|Publication number||US20060149316 A1|
|Application number||US 11/347,249|
|Publication date||Jul 6, 2006|
|Filing date||Feb 6, 2006|
|Priority date||Dec 31, 2003|
|Also published as||EP1706043A2, EP1706043B1, US20050149072, US20120004505, WO2005065552A2, WO2005065552A3|
|Publication number||11347249, 347249, US 2006/0149316 A1, US 2006/149316 A1, US 20060149316 A1, US 20060149316A1, US 2006149316 A1, US 2006149316A1, US-A1-20060149316, US-A1-2006149316, US2006/0149316A1, US2006/149316A1, US20060149316 A1, US20060149316A1, US2006149316 A1, US2006149316A1|
|Inventors||Robert DeVries, Roy Sullivan, Marc Tassy, Kristian DiMatteo, Tak Kwan, William Shaw|
|Original Assignee||Boston Scientific Scimed, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (23), Referenced by (31), Classifications (30), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to endoscopic devices and related methods. In particular, the present invention relates to endoscopic devices and methods used in, for example, a tissue invagination procedure for treatment of Gastroesophageal Reflux Disease (GERD).
Gastroesophageal reflux occurs when stomach acid enters the esophagus. This reflux of acid into the esophagus occurs naturally in healthy individuals, but also may become a pathological condition in others. Effects from gastroesophageal reflux range from mild to severe. Mild effects include heartburn, a burning sensation experienced behind the breastbone. More severe effects include a variety of complications, such as esophageal erosion, esophageal ulcers, esophageal stricture, abnormal epithelium (e.g., Barrett's esophagus), and/or pulmonary aspiration. These various clinical conditions and changes in tissue structure that result from reflux of stomach acid into the esophagus are referred to generally as Gastroesophageal Reflux Disease (GERD).
Many mechanisms contribute to prevent gastroesophageal reflux in healthy individuals. One such mechanism is the functioning of the lower esophageal sphincter (LES). With reference to
The physical interaction occurring between the gastric fundus 5 and the esophagus 3 also prevents gastroesophageal reflux. The gastric fundus 5 is a lobe of the stomach situated at the top of the stomach 7 distal to the esophagus 3. In asymptomatic individuals, the fundus 5 presses against the opening of the esophagus 3 when the stomach 7 is full of food and/or gas. This effectively closes off the esophageal opening to the stomach 7 and helps to prevent acid reflux back into the esophagus 3. More specifically, as the food bolus is immersed in gastric acid, it releases gas which causes the fundus 5 of the stomach 7 to expand and thereby exert pressure on the distal esophagus 3 causing it to collapse. The collapse of the esophagus lumen reduces the space for the stomach acid to splash past the closed esophagus lumen and thereby protect the proximal esophagus from its destructive contact
In individuals with GERD, the LES 2 functions abnormally, either due to an increase in transient LES relaxations, decreased muscle tone of the LES 2 during resting, or an inability of the esophageal tissue to resist injury or repair itself after injury. These conditions often are exacerbated by overeating, intake of caffeine, chocolate or fatty foods, smoking, and/or hiatal hernia. Avoiding these exacerbating mechanisms helps curb the negative side effects associated with GERD, but does not change the underlying disease mechanism.
A surgical procedure, known generally as fundoplication, has been developed to prevent acid reflux in patients whose normal LES functioning has been impaired, either as a result of GERD or other adverse effects. This procedure involves bringing the fundus wall 6 into closer proximity of the esophageal wall 4 to help close off the esophageal opening into the stomach 7, as shown in
As with any surgery, the attendant risks are great. Due to relatively large incisions necessary in the performance of open surgery, relatively large amount of blood is lost, the risk of infection increases, and the potential for post-operative hernias is high. Further, the relatively large incisions necessary in the performance of open surgery require extended recovery times for the incision to heal.
A laparoscopic procedure may involve performing laparotomies for trocar ports (penetrations of the abdominal wall), percutaneous endoscopic gastronomies (incisions through the skin into the stomach), and the installation of ports through which, for example, a stapler, an endoscope, and an esophageal manipulator (invagination device) are inserted. Under view of the endoscope, an a esophageal manipulator is used to pull the interior of the esophagus 3 into the stomach 7. When the esophagus is in position, with the fundus 5 of the stomach plicated, the stapler is moved into position around the lower end of the esophagus and the plicated fundus is stapled to the esophagus 3. The process may be repeated at different axial and rotary positions until the desired fundoplication is achieved. This procedure is still relatively invasive requiring incisions through the stomach, which has a risk of infection. The location of the incision in the abdominal wall presents a risk of other negative effects, such as sepsis, which can be caused by leakage of septic fluid contained in the stomach.
