Biopsy forceps for object removal in body lumen

Abstract

A biopsy forceps device for object removal in a body lumen includes a shaft assembly with a spiral-wound shaft, a spring at the distal end, and at least one pull wire. A handle assembly actuates the pull wire. A jaw assembly at the distal end comprises first and second jaws with serrated cutting edges along a majority of each jaw's periphery. A needle between the jaws anchors the assembly to a target surface. The pull wire causes the jaws to pivot between closed and open positions. The spring enables the jaw assembly to deflect so the jaws can be positioned perpendicular to the target surface.

Description

BIOPSY FORCEPS FOR OBJECT REMOVAL IN BODY LUMENCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of priority to United States Provisional Patent Application Serial No. 63 / 764,401, filed February 27, 2025, the entirety of which is incorporated herein by reference.FIELD OF THE INVENTION

[0002] The present disclosure relates to medical devices used in endoscopic procedures for the removal of tissue and foreign bodies from body lumens, especially but not limited to in the gastrointestinal tract.BACKGROUND

[0003] Endoscopic procedures such as colonoscopies and upper gastrointestinal endoscopies are commonly performed medical procedures that allow physicians to visualize and access internal body lumens for diagnostic and therapeutic purposes. During these procedures, physicians frequently encounter tissue abnormalities, polyps, and other growths that require sampling or removal. Colorectal polyps, for example, are abnormal growths that form on the lining of the colon or rectum, and removal of these polyps through polypectomy procedures can reduce the risk of colorectal cancer development. Biopsy forceps are specialized instruments designed to grasp and extract small tissue samples from within body lumens during endoscopic procedures. These instruments typically comprise an elongated flexible shaft that can be advanced through the working channel of an endoscope, with a jaw assembly at the distal end configured to open and close for grasping tissue.

[0004] Conventional biopsy forceps generally have a fixed orientation of the jaw assembly relative to the longitudinal axis of the shaft. When tissue surfaces are oriented perpendicular to the approach angle of the forceps, conventional instruments can effectively engage and sample the tissue. However, anatomical structures within the gastrointestinal tract and other body lumens present tissue surfaces at various orientations relative to the endoscope and any instruments advanced through the endoscope working channel. Tissue located on curved surfaces, in recessedareas, or at angles relative to the instrument approach direction can be difficult to access with conventional forceps having fixed jaw orientations. In such situations, the forceps may approach the tissue at an oblique angle rather than perpendicular to the tissue plane, which can result in superficial sampling rather than full-thickness tissue acquisition.

[0005] The quality of tissue samples obtained during biopsy procedures affects the accuracy of subsequent histopathologic examination and diagnosis. Samples that are too superficial, fragmented, or improperly oriented may provide insufficient tissue architecture for pathologists to render accurate diagnoses. When initial biopsy attempts yield inadequate samples, repeat procedures may be required, which increases procedure time, patient discomfort, and healthcare costs. Additionally, polyps located in anatomically challenging areas may be difficult to grasp securely with conventional forceps, potentially resulting in incomplete removal or a desire for alternative removal techniques.

[0006] Various approaches have been developed to address maneuverability limitations in endoscopic instruments. Some instruments incorporate mechanisms for deflecting or articulating the distal end of the instrument relative to the shaft. Other instruments include rotational capabilities that allow the distal end to be oriented in different directions. Handle configurations have been developed that provide physicians with controls for manipulating instrument orientation during procedures. Despite these developments, there remains interest in endoscopic biopsy instruments that can effectively access and sample tissue in anatomically challenging locations while maintaining compatibility with standard endoscope working channels and providing intuitive operation for physicians.BRIEF SUMMARY

[0007] According to an aspect of the present disclosure, a biopsy forceps device for object removal in a body lumen is provided. The biopsy forceps device includes a shaft assembly extending from a proximal end to a distal end along a longitudinal axis. The shaft assembly comprises a spiral-wound shaft, a spring coupled to the spiral-wound shaft at the distal end of the shaft assembly, and at least one pull wire disposed within the spiral-wound shaft. A handle assembly is coupled to the proximal end of the shaft assembly. The handle assembly is configured to actuate the at least one pull wire. A jaw assembly is coupled to the distal end of the shaft assembly. The jaw assembly comprises a first jaw and a second jaw. At least one of the first andsecond jaws comprises a serrated cutting edge extending along a majority of a periphery of the jaw. A needle extends along the longitudinal axis between the first and second jaws. The needle is configured to anchor the jaw assembly to a target surface in the body lumen. The first and second jaws are operably coupled to the at least one pull wire such that actuation of the at least one pull wire causes the first and second jaws to pivot about a hinge axis between a closed position and an open position. The spring is configured to enable the jaw assembly to deflect relative to the longitudinal axis such that the first and second jaws are positionable substantially perpendicular to the target surface.

[0008] According to another aspect of the present disclosure, a method of removing an object from a body lumen is provided. The method comprises advancing a biopsy forceps device through the body lumen. The biopsy forceps device comprises a shaft assembly extending along a longitudinal axis and a jaw assembly at a distal end of the shaft assembly. The jaw assembly has a first jaw and a second jaw configured to pivot about a hinge axis between a closed position and an open position. A needle extends between the first and second jaws. The method comprises deploying the jaw assembly from the shaft assembly and pivoting the first and second jaws to the open position. The method comprises deflecting the jaw assembly relative to the longitudinal axis via a spring coupled to the shaft assembly. The method comprises positioning the first and second jaws relative to a target surface in the body lumen. The method comprises anchoring the object with the needle. The method comprises grasping the object with the first and second jaws by transitioning the first and second jaws to the closed position. The method comprises cutting the object via a serrated cutting edge disposed along a majority of a periphery of at least one of the first and second jaws. The method comprises withdrawing the biopsy forceps device from the body lumen.

[0009] According to other aspects of the present disclosure, the method may include one or more of the following features. The object may comprise a polyp. The polyp may comprise a pedunculated polyp, a sub-pedunculated polyp, a sessile polyp, or a flat polyp. The object may comprise a tissue sample. The object may comprise a foreign body. Advancing the biopsy forceps device may comprise advancing the biopsy forceps device through a channel of an endoscope. Positioning the first and second jaws relative to the target surface may comprise positioning the first and second jaws substantially perpendicular to the target surface. Transitioning the first and second jaws to the closed position may comprise actuating at least one pull wire along thelongitudinal axis, the at least one pull wire operably coupled to the jaw assembly. Transitioning the first and second jaws to the closed position may comprise actuating a first pull wire and a second pull wire, each pull wire coupled to a respective jaw of the first and second jaws. Cutting the object may comprise engaging the object via serrated cutting edges of both the first and second jaws. Withdrawing the biopsy forceps device may further comprise retracting the jaw assembly into the shaft assembly after transitioning the first and second jaws to the closed position. The shaft assembly may comprise a spiral-wound shaft coupled to the spring. Positioning the first and second jaws relative to the target surface may comprise approaching the object along the longitudinal axis of the shaft assembly. Grasping the object with the first and second jaws may comprise cold resection of the object without application of thermal energy.

[0010] According to another aspect of the present disclosure, a biopsy forceps device for object removal in a body lumen is provided. The biopsy forceps device includes a shaft assembly extending from a proximal end to a distal end along a longitudinal axis. The shaft assembly comprises a spiral-wound shaft and at least one pull wire disposed within the spiral-wound shaft. A handle assembly is coupled to the proximal end of the shaft assembly. The handle assembly is configured to actuate the at least one pull wire. A jaw assembly is coupled to the distal end of the shaft assembly. The jaw assembly comprises a first jaw and a second jaw. At least one of the first and second jaws comprises a serrated cutting edge extending along a majority of a periphery of the jaw. A needle extends along the longitudinal axis between the first and second jaws. The needle is configured to anchor the jaw assembly to a target surface in the body lumen. A hinge is positioned between the shaft assembly and the first and second jaws. The first and second jaws are operably coupled to the at least one pull wire such that actuation of the at least one pull wire causes the first and second jaws to pivot about a hinge axis between a closed position and an open position. The hinge is configured to enable the jaw assembly to deflect relative to the longitudinal axis such that the first and second jaws are positionable substantially perpendicular to the target surface.

