Polyp resection system, device, and method

Abstract

A polyp removal apparatus comprising: an outer tubular body; an inner tubular body; a tubular cutter coupled to or formed as part of a distal end of the inner tubular body; a spring positioned to bias the inner tubular body in an extension direction relative to the outer tubular body; a handle coupled to a proximal end of the outer tubular body; an actuation member movably coupled to the handle; and a disconnect mechanism for selectively coupling and decoupling the actuation member to and from the inner tubular body, the disconnect mechanism configured to automatically decouple the inner tubular body from the actuation member when the actuation member is moved in a first direction by a distance greater than a predetermined distance.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 519,490, entitled "POLYPECTOMY SYSTEMS, DEVICES, AND METHODS," filed June 14, 2017. This application is related to the subject matter of U.S. Patent Application No. 15 / 616,148, entitled "POLYPECTOMY SYSTEMS, DEVICES, AND METHODS," filed June 7, 2017, which is a continuation of U.S. Patent Application No. 15 / 222,021, entitled "POLYPECTOMY SYSTEMS, DEVICES, AND METHODS," filed July 28, 2016, which claims the benefit of U.S. Provisional Patent Application No. 62 / 199,494, entitled "POLYPECTOMY SYSTEMS, DEVICES, AND METHODS," filed July 31, 2015. Each of the foregoing applications is hereby incorporated by reference in its entirety. TECHNICAL FIELD

[0003] The present disclosure relates generally to the field of medicine, and more specifically, to devices and methods for performing polypectomy. BACKGROUND

[0004] Polyps are abnormal growths of tissue from the mucosa. Polypectomy can be performed to remove polyps. Endometrial or uterine polyps are abnormal growths that attach to the inner wall of the uterus. Uterine polyps are usually benign, but they can become cancerous, or eventually become cancer. SUMMARY

[0005] The present disclosure provides polypectomy systems, methods, and devices of various embodiments to safely remove polyps, such as uterine polyps. In some embodiments, the polypectomy devices are configured to be inserted into the uterus through the vagina and to remove polyps by one or both of vacuum suction and mechanical dissection. In some embodiments, the polypectomy devices disclosed herein are specifically designed to remove polyps, which are generally relatively small in consistency and gelatinous, and are not necessarily designed to remove larger and / or more solid objects, such as fibroids. This can make the embodiments disclosed herein smaller and, in some cases, mechanically simpler than more robustly constructed tools that are intended to remove those larger and / or more solid objects, such as fibroids. The polypectomy devices disclosed herein can be safer, easier to use, less costly, and / or easier to manufacture.

[0006] According to some embodiments, a polyp removal device includes an outer tubular body having a cylindrical outer surface, a proximal end and a distal end, and an opening in the cylindrical outer surface at or near the distal end, an inner tubular body positioned within a lumen of the outer tubular body, the inner tubular body having a proximal end and a distal end and being movable relative to the outer tubular body, a tubular cutter coupled to or formed as part of the distal end of the inner tubular body, the tubular cutter positioned adjacent the opening of the outer tubular body, a spring positioned to bias the inner tubular body in an extension direction relative to the outer tubular body, a handle coupled to the proximal end of the outer tubular body, an actuation member movably coupled to the handle, the actuation member configured to be manipulated by a user by at least one of sliding or rotating the actuation member relative to the handle, the actuation member configured to be movable relative to the handle in at least a first direction and a second direction, and a disconnect mechanism for selectively coupling and decoupling the actuation member to and from the inner tubular body, the disconnect mechanism configured to keep the inner tubular body coupled to the actuation member while the actuation member is moved in the first direction a predetermined distance, thereby causing the inner tubular body to retract relative to the outer tubular body, the disconnect mechanism further configured to automatically decouple the inner tubular body from the actuation member when the actuation member is moved in the first direction a distance greater than the predetermined distance, thereby allowing the spring to extend the inner tubular body relative to the outer tubular body, and the disconnect mechanism further configured to recouple the inner tubular body to the actuation member when the actuation member is moved in the second direction.

[0007] In some embodiments, the disconnect mechanism includes a rotatable connection link biased in a direction to couple the inner tubular body to the actuation member, and a cam surface positioned to engage the connection link and rotate the connection link in a direction to decouple the inner tubular body from the actuation member in response to movement of the actuation member in a first direction. In some embodiments, the disconnect mechanism includes a resiliently bendable connection link biased in a direction to couple the inner tubular body to the actuation member, and a cam surface positioned to engage the connection link and bend the connection link in a direction to decouple the inner tubular body from the actuation member in response to movement of the actuation member in a first direction. In some embodiments, the first direction includes translation of the actuation member relative to the handle in a proximal direction, and the second direction includes translation of the actuation member relative to the handle in a distal direction. In some embodiments, the first direction includes rotation of the actuation member relative to the handle in a clockwise or counterclockwise direction, and the second direction includes rotation of the actuation member relative to the handle in a direction opposite the first direction. In some embodiments, the polyp removal device further includes a cam mechanism configured to rotate the inner tubular body about a longitudinal axis as the inner tubular body extends relative to the outer tubular body. In some embodiments, the cam mechanism includes a pin positioned at least partially within a helical groove, wherein the pin is coupled to or formed as part of one of the inner tubular body or the handle, and the helical groove is coupled to or formed as part of the other of the inner tubular body or the handle. In some embodiments, the cam mechanism is configured to rotate the inner tubular body about the longitudinal axis no more than 180 degrees as the inner tubular body extends relative to the outer tubular body. In some embodiments, the cam mechanism is configured to rotate the inner tubular body about the longitudinal axis no more than 270 degrees as the inner tubular body extends relative to the outer tubular body.In some embodiments, the polyp removal device further comprises a cutting block positioned at a distal end of the outer tubular body and at least partially distal of the opening, the cutting block comprising a blunt, rounded distal portion at least partially forming a distal tip of the polyp removal device, the cutting block further comprising a proximally extending cutting portion positioned within a lumen of the outer tubular body, the cutting portion comprising a cylindrical outer surface, a concave proximal face, and a cutting edge where the cylindrical outer surface and the concave proximal face intersect, wherein the tubular cutter is sized to fit at least partially within an annular gap between a lumen of the outer tubular body and the cylindrical outer surface of the cutting portion of the cutting block when the inner tubular body is in an extended position relative to the outer tubular body. In some embodiments, the tubular cutter comprises a rounded cutting edge positioned at an inner diameter of a distal end of the tubular cutter. In some embodiments, the outer tubular body comprises a distal cutting surface at a distal end of the opening, the distal cutting surface comprising a shape that is not perpendicular to a longitudinal axis of the outer tubular body. In some embodiments, the outer tubular body comprises a distal cutting surface at a distal end of the opening, the distal cutting surface comprising a shape that comprises one or more rounded portions or comprises one or more portions oriented at a non-perpendicular angle relative to the longitudinal axis when viewed perpendicular to the longitudinal axis of the outer tubular body and normal to a center of the opening. In some embodiments, the outer tubular body is rotatably coupled to the handle to allow the outer tubular body to rotate relative to the handle about a longitudinal axis. In some embodiments, the outer tubular body is rotatably coupled to the handle via a hub, the hub comprising at least one radial protruding member to be engaged by a user to rotate the hub and the outer tubular body relative to the handle. In some embodiments, the polyp removal device further comprises a ball detent mechanism configured to resist rotation of the hub relative to the handle until a pre-load force of the ball detent mechanism is overcome, the ball detent mechanism comprising at least a ball, a ball pre-load device, and a plurality of detents for the ball to engage. In some embodiments, the tubular cutter comprises a rounded cutting edge positioned at an inner diameter of a distal end of the tubular cutter. In some embodiments, the outer tubular body comprises a distal cutting surface at a distal end of the opening, the distal cutting surface comprising a shape that is not perpendicular to a longitudinal axis of the outer tubular body. In some embodiments, the outer tubular body comprises a distal cutting surface at a distal end of the opening, the distal cutting surface comprising a shape that comprises one or more rounded portions or comprises one or more portions oriented at a non-perpendicular angle relative to the longitudinal axis when viewed perpendicular to the longitudinal axis of the outer tubular body and normal to a center of the opening.

[0008] According to some embodiments, a polyp removal device comprises: an outer tubular body having a proximal end and a distal end; an inner tubular body positioned within a lumen of the outer tubular body, the inner tubular body having a proximal end and a distal end and being movable relative to the outer tubular body; a handle coupled to the proximal end of the outer tubular body; an actuation member movably coupled to the handle, the actuation member configured to cause at least translation of the inner tubular body relative to the outer tubular body upon movement of the actuation member relative to the handle; a vacuum port for coupling to a vacuum source, the vacuum port in fluid communication with a lumen of the inner tubular body; an opening proximate the distal end of the polyp removal device, the opening configured to allow fluid communication between an environment external to the polyp removal device and the lumen of the inner tubular body; a cutting block positioned at the distal end of the outer tubular body and at least partially distal of the opening, the cutting block comprising a blunt, rounded distal portion at least partially forming a distal tip of the polyp removal device, the cutting block further comprising a proximally extending cutting portion positioned within the lumen of the outer tubular body, the cutting portion comprising a cylindrical outer surface, a concave proximal face, and a cutting edge at an intersection of the cylindrical outer surface and the concave proximal face; and a tubular cutter positioned at the distal end of the inner tubular body, the tubular cutter sized to fit at least partially within an annular gap between the lumen of the outer tubular body and the cylindrical outer surface of the cutting portion of the cutting block when the inner tubular body is in an extended position relative to the outer tubular body.

[0009] In some embodiments, a diameter gap between an inner diameter of the tubular cutter and an outer diameter of a cylindrical outer surface of a cutting portion of the cutting block is no greater than 0.0025". In some embodiments, the outer tubular body is rotatably coupled to the handle to allow the outer tubular body to rotate relative to the handle about a longitudinal axis. In some embodiments, the outer tubular body is rotatably coupled to the handle via a hub comprising at least one radial protruding member to be engaged by a user to rotate the hub and the outer tubular body relative to the handle. In some embodiments, the polyp removal device further comprises a ball pawl mechanism configured to resist rotation of the hub relative to the handle until a pre-loaded force of the ball pawl mechanism is overcome, the ball pawl mechanism comprising at least a ball, a ball pre-loading device, and a plurality of pawls for the ball to engage. In some embodiments, the tubular cutter comprises a rounded cutting edge positioned at an inner diameter of a distal end of the tubular cutter. In some embodiments, the outer tubular body comprises a distal cutting surface at a distal end of the opening, the distal cutting surface comprising a shape that is not perpendicular to a longitudinal axis of the outer tubular body. In some embodiments, the outer tubular body comprises a distal cutting surface at a distal end of the opening, the distal cutting surface comprising a shape that comprises one or more rounded portions or comprises one or more portions oriented at a non-perpendicular angle relative to the longitudinal axis when viewed perpendicular to the longitudinal axis of the outer tubular body and normal to a center of the opening. In some embodiments, a ratio of a longitudinal length of the outer tubular body to an outer diameter of the outer tubular body is at least 100.

[0010] According to some embodiments, a polyp removal device includes an outer tubular body having a cylindrical outer surface, a proximal end and a distal end, and an opening in the cylindrical outer surface proximate the distal end; an inner tubular body positioned within a lumen of the outer tubular body, the inner tubular body having a proximal end and a distal end, and being longitudinally and rotationally movable relative to the outer tubular body, the inner tubular body including an extended position and a retracted position relative to the outer tubular body; a tubular cutter coupled to or formed as part of the distal end of the inner tubular body, the tubular cutter positioned proximate the opening of the outer tubular body; a spring positioned to bias the inner tubular body toward the extended position relative to the outer tubular body; a handle coupled to the proximal end of the outer tubular body; a cam mechanism coupled to the handle and configured to rotate the inner tubular body about a longitudinal axis as the inner tubular body moves relative to the outer tubular body from the retracted position to the extended position; and a disconnect mechanism coupled to the handle and configured to selectively hold the inner tubular body in the retracted position or release the inner tubular body from the retracted position, thereby allowing the spring to move the inner tubular body toward the extended position.

[0011] In some embodiments, the camming mechanism includes a pin positioned at least partially within a helical groove, wherein the pin is coupled to or formed as part of one of the inner tubular body or the handle, and the helical groove is coupled to or formed as part of the other of the inner tubular body or the handle. In some embodiments, the camming mechanism is configured to rotate the inner tubular body about the longitudinal axis in a range of 90-270 degrees as the inner tubular body is extended relative to the outer tubular body. In some embodiments, the disconnect mechanism includes a pawl that engages an actuation surface of the inner tubular body or a component coupled to the inner tubular body, and wherein the pawl is movable out of engagement with the actuation surface to allow the spring to move the inner tubular body toward the extended position. In some embodiments, the pawl is pivotably movable to engage or disengage the actuation surface, and the disconnect mechanism further includes a spring that biases the pawl toward engagement with the actuation surface. In some embodiments, the pawl is biased toward engagement with the actuation surface, and the pawl includes a resiliently flexible material that is flexible to disengage the actuation surface. In some embodiments, the disconnect mechanism includes a manually operable release coupled to or formed as part of the pawl to allow the pawl to be manually moved out of engagement with the actuation surface. In some embodiments, the polyp removal device further includes an actuation member movably coupled to the handle and the disconnect mechanism, the actuation member configured to be manipulated by a user by at least one of sliding or rotating the actuation member relative to the handle; wherein movement of the actuation member relative to the handle causes the inner tubular body to move relative to the handle when the pawl of the disconnect mechanism is engaged with the actuation surface; and wherein movement of the actuation member relative to the handle does not cause the inner tubular body to move relative to the handle when the pawl of the disconnect mechanism is not engaged with the actuation surface. In some embodiments, the disconnect mechanism further includes a camming surface positioned to automatically disengage the pawl from the actuation surface in response to movement of the actuation member relative to the handle. In some embodiments, the actuation member is coupled to the disconnect mechanism by a gear train or linkage that converts pivotal movement of the actuation member to sliding movement of at least a portion of the disconnect mechanism. In some embodiments, the outer tubular body is rotatable relative to the handle to allow the rotational position of the opening relative to the handle to be changed.In some embodiments, the polyp removal device further comprises a cutting block positioned at the distal end of the outer tubular body and at least partially distal of the opening, the cutting block comprising a blunt, rounded distal portion at least partially forming a distal tip of the polyp removal device, the cutting block further comprising a proximally extending cutting portion positioned within the lumen of the outer tubular body, the cutting portion comprising a cylindrical outer surface, a concave proximal face, and a cutting edge where the cylindrical outer surface and the concave proximal face intersect; and wherein the tubular cutter is sized to fit at least partially within an annular gap between the lumen of the outer tubular body and the cylindrical outer surface of the cutting portion of the cutting block when the inner tubular body is in an extended position relative to the outer tubular body. In some embodiments, the tubular cutter comprises a rounded cutting edge positioned at an inner diameter of a distal end of the tubular cutter. In some embodiments, the outer tubular body comprises a distal cutting surface at a distal end of the opening, the distal cutting surface comprising a shape that is not perpendicular to the longitudinal axis. In some embodiments, the outer tubular body comprises a distal cutting surface at a distal end of the opening, the distal cutting surface comprising a shape that comprises one or more rounded portions or comprises one or more portions oriented at a non-perpendicular angle relative to the longitudinal axis when viewed perpendicular to the longitudinal axis and normal to a center of the opening.

[0012] According to some embodiments, a polyp removal device includes an outer tubular body having a cylindrical outer surface, a proximal end and a distal end, and an opening in the cylindrical outer surface proximate the distal end; an inner tubular body positioned within a lumen of the outer tubular body, the inner tubular body having a proximal end and a distal end, and being movable relative to the outer tubular body; a cutter coupled to or formed as part of the distal end of the inner tubular body, the cutter positioned proximate the opening of the outer tubular body; a spring positioned to bias the inner tubular body in a retraction direction relative to the outer tubular body; a handle coupled to the proximal end of the outer tubular body; an actuation member movably coupled to the handle, the actuation member configured to be manipulated by a user by at least one of sliding or rotating the actuation member relative to the handle, the actuation member configured to be movable relative to the handle in at least a first direction and a second direction; and a disconnect mechanism for selectively coupling and decoupling the actuation member to and from the inner tubular body, the disconnect mechanism configured to maintain the inner tubular body coupled to the actuation member while the actuation member is moved in the first direction a predetermined distance, thereby causing the inner tubular body to extend relative to the outer tubular body, the disconnect mechanism further configured to automatically decouple the inner tubular body from the actuation member when the actuation member is moved in the first direction a distance greater than the predetermined distance, thereby allowing the spring to retract the inner tubular body relative to the outer tubular body, and the disconnect mechanism further configured to re-couple the inner tubular body to the actuation member when the actuation member is moved in the second direction.

[0013] In some embodiments, the disconnect mechanism includes a rotatable connection link biased in a direction to couple the inner tubular body to the actuation member, and a cam surface positioned to engage the connection link and rotate the connection link in a direction to decouple the inner tubular body from the actuation member in response to movement of the actuation member in a first direction. In some embodiments, the disconnect mechanism includes a resiliently bendable connection link biased in a direction to couple the inner tubular body to the actuation member, and a cam surface positioned to engage the connection link and bend the connection link in a direction to decouple the inner tubular body from the actuation member in response to movement of the actuation member in a first direction. In some embodiments, the first direction includes translation of the actuation member relative to the handle in a distal direction, and the second direction includes translation of the actuation member relative to the handle in a proximal direction. In some embodiments, the first direction includes rotation of the actuation member relative to the handle in a clockwise or counterclockwise direction, and the second direction includes rotation of the actuation member relative to the handle in a direction opposite the first direction. In some embodiments, the polyp removal device further includes a cam mechanism configured to rotate the inner tubular body about a longitudinal axis as the inner tubular body is retracted relative to the outer tubular body. In some embodiments, the cam mechanism includes a pin positioned at least partially within a helical groove, wherein the pin is coupled to or formed as part of one of the inner tubular body or the handle, and the helical groove is coupled to or formed as part of the other of the inner tubular body or the handle. In some embodiments, the cam mechanism is configured to rotate the inner tubular body about the longitudinal axis no more than 180 degrees as the inner tubular body is retracted relative to the outer tubular body. In some embodiments, the cam mechanism is configured to rotate the inner tubular body about the longitudinal axis no more than 270 degrees as the inner tubular body is retracted relative to the outer tubular body. In some embodiments, the outer tubular body is rotatably coupled to the handle to allow the outer tubular body to rotate relative to the handle about a longitudinal axis. In some embodiments, the outer tubular body is rotatably coupled to the handle via a hub, the hub including at least one radial protrusion member to be engaged by a user to rotate the hub and the outer tubular body relative to the handle. In some embodiments, the polyp removal device further includes a ball pawl mechanism configured to resist rotation of the hub relative to the handle until a preload force of the ball pawl mechanism is overcome, the ball pawl mechanism including at least a ball, a ball preload device, and a plurality of pawls for the ball to engage.

[0014] According to some embodiments, a polyp removal device includes: an outer tubular body having a proximal end and a distal end; an inner tubular body positioned within a lumen of the outer tubular body, the inner tubular body having a proximal end and a distal end and movable relative to the outer tubular body; a handle coupled to the proximal end of the outer tubular body; an actuating member movably coupled to the handle, the actuating member being configured to cause the inner tubular body to move relative to the outer tubular body when the actuating member moves relative to the handle; a vacuum port coupled to a vacuum source, the vacuum port being in fluid communication with the lumen of the inner tubular body; and an opening near the distal end of the polyp removal device, the opening being configured to allow fluid communication between an environment outside the polyp removal device and the lumen of the inner tubular body, wherein the size of the opening is variable based on the movement of the inner tubular body relative to the outer tubular body.

[0015] In some embodiments, the inner tubular body is translationally or rotatably oriented relative to the outer tubular body, but not both. In some embodiments, the polyp removal device further includes a blunt distal end. In some embodiments, the opening is formed by the non-sharp edges of the outer and inner tubular bodies. In some embodiments, the opening is formed by: a first protruding member extending from the distal end of the outer tubular member; and a second protruding member extending from the distal end of the inner tubular member, wherein each of the first and second protruding members has a semi-circular cross-sectional shape at a section selected through the transverse plane, and wherein the second protruding member is nested within the first protruding member and is rotatable about a longitudinal axis relative to the first protruding member. In some embodiments, the opening is formed by: a first protruding member extending from the distal end of the outer tubular member; and a second protruding member extending from the distal end of the inner tubular member, the second protruding member being nested within the first protruding member and rotatable relative to the first protruding member about a longitudinal axis, wherein the first protruding member includes an arcuate cross-sectional shape at least at a section selected through a transverse plane located at the midpoint of the first protruding member in the longitudinal direction, and wherein the second protruding member includes an arcuate cross-sectional shape at least at a section selected through a transverse plane located at the midpoint of the second protruding member in the longitudinal direction. In some embodiments, the angular lengths of the arcuate cross-sectional shapes are equal. In some embodiments, the angular length of the arcuate cross-sectional shape of the first protruding member is greater than the angular length of the arcuate cross-sectional shape of the second protruding member. In some embodiments, the angular length of the arcuate cross-sectional shape of the first protruding member is less than the angular length of the arcuate cross-sectional shape of the second protruding member. In some embodiments, the angular length of the arcuate cross-sectional shape of the first protruding member is equal to or greater than 180 degrees. In some embodiments, the distal end of the second protruding member includes a lip extending laterally beyond a longitudinal plane that passes through the endpoint of the arcuate cross-sectional shape of the second protruding member. In some embodiments, the lip is sized and positioned such that when the second and first protruding members are rotated relative to each other, the lip prevents the second protruding member from translating distally beyond the first protruding member. In some embodiments, the distal end of the first protruding member includes a blunt, rounded surface. In some embodiments, the first protruding member includes a U-shaped cutting edge configured to engage with the U-shaped cutting edge of the second protruding member to cut polyp tissue located therebetween when the second protruding member rotates relative to the first protruding member. In some embodiments, the distal end of the first protruding member includes a flat surface.In some embodiments, the opening is formed by: an external aperture in the sidewall of an outer tubular member, the external aperture including distal and proximal cut edges; and an internal aperture in the sidewall of an inner tubular member, the internal aperture including distal and proximal cut edges, wherein translation of the inner tubular member relative to the outer tubular member in a proximal direction causes the distal cut edge of the internal aperture to approach the proximal cut edge of the external aperture, and wherein translation of the inner tubular member relative to the outer tubular member in a distal direction causes the proximal cut edge of the internal aperture to approach the distal cut edge of the external aperture. In some embodiments, the inner tubular member includes a blunt, rounded distal end, and the outer tubular member includes an open distal end, wherein translation of the inner tubular member relative to the outer tubular member in a distal direction causes the blunt, rounded distal end of the inner tubular member to protrude distally from the open distal end of the outer tubular member. In some embodiments, the inner tubular member is translatable relative to the outer tubular member but not rotatable relative to the outer tubular member. In some embodiments, a first longitudinal length measured from the distal cut edge of the outer orifice to the distal end of the outer tubular member is equal to or greater than a second longitudinal length measured from the proximal cut edge of the inner orifice to the distal cut edge of the inner orifice. In some embodiments, the first longitudinal length is not greater than 110% of the second longitudinal length. In some embodiments, the first longitudinal length is not greater than 120% of the second longitudinal length. In some embodiments, the longitudinal length of the opening is not less than 5 mm at its maximum size. In some embodiments, the longitudinal length of the opening is not less than 10 mm at its maximum size. In some embodiments, the outer tubular body includes an outer diameter not greater than 0.125 inches. In some embodiments, the polyp removal device further includes a second opening adjacent to the distal end of the polyp removal device, configured to allow fluid communication between the environment outside the polyp removal device and the lumen of the inner tubular body. In some embodiments, the polyp removal device further includes: a cutting block positioned at the distal end of the outer tubular body, the cutting block having an outer diameter sized to fit the inner diameter of the distal end of the inner tubular member, wherein the cutting block includes a proximal side inclined relative to the transverse plane of the outer tubular member. In some embodiments, the distal end of the inner tubular member includes a circular cutting edge oriented parallel to the transverse plane. In some embodiments, the distal end of the inner tubular member includes a cutting edge inclined relative to the transverse plane. In some embodiments, the transverse width of the opening is at least 60% of the outer diameter of the outer tubular member. In some embodiments, the handle includes a gripping portion shaped for human hand gripping and radially projecting in a direction oriented at an angle in the range of 90-180 degrees relative to the opening.

