End effector control mechanism and method of use

The medical device addresses jaw misalignment and friction issues in surgical devices by using a control mechanism that pivots jaws through a cam action and channels, improving the efficiency and safety of tissue stapling and cutting.

JP7731899B2Active Publication Date: 2025-09-01BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
JP2022559746
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-04-01
Filing Date
2021-03-25
Publication Date
2025-09-01
Estimated Expiration
2041-03-25

AI Technical Summary

Technical Problem

Existing surgical devices face challenges such as misalignment of jaws during tissue grasping and increased friction when releasing clamps, leading to improper stapling and cutting, which can increase treatment time and cause patient trauma.

Method used

A medical device with a control mechanism that translates between states to pivot jaws from an open to a closed configuration, utilizing a cam action and channels to prevent relative movement, ensuring proper alignment and reducing friction.

Benefits of technology

Improves jaw alignment and reduces friction, enhancing the efficiency and safety of tissue stapling and cutting procedures by maintaining precise jaw positioning and reducing treatment time.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

The medical device includes a shaft, an end effector at a distal end of the shaft having a first jaw that pivots relative to a second jaw about a pivot axis, and a control mechanism that engages a surface of the first jaw, such that when the control mechanism translates from a first state to a second state relative to the pivot axis, the surface of the first jaw moves relative to the control mechanism and pivots about the pivot axis. The medical device further includes an actuator extending through the shaft and coupled to the control mechanism, such that translation of the actuator translates the control mechanism from the first state to the second state.
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Description

[Technical Field]

[0001] The present disclosure relates to minimally invasive (e.g., endoscopic and / or laparoscopic) medical devices and related methods of use. In embodiments, the present disclosure relates to, among other aspects, one or more control mechanisms for end effectors, such as tissue fastening devices, e.g., stapler devices, and related methods of use. [Background technology]

[0002] Technological developments provide users of medical systems, devices, and methods with the ability to perform increasingly complex procedures on subjects. For example, joining tissue in a subject's gastrointestinal tract or elsewhere in the body is one type of procedure that can present challenges. Surgical devices are known that grasp or clamp tissue between opposing jaw structures and then join the tissue with surgical fasteners. The fasteners may include surgical staples. In some procedures, a cutting instrument may be provided to cut the tissue that has been joined by the fasteners. Drawbacks to these systems can include, for example, misalignment of the jaws of the grasping or clamping device during operation and / or increased friction when the jaws are released after clamping the jaws to the tissue. This can result in tissue not being properly stapled and / or cut, which can increase treatment time and / or cost and / or cause trauma to the patient. The present disclosure may solve one or more of these problems or other problems in the art. However, the scope of the present disclosure is defined by the appended claims, not by its ability to solve a particular problem. Summary of the Invention

[0003] According to one aspect, a medical device includes a shaft, an end effector including a first jaw at a distal end of the shaft and pivoting about a pivot axis relative to a second jaw, a control mechanism engaging a surface of the first jaw and translating about the pivot axis from a first state to a second state to cause the surface of the first jaw to move relative to the control mechanism and pivot about the pivot axis, and an actuator extending through the shaft and coupled to the control mechanism, wherein translation of the actuator causes the control mechanism to translate from the first state to the second state.

[0004] Translation of the control mechanism from the first state to the second state may be configured to transition the first jaw and the second jaw from the open configuration to the closed configuration, respectively. The second jaw may include a plurality of channels, and the control mechanism may be configured to move along the plurality of channels between the first state and the second state.

[0005] The second jaw may include a protrusion extending generally perpendicular to the longitudinal axis of the end effector, and the protrusion may be configured to contact the control mechanism to prevent the control mechanism from translating distally of the protrusion.

[0006] The control mechanism may include a base, a distal member protruding from the base, a proximal member protruding from the base, and a slot defined between the proximal and distal members. The distal member of the control mechanism may include a first surface extending from the base along a first axis, a second surface extending along a second axis, and a third surface connecting the first and second surfaces, wherein the first and second axes may not be parallel.

[0007] Cam action between a surface of the first jaw and the control mechanism may cause the first jaw to pivot about the pivot axis. When the control mechanism translates between the first state and the second state, a surface of the first jaw may contact each of the first surface, the second surface, and the third surface of the distal member of the control mechanism.

[0008] A first angle defined between the first axis and the longitudinal axis of the end effector may be up to about 45 degrees, and a second angle defined between the second axis and the longitudinal axis of the end effector may be less than the first angle and may be up to about 15 degrees.

