US20050187565A1 - Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same - Google Patents
Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same Download PDFInfo
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- US20050187565A1 US20050187565A1 US10/783,717 US78371704A US2005187565A1 US 20050187565 A1 US20050187565 A1 US 20050187565A1 US 78371704 A US78371704 A US 78371704A US 2005187565 A1 US2005187565 A1 US 2005187565A1
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- fastener
- members
- tissue
- assembly
- connecting member
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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
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic 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
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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
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0419—H-fasteners
Definitions
- the connecting member of the fastener may be formed of plastic elastic material.
- the connecting member may be formed of a plastic, permanently deformable material.
- the plastic material may include a color pigment contrasting with body tissue color to enable visualization of the fastener with an endoscope.
- FIG. 24 is a perspective view of the fastener of FIG. 13 showing the fastener embedded within a layer of tissue;
- the pusher 166 may be utilized to push the first member 172 of the fastener 162 through the tissue layers 180 and 182 on the tissue piercing wire 164 . This is illustrated in FIG. 6 . As the pusher 166 pushes the first member 172 through the tissue layers 180 and 182 , the connecting member 176 follows along beside and immediately adjacent to the first member 172 of the fastener 162 and the pusher 166 . As may be seen in FIG.
- the tissue piercing wire 164 is then retracted within the pusher 166 to release the first member 172 .
- the first member 172 being thus released from the tissue piercing wire 164 will return to its original configuration substantially parallel to the second member 174 and substantially perpendicular to the connecting member 176 .
- the tissue piercing wire 164 and pusher 166 may be withdrawn.
- FIG. 11 shows another fastener 200 embodying the present invention.
- the fastener 200 is illustrated in an initial stage of deployment by the tissue piercing deployment wire 164 , the pusher 166 , and the guide tube 168 to fasten tissue layers 180 and 182 together.
- FIG. 12 shows the fastener 200 after deployment fastening tissue layers 180 and 182 together.
- the fastener 200 may be deployed as previously described in connection with FIGS. 5-9 .
- FIG. 20 illustrates the second member 214 of the fastener 210 in its deployed configuration within the slot 370 .
- the connecting member 216 is permitted to assume its preshaped configuration and the second member 214 is permitted to slide along the tissue piercing wire 164 within the notch 226 .
- the pusher 166 may now push the first member 212 through the tissue layers 180 and 182 on the tissue piercing wire 164 .
- the tissue piercing wire 164 need not be fully retracted to free the second member 314 from the tissue piercing wire 164 after it has been deployed.
Abstract
Description
- The present invention generally relates to tissue fixation devices, and more particularly to devices for treating gastroesophageal reflux disease using the same. The present invention more particularly relates to such tissue fixation devices which may be used in surgical environments and which are self-deploying.
- Gastroesophageal reflux disease (GERD) is a chronic condition caused by the failure of the anti-reflux barrier located at the gastroesophageal junction to keep the contents of the stomach from splashing into the esophagus. The splashing is known as gastroesophageal reflux. The stomach acid is designed to digest meat, and will digest esophageal tissue when persistently splashed into the esophagus.
- A principal reason for regurgitation associated with GERD is the mechanical failure of a deteriorated gastroesophageal flap to close and seal against high pressure in the stomach. Due to reasons including lifestyle, a Grade I normal gastroesophageal flap may deteriorate into a malfunctioning Grade III or absent valve Grade IV gastroesophageal flap. With a deteriorated gastroesophageal flap, the stomach contents are more likely to be regurgitated into the esophagus, the mouth, and even the lungs. The regurgitation is referred to as “heartburn” because the most common symptom is a burning discomfort in the chest under the breastbone. Burning discomfort in the chest and regurgitation (burping up) of sour-tasting gastric juice into the mouth are classic symptoms of gastroesophageal reflux disease (GERD). When stomach acid is regurgitated into the esophagus, it is usually cleared quickly by esophageal contractions. Heartburn (backwashing of stomach acid and bile onto the esophagus) results when stomach acid is frequently regurgitated into the esophagus and the esophageal wall is inflamed.
- Complications develop for some people who have GERD. Esophagitis (inflammation of the esophagus) with erosions and ulcerations (breaks in the lining of the esophagus) can occur from repeated and prolonged acid exposure. If these breaks are deep, bleeding or scarring of the esophagus with formation of a stricture (narrowing of the esophagus) can occur. If the esophagus narrows significantly, then food sticks in the esophagus and the symptom is known as dysphagia. GERD has been shown to be one of the most important risk factors for the development of esophageal adenocarcinoma. In a subset of people who have severe GERD, if acid exposure continues, the injured squamous lining is replaced by a precancerous lining (called Barrett's Esophagus) in which a cancerous esophageal adenocarcinoma can develop.
- Other complications of GERD may not appear to be related to esophageal disease at all. Some people with GERD may develop recurrent pneumonia (lung infection), asthma (wheezing), or a chronic cough from acid backing up into the esophagus and all the way up through the upper esophageal sphincter into the lungs. In many instances, this occurs at night, while the person is in a supine position and sleeping. Occasionally, a person with severe GERD will be awakened from sleep with a choking sensation. Hoarseness can also occur due to acid reaching the vocal cords, causing a chronic inflammation or injury.
- GERD never improves without intervention. Life style changes combined with both medical and surgical treatments exist for GERD. Medical therapies include antacids and proton pump inhibitors. However, the medical therapies only mask the reflux. Patients still get reflux and perhaps emphysema because of particles refluxed into the lungs. Barrett's esophagus results in about 10% of the GERD cases. The esophageal epithelium changes into tissue that tends to become cancerous from repeated acid washing despite the medication.
- Several open laparotomy and laproscopic surgical procedures are available for treating GERD. One surgical approach is the Nissen fundoplication. The Nissen approach typically involves a 360-degree wrap of the fundus around the gastroesophageal junction. The procedure has a high incidence of postoperative complications. The Nissen approach creates a 360-degree moveable flap without a fixed portion. Hence, Nissen does not restore the normal movable flap. The patient cannot burp because the fundus was used to make the repair, and may frequently experience dysphagia. Another surgical approach to treating GERD is the Belsey Mark IV (Belsey) fundoplication. The Belsey procedure involves creating a valve by suturing a portion of the stomach to an anterior surface of the esophagus. It reduces some of the postoperative complications encountered with the Nissen fundoplication, but still does not restore the normal movable flap. None of these procedures fully restores the normal anatomical anatomy or produces a normally functioning gastroesophageal junction. Another surgical approach is the Hill repair. In the Hill repair, the gastroesophageal junction is anchored to the posterior abdominal areas, and a 180-degree valve is created by a system of sutures. The Hill procedure restores the moveable flap, the cardiac notch and the Angle of His. However, all of these surgical procedures are very invasive, regardless of whether done as a laproscopic or an open procedure.
