Suturing device

[0001] Various embodiments are directed to surgical devices and methods of using the same.

[0002] In endoscopic, laparoscopic, and other noninvasive surgical techniques, internal suturing or other tissue fastening must be performed with instruments small enough to fit through a trocar or endoscope working channel, which can often be quite narrow. For example, the working channel of a typical flexible endoscope has a diameter in the range of about 2.5 to about 4 millimeters. Current staplers and suturing devices cannot be easily redesigned to work through such small openings. In addition, performing procedures by way of the working channel does not easily permit using two instruments positioned at different angles with respect to the wound site in order to “pass and catch” a needle and apply sutures.

[0003] Various clips, suture fasteners and anchors have been developed such that clinicians may endoscopically close tissue perforations resulting from, for example, ulcers, polypectomy, incisions, etc. One type of suture anchor is known as a “T-tag” fastener. The T-tag is a small metallic pin with a suture attached at the middle. The physician may load the T-tag into the end of a cannulated needle of an applicator that may be inserted through the working channel of an endoscope. The physician may push the needle into the tissue near the perforation and implant the T-tag into the tissue with the attached suture trailing through the working channel and out the proximal end of the endoscope. After two or more T-tags are attached to the tissue near the wound in this manner, the physician may pull the sutures to appose the tissue around the wound. The physician may then fasten the sutures together by applying a plurality of alternating, right and left overhand knots using a knot pushing device or by applying a knotting element or other type of fastener through the working channel of the endoscope.

[0018] Various embodiments are directed to curved, flexible suturing needles as well as devices and methods for manipulating such needles to place sutures during surgical operations. A flexible needle may be made from any resilient, flexible material. In its rest position, the flexible needle may have a curved shape. In use, the needle may be provided to a surgical site through a hollow lumen, such as the working channel of an endoscope, a trocar, an accessory channel, etc. When the flexible needle is within the lumen, it may be held in a straight position. At the surgical site, the flexible needle may be extended through a distally facing end of the lumen where it may encounter and pierce tissue. As the needle exits the lumen and extends through the tissue, it may regain its curved shape. This may cause the needle to curve back on itself and exit the tissue, for example, through the same surface that it entered. A collet, jaws, or other grasper device may then be used to grasp the leading end of the needle, pull the needle through the tissue, and complete the stitch. For subsequent stitches, the needle may be retracted into the lumen to straighten it and then used again, for example, in the manner described above.

[0019] FIG. 1 illustrates one embodiment of an endoscope 14 (illustrated here as a gastroscope) inserted into the upper gastrointestinal tract of a patient. The endoscope 14 may be used to provide flexible suturing needles, and tools for manipulating the needles, to a surgical site, for example, as described herein. The endoscope 14 has a distal end 16 that may include various optical channels, illumination channels, and working channels. According to various embodiments, the endoscope 14 may be a flexible endoscope and may be introduced via natural orifices and may be combined with trans-organ techniques. In one embodiment, Natural Orifice Translumenal Endoscopic Surgery (NOTES)™ techniques may be employed to introduce instruments into the patient and carry out the various procedures described hereinbelow. A NOTES™ technique is a minimally invasive therapeutic procedure that may be employed to treat diseased tissue or perform other therapeutic operations through a natural opening of the patient without making incisions in the abdomen. A natural opening may be the mouth, anus, and/or vagina. Medical implantable instruments may be introduced into the patient to the target area via the natural opening. In a NOTES™ technique, a clinician inserts a flexible endoscope into one or more natural openings of the patient to view the target area using a camera. During endoscopic surgery, the clinician inserts surgical devices through one or more lumens or working channels of the endoscope 14 to perform various key surgical activities (KSA). These KSAs include forming an anastomosis between organs, repairing ulcers and other wounds, etc. In some embodiments, surgical devices may be provided to surgical sites other than through the working channel of an endoscope including, for example, via one or more accessory channels. Also, although the devices and methods described herein may be used with NOTES™ techniques, it will be appreciated that they may also be used with other surgical techniques including, for example, other endoscopic techniques, laparoscopic techniques, etc.

