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WO2018170143A1 - Systèmes et procédés destinés à une rétraction de tissu escamotable - Google Patents

Systèmes et procédés destinés à une rétraction de tissu escamotable Download PDF

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Publication number
WO2018170143A1
WO2018170143A1 PCT/US2018/022460 US2018022460W WO2018170143A1 WO 2018170143 A1 WO2018170143 A1 WO 2018170143A1 US 2018022460 W US2018022460 W US 2018022460W WO 2018170143 A1 WO2018170143 A1 WO 2018170143A1
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WIPO (PCT)
Prior art keywords
tissue
actuator
tissue retraction
retraction
retraction mechanism
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Application number
PCT/US2018/022460
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English (en)
Inventor
Samuel BECKER
Tommaso RANZANI
Sheila RUSSO
Robert J. Wood
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President And Fellows Of Harvard College
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Publication of WO2018170143A1 publication Critical patent/WO2018170143A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
    • A61B17/0218—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors for minimally invasive surgery
    • 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
    • A61B1/018—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
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00269—Type of minimally invasive operation endoscopic mucosal resection EMR
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00296—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/30—Surgical pincettes, i.e. surgical tweezers without pivotal connections
    • A61B2017/306—Surgical pincettes, i.e. surgical tweezers without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482—Digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes

Definitions

  • the present disclosure relates to systems and methods for retracting tissue during medical procedures, including endoscopic procedures.
  • EMD endoscopic submucosal dissection
  • EMR Endoscopic mucosal resection
  • Additional research has included the development of endoscopic add-ons to supplement the existing capabilities of conventional endoscopes, but these are similarly hampered by the inherent flexibility of the endoscope. Although this flexibility is crucial for navigating the curving GI tract to reach the surgical site, the flexibility of the distal tip of the endoscope limits the capabilities of endoscopic therapeutic procedures.
  • Proposed solutions of anchoring the endoscope are numerous in the literature, with examples including inflatable balloons, pop-up structures, and adhesives. Work has also been done to enhance distal tip dexterity with a highly-controllable means of steering the endoscope tools, minimizing the need to move the endoscope itself.
  • a tissue retraction device includes a tissue retraction mechanism configured to anchor and retract a tissue to be manipulated, and at least one actuator associated with the tissue retraction mechanism.
  • the at least one actuator is configured to move between an unexpanded state such that the tissue retraction mechanism can adhere to the tissue, and an expanded state such that the tissue retraction mechanism applies a force to the tissue to anchor the tissue and cause retraction thereof.
  • the tissue retraction mechanism is in the form of a vacuum gripper.
  • the at least one actuator comprises a first actuator and a second actuator.
  • the first actuator and the second actuator can be in the form of bellows.
  • the tissue retraction mechanism is positioned between the first actuator and the second actuator.
  • the at least one actuator is in the form of at least one multistage actuator having a rigid portion between each stage of the multi-stage actuator.
  • the tissue retraction mechanism includes at least a rigid portion configured to provide structural support to the at least one actuator in the expanded state.
  • the rigid portion can be in the form of a folding structure that is configured to unfold upon deployment of the at least one actuator into the expanded state.
  • the tissue is manipulated by a medical device that extends from a distal end of an endoscopic device.
  • An endoscopic device can also be provided, and can include an elongate body having a lumen extending therethrough such that at least one tissue manipulation instrument can be passed therethrough for manipulating tissue at a distal end of the elongate body, and a tissue retraction device coupled to an outer surface of the elongate body configured to anchor and retract tissue such that tissue grasping is decoupled from movement of the endoscopic device during manipulation of the tissue.
  • the tissue retraction device comprises a tissue retraction mechanism configured to anchor and retract a tissue to be manipulated during a procedure using the endoscopic device, and at least one actuator configured to move between an unexpanded state such that the tissue retraction mechanism can adhere to the tissue, and an expanded state such that the tissue retraction mechanism applies a force to the tissue and cause retraction thereof.
  • the endoscopic device can further comprise a hollow overtube.
  • the endoscopic device can be positioned within the hollow overtube such that the tissue retraction device can be deployed when the hollow overtube is retracted from the endoscope to expose the tissue retraction device.
  • the tissue retraction mechanism is in the form of a vacuum gripper.
  • the at least one actuator comprises a first actuator and a second actuator.
  • the tissue retraction mechanism can be positioned between a first actuator and a second actuator.