- New, less surgically invasive approaches to treating GERD involve transoral endoscopic procedures. One procedure contemplates a machine device with robotic arms that is inserted transorally into the stomach. While observing through an endoscope, an endoscopist guides the machine within the stomach to engage a portion of the fundus with a corkscrew-like device on one arm. The arm then pulls on the engaged portion to create a fold of tissue or radial plication at the gastroesophageal junction. Another arm of the machine pinches the excess tissue together and fastens the excess tissue with one pre-tied implant. This procedure does not restore normal anatomy. The fold created does not have anything in common with a valve. In fact, the direction of the radial fold prevents the fold or plication from acting as a flap of a valve.
- Another transoral procedure contemplates making a fold of fundus tissue near the deteriorated gastroesophageal flap to recreate the lower esophageal sphincter (LES). The procedure requires placing multiple U-shaped tissue clips around the folded fundus to hold it in shape and in place.
- This and the previously discussed procedure are both highly dependent on the skill, experience, aggressiveness, and courage of the endoscopist. In addition, these and other procedures may involve esophageal tissue in the repair. Esophageal tissue is fragile and weak. Involvement of esophageal tissue in the repair of a gastroesophageal flap valve poses unnecessary risks to the patient.
- A new and improved apparatus and method for restoration of a gastroesophageal flap valve is fully disclosed in copending U.S. application Ser. No. 10/150,740, filed May 17, 2002, for TRANSORAL ENDOSCOPIC GASTROESOPHAGEAL FLAP VALVE RESTORATION DEVICE, ASSEMBLY, SYSTEM AND METHOD, is assigned to the assignee of this invention, and is incorporated herein by reference. That apparatus and method provides a transoral endoscopic gastroesophageal flap valve restoration. A longitudinal member arranged for transoral placement into a stomach carries a tissue shaper that non-invasively grips and shapes stomach tissue. A tissue fixation device is then deployed to maintain the shaped stomach tissue in a shape approximating a gastroesophageal flap.
- Whenever tissue is to be maintained in a shape as, for example, in the improved assembly last mentioned above, it is necessary to fasten at least two layers of tissue together. In applications such as gastroesophageal flap valve restoration, there is very limited room to maneuver a fastener deployment device. For example, this and other medical fastening applications provide confined working channels and spaces and often must be fed through an endoscope to permit visualization or other small lumen guide catheters to the place where the fasteners are to be deployed. To make matters worse, multiple fasteners may also be required. Hence, with current fasteners and deployment arrangements, it is often difficult to direct a single fastener to its intended location, let alone a number of such fasteners.
- Once the fastening site is located, the fasteners employed must be truly able to securely maintain the tissue. Also, quite obviously, the fasteners are preferably deployable in the tissue in a manner which does not unduly traumatize the tissue.
- The present invention provides a fastener for use in a mammalian body, comprising a first member, a second member, the first and second members having first and second ends, and a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members. The first and second members are separated by the connecting member, and one of the first and second members has a longitudinal axis and a through channel along the axis arranged to be slidingly received on a tissue piercing deployment wire.
- The connecting member may be flexible permitting another one of the first and second members to be next to the one of the first and second members when the one of the first and second members is on the tissue piercing deployment wire.
- One end of the one of the first and second members may include a pointed tip. The pointed tip may be conical or comprise a tapered sectioned portion.
- Both the first and second members may include a longitudinal axis and a through channel along each respective axis. One end of both the first and second members may include a pointed tip. The pointed tips may point in opposite directions.
- The through channels are arranged to be slidingly received by the tissue piercing deployment wire. The connecting member may be flexible permitting the first and second members to be in line with each other on the tissue piercing deployment wire.
- The first member, second member, and the connecting member may all be formed of plastic material and in one piece or multiple pieces.
- The connecting member of the fastener may be formed of plastic elastic material. Alternatively, the connecting member may be formed of a plastic, permanently deformable material. The plastic material may include a color pigment contrasting with body tissue color to enable visualization of the fastener with an endoscope.
- The connecting member has a vertical dimension and a horizontal dimension transverse to the vertical dimension, and the horizontal dimension may be substantially less than the vertical dimension rendering the connecting member readily bendable in a horizontal plane. At least one of the first and second members may include a plurality of longitudinally spaced vertical slots rendering the at least one of the first and second members flexible in a direction opposite the slots but stiff in a direction of the slots. The device may comprise a plurality of the connecting members.
- The fastener may alternatively be formed of metal and particularly a shape memory material. The first and second members may then be self-deployable. One of the first and second members may be self-deployable while on the tissue piercing deployment wire.
- At least one of the first and second members may be self-deployable upon removal from the tissue piercing deployment wire. The at least one of the first and second members is preferably distal to another one of the first and second members and the another one of the first and second members may include a crimp that provides a controlled resistance to movement on the tissue piercing deployment wire.
- The first member, the second member, and the connecting member may be integrally formed from a same tubular member stock. The connecting member may comprise a strip of the tubular member formed by a pair of longitudinal substantially parallel, substantially coextensive cuts within the tubular member and the first and second members may be formed by a substantially transverse circumferential cut between the substantially parallel coextensive cuts.
- The tubular member may have first and second opposed ends and the substantially parallel substantially coextensive cuts may begin spaced from the first end and terminate spaced from the second end. The first and second members may then be tubular member sections between the circumferential cut and the tubular member first and second ends. An elongated notch may extend from one of the ends of the tubular member, substantially diametrically opposite and juxtaposed to a portion of the connecting member strip.
- The invention further provides a fastener assembly for use in a mammalian body. The assembly includes a fastener including a first member, a second member, the first and second members having first and second ends, and a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members. The first and second members are separated by the connecting member, and one of the first and second members may have a longitudinal axis and a through channel along the axis. The assembly further includes a deployment wire that slidingly receives the through channel of the one of the first and second members and pierces into the tissue, and a pusher that pushes the one of first and second members into the tissue while on the deployment wire.
- The pusher is preferably also arranged to be slidingly received on the deployment wire. The connecting member of the fastener may be flexible, and the assembly may further comprise a guide tube extending over the deployment wire and the fastener. The other one of the first and second members may be disposed next to the one of the first and second members within the guide tube.
- One end of the one of the first and second members of the fastener may further include a pointed tip. The pointed tip may comprise a truncated cone. Alternatively, the pointed tip may comprise a sectioned portion. Either one or both of the first and second members may include a longitudinal axis and a through channel along each respective axis. The through channels of the first and second members may be arranged to be slidingly received by the tissue piercing deployment wire and the connecting member is preferably flexible permitting the first and second members to be in line with each other on the tissue piercing deployment wire. The guide tube may then extend over the deployment wire and the fastener.