Therefore, it is accordingly an object of the present invention to provide less invasive devices and methods for performing the fundoplication procedure. This is achieved by using an invagination device which can be endoluminally delivered through the esophagus, thereby eliminating the need for highly invasive, physiologically insulting surgical procedures.
To attain the advantages and in accordance with the purpose of the invention, as embodied and broadly described herein, one aspect of the invention provides a surgical device for holding esophageal tissue during a fundoplication procedure. The device includes a proximal member having a vacuum port connectable to a source of vacuum, a substantially flexible conduit having a proximal end connected to the proximal member and a lumen in fluid communication with the source of vacuum, and a distal member connected to a distal end of the conduit and configured to hold the esophageal tissue when suction is supplied to the vacuum port from the source of vacuum.
Another aspect of the present invention is to provide a surgical device for invaginating esophageal tissue of a body. The device includes, an elongated tube having a proximal end configured to extend outside of the body and a distal end configured to extend proximate the esophageal tissue of the body, and a distal member coupled to the distal end of the tube. The distal member further includes a friction member for frictionally engaging the esophageal tissue.
In yet another aspect of the present invention, a surgical device for invaginating tissue of a first organ into a second organ in a body is provided. The device includes an elongated tube having a proximal end configured to extend outside of the body and a distal end configured to extend proximate the tissue of the first organ, and a distal member coupled to the distal end of the tube and configured to extend beyond the tissue to be invaginated and into the second organ. The distal member further includes an expandable portion for applying a force to tissue of the second organ and thereby invaginate the tissue of the first organ into the second organ.
In still another aspect of the present invention, a device for displacing tissue of a body is provided. The device includes an elongated tube having a proximal end configured to extend outside of the body and a distal end configured to extend proximate the tissue, and a distal member coupled to the distal end of the tube and having at least one rotating member. The rotating member is configured to contact the tissue layer and displace the tissue in the rotating direction.
In still another aspect of the present invention, a surgical device for displacing tissue of a body is provided. The device includes an elongated tube having a proximal end configured to extend outside of the body and a distal end configured to extend proximate the tissue, and a distal member coupled to the distal end of the tube and having a rotatable arm configured to rotate relative to the axis of the tube. At least one end of the rotatable arm is configured to contact the tissue when the rotatable arm rotates relative to the axis of the tube.
In still another aspect of the present invention, a device for grasping tissue of a body is provided. The device includes an elongated tube having a proximal end configured to extend outside of the body and a distal end configured to extend proximate the tissue, and a distal member coupled to the distal end of the tube and having a plurality of legs each configured to extend radially outwardly in an expanded state and engage the tissue.
In still another aspect of the present invention, a surgical device for grasping esophageal tissue of a body is provided. The device includes a flexible elongated tube having a proximal end configured to extend outside of the body and a distal end configured to extend proximate the esophageal tissue of the body, and a distal member coupled to the distal end of the tube and having at least one forceps to grasp the esophageal tissue.
In still another aspect of the present invention, a method of invaginating tissue toward an organ having an opening is provided. The method includes inserting an elongated tubular member into a body passage so that a distal end of the tubular member is proximate the tissue, contacting the tissue with the a distal end, and displacing the tissue toward the opening of the organ by displacing the distal end of the member.
In another aspect of the present invention, a device to cover a distal end of an endoscopic instrument includes a distal tube having a lumen sized to receive an endoscope, an inflatable member coupled to the distal tube, a sleeve configured to cover the distal end of the endoscopic instrument, the inflatable member covering a distal end of the sleeve, and a tube having an inflation lumen in fluid communication with the inflatable member.
In another aspect of the present invention, a method of inserting an endoscopic instrument into a tissue tract of a patient includes placing a protective device over a distal end of the endoscopic instrument, the protective device including a sleeve to cover the distal end of the endoscopic instrument and an inflatable member covering a distal end of the sleeve, inflating the inflatable member, and inserting the endoscopic instrument into the tissue tract of the patient with the inflatable member inflated.
Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description, serve to explain the principles of the invention.
