The present disclosure relates to methods and apparatus for manipulating and/or securing tissue. More particularly, the present disclosure relates to methods and apparatus for manipulating and/or securing tissue endoscopically and/or endolumenally, for instance, to form tissue folds, to approximate regions of tissue, and/or to deploy tissue anchors.
A number of surgical techniques have been developed to treat various gastrointestinal disorders. One example of a pervasive disorder is morbid obesity. Conventional surgical treatment for morbid obesity typically includes, e.g., bypassing an absorptive surface of the small intestine, or reducing the stomach size. However, many conventional surgical procedures may present numerous life-threatening post-operative complications, and may cause atypical diarrhea, electrolytic imbalance, unpredictable weight loss and reflux of nutritious chyme proximal to the site of the anastomosis.
Furthermore, the sutures or staples that are often used in surgical procedures for gastrointestinal disorders typically require extensive training by the clinician to achieve competent use, and may concentrate significant force over a small surface area of the tissue, thereby potentially causing the suture or staple to tear through the tissue. Many of the surgical procedures require regions of tissue within the body to be approximated towards one another and reliably secured. The gastrointestinal lumen, for instance, includes four tissue layers, where the mucosa layer is the inner-most tissue layer followed by connective tissue, the muscularis layer, and where the serosa layer is the outer-most tissue layer.
One problem with conventional gastrointestinal reduction systems is that the anchors (or staples) should engage at least the muscularis tissue layer in order to provide a proper foundation. In other words, the mucosa and connective tissue layers typically are not strong enough to sustain the tensile loads imposed by normal movement of the stomach wall during ingestion and processing of food. In particular, these layers tend to stretch elastically rather than firmly hold the anchors (or staples) in position, and accordingly, the more rigid muscularis and/or serosa layer should ideally be engaged. This problem of capturing the muscularis or serosa layers becomes particularly acute where it is desired to place an anchor or other apparatus transesophageally rather than intra-operatively, since care must be taken in piercing the tough stomach wall not to inadvertently puncture adjacent tissue or organs.
One conventional method for securing anchors within a body lumen to the tissue is to utilize sewing devices to suture the stomach wall into folds. This procedure typically involves advancing a sewing instrument through the working channel of an endoscope and into the stomach and against the stomach wall tissue. The contacted tissue is then typically drawn into the sewing instrument where one or more sutures or tags are implanted to hold the suctioned tissue in a folded condition known as a plication. Another method involves manually creating sutures for securing the plication.
One of the problems associated with these types of procedures is the time and number of intubations needed to perform the various procedures endoscopically. Another problem is the time required to complete a plication from the surrounding tissue with the body lumen. In the period of time that a patient is anesthetized, procedures such as for the treatment of morbid obesity, revision of obesity procedures, or for GERD must be performed to completion. Accordingly, the placement and securement of the tissue plication should ideally be relatively quick and performed with a high degree of confidence.
Another problem with conventional methods involves ensuring that the staple, knotted suture, or clip is secured tightly against the tissue and that the newly created plication will not relax under any slack which may be created by slipping staples, knots, or clips. Other conventional tissue securement devices such as suture anchors, twist ties, crimps, etc. are also often used to prevent sutures from slipping through tissue. However, many of these types of devices are typically large and unsuitable for low-profile delivery through the body, e.g., transesophageally.
Moreover, when grasping or clamping onto or upon the layers of tissue with conventional anchors, sutures, staples, clips, etc., many of these devices are configured to be placed only after the tissue has been plicated and not during the actual plication procedure.
In one general aspect, devices according to the present invention include mechanisms for deploying tissue anchors and tissue anchor assemblies into and/or through tissue within a patient. In some embodiments, the devices are introduced endolumenally (e.g., transorally, transanally, etc.) into the patient's body and into or around the gastrointestinal (“GI”) tract. Once the instruments are positioned within the stomach or other target site, tissue at the target site is temporarily engaged or grasped and the engaged tissue is manipulated by a surgeon or practitioner from outside the patient's body.
