SYSTEMS AND METHODS FOR ENDOSCOPIC ADAPTING AND SUTURING TISSUE

Abstract

[0079] A device comprises a housing having an instrument interface. The instrument interface is configured to releasably engage a distal portion of an endoscope. The device also comprises a drive system coupled to the housing and configured to releasably engage a drive element extending from the endoscope. The device may also comprise a curved needle coupled to the drive system and a tissue adaptation system. The tissue adaptation system may comprise a tissue chamber within the housing through which a path of the curved needle extends, and a tissue tension component configured to draw tissue into the tissue chamber.

Description

CROSS-REFERENCED REGISTRATION

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 421,029, filed October 31, 2022, entitled "Systems and Methods for Endoscopic Tissue Apposition and Suturing," which is incorporated by reference in its entirety into this application. AREA

[0002] Examples described here relate to systems and methods for endoscopically adapting and suturing tissue. In particular, examples may relate to adapting and suturing tissue during an endoscopic procedure. BACKGROUND

[0003] Minimally invasive medical techniques can generally be used to reduce the amount of tissue damaged during medical procedures, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques can be performed through natural openings in a patient's anatomy or through one or more surgical incisions. Through these natural openings or incisions, a surgeon can insert minimally invasive medical instruments such as therapeutic instruments, diagnostic instruments, imaging instruments, and surgical instruments. Some minimally invasive medical instruments can be used to perform endoscopic coaptation and suturing. Systems and methods for effective coaptation and suturing of tissue are needed. SUMMARY

[0004] The following discussion is a simplified summary of various examples described herein and is not intended to identify important or critical elements or to delimit the scope of the claims.

[0005] In some examples, a device may include a housing having an instrument interface. The instrument interface may be configured to releasably engage a distal portion of a flexible elongate body, such as an endoscope. The device may also include a drive system coupled to the housing and configured to releasably engage a drive member extending from the endoscope. The device may also include a curved needle coupled to the drive system and a tissue adaptation system. The tissue adaptation system may include a tissue chamber within the housing through which a path of the curved needle extends, and a tissue tension component configured to draw tissue into the tissue chamber.

[0006] In some examples, an instrument system may include a flexible instrument or device body having a distal end portion. The distal end portion may include a housing, a gear system within the housing, a curved needle coupled to the gear system for bidirectional movement of the curved needle relative to the housing, and a tissue adaptation system. The tissue adaptation system may include a tissue chamber within the housing through which a path of the curved needle extends, and a tissue tension component configured to draw tissue into the tissue chamber.

[0007] In some examples, an instrument system may include a flexible instrument or device body having a plurality of working channels configured to receive one or more instruments, and a drive member extending within a first of a plurality of working channels. The instrument system may also include a housing configured to engage a distal portion of the flexible device body and a drive system extending within the housing. The drive system may be configured for coupling to a distal end of the drive member. The instrument system may also include a curved needle coupled to the drive system. The curved needle may be configured for bidirectional movement.The instrument system may also include a tissue adaptation system including a tissue chamber in the housing through which a path of the arcuate needle passes, and a tissue tension component configured to draw tissue into the tissue chamber.

[0008] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In this regard, additional aspects, features, and advantages of the present disclosure will become apparent to one skilled in the art from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1A illustrates a side view of a distal portion of an instrument system including a suturing device according to some examples. Fig. 1B illustrates a side view of a distal portion of an instrument system including a suturing device according to some examples. Fig. 2 illustrates an exploded view of a distal portion of an instrument system including a suturing device according to some examples. Fig. Figure 3 is an end view of a distal portion of the suturing device of Fig. 2 according to some examples. Fig. Figure 4 is a side view of a distal portion of the instrument system of Fig. 2 with the suturing device according to some examples. Fig. 5 represents a gear system of the suture device of Fig. 2 according to some examples. Fig. 6A and Fig. 6B illustrate a needle system for use with a suturing device according to some examples. Fig. 7A illustrates tissue engagement features at a distal end of a suture device according to some examples. Fig. 7B illustrates a side view of tissue in adaptation with a needle and tissue engagement features, according to some examples. Fig. 7C illustrates tissue engagement features at a distal end of a suture device according to some examples. Fig. 7D illustrates a side view of a distal portion of an instrument system including a suturing device according to some examples. Fig. 7E-7G illustrate a suturing device according to some examples. Fig. 8 illustrates a gear system of a suturing device according to some examples. Fig. 9 illustrates a side view of a distal portion of an instrument system including a suturing device according to some examples. Fig. 10 is a flowchart illustrating a suturing process. Fig. Figure 11 is a simplified representation of a patient's anatomy according to some examples. Fig. 12 is a robot-assisted medical system according to some examples.

[0009] Examples of the present disclosure and their advantages can best be understood from the following detailed description. It should be noted that like reference numerals are used to identify like elements shown in one or more of the figures, which are intended to illustrate examples of the present disclosure and are not intended to be limiting. DETAILED DESCRIPTION

[0010] The technology described herein provides techniques and treatment systems for grasping, adapting, and suturing tissue. Although the examples provided herein may be used for suturing gastric tissue, such as in an endoscopic sleeve gastroplasty ("ESG"), it is understood that the described technology may be used to perform procedures in artificially created lumens or any endoluminal passageways or cavities, including, but not limited to, a patient's trachea, colon, intestine, stomach, liver, kidneys and calyces, brain, heart, circulatory system including vessels, fistulas, and / or the like. In various examples, flexible instrumentation systems may include a suturing device that can fold, bend, pinch, or otherwise effect the adaptation of tissue so that two sections of tissue are brought close to or into contact with each other in preparation for the insertion of a suture through the tissue.

[0011] Fig. 1A illustrates a side view of a distal portion of an instrument system 100 including an elongated flexible device 102 and a suturing device 104. In some examples, the instrument system 100 may be an endoscopic instrument system, and the elongated flexible device 102 may be a steerable endoscope, gastroscope, etc. The device 102 may serve as a platform to drive the movement of mechanisms within the suturing device, introduce working components into the anatomical structures accessed by the instrument system 100, and acquire image data of the anatomical structures. The device 102 may include a flexible body 106 through which one or more working channels 108 extend. The working channels 108 may extend through the flexible body 106 to provide a passageway for removable instrument systems and to facilitate the exchange of instruments during a procedure.The working channels 108 may also or alternatively allow fluid passage, create vacuum pressure, or otherwise provide access between the proximal and distal portions of the elongated flexible device 102. Each working channel 108 may define an opening 110 in a distal end portion 112 of the device 102.

[0012] An imaging channel 114 may also extend through the flexible body 106 and terminate at an opening 116 to provide a passageway for an imaging system 118 (e.g., the imaging system 909 or a component thereof). The imaging system 118 may be an integral component of the device 102 (e.g., permanently coupled) or may be slidably received in and out of the channel 114. In some examples where the imaging system 118 is permanently coupled, the imaging system 118 may be pivotable relative to the device 102, while in other examples, the imaging system 118 may be fixed relative to the device 102 when permanently coupled. In some examples, the imaging system 118 may transmit images via one or more flexible optical fibers.Digital image-based imaging systems may utilize a chip-on-the-tip design, where a distal digital sensor such as one or more charge-coupled devices (CCDs) or complementary metal oxide semiconductors (CMOSs) stores image data. Imaging system 118 may acquire two- or three-dimensional image data. For example, stereo imaging systems may use stereo cameras to capture stereo images of the patient's anatomy. In some examples, the imaging channel may be omitted, and an imaging system may be delivered via working channel 108.

