WO2004026348A2 - Instrument for applying a surgical fastener particularly for the transoral treatment of gastroesophageal reflux disease (gerd) - Google Patents
Instrument for applying a surgical fastener particularly for the transoral treatment of gastroesophageal reflux disease (gerd) Download PDFInfo
- Publication number
- WO2004026348A2 WO2004026348A2 PCT/US2003/029522 US0329522W WO2004026348A2 WO 2004026348 A2 WO2004026348 A2 WO 2004026348A2 US 0329522 W US0329522 W US 0329522W WO 2004026348 A2 WO2004026348 A2 WO 2004026348A2
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- WIPO (PCT)
- Prior art keywords
- jaws
- surgical instrument
- control element
- end effector
- fastener
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00818—Treatment of the gastro-intestinal system
- A61B2017/00827—Treatment of gastro-esophageal reflux
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2901—Details of shaft
- A61B2017/2905—Details of shaft flexible
Definitions
- the invention relates to surgical fasteners, endoscopic surgical instruments, and procedures. More particularly, the invention relates to surgical fasteners, endoscopic instruments, and procedures for the transoral plication and fastening together of portions of the stomach for the treatment of GERD.
- Gastroesophageal reflux disease or persistent heartburn is caused by an improper relaxation of the lower esophageal sphincter (LES) that allows the frequent regurgitation of acidic stomach contents into the esophagus. If left untreated, chronic reflux may cause esophageal stricture, bleeding ulcers, perforation, and scarring. Continued reflux may lead to Barrett's esophagus, which involves changes in the cells that make up the esophagus and may lead to cancer.
- GSD Gastroesophageal reflux disease
- LES lower esophageal sphincter
- the current mode of treatment is primarily pharmacological starting with antacids and progressing to proton pump inhibitors (PPIs) .
- PPIs proton pump inhibitors
- the progression of the disease is noted by the development of a hiatal hernia caused by the stomach being forced into the thoracic cavity.
- the pharmacological treatment ends with double and triple dosing of PPIs.
- surgical intervention is often recommended.
- the current standard for surgery is the Nissen fundoplication.
- the fundoplication procedure involves wrapping the fundus of the stomach around the lower end of the esophagus and fastening it in place to make the lower esophageal sphincter (LES) less compilable.
- the esophageal manipulator is used to pull the interior of the esophagus into the stomach.
- the stapler is moved into position around the lower end of the esophagus and the plicated fundus is stapled to the esophagus.
- the process is repeated at different axial and rotary positions until the desired fundoplication is achieved. While, the procedure disclosed by Harrison et al . is a vast improvement over open surgery, it is still relatively invasive requiring two incisions through the stomach.
- the invagination device is inserted first and is used to clamp the gastroesophageal junction.
- the device is then moved distally, pulling the clamped gastroesophageal junction into the stomach, thereby invaginating the junction and involuting the surrounding fundic wall.
- the stapler is then inserted transorally and delivered to the invaginated junction where it is used to staple the fundic wall.
- Bolanos et al. disclose several different invagination devices and several different staplers.
- each of the staplers disclosed by Bolanos et al. has an elongate body and a spring biased anvil which is rotatable approximately 15 degrees away from the body in order to locate the invaginated gastroesophageal junction between the body and the anvil.
- the body contains a staple cartridge holding a plurality of staples, and a staple firing knife.
- Each of the invagination devices disclosed by Bolanos et al . has a jaw member which is rotatable by at least 45 degrees and in some cases more than 90 degrees to an open position for grasping the gastroesophageal junction.
- U.S. Patent Number 6,086,600 to Kortenbach discloses an endoscopic surgical instrument adapted to perform fundoplication, between the stomach wall and the esophagus.
- the instrument includes a flexible tube, a grasping and fastening end effector coupled to the distal end of the tube, and a manual actuator coupled to the proximal end of the tube.
- the manual actuator is coupled to the end effector by a plurality of flexible cables which extend through the tube.
- the tube contains a lumen for receiving a manipulable endoscope and the end effector includes a passage for the distal end of the endoscope.
- the end effector has a store for a plurality of male fastener parts, a store for a plurality of female fastener parts, a rotatable grasper, a rotatable fastener head for aligning a female fastener part and a male fastener part with tissues therebetween, and a firing member for pressing a male fastener part through tissues grasped by the grasper and into a female fastener part.