[0020] FIG. 2 illustrates one embodiment of the distal end 16 of the endoscope 14 showing a flexible needle 202 and grasper device 204 extending from a working channel 18. The distal end 16 of the endoscope 14 comprises a distal face 4 defining illumination channels 20, an optical channel 22, and the working channel 18. The illumination channels 20 may comprise one or more optical fibers or other suitable waveguides for directing light from a proximally positioned light source (not shown) to the surgical site. The optical channel 22 may comprise one or more optical fibers or other suitable waveguides for receiving and transmitting an image of the surgical site proximally to a position where the image may be viewed by a clinician operating the endoscope 16. As described above, the working channel 10 may allow the clinician to introduce one or more surgical tools to the surgical site including, for example, the needle 202 and grasper device 204. It will be appreciated that the endoscope 14 as illustrated is but one example of an endoscope that may be used in accordance with various embodiments. Endoscopes having alternate configurations of optical channels 22, illumination channels 20 and/or working channels 18 may also be used.

[0021] FIG. 3 illustrates one embodiment of the curved needle 202. The needle 202 may comprise a sharp leading end 206 for piercing tissue and a back end 208. The back end 208 may define a suture hole 212, through which suture 210 may be threaded. According to various embodiments, the suture hole 212 may be placed at other positions in the needle 202 including, for example, at about a midpoint between the leading end 206 and the back end 208. The needle 202 may be made from any suitably resilient material. For example, the needle 202 may be made from nitinal (an alloy of Ni and Ti) or another shape memory alloy. In some embodiments, the needle 202 may be made from a resilient alloy of stainless steel or a suitable synthetic material. The resiliency of the needle 202 may allow it to return to the curved, rest position shown in FIG. 3 after it has been straightened, for example, to pass through the working channel 18 as described herein.

[0022] FIG. 4A illustrates one embodiment of the grasper device 204 grasping the back end 208 of the needle 202. Some components of the grasper device 204 are also illustrated in FIG. 2. The grasper device 204 may comprise a collet 250 positioned within a collet lumen 256. On its distal-facing end, the collet 250 may comprise a plurality of fingers 252. The proximal portions of the fingers 252 may merge into a flexible, collet shaft 254 that may extend proximally through the collet lumen 256. When the collet 250 is extended distally relative to the collet lumen 256, such that the fingers 252 clear the collet lumen 256, the fingers 252 may be separated from one another such that there is an opening between them. When the collet 250 is retracted proximally relative to the collet lumen 256, the collet lumen 256 may exert a force on the collet 250, causing the fingers 252 to close. In this way, the collet 250 may be used as a grasper to grasp the needle 202.

[0023] The collet 250 and collet lumen 256 may be actuated by the clinician to open and close the fingers 252 according to any suitable manner. For example, FIG. 4B illustrates one embodiment of a surgical instrument 400 comprising the grasper device 204, a shaft assembly 402 and a handle or hand piece 404. The hand piece 404 may be configured to be grasped by the clinician. In at least one embodiment, the hand piece 404 may comprise a pistol grip including a stationary member 406 and movable member, or trigger 408. In use, the trigger 408 may be moved toward the stationary member 406 as indicated by arrow 410, for example, in order to operate the grasper device 204 within a surgical site. The collet shaft 254 may extend proximally from the collet fingers 252 to the trigger 408. When the trigger 408 is moved toward the stationary member 406, it may cause a distally directed force to be exerted on the collet shaft 254. This may force the collet 250 in a distal direction relative to the collet lumen 256, causing the collet fingers 252 to open. The clinician may close the collet fingers 252 by moving the trigger 408 away from the stationary member 406. This may tend to pull the collet shaft 254 in a proximal direction relative to the collet lumen 256, which may pull the collet 250 into the collet lumen 256, causing the fingers 252 to close.

[0024] The grasper device 204 (e.g., the collet 250 and the collet lumen 256) may be slidably coupled within an outer lumen 258. Referring to FIG. 4B, the clinician may be able to slide the outer lumen 258 relative to the working channel 18 of the endoscope 14 and relative to grasper device 204. For example, near the position of the handle 404, the outer lumen 258 may be coupled to pair of loops 412 or other suitable control mechanism. The clinician may grasp the loops 412 and the handle 404 to change the relative positions of the outer lumen 258 and the grasper device 204. The clinician may also use the loops 412 to change the relative position of the outer lumen 258 and the working channel 18 of the endoscope 14 (not shown in FIG. 4B). In use, when the needle 202 is grasped by the grasper device 204, the grasper device 204 and the needle 202 may be retracted proximally relative to the outer lumen 258. This may bring the needle 202 within the walls of the outer lumen 258, which may force the needle 202 from its curved, rest position into a straight position. In some example embodiments, the outer lumen 258 may be omitted. For example, the walls of the working channel 18 may serve to straighten the needle 202. Also, for example, an accessory channel provided outside of the working channel 18 may be used to serve the function of the outer lumen 258.

