Medical implant systems

• US 20040243207A1
• Filed: 05/26/2004
• Published: 12/02/2004
• Est. Priority Date: 05/30/2003
• Status: Abandoned Application

• Current Assignee: Medi-Screw Incorporated
• Original Assignee: Medi-Screw Incorporated
• Inventors: Altman, David W., Olson, Donald R.
• Application Number:
  US10/854,431
• Publication Number:
  US 20040243207A1
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925

Abstract

Medical implant systems for a variety of medical uses including stimulating tissue, locating nerves during a medical procedure, measuring nerve activity, stimulating bone growth, assisting hearing, providing eyesight, delivering medicaments, and facilitating positioning and tracking of positions of medical implants.

Claims

1. A medical fastener system, comprising a fastener and a driver for installing the fastener within a patient, wherein the driver and fastener are each configured to have communicating bores extending through their lengths for passage of an electrically communicative element, such that the electrically communicative element is exposed to and in electrical communication with the exterior of the fastener, a source of electrical power and a detector each in electrical communication with the electrically conductive element, wherein when an electrical force is applied to the electrically communicative element via the source of electrical power, electrical signals will be generated by the patient if electrically responsive tissue is proximate the fastener, with such electrical signals being conducted via the fastener and the electrically communicative element to the detector to indicate the presence of electrically responsive tissue proximate the fastener.

2. The system of claim 1, wherein the fastener comprises a screw.

3. The system of claim 1, wherein the fastener comprises a screw having a castellated head and the driver has a tip configured to interfit with the castellated head of the screw.

4. The system of claim 1, wherein the electrically conductive element comprises an electrode wire.

5. The system of claim 1, wherein the electrically communicative element is of one-piece construction.

6. The system of claim 1, wherein the electrically communicative element comprises a plurality of electrically conductive elements electrically coupled together.

7. The system of claim 1, wherein the fastener is made of a non-electrically conductive material.

8. The system of claim 1, wherein the fastener is made of an electrically conductive material.

9. The system of claim 1, wherein the source of electrical power applies electrical force in pulses.

10. The system of claim 1, wherein the source of electrical power is a direct current source.

11. The system of claim 1, wherein the source of electrical power is an alternating current source.

12. The system of claim 1, wherein the detector comprises an audible alarm.

13. The system of claim 1, wherein the detector comprises a light.

14. The system of claim 1, wherein the communicating bores define passages for introduction of a medicament to a patient, and wherein the system further includes a seal operatively associated with an inlet end of the bore of the fastener for selectively sealing and unsealing the inlet.

15. The system of claim 1, wherein fastener includes a head defining a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes;

the driver including a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated, with a plurality of first sensors being located on the reference structures and a plurality of second sensors being located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween; and

a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals.

16. A medical fastener system, comprising a fastener and a driver for installing the fastener within a patient, wherein the driver and fastener are each configured to have communicating bores for passage of a tissue stimulating device, such that the tissue stimulating device is exposed to and in communication with the exterior of the fastener, a source of stimulating power and a detector each in communication with the tissue stimulating device, wherein when a stimulating force is applied to the stimulating device, signals will be generated by the patient if electrically responsive tissue is proximate the fastener, with such signals being communicated to the detector to indicate that electrically responsive tissue is proximate the fastener.

17. The system of claim 16, wherein the communicating bores extend through the lengths of the driver and fastener.

18. The system of claim 16, wherein the communicating bore of the fastener comprises a blind bore and the stimulating device comprises a pair of wires, each in electrical communication with one of a pair of contacts located within the blind bore and extending through a sidewall of the fastener to an exterior portion thereof.

19. The system of claim 16, wherein the fastener comprises a screw.

20. The system of claim 16, wherein the fastener comprises a screw having a castellated head and the driver has a tip configured to interfit with the castellated head of the screw.

21. The system of claim 16, wherein the stimulating device comprises an electrode wire.

22. The system of claim 16, wherein the stimulating device is of one-piece construction.

23. The system of claim 16, wherein the stimulating device comprises a plurality of electrically conductive elements electrically coupled together.

24. The system of claim 16, wherein the fastener is made of a non-electrically conductive material.

25. The system of claim 16, wherein the fastener is made of an electrically conductive material.

26. The system of claim 16, wherein the source of electrical power applies electrical force in pulses.

27. The system of claim 16, wherein the source of electrical power is a direct current source.

28. The system of claim 16, wherein the source of electrical power is an alternating current source.

29. The system of claim 16, wherein the detector comprises an audible alarm.

30. The system of claim 16, wherein the detector comprises a light.

31. The system of claim 16, wherein the communicating bores define passages for introduction of a medicament to a patient, and wherein the system further includes a seal operatively associated with an inlet end of the bore of the fastener for selectively sealing and unsealing the inlet.

