Medical appliance delivery apparatus and method of use

• US 7,608,099 B2
• Filed: 02/17/2006
• Issued: 10/27/2009
• Est. Priority Date: 10/26/2002
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Johnson, Liann M, Mangiardi, Eric K, Sherburne, Paul S, Smelser, Ricci D., Heck, Alicia F.
• Primary Examiner(s): Bui; Vy Q.
• Application Number:
  US11/357,366
• Publication Number:
  US 20060200222A1
• Time in Patent Office: 1,348 Days
• Field of Search: 623/1.11, 606/198, 606/191, 606/194, 606/195
• 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
• CPC Class Codes: A61F 2250/008 Alarm means

Abstract

The present invention, in an exemplary embodiment, provides a stent deployment apparatus comprising excellent safety and stent placement and deployment features. An exemplary stent deployment apparatus in accordance with the present invention can facilitate the precise delivery of stents in a safe and repeatable fashion. In particular, a preferred deployment apparatus allows the physician to concentrate on correct placement without having to estimate extent of deployment by providing a physical safety mechanism that limits deployment to the critical deployment point. Moreover, to exceed this threshold, an audible and/or tactile indicator informs the physician that she can no longer retract the stent beyond this point. The stent deployment apparatus guidewire may also be extended rather than retracting the outer catheter to deliver the stent. Moreover, the distal tip is designed to comfortably guide the deployment apparatus through a diseased or occluded lumen so that the stent can be delivered in the most beneficial location. Additionally, the distal tip facilitates the removal of the deployment apparatus even if a defective stent is only partially radially expanded. In alternative embodiments, the stent deployment apparatus allows for the insertion of an optical scope to facilitate stent delivery.

Claims

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

a longitudinally extending inner tubular member having distal and proximal ends, the distal end comprising a tip;

a longitudinally extending outer tubular member having an outer and inner diameter, the outer tubular member being longitudinally and axially displaceable relative to the inner tubular member;

a handle, coupled with a portion of the outer tubular member, the handle having first and second ends and the second end defining a cavity having at least one stop compatible male or female locking member formed therein;

a stop formed about the inner tubular member, the outer surface of the stop comprising at least one female or male locking member configured to coaxially engage the male or female locking member, respectively, of the handle cavity to form a safety mechanism, wherein the locking members are configured to engage one another along an axis coaxial to a longitudinal axis of the inner and outer tubular members;

wherein the outer tubular member and inner tubular member are axially displaceable relative to each other without requiring rotational motion with respect to one another to a predetermined threshold corresponding to partial deployment of a stent and engagement of the locking members absent intervention by the user of the device such that relative axial displacement of the outer tubular member and inner tubular member and a corresponding degree of stent deployment is limited by the safety mechanism absent the user intervention.

2. The device of claim 1, wherein the inner tubular member defines a lumen longitudinally extending substantially the distance from the distal end to the proximal end of the inner tubular member, which allows a guidewire to extend through the lumen thereof.

3. The device of claim 1, wherein the user intervention comprises displacing the outer tubular member axially relative to the inner tubular member.

4. The device of claim 3, wherein an audible indication follows the user intervention.

5. The device of claim 3, wherein a tactile indication follows the user intervention.

6. The device of claim 3, further comprising at least one tab formed on the stop, which serves as the audible indication when broken during user intervention.

7. The device of claim 3, wherein the outer tubular member when moved longitudinally relative to the inner tubular member in a proximal direction away from the selected location, releases the stent for radial self-expansion.

8. The device of claim 1, wherein the predetermined threshold is about between 10% and 90% deployment.

9. The device of claim 8, wherein the predetermined threshold is about 60% deployment.

10. The device of claim 1, wherein a guidewire is coupled to a portion of the outer diameter of the outer tubular member.

11. The device of claim 1, wherein the inner tubular member is configured to receive an optical scope.

12. The device of claim 1, wherein the outer tubular member is clear.

13. The device of claim 12, wherein the outer tubular member is kink resistant.

14. The device of claim 1, wherein there is at least one marker coupled with a portion of the inner tubular member.

15. The device of claim 1, wherein the inner tubular member is of a material that is kink resistant.

16. The device of claim 1, wherein the distal end comprising the tip has first, medial and second sections, the first and second sections having outer diameters that are less than that of the medial section.

17. The device of claim 1, wherein a portion of the inner tubular member about the proximal end further comprises a stent carrier adapted to carry a radially self-expanding stent in a radially contracted state.

18. The device of claim 17, further including a radially self expanding stent carried by the stent carrier, extended along and surrounding at least part of the distal end region, and surrounded by a portion of the outer tubular member and thereby maintained in the radially contracted state.

19. The device of claim 1, wherein the cavity of the handle has at least one stop compatible male or female locking member integrally formed therein.

20. The device of claim 1, further comprising a hypotube having a first end, a second end, an outer surface, an inner surface, wherein the stop is formed on the hypotube between the first and second ends.

21. The device of claim 1, wherein the cavity is defined circumferentially about the outer tubular member.

22. The device of claim 1, wherein the stop is disposed circumferentially about the inner tubular member.

23. The device of claim 1, wherein the handle has proximal and distal ends, and wherein the cavity is defined in the proximal end of the handle.

24. The device of claim 23, wherein the stop is positioned proximally of the cavity such that the stop is configured to engage the cavity when the handle is displaced in a proximal direction.

25. The device of claim 1, wherein the stop is spaced distally from the proximal end of the inner tubular member.

26. The device of claim 1, wherein the outer tubular member is configured to partially overlie the stent at the predetermined threshold.

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

a longitudinally extending inner tubular member having distal and proximal ends, the distal end comprising a tip;

a longitudinally extending outer tubular member having an outer and inner diameter, the outer tubular member being longitudinally and axially displaceable relative to the inner tubular member;

a handle, coupled with a portion of the outer tubular member, the handle having first and second ends and the second end defining a cavity having at least one stop compatible male or female locking member formed therein, wherein the cavity is disposed around a circumference of the outer tubular member;

a stop disposed about the inner tubular member, the outer surface of the stop comprising at least one female or male locking member configured to coaxially engage the male or female locking member, respectively, of the handle cavity to form a safety mechanism;

wherein the outer tubular member and inner tubular member are axially displaceable relative to each other without requiring rotational motion with respect to one another to a predetermined threshold corresponding to partial deployment of a stent and engagement of the locking members absent intervention by the user of the device such that relative axial displacement of the outer tubular member and inner tubular member and a corresponding degree of stent deployment is limited by the safety mechanism absent the user intervention.

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

a longitudinally extending inner tubular member having distal and proximal ends, the distal end comprising a tip;

a longitudinally extending outer tubular member having an outer and inner diameter, the outer tubular member being longitudinally and axially displaceable relative to the inner tubular member;

a handle, coupled with a portion of the outer tubular member, the handle having first and second ends and the second end defining a cavity having at least one stop compatible male or female locking member formed therein;

a stop disposed around a circumference of the inner tubular member, the outer surface of the stop comprising at least one female or male locking member configured to coaxially engage the male or female locking member, respectively, of the handle cavity to form a safety mechanism;

wherein the outer tubular member and inner tubular member are axially displaceable relative to each other without requiring rotational motion with respect to one another to a predetermined threshold corresponding to partial deployment of a stent and engagement of the locking members absent intervention by the user of the device such that relative axial displacement of the outer tubular member and inner tubular member and a corresponding degree of stent deployment is limited by the safety mechanism absent the user intervention.