In engaging, manipulating, and/or securing the tissue, various methods and devices may be implemented. For instance, tissue securement devices may be delivered and positioned via an endoscopic apparatus for contacting a tissue wall, creating one or more tissue folds, and deploying one or more tissue anchors through the tissue fold(s). The tissue anchor(s) may be disposed through the muscularis and/or serosa layers of the tissue. An endoscopic access device having an elongate body, a steerable distal portion, and multiple lumens defined therethrough may be advanced into a patient per-orally and through the esophagus. A tissue manipulation assembly positioned at the distal end of a tubular body may be passed through the endoscopic access device for engaging and securing the tissue.
Utilizing one or more of the instruments, the endoscopic access device may be used to pass the flexible body therethrough and into the stomach where it may be used to engage tissue and form folds, invaginations, or other reconfigurations of tissue which are secured via expandable tissue anchors expelled from the tissue manipulation assembly. Any number of tissue folds and/or invaginations, i.e., one or more, may be created.
In an embodiment, a delivery catheter is advanced through a patient's mouth and esophagus and into the patient's stomach or other target site, with the delivery catheter including a flexible tube having a needle at its distal end and with a first tissue anchor assembly being contained within the flexible tube of the delivery catheter. One or more instruments associated with the delivery catheter are used to form a first tissue fold in the tissue at the target site, the tissue fold preferably including a serosa-to-serosa contact of tissue on the peritoneal surface of the tissue. The needle of the delivery catheter is passed through the first tissue fold, and a first tissue anchor assembly is deployed from the delivery catheter through the first tissue fold to thereby secure the first tissue fold. A plurality of additional tissue folds may be also secured in the tissue.
In some embodiments, the devices and systems include an endoscopic access device, a tissue manipulation assembly, and a needle deployment assembly containing a tissue anchor or tissue anchor assembly. The tissue manipulation assembly includes a handle having several optional features and functions, including a handle stop member for preventing actuation of the handle under certain circumstances, a needle stop member for preventing advancement of the needle deployment assembly under certain circumstances, a pin and track mechanism that defines a series of handle actuation steps corresponding to deployment steps for the tissue manipulation assembly and the needle deployment assembly, and others.
Endoscopic and endolumenal surgical methods and devices are described herein. In several embodiments, the methods entail performing surgery through a patient's mouth or other natural orifices, reducing or eliminating the need for external incisions into the body. Operating through the body's natural orifices offers promise for faster healing times, less scarring and less pain which could lead to reduced hospitalization and quicker recovery.
USGI Medical, Inc. of San Clemente, Calif. has developed several devices and methods that facilitate endoscopic and endolumenal diagnostic and therapeutic procedures. Several endoscopic access devices are described, for example, in the following United States patent applications:
Several tissue manipulation and tissue anchor delivery devices are described in the following United States patent applications:
Endolumenal tissue grasping devices are described in several of the United States patent applications listed above, and in the following United States patent applications:
Tissue anchors are described in several of the United States patent applications listed above, and in the following United States patent applications:
Each of the foregoing patent applications is hereby incorporated by reference in its entirety.
Several endoscopic and/or endolumenal therapeutic procedures described in the above patent applications include the steps of acquiring (e.g., grasping) tissue to form a tissue fold and deploying or implanting a fold retaining device (e.g., a tissue anchor assembly) that is used to maintain the fold. Other such procedures include the steps of grasping at least two sections of tissue, approximating the at least two sections of tissue, and deploying or implanting a tissue retaining device (e.g., a tissue anchor assembly) that is used to maintain the at least two sections of tissue in their approximated state. For simplicity, the discussion herein will describe tissue anchor assemblies holding tissue folds, with it being understood that other portions or sections of tissue that do not constitute tissue folds are suitably retained by the tissue anchor assemblies. The following sections include descriptions of several embodiments of devices that are suitable for performing these and other endoscopic and/or endolumenal surgical procedures.
