Device incorporating a hollow element for being positioned along a body cavity of a patient and method of positioning the same

• US 20030208223A1
• Filed: 04/21/2003
• Published: 11/06/2003
• Est. Priority Date: 03/23/2000
• Status: Abandoned Application

• Current Assignee: Daniel Eduard Kleiner
• Original Assignee: Daniel Eduard Kleiner
• Inventors: Kleiner, Daniel Eduard
• Application Number:
  US10/239,590
• Publication Number:
  US 20030208223A1
• Time in Patent Office: Days
• US Class Current: 606/198
• CPC Class Codes: A61B 1/00151 using everted tubes
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes

Abstract

There is provided apparatus (14) incorporating an elongate hollow element (22) for being positioned along a body cavity of a patient. The hollow element has a leading region and a trailing region and is arranged for being progressively everted along the hollow element from the leading region to thereby be increasingly extended for progressively lining the body cavity as the trailing region follows along. The apparatus generally further comprises an enclosure comprising an insertion head (16) for being inserted into an entrance of the body cavity and a flexible bag (18) in which the hollow element is housed. The hollow element is extended from the insertion head by increasing pressure within the enclosure. Methods for positioning the hollow element along the body are disclosed. The apparatus is particularly suitable for use as a tamponade device for use in the lower gastrointestinal tract for stemming internal bleeding.

Claims

1. A method of positioning an elongate hollow element along a body cavity in a patient, wherein the hollow element has a leading region and a trailing region, and the method comprises:

causing the hollow element to be everted progressively along the hollow element from the leading region thereof such that the hollow element is forced to be increasingly extended and thereby progressively line a surrounding wall defining the body cavity as the trailing region follows along; and

wherein the hollow element self navigates along within the body cavity following a path determined by the surrounding wall defining the body cavity.

2. A method according to claim 1 further comprising inserting an insertion head in an entrance of the body cavity for guiding the hollow element into the body cavity, wherein the insertion head has a through passageway and the hollow element progressively passes through an opening of the insertion head into the body cavity.

3. A method according to claim 1 or 2 comprising inflating the hollow element to thereby cause the hollow element to be everted and self navigate along the body cavity.

4. A method according to claim 3 further comprising monitoring pressure within the hollow element for determining whether the pressure is at or below an upper predetermined limit.

5. A method according to claim 4 further comprising regulating pressure within the hollow element during the eversion of the hollow element to maintain the pressure at or below the upper predetermined limit.

6. A method according to any one of claims 3 to 5 wherein the inflating comprises inflating the hollow element with a gas.

7. A method according to claim 6 wherein the inflating comprises pumping the gas into the hollow element to thereby cause the hollow element to be everted progressively.

8. A method according to any one of claims 3 to 5 wherein the inflating comprises introducing a liquid into the hollow element to thereby cause the hollow element to be everted progressively.

9. A method according to claim 8 wherein the hollow element is arranged within a flexible enclosure at least partly filled with the liquid, and the liquid is introduced into the hollow element to thereby cause the hollow element to be increasingly extended by forcing liquid from the enclosure into the hollow element.

10. A method according to any one of claims 1 to 9 wherein the hollow element is adapted for limiting swelling thereof during the inflation of the hollow element, for thereby preferentially causing the trailing region to be drawn along.

11. A method accordingly to claim 1 or 2 further comprising feeding the hollow element through at least one pair of counter-rotatable rolls for driving and thereby causing the hollow element to be everted progressively.

12. A method according to claim 1 wherein the body cavity is that of the uterus, urethra, ureter, bladder, oesophagus, stomach, a bronchi, a fallopian tube, a blood vessel, intestine, gastrointestinal tract, or colon.

13. A method of positioning an inflatable hollow element in a body cavity of a patient, wherein the hollow element has a leading region and a trailing region, and the method comprises:

inflating the hollow element to cause the hollow element to be everted progressively therealong from the leading region and thereby be increasingly extended into the body cavity as the trailing region of the hollow element follows along; and

wherein the hollow element is adapted for limiting swelling during the inflation thereof thereby preferentially causing the trailing region to be drawn along.

14. A method accordingly to claim 13 further comprising inserting an insertion head in an entrance of the body cavity for guiding the hollow element into the body cavity, wherein the insertion head has a through passageway and the hollow element progressively passes through an opening of the insertion head into the body cavity.