[0013] A drive channel 120 may also extend through the flexible body 106 and terminate in an opening 122. The drive channel 120 may provide a passage for a drive element 124. The drive element 124 may be an integral component of the device 102 (e.g., permanently coupled) or may be slidably received in and out of the channel 120. In some examples where the drive element 124 is permanently coupled, the drive element 124 may be axially and rotationally adjustable relative to the device 102, while in other examples, the drive element 124 may be axially fixed relative to the device 102 when permanently coupled. In some examples, the drive element 124 may include a flexible torque drive shaft that allows for flexion of the flexible body 106 while providing torque from a motor or other drive system coupled to a proximal end of the drive element.In some examples, the drive channel may be omitted, and the drive element 124 may be supplied through a working channel 108. In some examples, the drive element 124 may be coupled to a motor of a robot-assisted manipulator (e.g., the manipulator assembly 902).

[0014] In some examples, the suturing device 104 may be permanently coupled to the device 102 or formed integrally therewith. In other examples, the suturing device 104 may be removably coupled to the device 102. For example, the device 102 may be a flexible, steerable endoscope, colonoscope, duodenoscope, gastroscope, or the like (collectively referred to herein as an endoscope), and the suturing device 104 may be a removable attachment removably coupled to a distal end of the device 102. The suturing device 104 may include a housing 130 that supports and covers at least a portion of a needle drive system 132. The needle drive system 132 may include a drive input 134 coupled to the drive member 124 of the device 102 to transmit torque from the drive member 124.The needle drive system 132 may also include a gear system 136 to drive the movement of a needle 138. The gear system 136 may be coupled between the needle 138 and the drive input 134. The gear system 136 may include a gear train having one or more gears to transmit torque from the drive input 134 to drive the movement of the needle 138. The needle 138 may have a curved or arcuate shape and rotate to glide through adapted tissue located within or adjacent to the housing 130. The housing 130 may include a distal engagement surface 140 that can contact, seal, or otherwise engage a tissue surface during a suturing procedure. The housing 130 may also include a tissue adaptation system having a tissue chamber 142 and a tissue tensioning component 144.The tissue chamber 142 defines a space into which tissue can be drawn in a folded, bent, pinched, or otherwise adapted configuration. The tissue tensioning component 144 can, for example, be one or more vacuum sources or vacuum ports that transmit a tensioning force to draw tissue into the tissue chamber 142. The tissue tensioning component 144 can, for example, be a port having an opening coupled to the working channel through which a vacuum can be applied to the suturing device 104. In some examples, the tissue tensioning component can include multiple redundant vacuum ports and channels to maintain vacuum pressure if a port or channel becomes occluded.In various embodiments, the multiple redundant vacuum ports may be connected to a single working channel 108, or the multiple redundant vacuum ports may be connected to separate working channels 108.

[0015] In some examples, such as Fig. 1B, the tissue tensioning component of the tissue adaptation system may include a tissue adaptation instrument 111 that assists in drawing tissue into the tissue chamber 142. The tissue adaptation instrument 111 extends through a working channel in the device 102 and through the housing 130 to engage the target tissue. For example, the tissue adaptation instrument 111 may extend through the working channel 108 in the device 102 and through a port or opening in the housing 130 coupled to the working channel 108, with the tissue adaptation instrument 111 extending further distally from the housing 130 to contact the target tissue. In some embodiments, the tissue adaptation instrument 111 may extend through the opening forming the tissue tensioning component 144, while in other embodiments, the tissue adaptation instrument 111 may extend through a separate opening in the housing 130.In some examples, a tissue adaptation instrument 111 includes a tissue-engaging component in the form of a helical component extending from the working channel 108 of the device 102 through the housing 130 and toward a tissue surface. The helical component can be pushed forward against the tissue while being rotated, causing the helical component to penetrate the tissue in a corkscrew motion. Once the helical component has been rotated into the tissue to a desired depth, the helical component can be retracted without twisting, thereby bringing the tissue into the tissue chamber 142 and into the path of the suture needle.In some examples, the tissue adaptation instrument 111 may include a tissue-engaging component with an additional or alternative configuration than a helical component, such as opposing jaws, clamps, or other configurations. In some examples, multiple tissue adaptation instruments 111 may be used, and the multiple instruments may include a helical component, opposing jaws, clamps, or other configurations. In some examples, the tissue adaptation instrument 111 may be used as part of the tissue tensioning component in addition to the vacuum adaptation described herein to draw tissue into the tissue chamber 142. In other examples, the tissue adaptation instrument 111 may be used to aspirate tissue without a vacuum adaptation.In still other examples, the vacuum adaptation may be used without the tissue adaptation instrument 111 and the tissue adaptation instrument 111 may be omitted.

[0016] The housing 130 may also include a viewing port 146, which may include a channel or open space through the housing 130 that allows an imaging system 118 to capture images of a field of view distal to the housing 130. In some examples, the viewing port may accommodate the passage of imaging instruments, such as portions of the imaging system 118, which may be positioned to extend distally from the flexible body 106 and into the housing 130. In some examples, portions of the imaging system 118 may be positioned to extend distally from the flexible body 106 and through and distally from the housing 130.

[0017] In some examples, a suturing procedure can be performed with the system 100. In the suturing procedure, a full-thickness suture through adapted tissue, including all tissue layers, can be achieved. For example, in a gastric suture procedure, the needle and suture thread can penetrate all four tissue layers, including the submucosa, the mucosa, the muscle layers, and the serosa. In some examples, the tissue thickness, including the four layers, can be between approximately 2 mm and 10 mm. In some examples, the tissue thickness can be approximately 5 mm. In some examples of a suturing procedure, the distal engagement surface 140 can be placed near or in contact with a tissue surface. A vacuum can be applied via the tissue tension component 144 to create suction that draws the tissue into the chamber 142.In addition or alternatively to vacuum adaptation, a tissue adaptation instrument 111 can be advanced and retracted into contact with the tissue to draw the tissue into the chamber 142. The tissue adaptation instrument 111 can be applied through the tissue tension component 144 or through a separate port. With the tissue within the chamber 142, the drive member 124 can be actuated to activate the needle drive system 132 and advance the arcuate needle 138 through the tissue to create a suture. The needle drive system 132 can be positioned to fit radially within an outer diameter of the housing 130, while portions of the needle drive system 132 can extend beyond an axial length of the housing 130.Furthermore, the path of the arcuate needle 138 may be such that the needle 138 fits radially within the outer diameter of the housing 130, while portions of the needle 138 may extend beyond the axial length of the housing 130 in use.

[0018] Fig. 2 illustrates an exploded view of a distal portion of an instrument system 200 including an elongated flexible device or instrument 202 (e.g., an example of an elongated flexible device 102) and a suturing device 204 (e.g., an example of a suturing device 104). In this example, the instrument system 200 may be an endoscopic instrument system, and the elongated flexible device 202 may be a steerable monoscopic endoscope (although a stereoscopic endoscope may be used in other examples). The elongated flexible device 202 may include a flexible body 206 through which one or more working channels 208 and one or more drive channels 220 extend. In some examples, the elongated flexible device 202 may include one, two, three, or more working channels 208.The working channels 208 may extend through the flexible body 206 to provide a passage for removable or replaceable instrument systems such as ablation instruments, biopsy instruments, imaging instruments, or irrigation instruments. In some examples, one or more working channels 208 may be coupled to a vacuum source to create suction through the working channels 208. The working channels 208 may additionally or alternatively provide a passage for a tissue conformation instrument 111, as described above. The working channels 208 may also or alternatively allow fluid passage or otherwise provide access between the proximal and distal portions of the elongated flexible device 202. Each working channel 208 may define an opening 210 in a distal end portion 212 of the device 202. Each working channel 220 may define an opening 221 in the distal end portion 212.In some examples, other auxiliary channels and openings may be used for irrigation or for introducing tools and instruments. In some examples, the elongated flexible device 202 may include cables, connectors, or other actuators (not shown) extending between the proximal and distal ends of the elongated flexible device 202 to controllably bend or adjust and steer at least a portion of the elongated flexible device 202. An imaging channel 214 may also extend through the flexible body 206 and terminate at an opening 216 to provide a passageway for an imaging system 218 (e.g., the imaging system 909 or a component thereof), which in this example may be a monoscopic imaging system.

