Devices and methods for removing a matter from a body cavity of a patient

• US 20050228417A1
• Filed: 03/23/2005
• Published: 10/13/2005
• Est. Priority Date: 03/26/2004
• Status: Abandoned Application

• Current Assignee: University of Southern California
• Original Assignee: University of Southern California
• Inventors: Teitelbaum, George P., Larsen, Donald W.
• Application Number:
  US11/087,780
• Publication Number:
  US 20050228417A1
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/20 for vaccinating or cleaning the skin previous to the vaccination diagnosis by vaccination other than by injuring the skin A61B10/0035 ; apparatus for injections A61M
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels

Abstract

Disclosed are devices for removing a matter from a body cavity of a patient. One of such devices has an elongated carrier having a distal portion adapted to move through or within the cavity and a proximate portion. A radially expandable polymer is circumferentially attached to the distal portion of the carrier and adapted to enter the matter while in a compressed configuration and capable of transitioning to an expanded configuration while inside the matter to penetrate and engage it from within. Methods of removing a matter from a body cavity and methods of localized delivery of a therapeutic agents also are disclosed.

Claims

1. A device for removing a matter from a body cavity of a patient, the device comprising:

an elongated carrier having a distal portion adapted for positioning inside the body cavity and a proximate portion; and

a radially expandable polymer circumferentially attached to the distal portion of the carrier and adapted to enter the matter while in a compressed configuration and capable of transitioning to an expanded configuration while inside the matter to penetrate and engage it from within.

2. The device of claim 1, wherein the polymer is a shape-memory polymer selected from a group consisting of polyurethane, polyethylene, polyethylene terephthalate, polyisoprene, styrene-butadiene copolymers and other styrenes, copolyester, ethylene-vinylacetate and other ethylene copolymers, polyacrylamide gel, polyacrylic acid and other acrylates, norbornane, polystyrene, and polynorbornene.

3. The device of claim 1, wherein the transition of the polymer between the compressed configuration and the expanded configuration is triggered by a physiological stimulus, an external stimulus, by a mechanical device, or their combination.

4. The device of claim 3, wherein the physiological stimulus is selected from a group consisting of body temperature, blood pH, an ion concentration in blood, and blood composition.

5. The device of claim 3, wherein the external stimulus is selected from a group consisting of solutions, the introduction of which into the blood vessel causes changes in the local chemical environment, changes in external temperature, light, magnetic field, ultrasound, radiation, and electrical field.

6. The device of claim 3 further comprising a delivery device adapted for positioning inside the cavity and having an internal lumen, wherein the distal portion of the carrier is slidably positioned within the lumen of the delivery device, wherein the polymer remains in the compressed configuration inside the delivery device and the polymer transitions into the expanded configuration when it exits the delivery device.

7. The device of claim 1, wherein the polymer comprises a predetermined amount of a therapeutic agent.

8. The device of claim 7, wherein the therapeutic agent is released when the polymer transitions to the expanded configuration.

9. The device of claim 7, wherein the therapeutic agent is selected from a group consisting of anti-thrombogenic, thrombolytic, anti-proliferative, anti-spasmodic, anti-coagulant, anti-platelet adhesion drugs, endothelial cells, and gene vectors.

10. The device of claim 1, wherein said polymer is a hydrogel or a foam.

11. The device of claim 10, wherein the hydrogel is selected from a group consisting of polyethylene oxide, polyvinyl alcohol, polyvinylpyrrolidone, polyhydroxyethyl methacrylate, polyetherpolycarbonatecollagen and polysaccharides.

12. The device of claim 10, wherein the polymer is the hydrogel and the transition of the hydrogel into the expanded configuration is triggered by hydration of the hydrogel or by application of a triggering fluid to the hydrogel.

13. The device of claim 11, wherein the triggering fluid has a predetermined pH or a composition that causes the hydrogel to transition into the expanded configuration.

14. The device of claim 10, wherein said foam is a shape-memory foam selected from a group consisting of polyurethane, a cross-linked ethylene-vinyl acetate, and polyethylene copolymers.

15. The device of claim 10, wherein said foam is a shape-memory foam having an original expanded configuration that can be compressed at a temperature above a glass transition temperature, Tg, to form the compressed configuration, wherein the foam retains its compressed configuration at a temperature below the Tg but returns substantially to its original expanded configuration when it is exposed to a temperature above the Tg.

16. The device of claim 15, wherein the Tg is above a body temperature and the device further comprises an external source of heat.