- the overall diameters of the flexible tube and the end effector do not exceed approximately 20 mm so that the instrument may be delivered transorally to the fundus of the stomach.
- PCT WO 00/78227 (NDO Surgical Inc.) has disclosed a device sized to receive an endoscope and which is purportedly capable of plicating and damaging portions of the stomach wall to effect serosa-to-serosa contact which results in stomach wall tissue adhesion.
- compliance of the tissue about the esophagus would be reduced and a flap (i.e., valve) would be formed about the LES.
- the plication and adhesion should preferably be created at the horseshoe-shaped tissue in the stomach surrounding the LES.
- the distance from the Z line (esophageal/stomach borderline) to the horseshoe-shaped target tissue is approximately 1 to 3 cm into the stomach and plication at this location permits the greatest stress to be placed on the tissue about the LES.
- the device In order to approach plication at this location the device has a particularly complicated and unwieldy multi-component end effector adapted to grab tissue, plicate the tissue, and fasten the tissue together. That is, while the above referenced device appears to offer a solution, it may not be practical to implement mechanically or operate during the procedure.
- the above referenced device while respectfully having a relatively smaller diameter than other prior art (approximately 18 mm in diameter and 254 mm 2 in cross- sectional area) maintains that cross-sectional area over its entire length.
- the size of the device renders it difficult to traverse the tracheopharangeal passage.
- it is desirable to plicate the stomach wall in a direction parallel to the esophagus in order to satisfactorily reduce compliance of the tissue it is noted that the end effector of the above referenced device is unable to approach the target tissue from the desired direction.
- any fastener used for the apposition of tissue in the stomach cavity be removable in the event of tissue ischemia, vagus nerve irritation, or continued reflux, and be relatively non-injurious to the patient should the fastener inadvertently become loose from the device or dislodged from the tissue.
- current fasteners are difficult to locate within the stomach via an endoscope if it becomes necessary to find the fastener for removal.
- LES lower esophageal sphincter
- a two-part fastener and an instrument and system for application of the fastener to the stomach wall in a manner which effectively treats gastroesophageal reflux disease (GERD) are provided.
- GEF gastroesophageal reflux disease
- the fastener includes male and female parts which can be adjustably coupled together to define various spaces therebetween such that depending on the amount of tissue between the components a desired amount of force can be applied to the tissue therebetween by the fastener, i.e., such that the tissue does not necrose.
- the male part includes a plurality of tissue-piercing posts which are spring-biased to collapse into a base of the male part to prevent injury to the patient should the male part inadvertently become separated from its respective jaw prior to coupling with the female part or separated from the female part after coupling therewith.
- the female part is provided with a cover which shields the piercing tips of the posts after the male and female parts are coupled together.
- the fastener when in a fastened configuration may be unfastened by moving portions of the cover relative to each other. This can be performed, e.g., using a snare device to lasso the device and moves portions of the female part relative to each other.
- the instrument includes a relatively short distal end effector which may be coupled over a portion of the endoscope, a proximal actuation handle, and a relatively small diameter control shaft extending between the handle and the end effector.
- the control shaft extends from the handle of the instrument to the end effector, during use, the cross-sectional area of the system within the esophagus at all locations other than the distal end of the instrument, is substantially small (the sum of the areas of the endoscope and the control shaft); i.e., less than half that of other proposed systems.
- the system cross-sectional area is also smaller than that of prior art systems.
- the distal end effector may be provided with a sleeve that can be slidably positioned over the end of the endoscope and likewise slidably removed therefrom.
- the sleeve is preferably proximally and distally tapered to ease insertion into and removal from the esophagus.
- the distal end effector also includes a clevis about which a pair of rotatable jaws are coupled.
- the jaws are laterally displaced relative to the control shaft.
- the jaws are each adapted to each hold one part of the two-part fastener. When the jaws are in a closed position with the parts of the fastener located therebetween, the jaws extend substantially parallel to the longitudinal axis of the control shaft.
- the jaw assembly is fixed in a retroflexed or "looking back" arrangement, directed 180° from the distal end of the control shaft.
- the jaws and fastener parts together define posts adapted to grab the stomach tissue, pierce and damage the serosa of the stomach tissue, and plicate the stomach tissue when the jaws are moved from an open position to a closed position.
