Vaginal operation method for the treatment of anal incontinence in women

• US 9,949,812 B2
• Filed: 07/19/2010
• Issued: 04/24/2018
• Est. Priority Date: 07/17/2009
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Kirk Promotion Ltd.
• Inventors: Forsell, Peter
• Primary Examiner(s): MATTHEWS, CHRISTINE HOPKINS
• Application Number:
  US12/839,162
• Publication Number:
  US 20110015474A1
• Time in Patent Office: 2,836 Days
• Field of Search: 600 30, 600 31, 600 37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/3067 for data transfer
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

There is disclosed a method for treating anal incontinence in women. The method comprises accessing the rectum or colon or anus though an incision in the vagina and implanting a powered restriction device on the rectum, colon or anal sphincter. There are also disclosed methods for energizing and controlling the restriction device.

Claims

1. A method for treating a female anal incontinent patient, the method comprising the steps of:

a) incising one opening in the vaginal wall of the patient,

b) accessing through the incised opening in the vaginal wall of the patient at least one organ with a fecal passageway selected from the group consisting of;

a colon, an anal channel, a rectum, a small intestine connected to the anus, and an anal sphincter;

with an instrument having a flexible tip adapted for bending around said at least one organ,

c) dissecting an area surrounding the at least one organ,

d) implanting a powered restriction device, by attaching the powered restriction device to said instrument and bending the tip of said instrument through the dissected area, and in a loop around said at least one organ, thereby enabling the powered restriction device to decrease the cross-sectional area of the patient'"'"'s fecal passageway in the at least one organ in order to completely close the fecal passageway and thereby stop the movement of feces through said passageway, and

e) implanting a rechargeable energy source, an energy receiver, or a rechargeable energy source and an energy receiver, using a vaginal approach or using a vaginal approach in combination with a small skin incision, connecting the powered restriction device directly or indirectly to the rechargeable energy source or the energy receiver, adapted to provide to power;

either directly during a wireless energy transfer to a motor or pump, or indirectly through the rechargeable energy source, to one or more energy consuming parts of the restriction device.

2. The method according to claim 1, comprising the additional step of postoperatively non-invasively adjusting said restriction device to control the fecal passageway.

3. The method according to claim 1, the method further comprising the step of implanting a switch and allowing the additional step of adjusting said restriction device using said implantable switch.

4. The method according to claim 1 further comprising the additional step of adjusting said restriction device from outside the body of the patient.

5. The method according to claim 1 further comprising the step of adjusting said restriction device postoperatively using a remote control.

6. The method according to claim 1 comprising the additional step of implanting in the body of the patient at least one sensor adapted to measure at least one physiological parameter of the patient, said at least one sensor being adapted to sending an alarm signal to the patient.

7. The method according to claim 6, wherein said at least one physiological parameter is at least one selected from the group consisting of pressure, volume, diameter, stretching, elongation, extension, movement, elasticity, muscle contraction, temperature and nerve impulse.

8. The method according to claim 1 comprising the additional step of implanting in the body of the patient at least one sensor that measures at least one functional parameter of said restriction device, said at least one sensor being adapted to sending an alarm signal to the patient.

9. The method according to claim 8 wherein said at least one functional parameter is an electrical parameter.

10. The method according to claim 8 wherein said at least one functional parameter is at least one parameter selected from the group consisting of pressure, volume, diameter, stretching, elongation, extension, movement and elasticity, temperature and flow.

11. The method according to claim 1, wherein the method further comprises implanting at least two restriction devices.

12. The method according to claim 1 further comprising the step of adjusting said restriction device by at least one of the following:

mechanically, hydraulically, and electrically.

13. The method according to claim 1, further comprising the step of using a coloscopic method for at least one of:

observing the patient, placing a sensor in the patient, and calibrating said restriction device.

14. The method according to claim 8, further comprising the additional step of measuring an electrical parameter.

15. The method according to claim 6, further comprising the additional step of measuring at least one parameter from the group consisting of pressure, volume, diameter, stretching, elongation, extension, movement, elasticity, muscle contraction, temperature, flow and nerve impulse.