15. A method according to claim 13 or 14 further comprising monitoring pressure within the hollow element for determining whether the pressure is at or below an upper predetermined limit.

16. A method according to claim 15 further comprising regulating pressure within the hollow element during the eversion of the hollow element to maintain the pressure at or below the upper predetermined limit.

17. A method according to any one of claims 13 to 16 wherein the inflating comprises inflating the hollow element with a gas.

18. A method according to claim 17 wherein the inflating comprises pumping the gas into the hollow element to thereby cause the hollow element to be everted progressively.

19. A method according to any one of claims 13 to 16 wherein the inflating comprises introducing a liquid into the hollow element to thereby cause the hollow element to be everted progressively.

20. A method according to claim 19 wherein the hollow element is arranged within a flexible enclosure at least partly filled with the liquid, and the liquid is introduced into the hollow element to thereby cause the hollow element to be increasingly extended by forcing liquid from the enclosure into the hollow element.

21. A method of examining a patient utilising an elongate hollow element for being positioned along a body cavity of the patient, wherein the hollow element is adapted for facilitating the examination of the patient and has a leading region and a trailing region, and the method comprises:

causing the hollow element to be everted progressively along the hollow element from the leading region thereof such that the hollow element is forced to be increasingly extended and thereby progressively positioned along the body cavity; and

examining the patient.

22. A method according to claim 21 wherein a device for use in examining the patient is attached to the hollow element and is located in the body cavity by the eversion of the hollow element, and the examining comprises utilising the device to examine the patient.

23. A method according to claim 22 wherein the device is an instrument for enabling the body cavity to be viewed and the examining comprises utilising the instrument to view within the body cavity.

24. A method according to claim 22 or 23 wherein the instrument is selected from a group consisting of an endoscope, a fibroscope, a colonoscope, a bronchioscope, a laproscope, and a gastroscope.

25. A method according to claim 22 wherein the device transmits signals for enabling visualisation within the body cavity, and the examining comprises utilising an image generated from the signals to examine the patient.

26. A method according to claim 22 wherein the hollow element carriers one or more optic fibres for enabling the body cavity to be viewed and the optic fibres are located in position within the body cavity by the hollow element, and wherein the examining comprises viewing within the body cavity utilising the optic fibres.

27. A method according to any one of claims 21 to 26 further comprising withdrawing the hollow element from the body cavity, and wherein the examining comprises examining the patient as the hollow element is withdrawn from the body cavity.

28. A method of locating an instrument along a body cavity of a patient utilising an elongate hollow element, wherein the instrument is attached to the hollow element and the hollow element has a leading region and a trailing region, and the method comprises:

causing the hollow element to be everted progressively along the hollow element from the leading region thereof such that the hollow element is forced to be increasingly extended and the apparatus thereby increasingly drawn along the body cavity as the trailing region follows along, whereby the instrument is located in position within the body cavity.

29. A method accordingly to claim 28 comprising inflating the hollow element to thereby cause the hollow element to be everted and by increasingly extended.

30. A method accordingly to claim 29 wherein the hollow element is adapted for limiting swelling thereof while being inflated, for thereby preferentially causing the trailing region of the hollow element to be drawn along.

31. A method accordingly to any one of claims 28 to 30 wherein the instrument is an instrument for facilitating examination of the patient.

32. A method according to claim 31 wherein the instrument is an instrument selected from a group consisting of an endoscope, a fibroscope, a colonoscope, a bronchioscope, a laproscope, and a gastroscope.

33. A method accordingly to any one of claims 28 to 30 wherein the instrument is selected from a group consisting of an instrument for collecting a biopsy, and instrument for performing a surgical task, an instrument for cauterising a site, and an instrument for indicating a biological parameter within the body cavity.

34. A method of applying a substance to a surrounding wall defining a body cavity of a patient utilising a hollow element with an internal surface coated with the substance, wherein the hollow element has a leading region and a trailing region, and the method comprises:

causing the hollow element to be everted progressively along the hollow element from the leading region thereof such that the hollow element is forced to be increasingly extended and the interior surface of the hollow element thereby brought into contact with the surrounding wall of the body cavity as the surrounding wall is progressively lined with the hollow element and as the trailing region follows along;

wherein the hollow element self navigates along within the body cavity following a path determined by the surrounding wall defining the body cavity.

