Bi-directional endoscopic suturing system

Abstract

A bi-directional endosuturing device, including a housing defining an endoscope aperture and having an axis. The endosuturing device further including a first plication arm and a second plication arm extending distally from the housing, the first plication arm and second plication arm facing one another and configured to engage tissue disposed therebetween. Additionally, the endosuturing device includes a first needle receiver disposed adjacent the first plication arm, the first needle receiver configured to releasably secure a needle and orient needle transverse to the axis; and a second needle receiver disposed adjacent the second plication arm, the second needle receiver configured to releasably secure the needle and orient the needle transverse to the axis, the first and second needle receiver aligned with one another to pass the needle therebetween.

Description

BI-DIRECTIONAL ENDOSCOPIC SUTURING SYSTEMCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the benefit of the filing date of provisional U.S. Patent Application No. 63 / 515,439, filed on July 25, 2023. The entire contents of the provisional application are hereby expressly incorporated herein by reference.FIELD

[0002] The present disclosure relates to bi-directional endoscopic suturing systems.BACKGROUND

[0003] Endoscopic suturing is a procedure that permits a medical professional to stitch inside a person (e.g., within the Gl tract). Endoscopic suturing requires an endoscope equipped with a stitching device and a mechanism for cinching a suture strand. An endoscope is medical tool including an image sensor and light source to view, in real time, the internal organs of a person.

[0004] In one example, endoscopic suturing involves suturing plication lines in stomach tissue to reduce the overall volume of the stomach. The endoscope assists in accurate location and formation of the necessary plications within the stomach for a successful procedure. Endoscopic suturing devices require complicated operation of the endoscope and attached stitching devices in order to properly for the plication lines.SUMMARY

[0005] Disclosed herein is an endosuturing device, including a housing defining an endoscope aperture and having an axis. The endosuturing device further includes a first plication arm and a second plication arm extending distally from the housing. The first plication arm and second plication arm facing one another and configured to compress tissue disposed therebetween. The endosuturing device also includes a first needle receiver and a second needle receiver disposed adjacent the first plication arm. The first needle receiver configured to hold a needle, orient the needle transverse to the axis, move the needle across the axis to engage the second needle receiver, and release the needle to the second needle receiver. The second needle receiver also configured to hold the needle, orient the needle transverse to theaxis, move the needle across the axis to engage the first needle receiver, and release the needle to the first needle receiver.

[0006] In some variations, at least one of the first plication arm and the second plication arm is actuatable. Additionally, in some examples, the first needle receiver holds the needle with a friction fit. Additionally or alternatively, the second needle receiver holds the needle with a releasable securing mechanism.

[0007] In other variations, the first needle receiver may include a first position and a second position, the first needle receiver being configured to be actuated between the first position and the second position. In such examples, first needle receiver is configured to deposit the needle in the second needle receiver in the second position.

[0008] In yet other variations, the endosuturing device may further include an actuation mechanism configured for simultaneous control of the first and second needle receivers. Alternatively, the endosuturing device may include an actuation mechanism configured for independently controlling the first and second needle receivers.

[0009] In yet further variations, the first plication arm and the second plication arm each include a needle shield. At least one of the first plication arm and the second plication arm may include a slot opening for needle to pass through. In some such examples, the endosuturing device may further include a second actuation mechanism configured to individually control the first plication arm and the second plication arm.

[0010] In other variations, the needle is straight.

[0011] Also disclosed herein is an endosuturing device including a housing defining an endoscope aperture and having a first axis. The endosuturing device also including a first plication arm and a second plication arm extending from the housing. The second plication arm disposed opposite the first plication arm and the first and second plication arms configured to be actuated towards and away from the first axis. Additionally, the endosuturing device includes a first suturing arm including a first needle receiver disposed on a second axis perpendicular to the first axis and disposed adjacent the first plication arm, and a second suturing arm including a second needle receiver disposed on the second axis and disposed adjacent the second plication arm. The first needle receiver configured to pass and release a needle to the second needle receiver and the second needle receiver may be configured to pass and release the needle to the first needle receiver.

[0012] In some variations, the first plication arm and the second plication arm are pivotably coupled to the housing. For example, the first plication arm may include a first position radially away from the second plication arm and a second position proximate to the second plication arm. The first plication arm actuatable between the first position and the second position. In some such examples, the endosuturing device may further include an actuation mechanism configured to individually actuate the first plication arm and the second plication arm. Alternatively, the endosuturing device may include an actuation mechanism configured to simultaneously actuate the first plication arm and the second plication arm.

[0013] In other variations, the first and second suturing arms have a first position and a second position. The first position is radially away from the first axis and the second position is adjacent the first or second plication arms, respectively. In some such examples, each of the first and second suturing arms may include a counter pivot mechanism. In some examples, the housing further includes an alignment feature and the first needle receiver, the first needle receiver is pivotable and alignable relative to the alignment feature.

[0014] In yet other variations, the first plication arm and the second plication arm include a needle shield. Additionally, the needle shield may include a slot for the needle to pass through. In some examples, at least one of the first plication arm and the second plication arm is spring loaded.

[0015] Also disclosed herein is an endosuturing device, including a housing defining an endoscope aperture and having an axis. The endosuturing device includes a first plication arm extending distally from the housing and a second plication arm extending distally from the housing. The second plication arm faces the first plication arm and configured to compress tissue therebetween. A first needle receiver includes a distal end disposed perpendicular to the axis, the first needle receiver being shiftable relative to the first plication arm to move the distal end therepast; and a second needle receiver operatively coupled to the second plication arm and including a distal end disposed perpendicular to the axis, first and second needle receivers axially aligned with one another.

[0016] In some variations, the housing includes a cap to be disposed on distal end of endoscope to align the first plication arm with a working channel of an endoscope.

[0017] In other variations, the first plication arm is configured to engage the working channel of the endoscope. Additionally, the second plication arm may be coupled to an exterior surface of the endoscope. In such examples, at least one of the first plication arm and thesecond plication arm may be flexible. Additionally or alternatively, at least one of the first plication arm and the second plication arm is curved.

[0018] In yet other variations, at least one of the first needle receiver and the second needle receiver comprises a catheter. In other examples, the first needle receiver includes a first releasable securement mechanism and the second needle receiver includes a second releasable securement mechanism. In such examples, the first releasable securement mechanism may include a friction fit between the first needle receiver and the needle. Additionally or alternatively, the second releasable securement mechanism comprising an actuatable securement mechanism. In such examples, the actuatable securement mechanism may include a collet.

[0019] In further variations, the first plication arm includes a first inclined plane and the first needle receiver includes a second inclined plane configured to engage the first inclined plane for providing increased linear force in response to a rotational force.

[0020] In some variations, the needle is straight.

[0021] Also disclosed herein is a method of operating a bi-directional endosuturing device. The bi-directional endosuturing device includes a housing, a tissue grabber, a first needle receiver, and a second needle receiver. The method includes operating the tissue grabber to pull a first portion of tissue between the first needle receiver and the second needle receiver. The method further includes driving a needle from the first needle receiver, through the tissue, to the second needle receiver, the needle being straight. Then, the method includes securing the needle in the second needle receiver, releasing the needle from the first needle receiver, and operating the tissue grabber to release the tissue.

[0022] In some variations, securing the needle in the second needle receiver includes actuating a releasable securement mechanism. Additionally, securing the needle in the first needle receiver includes overcoming a friction fit between the needle and the second needle receiver. In some examples, the method includes returning the needle to the first needle receiver before advancing a plication line.

[0023] In other variations, the method further includes operating the tissue grabber to pull a second portion of tissue between the first needle receiver and the second needle receiver; driving the needle from the second needle receiver, through the tissue, to the first needlereceiver; securing the needle in the first needle receiver; and operating the tissue grabber to release the tissue.