  • the tissue retraction device includes at least a rigid portion configured to provide structural support to the at least one actuator in the expanded state.
  • a method of performing tissue retraction comprising deploying a tissue retraction device from an outer surface of an elongate body of an endoscopic device such that the tissue retraction device is positioned adjacent to a target tissue to be retraction and manipulated by the endoscopic device, and anchoring the tissue retraction mechanism to the target tissue using a tissue retraction mechanism.
  • At least one actuator coupled to the tissue retraction mechanism is deployed from an unexpanded state during which the tissue retraction mechanism anchors the target tissue into an expanded state such that the tissue retraction mechanism applies a force to the target tissue to cause retraction of the target tissue.
  • deploying the at least one actuator allows for the at least one actuator to expand from an initial height in the unexpanded state to an expanded height in the expanded state such that the target tissue is retracted to substantially the expanded height of the least one actuator.
  • the expanded height allows for one or more tools extending through the elongate body of the endoscopic device to access the target tissue.
  • the at least one actuator is in the form of first and second actuators such that the first and second actuators provide balanced support for the tissue retraction mechanism to anchor to the target tissue and retract the target tissue.
  • FIG. 1A, FIG. IB, FIG. 1C, and FIG. ID illustrate an embodiment of a tissue retraction device in use with an endoscope
  • FIG. 2A, FIG. 2B, FIG. 2C, and FIG. 2D illustrate an exemplary fabrication workflow for an embodiment of a bellows actuator
  • FIG. 3A is an embodiment of a bellows actuator
  • FIG. 3B is an embodiment of a vacuum gripper
  • FIG. 3C is an embodiment of a MEMS structure
  • FIG. 3D is an embodiment of a tissue retraction device in an undeployed state
  • FIG. 3E is the tissue retraction device of FIG. 3D is an expanded state
  • FIG. 4 is an exemplary graph of pressure versus force for an embodiment of a bellows actuator
  • FIG. 5 is an exemplary graph of displacement versus pressure during inflation of an embodiment of a bellows actuator
  • FIG. 6 is an exemplary graph of pressure versus force for an embodiment of a bellows actuator in retraction
  • FIG. 7A illustrates an embodiment of an actuator undergoing buckling
  • FIG. 7B illustrates an embodiment of an actuator with a rigid internal disk that is configured to resist buckling
  • FIG. 8A, FIG. 8B, FIG. 8C, and FIG. 8D illustrate an embodiment of a tissue retraction device in use
  • FIG. 9 illustrates an embodiment of a tissue retraction device deployed on target tissue.
  • individual embodiments may be described as a process which is depicted as a flowchart, a flow diagram, a data flow diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations may be re-arranged. A process may be terminated when its operations are completed, but could have additional steps not discussed or included in a figure. Furthermore, not all operations in any particularly described process may occur in all embodiments. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination corresponds to a return of the function to the calling function or the main function.
  • terms, such as “a,” “an,” or “the,” again, may be understood to convey a singular usage or to convey a plural usage, depending at least in part upon context.
  • the term “based on” may be understood as not necessarily intended to convey an exclusive set of factors and may, instead, allow for existence of additional factors not necessarily expressly described, again, depending at least in part on context.
  • a device can be used to assist with anchoring and tissue retraction during endoscopic surgical procedures, which can decouple the tissue grasping function from the movement of the endoscope tip, leaving the surgeon free to use the endoscope tip solely for positioning of electro-cautery or biopsy tools deployed through the endoscope working channel.
  • the anchoring and retraction device uses pop-up book MEMS techniques, allowing for a flat structure to expand into a 3 -dimensional structure many times its initial height.
  • the device has three main integrated components: a rigid expandable geometric structure, one or more inflatable pneumatic actuators, and a tissue retraction mechanism, such as a vacuum gripper.
  • These inflatable actuators include internal rigid discs, allowing for resistance to buckling while maintaining the benefits of the established lightweight, low profile actuator design scheme.
  • Proof-of concept ex vivo testing demonstrates that the integrated device can be used to retract tissue to a height of 13.5 mm, providing access for endoscopy tools to contact a sample of porcine stomach tissue.
  • a tissue retraction device is a deployable device that can be fully detached and independent from movement of an endoscope. Using a tissue retraction device, the tissue-grasping function is decoupled from the movement of the endoscope tip, leaving the surgeon free to use the endoscope tip solely for positioning of electro-cautery or biopsy tools deployed through the endoscope working channel.
