Surgical instruments with sensors for detecting tissue properties, and system using such instruments

• US 20090054908A1
• Filed: 04/14/2006
• Published: 02/26/2009
• Est. Priority Date: 04/15/2005
• Status: Active Grant

• Current Assignee: Surgisense Corporation
• Original Assignee: Surgisense Corporation
• Inventors: Zand, Jason Matthew, Fischer, Gregory Scott
• Granted Patent: US 9,204,830 B2
• Time in Patent Office: Days
• US Class Current: 606/130
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00066 intensity
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/07228 Arrangement of the staples
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/14542 : for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1455 : using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1459 : invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/413 : Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61B 5/6837 : Sutures
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7405 : using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 : characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: Y10S 901/09 : Closed loop, sensor feedback controls arm movement
• CPC Class Codes: Y10S 901/44 : inspection

Abstract

A system is provided that furnishes expert procedural guidance based upon patient-specific data gained from surgical instruments incorporating sensors on the instrument'"'"'s working surface, one or more reference sensors placed about the patient, sensors implanted before, during or after the procedure, the patient'"'"'s personal medical history, and patient status monitoring equipment. Embodiments include a system having a surgical instrument with a sensor for generating a signal indicative of a property of a subject tissue of the patient, which signal is converted into a current dataset and stored. A processor compares the current dataset with other previously stored datasets, and uses the comparison to assess a physical condition of the subject tissue and/or to guide a procedure being performed on the tissue.

Claims

1. A system comprising:

a surgical instrument having a sensor for generating a signal indicative of a property of a subject tissue of a patient;

a signal processor for receiving the signal and converting the signal into a current dataset;

a memory for storing the current dataset; and

a processor configured to compare the current dataset with other datasets previously stored in the memory, and to assess a physical condition of the subject tissue or guide a current procedure being performed on the tissue, responsive to the comparison.

2. The system of claim 1, wherein the processor is further configured to predict the likelihood of success of the current procedure being performed on the subject tissue responsive to the comparison.

3. The system of claim 1, further comprising a recorder for recording the signal from the sensor and the current dataset.

4. The system of claim 2, wherein the memory includes data relating to at least one of pre-procedure data, during-procedure data, post-procedure data, immediate outcomes, short-term outcomes, and long-term outcomes of previous instances of the procedure, and the processor is configured to predict the likelihood of success of the current procedure responsive to the data relating to the outcomes.

5. The system of claim 4, wherein the processor is further configured to add at least one of pre-procedure data, during-procedure data, post-procedure data, and immediate outcomes of the current procedure to the memory.

6. The system of claim 4, wherein the processor is further configured to add short-term and long-term outcomes of the current procedure to the memory.

7. The system of claim 2, further comprising a communications device for communicating with a remote database comprising previously stored datasets and data relating to outcomes of previous instances of the procedure;

wherein the processor is configured to compare the current dataset with the datasets and data of the remote database.

8. The system of claim 7, wherein the processor is further configured to update the remote database using the current dataset and at least one of pre-procedure data, during-procedure data, post-procedure data, immediate outcomes, short-term outcomes, and long-term outcomes of the current procedure.

9. The system of claim 2, further comprising a communications device for communicating with a patient data store comprising a medical history of the patient undergoing the current procedure;

wherein the processor is configured to predict the likelihood of success of the current procedure responsive to the medical history of the patient.

10. The system of claim 9, wherein the processor is further configured to update the medical history of the patient using the current dataset and the outcome of the current procedure.

11. The system of claim 1, wherein the surgical instrument includes at least one of a surgical stapler, a clip applier, a grasper, a retractor, a scalpel, a forceps, a laparoscopic tool, an open surgical tool, a cauterizing tool, a robotic tool, a scissors, a clamp, a needle, a catheter and a trochar.

12. The system of claim 1, further comprising a reference measurement instrument having a sensor for measuring a reference tissue and generating a reference measurement signal.

13. The system of claim 12, wherein the reference tissue is a tissue of the patient.

14. The system of claim 12, wherein the signal processor is for converting the reference measurement signal to a reference baseline measurement dataset, and the processor is configured to assess the physical condition of the subject tissue responsive to the reference baseline measurement dataset.