[0024] In yet other variations, the method includes, after operating the tissue grabber, compressing tissue between a first plication arm and a second plication arm. In some examples, the first and second plication arms are simultaneously actuated. Alternatively, the first and second plication arms are independently actuated.

[0025] In further variations, the method includes replacing a needle, including aligning the first needle receiver with a channel disposed through or on the housing to receive a needle passed through the channel. Alternatively, the method includes replacing a needle, including withdrawing the first needle receiver from the bi-directional suturing device and replacing the first needle receiver in the bi-directional suturing device with the replacement needle.BRIEF DESCRIPTION OF DRAWINGS

[0026] The present disclosure is described in the following detailed description in conjunction with the drawings, wherein:

[0027] FIG. 1 A is a simplified diagram of a medical system according to some embodiments.

[0028] FIG. 1 B is a schematic diagram of an instrument system according to examples described herein.

[0029] FIG. 1 C illustrates a distal portion of the instrument system of FIG. 1 B with an extended example of an instrument according to examples described herein.

[0030] FIG. 2 is a perspective view of a bi-directional endosuturing device made in accordance with the present disclosure.

[0031] FIG. 3 is a perspective view of the suturing assemblies of the bi-directional endosuturing device of FIG. 2.

[0032] FIG. 4 is a side view of a linear suture needle useable in the bi-directional endosuturing device of FIG. 2.

[0033] FIG. 5A is a diagram of a counter pivoting mechanism of the endosuturing device of FIG. 2 disposed in a first position.

[0034] FIG. 5B is a diagram of the counter pivoting mechanism of FIG. 5A disposed in a second position.

[0035] FIG. 6 is a diagram of the bi-directional endosuturing device of FIG. 2.

[0036] FIG. 7 is a side-view of the bi-directional endosuturing device of FIG. 2 deploying a tissue grabber.

[0037] FIG. 8 is a side-view of the bi-directional endosuturing device of FIG. 2 with the tissue grabber retracted to draw tissue into the device.

[0038] FIG. 9 is a side-view of the bi-directional endosuturing device of FIG. 2 with a needle partially passing through the tissue.

[0039] FIG. 10 is a side-view of the bi-directional endosuturing device of FIG. 2 with a suture strand passing through the tissue and the needle retracted.

[0040] FIG. 1 1 is a side-view of the bi-directional endosuturing device of FIG. 2 with the tissue returned to its undrawn condition.

[0041] FIG. 12 is a perspective view of an example plication line in accordance with the present disclosure.

[0042] FIG. 13 is a perspective view the bi-directional endosuturing device of FIG. 2 configured for receiving a replacement needle.

[0043] FIG. 14 is a perspective view of a second version of a bi-directional endosuturing device made in accordance with the present disclosure.

[0044] FIG. 15 is a side view of an example needle collet used in the bi-directional endosuturing device of FIG. 14.

[0045] FIG. 16 is a cross-sectional view of an external channel of the second bidirectional endosuturing device of FIG. 14.

[0046] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order tofacilitate a less obstructed view of these various embodiments. It will further be appreciated that certain actions and / or steps may be described or depicted in a particular order of occurrence while those skilled in the art will understand that such specificity with respect to sequence is not actually required. It will also be understood that the terms and expressions used herein have the ordinary technical meaning as is accorded to such terms and expressions by persons skilled in the technical field as set forth above except where different specific meanings have otherwise been set forth herein.DETAILED DESCRIPTION

[0047] FIG. 1 A illustrates an embodiment of a robotically-assisted manipulator system for use with the endoscopic suture systems described herein. The manipulator system can be used, for example, in surgical, diagnostic, therapeutic, biopsy, or non-medical procedures, and is generally indicated by the reference numeral 100. As shown in FIG. 1 , a robotically-assisted manipulator system 100 can include one or more manipulator assemblies 102 for operating one or more medical instrument systems 104 in performing various procedures on a patient P positioned on a table T in a medical environment 101. For example, the manipulator assembly 102 can drive catheter or end effector motion, can apply treatment to target tissue, and / or can manipulate control members. The manipulator assembly 102 can be teleoperated, nonteleoperated, or a hybrid teleoperated and non-teleoperated assembly with select degrees of freedom of motion that can be motorized and / or teleoperated and select degrees of freedom of motion that can be non-motorized and / or non-teleoperated. An operator input system 106, which can be inside or outside of the medical environment 101 , generally includes one or more control devices for controlling manipulator assembly 102. Manipulator assembly 102 supports medical instrument system 104 and can optionally include a plurality of actuators or motors that drive inputs on medical instrument system 104 in response to commands from a control system 112. The actuators can optionally include drive systems that when coupled to medical instrument system 104 can advance medical instrument system 104 into a naturally or surgically created anatomic orifice. Other drive systems can move the distal end of medical instrument in multiple degrees of freedom, which can include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). The manipulator assembly 102 can support various other systems for irrigation, treatment, or other purposes. Such systems can include fluid systems (including, for example, reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.

[0048] Robotically-assisted manipulator system 100 also includes a display system 110 for displaying an image or representation of the surgical site and medical instrument system 104 generated by an imaging system 109 which can include an imaging system, such as an endoscopic imaging system. Display system 110 and operator input system 106 can be oriented so an operator O can control medical instrument system 104 and operator input system 106 with the perception of telepresence. A graphical user interface can be displayable on the display system 1 10 and / or a display system of an independent planning workstation.

[0049] In some examples, the endoscopic imaging system components of the imaging system 109 can be integrally or removably coupled to medical instrument system 104. However, in some examples, a separate imaging device, such as an endoscope, attached to a separate manipulator assembly can be used with medical instrument system 104 to image the surgical site. The endoscopic imaging system 109 can be implemented as hardware, firmware, software, or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of the control system 112.

[0050] Robotically-assisted manipulator system 100 can also include a sensor system 108. The sensor system 108 can include a position / location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., an optical fiber shape sensor) for determining the position, orientation, speed, velocity, pose, and / or shape of the medical instrument system 104. The sensor system 108 can also include temperature, pressure, force, or contact sensors or the like.

[0051] Robotically-assisted manipulator system 100 can also include a control system 112. Control system 112 includes at least one memory 116 and at least one computer processor 1 14 for effecting control between medical instrument system 104, operator input system 106, sensor system 108, and display system 110. Control system 112 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement a procedure using the robotically-assisted manipulator system including for navigation, steering, imaging, engagement feature deployment or retraction, applying treatment to target tissue (e.g., via the application of energy), or the like.

[0052] Control system 112 can optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instrument system 104 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system can be based upon reference to an acquired pre-operative or intra-operative dataset ofanatomic passageways. The virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The control system 112 can use a pre-operative image to locate the target tissue (using vision imaging techniques and / or by receiving user input) and create a pre-operative plan, including an optimal first location for performing treatment. The pre-operative plan can include, for example, a planned size to expand an expandable device, a treatment duration, a treatment temperature, and / or multiple deployment locations.

[0053] FIG. 1 B shows a medical instrument system 120 according to some embodiments. In some embodiments, medical instrument system 120 can be used in an image- guided medical procedure. In some examples, medical instrument system 120 can be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. In some embodiments, medical instrument system 120 is interchangeable with, or a variation of, medical instrument system 104 of FIG. 1A.

[0054] Medical instrument system 120 includes elongate flexible device 122, such as a flexible catheter or endoscope (e.g., gastroscope, bronchoscope), coupled to a drive unit 124. Elongate flexible device 122 includes a flexible body 136 having proximal end 137 and distal end, or tip portion, 138. In some embodiments, flexible body 136 has an approximately 14-20 mm outer diameter. Other flexible body outer diameters can be larger or smaller. Flexible body 136 can have an appropriate length to reach certain portions of the anatomy, such as the lungs, sinuses, throat, or the upper or lower gastrointestinal region, when flexible body 136 is inserted into a patient’s oral or nasal cavity.

