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WO2025212662A1 - Agrafeuse endoscopique flexible - Google Patents

Agrafeuse endoscopique flexible

Info

Publication number
WO2025212662A1
WO2025212662A1 PCT/US2025/022559 US2025022559W WO2025212662A1 WO 2025212662 A1 WO2025212662 A1 WO 2025212662A1 US 2025022559 W US2025022559 W US 2025022559W WO 2025212662 A1 WO2025212662 A1 WO 2025212662A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal end
elongated shaft
deployment unit
end effector
fastener deployment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/022559
Other languages
English (en)
Inventor
Mouen A. Khashab
Venkata S. AKSHINTALA
Joseph Aguila
Henry Holsten
Damian Tomlin
Scott Arp
Alex Espinosa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johns Hopkins University
TAG3 Engineering LLC
Original Assignee
Johns Hopkins University
TAG3 Engineering LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Johns Hopkins University, TAG3 Engineering LLC filed Critical Johns Hopkins University
Publication of WO2025212662A1 publication Critical patent/WO2025212662A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00087—Tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00066—Proximal part of endoscope body, e.g. handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/05—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0676—Endoscope light sources at distal tip of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00734—Aspects not otherwise provided for battery operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system

Definitions

  • ESG Endoscopic sleeve gastroplasty
  • one aspect is a device for endoscopic procedures that includes an elongated shaft having a proximal end and a distal end.
  • the elongated shaft defines a luminal structure throughout the elongated shaft.
  • the elongated shaft is configured to be flexible.
  • the device includes a distal end effector coupled to the distal end of the elongated shaft.
  • the device may also include one or more cameras and/or light sources for visualization, and in one embodiment a camera and/or a light source is coupled to the distal end effector.
  • the device includes a handle coupled to the proximal end of the elongated shaft. The handle is configured for control of the distal end effector through elongated shaft.
  • the size of the device is configured to allow for introduction to and passage through an upper esophageal sphincter, esophagus, lower esophageal sphincter, stomach and into the duodenum across the pyloric sphincter.
  • the size and length of the device are also configured to allow for introduction to and passage transanally into the rectum and more proximally into the colon.
  • FIG. IB illustrates a perspective view of a staple cartridge, according to an embodiment of the present invention.
  • FIG. 2 illustrates a sectional view of a proximal handle of the endoscopic stapler device, according to an embodiment of the present invention.
  • FIG. 3 illustrates a side view of a flexible shaft of an endoscopic stapler device according to an embodiment of the present invention.
  • FIGS. 4A-4C illustrates sectional and perspective views of internal structure of the attachment region of the flexible, elongated shaft of the endoscopic stapler device to the handle/ actuator, according to an embodiment of the present invention.
  • FIG. 6 illustrates a sectional view of the end effector highlighting a flexible pusher bar used to actuate or fire the staples, according to an embodiment of the present invention.
  • FIGS. 8B and 8C illustrate side and perspective views, respectively, of a handle of an endoscopic stapler device, according to an embodiment of the present invention.
  • FIGS. 9 A and 9B illustrate side and sectional views, respectively, of a handle of an endoscopic stapler device, according to an embodiment of the present invention.
  • FIGS. 9C and 9D illustrate side and perspective views, respectively, of an attachment region of an endoscopic stapler device, according to an embodiment of the present invention.
  • FIGS. 10D-10F illustrate various side views of an end effector/stapling unit of an endoscopic stapler device, according to an embodiment of the present invention.
  • FIG. 11 A illustrates a perspective view of a cartridge anvil assembly of an endoscopic stapler device with a detailed view of a camera lighting, according to an embodiment of the present invention.
  • FIGS. 1 IB and 11C illustrate side and sectional views, respectively, of an end effector/stapling unit of an endoscopic stapler device, according to an embodiment of the present invention.
  • FIG. 12 illustrates an exemplary system, according to an embodiment of the present invention.