15. The system of claim 12, wherein the reference measurement instrument comprises a sensor for grasping the reference tissue.

16. The system of claim 1, wherein the sensor comprises one of an optical sensor, a chemical sensor, mechanical sensor, a MEMS device, a nano sensor, an acoustic sensor, a fluid sensor and an electrical sensor.

17. The system of claim 13, wherein the sensor is for measuring at least one of oxygenation, fluorescence, tissue perfusion, general health, tissue electrical impedance, tissue electrical activity, interaction force, pH, electromyography, temperature, spectroscopy, fluid flow rate, fluid flow volume, pressure, biomarkers, radiotracers, immunologic characteristics, biochemical characteristics, nerve activity, and evoked potential.

19. The system of claim 12, further comprising a robotic manipulator for controlling the reference measurement instrument.

20. The system of claim 4, further comprising patient monitoring equipment for generating patient condition data and transferring the patient condition data to the processor, wherein the processor is configured to assess the tissue condition and predict the likelihood of success of the current procedure responsive to the patient condition data.

21. The system of claim 20, wherein the patient monitoring equipment is for at least one of systemic monitoring, local monitoring, extracorporeal monitoring, intracorporeal monitoring, invasive monitoring and noninvasive monitoring.

22. The system of claim 20, wherein the patient monitoring equipment includes at least one of a vital sign monitor and anesthesia equipment.

23. The system of claim 4, further comprising patient status sensing equipment for generating patient status data and transferring the patient status data to the processor, wherein the processor is configured to assess the tissue condition, guide the current procedure, or predict the likelihood of success of the current procedure responsive to the patient status data.

24. The system of claim 23, wherein the patient status sensing equipment comprises at least one of thermal imaging equipment and spectroscopic imaging equipment.

25. The system of claim 1, wherein the sensor is for generating signals before, during and after actuation of the surgical instrument, and the signal processor is for processing such signals and including such signals in the dataset.

46. The system of claim 20, wherein the patient monitoring equipment comprises a sensor consisting essentially of a rigid or flexible substrate and a plurality of sensing elements mounted to the substrate for monitoring a property of a living tissue.

47. The system of claim 20, wherein the patient monitoring equipment comprises at least one of an implantable sensor and a marker introduced to the subject tissue, the monitoring equipment remaining at the subject tissue after the current procedure for generating the patient condition data.

79. The system of claim 1, further comprising an attaching device removably mountable to the surgical instrument for holding the sensor and for positioning the sensor relative to the surgical instrument.

80. The system of claim 79, wherein the attaching device comprises at least one of a shell, a sleeve, and a clip.

81. The system of claim 79, wherein the surgical instrument comprises a stapler.

18. The system of claim I, further comprising a robotic manipulator for controlling the surgical instrument.

26. A system comprising:

a surgical instrument comprising an incident light source and a sensor for using incident light from the light source to generate a signal indicative of fluorescence of a subject tissue into which a fluorescent medium has been introduced; and

a processor configured to receive the signal and to determine a tissue characteristic of the subject tissue responsive to the response of the fluorescence as indicated by the signal.

27. The system of claim 26, wherein the processor is configured to determine the tissue characteristic responsive to a slope, rise time, magnitude, steady state value, shape, integral or other curve property of the response of the fluorescence.

28. The system of claim 26, wherein the processor is further configured to determine a characteristic of the subject tissue based on steady-state values of the incident light and the fluorescence.

29. The system of claim 28, wherein the characteristic of the subject tissue is a perfusion of the tissue.

30. The system of claim 26, comprising an array of the sensors disposed on a surface of the surgical instrument.

31. The system of claim 30, wherein the surgical instrument comprises one of a stapler, a retractor, a grasper, a clip applier, a probe, a scope, a needle, a catheter and a mesh substrate.

32. A sensor consisting essentially of a rigid or flexible substrate and a plurality of sensing elements mounted to the substrate for monitoring a property of a living tissue.