[0016] According to some embodiments, a polyp removal device includes: an outer tubular body having a proximal end and a distal end; an inner tubular body positioned within a lumen of the outer tubular body, the inner tubular body having a proximal end and a distal end and movable relative to the outer tubular body; a handle coupled to the proximal end of the outer tubular body; an actuating member movably coupled to the handle, the actuating member being configured to cause movement of the inner tubular body relative to the outer tubular body when the actuating member moves relative to the handle; and a vacuum port coupled to a vacuum source, the vacuum port being in fluid communication with the lumen of the inner tubular body, wherein the distal end of the outer tubular body includes an opening configured to allow fluid communication between an environment outside the polyp removal device and the lumen of the inner tubular body, and wherein the distal end of the inner tubular body is shaped such that movement of the inner tubular body relative to the outer tubular body causes at least a portion of the opening of the outer tubular body to be blocked by the distal end of the inner tubular body.

[0017] In some embodiments, the opening at the distal end of the outer tubular body is formed by a first protruding member, which includes an arcuate cross-sectional shape at least in a cross-section taken through a transverse plane located at the midpoint of the first protruding member in the longitudinal direction. In some embodiments, the distal end of the inner tubular member includes a second protruding member, which is nested within the first protruding member and is rotatable relative to the first protruding member about a longitudinal axis, wherein the second protruding member includes an arcuate cross-sectional shape at least in a cross-section taken through a transverse plane located at the midpoint of the second protruding member in the longitudinal direction.

[0018] According to some embodiments, a polyp removal device includes: an outer tubular body having a proximal end and a distal end, the distal end including an opening configured to allow fluid communication between an environment outside the polyp removal device and a lumen of the outer tubular body; a handle coupled to the proximal end of the outer tubular body, the handle including a body and an actuation mechanism; a cutting member disposed within the distal end of the outer tubular body, the cutting member being movable relative to the outer tubular body, the cutting member including at least one cutting edge configured to cut polyp tissue already positioned through the opening of the outer tubular body; an actuation member functionally coupled between the actuation mechanism and the cutting member, wherein movement of the actuation mechanism relative to the body of the handle causes the actuation member to move the cutting member relative to the outer tubular body; and a vacuum port coupled to a vacuum source, the vacuum port being in fluid communication with the lumen of the outer tubular body.

[0019] In some embodiments, the actuation mechanism includes a trigger. In some embodiments, the actuation member includes a lever.

[0020] According to some embodiments, a method for removing a polyp from a human uterus includes: inserting a medical device into the uterus, the medical device including a working channel; inserting a polyp removal device through the working channel of the medical device; extending a distal end of the polyp removal device beyond the distal end of the working channel of the medical device into the uterus; positioning at least a portion of the polyp as an opening through the distal end of the polyp removal device; actuating an actuating member of the polyp removal device to dimensionally reduce the opening in the distal end of the polyp removal device, separating at least a portion of the polyp from the uterus; and transferring the separated portion of the polyp to a proximal end of the polyp removal device via suction. In some embodiments, the polyp removal device includes any polyp removal device described herein.

[0021] According to some embodiments, a tissue removal device includes: an outer tubular body having a proximal end, a distal end having a rounded end, and an inner lumen therebetween; a housing; and an inner tubular body having a distal end having a rounded end and an inner lumen, wherein the distal end of the outer tubular body has a resection portion that is at least half of the distal end and is at least 90 degrees and includes a non-oblique cut edge that begins at the outer tubular body and terminates at the end of the rounded end of the distal end of the outer tubular body, and the resection portion serves as a tissue receiver; wherein The inner tubular body has a cut portion, which is at least half of the distal end, at at least 90 degrees, and a non-oblique cut edge that begins at the inner tubular body and terminates at the rounded end of the distal end of the inner tubular body. The cut portion of the inner tubular body is configured as a tissue receiver. The cut portion of the inner tubular body forms a chamber that engages with the lumen of the outer tubular body when the inner tubular body rotates. The lumen of the inner tubular body is configured to receive tissue cut off by the rotation of the inner tubular body when the cut portions of the inner tubular body and the cut portions of the outer tubular body contain tissue.

[0022] According to some embodiments, a tissue removal device includes: an outer tubular body having a proximal end, a distal end having a rounded end, and an inner lumen therebetween; an inner tubular body having a distal end having a coaxially removed end having a non-oblique edge; and wherein the distal end of the outer tubular body has two parallel excision portions having non-oblique edges that do not terminate at the distal end, the excision portions acting as tissue receivers; and wherein the inner tubular body is translatable to the distal end of the lumen of the outer tubular body, the full extension of the inner tubular body forming a chamber that engages with the lumen of the outer tubular body when the inner tubular body is translated to the distal end of the outer tubular body; wherein the tubular body within the lumen receives tissue excised by the translation of the inner tubular body when tissue is received by either excision portion of the outer tubular body; and wherein the proximal ends of the outer tubular body and the inner tubular body terminate in a connector for an outlet port connected to an external vacuum source.

[0023] According to some embodiments, a tissue removal device includes: an outer tubular body having a proximal end, a distal end having a rounded end, and an inner lumen therebetween housing a cutter; wherein the distal end of the outer tubular body, near its distal end, configured as a tissue receiver, has an eyelet; wherein the cutter is an inner body having an inner lumen, and the distal end, near its distal end, configured as a tissue receiver, has an eyelet with a chamfered edge, the eyelets of the inner tubular body and the eyelets of the outer tubular body uniformly corresponding; wherein translation of the inner tubular body (whether extension or retraction of the inner tubular body) establishes a chamber in the lumen of the outer tubular body, the lumen of the inner tubular body retaining the cut tissue resulting from translation of the chamfered edge of the inner tubular body; and wherein the proximal ends of the outer tubular body and the inner tubular body terminate in a connector for an outlet port connected to an external vacuum source. Attached Figure Description

[0024] The foregoing and other features, aspects, and advantages of the present invention are described in detail below with reference to the accompanying drawings of various embodiments, which are intended to illustrate but not limit the invention. The drawings include the following figures, in which:

[0025] FIG. 1A and 1B An embodiment of a polypectomy device is shown, which uses the translation of an inner tubular member to remove polyps.

[0026] FIG. 2A and 2B An embodiment of a polypectomy device that uses rotation of an inner tubular member to remove polyps is shown.

[0027] FIG. 3 An example of a hysteroscope with a straight working channel is shown, which can be used in embodiments of the polypectomy device disclosed herein.

[0028] FIG. 4 It shows the relationship with FIG. 3 Used together with laparoscopy FIG. 1A Examples of polyp removal equipment and human uterus.

[0029] FIG. 5A-5C It shows FIG. 1A Additional details regarding the distal end portion of the polyp removal device.

[0030] FIG. 6A-6E It shows FIG. 2A Additional details regarding the distal end portion of the polyp removal device.

[0031] FIG. 7A-7E Another embodiment of the distal end construction of the polypectomy device is shown.

[0032] FIG. 8A-8F Another embodiment of the distal end construction of the polypectomy device is shown.

[0033] FIG. 9A-9G Another embodiment of the distal end construction of the polypectomy device is shown.

[0034] FIG. 10A-10G Another embodiment of the distal end construction of the polypectomy device is shown.

[0035] FIG. 11A-11G Another embodiment of the distal end construction of the polypectomy device is shown.

[0036] FIG. 12A-12F Another embodiment of the distal end construction of the polypectomy device is shown.

[0037] FIG. 13A-13C Another embodiment of the distal end construction of the polypectomy device is shown.

[0038] FIG. 14A-14F Another embodiment of the distal end construction of the polypectomy device is shown.

[0039] FIG. 15A-15C Examples of materials that can be used in polypectomy devices are shown, the materials having sharp or non-sharp edges.

[0040] FIG. 16A and 16B It shows FIG. 1A Additional details of the handle portion of the embodiment.

[0041] FIG. 17A and 17B It shows FIG. 2A Additional details of the handle portion of the embodiment.

[0042] FIG. 18A and 18B Another embodiment of the handle portion of the polyp removal device is shown.

[0043] FIG. 19A-19I Another embodiment of the polyp removal device is shown.

[0044] FIG. 20A-20C Another embodiment of the polyp removal device is shown.

[0045] FIG. 21 A portion of another embodiment of the polyp removal device is shown.

[0046] FIG. 22A-22C Details of the distal end portion of another embodiment of the polyp removal device are shown.

[0047] FIG. 23 An example of a method for performing polyp removal is shown.

[0048] FIG. 24A-24C Another embodiment of the distal end construction of the polypectomy device is shown.

[0049] FIG. 25A-25U Another embodiment of the polyp removal device is shown.

[0050] FIG. 26A-26F An embodiment of a mechanism for controlling the movement of a cutter is shown.

[0051] FIG. 27A-27D Another embodiment of a mechanism for controlling the movement of a cutter is shown.

[0052] FIG. 28A-28D Another embodiment of a mechanism for controlling the movement of a cutter is shown.

[0053] FIG. 29A-29C Another embodiment of a mechanism for controlling the movement of a cutter is shown.

[0054] FIG. 30A-30C An embodiment of the external tubular component of a polyp removal device is shown.

[0055] FIG. 31A-31D Another embodiment of a mechanism for controlling the movement of a cutter is shown.

[0056] FIG. 32A-32C Another embodiment of the external tubular component of a polyp removal device is shown.

[0057] FIG. 33A-33D Another embodiment of the external tubular component of a polypectomy device is shown. Detailed Implementation

[0058] Although several embodiments, examples, and illustrations are disclosed below, it will be understood by those skilled in the art that the invention described herein extends beyond the specific disclosed embodiments, examples, and illustrations, and includes other uses of the invention and its obvious modifications and equivalents. Embodiments of the invention are described with reference to the accompanying drawings, wherein similar reference numerals always refer to similar elements. The terminology used in the description herein is not intended to be interpreted in any limiting or restrictive manner merely because it is used in conjunction with the detailed description of certain particular embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, and no single feature is solely responsible for its desired properties or is necessary for carrying out the invention described herein. Moreover, it should be understood that any examples herein are non-limiting. Therefore, the invention disclosed herein is not limited to any particular embodiment, aspect, concept, structure, function, or example described herein.

[0059] Polyps are abnormal growths of tissue from the uterine lining. They can be removed through a polypectomy. Endometrial or uterine polyps are abnormal growths attached to the inner wall of the uterus. Uterine polyps are usually benign, but they can become cancerous or eventually develop into cancer. One method for removing uterine polyps is hysteroscopic polypectomy, in which a hysteroscopic electrocautery device is inserted into the uterus along with a loop wire. An electric current is transmitted through the loop wire to cut the polyp by raising the temperature of the loop to 100°C to 200°C. This technique has its own set of challenges. The surgeon has to manually remove the cut polyp, which is time-consuming. Furthermore, using electrocautery to cut tissue can damage uterine tissue and may impair the uterus's ability to maintain a pregnancy. For this reason, reproductive endocrinologists may even avoid using this technique, fearing they might damage the tissue where a fertilized egg might implant. Additionally, the loop wire may not always remove the entire polyp, potentially requiring the procedure to be repeated later. The loop wire also carries the risk of thermal damage to surrounding tissues, and it is particularly dangerous if accidentally pushed through the uterine wall into contact with sensitive intestinal tissue. Morbidity and mortality are known complications of uterine perforation caused by circular silk loops, resulting in accidental intestinal thermal injury. Additionally, most patients will require anesthesia to alleviate pain caused by the heat generated by the silk loops on the sensitive tissues lining the uterus. Finally, if monopolar silk loops are used, uterine dilation requires non-electrolyzed fluids, which can lead to sodium imbalance or fluid overload in the patient.

[0060] Another potential method for removing uterine polyps is to use a mechanical device designed to cut uterine fibroids (also known as leiomyomas or myomas) from the uterine wall. Fibroids are growths in the uterus that typically grow much larger than typical polyps. Furthermore, fibroids are usually formed from tougher, more fibrous tissue than polyps, which are somewhat gel-like in consistency. Due to the general size and toughness of fibroids, tools designed to remove them are more robustly constructed, higher-powered instruments that employ sharp blades, drilling mechanisms, and / or similar techniques to gradually break up and remove the fibroid. While this design could be used to remove polyps, it is overkill for the task at hand and introduces various unnecessary safety risks and mechanically complex equipment. For example, a sharp and robust fibroid removal tool could potentially inadvertently traumatize and / or even puncture adjacent uterine wall tissue. Additionally, because fibroid removal tools are designed to cut into relatively tough material, the cutting features of the tool must be designed to be relatively robust. This allows the tool to be designed to be larger and / or to use thicker tubes than are needed or required for the safe and efficient removal of polyps. They also include a motorized power delivery system to provide the energy needed to cut the fibroid.

[0061] Ideally, polyp removal should be performed in a physician's office setting, rather than in a hospital surgical environment. However, because existing methods for removing polyps (such as uterine polyps) require a high level of skill, expensive equipment, and / or come with a high level of risk, polyp removal is typically not performed in an office setting. However, the devices, systems, and methods disclosed herein can provide a safer and more cost-effective way to perform polyp removal in an office setting.

[0062] Removing uterine polyps via hysteroscopic polypectomy presents various challenges, as described above. Accordingly, devices and methods, as disclosed in this article, are needed to address some of the drawbacks associated with conventional hysteroscopic polypectomy.

[0063] The various embodiments disclosed herein provide safer and more effective polyp removal devices, methods, and systems. In some embodiments, the polyp removal device includes an elongated tube having a handle with a trigger or other actuation mechanism at a proximal end and one or more openings (e.g., openings, holes, apertures, windows, incisions, and / or the like) at a distal end. The one or more openings at the distal end may be sized and configured to: (1) allow the use of a vacuum to aspirate the polyp through it, and / or (2) mechanically separate the polyp from the uterine wall using a movable member operatively coupled to the trigger or other actuation mechanism.

[0064] In some embodiments, the distal end of the polypectomy device is ideally designed to use a relatively large opening, large enough to receive as many polyps as possible at any given time. This differs from typical myoma removal devices, which require gradual cutting or grinding at the myoma site and therefore need to be relatively robust. Because polyps have a softer consistency than myomas, the tube used in the polypectomy device can be thinner than a myoma removal tool, allowing the polypectomy device to have a larger inner lumen, thus allowing larger tissue blocks to pass through it. Furthermore, because the mechanical stress present on the cutting features of the distal end of the polypectomy device is less than that of a myoma removal device, a larger opening can be present at the distal end of the polypectomy device, allowing for the removal of larger pieces of tissue at any given time.

[0065] In some embodiments, the polypectomy device disclosed herein includes one or more openings at its distal end, said openings being sized and configured to receive the entire polyp through which it is passed for removal of the entire polyp in one stroke of the cutting blade / surface. However, this disclosure is not limited to this configuration, and in some embodiments or in some cases, only a portion of the polyp may be capable of assembling through one or more openings at the distal end of the device at any given time.

[0066] The polyp removal devices, systems, and methods disclosed herein offer various benefits, such as easier and safer polyp removal, faster polyp removal, more efficient polyp removal, lower cost, and easier manufacture of surgical instruments, and / or the like. Some features contributing to these benefits in some embodiments disclosed herein include, but are not limited to: providing a relatively large opening at the distal end of the device; providing more than one opening at the distal end of the device; employing an inner tubular member coupled to or including a cutting surface, said cutting surface being translated or rotated relative to an outer tubular member, but not both; providing a non-sharp or blunt cutting surface; providing a blunt end to the polyp removal device; providing an opening in the distal end of the polyp removal device, which is formed on the side of the distal end and at the distal end of the distal end; providing a cutting member that cuts in two directions (e.g., along an extension and retraction direction or along clockwise and counterclockwise directions); and / or similar steps.

[0067] In some embodiments, the devices and methods disclosed herein allow for the cutting and removal of tissue. In some embodiments, the devices and methods disclosed herein allow for the simultaneous cutting and removal of tissue. This can reduce the operation time required for polyp removal procedures. This can reduce patient exposure to anesthesia and decrease the risk of fluid overload.

[0068] In some embodiments, the devices and methods disclosed herein allow for the use of vacuum or suction pressure to remove tissue. This can allow for improved removal of polyps or tissue. This can allow for reduced damage to the uterus. This can allow for the use of an electrolyzed balanced salt solution to dilate the uterus, unlike the use of electric current to remove tissue, which would require the use of a non-electrolyzed solution to achieve the same purpose. This can reduce the risk of electrolyte imbalance and / or thermal injury.

[0069] Polyp removal equipment

[0070] FIG. 1A and 2A Two exemplary embodiments of the polyp removal device as disclosed herein are shown. FIG. 1B and 2B Close-up views of the distal end of the polypectomy device are shown. (Reference) FIG. 1A and 1B The polyp removal device 100 includes a handle 102 and an outer elongated tubular member 104. The outer tubular member 104 includes a distal end 106 configured to receive and remove polyps. In this embodiment, the distal end includes two elongated openings 108 positioned opposite each other. These openings 108 are adjacent to a support arm 110, which supports a blunt, rounded end 112 at the distal end of the polyp removal device 100. The polyp removal device 100 further includes an actuating member (e.g., a trigger, switch, lever, button, or the like) 112 coupled to the handle 102. In this embodiment, the actuating member 112 is shaped and configured to engage a finger of a human hand, such as a user's thumb or index finger, and is configured to translate back and forth along or parallel to the longitudinal axis of the polyp removal device 100. The actuating member 112 is functionally coupled to an inner tubular member 114, which also translates back and forth along the longitudinal axis together with the actuating member 112. Accordingly, the movement of the actuating member 112 causes relative movement of the inner tubular member 114 relative to the outer tubular member 104.

[0071] The polypectomy device 100 further includes a vacuum port 116 configured, for example, to be coupled to a vacuum source via a flexible tube. In this embodiment, the vacuum port 116 is attached to the proximal end of the handle 102 and includes a connector in fluid communication with the internal lumen of the inner tubular member 114. In use, the outer tubular member 104 of the polypectomy device 100 can be inserted through a laparoscope (e.g., FIG. 3The exemplary endoscope shown in the diagram has a working channel, causing the distal end 106 to protrude into the uterus. The physician can then position one or more of the openings 108 near the polyp to be removed via the manipulator handle 102. Next, the physician can activate a vacuum source, such as by activating a foot pedal or the like, causing the polyp (or at least a portion of the polyp) to be at least partially aspirated into one of the openings 108 of the distal end 106. While this embodiment includes two openings 108, other embodiments may have only one opening or more than two openings. In some embodiments, it may be desirable to have only one opening, or to have methods to temporarily close other openings (such as sliding or rotating shutters, windows, and / or the like), because once the polyp has been aspirated through one opening, vacuum aspiration can begin to draw in dilution fluid through any remaining openings (i.e., via the path of least resistance). However, if there is only one opening, or other openings can be temporarily closed, vacuum aspiration can be focused on the polyp being removed.

[0072] In some embodiments, because polyps typically have a generally gel-like consistency, vacuum aspiration alone may be sufficient to separate the polyp from the uterine wall. In this case, the polyp will be aspirated into the lumen of the inner tubular member 114 and traveled posteriorly through the inner tubular member 114 toward the handle 102 (and potentially out through the vacuum port 116) for collection or disposal. In some embodiments, although vacuum aspiration alone may be sufficient to separate the polyp from the uterine wall, it may be desirable to have additional or alternative mechanical means for separating the polyp and / or assisting in its separation. For example, see reference... FIG. 1A and 1B The polyp removal device 100 shown has an inner tubular member 114 configured to translate forward or distally relative to an outer tubular member 104, causing the opening 108 to narrow and / or close, squeezing the polyp between the distal side of the inner tubular member 114 and the distal edge of the opening 108, and causing the polyp to be mechanically separated or removed.

[0073] One reason that mechanical separation techniques combined with, or even alternative to, vacuum might be desirable is that fluid pumped into the uterus is typically used to dilate it during procedures such as polypectomy. Any vacuum applied to the polyp removal device or instrument could also result in the removal of at least a portion of the dilating fluid from the uterine cavity. If a relatively small amount of fluid is removed, the procedure may not be significantly affected. However, if a larger amount of fluid is removed, this may require intervention, such as reintroducing new fluid during removal, stopping the polyp removal procedure and adding more fluid, and / or similar measures. Such procedures can make polypectomy a more complex and difficult surgery, and therefore are desirable to avoid by using the various devices disclosed herein.

[0074] One way the polypectomy device disclosed herein can limit the loss of dilation fluid is that vacuum aspiration can be used only to remove the removed polyp or a portion of the polyp after it has been mechanically separated, for example, by translation or rotation of the inner tubular member 114 relative to the outer tubular member 104. For example, a physician can: (1) manually manipulate the device (e.g., via handle 102) to position the polyp through one or more openings 108, (2) manipulate the actuating member 112 to translate the inner tubular member 114 and separate the polyp from the uterus, and (3) then initiate aspiration to draw the separated polyp proximally through the inner lumen of the inner tubular member 114 for collection. In this example, very little (if any) dilation fluid will be lost because the physician is able to hold the inner tubular member 114 in its most distal position, thereby substantially or completely closing the openings 108 during polyp removal. In some embodiments, at least some leakage from the opening 108 (or other locations) to the inner lumen of the inner tubular member 114 may be desirable, even when the inner tubular member 114 is fully positioned anteriorly or distally, to facilitate the transfer of the polyp from the distal end to the proximal end.

[0075] Another way the polypectomy device disclosed herein can limit the loss of dilation fluid is that the physician can use vacuum or suction to aspirate the polyp (or a portion of a polyp) through one or more openings 108, but then use mechanical movement of the inner tubular member 114 to separate the polyp from the uterine wall. The process of aspirating the polyp or a portion of a polyp into the openings 108 will generally require less suction force than would be needed to actually separate the polyp from the uterine wall using suction alone. Accordingly, by employing vacuum or suction to introduce the polyp or a portion of a polyp through the openings 108, but then using mechanical means, such as the translational inner tubular member 114, to separate the polyp from the uterine wall, suction can be utilized most efficiently and the loss of dilation fluid can be minimized. In some embodiments, at least some suction can still be applied during the mechanical manipulation of the inner tubular member 114 to keep the polyp aspirated through the openings 108 during mechanical separation.

[0076] It should be noted that although the various embodiments disclosed herein are described based on an inner tubular member concentrically positioned within an outer tubular member and polyps being aspirated and removed through the inner lumen of the inner tubular member, various other designs may be employed to achieve similar results. For example, instead of using an inner tubular member, an actuating rod or other mechanism may be used to move the cutting surface or blade at the distal end of the polypectomy device. In this case, the removed polyp will be aspirated through the lumen of the outer tubular member because it is not necessary to position the inner tubular member within the outer tubular member. An example of such a configuration will be described in more detail below. FIG. 12A-12FAs shown in the diagram. Similar constructions (e.g., using an actuator rod or the like to move the cutting portion at the distal end of the device) can be used with any other embodiments disclosed herein, including but not limited to those shown. FIG. 5A-5C Various distal end configurations are shown in 6A-6E, 7A-7E, 8A-8F, 9A-9G, 10A-10G, 11A-11G, 13A-13C, and 14A-14F. For embodiments configured to utilize longitudinal translation of the cutting member at the distal end, this actuating rod can be directly coupled to the cutting member. For embodiments configured to utilize rotational movement of the cutting member at the distal end, this actuating rod can be coupled to the cutting member via a connecting mechanism, gear train, and / or the like (which converts the translation of the actuating rod into rotation of the cutting mechanism).

[0077] In some embodiments, movement of the inner tubular member 114 can be entirely manually controlled, for example, by a physician moving the actuating member 112 forward and backward along the longitudinal axis. In some embodiments, the actuating member and / or the inner tubular member 114 can be biased or spring-loaded such that the actuating member 112 is configured to be manually actuated in one direction but will subsequently automatically return to the starting point when the physician or user releases the pressure used to initially move the actuating member 112. Furthermore, in some embodiments, the polypectomy device may include electrical actuation, pneumatic actuation, hydraulic actuation, and / or the like. For example, buttons, triggers, foot pedals, and / or the like may be configured to actuate or start a motor that causes movement of the inner tubular member 114 relative to the outer tubular member 104. Furthermore, although... FIG. 1A The embodiment shown illustrates an actuating member or trigger 112 directly coupled to the inner tubular member 114 (meaning their relative motion is one-to-one), but other embodiments may employ other actuation or triggering mechanisms. For example, the actuating member may be coupled to a gear train that allows for more precise control, provides mechanical advantages, allows for the conversion of one direction of motion of the actuating member into a different direction of motion of the inner tubular member, converts translational motion into rotational motion and / or vice versa, and / or similar.

