Endoscopic stapling device

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DESCRIPTION

Endoscopic stapling device.

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 endoscopically stapling tissue within body cavities.

BACKGROUND OF THE INVENTION

An anatomical view of a human stomach S and associated features are shown in Figure 1A. The esophagus E supplies food from the mouth to the proximal part of the stomach S. The gastroesophageal z-junction line 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 is the region comprising the distal part of the esophagus E, the line z, and the proximal portion of the stomach S.

The stomach S includes a fundus F at its proximal end and an antrum A at its distal end. Antrum A leads to pylorus P, which joins duodenum D, the proximal region of the small intestine. Inside the P pylorus there is a sphincter that prevents the backward movement of food from the D duodenum to the stomach. The middle region of the small intestine, located distal to duodenum D, is the jejunum J.

Figure 1B illustrates the layers of tissue that make up the stomach wall. The outermost wall is the serosal or “serosa” layer S and the innermost layer, which lines the interior of the stomach, is the mucosal or “mucosa” layer MUC. The submucosa SM and the multilayered M muscle lie between the mucosa and the serosa.

There are numerous applications for the endoscopic application of fasteners such as staples to tissue within the body cavity. Some of these applications involve the formation of tissue structures such as folds or folds in the tissue of the body cavity.

Several earlier applications, including International Application No. WO 2005/037152, which has an international filing date of October 8, 2004, and United States Application US 2008/065122, describe methods according to which implants are coupled. physicians to tissue structures formed within the stomach. In accordance with these applications, devices to induce weight loss (for example, by restricting or obstructing the flow of food into the stomach, and / or occupying a part of the stomach volume) can be attached to tunnels or tissue folds formed of stomach tissue.

For example, US 2008/065122 describes a restrictive and / or obstructive implant system to induce weight loss. In one embodiment, flexible loops are coupled to tissue folds formed in the gastroesophageal junction region of the stomach. An implant, such as a restrictive and / or obstructive implant, is passed through the loops 2 and is thereby retained in the stomach.

In other cases, the tissue folds may be sufficient on their own to provide the necessary treatment. For example, the pleats can be used to reduce the volume of the stomach or form a restriction to flow within the stomach, as described in WO 2005/037152, and in US2007 / 0219571, on which the shape is based. two-part of claim 1 appended.

Other types of implants can be attached to such folds or other tissue structures for a variety of purposes. These implants include, but are not limited to, valves for the treatment of gastro-esophageal reflux diseases, gastric simulators, pH monitors, and elution devices that deliver drugs, biological elements, or cells into the stomach or elsewhere in the stomach. GI tract. Such drug elution devices could include those that release leptin (a hormone that creates feelings of fullness), Ghrelin (a hormone that creates feelings of hunger), Octreotide (which reduces Ghrelin levels and thereby reduces hunger), Insulin, chemotherapeutic agents, natural biological substances (for example, growth factor , cytokines) that aid in post-surgical trauma, ulcers, lacerations, etc. Still other implants could be of the type that could provide a platform to which biologically active gene products could adhere, grow, and provide biologically active gene products to the GI tract, specific cell types, and / or a platform for radiation sources that can provide a local source of radiation for therapeutic purposes., o provide a platform whereby ligands are immobilized and used to sample the GI tract to obtain evidence of specific normal or pathological conditions, or provide an anchor point for imaging the GI tract using cameras and other acquisition devices of pictures.

The aforementioned applications are faced with the desirability of forming tissue folds, pockets, or tunnels so that regions of serosal tissue (ie, the tissue on the outer surface of the stomach) are retained in mutual contact. Over time, the adhesions formed between the opposing layers of serosal create strong bonds that can facilitate retention of the fold / pocket / tissue over extended durations, despite the forces imparted to them by movement of the stomach and implanted devices.

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Regardless of the application for which a fold is formed, it is highly desirable to form that fold using steps performed from within the stomach using instruments passed down the esophagus, rather than using more surgical or laparoscopic methods. The present application describes endoscopic staplers that can be passed transorally into the stomach and are used to form serosala-serosal folds in a stomach wall.

SUMMARY OF THE INVENTION

The invention consists of a stapler device (12) for applying a staple to tissue as set forth in claim 1. Preferred embodiments are defined in the dependent claims.

A method to capture a tissue fold is also described by the steps of:

(a) urging or drawing tissue (17) into a vacuum chamber (21) defined by relatively movable first and second members (25, 27) and a membrane, such as an elastomeric or pleated membrane (24), extending between both, (b) advancing a first tissue contact plate (78) and a second tissue contact plate (96) contained within the first and second members, respectively, toward each other by independent movement of the first and second tissue contact plates (78, 96), stapling into their associated members (25, 27), respectively, and moving the second member toward the first member;

(c) by continued application of vacuum during said advance, continuing to drive tissue into said chamber until a tissue fold (17a) is captured between the first and second tissue contact plates.

The particularities of the invention will become more clearly apparent when the following detailed description of the invention is read in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1A is a schematic illustration of a human stomach and a part of the small intestine, as is known in the prior art.

Figure 1B is a perspective view, in cross section, of a part of a stomach wall, illustrating the layers of tissue that make up the wall, as is also known in the prior art.

Figure 2 illustrates an endoscopic stapling system or instrument constructed in accordance with one embodiment of the invention.

Figures 3A-3C are perspective views showing the stapler head or device of the stapling system of Figure 2 in three different positions.

Figure 4 is a perspective view of the head or stapler device, with the membrane removed, showing the first and second members of the device.

Figure 5 is a perspective view of the proximal end of the staple housing of the stapler device of Figure 4.

Figure 6 is a perspective view of the distal end of the staple housing of the stapler device of Figure 4.

Figure 7 is an exploded perspective view showing elements that can be advanced within the staple housing during compression and stapling operations.

Figure 8 is a plan view of a staple reinforcing device.

Figure 9 is a side elevation view of a staple cartridge.

Figure 10 is a perspective view of the staple housing, similar to Figure 6, but showing some of the elements of Figure 7 within the housing.

Figures 11A-11D are series of schematic representations of the hydraulic chamber and pistons, illustrating operations of an example hydraulic system during compression and stapling of tissue.

Figure 11E is similar to Figure 11D and shows an alternative piston configuration.

Figure 12 is a perspective view of the anvil housing of the stapler head of Figure 4.

Figure 13 is a perspective view of the anvil support.

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Figure 14 is a plan view of the anvil.

Figure 15A is a cross-sectional side view of the cutting device and a first embodiment of a cutting board.

Figure 15B is a cross-sectional side view of the cutting device and a second embodiment of a cutting board.

Figure 16 is a perspective view of the articulated arm assemblies of the stapler head of Figure 4.

Figure 17 is a top plan view of the stapler head of Figure 4 in the streamlined position for insertion into the body. Both the membrane and the membrane riser are not shown for clarity.