  • the anchoring and retraction device uses "pop-up book MEMS" techniques, allowing for a "flat" structure to expand into a 3-dimensional structure many times its initial height.
  • FIG. 1A, FIG. IB, FIG. 1C, and FIG. ID illustrate an embodiment of a device and the workflow for deployment and tissue retraction using a tissue retraction device.
  • FIG. 1A illustrates an embodiment of a collapsed tissue retraction device 10 affixed to an endoscope 12 within a hollow overtube 14.
  • FIG. IB illustrates the deployment of the tissue retraction device 10 by retracting the overtube 14 to expose the device 10.
  • FIG. 1C illustrates the device 10 being positioned over the targeted tissue 18, such as a lesion. In the illustrated embodiment, the device 10 is positioned over the targeted tissue 18 with the use of a tool, such as forceps 20, extending from a distal end of the endoscope 12.
  • FIG. 1A illustrates an embodiment of a collapsed tissue retraction device 10 affixed to an endoscope 12 within a hollow overtube 14.
  • FIG. IB illustrates the deployment of the tissue retraction device 10 by retracting the overtube 14 to expose the device 10.
  • ID illustrates a mechanism for retracting tissue, allowing conventional tools, such as an electro-cautery tool 22, to be used to excise the lesion with electro-cautery. As shown in FIG. ID, the device 10 is used to retract the targeted tissue 18 (the lesion).
  • a tissue retraction device can be introduced into the body along the outside of the distal end of an endoscope 12 and encased in a retractable overtube 14 (as shown in FIG. 1A, FIG. IB, FIG. 1C, and FIG. ID).
  • a retractable overtube 14 as shown in FIG. 1A, FIG. IB, FIG. 1C, and FIG. ID.
  • a tissue retraction device can be affixed to the outside surface of the distal end of an endoscope and constrained within an overtube to shield the device from contacting tissue until at the surgical site in the GI tract, as shown in FIG. 1A.
  • the overtube is then retracted to expose the device (FIG. IB).
  • Forceps deployed through the endoscope working channel are used by the surgeon to position the device atop a lesion, with visual guidance and confirmation from the illuminated distal camera (FIG. 1C).
  • FIG. 1C the distal endoscope position and orientation can be adjusted by the surgeon to place the device in the GI tract regardless of orientation to horizontal.
  • the tissue retraction device can be repeatedly expanded, collapsed, and repositioned with forceps delivered through the endoscope working channel to adjust vacuum gripper location between rounds of electro-cautery.
  • negative pressure is applied to the bellows actuators to keep them in a deflated state, the overtube is advanced, and forceps are used to maneuver the device back into the overtube while the endoscope is retracted.
  • the thickness of the device before inflation should add less than 10 mm to the endoscope diameter to maintain overtube compatibility, and the device requires an expanded height of 13 mm or greater to retract tissue to a height of 10 mm, which offers sufficient access to the retracted tissue by endoscope end effectors.
  • the fabrication workflow presented here could be customized for different actuator use cases.
  • the tissue retraction device can be delivered to the target tissue in a variety of ways, including but not limited to delivering the tissue retraction device through the working channel of the endoscope, as long as the tissue retraction tissue is sized and shaped to fit therein.
  • the soft actuator of the tissue retraction device can have many configurations.
  • the soft actuators are in the form of bellows.
  • First and second bellows actuators 62, 64 which can include internal rigid PTFE disks, and a vacuum gripper 66 are incorporated into the pop-up structure to complete the tissue retraction device 60, as shown in FIG. 3D and FIG. 3E.
  • the vacuum gripper 66 is mechanically constrained between two layers of fiberglass-epoxy laminate sheets.
  • the bellows actuators 62, 64 are affixed on the top and bottom TPE layers with the same adhesive sheet. Input tubing lines for the bellows actuators are linked together by a tee-fitting to operate from a single input pressure line.
  • a variety of fabrication techniques can be used to form a tissue stabilization device.
  • a fabrication scheme for embedding rigid disks in TPE bellows actuators can be used, with planar manufacturing techniques.
  • Fabrication of an integrated device consisting of an expandable structure, inflatable bellows actuators, and a vacuum gripper to enable tissue retraction is also introduced.
  • the expandable structure is based upon a pop-up book MEMS fabrication methodology. Pop-up book MEMS has been used successfully for the development of medical devices in the literature.
