US20090236398A1 - Endoscopic stapling devices and methods - Google Patents

Abstract

Described herein are endoscopic staplers used to apply one or more fasteners to body tissue. In one embodiment, a fastener-applying device, which is preferably a stapler, is passed transorally into the stomach and used to plicate stomach tissue by engaging tissue from inside of the stomach and drawing it inwardly. In the disclosed embodiments, the tissue is drawn inwardly into a vacuum chamber, causing sections of serosal tissue on the exterior of the stomach to be positioned facing one another. The disclosed staplers allow the opposed sections of tissue to be moved into contact with one another, and preferably deliver staples for maintaining contact between the tissue sections at least until serosal bonds form between them. Each of these steps may be performed wholly from the inside of the stomach and thus can eliminate the need for any surgical or laparoscopic intervention. After one or more plications are formed, medical devices may optionally be coupled to the plication(s) for retention within the stomach.

Description

FIELD OF THE INVENTION
• The present invention relates generally to the field of systems and methods for performing endoscopic surgery, and specifically to systems and methods for endoscopic stapling of tissue within body cavities.
BACKGROUND OF THE INVENTION
• An anatomical view of a human stomach S and associated features is shown inFIG. 1A. The esophagus E delivers food from the mouth to the proximal portion of the stomach S. The z-line or gastro-esophageal junction Z is the irregularly-shaped border between the thin tissue of the esophagus and the thicker tissue of the stomach wall. The gastro-esophageal junction region G is the region encompassing the distal portion of the esophagus E, the z-line, and the proximal portion of the stomach S.
• Stomach S includes a fundus F at its proximal end and an antrum A at its distal end. Antrum A feeds into the pylorus P which attaches to the duodenum D, the proximal region of the small intestine. Within the pylorus P is a sphincter that prevents backflow of food from the duodenum D into the stomach. The middle region of the small intestine, positioned distally of the duodenum D, is the jejunum J.
• FIG. 1B illustrates the tissue layers forming the stomach wall. The outermost layer is the serosal layer or “serosa” S and the innermost layer, lining the stomach interior, is the mucosal layer or “mucosa” MUC. The submucosa SM and the multi-layer muscularis M lie between the mucosa and the serosa.
• There are a number of applications for endoscopic application of fasteners such as staples to tissue within a body cavity. Some of those applications involve forming tissue structures such as plications or folds in tissue of the body cavity.
• Several prior applications, including International Application No. WO 2005/037152 having an international filing date of Oct. 8, 2004 and U.S. application Ser. No. 11/439,461, filed May 23, 2006 (both incorporated herein by reference) describe methods according to which medical implants are coupled to tissue structures formed within the stomach. According to these applications, devices for inducing weight loss (e.g. by restricting and/or obstructing flow of food into the stomach, and/or by occupying a portion of the stomach volume) may be coupled to tissue tunnels or plications formed from stomach tissue.
• For example, U.S. application Ser. No. 11/439,461 describes a restrictive and/or obstructive implant system for inducing weight loss. In one embodiment, flexible loops are coupled to tissue plications formed in the gastroesophageal junction region of the stomach. An implant, such as a flow restrictive and/or obstructive implant, is passed through the loops2 and thus retained in the stomach.
• In other instances, tissue plications may themselves be sufficient to provide the necessary treatment. For example, the plications may be used to reduce stomach volume or form a flow restriction within the stomach as disclosed in WO 2005/037152 and in Applicants' co-pending application Ser. No. 11/542,457, filed Oct. 3, 2006, U.S. Publication No. 2007-0219571, which is incorporated herein by reference.
• Other types of implants may be coupled to such plications or other tissue structures for a variety of purposes. These implants include, but are not limited to prosthetic valves for the treatment of gastro-esophageal reflux disease, gastric stimulators, pH monitors and drug eluting devices that release drugs, biologics or cells into the stomach or elsewhere in the GI tract. Such drug eluting devices might include those which release leptin (a hormone which creates feelings of satiety), Ghrelin (a hormone which creates feelings of hunger), octreotide (which reduces Ghrelin levels and thus reduces hunger), Insulin, chemotherapeutic agents, natural biologics (e.g. growth factor, cytokines) which aid in post surgery trauma, ulcers, lacerations etc. Still other implants might be of a type which might provide a platform to which specific cell types can adhere, grow and provide biologically-active gene products to the GI tract, and/or a platform for radiation sources that can provide a local source of radiation for therapeutic purposes, or provide a platform whereby diagnostic ligands are immobilized and used to sample the GI tract for evidence of specific normal or pathological conditions, or provide an anchor point for imaging the GI tract via cameras and other image collecting devices.
• The prior applications listed above, address the desirability of forming tissue plications, pockets or tunnels in a way that regions of serosal tissue (i.e. the tissue on the exterior surface of the stomach) are retained in contact with one another. Over time, adhesions formed between the opposed serosal layers create strong bonds that can facilitate retention of the plication/pocket/tissue over extended durations, despite the forces imparted on them by stomach movement and implanted devices.
• Regardless of the application for which a plication is being formed, it is highly desirable to form that plication using steps carried out from within the stomach using instruments passed down the esophagus, rather than using more invasive surgical or laparoscopic methods. The present application describes endoscopic staplers which may be passed transorally into the stomach and used to form serosal-to-serosal plications in a stomach wall.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A is a schematic illustration of a human stomach and a portion of the small intestine.
• FIG. 1B is a cross-sectional perspective view of a portion of a stomach wall, illustrating the layers of tissue forming the wall.
• FIG. 2 illustrates an endoscopic stapling system.
• FIGS. 3A-3C are perspective views showing the stapler head of the stapling system ofFIG. 2 in three different positions.
• FIG. 4 is a perspective view of the stapler head, with the membrane removed.
• FIG. 5 is a perspective view of the proximal end of the staple housing of the stapler head ofFIG. 4.
• FIG. 6 is a perspective view of the distal end of the staple housing of the stapler head ofFIG. 4.
• FIG. 7 is an exploded perspective view showing elements advanceable within the staple housing during compression and stapling operations.
• FIG. 8 is a plan view of a staple reinforcement device.
• FIG. 9 is a side elevation view of a staple cartridge.
• FIG. 10 is a perspective view of the staple housing similar toFIG. 6, but showing some of the elements ofFIG. 7 within the housing.
• FIGS. 11A-11D are a series of schematic representations of the hydraulic chamber and pistons, illustrating operation of an exemplary hydraulic system during tissue compression and stapling.
• FIG. 11E is similar toFIG. 11D and shows an alternative piston configuration.
• FIG. 12 is a perspective view of the anvil housing of the stapler head ofFIG. 4.
• FIG. 13 is a perspective view of the anvil support.
• FIG. 14 is a plan view of the anvil.
• FIG. 15A is a cross-sectional side view of the cutting device and a first embodiment of a cutting board.
• FIG. 15B is a cross-sectional side view of the cutting device and a second embodiment of a cutting board.
• FIG. 16 is a perspective view of the hinged arm assemblies of the stapler head ofFIG. 4.
