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

• US 9,204,830 B2
• Filed: 04/14/2006
• Issued: 12/08/2015
• Est. Priority Date: 04/15/2005
• Status: Active Grant

• Current Assignee: Surgisense Corporation
• Original Assignee: Surgisense Corporation
• Inventors: Zand, Jason Matthew, Fischer, Gregory Scott
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US11/918,456
• Publication Number:
  US 20090054908A1
• Time in Patent Office: 3,525 Days
• Field of Search: 600/300, 600/310, 600/323, 600/317, 600/361, 600/407, 600/504, 600/549, 600/554, 606/139, 606/151, 606/32, 606/167, 606/205, 606/191, 606/210, 606/222, 604/19
• US Class Current: 1/1
• 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 configured to generate a signal indicative of a property of a subject tissue of a patient;

a signal processor configured to receive the signal and convert the signal into a current dataset;

a memory configured to store the current dataset; and

a processor configured to determine a relationship between the current dataset and datasets of signals indicative of the property of a subject tissue of other patients previously stored in the memory, to determine a weighting factor based on the determined relationship between the current dataset and the previously stored datasets, and to interpolate or extrapolate a physical condition of the subject tissue or guide a current procedure being performed on the subject tissue based on the determined weighting factor and outcomes of the other patients previously stored in the memory,

wherein the processor is further configured to predict the likelihood of success of the current procedure being performed on the subject tissue based on the weighting factor and the outcomes of the other patients previously stored in the memory.

2. The system of claim 1, further comprising a recorder configured to record the signal from the sensor and the current dataset into the memory.

3. The system of claim 1, wherein the memory is operative to store 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 further configured to predict the likelihood of success of the current procedure responsive to the data relating to the outcomes.

4. The system of claim 3, 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.

5. The system of claim 3, wherein the processor is further configured to add short-term and long-term outcomes of the current procedure to the memory.

6. The system of claim 3, further comprising patient monitoring equipment configured to generate patient condition data and transfer 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.

7. The system of claim 6, wherein the patient monitoring equipment is configured to perform at least one of systemic monitoring, local monitoring, extracorporeal monitoring, intracorporeal monitoring, invasive monitoring and noninvasive monitoring.

8. The system of claim 6, wherein the patient monitoring equipment includes at least one of a vital sign monitor and anesthesia equipment.

9. The system of claim 6, 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 and configured to monitor a property of a biological tissue of a patient.

10. The system of claim 6, 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 and configured to generate the patient condition data.

11. The system of claim 3, further comprising patient status sensing equipment configured to generate patient status data and transfer 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.

12. The system of claim 11, wherein the patient status sensing equipment comprises at least one of thermal imaging equipment, a camera, and spectroscopic imaging equipment.

13. The system of claim 1, further comprising a communications device configured to communicate 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.

14. The system of claim 13, 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.

15. The system of claim 1, further comprising a communications device configured to communicate 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.

16. The system of claim 15, 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.

17. 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.

18. The system of claim 1, further comprising a reference measurement instrument having a sensor configured to measure a reference tissue and generate a reference measurement signal.

19. The system of claim 18, wherein the reference tissue is a tissue of the patient.

20. The system of claim 19, wherein the sensor associated with the surgical instrument and the sensor associated with the reference measurement instrument are configured to measure 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.

21. The system of claim 18, wherein the signal processor is configured to convert 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.

22. The system of claim 18, wherein the reference measurement instrument is configured to grasp the reference tissue.

23. The system of claim 18, further comprising a robotic manipulator configured to control the reference measurement instrument.

24. 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.

25. The system of claim 1, further comprising a robotic manipulator configured to control the surgical instrument.

26. The system of claim 1, wherein the sensor is configured to generate signals before, during and after actuation of the surgical instrument, and the signal processor is configured to process such signals and include such signals in the dataset.

27. The system of claim 1, further comprising an attaching device removably mountable to the surgical instrument and configured to hold the sensor and configured to position the sensor relative to the surgical instrument.