[0078] like FIG. 1B As shown, the distal end 106 of the polypectomy device 100 includes a blunt, rounded tip 112. In polypectomy devices as disclosed herein, a blunt tip may be desirable because it helps to avoid unintentional trauma or damage to the uterine wall. Accordingly, for devices such as… FIG. 1BThe design shown reduces the risk of uterine wall trauma if the distal end of the polypectomy device 100 comes into contact with or rubs against a portion of the uterine wall compared to designs with a sharper distal end. This contrasts with some other medical devices, such as biopsy instruments, which include sharp distal ends because they are designed to puncture tissue to obtain tissue samples. This design could be dangerous when used with polypectomy devices as disclosed herein, as the sharp end could unintentionally puncture the uterine wall.

[0079] In addition to including a blunt end, the various embodiments disclosed herein include few (if any) sharp surfaces at the distal end of the polypectomy device (i.e., the portion of the polypectomy device that extends from the working channel of the laparoscope into the uterus). For example, although in various embodiments, the inner tubular member, such as FIG. 1B The inner tubular member 114, to some extent acting as a blade, separates the polyp from the uterine wall; however, due to the generally gel-like consistency of the polyp, the inner tubular member 114 or similar does not necessarily need to be sharpened. Accordingly, in some embodiments, the inner tubular member or its blade or cutting surface is not sharp, and / or may include smooth, blunt, and / or similar surfaces. Furthermore, the edges defining one or more openings 108 of the outer tubular member 104 may be non-sharp, smooth, blunt, and / or similar. In this configuration, there are few or no sharp surfaces at the distal end of the polyp removal device, significantly reducing the risk of accidental trauma to the uterine wall. This can be highly advantageous, especially when such a device can be used by physicians who are not typically skilled in uterine surgery. This design allows polyp removal to be performed by gynecologists in their offices, rather than requiring patients with polyps to be transported to the operating room.

[0080] Unlike the surgical environment of a hospital, a potential complication of performing uterine polyp removal in a physician's office setting is that the procedure may not be reimbursed as much by health insurance providers as the same or similar procedures performed in a surgical setting. For this and other reasons, such as general efficiency, it may be desirable to reduce the complexity of polyp removal equipment, thereby potentially reducing the cost of such equipment. If the polyp removal equipment disclosed herein can be manufactured at a more reasonable cost compared to heavier-duty tools such as myomectomy tools, then such tools are more likely to be used in an office setting.

[0081] A feature that helps reduce complexity in many of the embodiments disclosed herein is that many of the embodiments disclosed herein include an inner tubular member (or actuating member), such as inner tubular member 114, which is configured to move relative to an outer tubular member, such as outer tubular member 104, but only in one degree of freedom. For example, some embodiments, such asFIG. 1A The polyp removal device 100 shown allows the inner tubular member to translate relative to the outer tubular member 104 along the longitudinal axis, but the inner tubular member 114 is not configured to move in any other direction, such as rotating about the longitudinal axis. This is consistent with... FIG. 2A The embodiment shown in the figure forms a contrast, which allows rotation but not translation.

[0082] FIG. 2A An embodiment of a polyp removal device 200 is shown, which is similar in many respects to FIG. 1A A polypectomy device 100. A polypectomy device 200 includes a handle 202, an elongated outer tubular member 204 extending from a distal end of the handle, and a distal end 106 including two openings 108. However, in this embodiment, the inner tubular member 214 is configured to rotate relative to the outer tubular member 204 about a longitudinal axis, rather than translate along the longitudinal axis. To support this difference in movement, the handle 202 also has a different design than the handle 102. The handle 202 includes an actuating member 212 that rotates relative to a non-rotating portion 213. When the actuating member 212 rotates, it causes the inner tubular member 214 to also rotate relative to the outer tubular member 204, thereby narrowing or closing the openings 108, allowing the polyp to be separated from or removed from the uterine wall.

[0083] As noted above with respect to the polypectomy device 100, the actuating member 212 of the polypectomy device 200 can be designed differently. For example, in this case, the rotating portion 212 is directly connected to the inner tubular member 214, causing the inner tubular member 214 to rotate relative to the outer tubular member 204. However, in other embodiments, the handle 202 can be designed differently and includes various types of manual and / or automatic actuation mechanisms. For example, in some embodiments, the polypectomy device includes a more ergonomic grip that is shaped and configured to be comfortably held in the physician's hand. The ergonomic grip may include actuating members such as triggers, buttons, levers, or the like, positioned for operation by, for example, the physician's index finger or thumb, or even all of the physician's fingers simultaneously.

[0084] Polyp removal equipment in use

[0085] FIG. 3 An example of a hysteroscope 300 is shown, which can be used in conjunction with various embodiments of the polypectomy apparatus disclosed herein to perform polypectomy. The hysteroscope 300 includes an elongated member 307 having a working channel 301 passing therethrough. The working channel 301 may be sized to allow the external tubular component of the polypectomy apparatus, such as... FIG. 1AAn external tubular member 104, shown in the diagram, passes through the hysteroscope 300. The hysteroscope 300 further includes a visualization mechanism 303, which allows a physician to visualize the uterine cavity. The hysteroscope 300 further includes multiple ports 305. These ports 305 can be used, for example, to remove or introduce dilating fluid from the uterus.

[0086] although FIG. 3 A specific example of a hysteroscope 300 is shown, but the polypectomy device, method, and system disclosed herein can be used with any medical device having a working channel therein for insertion of the polypectomy device. Furthermore, in some embodiments, the polypectomy device can be used as a standalone medical device that does not pass through the working channel of the hysteroscope or other instrument, and / or the hysteroscope or other medical device may include any one or more features of embodiments of the polypectomy device disclosed herein. For example, alternative embodiments of the hysteroscope 300 may include a distal end configuration having features similar to the distal end of the polypectomy device disclosed herein, which allows polyps to be aspirated therein and separated from the uterine wall.

[0087] FIG. 4 It shows the relationship with the patient and FIG. 3 The hysteroscopy 300 was used together. FIG. 1A A schematic diagram of a polypectomy device 100. In this example, a hysteroscope 300, and particularly an elongated tubular member 307 of the hysteroscope 300, has passed through the cervix 425 into the cavity 421 of the patient's uterus 420. An outer tubular member 104 of the polypectomy device 100 has passed through the working channel of the hysteroscope 300, resulting in the distal end 106 of the polypectomy device extending into the cavity 421 of the uterus 420.

[0088] FIG. 4 The schematic diagram of the uterus 420 shown includes multiple polyps 422, 423 and a fibroid 424 attached to the uterine wall. Although all the fibroids and polyps are not the same size, this figure presents the relatively common sizes of fibroids 424 and polyps 422, 423. It can be seen that fibroid 424 is significantly larger than polyps 422, 423. Furthermore, due to the toughness of fibroids relative to polyps, removing fibroid 424 using this embodiment of the polyp removal device 100 may be difficult and / or inefficient. However, this embodiment of the polyp removal device 100 is ideally suited for removing polyps 422, 423. Due to the relatively large opening 108 of the distal end 106 of the polyp removal device 100 (e.g., FIG. 1BAs shown in the diagram, a large portion or even the entire polyp 422, 423 may be aspirated into the polypectomy removal device at once for separation from the uterine wall. However, even if substantially all or the entire polyp 422, 423 cannot be loaded into the distal end 106 of the polypectomy device 100 at once, the procedure can still be made more efficient by using one or more relatively large openings, thereby increasing the amount of tissue that can be removed at any given time on a device with smaller openings. Furthermore, as mentioned above, the various polypectomy devices disclosed herein are able to have such larger openings because, among other things, these devices are designed to remove polyps, not tougher tissue. Another reason is that the various polypectomy devices disclosed herein are not designed to be inserted into the body by piercing tissue and forming their own pathways within the body, which could introduce relatively large stress into the distal end of the instrument.

[0089] like FIG. 4 As can be seen, polyps can be located in different parts of the uterus 420. For example, in this figure, two polyps 422 are located on the lateral wall of the uterus, and two polyps 423 are located on the posterior wall of the uterus 420. Various embodiments of the polyp removal device disclosed herein make it easier to access and remove polyps in these different locations. For example, due to the relatively large opening 108 of the polyp removal device 100, the polyp removal device 100 is capable of removing not only lateral wall polyps 422 but also posterior wall polyps 423. However, as will be described in more detail below, other embodiments may be even more suitable for easier removal of posterior wall polyps 423. For example, FIG. 8A The embodiment shown includes an opening 808 that extends through the distal end of the distal end, thereby making it even easier to position the opening 808 near the posterior wall polyp 423.

[0090] FIG. 4 The figures also illustrate a collection system 430 fluidly coupled to a vacuum port 116 and a vacuum source 432 fluidly coupled to the collection system 430. The vacuum source 432 is further coupled to or includes a vacuum controller 434, such as, for example, a foot pedal, button, switch, trigger, and / or the like. The collection system 430 may optionally be used in some embodiments to allow the collection of samples of removed polyps, such as for later laboratory analysis. In some embodiments, the collection system 430 is a separate device or system fluidly coupled to the polypectomy device 100. In other embodiments, the collection system may be integrated into the polypectomy device. For example, as will be referenced below... FIG. 19B In more detail, the collection system can be integrated into the handle portion of the polypectomy device.

[0091] polyp removal

[0092] FIG. 5A-5C An example procedure for removing uterine polyps using the polypectomy device disclosed herein is shown. Although FIG. 5A-5C The embodiments shown employ FIG. 1A The polyp removal device 100, however, similar techniques can also be used with different devices. Furthermore, FIG. 5A-5C The operation focuses on the distal end 106 of the polypectomy device, and various modifications can be made to the proximal end while still obtaining the same or similar results.

[0093] refer to FIG. 5A In this example, the doctor wants to remove polyp 522 attached to the uterine wall 526. Accordingly, using... FIG. 1A In the example polypectomy device 100, the physician can ensure that the inner tubular member 114 is in the retracted position, thereby fully opening the opening 108 to allow the polyp 522 to be positioned and passed through it. FIG. 5A As can be seen, the bottom opening 108 has been manipulated such that at least a portion of the polyp 522 has passed through it. In some embodiments, positioning the polyp 522 through the opening 108 can be done entirely manually, meaning that suction is not employed. However, in some embodiments, at least some suction can be initiated to help draw the polyp 522 in through the opening 108.

[0094] Furthermore, although this embodiment shows the inner tubular member or blade 114 in a fully retracted position, such that the opening 108 is fully open at the start of the procedure, in other embodiments it may be desirable to advance the inner tubular member 114 at least partially before the polyp 522 is inserted through the opening 108. For example, if suction is to be used to assist in drawing the polyp 522 into the opening 108, it may be desirable in some embodiments to advance the inner tubular member 114 to a certain extent so as to narrow the size of the opening 108, thereby concentrating the suction force more narrowly. As those skilled in the art will understand, for a given amount of suction applied to a polypectomy device, a smaller opening size 108 at the distal end of the device will produce a higher, more concentrated suction force compared to a larger opening 108. This is analogous to the operation of a nozzle, where a smaller orifice size in the nozzle will generate higher pressure compared to a larger orifice size, even if the same or similar amount of fluid may pass through it.

[0095] refer to FIG. 5B The inner tubular member or blade 114 is now being advanced or extended distally toward the distal end 112 of the outer tubular member. The polyp 522, or at least a portion thereof, is located within the inner lumen of the inner tubular member 114. With continued advancement of the inner tubular member 114 and / or continued or increased application of suction, the polyp 522 will detach from the uterine wall 526. (Reference) FIG. 5CThe inner tubular member 114 has been fully advanced to the distal end of the polypectomy device, and the polyp 522 has been separated from the uterine wall 526. The polyp 522 can now continue to be aspirated through the lumen of the inner tubular member 114. FIG. 5C The left side of the center-oriented, and optionally collected in the collection system, such as FIG. 4 The collection system 430 shown in the figure.

[0096] It should be pointed out that, although in FIG. 5C The inner tubular member 114 is positioned entirely anteriorly or distally, but in some embodiments, this may not mean that the inner tubular member 114 is fluidly sealed to the distal end of the outer tubular member 104. To allow continued aspiration after removal to pass the polyp 522 through the lumen of the inner tubular member 114, it may be desirable to have at least some fluid communication between the environment outside the polypectomy device (e.g., the uterine cavity) and the lumen of the inner tubular member 114. This fluid communication can be achieved in one or more of various ways, such as by means of a distal edge of the inner tubular member 114 that does not form a complete seal to the distal end of the outer tubular member 104, an inner tubular member 114 including orifices in its sidewalls that allow dilating fluid to pass through, the distal end 112 of the outer tubular member 104 including orifices, and / or the like. In some embodiments, specific features such as cavities are not necessarily intended to allow a certain amount of leakage or fluid communication between the uterine cavity and the inner lumen of the inner tubular member 114, but the manufacturing method or tolerances of the inner tubular member 114 and the outer tubular member 104 are such that a fluid-free seal is not formed when the inner tubular member 114 is positioned in its fully extended configuration.

[0097] Furthermore, in some embodiments, it may be acceptable (or even desirable) for the inner tubular member 114 to form a leak-proof seal even when it is in its most distal or fully extended position. For example, in cases where multiple polyps are being removed and / or polyps are being removed in multiple steps rather than all at once, the physician may extend and retract the inner tubular member 114 multiple times. For instance, the inner tubular member 114 may be extended to cut off a portion of the polyp, and then retracted to allow the next portion of the polyp to be positioned through the opening 108 and within the lumen of the inner tubular member 114. The inner tubular member 114 may then be extended again to separate that next portion of the polyp. This procedure may be repeated multiple times as desired or required to remove all polyps. In the case where the inner tubular member 114 repeatedly moves back and forth, even if the inner tubular member seals or substantially seals the outer tubular member 104 in the fully extended position, sufficient fluid communication can exist when the inner tubular member 114 is in the partially extended position, allowing removed polyps or polyp masses to be transferred through the inner lumen of the inner tubular member 114 and into the collection system 430. Furthermore, even in cases where polyps are removed in a single cut, the physician may desire to control the amount of "leakage" of dilation fluid into the inner lumen, for example, by means of an actuating member of the manipulator.

[0098] although FIG. 5A-5C The process shown illustrates an example of a polyp removal device that uses an inner tubular member 114 translated relative to the outer tubular member 104 to remove polyps; however, a similar principle can be applied to polyp removal devices that include an inner tubular member that rotates relative to the outer tubular member. Various examples of such devices are described below.

[0099] It should be noted that although the various embodiments disclosed herein are described as having a cutting edge or cutting surface as part of the inner tubular member, this should not be construed as meaning that all embodiments include a cutting surface or cutting member integrally formed with the inner tubular member. For example, for FIG. 5A-5CThe embodiment shown in the diagram suggests that the most cost-effective way to manufacture the device could be with a single inner tubular member including a distal cutting surface integrally formed at its distal end. However, in some embodiments, a distal portion (e.g., a cutting member, cutting section, blade member, blade section, and / or the like) may be coupled to the inner tubular member and form one or more cutting surfaces for cutting polyps. For example, it might be desirable to have an elongated inner tubular member formed of one material and a cutting section formed of another material coupled to the end of the inner tubular member. For example, the inner tubular member may comprise a thin-walled stainless steel tube, and a cutting member comprising a polymer, composite material, or other material may be coupled to the end of the stainless steel tube. This can, for example, allow the main elongated portion of the inner tubular member to be relatively thin and have a relatively large inner lumen, while allowing the distal cutting member or cutting section to be relatively complex in design and / or have tighter tolerances than the rest of the inner tubular member. Any cut-out member or other portion attached to the distal end of an inner or outer tubular member may be attached by a variety of manufacturing methods, such as, for example, laser welding, adhesives, mechanical fasteners and / or the like.

[0100] distal end structure

[0101] Various configurations of the distal end of the polypectomy device (e.g., the portion protruding from the working channel of the laparoscope into the uterus) can be used with the embodiments disclosed herein. Many of these embodiments share common features including an outer tubular member and an inner tubular member, wherein the inner tubular member is movable relative to the outer tubular member in at least one degree of freedom. In many embodiments disclosed herein, the outer tubular member is configured to be fixed relative to the handle of the device, and the inner tubular member is configured to be movable relative to the outer tubular member and the handle. However, some embodiments may be configured to move the outer tubular member relative to the handle and the inner tubular member while keeping the inner tubular member fixed relative to the handle. Furthermore, some embodiments may be configured to move the outer tubular member and the inner tubular member relative to the handle and relative to each other.

[0102] Furthermore, as mentioned above, the various embodiments disclosed herein are configured to have one degree of freedom between the inner tubular member and the outer tubular member. Specifically, many embodiments disclosed herein are configured such that the inner tubular member is translatable relative to the outer tubular member along a longitudinal axis, or rotatable relative to the outer tubular member about a longitudinal axis, but not both. However, some embodiments may include both rotation and translation of the inner tubular member relative to the outer tubular member.

[0103] It should be noted that when this disclosure relates to tubular members (i.e., outer and inner tubular members), it is not intended to limit the embodiments disclosed herein to a configuration in which the inner and / or outer tubular members comprise a cylindrical or annular shape along their entire length. Rather, the term "tubular member" is intended to refer to a component of a polypectomy device comprising at least one outer wall extending longitudinally and forming a lumen defined by the inner surface of the member. In many embodiments, the tubular member is cylindrical or annular in shape, at least for a substantial portion of its length. However, it is contemplated that some embodiments may include non-cylindrical shapes for the inner and / or outer tubular members. Furthermore, although in some embodiments the inner and outer tubular members may comprise generally cylindrical or annular shapes along most of their length (e.g., intended to be positioned in the central portion within the working channel of a laparoscope or other medical device), the shape or configuration of the tubular members may differ at the distal and / or proximal ends of the polypectomy device, with an opening through which a polyp is inserted located at the distal end, where the inner and outer tubular members engage with a handle at the proximal end.

[0104] Various embodiments of the distal end structures are described below. Each of these distal end structures can be used with a wide variety of polypectomy device designs, including polypectomy devices with handles of different shapes and configurations, polypectomy devices with integrated vacuum aspiration and / or polyp collection features, polypectomy devices without integrated aspiration and / or collection features, manually operated polypectomy devices, electrically, pneumatically, or hydraulically operated polypectomy devices, and / or the like. Furthermore, these various distal end structures can be integrated into different medical devices, such as hysteroscopes, other endoscopic devices, and / or the like.

[0105] In some embodiments, the various distal end features disclosed herein are integrally formed into the inner and / or outer tubular members. For example, a cylindrical tube may have one or more openings or other features cut therein to form the distal end feature. However, in some embodiments, the distal end feature may be formed by attaching one or more separate components to the inner and / or outer tubular members. For example, to form a blunt, rounded end of the outer tubular member, a blunt, rounded portion may be attached to the end of the outer tubular member, such as via laser welding, adhesives, and / or other attachment methods. Furthermore, the inner tubular member may include a generally cylindrical or annular elongated portion having a blade or cutting portion attached to its distal end, wherein the attached blade or cutting portion is a portion that mechanically contacts the polyp to aid in the separation of the polyp from the uterine wall.

[0106] It should also be noted that, as discussed in more detail below, although several parts of the polypectomy device disclosed herein are described as having blades, cutting features, and / or the like, this is not necessarily intended to imply that the blades, cutting portions, and / or the like are sharp. As mentioned above, because polyps typically have a relatively gel-like consistency, the “blade” constructed to separate the polyp from the uterine wall may not need to be sharpened and may include blunt edges. This can have several benefits. For example, the risk of accidental trauma to the uterine wall can be reduced by having blunt edges with blades or cutting surfaces. Furthermore, if a sharpening operation is not required to establish the cutting surface, manufacturing costs can be reduced. This can further help reduce the cost of such polypectomy devices to a level suitable for practical use in a physician’s office setting rather than in a hospital surgical setting.

[0107] In various embodiments, various materials can be used to form the inner and / or outer tubular components of the polyp removal device disclosed herein. For example, the inner and / or outer tubular components can be formed from surgical-grade stainless steel tubing. However, other materials, such as, for example, liquid crystal polymer tubing, can also be used. Furthermore, in some embodiments, the inner and / or outer tubing is a composite design, meaning that two or more materials can be joined together to form the final component. For example, the inner and / or outer tubular components can be formed from stainless steel tubing that forms most of the elongated portion of the tubular component, but different materials, such as polymers, carbon fibers, composites, and / or the like, can be used to form the distal end, which includes one or more openings and / or blade / cutting surfaces for the polyp to pass through. These different materials can be coupled together using various manufacturer practices, such as laser welding, friction welding, adhesives, fasteners, and / or the like.

[0108] The following are descriptions of several sets of figures illustrating various embodiments of the distal end construction of the polypectomy device disclosed herein. The different constructions generally fall into two types: translational or rotational. As mentioned above, to maintain relative simplicity of manufacture and operation and reduce manufacturing costs, it may be desirable to design a polypectomy device that is operated using relatively simple mechanical actuation, such as translation or rotation of the inner tubular member, but not both. However, it should be noted that various other embodiments of the polypectomy device disclosed herein may include more than one degree of freedom in actuation.

[0109] FIG. 6A-6E An embodiment employing a translational inner tubular member 114 with a distal end configuration is shown. FIG. 6A-6E The embodiments shown provide an introduction FIG. 1A and 1B Additional details regarding the design are available in the reference.FIG. 6B The inner tubular member 114 includes a generally cylindrical tube concentrically nested within a generally cylindrical outer tubular member 104. The outer tubular member 104 includes two openings 108 positioned opposite each other. These two openings 108 are separated by two support arms 110, which are also positioned opposite each other.

[0110] In some embodiments, having more than one opening 108 may be advantageous, such as the opening 108 shown in this embodiment, so as to allow, among other things, removal of polyps located at different locations within the uterine cavity without requiring excessive rotation of the outer tubular member 104 and the handle attached thereto. For example, in embodiments including a pistol-grip type handle, similar to the following reference... FIG. 18A and 18B As described, it might be desirable for the pistol grip handle to be oriented directly downwards or not too far from downwards. For example, it might be desirable to use the tool with the pistol grip handle pointing downwards or within 45° clockwise or counterclockwise from directly downwards. This is achieved through methods such as... FIG. 6A-6E The configuration shown in the diagram allows doctors to potentially reach all or almost all polyps that may need to be removed without having to rotate the handle outside that 90° range.

[0111] In some embodiments, the outer tubular member 104 may be rotatable relative to the handle along a longitudinal axis. For example, this may allow selective angular positioning of the opening 108 without having to rotate the entire handle. For example, a knob or wheel attached to the handle may allow the physician to rotate the outer tubular member relative to the handle.

[0112] FIG. 6D This is a cross-sectional end view providing additional details about the shape and size of the openings 108. Because these openings 108 are positioned relative to each other, the radial or angular midpoints of two openings 108 can be considered to be positioned 180° apart from each other. In some embodiments, this angle can be different. For example, the relative orientation of the midpoints of two openings 108 can be, for example, exactly, approximately, no greater than or less than 180°, 170°, 160°, 150°, 140°, 130°, 120°, 110°, 100°, or 90°. As the relative angular position of the openings 108 relative to each other decreases, depending on the size of the openings 108, a point will arise where the size of the opening may need to be reduced, or one of the support arms 110 between the openings will disappear and the two openings will merge into a single opening.

[0113] Further reference FIG. 6DThe outer tubular member 104 includes an outer diameter 631, and the inner tubular member 114 includes an outer diameter 632. The outer diameter 632 may be sufficiently smaller than the inner diameter of the outer tubular member 104 to allow the inner tubular member 114 to translate or slide relative to the outer tubular member 104. The inner tubular member 114 further includes an inner diameter 633. It may be desirable to make the inner diameter 633 as large as possible to allow relatively large polyps or polyp masses that have been removed to pass through easily.

[0114] The embodiments disclosed herein, and others, can utilize tubing of various sizes in the manufacture of polypectomy devices. For example, the outer tubular member 104 and / or various other outer tubular members disclosed herein may, in some embodiments, include an outer diameter of 0.12 inches 631 and a wall thickness of 0.01 inches. This results in a nominal inner diameter of 0.10 inches. Furthermore, the inner tubular member 114 and / or various other inner tubular members disclosed herein may, in some embodiments, include an outer diameter of 0.095 inches 632 and a material thickness or wall thickness of 0.0065 inches. This yields a nominal inner diameter of 0.082 inches 633. The dimensions of the outer tubular member 104 may correspond to a standard 11TW hypodermic cannula.