  • Surgical staplers are essential tools in various surgical procedures that are used to simultaneously resect and staple tissue and perform surgical anastomoses.
  • the field of endoscopy has boomed in the last 10 years, mainly due to the maturation of the field of therapeutic endoscopy. This has been the direct result of investment in endoscopy and the development of dedicated instruments and accessories.
  • Therapeutic endoscopy often offers a minimally and less invasive alternative approach to counterpart surgical procedures. For example, peroral endoscopic myotomy has replaced Heller myotomy in the treatment of achalasia at most tertiary centers around the world. Despite the major advancements in the field, a flexible endoscopic stapler has yet to be introduced.
  • the present invention is engineered for use in the gastrointestinal tract, it aims to deliver the following benefits: (1) flexible compared to a traditional surgical stapler; (2) a long instrument (at least 135 cm) enabling the stapling to occur from a long distance as opposed to the short mechanism with today’s surgical staplers; (3) a “bending section” allowing the device end effector to reach to its target (often located at an angulation/comer/behind folds/or needing a retroflexed position); (4) small enough to insert through the upper esophageal sphincter (the size-limiting point in our field); and, (5) has additional channels to facilitate endoscopic procedures including: visualization, one or more accessory or instrument channels, one or more end effector actuation channels, suction port, and irrigation port.
  • the present invention will provide a technological adaptation of the LSG, able to reduce the stomach volume by about 50-70% by stapling the greater curvature of the stomach.
  • LSG demonstrates significantly superior long-term efficacy. This difference can be attributed to the distinct mechanisms of action employed by the two interventions.
  • LSG involves the irreversible removal of a part of the gastric wall, effectively reducing gastric volume permanently.
  • ESG does not involve removing any part of the gastric wall and carries the possibility of suture failure, especially when combined with inadequate eating behavior by the patient. This distinction in mechanisms can significantly impact the lasting effectiveness of these procedures in managing weight over time.
  • FIG. 1 illustrates a side view of an endoscopic stapler device, according to an embodiment of the present invention.
  • the device is a sterile, single-use, disposable, transoral, multilumen, with an integrated camera(s) and endoluminal stapler. Three elements of the device are described, the handle/actuator 10, a flexible shaft 20, and an end effector/ stapling unit 30 with a replaceable staple cartridge.
  • FIG. 2 illustrates a sectional view of the proximal handle/actuator of the endoscopic stapler device, according to an embodiment of the present invention.
  • the handle assembly is made of a polymer enclosure and is sterilizable, consisting of multiple components including a handle 40, a recharging element 50, the rotation element 60, electronic motor 70, a high/low travel limit switch 80, gearbox reduction 90, as well as a shaft 100.
  • the handle also includes access elements for instruments, potentially a chip camera and suction / irrigation 110.
  • the handle may be plugged in or coupled electronically 50, to charge a battery 130, which would be in the handle assembly.
  • a trigger mechanism 140 is also envisioned which couples to the motor allowing the shaft to move back and forward.
  • Limit switches 80 in the handle determine the amount of proper stroke forward and backward.
  • Alternative modes of drive may be a manual rack mechanism or a lead screw mechanism which could be in the handle instead of a motor. While limit switches are used as an example herein, other means known to or conceivable by one of skill in the art could also be used, such as an encoder or other means of quantifying stroke length.
  • the handle can include control for a number of additional functions of the endscopic stapler, including, but not limited to, suction and camera irrigation/cleaning.
  • FIG. 4 illustrates sectional and perspective views of internal structure of the attachment region of the elongated, flexible shaft of the endoscopic stapler device to the handle/ actuator, according to an embodiment of the present invention.
  • Internal to the flexible shaft would be a plurality of lumens, as illustrated in FIG. 4.
  • One or more of these lumens would be for the accelerator cable or drive mechanism 160, that would operate the distal end.
  • This is envisioned to be an accelerator cable or a flexible component which is resistant to torque and push-pull application.
  • Another lumen(s) 170 would be for suction / irrigation.
