Single-fold system for tissue approximation and fixation
A single fold system for tissue approximation and fixation is described herein. The devices are advanced in a minimally invasive manner within a patient's body to create at least one fold within a hollow body organ. The system comprises a tissue acquisition and folding device and a tissue stapling or fixation device, each of which is used together as a system. The acquisition device is used to approximate a single fold of tissue from within the hollow body organ and the stapling device is advanced through a main lumen defined through the acquisition device and is used to affix the tissue. The stapling device is keyed to maintain its rotational orientation relative to the acquisition device and to provide the user positional information of the stapling device. The acquisition device is also configured to provide lateral stability to the stapling device prior to the stapling device being clamped onto tissue.
The present invention relates generally to medical apparatus and methods. More particularly, it relates to devices and methods for approximating portions of a hollow body organ, particularly a stomach, intestine, or other region of the gastrointestinal tract, while affixing the tissue.
BACKGROUND OF THE INVENTIONIn cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to “tie off” or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.
Typically, these stomach reduction procedures are performed surgically through an open incision and staples or sutures are applied externally to the stomach or hollow body organ. Such procedures can also be performed laparoscopically, through the use of smaller incisions, or ports, through trocars and other specialized devices. In the case of laparoscopic banding, an adjustable band is placed around the proximal section of the stomach reaching from the lesser curve of the stomach around to the greater curve, thereby creating a constriction or “waist” in a vertical manner between the esophagus and the pylorus. During a VBG, a small pouch (approximately 20 cc in volume) is constructed by forming a vertical partition from the gastroesophageal junction to midway down the lesser curvature of the stomach by externally applying staples, and optionally dividing or resecting a portion of the stomach, followed by creation of a stoma at the outlet of the partition to prevent dilation of the outlet channel and restrict intake. In a Roux-En-Y gastric bypass, the stomach is surgically divided into a smaller upper pouch connected to the esophageal inflow, and a lower portion, detached from the upper pouch but still connected to the intestinal tract for purposes of secreting digestive juices. A resected portion of the small intestine is then anastomosed using an end-to-side anastomosis to the upper pouch, thereby bypassing the majority of the intestine and reducing absorption of caloric intake and causing rapid “dumping” of highly caloric or “junk foods”.
Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, use of general anesthesia, time and pain associated with the healing of the incisions, and other complications attendant to major surgery. In addition, these procedures are only available to a small segment of the obese population (morbid obesity, Body Mass Index ≧40) due to their complications, leaving patients who are considered obese or moderately obese with few, if any, interventional options.
In addition to surgical procedures, certain tools exist for approximating or otherwise securing tissue such as the stapling devices used in the above-described surgical procedures and others such as in the treatment of gastroesophageal reflux disease (GERD). These devices include the GIA® device (Gastrointestinal Anastomosis device manufactured by Ethicon Endosurgery, Inc. and a similar product by USSC), and certain clamping and stapling devices as described in U.S. Pat. Nos. 5,403,326; 5,571,116; 5,676,674; 5,897,562; 6,494,888; and 6,506,196 for methods and devices for fundoplication of the stomach to the esophagus for the treatment of gastroesophageal reflux disease (GERD). In addition, certain tools, such as those described in U.S. Pat. Nos. 5,788,715 and 5,947,983, detail an endoscopic suturing device that is inserted through an endoscope and placed at the site where the esophagus and the stomach meet. Vacuum is then applied to acquire the adjacent tissue, and a series of stitches are placed to create a pleat in the sphincter to reduce the backflow of acid from the stomach up through the esophagus. These devices can also be used transorally for the endoscopic treatment of esophageal varices (dilated blood vessels within the wall of the esophagus).
There is a need for improved devices and procedures. In addition, because of the invasiveness of most of the surgeries used to treat obesity and other gastric disorders such as GERD, and the limited success of others, there remains a need for improved devices and methods for more effective, less invasive hollow organ restriction procedures.
BRIEF SUMMARY OF THE INVENTIONA system for tissue approximation and fixation is described which may be used to approximate and/or tension at least one fold of tissue from within a hollow body organ, such as the stomach, esophageal junction, and other portions of the gastrointestinal tract. Generally, the devices of the system may be advanced in a minimally invasive manner within a patient's body, e.g., transorally, endoscopically, percutaneously, etc., to create one or several divisions or plications within the hollow body organ. Examples of placing and/or creating divisions or plications may be seen in further detail in U.S. Pat. No. 6,558,400; U.S. patent application Ser. No. 10/188,547 filed Jul. 2, 2002; and U.S. patent application Ser. No. 10/417,790 filed Apr. 16, 2003, each of which is incorporated herein by reference in its entirety. The system may comprise at least a tissue acquisition and folding device and a tissue stapling or fixation device, each of which may be used together as a single system.
