EXTENDING INTRABODY CAPSULE

• US 20070123809A1
• Filed: 01/25/2007
• Published: 05/31/2007
• Est. Priority Date: 07/26/2005
• Status: Active Grant

• Current Assignee: Mi Fitpill Medical Ltd.
• Original Assignee: Menachem Weiss, Ram Weiss
• Inventors: Weiss, Ram, Weiss, Menachem
• Granted Patent: US 8,021,384 B2
• Time in Patent Office: Days
• US Class Current: 601/84
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61H 21/00 Massage devices for cavities of the body , e.g. nose, ears and anus for the genitals A61H19/00; Vibration or percussion related aspects A61H23/00
• CPC Class Codes: A61H 23/0218 with alternating magnetic fields producing a translating or oscillating movement

Abstract

A medical device includes a device body for insertion into an organ of a patient and one or more arms, which are attached to the device body and are arranged to extend outward from the device body within the organ so as to contact respective points-of-contact on an inner surface of the organ, and to apply a repetitive motion at one or more of the points-of-contact.

Claims

1. A medical device, comprising:

a device body for insertion into an organ of a patient; and

one or more arms, which are attached to the device body and are arranged to extend outward from the device body within the organ so as to contact respective points-of-contact on an inner surface of the organ, and to apply a repetitive motion at one or more of the points-of-contact.

2. The device according to claim 1, wherein the repetitive motion comprises at least one motion type selected from a group of types consisting of a sliding motion, a tilting motion and a perpendicular pressure motion.

3. The device according to claim 1, wherein, when extended, the arms are arranged to apply at least one stimulation type selected from a group of types consisting of a mechanical, a vibratory, a tactile and a nociceptive stimulation at the respective points-of-contact on the inner surface of the organ.

4. The device according to claim 1, wherein the organ comprises a stomach of the patient.

5. The device according to claim 1, wherein the organ comprises one of a gastrointestinal tract of the patient, a blood vessel, a genito-urinary tract of the patient, part of a central nervous system, an intra-abdominal organ, a thoracic organ and a limb of the patient.

6. The device according to claim 1, wherein the device comprises a capsule that is arranged to be swallowed by the patient.

7. The device according to claim 1, wherein the device is arranged to be inserted into the organ using at least one procedure selected from a group of procedures consisting of an invasive procedure, an endoscopic procedure, a laparoscopic surgery procedure and a surgical laparotomy procedure.

8. The device according to claim 1, wherein the arms comprise at least one of a metal, a plastic, an electrically-actuated material, an ionic Electro-Active Polymer (EAP), an electronic EAP, a Dielectric Elastomer Actuator (DAE) and a piezoelectric material.

9. The device according to claim 1, wherein the arms have distal ends, and wherein the repetitive motion measured at the distal ends of the arms has a frequency between 0.1 Hz and 50 Hz and an amplitude of between 10 microns and 100 mm.

10. The device according to claim 1, and comprising an antenna and a receiver, which are arranged to receive external commands transmitted to the device from an external transmitter, and a controller, which is arranged to control an operation of the device responsively to the external commands.

11. The device according to claim 10, wherein the controller is arranged to cause the arms to extend from the device body responsively to the external commands.

12. The device according to claim 10, wherein the controller is arranged to cause the arms to disengage from the device body responsively to the external commands.

13. The device according to claim 1, wherein the arms have respective bases and comprise at least one releasable attachment mechanism for attaching the bases to the device body when the arms are extended, the attachment mechanism selected from a group of mechanisms consisting of a friction mechanism, a pin mechanism and a taper mechanism.

14. The device according to claim 1, and comprising a release mechanism, which is arranged to restrain the arms during the insertion into the organ, and a controller, which is arranged to actuate the release mechanism to release the arms, so as to permit extension of the arms within the organ.

15. The device according to claim 14, wherein the arms are elastic and arranged to assume an extended position when not restrained, and are wrapped around the device body during the insertion into the organ.