[0009] The first jaw may include a distal end and a proximal end, and the proximal end may be angled relative to the distal end. A proximal end of the first jaw may be disposed within the slot of the control member in the first state, and the proximal end may contact the distal member of the control mechanism in the second state.

[0010] The proximal end of the first jaw may contact a second surface of the control member in the second state. The proximal end of the first jaw may include a longitudinal axis, and the longitudinal axis of the proximal end may not be parallel to the first axis when the control mechanism is in the second state, and as the control mechanism moves from the second state to the first state, the longitudinal axis of the proximal end rotates relative to the first axis so that the longitudinal axis of the proximal end and the first axis approach a substantially parallel orientation.

[0011] The proximal end of the first jaw may be configured to contact the proximal member of the control mechanism when the control mechanism moves from the second state to the first state. The medical device may further include a pulley at the proximal end of the end effector, and the actuation wire may be configured to contact the pulley when the actuation wire is actuated, and the pulley may be configured to contact the control mechanism to prevent the control mechanism from translating proximally of the pulley.

[0012] According to another aspect, a medical device includes an end effector including a first jaw and a second jaw coupled to one another and configured to move between an open configuration and a closed configuration; a control mechanism including a distal member including a first surface and a second surface, a proximal member, and a slot defined between the proximal and distal members, wherein in the open configuration, the surface of the first jaw is received within the slot and engages the first surface of the distal member, and in the closed configuration, the surface of the first jaw is outside the slot and engages the second surface of the distal member to prevent relative movement of the first jaw and the second jaw.

[0013] The first jaw may include a proximal end and a distal end, the proximal end may extend along a longitudinal axis, and the longitudinal axis of the proximal end may be generally parallel to the longitudinal axis of the first surface of the distal member of the control mechanism in the open configuration.

[0014] The first jaw may be configured to contact a proximal member of the control mechanism between the closed and open configurations. According to yet another aspect, a medical method includes advancing an end effector to a target site within a patient, the end effector being prevented from transitioning from a closed orientation to an open orientation by a control mechanism including a proximal member, a distal member, and a slot defined between the proximal and distal members; actuating the control mechanism to transition the end effector from the closed orientation to the open orientation by overcoming a force between a proximal end of a first jaw of the end effector and the distal member of the control mechanism, wherein the proximal end of the first jaw moves into the slot as the end effector transitions from the closed orientation to the open orientation; positioning an object between the first and second jaws of the end effector; and actuating the control mechanism to create a cam action between the distal member of the control mechanism and the proximal end of the first jaw, transitioning the end effector from the open orientation to the closed orientation.

[0015] The control mechanism may be configured to translate relative to the end effector, and the control mechanism may be positioned closer to the proximal end of the end effector when the end effector is in the open position than when the end effector is in the closed position. [Brief explanation of the drawings]

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description serve to explain the principles of the disclosed embodiments. [Figure 1A] 1 is a schematic diagram of a medical device including an end effector, according to one embodiment. [Figure 1B] 1B is a diagram of a pivot arm of the medical device of FIG. 1A, according to one embodiment. [Figure 2] 1B is a diagram of an end effector of the medical device of FIG. 1A according to one embodiment. [Figure 3] 1B is a diagram of an end effector of the medical device of FIG. 1A according to one embodiment. [Figure 4] 1B is a diagram of an end effector of the medical device of FIG. 1A according to one embodiment. [Figure 5] FIG. 5 is a cross-sectional view along the longitudinal axis of the end effector of FIGS. 2-4 in a closed configuration, according to one embodiment. [Figure 6] FIG. 5 is a cross-sectional view along the longitudinal axis of the end effector of FIGS. 2-4 in an open configuration according to another embodiment. [Figure 7] FIG. 1B is a diagram of a control mechanism of the medical device of FIG. 1A, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0017] The present disclosure is described with reference to exemplary medical systems and tools for accessing target sites, for example, to grasp, cut, and / or staple tissue, and for providing control mechanisms for opening, closing, and / or locking the jaws of these devices. This may provide improved medical tool functionality and / or assist medical professionals in improving tissue cutting and / or fastening. However, it should be noted that reference to any particular device and / or any particular procedure is provided for convenience only and is not intended to limit the present disclosure. Those skilled in the art will recognize that the concepts underlying the disclosed devices and application methods may be used in any suitable procedure, medical or otherwise. The present disclosure can be understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals.