33. The sensor of claim 32, wherein the substrate is substantially conformable to the shape of the living tissue.

34. The sensor of claim 32, wherein the substrate is a flexible mesh.

35. The sensor of claim 32, wherein the sensing elements are for measuring oxygenation of the tissue.

36. The sensor of claim 32, wherein the sensing elements are arranged on the substrate for mapping the tissue property.

37. The sensor of claim 32, wherein the sensing elements are for measuring electrical activity of the tissue, and are arranged for mapping the electrical activity of the surface of the tissue.

38. The sensor of claim 32, wherein the sensing elements are for measuring fluorescence, and are arranged for mapping the fluorescence of the surface of the tissue.

39. A surgical fastening device comprising a sensor for measuring properties of and interactions with a living tissue on the fastening device.

40. The surgical fastening device of claim 39, comprising one of a staple, a suture or a clip.

41. The surgical fastening device of claim 39, comprising a plurality of strain sensors located at corners or on the sides of a staple on an outer surface of the staple.

42. The fastening device of claim 39, wherein the sensor comprises a sensing coating around a circumference of a staple.

43. The surgical fastening device of claim 42, wherein the sensor comprises at least one of a piezoelectric coating and a resistive coating.

44. The surgical fastening device of claim 39 comprising a staple, wherein the staple is hollow and a strain sensor is disposed inside the staple for measuring a bending load on a leg of the staple.

45. The surgical fastening device of claim 39, wherein the sensor comprises at least one of an electrode, a MEMS sensor, and a remotely powered radio frequency transmitter unit.

48. A system comprising:

a surgical instrument having a sensor for generating a signal indicative of a property of a subject tissue of a patient;

a reference measurement instrument having a sensor for measuring a reference tissue and generating a reference measurement signal;

a signal processor for receiving the signal and converting the signal into a current dataset, and for receiving the reference measurement signal and converting it into a current reference dataset;

a memory for storing the current dataset and the current reference dataset; and

a processor configured to compare the current dataset with the current reference dataset, and to assess a physical condition of the subject tissue or guide a current procedure being performed on the tissue, responsive to the comparison.

49. The system of claim 48, wherein the reference tissue is a tissue of the patient.

50. The system of claim 48, wherein the signal processor is for converting the reference measurement signal to a reference baseline measurement dataset, and the processor is configured to assess the physical condition of the subject tissue responsive to the reference baseline measurement dataset.

51. The system of claim 48, wherein the reference measurement instrument comprises a sensor for grasping the reference tissue.

52. The system of claim 48, wherein the reference measurement instrument sensor comprises one of an optical sensor, a chemical sensor, mechanical sensor, a MEMS device, a nano sensor, an acoustic sensor, a fluid sensor and an electrical sensor.

53. The system of claim 48, wherein the reference measurement instrument sensor is for measuring at least one of oxygenation, fluorescence, tissue perfusion, general health, tissue electrical impedance, tissue electrical activity, interaction force, pH, electromyography, temperature, spectroscopy, fluid flow rate, fluid flow volume, pressure, biomarkers, radiotracers, immunologic characteristics, biochemical characteristics, nerve activity, and evoked potential.

54. The system of claim 48, further comprising a robotic manipulator for controlling the reference measurement instrument.

55. A system for monitoring a living tissue of a patient'"'"'s body, comprising:

a sensor implantable in the patient'"'"'s body for generating a signal indicative of a property of the tissue;

a controller for receiving the signal outside the patient'"'"'s body; and

a communications interface for communicating the signal from the sensor to the controller.

56. The system of claim 55, wherein the sensor is for placing in, on, in contact with, embedded into, or surrounding the tissue.

57. The system of claim 56, wherein the sensor is fully or partially bioabsorbable or biodegradable in the patient'"'"'s body.

58. The system of claim 56, wherein the communications interface is a wireless receiver, and the sensor is for wirelessly communicating the signal to the communications interface.

59. The system of claim 58, wherein the sensor is powered externally from a radio frequency source.

60. The system of claim 56, wherein the sensor is for monitoring the tissue property before, during or after a procedure performed on the patient.

