Articulating medical cutting device and associated systems and methods

Abstract

An articulatable cutting instrument in which a limited distal portion of the instrument, from which the cutting element extends, is movable with respect to more proximal portions of the instrument. The cutting element is articulatable in at least a two-dimensional cutting plane. At least the articulatable portion of the instrument is rotatable to adjust the angular position of the cutting plane to cut along a non-planar target tissue.

Description

ARTICULATING MEDICAL CUTTING DEVICE AND ASSOCIATED SYSTEMS AND METHODSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 663,845, filed June 25, 2024, the entire disclosure of which is hereby incorporated by reference herein for all purposes.FIELD

[0002] The present disclosure relates generally to the field of medical cutting devices, and associated systems and methods. More particularly, the present disclosure relates to medical cutting devices having an articulatable cutting end, and associated systems and methods. Even more particularly, the present disclosure relates to cutting devices for use within a patient’s body, such as for endoscopic use, and associated systems and methods.BACKGROUND

[0003] During endoluminal surgical (ELS) procedures, physicians and other medical professionals use a host of tools to resect tumors both benign and cancerous. One of the tools utilized is an electrocautery cutting knife. Electrocautery cutting knives can cut through tissue efficiently and precisely, and may be capable of being held open at length or locked into position. Some electrocautery cutting knives are also equipped with the capability to inject water, a lifting agent, or other solution, such as to facilitate cutting of the interface between tissue layers (e.g., between muscularis and submucosal tissue layers). Physicians must consistently grapple with holding the endoscope in position and resecting the tissue. In some instances, the distal tip of the delivery device (which delivers the cutting knife) may migrate from the target tissue, requiring readjustment of the position of the delivery device and the cutting device to allow cutting to be continued. The challenges presented in holding and positioning of the knife may significantly add time to the duration of the procedure. Solutions to these and other challenges would be welcome, and it is with respect to these and other considerations that the present improvements may be useful.SUMMARY

[0004] This Summary is provided to introduce, in simplified form, a selection of concepts described in further detail below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. One of skill in theart will understand that each of the various aspects and features of the present disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances, whether or not described in this Summary. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, or the like in this Summary.

[0005] In accordance with various principles of the present disclosure, an endosurgical medical cutting device including a cutting element dimensioned to fit through the working channel of a medical scope; and a control element operably coupled with respect to the cutting element to articulate the cutting element along a cutting plane in a sweeping motion.

[0006] In some aspects, the control element is operably coupled to the cutting element to pivot the cutting element about a pivot point.

[0007] In some aspects, the device further includes a flexible elongate member, the cutting element extending distally from a distal end of the flexible elongate member. In some aspects, the control element is fixedly coupled with respect to an exterior surface of the distal end of the flexible elongate member at an anchor point, and extends proximally into a hole defined in the flexible elongate member proximal to the anchor point to define the pivot point. In some aspects, the flexible elongate member defines a lumen therethrough, and the control element is fixedly coupled with respect to the lumen at an anchor point along the distal end of the flexible elongate member. In some aspects, the flexible elongate member includes an articulatable distal portion extending at least from the anchor point proximally to the pivot point. In some aspects, the flexible elongate member includes an articulatable distal portion extending from a distalmost end of the flexible elongate member proximally to the pivot point, the articulatable distal portion being more flexible than portions of the flexible elongate member proximal to the pivot point.

[0008] In some aspects, the cutting element is articulatable in a two dimensional plane at least 15° from a longitudinal axis.

[0009] In some aspects, the cutting element is articulatable in increments or in a continuous motion.

[0010] In some aspects, the cutting element is an electrocautery cutting element.

[0011] In accordance with various principles of the present disclosure, an endoluminal surgery system includes a delivery device sized, shaped, configured, and / or dimensioned for transluminal insertion into a patient and delivery of a cutting device inside the patient, andhaving a proximal end and a distal end and defining a working channel therethrough; a cutting device extending through the working channel of the delivery device and distally out of the working channel to a position distal to the distal end of delivery device; and a control element operably coupled with respect to the cutting element to articulate the cutting element along a cutting plane in a sweeping motion.

[0012] In some aspects, the cutting device is articulatable with respect to tissue to cut the tissue while the delivery device remains stationary with respect to the tissue.

[0013] In some aspects, the cutting device is articulatable within a two dimensional cutting plane, and is rotatable with respect to the working channel of the delivery device to rotate the cutting plane with respect to a top dead center of the delivery device.

[0014] In some aspects, the cutting element is articulatable in a two dimensional plane at least 15° from a longitudinal axis of the delivery device.

[0015] In some aspects, the system further includes a stabilization element positioned between the working channel and the exterior of a portion of the medical cutting device, and shiftable between an expanded configuration maintaining a position of the medical cutting device with respect to the working channel, and an unexpanded configuration allowing movement of the medical cutting device with respect to the working channel.

[0016] In accordance with various principles of the present disclosure, a method of cutting tissue with a medical cutting device having a proximal end and a distal end is disclosed. In some aspects, the method includes articulating a cutting element extending distally from the distal end of the medical cutting device with respect to proximal portions of the medical cutting device; and cutting tissue within a patient’s body with the articulating cutting element.

[0017] In some aspects, the method further includes articulating movement of the cutting element by pulling on a control element operably coupled with the cutting element.

[0018] In some aspects, the method further includes extending the medical device through a working channel of a delivery device and out the distal end of the working channel and delivery device, and articulating the cutting element with respect to tissue and with respect to the distal end of the delivery device. In some aspects, the method of claim 18, further includes moving the cutting element with respect to tissue while maintaining at least the distal end of the delivery device in a stationary position with respect to the tissue. In some aspects, the method further includes moving the delivery device in an arcuate motion to follow the curvature of curved tissue to be cut, and rotating the medical cutting device withinthe working channel to adjust an angular orientation of a cutting plane defined by articulation of the cutting element to cut along the curved tissue.

[0019] These and other features and advantages of the present disclosure, will be readily apparent from the following detailed description, the scope of the claimed invention being set out in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be appreciated that individual aspects can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for purposes of illustration only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may vary. For example, devices may be enlarged so that detail is discernable, but is intended to be scaled down in relation to, e.g., fit within a working channel of a delivery catheter or endoscope. In the figures, identical or nearly identical or equivalent elements are typically represented by the same reference characters. For purposes of clarity and simplicity, not every element is labeled in every figure, nor is every element of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure.

[0021] The detailed description will be better understood in conjunction with the accompanying drawings, wherein like reference characters represent like elements, as follows:

[0022] FIG. illustrates an example of an embodiment of a medical cutting device formed in accordance with aspects of the present disclosure.

[0023] FIG. 2 illustrates an elevational view, partially in cross-section, of an example of an embodiment of a distal end of the medical cutting device of FIG. 1.

[0024] FIG. 3 illustrates an elevational view of an example of an embodiment of a distal end of the medical cutting device of FIG. 1.

[0025] FIG. 4 illustrates a schematic representation of a medical cutting device formed in accordance with various principles of the present disclosure and cutting tissue in a patient’s body.