- the instrument includes a first control element that moves the jaws between open and closed positions, and a second control element that couples the fastener parts together and releases the fastener parts from the jaws.
- One embodiment of using the system includes sliding the sleeve of the instrument over the distal end of the endoscope and moving the sleeve to a central location on the scope.
- the endoscope is next inserted through the tracheoesophageal passage and into the stomach.
- the distal end of the instrument with the jaws in a closed low profile configuration, is then slid over the endoscope, through the tracheoesophageal passage, into the stomach, and off the distal end of the endoscope.
- the endoscope may be retroflexed during a portion of the insertion of the distal end of the instrument such that the instrument insertion is performed under view of the endoscope.
- the jaws of the instrument are then opened by actuation of the handle, and the handle and/or control shaft are pulled back to cause the open jaws to forcibly contact the stomach tissue surrounding the lower esophageal sphincter; i.e., the target tissue 1 cm to 3 cm into the stomach.
- a post on the female jaw and the posts of the male part of the fastener pierce the mucosa, deep muscle and/or serosa of the tissue.
- An endoscopic grasping instrument extending through the endoscope may be used in conjunction with the end effector to aid in pulling the target tissue between the jaws.
- the handle is then actuated to cause the jaws to move into a closed position, pulling into apposition two portions of the tissue to form a plication.
- the posts of the male part of the fastener extend through both layers of tissue at the ends of the plication and enter corresponding openings in the female part as the jaws are closed and the fastener is clamped, but not locked, about the tissue.
- the jaws can then be opened to apply a different clamping pressure to the tissue or entirely relocate the fastener.
- the handle is actuated to lock the fastener and release the fastener from the jaws.
- the instrument may then be recoupled to the endoscope, and the endoscope and the instrument may be withdrawn from the patient.
- Fig. 1 is a bottom perspective view of a two-part tissue fastener with male and female parts thereof shown mated but in an unlocked configuration;
- Fig. 2 is a perspective view of a male part of the two- part fastener of Fig. 1, shown with posts of the male part in an upright configuration
- Fig. 3 is a perspective view of a male part of the two- part fastener, similar to Fig. 2, shown with posts of the male part in a collapsed configuration;
- Fig. 7 is a bottom perspective view of the two-part tissue fastener in the same configuration as Fig. 6, shown with the latch body removed from the female part of the fastener to facilitate viewing the configuration of the interior structure of the female part of the fastener;
- Fig. 8 is a perspective view of an alternate post of a male part of the fastener and an alternate sliding assembly of a female part of the fastener;
- Fig. 9 is a broken side view of an endoluminal tissue plication and fastener applicator instrument according to the invention, shown with a fastener in the end effector;
- Fig. 10 is a side end perspective view of the distal end of the instrument of Fig. 9, shown with a fastener in the end effector;
- Fig. 11 is a top perspective view of the distal end of the instrument of Fig. 9, shown with a fastener in the end effector, but without the female jaw torsion spring;
- Fig. 12 is a perspective view of the distal end of the instrument, with control shaft removed for clarity, and shown with the jaws in an open configuration and without the fastener;
- Fig. 13 is a view similar to Fig. 12, shown with the fastener.
- Fig. 14 is a perspective view of the distal end of the instrument, with control shaft removed for clarity, and shown with the jaws in a closed configuration and without the fastener
- Fig. 15 is a side elevation view of the distal end of the instrument, with control shaft removed for clarity, and shown with the jaws in a closed configuration and without the fastener;
- Fig. 17 is a perspective view of the distal end of the instrument, with control shaft removed for clarity, and shown with the jaws in a closed configuration and without the fastener;
- Fig. 18 is a perspective view of the distal end of the instrument, with the control shaft and the mounting sleeve removed for clarity, and shown with the jaws in an open configuration with a fastener
- Fig. 19 is a plan view of the distal end of the instrument, with the control shaft and the mounting sleeve removed for clarity, and shown with the jaws in a closed configuration with a fastener
- Fig. 20 is a perspective view of the distal end of the instrument, with the control shaft and the mounting sleeve removed for clarity, and shown with the jaws in a closed configuration without a fastener;
- Fig. 21 is a partial view of the proximal actuation handle of the instrument of the invention.
