MEDICAL APPLIANCE OPTICAL DELIVERY AND DEPLOYMENT APPARATUS AND METHOD

• US 20100057183A1
• Filed: 11/12/2009
• Published: 03/04/2010
• Est. Priority Date: 03/31/2003
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Borg, Ulf R., Reynolds, Jason M., Mangiardi, Eric K.
• Granted Patent: US 8,298,277 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2250/0091 transparent or translucent

Abstract

Embodiments of the present invention are directed to devices for allowing a user to deploy a stent in an anatomical lumen of a patient. For example, one embodiment is directed to a device including a longitudinally extending inner tubular member and a longitudinally extending outer tubular member that are longitudinally and axially displaceable relative to one another. The outer tubular member includes at least one longitudinally extending channel formed between the exterior and interior diameter of the outer tubular member. In addition, the device includes a handle configured to displace the outer tubular member and inner tubular member relative to each other in response to user intervention and a stop configured to coaxially engage the handle to form a safety mechanism. Displaceability of the outer tubular member and inner tubular member relative to each other is limited by the safety mechanism to a predetermined threshold.

Claims

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

providing a stent deployment apparatus comprising;

a longitudinally extending inner tubular member having distal and proximal ends, the inner tubular member defining a lumen longitudinally extending substantially the distance from the distal end to the proximal end of the inner tubular member and forming a longitudinal expanse therebetween, the longitudinal expanse forming an aperture therethrough, and the inner tubular member having a tip coupled with the distal end;

a longitudinally extending outer tubular member having an exterior and interior diameter, the outer tubular member being longitudinally and axially displaceable relative to the inner tubular member and defining longitudinally extending channels formed between the exterior and interior diameter; and

a handle coupled with a portion of the outer tubular member;

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

inserting a scope through a longitudinally extending channel;

viewing a target area within the patient with the scope;

positioning the distal tip of the inner tubular member about a target area within the patient;

displacing the outer tubular member with respect to the inner tubular member so as to expose the stent short of its full deployment position; and

deploying the stent such that the stent expands forming a lumen therethrough at the target area.

2. The method of claim 1, further comprising removing the deployment apparatus through the lumen of the deployed stent.

3. The method of claim 1, wherein providing comprises providing a stent deployment apparatus comprising a safety catch assembly disposed between the distal and proximal ends of the outer tubular member, wherein the inner tubular member further comprises at least one catch along the longitudinal expanse thereof for operative interaction with the safety catch assembly to limit extent of stent deployment.

4. The method of claim 3, wherein displacing comprises displacing the outer tubular member relative to the inner tubular member to a predetermined threshold corresponding to engagement of the at least one catch with the safety mechanism.

5. The method of claim 1, wherein providing comprises providing a stent deployment apparatus comprising a stop disposed about the inner tubular member, wherein the handle comprises a cavity defined therein.

6. The method of claim 5, wherein displacing comprises displacing the outer tubular member relative to the inner tubular member to a predetermined threshold corresponding to engagement of the stop with the cavity.

7. The method of claim 1, wherein displacing comprises displacing the outer tubular member relative to the inner tubular member to a predetermined threshold corresponding to between about 10 to 90% deployment of the stent.

8. The method of claim 7, wherein displacing comprises displacing the outer tubular member relative to the inner tubular member to a predetermined threshold corresponding to about 60% deployment of the stent.

9. The method of claim 1, wherein displacing comprises displacing the outer tubular member proximally away from the target area.

10. The method of claim 1, further comprising repositioning the stent following the displacing step and prior to the deploying step.

11. The method of claim 1, wherein providing comprises providing a stent deployment apparatus comprising an inner tubular member comprising at least one optical window defined therein.

12. The method of claim 11, further comprising viewing the target area through the at least one window with the scope.

13. The method of claim 1, wherein providing comprises providing a stent deployment apparatus comprising a syringe system comprising a needle and a bioactive product, wherein at least the needle is disposable through a portion of the inner tubular member or the outer tubular member.

14. The method of claim 13, further comprising:

positioning the needle about the target area within the patient; and

introducing a therapeutic dosage of the bioactive product to the target site.

15. The method of claim 14, wherein the bioactive product is a chemotherapeutic agent.

16. The method of claim 15, wherein the chemotherapeutic agent is selected from the group consisting of DNA-interactive Agents, Antimetabolites, Tubulin-Interactive Agents, Hormonal agents, Asparaginase, and Hydroxyurea.

17. The method of claim 16, wherein the Antimetabolites are selected from the group consisting of folate antagonists comprising Methotrexate or trimetrexate;

pyrimidine antagonists comprising Fluorouracil, Fluorodeoxyuridine, CB3717, Azacytidine, or Cytarabine;

Floxuridine purine antagonists comprising Mercaptopurine, 6-Thioguanine, Fludarabine, or Pentostatin;

sugar modified analogs comprising Cyctrabine or Fludarabine; and

ribonucleotide reductase inhibitors comprising Hydroxyurea.

18. The method of claim 15, wherein the DNA-Interactive Agents are selected from the group consisting of alkylating agents, the DNA strand-breakage agents, the intercalating topoisomerase II inhibitors, and the nonintercalating topoisomerase II inhibitors.

19. The method of claim 18, wherein the alkylating agents are selected from the group consisting of Nitrogen mustards, aziridines, nitroso ureas, platinum complexes, bioreductive alkylator, DNA strand breaking agents, Intercalators, and nonintercalators.

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

providing a stent deployment apparatus comprising;

a longitudinally extending inner tubular member having distal and proximal ends, the inner tubular member defining a lumen longitudinally extending substantially the distance from the distal end to the proximal end of the inner tubular member and forming a longitudinal expanse therebetween, the longitudinal expanse forming an aperture therethrough, and the inner tubular member having a tip coupled with the distal end, the inner tubular member about the distal end and proximal the tip further comprises a stent carrier adapted to carry a radially self-expanding stent in a radially contracted state;

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

a radially self-expanding stent carried by the stent carrier, extending along and surrounding at least part of the distal end of the inner tubular member and surrounded by a portion of the outer tubular member maintaining the stent in the radially contracted state; and

a handle coupled with a portion of the outer tubular member;

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

positioning the distal tip of the inner tubular member about a target area within the patient;

displacing the outer tubular member with respect to the inner tubular member so as to expose the stent short of its full deployment position; and

deploying the stent such that the stent expands forming a lumen therethrough that is larger than the radially contracted state of the stent.

21. The method of claim 20, further comprising:

inserting a scope through the lumen of the inner tubular member; and

viewing a target area within the patient.

22. The method of claim 20, further comprising removing the deployment apparatus through the lumen of the deployed stent.

23. The method of claim 20, further comprising:

positioning a utility instrument about a target area within the patient; and

introducing a therapeutic treatment to the target site via the utility instrument.

24. The method of claim 23, wherein introducing the therapeutic treatment comprises introducing a therapeutic dosage of a bioactive product to the target site.

25. The method of claim 23, wherein the utility instrument is selected from the group consisting of guidewires, optical devices, syringe systems, and combinations thereof.

26. The method of claim 25, wherein the syringe system has capabilities selected from the group consisting of thermotherapy, cryotherapy, electrocautery therapy, photodynamic therapy, chemotherapy, and combinations thereof.