[0026] FIG. 5 illustrates a schematic representation of a medical cutting device formed in accordance with various principles of the present disclosure and cutting tissue along a curved anatomical structure in a patient’s body.

[0027] FIG. 6 illustrates an example of an embodiment of a distal end of a medical cutting device formed in accordance with various principles of the present disclosure with a stabilization member stabilizing the medical cutting device with respect to a delivery device.DETAILED DESCRIPTION

[0028] The following detailed description should be read with reference to the drawings, which depict illustrative embodiments. It is to be understood that the disclosure is not limited to the particular embodiments described, as such may vary. All apparatuses and systems and methods discussed herein are examples of apparatuses and / or systems and / or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles but are merely examples. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0029] It will be appreciated that the present disclosure is set forth in various levels of detail in this application. In certain instances, details that are not necessary for one of ordinary skill in the art to understand the disclosure, or that render other details difficult to perceive may have been omitted. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless defined otherwise, technical terms used herein are to be understood as commonly understood by one of ordinary skill in the art to which the disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0030] As used herein, “proximal” refers to the direction or location closest to the user (medical professional or clinician or technician or operator or physician, etc., such terms being used interchangeably herein without intent to limit, and including automated controller systems or otherwise), etc., such as when using a device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and / or closest to a delivery device, and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and / or closest to a delivery device. “Longitudinal” means extending along the longer or larger dimension of an element. A “longitudinal axis” extends along the longitudinal extent of an element, though is not necessarily straight and does not necessarily maintain a fixed configuration if the element flexes or bends, and “axial” generally refers to along the longitudinal axis. However, it will be appreciated that reference to axial or longitudinal movement with respect to the above-described systems or elements thereof need not be strictly limited to axial and / or longitudinal movements along a longitudinal axis or central axis of the referenced elements. “Central” means at least generally bisecting a center point and / or generally equidistant from a periphery or boundary, and a “central axis” means, with respect to an opening, a line that at least generally bisects a center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a strut, a channel, a cavity, or a bore. As used herein, a “lumen” or “channel” or “bore” or “passage” is not limited to a circular cross-section. As used herein, a “free end” of an element is a terminal end at which such element does not extend beyond. It will be appreciated that terms such as at or on or adjacent or along an end may be used interchangeably herein without intent to limit unless otherwise stated, and are intended to indicate a general relative spatial relation rather than a precisely limited location. Finally, reference to “at” a location or site is intended to include at and / or about the vicinity of (e.g., along, adjacent, proximate, etc.) such location or site. As understood herein, corresponding is intended to convey a relationship between components, parts, elements, etc., configured to interact with or to have another intended relationship with one another.

[0031] Various medical / surgical procedures involve the use of a medical cutting device having a cutting edge capable of cutting tissue, such as an electrocautery knife, and, more particularly, such as a monopolar electrocautery knife. It will be appreciated that terms such as cutting device, knife, blade, etc., may be used interchangeably herein without intent to limit; terms such as cutting edge, blade, etc., may be used interchangeably herein withoutintent to limit; and terms such as cutting, dissecting, resecting, incising, etc. (and other grammatical forms thereof), may be used interchangeably herein without intent to limit. There has been a growing interest in minimally-invasive procedures, e.g., transluminal, transcatheter, endoscopic, etc., procedures which do not require open surgery (cutting open the patient), but, instead, access a target site within the patient via a natural orifice (or, in some instances, a small incision not considered to constitute an open-surgery cut). The medical cutting device is inserted transluminally into the patient to cut (e.g., dissect or resect) tissue at a target site within the patient without an external cut (or with a minimal cut) to access the target site. In some instances, the target tissue at the target site is an unhealthy, diseased (i.e., cancerous, pre-cancerous etc.), or otherwise undesirable portion of tissue at the target site that may be healthy or unhealthy. A “target tissue” may also include tissues that are suspected of being unhealthy or diseased, but which require surgical removal for verification of their disease status by biopsy. It should be appreciated that surgical dissection or resection of a target tissue typically includes removal of a portion of the surrounding healthy tissue along the target tissue margin to ensure complete removal and to minimize the potential for metastasis of left-behind or dislodged target tissue cells to other body locations. The target tissue is within a target tissue area in the body, such as the gastrointestinal system. Terms such target tissue area, target tissue site, target area of tissue, target area, target site, target treatment area, treatment area, target treatment site, treatment site, etc., may be used interchangeably herein, without intent to limit, to refer to an area or region of tissue with respect to which a procedure is to be performed or which is to be treated or otherwise operated on or affected by the devices and / or systems and / or methods disclosed herein, including areas or regions extending outwardly from or around or surrounding the target tissue (specific tissue in the target tissue area). For the sake of convenience, and without intent to limit, reference is made herein to endoluminal surgical procedures, although the present disclosure is broadly applicable to other procedures beyond endoluminal surgical procedures.

[0032] Examples of endoluminal surgical procedures using a medical cutting device formed in accordance with various principles of the present disclosure include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). In such procedures, the mucosal layer of tissue typically is lifted with a lifting agent (e.g., saline is injected to create a “bleb” of lifted tissue). In an EMR procedure, target tissue in the mucosal layer is removed (resected). In an ESD procedure, target tissue in the submucosal layer of tissue isremoved (dissected). More particularly an endoscope is typically advanced to the target site, and a medical cutting device is advanced through the endoscope to cut the tissue along a plane (e.g., the interface) between the submucosa and the muscle to dissect the target tissue (cut and remove the target tissue). Such procedures typically require very fine movements of the medical cutting device and finesse with movement and manipulation of the endoscope. Typically, the medical cutting device is advanced just far enough out of endoscope to be within the field of view of the imaging device of the endoscope, and the endoscope is then moved along the tissue (e.g., along the interface of the tissue layers) to cut the tissue with the medical cutting device. In the case of an electrocautery knife, the medical cutting device is energized to perform the cut.

[0033] The present disclosure affords additional angles of articulation of the medical cutting device with respect to the delivery device. More particularly, a cutting device of a medical cutting device typically is limited to axial translation (proximal and / or distal axial movement) and / or rotational movement (e.g., about the longitudinal axis of the device). Articulation of a distal end of a medical cutting device of the present disclosure includes bending or otherwise moving the distal end to move in an at least two-dimensional articulation plane, such as to move side-to-side with respect to more proximal sections of the medical cutting device in a generally sweeping motion. Such movement may be considered angular movement with respect to a longitudinal axis through a portion of the medical cutting device immediately proximal to the articulatable portion. In some aspects, a distal end of the medical cutting device, such as a distal end of a flexible elongate member from which the cutting element extends, is articulatable relative to immediately proximal portions of the medical cutting device.