[0055] Medical instrument system 120 optionally includes a tracking system 150 for determining the position, orientation, speed, velocity, pose, and / or shape of distal end 138 and / or of one or more segments 144 along flexible body 136 using one or more sensors and / or imaging devices. The entire length of flexible body 136, between distal end 138 and proximal end 137, can be effectively divided into segments 144. Tracking system 150 can optionally be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of control system 1 12 in Fig. 1 A.

[0056] T racking system 150 can optionally track distal end 138 and / or one or more of the segments 144 using a shape sensor 142. In some embodiments, tracking system 150 can optionally and / or additionally track distal end 138 using a position sensor system 140, such as an electromagnetic (EM) sensor system. In some examples, position sensor system 140 can be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point or five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point.

[0057] Flexible body 136 includes one or more channels 141 sized and shaped to receive one or more medical instruments 146. In some embodiments, flexible body 136 includes two channels 141 for separate instruments 146, however, a different number of channels 141 can be provided. FIG. 1 C is a simplified diagram of flexible body 136 with medical instrument 146 extended according to some embodiments. In some embodiments, medical instrument 146 can be used for procedures and aspects of procedures, such as surgery, biopsy, ablation, mapping, imaging, illumination, irrigation, or suction. Medical instrument 146 can be deployed through channel 141 of flexible body 136 and used at a target location within the anatomy. Medical instrument 136 can include, for example, image capture devices, biopsy instruments, ablation instruments, catheters, laser ablation fibers, and / or other surgical, diagnostic, or therapeutic tools. Medical tools can include end effectors having a single working member such as a scalpel, a blunt blade, a lens, an optical fiber, an electrode, and / or the like. Other end effectors can include, for example, forceps, graspers, balloons, needles, scissors, clip appliers, and / or the like. Other end effectors can further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, imaging devices and / or the like. Medical instrument 146 can be advanced from the opening of channel 141 to perform the procedure and then retracted back into the channel when the procedure is complete. Medical instrument 146 can be removed from proximal end 137 of flexible body 136 or from another optional instrument port (not shown) along flexible body 136. The medical instrument 146 can be used with an image capture device (e.g., an endoscopic camera) also within the elongate flexible device 122. Alternatively, the medical instrument 146 can itself be the image capture device.

[0058] Medical instrument 146 can additionally house cables, linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably the bend distal end of medical instrument 146. Flexible body 136 can also house cables, linkages, or other steering controls (not shown) that extend between drive unit 124 and distalend 138 to controllably bend distal end 138 as shown, for example, by broken dashed line depictions 139 of distal end 138. In some examples, at least four cables are used to provide independent “up-down” steering to control a pitch motion of distal end 138 and “left-right” steering to control a yaw motion of distal end 138. In embodiments in which medical instrument system 120 is actuated by a robotically-assisted assembly, drive unit 124 can include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly. In some embodiments, medical instrument system 120 can include gripping features, manual actuators, or other components for manually controlling the motion of medical instrument system 120. The information from tracking system 150 can be sent to a navigation system 152 where it is combined with information from visualization system 151 and / or the preoperatively obtained models to provide the physician or other operator with real-time position information.accordance with the present disclosure, the medical instrument systems 104, 120 can include a flexible elongate device (e.g., an endoscope) 202 configured to be inserted through the mouth or anus of a patient, which will be generally referred to as an “endoscope” herein. The endoscope is equipped with an endoscopic suturing device at its distal end to repair holes or openings in the gastrointestinal (Gl) tract and / or perform other procedures such as endoscopic sleeve gastroplasty (ESG). In accordance with the present disclosure, the endoscopic suturing device is configured to be fixed to the distal end of the endoscope and can include a suture needle that is actuated linearly, and in some versions, parallel to a central axis of the distal end of the endoscope. As will be described more completely below, to facilitate suturing, the endoscopic suturing device can also include an off-axis tissue grabber and a cinch mechanism disposed coaxially about the suture needle.

[0060] FIG. 2 illustrates a first version of a bi-directional endosuturing device 200 made in accordance with the present disclosure. The bi-directional endosuturing device 200 includes a housing 202, a first suturing assembly 204a, a second suturing assembly 204b, and a needle 206. In the present example, the housing 202 is configured to couple to a distal end 209 of an endoscope 208. In various examples, the endoscope 208 may include various features, including an imaging system 212, working channels 214a, 214b, and light sources 216a, 216b. As shown in FIG. 2, the imaging system 212, working channels 214a, 214b, and light sources 216a, 216b of the endoscope 208 are depicted at least partially disposed on a distal face 218 at the distal end 209 of the endoscope 208. In various examples, the endoscope 208 may include more or fewer features than shown in FIG. 2.

[0061] The housing 202 includes a generally annular body 222 defining an endoscope aperture 223. The annular body 222 is configured to receive and selectively couple to the distal end 209 of the endoscope 208. In various examples, the housing 202 may be friction fit onto the endoscope 208, secured to the endoscope 208 with adhesive, secured to the endoscope 208 with a releasable mechanical securement mechanism (e.g., a clamp, threaded interface, etc.), permanently secured to the endoscope 208, or secured in any other manner suitable for the intended objective. Additionally, the housing 202 includes a proximal end 224a and a distal end 224b. Both the housing 202 and the endoscope 208 define a central longitudinal axis 226. But in some examples, the housing 202 and the endoscope 208 can be disposed parallel or angled relative to each other.

[0062] The first suturing assembly 204a includes a proximal end 230aa and a distal end 230ab. The second suturing assembly 204b includes a proximal end 230ba and a distal end 230bb. The proximal ends 230aa, 230ba of the first bi-directional suturing assembly 204a and the second bi-directional suturing assembly 204b are pivotably coupled to the housing 202 opposite each other. That is, the first and second bi-directional suturing assemblies 204a, 204b are disposed one hundred and eighty degrees (180°) offset from each other. As shown in FIG. 2, the first and second bi-directional suturing assemblies 204a, 204b are disposed at opposing points 232a, 232b, respectively, on the housing 202. But in various other examples, the first and second bi-directional suturing assemblies 204a, 204b may be disposed at any two points on the housing 202, as may be necessary to achieve the intended objective.

[0063] The first bi-directional suturing assembly 204a includes a first plication arm 234a, a first suturing arm 236a, and a first needle receiver 238b. Similarly, the second bi-directional suturing assembly 204b includes a second plication arm 234b, a second suturing arm 236b, and a second needle receiver 238b. In the present example, the first suturing arm 236a and the second suturing arm 236b are pivotable relative to the housing 202, the first plication arm 234a, and the second plication arm 234b. Additionally, in some examples, the first plication arm 234a and the second plication arm 234b are pivotable relative to the housing 202, the first suturing arm 236a, and the second suturing arm 236b. As shown in FIG. 2, the first and second plication arms 234a, 234b are disposed in an inner position 235.

[0064] The first and second plication arms 234a, 234b include needle shields 242a, 242b, and suture arm channels 244a, 244b, respectively. In the present example, the first and second needle shields 242a, 242b face each other. Additionally, the first and second suture arms 236a, 236b are selectively disposed in the suture arm channels 244a, 244b and can bepivoted such that the first and second suture arms 236a, 236b are mostly disposed outside the suture arm channels 244a, 244b, respectively. The needle shields 242a, 242b and the suture arm channels 244a, 244b are configured to shield and protect the suture arms 136a, 236b, the needle receivers 238a, 238b, and / or the needle 206. The needle shields 242a, 242b can also include opposing convex surfaces as shown at FIG. 3, to help facilitate drawings tissue in between the needle shields 242a, 242b. Additionally, the needle shields 242a, 242b and the suture arm channels 244a, 244b include smooth curved surfaces to facilitate insertion of the bidirectional endosuturing device 200 into a cavity of a patient (e.g., patient P of FIG. 1 ).