Figure 18 is similar to Figure 17 and illustrates hidden features of Figure 17.

Figure 19 is a perspective view of the stapler head in an intermediate position, partially expanded.

Figure 20 is a plan view similar to Figure 17, but showing the stapler head in the intermediate position.

Figure 21 is similar to Figure 20 and illustrates hidden features of Figure 20.

Figure 22 is a perspective view of the stapler head in a fully expanded, fully compressed position.

Figure 23 is a plan view similar to Figure 20, but showing the stapler head in the fully compressed position.

Figure 24 is similar to Figure 23 and illustrates hidden features of Figure 24.

Figures 25A-25B are perspective views showing the staple housing, cartridge, and a portion of the membrane riser. These figures illustrate the steps of detaching a staple cartridge from the staple housing.

Figure 26 is a perspective view of the stapler instrument of Figure 2, with the staple head detached.

Figure 27A is a plan view of the articulation section of the stapler of Figure 2, showing interspersed drive fluid lines.

Figure 27B shows an actuation fluid line having an alternating, longitudinally expandable shape.

Figure 28 is a cross-sectional side view of the handle of the stapler instrument of Figure 2.

Figure 29 is a perspective view of the handle of the stapler of Figure 2.

Figures 30A and 30B are plan views of the proximal face of the staple housing, showing a method of attaching the end plate of the stapler handle to the staple housing.

Figures 31A-31E are a series of drawings schematically illustrating the use of the system of Figure 2 to form a fold in a stomach.

Figures 32A-32C are a series of perspective views illustrating the use of the stapler of Figure 2 to acquire, compress and then staple stomach wall tissue to form a fold in the stomach. The membrane is not shown in these drawings.

Figure 33 is a top plan view of a fold formed in body tissue.

Figures 34 and 35 are perspective views of an alternative stapler head equipped to carry additional tools.

Figures 36 and 37 show alternative embodiments of the stapler alignment structure in the stapler device of the invention.

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DETAILED DESCRIPTION OF THE DRAWINGS

The present application describes endoscopic fastener application devices which in preferred embodiments can be passed transorally into the stomach and used to fold stomach tissue.

In the described embodiments, the tissue is driven into a vacuum chamber, although the tissue can be driven inward using other components (eg grips) that do not involve the use of vacuum. When a part of the inner wall of the stomach is pushed inward, sections of serosal tissue from the outside of the stomach face each other. The disclosed fastener application device allows opposing sections of tissue to be moved into contact with one another, and provides fasteners that will hold sections of tissue together at least until such time as serosal bonds are formed between them. Each of these steps can be performed entirely from inside the stomach, thereby eliminating the need for any surgical or laparoscopic intervention. After one or more pleats have been formed, medical devices (including, but not limited to, any of the types listed above) may be attached to the fold or pleats for retention within the stomach.

The disclosed embodiments include an optional feature that forms a hole or cut in a fold using the fastener application device. This hole or cut could be formed so that a portion of a medical implant could be passed through or linked to the hole / cut, or it could be formed so as to elicit a healing response that contributes to the resistance of the resulting tissue bond.

In the description of the embodiments given below, the fastener application devices are described as staplers, and exemplary methods are given regarding the formation of folds in the stomach tissue. However, it is to be understood that the embodiments described herein include features that have the same applicability for the application of other types of fasteners, and for applying staples or other fasteners for purposes other than pleating. More specifically, the term "staple" is used herein to designate any type of fastener that (i) can be pushed through tissue, and (ii) has one or more leg members that bend or bend when forced against an anvil. crimp to secure the fastener to the fabric and keep the fastened fabric folded together. The described embodiments and methods will also find use in parts of the body outside of the GI system. Furthermore, although the described embodiment is characterized by circular stapling and cutting of a concentric hole, modifications are conceivable in which linear stapling, as well as circular or linear stapling without cutting, are conceivable.

Figure 2 illustrates one embodiment of a system or instrument 10 for stapling tissue, which is suitable for endoscopic use, as well as surgical or laparoscopic use, if desired.

Generally speaking, a system 12 includes a stapler or stapler instrument 12 having a head or stapler device 14 located in a distal portion of a tube or shank 16. A handle 18 on tube 16 controls articulation of head 14 stapler and actuation functions of tissue acquisition, tissue compression and stapling with the stapler head 14. Vacuum and fluid sources 20, 31 of the system are coupled for fluid passage to handle 18 for use in tissue acquisition, compression, and stapling, as discussed below. The vacuum source 20 can be the "home vacuum" accessible through a coupling in the wall of the operating room, or an auxiliary suction pump. The stapler may include a switch 21 that allows the user to control the flow of air between the vacuum source and the stapler.

The stapler device also serves to capture a fold of tissue for stapling, and is thus also referred to herein as a tissue capture device for immobilizing a fold of tissue, for example to clamp the sides of the fold. The tissue capture device may operate independently to capture tissue, for example, in the absence of a separate stapling mechanism, or it may be combined with the stapling elements, as illustrated.

Fluid source 31 may be a single source of actuation fluid (eg, water, saline, oil, gas) or multiple sources, but in each case the fluid source preferably includes two actuators used separately to control flow to each one of the two hydraulic pipes (one for tissue compression and the other for stapling). An endoscope 22 can be inserted into the system through the bore of tube 16 to allow visualization of the folding procedure. The system may optionally include an overtube, such as an endoscopic guide tube 23, having a bore to receive the stapler 12.

Referring to Figure 3A, a stapler cover or membrane 24 encloses the stapler mechanism to form a vacuum chamber 21 (Figures 17-23) within the head 14 of the stapler. The side exposed to the fabric to be folded remains uncovered by the membrane 24 to allow the fabric to be propelled into the chamber during use. For example, membrane 24 may include a side opening 26, as shown in Figure 3B. The membrane 24 is preferably formed of silicone, elastomeric material, or any other biocompatible flexible or deformable non-elastic or elastic material, such as a folded mylar film, capable of forming a vacuum chamber 21 that expands in volume to receive the driven tissue. into chamber 21. Also shown in Figures 3A-3C is a hinge section 28 connecting the instrument tube to the stapling head, and drive described with reference to Figures 26 and 27.

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At least a part of the membrane is at least partially transparent. 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 inside the stapler head prior to application of the staples. The opening 26 may be surrounded by a reinforced section 27 formed of material that increases the strength of the area around the opening 26. The reinforced section 27 may be formed of a thicker section of the membrane material, and / or a material of higher durometric hardness. Alternatively, reinforcing ribs or other structures or elements may be formed within or on the membrane material, or embedded in the membrane material.