• FIG. 17 is a top plan view of the stapler head ofFIG. 4 in the streamlined position for introduction into the body. Both the membrane and the membrane raiser are not shown for purposes of clarity.
• FIG. 18 is similar toFIG. 17 and illustrates hidden features ofFIG. 17.
• FIG. 19 is a perspective view of the stapler head in an intermediate, partially expanded, position.
• FIG. 20 is a plan view similar toFIG. 17 but showing the stapler head in the intermediate position.
• FIG. 21 is similar toFIG. 20 and illustrates hidden features ofFIG. 20.
• FIG. 22 is a perspective view of the stapler head in a fully expanded, full compression position.
• FIG. 23 is a plan view similar toFIG. 20 but showing the stapler head in the full compression position.
• FIG. 24 is similar toFIG. 23 and illustrates hidden features ofFIG. 24.
• FIGS. 25A-25B are perspective views showing the staple housing, cartridge and a portion of the membrane raiser. These figures illustrate the steps of detaching a staple cartridge from the staple housing.
• FIG. 26 is a perspective view of the stapler ofFIG. 2, with the staple head removed.
• FIG. 27A is a plan view of the articulating section of the stapler ofFIG. 2, showing the drive fluid lines.
• FIG. 27B shows a drive fluid line having an alternate longitudinally expandable shape.
• FIG. 28 is a cross-sectional side view of the handle of the stapler ofFIG. 2.
• FIG. 29 is a perspective view of the handle of the stapler ofFIG. 2.
• FIGS. 30A and 30B are plan views of the proximal face of the staple housing, showing a method for attaching the end plate of the stapler handle to the staple housing.
• FIGS. 31A-31E are a series of drawings schematically illustrating use of the system ofFIG. 2 to form a plication in a stomach.
• FIGS. 32A-32C are a series of perspective views illustrating use of the stapler ofFIG. 2 to acquire, compress, and then staple stomach wall tissue to form a plication in the stomach. The membrane is not shown in these drawings.
• FIG. 33 is a top plan view of a plication formed in body tissue.
• FIGS. 34 and 35 are perspective views of an alternative stapler head equipped to carry additional tools.
DETAILED DESCRIPTION OF THE DRAWINGS
• The present application describes endoscopic fastener-applying devices which in preferred embodiments may be passed transorally into the stomach and used to plicate stomach tissue.
• In the disclosed embodiments, tissue is drawn inwardly into a vacuum chamber, although tissue may be drawn inwardly using other components (e.g. graspers) that do not involve the use of a vacuum. When a portion the interior stomach wall is drawn inwardly, sections of serosal tissue on the exterior of the stomach are positioned facing one another. The disclosed fastener applying device allows the opposed sections of tissue to be moved into contact with one another, and delivers fasteners that will hold the tissue sections together until at least such time as serosal bonds form between them. Each of these steps may be performed wholly from the inside of the stomach and thus can eliminate the need for any surgical or laparoscopic intervention. After one or more plications is formed, medical devices (including, but not limited to any of the types listed above) may be coupled to the plication(s) for retention within the stomach.
• The disclosed embodiments include an optional feature that forms a hole or cut in a plication using the fastener-applying device. This hole or cut might be formed so that a portion of a medical implant may be passed through or linked to the hole/cut, or it may be formed so as to provoke a healing response that will contribute to the strength of the resulting tissue bond.
• In the description of the embodiments given below, the fastener-applying devices are described as being staplers, and exemplary methods are given with respect to the formation of plications in stomach tissue. It should be understood, however, that the embodiments described herein include features having equal applicability for applying other types of fasteners, and for applying staples or other fasteners for purposes other than formation of plications. The disclosed embodiments and methods will also find use in parts of the body outside the GI system. Additionally, although the disclosed embodiment features circular stapling and cutting of a concentric hole, modifications are conceivable in which linear stapling can be accomplished, as well as circular or linear stapling without cutting.
• FIG. 2 illustrates one embodiment of a system10 for tissue stapling that is suitable for endoscopic use, as well as surgical or laparoscopic use if desired.
• Generally speaking, system10 includes astapler12 having astapler head14 positioned on a distal portion of ashaft16. Ahandle18 on theshaft16 controls articulation of thestapler head14 and actuation of the tissue acquisition, tissue compression, and stapling functions of thestapler head14. Vacuum andfluid sources20,25 are fluidly coupled to thehandle18 for use in tissue acquisition, compression and stapling as discussed below. Thevacuum source20 may be the “house vacuum” accessible through a coupling on the wall of the operating room, or an auxiliary suction pump. The stapler may include aswitch21 allowing the user to control airflow between the vacuum source and stapler.
• Thefluid source25 may be a single source of drive fluid (e.g. water, saline, oil, gas) or multiple sources, but in each case the fluid source preferably includes two actuators separately used to control flow into each of two hydraulic lines (one for tissue compression and one for stapling). Anendoscope22 insertable through a lumen in theshaft16 permits visualization of the plication procedure. The system may optionally include an overtube, such anendoscopic guide tube23, having a lumen for receiving thestapler12.
• Referring toFIG. 3A, a covering ormembrane24 encloses thestapler head14 to form a vacuum chamber within thestapler head14. The side exposed to the tissue to be plicated remains uncovered by themembrane24 to allow tissue to be drawn into the chamber during use. For example, themembrane24 may include aside opening26 as shown inFIG. 3B.Membrane24 is preferably formed of silicone, elastomeric material, or any other inelastic or elastic flexible or deformable biocompatible material capable of forming a vacuum chamber that will expand in volume to accommodate tissue drawn into the chamber.
• At least a portion of the membrane is at least partially transparent. In being at least partially transparent, the membrane is formed of a material, or includes sections of material, that will allow the user to see through the membrane well enough to confirm (via endoscopic observation) that an appropriate volume of tissue has been acquired into the stapler head prior to staple application. Theopening26 may be surrounded by a reinforcedsection27 formed of material that will strengthen the area around theopening26. Reinforcedsection27 may be formed of a thicker section of the membrane material, and/or a higher durometer material. Alternatively, reinforcing ribs or other structures or elements may be formed into or onto the membrane material, or embedded in the membrane material.
• Stapler Head
• Thestapler head14 is designed to have a minimum profile during insertion to the plication site, and to then transform into a much larger profile device having a large internal volume. For example, in one embodiment the vacuum chamber might have an initial internal volume of 0.2 cubic inches, and an expanded volume of 0.6 cubic inches (i.e. the internal chamber volume after subtracting the volume occupied by the stapler head components positioned within the vacuum chamber). This large internal volume allows a large volume of tissue to be drawn into the vacuum chamber and stapled. In this way, the stapler head creates a large plication without requiring invasive techniques for insertion. The unique features of the stapler head allow in situ volumetric expansion of the stapler head using a minimum of motion and force input.
• Features of the stapler head are shown inFIGS. 4-10. For clarity, the membrane is not shown in these figures. Referring toFIG. 4,stapler head14 generally includes a first member comprising a proximalstaple housing28, a second member comprising adistal anvil housing30, and at least one elongate member but preferably a pair of hingedarm assemblies32.