- The invention still further provides a tissue fixation assembly. The assembly includes a fastener and a pair of hingedly coupled first and second arms for receiving the tissue therebetween. The first arm includes a fastener director that directs the fastener into the tissue and the second arm includes an opening permitting the fastener to be driven through the tissue while being held between the first and second arms. The second arm is preferably a frame structure.
- The assembly may further comprise a tissue gripper that grips the tissue and pulls the tissue into and between the first and second arms. The first arm may have a tissue engaging surface and the fastener director may include a channel communicating with the tissue engaging surface through which the fastener passes into the tissue.
- The fastener director may include a plurality of the channels to direct a like plurality of fasteners into the tissue. The assembly may further comprise a fastener deployment wire that guides the fastener through one of the channels and into the tissue.
- The fastener of the assembly may comprise a first member, a second member, the first and second members having first and second ends, and a connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members. The first and second members are separated by the connecting member when the fastener is deployed. One of the first and second members preferably has a longitudinal axis and a through channel along the axis arranged to be slidingly received on the fastener deployment wire.
- The invention still further provides a transoral gastroesophageal flap valve restoration device. The device includes a longitudinal member, a portion of which is arranged for transoral placement into a stomach, a fastener, and a tissue shaper carried on the longitudinal member. The tissue shaper shapes stomach tissue into a shape and includes a pair of hingedly coupled first and second arms for receiving the stomach tissue therebetween, the first arm including a fastener director that directs the fastener into the stomach tissue and the second arm including an opening permitting the fastener to be driven through the stomach tissue while being held between the first and second arms.
- The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further objects and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like referenced numerals identify like elements, and wherein:
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FIG. 1 is a front cross-sectional view of the esophageal-gastro-intestinal tract from a lower portion of the esophagus to the duodenum; -
FIG. 2 is a front cross-sectional view of the esophageal-gastro-intestinal tract illustrating a Grade I normal appearance movable flap of the gastroesophageal flap valve (in dashed lines) and a Grade III reflux appearance gastroesophageal flap of the gastroesophageal flap valve (in solid lines); -
FIG. 3 is a perspective view of a fastener according to an embodiment of the invention; -
FIG. 4 is a perspective view of another fastener according to an embodiment of the invention; -
FIG. 5 is a perspective view with portions cut away of a fastener assembly according to an embodiment of the invention in an early stage of deploying a fastener embodiment of the invention; -
FIG. 6 is a perspective view of the assembly ofFIG. 5 shown with the fastener being driven in the tissue layers to be fastened; -
FIG. 7 is a perspective view of the assembly ofFIG. 5 shown with the fastener extending through the tissue layers to be fastened; -
FIG. 8 is a perspective view of the assembly ofFIG. 5 shown with the fastener initially deployed; -
FIG. 9 is a perspective view showing the fastener of the assembly ofFIG. 5 fully deployed and securely fastening a pair of tissue layers together; -
FIG. 10 is a perspective view with portions cut away of another fastener deployment assembly according to an embodiment of the invention in an early stage of deploying another fastener embodiment of the invention; -
FIG. 11 is a perspective view with portions cut away of another fastener deployment assembly according to an embodiment of the invention in an early stage of deploying another fastener embodiment of the invention; -
FIG. 12 is a perspective view showing the fastener of the assembly ofFIG. 11 fully deployed and securely fastening a pair of tissue layers together; -
FIG. 13A is a perspective view, to an enlarged scale, of the fastener ofFIG. 13 ; -
FIG. 14 is a perspective view of the assembly ofFIG. 13 shown with the fastener being driven in the tissue layers to be fastened; -
FIG. 15 is a perspective view of the assembly ofFIG. 13 shown with the fastener extending through the tissue layers to be fastened and partially deployed; -
FIG. 16 is a perspective view of the assembly ofFIG. 13 shown with the fastener initially fully deployed; -
FIG. 17 is a perspective view showing the fastener of the assembly ofFIG. 13 fully deployed and securely fastening a pair of tissue layers together; -
FIG. 18 is a perspective view with portions cut away of another fastener deployment assembly according to an embodiment of the invention in an early stage of deploying the fastener ofFIG. 13 ; -
FIG. 19 is a perspective view of the assembly ofFIG. 18 shown with the deployment wire driven through the tissue layers to be fastened; -
FIG. 20 is a perspective view of the assembly ofFIG. 18 shown as inFIG. 19 but with the proximal end of the fastener being released into a deployed configuration before the fastener is driven into the tissue layers to be fastened; -
FIG. 21 is a perspective view of the assembly ofFIG. 18 shown with the fastener extending through the tissue layers to be fastened; -
FIG. 22 is a perspective view of the assembly ofFIG. 18 shown with the fastener initially deployed; -
FIG. 23 is a perspective view showing the fastener of the assembly ofFIG. 18 fully deployed and securely fastening a pair of tissue layers together; -
FIG. 24 is a perspective view of the fastener ofFIG. 13 showing the fastener embedded within a layer of tissue; -
FIG. 25 is a perspective view with portions cut away of a fastener assembly according to an embodiment of the invention in an early stage of deploying a still further fastener embodiment of the invention; -
FIG. 26 is a side view, partly in cross-section of another fastener embodiment of the invention which provides resistance to relative movement between the fastener and a deployment wire; -
FIG. 27 is a perspective side view, partly in phantom of a gastroesophageal flap valve restoration device embodying the present invention shown in an initial state before use; -
FIG. 28 is another perspective side view, partly in phantom of the gastroesophageal flap valve restoration device ofFIG. 27 embodying the present invention shown in an intermediate state during use; -
FIG. 29 is a side view, partly in cross-section of the gastroesophageal flap valve restoration device ofFIG. 27 shown forming a gastroesophageal flap valve from stomach tissue prior to delivery of a fastener to maintain the flap valve. -
FIG. 30 is a perspective view of another fastener embodiment of the present invention; -
FIG. 31 is a top plan view of the fastener ofFIG. 30 ; -
FIG. 32 is a perspective view of still another fastener embodiment of the present invention, and; -
FIG. 33 is a top plan view of the fastener ofFIG. 32 . -