[0115] In various embodiments, various other tube sizes may be used for the inner and outer tubular members, depending on (among other factors) the size of the outer tubular member intended to be inserted through the laparoscopic working channel, the size of the opening 108 in the distal end of the tube, the expected stresses the tube will withstand during use, the torsional stresses that need to be transmitted through the rotating inner tubular member, and / or the like. For example, in any of the embodiments disclosed herein, the outer diameters 631 and 632 of the outer tubular member and the inner tubular member may be approximately, exactly, no greater than, or no less than 0.203 inches, 0.188 inches, 0.180 inches, 0.172 inches, 0.165 inches, 0.156 inches, 0.148 inches, 0.141 inches, 0.134 inches, 0.126 inches, 0.120 inches, 0.115 inches, 0.109 inches, 0.1 inches, 0.095 inches, 0.089 inches, 0.083 inches, 0.078 inches, 0.072 inches, 0.068 inches, 0.065 inches, 0.062 inches, 0.059 inches, 0.058 inches, or 0.050 inches, respectively, corresponding to sizes 6 to 18 of a hypodermal cannula. Furthermore, in any of the embodiments disclosed herein, the wall thickness of the outer tubular member and / or the inner tubular member may be approximately, exactly, no greater than, and no less than 0.015 inches, 0.014 inches, 0.013 inches, 0.012 inches, 0.011 inches, 0.010 inches, 0.009 inches, 0.008 inches, 0.007 inches, 0.006 inches, 0.005 inches, 0.004 inches, 0.003 inches, or 0.002 inches, corresponding to sizes 6 to 18 of a hypodermal cannula. Ideally, the outer diameter 632 of the inner tubular member is slightly smaller than the inner diameter of the outer tubular member to allow for relative sliding and / or rotational movement.

[0116] The openings 108 also include several dimensions defining their shape. The openings 108 include a longitudinal length 634, a transverse width 635, and an angular opening dimension or width 636. The longitudinal length 634 is measured longitudinally from the outermost radial edge of the outer tubular member 104. The width 635 is measured transversely from the innermost radial edge of the outer tubular member 104 at approximately the longitudinal midpoint of the opening 108, such as... FIG. 6D As shown in the cross-section. Similarly, referring to the centerline or longitudinal axis of the outer tubular member 104, the angular width 636 is measured from the innermost radial edge of the outer tubular member 104 at approximately the longitudinal midpoint of the opening 108, as... FIG. 6D As shown in the cross-section. The support arm 110 also includes a lateral width 637, which is measured approximately at the longitudinal midpoint of the opening 108, as shown in the cross-section. FIG. 6D As shown in the cross-section.

[0117] In this embodiment, the longitudinal length 634 is ideally approximately 10 mm, the transverse width 635 is ideally approximately 2.138 mm, and the transverse width 637 of the arm is ideally approximately 1.37 mm. However, other dimensions may be used in this and other embodiments. For example, it may be desirable for the length 634 of the opening 108 to be longer to allow a larger portion of the polyp to be inserted through it, or shorter to make the design more rigid or robust, or to cut off a smaller portion of the polyp to help prevent blockage. For example, in various embodiments, the length 634 of the opening 108 may be approximately, exactly, no greater than, or no less than 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. Furthermore, the width 637 of the arm 110, which is related to the radial depth of the opening 108, may vary in various embodiments based on, for example, the desired size of the opening and / or the desired robustness of the design. For example, in some embodiments, the width 637 of arm 110 may be approximately, exactly, and no greater than or less than 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, or 3.0 mm. Furthermore, the lateral width 635 of opening 108 may vary in various embodiments based on, for example, the desired size of the opening and / or the desired robustness of the design. For example, in some embodiments, the width 635 may be approximately, exactly, no greater than, or no less than 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, or 3.5 mm. Furthermore, the angular width 636 of the opening 108 may vary in different embodiments based on, for example, the desired size of the opening and / or the desired robustness of the design. For example, in some embodiments, the angular width 636 of the opening 108 may be approximately, exactly, not greater than or not less than 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, or 105°.

[0118]

[0119] 200°, 210°, 220°, 230°, 240°, 250°, 260°, or 270°. In some embodiments, the number of openings 108 can be more or less, depending (among others) on the angular width 636 of each opening. For example, when the angular width 636 is close to 180°, the device may be limited to a single opening, or a second or additional opening may need to have an angular width 636 of approximately less than 180° to allow space for the support arm 110. On the other hand, when the angular width 636 becomes less than 120°, the polypectomy device may be capable of having three or more openings 108. Furthermore, in various embodiments, two or more openings 108 need not include the same nominal dimensions. For example, one opening may be longer and / or wider than another opening.

[0120] In various embodiments, the ratio of the opening length 634 to the width 635 can be various values. For example, in this embodiment, the ratio is approximately 4.7. In other embodiments, it may be desirable to have a smaller ratio, such as approximately, exactly, or no greater than or less than 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, or 4.5. In other embodiments, it may be desirable to have a larger ratio, such as approximately, exactly, or no greater than or less than 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, or 10.0.

[0121] As mentioned above, because the embodiments disclosed herein are intended for removing polyps, and not necessarily more robust body tissue such as fibroids, the opening 108 of this embodiment, or similar openings in the various other embodiments disclosed herein, can be relatively large compared to the size and / or thickness of the tube with the opening. This is because the anticipated stresses, such as bending or torsional stresses, may be lower than when the tool is designed to cut or remove more robust tissue. For example, refer to... FIG. 6A-6EIn one embodiment, the length 634 of the opening 108 is approximately 10 mm, and the outer diameter 631 of the outer tubular member 104 is approximately 3.048 mm or 0.12 inches. Accordingly, the nominal ratio of the opening length to the outer diameter of the outer tubular member is approximately 3.28. In various embodiments, including this embodiment and various other embodiments disclosed herein, the ratio of the longitudinal length of the opening in the outer tubular member to the outer diameter of the outer tubular member may be approximately, exactly, and not greater than or less than 1.0, 1.5, 2.0, 2.5, 3.0, 3.28, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, or 8.0. This relatively large opening relative to the size of the outer tubular member may also be defined as the ratio of the longitudinal length 634 of the opening 108 to the wall thickness of the outer tubular member. For example, this embodiment includes an opening 108 with a longitudinal length 634 of approximately 10 mm or 0.394 inches, and an outer tubular member wall thickness of approximately 0.01 inches. Accordingly, the nominal ratio of the opening length to the outer tubular member wall thickness is approximately 39.4. In various embodiments, including this embodiment and various other embodiments disclosed herein, the ratio of the longitudinal length of the opening in the outer tubular member to the outer tubular member wall thickness may be approximately, exactly, and not greater than or less than 20, 25, 30, 35, 39.4, 40, 45, 50, 55, 60, 65, 70, 75, or 80.

[0122] The relatively large opening relative to the size of the outer tubular member can also be defined as the ratio of the lateral width 635 of the opening 108 to the outer diameter 631 of the outer tubular member. For example, this embodiment includes an opening lateral width 635 of approximately 2.138 mm or 0.084 inches, and an outer diameter 631 of the outer tubular member of approximately 0.12 inches. Accordingly, the nominal ratio of the lateral width of the opening to the outer diameter of the outer tubular member is approximately 0.7. In various embodiments, including this embodiment and various other embodiments disclosed herein, the ratio of the lateral width of the opening to the outer diameter of the outer tubular member can be approximately, exactly, and no greater than or less than 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 0.9. Because the lateral width 635 may depend to some extent on the outer tube wall thickness, especially with a higher ratio, a smaller tube thickness may be desirable as the ratio increases. Furthermore, this relatively large opening relative to the size of the outer tubular member can also be defined as the ratio of the lateral width 635 of the opening 108 to the wall thickness of the outer tubular member. For example, this embodiment includes an opening lateral width 635 of approximately 2.138 mm or 0.084 inches, and the wall thickness of the outer tubular member is approximately 0.01 inches. Accordingly, the nominal ratio of the lateral width of the opening to the wall thickness of the outer tubular member is approximately 8.4. In various embodiments, including this embodiment and various other embodiments disclosed herein, the ratio of the lateral width of the opening to the wall thickness of the outer tubular member can be approximately, exactly, and no greater than or less than 5, 6, 7, 8, 8.4, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20.

[0123] This relatively large opening relative to the size of the outer tubular member can also be defined as the percentage of the circumference of the outer tubular member that is cut away (e.g., removed or not originally present), thus forming an opening through it. For example, see reference... FIG. 6D The cross-sectional view shown in this embodiment illustrates an example where more than 50% of the outer circumference of the outer tubular member 631 is removed to form two openings 108, and therefore less than 50% of the outer circumference is retained to form the support arm 110. It may be desirable in some embodiments to maximize the percentage of the outer circumference of the outer tubular member removed to form one or more openings through the outer tubular member, while leaving sufficient material to adequately resist any anticipated bending and / or torsional stresses to be applied to the outer tubular member. In some embodiments, at approximately a central longitudinal location among one or more openings 108, the outer circumference of the outer tubular member is removed by approximately, exactly, no more than, or no less than 30%, 40%, 50%, 60%, 70%, or 80% to form one or more openings 108.

[0124] The various dimensions and ratios given herein that help define the dimensional limits of one or more openings relative to the outer tubular member can be used in any of the embodiments disclosed herein, even if the specific shape of the openings in other embodiments may differ in some other embodiments. For example, the dimensions and ratios given relative to the longitudinal length 634 can also be applied. FIG. 8E The longitudinal length shown is 840. FIG. 9F The longitudinal length of opening 908 shown in the figure, FIG. 10B Longitudinal length 1040 FIG. 14E The longitudinal length is 840, etc. As another example, the dimensions and ratios given relative to the lateral width of the opening, 635, can also be applied. FIG. 8A The horizontal width of the opening 808 FIG. 9A The horizontal width of the opening 908 FIG. 10A The horizontal width of the opening 1008 FIG. 14A The lateral width of the opening 1408, etc. Furthermore, the percentages given above regarding the removal of the outer circumference of the outer tubular member to form one or more openings can be applied to various other embodiments, such as... FIG. 7E , FIG. 8F , FIG. 9G , FIG. 10D , FIG. 11D , FIG. 14F Examples shown in the figures.

[0125] FIG. 6E yes FIG. 6B The detailed view of the cross-section shown illustrates enlarged details of the distal end of the inner tubular member 114, which serves as a blade or cutting surface. As mentioned above, in the polyp removal device disclosed herein, it may be desirable to employ a blade or cutting surface that is not actually as sharp as a typical blade. This can improve safety and also reduce manufacturing costs. From FIG. 6E As can be seen, the distal end of the inner tubular member 114 in this embodiment does indeed include a chamfered or beveled edge defined by angle 640. However, unlike designs requiring sharp edges, the chamfered or beveled edge does not extend beyond the outer diameter of the inner tubular member 114 towards the edge, thus leaving a blunt distal cut surface 652 with a lateral width 641. In this embodiment, the width 641 is approximately 0.04 mm. However, in other embodiments, the width 641 can be larger, smaller, or even the entire width of the material (e.g., without a chamfer). The cut surface 652 is positioned to mate with the opposing cut surface 653 of the outer tubular member when cutting the polyp. The following references... FIG. 15A-15C Provide additional examples of cut edges or surface textures, dimensions, and ratios.

[0126] FIG. 7A-7E An embodiment of the distal end construction is shown, which is similar to... FIG. 6A-6EThe embodiments shown share some similarities, with the exception that the inner tubular member 214 is configured for rotation rather than translation. In this embodiment, the outer tubular member 204 is designed similarly to... FIG. 6A-6E The outer tubular member 104, and the opposing opening 108 in the distal end of the outer tubular member 204 is similar to FIG. 6A-6E Those in the figure. Accordingly, the same reference numerals have been used for opening 108, and the above are relative to FIG. 6A-6E The given descriptions, dimensions, and ratios can also be applied to FIG. 7A-7E The design shown in the image.

[0127] FIG. 7A-7E One difference in the illustrated embodiment is that the inner tubular member 214 includes a protruding member 750 extending longitudinally in the distal direction. The protruding member 750 includes a cut or opening 751 that, depending on the instantaneous radial orientation of the inner tubular member 214 relative to the outer tubular member 204, allows the polyp to be drawn in through the external opening 108 and the cut 751 into the inner lumen of the inner tubular member 214. In this embodiment, instead of using the distal end face as the cutting surface, for example... FIG. 6E The facet or surface 652 shown, the protruding member 750 includes cutting surfaces 752, which are positioned relative to each other and positioned to separate the polyp from the uterine wall when the cutting surfaces 752 approach the edge 753 of the support arm 110 of the outer tubular member 204. As the inner tubular member 214 rotates, the radial movement of the cutting edges 752 causes a change in the effective opening size of one or more openings 108 (e.g., the size of a combined opening from the external environment into the inner lumen of the inner tubular member, resulting from the relative orientation of the inner and outer tubular members). For example, see reference... FIG. 7A The effective opening size 708 is approximately 50% of the full opening size 108 in the current orientation. If the inner tubular member 214 is rotated 90° from this position, one of the openings 108 will fully open into the inner lumen of the inner tubular member, while the other opening 108 will be completely isolated from the inner lumen by the protruding member 750.

[0128] As the inner tubular member 214 rotates and the effective opening size 708 decreases, the polyp positioned therethrough is eventually clamped and separated from the uterine wall. As with various other embodiments, due to the generally gel-like consistency of the polyp, the surface or edge 752 and / or side 753 of the support arm 110 that clamps the polyp does not necessarily need to be sharpened.

[0129] refer to FIG. 7B and 7E In this embodiment, the cut or opening 751 includes a longitudinal length 740 and a radial depth 742. Furthermore, the cut 751 includes, for example... FIG. 7EThe angular width 744 is shown in the figure. In this embodiment, the angular width 744 is ideally 180°, meaning that approximately half of the distal end of the inner tubular member 214 has been "cut off". However, in various embodiments, the angle 744 can be greater than or less than 180°. For example, the angle 744 can be approximately, roughly, not greater than or not less than 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, or 270°.

[0130] In this embodiment, the longitudinal length 740 of the opening or incision 751 is approximately 11.6 mm, and the radial or transverse depth 742 of the incision or opening 751 is approximately 1.2 mm. Furthermore, the outer diameter of the inner tubular member 214 is approximately 2.4 mm or 0.095 inches, and the wall thickness is approximately 0.229 mm or 0.009 inches. Similar to the discussion above regarding the opening 108, given that the medical device is intended to remove polyps and not necessarily more robust materials such as fibroids, the size and / or thickness of the incision or opening 751 relative to the inner tubular member 214 can be relatively large.

[0131] Similar to the opening in the outer tubular member, the opening or cutout 751 in the inner tubular member can include various dimensions and ratios. For example, the length 740 of the cutout 751 can be described as a ratio to the wall thickness or outer diameter of the inner tubular member 214. For example, this embodiment includes a length 740 of approximately 11.6 mm or 0.457 inches and an outer diameter of approximately 0.095 inches for the inner tubular member 214, thus giving a ratio of approximately 4.8. In various other embodiments, similar to... FIG. 7BIn embodiments shown or any other embodiments herein, this ratio may vary, for example, approximately, exactly, no greater than or no less than 1, 2, 3, 4, 4.8, 5, 6, 7, 8, 9, or 10. As a ratio of the cut length 740 to the material thickness of the inner tubular member, this embodiment includes a length 740 of approximately 0.457 inches and a wall thickness of approximately 0.009 inches, thus giving a ratio of approximately 50.8. In other embodiments, this ratio may be larger or smaller, for example, approximately, exactly, no greater than or no less than 10, 15, 20, 25, 30, 35, 40, 45, 50, 50.8, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100. Furthermore, the depth 742 of the cut 751 in this embodiment is approximately 50% of the outer diameter of the inner tubular member 214. In some embodiments, the depth 742 of the cut 751 can be more or less, for example, exactly, approximately, no more than or no less than 20%, 30%, 40%, 50%, 60%, 70%, or 80%. Generally, a lower percentage will result in a more rigid design, but a smaller overall opening 751. On the other hand, a higher percentage will result in a less rigid design, but a larger overall opening 751.

[0132] In terms of absolute dimensions, the length 740 of the cut 751 may include various other lengths in other embodiments, such as, for example, approximately, exactly, no greater than or no less than 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 11.6 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. Furthermore, the depth 742 of the notch 751 can include various depths, for example, approximately, exactly, and not greater than or less than 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, or 3.0 mm. Generally, as the outer diameter of the inner tubular member increases, the depth 742 of the notch 751 can also increase, while maintaining the same or similar level of torsional or bending stiffness.

[0133] The dimensions and ratios given in this document relative to cutout 751 can also be applied to other embodiments, such as... FIG. 8C The incision 751 shown in the figure, or FIG. 14E The cut in the inner tubular member 1414 shown in the figure.

[0134] FIG. 8A-8F Another embodiment of the distal end construction is shown, which employs relative rotation of the inner tubular member 214 relative to the outer tubular member 804 to separate the polyp from the uterine wall. In this embodiment, the inner tubular member 214 is designed to resemble... FIG. 7A-7E The inner tubular member 214 is shown in the figure. Accordingly, similar reference numerals are used, and the above references... FIG. 7A-7E The descriptions and various dimensions and ratios also apply. FIG. 8A-8F 214. Inner tubular component. FIG. 8A-8F One difference in the embodiment shown is that the outer tubular member 804 is different from... FIG. 7A-7E The outer tubular member 204. In this embodiment, the outer tubular member 804 includes a single opening 808, which is designed to resemble the cut or opening 751 of the inner tubular member 214. Instead of two support arms 110 having two openings 108 separating them, the outer tubular member 804 includes a single protruding member 850 having an opening or cut 808 similar to the opening or cut 751 of the inner tubular member 214.

[0135] During the procedure, the inner tubular member 214 is rotated relative to the outer tubular member 804, and the blades or cutting edges or surfaces 752 and 852 are brought close together and eventually converge to close the effective opening 808. When the blades or cutting surfaces 752 and 852 approach each other, the polyp is clamped and separated from the uterine wall.

[0136] Similar to the cut or opening 751, the cut or opening 808 of the outer tubular member 804 includes a longitudinal length 840, a radial depth 842, and an angular width 844. In this embodiment, the angular width 844 is ideally 180°, which is the same as the angular width 744 of the cut 751 of the inner tubular member 214. In some embodiments, it may be desirable to make the angular width 844 of the opening in the outer tubular member 804 larger or smaller. For example, if the angular width 844 of the opening 808 is less than 180°, and the angular dimension of the opening in the inner tubular member 744 is larger than the angular dimension of the opening in the outer tubular member, then the protruding member 750 of the inner tubular member 214 will be constrained in the lateral or radial direction during its rotation. This can help resist any bending moments that may be placed on the distal end of the protruding member 750 during polyp removal. However, if the angular dimension 844 of the opening 808 of the outer tubular member 804 is only slightly less than 180°, the protruding member 750 of the inner tubular member 214 may become clogged in the opening 808 due to elastic bending of the protrusion 750 during use and / or manufacturing tolerances. Accordingly, if it is desired in a particular embodiment that the angular opening dimension 844 of the opening 808 is less than 180°, it may be desirable, taking into account manufacturing tolerances and the expected bending moment that may be applied to the protruding member 750, to ensure that the angle is sufficiently less than 180° so that the protruding member 750 is unlikely to become clogged.

[0137] The shape and size of the cut or opening 751 can be similar to the above references. FIG. 7B The same or similar dimensions 740, 742 are described. Furthermore, openings 808 having corresponding dimensions 840 and 842 may include dimensions similar to cutout 751, but scaled up to a larger diameter tube. For example, in this embodiment, lengths 840 and 740 are both the same, approximately 10 mm. However, in some embodiments, the lengths of the two openings may differ. The same absolute length and ratio of length to tube diameter and / or tube thickness may apply to length 840 relative to the outer tubular member, as described above regarding length 740 relative to the inner tubular member. Furthermore, the same dimensions and ratios discussed above regarding depth 742 may apply. FIG. 8E The depth is 842, but this is relative to the outer tubular member rather than the inner tubular member.

[0138] FIG. 24A-24C An alternative embodiment of the inner tubular member 2414 is shown, which can replace... FIG. 8A-8F The inner tubular member 214 of the illustrated embodiment. Similar reference numerals are used to indicate the same... FIG. 8A-8FThe embodiments shown have similar or identical features. One difference between the inner tubular member 2414 and the inner tubular member 214 is that the longitudinal length 740 of the opening 751 is shorter in this embodiment. For example, this embodiment may include a length 740 of approximately 5 mm instead of 10 mm. However, any of the various other dimensions given above relative to the longitudinal length 740 may also be applicable to this embodiment.

[0139] and FIG. 24A-24C Another difference in the illustrated embodiment is that the cut or opening 751 does not include a generally flat U-shaped cut surface 752, such as FIG. 8A-8F The embodiments shown are illustrated. Instead, refer to... FIG. 24A and 24B The inner tubular member 2414 includes a cut 751, which is at least partially defined by two surfaces 752 on its laterally opposite sides, the cutting surfaces 752 extending in a direction parallel to the longitudinal axis of the inner tubular member 2414. However, at the distal end of the cut 751, the cutting surfaces rise or extend upward from the cutting surfaces 752 to form a raised lip or additional cutting edge 2452.

[0140] The raised lip or cut edge 2452 located at the distal end of the inner tubular member 2414 provides several benefits. For example, in some embodiments, such as those where the angular widths 744 and 844 of the openings in both the inner and outer tubular members are 180 degrees, the lip 2452 can prevent the inner tubular member 2414 from translating distally relative to the outer tubular member in the longitudinal direction when the opening 808 is in a fully closed configuration (e.g., the protruding members 750 and 850 are rotatably positioned relative to each other). FIG. 8A-8F (as shown in the embodiment), when the inner tubular member is oriented away from... FIG. 8FIn the 180° angular position shown, the protruding member 750 of the inner tubular member may potentially translate distally beyond the protruding member 850 of the outer tubular member (e.g., slide past the protruding member 850), which may, for example, prevent the inner tubular member from rotating. Note that this assumes the inner tubular member is not originally restricted or inhibited from longitudinal translation relative to the outer tubular member. However, in some embodiments, the inner tubular member may be at least somewhat restricted in the longitudinal direction relative to the outer tubular member by, for example, its connection to the device handle. However, given the relatively small size of such medical devices and the inherent tolerances in the manufacturing process, it may be desirable that the inner tubular member 2414 be biased distally relative to the outer tubular member 804, for example by a spring or other feature located on the handle or elsewhere, and that the distal end of the protruding member 750 pressing against the inner distal end surface of the protruding member 850 is a mechanical feature that restricts the distal longitudinal translation of the inner tubular member relative to the outer tubular member. This helps keep the cutting edge 2452 as close as possible to the corresponding cutting edge or surface 852 in the distal end of the outer tubular member, thereby improving cutting efficiency. This can be analogous to scissors, where cutting is relatively efficient if the two cutting edges are kept close to each other; however, cutting efficiency decreases if there is play between the two cutting edges.

[0141] FIG. 24A-24C Another advantage of the protruding member 750, including the lip edge or protruding cut edge 2452, is that it is compatible with... FIG. 8B Compared to the design shown, the cutting edge 2452 can more effectively cut or shear polyp tissue located at or through the distal end of the opening 751, where the two semi-circular edges meet at the distal end. In some embodiments, the outer tubular member may additionally or alternatively include a raised lip or cutting edge similar to the raised lip or cutting edge 2452 of the inner tubular member. Utilizing the lip 2452 of the inner tubular member, the lip 2452 ideally reaches a point or edge located distally (or laterally) to the material forming the circular distal end of the protrusion 750. If the protrusion 850 of the outer tubular member includes a similar lip, it will ideally reach a point or edge proximal (or medial) to the material forming the circular distal end of the protrusion 850, because that is the side of the material that will engage with the inner tubular member.