• The staple housing and anvil housing are arranged to allow tissue to be compressed between contact surfaces on each of the staple housing and the anvil housing. In the disclosed embodiment, the contact surfaces are on a staple holding portion of the staple housing and an anvil on the anvil housing.
• Thearm assemblies32 extend between thestaple housing28 andanvil housing30 on opposite sides of thestapler head14. Proximal anddistal pins34,36 pivotally couple eacharm assembly32 to thestaple housing28 and theanvil housing30. An expansion member comprising amembrane raiser37 also extends between thestaple housing28 and theanvil housing30. Although themembrane24 is not shown inFIG. 4, it should be understood that themembrane raiser37 is positioned opposite the opening26 (FIG. 3B) in the membrane. In the illustrated embodiment,membrane raiser37 includes alink38 pivotally mounted to the staple housing by apin42, acorresponding link40 pivotally mounted to the anvil housing bypin44, andspring wires46 coupling thelinks38,40 to one another.
• Staple Housing
• Turning to a more detailed discussion of the stapler head components, thestaple housing28 can be seen separated from other components inFIGS. 5 and 6. As shown inFIG. 5,proximal face48 of the staple housing includesinput ports50a,50bthrough which fluid is directed for hydraulic actuation of the tissue compression, stapling, and optional cutting operations of the stapler head. Seals51 surround theports50a,50bto minimize fluid leakage.
• Vacuum ports52 are fluidly coupled to a vacuum source20 (FIG. 2) that is selectively activated to create negative pressure in the vacuum chamber for tissue acquisition. Thevacuum ports52 are connected to thevacuum source20 by flexible tubing (not shown) in the stapler shaft16 (FIG. 2). Mountingholes54 are used to mount thestapler head14 to theshaft16.
• Thestaple housing28 includes upper andlower sections58a,58babove and belowopen side sections56. Theupper section58aincludes arecess60 within which thepivot pin42 for link38 (FIG. 4) is mounted. As best shown inFIG. 6, bores62 are positioned in the upper andlower sections58a,58bto receive pins34 (FIG. 4) that serve as the proximal pivot points forarm assemblies32.Guide slots64 extend longitudinally through the upper andlower sections58a,58b.
• Referring toFIG. 6, ahydraulic chamber66 is disposed within thestaple housing28. Within the hydraulic chamber66 (FIG. 6) is a dedicated hydraulic circuit for driving the tissue compression and stapling functions of the stapler.Chamber66 is fluidly coupled to thefluid input ports50a,50b(FIG. 5). As will be discussed in detail in connection withFIGS. 11A-11D, fluid driven into thehydraulic chamber66 viainput ports50a,50bsequentially advances a system of hydraulic pistons (not shown) that act on other components to compress the tissue, and that drive the staples and cutting element through the compressed tissue.
• FIG. 7 illustrates components of the stapler head that are driven by the hydraulic system for compression, stapling, and cutting. For clarity, these components are shown separated from the staple housing and from each other. In this discussion, the components that are driven by the hydraulic system will be described. The hydraulic system itself is described in a later section in connection withFIGS. 11A-11D.
• In particular,FIG. 7 illustrates a drive member which takes the form of adisk68 in the staple housing. In the assembled housing,disk68 is positioned such that it will be pushed distally by a hydraulic compression piston (not shown). The drive member is coupled to thearm assemblies32, anvil housing, and staple housing so that advancing the drive member distally effects tissue compression by bringing the contact surfaces of the staple housing and anvil housing relatively towards one another.
• Disk68 includes mounting bores70, acentral opening72, and alignment posts74. Referring briefly toFIG. 10, in the assembled stapler head,disk68 is coupled to thestapler housing28 usingpins84 that extend through the housing'sguide slots64 and through mountingbores70 in thedisk68.
• A portion of thestaple housing28 contains staples to be fired into the tissue. The staples are contained within a staple holder on the staple housing. The staple holder may have a number of different configurations. For example, it may be an integral portion of the staple housing, or a separate part mounted or attached to the staple housing, and/or it may be moveable relative to the body of the staple housing to effect tissue compression prior to stapling. In any of these examples, the staple holder may be a removeable/replaceable cartridge, and/or it may be refillable by inserting additional staples into it. In other embodiments, the staple holder may be neither replaceable nor refillable.
• In the disclosed embodiment, the staple holder is aremoveable staple cartridge78 that can be replaced with another cartridge after staple filing. In this embodiment, the staple cartridge is moveable relative to the body of the staple housing to compress the tissue prior to staple firing.
• Referring again toFIG. 7,staple cartridge78 is positionable within the staple housing, distal to thedisk68, such that distal advancement of the disk by the compression piston pushes the cartridge distally to compress tissue disposed between the cartridge and anvil.Grooves79 on the exterior of the cartridge slide over corresponding ones of the alignment posts74 during insertion of the cartridge into the stapler head.FIG. 10 shows the alignment posts prior to loading of a cartridge into the staple housing. As shown, the alignment posts74 may have tapered ends to facilitate loading of the cartridge over the posts.
• Again referring toFIG. 7,cartridge78 includes a number of staple locations80, each housing a staple. The staple cartridge is equipped withbosses81 to retain a stapleline reinforcement device83 of the type shown inFIG. 8 and disclosed in detail in commonly-owned U.S. application Ser. No. 11/542,457, entitled ENDOSCOPIC PLICATION DEVICES AND METHODS, filed Oct. 3, 2006, and published Sep. 20, 2007 as US 2007-0219571. To summarize briefly, this type ofreinforcement device83 may be a ring or other element positionable against the distal face of the staple cartridge. When the ring is placed on the cartridge,openings85 in the ring align with prongs of some of the staples in the cartridge. When staples are driven from the cartridge, these prongs pass through associated ones of theopenings85 and capture thering83 against the adjacent body tissue.
• Referring toFIGS. 7 and 9, a number ofundercut bosses81 on the anvil-facing side of the cartridge may be used to lock thereinforcement device83 in place on the face of the staple cartridge. Other positive shapes, such as mushrooms, hooks, and tilted bosses could be used to accomplish the same end. Negative shapes, such as pockets or grooves formed into the surface of the cartridge, may also be employed to engage corresponding features on thereinforcement device83. As another alternative, the reinforcement device may be held in place on the cartridge using adhesives.
• Acutter element86 extends through the central opening72 (FIG. 7) of thedisk68. The cutter element is shown as a tubular punch having a sharpened wall and alumen87, but may be provided in alternative forms. Astaple pusher76 is mounted to the cutter element, distally of the disk as can be seen in the assembled view ofFIG. 10.Staple pusher76 includespusher elements82 proportioned to slide into the cartridge's staple locations80 as thestaple pusher76 is advanced into thestaple cartridge78, thus driving the staples from the cartridge. A hydraulically-driven staple piston (not shown inFIG. 7) in thehydraulic chamber66 is coupled to thecutter element86 such that advancement of the stapler piston advances thestaple pusher76 andcutter element86 in a distal direction.
• Fluid Drive System