[0019] The drive channel 220 may provide a passage for a drive member 224. In this example, the drive member 224 is rotatable within and removable from the drive channel 220. In this example, the drive member 224 includes a flexible torque drive shaft 225 extending between a drive head 226 at a distal end portion of the drive member 224 and a proximal engagement portion 227 at a proximal end portion of the drive member 224. The proximal engagement portion 227 may engage an actuator (e.g., a motor) that causes rotation of the shaft 225 and the drive head 226 in one or both directions about the axis of the flexible torque drive shaft 225. Additionally or alternatively, the proximal engagement portion 227 may include a handle for manual actuation by a user.The flexible torque drive shaft 225 can flex with the flexible body 206 while applying torque to the drive head 226. In some examples, the drive element can be coupled to a gearbox at the distal end to reduce the torque transmitted along the length of the flexible body 206 and increase power. In some examples, the drive channel 220 can be omitted, and the drive element 224 can be delivered through a working channel 208.

[0020] In this example, the suturing device 204 may include a housing 230 that supports and covers at least a portion of a needle drive system 232. The needle drive system 232 may include a drive input 234 coupled to the drive head 226 of the drive member 224 and rotating in response to torque received from the drive member 224. The suturing device 204 may include an instrument interface portion 231 coupled to the distal end portion 212 of the device 202 and a tissue interface portion 233 that engages tissue distal from the suturing device 204. In some examples, the instrument interface portion 231 may include an attachment feature 237, such as a flange, that can be press-fitted into the distal end portion 212 of the device 202.The housing 230 may include a viewing port 246, which in this example is an arcuate channel through the housing 230 that allows the imaging system 218 to capture images of a field of view distal from the housing 230. The housing 230 may also include a tissue adaptation system having a tissue chamber and a tissue tensioning component 244. In this example, the tissue tensioning component 244 may be a vacuum port that creates suction to draw tissue into a tissue chamber 242. For example, the vacuum port 244 may be coupled to the working channel 208 such that a vacuum applied through the working channel 208 creates suction through the housing 230 to draw tissue into the tissue chamber 242. Additionally or alternatively, a port may provide a passageway for advancing a tissue adaptation instrument 111 to engage the tissue and retracting it to draw tissue into the tissue chamber 242 (see FIG. Fig. 7E-7G).

[0021] As in Fig. 3, the tissue interface portion 233 of the housing 230 may include an atraumatic distal engagement surface 240 that may contact a tissue surface during a suturing procedure. In this example, the distal engagement surface may be generally circular and extend generally perpendicular to a central axis A1 through the housing 230. The housing 230 may also include the tissue chamber 242 into which tissue may be drawn in a folded, bent, pinched, or otherwise adapted configuration. The surfaces of the tissue chamber 242 proximal to the engagement surface 240 may be sloped, curved, or otherwise shaped to provide a smooth, atraumatic interface with the drawn tissue and prevent tissue damage.The tissue tension opening 244 may extend from the instrument interface portion 231 to an opening 245 in the tissue chamber 242 to apply vacuum pressure to the tissue chamber 242. Additionally or alternatively, an opening may provide passage for a tissue adaptation instrument, as described above. As described in more detail below, the housing 230 may optionally include a first arcuate portion 270 and a second arcuate portion 272. As shown in FIG. Fig. 3-4, an opening 247 may extend through a sidewall of the second arcuate section 272 and an opening 249 may extend through a sidewall of the first arcuate section 270. A sealing member 251, such as heat shrink tubing, may be sealed around the housing 230 to create an airflow channel or path from the opening 249 to the opening 247 and through the fabric chamber 242 to the fabric tensioning opening 244. This configuration of ports may tension the inwardly drawn fabric toward the portion of the fabric chamber 242 within the lower second arcuate section 272. Alternatively, two or more vacuum openings (e.g., openings 244) in different areas of the fabric chamber 242 may allow for a more distributed and even application of vacuum, thereby allowing the fabric to be drawn more evenly and deeply into the chamber 242.In some examples, the housing may have a maximum outer diameter of approximately 16 mm.

[0022] With further reference to Fig. 3 and Fig. 5, the needle drive system 232 in this example may also include a gear system 236 to drive the movement of a needle 238. The gear system 236 may be coupled between the needle 238 and the drive input 234. The gear system 236 and the needle 238 may be supported within the housing 230 by a rail 250. A plate 252 may be coupled to the gear system 236 to hold the gear system 236 on the rail 250. The plate 252 may be coupled to the housing 230 by fasteners 254 such as screws. The plate 252 may be U-shaped and have a central gap 256 that provides space for the drawn-in fabric.

[0023] The gear system 236 can transmit torque from the drive input 234 to drive the movement of a needle 238. In this example, the gear system 236 can include three drive spur gears 260, 261, 262 arranged in a triangular configuration approximately equally spaced from each other. A larger central spur gear 263 can mesh with the three drive spur gears 260, 261, 262, thereby maintaining synchronous movement of the three gears. The triangular configuration of the three smaller spur gears is oriented so that the gear 260 and the gear 261 are on either side of the gap 256 and the tissue chamber 242. The gear 262 is located proximal of the gap 256. When a vacuum is applied and / or a tissue adaptation instrument retracts the tissue into the tissue chamber 242, the tissue can be pulled into the triangular configuration between the gears 260 and 261.The large synchronous gear 263 can rotate about an axis A2 that is generally perpendicular to the central axis A1 of the housing 230. The gear 263 can be positioned as far as possible from the plate 252 to maximize the amount of tissue drawn into the tissue chamber 242. As shown in FIG. Fig. As shown in Figure 3, a surface 266 of the housing 230 may shield the tissue from the gear engagement points to prevent damage to the drawn-in tissue. For example, the central gear 263 may be located outside the tissue chamber 242. The proximal spur gear 262 may be engaged and driven by a worm gear 268, which may be coupled to the drive input 234.

[0024] In some examples, the housing may be molded from a single piece. In this example, to improve manufacturability, maintenance, or functionality, the housing 230 may include two coupled components, a first arcuate portion 270 and a second arcuate portion 272. The bearings 274 may provide an interface for connecting the portions 270, 272. In some examples, the bearings 274 may be omitted and replaced with a flush connection to prevent tissue intrusion into the area surrounding the gear system 236. In some examples, the first arcuate portion 270 may surround the viewing port 246 and include a window made of a transparent polymer or ceramic material to allow viewing of the adjacent anatomical region within the field of view of the imaging system. In some examples, the entire portion 270 may be formed from the transparent material.