[0142] In this embodiment, the cut edge or lip 2452 includes a height 2442 relative to the transverse surface 752. This height 2442 can include various dimensions in various embodiments. For example, the height 2442 can be exactly, approximately, no greater than, and no less than 0.005 inches, 0.006 inches, 0.007 inches, 0.008 inches, 0.009 inches, 0.010 inches, 0.011 inches, 0.012 inches, 0.013 inches, 0.014 inches, 0.015 inches, 0.020 inches, 0.025 inches, 0.030 inches, 0.035 inches, 0.040 inches, 0.045 inches, or 0.050 inches. In some embodiments, the ratio of the lip height 2442 to the cut height 742 can be exactly, approximately, no greater than, and no less than 0.1, 0.2, 0.3, 0.4, or 0.5. In some embodiments, the raised edge or lip 2452 is formed as... FIG. 24B The progressively rounded corner profile 2443 is shown in the side view. It may be desirable to have this rounded corner profile 2443 to, for example, make the end or lip 2452 more durable and / or resistant to deformation. In some embodiments, the profile 2443 may have different shapes, such as, for example, a bevel, a smaller or larger radius, and / or the like.

[0143] FIG. 9A-9G Another example of a distal end construction embodiment is shown, which employs translation of the inner tubular member 914 relative to the outer tubular member 904 to separate the polyp from the uterine wall. In this embodiment, the outer tubular member includes an opening 908 positioned on the distal end sidewall of the outer tubular member 904. In this embodiment, the opening 908 is generally rectangular in shape. However, in other embodiments, the opening 908 may be shaped differently, and / or more than one opening 908 may be included at different angular locations and / or different longitudinal locations around the outer tubular member 904.

[0144] In this embodiment, the outer tubular member 904 further includes an opening 952 at its distal end. This opening 952 allows the blunt, rounded end 950 of the inner tubular member 904 to pass through it. One advantage of this configuration is that it allows the opening 908 to be positioned longitudinally relative to the end face or surface 964. In this embodiment, the distal portion of the opening 908 is positioned at a longitudinal distance 960 from the end face 964. This length 960 is ideally equal to or greater than the longitudinal length 940 of the opening or cutout 951 in the inner tubular member 914.

[0145] In this embodiment, the length 940 of opening 951 is approximately 0.08 inches, the length 962 of opening 908 is approximately 0.094 inches, and the length 960 defining the location of the farthest edge of opening 908 is approximately 0.088 inches. In other embodiments, these dimensions may differ. For example, the length 962 of opening 908 may be approximately, exactly, no greater than, or no less than 0.05 inches, 0.06 inches, 0.07 inches, 0.08 inches, 0.09 inches, 0.094 inches, 0.10 inches, 0.11 inches, 0.12 inches, 0.13 inches, 0.14 inches, 0.15 inches, 0.16 inches, 0.17 inches, 0.18 inches, 0.19 inches, 0.20 inches, 0.25 inches, 0.30 inches, 0.35 inches, or 0.40 inches. As another example, the length 940 of the opening 951 can be, for example, approximately, exactly, no greater than or no less than 0.05 inches, 0.06 inches, 0.07 inches, 0.08 inches, 0.09 inches, 0.094 inches, 0.10 inches, 0.11 inches, 0.12 inches, 0.13 inches, 0.14 inches, 0.15 inches, 0.16 inches, 0.17 inches, 0.18 inches, 0.19 inches, 0.20 inches, 0.25 inches, 0.30 inches, 0.35 inches, or 0.40 inches. As another example, the length 960 can be, for example, approximately, exactly, no greater than, and no less than 0.05 inches, 0.06 inches, 0.07 inches, 0.08 inches, 0.09 inches, 0.094 inches, 0.10 inches, 0.11 inches, 0.12 inches, 0.13 inches, 0.14 inches, 0.15 inches, 0.16 inches, 0.17 inches, 0.18 inches, 0.19 inches, 0.20 inches, 0.25 inches, 0.30 inches, 0.35 inches, or 0.40 inches. In some embodiments, it may be desirable for the length 940 to be equal to or less than the length 960.

[0146] In some embodiments, lengths 962, 940, and 960 can be described as ratios relative to the outer diameter or material thickness of the outer or inner tubular member. For example, this embodiment includes an outer tubular member 904 with an outer diameter of approximately 0.115 inches. Accordingly, lengths 962, 940, and 953 of this embodiment can be described as having ratios of approximately 0.82, 0.70, or 0.77 relative to the outer diameter of the outer tubular member 904, respectively. In other embodiments, any one of these three lengths can have a ratio of approximately, exactly, and no greater than or less than 0.5, 0.6, 0.7, 0.77, 0.8, 0.82, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 2.0, 2.5, 3.0, 3.5, or 4.0 relative to the outer diameter of the outer tubular member 904. Similar or identical ratios can be applied to these lengths relative to the outer diameter of the inner tubular member. However, it should be noted that if it is desired that the opening 951 does not extend beyond the end face 964 of the outer tubular member during the forward stroke cutting of the polyp, then the length 960 must also increase with the increase of the length 940, thereby pushing the opening 908 posteriorly or proximally. Accordingly, in some embodiments, it may be desirable to have a shorter length 940, thereby allowing the opening 908 to be closer to the distal interface 964, for example, for removing polyps located posteriorly near the uterus.

[0147] The wall thickness of the outer tubular member 904 in this embodiment is approximately 0.01 inches. Accordingly, the lengths 962, 940, and 953 in this embodiment can be described as having ratios of approximately 9.4, 8.0, and 8.8, respectively, relative to the wall thickness of the outer tubular member 904. In other embodiments, any of these three lengths may have a ratio of approximately, exactly, no greater than, and no less than 5, 6, 7, 8, 8.8, 9, 9.4, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 relative to the wall thickness of the outer tubular member. Similar or identical ratios may be applied to these lengths relative to the wall thickness of the inner tubular member.

[0148] In this embodiment, the opening 908 in the outer tubular member 904 and the opening 951 in the inner tubular member 914 are positioned and configured to engage in the forward or backward stroke of the inner tubular member 914 relative to the outer tubular member 904 to separate the polyp from the uterine wall. FIG. 9C to 9F An example of removing a polyp using this embodiment is shown. FIG. 9C In this view, opening 908 is positioned adjacent to polyp 922. In this view, opening 951 is currently positioned such that opening 908 is completely closed (e.g., its effective opening size is at its minimum or 0%), and polyp 922 cannot yet be aspirated into or positioned through opening 908.

[0149] refer to FIG. 9D The inner tubular member 914 has been pulled posteriorly or proximally relative to the outer tubular member 904. Accordingly, the opening 951 has been positioned adjacent to the opening 908, and thus the polyp 922 can be positioned through it. At this point, the polyp 922 can be separated from the uterine wall 926 by continuing to translate the inner tubular member 914 posteriorly, or by translating the inner tubular member 914 anteriorly or distally. FIG. 9E It is shown that the inner tubular member 914 has been further pulled in the proximal direction, resulting in the cutting surfaces 952 and 953 separating the polyp 922 from the uterine wall 926. FIG. 9F An example is shown in which the inner tubular member 914 is repositioned in a distal or anterior direction, causing surfaces 952 and 953 to separate the polyp 922 from the uterine wall 926. In either case, the polyp 922 can then be aspirated through the lumen of the inner tubular member 914 for removal and / or collection.

[0150] In this embodiment, the cut surface 952 of the inner tubular member is generally a blunt surface, and the cut surface 953 of the outer tubular member includes a chamfered or sharp edge. However, in various other embodiments, this relationship can be reversed, meaning that surface 952 is chamfered or sharp, while surface 953 is blunt. Furthermore, in some embodiments, all surfaces 952 and 953 can be chamfered or sharp, or all surfaces 952 and 953 can be blunt or non-sharp.

[0151] refer to FIG. 9B This embodiment illustrates a configuration in which the inner tubular member 914 comprises a composite structure, and a distal end portion 915 is coupled to a proximal portion 917. One advantage of this design is that the outer diameter 932 of the distal end portion 915 can be slightly larger than the outer diameter 934 of the proximal portion 917. This larger diameter 932 can form a tighter fit with the inner diameter of the outer tubular member 904, thereby controlling sliding friction between the inner and outer tubular members, and / or controlling the amount of lateral movement and / or leakage of the diffusing fluid that may pass between the inner and outer tubular members. In practice, when manufacturing tools as disclosed herein, it may be easier to control only the relatively tight fit between the distal end portion 915 and the outer tubular portion 904 compared to having the same relatively tight fit along the entire length of the inner tubular portion 914. In some embodiments, a seal, such as an O-ring, is included to help prevent leakage of the diffusing fluid between the inner and outer tubular members.

[0152] In this embodiment, the outer diameter 934 of the main elongated portion of the inner tubular member is approximately 0.089 inches. The outer diameter 932 of the distal end portion 915 is approximately 0.092 inches. Furthermore, the inner diameter of the outer tubular member 904 is approximately 0.095 inches. Accordingly, in this embodiment, there is a nominal total clearance of 0.006 inches between the main elongated portion of the inner tubular member 914 and the inner diameter of the outer tubular member 904. There is a nominal half-total clearance of 0.003 inches between the distal end portion 915 and the inner diameter of the outer tubular member 904. Various other specific dimensions may be used in other embodiments; however, in various embodiments, the general principle of having a tighter clearance between the distal end portion 915 and the outer tubular member 904 compared to the clearance between the elongated portion of the inner tubular member 914 and the outer tubular member 904 may be desirable. In some embodiments, a relatively tight gap (e.g., approximately or no greater than 0.001, 0.002, 0.003, 0.004, or 0.005 inches, for example, between the distal end portion and the outer tubular member when the inner tubular member translates longitudinally relative to the outer tubular member can facilitate smooth guidance of the inner tubular member relative to the outer tubular member. In some embodiments, different or additional mechanisms are used to assist in guiding the inner tubular member relative to the outer tubular member, such as, for example, linear rails, one or more bearings, and / or the like.

[0153] FIG. 10A-10G Another exemplary embodiment of the distal end construction of the polypectomy device is shown. FIG. 10A-10G The embodiment shown shares some similar features with other embodiments disclosed herein, and also includes some differences. This embodiment includes an outer tubular member 1004, an inner tubular member 114, and a cutting block 1060. The inner tubular member 114 is designed to be similar to... FIG. 6A-6E The inner tubular member 114 of the illustrated embodiment, and all the characteristics and dimensions discussed elsewhere with respect to the inner tubular member 114, are applicable to this inner tubular member 114. Furthermore, the outer tubular member 1004, its opening 1008, and its blunt end 112 are designed similarly to... FIG. 6A-6E The outer tubular member 104 is shown. However, instead of two openings 108 positioned opposite each other, this embodiment includes a single opening 1008, which in this embodiment ideally includes an angular width 1044 greater than 180°, such as... FIG. 10D As shown in the diagram. The angular width 1044 is measured to the outermost radial edge of the opening 1008, as... FIG. 10D As shown in the diagram. Furthermore, opening 1008 includes a depth 1042, which is greater than 50% of the outer diameter of the outer tubular member; however, various other depths can also be used, such as those described above with reference to depth 842. This opening 1008 is designed similarly to... FIG. 8A-8FThe opening 808 is shown in the diagram. However, instead of extending fully through the distal end of the outer tubular member, the opening 1008 terminates before a blunt distal end 112. There may be trade-offs between these two designs. For example, including... FIG. 10A The fully blunt distal end 112 shown helps to reduce the likelihood of trauma if the tool accidentally punctures the wrong tissue. However, opening at least a portion of the distal end (as shown) FIG. 8A The embodiment shown may make it easier to reach polyps located on the posterior or distal wall of the uterus, such as... FIG. 4 Polyp 423 is shown in the image.

[0154] refer to FIG. 10B The length 1040 of the opening 1008 may include, for example, the above reference. FIG. 6B The length 634 shown is any of the same dimensions described. The angular opening width 1044 of opening 1008 is as follows. FIG. 10D The examples shown may include, for example, those relative to the text. FIG. 8F The angle 844 shown is any of the dimensions described herein. Furthermore, in this embodiment and any other embodiments disclosed herein, the thicknesses of the outer and inner tubular members can be any thickness as described elsewhere herein.

[0155] and FIG. 6A-6E Compared to the previous embodiment, FIG. 10A-10G Another difference in the embodiment is that the distal end of the structure includes a cutting block 1060 positioned at the distal end of the opening 1008. The cutting block 1060 is generally cylindrical in shape and sized to have an outer diameter 1064 that fits within the inner diameter of the inner tubular member 114. The proximal surface of the cutting block 1060 includes an inclined shape indicated by angle 1062, which forms a cutting surface 653 that can be used to aid in cutting the polyp 1022 to remove it from the uterine wall 1026. The inclined proximal surface can help act as a cutter or other angular blade, making it easier to cut body tissue, i.e., by gradually cutting the tissue as the inner tubular member 114 advances, rather than attempting to cut through the entire polyp simultaneously. The cutting block 1060 further includes a longitudinal length 1066, which in FIG. 10E The distance is defined as the distance from the distal end of the opening 1008 of the outer tubular member 1004 to the nearest point on the angular proximal surface of the cutting block 1060. In this embodiment, the angle 1062 is approximately 30°. In other embodiments, the angle 1062 may be larger or smaller, for example, approximately, exactly, not greater than, and not less than 10°, 20°, 30°, 40°, 45°, 50°, or 60°.

[0156] FIG. 10E-10G An example of using this embodiment to remove polyp 1022 is shown.FIG. 10E In the middle, polyp 1022 has been located through opening 1008. In FIG. 10F In the middle, the inner tubular member 114 has advanced forward and is approaching the cutting block 1060. FIG. 10G In this process, the inner tubular member 114 has been advanced sufficiently such that there is no gap between the end opening of the inner tubular member 114 and the cutting block 1060, and the polyp 1022 has been separated from the uterine wall 1026. With continued vacuum suction, the polyp 1022 can be aspirated through the inner lumen of the inner tubular member 114. In some embodiments, the cutting block includes a zero-degree angle 1062, and the anterior cutting edge 652 of the inner tubular member 114 is alternatively angled (using any angle described above with reference angle 1062).

[0157] FIG. 11A-11G Another embodiment of the distal end construction for a polypectomy device is shown. Aside from the different design of the inner tubular member 1114 and the cutting block 1160, FIG. 11A-11G The embodiments shown are different from those described above. FIG. 10A-10G The described embodiments are the same. Opening 1108 is similar to opening 1008 and may have similar dimensions. Cutting block 1160 is similar to cutting block 1060 and may include... FIG. 10E The proximal surface angle 1062 is the same range as that of the cutting block 1060. However, the longitudinal length 1066 of the cutting block 1160 is ideally longer than the length of the cutting block 1060 because the inner tubular member 1114 includes angular surfaces configured to engage the cutting block 1160, rather than as FIG. 10E The distal surface shown in the figure.

[0158] Replace with such FIG. 10E The flat cylindrical or annular distal surface 652 shown in the diagram, the inner tubular member 1114 includes an angular annular portion 1170 extending from the distal end of the inner tubular member 1114 and having a distal cutting surface 652. The annular member 1170 is sized and shaped to assemble around the outer side of the cutting block 1160, thereby allowing the cutting surface 652 to engage with the cutting surface 653 to cut the polyp. The annular member 1170 and the cutting block 1160 work together to remove polyp material from the uterine wall. The annular member 1170 has a rearward angle, or includes a distal side, positioned at an angle 1164 measured from a vertical plane, such as... FIG. 11E As shown in the diagram. Furthermore, the distal surface 1167 of the inner tubular member 1114 (located behind the distal surface of the annular member 1170) is angled rearward at an angle 1168 relative to a vertical plane. The distal surface 1167 and / or surface 652 can be used as cutting surfaces, depending on where the polyp is located during the cutting process.

[0159] In this embodiment, angle 1062 may have the same angle as the above reference.FIG. 10E Similar dimensions are discussed. Angle 1164 is approximately 60° in this embodiment. However, in other embodiments, angle 1164 can be different dimensions, for example, approximately, exactly, not greater than, and not less than 10°, 20°, 30°, 40°, 50°, 60°, 70°, or 80°. In this embodiment, angle 1168 is approximately 25.6°. Furthermore, the distal end surface of the annular member 1170 may include an angle similar to or the same as angle 1062, such as... FIG. 11E As can be seen, the surface is shown to coincide with angle 1062. Each of these angles may be different in other embodiments, for example, approximately, exactly, no greater than or no less than 10°, 20°, 30°, 40°, 50°, 60°, 70° or 80°.

[0160] FIG. 12A-12F Another embodiment of the distal end configuration of the polyp removal device is shown. This embodiment includes an outer tubular member 1204 but does not include an inner tubular member as shown in many other embodiments disclosed herein. In many other embodiments disclosed herein, the inner tubular member is a member including an inner lumen through which the separated polyp will pass for collection or disposal. However, in this embodiment, the outer tubular member 1204 includes an inner lumen for removing or collecting the separated polyp.

[0161] The outer tubular member 1204 has a cutter mechanism 1270 attached to the distal end of the outer tubular member 1204. The cutter mechanism 1270 includes an opening 1208 providing access to the central lumen of the outer tubular member 1204. The cutter mechanism 1270 further includes a flexible cutter 1280 positioned therein, coupled to an actuating member (e.g., an actuating member, rod, linkage, connector, push rod, and / or the like), in this case, an actuating rod 1214. The actuating rod 1214 may be connected to, for example, an actuation mechanism or trigger of a handle in a manner similar to that of the inner tubular member in other embodiments (e.g., movement of the actuation mechanism or trigger of the handle causes translation of the actuating rod 1214). FIG. 12B In the retracted state shown, the flexible cutter 1280 is retracted within the cutting mechanism 1270. After the polyp has been aspirated or otherwise positioned into the cutting mechanism 1270 through the opening 1208 at the distal end of the cutting mechanism 1270, the actuator rod 1214 can be translated forward, causing the flexible cutter 1280 to move forward and downward through the cutter channel 1284, thereby separating the polyp from the uterine wall.

[0162] In some embodiments, the flexible cutter 1280 may be formed of, for example, a polymer or other material that allows the flexible cutter 1280 to flex and bend downward to be pushed through the cutter channel 1284. In some embodiments, reference... FIG. 12D The flexible cutter 1280 may include a thinner portion 1282, which may help allow the flexible cutter 1280 to flex.

[0163] FIG. 13A-13C Another embodiment of the distal end construction of the polyp removal device is shown. One difference between this embodiment and some other embodiments disclosed herein is that the opening 1308 through which the polyp passes for removal from the uterine wall is located on the distal end of the instrument, rather than on the sidewall of the distal end of the instrument. This is at least similar to the positioning of the opening 1308. FIG. 12F The location of opening 1208 is shown in the figure.

[0164] exist FIG. 13A-13C In the embodiment shown, the device includes FIG. 13A The outer tubular member 1304 shown in the figure and FIG. 13B The inner tubular member 1314 is shown (and the outer tubular member 1304 is hidden). FIG. 13C An end view of a polypectomy device is shown, in which the inner tubular member 1314 is partially shown with hidden lines because a portion of the inner tubular member 1314 is obscured by the distal end face 1370 of the outer tubular member 1304. FIG. 13C As can be seen, the cut or opening 1351 in the distal end face of the inner tubular member 1314 can rotate relative to the outer tubular member 1304, thereby causing a change in the effective opening size of the opening 1308 leading to the inner lumen of the inner tubular member 1314. In this embodiment, the openings in the outer and inner tubular members each include angular widths 1344 and 1345 of approximately 180°. Accordingly, in this embodiment, the cut or opening 1351 of the inner tubular member 1314 can be selectively fully exposed through the opening 1308, completely hidden by the end face 1370 of the outer tubular member 1304, or any combination thereof. In other embodiments, the angular widths 1344 and 1345 can vary. For example, if the angle 1344 of the outer tubular member 1304 is greater than 180° and the angle 1345 of the inner tubular member 1314 remains at 180°, the opening 1351 leading to the inner lumen of the inner tubular member 1314 will never be completely covered by the end face 1370. This may be desirable in some embodiments to provide at least a small, controlled amount of dilatational fluid leakage into the inner lumen of the inner tubular member 1314. This may also be desirable to allow or facilitate more efficient aspiration of removed polyps through the inner tubular member 1314 and into the collection chamber.

[0165] In some embodiments, the polyp removal device may include, for example, FIG. 13A The distal end opening shown in the figure and as... FIG. 7A The lateral opening is shown in the image. One advantage of having both a terminal and lateral opening is that the terminal opening may be more suitable for polyps located on the posterior uterine wall, such as… FIG. 4 The polyp 423 shown in the image, while a lateral opening may be more suitable for polyps located on the lateral wall of the uterus, such as... FIG. 4 Polyp 422 is shown in the diagram. Furthermore, openings positioned along the side of the tube can have a larger effective opening size than openings positioned at the distal end, which are limited by the tube diameter. In some embodiments, the benefits of side openings and end openings are combined as... FIG. 8A In the single opening shown. For FIG. 8A In the embodiment shown, the opening 808 extends from the side of the outer tube 804 through the distal end of the instrument.

[0166] FIG. 14A-14F Another embodiment of the distal end construction of the polypectomy device is shown. Except for the distal end construction, this embodiment is similar to that described above. FIG. 8A-8F The embodiment shown in the figure. This embodiment includes a flat distal end, rather than FIG. 8A The circular distal end. Furthermore, FIG. 14A Embodiments include a protrusion 1475, which may, for example, be configured to act as a pivot point for the inner tubular member 1414 during rotation. Although not shown in these figures, the inner tubular member 1414 may include a pin or other protrusion that fits into a cavity or recess in the protrusion 1475, thereby allowing the protrusion 1475 to act as a pivot point. In some embodiments, the protrusion 1475 may help limit distal translation of the inner tubular member 1414 beyond the outer tubular member 1404, similar to the reference above. FIG. 24A-24C The raised lip rim 2452 is described.

[0167] The dimensions 840 and 844 of the outer tubular member 1404 can be with FIG. 8A-8F The dimensions 840 and 844 of the embodiments are similar or identical, and these dimensions can take any of the numbers given above. Furthermore, the dimensions 740 and 744 of the inner tubular member 1414 can be similar or identical to those given above. FIG. 8C and 8F The dimensions 740 and 744 of the inner tubular member 214 shown are not given by any numbers. FIG. 14F As shown, in this embodiment, the angular width 844 is approximately 180 degrees, but the angular width 744 is less than 180 degrees. Therefore, in the inner tubular member and the outer tubular member, as... FIG. 14FWhen the rotation alignment is shown, the cut surface of the inner tubular member is ideally slightly recessed relative to the outer tubular member.

[0168] Blade or cutter construction

[0169] As mentioned above, various embodiments of the polyp removal device disclosed herein may include sharp or blunt blades or cutting surfaces configured to separate polyps from the uterine wall. Because polyps are relatively soft or gel-like, especially compared to other objects that need to be removed (such as fibroids), less sharp or blunt surfaces may be acceptable in polyp removal devices for cutting or removing polyps. Furthermore, blunt or less sharp surfaces may even be desirable because they may be safer if the surface comes into contact with body tissue that is not intended to be cut, due to a lower risk of causing trauma.

[0170] As discussed above, FIG. 6E An example of a cutting surface 652 is shown, which has a chamfered surface adjacent to it, but does not reach the extent that a typical cutting edge would achieve. These concepts can be applied to any embodiment disclosed herein. FIG. 15A-15C Simplified examples of cut surfaces, edges, or surfaces 1552, 1552', and 1552" are shown, which can be used in any of the embodiments disclosed herein (e.g., cut surfaces 652, 653, 752, 753, 852, 952, 953, 1167, or similar surfaces shown in the figures).

[0171] FIG. 15A A cross-sectional view of an inner or outer tubular member having a material thickness of 1515 and a sharp cutting edge 1552 is shown, the cutting edge 1552 being formed by a chamfer with a thickness of 1517 equal to the full thickness of the material 1515. This provides an example of a sharp cutter or blade. FIG. 15B An embodiment of an inner tubular member or an outer tubular member 1514' having a non-sharp cut surface or surface 1552' is shown. In this embodiment, the material thickness is 1515, and the cut surface 1552' has a thickness equal to the material thickness 1515.