[0011] The foregoing general description of the illustrative embodiments and the following detailed description thereof are merely exemplary aspects of the teachings of this disclosure and are not restrictive.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:

[0013] FIG. 1 illustrates a perspective view of a biopsy forceps device, according to aspects of the present disclosure;

[0014] FIG. 2 illustrates a perspective view of the biopsy forceps device of FIG. 1, in a straightened configuration;

[0015] FIG. 3 illustrates an exploded view of the biopsy forceps device of FIG. 2;

[0016] FIG. 4 illustrates a side view of a shaft assembly of the biopsy forceps device of FIG.2;

[0017] FIG. 5 illustrates a cross-sectional view of the shaft assembly taken along line 5-5 of FIG. 4;

[0018] FIG. 6 illustrates an isometric view of a handle assembly of the biopsy forceps device of FIGS. 1-2;

[0019] FIG. 7 illustrates a top view of the handle assembly of FIG. 6;

[0020] FIG. 8 is an enlarged exploded view of Detail 8 of FIG. 3 showing a distal portion of the shaft assembly;

[0021] FIG. 9 illustrates an isometric view of a jaw of the jaw assembly of FIG. 8;

[0022] FIG. 10 illustrates an isometric view of a portion of a needle of the jaw assembly of FIG. 8;

[0023] FIG. 11 illustrates a perspective view of the biopsy forceps device of FIG. 2 with the jaw assembly in a closed position;

[0024] FIG. 12 illustrates an enlarged view of Detail 12 of FIG. 11 showing the jaw assembly in a closed position;

[0025] FIG. 13 illustrates a perspective view of the biopsy forceps device of FIG. 2 with the jaw assembly in an open position;

[0026] FIG. 14 illustrates an enlarged view of Detail 14 of FIG. 13 showing the jaw assembly in an open position;

[0027] FIG. 15 illustrates a perspective view of the biopsy forceps device of FIG. 1 within a body lumen, according to aspects of the present disclosure;

[0028] FIG. 16 illustrates an isometric view of the jaw assembly of FIG. 15 engaging tissue within the body lumen; and

[0029] FIG. 17 illustrates an isometric view of the biopsy forceps device of FIGS. 15-16 in operation within the body lumen.DETAILED DESCRIPTION

[0030] Before the present devices and methods are described, it is to be understood that the present disclosure is not limited to the particular processes, compositions, or methodologies described, as these may vary. It is also to be understood that the terminology used in the description is for the purposes of describing the particular versions or embodiments only, and is not intended to limit the scope of the present disclosure.

[0031] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, the methods, devices, and materials in some embodiments are now described. All publications disclosed herein are incorporated by reference in their entireties. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such disclosure by virtue of prior invention.

[0032] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified unless clearly indicated to the contrary. Thus, as a nonlimiting example, a reference to “A and / or B,” when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A without B (optionally including elements other than B); in another embodiment, to B without A (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0033] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0034] Features of the present invention(s) may be implemented in software, hardware, firmware, or combinations thereof. In particular, the various units that form a part of the control circuit described herein may comprise software, hardware, firmware, and combinations thereof. Each such “unit” may comprise its own processor, or it may be coupled to a processor that is used for all components of the control circuit, or some combination of this may occur. The computer programs described herein are not limited to any particular embodiment, and may be implemented in an operating system, application program, foreground or background processes, driver, or any combination thereof. The computer programs may be executed on a single computer or server processor or multiple computer or server processors.

[0035] Processors (also referred to as controllers or control units) described herein may be any central processing unit (CPU), microprocessor, micro-controller, computational, or programmable device or circuit configured for executing computer program instructions (e.g., code). Various processors may be embodied in computer and / or server hardware of any suitable type (e.g., desktop, laptop, notebook, tablets, cellular phones, etc.) and may include all the usual ancillary components necessary to form a functional data processing device including without limitation a bus, software and data storage such as volatile and non-volatile memory, input / output devices, graphical user interfaces (GUIs), removable data storage, and wired and / or wireless communication interface devices including Wi-Fi, Bluetooth, LAN, etc. In one particular embodiment, a processor unit may reside on the device (snare device as described herein) itself and all processing can be done internally and integrally on the device without limitation and without the need of any outside resource.

[0036] Computer-executable instructions or programs (e.g., software or code) and data described herein may be programmed into and tangibly embodied in a non-transitory computer-readable medium that is accessible to and retrievable by a respective processor as described herein which configures and directs the processor to perform the desired functions and processes by executing the instructions encoded in the medium. A device embodying a programmable processor configured to such non-transitory computer-executable instructions or programs may be referred to as a “programmable device,” or “device,” and multiple programmable devices in mutual communication may be referred to as a “programmable system.” It should be noted that non-transitory “computer-readable medium” as described herein may include, without limitation, any suitable volatile or non-volatile memory including random access memory (RAM) and various types thereof, read-only memory (ROM) and various types thereof, USB flash memory, and magnetic or optical data storage devices (e g., internal / external hard disks, floppy discs, magnetic tape CD-ROM, DVD-ROM, optical disk, ZIP™ drive, Blu-ray disk, and others), which may be written to and / or read by a processor operably connected to the medium.

[0037] In some embodiments, the present invention(s) may be embodied in the form of computer-implemented processes and apparatuses such as processor-based data processing and communication systems or computer systems for practicing those processes. The present invention(s) may also be embodied in the form of software or computer program code embodied in a non-transitory computer-readable storage medium, which when loaded into and executed by the data processing and communications systems or computer systems, the computer program code segments configure the processor to create specific logic circuits configured for implementing the processes.

[0038] Referring to FIGS. 1-2, a biopsy forceps device 100 for object removal in a body lumen is shown. The biopsy forceps device 100 comprises three primary assemblies that cooperate to enable tissue sampling and object retrieval during endoscopic procedures: a shaft assembly 104, a handle assembly 108, and a jaw assembly 112. The shaft assembly 104 extends from a proximal end 113 to a distal end 114 along a longitudinal axis A. The handle assembly 108 is coupled to the proximal end 113 of the shaft assembly 104. The jaw assembly 112 is coupled to the distal end 114 of the shaft assembly 104. The functional cooperation of the shaft assembly 104, the handle assembly 108, and the jaw assembly 112 enables a physician to navigate through tortuousanatomical pathways, position the jaw assembly 112 at a target site within the body lumen, and grasp tissue samples, polyps, or foreign bodies for extraction.

[0039] In contrast to the biopsy forceps device 100 described herein, conventional biopsy forceps maintain a fixed relationship between the jaw assembly and the longitudinal axis of the shaft. This configuration may present challenges when targeting tissue surfaces that are not orthogonally aligned with the instrument's trajectory. For example, when approaching curved mucosal surfaces, recessed anatomical regions, or tissue planes oriented at an angle to the instrument path, the fixed jaw orientation may cause the instrument to engage tissue tangentially. Such tangential engagement may affect the depth of tissue samples and the ability to securely grasp polyps in certain anatomical locations. The biopsy forceps device 100 addresses these considerations through a passive articulation mechanism, as described below.

[0040] The biopsy forceps device 100 addresses these limitations through a passive articulation mechanism incorporated into the shaft assembly 104. The passive articulation mechanism allows the biopsy forceps device 100 to plant the tip of the jaw assembly 112 against tissue and achieve a more orthogonal approach to the target site without requiring additional controls or active manipulation by the user. When the biopsy forceps device 100 is advanced against tissue, the passive articulation mechanism enables the jaw assembly 112 to deflect relative to the longitudinal axis of the shaft assembly 104, thereby positioning the jaw assembly 112 substantially perpendicular to the tissue plane. This perpendicular tissue engagement improves the quality of tissue samples obtained during biopsy procedures and increases diagnostic yield by enabling full-thickness tissue acquisition rather than the superficial scraping that may occur with conventional forceps approaching tissue at oblique angles.

[0041] Continuing with FIG. 1, the biopsy forceps device 100 includes a 360-degree swivel capability that allows the jaw assembly 112 to rotate fully around the longitudinal axis of the shaft assembly 104. The 360-degree swivel capability provides enhanced maneuverability when navigating complex anatomical structures and positioning the jaw assembly 112 relative to tissue surfaces oriented in multiple directions within the body lumen.

[0042] The biopsy forceps device 100 is configured for use in gastrointestinal procedures including colonoscopies and endoscopies for polyp removal and tissue sampling. The shaft assembly 104 is configured to navigate through a channel of an endoscope, and the shaft assembly104 maintains a slim shaft profile suitable for typical working channels of standard gastrointestinal scopes. The slim profile of the shaft assembly 104 enables the biopsy forceps device 100 to be deployed through conventional endoscope working channels without requiring specialized equipment or modified endoscopes. The handle assembly 108 is configured for single-hand operation, allowing a user to control deployment, positioning, and actuation of the jaw assembly 112 using one hand while manipulating the endoscope with the other hand. The single-hand operation capability of the handle assembly 108 provides a familiar interface similar to existing biopsy forceps devices, facilitating adoption of the biopsy forceps device 100 without extensive additional training.

