Medical appliance optical delivery and deployment apparatus and method

• US 20040193243A1
• Filed: 03/31/2003
• Published: 09/30/2004
• 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 7,637,934 B2
• Time in Patent Office: Days
• 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 2/966 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

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 inner tubular member defines 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 there between, the longitudinal expanse forming an aperture there through, 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;

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 threads formed thereon;

a hypotube having a first end, a second end, an exterior surface, an interior surface and a stop formed on the hypotube between the first and second ends, the exterior surface of the stop complementary to the threads of the handle cavity to form a safety mechanism;

whereby the extent of displaceability of the outer tubular member and inner tubular member relative to the other is limited by the safety mechanism to a predetermined threshold absent intervention by the user of the device such that the degree of stent deployment is limited absent the user intervention.

2. The device of claim 1, wherein the longitudinally extending channels accommodate utility instruments through a lumen thereof.

3. The device of claim 2, wherein the utility instruments are selected from the group consisting of guidewires, optical devices, syringe systems or combinations thereof.

4. The device of claim 3, wherein the syringe system has capabilities selected from the group consisting of thermotherapy, cryotherapy, electrocautery therapy, photodynamic therapy, chemotherapy or combinations thereof.

5. The device of claim 4, wherein the syringe system is capable of administering a bioactive product.

6. The device of claim 5, wherein the bioactive product is a chemotherapeutic agent.

7. The device of claim 6, wherein the chemotherapeutic agent is selected from the group consisting of DNA-interactive Agents, Antimetabolites, Tubulin-Interactive Agents, Hormonal agents and others such as Asparaginase or Hydroxyurea.

8. The device of claim 6, 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.

9. The device of claim 8, 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.

10. The device of claim 7, wherein the Antimetabolites are selected from the group consisting of folate antagonists such as Methotrexate and trimetrexate;

pyrimidine antagonists, such as Fluorouracil, Fluorodeoxyuridine, CB3717, Azacytidine, Cytarabine;

Floxuridine purine antagonists include Mercaptopurine, 6-Thioguanine, Fludarabine, Pentostatin;

sugar modified analogs include Cyctrabine, Fludarabine; and

ribonucleotide reductase inhibitors include Hydroxyurea.

11. The device of claim 7, wherein the bioactive product comprises a hormonal agent.

12. The device of claim 11, wherein the hormonal agent is selected from the group consisting of estrogens, conjugated estrogens;

progestins; and

androgens.

13. The device of claim 7, wherein the bioactive product comprises an anti-hormonal agent.

14. The device of claim 13, wherein the anti-hormonal agent is selected from the group consisting of antiestrogenic, antiandrogen agents, and antiadrenal agents.

15. The device of claim 3, wherein the guidewire has optical capabilities.

16. The device of claim 3, wherein the guidewire has ultrasound capabilities.

17. The device of claim 1, further comprising a distal tip having an interior and an exterior surface and distal and proximal ends.

18. The device of claim 17, wherein the distal tip further comprises a light source.

19. The device of claim 18, wherein the distal tip further comprises a lens.

20. The device of claim 17, wherein the distal tip further comprises utility grooves formed along the exterior surface thereof, which extend substantially between the distal and proximal ends thereof.

21. The device of claim 17, wherein the distal tip defines a plurality of apertures formed there through.

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

23. The device of claim 22, wherein an audible indication follows the user intervention.

24. The device of claim 22, wherein a tactile indication follows the user intervention.

25. The device of claim 22, further comprising at least one tab formed on the stop when the stop is molded on the hypotube, which serves as the audible indication when broken during user intervention.

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

27. The device of claim 26, wherein the predetermined threshold is about 60% deployment.

28. The device of claim 22, 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.

29. The device of claim 1, wherein a guidewire is introduced through a portion of the exterior diameter of the outer tubular member.

30. The device of claim 1, wherein the longitudinally extending channels of the outer tubular member is configured to receive an optical scope.

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

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

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

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

35. The device of claim 1 or 34, wherein the outer tubular member is kink resistant.

36. The device of claim 1, wherein the distal tip has first, medial and second sections, the first and second sections having Exterior Diameters that are less than that of the medial section.

37. 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.

38. The device of claim 37, 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.

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

providing a stent deployment apparatus comprising a stent, a longitudinally extending outer tubular member having interior and exterior surfaces and distal and proximal ends, a safety catch assembly disposed between the distal and proximal ends and the outer tubular member defining a plurality of longitudinally extending channels formed between the interior and exterior surfaces thereof; 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 and wherein the distal end comprises a tip, the inner tubular member further comprises at least one catch along the longitudinal expanse thereof for operative interaction with the safety catch assembly of the longitudinally extending outer tubular member to limit extent of stent deployment;

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;

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 there through that is larger than the compressed diameter of the stent.

40. The method of claim 39, further comprising the step of:

removing the deployment apparatus through the lumen of the deployed stent.

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

providing a longitudinally extending inner tubular member having distal and proximal ends, 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 and forming a longitudinal expanse there between, the longitudinal expanse forming an aperture there through, 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;

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

a hypotube having a first end, a second end, an exterior surface and an interior surface formed between the handle and the inner tube;

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;

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 there through that is larger than the compressed diameter of the stent.

42. The method of claim 41, further comprising the step of:

moving the deployment apparatus through the lumen of the deployed stent.