16. The device according to claim 15, wherein the arms are wrapped around the device body in multiple layers.

17. The device according to claim 14, wherein the arms comprise at least one material selected from a group of materials consisting of a piezoelectric material, a Dielectric Elastomer Actuator (DEA), an ionic Electro-Active Polymer (EAP) and an electronic EAP and wherein the controller is arranged to apply a voltage to the material so as to cause the arms to extend.

18. The device according to claim 14, wherein the controller is arranged to determine a release condition and to actuate the release mechanism responsively to the release condition so as to cause the release mechanism to release the arms.

19. The device according to claim 18, wherein the release condition comprises at least one of a predetermined time schedule, an event schedule and an external command transmitted to the device.

20. The device according to claim 18, wherein the release mechanism comprises at least one actuation device selected from a group of mechanisms consisting of a shape memory alloy (SMA) element, a motor, a piezoelectric element, an Electro-Active Polymer (EAP) element, a Dielectric Elastomer Actuator (DEA), a solenoid, a magnetic lock and a detent, and wherein the controller is arranged to actuate the release mechanism using the actuation device.

21. The device according to claim 1, and comprising a cover comprising a dissolvable material, which is arranged to restrain the arms during the insertion into the organ and to dissolve in the organ so as to release the arms and permit the arms to extend.

22. The device according to claim 21, wherein dissolution of the cover is actuated by consumption of a substance by the patient.

23. The device according to claim 1, and comprising a disassembly mechanism, which is arranged, when activated, to disengage the arms from the device body so as to allow the device body and the arms to be disposed of.

24. The device according to claim 23, wherein the disassembly mechanism performs at least one action selected from a group of actions consisting of:

releasing a circumferential ring that holds a first side of a base of the arms;

moving outward parts that are adjacent to a second side of the base of the arms opposite the first side;

removing pivots connecting the arms to the device body;

releasing a friction mechanism; and

pushing the base of the arms out of a tapered locking mechanism.

25. The device according to claim 23, wherein the disassembly mechanism comprises one or more pre-energized springs that are released when the disassembly mechanism is activated.

26. The device according to claim 23, and comprising a controller, which is arranged to actuate the disassembly mechanism responsively to a disassembly condition.

27. The device according to claim 26, wherein the disassembly condition comprises at least one condition selected from a group of conditions consisting of a predetermined time schedule, a low power condition of a power source of the device and an external command transmitted to the device.

28. The device according to claim 26, wherein the disassembly mechanism comprises at least one actuation element selected from a group of elements consisting of a shape memory alloy (SMA) element, a motor, a piezoelectric element, an Electro-Active Polymer (EAP) element, a solenoid, a ball lock mechanism, a magnetic lock and a detent, and wherein the controller is arranged to actuate the disassembly mechanism using the actuation element.

29. The device according to claim 1, and comprising a resonator attached to the device body, which is arranged to vibrate the arms so as to apply the repetitive motion.

30. The device according to claim 29, wherein the resonator comprises at least one element selected from a group of elements consisting of a disk-shaped resonator, a bending resonator, a twist resonator, an electric motor that rotates an eccentric mass, a stepping motor, a piezoelectric exciter, an Electro-Active Polymer (EAP) resonator, an electrostrictive exciter and an electrostatic source.

31. The device according to claim 29, wherein the resonator is arranged to vibrate the arms with a random vibration having frequencies within a bandwidth containing respective resonant frequencies of the arms.

32. The device according to claim 1, wherein the arms comprise at least one material selected from a group of materials consisting of an electrically-actuated material, a piezoelectric material, a Dielectric Elastomer Actuator (DEA), an ionic Electro-Active Polymer (EAP) and an electronic EAP, and comprising a controller, which is arranged to drive the arms with respective electrical signals so as to cause the arms to apply the repetitive motion.

