Medical delivery system for delivery of a medically useful payload

Abstract

The present disclosure concerns a delivery system for delivering a medically useful payload through the vasculature to a site of interest in the patient's body. The medically useful payload may be a therapeutic device, such as a stent, and it may be a diagnostic tool, such as an imaging device. Owing to its structural attributes, the presently-inventive delivery system is well suited for carrying medical payload to and through vessel curvature and to branched regions (i.e., bifurcations) in same. Also, the device is well-suited to traveling through a vessel over a guiding element, such as a guidewire, which itself exhibits curvature.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a device of the present invention.

FIG. 2 is a cross sectional view of an aspect of the present invention.

FIG. 3 is a cross sectional view of another aspect of the present invention.

FIG. 4 is a cross sectional view of another aspect of the present invention.

FIG. 4A is a cross sectional view of another aspect of the present invention.

FIG. 4B is a cross sectional view of another aspect of the present invention.

FIG. 5 is a perspective view of an embodiment of a unidirectional bending member of the present invention;

FIG. 5A is a top plan view of the unidirectional bending member shown in FIG. 5;

FIG. 5B is a cross sectional view taken along line D-D in FIG. 5A;

FIG. 5C is a cross sectional view taken along line H-H in FIG. 5A;

FIG. 6 is a detailed view of the embodiment shown in FIG. 5;

FIG. 7 is a perspective view of the embodiment shown in FIG. 5, shown while flexing;

FIG. 8 is a top plan view of the embodiment shown in FIG. 5, shown while flexing;

FIG. 9 is a detailed view of the embodiment shown in FIG. 5, shown while flexing;

FIG. 10 is a side view of the embodiment shown in FIG. 5, shown while flexing;

FIG. 11 is a perspective view of an alternative embodiment of a unidirectional bending member of the present invention;

FIG. 12 is a cross-sectional view of an alternative embodiment of a unidirectional bending member of the present invention;

FIG. 13 is a cross-sectional view of yet another alternative embodiment of a unidirectional bending member of the present invention;

FIGS. 14A-14F are cross-sectional views of additional embodiments of a unidirectional bending member of the present invention;

FIG. 15 is a cross-sectional view of an alternative embodiment of a unidirectional bending member of the present invention;

FIG. 16 is a cross sectional view of a first bifurcation configuration in a patient's vasculature; and

FIG. 17 is a cross sectional view of a second bifurcation configuration in a patient's vasculature.

Claims

1. A device for carrying a medically useful payload positioned upon the device to a location of interest in a conduit of a patient, comprising: an intralumenal element sized and dimensioned to travel to a location of interest in a conduit of a patient;a flexible element positioned at a distal end of the intralumenal element wherein the flexible element exhibits the capability to bend substantially unidirectionally;wherein the flexible element, when encountering a non-linear path bends in the permitted direction in conformance to the non-linear path.

2. The device of claim 1 wherein the flexible element has a substantially symmetrical cross section.

3. The device of claim 1 wherein the flexible element has a substantially circular cross section.

4. The device of claim 1 wherein the flexible element comprises a plurality of segments defined by openings extending around a substantial portion of the element in a direction across the longitudinal axis of the element and a substantially longitudinal region wherein segments of the element are interconnected on one side.

5. The device of claim 1 wherein the flexible element comprises a tube cut into a plurality of segments in which openings between the segments extend around a substantial portion of the element circumference, wherein the isthmus-like connectors are present between the openings and extend substantially longitudinally along one element side.

6. The device of claim 1 wherein the flexible element has a substantially unidirectional bending member arrangement comprising a plurality of segments linked together by a weld or other linking means.

7. The device of claim 1 wherein the bending element is a tube having a stiffening material embedded on or within the tube walls in preselected regions to impart bending resistance, wherein at least one region does not possess substantial amounts of stiffness imparting material.

8. The device of claim 7 wherein the stiffening material is embedded within a predominant portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a minor portion of the tube wall periphery.

9. The device of claim 7 wherein the stiffening material is embedded within a minor portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a predominant portion of the tube wall periphery.

10. The device of claim 1 wherein the flexible element has a substantially unidirectional bending member arrangement effected by the manual placement or displacement of a stiffening material within the unidirectional bending member.

11. The device of claim 1 wherein the flexible element has a substantially unidirectional bending member arrangement effected by thermally modifying at least one portion of the unidirectional bending member.