In the drawings:
FIGS. 8A-B and 9A-B are schematic illustrations of various assembly stages of a jaw assembly, according to an embodiment of the present invention;
Reference will now be made in detail to the exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
A newly developed form of fundoplication, referred to as endoscopic fundoplication, is an endoluminal procedure in which the fundus wall 6 is folded back onto the esophagus wall 4 and wraps around the esophagus 3, as shown in
Various suitable tissue fasteners may be used, including adjustable fasteners that may be adjusted through various tools. Suitable fasteners are described in U.S. application Ser. No. 10/230,672 of Robert DeVries et al. entitled “Tissue Fasteners and Related Deployment Systems and Methods,” U.S. application Ser. No. 10/175,307 of Sergey Grigoryants et al. entitled “Endoscopic Fundoplication Devices and Methods for Treatment of Gastroesophageal Reflux Disease,” and U.S. application Ser. No. 10/230,682 of Robert DeVries et al. entitled “Devices and Methods for Fastening Tissue Layers.” Each of these disclosures is incorporated by reference herein.
During an endoscopic fundoplication, an invagination device can be used to hold or grasp the esophagus wall 4 and pull it down toward the stomach 7 in order to invaginate the lower end portion of the esophagus 3 into the stomach. For example, when the fundus wall 6 is ready to be folded back onto the esophagus wall 4, an invagination device can be inserted through the esophagus 3 and positioned proximate to the lower end portion of the esophagus wall 4. Once the invagination device is properly positioned, the device is actuated to hold/grasp the tissue. After the portion of esophagus wall 4 is firmly held/grasped by the device, the device is pushed down toward the stomach to displace the held/grasped esophagus wall 4 down toward the stomach (e.g., approximately 4 cm). A suitable tissue fastening member is then used to securely fasten the invaginated esophagus wall 4 and the fundus wall 6. This invagination procedure may effectively eliminate a hiatal hernia that may protrude out of the stomach through the esophagus and recreate the LES region.
After the jaws 14 a, 14 b are attached to the spring set 15, a jaw operating cable 18 is connected to the jaw assembly 14. As shown in
Other alternative wrapping configurations and methods may be used wherein cable 18 is guided through alternative looping, knotting, or tying patterns, and components 14 and/or 15 have other openings than those shown in the Figures and described above. As a further alternative, cable 18 may be welded or otherwise affixed to tabs 15 e, 15 f of spring set 15, without the need for holes 15 a, 15 b or grooves 14 c, 14 d.
In operation, pulling the jaw operating cable 18 in a proximal direction (by an actuation handle further described herein) causes the flexible spring set 15, 15′ to deform into a folded configuration, causing the pair of jaws 14 a, 14 b, 14 a′, 14 b′ to move towards each other, as shown in, for example,
Once the jaw assembly 14, 14′ is properly connected to the jaw operating cable 18, the jaw assembly 14, 14′ can be attached to the main body 12, 12′ by a suitable fixing mechanism, such as, for example, screws or welding. In the embodiment shown in
The invagination head 11 is connected to a distal end of the elongated conduit 20 via a suitable connecting member 21, such as, for example, a threaded bolt-nut arrangement, a snap-fit, a bond, a weld, as an integral component, or via any suitable means known in the art. The conduit 20 can be a hollow, single or multiple wound coil 20 covered with a suitable heat shrink material. Conduit 20 may comprise any of the conduit forming means known in the art, including, for example, a solid polymer tube, tubes having reinforcing braids, coils, weaves, or fibers, layered tubes, variable stiffness tubes, or the like. The conduit 20 may include more than one lumen. For example, while a single lumen of the conduit 20 can accommodate both the vacuum suction path and the jaw operating cable 18, the conduit 20 may be provided with separate lumens for accommodating them separately. The conduit 20 is sufficiently flexible to traverse tortuous anatomy of a body, yet rigid and strong enough to move the grasped esophageal tissue down toward the stomach during, for example, a fundoplication procedure. Other suitable conduits having similar characteristics can be utilized instead.
At its proximal end, the conduit 20 connects to a suitable actuation handle.