A tissue anchor assembly is used to maintain a tissue fold in tissue such as that present in the gastrointestinal lumen. Suitable tissue anchor assemblies include tissue anchors such as those described in several of the United States patent applications incorporated by reference above, including Ser. Nos. 10/841,411, 11/404,423, and 11/773,933. A schematic representation of a suitable tissue anchor assembly 48 is shown in
Preferably, the tissue anchor assemblies include a pair of tissue anchors 50a, 50b slidably retained by a connecting member, such as a suture 52. A locking mechanism, such as a cinch 62, is also slidably retained on the suture 52. The cinch 62 is configured to provide a cinching force against the anchors 50a, 50b in order to impart a tension force on the suture. Accordingly, the tissue anchor assembly 48 is adapted to hold a fold F of tissue T, as shown in
The cinch 62 functions by providing unidirectional translation over the suture thereby providing the ability to advance the tissue anchor(s) 50 into apposition and to retain the anchor(s) in place. An embodiment of a cinch 62 is shown in
In other embodiments of the cinch 62, the levers 65 are substantially rigid, and do not pivot or deflect. In those embodiments, the levers 65 create a sufficiently tortuous path for the suture 52 (or other connector) to traverse that the cinch effectively binds the suture from translating in the first direction, while allowing translation in the second direction.
The cinches 62 described herein are formed of biocompatible and/or bioabsorbable materials such as those described above. In several embodiments, the cinch is formed of nickel-titanium alloy (Nitinol). The size and shape of the cinch are primarily dependent upon the size and shape of the other parts of the tissue anchor assembly, such as the diameter and materials forming the suture 52 (or other connector) and/or the size of the passage in the tissue anchors 50. Additional embodiments of cinches and additional cinching mechanisms suitable for use in the tissue anchor assemblies 48 are described and illustrated in U.S. patent application Ser. Nos. 10/612,170; 10/840,950; 10/840,951; 10/841,245; 10/841,411; 10/865,736; 11/036,866; 11/036,946; and 11/404,423, each of which is hereby incorporated by reference in its entirety (including all references cited therein) as if fully set forth herein.
An illustrative side view of a tissue plication assembly 10 which may be utilized with the tissue anchors described herein is shown in
A tissue manipulation assembly 14 is located at a distal end of the tubular body 12 and is generally used to contact and form the tissue plication, as mentioned above.
The upper bail 20 is shown in the figure as an open looped member and the lower bail 26 is shown as a solid member; however, this is intended to be merely illustrative and either or both members may be configured as looped or solid members. A tissue acquisition member 28 may be an elongate member, e.g., a wire, hypotube, etc., which terminates at a tissue grasper or engager 30, in this example a helically-shaped member, configured to be reversibly rotatable for advancement into the tissue for the purpose of grasping or acquiring a region of tissue to be formed into a plication. The tissue acquisition member 28 may extend distally from the handle 16 through the body 12 and distally between the upper bail 20 and the lower bail 26. The tissue acquisition member 28 may also be translatable and rotatable within the body 12 such that the tissue engager 30 is able to translate longitudinally between the upper bail 20 and the lower bail 26. To support the longitudinal and rotational movement of the acquisition member 28, an optional guide or linear bearing 32 may be connected to the upper 20 or lower bail 26 to freely slide thereon. A guide 32 may also be slidably connected to the acquisition member 28 such that the longitudinal motion of the acquisition member 28 is supported by the guide 32.
A needle deployment assembly 650 may be deployed through the tissue plication assembly 10 by introducing the needle deployment assembly 650 into the handle 16 and through the tubular body 12, as shown in the assembly view of
Additional details concerning the structure and function of the tissue plication assembly 10 and needle deployment assembly 650 shown in
Turning next to
The launch tube 918 extends from a proximal launch tube control 919 to the tissue manipulation assembly 914 and in-between the arms of an upper extension member or bail 920. The launch tube 918 defines a launch tube opening 924 and is pivotally connected near or at its distal end via a hinge or pivot 922 to the distal end of the upper bail 920. A lower extension member or bail 926 similarly extends distally in a longitudinal direction substantially parallel to the upper bail 920. The upper bail 920 and lower bail 926 need not be completely parallel so long as an open space between the upper bail 920 and lower bail 926 is sufficiently large enough to accommodate the drawing of up to several layers of tissue between the two members. The upper bail 920 and/or lower bail 926 may similarly be configured as practicable in any of the bail variations described herein or in the applications incorporated by reference herein.