[0025] The needle 238 may have an arcuate or partially circular shape and rotate about axis A2 to slide through the tissue chamber 242 and through the tissue contained within the chamber. The needle 238 may include a series of involute teeth 280 arranged around an inner circumference of the needle 238, sized and spaced appropriately to engage the gear system 236. In some examples, the needle 238 may extend approximately 270 degrees and may engage at least two of the gears 260, 261, 262 simultaneously. The needle 238 may have a pointed end 282 and a pointed end 284 to allow the needle to be driven in either a clockwise or counterclockwise direction. The direction of rotation of the drive member 224 may drive the movement of the needle 238 in either a clockwise or counterclockwise direction. In some examples, the path of the needle may bisect the tissue chamber 242 approximately in half.In some examples, the needle 238 can rotate a full 360 degrees in a circular motion in a plane generally perpendicular to axis A2 to return the suture-loaded portion of the needle 238 to a deployed position. In some examples, the needle 238 can pivot in two directions in a semi-circular motion (e.g., approximately 180 degrees) in a plane generally perpendicular to axis A2 to return the suture-loaded portion of the needle to the deployed position. In the deployed position, the needle 238 can be rotated to a position where the needle does not obstruct the entry of tissue into the chamber 242. For example, in the deployed position, the pointed end 284 can be proximate the gear 260. In some examples, the path of the needle 238 can be outside the housing 230 and distal the distal engagement surface 240.In other examples, the path of the needle may be entirely within the confines of the housing 230. The suture may be attached to the needle at an attachment portion that is, for example, approximately equidistant from the pointed ends 282, 284. When the needle 238 is rotated about the axis A2, the needle 238 may pull the suture through the folded tissue located in the tissue chamber 242. In some embodiments, the needle 238 may have a single pointed end (e.g., the pointed end 282) and an opposing blunt end (e.g., the end 284).

[0026] The housing 230 can optionally include one or more sensors or sensory systems 257. For example, an image sensor, such as an ultrasonic sensor, positioned on the underside of the tissue chamber and oriented in direction A2 can be used to evaluate the shape or thickness of the tissue in the tissue chamber to verify that all tissue layers have been grasped before suturing. A pressure sensor can be used to confirm an expected vacuum pressure. One or more drive sensors, such as multiple Hall-effect sensors, inductive proximity sensors, and / or optical sensors acting as encoders, can measure the needle rotations either directly or by inference. The measurements can be taken at any moving element of the drive system.

[0027] Fig. 6A and Fig. 6B illustrate an alternative needle 300 that may be used with the suturing device 204. In this example, a needle 300 may be substantially similar to needle 238, with the differences described. The needle 300 may include a radial pocket 302 sized and shaped to receive a suture tab 304. The suture tab 304 may have an arcuate shape and be attached to the suture material 306. As the needle 300 is advanced through the tissue gathered within the tissue chamber 242, the suture tab 304 and the attached suture material 306 may be advanced through the tissue as a single unit. At the end of the suture run, the suture tab 304 may be released from the needle pocket 302 so that the suture tab serves as an anchor point for the completed suture run. A suture tab mechanism 312 in the housing may include a suture magazine and a suture release mechanism.In some examples, after the needle has been propelled in a 360-degree or 180-degree trajectory, a new suture tab is retrieved from the suture cartridge and inserted into the pocket 302 vacated by the previously released suture tab. In some examples, a new suture tab may be inserted into the pocket 302 by an external instrument. In some examples, the suture tab may be released into the tissue by activating the suture release mechanism. Activation may occur automatically after the needle has traversed a predetermined trajectory or may be manually triggered by a physician. In some embodiments, the suture tab 304 and suture tab mechanism 312 may be used with the needle 504 and needle drive system 500, which are described in more detail below.In addition to or alternatively to the suture tab 304, another portion of the needle may be attached to the suture material and removable from the needle body to serve as an anchor point (e.g., a distal tip of the needle or a proximal end of the needle).

[0028] In some examples, a flexible sheath or tube 310 may extend over the suture device 204 to prevent fluid or tissue from entering or exiting the housing 230. In some examples, the tube may be a heat-shrink tube.

[0029] Fig. 7A illustrates a suturing device 350 according to an alternative example. In this example, the suturing device 350 may be substantially similar to the suturing device 204, with the described differences. In this example, the suturing device 350 includes a housing 354 having a distal engagement surface 356 that engages a tissue 380 ( Fig. 7B). In this example, the distal engagement surface 356 may have an irregular shape or outline, including curved portions 358 and straight portions 360. The portions 358, 360 may form an entrance to a tissue chamber 364, with the straight portions 360 extending distally relative to the curved portions 358. Compared to a design with a fully curved (e.g., circular or oval) opening, the straight portions 360 may allow the size of the tissue chamber to be maximized without increasing the overall diameter of the suture device. The distal engagement surface 356 may be angled or beveled relative to the central axis A1. For example, the distal engagement surface may form an angle of between approximately 20 and 60 degrees relative to the axis A1.This oblique angle may allow the suturing device 350 to approach the anatomical tissue from a direction that is not perpendicular to the tissue, which may be a more desirable approach requiring less deformation of the flexible device. The angled distal opening of the suturing device may also allow for a larger field of view, a larger space for tissue entry, and a smoother entry into an anatomical opening. In some examples, the distance around the distal engagement surface 356 may be approximately the same distance as around the distal engagement surface 240 of FIG. Fig. 3. In other words, the distance around the distal engagement surface 356 may be the same as the distance around a circular distal engagement surface with a diameter of 16 mm. In this way, the device 350 can navigate through anatomical passageways that may conform to the shape of the housing 354.

[0030] As in Fig. 7A, the tissue engagement features 370 may extend from the distal engagement surface 356 or from another area near a distal portion of the suture device 350. Tissue engagement features may be included in any of the suture devices described herein. For example, the tissue engagement features 370 may include spikes, barbs, prongs, or other elongated projections capable of engaging adjacent tissue. The tissue engagement features 370 may provide counter-tension to a force exerted by a rotating needle 374 (which may, for example, resemble one of the needles 238, 300, 504). In some examples, the tissue engagement features 370 may be retractable so that they do not become caught in the tissue as the flexible device is navigated through anatomical passageways to the needle's tissue engagement site. As shown in Fig. 7B, the tissue engagement features 370 may engage one or more tissue layers 380. In this example, the tissue 380 may include a mucosal layer 381, a submucosal layer 382, ​​and a muscle layer 383. For example, the tissue engagement features 370 may engage the mucosal layer 381 of the tissue 380 and not the submucosal layer 382 and the muscle layer 383 of the tissue. The tissue engagement features 370 may prevent sliding of the mucosal layer 381 relative to the distal engagement surface 356, thereby enabling consistent grasping of the tissue 380 by securing the mucosal layer 381 relative to the distal engagement surface 356.When a portion of the mucosal layer 381 between the engaging features 370 is drawn into the tissue chamber 364 of the housing 354 by suction, the submucosal layer 382 and the muscle layer 383 not held by the tissue engaging features 370 may slide toward or into the tissue chamber 364 under the force of the vacuum. As shown in FIG. Fig. 7B, the tissue engagement features 370 may hold the tissue 380 as the needle 374 rotates through the tissue chamber 364 and through the fold of the tissue 380.

[0031] Fig. 7C illustrates a suturing device 400 according to an alternative example. In this example, the suturing device 400 may be substantially similar to the suturing device 204 or 350, with the described differences. In this example, the suturing device 400 includes a housing 402 having a distal engagement surface 404 that may contact tissue during a suturing procedure. In this example, the distal engagement surface 404 may have an irregular shape, including curved portions and straight portions. The distal engagement surface 404 may be angled or beveled relative to the central axis A1. In this example, the tissue engagement features 406 may be spaced approximately half or more than half of the distal engagement surface 404 to ensure secure attachment to the tissue.The secure attachment can provide greater resistance to the force of the needle pushing through the folded tissue and prevent slippage of the mucosal layer of the tissue at the distal engagement surface 404.