FIG. 1 is a front cross-sectional view of the esophageal-gastro-intestinal tract 40 from a lower portion of theesophagus 41 to theduodenum 42. Thestomach 43 is characterized by thegreater curvature 44 on the anatomical left side and thelesser curvature 45 on the anatomical right side. The tissue of the outer surfaces of those curvatures is referred to in the art as serosa tissue. As will be seen subsequently, the nature of the serosa tissue is used to advantage for its ability to bond to like serosa tissue. Thefundus 46 of thegreater curvature 44 forms the superior portion of thestomach 43, and traps gas and air bubbles for burping. Theesophageal tract 41 enters thestomach 43 at an esophageal orifice below the superior portion of thefundus 46, forming acardiac notch 47 and an acute angle with respect to thefundus 46 known as the Angle of His 57. The lower esophageal sphincter (LES) 48 is a discriminating sphincter able to distinguish between burping gas, liquids, and solids, and works in conjunction with thefundus 46 to burp. The gastroesophageal flap valve (GEFV) 49 includes a moveable portion and an opposing more stationary portion. The moveable portion of theGEFV 49 is an approximately 180 degree, semicircular, gastroesophageal flap 50 (alternatively referred to as a “normal moveable flap” or “moveable flap”) formed of tissue at the intersection between theesophagus 41 and thestomach 43. The opposing more stationary portion of theGEFV 49 comprises a portion of thelesser curvature 45 of thestomach 43 adjacent to its junction with theesophagus 41. Thegastroesophageal flap 50 of theGEFV 49 principally comprises tissue adjacent to thefundus 46 portion of thestomach 43, is about 4 to 5 cm long (51) at it longest portion, and the length may taper at its anterior and posterior ends. Thegastroesophageal flap 50 is partially held against thelesser curvature 45 portion of thestomach 43 by the pressure differential between thestomach 43 and the thorax, and partially by the resiliency and the anatomical structure of theGEFV 49, thus providing the valving function. TheGEFV 49 is similar to a flutter valve, with thegastroesophageal flap 50 being flexible and closeable against the other more stationary side. - The esophageal tract is controlled by an upper esophageal sphincter (UES) in the neck near the mouth for swallowing, and by the
LES 48 and theGEFV 49 at the stomach. The normal anti-reflux barrier is primarily formed by theLES 48 and theGEFV 49 acting in concert to allow food and liquid to enter the stomach, and to considerably resist reflux of stomach contents into theesophagus 41 past thegastroesophageal tissue junction 52. Tissue aboral of thegastroesophageal tissue junction 52 is generally considered part of the stomach because the tissue protected from stomach acid by its own protective mechanisms. Tissue oral of thegastroesophageal junction 52 is generally considered part of the esophagus and it is not protected from injury by prolonged exposure to stomach acid. At thegastroesophageal junction 52, the juncture of the stomach and esophageal tissues form a zigzag line, which is sometimes referred to as the “Z-line.” For the purposes of these specifications, including the claims, “stomach” means the tissue aboral of thegastroesophageal junction 52. -
FIG. 2 is a front cross-sectional view of an esophageal-gastro-intestinal tract illustrating a Grade I normal appearancemovable flap 50 of the GEFV 49 (shown in dashed lines) and a deteriorated Grade IIIgastroesophageal flap 55 of the GEFV 49 (shown in solid lines). As previously mentioned, a principal reason for regurgitation associated with GERD is the mechanical failure of the deteriorated (or reflux appearance)gastroesophageal flap 55 of theGEFV 49 to close and seal against the higher pressure in the stomach. Due to reasons including lifestyle, a Grade I normalgastroesophageal flap 50 of theGEFV 49 may deteriorate into a Grade III deterioratedgastroesophageal flap 55. The anatomical results of the deterioration include moving a portion of theesophagus 41 that includes thegastroesophageal junction 52 andLES 48 toward the mouth, straightening of thecardiac notch 47, and increasing the Angle of His 57. This effectively reshapes the anatomy aboral of thegastroesophageal junction 52 and forms a flattenedfundus 56. The deterioratedgastroesophageal flap 55 illustrates agastroesophageal flap valve 49 andcardiac notch 47 that have both significantly degraded. Dr. Hill and colleagues developed a grading system to describe the appearance of the GEFV and the likelihood that a patient will experience chronic acid reflux. L. D. Hill, et al., The gastroesophageal flap valve: in vitro and in vivo observations, Gastrointestinal Endoscopy 1996:44:541-547. Under Dr. Hill's grading system, the normalmovable flap 50 of theGEFV 49 illustrates a Grade I flap valve that is the least likely to experience reflux. The deterioratedgastroesophageal flap 55 of theGEFV 49 illustrates a Grade III (almost Grade IV) flap valve. A Grade IV flap valve is the most likely to experience reflux. Grades II and III reflect intermediate grades of deterioration and, as in the case of III, a high likelihood of experiencing reflux. With the deteriorated GEFV represented by deterioratedgastroesophageal flap 55 and thefundus 46 moved inferior, the stomach contents are presented a funnel-like opening directing the contents into theesophagus 41 and the greatest likelihood of experiencing reflux. Disclosed subsequently is a device for restoring the normal gastroesophageal flap valve anatomy, which device is one embodiment of the present invention. - Referring now to
FIG. 3 , it is a perspective view of afastener 100 according to an embodiment of the invention. Thefastener 100 generally includes afirst member 102, asecond member 104, and a connectingmember 106. As may be noted inFIG. 3 , thefirst member 102 andsecond member 104 are substantially parallel and substantially perpendicular to the connectingmember 106 which connects thefirst member 102 to thesecond member 104. - The first and
second members longitudinal axis 108 and 110 and a throughchannel longitudinal axes 108 and 110. The throughchannels - The
first member 102 also includes afirst end 116 and a second end 118. Similarly, thesecond member 114 includes afirst end 120 and asecond end 122. The first ends 116 and 120 form pointeddilation tips dilation tips tips 129 and 126 are pointed in opposite directions. - The first and
second members FIG. 3 , the connectingmember 106 has avertical dimension 128 and ahorizontal dimension 130 which is transverse to the vertical dimension. The horizontal dimension is substantially less than the vertical dimension to render the connectingmember 106 readily bendable in a horizontal plane. The connecting member is further rendered bendable by the nature of the plastic material from which thefastener 100 is formed. The connecting member may be formed from either an elastic plastic or a permanently deformable plastic. An elastic material would prevent compression necrosis in some applications. - Referring now to
FIG. 4 , it illustrates anotherfastener 140 embodying the present invention. As with thefastener 100 ofFIG. 3 , thefastener 140 includes afirst member 142, asecond member 144, and a connectingmember 146. Thefastener 140 may be formed in one piece and a plastic material similar to thefastener 100 ofFIG. 3 . Thefasteners FIG. 4 , thefastener 140 is impregnated with radioopaque material 148 so as to render thefastener 140 at least partially viewable under fluoroscopy. The radio opaque particles may be, for example, barium sulfate, bismuth subcarbonate, tungsten powder or tantalum powder. - In addition to the foregoing, the