61. The system of claim 60, wherein the sensor is for monitoring short and long-term outcomes of the procedure.

62. The system of claim 58, wherein the communications interface is portable.

63. The system of claim 62, wherein the communications interface comprises a radio frequency source for powering the sensor.

64. The system of claim 58, wherein the sensor comprises an antenna, and at least one of the sensor, the communications interface and the antenna is fully or partially bioabsorbable or biodegradable in the patient'"'"'s body.

65. The system of claim 57, wherein the sensor comprises a bioabsorbable or biodegradable optical fiber

66. The system of claim 65, wherein the optical fiber has a core and an outer cladding comprising bioabsorbable or biodegradable materials, and the cladding material degrades substantially more slowly relative to the core material.

67. A sensor comprising an attaching device removably mountable to a surgical instrument, and a plurality of sensing elements mounted to the attaching device for monitoring a property of a living tissue.

68. The sensor of claim 67, wherein the attaching device comprises at least one of a shell, a sleeve, and a clip.

69. The sensor of claim 68, wherein the sensor is single-use and disposable.

70. The sensor of claim 68, wherein the surgical instrument comprises a surgical stapler.

71. The sensor of claim 70, wherein the sensing elements are arranged along a working surface of the stapler.

72. The sensor of claim 67, wherein the sensor is for measuring at least one of oxygenation, fluorescence, tissue perfusion, general health, tissue electrical impedance, tissue electrical activity, interaction force, pH, electromyography, temperature, spectroscopy, fluid flow rate, fluid flow volume, pressure, biomarkers, radiotracers, immunologic characteristics, biochemical characteristics, nerve activity, and evoked potential.

73. The sensor of claim 72, comprising a processor for assessing tissue viability based on the monitored property.

74. The sensor of claim 72, wherein the sensor is for providing information to guide a procedure.

75. The sensor of claim 74, further comprising a reference measurement sensor for measuring a reference tissue and generating a reference measurement signal.

76. The sensor of claim 75, wherein the reference signal is for aiding in assessing tissue viability.

77. The sensor of claim 67, further comprising a processor configured to compare the sensor data with other data previously stored in a memory, and to assess a physical condition of the subject tissue or guide a current procedure being performed on the tissue, responsive to the comparison.

78. The sensor of claim 68, wherein the attaching device is removably mountable to the surgical instrument without impairing the functionality of the surgical instrument.

82. An apparatus comprising an attaching device attachable to a surgical instrument and a sensor mounted to the attaching device for monitoring the relative position of an element of the a surgical instrument.

83. The apparatus of claim 82, comprising a processor for synchronizing information from the sensor with measurements of at least one of oxygenation, fluorescence, tissue perfusion, general health, tissue electrical impedance, tissue electrical activity, interaction force, pH, electromyography, temperature, spectroscopy, fluid flow rate, fluid flow volume, pressure, biomarkers, radiotracers, immunologic characteristics, biochemical characteristics, nerve activity, and evoked potential.

84. The apparatus of claim 83, wherein the sensor information is used to guide a procedure.

85. The apparatus of claim 82, wherein the surgical instrument comprises a surgical stapler.

86. The apparatus of claim 85, wherein the relative position is the distance between the jaws of the stapler.

87. The apparatus of claim 86, wherein the sensor comprises an optical encoder.

88. The apparatus of claim 82, wherein the attaching device is for removably mounting the sensor to the surgical instrument.

89. An apparatus comprising an accessory for attachment to a surgical instrument, the accessory including a plurality of sensing elements.

90. The apparatus of claim 89, wherein the sensing elements are for measuring at least one of oxygenation, fluorescence, tissue perfusion, general health, tissue electrical impedance, tissue electrical activity, interaction force, pH, electromyography, temperature, spectroscopy, fluid flow rate, fluid flow volume, pressure, biomarkers, radiotracers, immunologic characteristics, biochemical characteristics, nerve activity, and evoked potential.

91. The apparatus of claim 89, wherein the accessory is for replacing an element of a standard surgical instrument.

92. The apparatus of claim 91, wherein the surgical instrument is a surgical stapler.

93. The apparatus of claim 92, wherein the element of the surgical instrument is an anvil.