Medical appliance optical delivery and deployment apparatus and method

• US 7,637,934 B2
• Filed: 03/31/2003
• Issued: 12/29/2009
• 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.
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): Prone; Christopher D
• Application Number:
  US10/404,197
• Publication Number:
  US 20040193243A1
• Time in Patent Office: 2,465 Days
• Field of Search: None
• US Class Current: 623/1.12
• 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 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 including at least one longitudinally extending channel formed between the exterior and interior diameter of the outer tubular member;

a handle configured to displace the outer tubular member and inner tubular member relative to each other in response to user intervention, the handle coupled with the outer tubular member, the handle having first and second ends and the second end including a cavity defined therein;

a stop disposed substantially about a circumference of the inner tubular member and configured to coaxially engage the cavity within the handle to form a safety mechanism;

whereby displaceability of the outer tubular member and inner tubular member relative to each other is limited by the safety mechanism to a predetermined threshold absent intervention by the user of the device such that the outer tubular member is configured to partially surround the stent at the predetermined threshold and the stent is not fully deployed when the stop is engaged with the cavity.

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 guidewire has optical capabilities.

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

6. 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.

7. The device of claim 6, wherein the syringe system is capable of administering a bioactive product.

8. The device of claim 7, wherein the bioactive product is a chemotherapeutic agent.

9. The device of claim 8, 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.

10. The device of claim 9, 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 8, wherein the DNA-interactive Agents are selected from the group consisting of alkylating agents, DNA strand-breakage agents, intercalating topoisomerase II inhibitors, and nonintercalating topoisomerase II inhibitors.

12. The device of claim 11, 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.

13. The device of claim 9, wherein the bioactive product comprises a hormonal agent.

14. The device of claim 13, wherein the hormonal agent is selected from the group consisting of estrogens, conjugated estrogens;

progestins; and

androgens.

15. The device of claim 9, wherein the bioactive product comprises an anti-hormonal agent.

16. The device of claim 15, wherein the anti-hormonal agent is selected from the group consisting of antiestrogenic, antiandrogen agents, and antiadrenal agents.

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, 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.

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

29. The device of claim 1, wherein the at least one longitudinally extending channel of the outer tubular member is configured to receive an optical scope.

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

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

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

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

34. The device of claim 1 or 33, wherein the outer tubular member is kink resistant.

35. 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.

36. 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.

37. The device of claim 36, 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.

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

39. The device of claim 38, further comprising at least one tab formed on the stop when the stop is molded on the hypotube, wherein the tab is configured to be broken during user intervention.

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

41. 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 distal tip coupled with the distal end, wherein the inner tubular member, about the distal end and proximal the distal tip, further comprises a stent carrier adapted to underlie and carry a stent in a radially contracted state, the lumen of the inner tubular member configured to receive an optical scope such that the scope is capable of extending through the lumen, through a stent disposed on the stent carrier, and distally of the distal tip, wherein the inner tubular member comprises at least one optical window defined therein and configured to facilitate visualization therethrough by the optical scope;

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 stop disposed about the inner tubular member and configured to engage the handle to form a safety mechanism; and

a hypotube having a first end and a second end, wherein the stop is formed on the hypotube between the first and second ends,

whereby the extent of displaceability of the outer tubular member and inner tubular member relative to each 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 by the safety mechanism absent intervention by the user and the outer tubular member is configured to partially surround the stent at the predetermined threshold.

42. The device of claim 41, wherein the outer tubular member defines longitudinally extending channels formed between the exterior and interior diameter of the outer tubular member, and wherein the longitudinally extending channels accommodate utility instruments through a lumen thereof.

43. The device of claim 42, wherein the utility instruments are selected from the group consisting of guidewires, optical devices, syringe systems or combinations thereof.

44. The device of claim 43, wherein the syringe system has capabilities selected from the group consisting of thermotherapy, cryotherapy, photodynamic therapy, chemotherapy or combinations thereof.

45. The device of claim 43, wherein the guidewire has optical capabilities.

46. The device of claim 43, wherein the guidewire has ultrasound capabilities.

47. The device of claim 44, wherein the syringe system is capable of administering a bioactive product.

48. The device of claim 47, wherein the bioactive product comprises a hormonal agent.

49. The device of claim 48, wherein the hormonal agent is selected from the group consisting of estrogens, conjugated estrogens;

progestins; and

androgens.

