US 20080190989 A1
In a method of stapling layers of tissue within a body cavity, an engaging instrument is passed between a stapler cartridge and anvil and used to engage a region of tissue. The engaging instrument is retracted to move the engaged tissue into the stapling position, and driving staples from the cartridge through at least two layers of the engaged tissue. The method and associated system may be used to form plications in body tissue, such as stomach wall tissue. Staples simultaneously driven through tissue may simultaneously capture a reinforcing elements positioned adjacent the cartridge and/or anvil prior to stapling.
1. A method of stapling layers of tissue within a body cavity, comprising the steps of:
positioning a stapler having a cartridge, an anvil and a stapling position between the cartridge and anvil, within the body cavity;
passing an engaging instrument through the stapling position and engaging the region of tissue using the engaging instrument;
retracting the engaging instrument to move the engaged tissue into the stapling position; and
driving staples from the cartridge through at least two layers of the engaged tissue.
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17. A stapling system, including:
a stapler head on a first elongate shaft, the stapler head having a cartridge containing staples and an anvil; and
an engaging instrument on a second elongate shaft, the engaging instrument advanceable in a first direction from a first position on a first side of the stapler head, between the cartridge and anvil, to a second position on a second side of the stapler head and into engagement with tissue on the second side, the engaging instrument retractable in a second direction from the second position to retract engaged tissue to a stapling position between the cartridge an anvil.
18. The stapling system including:
a main shaft having a distal portion, wherein the first elongate shaft forms a first branch of the distal portion and the second elongate shaft forms a second branch of the distal portion.
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29. A method of reinforcing an array of staples delivered to tissue, the method comprising;
providing a staple reinforcement comprising a framework having at least one member and at least one opening;
positioning the staple reinforcement adjacent to a anvil or cartridge of a stapler;
positioning body tissue between the cartridge and anvil;
simultaneously driving a plurality of staples from the cartridge, causing legs of the staples to fold around the member.
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This application claims the benefit of U.S. Provisional Application No. 60/825,534, filed Sep. 13, 2006. This application is also a continuation-in-part of U.S. application Ser. No. 11/542,457, filed Oct. 3, 2006, which claims the benefit of U.S. Provisional Application No. 60/723,160, filed Oct. 3, 2005; U.S. Provisional Application No. 60/754,417, filed Dec. 28, 2005; and U.S. Provisional Application No. 60/825,534, filed Sep. 13, 2006.
The present invention relates generally to the field of systems and methods for performing endoscopic surgery, and specifically to systems and methods for endoscopic plication of tissue within body cavities.
An anatomical view of a human stomach S and associated features is shown in
Stomach S includes a fundus F at its proximal end and an antrum A at its distal end. Antrum A feeds into the pylorus P which attaches to the duodenum D, the proximal region of the small intestine. Within the pylorus P is a sphincter that prevents backflow of food from the duodenum D into the stomach. The middle region of the small intestine, positioned distally of the duodenum D, is the jejunum J.
Prior applications, including Attorney Docket No. BARO-720PCT, WO 2005/037152 (incorporated herein by reference in its entirety) describe methods according to which medical implants are coupled to tissue structures formed within the stomach. According to these applications, devices for inducing weight loss (e.g. by restricting and/or obstructing flow of food into the stomach, and/or by occupying a portion of the stomach volume) may be coupled to tissue tunnels or plications P (
For example, U.S. application Ser. No. 11/439,461, Filed May 23, 2006, Attorney Docket BARO 910 (incorporated herein by reference in its entirety), describes a Restrictive and/Or Obstructive Implant System for Inducing Weight Loss. In one embodiment, flexible loops 2 (
U.S. application Ser. No. 11/542,457, filed Oct. 3, 2006 (Attorney Docket No. BARO-1110) discloses other implants, including a restrictive pouch having anchors extending from its outer surface. During implantation, the anchors are inserted to cutouts/holes formed in plicated tissue.
In other instances, tissue plications may themselves be sufficient to provide the necessary treatment. For example, the plications may be used to reduce stomach volume or form a flow restriction within the stomach. Two or more plications may be drawn together and retained in some way, such as to form a restriction and/or reduce stomach volume, as also described in U.S. application Ser. No. 11/542,457, filed Oct. 3, 2006.
Other types of implants may be coupled to such plications or other tissue structures for a variety of purposes. These implants include, but are not limited to gastric space occupiers, prosthetic valves for the treatment of gastro-esophageal reflux disease, gastric stimulators, pH monitors and drug eluting devices that release drugs, biologics or cells into the stomach or elsewhere in the GI tract. Such drug eluting devices might include those which release leptin (a hormone which creates feelings of satiety), Ghrelin (a hormone which creates feelings of hunger), octreotide (which reduces Ghrelin levels and thus reduces hunger), Insulin, chemotherapeutic agents, natural biologics (e.g. growth factor, cytokines) which aid in post surgery trauma, ulcers, lacerations etc. Still other implants might be of a type which might provide a platform to which specific cell types can adhere, grow and provide biologically-active gene products to the GI tract, and/or a platform for radiation sources that can provide a local source of radiation for therapeutic purposes, or provide a platform whereby diagnostic ligands are immobilized and used to sample the GI tract for evidence of specific normal or pathological conditions, or provide an anchor point for imaging the GI tract via cameras and other image collecting devices.
