The present invention relates to gastroplasties and methods and devices for performing gastroplasties.
Obesity is becoming a growing concern, particularly in the United States, as the number of obese people continues to increase and more is learned about the negative health effects of obesity. Morbid obesity, in which a person is 100 pounds or more over ideal body weight, in particular poses significant risks for severe health problems. Accordingly, a great deal of attention is being focused on treating obese patients. Surgical procedures to treat morbid obesity have included gastric bypasses (stomach stapling), adjustable gastric banding, and vertical banded gastroplasty and sleeve gastrectomies (removal of all or a portion of the stomach). Such surgical procedures have increasingly been performed laparoscopically. Reduced postoperative recovery time, markedly decreased post-operative pain and wound infection, and improved cosmetic outcome are well established benefits of laparoscopic surgery, derived mainly from the ability of laparoscopic surgeons to perform an operation utilizing smaller incisions of the body cavity wall. However, multiple abdominal incisions are often required in such obesity treatment procedures, thereby increasing chances for undesirable post-operative consequences such as cosmetic scarring.
Gastroplasties have become increasingly favored by surgeons and patients for treating obesity, as well as for treating stomach diseases such as cancer where a portion of the stomach is removed, because gastroplasties do not leave any foreign material in a patient and does not require a complicated intestinal bypass. Instead, the stomach's volume is reduced through partial division of the stomach, thereby leaving a stomach “sleeve” between the esophagus and intestine. A laparoscopic gastroplasty procedure generally involves insufflation of the abdominal cavity with carbon dioxide gas to a pressure of around 15 millimeters of mercury (mm Hg). The abdominal wall is pierced and a 5-10 mm in diameter straight tubular cannula or trocar is then inserted into the abdominal cavity. A laparoscopic telescope connected to an operating room monitor is used to visualize the operative field and is placed through one of the trocar(s). Laparoscopic instruments are placed through two or more additional trocars for manipulation by the surgeon and surgical assistant(s). Thus, such laparoscopic procedures can require multiple instruments to be introduced into a patient through multiple, potentially scarring incisions and/or can result in interference between instruments near each other. The placement of two or more standard cannulas and laparoscopic instruments in the abdomen next to each other and/or placement of two or more instruments into the abdomen through the same incision creates a so-called “chopstick” effect, which describes interference between the surgeon's hands, between the surgeon's hands and the instruments, and between the instruments. This interference greatly reduces the surgeon's ability to perform a described procedure.
Accordingly, there remains a need for methods and devices for performing gastroplasties that minimize patient recovery time, improve cosmetic outcome, and reduce the “chopstick” effect.
The present invention generally provides methods and devices for performing gastroplasties. In one embodiment, a surgical method is provided that includes positioning a housing having a plurality of sealing ports in an abdominal wall of a patient, and transecting a greater curvature of a stomach of the patient from a lesser curvature of the stomach using a surgical instrument, e.g., a surgical stapler, inserted through one of the plurality of sealing ports in the housing to form a gastric tube along the lesser curvature that drains into an antrum of the stomach. In some embodiments, the housing can be positioned to form an access hole through an umbilicus of the patient, and the access hole can have a diameter in a range of about 15 to 35 millimeters.
Various instruments can be used to facilitate formation of a gastric tube or stomach sleeve. For example, the method can include visualizing an abdominal cavity of the patient with a scoping device inserted through one of the plurality of sealing ports in the housing. For another example, the method can include transorally introducing a sizing device into the stomach and using the sizing device to size the portion of the stomach to be transected. As another example, the method can include retracting a liver of the patient using a device inserted through one of the plurality of sealing ports in the housing. As yet another example, the method can include tensioning a tissue attached to the stomach using a grasper inserted through one of the plurality of sealing ports in the housing, and detaching at least a portion of the tissue from the stomach using a second surgical instrument inserted through one of the plurality of sealing ports in the housing. The second surgical instrument can include an optically clear distal end to allow visualization of the stomach during detaching of at least a portion of the tissue. As another example, the method can include forming an access hole in the abdominal wall by inserting a trocar through the abdominal wall, and tensioning a tissue attached to the stomach using a grasper inserted through the trocar.
