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WO2025090620A1 - Devices for improving adenoma detection - Google Patents

Devices for improving adenoma detection Download PDF

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Publication number
WO2025090620A1
WO2025090620A1 PCT/US2024/052584 US2024052584W WO2025090620A1 WO 2025090620 A1 WO2025090620 A1 WO 2025090620A1 US 2024052584 W US2024052584 W US 2024052584W WO 2025090620 A1 WO2025090620 A1 WO 2025090620A1
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WO
WIPO (PCT)
Prior art keywords
distal end
end portion
endoscope
support member
distal
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/US2024/052584
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French (fr)
Inventor
Daniel P. DAMATO
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Conmed Corp
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Conmed Corp
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Filing date
Publication date
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Publication of WO2025090620A1 publication Critical patent/WO2025090620A1/en
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Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/31Instruments 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 for the rectum, e.g. proctoscopes, sigmoidoscopes, colonoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/00064Constructional details of the endoscope body
    • A61B1/00071Insertion part of the endoscope body
    • A61B1/0008Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00089Hoods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/00064Constructional details of the endoscope body
    • A61B1/00071Insertion part of the endoscope body
    • A61B1/0008Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00101Insertion part of the endoscope body characterised by distal tip features the distal tip features being detachable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/00131Accessories for endoscopes
    • A61B1/00135Oversleeves mounted on the endoscope prior to insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/00147Holding or positioning arrangements
    • A61B1/00148Holding or positioning arrangements using anchoring means

Definitions

  • the present disclosure relates to devices for improving adenoma detection during a colonoscopy and, more particularly, to devices positionable at a distal end of an endoscope and structured and/or configured to expand and retract upon longitudinal or rotational displacement of at least a portion of the device about the endoscope.
  • Adenomatous polyps are benign polyps or growths on the lining of the colon or rectum, which could become cancerous.
  • Adenoma Detection Rate is a measure of how consistently an endoscopist can the identify polyps in the gastrointestinal (GI) tract during a colonoscopy. ADR is sometimes also measured in terms of Adenomas Per Colonoscopy (APC).
  • a facilities ADR is a function of the ease of identification of polyps, the tools used for inspection (colonoscope, assistive devices) and the physician’s ability to recognize lesions. Higher definition video can aid ADR rate, as can experience and training on the physician side.
  • ADR devices can improve ADR rates, possibly resulting in earlier cancer identification and decreased treatment costs to the patient and hospital in the future.
  • colon (large bowel) anatomy varies widely and factors such as tortuosity, topology, existing morbidity, and size can all affect an endoscopist’s ability to recognize potentially malignant adenomas.
  • a physician’s view is oriented proximally along the colonic lumen, which can create blind spots behind bumps, folds, or twists in the receding anatomy. This can be further exacerbated by a colonoscope’ s limited field of view of -140°, which mandates that an endoscopist manipulate their scope at an angle to the lumen’s axis to get a close up, en-face examination of the tissue.
  • a non-limiting goal associated with the inventive device embodiments is to mechanically manipulate the GI tract during a colonoscopy to improve visualization and detection of adenomas and to stabilize the colonoscope (including the tip of the scope) during endoscopic procedures. Stabilization of the tip of the scope to limit movement of the scope tip relative to the GI tract wall dampens the effects of peristalsis on desired scope position. Further, embodiments of the device are configured to distend, smooth, and regulate the bowel (including colonic folds) to identify aberrations more easily in tissue topology. Finally, a tip of the device can be used as a scope cap, creating a longitudinally extended annular portion around a perimeter of the endoscope which can be used for suction or manipulation of tissue during a procedure.
  • embodiments of the disclosure provide devices that improve visualization and stabilization using a spiral cage structure that is both fixedly and slidably coupleable to an endoscope.
  • a distal portion of the device can be fixedly attached to the scope tip in the manner of a cap or nozzle, which extends forward geometry (and annular ring/tube) into the camera’s field of view.
  • a proximal portion of the device can be slidably coupled to the shaft of the endoscope, limiting radial displacement but allowing rotational and longitudinal (axial) movement.
  • the main body of the device can be comprised of a twisted cage that expands and retracts with longitudinal and/or rotational displacement of the rear coupling relative to the front coupling.
  • the diameter of the cage can be influenced by the degree of twist deformation of the individual support members.
  • Individual support members can be designed to elongate when the device is inserted (force is exerted on the proximal face of the device and cage in a distal vector) and to invert and bend when the device is retracted (force is exerted on the distal and outer faces of the device in the proximal direction).
  • distal and proximal are defined relative to the device, which is inverted from the frame of reference of the duct.
  • Embodiments of the device can help to smooth and distend bumps, folds, and divots in a patient’s colonic wall that create blind spots; center the endoscope in the lumen to eliminate bias of the camera due to tortuosity; adjust tissue tension during examination and manipulation of local tissue; and manipulate (through suction or direct contact) tissue in front of the scope using an annular cap.