16. The method according to claim 1, wherein the restriction device is adapted to be powered by the energy source, the method comprising the additional step of implanting said energy source in the body of the patient and thereby allowing use of said energy source to power any energy consuming parts of the restriction device or attached components.

17. The method according to claim 1 further comprising implanting at least one switch in the patient for allowing to manually and non-invasively control the implantable restriction device.

18. The method according to claim 1, further comprising implanting a hydraulic device having an implantable hydraulic reservoir, which is hydraulically connected to the restriction device, wherein the restricted device is adapted to be non-invasively regulated by manually pressing the hydraulic reservoir.

19. The method according to claim 1, further comprising using a wireless remote control for non-invasively controlling the restriction device comprising the method step of transmitting at least one wireless control signal for controlling the restriction device.

20. The method according to claim 19, wherein the at least one wireless control signal comprises a frequency, amplitude, or phase modulated signal or a combination thereof.

21. The method according to claim 1, further comprising the step of using a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the restriction device and components connected thereto with wireless energy.

22. The method according to claim 21, wherein the wireless energy comprises a wave signal selected from the following:

an ultrasound wave signal, an electromagnetic wave signal, a light signal, and a radio wave signal.

23. The method according to claim 21, wherein the wireless energy comprises one of the following:

an electric field, a magnetic field, a combined electric and magnetic field.

24. The method according to claim 20, wherein the at least one wireless control signal comprises an analogue signal, a digital signal, or a combination of an analogue and digital signal.

25. The method according to claim 1, further comprising the additional step of implanting the energy source for powering implantable energy consuming components of the restriction device.

26. The method according to claim 25, further comprising using an external energy source for transferring energy in a wireless mode, wherein the implanted energy source is chargeable by the energy transferred in the wireless mode.

27. The method according to claim 26, further comprising the additional step of implanting a sensor or measuring device sensing or measuring a functional parameter correlated to the transfer of energy for charging the implanted energy source, and a feedback device for sending feedback information from inside the patient'"'"'s body to the outside thereof, the feedback information being related to the functional parameter sensed by the sensor or measured by the measuring device.

28. The method according to claim 1, further comprising implanting a control device to allow use of a feedback device for sending feedback information from inside the patient'"'"'s body to the outside thereof, the feedback information being related to at least one of a physical parameter of the patient and a functional parameter related to the restriction device.

29. The method according to claim 1, further comprising implanting a sensor and/or a measuring device and an implantable internal control unit for controlling the restriction device in response to information being related to at least one of a physical parameter of the patient sensed by the sensor or measured by the measuring device and a functional parameter related to the restriction device sensed by the sensor or measured by the measuring device.

30. The method according to claim 1, further comprising implanting an external data communicator and an implantable internal data communicator communicating with the external data communicator, wherein the internal communicator feeds data related to the restriction device or the patient to the external data communicator and/or the external data communicator feeds data to the internal data communicator.

31. The method according to claim 1, further comprising implanting a motor or a pump for operating the restriction device.

32. The method according to claim 1, further comprising implanting a hydraulic operation device for operating the restriction device.

33. The method according to claim 1, further comprising implanting an operation device for operating the restriction device, wherein the operation device comprises a servo designed to decrease the force needed for the operation device to operate the restriction device.

34. The method according to claim 22, further comprising the additional step of implanting an operation device for operating the restriction device, thereby allowing wireless energy to be used to directly power the operation device to create kinetic energy for the operation of the restriction device, as the wireless energy is being transmitted by the energy-transmission device.

35. The method according to claim 22, further comprising the additional step of implanting and using an energy-transforming device for transforming the wireless energy transmitted by the energy-transmission device from a first form into a second form energy.

36. The method according to claim 35, wherein the energy-transforming device directly powers implantable energy consuming components of the restriction device with the second form energy, as the energy-transforming device transforms the first form energy transmitted by the energy-transmission device into the second form energy.