Stapler Head or Device

The stapler head 14 is designed to have a minimal profile during insertion at the fold site, and to later transform it into a much larger profile device having a large internal volume. For example, in one embodiment, the vacuum chamber could have an initial internal volume of 3.28 cubic centimeters, and an expanded volume of 9.83 cubic centimeters (that is, the internal volume of the chamber after removing the occupied volume by the stapler head components located within the vacuum chamber). This large internal volume allows a large volume of tissue to be aspirated and stapled within the vacuum chamber. In this way, the stapler head creates a large fold without requiring invasive techniques for insertion. The unique characteristics of the stapler head allow in situ volumetric expansion of the stapler head using minimal movement and use of force. In particular, as will be appreciated below with respect to Figures 32A-C and Figure 33, the fold can be sized such that the staples applied to the tissue, such as the two series of ring staples seen in Figure 33, are well separated from the edges of the stapled tissue, minimizing the risk of the tissue tearing around the staples.

Stapler head features are shown in Figures 4-10. For the sake of clarity, the membrane is not shown in these figures. Referring to Figure 4, stapler head 14 generally includes a first staple member 25 comprising a proximal staple housing 28, a second anvil member 27 comprising a distal anvil housing 30, and at least one elongated member. , but preferably a pair of articulated arm assemblies 32 that functionally connect the two housings, as described below.

The staple housing and the anvil housing are arranged to allow tissue to be compressed between contact surfaces at 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, ie, the outer face of the staple retainer, and an anvil on the anvil housing. Considering only the tissue capture operation of the device, the staple holder or container 78 (shown in Figure 7) functions as a tissue capture plate having a front tissue contacting surface 83, and anvil 96 ( shown in Figures 13 and 14) functions as a second tissue capture plate having a tissue contacting surface 103, which faces surface 83, where these two surfaces serve to capture the tissue fold during operation of the device, as will be described in more detail with respect to Figures 32A-32C.

Arm assemblies 32 extend between staple housing 28 and anvil housing 30 on opposite sides of stapler head 14. Proximal and distal pins 34, 36 pivotally couple each arm assembly 32 to staple housing 28 and to the anvil housing 30. An expansion member comprising a membrane riser 37 also extends between the staple housing 28 and the anvil housing 30. Although the membrane 24 is not shown in Figure 4, it is to be understood that the membrane riser 37 is positioned opposite the opening 26 (Figure 3B) of the membrane. In the illustrated embodiment, the membrane lifter 37 includes a link 38 pivotally mounted in the staple housing by means of a pin 42, a corresponding link 40 pivotally mounted in the anvil housing by means of a pin 44, and spring or elastic wires 46 that couple the old-fashioned bars 38, 40 to each other.

Staple housing

Turning now to a more detailed explanation of the components of the stapler head, in Figures 5 and 6 the staple housing 28 can be seen separated from the other components. As shown in Figure 5, the proximal face 48 of the staple housing includes inlet ports 50a, 50b through which fluid is directed for the hydraulic actuation of compression, stapling and optional cutting operations of the head of the clip. stapler. Gaskets 51 surround ports 50a, 50b to minimize fluid leakage.

Vacuum ports 52 are coupled for fluid passage to a vacuum source 20 (Figure 2) which is selectively activated to create negative pressure in the vacuum chamber for tissue intake. Vacuum ports 52 are connected to vacuum source 20 via pipes (not shown) in tube 16 of the stapler (FIG. 2). Mounting holes 54 are used to mount stapler head 14 to tube 16 through hinge section 128.

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Staple housing 28 includes upper and lower sections 58a, 58b above and below open side sections 56. Upper section 58a includes recess 60 within which pivot pin for link bar 38 is mounted (FIG. 4) . As best shown in Figure 6, bores 62 are located in upper and lower sections 58a, 58b to receive pins 34 (Figure 4) that serve as the proximal pivot points for arm assemblies 32. Guide grooves 64 they extend longitudinally through the upper and lower sections 58a, 58b.

Referring to Figure 6, a hydraulic chamber 66 is disposed within the staple housing 28. Within hydraulic chamber 66 (FIG. 6) is a dedicated hydraulic circuit to drive the stapler's tissue compression and stapling functions. Chamber 66 is coupled for fluid passage to fluid inlet ports 50a, 50b (FIG. 5). As will be explained in detail in connection with Figures 11A-11D, fluid propelled into hydraulic chamber 66 through inlet ports 50a, 50b, sequentially advances a system of hydraulic pistons (not shown) acting on other components to compress the tissue, and which drive the staples and the cutting element through the compressed tissue.

Figure 7 illustrates components of the stapler head that are actuated by the hydraulic system for compression, stapling and cutting. For clarity, these components are shown separately from the staple housing and from each other. In this explanation, the components that are driven by the hydraulic system will be described. The hydraulic system itself is described in a later section in connection with Figures 11A-11B.

In particular, FIG. 7 illustrates a drive member in the form of a disk 68 in the staple housing. In the assembled housing, disk 68 is positioned such that it will be pushed distally by a hydraulic compression piston (piston 106 in Figures 11A-11E). As will be appreciated in Figures 11A-11E, the actuating member is moved between a first, retracted position, shown in Figure 11A, to a second, extended position, shown in Figures 11C and 11D. Although the drive member illustrated here is driven by, but separate from, the piston 106, it will be appreciated that these two components may be formed as a single piece member, i.e., as a single piece drive member that includes both the piston and the disc. As will be seen below, the actuating member is coupled to the arm assemblies 32, the anvil housing, and the staple housing such that advancing the actuating member distally (toward the extended position) effects compression of the actuator. tissue by bringing the contact surfaces towards each other. The combination of the disk 68, the anvil housing, and the set of arms 32 that engage the two housings is referred to herein as a drive assembly, indicated at 29 in Figure 10. The drive assembly may further include rods. drive links 114 on the anvil member, which are functionally linkable to assemblies 32 as described below.

As best seen in Figure 7, disc 68 includes mounting holes 70, a central aperture 72, and alignment posts 74. Referring briefly to Figure 10, in the assembled stapler head, disc 68 is coupled to the housing. 28 of the stapler and its axial movement therein is constrained by pins 84 which pass through guide grooves 64 of the housing and through mounting holes 70 in disk 68.

A portion of the staple housing 28 contains, ie is loaded to contain, staples to be fired into tissue. The staples are contained within the staple carrier, such as a staple cartridge 78, in the staple housing 28. The staple carrier can have a number of different configurations. For example, it may be an integral part of the staple housing or a separate part mounted on or attached to the staple housing, and / or it may be movable relative to the body of the staple housing to effect compression of the tissue prior to stapling. . In any of these examples, the staple holder can be a refillable / replaceable cartridge, and / or can be refilled by inserting additional staples into it. In other embodiments, the staple holder may be non-refillable and non-replaceable, that is, intended for one-time use.

In the disclosed embodiment, the staple carrier is a removable staple cartridge 78 that can be replaced with another cartridge after it has been filled with staples. In this embodiment, the staple cartridge is movable relative to the stapler housing body to compress tissue prior to firing of the staples.

