Medical physiological simulator including a conductive elastomer layer

• US 20040126746A1
• Filed: 11/20/2003
• Published: 07/01/2004
• Est. Priority Date: 10/23/2000
• Status: Active Grant

• Current Assignee: Christopher C. Toly
• Original Assignee: Christopher C. Toly
• Inventors: Toly, Christopher C.
• Granted Patent: US 7,857,626 B2
• Time in Patent Office: Days
• US Class Current: 434/262
• CPC Class Codes: G09B 23/28 for medicine
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: G09B 23/30 Anatomical models G09B23/281 - G09B23/288 take precedence

Abstract

Conductive elastomeric circuits are used in various simulated physiological structures such as tissues and organs, enabling feedback to be provided indicating whether a simulated task is being performed correctly. For example, a surgical trainer has a simulated human tissue structure made of an elastomeric composition, at least one reinforcing layer of a fibrous material, and at least one flexible electrical circuit. The surgical trainer preferably includes multiple areas for practicing surgical skills, each with evaluation circuits for providing feedback regarding that skill. Conductive elastomers are also incorporated into other types of medical training simulators, to similarly provide feedback. In another embodiment, a simulated organ has a conductive elastomeric circuit in the periphery of the simulated organ, enabling feedback to be provided to evaluate whether a person is properly manipulating the organ in response to a manual applied pressure.

Claims

1. A physiological training and evaluation simulator suitable for training and testing personnel, comprising a simulated physiological structure and a circuit including a conductive elastomer.

2. A physiological training and evaluation simulator suitable for training and testing personnel, comprising a simulated physiological structure and an evaluation circuit including a conductive elastomer, said evaluation circuit configured to provide a signal relating to a simulated procedure being performed on the simulated physiological structure, the conductive elastomer enhancing the realism of the simulator.

3. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit is configured to provide the signal when a specific portion of the simulated physiological structure is manipulated.

4. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit is configured to provide the signal when a change in pressure applied to at least a portion of the simulated physiological structure.

5. The physiological training and evaluation simulator of claim 4, wherein the evaluation circuit comprises a piezoelectric element responsive to a change in pressure.

6. The physiological training and evaluation simulator of claim 4, wherein the evaluation circuit comprises a capacitance based sensor, and the signal corresponds to a magnitude of the applied pressure.

7. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit is configured to provide the signal when at least a portion of the simulated physiological structure is touched.

8. The physiological training and evaluation simulator of claim 7, wherein the evaluation circuit comprises a capacitance sensitive switch.

9. The physiological training and evaluation simulator of claim 7, wherein the evaluation circuit comprises a resistance sensitive switch.

10. The physiological training and evaluation simulator of claim 7, wherein the evaluation circuit comprises a radio sensitive switch.

11. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit is configured to provide the signal when a manipulation of at least a portion of the simulated physiological structure causes the evaluation circuit to close.

12. The physiological training and evaluation simulator of claim 11, wherein the evaluation circuit comprises an energized portion coupled to a power supply, and a target portion disposed adjacent to the energized portion, such that the target portion is coupled to the energized portion to complete the circuit and produce the signal when an instrument is properly employed in the simulated procedure.

13. The physiological training and evaluation simulator of claim 11, wherein the evaluation circuit is initially not energized, such that the evaluation circuit is energized and produces the signal when an instrument coupled with a power supply is properly employed in the simulated procedure, thereby completing the circuit.

14. The physiological training and evaluation simulator of claim 11, wherein the evaluation circuit is incomplete at a gap in the evaluation circuit, and wherein the evaluation circuit is completed when at least one of the follows occurs:

(a) a conductive probe employed in the simulated procedure is positioned in the gap to correctly perform the simulated procedure, thereby producing the signal; and

(b) adjacent ends of the evaluation circuit are coupled together to complete the circuit.

15. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit is configured to provide the signal when a manipulation of at least a portion of the simulated physiological structure causes the evaluation circuit to open.

16. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit is configured to provide the signal when an instrument is in proximity to at least a portion of the simulated physiological structure.

17. The physiological training and evaluation simulator of claim 2, further comprising a sensor coupled with the evaluation circuit, and the evaluation circuit is configured to provide the signal when the sensor indicates a change in a physical property has been detected.