The folder assembly may generally comprise, in part, a tissue acquisition assembly which may be used to initially acquire and/or approximate at least one fold of the tissue. The acquisition assembly may comprise a tensioning member and a pod member, each of which may be independently articulatable to form a first compact configuration and a second larger, expanded configuration. Each of the members may be connected to respective first and second actuation rods on the distal end of a yoke member, which connects the pod members to an elongate working body or shaft. The working body itself may be comprised of a plurality of aligned link members which are adapted to provide some flexibility to the working body and which defines a main lumen throughout a length of the working body as well as through the handle connected to a proximal end of the working body. Moreover, the working body may be covered by a sheath or a covering to enhance the lubricity of the shaft as well as to maintain the interior of the working body clear from body fluids and debris and seal the shaft to allow insufflation of the target organ. Various materials may be utilized for the sheath including various plastics, elastomers, latex, polyurethane, thermoplastics, e.g., PTFE, silicone, PVC, FEP, Tecoflex®, Pebax®, etc., so long as they are preferably biocompatible.
At least one of the members, such as the pod member, may additionally define a vacuum chamber or opening into which the tissue may be drawn within. The opening of the vacuum chamber may be slotted along a direction parallel to a longitudinal axis of the working body; alternatively, the opening may be defined a variety of shapes, e.g., oval, elliptical, etc., and furthermore may be offset such that it is defined transverse to the longitudinal axis of the working body. The distal end of the pod member may have a flexible and/or atraumatic tip such as a blunt, rounded, or “bullet” tip, made from any number of polymers to facilitate the guidance of the acquisition assembly into the hollow body organ without damaging tissue along the way. One example of a device utilizing two pod members is described in further detail in U.S. patent application Ser. No. 10/686,326 filed Oct. 14, 2003, which is commonly owned and is incorporated herein by reference in its entirety.
A guidewire may optionally be used with the folder assembly during initial deployment and positioning within the hollow body organ in a manner similar to a catheter for guiding the acquisition assembly to a predetermined position. The use of the guidewire may assist in initial placement of the device transorally, either through the main lumen of the device or it can also be exchanged through a lumen in the tip of the pod member. Both of the members may each be adapted to pivot on respective hinge members such that in a first compact configuration, the first and second pod members are immediately adjacent to one another. When desirably positioned within the hollow body organ, a vacuum force may be applied within a vacuum chamber defined within the pod member such that tissue enters within the vacuum chamber or opening. To assist in placement of the device, various indicators may be used. For instance, one or several indicators may be located directly on the device or indicators may be utilized with the device in relation to anatomical structures or landmarks. In one example, an orientation marker may be placed at a point on the distal portion of the device that is visible endoscopically and can be adjusted relative to structures such as the “z-line” of the gastroesophageal, i.e., the place where a change in color of the tissue from whitish (esophagus) to a salmon color (stomach) occurs delineating what is referred to as the squamocolumnar junction, i.e., the point where the lining changes from esophageal (squamous) to stomach (columnar). Then, in moving to a second expanded configuration, one or both of the tensioning member and/or the pod member may be translated via actuation rods into opposing radial directions from one another such that the tissue is drawn through the tensioning member by the pod member and approximated to create a fold of tissue. Once this tissue fold has been desirably created, the fixation assembly may be advanced distally through the main lumen of the folder assembly and positioned upon exiting the main lumen to become clamped directly over the folded tissue. It is also within the scope of this disclosure to actuate the members simultaneously, serially or singularly.
One or more vacuum tubes may be routed through the length, or a partial length, of the working body for communication with the pod member. The proximal ends of the vacuum tubes may be connected to one or more vacuum pumps. Furthermore, the vacuum tubes may utilize braided materials, e.g., stainless steel or superelastic materials such as Nickel-Titanium alloy, integrated throughout to prevent kinking or pinching of the tubes.
The fixation assembly comprises, in part, a manipulatable stapler assembly connected via a flexible shaft to a stapler handle. The stapler assembly itself generally comprises a staple cartridge housing within which one or more staples are housed. A corresponding anvil is positioned in apposition to the staple cartridge housing and may be used to provide a staple closure surface when tissue to be affixed is adequately positioned between the staple cartridge housing and the anvil. With the stapler assembly connected at the distal end of a flexible shaft, a handle is connected at the proximal end of the shaft. The handle itself may allow the surgeon or user to hold and manipulate the fixation assembly while articulating the stapler assembly between an open and closed configuration. Moreover, the configuration of the handle allows the surgeon or user to actuate the stapler assembly as well as deploy the staples from the staple cartridge housing.