  • the concept of integrating soft, inflatable devices with expandable rigid structures to constrain the inflation of the actuator has also been previously proposed. The integrated device and its components are tested with protocols presented, as discussed below, and the results of these experiments are presented.
  • the soft actuators for example, the bellows actuators.
  • heat- and pressure-bonded Thermoplastic Elastomer, TPE (Fiber Glast, USA) bellows actuators with Polytetrafluoroethylene (PTFE) mask layers can be used that demonstrate a linear relationship between blocked force and input pressure at low displacement heights, but exert limited retractive forces due to the tendency of bellows chambers to buckle inwards when vacuum is applied, rather than move axially.
  • rigid PTFE disks can be introduced within the enclosed chambers of the soft bellows actuators at the same scale.
  • the planar fabrication method of combining subunits to form complete bellows chambers enables the inclusion of additional bellows chambers and thus customizable inflation height.
  • the diameter of the bellows actuators and the number of bellows chambers can vary.
  • bellows actuators can have with a diameter of 9 mm and four bellows chambers. These dimensions were selected for suitability for integration into the tissue retraction device and limits on overtube size. It will be understood that the size and number of chambers can vary depending on the application and size of the endoscope and overtube. In some embodiments, each chamber of the bellows is approximately 9 mm.
  • the technology can be easily scalable up (larger sizes) or down. For example, it can be scaled down to a few millimeters using the process described herein.
  • endoscopes can be in the range of 12-18 mm, and the actuators can be designed accordingly.
  • soft actuators can be fabricated with 50 ⁇ thick Thermoplastic Elastomer - TPE following a 2D layer-by-layer manufacturing process. Different layers of TPE are laser cut with a C02 laser and alternated with laser cut 50 ⁇ thick Teflon layers o be selectively bonded. Layers of TPE and Teflon are aligned using precision dowel pins. Bonding is achieved by heating the laminate, for example, at 190 °C for one hour under 0.7MPa pressure. This manufacturing technique can be used to fabricate an integrated device consisting of an expandable rigid structure, inflatable bellows actuators, and a vacuum gripper to enable tissue retraction.
  • the first sub-unit of a soft bellows actuator is fabricated with two adjacent layers of 38 ⁇ thick TPE following the process shown in FIG. 2A, FIG. 2B, FIG. 2C, and FIG. 2D.
  • This double layer of TPE enhances robustness of the material when undergoing deformation during heating, as this deformation is required to accommodate internal disks of sufficient thickness to resist buckling under applied negative pressure.
  • Different layers of TPE are cut with a C02 laser cutter and alternated with laser-cut 254 ⁇ and 76.2 ⁇ PTFE layers to act as masks and forms. Layers of TPE and PTFE are aligned using precision dowel pins and stacked manually.
  • the layers of TPE in the first two steps of the process are bonded at 180°C for one hour under 0.07 MPa pressure, as shown in FIG. 2A and FIG. 2B.
  • the 76.2 ⁇ PTFE layers serve in the first step to mask the TPE and allow only desired areas to bond (FIG. 2A).
  • This first step produces the layer that interfaces between two bellows chambers.
  • the 254 ⁇ PTFE also serves as a mask to the TPE but also as a form to create sufficient vertical space while the TPE is heated to encase rigid PTFE disks within the bellows chambers.
  • FIG. 2A, FIG. 2B, FIG. 2C, and FIG. 2D illustrate an embodiment of a fabrication workflow for bellows actuators 30 with internal rigid disks.
  • FIG. 2A illustrates an interface layer 32 between adjacent bellows chambers 30, 34.
  • FIG. 2B illustrates additional mold layers with the result of the previous step, creating a pocket for an enclosed disk.
  • FIG. 2C illustrates a final bonding of a top TPE layer 38 and an input tubing 40.
  • FIG. 2D illustrates an example of the dimensions of the enclosed disk.
  • a and b can be 2mm and 8mm, respectively. In some embodiment, b can range from 5mm to 15mm. It will be understood that the dimensions of the disk, and other features of the actuators, can vary depending on a variety of factors, including but not limited to the size of the endoscope and the location of size of the target tissue.
  • multiple subunits resulting from the first step can be added, serving to customize expanded height of the finished actuator.
  • any number of units can be added to the soft actuators depending on the desired height of the actuator in the expanded state.
  • additional 254 ⁇ PTFE mold layers are added to transmit the vertically applied force of 0.07 MPa to the areas of TPE being bonded.
