Patent Application
20080140099
The present invention relates to surgical devices, and in particular to devices and methods for transgastric surgery.
Transgastric surgery is one type of minimally invasive surgery in which a surgeon can access the stomach via natural openings (e.g., mouth, anus) of the body and through the peritoneal lining of the abdominal cavity. In particular, once within the stomach, the surgeon can form an opening through the stomach wall to access the abdominal cavity. The surgeon can then use this opening to perform a variety of surgical procedures on organs located in the abdominal cavity.
A variety of techniques can be used to form an opening in the stomach wall. Typically, the patient's stomach is insufflated prior to accessing and forming the opening through the stomach wall. This causes the vital organs within the peritoneal cavity to move away from the stomach wall. As a result, the surgeon can puncture the wall of the stomach without the risk of injury to the organs within the peritoneal cavity. In some instances, where more time is needed to puncture the stomach wall, it will be necessary to inflate the stomach for a longer period of time. The longer the stomach is inflated, the greater the risk that fluid and air will escape through the pyloric valve and into the intestines. This can cause the intestines to inflate and fill the peritoneal cavity, thus hindering visualization and operability during the procedure.
Accordingly, there remains a need for improved devices and methods for transgastric surgery.
The present invention provides devices and methods for transgastric surgery. In one aspect, a surgical device includes an elongate member having a proximal end, a distal end, and an inner lumen extending through at least a portion thereof that is adapted to receive a fluid flow therethrough. A selectively expandable member is coupled to the distal end of the elongate member and is adapted to receive fluid from the elongate member. A mesh is disposed around at least a portion of the expandable member. The mesh has a pre-shaped configuration, and at least a portion of the mesh is adapted to be operatively positioned to occlude a portion of a hollow organ. In one embodiment, the expandable member is fully contained within the mesh such that the expandable member conforms to the pre-shaped configuration of the mesh when the expandable member is expanded.
The expandable member can have a variety of configurations, and in one embodiment it is annularly shaped. In other embodiments, it can be a balloon-like. The expandable member can also have a central opening formed therein, and a slit can be formed within a wall of the central opening that is configured to deliver fluid to the expandable member.
A variety of techniques can be used to deliver fluid to the expandable member, and in one embodiment, the elongate member can be disposed within at least a portion of the central opening of the expandable member. The elongate member can have an inner lumen with an outlet, and this outlet can be aligned with the slit formed in the central opening of such that fluid can flow from the elongate member to the expandable member. In one embodiment, a valve can be disposed between the outlet and an inlet of the expandable member to maintain the fluid within the expandable member. While the valve can have a variety of configurations, the valve can be a one-way valve.
The expandable member can also be frangibly coupled to the distal end of the elongate member such that it can break away from the elongate member and remain in the tissue. In one embodiment, the elongate member includes a break point that is proximal to the expandable member that enables the expandable member to be frangibly coupled to the elongate member.
In another aspect, a kit for transgastric surgery is provided that includes an insertion member having at least one delivery channel extending therethrough. The insertion member is configured to be delivered translumenally to a surgical site within a patient. The kit also includes an elongate member configured to be removably disposed within the delivery channel. The elongate member has proximal and distal ends and a fluid-conveying lumen that extends through at least a portion thereof. Additionally, an anchoring member is coupled to the distal end of the elongate member and includes an expandable member contained within a mesh. In one embodiment, the expandable member can be fully contained within the mesh such that the expandable member conforms to a pre-shaped configuration of the mesh when the expandable member is expanded.
The anchoring member can have a variety of configurations. In one embodiment, at least a portion of the member has a configuration such that it is adapted to occlude a portion of a hollow organ when it is in an expanded position. By way of non-limiting example, the mesh can have an enlarged proximal portion and a narrowed distal portion. The insertion member can also have a variety of configurations, however in one embodiment, it can be an endoscope.