12. The device of claim 1 wherein the flexible element has a substantially unidirectional bending member arrangement effected by chemically modifying at least one portion of the unidirectional bending member.

13. The device of claim 1 wherein the flexible element has a substantially unidirectional bending member arrangement effected by electrically inducing a variation in material phase change, change in modulus, or change in yield stress in the unidirectional bending member.

14. The device of claim 1 wherein the payload is selected from the group consisting of a diagnostic tool, ultrasound transducer (IVUS), pressure transducer, infrared sensor, and endoscope lens.

15. The device of claim 1 wherein the payload is selected from the group consisting of a therapeutic device, a stent, an atherectomy device, brachytherapy source, herniated or focal bump balloon, injection needle, laser, and thermal cauterization device.

16. In combination, the device of claim 1 positioned over a wire member having a length, wherein the wire member has a bendable section at a preselected location along the wire member length.

17. A device for carrying a medically useful payload to a location of interest in a conduit of a patient, comprising: an intralumenal element sized and dimensioned to travel to a location of interest in a conduit;a flexible element substantially rotatably coupled to a distal end of the intralumenal element wherein the flexible element exhibits the capability to bend substantially unidirectionally;

18. The device of claim 17 wherein the flexible element has a substantially symmetrical cross section.

19. The device of claim 17 wherein the flexible element has a substantially circular cross section.

20. The device of claim 17 wherein the flexible element comprises a plurality of segments defined by openings extending around a substantial portion of the element in a direction across the longitudinal axis of the element and a substantially longitudinal region wherein segments of the element are interconnected on one side.

21. The device of claim 17 wherein the flexible element comprises a tube cut into a plurality of segments in which openings between the segments extend around a substantial portion of the element circumference, wherein the isthmus-like connectors are present between the openings and extend substantially longitudinally along one element side.

22. The device of claim 17 wherein the flexible element has a substantially unidirectional bending member arrangement comprising a plurality of segments linked together by a weld or other linking means.

23. The device of claim 17 wherein the bending element is a tube having a stiffening material embedded on or within the tube walls in preselected regions to impart bending resistance, wherein at least one region does not possess substantial amounts of stiffness imparting material.

24. The device of claim 23 wherein the stiffening material is embedded within a predominant portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a minor portion of the tube wall periphery.

25. The device of claim 23 wherein the stiffening material is embedded within a minor portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a predominant portion of the tube wall periphery.

26. The device of claim 17 wherein the flexible element has a substantially unidirectional bending member arrangement effected by the manual placement or displacement of a stiffening material within the unidirectional bending member.

27. The device of claim 17 wherein the flexible element has a substantially unidirectional bending member arrangement effected by thermally modifying at least one portion of the unidirectional bending member.

28. The device of claim 17 wherein the flexible element has a substantially unidirectional bending member arrangement effected by chemically modifying at least one portion of the unidirectional bending member.

29. The device of claim 17 wherein the flexible element has a substantially unidirectional bending member arrangement effected by electrically inducing a variation in material phase change, change in modulus, or change in yield stress in the unidirectional bending member.

30. The device of claim 17 wherein the payload is selected from the group consisting of a diagnostic tool, ultrasound transducer (IVUS), pressure transducer, infrared sensor, and endoscope lens.

31. The device of claim 17 wherein the payload is selected from the group consisting of a therapeutic device, a stent, atherectomy device, brachytherapy source, herniated or focal bump balloon, injection needle, laser, and thermal cauterization device.

32. In combination, the device of claim 17 positioned over a wire member having a length, wherein the wire member has a bendable section at a preselected location along the wire member length.

33. A device for carrying a medically useful payload to a location of interest in a conduit of a patient, comprising: an intralumenal element sized and dimensioned to travel to a location of interest in a conduit;a flexible element positioned at the distal end of the intralumenal element, said flexible element having a substantially symmetrical cross section, wherein the flexible element exhibits the capability to bend substantially unidirectionally;

34. The device of claim 33 wherein the flexible element has a substantially circular cross section.

35. The device of claim 33 wherein the flexible element comprises a plurality of segments defined by openings extending around a substantial portion of the element in a direction across the longitudinal axis of the element and a substantially longitudinal region wherein segments of the element are interconnected on one side.