- Fig. 22 illustrates the instrument of the invention coupled to an endoscope during insertion of the two into the stomach
- Fig. 23A is an end view schematic illustration of a cross-sectional area across line 23A-23A in Fig. 9 across a portion of the distal end effector of the instrument;
- Fig. 23B is an end view schematic illustration of a cross-sectional area across line 23B-23B in Fig. 9 across a portion of the distal end effector of the instrument;
- Fig. 24 is a schematic illustration of the cross- sectional area of the endoscope and the control shaft;
- Fig. 25 is a schematic illustration of the cross- sectional area of a prior art device
- Fig. 26 illustrates the instrument separated from the endoscope and shown with the jaws in an open position
- Fig. 27 is a view similar to Fig. 26, and additionally shows a grasping instrument advanced through the endoscope and engaging the target tissue at which a plication is desired to be made;
- Fig. 28 illustrates the jaws of the instrument plicating the target tissue and the fastener in a locked configuration;
- Fig. 29 illustrates the jaws of the instrument in an open position and the fastener holding the plicated tissue together
- Fig. 30 illustrates an alternate embodiment of the procedure in which the end effector is operated while coupled to an endoscope
- Fig. 31 is a side elevation of a second embodiment of the distal end effector adapted to be coupled in the distal opening of a working channel of an endoscope;
- Fig. 32 is a perspective view of the second embodiment of the distal end effector shown in Fig. 31;
- FIG. 34 rear perspective view of the third embodiment of the distal end effector shown in Fig. 33;
- the fastener 10 includes male and female parts 12, 14.
- the male part 12 includes a base 18 defining two openings 20, 22 therethrough and, in one side, two elongate channels 24, 26 and two spring shelves 28, 30.
- Two tissue-piercing posts 32, 34 are rotatably coupled to the base 18 in alignment with the channels 24, 26.
- Each posts includes an enlarged portion 33, 35 having a diametric bore (not shown) .
- Axles 36, 38 extend across openings 20, 22, through the bores, and are press-fit into the base 18 such that the posts 32, 34 are rotatable thereabout.
- the posts 32, 34 have a length of preferably at least 2 mm such that they are adapted to penetrate the serosa of the stomach tissue, and a diameter of preferably less than 1.5 mm inch so that the holes made thereby in the stomach tissue are not prone to leakage. Furthermore, while the posts 32, 34 are adapted to pierce tissue, they are also slightly rounded at the tips so as to preferably only displace tissue rather than cut tissue.
- Torsion springs 40, 42 are coupled to the posts 32, 34 and are stopped against the base 18 at the shelves 28, 30. Referring to Figs. 1 through 3, the torsion springs 40, 42 operate to bias the posts 32, 34 toward a collapsed configuration in which the posts lie within the channels 24, 26.
- each post 32, 34 is provided with a plurality of slots (notches or grooves) 44 along a medial side thereof, and a lower end 43, 45 of each post is provided with a diametric bore 46, 48.
- the end portion 62 of the cover portion 56 defines a lower recess 68 and opening 69 at the recess 68.
- the sliding assembly 52 includes a latch slide 70, a latch lock 72, and a slide cover (or shield) 74.
- the latch slide 70 defines two elongate slots 82, 84, a lower recess 86, a head portion 76 having a relatively larger width than the remainder of the slide, and cutouts 78 between the head portion 76 and the remainder of the slide.
- the latch lock 72 resides in recess 86 and the recess is shaped to stably hold a central portion 88 of the lock 72 and to provide space for lateral displacement of elongate portions of the lock 72.
- the latch slide 70 with latch lock 72 positioned therein, is slidably inserted through the opening 69 of the cover portion 56 of the latch body 50, and the slide cover 74 is then fixed onto the latch slide 70 with pins 104 that are press fit into respective coupling holes 106, 108 (Figs. 4 and 5). It is appreciated that the latch lock 72 is retained in the recess 86 by the base portion 54 of the latch body 50.
- the slide cover 74 defines a central space 110.
- the latch slide 70 and slide cover 74 define a setback 112 at which the female part 14 can be engaged with an applicator instrument 200 (Fig. 9) , as described further below.
- the male part 12 has a length of 15 mm, a width of 6.25 mm, and a height of 2 mm (excluding the posts) .
- the female part 14 has a length of 15 mm, a width of 6.25 mm, and a height of 4 mm.