The lines of the operating cable 18 pass through the bore 31 of the base 32 to a section of the base 32 covered by the cover 36. These lines of the cable 18 are crimped together and positioned around a pin 33. The pin 33 extends through and connects with a follower 39 inside the base 32. The follower 39 includes holes 39 a to receive the pin 33 and a threaded hole 34 into which a threaded shaft 37 is inserted, such that the follower 39 can move axially along the threaded shaft 37. The threaded shaft 37 is disposed inside the proximal portion of the base 32 with its head 37 b protruding out of the base 32. While the axial movement of the threaded shaft 37 is limited by, a flange 37 a or a washer, the threaded shaft 37 is freely rotatable relative to the base 32 to move the follower 39 along the threaded shaft 37. Rotation of the threaded shaft 37 causes the follower 39 to move axially along the threaded shaft 37, which in turn pulls or pushes the operating cable 18 for opening and closing the jaws 14 a, 14 b, depending on the direction of rotation of the shaft 37. The protruded head 37 b of the shaft 37 is then mechanically coupled to the jaw knob 38 to facilitate rotating of the threaded shaft 37. This coupling may be achieved by a screw 38 a extending through the knob 38 and into the head 37 b, or any other suitable coupling.
For operation of the invagination device 10, a source of vacuum is connected to the tube fitting 35 to create a desired level of suction in the invagination head 11. The vacuum in the head 11 causes the tissue in the vicinity of the opening 13 of the head 11 to be sucked into and held in the opening 13. Once the tissue is properly held in the opening 13, the jaw knob 38 is rotated in the proper direction to cause axial movement of the follower 39 in the proximal direction away from the invagination head 11. The movement of the follower 39 then pulls the operating cables 18 and causes the pair of jaws 14 a, 14 b to close and grasp the tissue held in the opening 13 by suction. Suction can be continued, if desired, or tissue can be grasped by the force of the jaws 14 a, 14 b alone.
In alternative embodiments, various other types of tissue holding/grasping means, such as, but not limited to, needles, clamps, forceps, balloons, hooks, and suction cups or tubes, can be utilized.
In another embodiment of the present invention,
The needles 74 are configured to remain in a retracted position inside the head 71 during delivery of the device 70. Once the head 71 is placed proximate to the tissue to be invaginated, the plurality of needles 74 are guided to extend in radial direction and pierce the tissue to be invaginated. The needles 74 are flexible, yet sufficiently rigid to pierce through the tissue. The needles 74 with barbed ends 76 can push and drag the tissue downward when the invagination device 70 is displaced downwardly toward the stomach. The size and shape of the barbed distal ends 76 may be selected to minimize trauma to the patient, but at the same time, to sufficiently hold the tissue during the invagination procedure. The size, shape, and number of openings 72 may vary.
A further embodiment includes a barb activation means to deploy or retract barbs at the distal end of the needles. As an example, barbs may be within hollow needles and pushed forward or retracted relative to the needle, as desired. As a further alternative, barbs may be compliant so as to grasp and lift tissue but have sufficient flexibility to be removed from the tissue if sufficient force is applied. The barbs also may have a slightly rounded or ball-like shape to assist in removing the barbs from tissue. As an even further embodiment, the needles may be paired so as to lock together after piercing tissue and released through application of force for removal from tissue.
Preferably, the distal end of the actuation rod 95 is fixedly connected to the distal portion 99 while the proximal end of the actuation rod 95 is movably connected to the proximal portion 91, such that the distal and proximal portions 99, 91 are axially moveable relative to each other. The actuation rod 95 is flexible, yet rigid enough to move the distal portion 99 without bending. The plurality of wires 92 are made less rigid than the actuation rod 95 and, preferably, formed of a flexible, elastic material. During deployment, the distal and proximal portions 99, 91 of the expandable member 94 are separated apart by the length of the wires 92, so that the wires 92 form a substantially straight outer profile. Once the expandable member 94 is positioned proximate to the tissue to be invaginated, the distal and proximal portions 99, 91 are moved toward each other by pulling the actuation rod 95 in the proximal direction. This movement causes the plurality of wires 92 to bend outwardly and bring the members 97 in contact with the tissue to be invaginated. At this point, the tissue holding force applied by the members 97 through friction, grasping, snagging, or the like, is sufficient enough to maintain the firm holding while the device 90 is pushed down toward the stomach for invagination. It should be a understood that any other suitable activation mechanisms for expanding the plurality of wires 92 can be employed instead.
As an alternative embodiment, wires 92 may include a portion with a temporary adhesive or having a friction promoting surface, such as by addition of a suitable coating or otherwise shaping or scoring the surface, for adhering to tissue. Such an adhesive or friction promoting surface may be used in other embodiments described herein.