Referring to Figure 7, the staple cartridge 78 is located within the staple housing, distal of the disc 68, such that distal advancement of the disc by means of the compression piston urges the cartridge from a first retracted position. distally to a second extended position to compress tissue disposed between the cartridge and the anvil. Slots 79 on the exterior of the cartridge slide over corresponding ones of the posts 74 during insertion of the cartridge into the stapler head. Figure 10 shows the alignment posts prior to loading a cartridge into the staple housing. As shown, the alignment posts 74 may have tapered ends to facilitate loading of the cartridge onto the posts. It will be appreciated that the alignment posts retain the cartridge against movement within the housing 28 during operation of the stapler.

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Referring back to FIG. 7, cartridge 78 includes a number of staple locations 80, each housing a staple, such as staples 83 seen in FIG. 33. The staple cartridge is equipped with protrusions 81 to retain a staple line reinforcing device 83 of the type shown in Figure 8 and described in detail in commonly owned US application No. 11 / 542,457 entitled DEVICES AND METHODS OF FOLDING. ENDOSCOPICO, filed October 3, 2006, and published September 20, 2007 as US 20070219571. To summarize briefly, this type of reinforcement device 83 can be a ring or other element that can be positioned against the distal face of the staple cartridge. When the ring is located in the cartridge, the openings 85 in the ring align with prominences of some of the staples in the cartridge. When the staples are propelled from the cartridge, these prominences pass through associated ones of the openings 85 and capture the ring 83 against adjacent body tissue.

Referring to Figures 7 and 9, a number of carved protrusions 81 on the side of the cartridge facing the anvil can be used to secure the reinforcing device 83 in position on the face of the staple cartridge. Other positive shapes, such as mushrooms, hooks, and slanted bosses, can be used to achieve the same end. Negative shapes, such as pockets or grooves formed in the surface of the cartridge, can also be employed to engage corresponding features on the reinforcing device 83. As another alternative, the reinforcing device can be retained in place on the cartridge using adhesives.

In the embodiment shown, a cutting element 86 passes through the central opening 72 (FIG. 7) of the disk 68. The cutting element is shown as a tubular punch having a sharp wall and a bore 87, but may be provided in alternative ways. A staple pusher 76 is mounted on the cutting element, distally of the disk, as can be seen in the assembled view of Figure 10. The staple pusher 76 includes pusher elements 82 provided to slide toward the staple locations 80 of the cartridge as the staple pusher 76 is advanced into the staple cartridge 78, thereby urging the staples from the cartridge. A hydraulically actuated staple piston (shown at 116 in Figures 11A-11E) in hydraulic chamber 66 (disposed in a hydraulic chamber formed by piston 106) is coupled to cutter 86 such that advancement of the Staple piston advances staple pusher 76 and cutter 86 in the distal direction.

Fluid Drive System

The fluid actuation system used to activate compression, stapling and cutting can be configured in a number of ways. The following paragraphs describe an exemplary configuration of the fluid actuation system, which in this embodiment is a hydraulic system. Figures 11A and 11B schematically show fluid flow within hydraulic chamber 66 of staple housing 28 during both the compression and stapling actuation stages. Referring to Figure 11A, compression piston 106 is disposed within hydraulic chamber 66. Disc 68 (also shown in Figures 7b and 10) is located in contact with or slightly distal to piston 106. The compression piston 106 is generally cup-shaped, having a rear wall 108 and a side wall 110 surrounding the interior 111. O-ring seals 112 are spaced in a proximal portion of the side wall 110. Channels 115 are formed through side wall 110, between O-ring seals 112.

A second piston, referred to as staple piston 116, is located within 111 of compression piston 106, against rear wall 108. Although not shown in Figures 11A-11D, cutter 86 (FIG. 7), with the staple pusher 76 therein, is positioned in contact with the staple piston 116 or slightly distal to it. An O-ring seal 118 surrounds a portion of the staple piston 116 that is distal of the channels 115 of the compression piston.

A first fluid channel 120 extends from fluid port 50a in staple housing 28 to a proximal section of hydraulic chamber 66. A second fluid channel 122 extends from fluid port 50b in staple housing to a more distal section of hydraulic chamber 66. Fluid flow from port 50a and fluid channel 120 against the compression piston cylinder is shown in FIG. 11A. Fluid pressure within hydraulic chamber 66 advances compression piston 106, with stapler piston 116 within it, in a distal direction, from a first retracted position, shown in Figure 11A, to a second extended position. , shown in Figures 11C and 11D. Figure 11B shows the compression piston 106 approaching the end of its stroke, that is, in the fully extended position. Once the compression piston 106 reaches the end of its travel, as shown in Figure 11C, the channel 115 of the compression piston 106 is aligned with the channel 122 of the housing, allowing the fluid introduced through the port. fluid 50b enters the interior of compression piston 106 through channel 122. Fluid entering the interior of the compression piston drives the staple piston distally as shown in Figure 11D, from a first, retracted position, shown in Figure 11A-11C, to a second, extended position, shown in Figure 11A-11C. Figure 11D. In an alternative embodiment, shown in FIG. 11E, a third piston is provided to separately drive the cutter 86. In this embodiment, fluid introduced through a third actuation fluid port 50c causes third piston 117 to advance from a first, retracted position to a second, extended position (not shown). Pistons 106, 116, and 117 and associated fluid paths may be arranged such that fluid cannot enter the interior of the stapler piston to advance cutting piston 117 until compression piston 106 has traveled. until the

ES 2 383 993 T3 tissue compression position and the stapler piston 116 has in turn traveled to the stapling position.

The anvil housing (identified at 30 in FIG. 4) in the anvil member 27 will now be described with reference to FIG. 12. The anvil housing 30 includes mounting holes 88 for receiving pivot pins 36 in the anvil housing. distal end of articulated arm assemblies 32. The upper section of the anvil housing 30 includes a section 94 through which the pivot pin 44 for the link 40 is mounted (FIG. 4).

A central bore 90 extends longitudinally through the anvil housing 30. An anvil support 92 (FIG. 13) is longitudinally slidable within the bore. Both bore 90 and anvil support 92 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.

Figure 13 shows the anvil holder 92 separated from the anvil housing 30. The distal portion of the anvil holder 92 is slit forming upper and lower plates 95a, b. Plate 95a has a hole 93 axially aligned with a similar hole in plate 95b. The proximal portion of anvil holder 92 carries anvil 96. As shown in Figure 14, the anvil 96 includes a plurality of teeth or recesses 98 positioned such that when the staples are driven from the staple cartridge, each staple leg engages one of the teeth, resulting in the staple leg bends or kinks. In the embodiment shown, the anvil is designed for a series of staples having two separate staple ring rings, five staples per ring. A central opening 97 extends through anvil 96 and is contiguous with a bore of anvil holder 92.