[0034] In accordance with various principles of the present disclosure, a medical cutting device formed in accordance with various principles of the present disclosure articulates (moves within at least a two-dimensional articulation plane) to allow controlled small movements of the medical cutting device. When delivered though a delivery device such as an endoscope, the distal end of the medical cutting device extending distally out of the delivery device may be articulated to cause the cutting edge thereof to cut target tissue. Thus, the typically larger movements of the endoscope to adjust the position of the medical cutting device relative to the target site to cut the target tissue are not required. The articulation afforded by a medical cutting device formed in accordance with various principles of the present disclosure thus allows medical professionals to move the cutting element of themedical cutting device with respect to tissue using finer movements than achievable by moving the delivery device. Moreover, articulation of the cutting device relative to the delivery device allows the medical professional to continue cutting along the target tissue while the delivery device is not moved to effect cutting along the tissue (e.g., remains in a generally stationary position set by the medical professional). Fine controlled movements of the distal end of an endoscope, which require a steep learning curve, and continued challenges thereafter, are thereby no longer necessitated to perform the ELS procedure. Moreover, medical professionals may continue resecting or dissecting tissue even if the position of the distal end of the endoscope migrates away from the target tissue because the cutting element of the medical cutting device is movable independently of the endoscope. Rather than using an endoscope to try to achieve fine movements of a cutting element (e.g., to sweep the distal end of the endoscope and the cutting element across a cutting plane), the medical professional may perform macro movements of the endoscope and finer controlled movements of the cutting element. The medical professional may advance and position the endoscope adjacent the target tissue, may then park the endoscope in place, and use the endoscope as a platform for the medical cutting device, sweeping across the cutting plane with the cutting element itself without also moving the distal end of the endoscope. The movements of the cutting element may be leveraged by a control mechanism which achieves a mechanical advantage to reduce larger movements at a user-engaged controller (e.g., a knob, thumbwheel, slide, etc., manually engageable by the medical professional, such as with a finger such as a thumb) to smooth, fine movements of the cutting element.

[0035] It will be appreciated that reference herein to articulation of the distal end of the medical cutting device is intended to refer to the distal end independently of proximal- extending portions of the medical cutting device. The articulatable distal end of the medical cutting device may be along a defined extent from the distalmost terminal end of the medical cutting device in a proximal direction. However, it will be appreciated that the articulation may be limited to just the cutting element. Reference may be made interchangeably to articulation (or movement, generally) of the medical cutting device, the distal end thereof, a flexible elongate member thereof, the distal end of the flexible elongate member, an articulatable distal portion of the flexible elongate member, and / or the cutting element, without intent to limit unless otherwise stated. For the sake of convenience, and without intent to limit, angular, sweeping movements are referenced herein as articulation, asdistinguished from rotation and axial translation. References to movements, generally, are to be understood as including axial, angular, rotational, etc., movements, unless specified.

[0036] It will further be appreciated that articulation of a cutting element of a medical cutting device formed in accordance with various principles of the present disclosure may be described as articulation within an articulation plane. Because the medical cutting device cuts tissue with the articulating cutting element, the articulation plane may alternatively be referenced herein as a cutting plane. When a medical cutting device formed in accordance with various principles of the present disclosure is used to perform an ESD procedure, the cutting element may be articulated along an articulation plane which is substantially coextensive with the interface between / along the submucosal tissue and muscularis tissue.

[0037] Various embodiments of medical cutting devices, and associated systems and methods, will now be described with reference to examples illustrated in the accompanying drawings. Reference in this specification to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. indicates that one or more particular features, structures, concepts, and / or characteristics in accordance with principles of the present disclosure may be included in connection with the embodiment. However, such references do not necessarily mean that all embodiments include the particular features, structures, concepts, and / or characteristics, or that an embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics, in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment can be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiment are within the scope of the present disclosure. Moreover, references to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. It should further be understood that various features, structures, concepts, and / or characteristics of disclosed embodiments are independent of and separate from one another, and may be used or present individually or in various combinations with one another to create alternative embodiments which are considered part of the present disclosure. Therefore, the presentdisclosure is not limited to only the embodiments specifically described herein, as it would be too cumbersome to describe all of the numerous possible combinations and subcombinations of features, structures, concepts, and / or characteristics, and the examples of embodiments disclosed herein are not intended as limiting the broader aspects of the present disclosure. It should be appreciated that various dimensions provided herein are examples and one of ordinary skill in the art can readily determine the standard deviations and appropriate ranges of acceptable variations therefrom which are covered by the present disclosure and any claims associated therewith. The following description is of illustrative examples of embodiments only, and is not intended as limiting the broader aspects of the present disclosure.

[0038] Turning now to the drawings, an example of an embodiment of a medical cutting device 100 formed in accordance with various principles of the present disclosure is illustrated in FIG. 1. The medical cutting device 100 has a distal end lOOd from which a cutting element 110 and a control element 120, operably associated with the cutting element 110 to control movements of the cutting element 110 (as described in further detail below), extend. The medical cutting device 100 has a proximal end lOOp with a control handle 130. The control handle 130 may be in any form, such as user-operated, or generally machine-controlled. In the example of an embodiment illustrated in FIG. 1, the control handle 130 includes various controllers manipulable (e.g., manually) by a medical professional to adjust various components of the medical cutting device 100. Alternatively or additionally, the control handle 130 may include various connectors, such as communicating with the cutting element 110, as discussed in further detail below. In some aspects, a flexible elongate member 140 extends between the distal end lOOd and the proximal end lOOp of the medical cutting device 100. In some aspects, the flexible elongate member 140 operably couples the control handle 130 with the cutting element 110 and the control element 120, with the cutting element 110 extending distally from a distal end 140d of the flexible elongate member 140. It will be appreciated that the term flexible elongate member or flexible tubular elongate member is used herein generically to refer to elements such as catheters, shafts, cannulas, sheaths, tubes, stylets, etc., for the sake of convenience and without intent to limit. In some aspects, the flexible elongate member 140 is sufficiently flexible to bend and curve to navigate within and through tortuous body passages to be advanced transluminally within a patient’s body. For instance, the flexible elongate member 140 may be formed from a flexible polymer or polymer like material, such as,without limitation, polytetrafluoroethylene (PTFE), Polyvinyl chloride (PVC), Polyvinyl alcohol (PVA), Polyether ether ketone (PEEK), high density polyethylene (HDPE), etc.

[0039] As illustrated in further detail in FIG. 2 and FIG. 3, the cutting element 110 includes a cutting edge 112 extending distally from the distal end lOOd of the medical cutting device 100. The example of an embodiment of a cutting element 110 illustrated in FIG. 2 has a generally circular shape with a cutting edge 112 extending circumferentially therearound, typical of an electrosurgical / electrocautery knife. However, other shapes and configurations and types of cutting edges may be used with a medical cutting device 100 formed in accordance with various principles of the present disclosure, the present disclosure not being limited in this regard. As may be appreciated with reference to FIG. 2, if the cutting element 110 is energized, a wire 114 or other type of power connection may extend through or along the flexible elongate member 140 to provide an electrical signal and / or power to at least the cutting edge 112 of the cutting element 110. In some aspects, the wire 114 is formed of an electrically conductive material. In some aspects, the wire 114 is relatively flexible or capable of flexing with flexible elongate member 140 through which the wire 114 extends. In some aspects, the wire 114 is formed of Stainless Steel, such as either 303 or 304 stainless steel. One of the controllers of the control handle 130 may include a power connector 132, such as an electrocautery connection point, to supply power to the power connection to energize the cutting edge 112, such as to form an electrode tip at the end of the cutting element 110. In some aspects, the cutting element 110 may be energized at any of a variety of frequencies, resulting in different effects based on the physicians preference, to cauterize or cut tissue, such as known to those of ordinary skill in the art.