[0043] Referring to FIGS. 2-4, the shaft assembly 104 comprises a shaft 116, a compression spring 120, at least one pull wire 124, and a flexible outer sheath 128. The shaft assembly 104 is configured for insertion through a gastrointestinal tract and for navigation through a channel of an endoscope. The shaft assembly 104 has an overall length L0 measured from the proximal terminus of the handle assembly 108 to the distal tip of the jaw assembly 112. In addition, the shaft assembly 104 has a working length LI measured from the distal end of the handle assembly 108 to the distal tip of the jaw assembly 112, representing the insertable portion of the device. In the illustrated embodiment, the working length LI is in a range of about 200 cm to about 280 cm, for example, about 240 cm. The dimensional specifications of the shaft assembly 104 enable the biopsy forceps device 100 to be deployed through conventional endoscope working channels while providing adequate length to reach target sites within the gastrointestinal tract during colonoscopy and endoscopy procedures.

[0044] The components of the shaft assembly 104 are arranged concentrically about the longitudinal axis A. The at least one pull wire 124 is disposed at the center of the shaft assembly 104 along the longitudinal axis A. The shaft 116 is disposed over the at least one pull wire 124. The compression spring 120 is coupled to the shaft 116 at the distal end 114 of the shaft assembly 104, with the shaft 116 received within the compression spring 120 at a proximal end of the compression spring 120 and the jaw assembly 112 received within the compression spring 120 at a distal end of the compression spring 120. The outer sheath 128 is disposed over the shaft 116 and the compression spring 120, encasing the internal components of the shaft assembly 104. This concentric nesting arrangement enables the shaft assembly 104 to maintain a compact outer profde while accommodating the actuation and articulation mechanisms within. In the illustratedembodiment, the at least one pull wire 124 comprises a first pull wire 124A and a second pull wire 124B, each pull wire coupled to a respective jaw of the jaw assembly 112. In some embodiments, the at least one pull wire 124 comprises a single pull wire coupled to and configured to manipulate the jaw assembly 112.

[0045] Continuing with FIG. 3, the at least one pull wire 124 is disposed within the shaft 116. The at least one pull wire 124 extends from the handle assembly 108 at the proximal end 113 of the shaft assembly 104 through the interior of the shaft 116 to the jaw assembly 112 at the distal end 114 of the shaft assembly 104. The internal routing of the at least one pull wire 124 within the shaft 116 enables actuation forces to be transmitted distally from the handle assembly 108 to the jaw assembly 112. When the handle assembly 108 actuates the at least one pull wire 124, the actuation forces travel along the length of the at least one pull wire 124 through the shaft 116 to operate the jaw assembly 112 between open and closed positions. In the illustrated embodiment, the at least one pull wire 124 comprises stainless steel. In some embodiments, the at least one pull wire 124 comprises ni tinol, tungsten, cobalt-chromium alloy, titanium, or other biocompatible materials.

[0046] The shaft assembly 104 further includes a hypotube 137 positioned over the at least one pull wire 124. The hypotube 137 is crimped to secure the at least one pull wire 124 within the shaft assembly 104. In the illustrated embodiment, the hypotube 137 includes a bent tip configured to be received in the handle assembly 108 such that a user can manipulate and actuate the at least one pull wire 124 via the handle assembly 108. The hypotube 137 maintains the position of the at least one pull wire 124 relative to the shaft 116 and provides a stable pathway for transmission of actuation forces from the handle assembly 108 to the jaw assembly 112.

[0047] Continuing with FIG. 4, the outer sheath 128 is disposed over the shaft 116. The outer sheath 128 encases the shaft 116, the compression spring 120, and the at least one pull wire 124, providing a smooth exterior surface for the shaft assembly 104. The outer sheath 128 protects the internal components of the shaft assembly 104 and facilitates passage of the shaft assembly 104 through the working channel of an endoscope. In the illustrated embodiment, the outer sheath 128 comprises a thermoplastic polymer. In some embodiments, the outer sheath 128 is manufactured by extrusion from a polyether block amide thermoplastic material, such as PEBAX. In some embodiments, the outer sheath 128 comprises alternative thermoplastic polymers includingpolyurethane, polyethylene, or other biocompatible polymers appropriate for medical device applications.

[0048] Continuing with FIG. 5, the outer sheath 128 is disposed over the shaft 116 along a majority of the working length LI and is disposed over the compression spring 120 at the distal end 114 of the shaft assembly 104. The outer sheath 128 therefore has an outer diameter DI that varies along the length of the outer sheath 128 to accommodate the compression spring 120 at the distal end 114. In the illustrated embodiment, the outer diameter DI is in a range of about 1.8 mm to about 3.0 mm, for example, about 2.4 mm.

[0049] In the illustrated embodiment, the shaft 116 comprises a spiral-wound shaft that extends along the longitudinal axis A from the proximal end 113 of the shaft assembly 104 to the distal end 114 of the shaft assembly 104. The shaft 116 transmits torque from the handle assembly 108 to the jaw assembly 112 while permitting the shaft assembly 104 to navigate through tortuous anatomical pathways within the body lumen. The spiral -wound construction of the shaft 116 therefore provides structural support while allowing for flexibility along the longitudinal axis A. In some embodiments, the shaft 116 is manufactured using coiling or laser cutting processes.

[0050] In the illustrated embodiment, the shaft 116 comprises stainless steel. In some embodiments, the shaft 116 comprises alternative materials. The shaft 116 may comprise nitinol, or other metallic alloys that provide flexibility and torque transmission characteristics appropriate for endoscopic applications. In some embodiments, the shaft 116 comprises a nickel -titanium alloy that provides shape memory properties.

[0051] The compression spring 120 is coupled to the shaft 116 at the distal end 114 of the shaft assembly 104. The compression spring 120 is positioned within the shaft assembly 104 proximal to the jaw assembly 112. The compression spring 120 has an inner diameter D2 sized such that the shaft 116 is received within the compression spring 120 at a proximal end of the compression spring 120 and the jaw assembly 112 is received within the compression spring 120 at a distal end of the compression spring 120. The compression spring 120 is configured to enable the jaw assembly 112 to deflect relative to the longitudinal axis A such that the first and second jaws of the jaw assembly 112 are positionable substantially perpendicular to the target surface. The compression spring 120 enables controlled angular deflection of the jaw assembly 112 in a range of about 5 degrees to about 120 degrees relative to the longitudinal axis A. When the biopsyforceps device 100 is advanced against tissue, the compression spring 120 compresses and deflects, allowing the jaw assembly 112 to passively articulate and achieve a more orthogonal approach to the target site without requiring active manipulation by the user. In the illustrated embodiment, the diameter D2 is in a range of about 0.2 mm to about 0.5 mm, for example, about 0.355 mm.

[0052] In the illustrated embodiment, the shaft assembly 104 includes a collar 138. The collar 138 is positioned at the proximal end 113 of the shaft assembly 104. The collar 138 couples elements of the shaft assembly 104 and provides a connection point for attachment of the shaft assembly 104 to the handle assembly 108. The collar 138 secures the proximal end of the shaft 116 and the outer sheath 128 to the handle assembly 108, enabling transmission of actuation forces and rotational inputs from the handle assembly 108 to the shaft assembly 104.

[0053] Referring to FIGS. 6 and 7, the handle assembly 108 is coupled to the proximal end 113 of the shaft assembly 104 and is configured to actuate the at least one pull wire 124. The handle assembly 108 comprises a body 136, a slider control 140, a recess 144, and a gripping portion 148 positioned at a proximal terminus of the handle assembly 108. In the illustrated embodiment, the handle assembly 108 is made from injection molded polycarbonate or ABS material. This construction provides structural rigidity while maintaining a lightweight profile suitable for extended use during endoscopic procedures.

[0054] The body 136 is an elongated housing that extends from a proximal terminus to a distal terminus of the handle assembly 108. The body 136 defines internal passages and cavities configured to receive and guide the pull wire 124, the shaft 116, and the slider control 140. Specifically, the body 136 includes a central lumen through which the pull wire 124 extends. The body 136 further includes the recess 144 along which the slider control 140 is configured to actuate. The recess 144 permits the one or more slider control 140 to translate axially along the body 136 to actuate the pull wire 124 and control deployment, retraction, and contraction of the jaw assembly 112.

