# US 10,499,984 B2 · Apparatus and method for assessing tissue treatment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,499,984 B2 - Document ID: US10499984B2 - Status: Granted - Kind: B2 - Application number: 15/343,622 - Filed: 2016-11-04 - Published: 2017-03-16 - Granted: 2019-12-10 - Earliest claimed: 2012-07-18 - Applicants: Bernard Boon Chye Lim - Inventors: Bernard Boon Chye Lim - Web page: https://patentgrep.com/patent/US10499984B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 5/0044: {for the heart} - A61B 5/0073: {by tomography, i.e. reconstruction of 3D images from 2D projections (A61B5/0066 takes precedence)} - A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)} - A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)} - A61B 5/6855: {with a distal curved tip} - A61B 5/6857: {with a distal pigtail shape} - A61B 5/6858: {with a distal basket, e.g. expandable basket} - A61B 18/02: by cooling, e.g. cryogenic techniques - A61B 18/24: with a catheter (A61B18/26, A61B18/28 take precedence) - A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis - A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092}) - A61B 2018/0022: {Balloons} - A61B 2018/00267: {having a basket shaped structure} - A61B 2018/00351: {Heart} - A61B 2018/00577: {Ablation} - A61B 2018/00642: {with feedback, i.e. closed loop control} - A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes} - A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter} - A61B 2018/1467: {using more than two electrodes on a single probe} - A61B 2034/2048: {using an accelerometer or inertia sensor} - A61B 2090/306: {using optical fibres} - A61B 2090/3966: {Radiopaque markers visible in an X-ray image} - A61N 2007/0043: {intra-cavitary} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract The invention relates to a tissue monitoring apparatus, a tissue monitoring method and an ablation lesion monitoring, measuring, and controlling automated algorithm incorporating diffuse reflectance spectroscopy (DRS) and/or Arrhenius model thermal denaturation kinetics for determining the characteristics of the lesion or the tissue, especially for identifying the transmurality of the ablation lesion. The invention pertains to a device for and method of real time monitoring of lesion formation as ablation is being carried out. ## Claims ### Claim 1 A system for monitoring tissue comprising: a catheter, the catheter having an elongated body member having a proximal end and a distal end; a biasing element in the distal end, the biasing element configured to bias the distal end into contact with a first tissue portion, wherein the distal end includes: an optical emitting element, the optical emitting element oriented to emit optical radiation into the first tissue portion, an optical receiving element oriented to collect optical radiation, the optical radiation indicating characteristics of the first tissue portion; wherein the optical receiving element and the optical emitting element are arranged to be spatially offset along a first longitudinal axis of the distal end, and along the face of the first tissue portion, and a workstation, the workstation comprising an optical radiation analysis module stored in a memory and executed by a processor, configured to process the optical radiation collected by the optical receiving element using spatially offset diffuse reflectance spectroscopy, wherein the processing element is configured to calculate the rate of denaturation of the tissue adjacent to the distal portion. ### Claim 2 (depends on 1) The system of claim 1 wherein the biasing element comprises a biasing shape, a retention means, a steering means, a nitinol element, or an insertable stylet. ### Claim 3 (depends on 1) The system of claim 1 wherein the distal end further comprises a first aperture, and wherein the optical emitting element is configured to emit optical radiation through the first aperture into the first tissue portion. ### Claim 4 (depends on 3) The system of claim 3, wherein the distal end further comprises a second aperture, wherein the optical receiving element collects radiation that enters through the second aperture. ### Claim 5 (depends on 1) The system of claim 1, wherein the distal portion comprises a basket assembly, the basket assembly comprising a plurality of radially expanding splines adapted to position a first spline adjacent a tissue, the first spline including the optical emitting element and the optical receiving element. ### Claim 6 (depends on 5) The system of claim 5, further comprising a second spline with a second longitudinal axis, the second spline comprising: a second biasing element adapted to position the second spline adjacent a second tissue portion, a second optical emitting element configured to emit optical radiation into the second tissue portion, a second optical receiving element configured to collect optical radiation, the optical radiation indicating characteristics of the second tissue portion during the application of energy to the second tissue portion; wherein the second optical receiving element and the second optical emitting element are arranged to be spatially offset along the second longitudinal axis of the second spline. ### Claim 7 (depends on 1) The system of claim 1 further comprising a spatial offset displacement actuator configured to adjust the spatial offset between the optical receiving element and the optical emitting element along the first longitudinal axis such that the spatial offset between the optical receiving element and the optical emitting element is adjustable. ### Claim 8 (depends on 1) The system of claim 1, further comprising an electrode configured to apply energy to the first tissue portion. ### Claim 9 (depends on 1) The system of claim 1, wherein the processing element is configured to generate an optical spectra of the optical radiation collected by the optical receiving element. ### Claim 10 (depends on 1) The system of claim 1, wherein the processing element is configured to compare the processed optical radiation collected by the optical receiving element to a reference optical radiation for at least one of following tissue types: fat, nerve, muscle, or collagen. ### Claim 11 (depends on 10) The system of claim 10, wherein the processing element is configured to determine that adjacent tissue is at least one of the following tissue types: fat, nerve, muscle, or collagen based at least on the comparison between the generated optical spectra and the reference optical spectra. ### Claim 12 (depends on 9) The system of claim 9, wherein the processing element is configured to compare the generated optical spectra of the optical radiation collected by the optical receiving element to a reference optical spectra for tissue fluid. ### Claim 13 (depends on 1) The system of claim 1, wherein the processing element is configured to directly or indirectly control an ablation electrode based on a rate of thermal denaturation of the first tissue portion. ### Claim 14 (depends on 1) The system of claim 1, wherein the processing element is configured to extract a rate constant for the rate of denaturation of the first tissue portion. ### Claim 15 (depends on 14) The system of claim 14, wherein the processing element identifies when the tissue adjacent to the first radially expanding spline is sixty three percent denatured. ### Claim 16 (depends on 1) The system of claim 1, wherein the system determines the characteristics of a lesion, nerve, or tissue based on the rate of thermal denaturation of the tissue. ### Claim 17 (depends on 1) The system of claim 1, wherein the denaturation is a heat denaturation, a cold denaturation, or a mechanical denaturation. ### Claim 18 (depends on 1) The system of claim 1, wherein the spatial offset between the optical receiving element and the optical emitting element is at least 10 mm. ### Claim 19 (depends on 6) The system of claim 6, wherein the catheter is connected to an optical radiation source configured to provide optical radiation to the first and the second optical illuminating elements such that the first and the second optical illuminating elements substantially simultaneously emit optical radiation. ### Claim 20 (depends on 1) The system of claim 1, wherein the system determines the characteristics of a lesion, nerve, or tissue based on the optical reflectance from the tissue. ### Claim 21 (depends on 1) The system of claim 1, wherein a processing element identifies when the tissue adjacent to the distal end is transmurally denatured based on a change in the slope of a reflectance curve.