[0040] In some aspects, the cutting edge 112 extends from a distal end 116d of a shaft 116 (e.g., a hypotube) which extends proximally, through a lumen defined through the flexible elongate member 140, to the control handle 130. In some aspects, the cutting element 110 is axially translatable with respect to the flexible elongate member 140 to effectively adjust the length of the cutting element 110 (e.g., the distance the cutting edge 112 extends from the distal end 140d of the flexible elongate member 140). One of the controllers of the control handle 130 may be operably coupled with the shaft 116 to axially translate the shaft 116 within the flexible elongate member 140 to extend or retract the cutting edge 112 with respect to the distal end 140d of the flexible elongate member 140 (e.g., 1 mm, 2 mm, 4 mm, 6 mm, 8 mm, etc., including increments lower, higher, or therebetween). In the example of an embodiment illustrated in FIG. 1 , the control handle 130 includes an axial translationcontroller 134 operably coupled to a proximal end of the shaft 116 of the cutting element 110. The axial translation controller 134 may be slidable with respect to the control handle 130 to axially translate the shaft 116 with respect to the control handle 130 and the flexible elongate member 140. In some aspects, indicia 135 are provided to indicate the length of the cutting element 110 (e.g., the distance of the cutting edge 112 from the distal end 140d of the flexible elongate member 140). In some aspects, one or more features in the control handle 130 and / or along (e.g., within) the flexible elongate member 140 provide mechanical feedback to let the user know that the cutting element 110 has been extended with respect to the flexible elongate member 140, such as to indicate a certain length the cutting element 110 has been extended.

[0041] In some aspects, the shaft 116 of the cutting element 110 defines a lumen 117 therethrough, such as illustrated in FIG. 2, through which fluid may be injected to the tissue being cut by the cutting element 110. Injection of fluid through the injection tip defined by the outlet of the lumen 117 may be useful to inject material (e.g., a lifting solution, such as saline) under the tissue to be cut to create a “bleb” of lifted tissue to facilitate cutting thereof. The fluid may alternatively or additionally be used to clear material away from the target site, and / or to provide other therapeutic benefits during the procedure. The lumen 117 may be fluidly coupled with a fluid injection port 136 defined in the control handle 130 (such as illustrated in FIG. 1). In some aspects, the fluid injection port 136 may be configured for connection with a syringe or other fluid source, such as known to those of ordinary skill in the art, the present disclosure not being limited in this regard. It will be appreciated that reference to the cutting element 110 refers to the cutting edge 112 and optionally the distal end 116d of the shaft 116 from which the cutting edge 112 extends, but generally not the portion of the shaft 116 which extends proximally within the flexible elongate member 140 (and is not extended when adjusting the length of the cutting element 110) unless otherwise stated.

[0042] In accordance with various principles of the present disclosure, the cutting element 110 of the medical cutting device 100 of the present disclosure is not simply axially translatable with respect to the flexible elongate member 140 (such as described above), but is also rotatable as well as articulatable. As used herein, rotation of the cutting element 110 (and associated terms, such as rotatability, rotation, rotational, etc.) includes rotation about an axis, such as about an axis parallel to an axis of the cutting element 110 and / or an axis along which the cutting element 110 is advanced to tissue to be cut. For instance, a cuttingelement 110 formed in accordance with various principles of the present disclosure may be rotatable about a central longitudinal axis thereof (e.g., an axis through the lumen 117). As used herein, articulation of the cutting element 110 includes movement of an articulatable extent of the distal end lOOd of the medical cutting device 100 within an articulation plane. More particularly, a distal portion of the medical cutting device 100, distinct from more proximal portions, is movable in a controlled manner by a user of the medical cutting device 100 to actively control movement of the cutting element 110 to cut target tissue in a controlled intentional manner (intended by the user, instead of in response to unintended actions such as external unintended forces which move the medical cutting device 100). In some aspects, the flexible elongate member 140 has an articulatable distal portion 142 which articulates with, and, in some aspects, may cause articulation of, the cutting element 110. In such instances, articulation of the cutting element 110 may also include articulation of the articulatable distal portion 142 of the flexible elongate member 140. The articulatable distal portion 142 of the flexible elongate member 140 may be defined by the distalmost, terminal end of the flexible elongate member up to a pivot point 143 defining a point with respect to which the distal end of the medical cutting device 100 articulates (e.g., moves arcuately, angularly, pivotably, etc.). The articulatable distal portion 142 may be formed from a material more flexible than portions of the flexible elongate member 140 proximal thereto, or the wall of the flexible elongate member 140 along the articulatable distal portion 142 may be modified to flex more readily, as discussed in further detail below.

[0043] Because various portions and components of the medical cutting device 100 of the present disclosure are movable, and may move when the cutting element 110 is moved, it may be useful to describe articulation of the cutting element 110 relative to an arbitrary element, point, position, etc. In some aspects, the distal end llOd of the cutting element 110 may be described as being moved with respect to proximally extending portions of the medical cutting device 100, such as with respect to portions of the flexible elongate member 140 proximal to the articulatable distal portion 142, such as proximal to the pivot point 143, and / or the control handle 130 from which the cutting element 110 extends, to cause articulation of the cutting element 110. In some aspects, angular or arcuate movement includes movement of the cutting edge 112 with respect to a fixed point, such as a proximally spaced point along the flexible elongate member 140, the control handle 130, the distal end of a delivery device which delivers the medical cutting device 100 to a target site, etc., such as the above-noted pivot point 143. In some aspects, articulation of the cutting element 110may be described as angular and / or arcuate movement with respect to an initial or delivery position thereof, such as a position as delivered to a target site within a patient. In some aspects, articulation of the cutting element 110 includes angular or arcuate movement of at least the cutting edge 112 within an articulation plane, and sweeping across an arcuate path at angular increments with respect to an arbitrary linear extent. The arbitrary linear extent may be a longitudinal axis LA along portions of the flexible elongate member 140 proximal to the articulating portion of the medical cutting device 100, and which may not be articulatable by controlled movements actuated by a user. Alternatively or additionally, the arbitrary linear extent may be an arbitrary linear extent with respect to the cutting element 110, such as the initial position of the cutting element 110 when delivered to the target tissue. In some aspects, the articulation movement sweeps the cutting element 110 along at least an approximately 30°-90° angular movement or sweeping movement. In some aspects, the angular movement is at least 15°, or at least 20°, or even greater than 20°, such as approximately 45° (including increments of 1° from about 15° to about 45°) from the arbitrary linear extension in each direction (right and left), for an at least 0°-90° sweeping motion, the present disclosure not being limited in this regard. In some aspects, the angular movement need not be symmetrical, i.e., the same extent, on each side of an arbitrary linear extension. In some aspects, the motion may be in increments of locked-in angles (e.g., stepped sweeping motion) or in a continuum (continuous sweeping motion). Incremental articulation may be indicated along delineations on the control handle 130, and optionally controlled by the control handle 130 in a manner such as known to those of ordinary skill in the art. It will be appreciated that the cutting element 110 need not start in a linear configuration, or even along (e.g., parallel to) the arbitrary linear extent with respect to which the cutting element 110 moves angularly. For instance, the articulatable distal portion 142 may be offset (e.g., 20°) in a first direction from an arbitrary linear extent, and may be movable to generally parallel / coaxial with the arbitrary linear extent, and then articulate an additional extent (e.g., 20°) in a second direction from the arbitrary linear extent opposite the first direction.