[0032] Fig. 7D illustrates a suturing device 450 according to an alternative example. In this example, the suturing device 450 may be substantially similar to the suturing device 204, 350, or 400, with the described differences. In this example, the suturing device 450 includes a housing 452 having a distal engagement surface 454 that may contact tissue during a suturing procedure. In this example, the distal engagement surface 454 may be angled or beveled relative to the central axis A1 such that a length L1 of the housing is shorter than a length L2 of the housing. A viewing port 456 may extend through a shorter portion 455 of the housing 452, allowing for a larger field of view 458 for an imaging system acquiring image data through the viewing port 456, compared to a viewing port 456 that would extend the full length L2.In this example, portion 455 of housing 452 may be made of a transparent material.

[0033] Fig. 7E-7G illustrate a suturing device 460 according to an alternative example. In this example, the suturing device 460 may be substantially similar to the suturing device 204, 350, 400, or 450, with the described differences. In this example, the suturing device 460 includes an opening 462 through which a tissue adaptation instrument 464 extends to draw tissue into a tissue chamber 465 and into a path of a needle 466. The tissue adaptation instrument 464 may be part of a tissue tensioning component configured to draw tissue into the tissue chamber. The tissue adaptation instrument 464 may optionally be used in conjunction with the vacuum adaptation described herein or without vacuum adaptation. The tissue adaptation instrument 464 is an example of the tissue adaptation instrument 111.The illustrated tissue adaptation instrument 464 includes a helical component for engaging tissue, while other tissue engagement arrangements may include opposing jaws, clamps, etc. Fig. Figure 7E shows the tissue adaptation instrument 464 in an extended configuration distal to a housing 468 of the suturing device 460 to engage the target tissue. Fig. Figure 7F shows the tissue adaptation instrument 464 in a retracted configuration within the housing 468. Fig. Figure 7G shows the tissue adaptation instrument 464 in the retracted configuration within the housing 468 and engaged with tissue such that the tissue is in a position where the needle 466 can pierce the tissue through its full thickness. In use, the suturing device 460 may be coupled to a distal end of an elongated flexible device (e.g., an endoscope). The suturing device 460 may be permanently or releasably attached to the elongated flexible device. Once coupled, the tissue adaptation instrument 464 may be advanced distally through a working channel of the elongated flexible device, through the opening 462 in the suturing device 460, and distally past the housing 468 of the suturing device 460. The tissue adaptation instrument 464 may be urged forward against the tissue to engage the tissue.In embodiments where the tissue adaptation instrument 464 includes a helical tissue-engaging component, the tissue adaptation instrument 464 can be advanced distally while being rotated so that the helical component penetrates the tissue in a corkscrew motion. Once the helical component has been rotated into the tissue to a desired depth, the helical component can be retracted without twisting, thereby bringing the tissue into the tissue chamber 465 and into the path of the suture needle. In embodiments where the tissue adaptation instrument 464 has opposing jaws, the tissue adaptation instrument can be advanced distally and the jaws can be opened to grasp the tissue.The jaws can then be closed to grasp the tissue, and the tissue adaptation instrument 464 can be retracted proximally to pull the tissue into the tissue chamber 465. Following a suturing procedure with the needle 466, the tissue adaptation instrument 464 can be released from the tissue to release the tissue from the tissue chamber 465.

[0034] Fig. 8 illustrates a needle drive system 500 according to an alternative embodiment. In some examples, the needle drive system 500 may be used in place of the needle drive system 232. In this example, the needle drive system 500 may include a drive input 502 and a gear system 506 for driving a needle 504. The gear system 506 may be coupled between the drive input 502 and the needle 504. The gear system 506 may transmit torque from the drive input 502 to drive movement of the needle 504. In this example, the gear system 506 may include three bevel gears 510, 511, 512 arranged in a generally trapezoidal configuration. The gears 510 and 512 may be drive gears that releasably engage the needle 504 to drive movement of the needle 504. The middle bevel gear 511 may be attached to a gear 513.The gear 513 can mesh with a proximal spur gear 514. The spur gear 514 can mesh with and be driven by a worm gear 516, which can be coupled to the drive input 502. In this gear configuration, torque can be applied to the center bevel gear 511, which is generally located opposite the needle 504, so that torque and backlash between the two drive gears 510, 512 are balanced. The trapezoidal configuration of the three bevel gears 510, 511, 512 forms an open space 518 into which the tissue can be folded when a vacuum is applied. The gears 511, 513 can rotate about axis A2, which can be generally perpendicular to axis A1.The needle 504 may include drive engagement features 520 disposed along a centerline of the needle to avoid interaction with the engagement features and the adapted tissue, thus reducing tissue trauma and needle driving forces. The drive engagement features 520 of the needle 504 may engage the drive gears 510, 512. The drive engagement features 520 may include slots extending through the top and bottom surfaces of the needle between the inner and outer peripheries of the needle 504. The needle 504 may have an arcuate or partially circular shape and rotate about axis A2 to glide through the tissue chamber and through the tissue captured within the chamber. In some examples, the needle 504 may extend approximately 270 degrees. The needle 504 may have a pointed end 522 and a pointed end 524 to allow the needle to be driven in either a clockwise or counterclockwise direction.The direction of rotation of the drive input 502 can drive the movement of the needle 504 either clockwise or counterclockwise. In some examples, the needle 504 can rotate a full 360 degrees in a circular motion to return a suture-loaded portion 525 of the needle 504 to a deployed position. In some examples, the needle 504 can pivot bidirectionally in a semi-circular motion to return the suture-loaded portion 525 of the needle to the deployed position. In the deployed position, the needle 504 can be rotated to a position where the needle does not obstruct the entry of tissue into the chamber. Suture material can be attached to the needle, for example, to the suture-loaded portion 525. As the needle 504 is rotated about axis A2, the needle 504 can pull the suture material through the folded tissue within the tissue chamber to create a stitch.In some embodiments, the needle 238 may have a single pointed end (e.g., pointed end 522) and an opposite blunt end (e.g., end 524).

[0035] Fig. 9 illustrates a side view of a distal portion of an instrument system 600 including an elongated flexible device 602 and a suturing device 604. The instrument system 600 may be substantially similar to the instrument system 100, with the described differences. In particular, a concentric drive element may enable a larger working channel. The device 602 may serve as a platform to drive the movement of mechanisms within the suturing device, introduce working components into the anatomical structures accessed by the instrument system 600, and acquire image data of the anatomical structures. The device 602 may include a flexible body 606 through which one or more working channels 608 extend.The working channels 608 may extend through the flexible body 606 to provide passage for removable instrument systems and tissue adaptation instruments and to enable instrument exchange during a procedure. The working channels 608 may also, or alternatively, allow fluid passage or otherwise provide access between the proximal and distal portions of the elongated flexible device 602. The working channels 608 may define openings 610 in a distal end portion 612 of the device 602. An imaging system 614 may also extend through the flexible body 606.

[0036] In this example, a drive element 620 may be located outside of the flexible body 606 and concentric therewith. The drive element 620 may be coupled to a motor or other drive system, such as a motor of a robot-assisted manipulator. The drive element 620 may be coupled to a drive input 634 of the suturing device 604. The drive input 634 may, for example, have an inner engagement surface that communicates with an outer engagement surface of the drive element 620. The suturing device 604 may also include a housing 630 that houses a needle drive system 632 and a needle 638. The drive input 634 may be housed inside the housing 630 or coupled to an exterior of the housing 630.Rotation of drive member 620 can apply torque to drive input 634, causing needle 638 to rotate and engage the tissue folded within suturing device 604. Rotation of drive member 620 can be clockwise or counterclockwise to impart unidirectional or bidirectional movement to needle 638.

