US20060167481A1 - Slitted tissue fixation devices and assemblies for deploying the same - Google Patents

Abstract

Tissue fasteners carried on a tissue piercing deployment wire fasten tissue layers of a mammalian body together include a first member, a second member, and a connecting member extending between the first and second members. One of the first and second members has a configuration alterable by a deployment wire to permit release of the fastener from the deployment wire after deployment and without causing excessive tissue trauma.

Description

FIELD OF THE INVENTION
• 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.
BACKGROUND
• 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, in part due to the fact, that the esophagus is not covered by serosa, a layer of very sturdy, yet very thin tissue, covering and stabilizing all intraabdominal organs, similar like a fascia covering and stabilizing muscle. Involvement of esophageal tissue in the repair of a gastroesophageal flap valve poses unnecessary risks to the patient, such as an increased risk of fistulas between the esophagus and the stomach.
• 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. Still further, the fastener must be readily deployable. Also, quite obviously, the fasteners are preferably deployable in the tissue in a manner which does not unduly traumatize the tissue.
SUMMARY
• The invention provides a fastener for use in a mammalian body. The fastener comprises a first member and a second member, wherein the first and second members have first and second ends. The fastener further comprises 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 through channel along the axis arranged to be slidingly received on a tissue piercing deployment wire, and a slit extending between the first and second ends and communicating with the through channel.
• The slit is substantially parallel to the through channel. The slit may include an elongated slot portion dimensioned to receive the tissue piercing deployment wire. The slit further has a width less than the diameter of the through channel.
• The invention further provides a fastener assembly for use in a mammalian body, comprising a fastener including a first member and a second member. The first and second members have first and second ends. The fastener further comprises 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, a through channel along the axis, and a slit between the first and second ends and communicating with the through channel. The assembly further comprises a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and to pierce into the tissue. The deployment wire is arranged to be received by the slit to enable early deployment of the one of the first and second members and reduced tissue compression. The assembly further comprises a pusher that pushes the one of first and second members into the tissue while on the deployment wire.
• The invention further comprises a fastener assembly for use in a mammalian body compromising a fastener including a first member, and a second member, wherein the first and second members have first and second ends. The fastener further comprises a connecting member fixed to each of the first and second members intermediate the first and second ends and extends between and separates the first and second members. The one of the first and second members has a longitudinal axis, a through channel along the axis, and a slit extending between the first and second ends and communicating with the through channel. The assembly further comprises a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and has a pointed tip to pierce into tissue, the pointed tip having a cross-sectional dimension equal to or greater than the cross-sectional dimension of the through channel. The assembly further comprises a pusher that pushes the one of first and second members into the tissue while on the deployment wire.
• The invention still further provides a fastener assembly for use in a mammalian body, comprising a deployment wire having an end arranged to pierce into tissue to be fastened, a fastener including a member having a through channel dimensioned to be slidingly received on the deployment wire, and a pusher that pushes the fastener into the tissue while on the deployment wire. The pusher is tubular having a distal end, a sidewall, a lumen, and an opening in the sidewall communicating with the lumen. The pusher is carried on the deployment wire with the deployment wire extending through the sidewall opening, into the lumen, and beyond the distal end of the pusher. The fastener member is carried on the deployment wire between the deployment wire end and the distal end of the pusher arranged to pierce into the tissue upon being pushed by the pusher.
• The invention further 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 through channel arranged to be slidingly received on a tissue piercing deployment wire and a configuration alterable by the tissue piercing deployment wire that permits release of the fastener from the tissue piercing deployment wire.