[0018] For ease of description, some of the disclosed devices and / or their components are referred to as proximal and distal portions. Note that the term "proximal" is intended to refer to the portion of the device closer to the user, and the term "distal" is used herein to refer to the portion farther from the user. Similarly, "distally extending" indicates that a component extends in the distal direction, and "proximally extending" indicates that a component extends in the proximal direction. Furthermore, as used herein, the terms "about," "approximately," and "substantially" indicate a range of values ​​within + / - 10% of the stated or suggested value. Additionally, terms indicating the geometry of a component or surface refer to exact and approximate shapes.

[0019] Embodiments of the present disclosure may be used to cut and / or fasten tissue in an intraluminal space, or to facilitate these processes. By way of example, the fastening device may be a tissue stapling instrument, which may include a cutting or severing mechanism (e.g., an integrated knife) and a stapling mechanism (e.g., a stapler). The fastening device may be delivered to a target tissue site through an endoscope working channel. All or a portion of the fastening device may be metal (e.g., stainless steel, titanium, or cobalt chrome), plastic (e.g., polyetheretherketone (PEEK)), or may comprise a shape memory metal (e.g., nitinol), a shape memory polymer, a polymer, or any combination of materials. While reference is made herein to fastening devices with control mechanisms, the described control mechanisms may be used with any set of jaws or other end effectors pivotally coupled to one another at the distal end of a catheter, sheath, tube, or the like. The control mechanism may prevent relative (e.g., pivotal) movement between adjacent jaws and provide improved gripping of tissue. For example, preventing pivotal rotation between adjacent jaws connected through a single fixed pivot (e.g., compared to jaws connected through multiple pivots, such as pivot pins or other mechanisms) can improve jaw alignment, reduce friction when moving the jaws relative to one another, and reduce the size of the end effector.

[0020] 1A illustrates an instrument 10 according to an example of the present disclosure. The instrument 10 may be a surgical stapling instrument configured to engage body tissue and apply a plurality of fasteners thereto during minimally invasive surgery, such as laparoscopic or endoscopic surgery. In some embodiments, the instrument 10 may be a suturing instrument for delivering sutures for closing tissue during minimally invasive surgery. While the device 10 may be used to apply sutures, clips, or other fasteners, it will be described primarily in the context of grasping tissue in preparation for performing additional procedures on the tissue, such as, for example, stapling and / or cutting the tissue.

[0021] As shown in FIG. 1 , instrument 10 includes a handle assembly 30 at a proximal end, an end effector 100 at a distal end, and an elongated body 50 (e.g., a shaft, catheter, etc.) connecting the distal end of handle assembly 30 to the proximal end of end effector 100. Elongated body 50 may extend to any length appropriate for endoscopic or laparoscopic surgery and may be configured to be positioned within a working channel of an endoscope. Alternatively, elongated body 50 may extend along the outer surface of the endoscope, for example, if the endoscope includes only a single lumen and / or if the diameter of the endoscope's lumen is too small to accommodate elongated body 50. Elongated body 50 may be detachable from handle assembly 30 to facilitate insertion of elongated body 50 into the working channel of an endoscope or a channel of another device, for example, by backloading elongated body 50 into the working channel. In some examples, the elongate body 50 may be flexible, steerable, and / or rotatable about its axis. The elongate body 50 may include a lumen (or multiple lumens) so that actuation wires may be positioned therein for actuating the end effector 100 via the handle assembly 30 or for actuating any other portion of the instrument 10. The elongate body 50 may be configured to accept multiple actuation wires or a single actuation wire. In some examples, the elongate body 50 may be fixedly coupled to the end effector 100, while in other examples, the elongate body 50 may be detachably or releasably coupled to the end effector 100. Unless otherwise stated, any wire or actuation device described herein may extend through a lumen of the elongate body 50 from the handle assembly 30 to the end effector 100. Alternatively, or in addition, one or more of these actuation wires or devices may extend outside of (e.g., adjacent to) the elongate body 50 from the handle assembly 30 to the end effector 100. A catheter 55 (or any other sheath) including a lumen may extend distally from the distal end of the handle assembly 30.The elongate body 50 may be disposed within a lumen of the catheter 55 and may move relative to the catheter 55 .