28. The system of claim 27, wherein the attaching device comprises at least one of a shell, a sleeve, and a clip.

29. The system of claim 27, wherein the surgical instrument comprises a stapler.

30. A system comprising:

a particular synthetic light re-emitting medium adapted to be introduced into a subject tissue of a patient; and

a surgical instrument configured to manipulate biological tissue comprising;

an incident light source configured to illuminate the subject tissue into which the particular light re-emitting medium has been introduced;

a light sensor configured to receive an optical response from the light re-emitting medium introduced into the subject tissue and to generate a signal indicative of the optical response; and

a processor configured to receive the signal and to determine a physiologic tissue characteristic of the subject tissue responsive to the optical response as indicated by the signal and based on the particular light re-emitting medium introduced into the tissue,

wherein the processor is further configured to use the determined physiologic tissue characteristic to further guide a surgical procedure.

31. The system of claim 30, wherein the processor is configured to determine the physiologic tissue characteristic responsive to a slope, rise time, magnitude, steady state value, shape, integral or other curve property of the optical response.

32. The system of claim 30, wherein the processor is further configured to determine the physiologic tissue characteristic based on steady-state values of the optical response.

33. The system of claim 32, wherein the physiologic tissue characteristic of the subject tissue is a perfusion of the tissue.

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

35. The system of claim 34, 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.

36. The system of claim 30, wherein the light re-emitting medium is configured to be injected into the tissue.

37. The system of claim 30, wherein the system is configured to wirelessly communicate the signal generated by the light sensor to the processor.

38. A sensing device comprising a rigid or flexible substrate and a plurality of sensing elements mounted to the substrate for monitoring a property of a biological tissue of a patient,

wherein the sensing elements are communicatively connected to a processor configured to use a signal acquired by the sensing elements to determine a weighting factor based on a relationship between the acquired signal and datasets of signals indicative of the property of a biological tissue of other patients previously stored in a memory, to provide information to further guide a surgical procedure based on the property, and to predict the likelihood of success of the surgical procedure based on the determined weighting factor and outcomes of the other patients previously stored in the memory.

39. The sensing device of claim 38, wherein the substrate is substantially conformable to the shape of the biological tissue of a patient.

40. The sensing device of claim 38, wherein the substrate is a flexible mesh.

41. The sensing device of claim 38, wherein the sensing elements are configured to measure oxygenation of the tissue.

42. The sensing device of claim 38, wherein the sensing elements are arranged on the substrate and configured to map the property of the biological tissue of a patient.

43. The sensing device of claim 38, wherein the sensing elements are configured to measure electrical activity of the biological tissue of a patient, and are arranged for mapping the electrical activity of the biological tissue of a patient.

44. The sensing device of claim 38, wherein the sensing elements are configured to measure the optical response of a light re-emitting medium introduced into a subject tissue, and are arranged for mapping the optical response of the light re-emitting medium introduced into a subject tissue, on the surface of the biological tissue of a patient.

45. A surgical fastener comprising a sensor configured to measure mechanical or physiologic properties of a biological tissue of a patient, said sensor being in contact with the surgical fastener,

wherein:

said fastener is an implantable fastener configured to hold tissue together, and

said sensor is configured to obtain measurement results corresponding with mechanical or physiologic properties of the biological tissue of a patient.

46. The surgical fastener of claim 45, comprising one of a staple, a suture or a clip.

47. The surgical fastener of claim 45, comprising a plurality of strain sensors located at corners or on the sides of a staple on an outer surface of the staple.

48. The surgical fastener of claim 45, wherein the sensor comprises a sensing coating around a circumference of a staple.

49. The surgical fastener of claim 48, wherein the sensor comprises at least one of a piezoelectric coating and a resistive coating.

50. The surgical fastener of claim 45 comprising a staple, wherein the staple is hollow and a strain sensor is disposed inside the staple and configured to measure a bending load on a leg of the staple.

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

52. The surgical fastener of claim 45, wherein the fastener is an implantable fastener configured to substantially permanently hold the tissue together.

53. A system comprising:

a surgical instrument configured to manipulate biological tissue having a sensor configured to generate a signal indicative of a property of a subject tissue of a patient;

a reference measurement instrument having a sensor configured to measure a reference tissue and generate a reference measurement signal,

wherein the surgical instrument and the reference measurement instrument are physically distinct instruments that are configured to be separately mounted on the subject tissue and the reference tissue;

a signal processor configured to receive the signal and convert the signal into a current dataset, and configured to receive the reference measurement signal and convert it into a current reference dataset;

a memory configured to store 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 and guide a current procedure being performed on the tissue, responsive to the comparison,

wherein the reference tissue is a tissue of the patient, and

wherein the signal processor is configured to convert 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.