A tissue acquisition member 928 may be an elongate member, e.g., a wire, hypotube, etc., or any of the variations as described herein, which terminates at a tissue grasper or engager 930, in this example a helically-shaped member configured to be reversibly rotatable for advancement into the tissue, for the purpose of grasping or acquiring a region of tissue to be formed into a plication. Alternatively, the tissue grasper or engager 930 may be formed in any of the tissue grasping variations as described herein. The tissue acquisition member 928 extends distally from the tissue acquisition control 916 through a working channel 1002 of the endoscope 1000 and distally between the upper bail 920 and lower bail 926. The tissue acquisition member 928 is translatable and rotatable within the working channel 1002 such that the tissue engager 930 is able to translate longitudinally and rotate between the upper bail 920 and lower bail 926. To support the longitudinal and rotational movement of the acquisition member 928, an optional guide or linear bearing (not shown) may be connected to the upper bail 920 or lower bail 926 to freely slide thereon. The guide may also be slidably connected to the tissue acquisition member 928, such that the longitudinal motion of the tissue acquisition member 928 is supported by the guide.
It is expected that reversibly attaching the tissue plication apparatus 900 to a standard endoscope 1000 will reduce a cross-sectional profile of the composite apparatus, as compared to providing an endoscope and tissue plication apparatus that do not attach to one another. The composite profile may be reduced to roughly that of the endoscope 1000. This is achieved by utilizing the working channel 1002 of the endoscope 1000 for advancement of the tissue acquisition member 928, and by obviating a need for a stand-alone catheter body for the apparatus 900. Furthermore, the endoscope 1000 may facilitate positioning of the apparatus 900 at a tissue site of interest by utilizing the steering capabilities of the endoscope 1000.
It is expected that providing a fixed distance between the distal end of the endoscope 1000 and the distal end of the assembly 914 may facilitate direct visualization via the endoscope 1000. Furthermore, a fixed distance may facilitate actuation of the launch tube 918, delivery of the needle 954 across the bails 920 and 926, and/or deployment of the anchor assemblies across tissue folds. Thus, tissue manipulation assembly 914 optionally may be reversibly coupled to a distal region of the endoscope 1000. For example, a proximal extension of the assembly may be positioned within a distal end of the endoscope working channel 1002, as described in more detail in U.S. application Ser. No. 11/002,369, filed Dec. 1, 2004, which is hereby incorporated by reference herein.
The launch tube 918 is typically configured to partially translate relative to the tissue manipulation assembly 914, e.g., via the launch tube control 919, such that a distal portion of the launch tube 918 may be articulated perpendicularly or transverse to tissue drawn between the bails 920 and 926. Thus, in this particular variation, at least a portion of the launch tube 918, or an actuator, preferably translates relative to the endoscope 1000. The connectors 912 may, for example, comprise through-holes or lumens through which the launch tube 918 is translationally disposed. In such a configuration, the connectors may, for example, comprise rigid connectors that are molded or machined, and then advanced over the endoscope 1000. The launch tube 918 then may be advanced through the lumens or through-holes of the connectors.
Alternatively or additionally, the launch tube 918 may comprise coaxially-disposed inner and outer tubes. The outer tube may be statically coupled to the connectors 912, and thereby the endoscope 1000, while the inner tube may be configured to translate relative to the outer tube. In this manner, the inner tube may partially translate relative to the tissue manipulation assembly 914. Additional methods and apparatus for translating the launch tube 918, per se known, will be apparent.
With the launch tube 918 articulated perpendicularly or transverse to tissue drawn between the bails 920 and 926, a needle 954 of a needle assembly 948 (e.g., previously described needle assembly 48) may be advanced through the lumen of the launch tube 918 via manipulation from its proximal end at the launch tube control 919 through a delivery push tube or catheter 964. The needle 954 preferably is a hollow needle having a tapered or sharpened distal end to facilitate its travel into and/or through tissue. The needle 954 may define a needle lumen through which, e.g., basket anchor assembly 66 may be situated during deployment and positioning of the assembly. An anchor push tube 978, disposed within the push tube 964 and needle assembly 948, may be used to deploy the basket anchor assembly 66 from the needle 954, as described above.