• The configuration of the one of the first and second members is alterable by being tearable by the tissue piercing deployment wire. The member may have a sidewall that is tearable by the tissue piercing deployment wire. The sidewall may have a varying thickness, such as by a scoring line, to assist in the sidewall tearing.
• Alternatively, the configuration of the one of the first and second members may be alterable by being deformable by the tissue piercing deployment wire. The member may have a sidewall that is deformable by the tissue piercing deployment wire. The sidewall may include a lengthwise slit. The lengthwise slit may be continuous from the first end to the second end. The slit may include a slot portion.
• The invention still further provides a fastener assembly for use in a mammalian body, comprising 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 has a longitudinal axis and a through channel along the axis. The assembly further includes a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and to pierce into the tissue and a pusher that pushes the one of first and second members into the tissue while on the deployment wire. The one of the first and second members has a configuration that is alterable by the tissue piercing deployment wire that permits release of the fastener from the tissue piercing deployment wire upon relative movement of the one of the first and second members and the tissue piercing deployment wire.
• The pusher is tubular having a distal end, a sidewall, a lumen, and an opening in the sidewall communicating with the lumen. The pusher is carried on the tissue piercing deployment wire which extends through the sidewall opening, into the lumen, and beyond the distal end of the pusher. The one of the first and second members is carried on the deployment wire between the deployment wire end and the distal end of the pusher to be arranged to pierce into the tissue upon being pushed by the pusher.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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 reference numerals identify like elements, and wherein:
• 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 embodying the invention;
• FIG. 4 is a side view of the fastener ofFIG. 3;
• FIG. 5 is a perspective view with portions cut away of a fastener assembly according to a first embodiment of the invention in an early stage of deploying the fastener ofFIGS. 3 and 4;
• 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 in an intermediate stage of deployment;
• FIG. 8 is a perspective view of the assembly ofFIG. 5 shown with the fastener almost completely 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 an exploded side view of a deployment wire and pusher arrangement according to an embodiment of the invention;
• FIG. 11 is a perspective view with portions cut away of a fastener assembly according to a second embodiment of the invention in an early stage of deploying a further fastener embodiment of the invention;
• FIG. 12 is a perspective view of the assembly ofFIG. 11 shown with the fastener being driven in the tissue layers to be fastened;
• FIG. 13 is a perspective view of the assembly ofFIG. 11 shown with the fastener in an intermediate stage of deployment;
• FIG. 14 is a perspective view of the assembly ofFIG. 11 shown with the fastener almost completely deployed;
• FIG. 15 is a perspective view showing the fastener of the assembly ofFIG. 11 fully deployed and securely fastening a pair of tissue layers together;
• FIG. 16 is a perspective view with portions cut away of a fastener assembly according to a still further embodiment of the invention in an early stage of deploying a still further fastener embodiment of the invention;
• FIG. 17 is a perspective view of the assembly ofFIG. 16 shown with the fastener being driven in the tissue layers to be fastened;
• FIG. 18 is a perspective view of the assembly ofFIG. 16 shown with the fastener in an intermediate stage of deployment;
• FIG. 19 is a perspective view of the assembly ofFIG. 16 shown with the fastener almost completely deployed; and
• FIG. 20 is a perspective view showing the fastener of the assembly ofFIG. 16 fully deployed and securely fastening a pair of tissue layers together.
DETAILED DESCRIPTION
• FIG. 1 is a front cross-sectional view of the esophageal-gastro-intestinal tract40 from a lower portion of theesophagus41 to theduodenum42. Thestomach43 is characterized by thegreater curvature44 on the anatomical left side and thelesser curvature45 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. Thefundus46 of thegreater curvature44 forms the superior portion of thestomach43, and traps gas and air bubbles for burping. Theesophageal tract41 enters thestomach43 at an esophageal orifice below the superior portion of thefundus46, forming acardiac notch47 and an acute angle with respect to thefundus46 known as the Angle of His57. The lower esophageal sphincter (LES)48 is a discriminating sphincter able to distinguish between burping gas, liquids, and solids, and works in conjunction with thefundus46 to burp. The gastroesophageal flap valve (GEFV)49 includes a moveable portion and an opposing more stationary portion. The moveable portion of theGEFV49 is an approximately 180 degree, semicircular, gastroesophageal flap50 (alternatively referred to as a “normal moveable flap” or “moveable flap”) formed of tissue at the intersection between theesophagus41 and thestomach43. The opposing more stationary portion of theGEFV49 comprises a portion of thelesser curvature45 of thestomach43 adjacent to its junction with theesophagus41. Thegastroesophageal flap50 of theGEFV49 principally comprises tissue adjacent to thefundus46 portion of thestomach43, is about 4 to 5 cm long (51) at it longest portion, and the length may taper at its anterior and posterior ends. Thegastroesophageal flap50 is partially held against thelesser curvature45 portion of thestomach43 by the pressure differential between thestomach43 and the thorax, and partially by the resiliency and the anatomical structure of theGEFV49, thus providing the valving function. TheGEFV49 is similar to a flutter valve, with thegastroesophageal flap50 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 theLES48 and theGEFV49 at the stomach. The normal anti-reflux barrier is primarily formed by theLES48 and theGEFV49 acting in concert to allow food and liquid to enter the stomach, and to considerably resist reflux of stomach contents into theesophagus41 past thegastroesophageal tissue junction52. Tissue aboral of thegastroesophageal tissue junction52 is generally considered part of the stomach because the tissue protected from stomach acid by its own protective mechanisms. Tissue oral of thegastroesophageal junction52 is generally considered part of the esophagus and it is not protected from injury by prolonged exposure to stomach acid. At thegastroesophageal junction52, 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 junction52.
• FIG. 2 is a front cross-sectional view of an esophageal-gastro-intestinal tract illustrating a Grade I normal appearancemovable flap50 of the GEFV49 (shown in dashed lines) and a deteriorated Grade IIIgastroesophageal flap55 of the GEFV49 (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 flap55 of theGEFV49 to close and seal against the higher pressure in the stomach. Due to reasons including lifestyle, a Grade I normalgastroesophageal flap50 of theGEFV49 may deteriorate into a Grade III deterioratedgastroesophageal flap55. The anatomical results of the deterioration include moving a portion of theesophagus41 that includes thegastroesophageal junction52 andLES48 toward the mouth, straightening of thecardiac notch47, and increasing the Angle of His57. This effectively reshapes the anatomy aboral of thegastroesophageal junction52 and forms a flattenedfundus56. The deterioratedgastroesophageal flap55 illustrates agastroesophageal flap valve49 andcardiac notch47 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 flap50 of theGEFV49 illustrates a Grade I flap valve that is the least likely to experience reflux. The deterioratedgastroesophageal flap55 of theGEFV49 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 flap55 and thefundus46 moved inferior, the stomach contents are presented a funnel-like opening directing the contents into theesophagus41 and the greatest likelihood of experiencing reflux. Disclosed subsequently is a fastener and assembly which may be employed to advantage in restoring the normal gastroesophageal flap valve anatomy.
• FIG. 3 is a perspective view andFIG. 4 is a side view of afastener100 embodying the present invention. Thefastener100 generally includes afirst member102, asecond member104, and a connectingmember106. As may be noted inFIG. 3, thefirst member102 andsecond member104 are substantially parallel to each other and substantially perpendicular to the connectingmember106 which connects thefirst member102 to thesecond member104.
• Thefirst member102 is generally cylindrical or can have any other shape. It has alongitudinal axis108 and a through channel112 along thelongitudinal axis108. The through channel112 is formed by a through bore which is dimensioned to be slidingly received on a tissue piercing deployment wire to be described.
• Thefirst member102 also includes afirst end116 and asecond end118. Similarly, thesecond member104 includes afirst end120 and asecond end122. Thefirst end116 ofmember102 forms apointed dilation tip124. Thedilation tip124 may be conical and more particularly takes the shape of a truncated cone. The tip can also be shaped to have a cutting edge in order to reduce tissue resistance.
• The first andsecond members102 and104 and the connectingmember106 may be formed of different materials and have different textures. These materials may include, for example, plastic materials such as polypropylene, polyethylene, polyglycolic acid, polyurethane, or a thermoplastic elastomer. The plastic materials may include a pigment contrasting with body tissue color to enable better visualization of the fastener during its deployment. Alternatively, the fastener may be formed of a metal, such as stainless steel or a shape memory metal, such as Nitinol.
• As may be further noted inFIG. 3, the connectingmember106 has avertical dimension128 and ahorizontal dimension130 which is transverse to the vertical dimension. The horizontal dimension is substantially less than the vertical dimension to render the connectingmember106 readily bendable in a horizontal plane. The connecting member is further rendered bendable by the nature of the material from which thefastener100 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.