17. The device of claim 16, wherein the external source of heat is selected from a group consisting of electrical resistance, inductive, optical, and convective heating elements.

18. The device of claim 17, wherein the electrical resistance element comprises a metal coil or a semiconductive plastic that is circumferentially attached to the distal portion of the carrier and electrically connected to a controller through an insulated pathway, the controller capable of adjusting a voltage applied to the resistance element to maintain a predetermined temperature.

19. The device of claim 15, wherein the Tg is below a body temperature and the foam spontaneously transitions into the expanded configuration after being exposed to the body temperature for a predetermined time.

20. The device of claim 19, wherein the distal portion of the elongated carrier further comprises a steerable tip.

21. The device of claim 20, wherein the steerable tip is a shape-able platinum or stainless steel wire.

22. The device of claim 1, wherein the carrier is a guidewire or a catheter.

23. The device of claim 1, wherein the carrier has a sufficient length to serve as an exchange guidewire to deliver a secondary device over the carrier downstream from the expandable polymer.

24. The device of claim 23, wherein the secondary device is selected from the group consisting of catheters, angioplasty balloons, stents, and microcatheters.

25. The device of claim 1, wherein the expanded configuration has a general shape selected from a group consisting of a coil, a twisted ribbon, a screwlike structure, a disk, a sphere, a parachutelike structure, a formation comprising a plurality of ridges and troughs, and a formation comprising a plurality of outwardly extending spears.

26. The device of claim 1 or claim 25 comprising at least two isolated formations of the radially expandable polymer attached to the distal portion of the carrier.

27. The device of claim 26 comprising a plurality of progressively decreasing in size formations of the radially expandable polymer.

28. The device of claim 25, wherein the expanded configuration has the parachutelike structure surrounding and attached to the carrier, the parachutelike structure comprises a basket portion for collecting the matter and at least two supporting struts, wherein the basket portion has an opening facing the proximate portion of the carrier.

29. The device of claim 28, wherein the struts are reinforced by embedded wires or polymer fibers.

30. The device of claim 28, wherein the basket portion is made of a foam material.

31. The device of claim 25, wherein the expanded configuration has the twisted ribbon shape, wherein the polymer is capable of storing torque energy when in compressed configuration and releasing it in the expanded configuration.

32. The device of claim 31 further comprising a microdevice attached to the distal end of the carrier and an amount of the released energy is sufficient to drive the microdevice for a predetermined time.

33. The device of claim 32, wherein the microdevice dissolves fragments or traps clots, athermatous plaques, or debris in the body cavity.

34. The device of claim 31 wherein the polymer is a heat-activated memory-shape polymer, and the torque energy is applied by twisting the ribbon at a temperature above a Tg of the polymer, the polymer is stabilized by cooling down the ribbon, and the torque energy is released by heating the polymer above Tg.

35. The device of claim 1, wherein the body cavity is naturally existing or surgically created.

36. The device of claim 35, wherein the body cavity is selected from a group consisting of lumens of blood vessels, lumens of the alimentary tract, lumens of the genitourinary system, ventricles and cisterns of the brain, urinary bladder, cysts, vagina, uterine cavity, pseudocysts, abcesses, and fistulae.

37. The device of claim 1 further comprising a polymer coating applied to the radially expandable polymer.

38. The device of claim 37, wherein the polymer coating is capable of preventing fragmentation of the expandable polymer.

39. The device of claim 37, wherein the body cavity is a blood vessel lumen, the polymer coating carries a positive charge, a negative charge, or both, and wherein the coating is capable of attracting or repelling blood clots.

40. The device of claim 1 wherein the polymer provides a surface that carries a magnetic field, a positive charge, a negative charge, or their combination.

41. The device of claim 40, wherein the charge or magnetic field is an intrinsic property of the polymer, produced by chemical modification of the polymer'"'"'s surface, or induced by application of external energy.

42. The device of claim 1, wherein the matter is a clot, an embolus, calculus, atherosclerotic plaque, loose tissue or neoplasm, inspissated fluid or secretion, or a foreign body.

43. The device of claim 1, wherein the compressed configuration of the radially expandable polymer has at least one feature imparting a flexibility to the polymer in the compressed configuration, improving the ability of the polymer to expand, or both.

44. The device of claim 43, wherein the feature is selected from a group consisting of cuts, slots, cells, cavities, holes, and indents.

45. The device of claim 44 comprising a plurality of cuts or slots oriented perpendicularly to a long axis of the carrier along an entire length of the expandable polymer, wherein each slot or cut is offset circumferentially from an immediately preceding slot or cut.