- the coupled fastener 10 has overall dimensions of a length of 15 mm, a width of 6.25 mm, and a height of 6 mm plus the thickness of the tissue between the male and female parts.
- the parts 12, 14 are preferably constructed of titanium or titanium alloy, and then anodized according to processes known in the art of metallurgy to impart to the parts a color distinct from the natural tissue of the stomach cavity. Preferred colors include purple, blue and black.
- the posts 32, 34 of the male part 12 can pierce through tissue and extend into the holes 58, 60 of the base portion 54 of the female part 14 (Fig. 1) .
- the chamfered openings of the holes 58, 60 facilitate this mating by guiding the posts into the holes 58, 60 even if the parts 12, 14 are slightly misaligned.
- the male and female parts 12, 14 of the fastener 10 are then clamped about the tissue.
- the slide cover 74 and cover portion 56 shield the sharp portions of posts 32, 34, respectively, which extend through the base portion 54 of the female part 14.
- this mechanism facilitates decoupling of a fastener and thereby permits atraumatic retrieval of an implanted fastener.
- One manner of effecting the decoupling can be performed with a standard endoscopic snare device.
- a loop of the snare device is provided over and about the slide cover 74 and cover portion 56 and the two parts are pulled toward each other by decreasing the size of the snare loop.
- a portion of the snare loop may be positioned through recess 68 to prevent the loop from slipping off the fastener 10.
- the unnatural color of the fastener 10 relative to the tissue of the stomach cavity facilitates endoscopically locating an implanted fastener for such retrieval.
- the instrument 200 generally includes a distal end effector 202, a proximal actuation handle 204, and a tubular control shaft 206 housing first and second control elements 208, 210 (wire, cables, coils, ribbons, etc.) extending between the handle 204 and the end effector 202.
- the control shaft 206 is preferably a stainless-steel flat wire wound coil covered in a lubricious sheath, and is substantially smaller in diameter than a conventional endoscope. The flat wire limits elongation of the control shaft when the control shaft is under tension due one or the other of the control elements 208, 210 being under compression.
- the distal end effector 202 includes a jaw assembly 218 having a clevis 224, first and second arms 220, 222 mutually rotatable about the clevis 224, a housing 290, and a sleeve (continuous or slit cuff) 320 integral with the housing 290 and adapted to be slidably positioned about (or, if slit, snapped over) an end of an endoscope.
- a jaw assembly 218 having a clevis 224, first and second arms 220, 222 mutually rotatable about the clevis 224, a housing 290, and a sleeve (continuous or slit cuff) 320 integral with the housing 290 and adapted to be slidably positioned about (or, if slit, snapped over) an end of an endoscope.
- the first arm 220 of the jaw assembly 218 includes a male jaw 226 (adapted to receive the male part 12 of the fastener 10) , and an opposite tang 230 having a coupling hole 232 adapted to receive a wire-like element.
- the second arm 222 includes a female jaw 228 (adapted to receive the female part 14 of the fastener 10), and an opposite tang 234 having a coupling hole 236.
- the inside of the male jaw 226 includes a rectangular recess 240 adapted to receive the back of the male part 12 of the fastener 10, two stepped throughbores 242, 244, and two threaded holes 248, 250. Referring to Figs.
- the outside of the male jaw 226 also includes a recess 246 through which the threaded holes 248, 250 are accessed, and an exit opening 252 in communication with a track 258 (which carries a release element, discussed below) through the first arm 220.
- the end of the male jaw 226 is also provided with a groove 254, the function of which is described below.
- a first release element 259 extends within the track 258 of the first arm 220 from a housing 290 of the clevis 224 and through the exit opening 252.
- the first release element 259 includes an actuation end 255 which is split to define two U- shaped portions 261, 263 which are respectively inserted into the bores 46, 48 (Fig. 3) of the lower end 43, 45 of the posts 32, 34 of the male part of the fastener.
- Friction plates 265, 267 are held over the U-shaped portions 261, 263, with screws 271, 273 inserted into the threaded holes 248, 250, to provide frictional resistance from inadvertently dislodging the U-shaped portions from within the bores 46, 48.
- the female jaw 228 includes a relatively large generally rectangular opening 260 sized to receive the latch body cover 56 and latch slide cover 74 of the female part 14 of the fastener 10.
- the jaw 228 also defines a ledge 275 (Fig. 16), and two catches 262, 264 that extend into the opening.