[0025] FIGS. 5A-5F illustrate one embodiment of a process for placing a stitch using the needle 202 and grasper device 204 described above. FIG. 5A illustrates one embodiment of the distal end 16 of the endoscope 14 in proximity to tissue 500 having a wound 502 to be sutured. The wound 502 may be, for example, an ulcer, incision or any other opening to be closed. The outer lumen 258 may be extended distally from the working channel 18 to be near or in contact with the tissue 500. Although the grasper device 204 is not visible in FIG. 5A, it may be positioned within the outer lumen 258. Also, for example, the needle 202 may be secured in the grasper device 204. The walls of the outer lumen 258 may hold the needle 202 in a straight position. When the outer lumen 258 is in position, as shown in FIG. 5A, the clinician may extend the needle 202 into the tissue 500, as shown, by extending the grasper device 204 distally relative to the outer lumen 258.

[0026] FIGS. 5B and 5C illustrate one embodiment of the needle 202 being pushed through the tissue 500. For example, the clinician may continue to extend the grasper device 204, and therefore the needle 202, distally within the outer lumen 258. As the needle 202 exits the outer lumen 258 and enters the tissue 500, it may tend to bend into its resting, curved shape, as shown. As more of the needle 202 enters the tissue, the curvature may increase, until the needle 202 bends back on itself and begins to exit the tissue 500, as shown in FIG. 5C.

[0027] FIG. 5D illustrates one embodiment of the needle 202 after it has been released by the grasper device 204. When the needle 202 is fully extended into the tissue 500, the grasper device 204 may extend distally from the lumen 258 as shown. The clinician may then cause the grasper device 204 to release the needle 202. For example, the collet 250 may be extended distally relative to the collet lumen 256 (not shown in FIG. 5D) causing the fingers 252 to release, thus releasing the grip on the needle 202. The needle 202 may remain embedded in the tissue 500 as shown. The suture 210, as shown in FIG. 5D, may extend proximally, for example, through the working channel 18. According to various embodiments, the collet 250 may have a hollow center allowing, the suture 210 to extend proximally through the collet 250.

[0028] After the needle 202 is released, the clinician may cause the grasper device 204 to grasp the leading end 206 of the needle 202, as shown in FIG. 5E. The grasper device 204 may then be retracted proximally relative to the outer lumen 258. This may cause the needle 202 to be pulled proximally out of the tissue 500 and into the outer lumen 258. Accordingly, the suture 210 may form a stitch tending to close the wound 502. FIG. 5F illustrates one embodiment where the needle 202 is retracted into the outer lumen 258 as described. To begin a new stitch, the needle 202 may be pulled proximally out of the working channel 18. The needle 202 may then be reloaded into the working channel 18 or other access device (e.g., trocar, accessory channel, etc.) with the leading edge 206 facing distally. At that point, a new stitch may be placed, for example, as illustrated in FIGS. 5A-5F.

[0029] FIG. 6 illustrates one embodiment of a double-pointed needle 600 that may be used with the grasper device 204 to place a stitch, for example, as described herein. The needle 600 may comprise two leading ends 602, each defining a point for piercing tissue. A suture hole 604 threaded with suture 210 is shown at approximately the mid-point of the needle 600. It will be appreciated, however, that the suture hole 604 may be positioned at any point in the needle 600. The needle 600 may be used to place a stitch in a manner similar to that described above with respect to FIGS. 5A-5F. It may not be necessary, however, to retract the needle 600 from the proximal end of the endoscope 14 after every stitch to turn it around. Because the needle 600 comprises two leading ends 602, it may always have one leading end 602 facing distally when it is in within the lumen 258. Accordingly, after being removed from the tissue 500 in a manner similar to that shown in FIG. 5F, the needle 600 may be retracted into the lumen 258 far enough to allow the lumen 258 to straighten the needle 600. Then the needle 600 may be used to place another stitch, this time with the opposite leading end 602 entering the tissue 500 first.