[0065] The suture arms 236a, 236b are pivotably coupled to the housing 202 about first counter pivoting axes 240aa, 240ba, respectively. The first counter pivoting axes 240aa, 240ba are disposed at the proximal ends 230aa, 230ba of the bi-directional suturing assemblies 204a, 204b, respectively. As shown in FIG. 2, the first plication arm 234a is also pivotable about the first counter pivoting axis 240aa and the second plication arm 234b is pivotable about the first counter pivoting axis 240ba. In other examples, the first plication arm 234a and the second plication arm 234b may pivot about different pivoting axes 240aa, 240ba than the first and second suturing arms 236a, 236b, respectively. Additionally, the needle receivers 238a, 238b are pivotably coupled to the suture arms 236a, 236b about second counter pivoting axes 240ab, 240bb at the distal ends 230ab, 230bb of the bi-directional suturing assemblies 204a, 204b. Additionally, the suture arms 236a, 236b include counter-pivot mechanisms 248a, 248b (counter pivot mechanism 248a shown in greater detail in FIGS. 5A and 5B). In various examples, the counter-pivot mechanisms 248a, 248b are mirrored about the longitudinal axis 226. The counter-pivot mechanisms 248a, 248b allow the needle receivers 238a, 238b to pivot relative to the housing 202 without adjusting an angle of the needle receivers 238a, 238b relative to the housing 202. As shown in FIG. 2, the needle receivers 238a, 238b are angled such that the needle 206, coupled with the needle receivers 238a, 238b, is disposed perpendicular to the longitudinal axis 226. The counter pivot mechanisms 248a, 248b are configured such that the needle receivers 238a, 238b are perpendicular to the longitudinal axis 226, regardless of the angular position of the first and second suture arms 236a, 236b.

[0066] Each of the suture arms 236a, 236b includes the corresponding needle receiver 238a, 238b. The needle receivers 238a, 238b are configured to hold the needle 206 and pass the needle 206 back and forth between the needle receivers 238a, 238b. Operation of the needle receivers 238a, 238b are described in greater detail in connection with FIGS. 6 and 7. In some examples, the needle receivers 238a, 238b are identical while in other examples, theneedle receivers 238a, 238b may be different. For example, each of the needle receivers 238a, 238b may include an actuatable securement mechanism (not shown). In such examples, the needle 206 can be passed back and forth between the first needle receiver 238a and the second needle receiver 238. Alternatively, in other examples, the first needle receiver 238a may include an actuatable securement mechanism while the second needle receiver 238b is configured to retain the needle via friction in a friction holding mechanism (described in greater detail in connection with FIG. 3). In such alternative examples, the first needle receiver 238a passes the needle into the second needle receiver 238b, actuates the actuatable securement mechanism of the first needle receiver 238a and the needle 206 is retained in the friction holding mechanism. In reverse, the second needle receiver 238b passes the needle to the first needle receiver 238a and the actuatable securement mechanism is actuated to engage the needle 206 and withdraw the needle from the second needle receiver 238b.

[0067] The needle 206 is a bi-directional suturing needle having a first end 402 and a second end 404 (described in greater detail in connection with FIG. 4). In some examples, the needle 206 may have only one needle tip (e.g., needle tip 412) disposed on the first end 402. In other examples, the needle 206 includes a first and second needle tip 412, 414 at both the first end 402 and the second end 404. The needle 206 is described in greater detail in connection with FIG. 4.

[0068] FIG. 3 illustrates a portion of the bi-directional endosuturing device 200 of FIG. 2. In FIG. 3, the suturing arms 236a, 236b are actuated to an outer position 302. In the outer position 302, the suture arms 236a, 236b are partially disposed outside the suture arm channels 244a, 244b.

[0069] As shown in FIG. 3, the second needle shield 242b includes a needle slot 312 and the first needle shield 242a includes a needle slot (not shown). The needle slot 312 is dimensioned to pass the needle 206 between the first needle receiver 238a and the second needle receiver 238b. In the present example, the needle slot 312 is a narrow slot having a rectangular or obround shape. But in various examples, the needle slot 312 could be any shape dimensioned to allow the needle 206 to pass through the needle slot 312.

[0070] Still referring to FIG. 3, the first and second needle receivers 238a, 238b include securing mechanisms 322, 324, respectively. In various examples, the securing mechanisms may include a passage 326 sized to receive and secure the needle 206 with friction. For example, the passage 326 could include a flexible cylinder or ring that stretch to receive theneedle 206 and applies a resilient compressive force onto the needle 206 such that the passage 326 generates sufficient friction force to secure the needle 206 therein. Additionally, at least one of the securing mechanisms can include a releasable securing mechanism. The releasable securing mechanism can include an actuatable securing mechanism to selectively secure the needle 206. For example, the releasable securing mechanism may include a collet (such as the needle collet 1500 described in greater detail in connection with FIG. 15), a locking hinge, a latch, or any other suitable mechanism actuatable by a medical professional (e.g., operator O of FIG. 1) to selectively secure the needle 206 in at least one of the first and second needle receivers 238a, 238b.

[0071] As shown in FIG. 3, the needle receivers 238a, 238b are still angled such that the needle 206, coupled with the needle receivers 238a, 238b, is disposed perpendicular to the longitudinal axis 226. The counter pivoting mechanisms 248a, 248b maintained the angle of the needle receivers 238a, 238b.

[0072] FIG. 4 is a side-view of an example needle 206 useable with the bi-directional endosuturing device 200. The needle 206 includes the first end 402 and the second end 404 with a linear body 406 disposed between the first end 402 and the second end 404. The needle 206 includes a first needle tip 412 disposed on the first end 402 and a second needle tip 414 disposed on the second end 404. In some examples, the needle 206 includes only the first needle tip 412 disposed on the first end 402 and the second end 404 does not include a tip.

[0073] The needle 206 is configured to secure a suture strand. The needle 206 includes an aperture 432 and securement mechanism 434 to prevent the suture strand from disconnecting from the needle. In the example needle 206, the securement mechanism 434 includes a biased lever to lock the suture strand against an interior surface (not shown) of the needle 206. In some examples, the suture strand is secured to the needle 206 via a self-locking friction lock. In such examples, the needle 206 may include various tabs about which the suture strand weaves to increase friction and inhibit the release of the suture strand from the needle 206 via, for example, the capstan effect (similar in operation to a friction belay, cleat hitch, etc.). In various other examples, the securement mechanism 434 can include an adhesive, a clamp, a collet, or any other device disposed on the suture strand and configured to engage a shoulder in the needle to prevent the suture strand from disconnecting from the needle 206.

[0074] FIGS. 5A and 5B illustrates the example counter pivot mechanism 248a implemented in the bi-directional endosuturing device 200 of FIG. 2. In various examples, thecounter pivot mechanism 248b (shown in FIG. 2) is functionally similar (e.g., a mirror about the longitudinal axis 226() but can differ in physical implementation. As shown in FIG. 2, the counter pivot mechanisms 248a, 248b are disposed in the first and second suture arms 236a, 236b, respectively, but could be disposed on the first and second suture arms 236a, 236b, respectively. Each counter pivot mechanism 248a, 248b maintains the angular position of each needle receiver 238a, 238b relative to the endoscope 208 (not shown in FIGS. 5A and 5B) as each suture arm 236a, 236b is pivoted. As a result, the first needle receiver 238a and the second needle receiver 238b can remain parallel and / or coaxial regardless of the angular position of the suture arms 236a, 236b.