37. The method according to claim 35, further comprising implanting an accumulator, wherein the second form energy is used at least partly to charge the accumulator.

38. The method according to claim 1, further comprising the additional step of implanting or using a control device comprising electrical components including at least one voltage level guard and/or at least one constant current guard.

39. The method according to claim 38, further comprising determining by means of a determination device an energy balance between the energy received by the implanted energy receiver and the energy used for the one or more implantable energy consuming components of the restriction device, controlling, by the control device, the transmission of wireless energy from an external energy-transmission device, based on the energy balance determined by the determination device, detecting a change or difference in the energy balance, by the determination device, and controlling by the control device, the transmission of wireless energy based on the detected energy balance change.

40. The method according to claim 1, further comprising placing an energy-transmission device comprising a coil and an electric circuit externally to the body, powering by the electric circuit the connected external coil with electrical pulses transmitting wireless energy, the electrical pulses having leading and trailing edges, the electric circuit varying first time intervals between successive leading and trailing edges and/or second time intervals between successive trailing and leading edges of the electrical pulses, varying the power of the transmitted wireless energy, thereby allowing the energy receiver placed internally in the human body to receive energy having a varied power.

41. The method according to claim 40, further comprising delivering by the electric circuit electrical pulses remaining unchanged except varying the first and/or second time intervals.

42. The method according to claim 40, wherein the electric circuit has a time constant, the method further comprising varying the first and second time intervals only in the range of a first time constant, so that when the lengths of the first and/or second time intervals are varied, the transmitted power over the coil is varied.

43. The method according to claim 1, further comprising:

transmitting wireless energy by an external energy transmitter, the energy transmitter having an external second coil and a second electronic circuit connected to the second coil,

receiving the wireless energy by a first coil of the energy receiver, and wherein the second electronic circuit includes a determination device,

receiving by the determination device feedback information, and

comparing an amount of transferred energy by the second coil with the feedback information related to an amount of energy received in the first coil, and

obtaining a coupling factor between the first and second coils.

44. The method according to claim 43, further comprising calibrating and regulating, by the energy transmitter, the transmitted energy in response to the obtained coupling factor.

45. The method according to claim 43, further comprising establishing an optimal placement of the second coil by moving the external second coil in relation to the first coil, in which the coupling factor is maximized.

46. The method according to claim 1 including the step of accessing the one opening in the vaginal wall with a minimally invasive surgical procedure using at least one trocar.

47. The method according to claim 43 further comprising:

using the external energy transmitter for transmitting wireless energy, the energy transmitter having an external second coil and a second electronic circuit connected to the second coil,

transmitting wireless energy by the external second coil of the energy transmitter,

receiving the wireless energy by the first coil of the energy receiver,

using an implanted power switch for switching the connection of the first coil to the electronic circuit on and off, such that feedback information related to charging of the first coil is received by the external energy transmitter in the form of an impedance variation in the load of the external second coil, when the power switch is switching the connection of the internal first coil to the first electronic circuit on and off.

48. The method according to claim 1 further comprising using at least two trocars.

49. The method according to claim 1 further comprising using at least one trocar with a diameter from 5 to 12 mm.

50. The method according to claim 1, further comprising inserting at least one laparoscopic trocar through the vaginal wall of the patient, and wherein said dissection is performed using at least one dissecting tool, which dissecting tool is inserted through said at least one laparoscopic trocar.

51. The method according to claim 1, wherein the opening in the vaginal wall is accessed after the area surrounding any of the colon, the rectum, anus, small intestine connected to the anus, or the anal sphincter has been insufflated with a gas.