In another aspect, a method for transgastric surgery is provided that includes positioning a portion of an anchor assembly located on a distal end of an elongate member within an opening of a pyloric valve of a patient's stomach. The method also includes expanding an expandable member of the anchor assembly such that a mesh disposed around the expandable member engages and anchors the expandable member within the opening of the pyloric valve. This can temporarily block fluid flow from the stomach through the pyloric valve. The method can also include, prior to positioning, inserting the elongate member through an insertion member extending through a body lumen to position the anchor assembly within the stomach.
In one embodiment, the method can include partially inflating the expandable member to a diameter that is substantially equal to a diameter of the pyloric valve, pushing a portion of the expandable member into the pyloric valve, and inflating the expandable member such that the mesh disposed around the expandable member engages and anchors the expandable member within the pyloric valve to block fluid flow from the stomach to the pyloric valve.
The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
The present invention generally provides devices and methods for occluding fluid (i.e., liquid or gas) flow from a hollow organ. In one embodiment, the device includes an elongate member having an anchoring assembly formed on a distal end thereof. The anchoring assembly can include an expandable member that is surrounded by a pre-formed mesh. In use, the device can be positioned within a hollow organ and the expandable member can be inflated such that it expands to the configuration of the pre-formed mesh and blocks an opening of the hollow organ. The anchoring assembly can optionally be severed from the elongate member, such that it can remain in place throughout the surgical procedure. Following completion of the surgical procedure, the expandable member can be deflated and the anchoring assembly removed from the organ. While the exemplary embodiment illustrates the device being used in the context of trans-gastric surgeries, such as for occluding the pyloric valve during insufflation of the stomach, one skilled in the art will appreciate that the device can be used with a variety of surgical procedures to occlude a variety of valves and hollow organs within a human body. One skilled in the art will also appreciate that the present invention has applications in conventional endoscopic and open surgical instrumentation as well applications in robotic-assisted surgery.
The elongate member 12 can have virtually any configuration that allows it to be laparoscopically or endoscopically inserted to a surgical site. The member 12 can be substantially cylindrical and sufficiently strong, yet flexible enough to bend during insertion through a tortuous lumen. In one embodiment, the elongate member 12 is preferably substantially solid to provide structural support, but can include a lumen 20 formed therein and extending therethrough, as will be discussed in more detail below. In one embodiment, the proximal end 12a of the elongate member 12 can be adapted to couple to a fluid delivery device, as is known in the art. Alternatively or additionally, the member 12 can include markings (not shown) formed thereon to facilitate positioning the device 10 within a hollow organ. While the member 12 can have a variety of sizes, the size of the member 12 generally depends upon the desired application of the device 10. In an exemplary embodiment, where the device 10 is used during trans-gastric surgeries, the member 12 can have a diameter in the range of about 2.8 mm to 4.0 mm.
As noted above, a lumen 20 can extend through the elongate member 12. The lumen 20 can have a variety of shapes and sizes, but in an exemplary embodiment it has a diameter that is significantly smaller than a diameter of the elongate member 12 so as not to interfere with the structural integrity thereof. The lumen 20 can also extend fully or only partially between the proximal and distal ends 12a, 12b of the elongate member 12 so that a fluid can be delivered to the expandable member 16, as will be discussed in more detail below.
The elongate member 12 can also optionally be adapted to separate from the anchoring assembly 14 upon the slight application of force. While a variety of techniques can be used to effect separation of the device 10, in one embodiment, the anchoring assembly 14 is frangibly coupled to the elongate member 12. For example, as shown in
As noted above, an anchoring assembly 14 is formed on the distal end 12b of the elongate member 12. The anchoring member 14 includes an expandable member 16 having a mesh 18 that is disposed around at least a portion thereof. FIGS. 1C and 3-4 illustrate the expandable member 16 in more detail. While the expandable member 16 can have a variety of configurations, it is generally adapted to selectively expand upon the receipt of fluid. As shown, the expandable member 16 is annularly shaped, however it can have other shapes, such as an oblong shape, to allow the expandable member 16 to match the opening in an organ when it is in the expanded position. One skilled in the art will appreciate that the expandable member 16 can be formed from any material that is biocompatible and able to be expanded. Exemplary materials include silicone or polyurethane.