  • Additional advantages over conventional devices include consistent radial force transmission around the full or substantially full (80-99%) device circumference; a slight torque exerted by the device during retraction that helps to smooth spiral patterned folds found in the colon; an ability to actively expand or collapse a section of contacted lumen by twisting the scope; protection of the scope camera outside of the patient (tip protector); and integrated scope cap that can facilitate tissue suction and manipulation.
  • FIG. 1 A is a side view schematic representation of a device for improving adenoma detection according to an embodiment.
  • FIG. 1B is a distal end perspective view schematic representation of a device for improving adenoma detection according to an embodiment.
  • FIG. 2 is a distal end view schematic representation of a device for improving adenoma detection according to an embodiment.
  • FIG. 3 A is a distal end view schematic representation of the distal end portion of a device for improving adenoma detection according to an embodiment.
  • FIG. 3B is a side view schematic representation of the distal end portion of a device for improving adenoma detection according to an embodiment.
  • FIG. 4 is a side perspective transparent/translucent view schematic representation of the device positioned on the distal end of an endoscope according to an embodiment.
  • FIG. 5 is a finite element analysis schematic representation showing a displacement graph of an embodiment of the device.
  • FIG. 6A is a stress plot schematic representation of the device during the inversion cycle according to an embodiment.
  • FIG. 6B is a stress plot schematic representation of the device during the inversion cycle according to an embodiment.
  • FIG. 6C is a stress plot schematic representation of the device during the inversion cycle according to an embodiment.
  • FIG. 6D is a representation of the device attached to an endoscope during the inversion cycle according to an embodiment.
  • FIG. 6E is a representation of the device attached to an endoscope during the inversion cycle according to an embodiment.
  • FIG. 6F is a representation of the device attached to an endoscope during the inversion cycle according to an embodiment.
  • FIG. 7A is a representation of stress plots in a schematic representation of the device shown during the extension cycle according to an embodiment.
  • FIG. 7B is a representation of the device attached to an endoscope during the extension cycle according to an embodiment.
  • FIG. 7C is a representation of the device attached to an endoscope during the extension cycle according to an embodiment.
  • FIG. 8A is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
  • FIG. 8B is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
  • FIG. 8C is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
  • FIG. 9A is a front view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
  • FIG. 9B is a rear view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
  • FIG. 10A is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
  • FIG. 10B is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
  • FIGS. 1A, 1B, and 2 are a side isometric view schematic representation, a distal end perspective view schematic representation, and a distal end view schematic representation, respectively, of a device 100 for improving adenoma detection according to an embodiment.
  • device 100 includes a distal end portion 1, a proximal end portion 3, and a body portion 2 positioned therebetween.
  • Body portion 2 includes support members 5 which are structured and/or positioned at specific (preferably at rest) angles a, 0, 0, and cp which control or affect certain mechanics/functionality of device 100.
  • Support members 5 can be connected to the distal portion 1 and to the proximal portion 3 via connections 4a and 4b (or directly fused or integrally formed with), respectively.
  • Support members 5 can be configured and adapted to deflect radially and rotationally with respect to central axis 6.
  • FIG. 1A provides an isometric view to show a 3D curvature of support members 5.
  • device 100 can be structured and configured to be fixedly attached to an endoscope/colonoscope 200 (see FIG. 4) via compression and friction exerted by open front/distal barrel 7 (or heat shrink, adhesive or other means of fixation as should be understood by person of ordinary skill in the art in conjunction with a review ofthis disclosure), and slidably coupled to the endoscope/colonoscope via open rear/proximal barrel 8 (each of the barrels 7 and ⁇ can be annular shaped having an inner, outer, front, and rear surface).
  • Proximal barrel 8 can have an inner aperture configured, structured and adapted to move, translate, and rotate along the outer diameter of the endoscope/colonoscope 200 (which can have a larger inner diameter vs. the distal barrel 7).
  • the fixed attachment of distal barrel 7 prevents the device 100 from decoupling from the endoscope prematurely.
  • a distally extending portion of distal barrel 7 can be substantially circular and can (but does not have to) protrude past the distal face of the endoscope/colonoscope by a sufficient amount (e.g., at least 0.1mm) to create an annular structure around the circumference of the scope 200.
  • annular portion of front barrel 7 may be used to provide an extended cavity in front of the endoscope/colonoscope that can be used for suctioning or manipulating tissue.
  • Distal barrel 7 / distal portion 1 may have non-symmetric features or radial apertures that can aid in tissue manipulation.
  • the respective functionalities, and relative fixed/movable configuration of distal barrel 8 and proximal barrel 7 can be switched, while the device as a whole continues to be configured to perform the same/similar overall functionalities.
  • support members 5 are coupled to distal portion 1 at an angle 6 relative to a vector extending perpendicularly from central axis 6.
  • the particular angle 9 and related configuration can control certain mechanics of the device 100 as described herein.
  • Distal barrel 7 can be made of an elastic or plastic material (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure) and can be designed to have an interference fit with the outer diameter of the endoscope/colonoscope 200 to achieve fixation.
