# US 10,765,474 B2 · Injectate delivery devices, systems and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,474 B2 - Document ID: US10765474B2 - Status: Granted - Kind: B2 - Application number: 15/274,948 - Filed: 2016-09-23 - Published: 2017-01-12 - Granted: 2020-09-08 - Earliest claimed: 2014-03-24 - Assignees: Fractyl Laboratories, Inc. - Applicants: Fractyl Laboratories, Inc. - Inventors: Christopher J. Kadamus; Mark A. Manasas; Andrew Coats; Jay Caplan; Harith Rajagopalan; R. Maxwell Flaherty; J. Christopher Flaherty - Web page: https://patentgrep.com/patent/US10765474B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00}) - A61B 5/00: Measuring for diagnostic purposes (radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00); Identification of persons - A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating} - A61B 5/6847: {mounted on an invasive device} - A61B 17/12186: {liquid materials adapted to be injected} - A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable} - A61M 25/0084: {being one or more injection needles} - A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)} - A61M 29/00: Dilators with or without means for introducing media, e.g. remedies - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61B 18/1477: {Needle-like probes} - A61B 2018/1472: {for use with liquid electrolyte, e.g. virtual electrodes} - A61M 2025/0087: {Multiple injection needles protruding laterally from the distal tip} - A61M 2025/0089: {Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip} - A61M 2025/009: {the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter} - A61M 2025/0092: {Single injection needle protruding laterally from the distal tip} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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)} ## Abstract An injectate delivery device for expanding tissue is provided. The injectate delivery device comprises: at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween; at least one fluid delivery element in fluid communication with the at least one fluid delivery tube lumen; a radially expanding element comprising the at least one fluid delivery element; a supply of vacuum constructed and arranged to cause tissue to tend toward the at least one fluid delivery element; and at least one control constructed and arranged to perform a function. The at least one control can be constructed and arranged to expand the radially expandable element and activate the supply of vacuum. Systems and method of injectate delivery are also provided. ## Claims ### Claim 1 An injectate delivery device for expanding tissue comprising: at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween; at least one fluid delivery element in fluid communication with the at least one fluid delivery tube lumen; a radially expanding element comprising the at least one fluid delivery element; a supply of vacuum constructed and arranged to cause tissue to tend toward the at least one fluid delivery element; and at least one operator activated control constructed and arranged to: expand the radially expandable element; and activate the supply of vacuum; advance the at least one fluid delivery element; and a force limiting assembly constructed and arranged to limit the force applied to the at least one fluid delivery element during the advancement by the at least one operator activated control, wherein the at least one operator activated control is attached to the at least one fluid delivery tube by the force limiting assembly, and wherein the force limiting assembly comprises at least one spring; wherein the device is constructed and arranged to deliver an injectate to target tissue through the at least one fluid delivery element. ### Claim 2 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control is further constructed and arranged to advance the at least one fluid delivery element. ### Claim 3 (depends on 2) The injectate delivery device according to claim 2, wherein the at least one control is constructed and arranged to advance the at least one fluid delivery element while limiting force applied to the at least one fluid delivery element. ### Claim 4 (depends on 2) The injectate delivery device according to claim 2, further comprising a compression element operably connecting the at least one control to the at least one fluid delivery tube. ### Claim 5 (depends on 2) The injectate delivery device according to claim 2, wherein the at least one fluid delivery tube comprises multiple fluid delivery tubes and the at least one fluid delivery element comprises multiple fluid delivery elements each attached to a fluid delivery tube, and wherein the at least one control is constructed and arranged to advance the multiple fluid delivery tubes. ### Claim 6 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control is further constructed and arranged to manipulate tissue toward the fluid delivery element such that the at least one fluid delivery element penetrates the tissue. ### Claim 7 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control is further constructed and arranged to initiate the flow of injectate through the at least one fluid delivery element and into tissue. ### Claim 8 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control is further constructed and arranged to modify the flow of