• The fluid drive system used to actuate compression, stapling and cutting may be configured in various ways. The following paragraphs describe one exemplary configuration for the fluid drive system, which in this embodiment is a hydraulic system.FIGS. 11A and 11B schematically show the fluid flow in thehydraulic chamber66 of thestaple housing28 during both compression and stapling stages of actuation. Referring toFIG. 11A,compression piston106 is disposed withinhydraulic chamber66. Disk68 (also shown inFIGS. 7 and 10) is positioned in contact with or slightly distal topiston106.Compression piston106 is generally cup-shaped, having arear wall108 and aside wall110 enclosing an interior111. O-ring seals112 are spaced-apart on a proximal portion of theside wall110.Channels114 are formed through theside wall110, between the o-ring seals112.
• A second piston, referred to as thestaple piston116, is positioned in theinterior111 ofcompression piston106, against therear wall108. Although not shown inFIGS. 11A-11D, cutting element86 (FIG. 7), with thestaple pusher76 thereon, is positioned in contact with or slightly distal to thestaple piston116. An o-ring seal118 surrounds a portion of thestaple piston116 that is distal to thechannels114 in the compression piston.
• Afirst fluid channel120 extends fromfluid port50ain thestapler housing28 to a proximal section of thehydraulic chamber66. Asecond fluid channel122 extends fromfluid port50bin the stapler housing to a more distal section of thehydraulic chamber66. Fluid flow fromport50aandfluid channel120 against the compression piston cylinder is shown inFIG. 11A. Fluid pressure within thehydraulic chamber66 advances thecompression piston106, with thestapler piston116 within in it, in a distal direction.FIG. 11B shows thecompression piston106 approaching the end of its travel. Once the compression piston reaches the end of its travel as shown inFIG. 11C,channel114 in thecompression piston106 aligns withchannel122 in the housing, allowing fluid introduced throughfluid port50bto enter the interior of thecompression piston106 viachannel122. The fluid entering the interior of the compression piston drives the staple piston distally as shown inFIG. 11D. In an alternative embodiment shown inFIG. 11E, athird piston117 is provided for separately driving the cuttingelement86. In this embodiment, fluid introduced into a thirddrive fluid port50ccauses advancement of thethird piston117. Thepistons106,116 and117 and associated fluid paths may be arranged so that fluid cannot enter the interior of the stapler piston to advance thecutting piston117 untilcompression piston106 has traveled to the tissue-compression position andstapler piston116 has in turn traveled to the stapling position.
• The anvil housing (identified by numeral30 inFIG. 4) will next be described with reference toFIG. 12. Theanvil housing30 includes mounting bores88 for receiving pivot pins36 at the distal end of the hingedarm assemblies32. The upper section of theanvil housing30 includes asection94 through which thepivot pin44 for link40 (FIG. 4) is mounted.
• Acentral bore90 extends longitudinally through theanvil housing30. Ananvil support92 is longitudinally slidable within the bore. Both thebore90 and theanvil support92 are preferably formed to have non-circular cross-sections (such as the illustrated rectangular cross-section) with flat bearing surfaces to prevent rotation of the piston within the bore.
• FIG. 13 shows theanvil support92 separated from theanvil housing30. The distal portion of theanvil support92 is split into upper andlower plates95a,b.Plate95ahas abore93 axially aligned with a similar bore inplate95b. The proximal portion of theanvil support92 carries theanvil96. As shown inFIG. 14,anvil96 includes a plurality ofindentations98 positioned such when staples are driven from the staple cartridge, each staple leg engages one of the indentations, which causes the staple leg to fold. Acentral opening97 extends through theanvil96 and is contiguous with a lumen in theanvil support92.
• Theanvil96 and the staple cartridge78 (FIG. 7) are the two parts of the stapler head which exert force on the tissue to be stapled. As shown inFIGS. 9 and 14, the preferred anvil and cartridge are designed to use a minimal amount of material surrounding theindentations98 of theanvil96 and the staple locations80 of thecartridge78—so that the amount of anvil/cartridge surface area contacting the tissue is as small as possible. When subjected to a constant force, a smaller footprint will damage less tissue than would a larger footprint, since a smaller area of tissue is squeezed between the anvil and cartridge. However, the tissue that does get squeezed experiences more pressure from the given force because the force is distributed over a smaller area. In other words, the minimized footprint creates more pressure on the tissue with less force. This is advantageous from a mechanical standpoint because the stapler head need not supply or withstand as much force as would be needed with a larger-footprint cartridge and anvil.
• Referring toFIG. 7, in the illustrated embodiments, thestaple cartridge78 has an outer wall that tracks the contours of the staples housed within it, thus forming a number ofpedals73 surrounding the outer staple positions orslots80a, with thegrooves79 disposed between the pedals, adjacent to the inner staple positions80b. Rather than providing each staple position to be fully surrounded by cartridge material, the staple positions80a,80bpreferably each include a back wall71aand a retaining element attached to the wall and positioned to retain a staple between the retaining element and the back wall. InFIG. 7, the retaining element comprises a pair of wings71bthat curve inwardly from the back wall71 to define a slot that is sufficiently bounded to retain a staple within the staple position, but that is preferably not bounded around its full circumference. The anvil has a similar pedal arrangement, as shown inFIG. 13.
• Referring again toFIG. 13, aplate99 is positioned on theanvil96 such that the distally-advancingcutting element86 will advance into contact with theplate99 during tissue cutting. In one embodiment, theplate99 may be seated within theopening97 in the anvil. Theplate99, which will also be referred to as the “cutting board”, has ahole101 in it which relieves the pressure of the captured tissue and prevents hydraulic locking, a condition in which the punch and plate create a closed volume. If it is desired to move the cuttingelement86 after contact is made, pressure will increase inside this closed volume and it will resist further motion. This may prevent or adversely affect tissue cutting.
• The cutting board is preferably designed so as to not serve as a hard stop against advancement of the cuttingelement86. If the cuttingelement86 is stopped by the cutting board, the stapling piston will also be stopped and incomplete staple formation may result. Therefore, it is preferred that the cuttingelement86 is allowed to penetrate or displace the cutting board during and after the tissue is cut.
• FIGS. 15A and 15B illustrate the cuttingelement86 advanced into contact with two different embodiments of cutting boards. In theFIG. 15A embodiment, the material of cuttingboard99ais a relatively soft material, such as an elastomeric silicone, which is cut by the advancing cutting element as shown. This material allows the sharp distal end of the cutting element to move into the cutting board during the final stage of staple formation. In theFIG. 15B embodiment, the cuttingboard99bcan be made of a harder material positioned with a compressible object such as anelastomeric spring99cbehind it. In the figure, this spring is an o-ring. Advancement of the cuttingelement86 against the cuttingboard99bcauses the cutting board to be displaced distally against thespring99c. The advancingcutting element86 experiences increasing resistance as the o-ring is compressed. Other spring shapes and materials, such as coiled wire, spring washers and leaf springs can be used to achieve the same result. Thechamfer99don the surface of the cuttingboard99bmay help to align the cuttingelement86 as it is forced into contact with the cutting board.
• Arm Assemblies
• Following is a discussion of the features of thearm assemblies32.FIG. 16 shows thearm assemblies32 separated from the other elements of the stapler head. In general, each arm assembly has a first arm section pivotally coupled to the staple housing and a second arm section pivotally coupled between the first arm section and the anvil housing. While not present in the illustrated embodiment, additional arm sections may be positioned between the first and second arm sections.