[0075] The counter pivot mechanism 248a includes a first pivotable joint 502 and a second pivotable joint 504 disposed on opposing ends of the first suturing arm 236a. The first pivotable joint 502 is rotatably coupled to the second pivotable joint 504 via a belt 508, which alternatively can be a cable or linked member (e.g., a chain). In some embodiments, the belt is not used, and instead a plurality of intermeshed gears operates between the first pivotable joint 502 and the second pivotable joint 504. In the present example, the belt 508 is coupled to the first and second pivotable joints 502, 504 such that rotation of the first pivotable joint 502 causes the second pivotable joint 504 to rotate in the opposite direction. For example, clockwise rotation of the first pivotable joint 502 causes the second pivotable joint 504 to rotate counterclockwise.

[0076] In some embodiments, a first pivotable joint 502 can include a pulley that is operable by actuation of one or more cables (not shown). The cables can be tensioned and coupled to the housing 202 or a different aspect and extend proximally down the endoscope to a cable actuation mechanism for pulling the cable back and forth to affect movement of the counter pivot mechanism 248a. In some embodiments, counter pivot mechanism 248b includes a similar driving arrangement, or alternatively can be driven by an intermediatory cable from counter pivot mechanism 238a.

[0077] FIG. 5A illustrates the counter pivot mechanism 248a in a first position 512, as also shown in FIG. 3. FIG. 5B illustrates the counter pivot mechanism 248a in a second position 514 relative to the first position 512. In the first position 512, a longitudinal axis 522 of the needle receiver 238a is parallel to a longitudinal axis 526 and perpendicular to the longitudinal axis 226. Similarly, when the counter pivot mechanism 248a is in the second position 514, the longitudinal axis 526 is also disposed parallel to the reference axis 524 and perpendicular to the longitudinal axis 226. The counter-rotation of the second pivotable joint 504 relative to the firstpivotable joint 502 maintains the angle of the needle receiver 238a relative to the reference axis 524 and the longitudinal axis 226.

[0078] In some embodiment, the tension of belt 508 can be reduced to change the angular relationship between the longitudinal axis 522 and the longitudinal axis 226. Removing tension of the belt 508 can cause the longitudinal axis 522 to become non-perpendicular to axis 226. In some embodiments, removing tension of the belt 508 can cause the longitudinal axis 522 to become parallel with the longitudinal axis 522, or within an angle of less than 30 degrees. This positioning can facilitate access to remove and / or install a new needle via a device that is advanced through a working channel of an endoscope.

[0079] FIG. 6 is a diagram the bi-directional endosuturing device 200 of FIG. 2 including a possible actuation mechanism. As shown in FIG. 6, the bi-directional endosuturing device 200 further includes a first actuation mechanism 612 and a second actuation mechanism 622. In the present example, the first actuation mechanism 612 is coupled to the first and second suture arms 236a, 236b and the second actuation mechanism 622 is coupled to the first and second plication arms 234a, 234b. In some examples, the first and second actuation mechanisms 612, 622 are disposed in the housing 202. In various examples, the bi-directional endosuturing device 200 may include one actuation mechanism or may include an actuation mechanism for each of the first and second suture arms 236a, 236b and / or the first and second plication arms 234a, 234b.

[0080] In one example, the first actuation mechanism 612 includes a gear assembly 614. In some examples, the actuation mechanism 612 is configured for simultaneous control of the first suturing arm 236a and the second suturing arm 236b, but may be configured to individually control the first and second suturing arms 236a, 236b. The gear assembly 614 is configured to be actuated directly by a medical professional (e.g., operator O of FIG. 1 ) or indirectly via the control system 112. When the gear assembly 614 is actuated, the gear assembly 614 actuates both the first and second suturing arms 236a, 236b. In such examples, the gear assembly 614 simultaneously actuates the first and second suturing arms 236a, 236b to pivot away from or toward a central longitudinal axis (e.g., longitudinal axis 226 of FIG. 2). Alternatively, the gear assembly 614 may be adjustable such that it can actuate the first suturing arm 236a and the second suturing arm 236b independently. In other examples, the first actuation mechanism 612 may instead utilize one or more tethers to actuate the first and second suturing arms 236a, 236b.

[0081] Similarly, the second actuation mechanism 622 includes a gear assembly 624. In some examples, the actuation mechanism 612 is configured for simultaneous control of the first plication arm 234a and the second plication arm 234b, but may be configured to individually control the first and second plication arms 234a, 234b. The gear assembly 624 is configured to be actuated directly by a medical professional (e.g., operator O of FIG. 1) or indirectly via the control system 112 of FIG. 1 . When the gear assembly 614 is actuated, the gear assembly 624 actuates both the first and second plication arms 234a, 234b. In such examples, the gear assembly 624 simultaneously actuates the first and second plication arms 234a, 234b to pivot away from or toward a central longitudinal axis (e.g., longitudinal axis 226 of FIG. 2). Alternatively, the gear assembly 624 may be adjustable such that it can actuate the first suturing arm 234a and the second suturing arm 234b independently. In other examples, the second actuation mechanism 622 may instead utilize one or more tethers to actuate the first and second plication arms 234a, 234b.

[0082] In some examples, the first and second plication arms 234a, 234b include a biasing mechanism 628. The biasing mechanism 628 is configured to bias the plication arms 234a, 234b to either the outer position 302 (shown in FIG. 3) or the inner position 235 (shown in FIG. 2). When the biasing mechanism 628 biases the plication arms 234a, 234b to the inner position 235, the biasing mechanisms 628 assist in pinching tissue and facilitating needle 206 puncture. The biasing mechanism 628 may comprise a helical or torsional spring or other mechanism configured to bias the pivoted position of the first and second plication arms 234a, 234b.

[0083] FIGS. 7-11 illustrate operation of the bi-directional endosuturing device 200 of FIGS. 2-6 to form a plication line in a portion of tissue 702. As an initial step, the bi-directional endosuturing device 201 is brought adjacent to a portion of tissue 702. The tissue 702 includes an inner surface 704 and an outer surface 706. As shown, the first and second plication arms 234a, 234b and the first and second suture arms 236a, 236b are positioned such that the needle 206 is disposed in the second needle receiver 238b (or first needle receiver 236a) and a needle tip (e.g., needle tip 412) is not extending between the first and second plication arms 234a, 234b.

[0084] The bi-directional endosuturing device 200 further includes a tissue grabber 712. As shown in FIG. 7, the tissue grabber 712 is a helical tissue grabber configured to pass through a working channel of the endoscope (e.g., working channel 214b). The helical tissue grabber could be made of metal wire or other material with sufficient strength and rigidity totransform torque into a piercing force and push the helical tissue grabber into the tissue. In some examples, the helical tissue grabber includes a sharpened tip to facilitate the piercing action. Additionally, the helical tissue grabber is sufficiently rigid to pull and push tissue without experiencing any damage (e.g., plastic deformation). The tissue grabber 712 is configured to move parallel with the longitudinal axis 226. In various examples, the tissue grabber 712 moves along an axis disposed at a non-parallel angle relative to the longitudinal axis 226. The tissue grabber 712 is configured to be moved by pushing and pulling the actuating rod 714. Additionally the tissue grabber 712 is configured to rotate. While the present version of the disclosure includes a helical tissue grabber, other tissue grabbers could be used including, for example, jaw-based grippers / pinchers or any other type of grabber that is suitable for the intended purpose.

[0085] As shown in FIG. 8, the tissue grabber 712 is actuated to engage with the tissue 702. After the tissue grabber 712 engages the tissue 702, the tissue grabber 712 draws the tissue between the first and second plication arms 234a, 234b. The tissue 702 is folded and defining a first half 802 and a second half 804. In some examples, the first and second plication arms 234a, 234b pinch the tissue 702 to inhibit the tissue 702 from stretching when the needle 206 pierces the tissue 702. By inhibiting or reducing stretching, the needle 206 more easily pierces the tissue 702 with less chance of scratching or damaging the tissue 702 unnecessarily.