- the female part 14 is inserted into the jaw 228 in the locked position and then moved into the unlocked position such that the head 76 of the latch slide 70 (Fig. 5) lies over the ledge 275 and the catches 262, 264 extend within the setback 112 (Fig. 5) to lock the part 14 in the jaw 228.
- a tissue piercing post 256 is provided to the terminus of the female jaw 228. Referring to Figs.
- the clevis 224 also includes a mount 280 at which the control shaft 206 (Fig. 9) is attached to the distal end effector 202 of the instrument 200.
- the mount 280 includes a bracket 282 that is coupled to the clevis 224 at pivot 284.
- the clevis 224 also defines a housing 290 for a mechanical assembly 292 which operates to transmit an input force on the control elements 208, 210 to the end effector 202 to effect movement of the jaw arms 220, 222 and locking and release of the fastener 10 therefrom.
- the mechanical assembly 292 preferably includes a first bell crank 294 rotatably coupled about a pivot 296 that is preferably integrally formed with the housing.
- a distal end 298 of control element 208 is coupled to the first bell crank 294 at an input side of the bell crank, and a V-shaped wire 300 is attached to the bell crank at an output side of the bell crank.
- the V-shaped wire 300 extends to and is coupled within the coupling holes 232, 236 (Fig. 12) of the tangs 230, 234 of both of the two jaw arms 220, 222.
- two separate wires can be used to extend from the output side of the bell crank to the two tangs. Referring to Figs.
- each of the control elements may include an end provided with a U- shape in which the end of the control element defines a return extending non-coaxial but parallel to the remainder of the control element.
- the U-shaped end of the control element 208 can be coupled to the jaws such that when control element is placed under compression the return portion of the U-shape pulls the jaws closed.
- the Ushaped end of the control element 210 can be configured to act on release elements 259, 272 such that control element is placed under tension to the U-shaped portion pushed on the release elements 259, 272.
- Other mechanisms may likewise be used.
- the sleeve 320 of the distal end effector 218 preferably has an opening 321 with a diameter of approximately 9 mm, corresponding to the diameter of a relatively small endoscope.
- the exterior dimensions of the sleeve 320 are minimized to provide as low a profile as possible to facilitate passage of the distal end effector 218 through the tracheoesophageal passage of a patient.
- the sleeve 320 may also be provided with a slant nose or other tapered or otherwise streamlined shape that further facilitates introduction and withdrawal of the distal end effector 202 through the tracheoesophageal passage.
- the sleeve 320 is preferably constructed of a preferably soft, low friction, lubricious material such as polytetrafluoroethylene (PTFE) , nylon, or silicone to aid in movement over the endoscope and prevent injury to the human body.
- the sleeve 320 is coupled over the housing 290 to enclose the mechanical assembly 292 (Fig. 18).
- the sleeve 320 be provided with two holes 322, 324 and that pivots 296 and 304 (Fig. 18) for the first and second bell cranks 294, 302 be provided with an internal thread (Fig. 18) . Screws 326, 328 are inserted in holes 322, 324 and thread into the pivots 296, 304 to lock the sleeve over the housing 290.
- the proximal actuation handle 204 which according to one embodiment is a pistol- grip style handle, includes a stationary handle 340, and a lever 342 rotatable relative thereto.
- the stationary handle 340 is integral with a housing 344 which defines a longitudinal slot 346.
- a proximal end 356 of the control shaft 206 extends into the housing 344 and is coupled to an upper portion of the lever 342.
- the first control element 208 which is coupled at its distal end 298 to the jaw arms 220, 222 via the first bell crank 294, includes a proximal end 358 that extends out of the proximal end 356 of the control shaft 206 and is fixed at a second mount 360 within the housing 344.
- the second control element 210 which operates to lock and release the fastener 10 via the second bell crank 302, includes a proximal end 362 that is coupled to a cross bar 364 movable within the longitudinal slot 346.
- the cross bar 364 includes a handle portion 365 (Fig. 9) located external the housing 344.
- the lever 342 is biased into an open position with a first spring 350 that is coupled between a lever mount 352 on the lever and a first mount 354 within the housing 344.
- the lever 342 is also provided with a locking system 366 that operates to lock the position of the lever relative to the handle 340.
