Medical device delivery catheter

• US 20060089627A1
• Filed: 10/26/2004
• Published: 04/27/2006
• Est. Priority Date: 10/26/2004
• Status: Active Grant

• Current Assignee: BAROnova, Inc.
• Original Assignee: Polymorfix Inc.
• Inventors: Burnett, Daniel R., Hall, Gregory W., Bajor, Jordan T., Fisher, Winfield Scott, Hites, Tibor Laszlo
• Granted Patent: US 7,347,868 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12059 Joint of soluble material
• CPC Class Codes: A61B 2017/12081 detachable by inflation
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions

Abstract

Apparatus for delivering a medical device to a location in a patient'"'"'s body includes an elongate catheter body having a proximal end and a distal end, a pod coupled with the distal end of the catheter body and adapted to house the medical device during delivery to the location and to open to release the medical device, and at least one distal actuator coupled with at least one of the pod and the medical device. The distal actuator is adapted to promote opening of the pod. A method involves advancing a pod at the distal end of an elongate catheter to the location within the body and activating an actuator coupled with the pod and/or the medical device to cause the pod to open. Opening the pod releases the medical device.

Claims

1. Apparatus for delivering a medical device to a location in a patient'"'"'s body, the apparatus comprising:

an elongate catheter body having a proximal end and a distal end;

a pod coupled with the distal end of the catheter body and adapted to house the medical device during delivery to the location and to open to release the medical device; and

at least one distal actuator coupled with at least one of the pod and the medical device, the distal actuator adapted to promote opening of the pod.

2. Apparatus as in claim 1, wherein the pod comprises a material disposed over the medical device, the material adapted to tear or peel to open the pod.

3. Apparatus as in claim 2, wherein the material is selected from the group consisting of silicone, polyisoprene, polyimide, polyurethane, polyolefin, polyethylene, nylon, latex, neoprene, stainless steel, nitinol, ceramic, Teflon, a biodegradable material and a composite.

4. Apparatus as in claim 2, wherein the material comprises a shape-memory material adapted to curl inward after the material is torn or peeled.

5. Apparatus as in claim 2, wherein the material includes at least one set of perforations or slits to promote tearing or peeling of the material.

6. Apparatus as in claim 5, wherein the perforations are disposed along the pod in a configuration selected from the group consisting of straight line(s) parallel to a long axis of the pod, straight line(s) circumferential about and perpendicular to the long axis of the pod, spiral line(s), wavy line(s) and lines forming an open-mouth shape.

7. Apparatus as in claim 2, wherein the material includes a plurality of apertures disposed along opposite ends, the apparatus further comprising a cord for passing through the apertures to maintain the material over the medical device, wherein removing the cord causes the pod to open.

8. Apparatus as in claim 2, wherein the material includes at least one structurally weaker portion, relative to the rest of the material, to promote tearing or peeling of the material.

9. Apparatus as in claim 2, wherein the material includes at least one zip-lock member along at least part of its length, the zip-lock member adapted to unzip from a closed, locked configuration to an open configuration.

10. Apparatus as in claim 2, wherein the distal actuator is adapted to cut the material, and wherein the actuator is selected from the group consisting of blades, rip cords, wires, threads, wedges, other cutting members and zippers.

11. Apparatus as in claim 2, wherein the distal actuator comprises a pressure input member for introducing positive pressure into the pod to cause the material to burst.

12. Apparatus as in claim 2, wherein the distal actuator comprises an inflation device coupled with the medical device for inflating the medical device to cause the device to expand and rupture the material.

13. Apparatus as in claim 1, further comprising a retractable inner shaft extending axially through the housing, wherein the medical device includes at least one lumen to allow the medical device to reside over the inner shaft during delivery, and wherein retracting the inner shaft releases at least part of the medical device.

14. Apparatus as in claim 13, wherein the retractable shaft extends beyond a distal end of the pod, wherein retracting the shaft releases a distal portion of the medical device, and wherein opening the pod releases a proximal portion of the medical device.

15. Apparatus as in claim 1, wherein the pod comprises:

at least two opposed housing members for releasably housing the medical device; and

at least one hinge for movably coupling the housing members, wherein the housing members are adapted to move about the hinge(s) to cause the pod to open.

16. Apparatus as in claim 15, wherein the housing members comprise a material selected from the group consisting of a polymer, a ceramic, a metal, a composite and a biological material.

17. Apparatus as in claim 15, wherein the hinge is selected from the group consisting of a flexible material hinge, a living hinge, a pin joint and a universal joint.

18. Apparatus as in claim 15, wherein at least part of each housing member comprises at least one of a shape-memory material, a super-elastic material and a spring loaded material, and wherein the housing members are preformed to move away from one another when released from constraint.