In use, the fixation assembly may be advanced within the folder assembly main lumen with the fixation assembly configured in a closed configuration. To maintain an orientation, i.e., rotational stability, of the fixation assembly relative to the folder assembly and the approximated tissue, the fixation assembly may be configured to have a shape which is keyed to a cross-sectional area of the folder assembly main lumen. The keyed configuration helps to ensure that as the fixation assembly is advanced through the folder assembly, that the stapler assembly is optimally positioned to be clamped over the tissue for fixation.
When the stapler assembly is advanced and has exited the main lumen of the working body, the staple cartridge housing may be actuated into an open configuration when positioned between distally extending arm members of a yoke to receive the tissue folded between the pod members. The yoke arm members are configured such that when the stapler assembly is positioned therebetween, the stapler assembly is prevented from rotating or bending out of alignment for tissue affixation, i.e., the lateral stability of the stapler assembly is maintained relative to the yoke and the tissue. The stapler assembly may then be advanced distally over the folded tissue and clamped onto the tissue for deploying the staples. To avoid damaging tissue surrounding the acquisition assembly, one or several insertion indicators may be defined along a portion of flexible shaft of the fixation assembly, preferably near a proximal end of the shaft, to aid the user in knowing when the stapler assembly may be safely articulated while the fixation assembly is positioned within the working body, i.e., the longitudinal stability of the stapler assembly is maintained relative to the folder assembly. The indicators may be configured to align with a proximal end of the folder handle to correspondingly indicate, e.g., a position of the fixation assembly relative to the folder assembly when the stapler assembly may be opened, and/or how far distally the fixation assembly may be advanced relative to the folder assembly to engage the folded tissue, and when the devices are in a “safe to clamp” mode (e.g., in position around the tissue). Such positional indicators may utilize mechanical features, such as a stop or detent. In addition, the stapler assembly jaws my be spring-loaded open to assist insertion.
BRIEF DESCRIPTION OF THE DRAWINGS
A system for tissue approximation and fixation is described which may be utilized for approximating tissue regions from within a hollow body organ, such as the stomach, esophageal junction, and other portions of the gastrointestinal tract. The system may be advanced within a body through a variety of methods, e.g., transorally, transanally, endoscopically, percutaneously, etc., to create one or several divisions or plications within the hollow body organ. At least two devices may be utilized as part of the system, a tissue acquisition and folding system and a tissue stapling or fixation system, although it is contemplated that both devices can be integrated into a single mechanism. Each of these devices may be configured to efficiently operate with one another to provide optimal methods and devices for at least acquiring, approximating, and stapling regions of tissue from within the hollow body organ in a minimally invasive manner.
Turning now to the figures, the system will first be described generally in which one variation of system 10 is shown in
Acquisition assembly 16 may be located at the distal end of working body 28 which may be configured as a flexible shaft having one or several lumens defined through the length of the working body 28. The working body 28 may be covered by a sheath or covering 30 to enhance the lubricity of the shaft as well as to maintain the interior of the body 28 clear from body fluids and debris and provide a seal to allow insufflation of the target organ. Various materials may be utilized for sheath 30 including various plastics, elastomers, latex, polyurethane, thermoplastics, e.g., PTFE, FEP, silicone, PVC, Tecoflex®, Pebax®, etc., so long as they are preferably biocompatible.
A number of vacuum tubes 32 may also be routed through the length, or a partial length, of the working body 28 to acquisition assembly 16. The figure shows vacuum tubes 32 entering the working body 28 at its proximal end. Alternatively, vacuum tubes 32 may enter working body 28 at some distal point along the length of body 28 or vacuum tubes 32 may enter working body 28 through handle 34. In either case, vacuum tubes 32 may be positioned within one or several lumens defined through working body 28 and placed in fluid communication with pod member 20 to facilitate in vacuum actuation of tissue, as further described below. The proximal ends of vacuum tubes 32 may be connected to one or more vacuum pumps (not shown). Furthermore, vacuum tubes 32 may utilize braided materials, e.g., stainless steel, superelastic materials such as Nickel-Titanium alloy, integrated throughout to prevent kinking or pinching of the tubes 32. Such vacuum tubes 32 may also accommodate insertion of a snare or grasper type device that can be inserted once tissue is acquired to mechanically grasp the invaginated tissue, depending on the type of tissue manipulation desired. An example of a “gooseneck” snare by Microvena, Inc. which may be used with the vacuum tubes 32 is described in further detail in U.S. Pat. No. 5,171,233, which is incorporated herein by reference in its entirety.