[0044] Any of a variety of devices or elements may be operably associated with both the cutting element 110 and the control handle 130 so that a medical professional may control articulation of the cutting element 110 positioned within a patient’s body. As noted above, a control element 120 may be provided to control and / or to cause articulation of a cutting element 110 of a medical cutting device 100 formed in accordance with various principles ofthe present disclosure. In some aspects, the control element 120 is operably associated with a controller 138 provided on the control handle 130 and movable to manipulate the control element 120 to articulate the cutting element 110, as described in further detail below, the control element 120 may be any of a variety of flexible elongate elements including, without limitation, a control / pull wire, a string, a cord, etc. In some aspects, the control element 120 is formed of a material capable of withstanding multiple cycles and performing under tension, such as a metal or metal alloy, such as stainless steel (e.g., 303 or 304 stainless steel), or Nitinol. In some aspects, the control element 120 may be proximally pulled to articulate the cutting element 110. More particularly, a distal end 120d of the control element 120 may be operably coupled with respect to the cutting element 110 to articulate the cutting element 110. In some aspects, the control element 120 is operably coupled with respect to a distal end 140d of the flexible elongate member 140 from which the cutting element 110 distally extends so that articulation of the distal end 140d of the flexible elongate member 140 causes articulation of the cutting element 110. For instance, pulling on the control element 120 may pull the distal end 140d of the flexible elongate member 140 to articulate the distal end lOOd of the medical cutting device 100 to move the cutting element 110 in a generally arcuate, sweeping motion with respect to proximally-extending portions of the flexible elongate member 140 from which the cutting element 110 extends. The control element 120 may thus be considered to control articulation of the cutting element 110 and / or articulation of the articulatable distal portion 142 of the flexible elongate member 140.

[0045] In the example of an embodiment of a distal end lOOd of a medical cutting device 100 illustrated in FIG. 2, a portion of the control element 120, such as a distal end 120d thereof, is operably coupled or anchored with respect to the distal end 140d of the flexible elongate member 140. In some aspects, the control element 120 may be fixedly coupled with respect to the distal end 140d of the flexible elongate member 140 in any of a variety of manners, such as, without limitation, extending through a hole through the flexible elongate member 140 (with a distalmost or terminal end of the control element 120 widened, such as with a knot or a bead coupled thereto, to be prevented from withdrawal out of the hole), being adhered (e.g., with adhesive), welded, soldered or otherwise fixed attached to the flexible elongate member 140 (e.g., on an outer surface of the flexible elongate member 140), etc. The location (e.g., hole, weld, etc.) at which the control element 120 is fixedly coupled with respect to the distal end lOOd of the flexible elongate member 140 is referenced hereinas an anchor point 141 for the sake of convenience and without intent to limit. The control element 120 extends proximally from the anchor point 141 toward the control handle 130.As may be appreciated, proximal movement (e.g., pulling, or controlled movement such as by operation of an articulation controller operably associated with the control handle 130) of the control element 120 proximally pulls the distal end 140d of the flexible elongate member 140 along with the cutting element 110 to articulate the cutting element 110. In some aspects, the control element 120 extends along the exterior of the flexible elongate member 140 from the anchor point 141 to a hole through the wall defining the flexible elongate member 140, the hole defining a pivot point 143 about which the cutting element 110 may be described as articulating. The pivot point 143 may facilitate controlled flexing or bending and thus articulation of the articulatable distal portion 142 and the cutting element 110 by providing a point about which the control element 120 may bend to move the articulatable distal portion 142 and the cutting element llOwith respect to a point proximal to the pivot point 143. The control element 120 may extend from the anchor point 141 along the exterior of the articulatable distal portion 142 of the flexible elongate member 140 into the hole defining the pivot point 143 and then proximally through the interior of the flexible elongate member 140. The control element 120 may extend within the flexible elongate member 140 through a lumen (defined through the flexible elongate member 140) through which the shaft 116 of the cutting element 110 proximally extends, or a lumen dedicated to and separate from a lumen through which the shaft 116 extends.

[0046] It will be appreciated that the control element 120 need not extend along an exterior of the flexible elongate member 140, and may instead extend within the flexible elongate member 140 to the anchor point 141. For instance, in the example of an embodiment illustrated in FIG. 3, the control element 120 extends within the flexible elongate member 140 from a control handle 130 (such as illustrated in FIG. 1) distally to an anchor point 141 at the distal end 140d of the flexible elongate member 140. In some aspects, the control element 120 extends offset from a central longitudinal axis through the flexible elongate member 140 (e.g., offset from an axis substantially equidistant from the wall defining the flexible elongate member 140 which has a generally circular cross-section). Thus, proximal movement of the control element 120 (e.g., pulling, or controlled movement, such as by operation of a controller 138 operably associated with the control handle 130) proximally pulls the distal end 140d of the flexible elongate member 140 along with the cutting element 110 toward the side of the flexible elongate member 140 along which thecontrol element 120 extends, thereby articulating the cutting element 110. It will be appreciated that the pivot point 143 in the example of an embodiment illustrated in FIG. 3 may not be as well defined as in the example of an embodiment illustrated in FIG. 2, and thus is indicated generally, rather than by illustration of a specific point). In some aspects, the pivot point 143 is defined generally by the transition of the articulatable distal portion 142 with the remaining proximal portion of the flexible elongate member 140.

[0047] The articulatable distal portion 142 of the flexible elongate member 140 of a medical cutting device 100 formed in accordance with various principles of the present disclosure may be formed of a material which is softer, and / or weaker, and / or more flexible, and / or more deformable, and / or more bendable than the material of portions of the flexible elongate member 140 proximal thereto so that the articulatable distal portion 142 flexes, deforms, bends, etc., in the direction of the control element 120 in response to proximal movement of the control element 120. For instance, in the example of an embodiment illustrated in FIG. 3, a plurality of reliefs 144 are formed in the wall of the articulatable distal portion 142 of the flexible elongate member 140 to facilitate flexing or bending of the articulatable distal portion 142 toward the control element 120 (toward the side of the flexible elongate member 140 along which the control element 120 extends). The reliefs 144 may be in the form of cutouts, slits, weakened regions, regions of increased flexibility, etc., or any other form, material, configuration, shape, etc., known to those of ordinary skill in the art to facilitate bending in a given direction. In some aspects, the material of the wall of the flexible elongate member 140 along which the control element 120 extends is compressed, bunched, scrunched, crumpled, etc. In some aspects, the articulatable distal portion 142 may be biased to an initial position directed away (bent, flexed, etc.) from the side of the flexible elongate member 140 along which the control element 120 extends (in a manner as described above). In some aspects, by increasing the starting position (when delivered to the target site), and thus the initial distance of the cutting element 110 from the control element 120, the range of the articulation and sweep of the cutting element 110 may be increased. Other manners of forming the articulatable distal portion 142 may be appreciated by to those of ordinary skill in the art, the present disclosure not being limited in this regard.