In other embodiments, the method can include bending at least one flexible joint along a longitudinal length of the surgical instrument to position the surgical instrument for transecting. In some embodiments, the method can include, prior to transecting, forming an opening through anterior and posterior walls of the stomach. A location for the opening can be determined by using a scoping device inserted through one of the plurality of sealing ports in the housing to visualize the stomach between the antrum and an angle of His. The method can also include measuring a distance between a pylorus of the patient and the greater curvature of the stomach.
In another embodiment, a surgical method is provided that includes forming a first access hole in an abdominal wall of a patient by positioning a housing having a plurality of sealing ports therein in the abdominal wall, forming a second access hole in the abdominal wall by inserting a trocar through the abdominal wall, and transecting a portion of a stomach of the patient between an opening formed through posterior and anterior walls of the stomach and an angle of His of the stomach using a surgical instrument inserted through one of the housing and the trocar. In some embodiments, the first access hole has a diameter greater than a diameter of the second access hole. The method can have any number of variations. For example, the method can include visualizing an abdominal cavity of the patient with a scoping device inserted through one of the housing and the trocar. As another example, the method can include determining a location for the opening by using a scoping device inserted through one of the housing and the trocar to visualize the stomach between an antrum of the stomach and the angle of His. As still another example, the method can include transorally introducing a sizing device into the stomach and using the sizing device to size the portion of the stomach to be transected. As another example, the method can include bending at least one flexible joint along a longitudinal length of the surgical instrument to position the surgical instrument for transecting. As yet another example, the method can include tensioning a tissue attached to the stomach using a grasper inserted through one of the housing and the trocar, and detaching at least a portion of the tissue from the stomach using a dissecting surgical instrument inserted through one of the housing and the trocar. Tensioning a tissue attached to the stomach can include using at least one additional grasper inserted through the one of the housing and the trocar through which the other grasper is not inserted. The grasper can be inserted through one of the plurality of sealing ports in the housing, and the dissecting surgical instrument can be inserted through another one of the plurality of sealing ports in the housing. The dissecting surgical instrument can include an optically clear distal end to allow visualization of the stomach during detaching of at least a portion of the tissue.
In another embodiment, a surgical method is provided that includes positioning a housing having a plurality of sealing ports in an abdominal wall of a patient to form an access hole through the abdominal wall, transorally inserting a sizing device into a stomach of the patient, using the sizing device to size a portion of the stomach to be transected, and transecting the portion of the stomach using a surgical stapler inserted through the abdominal wall through one of the plurality of sealing ports in the housing. The method can have any number of variations. For example, the method can include inserting a scoping device through the abdominal wall through one of the plurality of sealing ports in the housing and using the scoping device to locate a starting location for the surgical stapler to start transecting the portion of the stomach. For another example, the method can include forming a second access hole in the abdominal wall by inserting a trocar through the abdominal wall, inserting a grasper through the abdominal wall through the trocar, and tensioning a tissue attached to the stomach using the grasper. The method can further include detaching at least a portion of the tissue from the stomach using a dissecting surgical instrument inserted through one of the plurality of sealing ports in the housing.
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.
Various exemplary methods and devices are provided for performing gastroplasties. In one embodiment, a method of performing a gastroplasty includes gaining access to a stomach of a patient through an opening formed in the patient's abdominal wall, such as in the umbilicus. A multiple port access device having two or more sealing ports through which surgical instruments can be inserted can be positioned in the abdominal opening. Various instruments can be inserted through the various sealing ports to perform certain steps, such as tensioning and cutting tissue, sizing and transecting the stomach, viewing the surgical site, etc. In certain embodiments, at least one percutaneous opening is formed in the patient's abdominal wall through which one or more surgical instruments can be inserted in addition to any instruments inserted through the multiple port access device. In an exemplary embodiment, the methods and devices are used to perform a Magenstrasse and Mill procedure in which only a portion of the stomach is transected.