50. The device of claim 47, wherein the bioactive product comprises an anti-hormonal agent.

51. The device of claim 50, wherein the anti-hormonal agent is selected from the group consisting of antiestrogenic, antiandrogen agents, and antiadrenal agents.

52. The device of claim 47, wherein the bioactive product is a chemotherapeutic agent.

53. The device of claim 52, 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.

54. The device of claim 53, 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.

55. The device of claim 52, wherein the DNA-interactive Agents are selected from the group consisting of alkylating agents, DNA strand-breakage agents, intercalating topoisomerase II inhibitors, and nonintercalating topoisomerase II inhibitors.

56. The device of claim 55, 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.

57. The device of claim 42, wherein the longitudinally extending channels of the outer tubular member are configured to receive an optical scope.

58. The device of claim 41, further comprising a distal tip having an interior and an exterior surface and distal and proximal ends.

59. The device of claim 58, wherein the distal tip further comprises a light source.

60. The device of claim 58, wherein the distal tip further comprises a lens.

61. The device of claim 58, wherein the distal tip further comprises utility grooves formed along the exterior surface thereof, which extend substantially between the distal and proximal ends thereof.

62. The device of claim 58, wherein the distal tip defines a plurality of apertures formed there through.

63. The device of claim 41, wherein the user intervention comprises displacing the outer tubular member axially relative to the inner tubular member.

64. The device of claim 63, wherein an audible indication follows the user intervention.

65. The device of claim 63, wherein a tactile indication follows the user intervention.

66. The device of claim 63, further comprising at least one tab formed on the stop, which serves as the audible indication when broken during user intervention.

67. The device of claim 63, 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.

68. The device of claim 41, wherein the predetermined threshold is about between 10% and 90% deployment.

69. The device of claim 68, wherein the predetermined threshold is about 60% deployment.

70. The device of claim 41, wherein a guidewire is introduced through a portion of the exterior diameter of the outer tubular member.

71. The device of claim 41, wherein the outer tubular member is clear.

72. The device of claim 41, wherein there is at least one marker coupled with a portion of the inner tubular member.

73. The device of claim 41, wherein there is at least one marker coupled with a portion of the outer tubular member.

74. The device of claim 41, wherein the inner tubular member is of a material that is kink resistant.

75. The device of claim 41, wherein the outer tubular member is kink resistant.

76. The device of claim 41, 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.

77. The device of claim 41, 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.

78. The device of claim 77, 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.

79. 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, wherein the tip comprises a plurality of apertures defined therethrough, the inner tubular member further comprising a stent carrier adapted to carry a radially self-expanding stent in a radially contracted state proximate to the distal end and proximal the distal tip; and

a longitudinally extending outer tubular member having proximal and distal ends and an exterior and interior diameter, the outer tubular member being longitudinally and axially displaceable relative to the inner tubular member, wherein the outer tubular member defines longitudinally extending channels formed between the exterior and interior diameter thereof, wherein the longitudinally extending channels are configured to align with a respective aperture defined in the distal tip, wherein an exterior diameter of a proximal end of the distal tip is substantially the same as the exterior diameter of the distal end of the outer tubular member, and wherein the exterior diameter of the outer tubular member is substantially the same between its proximal and distal ends.

80. The device of claim 79, 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.

81. The device of claim 80, 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.

82. The device of claim 79, wherein each of the longitudinally extending channels are configured to accommodate at least one utility instrument through a lumen thereof.

83. The device of claim 82, wherein the utility instruments are selected from the group consisting of guidewires, optical devices, syringe systems or combinations thereof.

84. The device of claim 83, wherein the guidewire has optical capabilities.

85. The device of claim 83, wherein the guidewire has ultrasound capabilities.

86. The device of claim 83, wherein the syringe system has capabilities selected from the group consisting of thermotherapy, cryotherapy, electrocautery therapy, photodynamic therapy, chemotherapy or combinations thereof.

87. The device of claim 86, wherein the syringe system is capable of administering a bioactive product.

88. The device of claim 87, wherein the bioactive product is a chemotherapeutic agent.

89. The device of claim 88, wherein the DNA-interactive Agents are selected from the group consisting of alkylating agents, DNA strand-breakage agents, intercalating topoisomerase II inhibitors, and nonintercalating topoisomerase II inhibitors.

90. The device of claim 89, 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.

91. The device of claim 88, 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.

92. The device of claim 91, 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, Fludorabine; and

ribonucleotide reductase inhibitors include Hydroxyurea.