Prior applications listed above address the desirability of forming tissue plications, pockets or tunnels in a way that regions of serosal tissue (i.e. the tissue on the exterior surface of the stomach) are retained in contact with one another. Over time, adhesions formed between the opposed serosal layers create strong bonds that can maintain the plication over extended durations, despite the forces imparted on them by abdominal movement and implanted devices. More durable plications can be created by placing any of a number of materials and/or substances (e.g. injectable sclerosing agents) between the serosal surfaces prior to plicating the serosal surfaces together. One example of material suitable for this purpose is polypropolyene mesh, commonly used for hernia repair, which when inserted in the plication fold provides a durable anchoring position within the GI tract.
Regardless of the application for which a plication is being formed, it is highly desirable to form that plication using steps carried out from within the stomach using instruments passed down the esophagus, rather than using more invasive surgical or laparoscopic methods.
The present application describes endoscopic plicators which may be passed transorally into the stomach and used to plicate stomach tissue by engaging tissue from inside of the stomach and drawing it inwardly. A section of stomach wall tissue drawn inwardly will be referred herein as a “pinch” of tissue, although it may be drawn inwardly using suction or other means. In preferred embodiments, a retracting component draws tissue into the path of travel of a stapler head. Vacuum and/or mechanical retractors may be used for retraction. By drawing a portion of the stomach wall between the stapler head and anvil, the retracting component causes sections of serosal tissue on the exterior of the stomach to be positioned facing one another. The disclosed plicators deliver staples to secure the opposed sections of tissue to one another, but instead may deliver sutures or other means for maintaining contact between the tissue sections at least until serosal bonds form between them. The plicator may pass a mesh element and/or sclerosing agent through the stomach wall into position between the opposed regions of serosal tissue thus enhancing serosal bonding. Each of these steps may be performed wholly from the inside of the stomach and thus can eliminate the need for any surgical or laparoscopic intervention. Medical devices may then be attached to the anchor for retention within the stomach.
While this application describes plication systems and methods with respect to the formation of plications in stomach tissue, the embodiments described herein have equal applicability for forming plications in parts of the body within or outside the GI system.
Generally speaking, system 10 includes a main shaft 11 having a distal portion extendable through the esophagus into the stomach. The distal portion of the main shaft 11 includes a retracting component 12 and a stapling component 13 comprised of an anvil 40 and a staple head 42. During use of the system 10, the retracting component 12 is used to engage stomach wall tissue and draw the tissue into a position between the anvil 40 and staple head 42, allowing staples to be driven through the stomach wall tissue to form a plication. By drawing a “pinch” of the stomach wall inwardly and then stapling the tissue, regions of serosal tissue are stapled to one another. Over time, these serosal tissue layers will adhere to form relatively strong bonds giving the plications sufficient durability to support implants within the stomach.
Retracting component 12 is provided with a vacuum head 14 and a flexible tube 16. Tube 16 preferably includes an insertion configuration in which it extends approximately longitudinally relative to the main shaft 11 for streamlined advancement of the tube 16 through the esophagus. Tube 16 is equipped with pull-wires (not shown) and/or alternative means for articulating or retroflexing the vacuum head 14 as needed for proper positioning within the stomach.
Vacuum head 14 defines a vacuum chamber 18 having an opening that, during use, is positioned into contact with stomach tissue so as to draw the tissue into the chamber 18. Vacuum chamber is preferably formed of a flexible material such as silicone, urethane or other suitable materials. Tube 16 is fluidly coupled to a source of negative pressure such as a syringe or vacuum pump such that application of suction to the tube 16 creates a vacuum in the vacuum chamber.
A hollow needle 20 is advanceable through the tube 16 into the vacuum chamber 18. Hollow needle 20 includes a pointed distal tip sufficiently sharp to penetrate stomach wall tissue (
Various types of engaging elements may be used for this purpose. In the embodiment shown in
As mentioned previously, stapling component 13 includes an anvil 40 and a stapler head 42. Although
The stapling component 13 is pivotable relative to the main shaft 11 so that once the stapling component 13 is positioned within the stomach, it may be moved laterally towards the stomach wall. In the
As best shown in
Once tissue is compressed between the cartridge 44 and anvil 40, fluid/gas is then directed through fluid line 58 b to pressurize cylinder 48 sufficiently to drive the staple driver 46 into contact with staples positioned in the staple cartridge 44. A tissue cutting element 50, which in the illustrated embodiment is a tubular element having a sharpened end, is coupled to the staple driver 46 such that it will core through the tissue during stapling to form a hole in the plication.