  • the aforementioned mechanics of the device 100 can be dictated, at least in part, by one or more angles a, p, 9, ⁇ p, and the cross section of support members 5.
  • the cross section of support members 5 may be of constant or variable thickness.
  • the degree of resistance to rotational twist of body 2 can largely be controlled by the sectional modulus of support members 5, and the angles p and 9.
  • thickening cross section base 5a will increase rotational stiffness significantly.
  • increasing angle 0 will decrease rotational stiffness in the direction of 9 and increase the degree of rotation during collapse or expansion.
  • Increasing angle p can also decrease rotational stiffness and increase the degree of rotation during collapse or expansion.
  • Increasing angles p, 0 can create a larger radius 9 which increases contact area of control arm apex 18 with the colonic wall.
  • Increasing angles P, 0 will also decrease the radial component of force exerted by control arm apex 8 when the arms invert (defined as when a > 90°).
  • the degree of radial force exerted by body 2 can be controlled by the sectional modulus of support members 5, and the angles a, p, q>, and 0. Decreasing angles 3 and 0 will increase radial stiffness. Angles of a closest to 90° can maximize radial stiffness, increasing thickness 5b of section modulus of 2 can increase radial resistance.
  • Increasing the radius 9 of control arm apex 8 can (in general) decrease radial resistance.
  • Angles of a ⁇ 90° can decrease radial stiffness but increase resistance to inversion. Angles of a > 90° can decrease radial stiffness and decrease resistance to inversion. In general, decreasing angle cp can decrease radial stiffness.
  • the angles and sectional modulus are preferably not independent variables, and thus lower order interactions can also dictate mechanics of the device.
  • the values of a, p, 9, ⁇ p, and control arm 5 section modulus and their interactions can be configured and adapted to achieve the following attributes of the device 100: 1) near constant radial force of body 2 independent of diameter (expansion), 2) easy inversion of support members 5 when force is exerted on body 2 in the distal direction (collapse); 3) easy extension of support members 5 when force is exerted on body 2 in the proximal direction (extension); and 4) torque exerted by support member apex 8 ⁇ radial force exerted by support member apex 18 but > 0.
  • Distal portion 1 can incorporate inward protrusions 10 on front barrel 7 to decrease hoop strength and sensitivity of compressive force to diameter. This concentrates hoop strength onto specific detents which increases stress in the detents allowing for higher deformation at a local level and less expansion of the hoop at a macro level. It also creates some bending stress in the hoop depending on the degree of rigidity of the material.
  • Front barrel 7 may also incorporate radial apertures 11 in place of or addition to inward protrusions 10 to decrease hoop strength.
  • FIG. 4 a side perspective transparent/translucent view schematic representation of the device 100 positioned on the distal end of an endoscope 200 is shown, according to an embodiment.
  • Distal portion 1 is shown wi th a cap configuration of front barrel 7 described above.
  • Proximal portion 3 is shown with its direction of translation relative to the scope (shown by an arrow indicating axial movement (along the central axis of the scope), and a separate arrow indicating rotational movement).
  • Front barrel 7 extends distally to form a partially enclosed volume distal to the distal tip of the endoscope 200.
  • Front barrel 7 and/or the entire device 100 may be comprised of a translucent material (but does not have to be) to allow visualization through the device 100 itself.
  • an external torque can be applied to the scope which could translate to the device 100 through the fixed attachment (e.g., friction fit, clip, flange into slot, etc.) of distal portion 1 via front barrel 7 and can cause the device to expand or contract; expansion can be achieved by the mechanics of body portion 2 when opposing friction/interference with the colonic wall is exerted on support members 5.
  • This can allow the end-user to selectively expand or contract the device 100 independent and/or in addition to its natural expansion and retraction due to axial motion (forward or backward). This could be especially useful during stabilization or to foreshorten the colonic tract.
  • a finite element analysis schematic representation shows a displacement graph of an embodiment of the device 100 in its inverted state (forward collapse).
  • the largest displacement is seen at the control arm apertures ⁇ and the proximal portion 3.
  • FIGS. 6A-C stress plot schematic representations are shown during the inversion cycle (retraction, active searching by the medical practitioner). The majority of the stress is seen at connections 4a and 4b in the form of bending stress. The model shows selfintersection of control arms 5 which is an artifact of model error.
  • FIGS. 6D-F representations of the device 100 attached to a scope 200 are shown during the inversion cycle through the colon 300.
  • the device 100 is shown in its inverted state (forward collapse - to make easier to move through the patient’s anatomy), as it is retracted out of the colon 300 during active searching by a practitioner.
  • a constant radial force of body 2 is provided, which is independent of diameter (expansion or retraction; and which can change via axial movement of the device within a patient’s body and/or via axial movement of the device), and allows the medical practitioner to conduct the procedure more effectively and efficiently with the ability to further/independently change the diameter via axial movement (to expand or retract the diameter of the device 100).