The expandable member 16 can have a variety of features that facilitate the selective expansion thereof. In one embodiment and as shown in
The expandable member 16 can also include features that can prevent the unintentional exit of fluid from the slit 36, resulting in the unintentional deflation of the expandable member 16. In one embodiment, a valve 22 can be positioned between the elongate member 12 and the wall 35 that forms the central opening 34, as discussed in more detail below. A variety of valves can be used, and in one embodiment, the valve is a one-way valve.
As noted above, at least a portion of the elongate member 12 is received within the central opening 34 to effect the delivery of fluid into the expandable member 16. The elongate member 12 can be secured within the central opening 34 using a variety of techniques, however in an exemplary embodiment an adhesive is used to enhance the connection. As shown in
As noted above, a mesh 18 can surround at least a portion of the expandable member 16.
The mesh 18 can also be adapted to provide traction to the anchoring assembly 14 such that it can remain in a desired position in the hollow organ. For example, the mesh 18 can be formed in a pattern that is adapted to engage with tissue, such as interlocking circles, a cross-hatched pattern, a helical pattern, etc. One skilled in the art will appreciate that the mesh can be formed a variety of biocompatible materials, such as polyethylene and polyester.
As previously indicated, the device 10 can be used to perform a variety of medical procedures. In an exemplary embodiment, however, the device 10 can be used to temporarily obstruct the pyloric valve prior to inflating the stomach of a patient during trans-gastric surgery. Following preparation of the patient as known in the art, the device 10 can be inserted into a natural or created orifice to a target site. As noted above, the device 10 is typically inserted in the delivery configuration shown in
Once the distal end of the insertion member 60 is positioned within the stomach 52, a fluid can be delivered through the inner lumen 20 of the elongate member 12. A variety of biocompatible fluids can be used to inflate the expandable member 16, such as saline or air. The fluid then exits the opening 24 in the lumen 20, and passes through the slit 36 and the valve 22. This causes the expandable member 16 to expand. While the expandable member 16 can be expanded to a variety of diameters, in one embodiment, the expandable member 16 can be initially expanded to a diameter equal to or slightly less than that of the pyloric valve 54, e.g., in the range of about 1.0 cm to 2.0 cm. The expandable member 16 can subsequently be expanded again to a larger diameter such that it occludes the pyloric valve 54, as will be discussed in more detail below.
After the initial expansion of the expandable member 16, the insertion member 60 can be used to push the anchoring assembly 14 into the pyloric valve 54, or even a distance beyond it, to ensure complete obstruction, as shown in
After the anchoring assembly 14 is operatively positioned and inflated, it can optionally be separated from the elongate member 12 at the frangible breaking point 28. Any endoscopic cutting device can be used to sever the elongate member 12 from the anchoring assembly 14, such as a grasper, etc. or a force can be applied to the elongate member 12 to pull the elongate member 12 apart from the anchoring assembly 14. As a result of separation, and as shown in
After the surgical procedure is completed, the expandable member 16 can be deflated so that can be removed from the pyloric valve 54. In an exemplary embodiment, the expandable member 16 is deflated by puncturing it with any type of device that is pointed or able to perforate the expandable member 16. Once at least some of the fluid is drained from within the expandable member 16, the anchoring assembly 14 can be removed from the pyloric valve 54 and pulled back through an accessory channel of the insertion member 60 using, for example, any type of endoscopic grasper.
While the exemplary method illustrates a technique where the expandable member is inflated both during and after placement in the hollow organ, one skilled in the art will appreciate that in alternate methods the expandable member can be inflated only after placement in the hollow organ.
One skilled in the art will appreciate that the system and the device described herein can be processed before surgery. First, a new or used device and/or insertion member is obtained and if necessary cleaned. The device and/or the insertion member can then be sterilized. In one sterilization technique, the device can be placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and the device are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in the sterile container, and the sealed container keeps the device sterile until it is opened in the medical facility. A similar technique can be used to sterilize the insertion member. In other embodiments, the device and/or the insertion member can be sterilized using any other technique that is known in the art, such as beta or gamma radiation, ethylene oxide, steam, etc.
One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