36. The device of claim 33 wherein the flexible element comprises a tube cut into a plurality of segments in which openings between the segments extend around a substantial portion of the element circumference, wherein the isthmus-like connectors are present between the openings and extend substantially longitudinally along one element side.

37. The device of claim 33 wherein the flexible element has a substantially unidirectional bending member arrangement comprising a plurality of segments linked together by a weld or other linking means.

38. The device of claim 33 wherein the bending element is a tube having a stiffening material embedded on or within the tube walls in preselected regions to impart bending resistance, wherein at least one region does not possess substantial amounts of stiffness imparting material.

39. The device of claim 38 wherein the stiffening material is embedded within a predominant portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a minor portion of the tube wall periphery.

40. The device of claim 38 wherein the stiffening material is embedded within a minor portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a predominant portion of the tube wall periphery.

41. The device of claim 33 wherein the flexible element has a substantially unidirectional bending member arrangement effected by the manual placement or displacement of a stiffening material within the unidirectional bending member.

42. The device of claim 33 wherein the flexible element has a substantially unidirectional bending member arrangement effected by thermally modifying at least one portion of the unidirectional bending member.

43. The device of claim 33 wherein the flexible element has a substantially unidirectional bending member arrangement effected by chemically modifying at least one portion of the unidirectional bending member.

44. The device of claim 33 wherein the flexible element has a substantially unidirectional bending member arrangement effected by electrically inducing a variation in material phase change, change in modulus, or change in yield stress in the unidirectional bending member.

45. The device of claim 33 wherein the payload is selected from the group consisting of a diagnostic tool, ultrasound transducer (IVUS), pressure transducer, infrared sensor, and endoscope lens.

46. The device of claim 33 wherein the payload is selected from the group consisting of a therapeutic device, a stent, an atherectomy device, brachytherapy source, herniated or focal bump balloon, injection needle, laser, and thermal cauterization device.

47. In combination, the device of claim 33 positioned over a wire member having a length, wherein the wire member has a bendable section at a preselected location along the wire member length.

48. A device for carrying a medically useful payload to a location of interest in a conduit of a patient, comprising: an intralumenal element sized and dimensioned to travel to a location of interest in a conduit;a flexible element substantially rotatably coupled to a distal end of the intralumenal element, said flexible element having a substantially symmetrical cross section, wherein the flexible element exhibits the capability to bend substantially unidirectionally;

49. The device of claim 48 wherein the flexible element has a substantially circular cross section.

50. The device of claim 48 wherein the flexible element comprises a plurality of segments defined by openings extending around a substantial portion of the element in a direction across the longitudinal axis of the element and a substantially longitudinal region wherein segments of the element are interconnected on one side.

51. The device of claim 48 wherein the flexible element comprises a tube cut into a plurality of segments in which openings between the segments extend around a substantial portion of the element circumference, wherein the isthmus-like connectors are present between the openings and extend substantially longitudinally along one element side.

52. The device of claim 48 wherein the flexible element has a substantially unidirectional bending member arrangement comprising a plurality of segments linked together by a weld or other linking means.

53. The device of claim 48 wherein the bending element is a tube having a stiffening material embedded on or within the tube walls in preselected regions to impart bending resistance, wherein at least one region does not possess substantial amounts of stiffness imparting material.

54. The device of claim 53 wherein the stiffening material is embedded within a predominant portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a minor portion of the tube wall periphery.

55. The device of claim 53 wherein the stiffening material is embedded within a minor portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a predominant portion of the tube wall periphery.

56. The device of claim 48 wherein the flexible element has a substantially unidirectional bending member arrangement effected by the manual placement or displacement of a stiffening material within the unidirectional bending member.

57. The device of claim 48 wherein the flexible element has a substantially unidirectional bending member arrangement effected by thermally modifying at least one portion of the unidirectional bending member.

58. The device of claim 48 wherein the flexible element has a substantially unidirectional bending member arrangement effected by chemically modifying at least one portion of the unidirectional bending member.

59. The device of claim 48 wherein the flexible element has a substantially unidirectional bending member arrangement effected by electrically inducing a variation in material phase change, change in modulus, or change in yield stress in the unidirectional bending member.

60. The device of claim 48 wherein the payload is selected from the group consisting of a diagnostic tool, ultrasound transducer (IVUS), pressure transducer, infrared sensor, and endoscope lens.