System 110 of
System 111 of
Vacuum chamber 18 a may be foldable or compressible for positioning within the sheath 89.
The FIG. 8/9 vacuum chamber 18 a additionally includes stabilizing arms 94 extending into the vacuum chamber 18 a. The stabilizing arms are retained in contact with the interior walls of the chamber 18 a to prevent the chamber from collapsing when vacuum is applied. The arms may be moveable between closed and opened positions to allow the vacuum chamber to collapse for passage through the esophagus, or they may remain fixed in the opened position.
Reinforcements of various types may be implanted in or on plications formed using the plication system. Such reinforcements may function to reinforce the staple array, help to more evenly distribute the forces applied to the tissue by the staples, and/or facilitate bonding between the opposed serosal layers. Suitable reinforcements include ones positionable on or between the serosal tissue layers (“serosal side reinforcements”), as well as those delivered on the side of the mucosal tissue (“mucosal side reinforcements”).
For serosal side reinforcements, a reinforcement similar to engaging element 22 a described in connection with
As shown in
In another embodiment shown in
In another embodiment shown in
Mucosal side reinforcements may take the form of reinforcements that are positioned on or adjacent to one or both of the mucosal surfaces lining the “pinch” of tissue that will form the plication. These reinforcements may be features of the staples or staple arrays, or they may be separate components engaged by staples as the staples are advanced through the tissue.
In alternative embodiments, staples are linked together by reinforcing members formed of metallic or polymeric materials, such as nitinol, titanium, stainless steel PEEK, or other biocompatible materials. According to these embodiments, the reinforcing members are positioned on one or both of the mucosal sides of the “pinch” of tissue engaged by the plication system such that they are captured by staples being driven through the tissue. In a preferred embodiment, the staples capture a cartridge side reinforcing ring 72 (
The reinforcing rings are preferably provided separate from the staples although they instead may be integral with the staples. In this embodiment, ring 74 is positioned against the staple anvil 40 as shown in
When staples 70 are driven from the cartridge, they advance further through openings 73, capturing ring 72 against the adjacent mucosal tissue as shown in
Rings 72, 74 are shown as generally circular, although alternative reinforcements of different shapes and patterns may also be used, including those shaped to accommodate linear, oval and other staple patterns.
The disclosed reinforcements may be sold as individual components that may be used together with commercially available staplers to reinforce the lines/rings of staples to be delivered by those staplers.
One method of using the illustrated system will next be described with reference primarily to
In preparation for use, the orientation of the staple head 42 and the vacuum chamber 18 a are adjusted using the appropriate pullwires to place them in their longitudinal positions.
Next, the assembled plicator 10 a is passed into the stomach S via the esophagus, preferably through a protective sheath passed through the esophagus. Endoscope 98 is also passed into the stomach to provide visualization of the procedure. The endoscope is preferably mounted to plicator 10 a, or it may be a separate component.
The plicator 10 a is advanced towards a target location at which a plication is to be formed. The rigidizable cable 86 is manipulated using pull wires to extend vacuum chamber 18 a between the fluid lines 58 a, 58 b and against adjacent stomach tissue. Suction is applied to the vacuum chamber 18 to draw stomach tissue into the vacuum chamber. The gripper arms 90 are closed to pinch the tissue within the chamber, and the vacuum chamber 18 a is withdrawn from between the fluid lines 58 a, 58 b, carrying the engaged tissue with it (see
If additional stabilization of the tissue is desired, such as during use of the
Referring again to
The procedure may be repeated to form multiple plications if needed. Following formation of the plication(s), a medical implant may be coupled to the hole/incision formed by the hollow needle 20. Coupling may be carried during the course of the same procedure or during a later procedure scheduled to permit sufficient formation of adhesions between the serosal tissue layers 102 to support the implant.
The system or other components described herein may be packaged with instructions for use instructing a user to utilize the system according to methods disclosed herein.
As is evident from above, the disclosed endoscopic systems function to draw a tissue into the stomach to form a depression on the exterior surface of the stomach, and staple (or suture, or fasten or adhere etc) the opposed stomach wall sections lining the depression together another to form a plication. The system may additionally place material of a type that will promote strong tissue adhesion within the depression (on the exterior of the stomach) and retain the material between the serosal surfaces to enhance. Additionally or alternatively, mucosal reinforcements such as structures that interconnect the staples may be implanted. While these systems provide convenient embodiments for carrying out this function, there are many other widely varying instruments or systems may alternatively be used within the scope of the present invention. Moreover, the disclosed embodiments may be combined with one another in varying ways to produce additional embodiments. Thus, the embodiments described herein should be treated as representative examples of systems useful for forming endoscopic tissue plications, and should not be used to limit the scope of the claimed invention.
Any and all patents, patent applications and printed publications referred to above, including those relied upon for purposes of priority, are incorporated herein by reference.