[0048] The control element 120 of either the example of an embodiment illustrated in FIG. 2 or the example of an embodiment illustrated in FIG. 3, may extend proximally to be operably associated with the control handle 130. In the example of an embodiment illustrated in FIG. 1, the control handle 130 includes an articulation controller 138 operably associatedwith the control element 120 to control movements of the control element 120 and thus articulation of the cutting element 110. For instance, the articulation controller 138 may be slidable with respect to the control handle 130 to proximally pull on the control element 120 to control articulation of the cutting element 110 and / or the articulatable distal portion 142 of the flexible elongate member 140. In some aspects, the articulation controller 138 may provide an inverse mechanical advantage to the control element 120, such that movements of the articulation controller 138 are subject to a reduction in movement of the control element 120. For instance, the movements of the articulation controller 138 and control element 120 may be at a 2: 1 ratio or a greater ratio to allow movements of the articulation controller 138 to effect fine control of the cutting element 110. Various manners of achieving such reduction include wrapping the control element 120 over a bearing surface such as a block and pulley; use of gears, a cog and gear arrangement, a worm gear, a spool, or other mechanism known to those of ordinary skill in the art to translate a movement of the articulation controller 138 (e.g., a sliding movement) into a smaller movement of the control element 120. The smaller movement of the control element 120 effect a smaller movement at the distal end lOOd of the medical cutting device 100 to effect finely controlled articulation of the cutting element 110.

[0049] Examples of various movements of a medical cutting device 100 formed in accordance with various principles of the present disclosure, and particularly the cutting element 110 thereof, may be appreciated with reference to FIG. 4 and FIG. 5, schematically illustrating the medical cutting device 100 delivered by a delivery device 200 (e.g., an endoscope) to target tissue T at a target site TS within a patient. As may be appreciated, the cutting element 110 extends from a distal end 140d of the flexible elongate member 140, which, in turn, extends distally from a distal end 200d of the delivery device 200. In some aspects, the medical cutting device 100 may be sized, shaped, configured, and / or dimensioned to extend and be delivered through a lumen or working channel 201 of the delivery device 200 (e.g. through a proximal end of the delivery device 200, such as through a port in a handle of a delivery device 200 such as an endoscope). Reference may be made herein to movement of the cutting element 110 with respect to the delivery device 200 and / or with respect to the distal end 200d of the delivery device 200 and / or with respect to the working channel 201 and / or with respect to the target site TS / target tissue T, as discussed in further detail below.

[0050] Articulation of a distal end lOOd of the medical cutting device 100 (extending distally out of the working channel 201 of the delivery device 200) and the cutting element 110 in accordance with various principles of the present disclosure allows for movement of the cutting element 110 independently of and / or without moving the delivery device 200, such as illustrated in FIG. 4 and FIG. 5. It will be appreciated that the various elements illustrated in FIG. 4 and FIG. 5 are not necessarily drawn to scale, and are not necessarily in proper proportion with respect to one another. Also, although the cutting element 110 of the medical cutting device 100 is illustrated as being delivered through and distally out of the working channel 201 of a delivery device 200 in the form of an endoscope, the present disclosure need not be limited in this regard. The illustrated working channel 201 may simply be a lumen defined by a wall of a tubular delivery device 200 such as a catheter. In accordance with various principles of the present disclosure, the movements of the cutting element 110 are more amenable to fine control, such as small incremental movements, in contrast with the larger, gross movements typical of a delivery device 200 such as an endoscope. A medical professional may control small movements of the cutting element 110 (e.g., on the order of a few millimeters at a time), such as with the articulation controller 138, with greater precision than achievable by moving the delivery device 200 to move the cutting element 110.

[0051] The fine control of the cutting element 110 in contrast with the gross control of a delivery device 200 may be appreciated with reference to FIG. 4, showing various positions of a cutting element 110 and various positions of a delivery device 200 to dissect target tissue T from a target site TS. The delivery device 200 may remain positioned at an initial Position 1, while the cutting element 110 is swept left and right with respect to the delivery device 200 to cause the cutting edge 112 to cut the target tissue T. It will be appreciated that the solid-line depiction of the medical cutting device 100 may be an initial position upon being distally advanced out of the working channel 201 of the delivery device 200, or, instead, may be an intermediate position, with the medical cutting device 100 being biased to the left or right upon distally exiting the working channel 201 (such as described above). Moreover, it will be appreciated that although the pivot point 143 of the articulatable distal portion 142 of the flexible elongate member 140 is illustrated extended distal to the working channel 201, articulation may alternatively be achieved while the pivot point 143 is within the working channel 201. The cutting element 110 may be considered to cut tissue along a cutting plane CPI, as illustrated in FIG. 5, and as discussed in further detail below. Once thecutting element 110 has been articulated to the left and to the right to cut the target tissue T to a desired extent (e.g., to the full extent of articulation, such as the full extent in the left and right directions), if further cutting of the target tissue T is medically advised, the delivery device 200 may be moved, such as in direction A, to Position 2. In some aspects, the cutting element 110 may be retracted proximally and the delivery device 200 may be retracted proximally from the target tissue T and then moved laterally in direction A and then advanced distally to Position 2. Once in Position 2, the cutting element 110 is once again articulated to cut along the target tissue T. If even further cutting is medically advised after cutting in Position 2 (e.g., to the full extent of articulation, such as the full extent in the left and right directions when the cutting element 110 is in Position 2), the delivery device 200 and the cutting element 110 may be moved in direction B to Position 3, and even further positions, with further articulation of the cutting element 110 (such as described above) until the target tissue T has been fully dissected, or otherwise cut as medically advised. As may be appreciated, the cutting element 110 may be retracted proximally and the delivery device 200 may be retracted proximally from the target tissue T after cutting at a position is complete, and then moved laterally to the next position, and then advanced distally to tissue to be cut. As may be appreciated the delivery device 200 may include a visualization device by which the position of the articulating portion of the medical cutting device 100 may be viewed. In some aspects, visual markers may be provided along the articulating portion of the medical cutting device 100 (e.g., along at least a portion of the articulatable distal portion 142 and / or a portion of the cutting element 110).

[0052] In some aspects, the distal end lOOd of the medical cutting device 100 may be described as articulating along a two-dimensional plane, such as defined (e.g., in terms based on Cartesian geometry) by the direction in which the medical cutting device 100 is advanced into the patient’s body (generally along the longitudinal axis LA of the medical cutting device 100 and / or a delivery device 200, which may be, in terms of Cartesian geometry, be identified as a Z axis) and a direction laterally / transverse to such direction (such as along an X axis in terms of Cartesian geometry). Articulation of a medical cutting device 100 along a generally planar dimension (two-dimensional space), such as along a Z axis and an X axis, provides various benefits, such as described above, over prior art medical cutting device 100 which are limited to linear translation or advancement along (parallel to, and optionally coextensively with) a longitudinal axis LA of the medical cutting device 100 and / or delivery device 200 (along just a Z axis).