• Each arm assembly includes aproximal arm100 and adistal arm102 joined to one another to form ahinge104. Each of theproximal arms100 has alongitudinal cutout108 and aspreader arm110 pivotally mounted within thecutout108. The distal end of eachspreader arm110 includes abore112.Pin84 is positioned within thebore112. As disclosed in connection withFIG. 10, thispin84 extends through thedisk68 and has ends that ride within the slots64 (FIG. 6) on the lower and upper sections of the stapler housing. Longitudinal movement of thedisk68 within the stapler housing will thus advance thepins84 within their correspondingslots64, causing thespreader arms110 to pivot relative to thepins84 and to thus drive thearm assemblies32 outwardly. Additional specifics concerning movement of thearm assemblies32 is set forth in the section entitled Stapler Head Operation.
• Distal arms102 of the arm assemblies includepins36 which, as discussed, are pivotally mounted to the anvil housing30 (FIG. 4). A pair ofdrive links114 are provided, each of which has a first end pivotally attached to a corresponding one thedistal arms102 and a second end pivotally coupled to acommon pin116. In the assembled stapler head,pin116 is positioned in thebores93 of the upper andlower plates95a,95bof the anvil support (seeplates95a,binFIG. 12). As detailed in the Stapler Head Operation section below, when thespreader arms110 drove thearm assemblies32 outwardly, drivelinks114 act on thepin116 to push the anvil support in a proximal direction, causing the anvil to advance proximally towards the staple cartridge.
• Stapler Head Operation
• The following discussion centers on the manner in which the arm assemblies function to expand the vacuum chamber and to compress tissue that has been drawn into the chamber using suction. As an initial step preceding chamber expansion, the stapler head is positioned with theopening26 in themembrane24 in contact with tissue at the location at which plication creation is desired. Vacuum source20 (FIG. 2) is activated to apply vacuum to the inside of the vacuum chamber defined by the membrane. Tissue in contact with the opening26 (FIG. 3B) will be drawn into the vacuum chamber between thestaple housing28 and theanvil housing30. After the tissue is drawn in, the stapler profile is changed, expanding the volume of the chamber within the membrane.
• The streamlined position of thestapler head28 prior to expansion is shown inFIGS. 4,17 and18. In particular, the hingedarm assemblies32 andmembrane raisers37 are in generally straight orientations. Theproximal arms100 serve as the drive arms for chamber expansion and tissue compression. Motion of these arms is initiated when water under pressure is forced into the hydraulic circuit of the staple housing. Referring toFIG. 19, the fluid pressure advances disk68 (by action of thecompression piston106, not shown inFIG. 19).Disk68 in turn pushes thestaple cartridge78 toward theanvil96 as shown inFIGS. 19-21, causing thestaple cartridge78 to extend further from thestaple housing28.
• Both thedisk68 and thearm spreaders110 are coupled to thepins84. For this reason, the longitudinal movement of thedisk68 within thestapler housing28 will carry thepins84 distally within their correspondingslots64. Thearm spreaders110 will consequently pivot relative to thepins84, driving theproximal arms100 outwardly. Outward movement ofproximal arms100 athinge104 causes thedistal arms102 to also pivot outwardly athinge104, forming an angle between the proximal anddistal arms100,102. Naturally, formation of the angle between thearms100,102 shortens the effective length between the remote ends of the arms, causing thedistal pins36 of thedistal arms102 to carry theanvil housing30 towards the staple cartridge. The pivoting movement of thedistal arms102 further causes drivelinks114 to act onpin116 to push the anvil support in a proximal direction. This moves the anvil support relative to the anvil housing in a proximal direction at the same time the anvil housing is also moving proximally.
• In essence, one motion, that of the hydraulically driven compression piston, creates at least three motions, illustrated by arrows A1, A2 and A3 inFIGS. 19-21. These three motions include: thestaple cartridge78 moving relative to the staple housing in a direction towards the anvil96 (arrow A1), theanvil housing30 moving toward the staple housing28 (arrow A2) and theanvil96 itself moving relative to theanvil housing30 in a direction towards the cartridge (arrow A3). This compound motion of the anvil toward the staple cartridge enables a small displacement of the compression piston to quickly compress tissue in the grip of stapler. The multiplication of motion also enhances force transmission between the two housings by keeping the angle athinge104, between the proximal (driven) arm and the distal (drive) arm, as large as possible.
• The relative motion of the twohousings28,30 toward each other also drivesupward links38,40 and their interconnectingspring wires46 on the top of thestapler head14. Together, the links and spring wires raise the top of the membrane, creating more volume to accommodate expansion of the tissue during compression.
• Compression of the tissue is halted when thepins84 traveling inslots64 in thestaple housing28 reach the limit of travel, as shown inFIGS. 22-24. Thus, the slots and associated components are dimensioned to set the desired separation distance between the tissue contact surfaces on the stapler side and the anvil side of the stapler head. Exemplary separation distances for use in stomach wall plications might include approximately 0.06-0.07 inches (e.g. for use with staples having legs of 5.5 mm length) or 0.109 inches for 6.5 mm leg length staples. Application of additional pressure into the hydraulic circuit will not compress the tissue any further.
• Moreover, because of the piston arrangement, the stapling function is effectively locked out until tissue compression is complete. With this arrangement, fluid introduced via thefluid port50b(FIG. 11A) into the staplefluid channel122 prior to completion of tissue compression will leak until the two o-rings112 of thecompression piston106 are straddling theinlet114. This design prevents premature staple firing.
• At the fully compressed position, thearm spreaders110 are nearly perpendicular to the longitudinal centerline of the stapler head. Once tissue is compressed betweencartridge78 andanvil96, the tissue is ready for stapling.
• Stapling is initiated by introducing hydraulic fluid throughport50b(FIG. 5). The staple piston advances, pushing cutting element86 (FIGS. 7 and 10) towards theanvil96. Because thestaple pusher76 is mounted to thecutter86, this action carries thestaple pusher76 through thecartridge78 where it simultaneously pushes all staples through the tissue. Staple piston travel is limited by internal stops, and is preset to yield optimal staple formation.
• During compression, as the angle at thehinge104 ofarm assemblies32 reaches its minimum, the force required to resist separation of the staple and anvil housings increases. These forces increase further when the forces of staple crushing are exerted on the anvil by the staple piston. To compensate, thearm spreaders110 serve as displacement struts to channel at least a portion of these forces into thedisk68. These forces, if not reacted by the pusher disk, would pull in thearms100,102 and potentially release the compression on the tissue, causing incomplete staple formation or tissue cutting. In this way, a truss-like structure is created for force displacement.
• When staples have been formed, staple pressure is released and a spring (not shown) returns thestaple pusher72 to its base position. Releasing fluid pressure will allow the deflectedspring wires46 onmembrane raiser37 to return the staple head to its minimum profile configuration and release the plication from the stapler. Once outside the patient, the used staple cartridge can be ejected and a new one installed.