• It may be noted inFIGS. 3 and 4, that thefirst member102 has a continuouslengthwise slit125 extending between the first and second ends116 and118. Theslit125 includes anoptional slot portion126 that communications with the through channel112. Theslot126 has a transverse dimension for more readily enabling receipt of a tissue piercing deployment wire during deployment of thefastener100. Also, because thefastener number102 is formed of flexible material, theslit125 may be made larger through separation to allow the deployment wire to be snapped into and released from the through channel112 as will be seen subsequently. This permits early release of the first member duringdeployment102 and decreases compression on the tissue layers. Theslit125 extends substantially parallel to the through channel112 and thecenter axis108 of thefirst member102. It may also be noted that theslit125 has a width dimension that is smaller or less than the diameter D of the through channel112. This assures that thefastener100 will remain on a tissue piercing deployment wire as it is pushed towards and into the tissue as will be seen subsequently.
• Referring now toFIG. 5, it is a perspective view with portions cut away of afastener assembly200 embodying the present invention for deploying thefastener100. The tissue layer portions above thefastener100 have been shown cut away inFIGS. 5-9 to enable the deployment procedure to be seen more clearly. Theassembly200 generally includes thefastener100, adeployment wire164, apusher166, and aguide tube168.
• Thefirst member102 of thefastener100 is slidingly received on thedeployment wire164. Thedeployment wire164 has a pointedtip178 for piercing the tissue layers180 and182 to be fastened together. Thetip178 is enlarged with respect to the diameter of thedeployment wire164 and preferably has a cross-sectional dimension greater than that of the through channel and preferably thefirst member102. This permits thetip178 to cut sufficient tissue to enable thefastener member102 to readily pass through the tissue layers180 and182. It may also serve as a guide to guide thewire164 off of themember102 at the end of the deployment. Thetissue piercing wire164,fastener100, and thepusher166 are all within theguide tube168. Theguide tube168 may take the form of a catheter, for example, as previously mentioned, or a guide channel within a block of material.
• As will be further noted inFIG. 5, thesecond member104 is disposed along side thefirst member102. This is rendered possible by the flexibility of the connectingmember106.
• With thefirst member102 of thefastener100 slidingly received on thetissue piercing wire164 and with thepusher166 just touching thefirst member102 on thetissue piercing wire164, thetip178 of thetissue piercing wire164 pierces the tissue layers180 and182. The subassembly of thetissue piercing wire164,fastener100, andpusher166 may be guided to its intended location relative to the tissue layers180 and182 by theguide tube168.
• As shown inFIG. 6, thetissue piercing wire164 has pierced the tissue layers180 and182 and thepusher166 has pushed thefirst member102 of thefastener100 through the tissue layers180 and182 on thetissue piercing wire164. This may be accomplished by moving thewire164 and thepusher166 together.
• As may be seen inFIG. 7,wire164 has been pushed further forward and independently from thefirst member102. Thefirst member102 has also been pushed forward by thepusher166 to cause thesecond member104 to engage thetissue layer180. Continued pushing of thefirst member102 causes the first member to pivot in a counter clockwise direction because thesecond member104 is held by thetissue layer180. The counter clockwise movement of thefirst member102 causes thewire164 to spread theslit125 open, to pass down the slit to enterslot portion126 and to eventually pass through theslit125 atend118. Thefastener100 is then released from thewire164.
• InFIG. 8, it will now be seen that thesecond end118 of thefirst member102 has cleared thewire164 andtissue layer182. Thetissue piercing wire164 may now be retracted into thepusher166 and thetissue piercing wire164 andpusher166 may be withdrawn.
• FIG. 9 illustrates thefastener100 in its fully deployed position. It will be noted that the fastener has returned to its original shape. The tissue layers180 and182 are fastened together between thefirst member102 of thefastener100 and thesecond member104 of thefastener100. The connectingmember106 extends through the tissue layers180 and182.
• The release of thefastener100 from thewire164 with minimal damage to the tissue layers180 and182 is made possible because thefirst member102 has a configuration alterable by thewire164. Theslit125 inmember102 assists in the configuration change and release.