  • FIG. 7 A stress plots in a schematic representation of the device 100 are shown during the extension cycle (‘collapse’ during insertion - to make easier to move through a patient’s anatomy). Again, stress is seen primarily at the connections 4a and 4b, but also at the distal arm apex 8.
  • FIGS. 7B-C representations of the device 100 attached to a scope 200 are shown during the extension cycle through the colon 300.
  • the device 100 is shown in its collapsed state during insertion into the colon 300 (rearward collapse) by a practitioner.
  • the stresses shown do not exceed the elastic limit of the device 100 material.
  • the material can have some elastomeric property to achieve this such as silicones in the 30-100 Shore A hardness ranges (which were tested and should be understood by a person of ordinary 7 skill in the art in conjunction with a review of this disclosure).
  • FIGS . 8A-C side view schematic representations of device 100 ! , 100 G , and 100 ni , respectfully, are shown according to alternative embodiments.
  • FIGS. 9A-B front and rear perspective view schematic representations of device 100 IV , respectfully, are shown according to an alternative embodiment.
  • the proximal end portion 3 of device 100 lv is not included and the proximal end is not coupled to the scope 200.
  • the mechanics of device 100 can behave similarly, but with less stability between individual support members 5.
  • the body portion can have less radial force, and be more prone to splay or deform.
  • the support members 5 can further unwind and extend distal to front barrel 7 to become spiraling arms extending distally from the distal portion of the device. These can likely be visible in the endoscopic view, yet still possess both a radial and rotational aspect of motion.
  • FIGS. 10A-B side view schematic representations of device 100 Vi , respectfully, are shown according to alternative embodiments.
  • support members 5 are attached at one end to the proximal end of the proximal end portion 3.
  • This collapsible device 100 VI with a cage structure represents alternate embodiments that can be similar in many ways to the design 100 discussed above, wdth some differences resulting from some of the illustrated structural differences.
  • angle ⁇ p can be >90° which can lead to a different collapse mechanism, which relies less on twisting and more on bending at proximal connection 4b.
  • the device can take on a ‘donut’ or ‘apple’ shape during retraction.
  • a method or device that “comprises”, “has”, “includes” or “contains” one or more steps or elements Likewise, a step of method or an element of a device that “comprises”, “has”, “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in w'ays that are not listed.

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Abstract

Devices for improving adenoma detection during a colonoscopy and, more particularly, to devices positionable at a distal end of an endoscope and structured or configured to expand and retract upon longitudinal or rotational displacement of at least a portion of the device about the endoscope.

Description

DEVICES FOR IMPROVING ADENOMA DETECTION
BACKGROUND
1. Field
[0001] The present disclosure relates to devices for improving adenoma detection during a colonoscopy and, more particularly, to devices positionable at a distal end of an endoscope and structured and/or configured to expand and retract upon longitudinal or rotational displacement of at least a portion of the device about the endoscope.
2. Description of Related Art
[0002] Adenomatous polyps (adenomas) are benign polyps or growths on the lining of the colon or rectum, which could become cancerous. Adenoma Detection Rate (ADR) is a measure of how consistently an endoscopist can the identify polyps in the gastrointestinal (GI) tract during a colonoscopy. ADR is sometimes also measured in terms of Adenomas Per Colonoscopy (APC). A facilities ADR is a function of the ease of identification of polyps, the tools used for inspection (colonoscope, assistive devices) and the physician’s ability to recognize lesions. Higher definition video can aid ADR rate, as can experience and training on the physician side. Recently, adjunct tools / methods have been developed to improve ADR rates, including image recognition (Al) assisted identification, mechanical distension, and additional optical fields of view. Several studies have supported that ADR devices can improve ADR rates, possibly resulting in earlier cancer identification and decreased treatment costs to the patient and hospital in the future.
[0003] Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents/publications/products are prior art for patent law purposes. For example, some or all of the discussed patents/publications/products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section and/or throughout the application, the descriptions/disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies). BRIEF SUMMARY
[0004] The inventor(s) recognize that colon (large bowel) anatomy varies widely and factors such as tortuosity, topology, existing morbidity, and size can all affect an endoscopist’s ability to recognize potentially malignant adenomas. When withdrawing a forward viewing colonoscope during a procedure, a physician’s view is oriented proximally along the colonic lumen, which can create blind spots behind bumps, folds, or twists in the receding anatomy. This can be further exacerbated by a colonoscope’ s limited field of view of -140°, which mandates that an endoscopist manipulate their scope at an angle to the lumen’s axis to get a close up, en-face examination of the tissue. When doing this, the opposing sides of the lumen are in a blind spot, meaning that the endoscopist is selectively losing visualization in one direction to gain visualization in another direction. Current solutions on the market may not fully contact the walls of the GI tract due to a small axial envelope. In addition, conventional devices do not ensure uniform radial force applied to colonic walls and can create ‘gaps’ as the device arms can splay easily. Accordingly, there is a need in the art for an improved device for detecting adenomas during a colonoscopy.