second member 144 of thefastener 140 includes a plurality of longitudinally spacedvertical slots 150. This renders thesecond member 144 flexible in a direction opposite the slots but stiff in a direction of the slots. Hence, thesecond member 144 is resistant to bending in a first direction indicated byarrow 152 while being substantially less resistant to bending in a direction indicated byarrow 154. The reduced resistance to bending in thedirection 154 of thesecond member 144 of thefastener 140 may be utilized to advantage in the deployment of thefastener 140. - Referring now to
FIG. 5 , it is a perspective view with portions cut away of a fastener assembly embodying the present invention. The tissue layer portions above thefastener 162 have been shown cut away inFIGS. 5-9 to enable the deployment procedure to be seen more clearly. Theassembly 160 generally includes afastener 162, adeployment wire 164, apusher 166, and aguide tube 168. - The
fastener 162 takes the form of a further fastener embodiment of the present invention and includes afirst member 172, asecond member 174, and a connectingmember 176. Thefastener 162 differs from thefasteners FIGS. 3 and 4 , respectively, in that thesecond member 174 is of solid construction and does not include a longitudinal through channel or a pointed tip. However, thefirst member 172 includes a through channel as previously described and apointed tip 178. - The
first member 172 of thefastener 162 is slidingly received on thedeployment wire 164. Thedeployment wire 164 has a pointedtip 178 for piercing the tissue layers 180 and 182 to be fastened together. As will be seen hereinafter, and in accordance with further aspects of the present invention, the tissue layers 180 and 182 may be folded stomach tissue which are to be fastened and maintained together to form and maintain a gastroesophageal flap valve. - As will be noted in
FIG. 5 , thetissue piercing wire 164,fastener 162, and thepusher 166 are all within theguide tube 168. Theguide tube 168 may take the form of a catheter, for example. - As will be further noted in
FIG. 5 , thesecond member 174 is disposed along side thefirst member 172. This is rendered possible by the flexibility of the connectingmember 176. Preferably, the first member, connecting member, and second member are arranged so that the connectingmember 176 lies to the side of thefirst member 172 and thesecond member 174. - With the
first member 172 of thefastener 162 slidingly received on thetissue piercing wire 164 and with thepusher 166 just touching thefirst member 172 on thetissue piercing wire 164, thetip 178 of thetissue piercing wire 164 pierces the tissue layers 180 and 182. The subassembly of thetissue piercing wire 164,fastener 162, andpusher 166 may be guided to its intended location relative to the tissue layers 180 and 182 by theguide tube 168. As will be seen hereinafter, this subassembly may be alternatively guided by guide channels arranged to accommodate thetissue piercing wire 164,fastener 162,pusher 166, and theguide tube 168. - Once the
tissue piercing wire 164 has pierced the tissue layers 180 and 182 to be fastened together, thepusher 166 may be utilized to push thefirst member 172 of thefastener 162 through the tissue layers 180 and 182 on thetissue piercing wire 164. This is illustrated inFIG. 6 . As thepusher 166 pushes thefirst member 172 through the tissue layers 180 and 182, the connectingmember 176 follows along beside and immediately adjacent to thefirst member 172 of thefastener 162 and thepusher 166. As may be seen inFIG. 7 , thepusher 166 continues to push thefirst member 172 of thefastener 162 through the tissue layers 180 and 182 on thetissue piercing wire 164 until theend 173 of thefirst member 172 engaging thepusher 166 clears thesecond tissue layer 182. It may also be noted that at this time, thesecond member 174 of thefastener 162 has engaged thesurface 181 oftissue layer 180. - Referring now to
FIG. 8 , it will be seen that once theend 173 of thefirst member 172 has cleared thetissue layer 182, thetissue piercing wire 164 is then retracted within thepusher 166 to release thefirst member 172. Thefirst member 172 being thus released from thetissue piercing wire 164 will return to its original configuration substantially parallel to thesecond member 174 and substantially perpendicular to the connectingmember 176. When thefirst member 172 is deployed as shown inFIG. 8 , thetissue piercing wire 164 andpusher 166 may be withdrawn. -
FIG. 9 illustrates thefastener 162 in its deployed position. It will be noted that the tissue layers 180 and 182 are fastened together between thefirst member 172 of thefastener 162 and thesecond member 174 of thefastener 162. The connectingmember 176 extends through the tissue layers 180 and 182. -
FIG. 10 is a perspective view with portions cut away of another fastener and fastener assembly embodying the present invention in an early stage of deploying the fastener. Thefastener 190 ofFIG. 10 includes afirst member 192, asecond member 194, and a connectingmember 196. Thefastener 190 is similar to thefastener 100 ofFIG. 3 in that both thefirst member 192 andsecond member 194 includes a through bore. This permits thefirst member 192 andsecond member 194 to be slidingly received in line with each other on thetissue piercing wire 164. With both thefirst member 192 andsecond member 194 being disposed on thetissue piercing wire 164, thesecond member 194 will not be deployed until after thetissue piercing wire 164 is retracted from thesecond member 194. As a result, the second member of thefastener 162 illustrated inFIGS. 5-9 will deploy before thesecond member 194 offastener 190. However, the arrangement illustrated inFIG. 10 may be advantageous where space is at a premium and theguide tube 168 has a reduced diameter. The deployment of thefastener 190 by thetissue piercing wire 164, thepusher 166, and theguide tube 168 is otherwise similar to the deployment procedure described above with respect toFIGS. 5-9 . -
FIG. 11 shows anotherfastener 200 embodying the present invention. Thefastener 200 is illustrated in an initial stage of deployment by the tissue piercingdeployment wire 164, thepusher 166, and theguide tube 168 to fastentissue layers FIG. 12 shows thefastener 200 after deployment fastening tissue layers 180 and 182 together. Thefastener 200 may be deployed as previously described in connection withFIGS. 5-9 . - The
fastener 200 includes afirst member 202, asecond member 204, and a connectingmember 206. The connectingmember 206 takes the form of a beaded chain and the second member is bifurcated at 208 to permit thesecond member 204 to be positioned between any pair of beads of the connectingmember 204. This renders the length of the connectingmember 206 between the first andsecond members -
FIG. 13 shows anotherfastener 210 embodying the present invention. Thefastener 210 is illustrated in an initial stage of deployment by the tissue piercingdeployment wire 164, thepusher 166, and theguide tube 168 to fastentissue layers FIG. 13A shows thefastener 210 in greater detail. - The fastener includes a
first member 212, asecond member 214, and a connectingmember 216. Thefirst member 212,second member 214, and connectingmember 216 are integrally formed from a same tubular member stock of material. Thefastener 212 may be formed of plastic or metal, such as stainless steel or nitinol. As will be seen hereinafter, it is preferred that thefastener 212, and all other fasteners embodying the present invention be formed of a material which is capable of returning to a desired shape or assuming a desired shape after being bent. Many plastics and metals are capable of providing this function to render thefirst member 212 andsecond member 214 self-deployable for fastening the tissue layers 180 and 182. - As may be best seen in
