Source: http://www.google.co.uk/patents/US9204830
Timestamp: 2017-10-17 17:09:58
Document Index: 19944253

Matched Legal Cases: ['§371', 'Application No. 60', 'Application No. 60', 'Application No. 2', 'Application No. 2006800021505', 'Application No. 201310328574', 'Application No. 200680021505', 'Application No. 200680021505', 'Application No. 200680021505', 'Application No. 200680021505', 'Application No. 06758332', 'Application No. 06758332', 'Application No. 06758332']

Patent US9204830 - Surgical instruments with sensors for detecting tissue properties, and ... - Google Patents
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,...http://www.google.co.uk/patents/US9204830?utm_source=gb-gplus-sharePatent US9204830 - Surgical instruments with sensors for detecting tissue properties, and system using such instruments
Publication number US9204830 B2
Application number US 11/918,456
PCT number PCT/US2006/013985
Also published as CA2604563A1, CN101495025A, CN101495025B, CN103622725A, EP1868485A2, EP1868485A4, EP1868485B1, EP3095379A1, US20090054908, US20160073909, WO2006113394A2, WO2006113394A3
Publication number 11918456, 918456, PCT/2006/13985, PCT/US/2006/013985, PCT/US/2006/13985, PCT/US/6/013985, PCT/US/6/13985, PCT/US2006/013985, PCT/US2006/13985, PCT/US2006013985, PCT/US200613985, PCT/US6/013985, PCT/US6/13985, PCT/US6013985, PCT/US613985, US 9204830 B2, US 9204830B2, US-B2-9204830, US9204830 B2, US9204830B2
Inventors Jason Matthew Zand, Gregory Scott Fischer
Original Assignee Surgisense Corporation
Patent Citations (41), Non-Patent Citations (14), Referenced by (2), Classifications (23), Legal Events (1)
US 9204830 B2
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.
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,
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.
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
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 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.
This application is the U.S. National Phase under 35 U.S.C. §371 of International Application No. PCT/US2006/013985, filed on Apr. 14, 2006, which in turn claims the benefit of U.S. Provisional Application No. 60/671,872, filed on Apr. 15, 2005 and U.S. Provisional Application No. 60/766,359, filed on Jan. 12, 2006, the disclosures of which Applications are incorporated by reference herein.
FIG. 5 a is a block diagram of a configuration for transmitting light for the optical sensor of FIGS. 4 a-4 e.
FIG. 5 b is a block diagram of a configuration for receiving light for the optical sensor of FIGS. 4 a-4 e.
FIG. 6 a is a graph showing the relationship between light absorption and incident wavelength for varying tissue oxygen saturation.
FIG. 12 b is a cross-sectional view the sensing staple or clip of FIG. 12 a.
FIG. 13 a illustrates a system according to an embodiment of the present invention where the staples or clips measure electrical impedance.
Large amounts of data are collected for each patient. The database 131 contains all of the collected information and the corresponding outcomes, or a statistically significant subset of the collected data and patient outcomes. The database, or a subset thereof, acts as a statistical atlas of predicted outcomes for a given set of sensor inputs. Conventional techniques are used for determining the relationship between the current sensor readings and those of the atlas, to interpolate or extrapolate a predicted outcome or likelihood of procedure success or failure. One technique well-known in the art represents the current patient's sensor and other inputs in a vector; the similar datasets from the atlas or database are represented in a similar form as a set of vectors. The “distance” between the current patient data and each set of previously stored data is determined; distance can be determined as the standard Euclidean distance between the vectors; i.e. the 2-norm of the difference between the vectors, or other distance measures as known in the art including other norms and the Mahalanobis distance. The difference between the vectors, or the vectors themselves, can be multiplied by a weighting matrix to take into account the differences in the significance of certain variables and sensor readings in determining the outcome. The set of distances of the current dataset from the previously stored sets is used as a weighting factor for interpolating or extrapolating the outcome, likelihood of success or failure, or other characteristics of the previously stored datasets. In another well-known technique, methods typically used in image processing and statistical shape modeling for deforming a statistical atlas can be incorporated. A base dataset generated from the database of previously collected datasets and the most statistically significant modes of deformation are determined, where the previously collected datasets act as training datasets. The magnitudes of the deformation for each mode are determined to best match the atlas model to the current dataset. The magnitudes are then used to deform the set of previous outcomes in a similar fashion, or otherwise interpolate between the previous outcomes by determining how the each outcome is dependent on each mode of deformation, to determine the best fit for the current patient. Other conventional techniques for predicting outcomes based on prior and current datasets are based on determining the similarity between the current dataset with those that were previously acquired from other patients, and using the similarity measure to determine a likelihood of a given outcome responsive to those corresponding to the prior datasets.