As an alternative, the wires 92 may be fixedly connected to the distal portion 99, but slidable within proximal portion 91. In this case, when the invagination device 90 is inserted into the esophagus, the actuation rod 96 may be pulled in the proximal direction so that the distal and proximal portions 99, 91 contact each other and the wires 92 are contained within the proximal portion 91 and its connected elongated conduit 98. In this manner, a risk of tissue damage to the esophagus during insertion can be minimized. When the device 90 is at the desired position in the esophagus, the actuation rod 95 may be extended in the distal direction to separate the distal and proximal portions 91, 99 and expose the wires 92 and the friction members 97 to hold the esophageal tissue. As a further alternative of the embodiment shown in
In an alternative embodiment shown in
The embodiment shown in
As a further alternative, head 132 may operate like a partial exposed, self-expanding stent. In this embodiment, head 132 is not connected to member 131 and instead slides within and relative to the outer tube. As head 132 exits the distal end of the tube, it naturally self-expands to contact the esophagus. As another embodiment, head 132 may be configured to bend backwards on itself to, create a flange-like head at its end that would contact the esophagus. The head may be coated or covered to have a friction surface to assist in invagination. Head 132 may also include hooks, barbs, or other graspers therein that may be exposed between wires 133. As an even further alternative, head 132 may operate like an expandable stent, which may be expanded by a balloon or other suitable dilating mechanism.
As further embodiments of the invention, any of the embodiments of invagination devices described herein may be configured to articulate so that the grasper, suction device, or other mechanism to grasp or otherwise hold tissue may be placed proximate the esophagus.
The A-frame head 220, shown in more detailed in
The downtube 250 connects to the A-frame head 220 and the A-frame handle 280 at its distal and proximal ends, respectively. The downtube 250 can extend from outside of a body to a site deep within the body, and is sufficiently flexible to traverse through tortuous paths within a body, such as, for example, to the gastroesophageal junction site. The downtube 250 contains a plurality of lumens that are designed to encompass various operating devices, such as, for example, endoscopes and invagination devices, and related activation means, such as, for example, cables and rods, for manipulating the operating devices.
Preferably, the various invagination devices disclosed herein are configured to be slidably insertable through a lumen of the A-frame device 200. For example, an invagination device has an outer diameter slightly less than the inner diameter of a working channel of the A-frame device 200, so that the invagination device can axially move within the working channel of the A-frame device 200.
It should be understood that, in place of the A-frame device 200 shown in
While the exemplary embodiments disclosed herein are described in connection with endoluminal procedure, it should be recognized that some of the embodiments may be utilized in various laproscopic procedures. That is, the disclosed invagination devices may be introduced through a small incision into the stomach to pull the interior of the esophagus 3 into the stomach 7.
With reference to
As shown in
The endoscope 320 is then retroflexed in the stomach 7 to view the A-frame head 220 and the working area. Once the A-frame head 220 is positioned in the stomach 7, the folding arm 222 of the A-frame head 220 is opened by using the A-frame handle 280 on the proximal end of the downtube 250, as shown in
As shown in
As an alternative embodiment, the A-frame device may be configured to also serve as the invagination device, eliminating the need for a separate invagination device during the procedure. As an example, the A-frame head may include a main body having a hollow portion. Ports in the main body may be placed in fluid communication with the hollow portion and a lumen in the downtube that communicates with a source of suction. With the folding arm open, the application of suction will grasp the esophagus. The entire device then may be pushed downward to invaginate the esophagus, and the arm folded to perform fundoplication. Suction may be applied during the folding to promote more accurate positioning. As a further alternative, various moving components of the disclosed A-frame devices, including especially components of the A-frame head, may be integrally manufactured, for example a living hinges.
Distal tube 430 may consist of a semi-rigid tube having open proximal and distal ends and a lumen of sufficient diameter to accommodate an endoscope that may be used for imaging/visualization purposes. Tube 430 may include an angled, open proximal end to permit easier entry of an endoscope into tube 430 and easier withdrawal of sleeve 400 into the working channel of an endoscopic device, such as an A-frame device, being protected by sleeve 400. The angle of the proximal end of tube 430 relative to its longitudinal axis may be approximately 45 degrees. Tube 430 may be made of any suitable biocompatible material known in the art so that tube 430 has sufficient strength to permit access for an endoscope.
Balloon 420 connects to tube 430 proximate the proximal and distal ends of tube 430. Balloon 420 may be made of any suitable biocompatible material known in the art. Balloon 420 at least partially surrounds sleeve 410 and may include a tab 422 at its proximal end. Tab 422 may be manipulated by a user should it be desired to reuse sleeve 400 during an endoscopic operation. Tab 422 permits a user to easily grasp and pull balloon 420 distally to permit access to wire loop portion 440 c. Upon access to wire loop portion 440 c, the user may loosen the tension of portion 440 c around sleeve 410 (i.e. uncinch the wire) and open sleeve 410 so that it may be replaced onto an endoscopic device.