  • the lumens can have other cross-sectional shapes known in the art including D-shape (semi-circle cross-section), crescent shaped.
  • a lumen diameter will be of a single diameter along the shaft length.
  • the lumen diameter can be variable across the shaft length (e.g. taper down, taper up).
  • the luminal structure includes multiple lumens extending through the elongated shaft wherein the lumens are configured for various functionality during the procedure: one or more lumens can provide suction and irrigation, one or more lumens can provide for the insertion and use of instruments (e.g. graspers), one or more lumens containing a drive shaft, and one or more lumens for an endoscope (standard or neonatal/small caliber).
  • the drive shaft lumens can specifically include at least one lumen to actuate the opening and closing (e.g. clamping) of the distal end effector and at least one lumen to actuate or fire a staple cartridge contained within the end effector.
  • FIG. 5 illustrates a perspective view of the end effector and stapler of the endoscopic stapler device, according to an embodiment of the present invention.
  • the end effector comprised of the stapler, apposition device 200.
  • This device consists of an anvil 210, a channel 220 which would hold a staple cartridge 230, containing a sled and pusher for lifting mechanical fasten er/staples.
  • the stapler length is envisioned in the preferred embodiment to be between 30 to 40 millimeters in length. It is envisioned that the overall stapler length can be between 10 and 75 millimeters.
  • the staples are to be aligned in a pitch staggered pattern with the plurality of rows.
  • the cartridge anvil assembly 260 may be opened or closed to manipulate and/or grasp tissue.
  • the cartridge anvil assembly can be articulated or rotated through communication between the flexible shaft and the handle.
  • Graspers 270 may be extended at the proximal side of the cartridge assembly through the instrument channels and be in opposition and be spaced 180° apart from each other. These graspers would provide tissue traction and manipulation into the staple cartridge assembly. The articulation needed is along the horizontal plane defined by opening of the anvil/cartridge.
  • FIG. 6 illustrates a sectional view of a flexible pusher bar of the endoscopic stapler device, according to an embodiment of the present invention.
  • the flexible pusher bar 280 is capable of articulating. Coupled to the shaft this element provides horizontal motion to the sled to lift the staples during actuation or firing. It is envisioned that in some embodiments, this pusher bar 280 will also provide for cutting capabilities to transect tissue while staples are being formed and provide for tissue gap control.
  • a bar 240 is present to couple the shaft/ screw motion to the sled. An alternate embodiment would be a lead screw to drive the sled forward in rotational motion to advance this sled and push the staples up.
  • the anvil channel assembly is closed by the following means.
  • a hoop or bar slides over the top of the anvil, forcing it toward the cartridge channel assembly for initial jaw closure.
  • the knife/pusher bar 280 in an alternate embodiment is envisioned to have a secondary form to maintain distance between the anvil and channel to maintain optimal tissue gap-
  • FIG. 7 illustrates an end view of a distal end of the endoscopic stapler device, according to an embodiment of the present invention.
  • the device could contain a plurality of cameras.
  • the device includes, three cameras.
  • a camera could be on the extreme distal end, to visualize insertion into the endoluminal opening through the esophagus into the stomach.
  • FIGS. 8-11 illustrate additional views of the device, according to an embodiment of the invention.
  • FIG. 8 illustrates multiple perspective views of the handle and an exemplary view of a luminal structure of the device shaft.
  • lumens (1) are for suction/irrigation
  • lumens (2) are for instruments/ graspers
  • lumen (3) is for a clamping drive shaft to actuate the jaws of a stapler assembly
  • lumen (4) is for a staple firing drive shaft
  • lumens (5) are for a camera cable lumen.
  • FIG. 9 illustrates perspective and sectional views of the handle and attachment region of the elongated, flexible shaft of the endoscopic stapler device to the handle/ actuator.
  • FIG. 10 illustrates perspective views of an end effector configured for stapling.
  • FIG. 11 illustrates perspective and sectional views of the end effector and camera placement, according to an embodiment of the present invention.