Anvil 96 and staple cartridge 98 (FIG. 7) are the two parts of the stapler head that exert force on the tissue to be stapled. As shown in Figures 9 and 14, the preferred anvil and cartridge are designed to use a minimal amount of material surrounding the teeth 98 of the anvil 96 and the staple positions 80 of the cartridge 78 - so that it is as small as possible. the amount of anvil / cartridge surface area in contact with tissue possible. When subjected to constant force, a smaller footprint will damage tissue less than a larger footprint would, since a smaller area of ​​tissue is crushed between the anvil and the cartridge. However, the tissue that is crushed 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 point of view, as more force would be required with a larger footprint cartridge and anvil.

Referring to Figure 7, in the illustrated embodiments, the staple cartridge 78 has an outer wall that follows the contours of the staples housed within it, thus forming a number of pedals 73 that surround the outer positions or grooves 80a of the staples, with the grooves 79 disposed between the pedals, adjacent to the interior positions 80b of the staples. Rather than arranging each staple position to be completely surrounded by cartridge material, each of the staple positions 80a, 80b preferably includes a rear wall 71a and a retainer attached to the wall and positioned to retain a staple between. the retainer and the rear wall. In Figure 7, the retention member comprises a pair of wings 71b that curve inwardly from the rear wall 71 to define a slot that is sufficiently delimited to retain a staple within the staple position, but is preferably not delimited. around its entire circumference. The anvil has a similar pedal arrangement, as shown in Figure 13.

Referring again to Figure 13, a plate 99 is positioned on the anvil 96 such that the distally advancing cutting element 86 will advance into contact with the plate 99 during tissue cutting. In one embodiment, plate 99 may be seated within anvil opening 97. Plate 99, referred to as the "cutting board," has a hole 101 through which pressure from the captured tissue is relieved and hydraulic locking is prevented, a state in which the punch and plate create a closed volume. If it is desired to move the cutter 86 after contact has been made, the pressure will increase within this closed volume and it will oppose further movement. This can prevent tissue from being cut or adversely affected.

The cutting board is preferably designed such that it does not serve as a hard stop against the advancement of the cutting element 86. If the cutting element 86 is stopped by the cutting board, the stapling piston will also be stopped and the incomplete staple conformation. Therefore, it is preferred that the cutting element 86 is allowed to penetrate or move the cutting board during and after the tissue has been cut; that is, the cutter may advance slightly after initial contact with the board has occurred.

Figures 15A and 15B illustrate cutting element 86 advanced into contact with different embodiments of cutting boards. In the embodiment of Figure 15A, the material of the cutting board 99a is a relatively soft material, such as an elastomeric silicone, which is cut and penetrated by the cutting element in advance, 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 shaping. In the embodiment of Figure 15B, the cutting board 99b can be made of a harder material positioned with a compressible object, such as an elastomeric spring 99c behind it. In the figure this spring is an O-ring. The advance of

ES 2 383 993 T3 cutting element 86 against cutting board 99b experiences increasing resistance as the O-ring is compressed. Other spring materials and shapes, such as coiled wire, spring washers, and leaf springs, can be used to achieve the same result. The chamfering 99d on the surface of the cutting board 99b can help align the cutting element 86 when it is forced into contact with the cutting board.

Arm sets

An explanation of the characteristics of the arm assemblies 32 follows. Figure 16 shows the arm assemblies 32 separated from the other elements of the stapler head. In general each arm assembly has a first arm section 100 pivotally coupled to the staple housing and a second arm section 102 pivotally coupled between the first arm section and the anvil housing. Although not present in the illustrated embodiment, additional arm sections may be located between the first and second arm sections.

That is, each set of arms includes a proximal arm 100 and a distal arm 102 joined together to form a hinge 104. Each of the proximal arms 100 has a longitudinal cutout 108 and an arm enterer 113 pivotally mounted within. of cutout 108. The distal end of each arm extender 113 includes a bore 112. Pin 84 is located within bore 112. As described in connection with FIG. 10, this pin 84 extends through disk 68 and has ends that run into slots 64 (FIG. 6) in the upper and lower sections of the stapler housing. Longitudinal movement of the disc 68 within the stapler housing will thereby advance the pins 84 into their corresponding slots 64, causing the arm extenders 113 to pivot relative to the pins 84 and thereby actuate the arm assemblies. 32 out. Additional particulars concerning the movement of the arm assemblies 32 are discussed in the section entitled Stapler Head Operation.

The distal arms 102 of the arm assemblies include pins 36 which, as explained, are pivotally mounted in the anvil housing 30 (FIG. 4). A pair of linkage actuation members 114 are provided, each of which has a first end pivotally attached to a corresponding one of the distal arms 102 and a second end pivotally attached to a common pin 116. In the assembled stapler head, pin 116 is located in bores 93 of upper and lower plates 95a, 95b of the anvil holder (see plates 95a, b of FIG. 12). As detailed in the following section, Stapler Head Operation, when the arm extenders 113 actuate the arm assemblies 32 outwardly, the actuating link bars 114 act on the pin 116 to push the anvil holder in a proximal direction. , causing the anvil to advance proximally toward the staple cartridge.

Stapler Head Operation

The following discussion focuses on how the arm assemblies work to expand the vacuum chamber and to compress tissue that has been pushed into the chamber using suction. As an initial step preceding chamber expansion, the stapler head is positioned with opening 26 of membrane 24 in contact with tissue at the location where crease creation is desired. The vacuum source 20 (FIG. 2) is activated to apply vacuum to the interior of the vacuum chamber defined by the membrane. Tissue in contact with opening 26 (FIG. 3B) will be pushed into the vacuum chamber between staple housing 28 and anvil housing 30. After the tissue has been introduced, the profile of the stapler is changed, expanding the volume of the chamber within the membrane.

The aerodynamic position of stapler head 28 prior to expansion is shown in Figures 4, 17 and 18. In particular, link arm assemblies 32 and membrane lifters 37 are in generally straight orientations. The proximal arms 100 serve as the drive arms for chamber expansion and tissue compression. The movement of these arms is initiated when pressurized water is forced into the hydraulic circuit of the staple housing. Referring to Figure 19, fluid pressure advances disk 68 (by action of compression piston 106, not shown in Figure 19). Disc 68 in turn urges staple cartridge 78 toward anvil 96, as shown in Figures 19-21, causing staple cartridge 78 to extend further from staple housing 28.

Both disk 68 and arm extenders 113 are coupled to pins 84. For this reason, longitudinal movement of disk 68 within stapler housing 28 may carry pins 84 distally into their corresponding grooves 64. arms 113 will pivot accordingly with respect to pins 84, driving proximal arms 100 outwardly. The outward movement of the proximal arms 100 on the hinge 104 causes the distal arms 102 to pivot outward on the hinge 104 as well, forming an angle between the proximal and distal arms 100, 102. Naturally, the formation of the angle between the arms 100, 102 shortens the effective length between the distal ends of the arms, causing the distal pins 26 of the distal arms 102 to drive the anvil housing 30 toward the staple cartridge. The pivotal movement of the distal arms 102 further causes the links 114 to act on the pin 116 to push the anvil holder in a proximal direction. This moves the anvil holder relative to the anvil housing in a proximal direction at the same time as the anvil housing is being moved.