[0053] In some aspects, although the cutting plane is generally planar, extending in two dimensions, the target tissue T may be curved and thus along more than two dimensions. For instance, the target tissue T may be convex or concave and extend along an X axis as well as along a Z axis as well as along a Y axis perpendicular to the X axis and the Z axis. Even more particularly, the target tissue T may be within a body cavity, or a generally tubular body passage, and along a curving wall W (see, e.g., FIG. 6), and not confined to an X-Z articulation plane of the medical cutting device 100. As may be appreciated, the cutting element 110 must be moved along the curvature (including complex curvatures) of the target tissue T, such as along an interior circumference of a body passage in which the target tissue T is located. If the tissue to be cut curves with the curvature of a body passage, then the cutting plane must be incrementally adjusted angularly to follow the curvature of the curved tissue to be cut. For instance, the medical cutting device 100 must be rotated about the Z axis to adjust the sweeping plane (defined by the Z and X axes) to be substantially aligned with (e.g., parallel to) the target tissue T (e.g., the interface of the tissue layers along which the cut is to be made). In the example of a target site TS illustrated in FIG. 5, the target site TS extends circumferentially about the direction of advancement or retraction of the medical cutting device 100 and the delivery device 200 (generally circumferentially about a longitudinal axis LA of the medical cutting device 100 and / or delivery device 200, along the illustrated Z axis). In such instances, the delivery device 200 is moved not only laterally (along the illustrated X axis) to advance along the target site TS to continue cutting the target tissue T, but is also moved arcuately / angularly (e.g., by moving along the illustrated X axis as well as along the illustrated Y axis), as illustrated in FIG. 5. Typically, the delivery device 200 is not rotated as it is advanced along a curved target site TS. However, the orientation of the cutting plane CP must be adjusted angularly to continue cutting along the curved target tissue T. In accordance with various principles of the present disclosure, the medical cutting device 100 may be rotated about a rotational axis generally parallel to the axis along which the medical cutting device 100 is translationally advanced into the body passage, such as parallel to the longitudinal axis LA of the working channel 201 of the delivery device 200, such as about an axis parallel to the Y axis illustrated in FIG. 5. For instance, at least the distal end lOOd of the medical cutting device 100, or at least the cutting element 110 and the control element 120 are rotated, such as with respect to the delivery device 200, such as within the working channel 201. The cutting plane CP in which the cutting element 110 is articulated to cut the target tissue T thus is rotated in direction R to follow the curvature of the target tissue T (e.g., to be substantially tangential to the targettissue T and / or parallel to an interface between tissue to be dissected and underlying tissue). For instance, as illustrated in the series schematic diagrams at each of Positions 1, 2, 3 in FIG. 5, the top dead center TDC of the delivery device 200 remains in generally the same alignment (in the example of an embodiment illustrated in FIG. 5, generally vertical along the Y axis) as the delivery device 200 is moved from Position 1 to Position 2 to Position 3, etc., whereas the cutting plane CP is moved angularly (e.g., in direction R) to cut along the curving target tissue T. As such, the sequential cutting planes CPI, CP2, and CP3 at respective Positions 1, 2, 3 of the cutting element 110 (corresponding to Positions 1, 2, 3 illustrated in FIG. 4) are created angularly with respect to one another to cut the curved target tissue T. In some aspects, the cutting element 110 and the control element 120 are rotated by rotating the flexible elongate member 140 to rotate the cutting plane CP. An optional additional controller may be provided on the control handle 130 to control rotation of the flexible elongate member 140 in a manner known to those of ordinary skill in the art, the present disclosure not being limited in this regard. For instance, the medical cutting device 100, or at least the distal end lOOd thereof, or at least the cutting element 110 and the control element 120 is rotated with respect to the delivery device 200, such as with respect to and / or within the working channel 201.

[0054] In some aspects, it may be desirable to maintain the position of the portion of the medical cutting device 100 which is not articulated, such as at least a portion of the flexible elongate member 140, with respect to the delivery device 200 during operation and articulation of the cutting element 110. Typically, the portion of the medical cutting device 100 which is stabilized is proximal to the cutting element 110, such as along or proximal to the articulatable distal portion 142, such as along the flexible elongate member 140 proximal to the pivot point 143. In accordance with various principles of the present disclosure, a stabilization element 150 is provided between the distal end lOOd of the medical cutting device 100 and the distal end 200d of the delivery device 200, such as illustrated in FIG. 6. The stabilization element 150 may be mounted on the exterior of the medical cutting device 100 (e.g., along the exterior of a portion of the flexible elongate member 140, such as along or adjacent the distal end 140d or the articulatable distal portion 142 of the flexible elongate member 140). Alternatively or additionally, the stabilization element 150 may be mounted within the working channel 201 of the delivery device 200 (e.g., on the interior wall of the working channel 201), such as within a portion of the working channel 201 along the distal end 200d of the delivery device 200. Thestabilization element 150 may extend circumferentially around the flexible elongate member 140, or may extend around only a portion of the circumferential extent of the flexible elongate member 140 (e.g., to push the flexible elongate member 140 against a side of the interior of the working channel 201 opposite the side adjacent to which the stabilization element 150 is positioned). In some aspects, the stabilization element 150 is adjustable between an unexpanded configuration and an expanded configuration. In the unexpanded configuration, movement of the flexible elongate member 140 with respect to the delivery device 200 is not affected / not inhibited by the stabilization element 150, and thus the cutting element 110 may be axially translated (distally advanced and / or proximally retracted) and / or rotated about a rotational axis. Once a desired cutting position of the cutting element 110 has been attained, the stabilization element 150 may be shifted into the expanded configuration, in which the stabilization element 150 stabilizes, and optionally also fixes / locks, the relative axial and rotational position of the cutting element 110 with respect to the distal end 200d of the delivery device 200. The stabilization element 150 thus maintains maximum stability of the system (the medical cutting device 100 and the delivery device 200) while the cutting element 110 is articulated to cut along the appropriate cutting plane to cut the target tissue T as medically indicated for the procedure being performed.

[0055] A control mechanism 152 may extend proximally from the stabilization element 150, such as to the control handle 130, for access by a medical professional to control expansion and contraction of the stabilization element 150. The stabilization element 150 may be shifted to an expanded configuration from an unexpanded configuration in any of a variety of manners. For instance, in some aspects, the stabilization element 150 is an inflatable element, such as a balloon, and the control mechanism 152 is an inflation lumen. The stabilization element 150 may be inflated (e.g., by delivery of an inflation medium thereto via the control mechanism 152) to maintain position of cutting element 110 with respect to the delivery device 200, or deflated (by suction, or otherwise withdrawing the inflation medium) to adjust the relative positions of the cutting element 110 and the delivery device 200. Additionally or alternatively, the stabilization element 150 may be formed with wires which extend generally linearly (in an unexpanded configuration) and which bow radially outward (into an expanded configuration) when put in tension or compression. Alternatively or additionally, the stabilization element 150 may include a friction seal that interferes with the working channel 120 of the delivery device 200. The seal would create enough friction to provide stability, but not so much that the physician could not manipulatethe medical cutting device 100, and, more particularly, the cutting element 110 thereof, with axial or rotational motion when applied with a threshold amount of force necessary to overcome the friction imparted by the friction seal.