• FIGS. 25A-25C illustrate one method for retaining aremovable staple cartridge78 within the staple housing. The cartridge is spring-loaded into the staple housing and retained by two latches170 (one visible), each pivotable relative to afulcrum172. As shown, thefulcrum172 may be coupled to thedisk68 bypin84. Eachlatch170 includes acatch174 which engages acorresponding catch176 on the cartridge. Thelatch170 is preferably spring biased to urge thecatch174 inwardly towards the cartridge.
• Depressing the proximal end175 of eachlatch170 as shown by arrow P inFIG. 25B pivots the latch against this bias, causing ejection of the staple cartridge. A new staple cartridge may then be positioned with itsgrooves79 aligned withalignment posts74 as shown inFIG. 25C and then pushed towards the staple housing. As the new cartridge slides into position, catch174 rides over the taperedproximal portion178 of thecatch176. Oncecatch174 passes over thedistal end180 of thecatch176, it drops inwardly towards the cartridge due to its spring bias, thus engaging the cartridge. When the cartridge is properly seated, a click will be felt or heard as the latches engage the new cartridge.
• Stapler Shaft and Handle
• Referring again toFIG. 2, thestapler shaft16 connecting thehandle18 and thestapler head14 is flexible enough to conform to the curvature of the upper digestive tract, yet maintains the ability to transmit enough torque to rotate the stapler head. The shaft is formed with sufficient stiffness to allow it to be pushed downesophageal guide tube23. Suitable materials include
• FIG. 26 shows a distal portion of theshaft16, with the stapler head removed from the shaft. As shown,shaft16 includes anendoscope lumen124 through which an endoscope is advanced to allow visualization of a stapling operation.Side lumens126 may also be provided for receiving other instruments useful during the procedure.
• An articulatingsection128 is positioned at the distal end of theshaft16, between theshaft16 and thestapler head14 so as to allow the stapler head to be articulated relative to the shaft. Tubing coupled to the vacuum source and the source of hydraulic fluid extends from the handle and through theshaft16 and the articulatingsection128.
• FIG. 27A shows one configuration that may be used for the hydraulic fluid lines130. During use, the hydraulic fluid lines are subjected to significant deflection and elongation in the articulating section of the stapler. They are also subjected at times to fluid pressure which may be in excess of 1000 psi. Typically, hydraulic lines in industrial applications are flexible and have a working loop of extra tubing that accommodates length changes during use. The illustrated configuration for the hydraulic lines is a lower profile solution particularly suitable for an endoscopic device having space constraints. A preferred hydraulic line is atube130 having a portion that is shaped into a longitudinally expandable shape so that it can accommodate effective length changes during bending. The longitudinally expandable portion of the tube is preferably disposed within the articulatingsection128 of thestapler12. In a preferred design, the longitudinally expandable shape is a coil shape as shown inFIG. 27A. In alternate embodiments, thetube130 may be formed into other longitudinally expandable shapes, such as regular or irregular undulating shapes (FIG. 27B).
• The preferred material for thetubes130 is stainless steel hypotube, although other materials may instead be used. In the preferred stapler configuration, two drive fluid lines are provided, one for actuating tissue compression, and the other for staple application (and cutting when used). In the present embodiment, the tubes are coiled together as shown inFIG. 27A. In alternate embodiments, two or more coiled tubes may be nested one inside the other. As the articulating section bends, it forces thecoiled tubes130 to bend and to change length in response to bending. The coiled tubes behave just as coiled wires would during these motions and are thus able to change length, deflect, and follow the contour of the articulating section without compromising flow through the lumens of the tubes or imparting undue stress to the connections at either end of the hydraulic system.
• The longitudinally expandable shapes for the fluid lines may be suitable for use in allowing delivery of fluid to the operative ends of other types of articulating medical devices, such as catheters or endoscopic devices for delivering therapeutic agents or irrigation fluids past an articulating or bendable section of the device.
• Referring again toFIG. 26, articulatingsection128 is comprised of a spine formed of a plurality oflinks132 strung over a pair of pull cables134 (only one shown inFIG. 26). In one embodiment, engagement of the pull cables allows thestapler head14 to be articulated in two directions through a range of motion of approximately 90 degrees in one direction (seeFIG. 3B) to 175 degrees in the opposite direction (seeFIG. 3C). Each pull cable is anchored at or near the stapler head, such as at thedistalmost link132 of thestapler housing28.
• The more proximal portions of thepull cables134 extend the length of theshaft16 and terminate in thehandle18. Referring toFIG. 28, thehandle18 includes arotating knob136 that may be selectively rotated in a clockwise or counterclockwise to articulate the stapler head up or down. Rotation in one direction applies tension to one of the pull cables to cause the stapler head to bend downwardly, whereas rotation in the opposite direction puts tension on the other cable, causing the head to bend upwardly.
• In a preferred handle configuration, theknob136 includes an internal threadedbore138.Knob136 is partially restrained within thehandle18 so that it remains fixed within the handle but can rotate freely. Acarriage140 having a threaded exterior surface is positioned within the threaded bore128 of the knob. The threads within thebore138 are engaged with the threads on thecarriage140 so that rotation of the knob causes thecarriage140 to translate, but not rotate, within the handle.
• Each of the two pull cables, identified inFIG. 28 ascables134aand134b, is terminated on a different member in the handle.Cable134ais mounted on the sliding carriage andcable134bis mounted to a stationary part of thehandle18. Each cable extends through a corresponding sheath.Cable134aextends through asheath135ahaving a proximal end fixed to a stationary part of thehandle18.Cable134bextends through asheath135bhaving a proximal end mounted to the sliding carriage.
• Thecables134a,bandsheaths135a,bare arranged such that translation of the carriage in one direction will cause deflection of the stapler head in one direction, and translation of the carriage on the other direction will deflect the stapler head in another direction.
• Referring toFIG. 28, ifknob136 is rotated to causes thecarriage140 to translate to the left of the page,cable134awill be tensioned andcable134bwill slacken, causing the stapler head to articulate in a first direction (e.g. upwardly). Rotation of theknob136 in the opposite direction will advance the carriage to the right of the page, releasing tension oncable134aand pushingsheath135bover thecable134btowards the distal end of the staple head, causing articulation in the second direction (e.g. downwardly) as thesheath135bis advanced against a distal portion of theshaft16. The proximal portion ofsheath135bis provided with sufficient working length prevent it from being placed under tension when the carriage moves distally. The positioning of the knob is advantageous in that the hand movement required for stapler articulation is always the same, regardless of the rotational orientation of the stapler. Also, the use of the threaded knob can prevent unintentional relaxation of the deflection angle, even if the knob is provided without a lock to retain its rotational position.
• Referring toFIGS. 28 and 29, theendoscope lumen124 extends along the center axis of the stapler. The positioning of the lumen and the coaxial relationship of the articulation knob in relative to theendoscope124 allows the endoscope and stapler to be rotated independently without one interfering with one another. Thus, if the user chooses to change the rotational orientation of thestapler head14 within the body, she may rotate thehandle18 andshaft16 while maintaining the rotational position of the endoscope.