[0086] Further, when the tissue 702 is disposed between the first and second plication arms 234a, 234b, the suture arms 236a, 236b are actuated to pass the needle 206 through the tissue 702. As shown in FIG. 8, the needle 206 passes through the inner surface 704 of the first half 802 and through the outer surface 706 of the first half 802 before passing through the outer surface 706 of the second half 804 and through the inner surface 704 of the second half 804.

[0087] Turning to FIG. 9, after the needle 206 passes out of and back into the tissue 702, the needle 206 is received in the first needle receiver 238a. As discussed above, in some examples, one or both of the first and second needle receivers 238a, 238b may be actuatable to release the needle 206 from the second needle receiver 238b and deposit the needle 206 in the first needle receiver 238a. Alternatively, one of the first and second needle receivers 238a, 238b provides a friction fit and engages the needle 206 but the friction fit can be overcome when the other needle receiver couples to the needle 206.

[0088] As shown in FIG. 9, the needle 206 includes a suture strand 902. As the needle 206 passes through the tissue 702, the suture strand 902 passes from the inside surface 704 tothe outside surface 706 and back to the inside surface 704 of the tissue 702. As a result, the suture strand 902 forms a stitch 904 in the tissue. In some examples, the suture strand 902 extends from the first working channel (e.g., working channel 214a shown in FIG. 2). As the plication line is formed, more suture strand 902 is provided through the working channel 214a.

[0089] FIG. 10 illustrates the needle 206 disposed within the suture arm channel 244a and the needle tip 414 is disposed behind the needle shield 242a. With the needle tip 414 disposed behind the needle shield 242a, the tissue grabber 712 can release the tissue 702 and the needle tip 414 will not interact with the tissue 702.

[0090] As shown in FIG. 11 , the tissue 702 is in a released state and the suture strand 902 is partially disposed along the outside surface 706 of the tissue 702. With the suture strand 902 partially disposed the tissue 702, the bi-directional endosuturing device 200 can move to another portion of tissue 702 and repeat the process described in connection with FIGS. 7-11 . The process of FIGS. 7-11 can be repeated as necessary to form a full plication line (as shown in FIG. 12). Repeating the process of FIGS. 7-1 1 would include passing the needle 106 from the first needle receiver 238a to the second needle receiver 238b and form a criss-cross stitch.

[0091] In some examples, before repeating the process of described in connection with FIGS. 7-11 , the needle 206 is released from the first needle receiver 238a and deposited in the second needle receiver 238b. Alternatively, a medical practitioner can rotate the bi-directional endosuturing device 200 one hundred eighty degrees (180°) about the longitudinal axis 226. In some examples, returning the needle 206 to the second needle receiver or rotating the bidirectional endosuturing device 200 will form a running stitch.

[0092] The operator O can decide whether to form a criss-cross stitch or a running stitch as a matter of operator O preference or based on conditions of the procedure. For example, a running stitch may minimize friction between the suture strand 902 and the tissue 702. Alternatively, the criss-cross stitch may result in simpler operation of the bi-directional endosuturing device 200, 1400 and a more secure plication line 1200 (discussed in greater detail in connection with FIG. 12). As a result, the operator O has additional control in the manner in which the operation is conducted over typical endosuturing devices.

[0093] FIG. 12 is an example plication line 1200 formed by operation of the bi-directional endosuturing device 200. As shown in FIG. 12, the plication line 1200 is formed after the suture strand 902 is tensioned and secured with a cinch 1210. As shown, the needle 206 forms a first suture anchor 1212 and the cinch 1210 forms a second suture anchor 1214, disposed oppositethe needle 206. The tensioned suture strand 902 forms three stitches 904 shown in FIG. 12, but in other examples, the plication line 1200 may have more or fewer stitches 904 than shown in FIG. 12.

[0094] FIG. 13 illustrates the bi-directional endosuturing device 200 with the plication arms 234a, 234b in a closed configuration and the suturing arms 236a, 236b disposed within the suture arm channels 244a, 244b. Additionally, the first needle receiver 238a is pivoted to be aligned with the first working channel 214a. So configured, a medical professional (e.g., operator O) can pass a replacement suture needle through the working channel 214a to be secured in the first needle receiver 238a. Alternatively, the first needle receiver 238a may be configured to align with an external channel coupled to the endoscope housing 202. As a result, the bi-directional endosuturing device 200 can form additional plication lines without removing the bi-directional endosuturing device 200 from a patient (e.g., patient P of FIG. 1 ). In other examples, the second needle receiver 238b is configured to align with a channel to receive a replacement needle. In some examples, the bi-directional endosuturing device 200 further includes an alignment feature (not shown) to ensure the first needle receiver 238a is aligned with the working channel to receive a replacement suture needle 206.

[0095] FIG. 14 is a second example bi-directional endosuturing device 1400 made in accordance with the present disclosure. The bi-directional endosuturing device 1400 includes an housing 1402, a first suturing assembly 1404a and a second suturing assembly 1404b, and a needle 1406 with a suture strand 1407. In the present example, the housing 1402 comprises a cap 1403 disposed over and coupled to a distal end 1409 of an endoscope 1408. In various examples, the endoscope 1408 may include various features, including an imaging system 1412, working channels 1414a, 1414b, and a light sources 1416. As shown in FIG. 14, the features of the endoscope 1408 are disposed at least partially on a distal face 1418 of the endoscope 1408. In various examples, the endoscope 1408 may include more or fewer features than shown in FIG. 14.

[0096] The housing 1402 includes the cap 1403. The cap 1403 is configured to receive and selectively couple to the endoscope 1408. In various examples, the cap 1403 may be friction fit onto the endoscope 1408, secured to the endoscope with adhesive, secured to the endoscope 1408 with a releasable mechanical securement mechanism, or permanently secured to the endoscope 1408. Additionally, the cap 1403 includes a proximal end 1424a and a distal end 1424b. Both the cap 1403 and the endoscope 1408 define a central longitudinal axis 1426,but, in some examples, the cap 1403 and the endoscope 1408 are disposed parallel or angled relative to each other.

[0097] The bi-directional endosuturing device 1400 includes a first bi-directional suturing assembly 1404a, having a proximal end 1430aa and a distal end 1430ab, and a second bidirectional suturing assembly 1404b, having a proximal end 1430ba and a distal end 1430bb. The first bi-directional suturing assembly 1404a and the second bi-directional suturing assembly 1404b are coupled to the housing 1402 and the proximal ends 1430aa, 1430ba and disposed opposite each other. As shown in FIG. 14, the first and second bi-directional suturing assemblies 1404a, 1404b are disposed at opposing points 1432a, 1432b, respectively. But in various other examples, the first and second bi-directional suturing assemblies 1404a, 1404b may be disposed at any two points on the housing 1402.

[0098] The first bi-directional suturing assembly 1404a includes a first plication arm 1434a and a first catheter 1436a. The second bi-directional suturing assembly 1404b includes a second plication arm 1434b and a second catheter 1436b. In some examples, one or both of the first and second catheters 1436a, 1436b includes a needle receiver. In some examples, the needle receiver is an actuatable needle receiver while in other examples, the needle receiver holds the needle 1406 via a friction fit. In the present example, the distal end 1430ab of the first plication arm 1434a and the distal end 1430bb of the second plication arm 1434b are axially aligned.

[0099] The first and second plication arms 1434a, 1434b are configured to shield and protect the needle 1406 when the needle 1406 is disposed within one of the first and second plication arms 1434a, 1434b. Accordingly, the first and second plication arms 1434a, 1434b are made of rigid or semi-rigid materials. Additionally, in the present example, the first and second plication arms 1442a, 1442b face each other. As shown in FIG. 16, the second plication arm 1434b is coupled to an external channel 1435. The external channel 1435 is coupled to the housing 1402 and configured to be disposed adjacent to the endoscope 1408.