19. Apparatus as in claim 18, wherein the distal actuator is adapted to releasably hold the pod in a closed configuration and, upon activation, to release the pod to allow it to assume the open configuration.

20. Apparatus as in claim 19, wherein the distal actuator is selected from the group comprising a ring, a retractable sleeve, a tearable sleeve, a pin and a clamp.

21. Apparatus as in claim 15, further comprising at least one spring disposed between the housing members to urge them apart.

22. Apparatus as in claim 15, wherein the distal actuator comprises at least one movable holder disposed about the housing members, wherein the holder is movable from a first position to hold the housing members together to a second position to allow the housing members to move apart.

23. Apparatus as in claim 22, wherein the holder is movable from the second position to the first position to move the housing members back together.

24. Apparatus as in claim 22, wherein the holder comprises at least one ring disposed around the housing members, and wherein the ring in the first position is disposed near a distal end of the pod and the ring in the second position is disposed near a proximal end of the pod.

25. Apparatus as in claim 22, wherein the holder comprises a sleeve movably disposed over the housing members.

26. Apparatus as in claim 22, wherein the actuator further comprises a wedge for urging the housing members apart when the holder is moved from the first to the second position.

27. Apparatus as in claim 1, wherein the pod comprises at least one radiopaque marker or material.

28. Apparatus as in claim 1, wherein the pod includes an open distal end.

29. Apparatus as in claim 28, wherein a distal end of the medical device extends out of the open distal end of the pod to form a flexible tip.

30. Apparatus as in claim 1, wherein the pod comprises a distal tip.

31. Apparatus as in claim 30, wherein the tip comprises a rigid, pointed tip adapted to pierce through tissue.

32. Apparatus as in claim 30, wherein the tip comprises a blunt, atraumatic tip to prevent tissue damage during advancement of the pod.

33. Apparatus as in claim 30, wherein the tip comprises a flexible nose having at least one aperture or lumen for accepting a guidewire.

34. Apparatus as in claim 1, further comprising a movable pusher member disposed in the pod to urge the medical device out of the opened pod.

35. Apparatus as in claim 34, wherein the pusher member comprises:

a platform disposed near a proximal end of the pod for contacting and urging the medical device; and

an elongate shaft coupled with the platform and extending through the catheter body to its proximal end to allow a user to advance and retract the platform.

36. Apparatus as in claim 34, wherein the pusher member comprises a spring-loaded platform disposed near a proximal end of the pod, the platform adapted to urge the medical device out of the pod upon release from constraint.

37. Apparatus as in claim 36, wherein the platform is automatically released from constraint when the pod opens.

38. Apparatus as in claim 36, wherein the platform is released from constraint by the user.

39. Apparatus as in claim 36, further comprising a safety mechanism releasably coupled with the platform to prevent the platform from advancing prematurely.

40. Apparatus as in claim 1, further comprising at least one support member disposed along at least part of a length of the pod for reducing bending of the pod.

41. Apparatus as in claim 40, wherein the at least one support member comprises multiple support members disposed along an inner surface of the pod.

42. Apparatus as in claim 41, wherein the support members comprise silicone.

43. Apparatus as in claim 1, further comprising a guidewire lumen disposed along at least part of the pod.

44. Apparatus as in claim 43, wherein the guidewire lumen is disposed along an outer surface of the pod.

45. Apparatus as in claim 43, wherein the guidewire lumen is disposed along an inner surface of the pod.

46. Apparatus as in claim 43, wherein the guidewire lumen extends onto at least part of the catheter body.

47. Apparatus as in claim 43, further comprising an additional guidewire lumen disposed along at least part of the medical device.

48. Apparatus as in claim 1, further comprising at least one proximal actuator coupled with the distal actuator to allow a user to activate the distal actuator.

49. Apparatus as in claim 48, wherein the proximal actuator is selected from the group consisting of a trigger, a pull cord, a button, a dial and a slide actuator.

50. Apparatus as in claim 48, wherein the proximal actuator is coupled with the distal actuator via at least one of a shaft and a cord extending through a lumen of the catheter body.

51. Apparatus as in claim 48, wherein the proximal actuator is coupled with the distal actuator via an electrical connection.

52. Apparatus as in claim 1, wherein the catheter body includes a series of depth markings on its outer surface to indicate to a user how far the pod is inserted within the patient'"'"'s body.

53. Apparatus as in claim 1, wherein the medical device is adapted to reside in a stomach and intermittently contact a pyloric valve.

54. Apparatus as in claim 53, wherein the device comprises:

a distal portion for residing in a duodenum;

a proximal portion for residing in the stomach; and

an elongate connecting portion for connecting the distal portion with the proximal portion and adapted to extend across the pyloric valve.

55. Apparatus as in claim 54, wherein the delivery apparatus is adapted to release the distal portion in the duodenum and then release the proximal portion in the stomach.