The proximal end of working body 28 is operatively connected to handle 34. Also connected to handle 34 are first and second actuators 36, 38 which may be used to actuate tensioning member 18 and pod member 20 from the first compact configuration to the second larger, expanded configuration. Each actuator 36, 38 may be actuated individually to control a corresponding member independently of the other member or may be actuated simultaneously, as described later herein. Main lumen 40 may be defined throughout the length of working body 28 and through handle 34 such that fixation assembly 14 may be advanced and withdrawn through the folder assembly 12. Fixation assembly 14 comprises, in part, stapler assembly 42 connected via flexible shaft 48 to a stapler handle 50. Stapler assembly 42 generally comprises staple cartridge 44, within which one or more staples are housed. Stapler assembly 42 may also have an optional tapered distal end to facilitate insertion of the device into or past tissue, as described in further detail below. Anvil 46 is in apposition to staple cartridge 44 and is used to provide a staple closure surface when tissue to be affixed is adequately positioned between staple cartridge 44 and anvil 46. With stapler assembly 42 connected at the distal end of flexible shaft 48, handle 50 is connected at the proximal end of shaft 48. Handle 50 may generally comprise a housing and grip 52 in apposition to actuation handle 54. Handle 50 allows for the surgeon or user to hold and manipulate fixation assembly 14 with grip 52 while articulating stapler assembly 42 between an open and close configuration via actuation handle 54. Moreover, the configuration of handle 50 allows the surgeon or user to articulate stapler assembly 42.
When fixation assembly 14 is advanced within folder assembly 12, stapler assembly 42 is preferably in a closed configuration. When stapler assembly 42 has exited working body 28, staple cartridge 44 may be articulated into an open configuration when positioned between yoke 26 to receive the tissue folded between tensioning member 18 and pod member 20. Stapler assembly 42 may then be advanced distally over the folded tissue and clamped close over the tissue for deploying the staples. To avoid damaging tissue surrounding acquisition assembly 16 and to facilitate proper stapling, one or several insertion indicator(s) 56 may be defined along a portion of flexible shaft 48 preferably near a proximal end of shaft 48, to aid the user in knowing when stapler assembly 42 may be safely articulated while fixation assembly 14 is positioned within working body 28. Indicators 56 may be configured to align with a proximal end of folder handle 34 to correspondingly indicate, e.g., a position of fixation assembly 14 relative to folder assembly 10 when stapler assembly 42 may be opened, and/or how far distally fixation assembly 14 may be advanced relative to folder assembly 10 to engage the folded tissue, etc. In addition to visual indicators, a mechanical indication, such as a stop or detent may be employed to give the operator a tactile indication of “safe to open” and “safe to clamp” device positions.
A brief description of the acquisition assembly 16 will be given in order to describe how the tissue may be manipulated by the devices described herein. A more detailed description will be given below. Perspective views of one variation of acquisition assembly 16 in an open and closed configuration are shown in
The pod member 20 may be comprised of a vacuum chamber or opening 60 into which tissue may be drawn therewithin. A vacuum tube 76, as may be seen in
In its compact configuration, tensioning member 18 and pod member 20 of acquisition assembly 16 may each be shaped to compactly fit with one another. For instance, in this variation, tensioning arms 62, 64 may be configured to become adjacently positioned on either side of vacuum chamber 60. In alternative variations, tensioning arms 62, 64 may be configured to move relative to one another to alter the area of tissue receiving region 90 between the arms 62, 64.