33. The device according to claim 32, wherein the electrical signals have frequencies that approximate respective resonant frequencies of the arms, so as to cause the arms to vibrate at the respective resonant frequencies.

34. The device according to claim 32, wherein the arms comprise respective feedback elements, which are arranged to sense vibrations of the arms, and wherein the controller is arranged to adjust respective frequencies of the vibrations of the arms to match resonant frequencies of the arms based on the vibrations sensed by the feedback elements.

35. The device according to claim 32, wherein the arms are partitioned into two or more subsets, and wherein the controller is arranged to drive the two or more subsets of the arms in alternation.

36. The device according to claim 1, wherein the arms are further arranged to transfer an electrical stimulation to the respective points-of-contact on the inner surface of the organ.

37. The device according to claim 1, wherein the device is arranged to discharge a substance within the organ.

38. The device according to claim 37, wherein the substance is impregnated in at least one of an outer surface of the device body and the arms.

39. The device according to claim 37, and comprising a container holding the substance fitted in the device body.

40. The device according to claim 39, wherein one or more of the arms comprise tubes, which are arranged to lead the substance from the container to the inner surface of the organ so as to discharge the substance in a vicinity of the points-of-contact.

41. The device according to claim 39, and comprising a substance discharge mechanism, which is arranged to discharge the substance using at least one effect selected from a group of effects consisting of a chemical reaction, a capillary effect, a pressure effect and a piezoelectric effect.

42. The device according to claim 37, and comprising a controller, which is arranged to discharge the substance responsively to at least one of an external command transmitted to the device and a pre-programmed schedule.

43. The device according to claim 1, and comprising a transmitter, which is arranged to transmit a status of the device to an external receiver.

44. The device according to claim 43, wherein the transmitter is arranged to transmit an alert message indicating an appropriate time for externally administering a systemically-acting substance to the patient, in order to enhance a therapeutic effect induced by the repetitive motion and the substance.

45. The device according to claim 1, wherein at least one of the device body and the arms comprise a material that provides visualization when imaged by a medical imaging system.

46. The device according to claim 1, wherein the arms have curved a-traumatic distal ends.

47. The device according to claim 1, wherein the arms have curved profiles so as to increase a structural rigidity of the arms.

48. The device according to claim 1, wherein the device comprises a power source comprising at least one of a battery, a rechargeable battery and a radio frequency (RF) coil arranged to accept externally-transmitted RF energy.

49. The device according to claim 1, and comprising a controller, which is pre-programmed with one or more activation profiles defining respective time schedules for activating functions of the device.

50. The device according to claim 49, wherein the functions comprise at least one function selected from a group of functions consisting of releasing the arms, applying the repetitive motion, disengaging the arms from the device body, discharging a substance from the device, switching to another activation profile and transmitting a status of the device.

51. The device according to claim 49, wherein the functions comprise applying the repetitive motion by the arms and discharging a substance from the device, and wherein the controller is arranged to synchronize a timing of applying the repetitive motion and of discharging the substance, so as to enhance a therapeutic effect induced by the repetitive motion and the substance.

52. A system for treating a patient, comprising:

a transmitter external to the patient, which is arranged to transmit commands using wireless signals; and

a device for insertion into an organ of the patient, comprising;

a device body;

a receiver fitted in the device body, which is arranged to receive the commands transmitted by the transmitter; and

one or more arms attached to the device body, which are arranged to extend outward from the device body within the organ responsively to a command received by the receiver, so as to contact respective points-of-contact on an inner surface of the organ, and to apply a repetitive motion at one or more of the points-of-contact.

53. The system according to claim 52, wherein the transmitter comprises a personal control unit.

54. A system for treating a patient, comprising:

one or more electromagnets, which are located externally to the patient and are arranged to induce a time-varying magnetic field in an organ of the patient; and

a device for insertion into an organ of the patient, comprising;

a body, which comprises a field-responsive element that is set in motion by the induced time-varying magnetic field; and

one or more arms attached to the body, which are arranged to extend outward from the device body within the organ so as to contact respective points-of-contact on an inner surface of the organ, and to apply mechanical stimulation, whose characteristics depend on the time-varying magnetic field, at one or more of the points-of-contact as a result of the motion of the field-responsive element in the body.