46. The device of claim 44 comprising a spiral cut.

47. The device of claim 1, wherein the radially expandable polymer exhibits an adhesive property to the matter.

48. The device of claim 1 further comprising a retrieval element adapted for positioning inside the body cavity, wherein the retrieval element has a proximal and a distal end, wherein the distal end comprises a self-deploying expandable sleeve, and wherein the retrieval element has a channel that extends through the entire length of the retrieval element and the expandable sleeve, wherein the distal portion of the carrier is sidably positioned within and adapted to move through the channel into the body cavity, and wherein the expandable polymer in its expanded configuration is capable of being at least partially retrieved into the expandable sleeve.

49. The device of claim 48 further comprising a pushing-pulling device operatively connected to the sleeve for deployment and retraction of the sleeve.

50. The device of claim 48, wherein the expandable sleeve is a balloon-expandable sleeve.

51. The device of claim 1 further comprising a wire coil running through the expandable polymer, the wire coil having a first end fixedly attached to the distal portion of the carrier and a second end movably attached to the proximate portion of the carrier, the device further comprising a barrier circumferentially attached to the carrier, wherein the barrier prevents movement of the second end when the carrier is pulled back, whereby the coil radially expands.

52. A method of retrieving a matter from a body cavity of a patient comprising:

(a) providing the device of claim 1;

(b) positioning the device inside the body cavity;

(c) allowing sufficient time for the expandable polymer to expand and engage the matter from within; and

(d) removing the device, whereby removing the matter.

57. The device of claim 52 comprising a plurality of progressively decreasing in size formations of the radially expandable polymer.

60. A method of retrieving a matter from a body cavity of a patient, the method comprising:

(a) providing the device of claim 52;

(b) positioning the device inside the body cavity;

(c) passing at least one formation through or around the matter;

(d) allowing sufficient time for the expandable polymer to transition from the initial compressed configuration to an expanded configuration, whereby trapping the matter between the formations; and

(e) removing the device.

67. A method of retrieving a matter from a body cavity of a patient, the method comprising:

(a) providing the device of claim 60;

(b) positioning the device inside the body cavity;

(c) allowing sufficient time for a physiological stimulus to act on the expandable polymer to cause its transition from the initial compressed configuration to an expanded configuration, thereby engaging the matter in a way that allows its removal; and

(d) retrieving the device, thereby removing the matter.

53. A device for retrieving a matter from a body cavity of a patient, the device comprising:

an elongated carrier having a distal portion adapted for positioning inside the body cavity; and

at least two isolated formations of radially expandable polymer attached to the distal portion of the carrier, wherein each formation encloses the entire circumference of the carrier and wherein the formations are adapted to move through or around the matter while having a compressed configuration and capable of transitioning to an expanded configuration to trap the matter there between.

54. The device of claim 53, wherein said polymer is a hydrogel or a foam.

55. The device of claim 54, wherein said foam is a shape-memory foam having an original expanded configuration that can be compressed at a temperature above a glass transition temperature, Tg, to form the compressed configuration, wherein the foam retains its compressed configuration at a temperature below the Tg but returns substantially to its original expanded configuration when it is exposed to a temperature above the Tg.

56. The device of claim 55, wherein the polymer is the hydrogel and the transition of the hydrogel into the expanded configuration is triggered by a hydration of the hydrogel or by application of a triggering fluid to the hydrogel.

58. The device of claim 53, wherein the expanded configuration has a general shape selected from a group consisting of a disk, a sphere, a formation comprising a plurality of ridges and troughs, and an outwardly extending spear.

59. The device of claim 53 further comprising a retrieval element adapted for positioning inside the body cavity, wherein the retrieval element has a proximal and a distal end, wherein the distal end comprises a self-deploying expandable sleeve and wherein the retrieval element has a channel that extends through an entire length of the retrieval element and the expandable sleeve, wherein the distal portion of the carrier is slidably positioned within and adapted to move through the channel into the body cavity, and wherein the isolated formations in their expanded configuration are capable of being at least partially retrieved into the expandable sleeve.

61. A device for retrieving a matter from a body cavity of a patient, the device comprising:

an elongated carrier having a distal portion adapted to be positioned inside the body cavity; and

a radially expandable polymer circumferentially attached to the distal portion of the carrier and adapted to move through the matter while having a compressed configuration and capable of transitioning to an expanded configuration to engage the matter for retrieval from the body cavity, wherein the transition of the polymer is triggered by a physiological stimulus.