ES 2 383 993 T3 also moving in a proximal direction.

In essence, one movement, that of the hydraulically actuated compression piston, creates at least three movements, illustrated by arrows A1, A2, and A3 in Figures 19-21. These three movements include: staple cartridge 78, which moves relative to the staple housing towards anvil 96 (arrow A1), anvil housing 30, which moves towards staple housing 28 (arrow A2) , and the anvil 96 itself, which is moved relative to the anvil housing 30 in the direction of the cartridge (arrow A3). This compound movement of the anvil towards the staple cartridge makes possible a small displacement of the corresponding piston to rapidly compress the tissue in the grip of the stapler. The multiplication of movement also improves the transmission force between the two housings by keeping the angle at the hinge 104, between the proximal (actuated) arm and the distal (actuated) arm, as great as possible.

The relative movement of the two housings 28, 30 towards each other also drives up the articulated parts 38, 40 and their interconnecting elastic wires 46 at the top of the head 14 of the stapler. Jointed pieces and elastic wires together lift the top of the membrane, creating more volume to absorb tissue expansion during compression.

Tissue compression is stopped when pins 84 moving in slots 64 of staple housing 28 reach the limit of travel, as shown in Figures 22-24. Thus, the slots and associated components are dimensioned. to set the desired gap distance between the tissue contacting surfaces on the stapler side and the anvil side of the stapler head. Exemplary standoff distances for use in stomach wall applications could include approximately 1.5241.778mm (for example for use with staples having 5.5mm length legs) or 2.768mm for 6.5mm staples length of legs. Applying additional pressure to the hydraulic circuit will not compress the tissue any more.

Furthermore, due to the arrangement of the piston, the stapling function is effectively blocked until compression of the tissue is completed. With this arrangement, fluid introduced through fluid port 50b (FIG. 11A) into staple fluid channel 122 prior to completion of tissue compression will leak until the two piston O-rings 112 compression 106 are spanning inlet 114. This design prevents premature firing of the staple.

In the fully compressed position, the arm extenders 113 are nearly perpendicular to the center line of the stapler head. Once the tissue is compressed between cartridge 78 and anvil 96, the tissue is ready for stapling.

Stapling is initiated by introducing hydraulic fluid through port 50b (Figure 5). The staple piston advances, pushing the cutting element 86 (Figures 7 and 10) toward the anvil 96. Because the staple pusher 76 is mounted on the cutter 86, this action drives the staple pusher 76 through the cartridge. 78, where it simultaneously pushes all the staples through the tissue. The movement of the staple piston is limited by internal stops, and is pre-set to perform the optimal shaping of the staples.

During compression, when the angle at the hinge 104 of the arm assemblies 32 reaches its maximum, the force required to resist separation of the staple and anvil housings increases. These forces increase further when staple crushing forces are exerted on the anvil by the staple piston. To compensate, the arm extenders 113 serve as posts to channel at least a portion of these forces toward the disk 68. These forces, if not reacted by the pusher disc, would pull the arms 100, 102 and potentially release the compression on the tissue, causing incomplete shaping of the staples or cutting of the tissue. In this way, a structure is created as a reinforcement for the force displacement.

When the staples have been formed, the pressure on the staples is released and a spring (not shown) returns the staple pusher 72 to its home position. Releasing the fluid pressure will allow the flexed elastic wires 46 on the membrane riser 37 to return the staple head to its minimum profile configuration and release the stapler fold. Once outside the patient, the used staple cartridge can be ejected and a new one installed.

Figures 25A-25C illustrate a method of retaining a removable staple cartridge 7 within the staple housing. The cartridge is spring loaded into the staple housing and retained by two latches 170 (one visible), each pivotal relative to a fulcrum 172. As shown, fulcrum 172 may be coupled to disk 68 via pin 84 Each latch 170 includes a hook 174 that engages a corresponding hook 176 on the cartridge. Latch 170 is preferably spring loaded to bias hook 174 inward toward the cartridge.

By squeezing the proximal end 175 of each latch 170 as shown by arrow P in FIG. 25B, the latch pivots against its load, causing ejection of the staple cartridge. A new staple cartridge can then be placed with its slots 79 aligned with alignment posts 74 as shown in FIG. 25C and then pushed into the staple housing. As the new cartridge slides into position, the

ES 2 383 993 T3 hook 174 runs over proximal tapered portion 178 of hook 176. Once hook 174 passes over distal end 180 of hook 176, it falls inward toward the cartridge due to spring loading. , thus being applied to the cartridge. When the cartridge is properly seated, a click will be heard or felt as the clips engage the new cartridge.

Stapler Alignment During Stapling

In operation, when the two stapler members have been brought together, a fold of tissue is captured between the outer face of the staple cartridge and the facing face of the anvil. When this tissue capture is occurring, such as just before and during the stapling of the tissue fold, variations in thickness and / or compressibility of regions of the captured tissue can divert the stapling operation, off-centering it, that is, off-axis, causing the legs to staples are received out of position within their associated anvil recesses, with the result that one or more of the staples may be improperly held, for example without complete folding of the staple legs, and / or the series of staples can be offset with respect to the central axis of the device, causing some staples, for example, to be too close to the hole cut in the center of the stapled fold .

To ensure that successful stapling operations occur for each series of staples in the cartridge (for example, two concentric series of five staples each), the device of the invention may include an alignment structure to maintain the proximal and distal members of the cartridge. device in axial alignment just before and during the stapling operation. This alignment structure is shown in side sectional views in Figures 36 and 37. Shown in FIG. 36 is the portion of staple device 12 that includes anvil 96 and cutting board 99a on distal member 27, and cutter 86 on proximal member 25. In operation, the two members and the staple cartridge are shown in FIG. Staples and the anvil disposed therein are first moved together to capture a fold of tissue between the facing surfaces of the cartridge and the anvil, as illustrated in Figures 22 and 23. The staple piston 116 is then moved from its retracted position to its extended position, as seen in FIG. 24, to move the cutter against the cutting board 99a, as shown, and drive the staples in the staple cartridge against the anvil.

The alignment structure includes a pin axially retained within cutter 86 for movement therewith, and a pin receiving slot formed in a sleeve 164 supported within a housing portion 27 attached to anvil 96 for axial movement therewith. In the embodiment shown in Figure 36, sleeve 164 is spring loaded, by means of spring 166, within housing 27, in a direction that opposes movement of the pin toward the sleeve, allowing the cutter and pin The attached, which has now penetrated through the captured tissue, sits on the chamfered end of the sleeve. As the cutter, pin, and staple pusher continue to move toward the second member, eventually forming a hole in the tissue and ejecting staples from the staple cartridge through the tissue and against the anvil, the two members of the device are held in axial alignment, such that the stapling operation occurs with all staples positioned in alignment with the respective recesses associated with the anvil. When this operation is completed, the staple piston and actuating member are retracted to release the stapled tissue and return the device to its linear state.