55. A method for treating a patient, comprising:

inserting into an organ of the patient a device comprising a device body and one or more arms attached thereto in a compact configuration;

causing the arms to extend outward from the device body within the organ so as to contact respective points-of-contact on an inner surface of the organ; and

applying a repetitive motion by the arms at one or more of the respective points-of-contact, so as to cause a therapeutic effect in the patient.

56. The method according to claim 55, wherein applying the repetitive motion comprises applying at least one motion type selected from a group of types consisting of a sliding motion, a tilting motion and a perpendicular pressure motion.

57. The method according to claim 55, wherein applying the repetitive motion comprises applying at least one stimulation type selected from a group of types consisting of a mechanical, a vibratory, a tactile and a nociceptive stimulation at the respective points-of-contact on the inner surface of the organ.

58. The method according to claim 55, wherein the organ comprises a stomach of the patient.

59. The method according to claim 55, wherein the organ comprises one of a gastrointestinal tract of the patient, a blood vessel, a genito-urinary tract of the patient, part of a central nervous system, an intra-abdominal organ, a thoracic organ and a limb of the patient.

60. The method according to claim 55, wherein inserting the device comprises swallowing the device by the patient.

61. The method according to claim 55, wherein inserting the device comprises inserting the device using at least one procedure selected from a group of procedures consisting of an invasive procedure, an endoscopic procedure, a laparoscopic surgery procedure and a surgical laparotomy procedure.

62. The method according to claim 55, wherein the arms comprise at least one of a metal, a plastic, an electrically-actuated material, an ionic Electro-Active Polymer (EAP), an electronic EAP, a Dielectric Elastomer Actuator (DAE) and a piezoelectric material.

63. The method according to claim 55, wherein the arms have distal ends, and wherein the repetitive motion measured at the distal ends of the arms has a frequency between 0.1 Hz and 50 Hz and an amplitude of between 10 microns and 100 mm.

64. The method according to claim 55, and comprising receiving external commands transmitted to the device from an external transmitter, and controlling an operation of the device responsively to the external commands.

65. The method according to claim 64, wherein controlling the operation of the device comprises causing the arms to extend from the device body responsively to the external commands.

66. The method according to claim 64, wherein controlling the operation of the device comprises causing the arms to disengage from the device body responsively to the external commands.

67. The method according to claim 55, wherein inserting the device comprises restraining the arms during the insertion into the organ, and wherein causing the arms to extend comprises releasing the arms so as to permit extension of the arms within the organ.

68. The method according to claim 67, wherein the arms are elastic and arranged to assume an extended position when not restrained, and wherein restraining the arms comprises wrapping the arms around the device body during the insertion into the organ.

69. The method according to claim 68, wherein wrapping the arms comprises wrapping the arms around the device body in multiple layers.

70. The device according to claim 67, wherein the arms comprise at least one material selected from a group of materials consisting of a piezoelectric material, a Dielectric Elastomer Actuator (DEA), an ionic Electro-Active Polymer (EAP) and an electronic EAP, and wherein causing the arms to extend comprises applying a voltage to the material.

71. The method according to claim 67, wherein releasing the arms comprises determining a release condition and releasing the arms responsively to the release condition.

72. The method according to claim 71, wherein the release condition comprises at least one of a predetermined time schedule and an external command transmitted to the device.

73. The method according to claim 71, wherein releasing the arms comprises actuating at least one actuation device selected from a group of mechanisms consisting of a shape memory alloy (SMA) element, a motor, a piezoelectric element, an Electro-Active Polymer (EAP) element, a Dielectric Elastomer Actuator (DEA), a solenoid, a magnetic lock and a detent.