18. The physiological training and evaluation simulator of claim 16, wherein the sensor is configured to detect a change in temperature.

19. The physiological training and evaluation simulator of claim 16, wherein the sensor is a chemical sensor.

20. The physiological training and evaluation simulator of claim 2, further comprising additional evaluation circuits, each additional evaluation circuit comprising a conductive elastomer, wherein each additional evaluation circuit is configured to provide a signal when a different portion of the simulated physiological structure is manipulated during a procedure performed on the simulated physiological structure.

21. The physiological training and evaluation simulator of claim 2, further comprising an indicator coupled to the evaluation circuit, such that in response to the signal the indictor provides an indication relating to the performance of the simulated procedure.

22. The physiological training and evaluation simulator of claim 21, wherein the indicator comprises a light source, light emitted by the light source providing feedback regarding the performance of the procedure.

23. The physiological training and evaluation simulator of claim 21, wherein the indicator comprises a meter, a change in the meter providing feedback regarding the performance of the procedure.

24. The physiological training and evaluation simulator of claim 2, wherein the simulated physiological structure is a simulated human tissue structure.

25. The physiological training and evaluation simulator of claim 24, wherein the simulated human tissue structure comprises:

(a) at least one simulated membranous layer comprising at least one elastomeric layer; and

(b) at least one simulated sub-membranous layer comprising at least one elastomeric layer underlying a first membranous layer.

26. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit is implemented in three dimensions.

27. The physiological training and evaluation simulator of claim 26, wherein the evaluation circuit is implemented as a three-dimensional grid.

28. The physiological training and evaluation simulator of claim 27, wherein the three-dimensional grid encompasses a majority of the simulated physiological structure.

29. The physiological training and evaluation simulator of claim 2, wherein said simulated physiological structure includes a plurality of integral fluid channels, and wherein the evaluation circuit formed of the conductive elastomer is incorporated into at least some of the integral fluid channels.

30. The physiological training and evaluation simulator of claim 29, wherein the evaluation circuit is incorporated into a wall of at least some of the fluid channels, such that the evaluation circuit provides the signal if such a wall is damaged during the simulated procedure.

31. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit couples to a processor configured to manipulate the signal.

32. The physiological training and evaluation simulator of claim 31, wherein the simulated physiological structure comprises a physiological control element configured to produce a simulated physiological response in the simulated physiological structure, the physiological control element being coupled to the evaluation circuit so that the processor uses the evaluation circuit to control the physiological control element.

33. The physiological training and evaluation simulator of claim 32, wherein the physiological control element comprises at least one of a servo and a pump.

34. The physiological training and evaluation simulator of claim 31, wherein the evaluation circuit is implemented with a plurality of branches that extend throughout at least a portion of the simulated physiological structure where the simulated procedure will be performed, so that by monitoring the plurality of branches, the processor determines a three-dimensional location of an instrument during the simulated procedure.

35. The physiological training and evaluation simulator of claim 2, wherein the simulated physiological structure comprises a simulated organ.

36. The physiological training and evaluation simulator of claim 35, wherein the evaluation circuit comprises a pressure sensor disposed at a periphery of the simulated organ.

37. The physiological training and evaluation simulator of claim 2, wherein the evaluation circuit is implemented as a neural network that substantially corresponds to a neural network in a physiological structure upon which the simulated physiological structure is modeled.

38. The physiological training and evaluation simulator of claim 2, wherein the simulated physiological structure comprises a simulated joint.

39. The physiological training and evaluation simulator of claim 38, wherein the evaluation circuit is disposed proximate to a location on the simulated joint at which a medical device will be employed in the simulated medical procedure, to evaluate whether a person performed the procedure properly.

40. The physiological training and evaluation simulator of claim 2, wherein the simulated physiological structure comprises a simulated bone.

41. The physiological training and evaluation simulator of claim 40, wherein the evaluation circuit is disposed at a periphery of the simulated bone, proximate a location on the simulated bone at which a medical device will be employed in the simulated medical procedure, to evaluate whether a person performed the procedure properly.

42. The physiological training and evaluation simulator of claim 2, wherein the conductive elastomer includes conductive carbon.