[0055] The slider control 140 is configured to control deployment and retraction of the jaw assembly 112. The slider control 140 is positioned along the body 136 and is configured to translate axially relative to the body 136. The slider control 140 includes a central lumen that mechanically links the pull wire 124 with the slider control 140. The slider control 140 includes an aperture configured to receive the bent tip of the hypotube 137 within the recess 144. When theuser moves the slider control 140 along the recess 144, the bent tip of the hypotube 137 translates within the aperture, thereby actuating the at least one pull wire 124 to transition the first and second jaws between the open position and the closed position. The mechanical linkage between the slider control 140 and the at least one pull wire 124 translates longitudinal movement of the slider control 140 into corresponding longitudinal movement of the at least one pull wire 124 within the shaft assembly 104. When a user advances the slider control 140 distally relative to the body 136, the at least one pull wire 124 advances toward the distal end 114 of the shaft assembly 104 such that the first and second jaws of the jaw assembly 112 transition to the open position. When a user retracts the slider control 140 proximally relative to the body 136, the at least one pull wire 124 retracts along the longitudinal axis A such that the first and second jaws transition to the closed position. The recess 144 secures the slider control 140 to the body 136 while permitting the sliding movement of the slider control 140 relative to the body 136.

[0056] The gripping portion 148 is positioned at the proximal terminus of the handle assembly 108. The gripping portion 148 comprises a ring-shaped finger loop that allows a user to grip and manipulate the biopsy forceps device 100. The ring-shaped configuration of the gripping portion 148 enables a user to insert a finger through the gripping portion 148 and maintain secure control of the handle assembly 108 during deployment, positioning, and actuation of the jaw assembly 112. The handle assembly 108 is configured for single-hand operation, allowing a user to control deployment, positioning, and actuation of the jaw assembly 112 using one hand while manipulating the endoscope with the other hand.

[0057] The handle assembly 108 is configured to control rotation of the jaw assembly 112 about the longitudinal axis A. The handle assembly 108 is operably connected to the shaft assembly 104 such that rotational input applied to the handle assembly 108 causes corresponding rotation of the jaw assembly 112 about the longitudinal axis A. The jaw assembly 112 is configured to rotate about the longitudinal axis A through a full 360-degree range, enabling the user to orient the jaw assembly 112 relative to tissue surfaces positioned in various directions within the body lumen. The rotating function is locked when the jaw assembly 112 is in the closed position, keeping the biopsy forceps device 100 stiff when placed into the port of an endoscope. In some embodiments, the rotating function is locked via a locking mechanism on the handle assembly 108. This configuration prevents inadvertent rotation of the jaw assembly 112 during insertion of the biopsy forceps device 100 through the working channel of an endoscope. When the jaw assembly 112 istransitioned to the open position via a handheld maneuver using the slider control 140, rotation of the jaw assembly 112 about the longitudinal axis A is allowed, enabling the jaw assembly 112 to orient itself to the tissue plane.

[0058] In some embodiments, the biopsy forceps device 100 includes dowel pins for assembly of the handle assembly 108. The dowel pins are inserted into the slider control 140 and the body 136 to secure the components of the handle assembly 108 in proper alignment during operation of the biopsy forceps device 100.

[0059] Referring to FIGS. 8-15, the jaw assembly 112 is coupled to the distal end 114 of the shaft assembly 104 and comprises a first jaw 152A, a second jaw 152B, a pivot pin 160, a needle 164, and a body 168. The jaw assembly 112 is configured to grasp and extract tissue samples, polyps, or foreign bodies during endoscopic procedures. The jaw assembly 112 includes a 120-degree articulation capability, which enables the first jaw 152A and the second jaw 152B to achieve perpendicular tissue engagement across a wide range of anatomical orientations. The first and second jaws 152 A, 152B each have a width W1 in a range of about 6 mm to about 10 mm, for example, about 8.5 mm. The jaw assembly 112 is manufactured using EDM or machining processes from stainless steel. The stainless steel construction of the jaw assembly 112 provides corrosion resistance and structural durability appropriate for repeated sterilization and use in medical procedures.

[0060] Continuing with FIGS. 8-9, each of the first jaw 152A and the second jaw 152B comprises a distal head portion 172 configured to grasp the object, a proximal portion 176 opposite the distal head portion 172 and coupled to the at least one pull wire 124, and a middle portion 180 extending between the distal head portion 172 and the proximal portion 176. The distal head portion 172A of the first jaw 152A and the distal head portion 172B of the second jaw 152B comprise a concave object-receiving surface. The concave object-receiving surface of each distal head portion 172 is configured to receive and retain tissue samples, polyps, or foreign bodies during grasping and extraction procedures. The configuration of the distal head portions 172 facilitates secure engagement with tissue and prevents slippage of the grasped object during withdrawal of the biopsy forceps device 100 from the body lumen.

[0061] At least one of the first jaw 152A and the second jaw 152B comprises a serrated cutting edge 184 extending along a majority of a periphery of the jaw. The serrated cutting edge 184COO-OQ8-PCTincludes multiple teeth arranged around the circumference of the distal head portion 172. The serrated cutting edge 184 enhances tissue gripping capability and enables cold resection of tissue without application of thermal energy. When the first jaw 152A and the second jaw 152B transition to the closed position, the serrated cutting edges 184 engage tissue and sever the tissue from the surrounding anatomical structures. The serrated configuration of the cutting edges 184 facilitates clean tissue separation while minimizing trauma to adjacent tissue.

[0062] In the illustrated embodiment, both the first jaw 152A and the second jaw 152B comprise a serrated cutting edge 184 disposed around the periphery of the respective distal head portions 172A, 172B. The serrated cutting edges 184 are arranged circumferentially along the distal head portions 172A, 172B of both jaws, providing bilateral cutting capability when the jaws transition to the closed position. In some embodiments, a single one of the first jaw 152A and the second jaw 152B comprises a serrated cutting edge 184, while the other jaw comprises a dull or smooth edge. For example, in some embodiments, the first jaw 152A may comprise a serrated cutting edge 184 positioned around the periphery of the distal head portion 172A, while the second jaw 152B comprises a smooth or non-serrated edge along the distal head portion 172B. In other embodiments, the second jaw 152B may comprise a serrated cutting edge 184 extending circumferentially along the distal head portion 172B, while the first jaw 152A comprises a dull edge. In some embodiments, one side of each of the first jaw 152 A and the second jaw 152B comprises a serrated cutting edge 184, while an opposite side of each jaw comprises a dull or smooth edge. In such configurations, the serrated portion of each jaw may be aligned such that the serrated edges of both jaws engage tissue on the same side of the jaw assembly 112, or the serrated portions may be arranged in an alternating configuration.

[0063] In some embodiments, the serrated cutting edge 184 comprises alternative geometries and configurations. The serrated cutting edge 184 may comprise teeth with varying pitch, depth, or profile depending on the intended tissue type and cutting characteristics. In some embodiments, the teeth of the serrated cutting edge 184 are arranged in a uniform pattern around the periphery of the jaw. In other embodiments, the teeth are arranged in a non-uniform pattern with varying spacing or tooth geometry at different locations along the periphery. The serrated cutting edge 184 may extend along the complete periphery of the jaw or along a portion of the periphery that constitutes a majority of the periphery.

[0064] Each of the middle portions 180 comprises a middle throughhole 188. The middle throughhole 188 defines the hinge axis H in which the first jaw 152A and the second jaw 152B are pivotably coupled. The pivot pin 160 extends through the middle throughholes 188A, 188B and defining a hinge axis H such that the first jaw 152A and the second jaw 152B are pivotably coupled at the middle portions 180A, 180B along the hinge axis H. The pivot pin 160 enables the first jaw 152A and the second jaw 152B to pivot relative to each other between the closed position and the open position. The pivot pin 160 extends through the first j aw 152A, the needle 164, and the second jaw 152B, securing the jaw components in a pivotable arrangement.

[0065] Each of the proximal portions 176 comprises a proximal throughhole 192. The proximal throughhole 192 is configured to couple the first and second jaws 152A, 152B tothepull wires 124A, 124B, respectively. In the illustrated embodiment, the distal end of the first pull wire 124A is coupled to the proximal portion 176A of the first jaw 152A via the proximal throughhole 192A of the first jaw 152A. A distal end of the second pull wire 124B is coupled to the proximal portion 176B of the second jaw 152B via the proximal throughhole 192B of the second jaw 152B.