- the locking system 366 includes a plurality of teeth 368 on the lever, a pawl 370 mounted on a pivot 372 and biased with a second spring 374 toward the teeth 368, and a cam 376 that can be manually rotated with an external knob 378 (Fig. 9) to contact the pawl 370 and effect disengagement of the pawl from the teeth 368.
- the control shaft 206 is moved distally relative to the first control element 208 to effect closing the jaws 226, 228.
- the cross bar 364 can be moved distally relative to the stationary handle 340 in order to operate the second bell crank 302 (via control element 210) to cause lock and release of the fastener 10.
- the cam 376 can be operated to release the handle locking system 366 and permit the handle lever 342 to rotate relative to the stationary handle 340, thereby allowing the jaws to reopen.
- While a pistol-grip embodiment of the handle 340 has been shown for operation of the instrument 200, as such a handle includes significant mechanical advantage, it may be preferred to use an inline-type handle or other handle configured to also provide the desired mechanical advantage.
- the instrument 200 may be operated as follows with respect to the treatment of GERD.
- the sleeve 320 of the distal end effector 202 is slidably coupled over the distal end of an endoscope 400 and the end effector is slid proximally over the endoscope.
- the distal end of the endoscope 400 is then inserted into the tracheopharangeal passage and moved through the esophagus and into the stomach, with the end effector 202 of the instrument 200 mounted preferably approximately 20 cm back from the distal end of the endoscope 400.
- the handle 204 and/or control shaft 206 are then manipulated in gross to slide the distal end effector 202 over the distal end of the inserted endoscope
- the endoscope 400 may optionally be retroflexed to look back toward to the LES 402 of the esophagus and visualize the advancement of the end effector 202.
- this area includes the footprint of the jaw assembly 218 loaded with a fastener as well as the control shaft 206 and the endoscope 400, and is approximately 178 mm 2 .
- the portions of the system having the cross-sectional areas of Figs. 23A and 23B are located within the esophagus only during insertion and removal of the end effector into the patient. Referring to Fig.
- the cross-sectional area of the system in the esophagus is substantially smaller, limited to the combined cross-sectional areas of the endoscope 400 (approximately 63.6 mm 2 for a 9 mm scope) and the control shaft 206 (approximately 12.6 mm for a 4 mm control shaft); i.e., a total cross-sectional area of approximately 76.2 mm 2 or less.
- a tissue grasping instrument 406 e.g., a forceps, helical needle, or tagging device, is preferably then inserted through a working channel 408 of the endoscope 400 and directed at target tissue 410 one to three centimeters into the stomach adjacent the LES where the center of a plication is to be located.
- the grasping instrument 406 engages the tissue 410 and pulls the tissue back between the jaws 226, 228 of the end effector 202 of the instrument 200.
- the handle 204 and/or control shaft 206 of the instrument 200 are pulled back in gross (i.e., in the direction of withdrawing the instrument) such that the jaws approach the tissue 410 in a direction substantially parallel to the esophagus.
- the female jaw 228 preferably pierces through the deep muscle of the tissue and sufficiently to damage the tissue to cause serosa to serosa contact.
- Experimental procedures have shown that this contact results in tissue adhesion after healing, such that the tissue is permanently reconfigured; i.e., even if the fastener 10 is later removed. In this manner, a zone of reduced compliance is created about the LES.
- the location and size of the plication as well as the relative positions of the fastener parts are observed via the scope. Moreover, more or less clamping pressure can be applied to the plicated tissue by control of the proximal actuation handle 204.
- the proximal actuation handle 204 is then operated, as described above, to lock the male and female parts 12, 14 of the fastener 10 and release the coupled fastener from the jaws 226, 228. If the plication or fastener position is not satisfactory, prior to locking and release, the jaws can be opened, reoriented if necessary, and another plication can be formed.
- the endoscope may be withdrawn first, followed by the withdrawal of the instrument preferably under visualization.
- the sharps on the fastener elements are adapted to assume a safe configuration or are permanently covered. As such, the fastener or its parts may be safely passed through the gastrointestinal system of the patient.
- the instrument may be operated while coupled to the endoscope. That is, referring to Fig. 30, the target tissue is approached by opening the jaws 226, 228 and simply retracting the instrument 200 along the endoscope 400 until the tissue about the LES is contacted. The jaws 226, 228 are then closed and the fastener 10 applied, as described above.