  • the bonds around the outer diameter of all bellows chambers except that with the inlet tubing are formed.
  • the top layers of this laminate are manually removed, and additional 254 ⁇ PTFE layers are added as forms to create bonds that will enclose the last bellows chamber with its inlet tubing.
  • a tube with internal diameter of 0.64 mm (for example, Micro Renathane Cather Tubing, Braintree Scientific, USA) is inserted and a drop of Loctite Vinyl, Fabric & Plastic Flexible Adhesive is added before the top sheet of TPE and an upper PTFE mold layer are added.
  • the resulting laminate is heated at 145°C for one hour under 0.06 MPa pressure, as shown in FIG. 2C.
  • the external PTFE layers are manually cut away before the laminate has cooled, and the inlet tubing is trimmed, producing a bellows actuator 50 shown in FIG. 3A.
  • F the force produced
  • P the input pressure
  • A the area of the circular bellows chamber when flat, as determined by the 254 ⁇ PTFE layers that transmit the applied force during heating in FIG. 2B and FIG. 2C.
  • This relationship holds true when expanding from flat, with decreased force output as the overall height increases and the TPE begins to strain.
  • AF ⁇ x A is a better description.
  • the rate at which force output increases with an increase in pressure will be relatively constant and dependent upon the area of a bellows chamber, and is detailed below.
  • the presently disclosed embodiments make it possible to fabricate a soft actuator that is less susceptible to bending and/or buckling when under pressure.
  • Previous iterations of soft bellows actuators fabricated with a 76.2 ⁇ PTFE film disk encased in each bellows chamber were susceptible to bending and buckling when under applied negative pressure, limiting the pulling force output to 0.50N.
  • Bellows actuators under retraction also undergo a time dependent decay in applied force as they approach a steady-state constant output, for example, when the TPE and 76.2 ⁇ PTFE have buckled to their minimum internal volume.
  • Actuators can also be fabricated to prevent time dependent decay.
  • the incorporation of a thicker, more rigid PTFE disk can minimize these effects and improve the retraction performance of the actuator.
  • Modeling the system as a disk under uniform radial compression, which the TPE would apply to the disk under applied negative pressure, as discussed in Eqn. 1 supports this.
  • the enclosed disk can be in the form of a circular plate with a concentric hole under uniform radial compression on its outer edge, with a being outside diameter of the disk, b being the inner diameter of the disk as shown in FIG. 2D, t being thickness of the disk, E being Young's modulus, ⁇ being Poisson's ratio, and ⁇ ' being critical unit compressive stress. Because the ratio of diameter to thickness - is greater than 10, this model holds and it is true that:
  • K is a tabulated value dependent upon ⁇ and equal to a linearly interpolated value of 0.285, thus ⁇ ' oc t 2 .
  • the mold is designed to yield a flat sheet of cast elastomer at the top of the vacuum gripper which could be mechanically constrained between two structural sheets with a pass-through for the tubing through which negative pressure is applied.
  • molds are 3D-printed on an SLA Formlabs 2 (Formlabs, Somerville, MA, USA).
  • a silicone elastomer, DragonSkin 20 (Smooth-On, Macungie, PA, USA), is cast into the molds and placed into a vacuum chamber until all trapped air escapes after about ten minutes, before being cured at 60°C for 60 minutes.
  • Pop-up book MEMS is a design and fabrication methodology in which thin layers of material are machined individually and selectively laminated together with adhesive and flexible layers, allowing a flat structure to expand into a 3-dimensional device based on flexure joints.
  • a pop-up structure can be designed to accommodate the incorporation of a vacuum gripper and strain-relieving expandable housing for two bellows actuators, without substantial deformation during use.
  • Materials for the fabrication of the pop-up structure can include but is not limited to 381 mm thick fiberglassepoxy laminate sheets as structural material (Garolite G-10/FR4), 25 ⁇ thick polyimide film as flexure layers, and pressure-sensitive 3M sheet adhesive (9877).
  • Each layer is individually machined using a diodepumped solid state (DPSS) laser, and aligned using precision dowel pins.
  • DPSS diodepumped solid state
  • the resulting laminate is laser machined to release the final device structure, shown in FIG. 3C from the bulk substrate before integration of the vacuum gripper.