When tensioning member 18 and pod member 20 are actuated between an open configuration, as shown in
A guidewire may optionally be used with the folder assembly 12 during initial deployment and positioning within the hollow body organ in a manner similar to a catheter for guiding acquisition assembly 16 to a predetermined position. Accordingly, an optional guidewire lumen may be defined in atraumatic tip 66. As seen in
The vacuum force which may be used to draw in the tissue within vacuum chamber 60 of pod member 20 may be controlled through a number of various methods. One variation is illustrated in
The different linings of the stomach, which include the mucosal layer MUC, muscular layer ML, and serosal layer SL, are shown in cross-section. The vacuum force may be applied such that at least the mucosal layer MUC of the tissue, e.g., an anterior wall AW and posterior wall PW, is drawn into vacuum chamber 60 and the tissue is sufficiently adhered to the pod member 20. While the vacuum force is applied, tensioning member 18 and pod member 20 may be translated away from one another in opposing direction such that the adhered tissue is drawn between the tensioning arms 62, 64 of tensioning member 18 and pod member 20 such that at least two adjacent folds of tissue are created to form an overlap region of tissue, as shown in
The methods described herein in acquiring a single, longitudinal fold, may be particularly effective for use in treatments such as GERD or to exclude certain portions of the wall of the body organ. In addition, the device can assist in the placement or revision (e.g. as a secondary operation or secondary step in a single procedure) of certain surgical procedures, such as a Roux En Y gastric bypass, or vertical banded gastroplasty, or other restrictive procedures where the resulting pouch may be stretched over time and may need further reduction. Further, certain procedures can lead to unforeseen results such as the formation of a gastric/gastric fistula. Such a fistula may be closed with the devices and methods described herein. In a further example, the efficacy of the placement of a series of sutures or staples to form what is typically referred to as a “Collis” procedure, may be enhanced by the addition of a tissue fold at the outlet of the “Collis” geometry, in the vicinity of the pylorus, or at any point along the resulting geometry to create resistance to food intake or enhance food dwell time in the gastric region. Examples of other treatments are described in further detail in co-pending U.S. patent application Ser. No. 10/417,790, which has been incorporated by reference above. When the single tissue overlap is created by folder assembly 12, the overlap preferably includes an overlap of at least the muscular layer ML and serosal layer SL to ensure a secure anchoring platform for the staples or fasteners to maintain the durability of the tissue overlap. Such an overlap can also serve as a way for securing an additional item within the organ such as pacing leads, sensors (e.g. monitoring of stretch receptors within the stomach), monitors, or other such diagnostic or therapeutic devices, including but not limited to those described in U.S. patent appliction Ser. No. 10/215,070 filed Aug. 7, 2002, which is incorporated herein by reference in its entirety. A more detailed discussion may be found in U.S. patent application Ser. No. 10/188,547 filed Jul. 2, 2002, which is incorporated herein by reference in its entirety.
Folder Assembly
Folder assembly 12 may typically comprise a handle 34 at a proximal end of the assembly 12, as described above. Handle 34 may comprise housing 110 which may enclose a pod actuation assembly within.
The handle mechanism 34 helps to ensure that relative or unwanted movement of the pods during flexing of the shaft of the folder in minimized or eliminated. Additionally, tubes 136, as further described below, function so that the shaft of the device is not loaded during actuation. These tubes 136 help to support the actuation load, but still allow sufficient shaft flexibility.
As shown in
As further seen in
An alternative variation on the folder assembly housing is shown in dual actuator assembly 150 in
When lever 158 is depressed, actuation link 162 translates proximal linkage 155 within actuation slot 164. Proximal linkage 155 is free to rotate about a pivot during flexure of the working body 154 and actuates proximal blocks 153 to slide longitudinally within channels 151, which are defined through housing 152. A spring or biased element 168 may be positioned within slot 164 to place a biasing force on link 162 and lever 158 such that the assembly maintains a neutral or fixed orientation, if desired. Proximal blocks 153 are connected to actuation rods 157 which may extend distally through distal blocks 159 and further into working body 154. Distal blocks 159 may be pivotally connected to distal linkage 163, which may be pivotally affixed to housing 152 via pivot 166 while allowing distal blocks 159 to translate within channels 151. Tubing members 161 may be configured to allow passage of actuation rods 157 therethrough while remaining connected to distal blocks 159. Although the specific configuration of this variation is shown and described, this is not intended to be limiting and is illustrative of one variation of a handle which allows for single activation and tunable mechanical advantage.
The working body 28, which extends between the handle and the pod assembly located at the distal end of the working body 28, may be comprised of a plurality of links or knuckles generally cylindrical in shape and positioned adjacently to one another, as shown and described above in
Although the transition link 170 is shown to be generally cylindrical in shape, it may alternatively be configured in a variety of shapes, e.g., ovular, elliptical, etc. Transition link 170 may also range in diameter, e.g., 0.75 in. (about 1.90 cm), so long as it is wide enough to accommodate the insertion of fixation assembly 14 therethrough yet small enough to be inserted into the body, e.g., through the esophagus. Link 170 may also range in length, e.g., 1.125 in. (about 2.85 cm), depending upon the desired design characteristics. Moreover, transition link 170 may be made from a variety of materials, e.g., metals, plastics, etc., so long as it is biocompatible. For example, transition link 170 may be made from stainless steel, nickel-titanium alloys, or it may be molded from plastics and thermoplastics, e.g., polycarbonate resins such as Makrolon® (Bayer Aktiengesellschaft, Germany).
A yoke member may be positioned at the terminal end of working body 28 for holding and maintaining pod assembly 16.