93. The device of claim 91, wherein the bioactive product comprises a hormonal agent.

94. The device of claim 93, wherein the hormonal agent is selected from the group consisting of estrogens, conjugated estrogens;

progestins; and

androgens.

95. The device of claim 91, wherein the bioactive product comprises on anti-hormonal agent.

96. The device of claim 95, wherein the anti-hormonal agent is selected from the group consisting of antiestrogenic, antiandrogen agents, and antiadrenal agents.

97. The device of claim 79, wherein the distal tip comprises an interior and an exterior surface and distal and proximal ends.

98. The device of claim 97, wherein the distal tip comprises a lumen extending between the proximal and distal ends of the distal tip that is configured to align with the lumen of the inner tubular member.

99. The device of claim 79, wherein a guidewire is introduced through a portion of the exterior diameter of the outer tubular member.

100. The device of claim 79, wherein the longitudinally extending channels of the outer tubular member is configured to receive an optical scope.

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

102. The device of claim 79, wherein there is at least one marker coupled with a portion of the inner tubular member.

103. The device of claim 79, wherein there is at least one marker coupled with a portion of the outer tubular member.

104. The device of claim 79, wherein the inner tubular member is of a material that is kink resistant.

105. The device of claim 104, wherein the outer tubular member is kink resistant.

106. 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, the lumen of the inner tubular member configured to receive an optical scope such that the optical scope is capable of extending through the lumen and distally of the tip, wherein the inner tubular member comprises at least one optical window defined therein and configured to facilitate visualization therethrough by the optical scope;

a longitudinally extending outer tubular member being longitudinally and axially displaceable relative to the inner tubular member;

a handle configured to displace the outer tubular member and inner tubular member relative to each other in response to user intervention, the handle coupled to the outer tubular member, the handle having first and second ends, wherein the second end of the handle includes a cavity defined circumferentially therein and about the outer tubular member;

a stop disposed substantially about a circumference of the inner tubular member and configured to engage the cavity within the handle to form a safety mechanism;

whereby displaceability of the outer tubular member and inner tubular member relative to each other is limited by the safety mechanism to a predetermined threshold absent intervention by the user of the device such that the outer tubular member is configured to partially surround the stent at the predetermined threshold and the stent is not fully deployed when the stop is engaged with the cavity.

107. 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, the lumen of the inner tubular member configured to receive an optical scope such that the optical scope is capable of extending through the lumen and distally of the tip, wherein the inner tubular member comprises at least one optical window defined therein and configured to facilitate visualization therethrough by the optical scope;

a longitudinally extending outer tubular member being longitudinally and axially displaceable relative to the inner tubular member;

a handle configured to displace the outer tubular member and inner tubular member relative to each other in response to user intervention, the handle coupled to the outer tubular member, the handle having proximal and distal ends, wherein the proximal end of the handle includes a cavity defined therein;

a stop coupled to the inner tubular member and disposed substantially about a circumference thereof such that the stop is configured to engage the cavity within the handle when the outer tubular member is displaced relative to the inner tubular member to a predetermined threshold;

whereby displaceability of the outer tubular member and inner tubular member relative to each other is limited to the predetermined threshold when the stop is in engagement with the cavity and such that complete deployment of the stent is limited absent intervention by the user and the outer tubular member is configured to partially surround the stent at the predetermined threshold.

108. 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, the lumen of the inner tubular member configured to receive an optical scope such that the optical scope is capable of extending through the lumen and distally of the tip, wherein the inner tubular member comprises at least one optical window defined therein and configured to facilitate visualization therethrough by the optical scope;

a longitudinally extending outer tubular member being longitudinally and axially displaceable relative to the inner tubular member;

a handle configured to displace the outer tubular member and inner tubular member relative to each other in response to user intervention, the handle coupled to the outer tubular member, the handle having proximal and distal ends, wherein the proximal end of the handle includes a cavity defined therein;

a stop disposed substantially about a circumference of the inner tubular member and positioned proximally of the cavity such that the stop is configured to engage the cavity when the handle is displaced in a proximal direction to a predetermined threshold;

whereby displaceability of the outer tubular member and inner tubular member relative to each other is limited by engagement of the stop within the cavity to the predetermined threshold absent intervention by the user of the device such that the outer tubular member is configured to partially surround the stent at the predetermined threshold and the stent is not fully deployed when the stop is engaged with the cavity.