  • the design of the pop-up structure depends upon the deployment method of the device, in which it is affixed to the outer diameter of the endoscope within a flexible overtube. As such, the pop-up structure is designed to minimize the marginal increase in endoscope diameter before the device is deployed.
  • a four-stage bellows actuator was tested on a materials testing machine (Instron®) by placing it between two flat rigid plates displaced from one another at various discrete heights. Dual syringe pumps provide controllable input pressure measured by a pressure gauge (BSP B010-EV002-A00A0B-S4, Balluff, USA), and force readings from the load cells (Instron® + 10N Static Load Cell, Cat. No: 2530-428) were taken at regular pressure intervals. These values were compared to the theoretical model. The top and bottom layers of TPE were adhered to 254 ⁇ fiberglass-epoxy laminate sheets with sheets of 3M® 9877 adhesive.
  • Bellows actuators were also tested under applied negative pressure to determine the efficacy of the rigid PTFE disks contained within each chamber in resisting buckling and exerting forces under applied negative pressure.
  • the top and bottom layers of TPE were adhered to 254 ⁇ fiberglass-epoxy laminate sheets with sheets of 3M® 9877 adhesive, with attached acrylic fixtures to hold these plates in the Instron® jaws.
  • the top and bottom plates were spaced 10 mm apart before negative pressure was applied.
  • Negative pressure was measured using a pressure sensor manifold (MPX4115V, Motorola Freescale Seminconductor, Inc., USA) and the retractive force was measured by the load cell of the Instron®. This test was performed for bellows actuators with internal PTFE disks of 254 ⁇ thickness and otherwise identical actuators with 76.2 ⁇ internal PTFE disks.
  • Vacuum grippers cast from silicone elastomers in 3D-printed molds were fixtured in a fiberglass-epoxy and acrylic jig to firmly retain the gripper and affix it to the movable vertical axis of the Instron®.
  • a vacuum was applied (92 kPa) once the base of the vacuum gripper was in contact with a sample of porcine stomach tissue.
  • the movable plate of the Instron® was raised vertically at a rate of 20 mm/min. Incrementally larger masses of tissue were lifted until the vacuum gripper could no longer fully raise the tissue from its enclosing container.
  • Pop-up structures and their component material selections described above and shown in FIG. 3D and FIG. 3E were evaluated by comparing performance relative to desired expanded height, and desired stiffness of the overall structure.
  • the flexure joints of the mechanism were also evaluated and manually flexed through their full range of motion to ensure sufficient gap distance to prevent the fiberglass-epoxy laminate layers from pinching the joint or contacting one another.
  • the integrated device was deployed from an Olympus CF-100L endoscope onto porcine stomach tissue samples using an FEP (Fluorinated Ethylene Propylene) tube to serve as an overtube to contain the integrated device, as described in FIG. 1A and FIG. IB.
  • FEP Fluorinated Ethylene Propylene
  • This added diameter is comparable to commercially available endoscopes in common use, which have outside diameters ranging from about 12.2 - 21 mm. Placing the device with thickness of 4.70 mm and width of 10 mm tangential to the outer surface of the endoscope increases the effective endoscope diameter to 20 mm, but geometric design changes could decrease this diameter to operate with a smaller overtube.
  • Negative pressure (92 kPa) was applied through the vacuum gripper to anchor the device to the tissue before the two bellows actuators were concurrently inflated.
  • porcine stomach is comprised of mucosa and muscularis layers which together measure 2500 ⁇ thick. This is thicker than reported thicknesses of human GI tract mucosa and muscularis layers of the intestinal wall, which vary from 495-1090 ⁇ , thus making porcine stomach an acceptable substitute for benchtop ex vivo testing.
  • the retracted porcine stomach tissue was successfully contacted by tools inserted through the endoscope working channel.
  • the deflated height of the four-stage bellows without rigid internal disks is 0.85 mm with an expanded height of 18 mm; the deflated height of the comparable actuator with internal disks is 1.8 mm with a comparable expanded height.
  • FIG. 3A, FIG. 3B, FIG. 3C, FIG. 3D, and FIG. 3E illustrates various components that can be integrated to form an embodiment of a tissue retraction device.
  • FIG. 3A illustrates an embodiment of a four-stage TPE bellows actuator 50 with rigid internal disks (shown in various stages of expansion) to expand the tissue retraction device.
  • FIG. 3B illustrates an embodiment of a silicone elastomer vacuum gripper 54 that is configured to grip the tissue to be retracted.