• For cost efficiency, thestapler12 may be designed to permit thestapler head14 to be discarded while allowing theshaft16 and handle18 to be sterilized and re-used. One mechanism for removably coupling the stapler head to theshaft16 is illustrated, although others are readily conceivable (e.g. a slip coupling type arrangement). Referring toFIG. 26, anend plate142 is mounted to the distalmost one of thelinks132. Each of theend plate142 and the corresponding rear surface of the stapler head are provided with latch features that allow the end plate and stapler head to be engaged to one another.
• End plate142 includes a cantileveredpin144 having a peg145 (which may be a spring pin), acentral opening146, and a pair ofu-shaped catches148 along its edges. Hydraulic feed holes156a,bare formed through theend plate142. The hydraulic tubes that deliver hydraulic fluid to the stapler head (seetubes130 ofFIG. 27) are preferably welded to the end plate to allow fluid from the tubes to be directed through the feed holes156a,b.
• FIGS. 30A and 30B show therear surface48aof the staple housing, which has been somewhat modified relative toFIG. 5. In this variation of therear surface48a, thehydraulic input ports50a,50bare repositioned as shown. Additionally, therear surface48ahas been modified to include a pair of catches in the form ofundercut bosses150, plus an aligningpin152, and ahole154.
• FIGS. 30A and 30B show theend plate142 positioned against therear surface48aof the staple housing. The other features of the articulatingsection128 are not shown inFIGS. 30A and 30B for clarity. To attach the stapler head to theshaft16, theplate142, attached to the handle assembly, is pressed against therear surface48aof the staple housing as shown inFIG. 30A. As the plate is pushed, it is rotated in a clockwise direction, causing the peg145 (FIG. 26) of the cantileveredpin144 to engagehole154 in the rear surface of the staple housing. When this latch is engaged, hydraulic feed holes156a,bof theend plate142 are lined up with thehydraulic inlets50a,50bon the staple head as shown inFIG. 30B. At the same time, portions of the end plate surroundingu-shaped catches148 slide beneath the undercutbosses152. Pressing the plate compresses the face-sealing o-rings surrounding thehydraulic input ports50a,50b. Compression on the o-rings is maintained by engagement of the catches and the undercut bosses overhanging the end plate. To remove the stapler head from the housing, the stapler housing is twisted in a counterclockwise direction to disengage theend plate142 from therear surface48a. The stapler shaft and handle may then be sterilized in preparation for mounting of a fresh stapler head.
• Exemplary Procedure
• One example of a method for using the system10 will next be described in the context of formation of plications in stomach wall tissue.
• As an initial step (FIG. 2),endoscopic guide tube23 is advanced into the stomach via the mouth and esophagus. Theendoscope22 is inserted into the endoscope channel in the stapler handle (not shown) and advanced down the lumen of the stapler handle. The stapler/endoscope are simultaneously passed through the endoscopic guide tube towards the stomach. Once the stapler and endoscope reach the gastroesophageal junction region of the stomach, the position of the stapler is maintained while the endoscope is advance further into the stomach.
• Thestapler head14 is advanced to the desired depth and location in the stomach. Using the articulation controls on the stapler handle, the angular orientation of the stapler head is adjusted to allow positioning of thestapler head12 at the pre-identified target tissue as shown inFIG. 31A. Theopening26 in themembrane24 is positioned against the target tissue. Theendoscope22 is placed in a retroflexed position as shown.
• The vacuum source20 (FIG. 2) is coupled to the vacuum port on the handle external to the body, and vacuum pressure is applied to draw tissue through theopening26 and into the vacuum chamber defined bymembrane24 as shown inFIGS. 31B and 32A. Acquisition of the target tissue will be readily identified endscopically through the wall oftransparent membrane24 on the stapler head.
• The fluid source (is shown) is coupled to the handle. Once it has been visually confirmed that a sufficient amount of tissue has been acquired, fluid is introduced to cause compression of the tissue and expansion of thearm assemblies32 andmembrane raiser37 as shown inFIGS. 32B and 31C. As can been seen, the expansion of the arm assemblies and the membrane allows a large volume of tissue to be acquired into the vacuum chamber and displaced further into the chamber during tissue compression.
• Once the tissue has been compressed, additional hydraulic fluid is introduced to cause stapling and cutting of the tissue as shown inFIGS. 31D and 32C, forming a plication P. The compression and stapling hydraulic sources are then deactivated to release fluid pressure within the hydraulic circuit. With the hydraulic pressure relieved, the spring wires of themembrane raiser37 help to restore thestapler head14 to its original streamlined configuration, allowing the stapler head to be withdrawn from the tissue as shown inFIG. 31E. The stapler head may be articulated relative to the shaft to assist in moving the stapler head away from the plication P.
• In a preferred plication configuration shown inFIG. 33 thestaples158 are arranged in two concentric rings of five staples, with thestaple reinforcement device83 retained by the staples and distributing forces around the staple pattern as shown. The plication P includes a hole H formed by the cutting element, through which various implants or anchors for various implants can be placed.
• If multiple plications are needed, thestapler12 is briefly withdrawn from the endoscopic guide tube and the staple cartridge is replaced in the manner described in connection withFIGS. 25A-25C. The procedure is repeated until all desired plications have been formed.
• The system may be packaged with instructions for use instructing the user to use the various disclosed features to perform a stapling procedure using methods disclosed herein.
Alternate Embodiments
• The basic architecture of the stapler disclosed above can be used as a foundation for other stapling tools.FIGS. 34-35 show a modified stapler in which the membrane and membrane raiser have been removed, and in which thestaple housing28 has been modified for the attachment of tools. As shown inFIG. 34, thestaple housing28 includes a pair ofgrooves160 proportioned to receive tools162. Tools162 may be seated in thesegrooves160 and mounted to the staple housing as shown inFIG. 35. This attachment will provide for a stable base from which to actuate the tools. The tools may be self-articulating, or thestaple housing28 may be equipped withdevices164 for moving the tools between streamlined positions for insertion of the assembly into a body cavity, and a deployed position such as that shown inFIG. 35. Tools similar to those inFIG. 35 might be used for tissue acquisition, by reaching between the cartridge and anvil and used to engage tissue and pull the tissue into position between the cartridge and anvil so that it may be stapled, or otherwise affected by various features added to or in place of the anvil and cartridge. Procedures which may benefit from adaptation of the stapler include, but are not limited to gastroplasty, stoma adjustment, polyectomy, lead placement, bleeding control, perforation or hole closure, biopsy and tumor removal.
• The disclosed systems provide convenient embodiments for carrying out the disclosed compression and stapling functions. However, there are many other widely varying instruments or systems may alternatively be used within the scope of the present invention. Moreover, features of the disclosed embodiments may be combined with one another and with other features in varying ways to produce additional embodiments. Thus, the embodiments described herein should be treated as representative examples of systems useful for forming endoscopic tissue plications, and should not be used to limit the scope of the claimed invention.
• Any and all patents, patent applications and printed publications referred to above, including those relied upon for purposes of priority, are incorporated herein by reference.

