Extending intrabody capsule

• US 8,021,384 B2
• Filed: 01/25/2007
• Issued: 09/20/2011
• Est. Priority Date: 07/26/2005
• Status: Expired due to Fees

• Current Assignee: Mi Fitpill Medical Ltd.
• Original Assignee: Menachem P. Weiss, Ram Weiss
• Inventors: Weiss, Menachem P., Weiss, Ram
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US11/627,189
• Publication Number:
  US 20070123809A1
• Time in Patent Office: 1,699 Days
• Field of Search: 604104-106, 623 2364- 2366, 623/23.75, 623/24, 606/191
• US Class Current: 606/191
• 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 swallowable intra-body capsule including;

a capsule housing which is automatically dissolvable within the stomach of a patient;

at least one arm, located within the dissolvable capsule housing, which is configured to automatically extend outwardly within the stomach of a patient so as to contact at least one point-of-contact on an inner surface of the stomach;

a resonator located within said capsule housing and being operative to cause said at least one arm to apply a repetitive motion at said at least one point-of-contact; and

a controller, located within said capsule housing, which is arranged to automatically control application of said repetitive motion.

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 at least one arm is 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 said at least one point-of-contact.

4. The device according to claim 1, wherein the capsule is adapted to be inserted into 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.

5. The device according to claim 1, wherein the device is adapted to be inserted into the stomach 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.

6. The device according to claim 1, wherein the at least one arm comprises 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.

7. The device according to claim 1, wherein:

the at least one arm has a distal end; and

the repetitive motion measured at the distal end has a frequency between 0.1 Hz and 50 Hz and an amplitude of between 10 microns and 100 mm.

8. 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 wherein said controller is operative to control an operation of the device responsively to the external commands.

9. The device according to claim 8, wherein the controller is arranged to cause the at least one arm extend responsively to the external commands.

10. The device according to claim 8, wherein the controller is arranged to cause the at least one arm disengage from the capsule responsively to the external commands.

11. The device according to claim 1, wherein the at least one arm has a base and includes at least one releasable attachment mechanism for attaching the base to the capsule when the at least one arm is extended, the attachment mechanism selected from a group of mechanisms consisting of a friction mechanism, a pin mechanism and a taper mechanism.

12. The device according to claim 1, and comprising a release mechanism, which is arranged to restrain the at least one arm during the insertion into the stomach, and wherein said controller is operative to actuate the release mechanism to release the at least one arm, so as to permit extension of the at least one within the stomach.

13. The device according to claim 12, wherein the at least one arm is elastic and arranged to assume an extended position when not restrained, and is wrapped around the capsule during the insertion into the stomach.

14. The device according to claim 12, wherein the at least one arm is wrapped around the capsule in multiple layers.

15. The device according to claim 12, wherein the at least one arm includes 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 at least one arm to extend.

16. The device according to claim 12, 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 at least one arm.

17. The device according to claim 16, wherein the release condition comprises at least one of a predetermined time schedule, an event schedule and an external command transmitted to the device.

18. The device according to claim 16, 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.

19. The device according to claim 1, and wherein said capsule housing is arranged to restrain the at least one arm during the insertion into the stomach and to dissolve in the stomach so as to release the at least one arm and permit the at least one arm to extend.

20. The device according to claim 19, wherein dissolution of the capsule housing is actuated by consumption of a substance by the patient.

21. The device according to claim 1, and comprising a disassembly mechanism, which is arranged, when activated, to disengage the at least one arm from the capsule so as to allow the capsule and the at least one arm to be disposed of.

22. The device according to claim 21, 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 at least one arm;

moving outward parts that are adjacent to a second side of the base of the at least one arm opposite the first side;

removing pivots connecting the at least one to the capsule;

releasing a friction mechanism; and

pushing the base of the at least one arm out of a tapered locking mechanism.

23. The device according to claim 21, wherein the disassembly mechanism comprises one or more pre-energized springs that are released when the disassembly mechanism is activated.

24. The device according to claim 21, and wherein said controller is operative to actuate the disassembly mechanism responsively to a disassembly condition.

25. The device according to claim 24, 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.

26. The device according to claim 24, 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.

27. The device according to claim 1, 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.

28. The device according to claim 1, wherein the resonator is arranged to vibrate the at least one arm with a random vibration having a frequency within a bandwidth containing a resonant frequency of the at least one arm.

29. The device according to claim 1, wherein the at least one arm includes 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 said controller is operative to drive the at least one arm with an electrical signal so as to cause the at least one arm to apply the repetitive motion.

30. The device according to claim 29, wherein the electrical signal has a frequency that approximates a resonant frequency of the at least one arm, so as to cause the at least one arm to vibrate at the resonant frequency.

31. The device according to claim 29, wherein the at least one arm includes a feedback element, which is arranged to sense vibration of the at least one arm, and wherein the controller is arranged to adjust the frequency of the vibration of the at least one arm to match the resonant frequency of the at least one arm based on the vibration sensed by the feedback element.

32. The device according to claim 29, wherein the at least one arm includes at least two arms are partitioned into two or more subsets, and wherein the controller is arranged to drive the two or more subsets in alternation.