43. A method of treating a target tissue in a patient during a stent delivery and deployment procedure, comprising the steps of:

providing an apparatus comprising having a longitudinally extending outer tubular member having interior and exterior surfaces and distal and proximal ends, a safety catch assembly disposed between the distal and proximal ends and the outer tubular member defining a plurality of longitudinally extending channels formed between the interior and exterior surfaces thereof wherein the channels have visualization capabilities; 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 and wherein the distal end comprises a tip, the inner tubular member further comprises at least one catch along the longitudinal expanse thereof for operative interaction with the safety catch assembly of the longitudinally extending outer tubular member to limit extent of stent deployment, and a syringe system comprising a need, a conduit, reservoir and bioactive product, wherein at least the needle is disposable through a portion of the inner tubular member or the outer tubular member;

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

viewing a target area within the patient through at least one of the longitudinally extending channels;

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

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

44. The method of claim 43, wherein the bioactive product is a chemotherapeutic agent.

45. The method of claim 44, wherein the chemotherapeutic agent is selected from the group consisting of DNA-interactive Agents, Antimetabolites, Tubulin-Interactive Agents, Hormonal agents and others such as Asparaginase or Hydroxyurea.

46. The method of claim 43, 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.

47. The method of claim 46, 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.

48. The method of claim 45, wherein the Antimetabolites are selected from the group consisting of folate antagonists such as Methotrexate and trimetrexate;

pyrimidine antagonists, such as Fluorouracil, Fluorodeoxyuridine, CB3717, Azacytidine, Cytarabine;

Floxuridine purine antagonists include Mercaptopurine, 6-Thioguanine, Fludarabine, Pentostatin;

sugar modified analogs include Cyctrabine, Fludarabine; and

ribonucleotide reductase inhibitors include Hydroxyurea.

49. 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 inner tubular member defines 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 there between, the longitudinal expanse forming an aperture there through, 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;

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

a hypotube having a first end, a second end, an exterior surface and an interior surface formed between the handle and the inner tube

whereby the extent of displaceability of the outer tubular member and inner tubular member relative to the other is limited by the safety mechanism to a predetermined threshold absent intervention by the user of the device such that the degree of stent deployment is limited absent the user intervention.

50. The device of claim 49, wherein the longitudinally extending channels accommodate utility instruments through a lumen thereof.

51. The device of claim 50, wherein the utility instruments are selected from the group consisting of guidewires, optical devices, syringe systems or combinations thereof.

52. The device of claim 51, wherein the syringe system has capabilities selected from the group consisting of thermotherapy, cryotherapy, photodynamic therapy, chemotherapy or combinations thereof.

53. The device of claim 52, wherein the syringe system is capable of administering a bioactive product.

54. The device of claim 53, wherein the bioactive product is a chemotherapeutic agent.

55. The device of claim 54, wherein the chemotherapeutic agent is selected from the group consisting of DNA-interactive Agents, Antimetabolites, Tubulin-Interactive Agents, Hormonal agents and others such as Asparaginase or Hydroxyurea.

56. The device of claim 54, 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.

57. The device of claim 56, 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.

58. The device of claim 55, wherein the Antimetabolites are selected from the group consisting of folate antagonists such as Methotrexate and trimetrexate;

pyrimidine antagonists, such as Fluorouracil, Fluorodeoxyuridine, CB3717, Azacytidine, Cytarabine;

Floxuridine purine antagonists include Mercaptopurine, 6-Thioguanine, Fludarabine, Pentostatin;

sugar modified analogs include Cyctrabine, Fludarabine; and

ribonucleotide reductase inhibitors include Hydroxyurea.

59. The device of claim 53, wherein the bioactive product comprises a hormonal agent.

60. The device of claim 59, wherein the hormonal agent is selected from the group consisting of estrogens, conjugated estrogens;

progestins; and

androgens.

61. The device of claim 53, wherein the bioactive product comprises an anti-hormonal agent.

62. The device of claim 61, wherein the anti-hormonal agent is selected from the group consisting of antiestrogenic, antiandrogen agents, and antiadrenal agents.

63. The device of claim 51, wherein the guidewire has optical capabilities.

64. The device of claim 51, wherein the guidewire has ultrasound capabilities.

65. The device of claim 49, further comprising a distal tip having an interior and an exterior surface and distal and proximal ends.

66. The device of claim 65, wherein the distal tip further comprises a light source.

67. The device of claim 65, wherein the distal tip further comprises a lens.

68. The device of claim 65, wherein the distal tip further comprises utility grooves formed along the exterior surface thereof, which extend substantially between the distal and proximal ends thereof.

69. The device of claim 65, wherein the distal tip defines a plurality of apertures formed there through.

70. The device of claim 49, wherein the user intervention comprises displacing the outer tubular member axially relative to the inner tubular member.

71. The device of claim 70, wherein an audible indication follows the user intervention.

72. The device of claim 70, wherein a tactile indication follows the user intervention.

73. The device of claim 70, further comprising at least one tab formed on the stop when the stop is molded on the hypotube, which serves as the audible indication when broken during user intervention.

74. The device of claim 49, wherein the predetermined threshold is about between 10% and 90% deployment.

75. The device of claim 74, wherein the predetermined threshold is about 60% deployment.

76. The device of claim 70, 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.

77. The device of claim 49, wherein a guidewire is introduced through a portion of the exterior diameter of the outer tubular member.

78. The device of claim 49, wherein the longitudinally extending channels of the outer tubular member is configured to receive an optical scope.

79. The device of claim 49, wherein the outer tubular member is clear.

80. The device of claim 49, wherein there is at least one marker coupled with a portion of the inner tubular member.

81. The device of claim 49, wherein there is at least one marker coupled with a portion of the outer tubular member.

82. The device of claim 49, wherein the inner tubular member is of a material that is kink resistant.

83. The device of claim 49, wherein the outer tubular member is kink resistant.

84. The device of claim 83, wherein the outer tubular member is kink resistant.

85. The device of claim 49, wherein the distal tip has first, medial and second sections, the first and second sections having Exterior Diameters that are less than that of the medial section.

86. The device of claim 49, 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.

87. The device of claim 86, 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.