43. The physiological training and evaluation simulator of claim 2, wherein the physiological training and evaluation simulator comprises a surgical trainer, and the simulated physiological structure comprises at least one of a simulated human tissue structure and a simulated organ included in the surgical trainer.

44. The physiological training and evaluation simulator of claim 43, wherein the surgical trainer comprises:

(a) at least one simulated structure corresponding to an internal anatomical structure of a human body;

(b) an exterior cover encompassing a substantial portion of the surgical trainer, the exterior cover having at least one predefined opening defining an operative site, so that each opening is disposed adjacent to a different structure, to facilitate access to said structure; and

(c) the simulated human tissue structure is incisable, and is disposed proximate to each predefined opening, such that access to said at least one structure via the adjacent predefined opening requires making an incision in said simulated human tissue structure, an exterior surface of each simulated human tissue structure being substantially flush with respect to an outer surface of the exterior cover, each simulated human tissue structure being removable to be replaced after use, said simulated human tissue structure comprising a plurality of layers, said plurality of layers generally corresponding to layers of tissue found in a human being at a location corresponding to the operative site, and at least one of the plurality of layers including the conductive elastomer.

45. A medical training simulator suitable for medical skills training and evaluation, the medical training model comprising a simulated physiological structure and an evaluation circuit including a conductive elastomer, said evaluation circuit being configured to provide data related to a simulated medical procedure being performed using the simulated physiological structure.

46. The medical training simulator of claim 45, wherein the evaluation circuit includes an elastomeric monomer to which conductive carbon has been added before being cast to form at least a portion of the evaluation circuit.

47. The medical training simulator of claim 45, wherein the simulated physiological structure comprises the evaluation circuit.

48. The medical training simulator of claim 45, wherein the evaluation circuit is configured to provide data in response to at least one of the following conditions:

(a) a specific portion of the simulated physiological structure is manipulated;

(b) pressure is applied to at least a portion of the simulated physiological structure;

(c) at least a portion of the simulated physiological structure is touched;

(d) a manipulation of at least a portion of the simulated physiological structure causes the evaluation circuit to close;

(e) a manipulation of at least a portion of the simulated physiological structure causes the evaluation circuit to open;

(f) a sensor coupled to the evaluation circuit detects a change in a physical property; and

(g) an instrument is placed in proximity to at least a portion of the simulated physiological structure.

49. The medical training simulator of claim 45, further comprising a light source coupled to the evaluation circuit, such that light emitted by the light source provides an indication of the quality with which the simulated medical procedure has been performed.

50. The medical training simulator of claim 49, wherein the electrical circuit conveys a potential that triggers activation of the light source.

51. The medical training simulator of claim 45, wherein the simulated medical device includes an inductor, and wherein the evaluation circuit is configured to receive a current induced by the inductor when the simulated medical device is correctly utilized to perform the simulated medical procedure.

52. The medical training simulator of claim 45, wherein the evaluation circuit comprises a capacitance based sensor configured to provide data relating to a position of the simulated medical device relative to the simulated physiological structure during the simulated medical procedure.

53. The medical training simulator of claim 45, wherein the evaluation circuit comprises conductive portions separated by a non conductive portion, such that the proper execution of the simulated medical procedure requires the removal of the non conductive portion and the conductive portions to be coupled to complete the circuit.

54. The medical training simulator of claim 45, wherein the evaluation circuit comprises conductive portions separated by a gap, such that the proper execution of the simulated medical procedure requires the conductive portions to be coupled to complete the circuit.

55. A medical training simulator suitable for medical skills training and evaluation, the medical training simulator comprising a simulated physiological structure and a circuit including a conductive elastomer, said conductive elastomer comprising a first elastomeric layer, a second elastomeric layer, and a conductor encapsulated by the first and second elastomeric layers.

56. The medical training simulator of claim 55, wherein the circuit is configured to provide data in response to at least one of the following conditions:

(a) a specific portion of the simulated physiological structure is manipulated;

(b) pressure is applied to at least a portion of the simulated physiological structure;

(c) at least a portion of the simulated physiological structure is touched;

(d) a manipulation of at least a portion of the simulated physiological structure causes the evaluation circuit to close;

(e) a manipulation of at least a portion of the simulated physiological structure causes the evaluation circuit to open;

(f) a sensor coupled to the evaluation circuit detects a change in a physical property; and

(g) an instrument is placed in proximity to at least a portion of the simulated physiological structure.