54. The system of claim 53, wherein the reference measurement instrument is configured to grasp the reference tissue, and

comprises a sensor.

55. The system of claim 53, 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.

56. The system of claim 53, wherein the reference measurement instrument sensor is configured to measure 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.

57. The system of claim 53, further comprising a robotic manipulator configured to control the reference measurement instrument.

58. The system of claim 53, wherein the system is configured to wirelessly communicate at least one of the signal generated by the sensor of the surgical instrument and the reference measurement signal generated by the sensor of the reference measurement instrument to the signal processor.

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

a sensor implantable in the patient'"'"'s body configured to generate a signal indicative of a property of the biological tissue;

a controller configured to receive the signal outside the patient'"'"'s body; and

a communications interface configured to communicate the signal from the sensor to the controller, wherein;

the sensor is configured to place in, on, in contact with, embedded into, or surrounding the biological tissue,

the sensor is fully or partially bioabsorbable or biodegradable in the patient'"'"'s body, and

the communications interface is wireless, and the sensor is configured to wirelessly communicate the signal to the communications interface.

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

61. The system of claim 59, wherein the sensor is configured to monitor the biological tissue property before, during or after a procedure performed on the patient.

62. The system of claim 61, wherein the sensor is configured to monitor short and long-term outcomes of the procedure.

63. The system of claim 59, wherein the communications interface is portable.

64. The system of claim 63, wherein the communications interface is configured to use a radio frequency source to power the sensor.

65. The system of claim 59, wherein the sensor comprises an antenna, and at least one of the communications interface and the antenna is fully or partially bioabsorbable or biodegradable in the patient'"'"'s body.

66. The system of claim 59, wherein the sensor comprises a bioabsorbable or biodegradable optical fiber.

67. The system of claim 66, 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.

68. A sensing device 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 subject tissue,

wherein said plurality of sensing elements are arranged to be directed to a working surface of the surgical instrument, and

wherein the sensing elements are communicatively connected to a processor configured to use a signal acquired by the sensing elements to determine a weighting factor based on a relationship between the acquired signal and datasets of signals indicative of the property of a biological tissue of other patients previously stored in a memory, to provide information to further guide a surgical procedure based on the property, and to predict the likelihood of success of the surgical procedure based on the determined weighting factor and outcomes of the other patients previously stored in the memory.

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

70. The sensing device of claim 69, wherein the sensing device is single-use and disposable.

71. The sensing device of claim 69, wherein the attaching device is configured to be removably mountable to a surgical stapler.

72. The sensing device of claim 71, wherein the sensing elements are arranged along a working surface of the surgical stapler.

73. The sensing device of claim 69, wherein the attaching device is removably mountable to the surgical instrument without impairing the functionality of the surgical instrument.

74. The sensing device of claim 68, wherein the sensing elements is configured to measure 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.

75. The sensing device of claim 74, wherein the processor is further configured to assess subject tissue viability based on the monitored property.

76. The sensing device of claim 74, wherein the sensing device further comprises an output configured to provide the information to guide a procedure.

77. The sensing device of claim 76, further comprising a reference measurement sensor configured to measure a reference tissue and generate a reference measurement signal.

78. The sensing device of claim 77, wherein the reference signal is configured to aid in assessing subject tissue viability.

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

wherein said plurality of sensing elements are arranged to be directed to a working surface of the surgical instrument, and

wherein the sensing elements are communicatively connected to a processor configured to use a signal acquired by the sensing elements to determine a weighting factor based on a relationship between the acquired signal and datasets of signals indicative of a property of a biological tissue of other patients previously stored in a memory, to provide information to further guide a surgical procedure based on the property, and to predict the likelihood of success of the surgical procedure based on the determined weighting factor and outcomes of the other patients previously stored in the memory.

80. The apparatus of claim 79, wherein the sensing elements are configured to measure 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.

81. The apparatus of claim 79, wherein the accessory is configured to replace an element of a standard surgical instrument.

82. The apparatus of claim 81, wherein the surgical instrument is a surgical stapler.

83. The apparatus of claim 82, wherein the element of the surgical instrument is an anvil.