In
All, or a portion of, the apparatus 900 may be configured for single-use, i.e., may be disposable. Alternatively or additionally, all, or a portion of, the apparatus 900 may be configured for sterilization and re-use. The apparatus 900 optionally may be reversibly attached to alternative endoscopic or laparoscopic tools to achieve tissue folding.
Turning next to the device embodiments shown in
In manipulating tissue or creating tissue folds, a device having a distal end effector may be advanced endoscopically or endolumenally, e.g., transorally, transgastrically, etc., into the patient's body, e.g., the stomach. The tissue may be engaged or grasped and the engaged tissue may be manipulated by a surgeon or practitioner from outside the patient's body. Examples of creating and forming tissue plications are described in further detail in U.S. patent application Ser. No. 10/955,245, filed Sep. 29, 2004, which is incorporated herein by reference, as well as U.S. patent application Ser. No. 10/735,030, filed Dec. 12, 2003, which is also incorporated herein by reference in its entirety.
In engaging, manipulating, and/or securing the tissue, various methods and devices may be implemented. For instance, tissue securement devices may be delivered and positioned via an endoscopic apparatus for contacting a tissue wall of the gastrointestinal lumen, creating one or more tissue folds, and deploying one or more tissue anchors through the tissue fold(s). The tissue anchor(s) may be disposed through the muscularis and/or serosa layers of the gastrointestinal lumen.
The delivery device 208 shown in
For example, in some embodiments, the tubular body 212 has a composite construction that includes a first layer or multiple layers of braided wire or mesh and a second layer or multiple layers of a polymeric material such as polyurethane, nylon, polyester, Pebax (polyether block amide), or the like. An optional inner liner of polytetraflouroethylene (PTFE) may be provided to seal and/or to improve friction characteristics. The physical properties (e.g., hardness, stiffness) of a composite construction tubular body 212 will vary depending upon the materials used, the specific construction, and other factors.
In some embodiments, the tubular body 212 includes a proximal section having a first hardness and/or stiffness, and a distal section having a second hardness and/or stiffness that is lower than the hardness and/or stiffness of the proximal section. In these embodiments, the proximal section corresponds with a portion of the tubular body 212 that traverses a relatively non-tortuous path (e.g., through the relatively straight esophagus), and the distal section corresponds with a portion of the tubular body 212 that traverses a relatively tortuous path (e.g., bending regions of the tubular body or endoscopic access device that are guided or steered to reach portions of the stomach, colon, peritoneum, etc.). In this way, the tubular body 212 provides improved maneuverability during deployment, either as a standalone instrument or as deployed through a channel of an endoscopic access device. In particular, a distal section having a relatively lower hardness and/or stiffness will provide an improved capability to be rotated around its longitudinal axis within the channel of an endoscopic access device in comparison to a distal section having a relatively higher hardness and/or stiffness.
In a preferred embodiment, the proximal and distal sections are each formed as composite tubes including an inner liner of PTFE, a layer of stainless steel wire braid, and a layer of Pebax block copolymer. The proximal section includes a braid wire formed from round wire having a diameter of from about 0.004″ to about 0.008″ and having from about 30 picks per inch (“ppi”) to about 60 ppi, and a layer of Pebax having a Shore D hardness of from about 30 to about 45, and/or a flexural modulus (ASTM D 790) of from about 72 MPa to about 87 MPa. The distal section includes a braid wire formed from round wire having a diameter of from about 0.004″ to about 0.008″ and having from about 45 ppi to about 75 ppi, and a layer of Pebax having a Shore D hardness of from about 20 to about 35, and/or a flexural modulus (ASTM D 790) of from about 15 MPa to about 28 MPa. Those skilled in the art will recognize that other combinations of materials, material properties, and constructions of the tubular body 212 are possible. Moreover, those skilled in the art will recognize that sections additional to the proximal section and distal section may be added, with each section having different performance characteristics, in order to obtain desired performance.