[0056] As may be appreciated the movements of a cutting element 110 of a medical cutting device 100 formed in accordance with various principles of the present disclosure, beyond the exclusively axial translation of cutting elements of prior medical cutting devices, allows for improved operation and more controlled cutting than achievable by prior medical cutting devices.

[0057] Although embodiments of the present disclosure may be described with specific reference to medical devices and systems and procedures for treating the gastrointestinal system, it should be appreciated that such medical devices and methods may be used to treat tissues of the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, and the like. It will be appreciated that reference to a body passage includes naturally-existing passages (e.g., the colon) as well as medically-created passages (e.g., a passage created with the use of a medical instrument, and not existing without medical intervention) or otherwise. Moreover, the medical devices, instruments, tools, etc. of the present disclosure are not limited, and may include a variety of medical devices for accessing body passageways, including, for example, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, and the like.

[0058] It is to be understood by one of ordinary skill in the art that the present discussion is a description of illustrative examples of embodiments only, and is not intended as limiting the broader aspects of the present disclosure. All apparatuses and methods discussed herein are examples of apparatuses and / or methods implemented in accordance with one or more principles of this disclosure. These examples are not the only way to implement these principles but are merely examples, not intended as limiting the broader aspects of the present disclosure. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure. It should be apparent to those of ordinary skill in the art that variations can be applied to the disclosed devices, systems, and / or methods, and / or to the sequence of steps of the method described hereinwithout departing from the concept, spirit, and scope of the disclosure. It will be appreciated that various features described with respect to one embodiment typically may be applied to another embodiment, whether or not explicitly indicated. The various features hereinafter described may be used singly or in any combination thereof. Therefore, the present invention is not limited to only the embodiments specifically described herein, and all substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the disclosure as defined by the appended claims.

[0059] The foregoing discussion has broad application and has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be clear to those skilled in the art that principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the concept, spirit, or scope, or characteristics thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of the certain aspects, embodiments, or configurations of the disclosure may be combined in alternate aspects, embodiments, or configurations. While the disclosure is presented in terms of embodiments, it should be appreciated that the various separate features of the present subject matter need not all be present in order to achieve at least some of the desired characteristics and / or benefits of the present subject matter or such individual features. One skilled in the art will appreciate that the disclosure may be used with many modifications or modifications of structure, arrangement, proportions, materials, components, and otherwise, used in the practice of the disclosure, which are particularly adapted to specific environments and operative requirements without departing from the principles or spirit or scope of the present disclosure. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of elements may be reversed or otherwise varied, the size or dimensions of the elements may be varied. Similarly, while operations or actions or procedures are described in a particular order, this should not be understood as requiring such particular order, or that all operations or actions or procedures are to be performed, to achieve desirable results. Additionally, other implementations are within the scope of the followingclaims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims, and not limited to the foregoing description or particular embodiments or arrangements described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and can be claimed separately or in combination with features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims, and not limited to the foregoing description.

[0060] In the foregoing description and the following claims, the following will be appreciated. The phrases “at least one”, “one or more”, and “and / or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a”, “an”, “the”, “first”, “second”, etc., do not preclude a plurality. For example, the term “a” or “an” entity, as used herein, refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise. As used herein, the conjunction “and” includes each of the structures, components, features, or the like, which are so conjoined, unless the context clearly indicates otherwise, and the conjunction “or” includes one or the others of the structures, components, features, or the like, which are so conjoined, singly and in any combination and number, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are only used for identification purposes to aid the reader’s understanding of the present disclosure, and / or serve to distinguish regions of the associated elements from one another, and do not limit the associated element, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, engaged, joined, etc.) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third,fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another.

[0061] The following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms “comprises”, “comprising”, “includes”, and “including” do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, singular references do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

Claims

WHAT IS CLAIMED IS:

1. An endosurgical medical cutting device comprising: a cutting element dimensioned to fit through the working channel of a medical scope; and a control element operably coupled with respect to said cutting element to articulate said cutting element along a cutting plane in a sweeping motion.

2. The endosurgical medical cutting device of claim 1, wherein said control element is operably coupled to said cutting element to pivot said cutting element about a pivot point.

3. The endosurgical medical cutting device of any one of claims 1-2, further comprising a flexible elongate member, said cutting element extending distally from a distal end of said flexible elongate member.

4. The endosurgical medical cutting device of claim 3, wherein said control element is fixedly coupled with respect to an exterior surface of the distal end of said flexible elongate member at an anchor point, and extends proximally into a hole defined in said flexible elongate member proximal to the anchor point to define the pivot point.

5. The endosurgical medical cutting device of claim 3, wherein said flexible elongate member defines a lumen therethrough, and said control element is fixedly coupled with respect to the lumen at an anchor point along the distal end of said flexible elongate member.

6. The endosurgical medical cutting device of claim 5, wherein said flexible elongate member includes an articulatable distal portion extending at least from the anchor point proximally to the pivot point.

7. The endosurgical medical cutting device of claim 3, wherein said flexible elongate member includes an articulatable distal portion extending from a distalmost end of said flexible elongate member proximally to the pivot point, the articulatable distal portion being more flexible than portions of said flexible elongate member proximal to the pivot point.

8. The endosurgical medical cutting device of any one of claims 1-7, wherein said cutting element is articulatable in a two dimensional plane at least 15° from a longitudinal axis.

9. The endosurgical medical cutting device of any one of claims 1-8, wherein said cutting element is articulatable in increments or in a continuous motion.

10. The endosurgical medical cutting device of any one of claims 1-9, wherein said cutting element is an electrocautery cutting element.

11. An endoluminal surgery system comprising: a delivery device sized, shaped, configured, and / or dimensioned for transluminal insertion into a patient and delivery of a cutting device inside the patient, and having a proximal end and a distal end and defining a working channel therethrough; a cutting device extending through the working channel of the delivery device and distally out of the working channel to a position distal to the distal end of delivery device; and a control element operably coupled with respect to said cutting element to articulate said cutting element along a cutting plane in a sweeping motion.

12. The system of claim 11, wherein said cutting device is articulatable with respect to tissue to cut the tissue while the delivery device remains stationary with respect to the tissue.

13. The system of any one of claims 11-12, wherein said cutting device is articulatable within a two dimensional cutting plane, and is rotatable with respect to the working channel of said delivery device to rotate the cutting plane with respect to a top dead center of said delivery device.

14. The system of any one of claims 11-13, wherein said cutting element is articulatable in a two dimensional plane at least 15° from a longitudinal axis of said delivery device.

15. The system of any one of claims 11-14, further comprising a stabilization element positioned between the working channel and the exterior of a portion of the medical cutting device, and shiftable between an expanded configuration maintaining a position of the medical cutting device with respect to the working channel, and an unexpanded configuration allowing movement of the medical cutting device with respect to the working channel.

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