[0037] Fig. 10 is a flowchart illustrating a method 700 for suturing tissue during a medical procedure. The method 700 is depicted as a series of operations or processes that may be performed in the same or a different order than that illustrated in Fig. 10. One or more of the illustrated processes may be omitted in some examples of the method. In addition, one or more of the processes shown in Fig. 10 are not expressly depicted, before, after, between the processes, or as part of the depicted processes. In some examples, one or more of the processes of method 700 may be implemented at least in part by a control system executing code stored on non-transitory, tangible, machine-readable media that, when executed by one or more processors (e.g., the processors of a control system), may cause the one or more processors to perform one or more of the processes. The method 700 may be used in connection with any of the suturing devices disclosed herein.

[0038] In a process 702, a distal engaging surface of a suturing device may be positioned near or in contact with a tissue surface. For example, an instrument system 100 may be used to perform the suturing procedure. The flexible device 102 with the permanently or releasably attachable suturing device 104 may be inserted through a patient's mouth into the esophagus and stomach. The distal end of the flexible device 102 and the suturing device 104 may be steered and aligned such that the distal engaging surface 140 comes into contact with or in close proximity to the mucosal layer of the tissue.

[0039] In an optional process 704, the tissue distal to the suture device may be viewed in the field of view of an imaging system. For example, the imaging system 118 may view the tissue through the viewing port 146 or through the suture device housing 130 if a portion of the housing is made of a transparent material or has a transparent window. Based on the images of the tissue, a physician can determine if the device needs to be repositioned or reoriented, if there are any obstructions to the suture, if there are any tissue lesions, or if there are any other conditions that may affect the suture procedure.

[0040] In an optional process 706, tissue engagement features extending from the suturing device may engage the tissue. For example, the tissue engagement features 370, 406 may extend into the tissue to resist or prevent movement of the tissue relative to the suturing device as the needle is advanced through all tissue layers. In some examples, the tissue engagement features may engage fewer than all layers of the tissue. For example, the tissue engagement features may engage the mucosal layer, but not the submucosa or muscle layer, allowing the uncaptured layers to be drawn into the tissue chamber while the captured layer remains fixed relative to the suturing device. The process 706 may optionally include extending and retracting deployable tissue engagement features.

[0041] In a process 708, vacuum pressure may be applied to draw the tissue into the tissue chamber of the suture device. For example, vacuum pressure may be applied by the tissue tension component 144 to create suction that draws the tissue into the chamber 142. The vacuum pressure and the shape of the tissue chamber may cause tissue conformation by forming the tissue into a convex fold within the tissue chamber. The tissue chamber may be located within the field of view of the imaging system so that the physician can observe whether tissue entry is sufficient before initiating needle engagement with the conformed tissue. Optionally, a tissue conformation instrument having a tissue engagement component may be extended to engage the target tissue and retracted to draw tissue into the tissue chamber 142.The tissue adaptation instrument can be used in addition to or instead of vacuum pressure to pull the tissue into the tissue chamber.

[0042] In an optional process 710, the shape and / or thickness of the tissue in the chamber can be evaluated to confirm full-layer adaptation. The sensor system 257 can, for example, include an imaging sensor, such as an ultrasonic sensor, positioned on the underside of the tissue chamber and oriented in direction A2, which can be used to evaluate the tissue shape or thickness in the tissue chamber to verify that all tissue layers have been grasped prior to suturing.

[0043] In an optional process 712, it may be confirmed that a desired vacuum pressure has been reached in the tissue chamber. For example, the sensor system 257 may include a pressure sensor that can be used to confirm an expected vacuum pressure.

[0044] In a process 714, the needle drive system may be activated to advance the needle through the adapted tissue. For example, when the tissue is within the chamber 142, the drive element 124 may be actuated to activate the needle drive system 132 and advance the arcuate needle 138 and attached suture through the tissue. More specifically, the drive element 124 may apply torque to the drive input 134, thereby activating the gear system 136 to rotate the needle 138 in a unidirectional or bidirectional path to pull suture through the adapted tissue within the tissue chamber 142. Processes 702-710 may be repeated as needed to achieve the surgical objective.

[0045] In an optional process 716, drive sensors may be used to control the rotational speed and stop position of the needle actuated by the drive system. The sensor system 257 may, for example, include one or more drive sensors, such as multiple Hall-effect sensors, inductive proximity sensors, and / or optical sensors acting as encoders to measure the needle's rotations either directly or by inference. The acquired measurements may be made on any moving element of the drive system.

[0046] With this suture technique, a full-thickness suture can be achieved through adapted tissue, including all tissue layers. In a gastric suture procedure, for example, the needle and suture thread can penetrate all three tissue layers, including the submucosa, mucosa, and muscle layers.

[0047] Fig. 11 illustrates an endoscopic instrument system 800 (e.g., instrument system 100) extending within the anatomical passageways 802 of an anatomical structure 804. In some examples, anatomical structure 804 may be a stomach. Anatomical structure 804 has an anatomical reference system (X A , Y A , Z A ). A distal end portion 806 of the endoscopic instrument system 800 can be advanced into an anatomical opening (e.g., a patient's mouth) and through the anatomical passageways 802 to perform a medical procedure, such as a suturing procedure, using any of the methods or systems described herein on or near target tissue located within a region 808 of the anatomical structure 804.

[0048] Fig. 12 illustrates a robot-assisted medical system according to some examples. In some examples, the systems and methods disclosed herein may be used in a suturing procedure performed with a robot-assisted medical system, as described in more detail below. As in Fig.12, a robot-assisted medical system 900 may include a manipulator assembly 902 for operating a medical instrument 904 (e.g., instrument system 100, 200, or any of the instruments described herein) in performing various procedures on a patient P positioned on a table T in a surgical environment 901. For example, the manipulator assembly 902 may engage the drive member 224 to apply torque to the drive input 234 of the suturing device 204. The manipulator assembly 902 may be teleoperated, non-teleoperated, or a hybrid teleoperated and non-teleoperated assembly with selected degrees of freedom of movement that may be motorized and / or teleoperated, and selected degrees of freedom of movement that may be non-motorized and / or non-teleoperated.A main assembly 906, which may be located inside or outside the surgical environment 901, generally includes one or more controllers for controlling the manipulator assembly 902. The manipulator assembly 902 supports the medical instrument 904 and may optionally include a plurality of actuators or motors that provide inputs to the medical instrument 904 in response to commands from a control system 912. The actuators may optionally include drive systems that, when coupled to the medical instrument 904, can advance the medical instrument 904 into a naturally or surgically created anatomical opening. Other drive systems may move the distal end of the medical instrument in multiple degrees of freedom, including three linear degrees of motion (e.g., linear motion along the Cartesian axes X, Y, Z) and three rotational degrees of motion (e.g.,Rotation about the Cartesian axes X, Y, Z). The manipulator assembly 902 may support various other systems for irrigation, treatment, or other purposes. Such systems may include fluid systems (including, for example, reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogation devices, and ablation components.

[0049] The robot-assisted medical system 900 also includes a display system 910 for displaying an image or representation of the surgical site and the medical instrument 904 generated by an imaging system 909, which may include an endoscopic imaging system. The display system 910 and the main assembly 906 may be oriented so that a surgeon O can control the medical instrument 904 and the main assembly 906 with the perception of telepresence. Any of the previously described graphical user interfaces may be displayed on a display system 910 and / or a display system of an independent planning workstation.

[0050] In some examples, the endoscopic imaging components of imaging system 909 may be fixedly or removably coupled to medical instrument system 904. However, in some examples, a separate endoscope attached to a separate manipulator assembly may be used with medical instrument system 904 to image the surgical site. Endoscopic imaging system 909 may be implemented as hardware, firmware, software, or a combination thereof, interacting with or otherwise executed by one or more computer processors, which may include the processors of control system 912.