The actuation rods for manipulating acquisition assembly 16 may extend through yoke 230 via first and second actuation rod channels 246, 248, which may be seen in the perspective view of yoke 230 in
As mentioned above and as shown in the top view of stapler cartridge/yoke assembly 250 in
To assist in alignment of the stapler assembly 42 to the target tissue, it may be desirable to vary the length of the open region 240. As further shown in
From the distal end of each arm member 232, 234 of yoke member 230, a hinge member may be connected pivotally and extend distally where it may be again pivotally connected to a pod member. An alternative angled hinge member 260 may be seen in
Alternatively, a variation of a yoke/hinge assembly 280 may be utilized, as shown in the top views of
Hinge members 294, 294′ may be actuated to an expanded configuration, as shown in
In another variation, the folder assembly 12 may include a hinge device adapted to actively angle the acquisition assembly 16 in an offset configuration. For example, the acquisition assembly 16 may be actuated to rotate the tensioning member 18 and pod member 20 about respective pivots such that the members 18, 20 may be offset at an angle, α, relative to a longitudinal axis of the working body 28. From this offset configuration, tissue may be approximated and affixed at various angles. Alternatively, members 18, 20 may also be configured to be passively flexed by contact against tissue or via an external device, including any of the tools described above. Furthermore, both members 18, 20 may also be offset at various angles depending upon the desired tissue configuration; moreover, each pod member may be also independently offset at its own angle, again depending upon the tissue configuration. These examples are merely intended to be illustrative and are not intended to be limiting.
A top cover 372 which defines opening 374, as shown in
Turning to
Basket insert 360 may have basket walls 362 forming a mesh-like vacuum chamber 370 with flange 364 surrounding the edges of one open side of insert 360. Each of the basket walls 362 may define a plurality of openings therethrough and the bottom surface of basket walls 362 may also define a plurality of supports 366 positioned in-between openings 368. These supports 366 may be configured to space each of the basket walls 362 away from the walls of vacuum chamber 340, as shown in
Alternatively, rather than utilizing a separate basket insert 360 for placement within vacuum chamber 340, the interior surface of vacuum chamber 340 may be textured, channeled, labyrinthed, or interdigitated to increase the surface area for vacuum adherence in the same manner as basket insert 360. Moreover, mechanical times or teeth may be formed within basket insert 360 or within vacuum chamber 340 to facilitate additional mechanical adherence of tissue within the pod member. Another alternative may utilize a snare-like wire or member positioned within vacuum chamber 340 around opening 374. In such a variation, once tissue has been drawn through opening 374, the snare may be drawn tightly around the adhered tissue.
Moreover, one or both pod members may also incorporate a number of other methods to facilitate tissue movement and/or adherence to the respective pod member. For instance,
Fixation Assembly
The fixation assembly, as mentioned above, may be delivered through the main lumen of the folder assembly for deployment over tissue which has been approximated into a folded configuration. One variation of a stapler which may be used with the folder assembly described herein is described in detail in U.S. Pat. No. 4,610,383 (Rothfuss et al.), which is incorporated herein by reference in its entirety. Another variation of a stapler assembly 390, which is positioned at the distal end of the fixation assembly, is shown in side views in
Detail views of the stapler assembly is shown in
Staples 414 may be deployed through staple apertures 418 defined over the surface of cartridge housing 412 in apposition to staple closure surface 424 of anvil 422. As the staggered wedges 416, 416′ are pulled proximally, each wedge 416, 416′ may engage one or more rows of staples and urge them through staple apertures 418, as shown in
As described above, cartridge housing 412 and/or anvil 422 may be configured to be atraumatic, e.g., blunted, rounded, etc.; however, it may be desirable to serrate or otherwise roughen the outside edges of both or either the cartridge 412 and/or anvil 422 to ensure full tissue capture upon clamping of the two surfaces. A variation of the stapler assembly 410 is shown in
To facilitate the deployment of the staples 414 as wedges 416, 416′ are urged through cartridge housing 412, staple pushers 430 may be utilized. As shown in
As mentioned above, cartridge housing 412 may be manipulated into an open and closed position for clamping over the tissue. To control the closure of cartridge housing 412 against anvil 422, a stapler control handle may be used, as shown in the cross-sectional views of the stapler control in
Slide block 466 may anchor actuation cable 404 thereto via a mechanical anchor 470, e.g., crimps, clamps, adhesives, etc. An upper surface of slide block 466 may comprise rack 468 having a plurality of gear teeth defined thereon. When actuation handle 454 is pulled and actuation linkage 464 is urged proximally, slide block 466 may be forced proximally within travel guide 480, as indicated by arrow 488, to thereby pull actuation cable 404 proximally and thereby force cam 400 to rotate and open the cartridge housing. Simultaneously, while slide block 466 is translated proximally, rack 468 may engage and urge gear 484 to rotate clockwise in the figure, which in turn may force gear 484 to engage and urge rack 474, which is located on a lower surface-of complementary slide block 472, to translate distally within travel guide 478, as indicated by arrow 486.