A patient can be prepared for a gastroplasty surgical procedure in any way, as will be appreciated by a person skilled in the art. For example, the patient can be fully sedated or consciously sedated for the procedure. Non-limiting embodiments of a conscious sedation system can be found in U.S. Patent Publication No. 2006/0042636 filed on Jun. 21, 2005 and entitled “Oral Nasal Cannula,” U.S. Pat. No. 6,807,965 issued Oct. 26, 2004 and entitled “Apparatus And Method For Providing A Conscious Patient Relief From Pain And Anxiety Associated With Medical Or Surgical Procedures,” U.S. Pat. No. 7,201,734 issued Apr. 10, 2007 and entitled “Apparatus For Drug Delivery In Association With Medical Or Surgical Procedures,” U.S. Pat. No. 7,247,154 issued Jul. 24, 2007 and entitled “Method For Drug Delivery In Association With Medical Or Surgical Procedures,” which are hereby incorporated by reference in their entireties.
In one exemplary embodiment of a gastroplasty procedure illustrated in
As shown in
The abdominal access hole 12 can be formed in any way, as will be appreciated by a person skilled in the art. The multiple port access device 16 can be positioned in the abdominal wall 14 following creation of the abdominal access hole 12 in any way such as by using a cutting instrument, e.g., a needle knife, a scalpel, a hook knife, etc. The multiple port access device 16 can have any configuration, but non-limiting embodiments of a multiple port access device can be found in U.S. Patent Publication No. 2006/0247673 filed Apr. 5, 2006 and entitled “Multi-port Laparoscopic Access Device,” U.S. application Ser. No. [ ] entitled “Surgical Access Device” [Atty. Docket No. 100873-310 (END6485USNP)] and filed on even date herewith, U.S. application Ser. No. [ ] entitled “Surgical Access Device with Protective Element” [Atty. Docket No. 100873-311 (END6485USNP1)] and filed on even date herewith, U.S. application Ser. No. [ ] entitled “Multiple Port Surgical Access Device” [Atty. Docket No. 100873-312 (END6485USNP2)] and filed on even date herewith, and U.S. application Ser. No. [ ] entitled “Variable Surgical Access Device” [Atty. Docket No. 100873-313 (END6485USNP3)] and filed on even date herewith, which are hereby incorporated by reference in their entireties.
In general, the multiple port access device used in the gastroplasty can provide access to a patient's abdominal cavity by positioning the multiple port access device within an access hole or opening in the patient's body. For non-limiting example, in the illustrated embodiment of
Optionally, one or more openings or access holes in addition to the abdominal access hole 12 can be formed in the patient's abdominal wall 14. Each additional abdominal access hole can have any size, shape, and configuration, but in an exemplary embodiment, the additional abdominal access hole(s) are each percutaneous openings. A person skilled in the art will appreciate that the term “percutaneous opening” or “percutaneous access hole” as used herein is intended to encompass a relatively small opening or access hole in a patient that preferably has a diameter in a range of about 3 to 5 mm. Any of the additional abdominal access hole(s) can be formed before and/or after the abdominal access hole 12, but in an exemplary embodiment, any additional abdominal access hole(s) are formed after the abdominal access hole 12 to allow prior insufflation of the patient's abdominal cavity using a surgical device inserted through the abdominal access hole 12, as discussed further below.
As will be appreciated by a person skilled in the art, access holes through the abdominal wall can be formed in any way. Non-limiting embodiments of a trocar that can be used to form an abdominal access hole can be found in U.S. Patent Publication No. 2007/0260273 filed on May 8, 2006 and entitled “Endoscopic Translumenal Surgical Systems,” which is hereby incorporated by reference in its entirety. An exemplary embodiment of a trocar can include a trocar housing configured to allow a surgical device to pass therethrough, and a trocar sleeve or overtube mated to or extending from the trocar housing. The trocar can also include an obturator configured to pass through the trocar housing and the trocar sleeve. The obturator can have an inner lumen formed therethrough for receiving a scoping device and/or other surgical device therein, and a distal end configured penetrate through tissue. The trocar sleeve can be slidably disposed over the obturator and can function as a placeholder after the trocar is inserted through tissue and the obturator is removed. Non-limiting embodiments of a sleeve and an obturator that can be used to form an abdominal access hole can be found in U.S. patent application Ser. No. [ ] filed on even date herewith and entitled “Methods And Devices For Performing Gastrectomies And Gastroplasties,” [Atty. Docket No. 100873-317 (END6488USNP)], which is hereby incorporated by reference in its entirety.