[0066] The first jaw 152A and the second jaw 152B are operably coupled to the at least one pull wire 124 such that actuation of the at least one pull wire 124 causes the first jaw 152A and the second jaw 152B to pivot about the hinge axis H between the closed position and the open position. Actuation of the first pull wire 124A and the second pull wire 124B causes the first jaw 152A and the second jaw 152B to pivot about the pivot pin 160 and about the proximal throughholes 192A, 192B of the first jaw 152A and the second jaw 152B such that the proximal portion 176A of the first jaw 152A and the distal head portion 172B of the second jaw 152B move toward and away from each other, and the proximal portion 176B of the second jaw 152B and the distal head portion 172A of the first jaw 152A move toward and away from each other.

[0067] In the illustrated embodiment, the first jaw 152A and the second jaw 152B are configured to deflect at an angle in a range of about 5 degrees to about 120 degrees relative to the longitudinal axis A. In some embodiments, the first jaw 152A and the second jaw 152B are configured to deflect at an angle in a range of about 10 degrees to about 90 degrees relative to the longitudinal axis A. In other embodiments, the first jaw 152A and the second jaw 152B are configured to deflect at an angle in a range of about 15 degrees to about 60 degrees relative to the longitudinal axis A. In further embodiments, the jaw assembly is configured to deflect at an anglein a range of about 20 degrees to about 45 degrees relative to the longitudinal axis A. The deflection angle range is selected based on the intended anatomical application and the range of tissue orientations expected to be encountered during endoscopic procedures.

[0068] Referring to FIG. 10, the needle 164 extends along the longitudinal axis A between the first jaw 152A and the second jaw 152B. The needle 164 is configured to anchor the jaw assembly 112 to a target surface in the body lumen. In the illustrated embodiment, the needle 164 comprises a teardrop-shaped profile with a rounded proximal end 193 and a tapered distal end 194 that terminates in a pointed tip. The needle 164 has a length L2 in a range of about 1 mm to about 5 mm, for example, about 3 mm. The proximal end 193 of the needle 164 features a circular through-hole 195 configured to receive the pivot pin 160. The pointed distal tip of the needle 164 is configured to engage and stabilize tissue during biopsy procedures. When the jaw assembly 112 is positioned against tissue, the needle 164 penetrates the tissue surface and anchors the jaw assembly 112 in position, preventing movement of the jaw assembly 112 relative to the target tissue during grasping and cutting operations.

[0069] In some embodiments, the needle 164 comprises alternative configurations and dimensions. In some embodiments, the needle 164 has a length in a range of about 1 mm to about 5 mm. In some embodiments, the needle 164 has a length of about 2 mm. In other embodiments, the needle 164 has a length of about 4 mm. The needle 164 may comprise alternative tip geometries including conical tips, beveled tips, or trocar-style tips. The needle 164 is formed from stainless steel, titanium, or other biocompatible materials appropriate for tissue penetration and anchoring.

[0070] Referring to FIGS. 11-12, in the closed position, the first jaw 152A and the second jaw 152B are aligned substantially along the longitudinal axis A. The closed configuration of the jaw assembly 112 presents a streamlined profile that facilitates insertion and withdrawal of the biopsy forceps device 100 through the working channel of an endoscope. When the first jaw 152A and the second jaw 152B are in the closed position, the distal head portions 172A, 172B are positioned adjacent to each other with the serrated cutting edges 184 in contact or near contact, securing any grasped tissue between the concave object-receiving surfaces.

[0071] Referring to FIGS. 13-14, in the open position, the first jaw 152A and the second jaw 152B are pivoted apart to expose the concave object-receiving surfaces of the distal head portions 172A, 172B and the needle 164. When the handle assembly 108 advances the first pull wire 124Aand the second pull wire 124B toward the distal end 114 of the shaft assembly 104, the first jaw 152A and the second jaw 152B transition to the open position. When the handle assembly 108 retracts the first pull wire 124A and the second pull wire 124B along the longitudinal axis A, the first jaw 152A and the second jaw 152B transition to the closed position. The open configuration enables the jaw assembly 112 to be positioned around tissue, polyps, or foreign bodies prior to grasping.

[0072] The jaw assembly 112 is configured to deflect relative to the longitudinal axis A via the compression spring 120 coupled to the shaft assembly 104. In the deflected configuration, the jaw assembly 112 is angled relative to the longitudinal axis A such that the first jaw 152A and the second jaw 152B are positionable substantially perpendicular to the target surface. The deflected configuration enables the serrated cutting edges 184 of the firstjaw 152A and the secondjaw 152B to engage tissue at an orthogonal angle, facilitating full -thickness tissue acquisition. The 120-degree articulation capability of the jaw assembly 112 enables the firstjaw 152A and the second jaw 152B to achieve perpendicular tissue engagement across a wide range of anatomical orientations.

[0073] Continuing with FIG. 14, the body 168 has a proximal end 196 coupled to the distal end 114 of the shaft assembly 104, a first distal arm 198, and a second distal arm 200. The first distal arm 198 and the second distal arm 200 are configured to receive the pivot pin 160 such that the first distal arm 198 and the second distal arm 200 are coupled to the middle portions 180A, 180B of the firstjaw 152A and the secondjaw 152B. The body 168 provides a structural transition between the shaft assembly 104 and the pivoting components of the jaw assembly 112. The first distal arm 198 and the second distal arm 200 extend distally from the body 168 and define a space therebetween that receives the middle portions 180A, 180B of the firstjaw 152A and the second jaw 152B. The pivot pin 160 extends through aligned holes in the first distal arm 198, the middle portion 180 A of the firstjaw 152A, the needle 164, the middle portion 180B of the secondjaw 152B, and the second distal arm 200, securing the jaw components in the pivotable arrangement.

[0074] In some embodiments, the biopsy forceps device includes alternative actuation configurations for operating the jaw assembly. As described above, the at least one pull wire comprises a first pull wire and a second pull wire, each pull wire coupled to a respective jaw of the first and second jaws. In alternative embodiments, the at least one pull wire comprises a singlepull wire operably coupled to both the first jaw and the second jaw. Tn the single pull wire configuration, actuation of the single pull wire causes the first and second jaws to pivot about the hinge axis between the closed position and the open position through a linkage mechanism that translates longitudinal movement of the single pull wire into pivoting motion of both jaws simultaneously. The single pull wire actuation configuration reduces the number of components within the shaft assembly and simplifies the mechanical coupling between the handle assembly and the jaw assembly.

[0075] In some embodiments, the jaw assembly further comprises a hinge positioned between the shaft assembly and the first and second jaws. The hinge is positioned at a junction point where the first and second jaws meet the body 168 of the jaw assembly 112. The hinge is configured to enable the jaw assembly to pivot or deflect relative to the longitudinal axis. The hinge provides an alternative deflection mechanism to the compression spring described above. In the hinge-based embodiment, the hinge is configured to enable the jaw assembly to deflect relative to the longitudinal axis such that the first and second jaws are positionable substantially perpendicular to the target surface. The hinge comprises a discrete mechanical joint that permits angular deflection of the jaw assembly relative to the shaft assembly while maintaining structural integrity during tissue grasping and cutting operations. The hinge-based deflection mechanism enables the jaw assembly to articulate side-to-side in a lateral direction relative to the longitudinal axis, providing flexibility at the tip of the biopsy forceps device for engaging tissue surfaces oriented at various angles within the body lumen. The hinge operates passively such that when the jaw assembly 112 contacts tissue, the hinge deflects to orient the first and second jaws at an angle that facilitates perpendicular engagement with the target surface. In some embodiments, the hinge is provided in addition to the compression spring 120 to provide increased deflection capability.

[0076] In some embodiments, the biopsy forceps device 100 is configured as a sterile, singleuse device sterilized using ethylene oxide. The single-use configuration avoids reprocessing and sterilization between procedures, reducing the risk of cross-contamination and ensuring consistent device performance. The ethylene oxide sterilization process is compatible with the thermoplastic and metallic materials of the biopsy forceps device. The sterile, single-use configuration is appropriate for regulatory classification as a Class II medical device.

[0077] Referring to FIGS. 15-17, a method of removing an object 10 from a body lumen 20 is described. The biopsy forceps device 100 is first advanced through the body lumen 20, typically through a channel of an endoscope 30, until the jaw assembly 112 reaches the vicinity of the target site.