• Referring now toFIG. 10, it shows a deployment wire/pusher arrangement160 which may be employed in theassembly200 ofFIGS. 5-9. Thearrangement160 includes thedeployment piercing wire164 and thepusher166. Thewire164 includes thetissue piercing tip178. Thepusher166 is tubular and has adistal end165, alumen162, and anopening167 through thepusher sidewall161 and communicating with thelumen162. Thelumen162 is configured to permit thepusher166 to slidingly be carried on thewire164. To that end, the wire extends within thelumen162 from thedistal end165 and through theopening167. Afastener100, of the type previously described, has been snapped onto thedeployment wire164 between thedeployment wire tip178 and thedistal end165 of thepusher166. Anoptional stiffener169 may also be provided for thepusher166.
• After a fastener is deployed, thepusher166 may be retracted from the patient while the pusher is still on thedeployment wire164, a further fastener may then be snapped onto the wire through theslit125. The pusher may then be advanced down the deployment wire to deploy the fastener as previously described.
• FIGS. 11-15 show a deployment sequence of anotherfastener assembly210 embodying the invention. As shown inFIG. 11, theassembly210 includes thedeployment wire164, thepusher166, theguide tube168, and afastener300. Thefastener300 includes afirst member302, asecond member304, and a connectingmember306. Thefastener300 is similar to thefastener100 previously described except that to render the configuration of thefirst member302 alterable by thedeployment wire164 as thefirst member102 is so alterable, thefirst member302 is stretchable to obviate the need for a slit. More specifically, thefirst member302 may be formed of rubber, for example, to permit thewire164 to be separated from themember302 by simply pulling thewire tip178 back through through the member. Deformation of themember302 occurs to permit this separation.
• FIG. 11 shows thefastener300 on the wire with thewire tip178 just piercing the tissue layer. Thefirst member302 is carried on thewire164 which extends through the through channel of thefirst member302.
• As seen inFIG. 12, thepusher166 andwire164 are moved forward together to cause thewire164 andmember302 to extend through the tissue layers180 and186. From this point, as may be seen inFIG. 13, the pusher pushes themember302 forward. Thesecond member304 first engagestissue layer180 and once so engaged, thefirst member302 is caused to rotate (counter clockwise inFIG. 13). The elasticity of themember302 causes the wire tip to stretch the sidewall of thefirst member302. As themember302 is continued to be pushed, and with optional retraction of the deployment wire114, it continues to rotate. Eventually, theend318 of themember302 pops free of the wire tip. This may be seen inFIG. 14. Theend318 of the member is now free of thewire164.
• Thepusher166 anddeployment wire164 may now be extracted. As shown inFIG. 15, the tissue layers180 and182 are now fixed together between the first andsecond members302 and304 with the connectingmember306 extending therebetween.
• FIGS. 16-20 show a deployment sequence of anotherfastener assembly220 embodying the invention. As shown inFIG. 16, theassembly220 includes thedeployment wire164, thepusher166, theguide tube168, and afastener400. Thefastener400 includes afirst member402, asecond member404, and a connectingmember406. Thefastener400 is similar to thefasteners100 and300 previously described except that, to render the configuration of thefirst member402 alterable by thedeployment wire164, thefirst member402 is tearable bytip178 of thewire164. More specifically, thefirst member402 may be formed, for example, to permit thewire164 to tear themember402 lengthwise as thewire tip178 is pulled back through through themember402. To assist the tearing, the member sidewall may have a varying thickness, such as a tearing or scoreline403.
• FIG. 16 shows thefastener400 on the wire with thewire tip178 just piercing the tissue layer. Thefirst member402 is carried on thewire164 which extends through the through channel of thefirst member402.
• As seen inFIG. 17, thepusher166 andwire164 are moved forward together to cause thewire164 andmember402 to extend through the tissue layers180 and186. From this point, thepusher166 pushes themember402 to cause thetip178 to begin tearing themember402 along thescore line402. As may be seen inFIG. 18, the pusher pushes themember402 forward. Thesecond member404 first engagestissue layer180 and once so engaged, thefirst member402 is caused to rotate (counter clockwise inFIG. 18). The turning of themember402 causes thewire tip178 to tear through the sidewall of thefirst member402. As themember402 is continued to be pushed, it continues to be turned lengthwise. Eventually, theend418 of themember402 releases from the wire tip. This may be seen inFIG. 19. Theend418 of the member is now free of thewire164.
• Thepusher166 anddeployment wire164 may now be extracted. As shown inFIG. 20, the tissue layers180 and182 are now fixed together between the first andsecond members402 and404 with the connectingmember406 extending therebetween.
• While the invention has been described by means of specific embodiments and applications thereof, it is understood that numerous modifications and variations may be made thereto by those skilled in the art without departing from the spirit and scope of the invention. It is therefore to be understood that within the scope of the claims, the invention may be practiced otherwise than as specifically described herein.