Attached to, or integrated directly into, the base control unit 120 is one or more output devices 134. Output device 134 is used to provide persons performing the procedure information about the physiologic condition of the tissue, and to help guide the procedure. The output device 134 takes information from the sensors, prior data, patient records, other equipment, calculations and assessments, and other information and presents it to the clinician and operating room staff in a useful manner. In one embodiment, the measured information is compared with prior datasets and prior patient outcomes, and the output device displays information to help assess the likelihood of success of a given procedure with the current configuration. The information displayed can simply be a message such as “go ahead as planned” or “choose another site.” In another embodiment, the information is encoded in some form of sensory substitution where feedback is provided via forms including, but not limited to, visual, audible, or tactile sensation.
FIG. 5 a schematically displays a configuration of the light emitting components for a single measurement point in one embodiment of the sensing stapler or other sensing instrument of the invention. A processor 501, contained in the base unit 120 or onboard the instrument, commands the light controller 502, which also is located either in the base unit 120 or onboard the instrument. The light controller 502 is coupled to the light sources for one sensing modality by connections 504. The light sources 506, 508, and 510 provide the light that is incident on the tissue 102. In one embodiment, these light sources are lasers with wavelengths centered at red (near 660 nm), near-infrared (near 790 nm), and infrared (near 880 nm), respectively. This configuration is used for oximetry-type sensing where one wavelength is situated at the isobestic point for light absorption in hemoglobin, one is situated at a greater wavelength, and one is situated at a lesser wavelength. Light sources 506, 508, and 510 are one, two, three, or more distinct light emitters and are laser, light emitting diode (LED), or other sources. Alternatively, these distinct light sources are a broadband light source such as a white light. If more than one light source is used, optical couplings 514 connect the sources to a light combiner 516. If more than one output is required (i.e. more than one measurement point using the same light source), optical coupling 518 takes the light into a light splitter 520. Optical couplings 524 take the light to the appropriate fiber assembly 530. Light is transmitted out of the fiber assembly at the fiber end 532 on the tip. This tip is as depicted in FIG. 4 a.
The light controller 502 controls the light emitter for one or more sensing modalities. In this embodiment, there are two optical sensing modalities: oximetry-type tissue oxygenation sensing and fluorescence sensing. Coupling 536 allows the light controller to control light source 538. Light source 538 is a high power blue LED with a center wavelength of 570 nm. This light emitter is a laser, LED, or other light source. This source is composed of one or more sources that emit light at one or more wavelengths or a broadband light source emitting at a spectrum of wavelengths. Optical filtering can also be performed on a broadband light source to produce the desired spectral output. The light from light source 538 is coupled optically 540 to a light splitter 542 if more than one measurement point uses the same source. Optical coupling 544 connects the light to the optical cable assembly 530, and light is emitted at tip 548.
In another embodiment of the invention, the light from optical fibers 524 and 544 is combined and the light is emitted from an optical fiber assembly as described in FIG. 4 b, 4 c, or 4 d (emitter as fiber 464). In a further embodiment, the light from optical fibers 524 and 544 is split, or combined and split, into multiple fibers to be used with a cable assembly as shown in FIG. 4 d (emitters as fibers 466) or FIG. 4 e.
FIG. 5 b schematically displays a configuration of light receiving components for a single measurement point in one embodiment of the sensing stapler or other sensing instrument 101. Light from the emitter described in FIG. 5 a is incident upon the tissue being queried and the transmitted and/or reflected light passes into the tip 552 and returns through the optical cable assembly 530. Optical coupling 554 directs the light to light sensors 556. In one embodiment, light sensor 556 is an avalanche photodiode. Sensor 556 is, but is not limited to, conventional photodiodes, avalanche photodiodes, CCDs, linear CCD arrays, 2 D CCD arrays, CMOS sensors, photomultipliers tubes, cameras, or other light sensing devices. In a further embodiment, light sensor 556 is a spectrometer or equivalent device that measures light intensity at one or more discrete wavelengths. In a still further embodiment, light sensor 556 is a set of selective photodiodes tuned to the wavelengths of emitted light from light sources 506, 508, and 510. Selective photodiodes are either naturally tuned to specific wavelengths or coupled with an appropriate optical filter. Light sensors 556 are coupled 558 with a signal processor 560. The signal processor 560 performs filtering, demodulating, frequency analysis, timing, and/or gain adjustment, and/or other signal processing tasks. The signal processor 560 is coupled with the processor 501 where further calculations, analysis, logging, statistical analysis, comparisons with reference, comparisons with database, visualization, notification, and/or other tasks are performed or directed.