[0100] The first and second catheters 1436a, 1436b are coaxial with the first and second plication arms 1434a, 1434b. The first and second catheters 1436a, 1436b are shiftable along the first and second plication arms 1434a, 1434b, respectively. In some examples, the first and second catheters 1436a, 1436b and the first and second plication arms 1434a, 1434b include linear force multipliers (discussed in greater detail in connection with FIG. 16). As aresult, a medical practitioner (e.g., operator O of FIG. 1 ) can apply a pushing and pulling force on the catheters 1436a, 1436b and control the position of the needle 1406.

[0101] The needle 1406 is a bi-directional suturing needle having a first end 1452 and a second end 1454. In some examples, the needle 1406 may have only one needle tip disposed on the first end. In other examples, the needle 1406 includes a needle tip at both the first end 1452 and the second end 1454. In some examples, the needle 1406 is substantially similar or identical to the needle 206 described in FIG. 4 and in connection with the bi-directional endosuturing device 200 of FIG. 2.

[0102] FIG. 15 illustrates an actuatable needle receiver configured to be used in the bidirectional endosuturing devices 200, 1400. The actuatable needle receiver is a needle collet 1500 having a collet body 1502 and collet arms 1504. In the present example, the collet arms 1504 are retractable into the collet body 1502. The collet body 1502 defines a longitudinal axis 1506, and the collet arms 1504 are biased radially away from the longitudinal axis 1506. When the collet arms 1504 are retracted into the collet body 1502, the collet arms 1504 move inwardly, toward the longitudinal axis 1506. As the collet arms 1504 move inwardly, the collet arms 1504 are configured to engage and releasably secure the needle 1406. In some examples, one or both of the first and second needle catheters 1436a, 1436b include a needle collet 1500.

[0103] FIG. 16 is a cross-sectional view of the external channel 1435. In some examples, the second needle catheter 1436b includes a first thread 1602 and the external channel 1435 includes a second thread 1604. The first thread 1602 and the second thread 1604 form an inclined plane 1612 configured to transform rotational force into linear force. To increase a pushing or pulling force exerted on the needle 1406, a medical practitioner (e.g., operator O of FIG. 1) can rotate the second needle catheter 1436b to utilize the mechanical advantage of a screw. As a result, the medical practitioner converts rotational force into increased linear force. In various examples, the first needle catheter 1436a may also utilize a screw to increase a pushing or pulling force exerted on the needle 1406 transferred from the first needle catheter 1436a.

[0104] In various examples, operation of the second bi-directional endosuturing device 1400 is substantially similar to the first bi-directional endosuturing device 200 of FIG. 2. For example, the second bi-directional endosuturing device 1400 may utilize a tissue grabber similar to the helical tissue grabber 712 of FIG. 7 to draw tissue between the first and second plicationarms 1434a, 1434b. Similar to the suture arms 236a, 236b, the first and second catheters 1436a, 1436b are configured to pass the needle 1406 through tissue to form a full plication line (as shown in FIG. 1 1 ).

[0105] After a plication line is formed (as shown in FIG. 12), either the first or second needle catheter 1436a, 1436b can be withdrawn from the bi-directional endosuturing device 1400. With the catheter removed, a new needle 1406 can be disposed on one of the first or second needle catheter 1436a, 1436b and the catheter 1436a, 1436b reinserted into the bidirectional endosuturing device 1400.

[0106] The endosuturing devices described herein provide numerous benefits over other endosuturing devices. Provided herein are endosuturing devices that pass a straight needle transverse to the axis of the endoscope from a first needle receiver to a second needle receiver. The transverse operation of the endosuturing device provides a device with simpler operation relative to conventional devices. Additionally, because the suture strand passes linearly through the tissue, the needle minimizes the damage to the tissue. In contrast, many typical endosuturing devices utilize curved needles that pass along a curved path when passing through tissue. The curved path can result in unnecessary damage to the tissue.

[0107] The endosuturing devices provided herein comprise a bi-directional endosuturing device disposed on a distal end of an endoscope. The bi-directional endosuturing device utilizes a tissue grabber, such as a helical tissue grabber, to pull tissue between the first and second needle receivers. Each of the first and second needle receivers extend distally from the endoscope and are configured to pass a needle transverse to an axis defined by a distal end of the endoscope. When the plication line is formed, the needle is configured to be released from the bi-directional suturing device and act as a first anchor for the suture strand. In some examples, the bi-directional suturing device further includes plication arms that can pinch the tissue and / or protect the tissue from unnecessary and damaging contact with the needle.

[0108] In a first embodiment, the endosuturing device includes two, actuatable plication arms and two needle receivers disposed opposite each other. The plication arms and needle receivers extend distally away from the endoscope. The needle receivers are oriented to hold the needle transverse to the plication arms and the axis of the endoscope. In some examples, the plication arms are operably linked together and the needle receivers are operably linked together. As a result, the plication arms and the needle receivers can be actuated together and apart simultaneously. The simultaneous operation of the plication arms and / or needle receiversmay require a geartrain or single push cable configured to actuate the plication arms and / or needle receivers simultaneously. In other examples, the components of the endosuturing device are separately controlled and operated.

[0109] The plication arms are configured to open up and receive tissue grabbed by the helical tissue grabber. The plication arms can then clamp onto the tissue and, in some examples, provide enough pressure to reduce the overall thickness of the tissue between the plication arms.

[0110] With the tissue held by the helical tissue grabber, one of the needle receivers passes the needle through the tissue. When the needle passes through the tissue, the second needle receiver receives and secures the needle and separates the needle from the first needle receiver. In various examples, one or both of the needle receivers may include a securement mechanism to releasably secure the needle in the needle receiver. Additionally or alternatively, one of the needle receivers may hold the needle with a friction fit.

[0111] Each needle receiver is disposed on a suture arm that is pivotably coupled to the endosuturing device housing. To ensure the needle receivers are aligned, each needle receiver may be disposed on a counter pivot mechanism. The counter pivot mechanism is configured to automatically pivot the needle receiver when the suture arm is pivoted relative to the endoscope. In such examples, if the needle receiver is pivoted an equal but opposite amount, the needle receiver should remain perpendicular to the endoscope.

[0112] After the needle is passed through the tissue, the helical tissue grabber can release the tissue and the endosuturing device can move to the next location to form the plication line. In some examples, the endosuturing device returns the needle to the original needle receiver before passing the needle through the tissue again. Alternatively, the endosuturing device can pass the needle through the tissue in the opposite direction to the first suture arm from the second needle receiver back to the first needle receiver.

[0113] After a plication line is formed and the suture strand is tightened and cinched, in some examples, a new needle can be delivered to the endosuturing device through the endoscope or a channel external to the endoscope. In one example, the needle is passed through the endoscope and rotated before being coupled with one of the two needle receivers. Alternatively, one of the needle receivers can be rotated to be axially aligned with the endoscope. As a result, the needle can pass through a working channel of the endoscope andbe received by the needle receiver before the needle receiver rotates and orients the needle transverse to the endoscope.

[0114] In a second embodiment, the endosuturing device includes two plication arms and two needle actuation catheters, one of which holds a double-ended needle. In some examples, one of the two plication arms passes through one of the working channels of the endoscope and the other plication arm is coupled to an exterior surface of the endosuturing device (e.g., within an external channel). Additionally, in some examples, the plication arms are rigid while in other examples, the plication arms can be flexible and actuatable.

[0115] In operation, the helical tissue grabber pulls tissue between the plication arms and the catheter passes the double-ended needle through the tissue. After the needle passes through the tissue, the other catheter receives the needle and the first catheter releases the needle. In some examples, one or both catheters may include an actuatable collet to releasably secure the needle in the catheter. In other examples, the needle may be secured to one of the catheters via a friction fit. In some examples, the plication arms include structures to increase the needle driving force. For example, one or both plication arms may include a helical screw to twist the catheter and convert a torque into linear force on the needle. But any mechanical structure to increase linear force on the needle passing through the tissue could be utilized.