Claims (73)

1. 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 being separated by the connecting member, and

one of the first and second members having a through channel along the axis arranged to be slidingly received on a tissue piercing deployment wire, and a slit extending between the first and second ends and communicating with the through channel.

2. The fastener ofclaim 1 wherein the slit includes an elongated slot portion dimensional to receive the tissue piercing deployment wire.

3. The fastener ofclaim 1 wherein the slit is substantially parallel to the through channel.

4. The fastener ofclaim 1 wherein the connecting member is 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.

5. The fastener ofclaim 1 wherein one end of the one of the first and second members further includes a pointed tip.

6. The fastener ofclaim 1 wherein the through channel comprises a through bore.

7. The fastener ofclaim 1 wherein the first member, the second member, and the connecting member are all formed of plastic material.

8. The fastener ofclaim 7 wherein the first member, the second member, and the connecting member are all formed in one piece.

9. The fastener ofclaim 7 wherein the connecting member is formed of plastic elastic material.

10. The fastener ofclaim 7 wherein the plastic material includes a color pigment contrasting with body tissue color to enable visualization of the fastener with an endoscope.

11. The fastener ofclaim 1 wherein the through channel has a diameter, wherein the slit has a width, and wherein the width of the slit is less than the diameter of the through channel.

12. A fastener assembly for use in a mammalian body, comprising:

a fastener including a first member, a second member, wherein the first and second members have 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, wherein the first and second members are separated by the connecting member, and wherein one of the first and second members has a longitudinal axis, a through channel along the axis, and a slit extending between the first and second ends and communicating with the through channel;

a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and to pierce into the tissue and arranged to be received by the slit to enable early deployment of the one of the first and second members and reduced tissue compression; and

a pusher that pushes the one of first and second members into the tissue while on the deployment wire.

13. The assembly ofclaim 12 wherein the slit includes a slotted portion dimensioned to receive the deployment wire.

14. The assembly ofclaim 12 wherein the slit is substantially parallel to the through channel.

15. The assembly ofclaim 12 wherein the pusher is also arranged to be slidingly received on the deployment wire.

16. The assembly ofclaim 12 wherein the connecting member of the fastener is flexible, and wherein the assembly further comprises a guide tube extending over the deployment wire and the fastener, the other one of the first and second members being disposed next to the one of the first and second members within the guide tube.

17. The assembly ofclaim 12 wherein the first and second members are arranged to be side by side when the one of the first and second members is slidingly received on the deployment wire.

18. The assembly ofclaim 12 wherein one end of the one of the first and second members of the fastener further includes a pointed tip.

19. The assembly ofclaim 12 further comprising a guide tube extending over the deployment wire and the fastener.

20. The assembly ofclaim 12 wherein the first member, the second member, and the connecting member of the fastener are all formed of plastic material.

21. The assembly ofclaim 12 wherein the one of the first and second members of the fastener is self-deployable when the tissue piercing deployment wire is received by the slit.

22. The assembly ofclaim 12 wherein the through channel has a diameter, wherein the slit has a width, and wherein the width of the slit is less than the diameter of the through channel.

23. A fastener assembly for use in a mammalian body, comprising:

a fastener including a first member, a second member, wherein the first and second members have 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, wherein the first and second members are separated by the connecting member, and wherein one of the first and second members has a cross-sectional dimension and a slit extending between the first and second ends and communicating with the through channel;

a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and having a pointed tip to pierce into tissue, the pointed tip having a cross-sectional dimension equal to or greater than the cross-sectional dimension of the through channel; and

a pusher that pushes the one of first and second members into the tissue while on the deployment wire.