52. The method according to claim 1 further comprising:

accessing said at least one organ through the opening in the vaginal wall of the patient using the steps of;

inserting a tube or needle into the body of the patient through the opening in the vaginal wall,

using said tube or needle to insufflate a site between the vaginal wall and any one of the anus, the small intestine connected to the anus, the anal channel, the rectum and the colon of the body of the patient with a gas,

inserting at least two laparoscopic trocars into said site through the opening in the vaginal wall,

inserting at least one camera through at least one of said at least two laparoscopic trocars,

inserting at least one dissecting tool through at least one of said laparoscopic trocars, and

dissecting in the patient the area surrounding the at least one organ.

53. The method according to claim 1, further comprising the additional step of fixating said restriction device for restricting any one of the anus, anal channel, small intestine connected to the anus, rectum and colon.

54. The method according to claim 1, comprising the additional step of fixating said restriction device in adjacent tissue.

55. The method according to claim 1, comprising the additional step of fixating said restriction device by creating a tunnel from a part of the colon or placing said device below the lower part of abdominal peritoneal sac around the rectum, being placed in a tunnel of fibrotic tissue.

56. The method according to claim 1, comprising the additional step of suturing the opening in the vaginal wall in layers.

57. The method according to claim 1 wherein the restriction device is placed surrounding at least one site selected from the group consisting of a) the colon, b) the rectum, c) anal channel, d) small intestine connected to the anus, e) the anal sphincter, and f) muscle surrounding at least one of said organs a-e.

58. The method according to claim 1 comprising the additional step of stimulating by using electricity, for contracting at least one of selected parts of the at least one organ selected.

59. The method according to claim 57, comprising the additional step of stimulating by a stimulation device in more than one location of the restriction device.

60. The method according to claim 1 wherein the energy receiver includes an energy transforming device for transforming wireless energy to non-wireless energy.

61. The method according to claim 1, further including implanting subcutaneously the energy receiver in at least one of the following:

the patient'"'"'s pelvic region, muscle fascia, and abdominal cavity.

62. The method according to claim 1, wherein the energy receiver to powers the adjustment of said restriction device non-invasively, and wherein the energy receiver comprises a motor or a pump for using wireless energy directly, to create kinetic energy to adjust the restriction device.

63. The method according to claim 1, wherein the energy receiver to powers the adjustment of said restriction device non-invasively, and wherein the energy receiver comprises an energy transforming device, transforming wireless energy to non-wireless energy.

64. The method according to claim 54, further comprising implanting a motor or pump, and wherein an energy transforming device is powering the motor or pump, directly during wireless energy transfer.

65. The method according to claim 59, further comprising using an energy transforming device for charging an energy storage device, indirectly supplying energy to any energy consuming parts of the device.

66. The method according to claim 1 further comprising using a system for implantation of said restriction device, said system comprising an introductionary hose having hollow space having at least partially a conical shape, adapted to hold said device inside the hollow space to compact the device and make it smaller and conical at a first introductionary end to ease the introduction of the device, wherein the method further comprises:

mounting the restriction device inside said introductionary hose,

introducing said restriction device around the colon or anus or a small intestine connected to the anus, by using said introductionary hose,

releasing said restriction device from said introductionary hose, and

withdrawing said hose from the device.

67. The method according to claim 66, wherein said hose comprises a holding part adapted to allow an instrument to hold said hose at the first introductionary end to ease the introduction of the device, wherein the method step of introducing said restriction device by using said introductionary hose comprises;

inserting said instrument via the vagina around the colon or anus or a small intestine connected to the anus,

attaching a holding part of said introductionary hose to said instrument, and

introducing said hose around the colon or anus or a small intestine connected to the anus.

68. The method according to claim 1 comprising the additional steps of:

entering the abdominal sac from the vaginal opening,

placing said device in the abdominal peritoneal cavity, and

fixating said device by a tunnel created in the mesenterium of the intestine.

69. The method according to claim 1 comprising the additional steps of:

entering the fibrotic tissue surrounding the anal channel below the abdominal sac from the vaginal opening,

placing said device in a tunnel of said fibrotic tissue below the abdominal peritoneal cavity, and

fixating said device by said tunnel.