32. The system of claim 16, wherein fastener includes a head defining a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes;

the driver including a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated, with a plurality of first sensors being located on the reference structures and a plurality of second sensors being located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween; and

a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals.

33. A screw system for stimulating tissue, the screw system comprising a screw including a threaded shaft portion having a terminal end and an opposite head end, the shaft including a bore and a tissue stimulating device located within the bore with a portion thereof exposed to and in communication with the exterior of the screw.

34. The system of claim 33, wherein the bore extends the length of the screw.

35. The system of claim 33, wherein the bore comprises a blind bore and the stimulating device comprises a pair of wires, each in electrical communication with one of a pair of contacts located within the blind bore and extending through a sidewall of the screw to an exterior portion thereof.

36. The system of claim 33, wherein the head is castellated.

37. The system of claim 33, wherein the stimulating device comprises an electrode wire.

38. The system of claim 33, wherein the stimulating device is of one-piece construction.

39. The system of claim 33, wherein the stimulating device comprises a plurality of electrically conductive elements electrically coupled together.

40. The system of claim 33, wherein the screw is made of a non-electrically conductive material.

41. The system of claim 33, wherein the screw is made of an electrically conductive material.

42. The system of claim 33, further comprising a source of electrical power electrically coupled to the stimulating device.

43. The system of claim 42, wherein the source of electrical power comprises a battery-operated power supply.

44. The system of claim 42, wherein the source of electrical power comprises an RF receiver electrically coupled to the stimulating device and a RF transmitter located remote from the RF receiver.

45. The system of claim 42, wherein the RF transmitter is electrically couplable to a camera and the stimulating device is proximate optical nerves.

46. The system of claim 42, wherein the source of electrical power comprises an inductance coil electrically coupled to the stimulating device and a source of a magnetic field located to induce a current to the coil.

47. The system of claim 42, wherein the source of electrical power is located to apply electrical power to a first portion of tissue located remote from the screw, and the system further comprises a receiver electrically coupled to the stimulating device for receiving electrical signals generated by a second portion of tissue in electrical communication with the first portion of tissue and located remote therefrom and proximate the screw such that electrical power applied to the first portion of tissue results in generation of corresponding electrical signals by the second portion of tissue for detection by the receiver, and a computer controller operatively associated with the source of electrical power and the receiver for measuring time lapse between application of electrical power to the first portion of the tissue and detection by the receiver of the electrical signals generated by the second portion of tissue.

48. The system of claim 33, wherein the communicating bores define passages for introduction of a medicament to a patient, and wherein the system further includes a seal operatively associated with an inlet end of the bore of the fastener for selectively sealing and unsealing the inlet.

49. The system of claim 33, wherein fastener includes a head defining a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes;

the driver including a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated, with a plurality of first sensors being located on the reference structures and a plurality of second sensors being located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween; and

a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals.

50. A method for stimulating tissue in a medical procedure, the method comprising the steps of locating a screw relative to a patient tissue, the screw comprising a threaded shaft portion having a terminal end and an opposite head end, the shaft including a bore and a tissue stimulating device located within the bore with a portion thereof exposed to and in communication with the exterior of the screw;

and providing a source of electrical power for electrically cooperating with the screw so as to stimulate the tissue in a desired manner in connection with a medical procedure.

51. The method of claim 50, further comprising the step of providing a detector in electrical communication with the tissue stimulating device and wherein the source of electrical power applies electrical power to the tissue stimulating device for stimulating the tissue to produce electrical signals and wherein the tissue stimulating device further functions to communicate the electrical signals to the detector for detecting the presence of the tissue proximate the screw.

52. The method of claim 50, wherein the electrical power is applied to the tissue stimulating device in pulses by the source of electrical power.

53. The method of claim 50, wherein the screw is placed proximate desired tissue and the source of electrical power is electrically coupled to the tissue stimulating device for applying electrical power to the desired tissue in a manner to interact with the desired tissue to modulate pain associated with the desired tissue.

54. The method of claim 50, wherein the screw is placed proximate desired tissue and the source of electrical power is electrically coupled to the tissue stimulating device for applying electrical power to the desired tissue in a manner to interact with the desired tissue to stimulate growth of bone adjacent the desired tissue.

