BIFURCATED MEDICAL APPLIANCE DELIVERY APPARATUS AND METHOD

• US 20090319021A1
• Filed: 08/26/2009
• Published: 12/24/2009
• Est. Priority Date: 05/01/2003
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Reynolds, Jason R., Borg, Ulf R., Mangiardi, Eric K.
• Granted Patent: US 8,353,946 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels

Abstract

The present invention, in preferred embodiments, provides delivery and deployment apparatuses for bifurcated stents capable of comfortably cradling the corina of bifurcated target tissue between the arms of the bifurcated stent as each arm of the bifurcated stent is delivered to a respective side branch. In particular, a family of apparatuses is provided that may be indicated for vascular and non-vascular intervention.

Additionally, these apparatuses do not require the use of an ancillary means, such as one or more balloon catheters to achieve complete and precise deployment. In preferred embodiments, delivery and deployment devices in accordance with the present invention also provide, direct visualization, deployment safety features and enhanced physician control.

Claims

1. A device for allowing a user to deploy a bifurcated stent having a primary lumen and left and right branch lumens in an anatomical lumen of a patient, the device comprising:

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

a longitudinally extending middle tubular member disposed in a longitudinally and axially displaceable manner about the inner tubular member, the middle tubular member having a distal end comprising a bifurcated stent retainer, the bifurcated stent retainer configured to enclose the entire bifurcated stent therein; and

a longitudinally extending outer tubular member disposed in a longitudinally and axially displaceable manner about the inner tubular member and the middle tubular member.

2. The device of claim 1, wherein the inner tubular member has a pusher coupled proximate to its distal end for urging egress of a bifurcated stent from the bifurcated retainer of the middle tubular member.

3. The device of claim 2, wherein displacement of the pusher in a distal direction with respect to the middle tubular member results in deployment of the bifurcated stent.

4. The device of claim 2, wherein displacement of the middle tubular member in a proximal direction with respect to the inner tubular member results in deployment of the bifurcated stent.

5. The device of claim 1, wherein the bifurcated stent retainer comprises a disassociatable seam formed on a portion thereof that is configured to facilitate separation of the bifurcated stent retainer for deploying the bifurcated stent.

6. The device of claim 1, wherein the bifurcated stent retainer has a generally Y-shaped configuration comprising a primary portion configured to enclose the primary lumen of the bifurcated stent therein and a pair of branch portions configured to enclose a respective left and right branch lumen of the bifurcated stent therein.

7. The device of claim 6, wherein each of the pair of branch portions comprises a disassociatable seam formed thereon that is configured to facilitate separation of the bifurcated stent retainer for deploying the bifurcated stent.

8. The device of claim 6, wherein the primary portion and the pair of branch portions of the bifurcated stent retainer are each generally cylindrical in shape.

9. The device of claim 6, wherein the pair of branch portions of the bifurcated stent retainer are offset at asymmetric angles with respect to the primary portion of the bifurcated stent retainer.

10. The device of claim 1, further comprising a safety mechanism configured to limit the degree of displacement of the inner and outer tubular members with respect to one another to a predetermined threshold such that the degree of stent deployment is limited absent user intervention.

11. The device of claim 1, further comprising a handle coupled with a portion of the outer tubular member and configured to displace the outer tubular member with respect to the inner and middle tubular members.

12. A device for allowing a user to deploy a bifurcated stent having a primary lumen and left and right branch lumens in an anatomical lumen of a patient, the device comprising:

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

a longitudinally extending middle tubular member disposed in a longitudinally and axially displaceable manner about the inner tubular member, the middle tubular member having a distal end comprising a bifurcated stent retainer, the bifurcated stent retainer having proximal and distal ends and configured to house the bifurcated stent therein, wherein the distal end of the inner tubular member is positioned proximate to the proximal end of the bifurcated stent retainer prior to deployment of the bifurcated stent, and wherein the bifurcated stent is configured to be released from the bifurcated stent retainer as a result of displacement of the inner and middle tubular members in opposite directions with respect to one another; and

a longitudinally extending outer tubular member disposed in a longitudinally and axially displaceable manner about the inner tubular member and the middle tubular member.

13. The device of claim 12, wherein displacement of the inner tubular member in a distal direction with respect to the middle tubular member results in deployment of the bifurcated stent.

14. The device of claim 12, wherein displacement of the middle tubular member in a proximal direction with respect to the inner tubular member results in deployment of the bifurcated stent.

15. The device of claim 12, wherein the bifurcated stent retainer comprises a disassociatable seam formed on a portion thereof that is configured to facilitate separation of the bifurcated stent retainer for deploying the bifurcated stent.

16. The device of claim 12, wherein the bifurcated stent retainer comprises a generally Y-shaped configuration, wherein the bifurcated stent retainer has a primary portion configured to enclose the primary lumen of the bifurcated stent therein and a pair of branch portions configured to enclose a respective left and right branch lumen of the bifurcated stent therein.

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

providing a placement and delivery apparatus comprising a longitudinally extending inner tubular member having distal and proximal ends;

a longitudinally extending middle tubular member disposed in a longitudinally and axially displaceable manner about the inner tubular member, the middle tubular member having a distal end comprising a bifurcated stent retainer, the bifurcated stent retainer configured to house the entire bifurcated stent therein; and

a longitudinally extending outer tubular member disposed in a longitudinally and axially displaceable manner about the inner tubular member and the middle tubular member;

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

positioning the distal region of the apparatus about a branched target area within the patient;

displacing the outer tubular member with respect to the inner tubular member so as to expose the middle tubular member about the branched target area within the patient; and

deploying the stent such that the first and second bifurcated lumens enter the respective branches of the target site within the patient.

18. The method of claim 17, further comprising removing the deployment apparatus following the deploying step.

19. The method of claim 17, wherein the deploying step comprises extending the inner tubular member distally with respect to the middle tubular member.

20. The method of claim 17, wherein the deploying step comprises extending the middle tubular member proximally with respect to the inner tubular member.