[0005] It is therefore a principal object and advantage of embodiments of the present disclosure to provide devices for improving adenoma detection during a colonoscopy that eliminate one or more of the problems/issues/deficiencies associated with conventional devices. The devices of an embodiment can also be used during EMR, ESD (resection and dissection) for stabilization or enteroscopy to help “reduce” scope position. In particular, the present disclosure is directed to embodiments of inventive devices positionable at a distal end of an endoscope and structured or configured to expand and retract upon longitudinal or rotational displacement about the endoscope. A non-limiting goal associated with the inventive device embodiments is to mechanically manipulate the GI tract during a colonoscopy to improve visualization and detection of adenomas and to stabilize the colonoscope (including the tip of the scope) during endoscopic procedures. Stabilization of the tip of the scope to limit movement of the scope tip relative to the GI tract wall dampens the effects of peristalsis on desired scope position. Further, embodiments of the device are configured to distend, smooth, and regulate the bowel (including colonic folds) to identify aberrations more easily in tissue topology. Finally, a tip of the device can be used as a scope cap, creating a longitudinally extended annular portion around a perimeter of the endoscope which can be used for suction or manipulation of tissue during a procedure. [0006] As further described and illustrated with reference to the figures below, embodiments of the disclosure provide devices that improve visualization and stabilization using a spiral cage structure that is both fixedly and slidably coupleable to an endoscope. According to an embodiment, a distal portion of the device can be fixedly attached to the scope tip in the manner of a cap or nozzle, which extends forward geometry (and annular ring/tube) into the camera’s field of view. A proximal portion of the device can be slidably coupled to the shaft of the endoscope, limiting radial displacement but allowing rotational and longitudinal (axial) movement. The main body of the device can be comprised of a twisted cage that expands and retracts with longitudinal and/or rotational displacement of the rear coupling relative to the front coupling. The diameter of the cage can be influenced by the degree of twist deformation of the individual support members. Individual support members can be designed to elongate when the device is inserted (force is exerted on the proximal face of the device and cage in a distal vector) and to invert and bend when the device is retracted (force is exerted on the distal and outer faces of the device in the proximal direction). In the former description, distal and proximal are defined relative to the device, which is inverted from the frame of reference of the duct.
[0007] Embodiments of the device can help to smooth and distend bumps, folds, and divots in a patient’s colonic wall that create blind spots; center the endoscope in the lumen to eliminate bias of the camera due to tortuosity; adjust tissue tension during examination and manipulation of local tissue; and manipulate (through suction or direct contact) tissue in front of the scope using an annular cap.
[0008] Additional advantages over conventional devices provided by devices of embodiments described and illustrated herein include consistent radial force transmission around the full or substantially full (80-99%) device circumference; a slight torque exerted by the device during retraction that helps to smooth spiral patterned folds found in the colon; an ability to actively expand or collapse a section of contacted lumen by twisting the scope; protection of the scope camera outside of the patient (tip protector); and integrated scope cap that can facilitate tissue suction and manipulation.
[0009] These and other aspects of the embodiments of this disclosure will be apparent from and elucidated with reference to the embodiment s) described hereinafter. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS)
[0010] Embodiments of the present disclosure will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the disclosed subject matter and are therefore not to be considered limiting of its scope, for the disclosed subject matter may admit to other equally effective embodiments. Reference is now made briefly to the accompanying drawings, in which:
[0011] FIG. 1 A is a side view schematic representation of a device for improving adenoma detection according to an embodiment.
[0012] FIG. 1B is a distal end perspective view schematic representation of a device for improving adenoma detection according to an embodiment.
[0013] FIG. 2 is a distal end view schematic representation of a device for improving adenoma detection according to an embodiment.
[0014] FIG. 3 A is a distal end view schematic representation of the distal end portion of a device for improving adenoma detection according to an embodiment.
[0015] FIG. 3B is a side view schematic representation of the distal end portion of a device for improving adenoma detection according to an embodiment.
[0016] FIG. 4 is a side perspective transparent/translucent view schematic representation of the device positioned on the distal end of an endoscope according to an embodiment.
[0017] FIG. 5 is a finite element analysis schematic representation showing a displacement graph of an embodiment of the device.
[0018] FIG. 6A is a stress plot schematic representation of the device during the inversion cycle according to an embodiment.
[0019] FIG. 6B is a stress plot schematic representation of the device during the inversion cycle according to an embodiment.
[0020] FIG. 6C is a stress plot schematic representation of the device during the inversion cycle according to an embodiment.
[0021] FIG. 6D is a representation of the device attached to an endoscope during the inversion cycle according to an embodiment.
[0022] FIG. 6E is a representation of the device attached to an endoscope during the inversion cycle according to an embodiment.
[0023] FIG. 6F is a representation of the device attached to an endoscope during the inversion cycle according to an embodiment. [0024] FIG. 7A is a representation of stress plots in a schematic representation of the device shown during the extension cycle according to an embodiment.