[0116] To add a new needle, one of the catheters can be withdrawn and a new needle can be disposed on the distal end of the catheter before returning the catheter to the distal end of the endoscope.

[0117] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described examples without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).

Claims

CLAIMSWhat is claimed is:1 . An endosuturing device, comprising: a housing defining an endoscope aperture and having an axis; a first plication arm and a second plication arm extending distally from the housing, the first plication arm and second plication arm facing one another and configured to compress tissue disposed therebetween; a first needle receiver and a second needle receiver disposed adjacent the first plication arm, the first needle receiver configured to hold a needle, orient the needle transverse to the axis, move the needle across the axis to engage the second needle receiver, and release the needle to the second needle receiver; and the second needle receiver configured to hold the needle, orient the needle transverse to the axis, move the needle across the axis to engage the first needle receiver, and release the needle to the first needle receiver.

2. The endosuturing device of claim 1 , wherein at least one of the first plication arm and the second plication arm is actuatable.

3. The endosuturing device of claim 1 , wherein the first needle receiver holds the needle with a friction fit.

4. The endosuturing device of claim 1 , wherein the second needle receiver holds the needle with a releasable securing mechanism.

5. The endosuturing device of claim 1 , wherein the first needle receiver includes a first position and a second position, the first needle receiver being configured to be actuated between the first position and the second position.

6. The endosuturing device of claim 5, the first needle receiver configured to deposit the needle in the second needle receiver in the second position.

7. The endosuturing device of claim 1 , further comprising an actuation mechanism configured for simultaneous control of the first and second needle receivers.

8. The endosuturing device of claim 1 , further comprising an actuation mechanism configured for independently controlling the first and second needle receivers.

9. The endosuturing device of claim 1 , wherein the first plication arm and the second plication arm each include a needle shield.

10. The endosuturing device of claim 9, wherein at least one of the first plication arm and the second plication arm include a slot opening for needle to pass through.11 . The endosuturing device of claim 1 , further comprising a second actuation mechanism configured to individually control the first plication arm and the second plication arm.

12. The endosuturing device of claim 1 , wherein the needle is straight.

13. An endosuturing device, comprising: a housing defining an endoscope aperture and having a first axis; a first plication arm and a second plication arm extending from the housing, the second plication arm disposed opposite the first plication arm and the first and second plication arms configured to be actuated towards and away from the first axis; a first suturing arm including a first needle receiver disposed on a second axis perpendicular to the first axis and disposed adjacent the first plication arm; and a second suturing arm including a second needle receiver disposed on the second axis and disposed adjacent the second plication arm, the first needle receiver configured to pass and release a needle to the second needle receiver and the second needle receiver configured to pass and release the needle to the first needle receiver.

14. The endosuturing device of claim 13, wherein the first plication arm and the second plication arm are pivotably coupled to the housing.

15. The endosuturing device of claim 13, wherein the first plication arm includes a first position radially away from the second plication arm and a second position proximate to the second plication arm, the first plication arm actuatable between the first position and the second position.

16. The endosuturing device of claim 13, further comprising an actuation mechanism configured to individually actuate the first plication arm and the second plication arm.

17. The endosuturing device of claim 13, further comprising an actuation mechanism configured to simultaneously actuate the first plication arm and the second plication arm.

18. The endosuturing device of claim 13, wherein the first and second suturing arms have a first position and a second position.

19. The endosuturing device of claim 18, wherein the first position is radially away from the first axis and the second position is adjacent the first or second plication arms, respectively.

20. The endosuturing device of claim 18, wherein each of the first and second suturing arms including a counter pivot mechanism.21 . The endosuturing device of claim 18, wherein the housing further includes an alignment feature, the first needle receiver is pivotable and alignable relative to the alignment feature.

22. The endosuturing device of claim 13, wherein the first plication arm and the second plication arm include a needle shield.

23. The endosuturing device of claim 22, wherein the needle shield includes a slot for the needle to pass through.

24. The endosuturing device of claim 13, wherein at least one of the first plication arm and the second plication arm is spring loaded.

25. The endosuturing device of claim 13, wherein the needle is straight.

26. An endosuturing device, comprising: a housing defining an endoscope aperture and having an axis; a first plication arm extending distally from the housing;a second plication arm extending distally from the housing, the second plication arm facing the first plication arm and configured to compress tissue therebetween; a first needle receiver including a distal end disposed perpendicular to the axis, the first needle receiver being shiftable relative to the first plication arm to move the distal end therepast; and a second needle receiver operatively coupled to the second plication arm and including a distal end disposed perpendicular to the axis, first and second needle receivers axially aligned with one another.

27. The endosuturing device of claim 26, wherein the housing includes a cap to be disposed on distal end of endoscope to align the first plication arm with a working channel of an endoscope.

28. The endosuturing device of claim 27, wherein the first plication arm is configured to engage the working channel of the endoscope.

29. The endosuturing device of claim 28, wherein the second plication arm is coupled to an exterior surface of the endoscope.

30. The endosuturing device of claim 26, wherein at least one of the first plication arm and the second plication arm is flexible.31 . The endosuturing device of claim 26, wherein at least one of the first plication arm and the second plication arm is curved.

32. The endosuturing device of claim 26, wherein at least one of the first needle receiver and the second needle receiver comprises a catheter.

33. The endosuturing device of claim 26, wherein the first needle receiver includes a first releasable securement mechanism and the second needle receiver includes a second releasable securement mechanism.

34. The endosuturing device of claim 33, wherein the first releasable securement mechanism includes a friction fit between the first needle receiver and the needle.

35. The endosuturing device of claim 33, the second releasable securement mechanism comprising an actuatable securement mechanism.

36. The endosuturing device of claim 35, wherein the actuatable securement mechanism includes a collet.

37. The endosuturing device of claim 26, wherein the first plication arm includes a first inclined plane and the first needle receiver includes a second inclined plane configured to engage the first inclined plane for providing increased linear force in response to a rotational force.

38. The endosuturing device of claim 26, wherein the needle is straight.

39. A method of operating a bi-directional endosuturing device including an housing, a tissue grabber, a first needle receiver, and a second needle receiver, the method comprising: operating the tissue grabber to pull a first portion of tissue between the first needle receiver and the second needle receiver; driving a needle from the first needle receiver, through the tissue, to the second needle receiver, the needle being straight; securing the needle in the second needle receiver; releasing the needle from the first needle receiver; and operating the tissue grabber to release the tissue.

40. The method of claim 39, wherein securing the needle in the second needle receiver includes actuating a releasable securement mechanism.41 . The method of claim 39, wherein securing the needle in the first needle receiver includes overcoming a friction fit between the needle and the second needle receiver.

42. The method of claim 39, wherein returning the needle to the first needle receiver before advancing a plication line.

43. The method of claim 39, further comprising operating the tissue grabber to pull a second portion of tissue between the first needle receiver and the second needle receiver; driving the needle from the second needle receiver, through the tissue, to the first needle receiver; securing the needle in the first needle receiver; and operating the tissue grabber to release the tissue.

44. The method of claim 39, the method further comprises, after operating the tissue grabber, compressing tissue between a first plication arm and a second plication arm.

45. The method of claim 44, wherein the first and second plication arms are simultaneously actuated.

46. The method of claim 44, wherein the first and second plication arms are independently actuated.

47. The method of claim 44, further comprising replacing a needle, including aligning the first needle receiver with a channel disposed through or on the housing to receive a needle passed through the channel.

48. The method of claim 44, further comprising replacing a needle, including withdrawing the first needle receiver from the bi-directional suturing device and replacing the first needle receiver in the bi-directional suturing device with the replacement needle.

Images