FIG. 13A , the connectingmember 216 is formed of a strip of a tubular member formed by a pair of longitudinal substantially parallel, substantially co-extensive cuts within the tubular body of thefastener 210. Onesuch cut 218 is illustrated in the drawing, and the other such cut is formed along the opposite side of the tubular body. Thefirst member 212 andsecond member 214 are formed by a substantially transversecircumferential cut 220 between the substantially parallelco-extensive cuts 218. The substantially parallel substantiallyco-extensive cuts 218 begin spaced from afirst end 222 of thefastener 210 and terminates spaced from asecond end 224 of a second end. Thefirst member 212 andsecond member 214 are thus tubular member sections between thecircumferential cut 220 and the tubular memberfirst end 222 andsecond end 224. Thefastener 210 still further includes anelongated notch 226 extending from thesecond end 224 of thefastener 210 and extends towards thesecond end 222 substantially diametrically opposite and juxtaposed to a portion of the connectingmember 216. Thenotch 226 terminates proximal to the transversecircumferential cut 220. - The foregoing results in
fastener 210 including a throughchannel 228 within thefirst member 212 and a throughchannel 230 within thesecond member 214 to permit thefastener 210 to be slidingly received on thetissue piercing wire 164 as illustrated inFIG. 13 . In addition, thefastener 210 at thefirst end 222 includes apointed tip 232 which is formed by a sectioned portion of the tubular stock of thefastener 210. - As may be best seen in
FIG. 13 , when thefastener 210 is to be deployed, it is placed on thetissue piercing wire 164 with thefirst member 212 andsecond member 214 in line with one another. Thetissue piercing wire 164 andfastener 210 are guided to their proper positionadjacent tissue layer 180. Next, thetissue piercing wire 164 is advanced to piercetissue layers FIG. 13 . - Next, as seen in
FIG. 14 , thepusher 166 is utilized to push thefastener 212 through the tissue layers 180 and 182 on thetissue piercing wire 164. As depicted inFIG. 14 , the end of thefirst member 212 has just cleared thesurface 181 oftissue layer 180. - Referring now to
FIG. 15 , when thepusher 166 pushes the fastener so that thefirst member 212 is through thetissue layer 182, thefirst member 212 is free to deflect to a preformed configuration with respect to connectingmember 216. Thefirst member 212 deflects as shown inFIG. 15 after thetissue piercing wire 164 is partially withdrawn as illustrated inFIG. 15 . At this point, thesecond member 214 remains on thetissue piercing wire 164 and has not deflected to its preshaped configuration. - As may be best seen in
FIG. 16 , apusher 166 and most importantly theguide tube 168 are retracted to free thesecond member 214 to deflect to its preformed configuration. By virtue of thenotch 226, thesecond member 214 is free to deflect as illustrated while on thetissue piercing wire 164. As illustrated inFIG. 16 , thefastener 210 is in its deployed configuration. Thefirst member 212 self-deployed with the partial retraction of thetissue piercing wire 164 and thesecond member 214 self-deployed with a retraction of theguide tube 168. With thefastener 210 thus deployed, thetissue piercing wire 164,pusher 166, and guidetube 168 may be fully retracted. This is illustrated inFIG. 17 . As may be best seen inFIG. 17 , thefastener 210 is deployed with thefirst member 212 andsecond member 214 in contact with opposite sides oftissues member 216 extending between thefirst member 212 andsecond member 214 through the tissue layers 180 and 182. The shape memory material of thefastener 210 also permits the connectingmember 216 to be provided with a preshaped arcuate configuration as shown to cause the connectingmembers -
FIGS. 18-22 show anothertissue fastening assembly 240 embodying the present invention. Theassembly 240 includes thefastener 210 previously described with reference toFIG. 13A and the tissue fastening assembly ofFIGS. 13-16 . - In addition to the
fastener 210, theassembly 240 includes thetissue piercing wire 164, thepusher 166, and aguide tube 368. Theguide tube 368 is similar to theguide tube 168 previously described. However, aguide tube 368 includes aslot 370 at itsdistal end 372. Theslot 372, as will be seen subsequently, permits thesecond member 214 to assume its deployed configuration before thefirst member 212 assumes its deployed configuration.FIG. 18 illustrates theassembly 240 in an early stage of deploying thefastener 210.FIG. 19 shows theassembly 240 wherein thetissue piercing wire 164 has been advanced to pierce the tissue layers 180 and 182 while theguide tube 368, thepusher 166, and thefastener 210 are held stationary. With thetissue piercing wire 164 piercing the tissue layers 180 and 182, theguide tube 368 may be partially retracted so that thenotch 370 is adjacent thesecond member 214. By virtue of thenotch 226, thesecond member 214 is permitted to assume its deployed configuration through theslot 370. -
FIG. 20 illustrates thesecond member 214 of thefastener 210 in its deployed configuration within theslot 370. As will be noted inFIG. 20 , the connectingmember 216 is permitted to assume its preshaped configuration and thesecond member 214 is permitted to slide along thetissue piercing wire 164 within thenotch 226. With thesecond member 214 in its deployed configuration, thepusher 166 may now push thefirst member 212 through the tissue layers 180 and 182 on thetissue piercing wire 164. -
FIG. 21 illustrates thefastener 210 with thefirst member 212 pierced through the tissue layers 180 and 182 and thesecond member 214 in its deployed configuration. Thesecond member 214 is now againstsurface 181 oftissue layer 180. - With the
second member 214 first deployed, as may be seen inFIG. 22 , thetissue piercing wire 164 may be partially retracted to free thefirst member 212 and to permit thefirst member 212 to assume its deployed configuration. At this point, thesecond member 214 is still on thetissue piercing wire 164. - Now that both of the first and
second members tissue piercing wire 164,pusher 160, and guidetube 368 may be fully retracted to leave thefastener 210 in its deployed configuration. -
FIG. 23 illustrates thefastener 210 in its deployed configuration after thetissue piercing wire 164,pusher 166, and guidetube 368 are fully retracted. Again, the tissue layers 180 and 182 are securely fastened together by thefastener 210 as previously described. -
FIG. 24 is a perspective view of thefastener 210 imbedded within atissue layer 184 which is adjacent thetissue layer 180. Here it will be seen that thefirst member 212 of thefastener 210 is fully imbedded within thetissue layer 184. Thefastener 210 may be deployed as illustrated inFIG. 24 by any one of the methods previously described with respect toFIGS. 13-16 andFIGS. 18-22 . Once thetissue piercing wire 164 is withdrawn to free thesecond member 212, thesecond member 212 will become imbedded within thetissue 184. This illustrates the flexibility provided by the fasteners of the present invention for use with varying types of tissue. -