Complementary slide block 472 may anchor actuation cable 406 thereto via anchor 476 in the same or similar manner as anchor 470. Actuation cable 406 may be attached to anchor 476 with a retention spring 482 optionally interposed between anchor 476 and slide block 472 to take up any excess slack in the cable 406.
The actuation cables 404, 406 as well as staple actuation wires 420 may each be routed through flexible shaft 456, which connects handle 450 to stapler assembly 410. Flexible shaft 456 may be comprised of a tubular member having an outer sheath and an optional inner sheath, either or both of which may be made from any of the polymeric materials described above. The shaft 456 may further utilize braided materials, e.g., superelastic materials such as Nickel-Titanium alloy, integrated throughout to increase column strength and to prevent kinking. Alternatively, shaft 456 may be formed of wire (round or square flat configuration) to enhance compressive and/or tensile strength.
In a further variation, although the tissue approximation device 500 may be configured to be flexible, it may also be desirable to actively or passively curve working body 502 to assist in overall placement of the system within the target organ for optimal presentation of tissue overlap 100 prior to placement of the stapler assembly, as shown in the perspective views of
In addition, as depicted in the detail view of
As mentioned above, optional cap or seal 517 may be placed over a proximal end of the base 506 to seal or cover an opening to the main lumen of the working body.
Once the tissue has been affixed, stapler assembly 410 may be removed from the main lumen of the folder assembly and an endoscopic device may be optionally inserted within the main lumen. The endoscopic device may be outfitted with a visual imaging system, e.g., fiberoptic, CCD, CMOS, etc., to view the tissue region. If necessary, stapler assembly 410, or some other tool, may be subsequently inserted through the main lumen to perform additional aspects of the procedure, or to complete the procedure with the placement of additional fixation elements.
In describing the system and its components, certain terms have been used for understanding, brevity, and clarity. They are primarily used for descriptive purposes and are intended to be used broadly and construed in the same manner. Having now described the invention and its method of use, it should be appreciated that reasonable mechanical and operational equivalents would be apparent to those skilled in this art. Those variations are considered to be within the equivalence of the claims appended to the specification.
Claims
1. A tissue acquisition and fixation system comprising:
- a tissue acquisition device having an elongate main body defining a main lumen therethrough, a distal end of the acquisition device having a tissue adhering member adapted to acquire tissue from within a hollow body organ, and a tissue tensioning member adapted to tension the acquired tissue; and
- a tissue fixation device adapted to be advanced through the main lumen for affixing the acquired tissue.
2. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are in apposition to one another.
3. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are longitudinally positioned relative to one another at a distal end of the main lumen such that the tissue fixation device is stabilized from lateral movement between the at least two opposing members.
4. The system of claim 1 wherein the tissue tensioning member is further adapted to configure the acquired tissue into at least one fold of tissue.
5. The system of claim 1 wherein the tissue fixation device comprises a flexible shaft connected to a cartridge assembly, the flexible shaft having at least one indicator defined thereon for alignment with the tissue acquisition device, wherein a position of the indicator relative to the tissue acquisition device corresponds to a predetermined position of the cartridge assembly relative to the main body.
6. The system of claim 5 wherein the flexible shaft defines at least a second indicator thereon spaced apart relative to the at least one indicator.
7. The system of claim 5 wherein the tissue acquisition device comprises a complementary indicator thereon for corresponding alignment with the at least one indicator, wherein alignment of each indicator is indicative of the cartridge assembly being actuatable.
8. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are each articulatable via a corresponding actuation rod disposed along a length of the main body, wherein each actuation rod is manipulatable via its proximal end.
9. The system of claim 8 wherein each actuation rod further comprises an actuation rod tubing through which each actuation rod is slidably positionable.
10. The system of claim 9 wherein a distal end of each actuation rod tubing is adapted to terminate proximally of a distal end of the actuation rod, wherein each actuation rod tubing is attached near or at a distal end of the main body.
11. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are each individually articulatable from a first delivery configuration to a second expanded configuration.
12. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are simultaneously articulatable from a first delivery configuration to a second expanded configuration.
13. The system of claim 1 wherein the tissue adhering member defines at least one opening adapted to adhere tissue thereto via a vacuum.
14. The system of claim 13 further comprising at least one vacuum tubing positioned along at least a portion of the main body, wherein the vacuum tubing is adapted to maintain fluid communication through the opening.
15. The system of claim 1 further comprising at least one meshed basket positioned within the tissue adhering member.
16. The system of claim 1 further comprising a first hinge member and a second hinge member each pivotally connecting a corresponding tissue adhering and tissue tensioning member to the main body.
17. The system of claim 16 wherein at least one hinge member is angled relative to its corresponding member.
18. The system of claim 1 further comprising a guidewire for positioning the distal end of the tissue acquisition device.