[0025] FIG. 7B is a representation of the device attached to an endoscope during the extension cycle according to an embodiment.
[0026] FIG. 7C is a representation of the device attached to an endoscope during the extension cycle according to an embodiment.
[0027] FIG. 8A is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
[0028] FIG. 8B is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
[0029] FIG. 8C is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
[0030] FIG. 9A is a front view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
[0031] FIG. 9B is a rear view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
[0032] FIG. 10A is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
[0033] FIG. 10B is a side view schematic representation of a device for improving adenoma detection according to an alternative embodiment.
DETAILED DESCRIPTION
[0034] Aspects of the present embodiments and certain features, advantages, inventive features, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the inventive features of the embodiments in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the inventive features of the embodiments, are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and/or arrangements, within the spirit and/or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.
[0035] While embodiments of the disclosure have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by one skilled in the art that various changes in detail may be affected therein without departing from the spirit and scope of the inventive features of the embodiments as defined by claims that can be supported by the written description and drawings. Further, where exemplary embodiments are described with reference to a certain number of elements or number/order of steps it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements or number/order of steps. If elements are shown in a particular Figure discussed below are not specifically identified with respect to that Figure, the elements should be sufficiently identified with respect to at least one other Figure (and/or as should be appreciated by a person of ordinary skill in the art with reference to this disclosure).
[0036] Referring now to the figures, wherein like reference numerals refer to like parts throughout, FIGS. 1A, 1B, and 2 are a side isometric view schematic representation, a distal end perspective view schematic representation, and a distal end view schematic representation, respectively, of a device 100 for improving adenoma detection according to an embodiment.
[0037] Referring to FIG. 1A, device 100 includes a distal end portion 1, a proximal end portion 3, and a body portion 2 positioned therebetween. Body portion 2 includes support members 5 which are structured and/or positioned at specific (preferably at rest) angles a, 0, 0, and cp which control or affect certain mechanics/functionality of device 100. Support members 5 can be connected to the distal portion 1 and to the proximal portion 3 via connections 4a and 4b (or directly fused or integrally formed with), respectively. Support members 5 can be configured and adapted to deflect radially and rotationally with respect to central axis 6. FIG. 1A provides an isometric view to show a 3D curvature of support members 5.
[0038] Referring to FIG. 1B, device 100 can be structured and configured to be fixedly attached to an endoscope/colonoscope 200 (see FIG. 4) via compression and friction exerted by open front/distal barrel 7 (or heat shrink, adhesive or other means of fixation as should be understood by person of ordinary skill in the art in conjunction with a review ofthis disclosure), and slidably coupled to the endoscope/colonoscope via open rear/proximal barrel 8 (each of the barrels 7 and § can be annular shaped having an inner, outer, front, and rear surface). Proximal barrel 8 can have an inner aperture configured, structured and adapted to move, translate, and rotate along the outer diameter of the endoscope/colonoscope 200 (which can have a larger inner diameter vs. the distal barrel 7). The fixed attachment of distal barrel 7 prevents the device 100 from decoupling from the endoscope prematurely. A distally extending portion of distal barrel 7 can be substantially circular and can (but does not have to) protrude past the distal face of the endoscope/colonoscope by a sufficient amount (e.g., at least 0.1mm) to create an annular structure around the circumference of the scope 200. In the embodiment where the annular portion of front barrel 7 is of closed form, it may be used to provide an extended cavity in front of the endoscope/colonoscope that can be used for suctioning or manipulating tissue. Distal barrel 7 / distal portion 1 may have non-symmetric features or radial apertures that can aid in tissue manipulation. In accordance with an alternative embodiment, the respective functionalities, and relative fixed/movable configuration of distal barrel 8 and proximal barrel 7 can be switched, while the device as a whole continues to be configured to perform the same/similar overall functionalities.
[0039] Referring to FIG. 2, support members 5 are coupled to distal portion 1 at an angle 6 relative to a vector extending perpendicularly from central axis 6. The particular angle 9 and related configuration can control certain mechanics of the device 100 as described herein. Distal barrel 7 can be made of an elastic or plastic material (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure) and can be designed to have an interference fit with the outer diameter of the endoscope/colonoscope 200 to achieve fixation.