Claims (21)

1-179. (canceled)

180. A tissue fastening device, comprising:

a fastener head positioned on an elongate shaft;

a fastener cartridge carrying at least one fastener, the cartridge attachable to the head by a latch having a first portion on the fastener head and a second portion on the cartridge, the first and second portions positioned such that advancing the cartridge into contact with the fastener head causes engagement of the first and second portions.

181. The tissue fastening device ofclaim 180 wherein:

the first portion of the latch includes a spring biased member having first and second ends and a first catch on the second end, and the second portion of the latch includes a second catch engageable with the first catch.

182. The tissue fastening device ofclaim 180 wherein the spring biased member is pivotable relative to a fulcrum between a first position in which the first end extends inwardly relative to the second end, and a second position in which the first end extends outwardly relative to the second end.

183. The tissue fastening device ofclaim 182 wherein the spring biased member is spring biased in the first position.

184. The tissue fastening assembly ofclaim 183, wherein the second end of the spring biased member is manually depressible to pivot the member from the first position to the second position.

185. The tissue fastening assembly ofclaim 181, wherein the spring biased member is mounted to the fastener head and the second catch is positioned on the cartridge.

186. The tissue fastening assembly ofclaim 180, wherein the fastener head includes at least one alignment pin and wherein the cartridge includes a receptacle for receiving the alignment pin.

187. The tissue fastening assembly ofclaim 186 wherein the alignment pin includes a tapered end.

188. The tissue fastening assembly ofclaim 186, wherein the receptacle includes a slot in an exterior surface of the cartridge.

189. The tissue fastening assembly ofclaim 186, wherein the receptacle includes a bore formed in the cartridge.

190. The tissue fastening assembly ofclaim 186, wherein the fastener head includes a plurality of alignment pins, and wherein the cartridge includes a plurality of receptacles positioned to receive the alignment pins.

191. A method of loading a fastener cartridge onto a tissue fastening device, the method comprising:

providing a cartridge carrying at least one tissue fastener and a tissue fastening instrument having an elongate shaft and an instrument head on the elongate shaft;

advancing the cartridge into contact with the instrument head, causing a first engaging portion on the instrument to engage a second engaging portion on an exterior surface of the cartridge.

192. The method ofclaim 191, wherein at least one of the first and second engaging portions comprises a pivotable spring latch, and the other of the first and second engaging portions includes a catch, and wherein advancing the cartridge into contact with the instrument includes pivoting a first end of the spring latch outwardly and then pivoting the first end of the spring latch inwardly to engage the catch.

193. The method ofclaim 192 wherein pivoting the spring latch outwardly includes advancing the first end of the spring latch into contact with the catch to cause the first end of the spring latch to pivot outwardly.

194. The method ofclaim 192, wherein pivoting the spring latch outwardly includes manually depressing a second end of the spring latch.

195. The method according toclaim 191, wherein causing the first engaging portion to engage the second engaging portion includes advancing an alignment pin on the fastener head into a receptacle on an exterior surface of the cartridge.

196. The method ofclaim 192, wherein the method further includes advancing an alignment pin on the fastener head into a receptacle on the cartridge.

197. The method ofclaim 196 wherein the receptacle is a slot in the exterior surface of the cartridge.

198. The method ofclaim 196, wherein the receptacle is a bore in the cartridge.

199-242. (canceled)

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