57. A method for making a medical training simulator suitable for medical skills training and evaluation, the method comprising the steps of:

(a) determining a physiological structure that the medical training simulator is to simulate;

(b) determining a simulated medical procedure that will be performed on a simulated physiological structure corresponding to the physiological structure; and

(c) constructing a medical training simulator including;

(i) a simulated physiological structure corresponding to the physiological structure of step (a); and

(ii) an evaluation circuit comprising an conductive elastomer, the evaluation circuit being configured to provide feedback relating to the simulated medical procedure of step (b).

58. The method of claim 57, wherein the step of constructing the medical training simulator comprises the step of applying the evaluation circuit proximate to a location on the simulated physiological structure at which the simulated medical procedure is performed, to evaluate if a person performed the simulated medical procedure properly.

59. The method of claim 58, wherein the step of applying the evaluation circuit comprises the step of incorporating the evaluation circuit proximate to a periphery of the simulated physiological structure.

60. The method of claim 57, wherein the step of constructing the medical training simulator comprises the step of configuring the evaluation circuit to provide data in response to at least one of the following conditions:

(a) a specific portion of the simulated physiological structure is manipulated;

(b) pressure is applied to at least a portion of the simulated physiological structure;

(c) at least a portion of the simulated physiological structure is touched;

(d) a manipulation of at least a portion of the simulated physiological structure causes the evaluation circuit to close;

(e) a manipulation of at least a portion of the simulated physiological structure causes the evaluation circuit to open;

(f) a sensor coupled to the evaluation circuit detects a change in a physical property; and

(g) an instrument is placed in proximity to at least a portion of the simulated physiological structure.

61. The method of claim 57, wherein the step of constructing the medical training simulator comprises the step of configuring the electrical evaluation circuit to include an indicator that provides an indication of whether the medical device is properly utilized to perform the simulated medical procedure.

62. A method for making a conductive elastomer-based evaluation circuit for use in a medical training simulator, comprising the steps of:

(a) determining a desired configuration for the evaluation circuit;

(b) providing a first elastomeric mass to serve as a base for the evaluation circuit;

(c) using a conductive material to produce the evaluation circuit having the desired configuration;

(d) positioning the evaluation circuit on the first elastomeric mass; and

(e) placing a second elastomeric mass over the first elastomeric mass and the evaluation circuit, thereby encapsulating the evaluation circuit in an elastomeric matrix.

63. The method of claim 62, wherein the step of providing a first elastomeric mass comprises the steps of:

(a) providing the first elastomeric mass in an uncured form; and

(b) causing the first elastomeric mass to begin to cure; and

wherein the step of positioning the evaluation circuit comprises the step of positioning the evaluation circuit on the first elastomeric mass before it has fully cured, thereby bonding the evaluation circuit to the first elastomeric mass.

64. The method of claim 62, wherein the step of placing a second elastomeric mass over the first elastomeric mass and the evaluation circuit comprises the steps of:

(a) placing the second elastomeric mass over the first elastomeric mass and the evaluation circuit such that the second elastomeric mass in an uncured form, and

(b) causing the second elastomeric mass to cure, thereby bonding the second elastomeric mass to the evaluation circuit and the first elastomeric mass.

65. The method of claim 62, wherein the step of placing a second elastomeric mass over the first elastomeric mass and the evaluation circuit comprises the step of ensuring that the second elastomeric mass has a different composition than the first elastomeric mass.

66. The method of claim 62, wherein the step of using a conductive material comprises the step of using an inherently conductive polymer.

67. The method of claim 62, wherein the step of using a conductive material comprises the step of using a conductive fabric.

68. The method of claim 62, wherein the step of using a conductive material to produce the evaluation circuit having the desired configuration comprises the step of printing the evaluation circuit onto a substrate using a conductive ink.

69. The method of claim 68, wherein the substrate is soluble in a solvent that does not dissolve the first elastomeric mass and the evaluation circuit, further comprising the step of using the solvent to dissolve the substrate.