  • FIG. 3C illustrates an embodiment of a pop-up book MEMS structure 52 comprised of structural, flexural, and adhesive layers. These are laminated together to create the tissue retraction device 60 as shown in FIG. 3D and FIG. 3E.
  • FIG. 3D illustrates the integrated device 60 in an undeployed state
  • FIG. 3E illustrates the integrated device 60 fully expanded by inflated bellows actuators 62, 64.
  • FIG. 4 illustrates an example graph of pressure vs. force for four-stage bellows actuators in extension at various displacement heights.
  • FIG. 5 illustrates an example graph of displacement (mm) vs. pressure (kPa) during inflation of a four-stage bellows actuator with top and bottom TPE faces attached to 381 mm FR4 with 3MR 9877 sheet adhesive.
  • the required pressure value can be interpolated from FIG. 5, or approximated by a linear fit, with the linear change added to this fixed offset.
  • FIG. 6 illustrates an example graph of pressure vs. force for four-stage bellows actuators in retraction, with and without rigid intemal disks.
  • FIG. 7 A illustrates an embodiment of a bellows actuator with internal PTFE film undergoing buckling during retraction testing with applied vacuum.
  • FIG. 7B illustrates one embodiment of a bellows actuator with rigid internal disks resisting buckling under applied vacuum. The buckling of actuators with 76.2 ⁇ internal disks is shown in FIG. 7A, and the resistance to buckling for actuators with 254 ⁇ internal disks is visible in FIG. 7B.
  • Vacuum grippers made from a cast silicon elastomer were successful in lifting 40 g masses of porcine stomach tissue, corresponding to exerted forces in excess of 0.40 N. This is comparable to those measured in the literature for similar grippers that produced up to 1.2 N.
  • FIG. 8A illustrates an embodiment of an integrated device encased in 23.81 mm outer diameter overtube.
  • FIG. 8B illustrates the integrated device during deployment and overtube retraction.
  • FIG. 8C illustrates a view from an endoscope distal camera, showing an end-effector in the foreground.
  • FIG. 8D illustrates the deployed device retracting tissue, the endoscope with a tool contacting tissue retracted by integrated device, as an electrocautery tool that can be used to ablate tissue.
  • FIG. 8 A The integrated device was placed inside an FEP overtube (23.81 mm outer diameter and 22.23 mm inner diameter) with the Olympus CF-100L endoscope (FIG. 8 A). Following the scheme described in FIG. 1, the overtube was retracted from the endoscope to expose the device, as shown in FIG. 8B.
  • This proof of concept demonstration of deployment validates the described workflow as a means of conducting the device to the site of a lesion.
  • the vacuum gripper is then actuated with applied negative pressure, and inflation of the soft bellows actuators begins, retracting the porcine stomach tissue, as shown in FIG. 9.
  • FIG. 9 illustrates an embodiment of an integrated device deployed on porcine stomach tissue. As shown, the tissue is retracted to height of 13.5 mm.
  • An end-effector is deployed through the working channel of the endoscope, which is capable of interacting with the retracted tissue with visual feedback provided by the endoscope distal illuminated camera, as shown in FIG. 8C.
  • the tip of the endoscope is decoupled from the integrated tissue retraction device (linked only by flexible tubing for the vacuum gripper and soft bellows actuators). Once the tissue retraction device is deployed and retracting tissue, the surgeon is free to manipulate the endoscope to best approach the retracted tissue for electrocautery and biopsy.
  • the MEMS has a sharp, planar structure due to the nature of the laser micro- machined layers.
  • the MEMS can have a geometric design that includes fillets to the corners or encasing the structure in a layer of soft silicone elastomer.
  • a device fabricated with pop-up book MEMS techniques can be used to retract tissue in the GI tract while remaining decoupled from the endoscope tip.
  • a layer-by-layer manufacturing method is provided for using heat and pressure to bond TPE sheets to create pockets with sufficient depth to contain a rigid PTFE disk within each chamber of a larger bellows actuator, using PTFE forms to deform the TPE while at elevated temperatures. The manufacturing method allows for batch fabrication, as well as the inclusion of additional bellows chambers to customize the final stroke of the actuator.
  • the retraction device can be deployed from conventionally used endoscopes to provide the necessary counteraction to ablate tissue, paving the way for applications in endoscopic removal of early stage cancers.
  • the tissue retraction devices described herein can be utilized by surgeons and endoscopists who perform complex surgical and diagnostic procedures in the gastrointestinal tract with flexible endoscopes.