35. A method according to claim 34 comprising inflating the hollow element to thereby cause the hollow element to be everted and self navigate along the body cavity.

36. A method according to claim 34 or 35 wherein the substance is selected from a group consisting of a drug, a therapeutic compound for treating a site on the surrounding wall defining the body cavity, an agent for promoting coagulation, an isotope, and a steroid.

37. A method according to claim 36 wherein the substance is thrombin or a thrombogenic substance.

45. A method according to any one of claims 37 to 43 wherein the body cavity is that of the urethra, ureter, bladder, oesophagus, stomach, a bronchi, a fallopian tube, a blood vessel, intestine, gastrointestinal tract, or colon.

38. A method of treating a patient utilising a hollow element for being positioned along a body cavity of a patient and having a leading region and a trailing region, the method comprising:

causing the hollow element to be everted progressively along the hollow element from the leading region thereof such that the hollow element is forced to be increasingly extended and thereby progressively line a surrounding wall defining the body cavity as the trailing region follows along, to thereby effect the treatment.

39. A method according to claim 38 wherein the treating comprises utilising the hollow element to apply pressure to a site on the surrounding wall defining the body cavity.

40. A method according to claim 38 or 39 wherein the hollow element acts as a tamponade and the treating comprises treating the patient to stem blood flow.

41. A method according to claim 38 wherein the treating comprises utilising the hollow element to apply a substance to the surrounding wall.

42. A method according to claim 41 wherein the hollow element has an internal surface coated with the substance and the substance is applied to the surrounding wall defining the body cavity as the internal surface is progressively pressed against the surrounding wall as the hollow element is everted.

43. A method according to claim 42 wherein the substance is selected from a group consisting of a drug, a therapeutic compound for treating a site on the surrounding wall defining the body cavity, an agent for promoting coagulation, an isotope, and a steroid.

44. A method according to claim 43 wherein the substance is thrombin or a thrombogenic substance.

46. A device incorporating an inflatable hollow element for being positioned along a body cavity of a patient, wherein the hollow element has a leading region and a trailing region and is arranged for being everted progressively along the hollow element from the leading region thereof to thereby be increasingly extended for progressively lining a surrounding wall defining the body cavity as the trailing region follows along, and wherein the hollow element has a substantially constant diameter therealong upon being everted and fully inflated.

47. A device according to claim 46 wherein the hollow element is arranged for self navigation along the body cavity following a path determined by the surrounding wall defining the body cavity.

48. A device according to claim 46 or 47 wherein the hollow element is adapted for limiting swelling thereof during inflation of the hollow element, for thereby preferentially causing the trailing region to be drawn along.

49. A device accordingly to any one of claims 46 to 48 further comprising an enclosure in which the hollow element is located and which is provided with an opening for progressive passage therethrough of the hollow element from the interior of the enclosure, and wherein the interior of the enclosure is sealed from the opening by the hollow element.

50. A device according to claim 49 wherein the enclosure incorporates an insertion head for being inserted into an entrance of the body cavity for guiding the hollow element into the body cavity, wherein the insertion head has a through passageway defining the opening.

51. A device according to claim 50 wherein the hollow element is received in the through passageway and the leading region of the hollow element is folded back over the insertion head such that the hollow element is thereby invaginated.

52. A device according to claim 51 wherein an inlet is defined in the enclosure for the entry of a gas or liquid into the interior for progressively inflating and thereby causing to the hollow element to be progressively forced from the enclosure through the opening.

53. A device accordingly to claim 50 or 51 wherein the enclosure further comprises a flexible bag sealingly secured to the insertion head and which houses the hollow element.

54. A device accordingly to claim 53 wherein the bag is adapted for preferentially causing the hollow element to be forced from the enclosure through the opening of the insertion head upon pressure within the enclosure being increased for causing the hollow element to be inflated.

55. A device according to claim 53 or 54 wherein the bag is at least partially filled with a liquid and the device further comprises a collar receiving the bag, wherein the collar constricts the bag and is slidable along the bag toward the insertion head for forcing the liquid into the hollow element and thereby causing the hollow element to be progressively inflated.

56. A device according to any one of claims 49 to 51 further comprising a pump arranged for pumping a gas or liquid into the enclosure for increasing pressure within the enclosure to thereby cause the hollow element to be progressively everted.