injectate into tissue. ### Claim 9 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control is further constructed and arranged to compact the radially expandable element. ### Claim 10 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control is further constructed and arranged to control a separate device. ### Claim 11 (depends on 1) The injectate delivery device according to claim 1, further comprising at least one vacuum lumen fluidly attached to the supply of vacuum, wherein the at least one control is further constructed and arranged to apply a positive pressure to the at least one vacuum lumen. ### Claim 12 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control comprises multiple controls. ### Claim 13 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control comprises one or more controls selected from the group consisting of: electrical control; mechanical control; button; knob; switch; lever; touchscreen; and combinations thereof. ### Claim 14 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one control comprises a control biased in an off state. ### Claim 15 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one fluid delivery element comprises one or more elements selected from the group consisting of: needle; fluid jet; iontophoretic element; a porous element; and combinations thereof. ### Claim 16 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one fluid delivery element comprises one or more needles. ### Claim 17 (depends on 16) The injectate delivery device according to claim 16, wherein at least one fluid delivery element comprises a needle with a diameter greater than 30 ga. ### Claim 18 (depends on 17) The injectate delivery device according to claim 17, wherein at least one fluid delivery element comprises a needle with a diameter greater than 27 ga. ### Claim 19 (depends on 16) The injectate delivery device according to claim 16, wherein the at least one fluid delivery element comprises a curved needle. ### Claim 20 (depends on 1) The injectate delivery device according to claim 1, wherein the at least one fluid delivery element comprises multiple fluid delivery elements. ### Claim 21 (depends on 20) The injectate delivery device according to claim 20, wherein the multiple fluid delivery elements comprise at least three fluid delivery elements disposed in a circumferential array. ### Claim 22 (depends on 1) The injectate delivery device according to claim 1, wherein the radially expandable element is constructed and arranged to apply a force to luminal tissue at a pressure of no more than 2.0 psi. ### Claim 23 (depends on 1) The injectate delivery device according to claim 1, wherein the radially expandable element is constructed and arranged to contact luminal tissue at a pressure of at least 0.6 psi as the injectate is delivered to the target tissue. ### Claim 24 (depends on 1) The injectate delivery device according to claim 1, wherein the radially expandable element is constructed and arranged to expand to a target diameter in less than 60 seconds. ### Claim 25 (depends on 1) The injectate delivery device according to claim 1, wherein the radially expandable element comprises a proximal portion attached to multiple fluid delivery tubes, wherein the multiple fluid delivery tubes define an opening positioned proximate the radially expandable element proximal portion and sized to receive the distal end of an elongate device positioned within 9 cm of the radially expandable element proximal portion. ### Claim 26 (depends on 1) The injectate delivery device according to claim 1, further comprising a handle, wherein the handle comprises the at least one control. ### Claim 27 (depends on 1) The injectate delivery device according to claim 1, further comprising a handle including a user interface, wherein the user interface comprises the at least one control. ### Claim 28 (depends on 27) The injectate delivery device according to claim 27, wherein the handle user interface is constructed and arranged to display information selected from the group consisting of: fluid delivery element position; vacuum status; occlusion status; expandable element status; volume of injection from the at least one fluid delivery element; total injected volume of injectate; pressure of injection; catheter position relative to the papilla; number of completed injections; and combinations thereof. ### Claim 29 (depends on 1) The injectate delivery device according to claim 1, further comprising a handle with a first portion constructed and arranged for use in a plurality of medical procedures, and a second portion constructed and arranged for fewer uses than the first. ### Claim 30 (depends on 1) The injectate delivery device according to claim 1, further comprising a handle comprising an attachment element constructed and arranged to removably attach to an endoscope. ### Claim 31 (depends on 1) The injectate delivery device according to claim 1, further comprising a fluid delivery assembly, wherein the at least one control is configured to control a fluid delivery assembly parameter. ### Claim 32 (depends on 31) The injectate delivery device according to claim 31, wherein the fluid delivery assembly comprises the at least one control. ### Claim 33 (depends on 1) The injectate delivery device according to claim 1, further comprising