[0078] With continued reference to FIG. 15, once the biopsy forceps device 100 is positioned near the target site, the jaw assembly 112 is deployed from the shaft assembly 104 by advancing the jaw assembly 112 distally from the working channel of the endoscope 30 such that it extends beyond the distal tip of the endoscope 30 and into the body lumen 20. The first jaw 152A and the second jaw 152B are then pivoted to the open position by actuating the at least one pull wire 124 along the longitudinal axis A. In the illustrated embodiment, transitioning the first jaw 152A and the second jaw 152B to the open position involves actuating the first pull wire 124A and the second pull wire 124B, each pull wire coupled to a respective jaw. As the handle assembly 108 advances the first pull wire 124A and the second pull wire 124B toward the distal end 114 of the shaft assembly 104, the first jaw 152A and the second jaw 152B pivot apart to expose the concave object-receiving surfaces and the needle 164.

[0079] As the biopsy forceps device 100 is advanced against tissue within the body lumen 20, the compression spring 120 coupled to the shaft assembly 104 compresses and deflects, allowing the jaw assembly 112 to passively articulate relative to the longitudinal axis A. This passive deflection enables the first jaw 152A and the second jaw 152B to achieve a more orthogonal approach to the target surface without requiring active manipulation by the user.

[0080] Continuing with FIGS. 15-16, the user positions the first jaw 152A and the second jaw 152B relative to a target surface in the body lumen 20 by approaching the object 10 along the longitudinal axis A of the shaft assembly 104. The passive articulation provided by the compression spring 120 enables the jaw assembly 112 to automatically adjust its orientation when pressed against tissue, thereby achieving perpendicular alignment with the tissue plane. This substantially perpendicular positioning facilitates full-thickness tissue acquisition rather than superficial sampling.

[0081] Once the jaw assembly 112 is properly positioned, the needle 164 penetrates the tissue surface to anchor the object 10 and stabilize the jaw assembly 112 in position relative to the targettissue. This anchoring function prevents movement of the jaw assembly 112 during subsequent grasping and cutting operations, ensuring secure engagement with the object 10.

[0082] Continuing with FIG. 17, with the object 10 anchored, the user grasps the object 10 by transitioning the first jaw 152A and the second jaw 152B to the closed position. This is accomplished by actuating the at least one pull wire 124 along the longitudinal axis A. When the handle assembly 108 retracts the first pull wire 124A and the second pull wire 124B proximally along the longitudinal axis A, the first jaw 152A and the second jaw 152B pivot toward each other and close around the object 10. The concave object-receiving surfaces of the distal head portions 172A, 172B receive and retain the object 10 securely between the first jaw 152A and the second jaw 152B.

[0083] As the first jaw 152A and the second jaw 152B transition to the closed position, the serrated cutting edges 184 disposed along a majority of the periphery of the jaws engage the tissue and sever the object 10 from the surrounding anatomical structures. In the illustrated embodiment, serrated cutting edges 184 of both the first jaw 152A and the second jaw 152B engage the object 10 during cutting. This grasping and cutting action constitutes cold resection of the object 10 without application of thermal energy, as the serrated cutting edges 184 sever tissue through mechanical cutting action without the use of electrocautery or other thermal energy sources.

[0084] Following tissue acquisition, the biopsy forceps device 100 is withdrawn from the body lumen 20. Prior to withdrawal, the jaw assembly 112 is retracted into the shaft assembly 104 while the first jaw 152A and the second jaw 152B remain in the closed position. The closed configuration of the jaw assembly 112 presents a streamlined profile that facilitates passage back through the working channel of the endoscope 30, and the object 10 remains secured between the first jaw 152A and the second jaw 152B during withdrawal for subsequent histologic examination.

[0085] In the illustrated embodiment, the object 10 comprises a polyp. In some embodiments, the polyp comprises a pedunculated polyp, a sub-pedunculated polyp, a sessile polyp, or a flat polyp. In some embodiments, the object comprises a tissue growth or sample. Tissue growths include abnormal tissue formations within the body lumen that are to be removed for diagnostic or therapeutic purposes. In some embodiments, the object comprises a stone. In some embodiments, the object comprises a foreign body. Foreign bodies include objects that have been ingested or otherwise introduced into the body lumen and are to be extracted.

[0086] A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, other implementations are within the scope of the following claims.

[0087] EXEMPLARY CLAIMS

[0088] Exemplary Claim 1. A biopsy forceps device for object removal in a body lumen, comprising: a shaft assembly extending from a proximal end to a distal end along a longitudinal axis, the shaft assembly comprising a spiral-wound shaft, a spring coupled to the spiral-wound shaft at the distal end of the shaft assembly, and at least one pull wire disposed within the spiralwound shaft; a handle assembly coupled to the proximal end of the shaft assembly, the handle assembly configured to actuate the at least one pull wire; and a jaw assembly coupled to the distal end of the shaft assembly, the jaw assembly comprising: a first jaw and a second jaw, at least one of the first and second jaws comprising a serrated cutting edge extending along a majority of a periphery of the jaw; and a needle extending along the longitudinal axis between the first and second jaws, the needle configured to anchor the jaw assembly to a target surface in the body lumen; wherein the first and second jaws are operably coupled to the at least one pull wire such that actuation of the at least one pull wire causes the first and second jaws to pivot about a hinge axis between a closed position and an open position; wherein the spring is configured to enable the jaw assembly to deflect relative to the longitudinal axis such that the first and second jaws are positionable substantially perpendicular to the target surface.

[0089] Exemplary Claim 2. The biopsy forceps device according to exemplary claim 1, wherein the spring comprises a compression spring.

[0090] Exemplary Claim 3. The biopsy forceps device according to exemplary claim 1 or exemplary claim 2, wherein the shaft assembly further comprises a flexible outer sheath disposed over the spiral-wound shaft.

[0091] Exemplary Claim 4. The biopsy forceps device according to exemplary claim 3, wherein the outer sheath comprises a thermoplastic polymer.

[0092] Exemplary Claim 5. The biopsy forceps device according to any one of exemplary claims 1 to 4, wherein the spiral-wound shaft comprises stainless steel.

[0093] Exemplary Claim 6. The biopsy forceps device according to any one of exemplary claims 1 to 5, wherein each of the first and second jaws comprise: a distal head portion configured to grasp the object, a proximal portion opposite the distal head portion and coupled to the at least one pull wire, and a middle portion extending between the distal head portion and the proximal portion.

[0094] Exemplary Claim 7. The biopsy forceps device according to exemplary claim 6, wherein the distal head portions comprise a concave object-receiving surface.

[0095] Exemplary Claim 8. The biopsy forceps device according to exemplary claim 6 or exemplary claim 7, wherein each of the middle portions comprise a middle throughhole, and wherein the jaw assembly further comprises a pin extending through the middle throughholes and defining the hinge axis such that the first and second jaws are pivotably coupled at the middle portions along the hinge axis.

[0096] Exemplary Claim 9. The biopsy forceps device according to exemplary claim 8, wherein the at least one pull wire comprises a first pull wire and a second pull wire, each pull wire coupled to a respective jaw of the first and second jaws.

[0097] Exemplary Claim 10. The biopsy forceps device according to exemplary claim 9, wherein each of the proximal portions comprise a proximal throughhole, and wherein a distal end of the first pull wire is coupled to the proximal portion of the first jaw via the proximal throughhole of the first jaw, and a distal end of the second pull wire is coupled to the proximal portion of the second jaw via the proximal throughhole of the second jaw.

[0098] Exemplary Claim 11. The biopsy forceps device according to exemplary claim 10, wherein actuation of the first and second pull wires causes the first and second jaws to pivot about the pin and about the proximal throughholes of the first and second jaws such that the proximal portion of the first jaw and the distal head portion of the second jaw move toward and away from each other, and the proximal portion of the second jaw and the distal head portion of the first jaw move toward and away from each other.

[0099] Exemplary Claim 12. The biopsy forceps device according to exemplary claim 10 or exemplary claim 11, wherein the jaw assembly further comprises a body having a proximal end coupled to the distal end of the shaft assembly, a first distal arm, and a second distal arm, the firstand second distal arms configured to receive the pin such that the first and second distal arms are coupled to the middle portions of the first and second jaws.

[0100] Exemplary Claim 13. The biopsy forceps device according to any one of exemplary claims 1 to 12, wherein in the closed position, the first and second jaws are aligned substantially along the longitudinal axis.