A tissue manipulation end effector 214 is located at the distal end of the tubular body 212 and is generally used to contact and form tissue folds and/or to otherwise bring portions of tissue into apposition. The end effector is also shown in
A launch tube 228 extends from the handle 216, through the tubular body 212, and distally from the end of the tubular body 212 where a distal end of the launch tube 228 is pivotally connected to the upper jaw member 222 at a launch tube pivot 230. A distal portion of the launch tube 228 may be pivoted into position within a channel or groove defined in upper jaw member 222, to facilitate a low-profile configuration of tissue manipulation end effector 214. When articulated, either via the launch tube 228 or other mechanism, the jaw members 220, 222 may be urged into an open configuration to receive tissue in the opening between the jaw members 220, 222. (See, e.g.,
The launch tube 228 may be advanced from its proximal end at the handle 216 such that the portion of the launch tube 228 that extends distally from the body 212 is forced to rotate at a hinge or pivot 230 and reconfigure itself such that the exposed portion forms a curved or arcuate shape that positions the launch tube opening perpendicularly relative to the upper jaw member 222. (See, e.g.,
For example, turning to
The launch tube distal region 238 embodiment shown in
Turning next to
Finally, turning to
Returning again to
The elongate and flexible sheath or catheter 264 extends removably from the needle assembly control or housing 262. The sheath or catheter 264 and the housing 262 may be interconnected via an interlock 270 which may be adapted to allow for the securement as well as the rapid release of the sheath 264 from the housing 262 through any number of fastening methods, e.g., threaded connection, press-fit, releasable pin, etc. The needle body 272, which may be configured into any one of the variations described above, extends from the distal end of the sheath 264 while maintaining communication between the lumen of the sheath 264 and the needle opening 274.
An elongate pusher 276 comprises a flexible wire or hypotube that is translationally disposed within the sheath 264 and movably connected within the housing 262. A proximally-located actuation member 278 is rotatably or otherwise connected to the housing 262 to selectively actuate the translational movement of the elongate pusher 276 relative to the sheath 264 for deploying the anchors from the needle opening 274. The tissue anchor assembly 48 is positioned distally of the elongate pusher 276 within the sheath 264 for deployment from the sheath 264. Needle assembly guides 280 protrude from the housing 262 for guidance through the locking mechanism described above.
In several embodiments, the delivery device 210 and needle deployment assembly 260 are advanced into the gastrointestinal lumen using an endoscopic or endolumenal access system such as those described in the United States patent applications referenced above in Table 1. Examples of endoscopic and endolumenal access systems 290 are shown in
Turning to
The illustrated actuator mechanism 70 includes a main housing 72 and a handle body 74 that is pivotably attached to the main housing by a hinge pin 76, such that a user is able to grasp the main housing 72 and handle body 74 in one hand and actuate the mechanism by pulling the handle body 74 toward the main housing 72. A linkage arm 78 is interposed between the main housing 72 and the handle body 74, as discussed in more detail below. A nose cone 80 is attached to the distal end of the main housing 72 and surrounds the proximal end 82 of the tubular body 212.
In the embodiment shown, the proximal end 82 of the tubular body 212 is formed of a rigid material such as a rigid polymer material or stainless steel tubing. The remainder of the tubular body 212 is flexible and is formed of materials used to form the insertion portion of endoscopes and endoscopic devices. In alternative embodiments, the tubular body portion is formed of a composite tube that includes one or more polymeric materials (e.g., Pebax) and one or more braided layers (e.g., stainless steel or polymeric braid) to provide the tubular body 212 with improved torque transmission and resistance to stretching.
A needle deployment assembly actuation mechanism 90 includes a needle launch bushing 92, a needle launch button 94, and a needle launch track 96. The needle launch track 96 includes a plurality of substantially equally spaced, scallop-shaped cutouts 98 formed along the length of the track 96. More details of the structure and function of the needle deployment assembly actuation mechanism 90 is provided in the '578 application referenced above.
Turning next to
Turning to FIGS. 15 and 16A-B, another embodiment of an actuator mechanism 370 for a tissue anchor delivery device 208 is shown. The actuator mechanism 370 comprises another alternative embodiment to the handle 216 described above in relation to
Turning first to FIGS. 15 and 16A-B, the illustrated actuator mechanism 370 includes a main housing 372 and a handle body 374 that is pivotably attached to the main housing by a hinge pin 376, such that a user is able to grasp the main housing 372 and handle body 374 in one hand and actuate the mechanism by pulling the handle body 374 toward the main housing 372. A linkage arm 378 is interposed between the main housing 372 and the handle body 374, as discussed in more detail below. A nose cone 380 is attached to the distal end of the main housing 372 and surrounds the proximal end 82 of the tubular body 212.