Inflation tube 450 has a lumen in fluid communication with an interior of balloon 420. A distal end of tube 450 connects to balloon 420 at the proximal end of distal tube 430. A proximal end of tube 450 (not shown) may connect to any suitable source of inflation fluid and inflation actuation mechanism known in the art that may be used to supply inflation fluid, such as air, to balloon 420. Tube 450 may be made of any suitable material known in the art, such as polyethylene or other suitable polymers, and may have a length that approximates that of the endoscopic instrument that sleeve 400 is used with, for example approximately 60 cm.
Sleeve 410 may be made of balloon material, an extrusion material, or any other material sufficient to cover and protect the distal end of an endoscopic instrument from damaging a tissue tract during insertion. Balloon 420 is sealed to sleeve 410 along seals 472 and 474 that extend around the circumference of sleeve 410. Seals 472, 474 may be formed by any suitable method known in the art, such as heat treatment or adhesives, for example.
Actuator wire 440 may be a single wire, cable, or like actuator. The ends of wire 440 remain at the proximal end of sleeve 400 (not shown) and may connect to a suitable handle or other actuation mechanism to permit the user to apply tension to the ends of wire 440. From its ends, wire 440 extends distally within a lumen of an actuation tube 460 (see wire portions 440 a and 440 b of wire 440), past a distal end of tube 460, to within sleeve 410. Wire portions 440 a and 440 b then exit through a hole 476 in sleeve 410 and form a loop portion 440 c around an exterior of sleeve 410.
Actuation tube 460 may be made of any suitable material known in the art, such as polyethylene or other suitable polymers, and may have a length that approximates that of the endoscopic instrument that sleeve 400 is used with, for example approximately 60 cm. Outer tube layer 470 may be a heat shrinkable tubing that covers both tube 450 and tube 460. As an alternative to tubes 450 and 460 and layer 470, any dual-lumen tube may be used for inflation of balloon 420 and actuation of wire 440.
Sleeve 400 may be constructed through any number and order of manufacturing steps desired.
As shown in
As shown in
As shown in
As shown in
As an initial step in the method of use, a user should make sure that wire loop portion 440 c is open around sleeve 410. To loosen loop portion 440 c, the user may lift tab 422 of balloon 420 and pull balloon 420 distally to permit access to wire 440. Upon access to wire 440, the user may loosen the tension of wire loop portion 440 c and open sleeve 410.
Sleeve 400 then is backloaded through a working channel of A-frame device 200 until sleeve 400 is in the position shown in
Protective sleeve 400 and A-frame device 200 then are inserted into a patients tissue tract, such as an esophagus, until sleeve 410 and device 200 reach a desired position, such as that shown in
Once A-frame device 200 is in the desired position, the endoscope should be pulled proximally into the A-frame head 220 and balloon 420 deflated. Sleeve 400 then is advanced distally (as shown by the arrow in
Should it be desired to reuse sleeve 400 during the endoscopic operation, tab 422 may be manipulated by a user, as described above, to permit access to wire loop portion 440 c and thereby loosen the tension of loop portion 440 c around sleeve 410.
Although the present invention is depicted in this disclosure as being used in the treatment of GERD, e.g., a fundoplication procedure performed in the gastro-esophageal junction, it is to be understood that the invagination devices and related deployment methods of the present invention can be used in a variety of different types of surgical procedures.
Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
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|International Classification||A61B17/11, A61B17/128, A61B17/064, A61B17/02, A61B17/28, A61B17/00, A61B17/072, A61B17/30, A61B1/32, A61B17/068, A61B17/04|
|Cooperative Classification||A61B2017/308, A61B2017/306, A61B2017/0419, A61B2017/00827, A61B2017/00557, A61B2017/00336, A61B17/29, A61B17/1285, A61B17/1114, A61B17/0469, A61B17/0218, A61B17/00234, A61B1/32|
|European Classification||A61B17/00E, A61B17/04E, A61B1/32, A61B17/02E, A61B17/128E|
|Jul 3, 2006||AS||Assignment|
Owner name: COUNCIL OF SCIENTIFIC AND INDUSTRIAL RESEARCH, IND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SINGH, ARUN KUMAR;PANDEY, NAVAL KISHORE;GUPTA, ASHOK KUMAR;REEL/FRAME:018078/0381
Effective date: 20060606