  • the present invention is designed to ensure a balance between flexibility, strength of stapling, and length of the shaft. Additionally, the device is designed to address size limitations to pass through the upper esophageal sphincter, the positioning of one or more camera(s), and accessory channels to advance instruments including grasping devices for tissue approximation under direct visualization, and maintaining cost-effectiveness in manufacturing are other potential problems.
  • the size of the device is configured to allow for introduction to and passage through an upper esophageal sphincter, esophagus, lower esophageal sphincter, stomach and into the duodenum across the pyloric sphincter.
  • the size and length of the device are also configured to allow for introduction to and passage transanally into the rectum and more proximally into the colon.
  • the design of the present invention includes cameras to allow for navigation of small insertion paths and minimizing the device size to facilitate insertion. Moreover, to resolve the rotational dynamics of the End Effector (rotating to 90° clockwise and counterclockwise), a specialized bending section is integrated. Additionally, the incorporation of one or more camera(s) and their positioning for direct visualization during staple deployment is critical.
  • One exemplary use of a device of the present invention is for gastric reduction particularly in the stomach through the means of tissue apposition.
  • Other uses include closure of gastrointestinal defects (e.g. leaks, perforation and fistulas), stoma reduction, remnant stomach reduction, and closure of post resection defects including full thickness defects in the gastrointestinal tract.
  • Future uses may also include simultaneous resection and closure in addition to endoscopic gastroenteric or entero-enteric anastomoses.
  • the device can take the form of a stand-alone device, i.e. one device with features of both an endoscope and a stapler.
  • Another iteration is a flexible stapler that goes over an endoscope (standard or slim endoscope).
  • the stapler will be guided by the endoscope camera.
  • the suction and irrigation and traction are all provided by the endoscope.
  • the stapler will have a sleeve where the endoscope will be placed.
  • the endoscope will act as a monorail along which the stapler is advanced.
  • the present disclosure also provides various systems and computer program products or machine-readable media, as described further herein, that are useful in performing the methods disclosed herein.
  • the methods described herein are optionally performed or facilitated at least in part using systems, distributed computing hardware and applications (e.g., cloud computing services), electronic communication networks, communication interfaces, computer program products, machine readable media, electronic storage media, software (e.g., machine-executable code or logic instructions) and/or the like.
  • FIG. 12 provides a schematic diagram of an exemplary system suitable for use with implementing at least aspects of the methods disclosed in this application.
  • system 1200 includes at least one controller or computer, e.g., server 1202 (e.g., a search engine server), which includes processor 1204 and memory, storage device, or memory component 1206, and one or more other communication devices 1214, 1216, (e.g., client-side computer terminals, telephones, tablets, laptops, other mobile devices, etc. (e.g., for receiving data for further analysis, etc.)) positioned remote from endoscopic stapler device 1218, and in communication with the remote server 1202, through electronic communication network 1212, such as the Internet or other internetwork.
  • server 1202 e.g., a search engine server
  • server 1202 e.g., a search engine server
  • processor 1204 e.g., memory, storage device, or memory component 1206, and one or more other communication devices 1214, 1216, (e.g., client-side computer terminals, telephones, tablets, laptops, other mobile devices, etc. (e.g., for receiving data for further analysis, etc.)) positioned
  • Communication devices 1214, 1216 typically include an electronic display (e.g., an internet enabled computer or the like) in communication with, e.g., server 1202 computer over network 1212 in which the electronic display comprises a user interface (e.g., a graphical user interface (GUI), a web-based user interface, and/or the like) for displaying results upon implementing the methods described herein.
  • a user interface e.g., a graphical user interface (GUI), a web-based user interface, and/or the like
  • communication networks also encompass the physical transfer of data from one location to another, for example, using a hard drive, thumb drive, or other data storage mechanism.
  • System 1200 also includes program product 1208 stored on a computer or machine readable medium, such as, for example, one or more of various types of memory, such as memory 1206 of server 1202, that is readable by the server 1202, to facilitate, for example, a guided search application or other executable by one or more other communication devices, such as 1214 (schematically shown as a desktop or personal computer).