74. The method according to claim 55, wherein inserting the device comprises restraining the arms using a cover comprising a dissolvable material, and wherein causing the arms to extend comprises causing the cover to dissolve in the organ so as to release the arms and permit the arms to extend.

75. The method according to claim 64, wherein causing the cover to dissolve comprises consuming a substance by the patient.

76. The method according to claim 55, and comprising disengaging the arms from the device body so as to allow the device body and the arms to be disposed of.

77. The method according to claim 76, wherein disengaging the arms comprises performing at least one action selected from a group of actions consisting of:

releasing a circumferential ring that holds a first side of a base of the arms;

moving outward parts that are adjacent to a second side of the base of the arms opposite the first side;

removing pivots connecting the arms to the device body;

releasing a friction mechanism; and

pushing the base of the arms out of a tapered locking mechanism.

78. The method according to claim 76, wherein disengaging the arms comprises releasing one or more pre-energized springs.

79. The method according to claim 76, wherein disengaging the arms comprises disengaging the arms responsively to a disassembly condition.

80. The method according to claim 79, wherein the disassembly condition comprises at least one condition selected from a group of conditions consisting of a predetermined time schedule, a low power condition of a power source of the device and an external command transmitted to the device.

81. The method according to claim 79, wherein disengaging the arms comprises actuating at least one actuation element selected from a group of elements consisting of a shape memory alloy (SMA) element, a motor, a piezoelectric element, an Electro-Active Polymer (EAP) element, a solenoid, a ball lock mechanism, a magnetic lock and a detent.

82. The method according to claim 55, wherein applying the repetitive motion comprises vibrating the arms using a resonator attached to the device body.

83. The method according to claim 82, wherein the resonator comprises at least one element selected from a group of elements consisting of a disk-shaped resonator, a bending resonator, a twist resonator, an electric motor that rotates an eccentric mass, a stepping motor, a piezoelectric exciter, an Electro-Active Polymer (EAP) resonator, an electrostrictive exciter and an electrostatic source.

84. The method according to claim 82, wherein vibrating the arms comprises vibrating the arms with a random vibration having frequencies within a bandwidth containing respective resonant frequencies of the arms.

85. The method according to claim 55, wherein the arms comprise at least one material selected from a group of materials consisting of an electrically-actuated material, a piezoelectric material, a Dielectric Elastomer Actuator (DEA), an ionic Electro-Active Polymer (EAP) and an electronic EAP, and wherein applying the repetitive motion comprises driving the arms with respective electrical signals.

86. The method according to claim 85, wherein the electrical signals have frequencies that approximate respective resonant frequencies of the arms, so as to cause the arms to vibrate at the respective resonant frequencies.

87. The method according to claim 86, wherein applying the repetitive motion comprises sensing vibrations of the arms using respective feedback elements attached to the arms, and adjusting respective frequencies of the vibrations of the arms to match respective resonant frequencies of the arms based on the vibrations sensed by the feedback elements.

88. The method according to claim 85, wherein the arms are partitioned into two or more subsets, and wherein driving the arms comprises driving the two or more subsets of the arms in alternation.

89. The method according to claim 55, and comprising transferring an electrical stimulation to the respective points-of-contact on the inner surface of the organ using the arms.

90. The method according to claim 55, and comprising discharging a substance from the device within the organ in order to induce the therapeutic effect.

91. The method according to claim 90, wherein discharging the substance comprises impregnating the substance in at least one of an outer surface of the device body and the arms.

92. The method according to claim 90, wherein discharging the substance comprises discharging the substance from a container fitted in the device body.

93. The method according to claim 92, wherein discharging the substance comprises leading the substance from the container to the inner surface of the organ using tubes along one or more of the arms, so as to discharge the substance in a vicinity of the points-of-contact.

94. The method according to claim 92, wherein discharging the substance comprises releasing the substance using at least one effect selected from a group of effects consisting of a chemical reaction, a capillary effect, a pressure effect and a piezoelectric effect.