FIG. 25 is a perspective view with portions cut away of afurther fastener 310 embodying the present invention in association with thetissue piercing wire 164, thepusher 166, and theguide tube 168 for fastening tissue layers 180 and 182 together. Thefastener 310 includes afirst member 312, a second member 314, and a connectingmember 316. Thefastener 310 is essentially identical to thefastener 210 previously described except that itsnotch 326 extends the entire longitudinal length of the second member 314. As a result, the second member 314 may assume its deployed configuration off of thetissue piercing wire 164. In other words, when the second member 314 deploys, it will be, by virtue of thecontinuous notch 326, free of thetissue piercing wire 164. As a result, thetissue piercing wire 164 need not be fully retracted to free the second member 314 from thetissue piercing wire 164 after it has been deployed. -
FIG. 26 is a side view, partly in cross-section, of anotherfastener embodiment 410 of the invention. Thefastener 410 includes afirst member 412, asecond member 414, and a connecting member which cannot be seen in the figure. One of the first andsecond members second member 414 includes thecrimp 418. The depth of thecrimp 418 is controlled to exert a controlled amount of pressure against thetissue piercing wire 164. The controlled pressure by thecrimp 418 on thetissue piercing wire 164 provides controlled resistance to movement between thefastener 410 and thetissue piercing wire 164. This may provide a more “in control” feel between thefastener 410 andtissue piercing wire 164 during the deployment of thefastener 410. It may also be noted inFIG. 26 that thedeployment wire 164 has a bent or curved tip 165. The bent tip 165 renders thedevelopment wire 164 steerable to aid in guiding the fastener to its intended location within the body. - Referring now to
FIGS. 27-29 , they illustrate atissue fixation assembly 500 which may utilize the fasteners and fastener deployment assemblies previously described and embodying the present invention to advantage. Although the fasteners and deployment assemblies previously described and embodying the present invention may be used in numerous applications, theassembly 500 ofFIGS. 27-29 is particularly configured as a transoral gastroesophageal flap valve restoration device for restoring a gastroesophageal flap valve. - With initial reference to
FIG. 27 , the device ofFIG. 27 generally includes a longitudinal member 502 and atissue shaper 504 carried at the distal end of the longitudinal member 502. Thetissue shaper 504 and longitudinal member 502 are dimensioned for passing through the esophagus for transoral placement into a stomach. - The
tissue shaper 504 includes afirst arm 506 and asecond arm 508. Thefirst arm 506 andsecond arm 508 are hingedly coupled together at ahinge point 510. - The first arm includes a
fastener director 512. As will be seen hereinafter, stomach tissue layers to be fastened together may be shaped by thetissue shaper 504 by thefirst arm 506 andsecond arm 508 confining the stomach tissue layers therebetween. Thefirst arm 506 has atissue engaging surface 514. The first arm further includes a plurality offastener directing channels 516. The fastener directlychannels 516 communicate with thetissue engaging surface 514. Each of thefastener directing channels 516 serves to direct a fastener into the tissue layers to be fastened together. Accordingly, thefastener directing channels 516 are configured and dimensioned for receiving a tissue fastener such as, for example, any one of the fasteners previously described herein and embodying the present invention. - The
second arm 508 is aframe structure 518. Theframe structure 518 defines anopening 520 to permit the fasteners to be driven through the tissue layers while being held between thefirst arm 506 andsecond arm 518. - The
tissue shaper 504 further includes atissue gripper 522. Thetissue gripper 522 takes the form of a helical coil that grips the stomach tissue. As will be seen hereinafter, the tissue gripper is arranged to pull the stomach tissue into and between the first andsecond arms - Referring now to
FIG. 28 , it illustrates the configuration of thedevice 50 when shaping stomach tissue into a gastroesophageal flap valve. Here it may be seen that thesecond arm 508 has been pivoted relative to thefirst arm 506. This permits stomach tissue pulled between thearms FIG. 29 shows this in greater detail. Here it may be seen that thetissue gripper 522 has gripped stomach tissue 581 to form tissue layers 580 and 582 in the shape approximating a gastroesophageal flap. With the stomach tissue 581 drawn into and between thefirst arm 506 andsecond arm 508 with the tissue engaging thetissue engaging surface 514, fasteners may now be directed through thechannels 516 and deployed for fastening stomach tissue layers 580 and 582 together. A plurality ofchannels 516 are provided to enable a plurality of fasteners to be deployed. - In deploying the fasteners, the
fastener directing channels 516 may serve as guide tubes for guiding tissue piercing wires and pushers as previously described for deploying the fasteners. Alternatively, fastener guide tubes taking the form, for example, ofguide tube 168 previously described, may also be utilized and directed by thechannels 516 in the deployment of the fasteners. - Once the tissue layers 580 and 582 are fastened together, they will be maintained in the folded configuration to approximate a gastroesophageal flap valve. The
helical coil 522 may then be rotated to disengage from the tissue and the first andsecond arms - Because in this embodiment, the contacting tissue layers held by the fastener are both serosa tissue, the tissue layers will eventually grow together. Hence, the fasteners of the present invention may be formed of reabsorbable material which, after sufficient time to permit fusion of the tissue layers, will be absorbed by the body.
- Referring now to
FIGS. 30 and 31 , they illustrate still anotherfastener 600 according to an embodiment of the invention. Thefastener 600 generally includes afirst member 602, asecond member 604, and a connectingmember structure 606. As may be noted inFIGS. 30 and 31 the connecting member structure includes a plurality of connectingmembers 608 and 610. The connectingmembers 608 and 610 connect thefirst member 602 to thesecond member 604. - The
first member 602 is cylindrical and thesecond member 604 is a cylindrical half-section. Each has a longitudinal throughchannel channel 614 is a through bore which is dimensioned to be a slidingly received on a tissue piercing deployment wire. Thechannel 614 is dimensioned to be optionally carried on the deployment wire prior to deployment. - The
first member 602 also includes a conicalpointed tip 614. - The
fastener 600 may be formed of any of the plastic or metal material previously described. As may be further noted inFIGS. 30 and 31 the connectingmembers 600 and 610 are relatively thin to render the connectingmember structure 606 readily bendable for ease of deployment. The connecting member structure is further rendered bendable of course by the nature of the plastic or metal material from which thefastener 600 is formed. - Referring now to
FIGS. 32 and 33 , they illustrate anotherfastener 700 embodying the present invention. As with the previous fastener, thefastener 700 includes a cylindricalfirst member 702, cylindrical half-section 704 and a connectingmember structure 706. The connectingmember structure 706 includes connectingmembers 708 and 710. Here however, thepointed tip 714 takes the form of a tapered section of thefirst member 702. - As in the previous embodiment the
first member 702 of thefastener 700 may be slidingly received on a deployment wire. The deployment wire may be received by a bore 712. Thefasteners - While particular embodiments of the present invention have been shown and described, modifications may be made, and it is therefore intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention.