  • system 1200 optionally also includes at least one database server, such as, for example, server 1210 associated with an online website having data stored thereon searchable either directly or through search engine server 1202.
  • System 1200 optionally also includes one or more other servers positioned remotely from server 1202, each of which are optionally associated with one or more database servers 1210 located remotely or located local to each of the other servers.
  • the other servers can beneficially provide service to geographically remote users and enhance geographically distributed operations
  • Control of the device of the present invention or display of visual images or data related to the device, camera feed, and procedure of the present invention can be carried out using a computer, non-transitory computer readable medium, or alternately a computing device or non-transitory computer readable medium incorporated into the robotic device or the imaging device.
  • Visual displays may include images from associated endoscopic cameras used in conjunction with the device or image guidance of the device within the surgical field.
  • a non-transitory computer readable medium is understood to mean any article of manufacture that can be read by a computer.
  • Such non-transitory computer readable media includes, but is not limited to, magnetic media, such as a floppy disk, flexible disk, hard disk, reel-to-reel tape, cartridge tape, cassette tape or cards, optical media such as CD-ROM, writable compact disc, magneto-optical media in disc, tape or card form, and paper media, such as punched cards and paper tape.
  • the computing device can be a special computer designed specifically for this purpose.
  • the computing device can be unique to the present invention and designed specifically to carry out control or displays associated with a device of the present invention.
  • the computing device can also take the form of an operating console computer.
  • the operating console is a non-generic computer specifically designed by the manufacturer. It is not a standard business or personal computer that can be purchased at a local store. Additionally, the console computer can carry out communications with any associated imaging modality through the execution of proprietary custom built software that is designed and written by the manufacturer for the computer hardware to specifically operate the hardware.
  • a device for endoscopic surgery comprising: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible; a distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; and a handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector.
  • Clause 2 The device of Clause 1 wherein the fastener deployment unit deploys one or more staples.
  • Clause 3 The device of Clause 1 or Clause 2 wherein the fastener deployment unit comprises a removable staple cartridge.
  • Clause 4 The device of any one of Clauses 1-3 further comprising a camera and/or a light source for visualization coupled to the distal end effector.
  • Clause 5 The device of any one of Clauses 1-4 wherein the handle comprises one or more of a recharging element, a rotation element, a motor, a high/low travel limit switch, a gearbox reduction, and a shaft.
  • Clause 6 The device of any one of Clauses 1-5 wherein the distal end effector comprises a section configured for bending and rotation.
  • Clause 7 The device of any one of Clauses 1-6 wherein the luminal structure includes at least five lumens and up to twelve lumens extending through the elongated shaft, wherein the lumens are configured for various functionality including: one or more lumens for applying suction and irrigation, one or more lumens for insertion of instruments, one or more lumens containing a drive shaft for the distal effector, and one or more lumens for a camera and/or a light source cable.
  • Clause 8 The device of any one of Clauses 1-7 wherein the instruments comprise one or more graspers.
  • Clause 9 The device of any one of Clauses 1-8 comprising two graspers that can be extended in opposition to each other at a proximal side of the fastener deployment unit.
  • Clause 10 The device of any one of Clauses 1-9 wherein two of the lumens are dedicated as drive shaft lumens, one to actuate the opening and closing of the distal end effector and a second to actuate or fire a staple cartridge contained within the distal end effector.
  • Clause 11 The device of any one of Clauses 1-10 wherein a size of the device is configured to allow for passage through an upper esophageal sphincter.
  • Clause 12 The device of any one of Clauses 1-11 wherein the fastener deployment unit comprises a pusher bar that provides cutting capabilities to transect tissue while fasteners are being formed and to provide for tissue gap control.
  • Clause 13 The device of any one of Clauses 1-12 wherein the fastener deployment unit comprises a cartridge anvil assembly that comprises an anvil and a channel configured to hold a staple cartridge.