[0172] In practice, it may be difficult to form an edge or surface that does not have some kind of chamfer or defect at its edges. Furthermore, if a surface similar to surface 1552' is used, without any chamfer or rounded corners at its corners, the side edges of surface 1552' may still be relatively sharp. Accordingly, in some embodiments, it may be desirable for the cut surface not to be sharpened (e.g., using a manufacturing process that makes the cut edge pointed), but it may still have some kind of chamfer, rounded corner, or defect at its edges. FIG. 15CAn example of this is shown, wherein the inner or outer tubular member 1514” includes a cut surface or surface 1552” and a chamfer 1554 at its edge. In this example, the width 1517” of the chamfer 1554 is less than the width 1515 of the material of the tubular member 1514”. FIG. 15C The example shown is similar to FIG. 6E The example shown is for reference only, but can be used in any other embodiment. The chamfer, fillet, or defect 1554 can be formed in various ways. For example, it can be formed using a secondary operation, such as cutting, grinding, or deburring. It can also be formed into the material during injection molding or the like. In some embodiments, the chamfer, fillet, or defect 1554 can be the result of any manufacturing process used to create the cut surface 1552” and may not require a secondary operation. In some embodiments, both sides of the surface 1552” include chamfers, fillets, or defects, but at least a portion of the surface 1552” remains flat or blunt (e.g., unsharpened to a point).

[0173] As discussed above, the multiple components used to build the polyp removal device disclosed herein (including) FIG. 15A-15C The tube (shown as an example blade or cutting surface) can include various thicknesses. For example, the tube thickness thus... FIG. 15A-15C The thickness 1515 shown in some embodiments may be somewhere in the range of 0.015 inches to 0.002 inches, or approximately, exactly, no greater than or less than 0.015 inches, 0.014 inches, 0.013 inches, 0.012 inches, 0.011 inches, 0.010 inches, 0.009 inches, 0.008 inches, 0.007 inches, 0.006 inches, 0.005 inches, 0.004 inches, 0.003 inches, or 0.002 inches, corresponding to hypodermal injection tube sizes from 6 to 18. The chamfer, fillet, or defect 1517” can be a various percentage of the overall width 1515 in various embodiments. For example, in some embodiments, the width 1517” can be approximately, exactly, not less than, and not greater than 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, or 75% of the total material thickness 1515.

[0174] Polyp removal equipment handle

[0175] Various human-machine interface features can be used in the polypectomy device disclosed herein. For example, various embodiments disclosed herein include a handle portion that is sized and configured to be held and / or manipulated by a human hand during use. The handle portion may include multiple features that allow a user to grasp the handle and reposition the polypectomy device, such as by rotating the device about the longitudinal axis of the outer tubular member and / or inserting or retracting the outer tubular member into or from the patient's uterus (e.g., through the working channel of a laparoscopy or other instrument). The handle portion may further include one or more actuating members, such as triggers, buttons, levers, and / or the like, that allow a user to cause relative movement of the inner tubular member relative to the outer tubular member, and / or relative movement of another actuating member relative to the outer tubular member, such as... FIG. 12C Actuator 1214.

[0176] FIG. 16A and 16B It shows FIG. 1A Additional details of the handle 102 of the polyp removal device 100. The handle 102 includes a main body 1601 having an actuating member 112 slidably coupled thereto. The actuating member 112 is translatable back and forth to cause a back-and-forth translational movement of the inner tubular member 114 relative to the outer tubular member 104. The handle 102 further includes a spring 1602 positioned to bias the actuating member 112 in one direction. In this embodiment, the actuating member 112 is biased forward or distally by the spring 1602. However, in other embodiments, the actuating member 112 may be biased proximally (or even biased to a central position between the proximal and distal boundaries). The actuating member 112 further includes a finger surface 1604 shaped to engage a human finger. The surface 1604 may, for example, be shaped to engage the index finger or thumb or other fingers of the user's hand.

[0177] In this embodiment, the outer tubular member 104 is attached to the main body 1601 of the handle 102, and the inner tubular member 114 is coupled to and moves with the actuating member 112. In this embodiment, the inner tubular member 114 extends into the vacuum port 116, thereby allowing polyps or portions of polyps that have been removed from the uterine wall and aspirated through the inner tubular member 114 to be discharged at the vacuum port 116, ideally into a collection system fluidly coupled to the vacuum port 116.

[0178] FIG. 17A and 17B It shows FIG. 2A and 2BAdditional details of the handle portion 202 in the illustrated embodiment are provided below. In this embodiment, the handle portion 202 includes a main body 1701 attached to an outer tubular member 204. The handle 202 further includes an actuating member 212 coupled to an inner tubular member 214, such that rotation of the actuating member 212 relative to the main body 1701 causes relative rotation of the inner tubular member 214 relative to the outer tubular member 204. A spring 1702 provides compression or tension, preventing the actuating member 212 and the main body 1701 from rotating freely relative to each other. Accordingly, depending on the strength of the spring 1702, a specific predetermined torque must be applied to the actuating member 212 to initiate rotation of the rotating member 212 relative to the main body 1701.

[0179] It should be pointed out that, FIGS. 16A-16B The handle design of the 17A-17B is relatively simple, which can be used to build functional devices at a relatively low cost. However, in some embodiments, it may be desirable to have a handle design that is at least slightly more complex, which may make it easier and / or more comfortable to use. For example, FIG. 18A and 18B The embodiment shown illustrates an example of a more ergonomically shaped handle 1802. Handle 1802 includes a housing 1801 having two halves (e.g., two injection-molded polymer halves capable of being joined during assembly). Handle 1802 further includes a trigger or actuation member 1812, which, when the spring 1820 is engaged with a protruding member 1821 of the actuation member 1812 (although...) FIG. 18B A spring 1820, disconnected from the protruding member 1821, is shown biased in the extended position by the spring 1820. When using the handle 1802, the user can repeatedly compress the trigger or actuating member 1812, pulling it toward the protruding member 1803, to rotate the inner tubular member 114 relative to the outer tubular member 104 (not shown). In various embodiments, the protruding member 1803 is shaped to be gripped by a hand and is positioned relative to an opening (e.g., FIG. 8A The opening 808, or any other distal end opening disclosed herein, protrudes radially in a direction oriented at a specific angle. For example, the protruding member 1803 may be oriented at 90 degrees relative to the opening (similar to...). FIG. 1AAs shown, the actuating member 112 is oriented at approximately 90 degrees from the opening 108. In various embodiments, this orientation can be at various angles. In some embodiments, the angle is ideally configured such that the protruding member 1803 points downward when the polyp is removed at the most common location. For example, in some embodiments, the orientation is in the range of 90-180 degrees. In this embodiment, the handle 1802 further includes a gear train 1804 or more gears 1804 that converts the pivoting motion of the trigger or actuating member 1812 into rotation about different axes of the inner tubular member 114. Other embodiments may use different gear train configurations, and other embodiments may use configurations that convert the rotational motion of the trigger 1812 into translational motion of the inner tubular member instead of rotational motion.

[0180] The polypectomy device disclosed herein is not limited to use with the handle of the specific design shown in the figures of this application. Those skilled in the art will recognize that various other handles and triggering mechanisms can be used to cause relative movement of one component relative to another within the uterus.

[0181] Additional Examples

[0182] In some embodiments, the devices and methods disclosed herein allow for the removal of tissue using rotational motion in conjunction with a blade or cutting edge or surface (sharp or dull). In some embodiments, the devices and methods disclosed herein allow for the removal of tissue using mechanical biting motion via a set of cutting clamps. In some embodiments, the devices and methods disclosed herein allow for the removal of tissue using fixed clamps and movable wires. Using mechanical motion to remove tissue can further allow for the use of saline solutions to dilate the uterus, which can reduce the risk of electrolyte imbalance and prevent thermal damage.

[0183] The following is a description of various embodiments of additional polypectomy devices, any of which may include features that can be combined with any other polypectomy devices disclosed herein. For example, the handle and drive mechanism configurations discussed below may be combined with any of the distal end configurations described above or below.

[0184] FIGS. 19A-19I Another embodiment of the polyp removal device 1900 is shown. FIG. 19A A side view of a polyp removal device 1900 is shown. The device may have a shaft 1901, a handle 1902, a trigger 1612, a port 1916, and / or a vacuum source 1932. The vacuum source 1932 may be fluidly connected to the handle 1902 or the shaft 1901 via the port 1916.

[0185] Device 1900 can be a handheld device that mechanically rotates a tube with a "blade". The blade can be formed by bending certain cut sections of the thin-walled tube (e.g., ...).FIGS. 19E-19G (As shown in the diagram). The device can be connected to a vacuum source, which is used to pull a sample (such as a polyp) into the distal end of the device shaft. In some embodiments, vacuum pressure can be applied to the shaft only when the trigger has been pressed. Vacuum control can be important for maintaining uterine dilation. However, in some embodiments, the vacuum can be controlled by another element, such as a foot pedal.

[0186] Shaft 1901 may include a pair of concentrically aligned tubes (e.g., an outer tubular member and an inner tubular member, similar to those described above with respect to other embodiments). The inner tube may be modified to create a cutting edge to cut off the polyp after it has been aspirated into the inner tube (e.g., as...). FIGS. 19E-19G (as shown in the image).

[0187] The polyp removal device 1900 will use a similar method FIG. 3 The endoscope is inserted into the uterus to provide an inflow port for saline solution needed to visualize and dilate the uterus.

[0188] Trigger 1912 can have multiple positions. The trigger can have three positions. In the first position, suction in the device can be turned off. In the second position, suction in the device can be turned on. In the third position, the blade of the device can be activated. Among other things, it may be desirable to activate suction only slightly before cutting the polyp to minimize loss of dilatation fluid. However, in some embodiments, suction may be controlled by a foot pedal or other device, rather than by the multi-stage trigger 1912.

[0189] FIG. 19D A shaft 1901 of an improved polypectomy device 1900 according to one embodiment is shown in more detail. The shaft 1901 may have an outer tube 1904, an inner tube 1914 with a cutting edge 1915, a drive gear 1917, and a bearing 1919. The shaft may be connected to a vacuum source 1932.

[0190] A gear 1917 may be present, which is welded (or otherwise coupled) to the inner tube 1914, and allows the inner tube 1914 to pass through a set of gears in the handle (e.g., similar to...). FIG. 18B The gear train 1804 is rotated. Rotation of the inner tube 1914 allows the cutting edge 1915 to cut the tissue. In some embodiments, suction or vacuum can be used alone to transversely cut the polyp. The cutting efficiency of the blade may not be very high. This may be intentional, for example, by not sharpening the blade, which can increase safety and reduce manufacturing costs. The rotational speed and torque of the shaft may not be very high because, for example, the inner tube 1914 can be rotated by hand operating the trigger 1912, rather than by a motor rotating the tube 1914.

[0191] In this and various other embodiments disclosed herein, the speed of the reciprocating motion (e.g., the cutter translating and / or rotating back and forth) may be, for example, approximately, exactly, no greater than or no less than 0.5, 1, 2, 3, 4, or 5 cycles per second. In some embodiments, it may be desirable to have a relatively low speed (e.g., cycles per second) to allow for manual positioning of the opening for each cut.

[0192] FIGS. 19E-19G An example process for forming a cutting edge 1915 of an improved polypectomy device according to one embodiment is shown in more detail. The cutting edge 1915 may be formed in the inner tube 1914 of the device.

[0193] The cut edge 1915 can be formed, for example, by cutting and trimming the end of the hyaluronic acid tube to allow for the formation of a tip. These tips may include teeth, which can be created by removing adjacent material (e.g., as...). FIG. 19E As shown in the diagram). Once these tips are formed (e.g., as shown in the diagram), FIG. 19F As shown in the diagram, they can be bent or folded back inside the end of the tube to form one or more reverse-facing cut edges (e.g., as shown in the diagram). FIG. 19G (as shown in the image).

[0194] FIG. 19H and 19I The diagram illustrates how the cutting edge 1915 of the improved polypectomy device 1900 can remove tissue according to one embodiment. A vacuum can draw a polyp or tissue sample 1922 through the end of the tube with the cutting edge 1915 into the tube 1914. As the vacuum continues to be applied, rotating the tube 1914 allows the cutting edge 1915 to shear the polyp or sample 1922, thereby detaching it from the uterine wall or other body tissue 1926. The vacuum can then further prevent the sample from falling out of the tube.

[0195] FIG. 19B This illustrates how the improved polyp removal device 1900 can perform tissue capture according to one embodiment. FIG. 19B In the embodiment shown, the device may be capable of capturing cut and removed tissue. The device may have a tissue capture chamber 1920 in the handle 1902, which would allow a physician to send a sample 1922 to a pathology laboratory without the need for an auxiliary tissue capture device. The capture chamber 1920 eliminates the risk of handling biohazardous materials.

[0196] Trigger 1912 may be attached to component 1950, which translates through a slot in the handle to provide a means of controlling the vacuum. For example, gate 1950 may selectively close or open tube 1951 to selectively allow a vacuum to be applied to tube 1951, thereby applying it to tissue capture chamber 1920. It may be important to limit the duration of the vacuum, as pressure will drain the dilation fluid from the uterus and force the use of a larger volume of fluid. Ideally, the total volume of dilation fluid should be less than 1 liter to minimize safety concerns and the effort required to replace multiple fluid bags.

[0197] The tissue capture chamber 1920 may be in fluid communication with the cutting tube 1914. The tissue capture chamber 1920 may be removable, allowing the device to operate without the tissue capture chamber 1920. The tissue capture chamber 1920 may have a screen 1952 disposed therein. The tissue capture chamber 1920 may contain fluid for holding any collected samples. The tissue capture chamber 1920 may be in fluid connection with a vacuum source, such as by means of a hose, tube, or vacuum line 1951.

[0198] A vacuum line can pass through gate 1950. Gate 1950 can have an opening mechanism and a closing mechanism. When gate 1950 is closed, the flow path of vacuum line 1951 can be closed. When gate 1950 is open, the flow path of vacuum line 1951 can be opened. When the trigger 1912 of the device is pressed, gate 1950 can slide across vacuum line 1951 into its opening mechanism, and the flow path of vacuum line can be opened.

[0199] FIG. 19C The improved polyp removal device 1900 is shown in one embodiment how rotation of the cutting tube 1914 can be performed. FIG. 19C In one embodiment, a drive mechanism 1980 is present, which connects the translation of the trigger 1912 to the rotation of the cutting tube 1914. The inner tube 1914 may be connected to a drive gear 1917, and the drive gear 1917 may be mechanically communicated with a second spur gear 1919. The second spur gear 1919 may be mechanically communicated with a set of bevel gears 1921. The set of bevel gears 1921 may be mechanically communicated with a first spur gear 1923. The trigger may have a rack 1925, which drives the pinion (or the first spur gear) 1923 and the set of bevel gears 1921 to convert motion and energy.

[0200] When trigger 1912 is pressed, rack 1925 can engage the first spur gear 1923, thereby causing rotation of the set of bevel gears 1921 and the second spur gear 1919. Rotation of the second spur gear 1919 will rotate drive gear 1917, thereby causing the cutting tube 1914 to rotate. In some embodiments, trigger 1912 includes a dead zone 1927, which, for example, allows vacuum suction to begin before the inner tube 1914 begins to rotate (e.g., via...). FIG. 19B The movement of the gate in 1950).

[0201] FIGS. 20A-20C Another embodiment of the improved polyp removal device 2000 is shown. The illustrated device 2000 can be a handheld device that mechanically opens and closes clamps 2090 to bite and remove polyps, rather than cutting polyps by rotating and / or translating cutting edges. A shaft 2001 with cutting clamps 2090, a handle 2002, a trigger 2012, a removable tissue chamber 2020, a vacuum gate 2050, and / or a vacuum line 2051 connected to a vacuum source 2032 may be present. The removable tissue chamber 2020 and the vacuum gate 2050 may be located within the handle 2002 along with some portions of the vacuum line 2051, and may be similar to, for example... FIG. 19B The vacuum gate 1950 and tissue chamber 1920 may have ports that connect portions of the vacuum line to the handle. The handle may include something similar to... FIG. 19B The vacuum control gate concept shown in the figure is a vacuum control gate concept.

[0202] The cutting clamps 2090 may have an open tissue pathway at their proximal attachment point (where a vacuum is applied to remove the sample from the clamp). A “cutting edge” 2091 can be formed at the end of one clamp (or both clamps) by employing a thin wall at the clamp tip. The cutting clamps 2090 may have an opening structure (e.g., FIG. 20C ) and closing constructs (e.g., FIG. 20B In the open configuration, the cutting clamps 2090 can be positioned around the polyp or tissue sample. In the closed configuration, the cutting clamps 2090 can move toward each other, allowing the cutting edge 2091 to cut away the polyp.

[0203] The trigger 2012 can have multiple positions. The trigger 2012 can have two positions. In the first position, the clamps 2090 can be in an open configuration and the vacuum is off. In the second position, the clamps 2090 can move to their closed configuration and the vacuum is on. The trigger 2012 may include a dead time such that the vacuum cannot be activated simultaneously with the start of movement of the clamps 2090.

[0204] FIG. 21The diagram illustrates how the cutting clamp 2090 can be opened and closed according to one embodiment. The clamp 2090 can be closed using a translation tube 2014, which slidably engages a cam surface 2015 on the clamp to force it closed. A trigger can be used to slide the translation tube 2014. Once cutting is complete, a spring or elastic member 2017 can be used to return the clamp 2090 to the open position. A coil spring 2017 can also hold the clamp 2090 open until the translation tube 2014 closes it.

[0205] FIGS. 22A-22C The distal end 2206 of the improved polyp removal device is shown as an example of how a polyp slicer can be used according to one embodiment. The device can be a handheld device that mechanically opens and closes to bite and remove polyps. The cutting mechanism may include a fixed lower clamp 2209 (e.g., by forming an outer tube 2204) and a movable wire 2211. Therefore, no... FIGS. 20A-20C The cutting clamp 2090 shown in the figure may have the same or similar handle and shaft.

[0206] The lower cutting clamp has been replaced by a fixed plane 2209 formed by sculpting the outer tube 2204. The upper clamp has been replaced by a filament 2211, strong enough to cut tissue but fine enough to slice it. The filament 2211 is ideally configured to bypass the lower clamp 2209 to produce a shearing action similar to the blade of scissors. The formed filamentous upper clamp 2211 can be closed using a translation tube 2214, which slidably engages a surface 2215 on the clamp to force it to close. Once cutting is complete, a spring (similar to...) FIG. 21 The spring 2017 can be used to reset the clamp 2211 to the open position.

[0207] Additional / alternative features

[0208] The following are various options / features that may be included in any of the various embodiments of the polypectomy device disclosed herein. In some embodiments, the cutting tube may be a thin-walled tube. In some embodiments, the distal end of the cutting tube may not be bulbous. In some embodiments, the device may be configured to directly access polyp tissue (e.g., with an opening at the distal end). In some embodiments, the distal end of the cutting tube may be open to receive polyp tissue. In some embodiments, a side window may or may not be present in the cutting tube. In some embodiments, the inner and outer tubes in the shaft may be concentrically aligned tubes, both having open distal ends. In some embodiments, the blade or cutting edge (which may or may not be sharpened) bends inward (towards the proximal end of the cutting tube) back into the device such that once tissue is drawn into the tube, any engaged tissue cannot escape or fall out of the device.

[0209] In some embodiments, the device's vacuum function can be used alone to cut and capture polyps. The vacuum may not need to be paired with another cutting mechanism. In some embodiments, the device may not require mechanical action to cut and remove polyp tissue, some examples of which include the use of a lasso or loop, or rotation of a tube with blades therein. In some embodiments, the device can maintain or maximize uterine dilation during polyp removal. In some embodiments, the device can help conserve dilation fluid throughout the polyp removal procedure. In some embodiments, the device may have a dual-trigger design to engage the mechanism for mechanically cutting the polyp and to change the suction power of the vacuum source. In some embodiments, the device has a single trigger that can control both the cutting function (e.g., tube rotation) and the suction function (e.g., changing the power of the vacuum source). In some embodiments, the device has a single trigger that can be a multi-functional trigger.

[0210] In some embodiments, the device may have a thin-walled cutting tube with a non-bulb-shaped end, the end of which may open at the distal end to receive tissue. The cutting tube may have no openings in its sidewalls. In some embodiments, the device may have cutting clamps capable of simultaneously cutting, encapsulating, and removing polyp tissue. Removal of the polyp tissue may be assisted by suction. In some embodiments, the device may use a gear mechanism to rotate the device's shaft or cutting element.

[0211] Polyp removal methods

[0212] The various methods described herein can be used to remove polyps or portions of polyps using the polypectomy devices disclosed herein. FIG. 23 An exemplary embodiment of this process is shown; however, FIG. 23 The process flow shown is not the only process that can be used to remove polyps with the equipment disclosed herein.

[0213] The procedure begins at frame 2302. At frame 2304, the doctor inserts a laparoscope into the uterus, for example... FIG. 3 and 4 The laparoscope 300 is shown in the image. At box 2306, the physician dilates the patient's uterus. For example, the physician can allow dilation fluid to pass through the laparoscope and into the uterus. At box 2308, the physician inserts a long, tubular component of a polypectomy device through the working channel of the laparoscope. For example, FIG. 4 The external tubular member 104 shown can be inserted through the working channel of the endoscope 300. At frame 2310, as the elongated tubular member is further inserted into the working channel of the endoscope, the physician extends the distal end of the polypectomy device into the uterus beyond the distal end of the endoscope's working channel. An example of this can be seen in... FIG. 4As seen in the image, the distal end 106 protrudes into the uterus 420.

[0214] At box 2312, the physician positions the opening in the distal end of the polypectomy device adjacent to the polyp. For example, the physician may manipulate the handle of the polypectomy device to position the opening in the distal end adjacent to the polyp for removal. At box 2314, the physician positions at least a portion of the polyp through the opening. This can be achieved by manipulating the distal end of the polypectomy device and / or initiating vacuum suction, which causes a portion of the polyp to be drawn through the cavity.

[0215] At box 2316, the physician manipulates an actuating component, such as a trigger, button, and / or the like, to cause a cutting surface to separate the polyp or a portion of the polyp from the uterine wall. For example, the physician may manipulate a trigger, which causes the inner tubular component to translate and / or rotate relative to the outer tubular component, and causes one or more cutting surfaces to separate the polyp or a portion of the polyp from the uterine wall.

[0216] At box 2318, vacuum aspiration is used to transfer the separated polyp or a portion of a polyp through an elongated tubular member. For example, a physician may manually initiate vacuum aspiration, such as by using a foot pedal or other actuation mechanism, and / or vacuum aspiration may be automatically initiated using a multi-stage trigger and / or the like. This vacuum can cause the removed polyp or a portion of a polyp to be aspirated through the inner or outer tubular member and drawn into a collection system.

[0217] At box 2320, the procedure changes depending on whether it is necessary to remove additional tissue (such as an attached polyp or an additional portion of the same polyp). If it is necessary to remove additional tissue, the procedure returns to box 2312 and proceeds as described above. If it is not necessary to remove additional tissue, the procedure proceeds to box 2322. At box 2322, dilating fluid, such as through a laparoscopy, is removed, and the polypectomy equipment and laparoscopy are removed from the uterus. The procedure terminates at box 2324.

[0218] Additional embodiments of polyp removal equipment

[0219] FIGS. 25A-25U A polypectomy device 2500 is shown as another exemplary embodiment. FIG. 25A and 25B The side view and sectional view of the entire component are shown respectively. FIG. 25C and 25D A detailed sectional view is shown. FIGS. 25E-25G Various views of the actuating components or triggers of the component are shown. FIG. 25H and 25I The outer tubular component assembly 2504 is shown. FIGS. 25J to 25LCutting block 2560 is shown, and FIG. 25M and 25N An outer tubular member 2505 is shown, which can be coupled to a cutting block 2560 to form an outer tubular member assembly 2504. FIG. 25O An inner tubular member assembly 2590 is shown, which includes an inner tubular member 2514, a tubular cutter 2515, and a guide member 2517. FIGS. 25P to 25R Additional details of the tubular cutter 2515 are shown. (Reference) FIG. 25O The tubular cutter 2515 can be attached to the inner tubular member 2514 at the connecting portion 2588. In this figure and some other figures, such as... FIG. 25S and 25T The diagram shows a chamfer at the distal end of the inner tubular member 2514 (e.g., at the connection 2588), although this chamfer may not be visible in the final product. This chamfer can, for example, facilitate the connection process, such as laser welding or other processes. When the connection process is complete, the chamfered area at the distal end of the inner tubular member 2514 can be filled. FIG. 25S and 25T Additional details of the inner tubular member 2514 are shown. FIG. 25U Additional details of the ball pawl mechanism 2599 are shown. Various components or sub-assemblies of this embodiment can be used in any other embodiments disclosed herein. For example, the additional figures described below, including but not limited to… FIGS. 26A-26F Models 27A-27D, 28A-28D, 29A-29C, and 31A-31D focus on the proximal portion (e.g., the handle portion) of the polypectomy device, but any of those designs can be used for... FIGS. 25A-25U The distal portion of the polyp removal device shown in the figure (e.g., including the inner tubular body and the outer tubular body, as well as the cutting portion near the distal end).