[0022] The handle assembly 30 may include a handle 32 and a body 34. The handle 32 may include a fixed portion 32a and an actuator portion 32b. The fixed portion 32a of the handle 32 may be fixedly coupled to the body 34. The actuator portion 32b may include a circular or oval portion or ring for positioning a user's fingers therein, which may assist the user in gripping the handle assembly 30. In some embodiments, the actuator portion 32b of the handle 32 may be an actuator that is pivotally coupled to the body 34 and may be movable relative to the fixed portion 32a of the handle 32. In some examples, the actuator portion 32b of the handle 32 may be coupled to a proximal portion of an actuation wire, such as actuation wire 40a, via an adjustable coupler 36, as described herein. The control mechanism 150 of the end effector 100 may be actuated via the actuation wire 40a extending between the end effector 100 and the handle assembly 30. In other examples, the actuator portion 32b of the handle 32 may be configured to control any other mechanism of the instrument 10, such as actuation of staple deployment from the end effector 100. It will be appreciated that the wire 40a may have sufficient stiffness to be pushed distally and pulled proximally.

[0023] In some examples, the handle assembly 30 may include a movable cover 38 pivotally coupled to the housing 34 at a pivot point 38b. In FIG. 1, the cover 38 is shown in an open position, exposing the interior of the body 34. The cover 38 may be coupled to a proximal portion of the body 34 and may cover the internal components of the handle assembly 30 when positioned in a closed configuration, such as when a distal-most end 38a of the cover 38 faces a surface 34a of the body 34. The cover 38 may be positioned to cover the internal components of the body 34 (e.g., in the closed configuration) via a coupling mechanism, such as a snap-fit ​​mechanism, at a distal portion of the cover 38 and a distal portion of the handle assembly 30. When in the closed configuration, the cover 38 may form a pair of slots (not shown) in the body 34. When the distal portion of the cover 38 is disconnected from the distal portion of the body 34, a user may rotate or pivot the cover 38 at the pivot point 38b to access the internal components of the handle assembly 30.

[0024] The handle assembly 30 may include one or more adjustable couplers 36, 39 that may be configured to receive a portion of an actuation wire, such as the actuation wire 40a. Any of the adjustable couplers 36, 39 may be a movable vice to clamp the actuation wire 40a and securely couple the actuation wire 40a to the adjustable coupler 36, 39. In some examples, the adjustable couplers 36, 39 may be movable by a screw to adjust the coupler 36, 39 and couple or uncouple the actuation wire 40a to the coupler 36, 39. The couplers 36, 39 may be used in the movement of additional wires as described herein.

[0025] The adjustable coupler 39 may be coupled to the longitudinal actuator 31 and may be longitudinally movable by translating the longitudinal actuator 31 within the body 34. The longitudinal actuator 31 may be positioned partially within the housing 34 and may be longitudinally slidable within two slots formed when the cover 38 is positioned over the internal components of the handle assembly 30. The longitudinal actuator 31 may include a pair of opposing circular or oval portions or rings, each circular portion defining an opening for a user to position a respective finger therein. In some examples, the longitudinal actuator 31 may be coupled to an actuation wire (not shown), such as via the adjustable coupler 39 or via a different coupler within the body 34, and may be configured to control staple deployment from the end effector 100. In other examples, the longitudinal actuator 31 may be configured to control any other mechanism of the instrument 10, such as the proximal or distal movement of a control mechanism 150, etc. Alternatively, two actuators may be used, a first actuator for actuating the cutting device and a second actuator for actuating the stapling device.

[0026] 1A and 2, end effector 100 may include a pair of jaws, such as anvil 120 and body 130 of a stapler device, that may be coupled to a distal end of elongated body 50. For example, connector 52 at the distal end of elongated body 50 may be pivotally attached to the proximal end of end effector 100 via a first pin secured in pinhole 136b.

[0027] The pivot arm 60 may be pivotally attached to a side of the body 130 of the end effector 100 via a pin 131 a (the pin 131 a may define a pivot axis). For example, one or more protrusions 131 may extend from a side of the body 130 and receive the pin 131 a through a pin hole 131 b in the protrusion 131, thereby securing the pin 131 a relative to the protrusion 131. The pin 131 a defines a pivot axis of the end effector 100 relative to the pivot arm 60. The pin 131 a may also be received in an opening 66 ( FIG. 1B ) at the distal end of the pivot arm 60, thereby securing the pivot arm 60 between the protrusions 131 and allowing the end effector 100 to pivot relative to the pivot arm 60.