[0040] Referring to each of FIGS. 1A, 1B, and 2, the aforementioned mechanics of the device 100 can be dictated, at least in part, by one or more angles a, p, 9, <p, and the cross section of support members 5. The cross section of support members 5 may be of constant or variable thickness. The degree of resistance to rotational twist of body 2 can largely be controlled by the sectional modulus of support members 5, and the angles p and 9. In some embodiments, thickening cross section base 5a will increase rotational stiffness significantly. In some embodiments, increasing angle 0 will decrease rotational stiffness in the direction of 9 and increase the degree of rotation during collapse or expansion. Increasing angle p can also decrease rotational stiffness and increase the degree of rotation during collapse or expansion. Increasing angles p, 0 can create a larger radius 9 which increases contact area of control arm apex 18 with the colonic wall. Increasing angles P, 0 will also decrease the radial component of force exerted by control arm apex 8 when the arms invert (defined as when a > 90°). The degree of radial force exerted by body 2 can be controlled by the sectional modulus of support members 5, and the angles a, p, q>, and 0. Decreasing angles 3 and 0 will increase radial stiffness. Angles of a closest to 90° can maximize radial stiffness, increasing thickness 5b of section modulus of 2 can increase radial resistance. Increasing the radius 9 of control arm apex 8 can (in general) decrease radial resistance. Angles of a < 90° can decrease radial stiffness but increase resistance to inversion. Angles of a > 90° can decrease radial stiffness and decrease resistance to inversion. In general, decreasing angle cp can decrease radial stiffness. In one embodiment, the angles and sectional modulus are preferably not independent variables, and thus lower order interactions can also dictate mechanics of the device.
[0041] In accordance with an embodiment, the values of a, p, 9, <p, and control arm 5 section modulus and their interactions can be configured and adapted to achieve the following attributes of the device 100: 1) near constant radial force of body 2 independent of diameter (expansion), 2) easy inversion of support members 5 when force is exerted on body 2 in the distal direction (collapse); 3) easy extension of support members 5 when force is exerted on body 2 in the proximal direction (extension); and 4) torque exerted by support member apex 8 < radial force exerted by support member apex 18 but > 0.
[0042] Turning to FIGS. 3A-B, a distal end view schematic representation of the distal end portion 1 of the device 100 and a side view schematic representation of the distal portion 1 of the device 100 are shown, respectively, according to an embodiment. Distal portion 1 can incorporate inward protrusions 10 on front barrel 7 to decrease hoop strength and sensitivity of compressive force to diameter. This concentrates hoop strength onto specific detents which increases stress in the detents allowing for higher deformation at a local level and less expansion of the hoop at a macro level. It also creates some bending stress in the hoop depending on the degree of rigidity of the material. Front barrel 7 may also incorporate radial apertures 11 in place of or addition to inward protrusions 10 to decrease hoop strength.
[0043] Referring to FIG. 4, a side perspective transparent/translucent view schematic representation of the device 100 positioned on the distal end of an endoscope 200 is shown, according to an embodiment. Distal portion 1 is shown wi th a cap configuration of front barrel 7 described above. Proximal portion 3 is shown with its direction of translation relative to the scope (shown by an arrow indicating axial movement (along the central axis of the scope), and a separate arrow indicating rotational movement). Front barrel 7 extends distally to form a partially enclosed volume distal to the distal tip of the endoscope 200. Front barrel 7 and/or the entire device 100 may be comprised of a translucent material (but does not have to be) to allow visualization through the device 100 itself. Referring to the endoscope portion 200, an external torque (twisting) can be applied to the scope which could translate to the device 100 through the fixed attachment (e.g., friction fit, clip, flange into slot, etc.) of distal portion 1 via front barrel 7 and can cause the device to expand or contract; expansion can be achieved by the mechanics of body portion 2 when opposing friction/interference with the colonic wall is exerted on support members 5. This can allow the end-user to selectively expand or contract the device 100 independent and/or in addition to its natural expansion and retraction due to axial motion (forward or backward). This could be especially useful during stabilization or to foreshorten the colonic tract.
[0044] Referring to FIG. 5, a finite element analysis schematic representation shows a displacement graph of an embodiment of the device 100 in its inverted state (forward collapse). In some embodiments, the largest displacement is seen at the control arm apertures § and the proximal portion 3.
[0045] Referring to FIGS. 6A-C, stress plot schematic representations are shown during the inversion cycle (retraction, active searching by the medical practitioner). The majority of the stress is seen at connections 4a and 4b in the form of bending stress. The model shows selfintersection of control arms 5 which is an artifact of model error.
[0046] Turning to FIGS. 6D-F, representations of the device 100 attached to a scope 200 are shown during the inversion cycle through the colon 300. The device 100 is shown in its inverted state (forward collapse - to make easier to move through the patient’s anatomy), as it is retracted out of the colon 300 during active searching by a practitioner. As discussed above, a constant radial force of body 2 is provided, which is independent of diameter (expansion or retraction; and which can change via axial movement of the device within a patient’s body and/or via axial movement of the device), and allows the medical practitioner to conduct the procedure more effectively and efficiently with the ability to further/independently change the diameter via axial movement (to expand or retract the diameter of the device 100).
[0047] Referring to FIG. 7 A, stress plots in a schematic representation of the device 100 are shown during the extension cycle (‘collapse’ during insertion - to make easier to move through a patient’s anatomy). Again, stress is seen primarily at the connections 4a and 4b, but also at the distal arm apex 8.
[0048] Turning to FIGS. 7B-C, representations of the device 100 attached to a scope 200 are shown during the extension cycle through the colon 300. The device 100 is shown in its collapsed state during insertion into the colon 300 (rearward collapse) by a practitioner.