[0220] The polyp removal device 2500 is similar in many respects to the polyp removal device 100 described above, and similar reference numerals are used to refer to similar objects. Furthermore, for efficiency, the description of this embodiment and the other embodiments given herein focuses on the differences from the embodiments described above. The polyp removal device 2500 includes features similar to those in the embodiments described above, particularly... FIG. 1A Several differences are shown in the polyp removal device 100.

[0221] Rotatable outer tubular component

[0222] One difference is that in the polyp removal device 2500, the outer tubular member 2504 is configured to be rotatable relative to the handle 102 about the longitudinal axis of the device. Allowing the outer tubular member 2504 to rotate relative to the handle 102 is advantageous in some embodiments because it allows for rotational positioning of the opening 2508 in the distal end of the device without rotating the handle 102. Accordingly, if a physician wishes to position the handle 102 and the actuating member or trigger or knob 112 in a particular orientation that is most comfortable and / or controllable for that physician, they can do so and then rotate the outer tubular member 2504 relative to the handle 102 to achieve the most ideal rotational orientation of the opening 2508 for the removal of the current polyp.

[0223] In this embodiment, rotation of the outer tubular member or outer tubular body 2504 is ideally achieved via a rotating hub 2591, which is attached to the outer tubular member 2504 and rotatably coupled to the main body of the housing 102. In this embodiment, the hub 2591 includes a projecting shaft 2593 that fits into a corresponding cavity 2595 in the main body of the handle 102. The shaft 2593 is ideally sized to have a sliding fit with the cavity 2595, thereby allowing rotation about the longitudinal axis of the hub 2591 relative to the main body of the handle 102. Furthermore, a retaining ring or pin 2597 is ideally employed to limit translation relative to the handle 102 along the longitudinal axis of the hub 2591. Some embodiments may further include bearings, sleeves, and / or the like, operatively positioned between the main body of the housing 102 and the shaft 2593 to reduce friction between the hub 2591 and the handle 102 and / or allow for more controlled rotation. In addition, other embodiments may employ other mechanical methods that allow the outer tubular member 2504 to rotate relative to the handle 102.

[0224] In this embodiment, hub 2591 includes a radially projecting member 2592 comprising a plurality of concave recesses ideally sized to engage with a human finger. For example, the radially projecting member 2592 and / or its plurality of concave recesses may allow a user of the device to place his or her thumb on the radially projecting member 2592 and press laterally to cause rotation of the radially projecting member 2592, thereby causing rotation of hub 2591 and outer tubular member 2504. While this design can be relatively ergonomic, various other embodiments may include various other types of projecting members, knurled or other friction-increasing surfaces and / or the like, allowing a user to use his or her finger to cause rotation of outer tubular member 2504. Furthermore, some embodiments may include gear trains, coupling mechanisms, and / or the like configured to convert the motion of triggers, buttons, and / or the like into rotational motion of outer tubular member 2504.

[0225] While it might be desirable to allow the outer tubular member 2504 to rotate relative to the main body of the handle 102, it might also be desirable to selectively restrict this rotation to prevent unintentional rotation of the outer tubular member 2504 relative to the handle 102 during use. This embodiment achieves this feature by including a ball or pin catch mechanism 2599. In this embodiment, reference... FIG. 25U The ball pawl mechanism 2599 includes: a spring-loaded ball or plunger 3198 extending at least partially beyond the proximal surface of the hub 2591; and a plurality of pawls, recesses, grooves, and / or similar features 3194 in the distal surface of the housing 102. The spring-loaded ball or plunger 3198 can be at least partially held within one of the pawls, recesses, grooves, and / or similar features 3194 under internal bias (e.g., a spring 3196 operably positioned between the ball and the hub), which maintains the outer tubular member 2504 in a specific rotational orientation relative to the handle 102 until sufficient rotational force is applied to force the ball or plunger 3198 away from the pawl 3194. Although FIG. 25U Only one of the multiple claw levers 3194 is shown, but the housing 102 may include similar... FIG. 31D The multiple claws 3194 shown in the figure.

[0226] Although this embodiment uses a ball-operated pawl mechanism to selectively restrict the rotation of the outer tubular member 2504 relative to the handle 102, other mechanisms can be used instead of or added to the ball-operated pawl mechanism. For example, a collet-type mechanism can be used, which allows the user to flip the control lever, rotating member, and / or the like to unlock the rotational movement of the outer tubular member 2504 relative to the housing 102, and then reverse the movement of the control lever, member, and / or the like to relock the rotational orientation of the outer tubular member 2504 relative to the handle 102. Compared to a pawl-type mechanism, this embodiment can allow for a more rigid or more secure locking of the rotation of the outer tubular member 2504. However, a pawl-type mechanism may be desirable because it may be simpler for the user to use.

[0227] and FIG. 1A and 1B One reason why the rotatable outer tubular member 2504 may be more ideal in this embodiment compared to the embodiment shown is that this embodiment includes a single opening 2508, while FIG. 1BThe embodiment shown includes two openings 108. For embodiments with more than one opening at the distal end, less rotation of the outer tubular member may be required to align any particular opening with a particular polyp. However, as discussed above, having only one opening at the distal end can also be advantageous to allow for more precise control of aspiration. By including a single opening 2508, but also the ability of the outer tubular member 2504 to rotate relative to the handle 102, a polypectomy device can be provided that offers relatively fine aspiration control and relatively easy alignment of the opening with the polyp.

[0228] Replacement cutting block

[0229] Polyp removal equipment 2500 relative to FIG. 1A Another difference in the polyp removal device is the use of a cutting block 2560 at the distal end. The cutting block 2560 is constructed in... FIG. 25H and 25I The outer tubular component assembly view is shown, and the individual view of the cut block 2560 is shown in... FIGS. 25J to 25L As shown in the image. Cutting block 2560 is somewhat similar to the one described in the reference above. FIGS. 10A to 10G The described cutting block 1060. However, one difference from cutting block 2560 is that cutting block 2560 includes a blunt, rounded distal surface 2581, which is configured such that when cutting block 2560 is assembled to FIG. 25M and 25N The distal end of the outer tubular member 2505 shown subsequently becomes the distal end of the polypectomy device. This configuration can be manufactured more easily and less expensively, and can also result in a smoother, less invasive distal end of the polypectomy device. It may be desirable, for example, to reduce the chance of trauma when the distal end of the polypectomy device contacts uterine tissue during a polypectomy procedure.

[0230] refer to FIG. 25N The cutting block 2560 further includes a cylindrical surface 2583, which is sized for assembly on... FIG. 25I The outer tubular member 2505 shown is within and coupled to its inner diameter. The cylindrical surface 2583 may include a press fit in some embodiments to hold the two components together. In some embodiments, the two components may be held together by adhesives, threaded connections, laser welding, and / or the like.

[0231] The cutting block 2560 further includes a proximal cylindrical surface 2585, sized to fit within the inner diameter of the outer tubular member 2505, and establishing an annular gap between the cylindrical surface 2585 and the inner surface of the tubular member 2505. This annular gap or void... FIG. 10G The component is marked as element 2587. Similar to the one described above. FIG. 25RAs shown, the inner tubular member and / or the tubular cutter located at the end of the inner tubular member may be sized to assemble around the cylindrical surface 2585 and enter the gap or void 2587 to aid in the separation of polyp tissue. In some embodiments, it may be desirable to control the outer surface 2585 of the cutting block 2560 relative to the inner surface of the cutter or the inner tubular member (e.g., FIG. 10E The gap between the inner surface 2586 (shown in the diagram) and the outer surface 2585. A tighter gap can help to effectively separate polyp tissue, while an overly tight gap may cause tool clogging. In some embodiments, it is desirable that the diametrical gap between the inner surface 2586 and the outer surface 2585 (i.e., the diameter of the inner surface 2586 minus the diameter of the outer surface 2585) be in the range of 0.0005-0.0015, 0.001-0.002, 0.001-0.003, or 0.002-0.005 inches. In some embodiments, it may be desirable to have a relatively deep gap or void 2587 (measured in the longitudinal direction as the longitudinal depth beyond the distal edge of the opening 2508). A relatively deep gap or void 2587 can increase the likelihood of complete and effective removal of polyp tissue by allowing the cutting end of the inner tubular body to move beyond the distal edge of the opening 2508. In some embodiments, it is desirable that the gap or void 2587 has a longitudinal depth of at least 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the inner diameter of the outer tubular body.

[0232] The cutting block 2560 further includes a circular cutting edge 2589 located at the junction between the nearest edge of the outer cylindrical surface 2585 and the proximal concave surface 2571. While some embodiments may include a flat (or other shaped) proximal surface instead of a concave proximal surface 2571, the concave proximal surface 2571 can help create a sharper cutting edge 2589 that can interact with the inner tubular member and / or a tubular cutter attached to the distal end of the inner tubular member to cut or shear polyp tissue. It may be desirable to employ a proximal concave surface 2571 with a spherical radius in the range of 0.100-0.200 or 0.150-0.250 inches. In some embodiments, the ratio of the spherical radius of the proximal concave surface 2571 to the outer diameter of the outer cylindrical surface 2585 is ideally in the range of 1.0-2.0, 1.5-2.0, or 1.0-3.0. Although in this exemplary embodiment the sharp cutting edge 2589 is formed by the connection between the outer surface 2585 and the concave spherical surface, other embodiments may form the sharp cutting edge 2589 in various other ways.

[0233] Another difference between cutting block 2560 and cutting block 1060 is that the cutting edge 2589 lies in a plane that is substantially perpendicular to the longitudinal axis of the tool. However, inFIG. 25K In the embodiment shown, the proximal surface of the cutting block 1060 is angled at angle 1062 relative to a plane perpendicular to the longitudinal axis. Both designs facilitate the cutting of polyp tissue. However, FIG. 25I One advantage of the design shown is that manufacturing a cutting block with a circular cutting edge 2589 created by adding a concave proximal surface 2571 may be easier and / or cheaper. Furthermore, reference... FIG. 25K In this embodiment, the proximal cutting edge of the cutting block 2560 (e.g., FIG. 25D and 25L The cutting edge 2589 shown may be recessed distally beyond the distal edge of the opening 2508, which helps to maximize the use of space within the tool and / or position the distal end of the opening 2508 closer to the distal end of the polypectomy device. Other embodiments may have the proximal cutting edge approximately aligned with the distal edge of the opening 2508, or may have the proximal cutting edge extended slightly longitudinally adjacent to the opening region 2508. Furthermore, some embodiments may have the cutting edge 2589 oriented at a non-perpendicular angle relative to the longitudinal axis, such as any of the angles discussed above relative to the cutting block 1060.

[0234] Spring-loaded cutter

[0235] Another difference in the polyp removal device 2500 is that it includes a spring-loaded cutter release or disconnection mechanism 2570, which... FIGS. 25E to 25G It is shown in the detailed sectional view, and also in FIG. 25O Partially shown. The spring-loaded cutter release mechanism 2570 is ideally configured to allow... FIG. 25D The inner tube assembly 2590 shown herein automatically moves forward relative to the outer tubular member in response to the actuating member or trigger 112 being pulled beyond a predetermined point (or otherwise activated, such as as described below with reference to other spring-loaded embodiments). In some embodiments, it may be desirable to allow the inner tube and / or a cutter integrated into or coupled to the distal end of the inner tube to move or extend relative to the outer tube in a relatively rapid manner to assist in cutting polyp tissue. As an example, see reference to FIG. 25DThe spring-loaded cutter release or disconnect mechanism 2570 includes a trigger 112 having an actuator link 2571 rotatably coupled thereto. In this embodiment, the actuator link 2571 is rotatably coupled to the trigger 112 via a pin 2572. In this embodiment, the actuator link 2571 is ideally biased in a downward or clockwise direction by a torsion spring 2573 (e.g., toward engagement with the actuating surface 2575 of the actuating member 2576, as described below). By biasing the actuator link 2571 downward or clockwise, this causes the protruding member or gripper portion 2574 to engage the distal surface or actuating surface 2575 of the actuating member 2576. The actuating member 2576 is ideally coupled to an inner tubular member 2514. Accordingly, reference continues to... FIG. 25D If trigger 112 is along the proximal or retraction direction (towards such as...) FIGS. 25A-25T If the trigger 112 is translated to the left (center-oriented), the gripper portion 2574 will cause the actuating member or block 2576 to also translate to the left or in the retraction direction along with the trigger 112. Once the trigger 112 has translated sufficiently in the retraction direction, the bottom surface 2577 of the actuator link 2571 will engage the ramp or cam portion 2578 of the handle 102. Continued translation of the trigger 112 in the retraction direction will cause the ramp 2578 to press the actuator link 2571 upward or in a counterclockwise direction (e.g., away from the direction of engagement with the actuating surface 2575). Once the actuator link 2571 has rotated fully counterclockwise, the gripper portion 2574 will no longer engage the actuating surface 2575 of the actuating member 2576, and the actuating member 2576 and the inner tubular member 2514 will ideally spring forward in the extension direction under the biasing force of the spring 2579 (which is operably positioned between the handle 102 and the actuating member 2576).

[0236] The bottom surface 2577 of the inclined or cam portion 2578 and the actuator link 2571 is ideally designed such that the gripper portion 2574 will release the actuating member 2576 when the trigger 112 has moved a predetermined distance. The predetermined distance that causes the actuating member 2576 to release and thus spring the cutter forward can be ideally selected based on the desired position of the distal end of the inner tubular body and / or the cutting edge 2552 of the tubular cutter relative to the opening 2508. For example, it may be desirable to select a predetermined distance such that the cutting edge 2552 will retract so that it is flush with the proximal end of the opening 2508 before springing forward, or even behind (or proximal to) the proximal end of the opening 2508. This design may be desirable because it allows the entire length of the opening 2508 to be accessed by tissue for insertion before the cutter is springed forward. In some embodiments, it may be desirable to design the cam or bevel portion 2578 and the bottom surface 2577 such that a predetermined distance causing the cutter to spring forward occurs before the cutting edge 2552 of the tubular cutter reaches the proximal end of the opening 2508. For example, the opening 2508 includes a length in the longitudinal direction, and it may be desirable to set the predetermined distance such that when the disconnecting mechanism releases the inner tubular body, the longitudinal distance from the proximal end of the opening 2508 to the cutting edge 2552 is no greater than 1 / 3, 1 / 4, or 1 / 8 of the longitudinal length of the opening. This design may be desirable, for example, because not fully retracting the cutting edge 2552 to the proximal end of the opening 2508 can help avoid blockage by potentially cutting away smaller pieces of polyp tissue, compared to the case where the cutting edge 2552 is retracted all the way back to or beyond the proximal end of the opening 2508. It should be noted that, although references FIG. 25D The embodiments described herein relate to the design of a disconnection mechanism that releases the cutter when the cutting edge of the tubular cutter reaches a specific position relative to the opening. However, the same design considerations and predetermined distances can be applied to other disconnection mechanisms described herein. For example, the disclosure regarding the design of the inclined or cam surface 2578 and the bottom surface 2577 as a release mechanism when the cutter is in a specific position can also be applied to the cam surface 3178 and the bottom or angled surface 3177 described below.

[0237] The user can then move or allow trigger 112 to move back as shown. FIG. 31B The starting position shown is such that the gripper portion 2574 is pressed downward by the torsion spring 2573 or rotated clockwise, re-engaging the distal surface 2575 of the actuating member 2576. In some embodiments, a biasing member (such as a spring) is used to automatically reset the trigger 112 to its forward or starting position (e.g., similar to...). FIG. 1A(Spring 3153 in the illustrated embodiment). To allow for a gap for the gripper portion 2574 to re-engage with the distal surface 2575 of the actuating member 2576, the actuating member 2576 further includes a distally extending protrusion 2569 that prevents the actuating member 2576 from translating sufficiently far along the extending direction such that no space remains for the gripper portion 2574 to engage with the distal surface 2575.

[0238] This embodiment illustrates only one example of a spring-loaded cutter release mechanism, which can also be referred to as a disconnect mechanism, allowing selective and / or automatic disconnection or decoupling of the inner tubular member from the trigger. By using a method similar to... FIGS. 27A-27D The embodiment shown, which allows the user to simply remove his or her finger from the trigger after pulling it back, could potentially achieve a slightly similar function, allowing the spring to reset the trigger and the inner tubular member to the extended position. However, it might be desirable to automate this release of the inner tubular member using a disconnect or decoupling mechanism, as this is easier for the user to operate and also allows or enables the inner tubular member to extend more quickly. For example, by disconnecting or decoupling the trigger 112 from the inner tubular member 2514, less mass is available for the spring 2579 to accelerate forward in the extension direction. Accordingly, when the inner tubular member 2514 has been decoupled from the trigger 112, the spring 2579 will ideally move the inner tubular member 2514 to the extended position more quickly than when the inner tubular member 2514 is not decoupled from the trigger 112. As a non-limiting example, an embodiment that does not decouple the trigger from the inner tubular member may have an extension speed of approximately 20 inches per second, and a similar embodiment that decouples the trigger from the inner tubular member may have an extension speed of approximately 65 inches per second. This increase in speed can contribute to more efficient and / or cleaner cutting of polyp tissue. In some embodiments, it may be desirable for spring 2579 to have a higher spring ratio to increase the extension speed of the inner tubular member 2514 upon release. In some embodiments, it may be desirable for spring 2579 to include a spring ratio of approximately, no greater than, or no less than 1, 2, 3, 4, 4.5, 5, or 6 pounds per inch. In some embodiments, it may be desirable for spring 2579 to include a spring ratio in the range of 2.5–3.5 pounds per inch. In some embodiments, it may be desirable to provide a mechanism for flipping or moving the assembly to a retracted position that provides a mechanical advantage rather than requiring the user to directly apply such axial force. For example, as will be referenced below. FIGS. 25A-25T As described in more detail in the embodiments shown in 28A-28D, 29A-29C, and 31A-31D, some embodiments may include a trigger that employs a connecting mechanism, gear train, and / or the like to provide mechanical advantages. These embodiments of the trigger mechanism can be combined with... FIGS. 9C-9EAll other features of the embodiments are used together. In some embodiments, this mechanical advantage is configured to be approximately, exactly, not less than or not greater than 1.5, 2.0, 2.5 or 3.0.

[0239] In some embodiments, it may be desirable to include damping features to dampen impact loads applied to the inner tubular member assembly and / or handle at the end of the extended stroke. For example, an O-ring, washer, or other resilient member may be positioned between the distally extending protrusion 2569 and a corresponding mating surface of the housing 102.

[0240] Various other methods can be used to decouple the inner tubular member from the trigger or actuation member, and some of these other methods will be described with reference to the following additional figures. Furthermore, although the various embodiments described herein depict a spring-loaded cutter that springs forward (e.g., toward the distal end of the device), similar features can also be used for cutters that spring backward (e.g., toward the proximal end of the device). For example, this design can be used in similar... FIG. 25B The cutter shown cuts polyp tissue as it retracts. For example, a spring can be used to bias the cutter in the retraction direction, and movement of the actuating element or trigger by the user can cause the cutter to move in the extension direction until a disconnecting mechanism releases the cutter to allow it to spring back. Accordingly, the disconnecting mechanism can be designed substantially similar to... FIGS. 26A-26F , 26E The design shown in 27B, 28B, 29C, and 31B is the opposite. One reason this design may be desirable is that the cutter will move in the same direction as the vacuum pressure (which will pull the polyp tissue toward the proximal end of the device), which can help generate a larger sample for each cut.

[0241] Spring-loaded cutter with rotation

[0242] FIGS. 26A-26FAn exemplary embodiment of a mechanism for a polyp removal device is shown, comprising a spring-loaded release or decoupling feature for a cutting tube or inner tubular member 2614, and an automatic rotation mechanism that causes the inner tubular member 2614 to rotate relative to the outer tubular member 2604 when the inner tubular member 2614 also translates relative to the outer tubular member 2604. As the inner tubular member 2614 translates forward relative to the outer tubular member 2604, causing the cutting edge or surface at the distal end of the inner tubular member 2614 to include at least some rotation facilitates efficient cutting in polyp tissue. One reason for the increased cutting efficiency is that the absolute velocity of the cutting edge of the inner tubular member 2614 relative to the corresponding cutting surface coupled to or formed by the outer tubular member 2604 can be increased. Another reason for the improved cutting efficiency is that the combination of rotation and translation tends to result in more slicing motions than simple translational movements.

[0243] FIG. 26C The embodiment shown is a simplified design intended to illustrate how such a decoupling and rotation mechanism 2670 can operate. Accordingly, the housing 102 is simply a rectangular box, but in other embodiments, an ergonomic handle may be included, as shown in some other embodiments illustrated herein. Furthermore, the decoupling and rotation mechanism 2670 includes a trigger 112 that can be manually flipped up and then manually released by a user pressing a release member 2612 (e.g., a lever, button, trigger, latch, and / or the like). However, in some embodiments, it may be more desirable for the inner tubular member to release automatically when the trigger 112 reaches a certain point, similar to what is described above with respect to the polyp removal device 2500. However, in this simplified example, the assembly is flipped up by the user sliding the trigger 112 in the retraction direction until the gripper 2605 engages the corresponding gripper 2606 of the rocker arm or latch 2612. This compresses the spring 2613. When the user operates the rocker arm or latch 2612, the grippers 2605, 2606 disengage, allowing the spring 2613 to push the trigger 112 along the extension direction, thereby also translating the inner tubular member 2614 relative to the outer tubular member 2604 along the extension direction. In some embodiments, including this embodiment and other embodiments disclosed herein, a spring (e.g., spring 2613) that biases the inner tubular body forward may be positioned against a spring seat (e.g., spring seat 2615), which is adjustable (e.g., slidable in the longitudinal direction) to adjust the spring's preload force. Additionally or alternatively, the spring may be replaced by a spring with a different spring ratio and / or length to adjust the spring's preload force.

[0244] Another feature of the decoupling and rotation mechanism 2670 is that it includes a body 2620 coupled to an inner tubular member 2614. The body 2620 includes a helical cam recess 2621 in which a pin 2622 is positioned. The pin 2622 is ideally held fixed relative to the housing (for clarity, in...). FIG. 26C and 26D (Not shown in the image). Accordingly, when the inner tubular member 2614 and the attached body 2620 are pressed forward by the spring 2613, the body 2620 and the inner tubular member 2614 will also be caused to rotate relative to the outer tubular member 2604 as the pin 2622 follows the path of the helical cam groove 2621. In some embodiments, the pin 2622 is coupled to the inner tubular member 2614 and follows a groove coupled to or part of the housing (substantially with...). FIGS. 27A-27D and 26D (The construction shown is the opposite). This allows for less rotational mass, potentially allowing for faster movement of the inner tubular member 2614. Furthermore, some embodiments may include more than one pin (or equivalent feature), such as two, three, or four pins equidistantly spaced around the inner tubular member 2614 or the body 2620.

[0245] In some embodiments, it may be desirable for the helical cam recess 2621 to have a relatively high lead or pitch. For example, it may be desirable for the helical cam recess 2621 to have a lead or pitch such that when the inner tubular member 2614 translates from a fully retracted position to a fully extended position, it causes the inner tubular member 2614 to rotate only 180°. Using such a relatively high pitch or lead reduces friction, thereby allowing the inner tubular member 2614 to translate and / or rotate more quickly. In various embodiments, the helical cam recess 2621 may be configured to cause the inner tubular member 2614 to rotate or partially rotate by a smaller or larger amount when the inner tubular member moves from a fully retracted position to a fully extended position, for example, approximately, not less than, or not greater than 45°, 90°, 135°, 180°, 225°, 270°, 315°, or 360°. In some embodiments, the device is configured to allow the inner tubular member 2614 to rotate within a range of 160-200 degrees, 90-270 degrees, or 45-315 degrees as the inner tubular member moves from a fully retracted position to a fully extended position. Furthermore, some embodiments may include variable pitch or guide pitch, or even non-helical grooves. For example, some embodiments may include a groove shaped to allow the inner tubular member to rotate back and forth as it extends from a fully retracted position to a fully extended position, such as at least once clockwise and at least once counterclockwise. In some embodiments, the body 2620 may include a material configured to reduce friction between the cam groove 2621 of the body 2620 and the pin 2622. For example, the body 2620 may include an acetal polymer formulated with polytetrafluoroethylene (PTFE). Furthermore, some embodiments may include grease, oil, bearings, and / or the like to reduce such friction. Some embodiments may include a lead screw coupled to a lead nut to cause rotation of the inner tubular member as it translates.