56. Apparatus as in claim 53, wherein the medical device is adapted to slow the passage of food from through the pyloric valve to help treat obesity.

57. Apparatus as in claim 53, wherein the medical device is adapted to house or anchor a second medical device disposed in the stomach, a small intestine or both to perform a function within the stomach and/or small intestine.

58. Apparatus for delivering a medical device to a location in a patient'"'"'s body, the apparatus comprising:

an elongate catheter body having a proximal end and a distal end; and

a pod coupled with the distal end of the catheter body and adapted to house the medical device during delivery to the location and to open to release the medical device,

wherein the pod is adapted to automatically open after being positioned in the location.

59. Apparatus as in claim 58, wherein the pod comprises a material disposed over the medical device, and wherein at least part of the material is biodegradable.

60. Apparatus as in claim 59, the pod further comprising at least two opposed housing members disposed within the material, wherein the housing members automatically move apart to cause the pod to open when the material at least partially degrades.

61. Apparatus as in claim 59 or 60, wherein the location is a stomach of the patient, and wherein at least part of the material is rapidly biodegradable in the stomach.

62. Apparatus as in claim 58, wherein the pod comprises a material disposed over the medical device, and wherein at least part of the material degrades upon reaching a temperature present at a desired delivery location.

63. A system for delivering a medical device to a location in a patient'"'"'s body, the system comprising:

an elongate catheter body having a proximal end and a distal end;

a pod coupled with the distal end of the catheter body and adapted to house the medical device during delivery to the location and to open to release the medical device;

at least one distal actuator coupled with at least one of the pod and the medical device, the distal actuator adapted to promote opening of the pod; and

a medical device releasably housed within the pod.

64. A system as in claim 63, wherein the device comprises:

a distal portion for residing in a duodenum;

a proximal portion for residing in the stomach; and

an elongate connecting portion for connecting the distal portion with the proximal portion and adapted to extend across the pyloric valve.

65. A system as in claim 64, wherein the delivery apparatus is adapted to release the distal portion in the duodenum and then release the proximal portion in the stomach.

66. A system as in claim 63, wherein the medical device is adapted to reside in a stomach and intermittently contact a pyloric valve.

67. A system as in claim 66, wherein the medical device is adapted to slow the passage of food from through the pyloric valve to help treat obesity.

68. A system as in claim 66, wherein the medical device is adapted to house or anchor a second medical device disposed in the stomach, a small intestine or both to perform a function within the stomach and/or small intestine.

69. A system as in claim 63, further comprising a tether coupling the medical device to at least one of the catheter body and the pod, wherein removing the catheter from the patient removes the medical device from the patient.

70. A method for delivering a medical device to a location in a patient'"'"'s body, the method comprising:

advancing a pod at the distal end of an elongate catheter to the location within the body; and

activating an actuator coupled with at least one of the pod and the medical device to cause the pod to open,

wherein opening the pod releases the medical device.

71. A method as in claim 70, wherein at least a distal portion of the pod is advanced across the patient'"'"'s pyloric valve, such that when the pod is opened, a distal portion of the medical device resides in the patient'"'"'s duodenum, a proximal portion of the device resides in the patient'"'"'s stomach, and an elongate connecting portion extends between the distal and proximal portions, across the pyloric valve.

72. A method as in claim 70, wherein activating the actuator comprises at least one of tearing, peeling and cutting the pod.

73. A method as in claim 72, wherein the pod is torn, peeled or cut along one or more perforated lines or lines of structural weakness.

74. A method as in claim 70, wherein activating the actuator comprises withdrawing a cord from a plurality of apertures in the pod, the cord adapted to hold the pod together around the medical device.

75. A method as in claim 70, wherein activating the actuator comprises retracting a sleeve disposed over shape-memory, super-elastic or spring loaded housing.

76. A method as in claim 70, wherein activating the actuator comprises retracting a ring disposed over two or more housing members of the pod, wherein the housing members automatically move apart when released from constraint within the ring.

77. A method as in claim 70, wherein activating the actuator comprises pressurizing the pod to cause it to burst open.

78. A method as in claim 70, wherein activating the actuator comprises inflating the medical device to cause it to expand and thus burst open the pod.

79. A method as in claim 70, further comprising urging the medical device out of the opened pod with a pusher member.

80. A method as in claim 70, further comprising retracting an inner shaft extending through a longitudinal lumen of the medical device, wherein retracting the shaft releases at least a portion of the device.

81. A method as in claim 80, wherein the released portion of the medical device comprises a distal shape-memory portion configured to change from a straight configuration when disposed over the shaft to a non-linear configuration when released from the shaft.

82. A method as in claim 70, wherein the pod is advanced over a guidewire extending through a guidewire lumen on the pod.