[0028] The pivot arm 60 may include an opening at its proximal end. The opening may be connected to a lumen extending from the proximal end to the distal end of the arm 60. A slot 65 (e.g., an opening) may be formed in a side of the pivot arm 60 and connected to the lumen of the pivot arm 60. The slot 65 may be oval, rectangular, or any other suitable shape. The proximal opening, the lumen of the pivot arm 60, and the slot 65 may be sized and shaped to receive a portion of the elongate body 50 such that the elongate body 50 may enter the pivot arm 60 through the proximal opening and extend out of the slot 65 ( FIG. 1A ). An opening 66 may be provided at the distal end of the pivot arm 60. The opening 66 may receive the pin 131 a so that the pivot arm 60 can pivot relative to the pin 131 a. As described herein, movement of the elongate body 50 relative to the pivot arm 60 may cause the end effector 100 to rotate about pin 131a relative to the pivot arm 60. While the pivot arm 60 is shown as a rectangular parallelepiped, the pivot arm 60 may be any shape, including a cylinder, a rectangular parallelepiped with rounded edges, etc. Additionally, the pivot arm 60 may be an integral part of the catheter 55, or the pivot arm 60 may be fixedly attached to the distal end of the catheter 55 by ultrasonic welding, adhesive, crimping, etc. This may prevent the pivot arm 60 from moving when the elongate member 50 is moved relative to the catheter 55 and / or pivot arm 60. For ease of understanding, only the catheter 55 is shown in FIG. 1A .

[0029] The anvil 120 may include a proximal end 122 and a distal end 124 and may be rotatably or pivotally coupled to the body 130 via a pin 120a (which may define a pivot axis). The anvil 120 and the body 130 may collectively be referred to as jaws, gripping elements, and / or opposing members. In some examples, the anvil 120 may be rotatably biased about the pin 120a and may be biased into an open or closed configuration. For example, the distal end 124 of the anvil 120 may be biased away from the body 130 using a spring or the like, thereby creating a space between the distal end 124 of the anvil 120 and a distal portion of the body 130. Alternatively, the distal end 124 of the anvil 120 may be biased toward the body 130 using a spring or the like. As shown in FIG. 5 , body 130 may include a longitudinal axis A, and anvil 120 may include a longitudinal axis F (longitudinal axes A and F are generally parallel in FIG. 5 ). Proximal end 122 of anvil 120 may be angled relative to distal end 124 and / or longitudinal axis F, and proximal end 122 may extend along longitudinal axis B. An angle β may be formed between longitudinal axis F and longitudinal axis B. The angle of proximal end 122 relative to longitudinal axis F may assist in opening and closing end effector 100 by allowing proximal end 122 to engage control mechanism 150 in the closed and open configurations.

[0030] The anvil 120 may pivot about the pin 120a and may contact or approximate the body 130 in a closed position, for example, to hold tissue between the anvil 120 and the body 130. In some examples, the body 130 may include a channel (not shown) that supports a cartridge of staples or other fastening devices. The closed position of the anvil 120 may provide a surface against which staples may be driven when ejected from the cartridge of the end effector 100. The cartridge may contain multiple surgical fasteners, such as staples, which may be deployed from the cartridge when under the influence of a driving force applied by an actuation sled or other actuation mechanism. A suitable stapler and associated actuation mechanism are described in commonly owned U.S. Patent Application No. 16 / 804,887, filed February 28, 2020, the entire disclosure of which is incorporated herein by reference.

[0031] 2-4 , the proximal end of the body 130 includes a first pin (the first pin may define a pivot axis) secured in a pin hole 136b to pivotally couple the connector 52 to the distal end of the end effector 100. A second pin (the second pin may define a pivot axis) is secured in a pin hole 136a to pivotally couple the rotatable member 56 (e.g., a pulley or roller) to the distal end of the end effector 100. The first pin may extend from the pin hole 136b in the base of the body 130 to the pin hole 136b in the second arm 135b of the body 130. A recess 132 (e.g., a slot) may be defined between the first arm 135a and the second arm 135b. The recess 132 may receive a portion of the control mechanism 150 during operation, as described herein.

[0032] The rotatable member 56 may be attached to the same side of the body 130 as the protrusion 131, and the connector 52 may be attached to the opposite side of the body 130 from the rotatable member 56. A second pin may extend from a pin hole 136a in the base of the body 130 to a pin hole 136a in the first arm 135a of the body 130. The rotatable member 56 may rotate about a pivot axis defined by the second pin secured in the pin hole 136a. The actuation wire 40a may contact the rotatable member 56 upon actuation of the fixation member 150 and / or upon movement of the end effector 100 relative to the pivot arm 60 or movement of the end effector 100 relative to the connector 52. The rotatable member 56 may rotate about the second pin secured in the pin hole 136a upon contact between the rotatable members 56, thereby reducing frictional and / or other forces on the wire 40a. The connector 52 may include an inner surface 52a facing the rotatable member 56 and an outer surface 52b (FIG. 3) opposite the inner surface 52a. The inner surface 52a may have a curved surface, concave toward the rotatable member 56 and convex toward the outer surface 52b. A bore 54 is disposed at the proximal end of the connector 52. The elongate body 50 is coupled to the connector 52 and terminates in the bore 54. The actuation wire 40a may extend from a lumen of the elongate body 50 through the bore 54 and may be attached to the control mechanism 150 at its distal end.