[0051] The sensor system 908 (which may include the sensor system 257) may include a position / attitude sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., a fiber optic shape sensor) for determining the position, orientation, velocity, attitude, and / or shape of the medical instrument 904. The sensor system 908 may also include temperature, pressure, force, or contact sensors, or the like.

[0052] The robot-assisted medical system 900 may also include a control system 912. The control system 912 includes at least one memory 916 and at least one computer processor 914 to effect control between the medical instrument 904, the main assembly 906, the sensor system 908, and the display system 910. The control system 912 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement a suturing procedure using the robot-assisted medical system for navigation, steering, imaging, extending or retracting interventional features, and driving the needle.

[0053] The control system 912 may optionally also include a virtual visualization system to provide navigation assistance to the surgeon O in controlling the medical instrument 904 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system may be based on a captured preoperative or intraoperative data set of anatomical passages. The virtual visualization system processes images of the surgical site acquired using imaging techniques such as computed 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 912 may use a preoperative image to locate the target tissue (using imaging techniques and / or user input) and create a preoperative plan including an optimal initial site for performing occlusion of the bronchial channels and vessels. The preoperative plan may include, for example, a planned size for the expansion of the expandable device, a treatment duration, a treatment temperature, and / or multiple deployment sites.

[0054] Specific details are set forth in the description that describe some examples. Numerous specific details are set forth to provide a thorough understanding of the examples. However, one skilled in the art will appreciate that some examples may be practiced without some or all of these specific details. The specific examples disclosed herein are intended to be illustrative but not limiting. One skilled in the art may recognize other elements that, while not specifically described herein, fall within the scope and spirit of this disclosure.

[0055] Elements described in detail with reference to one example, implementation, or application may, whenever practical, optionally be included in other examples, implementations, or applications in which they are not specifically shown or described. For example, if an element is described in detail with reference to one example and is not described with reference to a second example, the element may still be claimed as included in the second example.Therefore, to avoid unnecessary repetition in the following description, one or more elements shown and described in connection with one example, implementation, or application may be included in other examples, implementations, or aspects, unless expressly described otherwise, unless the one or more elements would render an example or implementation non-functional, or unless two or more of the elements provide conflicting functionality. Not all illustrated processes can be performed in all examples of the disclosed methods. In addition, one or more processes not expressly illustrated may be included before, after, between, or as part of the illustrated processes.In some examples, one or more of the processes may be performed by a control system or implemented at least in part in the form of executable code stored on non-transitory, tangible, machine-readable media that, when executed by one or more processors, may cause the one or more processors to perform one or more of the processes.

[0056] Any changes and further modifications to the described devices, instruments, and methods, as well as any further application of the principles of the present disclosure, are fully contemplated as would normally occur to one of ordinary skill in the art to which the disclosure relates. Furthermore, the dimensions given herein are to be understood as specific examples, and it is contemplated that other sizes, dimensions, and / or ratios may be used to implement the concepts of the present disclosure. To avoid unnecessary repetition of description, one or more components or actions described according to an illustrative example may be used in or omitted from other examples, as appropriate. For brevity, the numerous repetitions of these combinations will not be separately described.For the sake of simplicity, in some cases the same reference numerals are used in the drawings to refer to the same or similar parts.

[0057] The systems and methods described herein may be suitable for imaging via natural or surgically created connected channels in a variety of anatomical systems, including the lungs, colon, intestines, stomach, liver, kidneys and renal calyces, brain, heart, circulatory system including vessels, and / or the like. While some examples are provided herein with respect to medical procedures, any reference to medical or surgical instruments and medical or surgical procedures is non-limiting. Thus, the instruments, systems, and methods described herein may also be used for non-medical purposes, for example, in industry, for general robotic applications, and for grasping or manipulating non-tissue workpieces.Other application examples include cosmetic enhancements, the imaging of human or animal anatomy, the acquisition of data from human or animal anatomy, and the training of medical or non-medical personnel. Further application examples include procedures on tissue removed from the human or animal anatomy (without reintegration into the human or animal anatomy), as well as procedures on human cadavers or animal carcasses. Furthermore, these techniques can also be used for surgical and non-surgical medical treatment or diagnostic procedures. Furthermore, these techniques can also be used for surgical and non-surgical medical treatment or diagnostic procedures.

[0058] One or more elements in the examples of this disclosure may be implemented in software to execute on a processor of a computer system, e.g., a control processing system. When implemented in software, the elements of the examples of this disclosure may be code segments that perform various tasks. The program or code segments may be stored in a processor-readable storage medium or device, which may have been downloaded via a transmission medium or communication link using a computer data signal embodied in a carrier wave.The processor-readable storage medium may comprise any medium capable of storing information, including an optical medium, a semiconductor medium, and / or a magnetic medium. Examples of a processor-readable storage device include an electronic circuit, a semiconductor device, a semiconductor storage device, a read-only memory (ROM), a flash memory, an erasable programmable read-only memory (EPROM), a floppy disk, a CD-ROM, an optical disk, a hard disk, or another storage device. The code segments may be downloaded over computer networks such as the Internet, intranet, etc. A wide range of centralized or distributed computing architectures may be used.The programmed instructions can be implemented as a series of separate programs or subroutines, or they can be integrated into various other aspects of the systems described herein. In some examples, the control system can support wireless communication protocols such as Bluetooth, Infrared Data Association (IrDA), HomeRF, IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), Ultra-Wideband (UWB), ZigBee, and wireless telemetry.

[0059] Note that the processes and displays presented are not necessarily associated with any particular computer or other device. Various general-purpose systems may be used with programs according to the teachings contained herein, or it may prove convenient to construct a more specialized device to perform the described operations. The required structure for various such systems will appear as elements in the claims. Furthermore, the examples of the invention are not described with reference to any particular programming language. It will be understood that various programming languages ​​may be used to implement the teachings of the invention as described herein.

[0060] In this disclosure, various instruments, parts of instruments, and anatomical structures are described with respect to their state in three-dimensional space. As used herein, the term "position" refers to the attitude of an object or part of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x, y, and z coordinates). As used herein, the term "orientation" refers to the rotational position of an object or part of an object (e.g., in one or more rotational degrees of freedom such as roll, pitch, and / or yaw). As used herein, the term "attitude" refers to the position of an object or part of an object in at least one translational degree of freedom and to the orientation of that object or part of the object in at least one rotational degree of freedom (e.g., up to six degrees of freedom in total).The term “shape” as used here refers to a series of postures, positions, or orientations measured along an object.