The embodiment of device 12 shown in Figure 37 is similar to that just described, but in which the alignment pin 168 disposed in the cutter housing is elastically loaded by a spring 174 in the direction of the second member, and A pin receiving slot 170 is in a fixed position sleeve 172 disposed below the anvil (not shown) in member 27. In this embodiment, the movement of the two members toward each other, once the pin has been initially seated in the groove of the sleeve, is absorbed by movement of the pin in the direction that it moves away from the second member, as the The piston continues to move to its fully extended position to cut and staple the captured tissue between the two members, as described above.

Stapler handle and tube

Referring to Figure 2, the stapler tube 16 that connects the handle 18 and the stapler head 14 is flexible enough to accommodate the curvature of the upper digestive tract, yet maintains the ability to transmit enough torque to rotate the head. of the stapler. The tube is formed with sufficient rigidity to allow it to be pushed down by the esophageal guide tube 23. Appropriate materials include

Figure 26 shows a distal wall of tube 16, with the stapler head removed from the tube. As shown, tube 16 includes an endoscopic bore 124 through which an endoscope is advanced to allow viewing of a stapling operation. Side bores 126 may also be provided to receive other useful instruments during operation.

An articulation section 128 is located at the distal end of tube 16, between tube 16 and stapler head 14 such that the head of the stapler is allowed to be articulated relative to the tube. A tubing coupled to the vacuum source and the hydraulic fluid source extends from the handle through tube 16 and hinge section 128.

ES 2 383 993 T3

Figure 27A shows a configuration that can be used for hydraulic fluid lines 130. During use, hydraulic fluid lines are subject to significant flexing and elongation at the articulating section of the stapler. They are also sometimes subjected to fluid pressure that can exceed 105.45 kg / cm². Typically, in industrial applications, hydraulic lines are flexible and have additional tubing work loops that absorb length changes during use. The illustrated configuration for the hydraulic lines is a particularly appropriate bottom profile solution for an endoscopic device that has space limitations. A preferred hydraulic pipe is a pipe 130 having a portion that is formed into a longitudinally expandable shape so that it can absorb effective length changes during bending. The longitudinally expandable portion of the tube is preferably disposed within hinge section 128 of stapler 12. In a preferred design, the longitudinally expandable shape is a helix shape as shown in Figure 27A. In alternative embodiments, tube 130 may be configured in other longitudinally expandable shapes, such as regular or irregular wavy shapes (Figure 27B).

The preferred material for tubes 130 is stainless steel hypotube, although other materials may be used instead. In the preferred stapler configuration, two drive fluid lines are provided, one for activating tissue compression and the other for stapling (and cutting when in use). In the present embodiment, the tubes are wound together as shown in Fig. 27A. In alternative embodiments, two or more tubes wound in a helix may be nested within each other. When the hinge section is bent, this forces the coiled tubes 130 to bend and change in length in response to the bending. Coiled tubes behave precisely like coiled wires during these movements and can thereby change in length, flex, and follow the contour of the articulating section without compromising flow through tube bores or imparting undue stress to connections. at either end of the hydraulic system.

Longitudinally expandable forms for fluid lines may be appropriate for use in allowing fluid delivery to the operating ends of other types of articulating medical devices, such as catheters or endoscopic devices to deliver therapeutic agents or irrigation fluids beyond a hinge or bendable section of the device.

Referring again to Figure 26, the hinge section 128 is comprised of a spine formed from a plurality of links 132 threaded over a pair of traction cables 134 (only one is shown in Figure 26). In one embodiment, the engagement of the traction cables allows the stapler head 14 to be hinged in two directions through a range of motion of approximately 90 degrees in one direction (see FIGS. 3B) and 175 degrees in the opposite direction. (see figure 3C). Each pull wire is anchored at or near the head of the stapler, such as the most distal link 132 of the stapler housing 28.

The most proximal portions of traction cables 134 extend the length of tube 16 and terminate at handle 18. Referring to Figure 28, handle 18 includes a rotation knob 136 that can be selectively rotated clockwise. clockwise or counterclockwise to articulate the stapler head up or down. Rotation in one direction applies tension to one of the traction cables to cause the stapler head to bend downward, while rotation in the opposite direction puts tension on the other cable, causing the head to bend upward.

In a preferred handle configuration, button 136 includes an internal threaded hole 138. Button 136 is partially retained within handle 18 so that it remains fixed within the handle, but is freely rotatable. A carriage or slider 140 having a threaded outer surface is located within threaded hole 128 of the button. The threads within the bore 138 mate with the threads of the carriage 140 such that rotation of the button causes the carriage 140 to translate, but not rotate, within the handle.

Each of the two traction cables, identified in Figure 28 as cables 134a and 134b, terminate in a different member of the handle. Cable 134a is m mounted on the slide carriage and the cable 134b is mounted on a stationary part of the handle 18. Each cable extends through a corresponding sheath. Lead 134a extends through sheath 135a having a proximal end attached to a stationary portion of handle 18. Cable 134b extends through sheath 135b having a proximal end mounted on the slide carriage.

The cables 134a, b and the sleeves 135a, b are arranged in such a way that translation of the carriage in one direction will cause the head of the stapler to flex in one direction, and translation of the carriage in the other direction will deflect the head of the stapler. stapler in another sense.

Referring to Figure 28, if knob 136 is rotated to cause carriage 140 to translate to the left of the page, cable 134a will be taut and cable 134b will bundle, causing the stapler head to articulate. in a first sense (for example upwards). Rotation of button 136 in the opposite direction will advance the carriage to the right of the page, releasing the tension on cable 134a and pushing sheath 135b over cable 134b toward the distal end of the stapler head, causing the hinge at the second direction (eg downward) as sheath 135b is advanced against a distal portion of tube 16. The proximal portion of the sheath 135b is provided with sufficient working length to prevent it from being placed

ES 2 383 993 T3 in tension when the carriage moves distally. The positioning of the button is advantageous because the manual movement required for the articulation of the stapler is always the same, regardless of the rotational orientation of the stapler. Also, the use of the threaded button can prevent unintended relaxation of the flex angle, even if the button is arranged without a latch to retain its rotational position.

Referring to Figures 28 and 29, the endoscope bore 124 extends along the central axis of the stapler. The positioning of the bore and the coaxial relationship of the hinge knob relative to the endoscope 124 allow the endoscope and stapler to be rotated independently without interference with each other. Thus, if the user chooses to change the rotational orientation of the stapler head 14 within the body, the user can rotate the handle 18 and tube 16 while maintaining the rotational position of the endoscope.