[0033] 3 and 4, a pair of channels 134 (only one channel is shown in FIG. 3) are defined by the inner surface of the body 130. As shown in FIG. 4, the channels 134 are defined between rails 136 that protrude from opposing inner sidewalls of the body 130 toward the center of the body 130 and the bottom inner surface of the body 130. The channels 134 extend parallel to the longitudinal axis A of the end effector 100 (see FIG. 5). The channels 134 define a path along which the control mechanism 150 may move, for example, parallel to the longitudinal axis A. The base 152 of the control mechanism 150 may slide within the channels 134 parallel to the longitudinal axis A. The rails 136 prevent movement of the control mechanism 150 in a direction perpendicular to the longitudinal axis A, toward the arms 135 a, 135 b. A lip 137 (e.g., a protrusion) extends upward from the bottom inner surface of body 130 toward the center of body 130. During operation, the distal end of base 152 of control mechanism 150 may contact lip 137, which may prevent control mechanism 150 from moving distally of lip 137. The proximal end of base 152 may contact one or both of rotatable member 56 or connector 52 ( FIG. 2 ), which may prevent control mechanism 150 from moving proximally of one or both of member 56 or connector 52.

[0034] The control mechanism 150 shown in FIG. 7 includes a distal member 154 protruding from the distal end of the base 152 and a proximal member 156 extending from the proximal end of the base 152. The distal member 154 includes a first surface 154a, a second surface 154b, and a third surface 154c joining the first surface 154a and the second surface 154b. The first surface 154a is generally planar and extends along a longitudinal axis E. The second surface 154b is generally planar and extends along a longitudinal axis D. The first and second surfaces 154a, 154b are not limited to being planar and may include curved surfaces, such as convex or concave surfaces, or surfaces of any other shape. The third surface 154c may be generally curved and may have a convex surface facing away from the base 152. However, the shape of third surface 154c is not limited and may be flat or curved in a direction different from that shown in FIG. 7, etc. As described herein, third surface 154c may guide proximal end 122 of anvil 120 from contact with second surface 154b to contact with first surface 154a, and from contact with first surface 154a to contact with second surface 154b, during operation of control mechanism 150. This movement may be a cam action, with proximal end 122 progressing along first surface 154a, second surface 154b, and third surface 154c.

[0035] The proximal member 156 may extend away from the base 152. A cross-section (taken along a plane parallel to the top surface of the base 152) of the proximal member 156 at or near the base 152 may have a smaller dimension than a cross-section of the proximal member 156 further from the base 152. For example, the third surface 156a is generally planar, extends generally perpendicular from the base 152, and faces the first surface 154a of the distal member 154. The third surface 156a is joined to the fourth surface 156b at the end of the third surface 156a opposite the base 152. The fourth surface 156b is generally planar and angled relative to the third surface 156a. The fourth surface 156b faces the first surface 154a and extends generally parallel to the first surface 154a and the longitudinal axis E. A slot 155 is defined between the first surface 154a and the third and fourth surfaces 156a, 156b. The slot 155 is configured to receive the proximal end 122 of the anvil 120 when the end effector 100 is in the open configuration. The upper surface 158 defines the top surface of the proximal member 156 and may be generally parallel to the top surface of the base 152. In some examples, the distance between the upper surface 158 and the base 152 is greater than the distance between the top surface of the distal member 154 and the base 152. During operation of the control mechanism 150, the proximal member 156 and / or the distal member 154 may extend into the recess 132 between the first arm 135a and the second arm 135b.