[0049] With respect to FIGS. 6A-7C, the stresses shown do not exceed the elastic limit of the device 100 material. The material can have some elastomeric property to achieve this such as silicones in the 30-100 Shore A hardness ranges (which were tested and should be understood by a person of ordinary7 skill in the art in conjunction with a review of this disclosure). [0050] Referring to FIGS . 8A-C, side view schematic representations of device 100!, 100G, and 100ni, respectfully, are shown according to alternative embodiments. These alternative embodiments include differences in the number of support members 5, thickness of support members/control arm 5, a, 0, <p, and 9 angles and control arm 5 section modulus (and such variations are described above with respect to the mechanics/associated functionality of the device 100; see, e.g., FIG. 1). Each ofthese configurations possess different radial force values, ease of inversion, and maximum diameters 12 (see FIG. 8C).
[0051] Referring to FIGS. 9A-B, front and rear perspective view schematic representations of device 100IV, respectfully, are shown according to an alternative embodiment. The proximal end portion 3 of device 100lv is not included and the proximal end is not coupled to the scope 200. In this configuration, the mechanics of device 100 can behave similarly, but with less stability between individual support members 5. The body portion can have less radial force, and be more prone to splay or deform. After a certain amount of inversion, wherein the support members 5 were pushed in the distal direction and inversion was achieved, the support members 5 can further unwind and extend distal to front barrel 7 to become spiraling arms extending distally from the distal portion of the device. These can likely be visible in the endoscopic view, yet still possess both a radial and rotational aspect of motion.
[0052] Referring to FIGS. 10A-B, side view schematic representations of device 100Vi, respectfully, are shown according to alternative embodiments. As shown, support members 5 are attached at one end to the proximal end of the proximal end portion 3. This collapsible device 100VI with a cage structure represents alternate embodiments that can be similar in many ways to the design 100 discussed above, wdth some differences resulting from some of the illustrated structural differences. For example, angle <p can be >90° which can lead to a different collapse mechanism, which relies less on twisting and more on bending at proximal connection 4b. This can lead to less axial extension and retraction on the endoscope and can lead to a design in which body 2 and support members 5 do not invert as much or at all during retraction. The device can take on a ‘donut’ or ‘apple’ shape during retraction.
[0053] While embodiments of the disclosure have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by one skilled in the art that various changes in detail may be affected therein without departing from the spirit and scope of the inventive features of the embodiments as defined by claims that can be supported by the written description and drawings. Further, where exemplary embodiments are described with reference to a certain number of elements it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements.
[0054] While various embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.
[0055] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the inventive features of the embodiments. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as, “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises”, “has”, “includes” or “contains” one or more steps or elements. Likewise, a step of method or an element of a device that “comprises”, “has”, “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in w'ays that are not listed. [0056] The corresponding structures, materials, acts and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material or act for performing the function in combination with other claimed elements as specifically claimed. Descriptions of the embodiments have been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the inventive features of the embodiments in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the inventive features of the embodiments. The embodiments were chosen and described in order to best explain the principles of one or more aspects of the inventive features of the embodiments and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the inventive features for various embodiments with various modifications as are suited to the particular use contemplated.

Claims

Claims
1. A device for improving adenoma detection, comprising: an annular shaped distal end portion positionable in a fixed relation to a distal end of an endoscope having a central longitudinal axis positioned therethrough; an annular shaped proximal end portion slidably attachable to the endoscope proximally to the distal end portion; and a body portion positioned therebetween, wherein the body portion comprises at least one support member having a first end and a second end, wherein: the first end is attached to the distal end portion and the second end is attached to the proximal end portion; and the at least one support member is configured or structured to deflect radially or rotationally forming a first dynamic angle between the at least one support member and the distal end portion or the proximal end portion.
2. The device of claim 1, wherein the support member is coupled to the distal end portion at an angle 0 relative to a vector extending perpendicularly from the central longitudinal axis.
3. The device of claim 2, wherein increasing the angle 0 decreases a rotational stiffness of the device.
4. The device of claim 2, wherein decreasing the angle 0 increases a degree of rotation of the device.
5. The device of claim 1, wherein the at least one support member is configured to invert with respect to the body when a force is exerted on the body in a direction of the distal end.
6. The device of claim 1, wherein the at least one support member is configured to extend with respect to the body when a force is exerted on the body in a direction of the proximal end.
PCT/US2024/052584 2023-10-23 2024-10-23 Devices for improving adenoma detection Pending WO2025090620A1 (en)

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JP2003180611A (en) * 2001-12-18 2003-07-02 Olympus Optical Co Ltd Insertion aid for endoscope
CN106137482A (en) * 2015-04-27 2016-11-23 浦易(上海)生物技术有限公司 A kind of nasal sinuses support and induction system
WO2016209240A1 (en) * 2015-06-25 2016-12-29 Medivators Inc. Expandable fitting for a medical scoping device
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