- the sleeve 320 of the instrument should be offset relative to the jaws 226, 228 so that the jaws can clear the endoscope when opening and closing.
- a first alternative embodiment of a distal end effector 502 of the instrument 200 according to the invention is shown.
- the end effector 502 is adapted to couple within the distal end of a working channel of an endoscope, rather than be coupled about the endoscope with a sleeve.
- the housing 590 of the end effector 502 is provided with a proximally directed peg 620 preferably located above, but in line with the control shaft 206, and sized to be received within the distal end of a working channel of an endoscope.
- the housing 590 also includes a concave surface 622 permitting the housing 590 and endoscope to be adjacent in a minimized profile.
- a second alternate embodiment of the distal end effector 702 of the instrument 200 is shown.
- the housing 790 of the end effector 702 is provided with a tapered nose piece 820 defining a longitudinal passage 822 sized to receive a guidewire 824.
- the guidewire may have a diameter less than one millimeter.
- the nose piece 820 is preferably formed from a highly flexible material such as silicone.
- an endoscope 400 is preferably first inserted through the tracheopharangeal passage 414 and into the stomach 416 in accord with a well-known procedure.
- a guidewire 924 is advanced through the endoscope into the stomach. Referring to Fig.
- the jaws 726, 728 of the end effector 702 are also opened and brought adjacent the tissue which is to be plicated.
- a tissue grabbing device 920 is deployed through a working channel of the endoscope 400 and operated to engage tissue 910 at a location at which the fold of a plication is desired.
- the tissue grabbing device preferably includes piercers which extend through the mucosa and the muscularis (deep muscle) to thereby hold these layers together and prevent delamination.
- the jaws of the end effector 702 are closed, forming a plication 812 about the engaged tissue 910, the plication 912 being substantially parallel to the esophagus.
- a "looking back” instrument has been disclosed particularly for fastener application designed to treat GERD
- a "forward looking” straight instrument with similar jaw assembly can be used to apply the fastener for treatments of other conditions, e.g., obesity, ulceration, stomach cancer, implantation of pH measurement or monitoring devices, feeding tubes, etc.
- a straight device can be smaller in diameter and be operated through a working channel of an endoscope.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP03756839A EP1553879A2 (en) | 2002-09-20 | 2003-09-19 | Instrument for applying a surgical fastener particularly for the transoral treatment of gastroesophageal reflux disease (gerd) |
AU2003299032A AU2003299032A1 (en) | 2002-09-20 | 2003-09-19 | Instrument for applying a surgical fastener particularly for the transoral treatment of gastroesophageal reflux disease (gerd) |
JP2004538249A JP2006500111A (en) | 2002-09-20 | 2003-09-19 | A device that adds surgical fasteners for oral treatment of gastroesophageal reflux disease in particular |
CA002499879A CA2499879A1 (en) | 2002-09-20 | 2003-09-19 | Instrument for applying a surgical fastener particularly for the transoral treatment of gastroesophageal reflux disease (gerd) |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/252,069 | 2002-09-20 | ||
US10/252,069 US6966919B2 (en) | 2002-09-20 | 2002-09-20 | Instrument for applying a surgical fastener particularly for the transoral treatment of gastroesophageal reflux disease (GERD) |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2004026348A2 true WO2004026348A2 (en) | 2004-04-01 |
WO2004026348A3 WO2004026348A3 (en) | 2004-05-21 |
Family
ID=31992873
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2003/029522 WO2004026348A2 (en) | 2002-09-20 | 2003-09-19 | Instrument for applying a surgical fastener particularly for the transoral treatment of gastroesophageal reflux disease (gerd) |
Country Status (6)
Country | Link |
---|---|
US (1) | US6966919B2 (en) |
EP (1) | EP1553879A2 (en) |
JP (1) | JP2006500111A (en) |
AU (1) | AU2003299032A1 (en) |
CA (1) | CA2499879A1 (en) |
WO (1) | WO2004026348A2 (en) |
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Also Published As
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JP2006500111A (en) | 2006-01-05 |
AU2003299032A1 (en) | 2004-04-08 |
EP1553879A2 (en) | 2005-07-20 |
CA2499879A1 (en) | 2004-04-01 |
WO2004026348A3 (en) | 2004-05-21 |
US20040059349A1 (en) | 2004-03-25 |
US6966919B2 (en) | 2005-11-22 |
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