62. The device of claim 61, wherein the physiological stimulus is selected from a group consisting of body temperature, blood pH, an ion concentration in blood, and blood composition.

63. The device of claim 61, wherein said polymer is a hydrogel or a foam.

64. The device of claim 61, wherein the polymer is the hydrogel and the transition of the hydrogel into the expanded configuration is triggered by a hydration of the hydrogel inside the blood vessel.

65. The device of claim 61, wherein the expanded configuration has a general shape selected from a group consisting of a coil, a twisted ribbon, a screwlike structure, a disk, a sphere, a parachutelike structure, a formation comprising a plurality of ridges and troughs, and a formation comprising a plurality of outwardly extending spears.

66. The device of claim 61 further comprising a retrieval element adapted for positioning inside the body cavity, wherein the retrieval element has a proximal and a distal end, wherein the distal end comprises a self-deploying expandable sleeve and wherein the retrieval element has a channel that extends through an entire length of the retrieval element and the expandable sleeve, wherein the distal portion of the carrier is slidably positioned within and adapted to move through the channel into the body cavity, and wherein the expandable polymer in its expanded configuration is capable of being at least partially retrieved into the expandable sleeve.

68. A device for retrieving a matter from a body cavity of a patient, the device comprising:

a retrieval element adapted for positioning inside the body cavity, wherein the retrieval element has a proximal end and a distal end, wherein the distal end comprises an expandable sleeve, wherein the retrieval element has a channel that extends through the entire length of the retrieval element and the expandable sleeve, the retrieval element further comprising an inflatable balloon positioned concentrically inside the channel, the balloon, when inflated, is capable of radially expanding the expandable sleeve;

an elongated carrier slidably positioned within the channel of the retrieval element, wherein the elongated carrier has a distal portion adapted to move through the expandable sleeve of the retrieval element and into the body cavity; and

a radially expandable polymer circumferentially attached to the distal portion of the carrier and adapted to move through or around the matter while having a compressed configuration and capable of transitioning to an expanded configuration to engage the matter, wherein the expandable polymer in its expanded configuration is capable of being at least partially retrieved into the expanded sleeve.

69. The device of claim 68, wherein the balloon is maintained in a deflated state during insertion of the retrieval element into the body cavity and is in an inflated state when the retrieval element is positioned in a desired location within the cavity.

70. The device of claim 68, wherein the carrier is slidably positioned through the balloon.

71. A method of retrieving a matter from a body cavity of a patient, the method comprising:

(a) providing the device of claim 68;

(b) positioning the retrieval element into the body cavity;

(c) advancing the distal portion of the carrier through the lumen of the retrieval element and the expandable sleeve of the retrieval element lumen into the blood vessel;

(d) moving the distal portion of the carrier through or around the matter;

(e) allowing sufficient time for the expandable polymer to transition from the initial compressed configuration to an expanded configuration, whereby trapping the matter;

(f) inflating the balloon, whereby expanding the sleeve; and

(g) retrieving, at least partially, the carrier with the expandable polymer in its expanded configuration into the expanded sleeve.

72. A method of retrieving a matter from a body cavity of a patient, the method comprising:

(a) providing a device having a carrier with a distal portion and a radially expandable polymer circumferentially attached to the distal portion of the carrier, wherein the expandable polymer has an initial compressed configuration;

(b) positioning the distal portion of the carrier inside the body cavity;

(c) positioning the expandable polymer inside the matter;

(d) allowing sufficient time for the expandable polymer to transition from the initial compressed configuration to an expanded configuration, whereby penetrating and engaging the matter from within; and

(e) retrieving the device from the body cavity, thereby removing the matter.

73. The method of claim 72, wherein the polymer is a hydrogel and step (d) further comprises applying a triggering fluid to the hydrogel to cause its transition into the expanded configuration.

74. The method of claim 72, wherein the polymer is a foam and step (d) further comprises applying an external stimulus to cause its transition into the expanded configuration.

75. The method of claim 72, wherein the device further comprises a retrieval element adapted for positioning inside the body cavity, wherein the retrieval element has a proximal and a distal end, wherein the distal end comprises a self-deploying expandable sleeve, and wherein the retrieval element has a channel that extends through the entire length of the retrieval element and the expandable sleeve, wherein the distal portion of the carrier is slidably positioned within and adapted to move through the channel into the body cavity, the method further comprising a step of retrieving, at least partially, the carrier with the expandable polymer in its expanded configuration into the expandable sleeve before the step of retrieving the device from the body cavity.

