# US 11,298,505 B2 · Deployable bellows for delivery of a flexible, elongate device and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,505 B2 - Document ID: US11298505B2 - Status: Granted - Kind: B2 - Application number: 16/291,398 - Filed: 2019-03-04 - Published: 2019-09-05 - Granted: 2022-04-12 - Earliest claimed: 2018-03-05 - Assignees: Intuitive Surgical Operations, Inc. - Applicants: Intuitive Surgical Operations, Inc. - Inventors: David W. Bailey; Jared J. Butler; Larry L. Howell; Brian D. Jensen; Spencer P. Magleby; Brandon Scott Sargent; Kendall Hal Seymour - Web page: https://patentgrep.com/patent/US11298505B2 ## CPC - A61B 1/009: {with bending or curvature detection of the insertion part} - A61M 25/0054: {with regions for increasing flexibility} - A61B 1/00133: {Drive units for endoscopic tools inserted through or with the endoscope} - A61B 1/00135: {Oversleeves mounted on the endoscope prior to insertion} - A61B 1/0016: {using motor drive units} - A61B 1/0055: {Constructional details of insertion parts, e.g. vertebral elements} - A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)} - A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis - A61B 34/30: Surgical robots - A61B 34/37: Leader-follower robots (A61B34/35 takes precedence) - A61B 34/74: {Manipulators with manual electric input means} - A61M 25/0029: {characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports (catheter shaft surface irregularities A61M2025/006)} - A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid} - A61B 90/37: {Surgical systems with images on a monitor during operation} - A61B 2017/003: {Steerable} - A61B 2017/00305: {Constructional details of the flexible means} - A61B 2034/2051: {Electromagnetic tracking systems} - A61B 2034/2055: {Optical tracking systems} - A61B 2034/2059: {Mechanical position encoders} - A61B 2034/2061: {using shape-sensors, e.g. fiber shape sensors with Bragg gratings} - A61B 2034/2065: {Tracking using image or pattern recognition} - A61B 2034/301: {for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes} - A61B 2034/741: {Glove like input devices, e.g. "data gloves"} - A61B 2034/742: {Joysticks} - A61B 2090/3614: {using optical fibre} - A61B 2090/371: {with simultaneous use of two cameras} - A61M 2025/0059: {having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking} - 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 origami bellows includes a plurality of layers including a support layer having a diameter that remains fixed irrespective of axial expansion or compression of the origami bellows. The origami bellows may be used as an anti-buckling device providing lateral support to a catheter or other elongated medical instrument. ## Claims ### Claim 1 An apparatus for laterally supporting a flexible elongate device introducible using a manipulator assembly, the apparatus comprising: an origami bellows having a distal end, a proximal end, and a lumen extending from the distal end to the proximal end, the origami bellows having a fixed diameter portion configured to support the flexible elongate device and having a non-fixed diameter portion that changes when the origami bellows is axially compressed from an expanded condition to a compressed condition; a first connector disposed at and coupled to the distal end, the first connector being configured to connect the distal end to the manipulator assembly; and a second connector disposed at and coupled to the proximal end, the second connector being configured to connect the proximal end to the manipulator assembly. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the lumen is sized to provide lateral support to the flexible elongate device when, during compression and expansion of the origami bellows, the flexible elongate device extends therethrough. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the first connector or the second connector comprises a passage formed therein aligned with a longitudinal axis of the lumen of the origami bellows, the passage being sized to permit passage of the flexible elongate device into the lumen of the origami bellows. ### Claim 4 (depends on 1) The apparatus of claim 1, wherein the origami bellows comprises a plurality of mirrored pairs of layers formed by folds, the pairs of layers having offsetting rotational directions to prevent rotation of the distal end and the proximal end. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the origami bellows has an inner diameter in a range of 3 mm to 7 mm to accommodate the flexible elongate device when the origami bellows is in the compressed condition. ### Claim 6 (depends on 1) The apparatus of claim 1, wherein the origami bellows and the first and the second connectors are single use materials. ### Claim 7 (depends on 1) The apparatus of claim 1, wherein the origami bellows and the first connector and the second connector are sterilizable. ### Claim 8 (depends on 1) The apparatus of claim 1, wherein the origami bellows is formed from a single, monolithic sheet of material. ### Claim 9 A method comprising: introducing a flexible elongated instrument into a lumen of an origami bellows, the lumen having walls forming an inner diameter configured to support the flexible elongate device and having walls forming an inner diameter that changes when the origami bellows is axially actuated; and advancing the flexible elongated instrument while simultaneously compressing the origami bellows so that walls of the lumen laterally support the flexible elongated instrument and reduce a likelihood of buckling of the flexible elongated instrument. ### Claim 10 (depends on 9) The method of claim 9, wherein the inner diameter of the lumen maintains a substantially constant size during compression of the origami bellows. ### Claim 11 (depends on 9) The method of claim 9, further comprising introducing the flexible elongated instrument into a passage of a first connector aligned with the lumen of the origami bellows so that the flexible elongated instrument extends through the passage and into the lumen. ### Claim 12 (depends on 9) The method of claim 9, further comprising introducing the flexible elongated instrument into a first passage of a first connector supporting a distal end of the origami bellows and into a second passage of a second connector supporting a proximal end of the origami bellows. ### Claim 13 (depends on 9) The method of claim 9, wherein the origami bellows comprises a plurality of mirrored pairs of layers formed by folds, and wherein the mirrored pairs offsetting rotation of the origami bellows when compressing the origami bellows. ### Claim 14 (depends on 9) The method of claim 9, wherein the origami bellows is formed from a single, monolithic sheet of material. ### Claim 15 A deployable origami bellows apparatus configured to laterally support a flexible elongate device for patient treatment, comprising: a distal end; a proximal end; a lumen extending from the distal end to the proximal end, the origami bellows being configured to axially actuate between an expanded condition to a compressed condition; and a plurality of layers including: at least one monostable layer, the monostable layer being stable in one of a compressed or extended condition, and at least one bistable layer adjacent the monostable layer, the bistable layer being stable in the compressed condition and in the expanded condition. ### Claim 16 (depends on 15) The apparatus of claim 15, wherein the at least one bistable layer comprises a substantially constant inner diameter in the compressed condition and in the expanded condition. ### Claim 17 (depends on 15) The apparatus of claim 15, comprising apertures formed at locations of fold vertices in the at least one monostable layer or the at least one bistable layer. ### Claim 18 (depends on 15) The apparatus of claim 15, comprising at least two monostable layers and at least two bistable layers, the monostable layers being combined with the bistable layers in alternating order, and wherein the at least one monostable layer is stable in the expanded condition. ### Claim 19 (depends on 15) The apparatus of claim 15, comprising one of: an even number of mono stable layers to inhibit rotation of the origami bellows; or an even number of bistable layers that inhibits rotation. ### Claim 20 (depends on 15) The apparatus of claim 15, comprising axially extending connection tabs extending from the distal end or the proximal end of the origami bellows.