a second device, wherein the at least one control controls the second device. ### Claim 34 (depends on 33) The injectate delivery device according to claim 33, wherein the second device comprises a device selected from the group consisting of: an endoscope; an energy delivery device; a fluid delivery assembly; and combinations thereof. ### Claim 35 (depends on 1) The injectate delivery device according to claim 1, further comprising a tissue capture port surrounding the at least one fluid delivery element. ### Claim 36 (depends on 35) The injectate delivery device according to claim 35, wherein the tissue capture port comprises an opening, and wherein the opening comprises a dimension selected from the group consisting of: length of at least 0.1″; length of between 0.14″ and 0.20″; length of approximately 0.16″; width of at least 0.4″; width of between 0.05″ and 0.08″; width of approximately 0.06″. ### Claim 37 (depends on 35) The injectate delivery device according to claim 35, wherein the at least one fluid delivery element is constructed and arranged to travel from a retracted position to an advanced position and remain within the tissue capture port for the length of travel. ### Claim 38 (depends on 1) The injectate delivery device according to claim 1, further comprising the injectate delivered by the at least one fluid delivery element to the target tissue. ### Claim 39 (depends on 38) The injectate delivery device according to claim 38, wherein the injectate comprises a material selected from the group consisting of: water; saline; dye; visible dye; indigo carmine; methylene blue; India ink; a gel; a hydrogel; a protein hydrogel; a visualizable media; an x-ray visualizable media; an ultrasonically visualizable media; an MRI visualizable media; and combinations thereof. ### Claim 40 (depends on 38) The injectate delivery device according to claim 38, wherein the injectate comprises a material selected from the group consisting of: a biopolymer; ethylene vinyl alcohol; an adhesive; cyanoacrylate; and combinations thereof. ### Claim 41 (depends on 1) The injectate delivery device according to claim 1, further comprising a mechanical stop constructed and arranged to limit the advancement of the at least one fluid delivery element. ### Claim 42 (depends on 1) The injectate delivery device according to claim 1, wherein the injectate delivery device comprises a distal end and a bulbous tip positioned on the distal end, wherein the bulbous tip comprises a diameter of at least 2 mm. ### Claim 43 (depends on 1) The injectate delivery device according to claim 1, further comprising an elongate shaft with a proximal end and a distal portion. ### Claim 44 (depends on 43) The injectate delivery device according to claim 43, wherein the elongate shaft comprises multiple shafts. ### Claim 45 (depends on 44) The injectate delivery device according to claim 44, wherein the multiple shafts comprise a helical arrangement along at least a portion of the elongate shaft. ### Claim 46 (depends on 43) The injectate delivery device according to claim 43, further comprising a steering mechanism positioned within the shaft. ### Claim 47 (depends on 1) The injectate delivery device according to claim 1, further comprising an elongate shaft and a camera positioned within the elongate shaft. ### Claim 48 (depends on 1) The injectate delivery device according to claim 1, wherein the injectate delivery device is constructed and arranged to deliver insufflation fluid. ### Claim 49 (depends on 1) The injectate delivery device according to claim 1, wherein the expanded tissue comprises a tissue layer of the gastrointestinal tract. ### Claim 50 (depends on 49) The injectate delivery device according to claim 49, wherein the expanded tissue layer comprises one or more layers of submucosal tissue. ### Claim 51 (depends on 50) The injectate delivery device according to claim 50, wherein the expanded tissue layer comprises one or more layers of duodenal submucosal tissue. ### Claim 52 (depends on 1) The injectate delivery device according to claim 1, wherein the injectate delivery device is constructed and arranged to perform an approximately full circumferential expansion of luminal wall tissue. ### Claim 53 (depends on 1) The injectate delivery device according to claim 1, wherein the injectate delivery device is constructed and arranged to create a therapeutic restriction in the gastrointestinal tract. ### Claim 54 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53) A system comprising the injectate delivery device according to any of claims 1 through 53, further comprising a component selected from the group consisting of: an endoscope; injectate for delivery through the at least one fluid delivery element; an ablation catheter comprising a treatment element for treating target tissue proximate the expanded tissue layer; a sizing device constructed and arranged to provide lumen diameter information; a guidewire; and combinations thereof. ### Claim 55 (depends on 54) The system of according to claim 54, wherein the system is constructed and arranged to treat a disease or disorder selected from the group consisting of: diabetes; obesity or otherwise being overweight; hypercholesterolemia; exercise intolerance; psoriasis; hypertension; metabolic syndrome; and combinations thereof.