24. The assembly ofclaim 23 wherein the slit includes a slot portion dimension to receive the deployment wire.

25. The assembly ofclaim 23 wherein the pusher is also arranged to be slidingly received on the deployment wire.

26. The assembly ofclaim 23 wherein the connecting member of the fastener is flexible, and wherein the assembly further comprises a guide tube extending over the deployment wire and fastener, the other one of the first and second members being disposed next to the one of the first and second members within the guide tube.

27. The assembly ofclaim 23 wherein the first and second members are arranged to be side by side when the one of the first and second members is slidingly received on the deployment wire.

28. The assembly ofclaim 25 wherein one end of the one of the first and second members of the fastener further includes a pointed tip.

29. The assembly ofclaim 28 wherein the pointed tip comprises a truncated cone.

30. The assembly ofclaim 23 further comprising a guide tube extending over the deployment wire and the fastener.

31. The assembly ofclaim 23 wherein the one of the first and second members is formed of a flexible material to permit the deployment wire to be received within the through channel through the slit.

32. The assembly ofclaim 31 wherein the first member, the second member, and the connecting member of the fastener are all formed of plastic material.

33. The assembly ofclaim 31 wherein the first member, the second member, and the connecting member of the fastener are all formed in one piece.

34. The assembly ofclaim 31 wherein the fastener is formed of one of polyurethane, thermoplastic elastomer, and polypropylene.

35. The assembly ofclaim 31 wherein the fastener is formed of metal.

36. The assembly ofclaim 23 wherein the one of the first and second members of the fastener is self-deployable when the tissue piercing deployment wire is received by the slit during retraction.

37. The assembly ofclaim 23 wherein the through channel has a diameter, wherein the slit has a width, and wherein the width of the slit is less than the diameter of the through channel.

38. A fastener assembly for use in a mammalian body, comprising:

a deployment wire having an end arranged to pierce into tissue to be fastened;

a fastener including a member having a through channel dimensioned to be slidingly received on the deployment wire; and

a pusher that pushes the fastener into the tissue while on the deployment wire,

the pusher being tubular having a distal end, a sidewall, a lumen, and an opening in the sidewall communicating with the lumen,

wherein the pusher is carried on the deployment wire, the deployment wire extending through the sidewall opening, into the lumen, and beyond the distal end of the pusher, and

wherein the fastener member is carried on the deployment wire between the deployment wire end and the distal end of the pusher arranged to pierce into the tissue upon being pushed by the pusher.

39. The assembly ofclaim 38 wherein the fastener member includes first and second ends and a slit extending between the first and second ends and communicating with the through channel.

40. The assembly ofclaim 39 wherein the through channel has a diameter, wherein the slit has a width, and wherein the width of the slit is less than the diameter of the through channel.

41. The fastener assembly ofclaim 38 wherein the fastener member is a first member, and wherein the fastener includes the first member, a second member and a connecting member extending between the first and second members.

42. The assembly ofclaim 41 wherein the first member, the second member, and the connecting member of the fastener are all formed of plastic material.

43. The assembly ofclaim 41 wherein the first member includes first and second ends and a slit extending between the first and second ends and communicating with the through channel.

44. The assembly ofclaim 43 wherein the slit includes an elongated slot.

45. The assembly ofclaim 44 wherein the first member of the fastener is self-deployable when the tissue piercing deployment wire is received by the elongated slot.

46. The assembly ofclaim 41 wherein the connecting member of the fastener is flexible, and wherein the assembly further comprises a guide tube extending over the deployment wire and the fastener, the second member being disposed next to the first member within the guide tube.

47. The assembly ofclaim 41 wherein the first and second members are arranged to be side by side when the first member is a slidingly received on the deployment wire.

48. The assembly ofclaim 41 wherein one end of the first member of the fastener further includes a pointed tip.

49. The assembly ofclaim 47 wherein the first member, the second member, and the connecting member of the fastener are all formed in one piece.