76. A method of localized delivery of a therapeutic agent, the method comprising:

(a) providing a removable device having a carrier with a distal portion and a radially expandable polymer circumferentially attached to the distal portion of the carrier, wherein the expandable polymer has an initial compressed configuration;

(b) advancing the distal portion of the carrier to a site in a body; and

(c) allowing sufficient time for the expandable polymer to transition from the initial compressed configuration to an expanded configuration delivering the therapeutic agent.

77. The method of claim 76, wherein the site is located in a lumen, a cavity, or a solid tissue of the body.

78. The method of claim 76, wherein step (c) further comprises applying an external or a physiological stimulus to the polymer to cause its expansion.

79. The method of claim 78, wherein the physiological stimulus is selected from a group consisting of body temperature, blood pH, an ion concentration in blood, and blood composition.

80. The method of claim 78, wherein the external stimulus is selected from a group consisting of solutions, the introduction of which into the blood vessel causes changes in the local chemical environment, changes in external temperature, light, magnetic field, ultrasound, radiation, and electrical field.

81. The method of claim 76, wherein the therapeutic agent is selected from a group consisting of anti-thrombogenic, thrombolytic, anti-proliferative, anti-spasmodic, anti-coagulant, anti-platelet adhesion drugs, endothelial cells, drugs encased in nanoshells, and gene vectors.

82. The method of claim 81, wherein the thrombolytic drug is selected from a group consisting of tissue plasminogen activator (tPA), streptokinase, a calcium ion influx inhibitor, urokinase, and their analogs.

83. The method of claim 76, wherein the site comprises a lumen of a blood vessel containing a matter obstructing the lumen, wherein step (b) further comprises positioning expandable polymer inside the matter and step (c) comprises delivering the therapeutic agent from within the matter.

84. A method of retrieving a matter from a body cavity of a patient, the method comprising:

(a) providing a device having a carrier with a distal portion and at least two isolated formations of radially expandable polymer attached to the distal portion of the carrier, wherein each formation encloses the entire circumference of the carrier and the expandable polymer has an initial compressed configuration;

(b) positioning the distal portion of the carrier inside the body cavity;

(c) passing at least one formation through or around the matter;

(d) allowing sufficient time for the expandable polymer to transition from the initial compressed configuration to an expanded configuration, whereby trapping the matter between the formations; and

(e) retrieving the device, thereby removing the matter.

85. A method of retrieving a matter from a body cavity of a patient, the method comprising:

(a) providing a device having a radially expandable polymer circumferentially attached to the distal portion of the carrier, wherein the expandable polymer has an initial compressed configuration;

(b) positioning the distal portion of the carrier inside the body cavity, through or around the matter;

(c) allowing a sufficient time for a physiological stimulus to act on the expandable polymer to cause its transition from the initial compressed configuration to an expanded configuration, whereby engaging the matter in a way that allows its removal; and

(d) retrieving the device, thereby removing the matter.

86. The method of claim 85, wherein the physiological stimulus is selected from a group consisting of body temperature, blood pH, an ion concentration in blood, and blood composition.

87. A method of retrieving a matter from a body cavity of a patient, the method comprising:

(a) providing a device comprising;

a retrieval element adapted for positioning inside the body cavity, wherein the retrieval element has a proximal and a distal end, wherein the distal end comprises an expandable sleeve, wherein the retrieval element has a channel that extends through the entire length of the retrieval element and the expandable sleeve, the retrieval element further comprising an inflatable balloon positioned concentrically inside the channel, and the balloon, when inflated, is capable of radially expanding the expandable sleeve;

an elongated carrier slidably positioned within the channel of the retrieval element, the elongated carrier having a distal portion; and

a radially expandable polymer circumferentially attached to the distal portion of the carrier, wherein the expandable polymer has an initial compressed configuration;

(b) positioning the retrieval element inside the body cavity;

(c) advancing the distal portion of the carrier through the channel of the retrieval element and the expandable sleeve of the retrieval element into the body cavity;

(d) moving the distal portion of the carrier through or around the matter;

(e) allowing sufficient time for the expandable polymer to transition from the initial compressed configuration to an expanded configuration, whereby trapping the matter;

(f) inflating the balloon, whereby expanding the sleeve; and

(g) retrieving, at least partially, the carrier with the expandable polymer in its expanded configuration into the expanded sleeve.