57. A device accordingly to claim 56 further comprising a pressure release valve operable for enabling pressure in the interior of the bag to be decreased.

58. A device according to any one of claims 49 to 51 wherein the hollow element is arranged in a concertinaed conformation in the interior of the enclosure.

59. A device according to any one of claims 46 to 58 wherein the device is other than a catheter.

60. A device incorporating an inflatable hollow element for being positioned along a body cavity of a patient, wherein the hollow element has a leading region and a trailing region and is arranged for being everted progressively along the hollow element from the leading region to thereby be increasingly extended for achieving said positioning in the body cavity as the trailing region of the hollow element follows along, and wherein the hollow element is adapted for limiting swelling during inflation thereof for thereby preferentially causing the trailing region to be drawn along.

61. A device according to claim 60 wherein the hollow element is arranged for self navigation along the body cavity following a path determined by the surrounding wall defining the body cavity.

62. A device according to claim 60 or 61 further comprising an enclosure in which the hollow element is located and which is provided with an opening for progressive passage therethrough of the hollow element from the interior of the enclosure, and wherein the interior of the enclosure is sealed from the opening by the hollow element.

63. A device according to claim 62 wherein the enclosure incorporates an insertion head for being inserted into an entrance of the body cavity for guiding the hollow element into the body cavity, wherein the insertion head has a through passageway defining the opening.

64. A device according to claim 63 wherein the hollow element is received in the through passageway and the leading region of the hollow element is folded back over the insertion head such that the hollow element is thereby invaginated.

65. A device according to claim 64 wherein an inlet is defined in the enclosure for the entry of a gas or liquid into the interior for progressively inflating and thereby causing to the hollow element to be progressively forced from the enclosure through the opening.

66. A device according to any one of claims 62 to 64 wherein the enclosure further comprises a flexible bag sealingly secured to the insertion head and which houses the hollow element.

67. A device according to claim 66 wherein the bag is adapted for preferentially causing the hollow element to be forced from the enclosure through the opening of the insertion head upon pressure within the enclosure being increased for causing the hollow element to be inflated.

68. A device according to claim 66 or 67 wherein the bag is at least partially filled with a liquid and the device further comprises a collar receiving the bag, wherein the collar constricts the bag and is slidable along the bag toward the insertion head for forcing the liquid into the hollow element and thereby causing the hollow element to be progressively inflated.

69. A device according to any one of claims 62 to 64 further comprising a pump arranged for pumping a gas or liquid into the enclosure for increasing pressure within the enclosure to thereby cause the hollow element to be progressively everted.

70. A device according to claim 69 further comprising a pressure release valve operable for enabling pressure in the interior of the bag to be decreased.

71. A device according to any one of claims 62 to 64 wherein the hollow element is arranged in a concertinaed conformation in the interior of the enclosure.

72. A device according to any one of claim 60 to 71 wherein the device is other than a catheter.

73. Apparatus for being inserted into a body cavity of a patient and comprising:

an instrument; and

at least one inflatable hollow element having a leading region and a trailing region, and being secured to the instrument;

wherein the hollow element is arranged for being everted progressively from the leading region thereof while being inflated, to thereby be increasingly extended for progressively lining a surrounding wall defining the body cavity and drawing along the instrument as the trailing region follows along behind.

74. Apparatus according to claim 73 incorporating one said hollow element wherein the instrument extends longitudinally along a central region of the hollow element such that the hollow element thereby surrounds the instrument.

75. Apparatus according to claim 73 or 74 wherein the hollow element is adapted for limiting swelling thereof while being inflated, for thereby preferentially causing the trailing region to be drawn along.

76. Apparatus according to any one of claims 73 to 75 wherein the hollow element is arranged for self navigation along the body cavity following a path determined by a surrounding wall defining the body cavity.

77. Apparatus according to any one of claim 73 to 76 wherein the instrument is an instrument for facilitating examination of the patient.

78. Apparatus according to any one of claims 73 to 76 wherein the instrument is selected from a group consisting of an instrument for collecting a biopsy, and instrument for performing a surgical task, an instrument for cauterising a site, and an instrument for indicating a biological parameter within the body cavity.

