Medical appliance delivery apparatus and method of use

• US 8,267,987 B2
• Filed: 09/17/2009
• Issued: 09/18/2012
• Est. Priority Date: 10/26/2002
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Johnson, Liann M, Sherburne, Paul S, Heck, Alicia F., Smelser, Ricci D., Mangiardi, Eric K
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US12/561,657
• Publication Number:
  US 20100004732A1
• Time in Patent Office: 1,097 Days
• Field of Search: 606/108, 606/198, 606/200, 623/1.11, 623/1.12
• 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 safety and stent placement and deployment features. An exemplary stent deployment apparatus includes a longitudinally extending outer tubular member and a safety mechanism coupled thereto, wherein the safety mechanism includes a diverted channel. The apparatus also includes a longitudinally extending inner tubular member being longitudinally and axially displaceable relative to the outer tubular member, wherein the inner tubular member further comprises at least one detent along the longitudinal expanse thereof for operative interaction with the diverted channel. The extent of displaceability of the outer tubular member and inner tubular member relative to the other is limited to a predetermined threshold corresponding to engagement of the detent with the diverted channel absent intervention by the user of the device such that the degree of stent deployment is limited absent the user intervention.

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 outer tubular member having distal and proximal ends;

a safety mechanism coupled to the outer tubular member and comprising a diverted channel; and

a longitudinally extending inner tubular member having distal and proximal ends, the inner tubular member being longitudinally and axially displaceable relative to the outer tubular member during deployment of the stent in an anatomical lumen, the inner tubular member further comprising at least one detent along the longitudinal expanse thereof for operative interaction with the diverted channel,

wherein the extent of longitudinal displaceability of the outer tubular member and the inner tubular member relative to the other is limited to a predetermined threshold corresponding to engagement of the detent with the diverted channel, and

wherein the diverted channel is configured to allow further movement of the detent within the channel and beyond the predetermined threshold to deploy the stent.

2. The device of claim 1, wherein the the outer tubular member is rotated relative to the inner tubular member to allow further movement of the detent within the channel to deploy the stent.

3. The device of claim 2, wherein the outer tubular member is configured to be axially displaced longitudinally relative to the inner tubular member in a proximal direction following rotation of the inner and outer tubular members relative to one another to fully release the stent for radial self-expansion.

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

5. The device of claim 4, wherein the predetermined threshold is about 60% deployment.

6. The device of claim 1, wherein the diverted channel comprises a Z-shaped configuration for receiving and guiding the detent therein.

7. The device of claim 1, wherein the diverted channel comprises a pair of longitudinally extending slots each configured to receive and guide the detent therein.

8. The device of claim 7, wherein the diverted channel is configured to receive and guide the detent therein such that the inner and outer tubular members are configured to be axially displaced with respect to one another as the detent is moved along a first of the pair of slots to the predetermined threshold and then further axially displaced with respect to one another as the detent is moved along a second of the pair of slots following user intervention.

9. The device of claim 7, wherein the longitudinally extending slots extend parallel to a longitudinal axis of the inner and outer tubular members.

10. The device of claim 1, further comprising a hypotube disposed about the inner tube, wherein the detent is formed on the hypotube.

11. The device of claim 1, further comprising a handle coupled with the proximal end of the outer tubular member.

12. The device of claim 11, wherein the diverted channel is defined in the handle and is configured to receive and guide the detent therein.

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

14. The device of claim 1, 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 the predetermined threshold.

15. A method of deploying a radially expandable stent comprising the steps of:

providing a stent deployment apparatus comprising;

a longitudinally extending outer tubular member having distal and proximal ends and a safety mechanism coupled thereto, the safety mechanism comprising a diverted channel; and

a longitudinally extending inner tubular member having distal and proximal ends, the inner tubular member being longitudinally and axially displaceable relative to the outer tubular member during deployment of the stent in an anatomical lumen, the inner tubular member further comprising at least one detent along the longitudinal expanse thereof for operative interaction with the diverted channel, and wherein the diverted channel is configured to allow movement of the detent within the channel to fully deploy the stent;

inserting the deployment apparatus through a portion of the anatomy of a patient;

positioning the distal ends of the inner and outer tubular members proximate to a target area within the patient;

displacing the outer tubular member longitudinally with respect to the inner tubular member such that the detent is guided by the diverted channel to a predetermined threshold whereby the detent engages the diverted channel and the stent is exposed short of its full deployment position; and

moving the detent within the channel and beyond the predetermined threshold to thereby enable further longitudinal displacement of the outer tubular member with respect to the inner tubular member to fully deploy the stent;

fully deploying the stent by further longitudinally displacing the outer tubular member relative to the inner tubular member, such that the stent expands forming a lumen there through that is larger than the compressed diameter of the stent.

16. The method of claim 15, further comprising removing the deployment apparatus through the lumen of the fully deployed stent.

17. The method of claim 15, wherein fully deploying comprises rotating the outer tubular member relative to the inner tubular member.

18. The method of claim 17, wherein fully deploying comprises axially displacing the outer tubular member relative to the inner tubular member in a proximal direction following rotation of the inner and outer tubes relative to one another.

19. The method of claim 15, wherein displacing the outer tubular member relative to the inner tubular member does not require rotational motion with respect to one another to the predetermined threshold.

20. The method of claim 15, wherein providing comprises providing a stent deployment apparatus further comprising a handle coupled to the proximal end of the outer tubular member, wherein the diverted channel is defined in the handle and is configured to receive and guide the detent therein.

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

a longitudinally extending outer tubular member having distal and proximal ends;

a safety mechanism coupled to the outer tubular member and comprising a diverted channel; and

a longitudinally extending inner tubular member having distal and proximal ends, the inner tubular member being longitudinally and axially displaceable relative to the outer tubular member, the inner tubular member further comprises at least one detent along the longitudinal expanse thereof for operative interaction with the diverted channel,

whereby the extent of displaceability of the outer tubular member and inner tubular member relative to the other is limited to a predetermined threshold corresponding to engagement of the detent with the diverted channel absent intervention by the user of the device such that the degree of stent deployment is limited absent the user intervention,

wherein the user intervention comprises rotating the outer tubular member relative to the inner tubular member, and

wherein the outer tubular member is configured to be axially displaced longitudinally relative to the inner tubular member in a proximal direction following rotation of the inner and outer tubular members relative to one another to fully release the stent for radial self-expansion.

22. A method of deploying a radially expandable stent comprising the steps of:

providing a stent deployment apparatus comprising a longitudinally extending outer tubular member having distal and proximal ends and a safety mechanism coupled thereto, the safety mechanism comprising a diverted channel; and

a longitudinally extending inner tubular member having distal and proximal ends, the inner tubular member being longitudinally and axially displaceable relative to the outer tubular member, the inner tubular member further comprises at least one detent along the longitudinal expanse thereof for operative interaction with the diverted channel;

inserting the deployment apparatus through a portion of the anatomy of a patient;

positioning the distal ends of the inner and outer tubular members proximate to a target area within the patient;

displacing the outer tubular member with respect to the inner tubular member such that the detent is guided by the diverted channel to a predetermined threshold whereby the detent engages the diverted channel and the stent is exposed short of its full deployment position; and

fully deploying the stent such that the stent expands forming a lumen there through that is larger than the compressed diameter of the stent,

wherein fully deploying the stent comprises rotating the outer tubular member relative to the inner tubular member.