Claims (114)
Priority Applications (15)
Application Number | Priority Date | Filing Date | Title |
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US10/783,717 US20050187565A1 (en) | 2004-02-20 | 2004-02-20 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US10/949,737 US7632287B2 (en) | 2004-02-20 | 2004-09-23 | Tissue fixation devices and assemblies for deploying the same |
JP2006554157A JP2007522878A (en) | 2004-02-20 | 2005-02-14 | Tissue fixation device, oral endoscopic gastroesophageal flap valve treatment device, and assembly using the device |
PCT/US2005/004619 WO2005081817A2 (en) | 2004-02-20 | 2005-02-14 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
CNA2005800113761A CN101056588A (en) | 2004-02-20 | 2005-02-14 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
EP05713502A EP1725173A4 (en) | 2004-02-20 | 2005-02-14 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US11/172,363 US20060009792A1 (en) | 2004-02-20 | 2005-06-29 | Tissue fixation assembly having prepositioned fasteners and method |
US11/811,392 US20080004638A1 (en) | 2004-02-20 | 2007-06-08 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US12/460,247 US8337523B2 (en) | 2004-02-20 | 2009-07-15 | Tissue fixation assembly having prepositioned fasteners and method |
US12/460,510 US8657837B2 (en) | 2004-02-20 | 2009-07-18 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US12/590,203 US8911473B2 (en) | 2004-02-20 | 2009-11-04 | Tissue fixation devices and assemblies for deploying the same |
US13/604,276 US10064615B2 (en) | 2004-02-20 | 2012-09-05 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US13/678,474 US8961540B2 (en) | 2004-02-20 | 2012-11-15 | Tissue fixation assembly having prepositioned fasteners and method |
US16/115,015 US11090037B2 (en) | 2004-02-20 | 2018-08-28 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US17/378,672 US20210338230A1 (en) | 2004-02-20 | 2021-07-17 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
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US10/783,717 US20050187565A1 (en) | 2004-02-20 | 2004-02-20 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
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US10/949,737 Continuation-In-Part US7632287B2 (en) | 2004-02-20 | 2004-09-23 | Tissue fixation devices and assemblies for deploying the same |
US11/172,363 Continuation-In-Part US20060009792A1 (en) | 2004-02-20 | 2005-06-29 | Tissue fixation assembly having prepositioned fasteners and method |
US11/811,392 Continuation US20080004638A1 (en) | 2004-02-20 | 2007-06-08 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US12/460,510 Continuation US8657837B2 (en) | 2004-02-20 | 2009-07-18 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
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US10/783,717 Abandoned US20050187565A1 (en) | 2004-02-20 | 2004-02-20 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US11/811,392 Abandoned US20080004638A1 (en) | 2004-02-20 | 2007-06-08 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US12/460,510 Active 2025-03-05 US8657837B2 (en) | 2004-02-20 | 2009-07-18 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US13/604,276 Active 2025-10-25 US10064615B2 (en) | 2004-02-20 | 2012-09-05 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US16/115,015 Active 2024-12-06 US11090037B2 (en) | 2004-02-20 | 2018-08-28 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US17/378,672 Abandoned US20210338230A1 (en) | 2004-02-20 | 2021-07-17 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
Family Applications After (5)
Application Number | Title | Priority Date | Filing Date |
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US11/811,392 Abandoned US20080004638A1 (en) | 2004-02-20 | 2007-06-08 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US12/460,510 Active 2025-03-05 US8657837B2 (en) | 2004-02-20 | 2009-07-18 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US13/604,276 Active 2025-10-25 US10064615B2 (en) | 2004-02-20 | 2012-09-05 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US16/115,015 Active 2024-12-06 US11090037B2 (en) | 2004-02-20 | 2018-08-28 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
US17/378,672 Abandoned US20210338230A1 (en) | 2004-02-20 | 2021-07-17 | Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same |
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US (6) | US20050187565A1 (en) |
EP (1) | EP1725173A4 (en) |
JP (1) | JP2007522878A (en) |
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WO2008044146A3 (en) * | 2006-10-13 | 2008-06-12 | Sofradim Production | Instrument for storing and dispensing a surgical fastener |
US20090204147A1 (en) * | 2007-12-05 | 2009-08-13 | Rahmani Emad Y | Methods and apparatuses for delivering achoring devices into body passage walls |
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US20100211075A1 (en) * | 2006-09-29 | 2010-08-19 | Biomet Sports Medicine, Llc | Fracture Fixation Device |
US20100262169A1 (en) * | 2005-01-25 | 2010-10-14 | Baker Steve G | Slitted tissue fixation devices and assemblies for deploying the same |
US7909851B2 (en) * | 2006-02-03 | 2011-03-22 | Biomet Sports Medicine, Llc | Soft tissue repair device and associated methods |
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US8118836B2 (en) | 2004-11-05 | 2012-02-21 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to a bone |
US8128658B2 (en) | 2004-11-05 | 2012-03-06 | Biomet Sports Medicine, Llc | Method and apparatus for coupling soft tissue to bone |
US8137382B2 (en) | 2004-11-05 | 2012-03-20 | Biomet Sports Medicine, Llc | Method and apparatus for coupling anatomical features |
US8221454B2 (en) | 2004-02-20 | 2012-07-17 | Biomet Sports Medicine, Llc | Apparatus for performing meniscus repair |
US8251998B2 (en) | 2006-08-16 | 2012-08-28 | Biomet Sports Medicine, Llc | Chondral defect repair |
US8257394B2 (en) | 2004-05-07 | 2012-09-04 | Usgi Medical, Inc. | Apparatus and methods for positioning and securing anchors |
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US11090037B2 (en) | 2021-08-17 |
US20190021720A1 (en) | 2019-01-24 |
WO2005081817A3 (en) | 2006-12-14 |
US10064615B2 (en) | 2018-09-04 |
EP1725173A4 (en) | 2012-02-22 |
EP1725173A2 (en) | 2006-11-29 |
WO2005081817A2 (en) | 2005-09-09 |
US20120330328A1 (en) | 2012-12-27 |
JP2007522878A (en) | 2007-08-16 |
US20080004638A1 (en) | 2008-01-03 |
US20210338230A1 (en) | 2021-11-04 |
US8657837B2 (en) | 2014-02-25 |
CN101056588A (en) | 2007-10-17 |
US20100030243A1 (en) | 2010-02-04 |
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