Once access to the abdominal cavity is obtained, the surgeon can insufflate the patient's abdominal cavity through an opening in the patient's abdomen, as will be appreciated by a person skilled in the art, to expand the abdominal cavity and provide a larger, more easily navigable surgical workspace. In an exemplary embodiment, the surgeon can insufflate the abdominal cavity by passing a fluid under pressure, e.g., nontoxic carbon dioxide gas, through at least one of the sealing ports 20a, 20b, 20c in the multiple port access device 16. The fluid can have a pressure in the range of about 10 to 15 mm Hg, or any other pressure, as will be appreciated by a person skilled in the art. As mentioned above, the multiple port access device 16 can include one or more sealing elements that prevent the insufflation fluid from escaping the abdominal cavity through the multiple port access device 16. If one or more openings in addition to the abdominal access hole 12 having the multiple port access device 16 positioned therein are formed through the patient's abdominal wall 14 and have a surgical device, e.g., a trocar, extending therethrough, the device can be configured to provide a seal that prevents the insufflation fluid from escaping the abdominal cavity therethrough. A non-limiting example of a sealing trocar that does not use seals is the SurgiQuest AirSeal™ available from SurgiQuest, Inc. of Orange, Conn.
Any number of scoping devices can be advanced through any one or more openings or access holes (natural or surgically created) into the patient 10 to provide visualization inside the patient's body during the surgical procedure. In an exemplary embodiment, as shown in
In one embodiment, a scoping device inserted into the patient 10 can include one or more distal, flexible joints that can help orient the scoping device inside the patient 10. Non-limiting embodiments of flexible joints on a surgical device can be found in previously mentioned U.S. patent application Ser. No. [ ] filed on even date herewith and entitled “Methods And Devices For Performing Gastrectomies And Gastroplasties,” [Atty. Docket No. 100873-317 (END6488USNP)]. In general, the flexible joint(s) can be configured to flex or bend. The flexible joint(s) can be passively actuated, e.g., moveable when abutted by one or more adjacent structures, and/or actively actuated, e.g., through manipulation of a mechanical and/or manual actuation mechanism. The flexible joint(s) can be configured to bend in a single direction when actuated, and the single direction can be selectively chosen, e.g., left, right, up, down, etc. If a surgical device includes a plurality of flexible joints, each of the flexible joints can be configured to be independently actuated in any direction same or different from any of the other flexible joints of the surgical device. The actuation mechanism can be configured to control the amount of movement in a chosen direction. The flexible joint(s) can be formed in any way, same or different from one another, as will be appreciated by a person skilled in the art. For non-limiting example, the flexible joint(s) can be made from a flexible material, can include one or more features formed therein to facilitate flexibility, e.g., a plurality of cut-outs, slots, etc., and/or can be formed from a plurality of linkages that are movably coupled to one another. In an alternate embodiment, a scoping device can have two or more flexible joints each at different locations along its longitudinal axis, with or without use of a sleeve, to allow the scoping device to bend in at least two directions relative to the scoping device's longitudinal axis. A non-limiting example of a multibending scoping device is the R-Scope XGIF-2TQ260ZMY available from Olympus Corp. of Tokyo, Japan.