[0036] A longitudinal axis C extends from the proximal end of the base 152 to the distal end of the base 152 and is parallel to the longitudinal axis A ( FIG. 5 ) of the end effector 100. An opening 159 extends into the base 152 parallel to the longitudinal axis C from the proximal end of the base 152 toward the distal end of the base 152. The opening 159 terminates proximal to the distal end of the base 152. The opening 159 is configured to receive and secure the actuation wire 40 a. The actuation wire 40 a may be secured to the base 152 within the opening 159 using an adhesive, welding, or the like. The opening 159 may be any shape, including spherical, arcuate, cylindrical, or the like. In some examples, aperture 159 may open on the side of base 152 opposite proximal member 156 and distal member 154 (bottom as shown in FIG. 4 ) so that a portion of actuation wire 40a may be exposed from aperture 159 when actuation wire 40a is attached to aperture 159. Alternatively, aperture 159 may be a through-hole with a countersink at its distal end to receive a hypotube at the distal end of actuation wire 40a.

[0037] An angle beta can be defined between longitudinal axis D and longitudinal axis C. Angle beta can be between about 0 degrees and 15 degrees, or can be about 5 degrees. An angle γ can be defined between longitudinal axis E and longitudinal axis C. Angle γ can be greater than 0 degrees and up to about 45 degrees, or can be about 30 degrees.

[0038] The end effector 100 is shown in closed and open configurations in FIGS. 5 and 6 , respectively. In the closed configuration, the proximal end of the base 152 of the control mechanism 150 is adjacent to and / or in contact with one or both of the connector 52 or the rotatable member 56. The control mechanism 150 is in its proximal-most position. In this configuration, the proximal end 122 of the anvil 120 contacts the second surface 154b of the distal member 154, thereby securing the anvil 120 in the closed configuration. For example, a frictional force secures the proximal end 122 to the second surface 154b. The applied frictional or other applied force is sufficient to maintain the anvil 120 in the closed configuration in the absence of user intervention. User intervention may include actuating the actuation wire 40a to move the control mechanism 150 distally, thereby overcoming the force and unlocking the proximal end 122 from the second surface 154b. In some examples, additional locking mechanisms may be provided to help maintain the anvil 120 in the open or closed configuration relative to the body 130.

[0039] 6, the distal end of base 152 of control mechanism 150 is adjacent to (and may contact) lip 137. Control mechanism 150 is in its distal-most position, and the surface of proximal end 122 contacts third surface 156b, allowing anvil 120 to be positioned in the open configuration. User intervention is required to move control mechanism 150 proximally and move anvil 120 from the open configuration toward the closed configuration. Translational movement of control mechanism 150 will open or close the end effectors, lock them in the closed configuration, or position them in the open configuration.

[0040] A method of operation of the device 10 will now be described. The device 10 may be introduced into the body through a natural orifice (e.g., the mouth or anus) or through an incision or other medically induced opening. The end effector 100 may be advanced to a target site within the body, for example, via a catheter or some other similar device. The end effector 100 may be advanced along the catheter in a closed configuration, which may allow the end effector 100 to traverse one or more tortuous paths within the body. Alternatively, the end effector 100 may be advanced in an open configuration.

[0041] Once the end effector 100 reaches the target site, it can be manipulated to grasp tissue or an object at the target site. The end effector 100 may be rotated about a pivot axis defined by the first pin secured in the pin hole 136b and / or pin 131a, for example, by relative movement between the pivot arm 60 and the elongate body 50, to properly position the end effector 100 relative to the target site. In this case, the end effector 100 may be in a closed configuration. In this position, the base 152 is in its proximal-most position adjacent one or both of the connector 52 or the rotatable member 56. As shown in FIG. 5 , the second surface 154b engages the proximal end 122 of the anvil 120, thereby securing the anvil 120 in the closed configuration, as described above. Distal movement of the actuation wire 40a may move the control mechanism 150 distally. As control mechanism 150 moves distally, second surface 154b disengages proximal end 122. Proximal end 122 is subsequently engaged by an upper portion of fourth surface 156b (in some instances, second surface 154b and fourth surface 156b may simultaneously engage or contact proximal end 122). Continued distal movement of control mechanism 150 moves proximal end 122 further along fourth surface 156b and into slot 155, causing anvil 120 to rotate about the pivot axis defined by pin 120a. Distal movement of control mechanism 150 is stopped by lip 137, thereby securing anvil 120 in an open configuration in which longitudinal axis B is substantially parallel to longitudinal axis E.