95. The method according to claim 90, wherein discharging the substance comprises discharging the substance responsively to at least one of an external command transmitted to the device and a pre-programmed schedule.

96. The method according to claim 55, and comprising transmitting a status of the device to an external receiver.

97. The method according to claim 96, wherein transmitting the status comprises transmitting an alert message indicating an appropriate time for externally administering a substance to the patient, in order to enhance the therapeutic effect.

98. The method according to claim 55, and comprising imaging the device using a medical imaging system, wherein at least one of the device body and the arms comprise a material that provides visualization when imaged by the medical imaging system.

99. The method according to claim 55, and comprising activating functions of the device in accordance with one or more time schedules defined by respective activation profiles pre-programmed in the device.

100. The method according to claim 99, wherein activating the functions comprises performing at least one action selected from a group of actions consisting of releasing the arms, applying the repetitive motion, disengaging the arms from the device body, discharging a substance from the device, switching to another activation profile and transmitting a status of the device.

101. The method according to claim 99, wherein activating the functions comprises synchronizing a timing of applying the repetitive motion by the arms and of discharging a substance from the device, so as to enhance the therapeutic effect.

102. The method according to claim 55, wherein the device includes a field-responsive element, and wherein applying the repetitive motion comprises setting the device in motion by inducing a time-varying magnetic field in the field-responsive element using one or more electromagnets located externally to the patient, such that characteristics of the repetitive motion applied by the arms depend on the time-varying magnetic field.

103. The method according to claim 55, wherein the therapeutic effect comprises at least one effect selected from a group of effects consisting of a systemic physiological effect and a therapeutic effect distant from the organ.

104. The method according to claim 55, wherein the therapeutic effect comprises an alteration of a caloric intake of the patient.

105. The method according to claim 55, wherein the therapeutic effect comprises an alteration of a metabolic profile of mucosa in a vicinity of the device.

106. The method according to claim 55, wherein applying the repetitive motion comprises inducing a secretion of at least one substance selected from a group of substances consisting of a hormone, a peptide, a cytokine and a molecule by the organ, and wherein the therapeutic effect comprises at least one effect selected from a group of effects consisting of an endocrine, an autocrine and a paracrine effect.

107. The method according to claim 55, wherein the therapeutic effect comprises at least one effect selected from a group of effects consisting of a systemic effect and a local neurally-mediated physiological systemic effect, which is induced via afferent and efferent nervous system fibers.

108. The method according to claim 55, wherein applying the repetitive motion comprises causing a secretion of at least one substance selected from a group of substances consisting of a hormone, a peptide, a cytokine and a molecule from an organ other than the organ into which the device is inserted.

109. The method according to claim 55, wherein applying the repetitive motion comprises stimulating mechanically-activated tissue receptors at the points-of-contact.

110. The method according to claim 55, wherein applying the repetitive motion comprises altering a physical tissue property at the points-of-contact.

111. The method according to claim 110, wherein the physical tissue property comprises at least one property selected from a group of properties consisting of a permeability, an excitability, a temperature and a consistency at the points-of-contact.

112. The method according to claim 55, wherein applying the repetitive motion comprises modifying an intra-luminal pressure at the points-of-contact, so as to induce a counter-dilation reaction.

113. The method according to claim 55, wherein applying the repetitive motion comprises affecting a secretion of at least one of a pro-feeding (orexigenic) and an anti-feeding (anorexogenic) hormone in accordance with a treatment profile, so as to control a caloric intake of the patient.

114. The method according to claim 55, and comprising administering to the patient a systemically-administered substance that contributes to the therapeutic effect, so as to enhance the therapeutic effect by synergistically using the substance and the repetitive motion.

115. The method according to claim 114, wherein administering the drug and applying the repetitive motion comprises synchronizing a timing of administering the drug and of applying the repetitive motion so as to enhance the therapeutic effect.