61. The device of claim 48 wherein the payload is selected from the group consisting of a therapeutic device, a stent, an atherectomy device, brachytherapy source, herniated or focal bump balloon, injection needle, laser, and thermal cauterization device.

62. In combination, the device of claim 48 positioned over a wire member having a length, wherein the wire member has a bendable section at a preselected location along the wire member length.

63. A device for carrying a medical implant, optionally, a stent, to a bifurcated vessel of a patient, comprising: a guidewire entry port,an intralumenal element sized and dimensioned to travel to the bifurcated vessel;a lumen positioned within the intralumenal element in communication with the guidewire port;a guidewire exit port;a guidewire passing into the guidewire entry port and out of the guidewire exit port and extending distally beyond the device;a flexible element positioned on a distal end of the intralumenal element, wherein the flexible element exhibits the capability to bend substantially unidirectionally and is capable of receiving the guidewire in the interior of the flexible element;

64. The device of claim 63 wherein the flexible element has a substantially symmetrical cross section.

65. The device of claim 63 wherein the flexible element has a substantially circular cross section.

66. The device of claim 63 wherein the flexible element comprises a tube cut into a plurality of segments in which openings between the segments extend around a substantial portion of the element circumference, wherein the isthmus-like connectors are present between the openings and extend substantially longitudinally along one element side.

67. The device of claim 63 wherein the flexible element has a substantially unidirectional bending member arrangement comprising a plurality of segments linked together by a weld or other linking means.

68. The device of claim 63 wherein the bending element is a tube having a stiffening material embedded on or within the tube walls in preselected regions to impart bending resistance, wherein at least one region does not possess substantial amounts of stiffness imparting material.

69. The device of claim 68 wherein the stiffening material is embedded within a predominant portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a minor portion of the tube wall periphery.

70. The device of claim 68 wherein the stiffening material is embedded within a minor portion of the tube wall periphery, wherein the at least one region not possessing substantial amounts of stiffness imparting material is a predominant portion of the tube wall periphery.

71. The device of claim 63 wherein the flexible element has a substantially unidirectional bending member arrangement effected by the manual placement or displacement of a stiffening material within the unidirectional bending member.

72. The device of claim 63 wherein the flexible element has a substantially unidirectional bending member arrangement effected by thermally modifying at least one portion of the unidirectional bending member.

73. The device of claim 63 wherein the flexible element has a substantially unidirectional bending member arrangement effected by chemically modifying at least one portion of the unidirectional bending member.

74. The device of claim 63 wherein the flexible element has a substantially unidirectional bending member arrangement effected by electrically inducing a variation in material phase change, change in modulus, or change in yield stress in the unidirectional bending member.

75. The device of claim 63 wherein the payload is selected from the group consisting of a diagnostic tool, ultrasound transducer (IVUS), pressure transducer, infrared sensor, and endoscope lens.

76. The device of claim 63 wherein the payload is selected from the group consisting of a therapeutic device, a stent, an atherectomy device, brachytherapy source, herniated or focal bump balloon, injection needle, laser, and thermal cauterization device.

77. The delivery device of claim 63 wherein the intralumenal element further comprises a second lumen for receiving a second guidewire and a second guidewire exit port.

78. The delivery device of claim 63 wherein the device further comprises an inflation port at its proximal end, an inflation balloon at its distal end, and an inflation fluid passageway through the intralumenal element which is in fluid communication with the inflation port and the inflation balloon.

79. The delivery device of claim 63 wherein the implant is carried by the flexible element.

80. The delivery device of claim 63 wherein the flexible element is substantially rotatably coupled to the intralumenal shaft.

81. The delivery device of claim 63 wherein the flexible element is substantially symmetrical in cross section.

82. The delivery device of claim 63 wherein the flexible section.

83. The delivery device of claim 63 wherein the flexible element is substantially circular in cross section.

84. The delivery device of claim 63 wherein the device further includes an inflation fluid port positioned at a device proximal end in fluid communication with an inflation balloon positioned at a distal end of the device.

85. The device of claim 63 wherein the flexible element has a substantially unidirectional bending member arrangement effected by the manual placement or displacement of a stiffening material within the unidirectional bending member.

86. A method of performing a medical procedure on a patient comprising the steps of inserting the device of claim 1 in a conduit within a patient, moving the device to a site of diagnosis or therapy, permitting the device to orient into position within the conduit, deploying a payload to effect the diagnosis or therapy, and removing the device from the patient.