[0101] Exemplary Claim 14. The biopsy forceps device according to any one of exemplary claims 1 to 13, wherein the at least one pull wire comprises stainless steel.

[0102] Exemplary Claim 15. The biopsy forceps device according to any one of exemplary claims 1 to 14, wherein actuation of the at least one pull wire comprises: advancing the at least one pull wire toward the distal end such that the first and second jaws transition to the open position; and retracting the at least one pull wire along the longitudinal axis such that the first and second jaws transition to the closed position.

[0103] Exemplary Claim 16. The biopsy forceps device according to any one of exemplary claims 1 to 15, wherein the jaw assembly is configured to deflect at an angle in a range of about 5 degrees to about 120 degrees relative to the longitudinal axis.

[0104] Exemplary Claim 17. The biopsy forceps device according to any one of exemplary claims 1 to 16, wherein the handle assembly comprises a slider control configured to control deployment and retraction of the jaw assembly.

[0105] Exemplary Claim 18. The biopsy forceps device according to any one of exemplary claims 1 to 17, wherein the handle assembly comprises a gripping portion positioned at a proximal terminus of the handle assembly.

[0106] Exemplary Claim 19. The biopsy forceps device according to any one of exemplary claims 1 to 18, wherein the shaft assembly is configured to navigate through a channel of an endoscope.

[0107] Exemplary Claim 20. The biopsy forceps device according to any one of exemplary claims 1 to 19, wherein the shaft assembly has a length of about 240 cm.

[0108] Exemplary Claim 21. The biopsy forceps device according to any one of exemplary claims 1 to 20, wherein the shaft assembly has an outer diameter of about 2.4 mm.

[0109] Exemplary Claim 22. The biopsy forceps device according to any one of exemplary claims 1 to 21, wherein the shaft assembly has a length configured for insertion through a gastrointestinal tract.

[0110] Exemplary Claim 23. The biopsy forceps device according to any one of exemplary claims 1 to 22, wherein the jaw assembly further comprises a hinge positioned between the shaft assembly and the first and second jaws, the hinge configured to enable the jaw assembly to pivot relative to the longitudinal axis.

[0111] Exemplary Claim 24. The biopsy forceps device according to any one of exemplary claims 1 to 23, wherein the jaw assembly is configured to rotate about the longitudinal axis.

[0112] Exemplary Claim 25. The biopsy forceps device according to any one of exemplary claims 1 to 24, wherein the handle assembly is further configured to control rotation of the jaw assembly about the longitudinal axis.

[0113] Exemplary Claim 26. The biopsy forceps device according to any one of exemplary claims 1 to 25, further comprising a locking mechanism configured to lock rotation of the jaw assembly when the first and second jaws are in the closed position.

[0114] Exemplary Claim 27. The biopsy forceps device according to any one of exemplary claims 1 to 26, wherein the handle assembly is configured for single-hand operation.

[0115] Exemplary Claim 28. A method of removing an object from a body lumen, the method comprising: advancing a biopsy forceps device through the body lumen, the biopsy forceps device comprising a shaft assembly extending along a longitudinal axis and ajaw assembly at a distal end of the shaft assembly, the jaw assembly having a first jaw and a second jaw configured to pivot about a hinge axis between a closed position and an open position, and a needle extending between the first and second jaws; deploying the jaw assembly from the shaft assembly and pivoting the first and second jaws to the open position; deflecting the jaw assembly relative to the longitudinal axis via a spring coupled to the shaft assembly; positioning the first and second jaws relative to a target surface in the body lumen; anchoring the object with the needle; grasping the object with the first and second jaws by transitioning the first and second jaws to the closed position; cutting the object via a serrated cutting edge disposed along a majority of a periphery of at least one of the first and second jaws; and withdrawing the biopsy forceps device from the body lumen.

[0116] Exemplary Claim 29. The method according to exemplary claim 28, wherein the object comprises a polyp.

[0117] Exemplary Claim 30. The method according to exemplary claim 29, wherein the polyp comprises a pedunculated polyp, a sub-pedunculated polyp, a sessile polyp, or a flat polyp.

[0118] Exemplary Claim 31. The method according to exemplary claim 28, wherein the object comprises a tissue sample.

[0119] Exemplary Claim 32. The method according to exemplary claim 28, wherein the object comprises a foreign body.

[0120] Exemplary Claim 33. The method according to any one of exemplary claims 28 to 32, wherein advancing the biopsy forceps device comprises advancing the biopsy forceps device through a channel of an endoscope.

[0121] Exemplary Claim 34. The method according to any one of exemplary claims 28 to 33, wherein positioning the first and second jaws relative to the target surface comprises positioning the first and second jaws substantially perpendicular to the target surface.

[0122] Exemplary Claim 35. The method according to any one of exemplary claims 28 to 34, wherein transitioning the first and second jaws to the closed position comprises actuating at least one pull wire along the longitudinal axis, the at least one pull wire operably coupled to the jaw assembly.

[0123] Exemplary Claim 36. The method according to any one of exemplary claims 28 to 35, wherein transitioning the first and second jaws to the closed position comprises actuating a first pull wire and a second pull wire, each pull wire coupled to a respective jaw of the first and second jaws.

[0124] Exemplary Claim 37. The method according to any one of exemplary claims 28 to 36, wherein cutting the object comprises engaging the object via serrated cutting edges of both the first and second jaws.

[0125] Exemplary Claim 38. The method according to any one of exemplary claims 28 to 37, wherein withdrawing the biopsy forceps device further comprises retracting the jaw assembly into the shaft assembly after transitioning the first and second jaws to the closed position.

[0126] Exemplary Claim 39. The method according to any one of exemplary claims 28 to 38, wherein the shaft assembly comprises a spiral-wound shaft coupled to the spring.

[0127] Exemplary Claim 40. The method according to any one of exemplary claims 28 to 39, wherein positioning the first and second jaws relative to the target surface comprises approaching the object along the longitudinal axis of the shaft assembly.

[0128] Exemplary Claim 4E The method according to any one of exemplary claims 28 to 40, wherein grasping the object with the first and second jaws comprises cold resection of the object without application of thermal energy.

[0129] Exemplary Claim 42. A biopsy forceps device for object removal in a body lumen, comprising: a shaft assembly extending from a proximal end to a distal end along a longitudinal axis, the shaft assembly comprising a spiral-wound shaft and at least one pull wire disposed within the spiral-wound shaft; a handle assembly coupled to the proximal end of the shaft assembly, the handle assembly configured to actuate the at least one pull wire; and a jaw assembly coupled to the distal end of the shaft assembly, the jaw assembly comprising: a first jaw and a second jaw, at least one of the first and second jaws comprising a serrated cutting edge extending along a majority of a periphery of the jaw; a needle extending along the longitudinal axis between the first and second jaws, the needle configured to anchor the jaw assembly to a target surface in the body lumen; and a hinge positioned between the shaft assembly and the first and second jaws; wherein the first and second jaws are operably coupled to the at least one pull wire such that actuation of the at least one pull wire causes the first and second jaws to pivot about a hinge axis between a closed position and an open position; wherein the hinge is configured to enable the jaw assembly to deflect relative to the longitudinal axis such that the first and second jaws are positionable substantially perpendicular to the target surface.

Claims

COO-OQ8-PCTCLAIMSWHAT IS CLAIMED IS:

1. A biopsy forceps device for object removal in a body lumen, comprising:a shaft assembly extending from a proximal end to a distal end along a longitudinal axis, the shaft assembly comprising a spiral-wound shaft, a spring coupled to the spiral-wound shaft at the distal end of the shaft assembly, and at least one pull wire disposed within the spiral-wound shaft;a handle assembly coupled to the proximal end of the shaft assembly, the handle assembly configured to actuate the at least one pull wire; anda jaw assembly coupled to the distal end of the shaft assembly, the jaw assembly comprising:a first jaw and a second jaw, at least one of the first and second jaws comprising a serrated cutting edge extending along a majority of a periphery of the jaw; anda needle extending along the longitudinal axis between the first and second jaws, the needle configured to anchor the jaw assembly to a target surface in the body lumen;wherein the first and second jaws are operably coupled to the at least one pull wire such that actuation of the at least one pull wire causes the first and second jaws to pivot about a hinge axis between a closed position and an open position;wherein the spring is configured to enable the jaw assembly to deflect relative to the longitudinal axis such that the first and second jaws are positionable substantially perpendicular to the target surface.