33. The device according to claim 1, wherein the at least one arm is further arranged to transfer an electrical stimulation to the at least one point-of-contact.

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

35. The device according to claim 34, wherein the substance is impregnated in at least one of an outer surface of the capsule and the at least one arm.

36. The device according to claim 34, and comprising a container holding the substance fitted in capsule.

37. The device according to claim 36, wherein one or more of the at least one arm comprises tubes, which are arranged to lead the substance from the container to the inner surface of the stomach so as to discharge the substance in a vicinity of the point-of-contact.

38. The device according to claim 36, 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.

39. The device according to claim 34, and wherein said controller is operative to discharge the substance responsively to at least one of an external command transmitted to the device and a pre-programmed schedule.

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

41. The device according to claim 40, 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.

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

43. The device according to claim 1, wherein the at least one arm has curved a-traumatic distal ends.

44. The device according to claim 1, wherein the at least one arm has a curved profile so as to increase a structural rigidity of the at least one arm.

45. 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.

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

47. The device according to claim 46, wherein the functions comprise at least one function selected from a group of functions consisting of releasing the at least one arm, applying the repetitive motion, disengaging the at least one arm from the capsule, discharging a substance from the device, switching to another activation profile and transmitting a status of the device.

48. The device according to claim 46, wherein the functions comprise applying the repetitive motion by the at least one arm 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.

49. The device according to claim 1, wherein said repetitive motion causes a therapeutic effect in the patient, the therapeutic effect comprising at least one effect selected from a group of effects consisting of a systemic physiological effect and a therapeutic effect distant from the stomach.

50. The device according to claim 1, wherein said repetitive motion causes a therapeutic effect in the patient, the therapeutic effect comprising an alteration of a caloric intake of the patient.

51. The device according to claim 1, wherein said repetitive motion causes a therapeutic effect in the patient, the therapeutic effect comprising an alteration of a metabolic profile of mucosa in a vicinity of the device.

52. The device according to claim 1, wherein the repetitive motion induces 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 stomach, and said repetitive motion causes a therapeutic effect in the patient, the therapeutic effect comprising at least one effect selected from a group of effects consisting of an endocrine, an autocrine and a paracrine effect.

53. The device according to claim 1, wherein said repetitive motion causes a therapeutic effect in the patient, the therapeutic effect comprising 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.

54. The device according to claim 1, wherein the repetitive motion causes 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 stomach.

55. The device according to claim 1, wherein the repetitive motion stimulates mechanically-activated tissue receptors at the at least one point-of-contact.

56. The device according to claim 1, wherein the repetitive motion alters a physical tissue property at the at least one point-of-contact.

57. The device according to claim 56, 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 at least one point-of-contact.

58. The device according to claim 1, wherein the repetitive motion modifies an intra-luminal pressure at the at least one point-of-contact, so as to induce a counter-dilation reaction.

59. The device according to claim 1, wherein the repetitive motion affects 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.

60. A method for treating a patient, comprising:

inserting into a stomach of the patient a swallowable intra-body capsule comprising a capsule housing which is automatically dissolvable within the stomach of a patient and at least one arm, located within the capsule housing which is configured to automatically extend outwardly within the stomach of a patient so as to contact at least one point-of-contact on an inner surface of the stomach, a resonator located within the capsule housing and being operative to cause the at least one arm to apply a repetitive motion at the at least one point-of-contact, and a controller, located within the capsule housing which is arranged to automatically control application of the repetitive motion;

causing the at least one arm to extend outward from the capsule within the stomach so as to contact the at least one point-of-contact; and

applying a repetitive motion by the at least one arm the at least one point-of-contact, so as to cause a therapeutic effect in the patient.

61. The method according to claim 60, wherein said applying 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.

62. The method according to claim 60, wherein said 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 at least one point-of-contact.

63. The method according to claim 60, wherein the inserting comprises inserting via at least 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.

64. The method according to claim 60, wherein said inserting comprises swallowing the capsule by the patient.

65. The method according to claim 60, wherein said inserting 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.

66. The method according to claim 60, wherein the at least one arm comprises 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.

67. The method according to claim 60, wherein the at least one arm has a distal end, and wherein the repetitive motion measured at the distal end has a frequency between 0.1 Hz and 50 Hz and an amplitude of between 10 microns and 100 mm.

68. The method according to claim 60, and comprising receiving external commands transmitted to the capsule from an external transmitter, and controlling an operation of the capsule responsively to the external commands.

69. The method according to claim 68, wherein said controlling comprises causing the at least one arm to extend from the capsule responsively to the external commands.

70. The method according to claim 68, wherein said controlling comprises causing the at least one arm to disengage from the capsule responsively to the external commands.

71. The method according to claim 60, wherein said inserting the device comprises restraining the at least one arm during the insertion into the stomach, and wherein causing the at least one arm to extend comprises releasing the at least one arm so as to permit extension of the at least one arm within the stomach.

72. The method according to claim 71, wherein the at least one arm is elastic and arranged to assume an extended position when not restrained, and wherein said restraining the comprises wrapping the at least one arm around the capsule during the insertion into the stomach.