  • Clause 14 The device of any one of Clauses 1-13 wherein the cartridge anvil assembly can be opened and closed to manipulate and/or grasp tissue.
  • Clause 16 The device of any one of Clauses 1-15 wherein the fastener deployment unit forms fasteners having a length of approximately 2.0 mm.
  • Clause 18 The kit of Clause 17 wherein the kit further comprises one or more fasteners, one or more grasper instruments, one or more light sources, and/or one or more cameras.
  • Clause 19 The kit of Clause 17 or Clause 18 wherein the fasteners comprise one or more staples.
  • Clause 20 A system comprising the device of any one of Clauses 1-16.
  • Clause 23 The system of Clause 21 or Clause 22 wherein the fastener deployment unit deploys one or more staples.
  • Clause 24 The system of any one of Clauses 21-23 wherein the fastener deployment unit comprises a removable staple cartridge.
  • Clause 25 The system of any one of Clauses 21-24 wherein the handle comprises one or more of a recharging element, a rotation element, a high/low travel limit switch, a gearbox reduction, and a shaft.
  • Clause 26 The system of any one of Clauses 21-25 wherein the luminal structure includes at least five lumens and up to twelve lumens extending through the elongated shaft, wherein the lumens are configured for various functionality including: one or more lumens for applying suction and irrigation, one or more lumens for insertion of instruments, one or more lumens containing a drive shaft for the distal effector, and one or more lumens for a camera and/or a light source cable.
  • Clause 29 The system of any one of Clauses 21-28 wherein two of the lumens are dedicated as drive shaft lumens, one to actuate the opening and closing of the distal end effector and a second to actuate or fire a staple cartridge contained within the distal end effector.
  • Clause 30 The system of any one of Clauses 21-29 wherein a size of the device is configured to allow for passage through an upper esophageal sphincter.
  • Clause 31 The system of any one of Clauses 21-30 wherein the fastener deployment unit comprises a pusher bar that provides cutting capabilities to transect tissue while fasteners are being formed and to provide for tissue gap control.
  • Clause 32 The system of any one of Clauses 21-31 wherein the fastener deployment unit comprises a cartridge anvil assembly that comprises an anvil and a channel configured to hold a staple cartridge.
  • Clause 33 The system of any one of Clauses 21-32 wherein the cartridge anvil assembly can be opened and closed to manipulate and/or grasp tissue.
  • Clause 34 The system of any one of Clauses 21-33 wherein the fastener deployment unit is between 10 and 75 millimeters in length or between 30 and 40 millimeters in length.
  • Clause 35 The system of any one of Clauses 21-34 wherein the fastener deployment unit forms fasteners having a length of approximately 2.0 mm.
  • a method of approximating tissue in a patient comprising: positioning a distal end effector of a device at least proximal to the tissue in the patient, wherein the device comprises: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible; the distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; and a handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector; and, fastening the tissue using the fastener deployment unit, thereby approximating the tissue in the patient.
  • Clause 37 The method of Clause 36 wherein the fastener deployment unit deploys one or more staples and wherein the fastening step comprising stapling the tissue using the fastener deployment unit.
  • Clause 40 The method of Clause 39 wherein the fastener deployment unit deploys one or more staples.
  • Clause 41 The method of Clause 39 or Clause 40 wherein the fastener deployment unit comprises a removable staple cartridge.
  • a method of manufacturing a device comprising forming a device comprising: an elongated shaft having a proximal end and a distal end, wherein the elongated shaft defines a luminal structure throughout the elongated shaft, and wherein the elongated shaft is configured to be flexible; a distal end effector coupled to a distal end of the elongated shaft, wherein the distal end effector includes a fastener deployment unit; and a handle coupled to the proximal end of the elongated shaft, wherein the handle is configured for control of the elongated shaft and the distal end effector, thereby manufacturing the device.
  • Clause 43 The method of Clause 42 wherein the fastener deployment unit deploys one or more staples.