50. The assembly ofclaim 41 wherein the fastener is formed of a shape memory material.

51. The assembly ofclaim 41 further comprising a guide tube extending over the deployment wire and the fastener.

52. The assembly ofclaim 28 wherein the fastener member has a slit communicating with the through channel to enable the through channel to be received by the deployment wire and wherein the deployment wire includes a piercing tip, the piercing tip having a cross-sectional dimension and the fastener member having a cross-sectional dimension and wherein the cross-sectional dimension of the piercing tip is greater than the cross-sectional area of the fastener member.

53. 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 being separated by the connecting member, and

one of the first and second members having a through channel arranged to be slidingly received on a tissue piercing deployment wire, and a configuration alterable by the tissue piercing deployment wire that permits release of the fastener from the tissue piercing deployment wire.

54. The fastener ofclaim 53, wherein the configuration of the one of the first and second members is tearable by the tissue piercing deployment wire.

55. The fastener ofclaim 54, wherein the one of the first and second members has a sidewall, and wherein the sidewall is tearable by the tissue piercing deployment wire.

56. The fastener ofclaim 55, wherein the sidewall has a varying thickness.

57. The fastener ofclaim 53, wherein the configuration of the one of the first and second members is deformable by the tissue piercing deployment wire.

58. The fastener ofclaim 57, wherein the one of the first and second members has a sidewall, and wherein the sidewall is deformable by the tissue piercing deployment wire.

59. The fastener ofclaim 58, wherein the sidewall includes a lengthwise slit.

60. The fastener ofclaim 59, wherein the lengthwise slit is continuous from the first end to the second end.

61. The fastener ofclaim 60, wherein the slit includes a slot portion.

62. A fastener assembly for use in a mammalian body, comprising:

a fastener including a first member, a second member, wherein the first and second members have 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, wherein the first and second members are separated by the connecting member, and wherein one of the first and second members has a longitudinal axis and a through channel along the axis;

a deployment wire arranged to be slidingly received by the through channel of the one of the first and second members and to pierce into the tissue; and

a pusher that pushes the one of first and second members into the tissue while on the deployment wire,

the one of the first and second members having a configuration that is alterable by the tissue piercing deployment wire that permits release of the fastener from the tissue piercing deployment wire upon relative movement of the one of the first and second members and the tissue piercing deployment wire.

63. The fastener assembly ofclaim 62, wherein the configuration of the one of the first and second members is tearable by the tissue piercing deployment wire.

64. The fastener assembly ofclaim 63, wherein the one of the first and second members has a cross-sectional dimension and wherein the tissue piercing deployment wire has a tip end having a cross-sectional dimension that is greater than or equal to the cross-sectional dimension of the through channel.

65. The fastener assembly ofclaim 63, wherein the one of the first and second members has a sidewall, and wherein the sidewall is tearable by the tissue piercing deployment wire.

66. The fastener assembly ofclaim 65, wherein the sidewall has a varying thickness.

67. The fastener assembly ofclaim 62, wherein the configuration of the one of the first and second members is deformable by the tissue piercing deployment wire.

68. The fastener assembly ofclaim 67, wherein the one of the first and second members has a cross-sectional dimension and wherein the tissue piercing deployment wire has a tip end having a cross-sectional dimension that is greater than or equal to the cross-sectional dimension of the through channel.

69. The fastener assembly ofclaim 67, wherein the one of the first and second members has a sidewall, and wherein the sidewall is deformable by the tissue piercing deployment wire.

70. The fastener assembly ofclaim 69, wherein the sidewall includes a lengthwise slit.

71. The fastener assembly ofclaim 70, wherein the lengthwise slit is continuous from the first end to the second end.

72. The fastener assembly ofclaim 71, wherein the slit includes a slot portion.

73. The fastener assembly ofclaim 62, wherein the pusher is tubular having a distal end, a sidewall, a lumen, and an opening in the sidewall communicating with the lumen, wherein the pusher is carried on the tissue piercing deployment wire, the tissue piercing deployment wire extending through the sidewall opening, into the lumen, and beyond the distal end of the pusher, and wherein the one of the first and second members is carried on the deployment wire between the deployment wire end and the distal end of the pusher arranged to pierce into the tissue upon being pushed by the pusher.

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