[0042] Once in the open configuration, the end effector 100 may be further manipulated to position tissue or an object between the anvil 120 and the body 130. The open configuration may have an angle between the anvil 120 and the body 130 equal to the difference between angle γ and angle α, which may be greater than 0 degrees and up to about 30 degrees. The actuation wire 40a may then be moved (e.g., pulled) in a proximal direction, moving the control mechanism 150 proximally. The first surface 154a may push against the proximal end 122, rotating the anvil 120 toward the closed position. The second surface 154b may re-engage the proximal end 122 as the control mechanism 150 approaches the connector 52 and / or the rotatable member 56, further assisting in rotating the anvil 120 to the closed configuration. When control mechanism 150 is adjacent one or both of connector 52 or rotatable member 56, anvil 120 can be locked in a closed position, as described above, capturing tissue or an object between anvil 120 and body 130. One or more additional medical procedures, such as, for example, stapling, cutting, etc., can then be performed. After the additional medical procedures, the object and / or tissue can be released by moving anvil 120 to the open configuration. Instrument 10 can be removed from the body after all medical procedures are completed and / or removed and reintroduced multiple times to perform multiple procedures within the body.

[0043] While exemplary medical systems are described, it will be understood that the particular arrangement of elements in these fastening systems is not limited. Furthermore, the size, shape, and / or material of the fastening system are not limited. Control mechanisms for opening, closing, and securing the end effector are included as described herein. Performance of various medical procedures may be improved by reducing the size of the end effector by ensuring proper alignment of the jaws of the end effector and / or by reducing the number of pivoting members for securing and / or opening and closing the end effector.

[0044] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed apparatus without departing from the scope of the present disclosure. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

1. A shaft and an end effector at a distal end of the shaft, the end effector including a first jaw having a distal end and a proximal end, the first jaw pivoting relative to a second jaw about a pivot axis perpendicular to a longitudinal axis of the distal end of the first jaw; a control mechanism engaging the proximal end of the first jaw, the control mechanism including a base, a distal member projecting upwardly from the base, a proximal member projecting upwardly from the base, and a slot defined between the proximal and distal members; an actuator extending through the shaft and coupled to the control mechanism, wherein translation of the actuator causes the control mechanism to translate from a first state to a second state along the longitudinal axis of the second jaw; a longitudinal axis of the proximal end of the first jaw is angled toward the slot relative to the longitudinal axis of the distal end of the first jaw; In the first state, the proximal end of the first jaw is disposed within the slot of the control mechanism and the first and second jaws are in an open configuration, and in the second state, the proximal end of the first jaw contacts the distal member of the control mechanism and the first and second jaws are in a closed configuration; translation of the control mechanism from the first state to the second state moves the proximal end of the first jaw out of the slot in the control mechanism, pivots the first jaw about the pivot axis, and transitions the first and second jaws from the open configuration to the closed configuration.

2. The medical device of claim 1 , wherein the second jaw includes a plurality of channels, and the control mechanism is configured to move along the plurality of channels between the first state and the second state.

3. 3. The medical device of claim 1, wherein the second jaw includes a protrusion extending perpendicular to the longitudinal axis of the second jaw, the protrusion configured to contact the control mechanism and prevent the control mechanism from translating distally of the protrusion.

4. 4. The medical device of claim 1, wherein the distal member of the control mechanism includes a first surface extending distally from the base, a second surface constituting an upper surface of the distal member, and a third surface connecting the first and second surfaces, the first and second surfaces being non-parallel.

5. The medical device of claim 4 , wherein the first jaw is pivoted about the pivot axis by cam action between the proximal end of the first jaw and the control mechanism.

6. 6. The medical device of claim 4, wherein the proximal end of the first jaw contacts each of the first surface, the second surface, and the third surface of the distal member of the control mechanism when the control mechanism translates between the first state and the second state.

7. 5. The medical device of claim 4, wherein a first angle defined between a longitudinal axis of the first surface and the longitudinal axis of the second jaw is at most 45 degrees, and a second angle defined between a longitudinal axis of the second surface and the longitudinal axis of the second jaw is less than the first angle and is at most 15 degrees.

8. A medical device as described in claim 7, wherein the longitudinal axis of the proximal end of the first jaw is not parallel to the longitudinal axis of the first surface when the control mechanism is in the second state, and as the control mechanism moves from the second state to the first state, the proximal end of the first jaw rotates relative to the first surface, such that the longitudinal axis of the proximal end of the first jaw and the longitudinal axis of the first surface approach a parallel orientation.

9. 9. The medical device of claim 1, wherein the proximal end of the first jaw is configured to contact the proximal member of the control mechanism when the control mechanism moves from the second state to the first state.

10. a pulley at a proximal end of the end effector; 10. The medical device of claim 1, wherein the actuator includes an actuation wire coupled to the control mechanism, the actuation wire configured to contact the pulley, and the pulley configured to contact the control mechanism and prevent the control mechanism from translating proximally of the pulley.

Citation Information

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