Light from the emitter described in FIG. 5 a is incident upon the tissue being queried and the transmitted and/or reflected light also passes into the tip 564 and returns through the optical cable assembly 530. Light is directed via optical coupling 568 to optical filters 572. In the fluorescence sensing modality, the optical filter 568 is a band pass or other filter that blocks the incident, excitation light while allowing the fluoresced light to pass. Filter 572 is also useful to block the emitted light from other sensing modalities and/or other light including ambient light. The filter light is coupled optically via coupling 574 to light sensors 578. In one embodiment, light sensor 578 is an avalanche photodiode. In other embodiments, light sensor 578 is the same form as light sensors 556. Light sensors 578 are coupled 580 with the signal processor 560 which is in tern coupled with the processor 501. The processor 501 and signal processor 560 perform the same functions as described previously with reference to FIG. 5 a.
FIGS. 6 a and 6 b show plots that are used to describe oximetry sensing modality. FIG. 6 a shows the relationship between light absorption 601 and light wavelength 602 for a range of tissue oxygenation levels 603. The vertical lines 620, 624 and 628 correspond to the wavelengths of 660 nm, 790 nm and 880 nm respectively. The light absorption 601 for the range of oxygen saturation levels 603 is different for each of the wavelengths. As oxygen saturation 603 decreases, the absorption increases for red light 620 and decreases for near-infrared light 628. At the isobestic wavelength near 624, light absorption is invariant to oxygen saturation. This wavelength can be used for calibration and for normalization of the signal to allow for consistent readings regardless of optical density of the tissue. One embodiment of the oxygen sensing modality emits light at the isobestic wavelength, one wavelength greater than the isobestic and one wavelength less than the isobestic, and senses the absorption responsive to the measured response. Other embodiments emit one or more wavelengths of light and measure the transmitted, reflected, or otherwise measurable light to determine the absorption, slope of the absorption function, or other characteristics of the response that can be related to the blood oxygen saturation and tissue health.
A measure related to tissue oxygenation can be calculated responsive to the output and corresponding receiver light intensities. Initially, the “red ratio” is defined and is evaluated as (H−G)/(C−D), and the “infrared ratio” is defined and is evaluated as (F−G)/(A−E), where the letters correspond to the magnitudes of the light intensities as described. The numerator of the ratios determines the response after eliminating effects of ambient or other external light sources. The denominator of the ratios normalizes the response by the amount of light that was actually incident on the tissue that made it back to the sensor. The oxygenation is responsive to the two ratios. The “relative oxygen saturation” is defined as the red ratio divided by the infrared ratio and is related, not necessarily linearly, to the oxygen saturation of the tissue being measured. The relative oxygen saturation is useful for determining trends in oxygenation and also as a comparison with respect to time and/or a separate reference sensor. One important difference between the technique described and that of standard pulse oximetry is that the employed algorithms are not based on pulsatile flow in the tissue. Therefore, it is possible to acquire the tissue oxygen saturation even if blood flow is non-pulsatile, or even not flowing. Further, the algorithms incorporated improve measurement robustness and stability by compensating for tissue thickness and type (or more specifically, the optical impedance of the tissue being measured).
The sensing surgical mesh can be generally described as a rigid or flexible surface that contains sensing elements. The sensing elements detect information about the tissue upon which they are placed. The mesh is flexible, or preshaped to conform to the tissue being monitored. In one embodiment wherein the mesh is bioabsorbable, the mesh is made of bioabsorbable polymers similar to those used in conventional absorbable sutures. In another embodiment wherein the mesh is durable, the mesh is made of polymers similar to those used in conventional non-absorbable sutures. In a further embodiment, the substrate is an adhesion barrier material, such as Seprafilm®, available from Genzyme Corp. of Cambridge, Mass. The tissue being monitored is either internal tissue, such as an organ being monitored after transplant or a bowel segment whose perfusion is to be verified, or is external tissue, such as a skin flap being monitored for reconstructive surgery, or skin being monitored for the prevention of bed sores. The mesh sensor array is either a temporary device used during a procedure (either single use or reusable), permanently implantable, or of a bio degradable, bio absorbable nature as is known in the art.
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US20170007146 * 8 Jul 2015 12 Jan 2017 Warsaw Orthopedic, Inc. Wireless sensors and corresponding systems and methods for intra-operative nerve root decompression monitoring
International Classification A61B5/026, A61B5/00, A61B5/1459, A61B5/145, A61B17/00, A61B5/1455
Cooperative Classification Y10S901/44, A61B17/068, A61B5/7455, A61B5/7405, A61B5/14542, A61B5/0261, Y10S901/09, A61B5/742, A61B5/7275, A61B5/6837, A61B5/413, A61B5/0071, A61B5/0084, A61B5/0075, A61B5/0086, A61B5/1459, A61B2017/00022
Owner name: SURGISENSE CORPORATION, MARYLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ZAND, JASON MATTHEW;FISCHER, GREGORY SCOTT;SIGNING DATESFROM 20151029 TO 20151030;REEL/FRAME:036923/0149