[0061] While certain illustrative examples of the invention have been described and shown in the accompanying drawings, it is to be understood that such examples are merely illustrative of the broad invention and not limiting thereof, and that the examples of the invention are not limited to the specific constructions and arrangements shown and described, since various other modifications may occur to those sufficiently skilled in the art. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 63 / 421,029

[0001]

Claims

[1] Device comprising: a housing having an instrument interface, the instrument interface being adapted to releasably engage a distal portion of an endoscope; a drive system coupled to the housing and configured to releasably engage a drive element extending from the endoscope; an arcuate needle coupled to the drive system, the drive element being configured to move the arcuate needle when the drive system is engaged with the drive element; and a tissue adaptation system comprising: a tissue chamber in the housing through which a path of the curved needle passes; and a tissue tension component designed to draw tissue into the tissue chamber. [2] The device of claim 1, wherein the drive system is configured to impart bidirectional movement to the arcuate needle. [3] The device of claim 1, wherein the housing comprises a generally transparent material through which a field of view of the endoscope is visible. [4] The device of claim 1, wherein a proximal end of the housing includes an attachment feature configured to connect to the endoscope. [5] The device of claim 1, wherein the housing has a maximum outer diameter of approximately 16 mm. [6] The device of claim 1, wherein the drive system comprises a drive input at a proximal end of the housing, the drive input being adapted to releasably engage the drive element extending from the endoscope. [7] The device of claim 6, wherein the drive element comprises a distal drive head and a drive shaft, the drive element being adapted to be inserted into a working channel of the endoscope to releasably couple the distal drive head to the drive input at the proximal end of the housing. [8] The device of claim 6, wherein the drive system comprises a gear system serving as a connecting link between the drive input and the arcuate needle. [9] The device of claim 8, wherein the gear system comprises a central gear and at least two drive gears on opposite sides of the tissue chamber. [10] The apparatus of claim 9, wherein at least one of the central gear and the drive gears comprises a bevel gear. [11] The device of claim 9, wherein the central gear is positioned outside the tissue chamber. [12] The device of claim 1, wherein the tissue chamber is sized to accommodate a fold of all layers of a tissue. [13] The device of claim 1, wherein the arcuate needle has a needle track extending 360 degrees in a plane approximately parallel to a longitudinal axis of the housing. [14] The device of claim 1, wherein the arcuate needle has a needle path that approximately bisects the tissue chamber. [15] The device of claim 1, wherein the tissue tension component comprises an opening through which a vacuum force is applied to draw the tissue into the tissue chamber. [16] The device of claim 1, wherein the tissue tensioning component comprises a tissue adaptation instrument configured to be advanced to grasp tissue and retracted to draw the tissue into the tissue chamber. [17] The device of claim 16, wherein the tissue adaptation instrument comprises a helical component for engaging tissue. [18] The apparatus of claim 16, wherein the tissue tension component further comprises an opening through which a vacuum force is applied to draw the tissue into the tissue chamber. [19] The device of claim 1, wherein the housing includes a viewing port configured to align with an imaging system of the endoscope. [20] The device of claim 19, wherein the viewing aperture is sized to receive imaging components extending distally from the endoscope. [21] The device of claim 1, wherein the arcuate needle extends approximately 270 degrees. [22] The apparatus of claim 1, wherein the arcuate needle comprises a first pointed end and a second pointed end; wherein the first pointed end is a leading end of the arcuate needle when the drive system is rotated in a first direction; and the second pointed end is a leading end of the arcuate needle when the drive system is rotated in a second direction opposite the first direction. [23] The device of claim 1, wherein the arcuate needle includes an attachment portion for attachment to a suture thread. [24] The apparatus of claim 1, wherein the arcuate needle includes teeth along an inner diameter of the needle adapted to engage the drive system. [25] The device of claim 1, wherein the arcuate needle includes a slotted latch adapted to engage the drive system. [26] The device of claim 1, wherein the arcuate needle comprises a releasable suture tab. [27] The device of claim 1, wherein the housing comprises a rail on which the arcuate needle is carried. [28] The device of claim 1, wherein the arcuate needle has a needle track that remains entirely within the housing. [29] The device of claim 1, wherein the arcuate needle has a needle track extending beyond a distal end of the housing. [30] The device of claim 1, wherein the housing includes a distal engagement surface that provides a seal between the housing and the tissue. [31] The device of claim 30, wherein the distal engagement surface comprises a plurality of tissue engagement features. [32] The device of claim 30, wherein the distal engagement surface has an angle between approximately 20 and 60 degrees. [33] The device of claim 1, further comprising an outer tube extending over the housing. [34] The apparatus of claim 1, further comprising a sensor configured to image the tissue in the tissue chamber. [35] The apparatus of claim 1, further comprising a sensor for measuring the vacuum pressure in the tissue chamber. [36] The apparatus of claim 1, further comprising a sensor to measure an operation of the drive system. [37] The apparatus of claim 1, further comprising a suture flap mechanism having a suture magazine and a suture release mechanism. [38] The device of claim 1, wherein the housing includes an auxiliary opening adapted to engage a system of the endoscope. [39] Instrument system comprising: a flexible device body comprising a distal end portion, the distal end portion comprising: a housing; a gear system within the housing; an arcuate needle coupled to the gear system for bidirectional movement of the arcuate needle relative to the housing; and a tissue adaptation system comprising: a tissue chamber in the housing through which a path of the curved needle passes; and a tissue tension component designed to draw tissue into the tissue chamber. [40] The instrument system of claim 39, further comprising a flexible drive member extending within the flexible device body, the flexible drive member being configured to rotate to apply a torque input to the gear system. [41] The instrument system of claim 39, wherein the tissue tension component comprises an opening in the tissue chamber through which a vacuum force is applied to draw the tissue into the tissue chamber. [42] The instrument system of claim 39, wherein the tissue tensioning component comprises a tissue adaptation instrument configured to be advanced to grasp tissue and retracted to draw the tissue into the tissue chamber. [43] The instrument system of claim 42, wherein the tissue adaptation instrument comprises a helical component for engaging tissue. [44] The instrument system of claim 42, wherein the tissue tension component further comprises an opening through which a vacuum force is applied to draw the tissue into the tissue chamber. [45] The instrument system of claim 39, wherein the housing is releasably coupled to the flexible device body. [46] The instrument system of claim 39, wherein the gear system comprises a central gear and at least two drive gears on opposite sides of the tissue chamber. [47] The instrument system of claim 46, wherein at least one of the central gear and the drive gears comprises a bevel gear. [48] ​​The instrument system of claim 46, wherein the central gear is located outside the tissue chamber. [49] The instrument system of claim 39, wherein the arcuate needle includes teeth along an inner circumference of the needle adapted to engage the gear system. [50] The instrument system of claim 39, wherein the arcuate needle includes a slotted latch configured to engage the gear system. [51] Instrument system comprising: a flexible device body having a plurality of working channels designed to receive one or more instruments; a drive element extending in a first of a plurality of working channels; a housing configured to engage a distal portion of the flexible device body; a drive system extending within the housing, the drive system being configured for coupling to a distal end of the drive element; a curved needle coupled to the drive system, the curved needle being configured for bidirectional movement; and a tissue adaptation system having a tissue chamber in the housing through which a path of the arcuate needle passes, and a tissue tension component configured to draw tissue into the tissue chamber. [52] The instrument system of claim 51, wherein a second of the plurality of working channels is a vacuum channel, and wherein the tissue tension component is configured to couple to the vacuum channel. [53] The instrument system of claim 51, wherein the tissue tensioning component comprises a tissue adaptation instrument configured to be advanced through a second of the plurality of working channels and through the housing to grasp tissue and retracted to draw the tissue into the tissue chamber. [54] The instrument system of claim 53, wherein the tissue adaptation instrument comprises a helical component for engaging tissue. [55] The instrument system of claim 53, wherein the tissue tensioning component further comprises an opening in the housing through which a vacuum force is applied to draw the tissue into the tissue chamber. [56] The instrument system of claim 51, further comprising an imaging system extending within the flexible device body. [57] The instrument system of claim 56, wherein the housing includes a viewing opening through which a field of view of the imaging system passes. [58] The instrument system of claim 51, wherein the drive system is configured to rotate clockwise or counterclockwise to impart bidirectional movement to the arcuate needle. [59] The instrument system of claim 51, wherein the arcuate needle includes teeth along an inner diameter of the needle configured to engage the drive system. [60] The instrument system of claim 51, wherein the arcuate needle includes a slotted latch configured to engage the drive system. [61] The instrument system of claim 51, wherein the drive system comprises a drive input at a proximal end of the housing, the drive member comprising a distal drive head and a drive shaft, and the distal drive head of the drive member engaging the drive input to move the arcuate needle.

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