the longitudinal axis, and

wherein the tip of the inner tubular member engages the proximal end of the stent for advancing the stent toward the distal end of the outer tubular member as the first and second release members move toward the support member, and

wherein the first release member and the second release member are configured to be serially retracted to provide staged release of the stent such that slidably retracting the second release member moves the first release member and the outer tubular member proximally and longitudinally relative to the inner tubular member from a first position to a second position to partially deploy the stent, and wherein subsequent sliding retraction of the first release member moves the outer tubular member proximally and longitudinally relative to the inner tubular member from the second position to a third position to fully deploy the stent.

11. The stent delivery system as recited in claim 10, wherein a portion of the stent is exposed outwardly of the distal end of the outer tubular member.

12. The stent delivery system as recited in claim 11, wherein the stent is deployed from the distal end of the outer tubular member.

13. The stent delivery system as recited in claim 10, further comprising a safety member for preventing movement of the first release member and the outer tubular member toward the support member beyond a predetermined position of the outer tubular member relative to the inner tubular member.

14. The stent delivery system as recited in claim 13, wherein movement of the first release member from the first position of the outer tubular member relative to the inner tubular member to the predetermined position exposes at least a portion of the stent outwardly of the distal end of the outer tubular member.

15. The stent delivery system as recited in claim 14, wherein the portion of the stent exposed is from about 5% to about 95% of the length of the stent.

16. The stent delivery system as recited in claim 13, wherein the safety member comprises a removable tab disposed between the support member and the outer tubular member.

17. The stent delivery system as recited in claim 10, further comprising an elongated viewing device having a proximal end and distal end, the viewing device slidably disposed in the outer tubular member such that the proximal end of the viewing device extends outwardly of the proximal end of the outer tubular member.

18. The stent delivery system as recited in claim 17, further comprising means for releasably securing the viewing device with respect to the outer tubular member.

19. The stent delivery system as recited in claim 18, wherein the viewing device securing means is associated with the support member.

20. The stent deployment device as recited in claim 19, wherein the viewing device securing means comprises a clamp threadably received in the support member.

21. A method for delivering a stent in an anatomical lumen of a patient, the method of stent delivery comprising:

providing a delivery device including

a support member configured to abut against a palm of a hand of the user,

a longitudinally extending outer tubular member having distal and proximal ends along a longitudinal axis, the distal end configured to receive the stent such that the stent is slidably disposed within the outer tubular member,

a longitudinally extending inner tubular member having distal and proximal ends, the distal end of the inner tubular member comprising a tip, the inner tubular member coupled with the support member and at least a portion of the inner tubular member disposed within the outer tubular member such that the inner tubular member is longitudinally and axially displaceable relative to the outer tubular member, and

a deployment mechanism coupled with the outer tubular member and configured to allow staged release of the stent, the deployment mechanism comprising

a graspable first release member to at least partially move the outer tubular member proximally and longitudinally relative to the inner tubular member, and

a graspable second release member positioned proximal to the first release member and operably connected to the first release member to move the outer tubular member proximally and longitudinally relative to the inner tubular member,

wherein the first release member is slidable along the longitudinal axis and has a first flange extending transverse to the longitudinal axis, and the second release member is slidable along the longitudinal axis and has a second flange extending transverse to the longitudinal axis, and

wherein the first release member and the second release member are configured to be serially retracted to provide staged deployment of the stent,

slidably disposing a stent having a proximal end and a distal end within a distal portion of the outer tubular member and around a distal portion of the inner tubular member, wherein the tip of the inner tubular member engages the proximal end of the stent to advance the stent toward the distal end of the outer tubular member as the outer tubular member moves toward the support member relative to the inner tubular member;

positioning the distal portion of the outer tubular member within the anatomical lumen of the patient at a desired location;

slidably retracting the second release member in a direction toward the support member to thereby retract the first release member and the outer tubular member relative to the inner tubular member from a first position to a second position to partially deploy the distal end of the stent; and

slidably retracting the first release member in a direction toward the support member and toward the second release member to thereby retract the outer tubular member relative to the inner tubular member from the second position to a third position to completely deploy the stent in the anatomical lumen of the patient.

22. The method of stent delivery as recited in claim 21, wherein a portion of the stent is exposed outwardly of the distal end of the outer tubular member.

23. The method of stent delivery as recited in claim 22, wherein the stent is deployed from the distal end of the outer tubular member.

24. The method of stent delivery as recited in claim 21, further comprising preventing movement of the first release member and the outer tubular member toward the support member beyond a predetermined position of the outer tubular member relative to the inner tubular member.

25. The method of stent delivery as recited in claim 21, further comprising

providing an elongated viewing device having a proximal end and distal end, and

slidably disposing the viewing device in the outer tubular member such that the proximal end of the viewing device extends outwardly of the proximal end of the outer tubular member.

26. The stent delivery system as recited in claim 25, further comprising releasably securing the viewing device with respect to the outer tubular member.

28. A stent deployment device for allowing a user to deploy a stent in an anatomical lumen of a patient, the stent deployment device comprising:

a support member configured to abut against a palm of a hand of the user;

a longitudinally extending outer tubular member having distal and proximal ends along a longitudinal axis, the distal end configured to receive the stent such that the stent is slidably disposed in the outer tubular member;

a longitudinally extending inner tubular member having distal and proximal ends, the distal end of the inner tubular member comprising a tip, the inner tubular member coupled with the support member and at least a portion of the inner tubular member disposed within the outer tubular member such that the inner tubular member is longitudinally and axially displaceable relative to the outer tubular member; and

a deployment mechanism coupled with the outer tubular member and configured to allow staged release of the stent, the deployment mechanism comprising

a graspable first release member configured to retract proximally and longitudinally with respect to the inner tubular member and configured to at least partially move the outer tubular member proximally and longitudinally relative to the inner tubular member, and

a graspable second release member positioned proximal to the first release member and operably connected to the first release member, the second release member configured to retract proximally and longitudinally with respect to the inner tubular member and configured to move the outer tubular member proximally and longitudinally relative to the inner tubular member,

wherein the first release member is slidable along the longitudinal axis and has a first flange extending transverse to the longitudinal axis, and the second release member is slidable along the longitudinal axis and has a second flange extending transverse to the longitudinal axis, and

wherein the first release member and the second release member are configured to be serially retracted to provide staged release of the stent such that slidably retracting the second release member proximally and longitudinally with respect to the inner tubular member moves the first release member and the outer tubular member proximally and longitudinally relative to the inner tubular member from a first position to a second position to partially deploy the stent, and wherein subsequent sliding retraction of the first release member proximally and longitudinally with respect to the inner tubular member moves the outer tubular member proximally and longitudinally relative to the inner tubular member from the second position to a third position to fully deploy the stent.