[0246] Alternative automatic decoupling mechanism

[0247] FIG. 25D 28A-28D and 29A-29C respectively illustrate three alternative embodiments of automatic decoupling or release mechanisms 2770, 2870, and 2970. These automatic decoupling mechanisms are ideally coupled with... FIGS. 26A-26F The automatic decoupling mechanism 2570 shown operates on a similar principle, but with a different trigger configuration. Furthermore, any of these automatic decoupling mechanisms can include elements as described in the above references. FIG. 27BThe described automatic rotation feature. Automatic decoupling mechanisms 2770, 2870, and 2970 each include a trigger 112 rotatably or pivotally coupled to the handle 102 at a pivot axis 2780, rather than slidably coupled to the handle 102. Accordingly, the user can squeeze the trigger 112 to cause the inner tubular member 2514 to move in the retraction direction, rather than the user sliding the trigger 112 in the retraction direction to cause the inner tubular member 2514 to move in the retraction direction. This configuration may be more ergonomic than a sliding trigger in some cases. This configuration can also achieve greater mechanical advantages than a sliding trigger.

[0248] refer to FIG. 27D The decoupling mechanism 2770 includes an actuator link 2771 having a spring-loaded or elastically flexible connecting link or portion 2772 that engages the gripper 2775 of the actuating member 2576. When the trigger 112 is actuated, the connector 2760, pivotally coupled to the trigger 112 and the actuator link 2771, causes the actuator link 2771 to be pulled in the retraction direction, thereby causing the gripper 2775 and the actuating member 2576 to also be pulled in the retraction direction. This also causes the inner tubular member 2514 to be pulled in the retraction direction. When the actuator link 2771 is pulled in the retraction direction, the bottom or angled portion 3177 of the flexible connecting link 2772 will ideally engage a cam surface or ramp 3178, which is coupled to or integrated into the interior of the handle 102. As actuator link 2771 continues to be pulled in the retraction direction, cam surface 3178 will eventually press the flexible portion 2772 outward (e.g., away from actuator 2576) and disengage from gripper 2775, thereby decoupling trigger 112 from actuator 2576 and inner tubular member 2514. This allows spring 2579 to release or actuate inner tubular member 2514 forward or in the extension direction. FIG. 27B The diagram shows the trigger 112 in a fully compressed configuration. In this case, the spring-loaded portion 2772 is still shown engaging the gripper 2775. However, ideally, as described above, in this position of the trigger 112, the cam surface 3178 would disengage the already moved flexible portion 2772 from the gripper 2775. In this and other embodiments, the flexible portion 2772 may comprise spring steel, plastic, or other sufficiently elastic materials to bend and disengage from the gripper 2775 without plastic deformation.

[0249] Continue to refer to FIG. 31CThe flexible portion 2772 further includes another bottom or angular surface 3179 positioned to engage the cam surface 3180 of the actuating member 2576. The angular surface 3179 and the cam surface 3180 are positioned to engage to push the distal end of the flexible portion 2772 upward and over the gripper 2775, allowing the flexible portion 2772 to re-engage the gripper 2775 when the trigger 112 is released. The flexible portion 2772 can engage the gripper 2775, similar to what is described below. FIGS. 29A-29C As shown in the image.

[0250] FIGS. 27A-27D The embodiment shown, namely the decoupling mechanism 2970, is similar in design to... FIGS. 29A-29C The embodiment 2770 shown in the figure uses similar reference numerals to refer to similar elements. Some differences in the embodiments of the decoupling mechanism 2970 are that the housing and triggers 102, 112 have different shapes, and the actuator link 2971 is coupled to the connector 2760 at different points. In this embodiment, the connector 2760 is pivotally coupled to the actuator link 2971 at a point in front of the proximal protruding member 2972 ​​(instead of at the proximal end of the actuator link), which alters the mechanical advantages provided by the connector 2760. Furthermore, FIGS. 26A-26F The embodiments shown include those similar to those referenced above. FIGS. 28A-28D The body 2620 is designed to cause the inner tubular body to rotate as it extends.

[0251] FIG. 28B Another alternative embodiment of the disconnect mechanism 2870 is shown. This mechanism is somewhat similar to the disconnect mechanism 2770, with similar reference numerals used to denote similar elements, but uses a gear-driven mechanism instead of a connecting mechanism to convert the rotational motion of the trigger 112 into the translational motion of the actuator link 2871. In this embodiment, when the trigger 112 is pressed, this causes the first gear 2865 to rotate the second gear 2866, which causes the rack 2867 to translate or slide. (Refer to...) FIG. 28B If trigger 112 is squeezed (i.e., as FIG. 28D As shown in the counterclockwise rotation, gear 2866 will be caused to rotate clockwise, thereby causing rack 2867 to move to the right or in the retraction direction. Rack 2867 is pivotally coupled to actuation link 2871 at its proximal end, thereby causing actuation link 2871 to also move in the retraction direction. In this embodiment, once actuation link 2871 has been fully retracted, the bottom surface 3177 of actuation link 2871 will ideally contact and couple to the cam surface, ramp, or equivalent feature 3178 of housing 102, which will cause gripper portion 2574 to disengage or decouple from actuation member 2576, thereby allowing inner tubular member 2514 to automatically extend forward under the energy of spring 2579.FIG. 28B The fully compressed trigger position is shown, with the exception that actuation link 2871 will be lifted away from actuation member 2576 instead of remaining engaged with actuation member 2576. Back FIGS. 30A-30C The actuating member 2576 further includes a cam surface 3180 that can push the gripper 2574 upward and over the actuating member 2576 when the trigger is released from the compressed position, thereby allowing the gripper 2574 to re-engage the actuating member 2576 when the trigger 112 is in the extended position.

[0252] Alternative opening

[0253] FIG. 25H 32A-32C and 33A-33D respectively illustrate alternative embodiments of the outer tubular member 3004, 3204 and 3304, which can be used in any of the embodiments disclosed herein, including FIGS. 30A-30C and 25I And other embodiments of the outer tubular component assembly 2504 shown in the figures. Reference FIG. 25H The outer tubular component 3004 is relative to FIGS. 32A-32C One difference in the outer tubular member 2505 is that the outer tubular member 3004 includes an opening 3008 having a distal cut surface 3009 that is angled or inclined relative to a transverse plane (e.g., a plane oriented perpendicular to the longitudinal axis of the outer tubular member). In this embodiment, the distal cut surface 3009 is oriented at an angle A of approximately 30° relative to the transverse plane; however, other embodiments may position the distal cut surface 3009 at different angles A, for example, approximately, exactly, not less than, and not greater than 10°, 20°, 30°, 40°, 50°, 60°, 70°, or 80°. In some embodiments, angle A may be in the range of 10-50° or 20-40°.

[0254] Furthermore, some embodiments may include a distal cutting surface that is curved, rounded, rounded, and / or similar, rather than positioned at a specific angle. For example, FIG. 32B Another exemplary embodiment of the outer tubular member 3204 is shown, which is similar to the outer tubular member 3004, except for the design of the opening 3208. In this embodiment, the outer tubular member 3204 includes a distal cut surface 3209, which, when viewed perpendicular to the longitudinal axis of the outer tubular body and orthogonal to the center of the opening 3208 (e.g., as shown in the image), is... FIGS. 33A-33D When oriented as shown in the image, it is circular. In this embodiment, when viewed perpendicular to the longitudinal axis and orthogonal to the center of the opening 3208, the distal cut surface 3209 comprises a single convex circular shape. Other embodiments may include multiple circular shapes and / or concave shapes instead of convex shapes. For example, FIG. 33BAnother exemplary embodiment of the outer tubular member 3304 is shown, which is similar to the outer tubular member 3004, except for the design of the opening 3308. In this embodiment, the outer tubular member 3304 includes a distal cut surface 3309, which, when viewed perpendicular to the longitudinal axis of the outer tubular member 3304 and orthogonal to the center of the opening 3308 (e.g., as shown in the image), is... FIG. 33B When oriented as described above, it includes multiple concave circular surfaces. FIG. 32A The design shown (which includes multiple concave surfaces) also creates multiple pointed portions 3310, which can help to cut tissue more effectively.

[0255] Back FIG. 32A When viewed perpendicular to the longitudinal axis and from the side of opening 3208 (e.g., as shown in the image), FIGS. 30A-30C When oriented as described above, the outer tubular member 3204 further includes a recess 3211. The recess 3211 is at least partially defined by a distal cutting surface 3209 extending at an angle B into the opening 3208. In this embodiment, the angle B is approximately 45°. However, in other embodiments, the angle B may be approximately, no greater than, or no less than 20°, 30°, 40°, 50°, 60°, or 70°. In some embodiments, the angle B may be in the range of 30° to 60°. The recess 3211 may help to shape the circular cutting surface 3209 into a shape that facilitates more efficient tissue severing. It may be desirable to make the distal cutting surface of the opening angular, circular, or otherwise non-parallel to the transverse plane in order to, for example, facilitate more efficient tissue severing. Embodiments disclosed herein include... FIG. 6D The embodiments shown in 32A-32C and 33A-33D can further help prevent polyp tissue from slipping out of the cutting compartment (e.g., openings 3008, 3208, 3308) after the cutter tube (e.g., tubular cutter 2515) impacts the tissue. For example, distal cutting surfaces 3009, 3209, 3309 can help “capture” the tissue between the distal cutting surfaces and the tubular cutter to prevent the tubular cutter from pushing the tissue out of the opening when it impacts the tissue.

[0256] Furthermore, the angular width of openings 3008, 3208, 3308, or any other external tubular member opening disclosed herein may include various values. For example, referring to the above regarding FIG. 25QThe discussion of angle 636 shown herein suggests that the same range of angular width 636 may be applied to openings 3008, 3208, 3308, or any other external tubular member opening disclosed herein. For example, openings 3008, 3208, or 3308 may include an angular width as defined above relative to angular width 636, which is approximately, exactly, and not greater than or less than 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°, 250°, 260°, or 270°. In some embodiments, it may be desirable to have an angular width of the opening greater than 90°, such as 120°, 150°, 180°, or any other angle given above, to increase the size of polyp tissue that may pass through the opening and be cut at any given time, thereby improving the efficiency of the polyp removal device. In some embodiments, it may be desirable to have an angular width of the opening in the range of 100°–140°. Test results confirm this desired range, as shown in the following two tables, which compare the cutting dimensions (in grams per cut) of a device with a 120-degree opening (Table 1) and a device with a 90-degree opening (Table 2).

[0257] Table 1

[0258]

[0259] Table 2

[0260]

[0261] In some embodiments, the efficiency of the polypectomy device can also be improved by changing the angle and / or direction of the chamfer of the distal cutting edge of the tubular cutter forming the inner tubular member. For example, refer to FIG. 25Q In this embodiment, the tubular cutter 2515 includes a chamfer 1554 (measured at angle A relative to the longitudinal plane) of approximately 22.5° forming a distal cutting edge 2552. In other embodiments, this angle A may be lower or higher (measured relative to the longitudinal plane). For example, the angle A may be approximately, exactly, no greater than, or no less than 45°, 40°, 30°, 22.5°, or 20°. In some embodiments, angle A may be in the range of 40-50 degrees, 30-60 degrees, 18-26 degrees, or 15-30 degrees. In some embodiments, the chamfered cutting edge is ideally formed using a grinding process to produce a sharper cutting edge than typical machining processes. In some embodiments, such asFIGS. 31A-31D As shown, the tubular cutter is designed such that the cutting edge 2552 is positioned at the inner diameter of the tubular cutter. In other words, the chamfer 1554 forming angle A is positioned radially outward of the cutting edge 2552. Positioning the cutting edge 2552 inside the chamfer 1554 and / or at the inner diameter of the tubular cutter (rather than positioning the cutting edge 2552 radially outward of the inner diameter) helps improve the efficiency of the device and / or reduce clogging. This is because a cutting edge positioned more radially outward may produce larger diameter tissue blocks, which may be more difficult to pass through the inner lumen of the tubular cutter 2515 and / or the inner tubular member 2514. In this embodiment, the cutting edge 2552 includes a circular cutting edge oriented such that the circle lies in a plane perpendicular to the longitudinal axis of the tubular cutter. Other embodiments may include cutting edges of different shapes, such as elliptical cutting edges oriented such that the ellipse lies in a plane not perpendicular to the longitudinal axis of the tubular cutter.

[0262] Alternative release mechanism

[0263] FIGS. 31A-31D An automatic decoupling or release mechanism 3170, another exemplary embodiment, is shown, which can be used in any other embodiment of the polyp removal device disclosed herein. For example, FIGS. 25A-25U The embodiments shown can be used for FIGS. 29A-29C The distal end configuration of the embodiment, or any other distal end configuration disclosed herein. Mechanism 3170 is similar in many respects to... FIG. 31A Mechanism 2970 is shown in the figure. Accordingly, similar reference numerals are used, and the description focuses on the differences in this embodiment relative to other embodiments disclosed herein. The automatic decoupling or release mechanism 3170 includes a housing 102 (with a pivotally coupled trigger 112) and various components located within a cavity of the housing 102. FIG. 31B An exterior view of mechanism 3170 is shown, and FIG. 31C A similar view is shown, but the internal components are shown with hidden lines. FIG. 31D A perspective view is shown with the housing 102 concealed. FIG. 29C A perspective view is shown with hub 2591 concealed to show the pawl mechanism 3199.

[0264] One difference in mechanism 3170 is the construction of the flexible and / or spring-loaded connecting rod or part 2772 (whose engaging gripper 2775). FIG. 31B In the embodiment shown, the flexible and / or spring-loaded connecting rod 2772 is coupled to the actuator connecting rod 2971. However, in FIG. 31BIn some embodiments, the flexible and / or spring-loaded connecting rod 2772 ideally comprises relatively thin sheets of spring steel (or any other material capable of performing a similar function), which is attached to the proximal body 3152 using one or more fasteners 3154 (such as screws, rivets, and / or the like). The proximal body 3152 is configured to move proximally (towards, for example, towards) when the trigger 112 is compressed. FIG. 31B (The right side shown in the diagram) moves. The proximal body 3152 is biased in the distal direction by the proximal spring 3153. The proximal body 3152 and the distal body (or actuating member) 2576 each include a lateral protrusion 3160 configured to engage a corresponding channel or groove in the housing 102 to guide the sliding movement of the bodies 3152, 2576 in the longitudinal direction.

[0265] The flexible connecting link 2772 is ideally configured such that when the proximal body 3152 and the distal body 2576 are in their farthest positions, the connecting link 2772 engages the gripper 2775 of the distal body 2576 (e.g., ...). FIG. 28B(As shown in the diagram). When the proximal body 3152 is translated proximally by pressing the trigger 112 (using the force transmitted through the connector 2760), the connecting rod 2772 causes the distal body 2576 to also translate proximally. The distal body 2576 is ideally coupled to the body 2620 such that the body 2620 also translates proximally together with the distal body 2576. With continued pressure on the trigger 112, as described above with reference to other embodiments, the bottom surface 3177 of the flexible connecting rod 2772 will ideally engage the cam surface 3178 of the housing, ultimately forcing the distal portion of the connecting rod 2772 to be pressed upward and over the gripper 2775 of the distal body 2576. Once the connecting rod 2772 has disengaged from the gripper 2775, the distal spring 3151 is configured to cause the distal body 2576 to spring forward or in a distal direction. This will cause the inner tubular member 2514 to translate in a distal direction. Furthermore, as the inner tubular member 2514 springs forward, the helical groove 2621 of the body 2620 ideally causes the inner tubular member 2514 to rotate about its longitudinal axis. The body 2620 is ideally coupled to the distal body 2576 in a way that allows rotation relative to the distal body 2576 about the longitudinal axis of the body 2620. Finally, when the user releases pressure on the trigger 112, the proximal spring 3153 ideally pushes the proximal body 3152 back to its furthest position, causing the connecting link 2772 to re-engage the gripper 2775. As described above with reference to other embodiments, the bottom or angled surface 3179 of the connecting link 2772 will engage with the cam surface 3180 to facilitate upward movement of the distal end of the connecting link 2772 over the gripper 2775 to re-engage the gripper. The device is then ready for the next actuation. The proximal spring 3153 may be advantageous, for example, because it will allow the trigger 112 to automatically “reset” to the extended position when the user releases pressure from the trigger 112. In some embodiments, the proximal spring 3153 includes a smaller spring ratio than the distal spring 3151. This may be advantageous, for example, because the proximal spring 3153 is used to reset the trigger 112, which may be expected to be a less forceful and / or slower movement compared to the forward bounce of the inner tubular body. In some embodiments, a restraining mechanism may be included to restrain the movement of the trigger 112 from the compressed position to the extended position. It should be noted that although this and other embodiments disclosed herein relate to a flexible portion capable of elastically bending to engage or disengage the gripper, any of these embodiments may additionally or alternatively include portions that rotate rather than bend to engage or disengage the gripper (e.g., FIGS. 31A-3 (As shown in the embodiments).

[0266] FIG. 31DThe embodiment shown in D also illustrates a claw mechanism 3199 of another embodiment for selectively restricting rotation of the outer tubular body relative to the handle. Specifically, for clarity, ​ A portion of the handle 102 with hub 2591 removed is shown. Similar to the pawl mechanism 2599, the pawl mechanism 3199 includes a spring-loaded plunger 3198, at least partially positioned within hub 2591 (not shown for clarity), and may extend at least partially into one of a plurality of pawls, recesses, grooves, and / or similar features 3194 in the distal surface of housing 102. The spring-loaded plunger 3198 may be at least partially held within one of the pawls, recesses, grooves, and / or similar features 3194 under its internal bias (e.g., a spring 3196 operably positioned between the plunger and the hub), which maintains the outer tubular member 2504 in a specific rotational orientation relative to handle 102 until sufficient rotational force is applied to force the ball or plunger 3198 out of the pawl 3194. Similar to the pawl mechanism described above, other forms of selective anti-rotation of the outer tubular member 2504 may also be used.

[0267] Unless otherwise expressly stated, or otherwise understood within the context in which they are used, conditional language such as “can,” “may,” “possibly,” or “may” is generally intended to convey that certain embodiments include certain features, elements, and / or steps that are not included in other embodiments. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are required in any way for one or more embodiments, or that one or more embodiments necessarily include logic for determining (with or without user input or prompts) whether such features, elements, and / or steps are included in or performed in any particular embodiment. The headings used herein are merely for the convenience of the reader and are not intended to limit the scope of the invention or the claims.

[0268] Although the invention has been disclosed in the context of certain preferred embodiments and examples, those skilled in the art will understand that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the invention, as well as their obvious modifications and equivalents. Additionally, those skilled in the art will recognize that any of the above methods can be implemented using any suitable apparatus. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, etc., disclosed herein in connection with the embodiments can be applied to all other embodiments given herein. For all embodiments described herein, the steps of the method need not be performed sequentially. Therefore, it is intended that the scope of the invention disclosed herein should not be limited to the specifically disclosed embodiments above. The scope disclosed herein also covers any and all overlapping, sub-scopes, and combinations thereof. Additionally, terms such as “up to,” “at least,” “greater than,” “less than,” “between,” etc., include the stated numbers. Numbers or characteristics or quantities, as used herein, beginning with terms such as “approximately,” “about,” and “roughly,” include the stated numbers (e.g., approximately 10% = 10%), and also indicate quantities close to the stated amount that still perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” and “roughly” can refer to a quantity that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity.

Claims

1. A polyp removal device, comprising: An outer tubular body having a cylindrical outer surface, a proximal end and a distal end, and an opening in the cylindrical outer surface near the distal end; An inner tubular body is positioned within the lumen of the outer tubular body, the inner tubular body having a proximal end and a distal end, and being longitudinally and rotatably movable relative to the outer tubular body, the inner tubular body including an extended position and a retracted position relative to the outer tubular body. A tubular cutter coupled to or formed as part of the distal end of the inner tubular body, the tubular cutter being positioned adjacent to an opening of the outer tubular body. A spring, positioned relative to the outer tubular body toward the extended position, biases the inner tubular body against it. A handle, which is coupled to the proximal end of the outer tubular body; A cam mechanism coupled to the handle and configured to cause the inner tubular body to rotate about a longitudinal axis as the inner tubular body moves relative to the outer tubular body from the retracted position to the extended position. as well as A disconnect mechanism, coupled to the handle, is configured to selectively hold the inner tubular body in the retracted position or release the inner tubular body from the retracted position, thereby allowing the spring to move the inner tubular body toward the extended position. The cam mechanism includes a pin at least partially positioned within a helical groove, wherein the pin is coupled to one of the inner tubular body or the handle or is formed as part of one of the inner tubular body or the handle, and the helical groove is coupled to the other of the inner tubular body or the handle or is formed as part of the other of the inner tubular body or the handle.

2. The polyp removal device according to claim 1, wherein, The cam mechanism is configured to allow the inner tubular body to rotate within a range of 90-270 degrees about the longitudinal axis as the inner tubular body extends relative to the outer tubular body.

3. The polyp removal device according to claim 1, wherein, The disconnection mechanism includes a gripper that engages with an actuating surface of the inner tubular body or a component coupled to the inner tubular body, wherein the gripper is movable to disengage from the actuating surface to allow the spring to move the inner tubular body toward the extended position.

4. The polyp removal device according to claim 3, wherein, The gripper is pivotally movable to engage or disengage from the actuating surface, and the disconnection mechanism further includes a spring that biases the gripper toward engagement with the actuating surface.

5. The polyp removal device according to claim 3, wherein, The gripper is biased toward engaging the actuating surface, and the gripper comprises an elastically bendable material that can be bent to detach from the actuating surface.

6. The polyp removal device according to claim 3, wherein, The disconnection mechanism includes a manually operable release element coupled to or formed as part of the gripper to allow the gripper to be manually moved to disengage from the actuating surface.

7. The polyp removal device according to claim 3, further comprising: An actuating member movably coupled to the handle and the disconnecting mechanism, the actuating member being manipulated by a user by at least one of sliding or rotating the actuating member relative to the handle; When the gripper of the disconnecting mechanism engages with the actuating surface, the movement of the actuating member relative to the handle causes the inner tubular body to move relative to the handle; and Specifically, when the claw of the disconnecting mechanism is not engaged with the actuating surface, the movement of the actuating member relative to the handle will not cause the inner tubular body to move relative to the handle.

8. The polyp removal device according to claim 7, wherein, The disconnecting mechanism further includes a cam surface positioned to automatically disengage the gripper from the actuating surface in response to movement of the actuating member relative to the handle.

9. The polyp removal device according to claim 7, wherein, The actuating member is coupled to the disconnecting mechanism via a gear train or a connecting member, which converts the pivotal movement of the actuating member into the sliding movement of at least a portion of the disconnecting mechanism.

10. The polyp removal device according to claim 1, wherein, The outer tubular body can rotate relative to the handle to allow for changes in the rotational position of the opening relative to the handle.

11. The polyp removal device according to claim 1, further comprising: A cutting block, positioned at the distal end of the outer tubular body and at least partially distal to the opening, the cutting block including a blunt, rounded distal portion that at least partially forms the distal end of the polyp removal device, the cutting block further including a proximal cutting portion positioned within the lumen of the outer tubular body, the cutting portion including a cylindrical outer surface, a concave proximal surface, and a cutting edge at the intersection of the cylindrical outer surface and the concave proximal surface; and The tubular cutter is sized such that, when the inner tubular body is in an extended position relative to the outer tubular body, it is at least partially fitted within the annular gap between the cavity of the outer tubular body and the cylindrical outer surface of the cutting portion of the cutting block.

12. The polyp removal device according to claim 11, wherein, The tubular cutter includes a circular cutting edge located at the inner diameter of the distal end of the tubular cutter.

13. The polyp removal device according to claim 1, wherein, The outer tubular body includes a distal cut surface located at the distal end of the opening, the distal cut surface having a shape not perpendicular to the longitudinal axis.

14. The polyp removal device according to claim 1, wherein, The outer tubular body includes a distal cut surface located at the distal end of the opening, the distal cut surface having a shape that, when viewed perpendicular to the longitudinal axis and orthogonal to the center of the opening, includes one or more circular portions or includes one or more portions oriented at a non-perpendicular angle relative to the longitudinal axis.

Images