79. Apparatus according to any one of claims 73 to 77 wherein the instrument is an instrument for facilitating visual examination within the body cavity.

80. Apparatus according to any one of claims 73 to 76 wherein the instrument is an instrument selected from a group consisting of an endoscope, a fibroscope, a colonoscope, a bronchioscope, a laproscope, and a gastroscope.

81. Apparatus according to any one of claims 73 to 76 wherein the instrument is other than a catheter.

82. Apparatus for being inserted into a body cavity of a patient and comprising:

an instrument; and

at least one inflatable hollow element secured to the instrument and for being pressed against a surrounding wall defining the body cavity;

wherein the hollow element is arranged for overlying a region of the instrument forward of a location or locations where the hollow element is secured to the instrument, for enabling the hollow element to be progressively everted upon the hollow element being inflated and the instrument being driven along within the body cavity, for thereby facilitating travel of the instrument along within the body cavity.

83. Apparatus according to claim 82 incorporating one said hollow element wherein the instrument extends longitudinally along a central region of the hollow element such that the hollow element thereby surrounds the instrument.

84. Apparatus according to claim 82 or 83 wherein the instrument incorporates one or more passageways opening into the hollow element for passage of a gas or a liquid into the hollow element for causing inflation of the hollow element.

85. Apparatus according to claim 84 further comprising one or more further passageways opening into the hollow element for subsequent passage of the gas or liquid from the hollow element for achieving deflation of the hollow element.

86. Apparatus according to any one of claims 82 to 85 wherein the instrument is for facilitating examination of the patient.

87. Apparatus according to any one of claims 82 to 86 wherein the instrument is an instrument for facilitating visual examination within the body cavity.

88. Apparatus according to any one of claims 82 to 85 wherein the instruments is selected from a group consisting of an instrument for collecting a biopsy, and instrument for performing a surgical task, an instrument for cauterising a site, and an instrument for indicating a biological parameter within the body cavity.

89. Apparatus according to any one of claims 82 to 85 wherein the instrument is an instrument selected from a group consisting of an endoscope, a fibroscope, a colonoscope, a bronchioscope, a laproscope, and a gastroscope.

90. Apparatus according to any one of claims 82 to 85 wherein the instrument is other than a catheter.

91. An arrangement incorporating an elongate hollow element for being positioned within a body cavity of a patient, comprising:

a guide head having a through passageway receiving the hollow element; and

at least one pair of opposed counter rotatable rolls for feeding the hollow element through an opening defined by the through passageway of the guide head;

wherein the hollow element has a leading region and a trailing region and is arranged for being everted progressively along the hollow element from the leading region thereof to thereby be increasingly extended from the guide head for progressively lining the body cavity upon being fed through the opening of the guide head by the counter rotatable rolls.

92. An arrangement according to claim 91 wherein the hollow element is folded back over the insertion head such that the hollow element is thereby invaginated.

93. An arrangement according to claim 91 or 92 wherein the hollow element is open at each end of the hollow element.

94. A method of locating a stent in position along a body cavity of a patient, wherein the stent has a leading region and a trailing region;

and the method comprises;

causing the stent to be everted progressively along the stent from the leading region thereof such that the stent is forced to be increasingly extended and thereby progressively line a surrounding wall defining the body cavity as the trailing region follows along.

95. A method according to claim 94 wherein the stent overlays an inflatable hollow element arranged in an invaginated conformation, and wherein the method further comprises inflating the hollow element to thereby cause the stent to be progressively everted as the hollow element is everted.

96. A method according to claim 95 wherein the inflating of the hollow element forces the stent to radially expand within the body cavity and be pressed against the surrounding wall.

97. A stent for being positioned along a body cavity of a patient, wherein the stent has a leading region and a trailing region and is arranged for being everted progressively therealong from the leading region to thereby be increasingly extended for progressively lining a surrounding wall defining the body cavity as the trailing region follows along.

98. A device for use in treating a patient and comprising:

an inflatable hollow element; and

a stent having a leading region and a trailing region and which is arranged for being everted progressively therealong from the leading region to thereby be increasingly extended for progressively lining a surrounding wall defining a body cavity as the trailing region follows along;

wherein the stent overlays the hollow element and the hollow element is arranged in an invaginated conformation for causing the stent to be everted for thereby lining the surrounding wall of the body cavity upon the hollow element being inflated.