19. The system of claim 1 wherein the tissue acquisition device further comprises an atraumatic distal tip.
20. The system of claim 19 wherein the atraumatic distal tip is tapered.
21. The system of claim 1 wherein the elongate main body of the tissue acquisition device is configured to be curved.
22. The system of claim 21 wherein the elongate main body is actively or passively curved.
23. The system of claim 22 wherein the elongate main body is passively curvable via a curved stylet removably insertable within the main body.
24. The system of claim 22 wherein the elongate main body is actively curvable via a proximally located position control.
25. The system of claim 1 wherein the elongate main body defines at least one bending region.
26. The system of claim 25 wherein the elongate main body is adapted to be uni-directionally curved.
27. The system of claim 25 wherein the elongate main body is adapted to be curved in a plurality of directions.
28. The system of claim 1 further comprising a handle connected to a proximal end of the main body.
29. The system of claim 28 wherein the handle further comprises at least one actuation mechanism adapted to articulate the distal end of the tissue acquisition device.
30. The system of claim 28 wherein the handle further comprises a gasket adapted to prevent fluid communication through an interior of the handle when the tissue fixation device is positioned therethrough.
31. The system of claim 1 wherein the main body is comprised of a plurality of adjacent links through which the main lumen is defined.
32. The system of claim 31 wherein at least a majority of the links are adapted to pivot with respect to the adjacent link.
33. The system of claim 1 wherein the tissue fixation device comprises a handle connected to a cartridge assembly via a flexible shaft.
34. The system of claim 33 wherein the handle is adapted to articulate the cartridge assembly from a clamped configuration to an open configuration.
35. The system of claim 33 wherein the handle is further adapted to deploy a plurality of staples from the cartridge assembly.
36. The system of claim 33 wherein the cartridge assembly comprises a stapler housing and an anvil in apposition to the stapler housing.
37. The system of claim 36 wherein the stapler housing is adapted to rotate about a pivot relative to the anvil from a clamped configuration to an open configuration.
38. The system of claim 36 further comprising a plurality of staples positionable within the stapler housing.
39. The system of claim 1 wherein the tissue fixation device is adapted to maintain a fixed orientation relative to the main lumen.
40. A method of acquiring and affixing tissue from within a hollow body organ, comprising:
- acquiring at least one region of tissue from within the hollow body organ via a tissue adhering member;
- articulating the tissue adhering member such that the acquired tissue is approximated through a tissue tensioning member to form a folded region of tissue between the tissue adhering member and tissue tensioning member; and
- affixing the folded region of tissue via a cartridge assembly.
41. The method of claim 40 further comprising advancing the cartridge assembly through a main lumen of an elongate main body while maintaining the cartridge assembly at a predetermined orientation relative to the main lumen prior to affixing the folded region of tissue.
42. The method of claim 40 further comprising advancing the tissue adhering member transorally prior to acquiring the at least one region of tissue.
43. The method of claim 40 further comprising advancing the tissue adhering member percutaneously prior to acquiring the at least one region of tissue.
44. The method of claim 40 wherein acquiring the at least one region of tissue comprises adhering the tissue to the tissue adhering member via a vacuum.
45. The method of claim 40 wherein articulating the tissue adhering member comprises articulating the tissue adhering member and the tissue tensioning member relative to one another such that acquired tissue is approximated between each member to create the folded region of tissue.
46. The method of claim 45 wherein each member is articulated simultaneously.
47. The method of claim 45 wherein each member is articulated sequentially.
48. The method of claim 40 further comprising laterally stabilizing the cartridge assembly via a yoke member positioned proximally of the tissue adhering member prior to affixing the folded region of tissue.
49. The method of claim 40 wherein affixing the folded region of tissue comprises deploying a plurality of staples from the cartridge assembly into the folded region of tissue.
50. The method of claim 40 further comprising removing the cartridge assembly and inspecting the folded region of tissue via an endoscopic imaging device positioned adjacent to the folded region of tissue.
51. The method of claim 40 further comprising removing the cartridge assembly and inspecting the folded region of tissue prior to affixing the folded region of tissue.
52. The method of claim 40 further comprising removing the tissue adhering member and tissue tensioning member from the region of tissue.
Type: Application
Filed: Feb 5, 2004
Publication Date: Aug 11, 2005
Inventors: Craig Gerbi (Mountain View, CA), Gary Weller (Los Gatos, CA), Jamy Gannoe (Redwood City, CA), Douglas Sutton (Pacifica, CA), Andrew Hancock (Fremont, CA), Gilbert Mata (Tracy, CA)
Application Number: 10/773,883