A needle deployment assembly actuation mechanism 390 includes a needle launch button 394, and a needle launch track 396. The needle launch track 396 includes a plurality of substantially equally spaced, scallop-shaped cutouts 398 formed along the length of the track 396. More details of the structure and function of the needle deployment assembly actuation mechanism 390 are contained in U.S. patent application Ser. No. 12/486,578, which was incorporated by reference above.
As shown in
Additional details concerning the structure and function of the devices and methods described above in relation to FIGS. 13 through 20A-B are contained in U.S. patent application Ser. No. 12/486,578, filed Jun. 17, 2009, which is hereby incorporated by reference in its entirety.
Turning next to the device embodiments shown in
The tissue anchor delivery device 1208 shown in
The actuator component of the delivery device 1208 embodiments shown in
In the embodiments shown, the end effector 1214 includes a generally cylindrical base portion 1219, an upper extension 1220 extending generally distally away from the base portion 1219, and a lower extension 1222 also extending generally distally away from the base portion in a generally parallel relation with the upper extension 1220. The upper extension 1220 and lower extension 1222 thereby together define: (1) a tissue acquisition and folding space 1221 between the upper extension 1220 and lower extension 1222, and (2) a slot 1223 on each side of the end effector 1214 in communication with the tissue acquisition and folding space 1221.
A launch tube 1228 is attached to the end effector 1214 via a launch tube pivot 1230. The launch tube 1228 and launch tube pivot 1230 have a construction and features comparable to those of the launch tube 228 and pivot 230 for the embodiments described above in relation to FIGS. 7 through 20A-B. The launch tube 1228 is actuated by the actuator mechanism 1370 via a drive tube that causes the launch tube 1228 to selectively transform to the arcuate shape shown, for example, in
Turning to
Turning to
In the embodiments shown in
Turning next to
The deployment device 1208 embodiment shown in
The devices described herein are suitable for use in many diagnostic and therapeutic procedures in which tissue manipulation and securement is performed endoscopically or endolumenally. Examples of such procedures include endolumenal treatment of obesity (see, e.g., U.S. patent application Ser. No. 12/409,335, filed Mar. 23, 2009, and U.S. Provisional Patent Application Ser. No. 61/239,709, filed Sep. 3, 2009, each of which is hereby incorporated by reference), revision of obesity procedures (see, e.g., U.S. patent application Ser. No. 11/342,288, filed Jan. 27, 2006, hereby incorporated by reference), treatment of gastroesophageal reflux disease (GERD) (see, e.g., U.S. patent application Ser. No. 11/290,304, filed Nov. 29, 2005, hereby incorporated by reference), gastrotomy closure procedures (see, e.g., U.S. patent application Ser. No. 11/238,279, filed Sep. 28, 2005, hereby incorporated by reference), wound closure, fistula repair, and other procedures in which two or more portions of tissue are grasped, manipulated, approximated, or secured. Additional examples of procedures are described in the other patent applications incorporated by reference herein.
Although various illustrative embodiments are described above, it will be evident to one skilled in the art that various changes and modifications are within the scope of the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.
This application claims the benefit of priority to U.S. Provisional Patent Application No. 61/307,764, filed on Feb. 24, 2010, the contents of which are incorporated herein by reference in their entirety. This application also relates to the subject matter disclosed in the following U.S. Patent Application Ser. No. 61/432,537, filed Jan. 13, 2011, Ser. No. 12/486,578, filed on Jun. 17, 2009, Ser. No. 12/409,335, filed on Mar. 23, 2009, Ser. No. 61/239,709, filed on Sep. 3, 2009, Ser. No. 11/070,845, filed on Mar. 1, 2005, Ser. No. 11/002,369, filed on Dec. 1, 2004, and Ser. No. 10/955,245, filed on Sep. 29, 2004 (now U.S. Pat. No. 7,347,863). The contents of each of the foregoing patent applications are incorporated herein by reference in its entirety.
Number | Date | Country | |
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61307764 | Feb 2010 | US |