55. The method of claim 50, wherein the tissue includes first and second portions of tissue located remote from one another and in electrical communication with one another, and the step of locating the screw comprises locating the screw proximate the first portion of tissue and the step of providing a source of electrical power comprises providing a source of electrical power to apply electrical power to the second portion of tissue, and the method further comprises the steps of providing a receiver in electrically communication with the stimulating device for receiving electrical signals generated by the first portion of tissue when electrical power is applied to the second portion of tissue so as to result in generation of corresponding electrical signals by the first portion of tissue for detection by the receiver, and a providing a computer controller operatively associated with the source of electrical power and the receiver and operating the controller to measure time lapses between application of electrical power to the second portion of the tissue and detection of the signals generated by the first portion in response thereto.

56. The method of claim 50, wherein the source of electrical power comprises a battery-operated power supply.

57. The method of claim 50, wherein the source of electrical power comprises an RF receiver electrically coupled to the stimulating device and a RF transmitter located remote from the RF receiver.

58. The method of claim 50, wherein the source of electrical power comprises an inductance coil electrically coupled to the stimulating device and a source of a magnetic field located to induce a current to the coil.

59. A tissue stimulating device comprising a light detector located adjacent tissue to be stimulated and a light emitter located remote from the light detector and in optical communication therewith, wherein the light detector generates electrical signals corresponding to the detected light.

60. The device of claim 59, wherein the light detector comprises a photodiode and the light emitter comprises a light emitting diode.

61. A medical fastener system, comprising a fastener and a driver for installing the fastener within a patient, the fastener comprising an elongate shaft having a head end and a terminal end, with a bore defined within the shaft and at least one aperture extending through a portion of the shaft to the exterior of the fastener, a first assembly located within the bore and comprising a light detector located adjacent the aperture for generating electrical signals in response to detected light for stimulating tissue of the patient, and a first optical fiber in optical communication with the light detector;

a driver having a bore which is open to a tip end of the driver which is configured for engaging the head end of the fastener; and

a second assembly located within the bore of the driver and comprising a light emitting diode and a second optical fiber, and a detector in optical communication with the second optical fiber, wherein the first and second optical fibers are placeable in optical communication with one another when the tip end of the driver is engaged with the head end of the fastener; and

wherein the light emitting diode is operable to stimulate the photodiode to stimulate tissue proximate the fastener such that electrical signals will be generated by the patient if electrically responsive tissue is proximate the fastener, with such electrical signals being communicated to the detector via the first and second optical fibers to indicate that electrically responsive tissue is proximate the fastener.

62. The system of claim 61, wherein the first assembly further comprises a lens.

63. The system of claim 61, wherein the second assembly further comprises an amplifier, an optical modulator, and a lens.

64. The system of claim 61, wherein the fastener comprises a screw having a castellated head and the driver has a tip configured to interfit with the castellated head of the screw.

65. The system of claim 61, wherein the terminal end of the fastener is open and the photodiode is in optical communication therewith.

66. The system of claim 61, wherein the bore defined within the shaft of the fastener is a blind bore and one or more apertures are defined through sidewalls of the bore with the photodiode being in optical communication with the apertures.

67. The system of claim 61, wherein the bores define passages for introduction of a medicament to a patient, and wherein the system further includes a seal operatively associated with the head end of the fastener for selectively sealing and unsealing the head end.

68. The system of claim 61, wherein the head end of the fastener defines a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes;

the driver including a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated, with a plurality of first sensors being located on the reference structures and a plurality of second sensors being located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween; and

a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals.

69. A method for stimulating tissue in a medical procedure, the method comprising the steps of locating a screw relative to tissue of a patient, the screw comprising a threaded shaft portion having a terminal end and an opposite head end, the shaft including a bore and a photodiode device located within the bore with a portion thereof exposed to and in optical communication with the exterior of the screw;

and providing a source of light for energizing the photodiode so as to stimulate the tissue in a desired manner in connection with a medical procedure.

70. A method for stimulating tissue within an ear canal for assisting hearing, the method comprising the steps of providing a photodiode system within the ear canal adjacent a tympanic membrane of the ear canal, and providing a light source system in optical communication with the photodiode;

and providing light from the light source system to energize the photodiode, wherein the photodiode stimulates the tympanic membrane in response thereto.