  • the integrated tissue retraction device offers surgeons an additional method to simplify endoscopic procedures, potentially solving the issues of limited distal tip dexterity and the extensive training requirements to perform these procedures.
  • the device can be adapted to retract larger portions of tissues using a row or array of vacuum grippers to excise larger lesions, as well as inflatable bellows actuators described here for other procedures where an initially-flat device capable of substantial expansion and exertion of force as a distance is beneficial, such as collapsed lungs or airways, as well as further applications in the GI tract.
  • the device can thus find applications in all endoscopic procedure where it is necessary to distally manipulate endoluminal tissues, for example, including but not limited to removal of early stage cancer to polyps.
  • an embodiment of a tissue retraction device can be introduced into the body along the outside of the distal end of an endoscope and encased in a retractable overtube.
  • the integrated devices herein have the potential to expand surgeons' capabilities and increase the number of surgeons capable of performing these types of procedures.
  • a method of performing tissue retraction comprising deploying a tissue retraction device from an outer surface of an elongate body of an endoscopic device such that the tissue retraction device is positioned adjacent to a target tissue to be retraction and manipulated by the endoscopic device, and anchoring the tissue retraction mechanism to the target tissue using a tissue retraction mechanism.
  • At least one actuator coupled to the tissue retraction mechanism is deployed from an unexpanded state during which the tissue retraction mechanism anchors the target tissue into an expanded state such that the tissue retraction mechanism applies a force to the target tissue to cause retraction of the target tissue.

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Abstract

L'invention concerne des systèmes et des procédés destinés à rétracter un tissu pendant une intervention endoscopique. Selon certains modes de réalisation, un dispositif de rétraction de tissu peut être utilisé conjointement avec un endoscope. Le dispositif de rétraction de tissu est conçu pour rétracter un tissu tout en restant découplé de l'endoscope. Selon un mode de réalisation, le dispositif de rétraction de tissu se présente sous la forme d'un dispositif MEMS escamotable qui comprend un ou plusieurs actionneurs destinés à déployer le dispositif et une pince à vide destinée à rétracter le tissu.
PCT/US2018/022460 2017-03-14 2018-03-14 Systèmes et procédés destinés à une rétraction de tissu escamotable WO2018170143A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12114839B2 (en) 2020-09-22 2024-10-15 Boston Scientific Medical Device Limited Medical device having independent articulation and methods of use

Citations (6)

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Publication number Priority date Publication date Assignee Title
US6090041A (en) * 1999-02-16 2000-07-18 Regents Of The University Of California vacuum actuated surgical retractor and methods
US6893394B2 (en) * 2002-12-19 2005-05-17 Ethicon, Inc. Illuminated and vacuum assisted retractor
US20050261674A1 (en) * 2004-05-14 2005-11-24 Nobis Rudolph H Medical devices for use with endoscope
WO2014106112A1 (fr) * 2012-12-27 2014-07-03 Spiral-E Solutions, Llc Dispositif de stabilisation de tissu par aspiration sous vide
US20150173996A1 (en) * 2013-12-20 2015-06-25 L'oreal Method for treating the skin and device
US20150265818A1 (en) * 2009-12-16 2015-09-24 Macroplata, Inc. Substantially rigid and stable endoluminal surgical suite for treating a gastrointestinal lesion

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Publication number Priority date Publication date Assignee Title
US6090041A (en) * 1999-02-16 2000-07-18 Regents Of The University Of California vacuum actuated surgical retractor and methods
US6893394B2 (en) * 2002-12-19 2005-05-17 Ethicon, Inc. Illuminated and vacuum assisted retractor
US20050261674A1 (en) * 2004-05-14 2005-11-24 Nobis Rudolph H Medical devices for use with endoscope
US20150265818A1 (en) * 2009-12-16 2015-09-24 Macroplata, Inc. Substantially rigid and stable endoluminal surgical suite for treating a gastrointestinal lesion
WO2014106112A1 (fr) * 2012-12-27 2014-07-03 Spiral-E Solutions, Llc Dispositif de stabilisation de tissu par aspiration sous vide
US20150173996A1 (en) * 2013-12-20 2015-06-25 L'oreal Method for treating the skin and device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12114839B2 (en) 2020-09-22 2024-10-15 Boston Scientific Medical Device Limited Medical device having independent articulation and methods of use

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