# US 10,869,683 B2 · Systems and methods for submucosal tissue separation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,869,683 B2 - Document ID: US10869683B2 - Status: Granted - Kind: B2 - Application number: 15/983,968 - Filed: 2018-05-18 - Published: 2018-11-22 - Granted: 2020-12-22 - Earliest claimed: 2017-05-19 - Assignees: Boston Scientific Scimed, Inc. - Applicants: Boston Scientific Scimed, Inc. - Inventors: Shawn Ryan; Samuel Raybin; Matthew B. Hollyer - Web page: https://patentgrep.com/patent/US10869683B2 ## CPC - A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)} - A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)} - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61L 31/042: {Polysaccharides} - A61L 31/148: {Materials at least partially resorbable by the body} - A61M 5/19: having more than one chamber - A61M 5/285: {with sealing means to be broken or opened} - G01R 33/0011: {comprising means, e.g. flux concentrators, flux guides, for guiding or concentrating the magnetic flux, e.g. to the magnetic sensor} - G01R 33/0017: {Means for compensating offset magnetic fields or the magnetic flux to be measured; Means for generating calibration magnetic fields} - H01F 27/346: {Preventing or reducing leakage fields (using magnetic shields H01F27/36; using auxiliary windings H01F27/38)} - A61B 18/082: {Probes or electrodes therefor} - A61B 18/14: Probes or electrodes therefor - A61B 2017/00269: {endoscopic mucosal resection EMR} - A61B 2017/0034: {adapted to be inserted through a working channel of an endoscope} - A61B 2017/00818: {Treatment of the gastro-intestinal system} - A61B 2017/00942: {hydrophilic} - A61B 2018/00494: {Stomach, intestines or bowel} - A61B 2018/00595: {Cauterization} - A61B 2018/00601: {Cutting} - A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes} - A61L 2400/06: Flowable or injectable implant compositions - A61M 2005/3106: {Plugs for syringes without needle} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - G01R: MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES (indicating correct tuning of resonant circuits H03J3/12) - H01F: MAGNETS; INDUCTANCES; TRANSFORMERS; SELECTION OF MATERIALS FOR THEIR MAGNETIC PROPERTIES ## Abstract The present disclosure relates to the field of medical devices generally and specifically, to endoscopic systems and methods for resection of malignant and pre-malignant lesions within the gastrointestinal (GI) tract. In particular, the present disclosure relates to systems and methods for delivering injectable compositions between tissue layers (e.g., between the muscularis and submucosa layers) to elevate and stabilize the lesion for fast and efficient resection. ## Claims ### Claim 1 A system, comprising: a delivery device comprising a proximal portion, distal portion, a lumen extending therebetween; a first injectable composition disposed within the distal portion of the delivery device; and a second injectable composition disposed within the proximal portion of the delivery device; wherein the delivery device is configured to (a) extend through a working channel of an endoscope that comprises a proximal end, a distal end and said working channel such that a distal end of the delivery device extends into tissue beyond the distal end of the endoscope and such that the distal end of the delivery device is positioned between adjacent first and second tissue layers and (b) inject the first and second injectable compositions between the first and second layers; and wherein a viscosity of the first injectable composition is less than a viscosity of the second injectable composition; wherein the first and second injectable compositions are separated by a barrier member; and wherein the barrier member is formed from a destructible membrane configured to rupture after the first injectable composition has been discharged from the distal portion of the delivery device. ### Claim 2 (depends on 1) The system of claim 1, wherein the first and second injectable compositions do not substantially mix within the lumen of the delivery device. ### Claim 3 (depends on 1) The system of claim 1, wherein the barrier member is configured to rupture above a threshold level of force. ### Claim 4 (depends on 1) The system of claim 1, wherein the barrier member includes a biocompatible or biodegradable material. ### Claim 5 (depends on 1) The system of claim 1, wherein the viscosity of the second injectable composition is at least ten times greater than the viscosity of the first injectable composition. ### Claim 6 (depends on 1) The system of claim 1, wherein the second injectable composition comprises a hydrophilic polymer selected from the group consisting of acrylate-based polymers, polyurethane-based polymers, polynorbornene-based polymer and polylactide-based polymers. ### Claim 7 (depends on 1) The system of claim 1, wherein the second injectable composition comprises a polysaccharide. ### Claim 8 (depends on 7) The system of claim 7, wherein the polysaccharide is a xanthan gum. ### Claim 9 (depends on 1) The system of claim 1, wherein the delivery device includes a sharpened distal end. ### Claim 10 (depends on 1) A method for resecting tissue using the system of claim 1, comprising: extending the delivery device through the working channel of the endoscope such the distal end of the delivery device is positioned between the adjacent first and second tissue layers; delivering the first injectable composition through the lumen of the delivery device into a region between the adjacent first and second tissue layers such that at least a portion of the first and second tissue layers are separated; delivering the second injectable composition through the lumen of the delivery device into the separation between the first and second tissue layers; and resecting at least a portion of the first tissue layer. ### Claim 11 (depends on 10) The method of claim 10, wherein a viscosity of the first injectable composition is less than a viscosity of the second injectable composition. ### Claim 12 (depends on 10) The method of claim 10, wherein the second injectable composition elevates the first tissue layer above the second tissue layer. ### Claim 13 (depends on 10) The method of claim 10, wherein the first tissue layer includes a submucosal tissue layer. ### Claim 14 (depends on 10) The method of claim 10, wherein the second tissue layer includes a muscularis tissue layer. ### Claim 15 (depends on 13) The method of claim 13, wherein the submucosal tissue layer includes a lesion. ### Claim 16 A system, comprising: a delivery device comprising a proximal portion, distal portion, a lumen extending therebetween; a first injectable composition disposed within the distal portion of the delivery device; a second injectable composition disposed within the proximal portion of the delivery device; and an endoscope comprising a proximal end, a distal end and a working channel; wherein the delivery device is configured to extend through the working channel of the endoscope and to inject the first and second injectable compositions into tissue beyond the distal end of the endoscope; and wherein a viscosity of the first injectable composition is less than a viscosity of the second injectable composition; wherein the first and second injectable compositions are separated by a barrier member; and wherein the barrier member is formed from a destructible membrane configured to rupture after the first injectable composition has been discharged from the distal portion of the delivery device. ### Claim 17 (depends on 16) The system of claim 16, wherein the barrier member is configured to rupture above a threshold level of force. ### Claim 18 (depends on 16) The system of claim 16, wherein the barrier member includes a biocompatible or biodegradable material. ### Claim 19 (depends on 16) The system of claim 16, wherein the viscosity of the second injectable composition is at least ten times greater than the viscosity of the first injectable composition. ### Claim 20 (depends on 16) The system of claim 16, wherein the second injectable composition comprises a hydrophilic polymer selected from the group consisting of acrylate-based polymers, polyurethane-based polymers, polynorbornene-based polymer and polylactide-based polymers.