2. The biopsy forceps device according to claim 1, wherein the spring comprises a compression spring.

3. The biopsy forceps device according to any one of claims 1 to 2, wherein the shaft assembly further comprises a flexible outer sheath disposed over the spiral-wound shaft.

4. The biopsy forceps device according to claim 3, wherein the outer sheath comprises a thermoplastic polymer.

5. The biopsy forceps device according to any one of claims 1 to 4, wherein the spiral -wound shaft comprises stainless steel.

6. The biopsy forceps device according to any one of claims 1 to 5, wherein each of the first and second jaws comprise:a distal head portion configured to grasp the object,a proximal portion opposite the distal head portion and coupled to the at least one pull wire, anda middle portion extending between the distal head portion and the proximal portion.

7. The biopsy forceps device according to claim 6, wherein the distal head portions comprise a concave object-receiving surface.

8. The biopsy forceps device according to claim 6 or claim 7, wherein each of the middle portions comprise a middle throughhole, and wherein the jaw assembly further comprises a pin extending through the middle throughholes and defining the hinge axis such that the first and second jaws are pivotably coupled at the middle portions along the hinge axis.

9. The biopsy forceps device according to claim 8, wherein the at least one pull wire comprises a first pull wire and a second pull wire, each pull wire coupled to a respective jaw of the first and second jaws.

10. The biopsy forceps device according to claim 9, wherein each of the proximal portions comprise a proximal throughhole, and wherein a distal end of the first pull wire is coupled to the proximal portion of the first jaw via the proximal throughhole of the first jaw, and a distal end of the second pull wire is coupled to the proximal portion of the second jaw via the proximal throughhole of the second jaw.

11. The biopsy forceps device according to claim 10, wherein actuation of the first and second pull wires causes the first and second jaws to pivot about the pin and about the proximal throughholes of the first and second jaws such that the proximal portion of the first jaw and the distal headportion of the second jaw move toward and away from each other, and the proximal portion of the second jaw and the distal head portion of the first jaw move toward and away from each other.

12. The biopsy forceps device according to claim 10 or claim 11, wherein the jaw assembly further comprises a body having a proximal end coupled to the distal end of the shaft assembly, a first distal arm, and a second distal arm, the first and second distal arms configured to receive the pin such that the first and second distal arms are coupled to the middle portions of the first and second jaws.

13. The biopsy forceps device according to any one of claims 1 to 12, wherein in the closed position, the first and second jaws are aligned substantially along the longitudinal axis.

14. The biopsy forceps device according to any one of claims 1 to 13, wherein the at least one pull wire comprises stainless steel.

15. The biopsy forceps device according to any one of claims 1 to 14, wherein actuation of the at least one pull wire comprises:advancing the at least one pull wire toward the distal end such that the first and second jaws transition to the open position; andretracting the at least one pull wire along the longitudinal axis such that the first and second jaws transition to the closed position.

16. The biopsy forceps device according to any one of claims 1 to 15, wherein the jaw assembly is configured to deflect at an angle in a range of about 5 degrees to about 120 degrees relative to the longitudinal axis.

17. The biopsy forceps device according to any one of claims 1 to 16, wherein the handle assembly comprises a slider control configured to control deployment and retraction of the jaw assembly.

18. The biopsy forceps device according to any one of claims 1 to 17, wherein the handle assembly comprises a gripping portion positioned at a proximal terminus of the handle assembly.

19. The biopsy forceps device according to any one of claims 1 to 18, wherein the shaft assembly is configured to navigate through a channel of an endoscope.

20. The biopsy forceps device according to any one of claims 1 to 19, wherein the shaft assembly has a length of about 240 cm.COO-OQ8-PCT21. The biopsy forceps device according to any one of claims 1 to 20, wherein the shaft assembly has an outer diameter of about 2.4 mm.

22. The biopsy forceps device according to any one of claims 1 to 21, wherein the shaft assembly has a length configured for insertion through a gastrointestinal tract.

23. The biopsy forceps device according to any one of claims 1 to 22, wherein the jaw assembly further comprises a hinge positioned between the shaft assembly and the first and second jaws, the hinge configured to enable the jaw assembly to pivot relative to the longitudinal axis.

24. The biopsy forceps device according to any one of claims 1 to 23, wherein the jaw assembly is configured to rotate about the longitudinal axis.

25. The biopsy forceps device according to any one of claims 1 to 24, wherein the handle assembly is further configured to control rotation of the jaw assembly about the longitudinal axis.

26. The biopsy forceps device according to any one of claims 1 to 25, further comprising a locking mechanism configured to lock rotation of the jaw assembly when the first and second jaws are in the closed position.

27. The biopsy forceps device according to any one of claims 1 to 26, wherein the handle assembly is configured for single-hand operation.

28. A method of removing an object from a body lumen, the method comprising:advancing a biopsy forceps device through the body lumen, the biopsy forceps device comprising a shaft assembly extending along a longitudinal axis and ajaw assembly at a distal end of the shaft assembly, the jaw assembly having a first jaw and a second jaw configured to pivot about a hinge axis between a closed position and an open position, and a needle extending between the first and second jaws;deploying the jaw assembly from the shaft assembly and pivoting the first and second jaws to the open position;deflecting the jaw assembly relative to the longitudinal axis via a spring coupled to the shaft assembly;positioning the first and second jaws relative to a target surface in the body lumen; anchoring the object with the needle;COO-OQ8-PCTgrasping the object with the first and second jaws by transitioning the first and second jaws to the closed position; andcutting the object via a serrated cutting edge disposed along a majority of a periphery of at least one of the first and second jaws; andwithdrawing the biopsy forceps device from the body lumen.

29. The method according to claim 28, wherein the object comprises a polyp.

30. The method according to claim 29, wherein the polyp comprises a pedunculated polyp, a sub-pedunculated polyp, a sessile polyp, or a flat polyp.

31. The method according to claim 28, wherein the object comprises a tissue sample.

32. The method according to claim 28, wherein the object comprises a foreign body.

33. The method according to any one of claims 28 to 32, wherein advancing the biopsy forceps device comprises advancing the biopsy forceps device through a channel of an endoscope.

34. The method according to any one of claims 28 to 33, wherein positioning the first and second jaws relative to the target surface comprises positioning the first and second jaws substantially perpendicular to the target surface.

35. The method according to any one of claims 28 to 34, wherein transitioning the first and second jaws to the closed position comprises actuating at least one pull wire along the longitudinal axis, the at least one pull wire operably coupled to the jaw assembly.

36. The method according to any one of claims 28 to 35, wherein transitioning the first and second jaws to the closed position comprises actuating a first pull wire and a second pull wire, each pull wire coupled to a respective jaw of the first and second jaws.

37. The method according to any one of claims 28 to 36, wherein cutting the object comprises engaging the object via serrated cutting edges of both the first and second jaws.

38. The method according to any one of claims 28 to 37, wherein withdrawing the biopsy forceps device further comprises retracting the j aw assembly into the shaft assembly after transitioning the first and second jaws to the closed position.COO-OQ8-PCT39. The method according to any one of claims 28 to 38, wherein the shaft assembly comprises a spiral-wound shaft coupled to the spring.

40. The method according to any one of claims 28 to 39, wherein positioning the first and second jaws relative to the target surface comprises approaching the object along the longitudinal axis of the shaft assembly.

41. The method according to any one of claims 28 to 40, wherein grasping the object with the first and second jaws comprises cold resection of the object without application of thermal energy.

42. A biopsy forceps device for object removal in a body lumen, comprising:a shaft assembly extending from a proximal end to a distal end along a longitudinal axis, the shaft assembly comprising a spiral-wound shaft and at least one pull wire disposed within the spiral-wound shaft;a handle assembly coupled to the proximal end of the shaft assembly, the handle assembly configured to actuate the at least one pull wire; anda jaw assembly coupled to the distal end of the shaft assembly, the jaw assembly comprising:a first jaw and a second jaw, at least one of the first and second jaws comprising a serrated cutting edge extending along a majority of a periphery of the jaw;a needle extending along the longitudinal axis between the first and second jaws, the needle configured to anchor the jaw assembly to a target surface in the body lumen; anda hinge positioned between the shaft assembly and the first and second jaws; wherein the first and second jaws are operably coupled to the at least one pull wire such that actuation of the at least one pull wire causes the first and second jaws to pivot about a hinge axis between a closed position and an open position;wherein the hinge is configured to enable the jaw assembly to deflect relative to the longitudinal axis such that the first and second jaws are positionable substantially perpendicular to the target surface.

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