71. A medicament delivery system, the system comprising a fastener having a bore defined therethrough to define an inlet for introducing a medicament into the bore and an outlet in flow communication with the inlet for passage of the medicament from the bore for introduction to a desired location within a patient;

and a seal operatively associated with the inlet for selectively sealing and unsealing the inlet.

72. The system of claim 71, wherein the seal comprises a cap and the fastener includes a socket configured for fixedly receiving the cap.

73. The system of claim 71, further comprising a driver for installing the fastener, wherein the driver is configured for introducing the medicament into the bore of the fastener.

74. The system of claim 71, further comprising a pump located within the bore of the fastener and in flow communication with a source of the medicament.

75. The system of claim 71, wherein the outlet defines a tip end of the fastener, with the tip end being configured for receiving a needle in flow communication with the outlet.

76. The system of claim 73, wherein fastener includes a head defining a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes;

and the driver includes a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated, with a plurality of first sensors being located on the reference structures and a plurality of second sensors being located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween; and

a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals.

77. A method for delivering medicament, the method comprising the steps of providing a screw having a bore defined therethrough to define an inlet for introducing a medicament into the bore and an outlet in flow communication with the inlet for passage of the medicament from the bore;

positioning the screw at a desired location within a patient;

introducing a first does of the medicament to the patient via the bore of the screw;

providing a seal at the inlet to seal the inlet following introduction of the medicament; and

removing the seal and introducing a second dose of the medicament to the patient via the bore of the screw.

78. The method of claim 77, wherein the medicament is delivered to nerve tissue.

79. The method of claim 77, wherein the medicament is delivered to bone marrow.

80. The method of claim 77, wherein the medicament is delivered to a blood flow vessel.

81. The method of claim 77, wherein the medicament is delivered to a ligament.

82. A positioning system, comprising:

a rotatable workpiece having a head thereon, the head defining a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes;

a driver having a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated,

first sensors located on the reference structures and second sensors located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween; and

a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals.

83. The system of claim 82, wherein the workpiece comprises a screw.

84. The system of claim 82, wherein the first set of sensors comprises transmitters and the second set of sensors comprises receivers.

85. The system of claim 82, wherein the second set of sensors comprises transmitters and the first set of sensors comprises receivers.

86. A method of positioning a workpiece, the method comprising the steps of:

providing a rotatable workpiece having a head thereon, the head defining a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes;

providing a driver having a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated,

providing first sensors located on the reference structures and second sensors located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween; and

providing a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals; and

receiving the generated electrical signals to determine positional information concerning the workpiece.

87. The system of claim 86, wherein the workpiece comprises a screw.

88. The system of claim 86, wherein the first set of sensors comprises transmitters and the second set of sensors comprises receivers.

89. The system of claim 88, wherein the second set of sensors comprises transmitters and the first set of sensors comprises receivers.

90. A medical workpiece system, comprising a medical workpiece having a head, and a driver having a tip configured to be matingly engageable with the head for guiding the workpiece to a desired position within a patient, the workpiece further including a first electronic device for communicating with a second electronic device operatively associated with the driver.

91. The device of claim 90, wherein the workpiece comprises an artificial spinal disc.

92. The device of claim 90, wherein the first and second electronic devices comprise wireless electronic devices.

93. The device of claim 90, wherein the first electronic device comprises an RF transmitter electrically coupled to an electronic position sensor for generating electronic signals corresponding to the position and orientation of the electronic position sensor in three dimensional space.

94. The device of claim 90, wherein the head includes a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes, and wherein the driver includes a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated, with the system further including first sensors located on the reference structures and second sensors located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween;

and a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals.

95. An artificial spinal disc system, comprising:

an artificial spinal disc having a transmitter coupled to an electronic position sensor for generating electronic signals corresponding to the position and orientation of the electronic position sensor in three dimensional space.

96. The system of claim 95, wherein the disc further includes a head having a plurality of reference structures located thereon and oriented to define a plurality of sets of the reference structures, with the reference structures of each set being arranged in a common plane, but with each set of reference structures being located in distinct but parallel planes, and the system further includes a driver mateably engageable with the head for installing the disc, with the driver having a plurality of drive surfaces located and configured to abut the reference structures when the driver and the head are mated, with the system further including first sensors located on the reference structures and second sensors located on the drive surfaces, with each of the first sensors being operable with one of the second sensors to enable electrical signals to be generated corresponding to signals transmitted and received therebetween;

and a computer control circuit in electrical communication with one of the first or second set of sensors for receiving the generated electrical signals.