[0030] FIG. 7 illustrates one embodiment of a grasper device 704 and a portion of a needle 700 having corresponding gripping features. FIG. 8 is a full view of one embodiment of the needle 700. The needle 700 may have a leading end 702 and a back end 705. A suture hole 706 may be optionally placed at the back end 705, as shown in FIG. 8. Also at the back end 705, the needle 700 may have a collar 708 extending around the needle shaft. The grasper device 704 may have corresponding grooves 756, formed as a concave feature, in the fingers 752 of its collet 750. Accordingly, when the grasper device 704 grips the back end 705 of the needle 700, the grooves 756 may receive the collar 708. In this way, the grasper device 704 may obtain an improved grip on the needle 700 during the stitching process. In addition to, or instead of, the collar 708, the needle 700 and/or fingers 752 may include other gripping features including, for example, textured, friction-enhancing surfaces, or features having various other shapes.

[0031] FIGS. 9 and 10 illustrate a needle 900 and grasper device 904 with another embodiment of a gripping feature. The needle 900 may have a leading end 902 and a back end 905. A suture hole 906 may be positioned at the back end 905 as shown, or at any other location on the needle 900. The needle 900 may also have a rounded or ball shaped feature 908 at its back end 905. The grasper device 904 may have a pair of jaw members 920 defining concave openings 922 configured to receive the ball 908. When the needle 900 is grasped by the jaw members 920, the ball 908 and cavities 922 may tend to improve the grip of the jaws 920 on the ball 908. Also, because of the round shape of the ball 908, the needle 900 may be free to pivot relative to the jaws 920 even when the jaws 920 are in a closed position.

[0032] The grasper device 904 illustrated in FIG. 9 utilizes a set of jaws 920 instead of the collets and collet lumens described above. The jaws 920 may be actuated by the clinician according to any suitable manner. For example, FIG. 11 illustrates an embodiment of a surgical instrument 1100 comprising the grasper device 904, a shaft assembly 1102 and a hand piece 1104. The hand piece 1104 may be configured to be grasped by the clinician and, in at least one embodiment, the hand piece 1104 may comprise a pistol grip including a stationary member 1106 and a movable member, or trigger 1108. In use the trigger 1108 may be moved toward the stationary member 1106 as indicated by arrow 1107, for example, in order to operate the grasper device 904 within a surgical site. In various embodiments, referring to FIG. 12, the jaw members 920 may be movably coupled to a housing, or clevis 1202 such that they may be moved, or pivoted, between open and closed positions about pivot pin 1204. In use, the jaw members 920 may be positioned in their closed, or at least partially closed, positions before they are inserted into a surgical site through a trocar or endoscope working channel 18, for example. Once positioned within the surgical site, the jaw members 920 may then be reopened. According to various embodiments, the shaft 1102 may be positioned within both the working channel 18 and the outer lumen 258, allowing the grasper device 904 to slide axially within the outer lumen 258, as described above.

[0033] In order to move the jaw members 920 between their open and closed positions, the trigger 1108 of the hand piece 1104 may be pivoted relative to the stationary member 1106 such that the trigger 1108 may displace an actuator, or rod 1110 relative to shaft 1102. In various embodiments, the actuator rod 1110 may be round, or any other suitable shape, and may be either solid or tubular. For example, the actuator rod 1110 may be hollow to allow suture to extend proximally therethrough. In either event, referring to FIG. 12, the actuator rod 1110 may be operably engaged with an actuator 1206 such that, when the trigger 1108 is pivoted toward the stationary member 1106 as described above, the actuator rod 1110 and the actuator 1206 may be slid proximally such that the actuator 1206 pulls on jaw links 1208 and 1210. When the jaw links 1208 and 1210 are pulled proximally, the jaw links 1208 and 1210 may apply a force to the jaws 920 such that they are pivoted about pivot pin 1204 into their closed state. In order to move jaws 920 into their open positions, the trigger 1108 may be moved away from the stationary member 1106 and, correspondingly, the actuator rod 1110 and the actuator 1206 may be moved distally by the trigger 1108. Similarly, the actuator 1206 may move links 1208 and 1210 distally such that the links 1208 and 1210 apply a force to jaws 920 and rotate them about pivot pin 1204 in the opposite, or open, direction. According to various embodiments, the instrument 1100 may also comprise a rotation knob 1112. The clinician may rotate the knob 1112 to cause the shaft 1102 and the grasper device 904 to rotate relative to the handle. FIG. 12 also illustrates the outer lumen 258 and loops 412 described above with respect to FIG. 4B. It will be appreciated that the outer lumen 258 may be used with the grasper device 904 in the same way that it is described above in use with the grasper device 204.