73. The method according to claim 72, wherein said wrapping comprises wrapping the at least one arm around the capsule in multiple layers.

74. The device according to claim 71, wherein the at least one arm comprises 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 said causing the at least one arm to extend comprises applying a voltage to the material.

75. The method according to claim 71, wherein said releasing comprises determining a release condition and releasing the at least one arm responsively to the release condition.

76. The method according to claim 75, wherein the release condition comprises at least one of a predetermined time schedule and an external command transmitted to the capsule.

77. The method according to claim 71, wherein said releasing 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.

78. The method according to claim 60, wherein said inserting comprises restraining the at least one arm using the capsule housing, and wherein causing the at least one arm to extend comprises causing the capsule housing to dissolve in the stomach so as to release the at least one arm and permit the at least one arm to extend.

79. The method according to claim 78, wherein said causing the capsule housing to dissolve comprises consuming a substance by the patient.

80. The method according to claim 60, and comprising disengaging the at least one arm from the capsule so as to allow the capsule and the at least one arm to be disposed of.

81. The method according to claim 80, wherein said disengaging the at least one arm 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 at least one arm;

moving outward parts that are adjacent to a second side of the base of the at least one arm opposite the first side;

removing pivots connecting the at least one arm to the capsule;

releasing a friction mechanism; and

pushing the base of the at least one arm out of a tapered locking mechanism.

82. The method according to claim 80, wherein said disengaging the at least one arm comprises releasing one or more pre-energized springs.

83. The method according to claim 80, wherein said disengaging the at least one arm comprises disengaging the at least one arm responsively to a disassembly condition.

84. The method according to claim 83, 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 capsule device and an external command transmitted to the capsule.

85. The method according to claim 80, wherein said disengaging the at least one arm 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.

86. The method according to claim 60, wherein said applying comprises vibrating the at least one arm using the resonator.

87. The method according to claim 86, wherein said vibrating the at least one arm comprises vibrating the at least one arm with a random vibration having a frequency within a bandwidth containing a resonant frequency of the at least one arm.

88. The method according to claim 60, 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.

89. The method according to claim 60, wherein the at least one arm comprises 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 said applying comprises driving the at least one arm with an electrical signal.

90. The method according to claim 89, wherein the electrical signal has a frequency that approximates a resonant frequency of the at least one arm, so as to cause the at least one arm vibrate at the resonant frequency.

91. The method according to claim 90, wherein said applying comprises sensing vibration of the at least one arm using a feedback element attached to the at least one arm, and adjusting a frequency of the vibration of the at least one arm to match the resonant frequency of the at least one arm based on the vibration sensed by the feedback element.

92. The method according to claim 89, wherein the at least one arm includes at least two arms partitioned into two or more subsets, and wherein said driving comprises driving the two or more subsets in alternation.

93. The method according to claim 60, and comprising transferring an electrical stimulation to the at least one point-of-contact using the at least one arm.

94. The method according to claim 60, and comprising discharging a substance from the capsule within the stomach in order to induce the therapeutic effect.

95. The method according to claim 94, wherein said discharging comprises impregnating the substance in at least one of an outer surface of the capsule and the at least one arm.

96. The method according to claim 94, wherein said discharging comprises discharging the substance from a container fitted in the capsule.

97. The method according to claim 96, wherein said discharging the substance from a container comprises leading the substance from the container to the inner surface of the stomach using tubes along one or more of the at least one arm, so as to discharge the substance in a vicinity of the at least one point-of-contact.

98. The method according to claim 94, wherein said discharging 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.

99. The method according to claim 94, wherein said discharging comprises discharging the substance responsively to at least one of an external command transmitted to the capsule and a pre-programmed schedule.

100. The method according to claim 60, and comprising transmitting a status of the capsule to an external receiver.

101. The method according to claim 100, wherein said transmitting comprises transmitting an alert message indicating an appropriate time for externally administering a substance to the patient, in order to enhance the therapeutic effect.

102. The method according to claim 60, and comprising imaging the capsule using a medical imaging system, wherein at least one of the capsule and the at least one arm comprise a material that provides visualization when imaged by the medical imaging system.

103. The method according to claim 60, and comprising activating functions of the capsule in accordance with one or more time schedules defined by respective activation profiles pre-programmed in the capsule.

104. The method according to claim 103, wherein said activating functions comprises performing at least one action selected from a group of actions consisting of releasing the at least one arm, applying the repetitive motion, disengaging the at least one arm from the capsule, discharging a substance from the capsule, switching to another activation profile and transmitting a status of the capsule device.

105. The method according to claim 103, wherein said activating functions comprises synchronizing a timing of applying the repetitive motion by the at least one arm and of discharging a substance from the capsule, so as to enhance the therapeutic effect.

106. The method according to claim 60, wherein the capsule includes a field-responsive element, and wherein said applying comprises setting the capsule 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 at least one arm depends on the time-varying magnetic field.

107. The method according to claim 60, 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.

108. The method according to claim 107, wherein said administering and applying comprises synchronizing a timing of said administering and of said applying so as to enhance the therapeutic effect.