70. A method for making an evaluation circuit including an conductive elastomer for use in a medical training simulator, comprising the steps of:

(a) providing conductive carbon and an elastomeric monomer;

(b) determining a desired configuration for the evaluation circuit;

(c) mixing the conductive carbon and the elastomeric monomer to form a mixture;

(d) casting the mixture into the desired configuration; and

(e) curing the mixture to produce the evaluation circuit having the desired configuration for use in the medical training simulator.

71. The method of claim 70, wherein the step of determining a desired configuration for the evaluation circuit includes the step of providing a mold corresponding to the desired configuration, and wherein the step of casting the mixture into the desired configuration includes the step of introducing the mixture into the mold.

72. The method of claim 70, wherein the step of determining a desired configuration for the evaluation circuit includes the step of designing an incomplete circuit that will be completed when the evaluation circuit is in use.

73. The method of claim 70, further comprising the step of incorporating the evaluation circuit in a medical training simulator.

74. A method for using a medical training simulator for medical skills training and evaluation, comprising the steps of:

(a) providing a medical training simulator comprising a simulated physiological structure and a conductive elastomer-based evaluation circuit configured to evaluate a simulated medical procedure; and

(b) using the conductive elastomer-based evaluation circuit to monitor a person'"'"'s performance of the simulated medical procedure, producing an indication of the performance.

75. The method of claim 74, wherein the indication produced by the conductive elastomer-based evaluation circuit is provided to another party, so that the person is unaware of the indication during the execution of the simulated medical procedure.

76. The method of claim 74, wherein the indication produced by the conductive elastomer-based evaluation circuit is used to provide at least one of a visual and an audible feedback to the person during the execution of the simulated medical procedure.

77. The method of claim 74, wherein the indication produced by the conductive elastomer-based evaluation circuit is used to determine a rate of learning.

78. The method of claim 74, wherein the indication produced by the conductive elastomer-based evaluation circuit is used to determine a physiological response for the medical training simulator to emulate.

79. A physiological training and evaluation simulator system for training and testing personnel, comprising:

(a) a simulated physiological structure including a conductive elastomer-based evaluation circuit configured to provide data relating to a simulated procedure being performed on the simulated physiological structure; and

(b) a controller coupled to the conductive elastomer-based evaluation circuit, the controller being configured to implement a plurality of functions, including;

(i) storing data obtained from the conductive elastomer-based evaluation circuit; and

(ii) processing the data obtained from the conductive elastomer-based evaluation circuit to determine a score rating a quality of the simulated procedure.

80. The physiological training and evaluation simulator system of claim 79, wherein the processor is further configured to implement the function of comparing the score for the simulated procedure to at least one score from a previous simulated procedure.

81. The physiological training and evaluation simulator system of claim 79, wherein the processor is further configured to implement the function of determining a rate of learning.

82. The physiological training and evaluation simulator system of claim 79, wherein the simulated physiological structure comprises a physiological control element configured to produce a simulated physiological response in the simulated physiological structure, the physiological control element being coupled with the controller via the conductive elastomer-based evaluation circuit, and wherein the processor is further configured to implement the function of controlling the physiological control element during the simulated procedure, such that the physiological control element produces a simulated physiological response during the simulated procedure that is consistent with the data provided to the controller by the conductive elastomer-based evaluation circuit.

83. The physiological training and evaluation simulator system of claim 82, wherein the physiological control element is a pump, and the simulated physiological response is a movement of a fluid in the simulated physiological structure.

84. The physiological training and evaluation simulator system of claim 82, wherein the physiological control element is a servo, and the simulated physiological response is a movement of at least a portion of the simulated physiological structure.

85. The physiological training and evaluation simulator system of claim 79, wherein the simulated physiological structure is a human patient simulator including a plurality of simulated anatomical features, thereby enabling the human patient simulator to support the simulation of a plurality of different simulated procedures.

86. The physiological training and evaluation simulator system of claim 85, wherein the conductive elastomer-based evaluation circuit is distributed throughout at least a portion of the human patient simulator as a three-dimensional grid.

87. The physiological training and evaluation simulator system of claim 85, wherein the conductive elastomer-based evaluation circuit is distributed throughout the human patient simulator as a neural network simulating a human nervous system.