  • Clause 44 The method of Clause 42 or Clause 43 wherein the fastener deployment unit comprises a removable staple cartridge.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Ophthalmology & Optometry (AREA)
  • Endoscopes (AREA)

Abstract

Une agrafeuse endoscopique de la présente invention permet un rapprochement tissulaire endoscopique par agrafage, en évitant des interventions chirurgicales invasives. L'agrafeuse endoscopique permet d'obtenir (1) une flexibilité par rapport à une agrafeuse chirurgicale classique; (2) un instrument long (au moins 135 cm) permettant à l'agrafage de se produire depuis une longue distance par opposition au mécanisme court à l'aide des agrafeuses chirurgicales actuelles; (3) une "section de courbure" permettant au dispositif d'atteindre sa cible (souvent située à un angle/un coin/derrière des plis/ou nécessitant une position rétrofléchie); (4) une petite taille pour permettre l'insertion à travers le sphincter œsophagien supérieur (le point de limitation de taille dans notre domaine); et, (5) des canaux supplémentaires pour faciliter des procédures endoscopiques comprenant : une ou plusieurs caméras, un ou plusieurs canaux accessoires, un orifice d'aspiration et un orifice d'irrigation. Ces fonctionnalités permettent un rapprochement tissulaire plus facile et plus rapide, améliorent l'efficacité des procédures d'endoscopie bariatrique, augmentent la durabilité du rapprochement tissulaire, et réduisent les coûts d'une intervention efficace de perte de poids.
PCT/US2025/022559 2024-04-02 2025-04-01 Agrafeuse endoscopique flexible Pending WO2025212662A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463573237P 2024-04-02 2024-04-02
US63/573,237 2024-04-02

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WO2025212662A1 true WO2025212662A1 (fr) 2025-10-09

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080255424A1 (en) * 2007-04-10 2008-10-16 Boston Scientific Scimed, Inc. Endoscopes including distal chamber and related methods of use
US20090138093A1 (en) * 2007-11-27 2009-05-28 Minos Medical System and method for esophageal sphincter repair
US20100191282A1 (en) * 2009-01-26 2010-07-29 Harris Jason L Surgical Stapler For Applying A Large Staple Through A Small Delivery Port And A Method of Using The Stapler To Secure A Tissue Fold
US20130098969A1 (en) * 2011-10-25 2013-04-25 Tyco Healthcare Group Lp Surgical Apparatus and Method for Endoscopic Surgery
US20130253271A1 (en) * 2010-11-24 2013-09-26 Samsung Electronics Co., Ltd. Endoscope
US20140277108A1 (en) * 2013-03-12 2014-09-18 The Ohio State University Surgical instrument for grasping multiple locations and methods of use
US20150223809A1 (en) * 2014-02-12 2015-08-13 Ethicon Endo-Surgery, Inc. Deliverable surgical instrument

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080255424A1 (en) * 2007-04-10 2008-10-16 Boston Scientific Scimed, Inc. Endoscopes including distal chamber and related methods of use
US20090138093A1 (en) * 2007-11-27 2009-05-28 Minos Medical System and method for esophageal sphincter repair
US20100191282A1 (en) * 2009-01-26 2010-07-29 Harris Jason L Surgical Stapler For Applying A Large Staple Through A Small Delivery Port And A Method of Using The Stapler To Secure A Tissue Fold
US20130253271A1 (en) * 2010-11-24 2013-09-26 Samsung Electronics Co., Ltd. Endoscope
US20130098969A1 (en) * 2011-10-25 2013-04-25 Tyco Healthcare Group Lp Surgical Apparatus and Method for Endoscopic Surgery
US20140277108A1 (en) * 2013-03-12 2014-09-18 The Ohio State University Surgical instrument for grasping multiple locations and methods of use
US20150223809A1 (en) * 2014-02-12 2015-08-13 Ethicon Endo-Surgery, Inc. Deliverable surgical instrument

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