[0034] Various embodiments are described herein with a jaw-based grasper device 904 and a collet-based grasper device 204, 704. It will be appreciated, however, that any of the embodiments described herein may be implemented with any suitable style of grasper device including, for example, a collet-based or a jaw-based grasper device. For example, the needle 700 could alternately be used with a jaw-based grasper device, where the jaws may have grooves for receiving the collar 708 (e.g., similar to the grooves 756 in the collet fingers 752 of the collet 750). Also, for example, the needle 900 could alternately be used with a collet-based grasper device where the collet fingers define a cavity corresponding to the shape of the ball 908.

[0035] FIG. 13 illustrates one embodiment of a flexible jointed needle 1300. The needle 1300 may comprise straight sections 1306 connected by curved sections 1304. Although four curved sections 1304 and four straight sections 1306 are shown, it will be appreciated that any suitable number of curved and straight sections, and hence, any suitable polygonal shape may be used. In some example embodiments, the curved sections 1304 and the straight sections 1306 may be made from the same material (e.g., nitinal, or another resilient material as described above). Also, in other example embodiments, the curved sections 1304 may be made from a resilient material while the straight sections 1306 may be made from another material (e.g., a less expensive material). The needle 1300 may be capable of being substantially straightened, for example, by straightening the curved sections 1304. Accordingly, the needle 1300 may be used with any of the grasper assemblies 204, 704, 902 described above. Although the needle 1300 is pictured with two leading edges 1302, it will be appreciated, that a jointed needle may be provided with a leading edge 1302 and a back end (not shown) for example, similar to the needles 202, 700 and 900 described above.

[0036] In various embodiments, surgical instruments utilizing various embodiments of the needles 202, 700, 900, 1300 and/or grasper assemblies 204, 704, 904 may be employed in conjunction with a flexible endoscope, such as a GIF-100 model available from Olympus Corporation, for example. In at least one such embodiment, the endoscope, a laparoscope, or a thoracoscope, for example, may be introduced into the patient trans-anally through the colon, the abdomen via an incision or keyhole and a trocar, or trans-orally through the esophagus, for example. These devices may assist the clinician to guide and position the grasper assemblies and/or needles near the tissue treatment region to treat diseased tissue on organs such as the liver, for example. In another embodiment, these devices may be positioned to treat diseased tissue near the gastrointestinal (GI) tract, esophagus, and/or lung, for example. In various embodiments, the endoscope may comprise a flexible shaft where the distal end of the flexible shaft may comprise a light source, a viewing port, and at least one working channel. In at least one such embodiment, the viewing port may transmit an image within its field of view to an optical device such as a charge coupled device (CCD) camera within the endoscope, for example, so that an operator may view the image on a display monitor (not shown).

[0037] It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician manipulating an end of an instrument extending from the clinician to a surgical site (e.g., through a trocar, through a natural orifice, through an open surgical site, etc.). The term “proximal” refers to the portion closest to the clinician, and the term “distal” refers to the portion located away from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0038] While several embodiments have been illustrated and described, and while several illustrative embodiments have been described in considerable detail, the embodiments are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. Those of ordinary skill in the art will readily appreciate the different advantages provided by these various embodiments.

[0039] While several embodiments have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the embodiments. For example, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope of the appended claims.

[0040] The devices disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either case, however, the device may be reconditioned for reuse after at least one use. Reconditioning may include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device may be disassembled, and any number of particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device may utilize a variety of different techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0041] Preferably, the embodiments described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that may penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument may then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

[0042] Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials do not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

[0043] The embodiments are not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the scope of the claims. Accordingly, it is expressly intended that all such equivalents, variations and changes that fall within the scope of the claims be embraced thereby.

[0044] In summary, numerous benefits have been described which result from employing the concepts described herein. The foregoing description of the one or more embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or limiting to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more embodiments were chosen and described in order to illustrate principles and practical applications to thereby enable one of ordinary skill in the art to utilize the various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the claims submitted herewith define the overall scope.