To be cost-effective, stapler 12 can be designed to allow stapler head 14 to be disposed of while allowing tube 16 and handle 18 to be sterilized and reused. One mechanism for removably coupling the stapler head to tube 16 is illustrated, although others are readily conceivable (eg, a slip-coupling type arrangement). Referring to Figure 26, an end plate 142 is mounted to the most distal end of links 132. Each end plate 142 and the corresponding rear surface of the stapler head are provided with latching features that allow Make sure the end plate and the stapler head engage each other.

End plate 142 includes cantilevered pin 144 having a leg 145 (which may be a resilient pin), a central aperture 146, and a pair of U-shaped engaging hooks or edges 148 along its edges. Through the end plate 142 are formed hydraulic feed holes or openings 156a, b. The hydraulic tubes supplying hydraulic fluid to the stapler head (see tubes 130 in FIG. 27) are preferably welded to the end plate to allow fluid in the tubes to be directed through feed ports 156a, b.

Figures 30A and 30B show the rear surface 48a of the staple housing, which was modified somewhat from Figure 5. In this variant of the rear surface 48a, the hydraulic inlet ports 50a, 50b are repositioned as shown. . Additionally, rear surface 48a has been modified to include a pair of engaging hooks or edges in the form of cut protrusions 150, plus an alignment pin 152 and a hole 154. The connection of the tube to the stapler device takes place by snap.

Figures 30A and 30B show the end plate 142 positioned against the rear surface 48a of the staple housing. The other features of hinge section 128 are not shown in Figures 30A and 30B for clarity. To attach the head of the stapler to the tube 16, the plate 142, attached to the handle assembly, is pressed against the rear surface 48a of the staple housing shown in FIG. 30A. When the plate is pushed, it rotates clockwise, causing the leg 145 (FIG. 26) of the cantilever pin 144 to engage the hole 154 in the rear surface of the staple housing. When this latch is engaged, the hydraulic feed holes 156a, b of the end plate 142 align with the hydraulic inlets 50a, 50b of the stapler head, as shown in FIG. 30B. At the same time, portions of the end plate surrounding the U-shaped hooks 148 slide under the cut protrusions 152. Pressing the plate compresses the face seal O-rings surrounding the hydraulic inlet ports 50a, 50b. The compression of the O-rings is maintained by engaging the hooks and the cut protrusions protruding from the end plate. To remove the stapler head from the housing, the stapler housing is twisted counterclockwise to disengage the end plate 142 from the rear surface 48a. The stapler tube and handle can then be sterilized in preparation for mounting a new stapler head.

Procedure Example

An exemplary method for using the system 10 in the context of folds in stomach wall tissue will now be described, with particular reference to Figures 31-33.

As an initial step (Figure 2), the endoscopic guide tube is advanced into the stomach through the mouth and esophagus. Endoscope 22 is inserted into the endoscope channel in the handle (not shown) of the stapler and advanced down the bore down the handle of the stapler. The stapler / endoscope are simultaneously passed through the endoscopic guide tube into the stomach. Once the stapler and endoscope reach the gastroesophageal junction region of the stomach, the position of the stapler is maintained as the endoscope is advanced further into the stomach.

The head 14 of the stapler 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 the stapler head 12 in previously identified target tissue, as shown in FIGS. 31A. The opening 26 of the membrane 24 is positioned against the target tissue. The endoscope is placed in a retroflexed position as shown.

ES 2 383 993 T3

Vacuum source 20 (Figure 2) is coupled to the vacuum port outside the body and vacuum pressure is applied to draw tissue 17 through opening 26 and into the vacuum chamber defined by membrane 24, as shown shown in Figures 31B and 32A. The achievement of the target tissue will be readily identified endoscopically through the transparent membrane wall 24 at the head of the stapler.

The fluid source (shown) attaches to the handle. Once it has been visually confirmed that a sufficient amount of tissue has been obtained, fluid is introduced to cause compression of the tissue and expansion of the arm assemblies 32 and membrane riser 37, as shown in Figures 32B and 31C. As can be appreciated, the expansion of the arm and membrane assemblies allows a large volume of tissue to be acquired in the vacuum chamber and moved further into the chamber during tissue compression. As noted above, aspiration of tissue into the expanded chamber during operation, well "above" the staple carrier and anvil in Figures 32B and 32C, provides a relatively large margin of tissue around the portion. stapled tissue, reducing the risk of the tissue tearing or weakening the tissue fold near the stapled part of the tissue. The captured tissue fold is indicated at 17a.

Once the tissue has been compressed, additional hydraulic fluid is introduced to effect stapling and cutting of the tissue, as shown in Figures 31D and 32C, forming a P-fold, indicated 17b in Figure 33. Hydraulic sources compression and clamping are then deactivated to release fluid pressure within the hydraulic circuit. With the hydraulic pressure relieved, the elastic wires of the membrane lifter 37 help to restore the stapler head 14 to its original streamlined configuration, allowing the stapler head to be pulled out of the tissue as shown in FIG. 31E. The stapler head may be hinged relative to the tube to aid movement of the stapler head away from the P-fold.

In a preferred configuration of the fold, shown in Figure 33, the staples 158 are arranged in two concentric rings of five staples, with the staple reinforcing device 83 retained by the staples and distribution forces around the staple pattern, depending on it shows. The fold P includes a hole H formed by the cutting element, through which various implants or anchors for various implants can be placed.

If multiple folds are required, the stapler 12 is briefly removed from the endoscopic guide tube and the staple cartridge is replaced in the manner described in connection with Figures 25A-25C. The procedure is repeated until all the desired folds have been formed.

The system can be packaged with instructions for use that inform the user how to use the various features described to perform a stapling procedure using the methods explained herein.

Alternative Realizations

The basic structure of the stapler described above can be used as a base for other stapling tools. Figures 34-35 show a modified stapler in which the membrane and membrane lifter have been removed, and in which the staple housing 28 has been modified for holding tools. As shown in FIG. 34, the staple housing 28 includes a pair of slots 160 arranged to receive tools 162. The tools 162 can be seated in these slots 160 and mounted in the staple housing as shown in Figure 35. This clamping will provide a stable base from which the tools are actuated. The tools may be self-articulating, or the staple housing 28 may be equipped with devices 164 to move the tools between positions aerodynamically for insertion of the assembly into a body cavity, and a deployed position, such as shown. in figure 35. Tools similar to those in Figure 35 could be used to obtain tissue, reaching between the cartridge and the anvil and used to grasp tissue and pull the tissue into position between the cartridge and the anvil so that it can be stapled, or otherwise directly affected by various added features or instead of the anvil and cartridge. Procedures that may benefit from stapler fitting include, but are not limited to, gastroplasty, stoma adjustment, polyjectomy, conductor placement, bleeding control, perforation or hole closure, biopsy, and tumor removal.

The described systems provide convenient embodiments for performing the described compression and stapling functions. However, there are many other various instruments or systems that may be used alternatively within the scope of the present invention, as defined in the appended claims.