70. The method according to claim 68 comprising the additional steps of:

placing the energy receiver for receiving wireless energy subcutaneously just above the symphysis bone,

placing an electrical wire between the energy receiver and the device using said vaginal opening as an intermediate passage or using an instrument therefore in said opening, and

tunnelating the wire subcutaneously from the energy receiver to the device.

71. The method according to claim 68 comprising the additional steps of:

placing the energy receiver for receiving wireless energy subcutaneously just above the symphysis bone,

placing a pump and reservoir above the symphysis bone, and

tunnelating a hydraulic tube subcutaneously from the pump to the device using said vaginal opening as an intermediate passage or using a instrument therefore in through said vaginal opening.

72. The method according to claim 68, comprising the additional step of introducing a camera through said vaginal opening.

73. The method according to claim 72, comprising the additional steps of:

when introducing a camera through said vaginal opening, using said camera to go around the intestine, and

attaching said device to said camera to thereby pass said device around the intestine using said camera.

74. The method according to claim 1, wherein the steps of dissecting and implanting are performed using an instrument to perform the additional operational steps of:

grabbing directly or indirectly the powered restriction device by a grabber in a distal end of the instrument,

looping the instrument by a distal part more proximal than the distal end of the instrument,

allowing looping at least partly around the at least one organ and muscle surrounding said at least one organs, and

bending the instrument by a joint placed proximal to the distal end of the instrument.

75. The method according to claim 74, further comprising, in addition to using the distal looping part, bending the instrument in two different joints.

76. The method according to claim 1, wherein the step of implanting the energy receiver comprises the additional operational steps of:

placing the energy receiver according to the following alternatives;

subcutaneously, inside an muscle fascia, in the pelvic region or the abdomen.

77. The method according to claim 1, wherein the step of implanting the powered restriction device comprises the additional operational steps of implanting both the restriction device and one or more additional components connected thereto, said one or more additional components selected from among:

any operation device, determination device, energy-transforming device, switches and other components connected or adapted to be connected, wireless or not, to the restriction device whether electrically, mechanically or hydraulically.

78. The method according to claim 1, further comprising the additional step of:

at least one of observing and calibrating the lumen of the colon or rectum while surgery is being performed, allowing to see how much the rectum contracts when the restriction device is engaged and allowing for verification of the correct positioning of the restriction device.

79. The method according to claim 1, comprising the additional steps of at least one of the following:

fixating said restriction device in adjacent tissue,

fixating said restriction device by creating a tunnel, and

suturing the tissue in layers.

80. The method according to claim 48, comprising the additional step of inserting at least one camera through at least one of said at least two laparoscopic trocars.

81. The method according to claim 52, wherein the steps of dissecting and implanting are performed using a special instrument performing the additional operational steps of:

grabbing directly or indirectly the powered restriction device by a grabber in a distal end of the instrument,

looping the instrument by a distal part more proximal than the distal end of the instrument,

allowing looping at least partly around at least one oft the colon, the rectum, the anal channel, anal sphincter, a small intestine connected to the anus, and muscle surrounding said at least one organ, and

bending the instrument by a joint placed proximal to the distal end of the instrument.

82. The method according to claim 81 further comprising in addition to using the distal looping part, bending the instrument in two different joints.

83. The method according to claim 52, wherein the step of implanting the powered restriction device comprises the additional operational steps of:

implanting both the restriction device and one or more additional components connected thereto, said one or more additional components selected from among;

any operation device, energy receiver, determination device, energy-transforming device, switches and other components connected or adapted to be connected, wireless or not, to the restriction device whether electrical, mechanical or hydraulically.

84. The method according to claim 52, further comprising the additional step of at least one of:

observing and calibrating the lumen of the colon or rectum while surgery is being performed, allowing to see how much the rectum contracts when the restriction device is engaged, and allowing for verification of the correct positioning of the restriction device.

85. The method according to claim 52, further comprising implanting an operation device for operating the restriction device, wherein the operation device comprises a servo designed to decrease the force needed for the operation device to operate the restriction device.