During the surgical procedure, the patient's stomach can be difficult to adequately access. The patient's liver can be retracted during the gastroplasty to help the surgeon gain better access to the patient's stomach. Although the liver can be retracted at any time during the surgical procedure, in an exemplary embodiment the liver is retracted after insertion into the patient 10 of a scoping device, e.g., the laparoscope 38 through the multiple port access device 16, to provide visualization of the abdominal cavity before and during retraction of the liver. The liver can be retracted in any way appreciated by a person skilled in the art, but the liver is preferably retracted using at least one device inserted into the abdominal cavity of the patient 10 through, e.g., the previously-formed abdominal access hole 12, through another abdominal opening, etc. Also as will be appreciated by a person skilled in the art, a draining device, e.g., a penrose drain, a Jackson-Pratt drain, etc., can be disposed in the patient's abdominal cavity to help hold the liver and/or drain excess fluid that can accumulate in the abdominal cavity during the surgical procedure, particularly following liver retraction.
In an exemplary embodiment, a retractor device, such as a Nathanson liver retractor, can be used to retract the patient's liver.
Optionally, as illustrated in
A person skilled in the art will appreciate that a support can be used to mount the Nathanson liver retractor 42 and/or any other surgical instrument used during the gastroplasty that does not require constant hands-on manipulation. Multiple supports can be used in a single surgical procedure.
In another embodiment, the surgeon can introduce into the patient 10 suture anchors, e.g., t-tags, hooks, etc., having sutures attached thereto. The sutures can be attached to the liver 44, tensioned to desirably position the liver 44, and extracorporeally tied or otherwise secured to maintain the liver 44 in a desired position. In still another embodiment, the liver 44 can be retracted using magnets. The surgeon can affix one or more internal magnets to the liver 44 and one or more external magnets on an outside surface of the patient's abdomen wall 14. The external magnets can attract the internal magnets, thereby moving the liver 44 toward an inner surface of the abdominal wall 14. A liver retracting device can be used alone or in combination with any one or more other liver retracting devices, e.g., magnets in combination with tackers and mesh, a Nathanson liver retractor in combination with suture anchors and sutures, a Nathanson liver retractor in combination with a surgical adhesive, etc.
Prior to transecting the stomach 40, the stomach 40 can be separated from tissue attached to the stomach 40, e.g., an omentum, vessels, any adhesions on the stomach 40, etc., to free a fundus of the stomach 40. As will be appreciated by a person skilled in the art, the tissue attached to the stomach 40 can be separated from the stomach 40 using any one or more dissecting devices. A person skilled in the art will also appreciate that the term “dissector,” “dissecting device,” or “dissecting surgical instrument” as used herein is intended to encompass any surgical instrument that is configured to cut tissue, e.g., a scalpel, a harmonic scalpel, a blunt dissector, a cautery tool configured to cut tissue, scissors, an endoscopic linear cutter, a surgical stapler, etc. The desired tissue can be separated from the stomach 40 in any way, but in an exemplary embodiment the surgeon cuts adjacent to the greater curvature of the stomach 40 to free the fundus from the omentum. The dissector can be introduced into the patient 40 through any access hole (natural or surgically created). In one embodiment shown in
In an exemplary embodiment, the omentum 68 and/or any other desired tissue can be tensioned using a grasper 70 while the dissector 66 dissects tissue from the stomach 40. The grasper 70 can be introduced into the patient 10 in any way, such as through the multiple port access device 16, but in an exemplary embodiment, the grasper 70 can be inserted through a percutaneous abdominal opening, e.g., through the trocar 32 of
In an alternate exemplary embodiment illustrated in
The shaft 76 can have any size, shape, and configuration, but as illustrated in this exemplary embodiment, the shaft 76 can have a substantially cylindrical shape and have a substantially circular cross-section A-A as best seen in
The dissector's hood 78 can also have any size, shape, and configuration. In an exemplary embodiment, the hood 78 is rigid and distally tapered with a rounded, bullet shaped tip, as best seen in
The hood 78 can be substantially smooth, or as illustrated, the hood 78 can include a penetrating element 86, e.g., a sharp knife edge, a beveled edge (including a chamfered edge), a pointed needle, an electronic cutter, a paddle, etc., that can protrude outward from an outer surface thereof to help the hood 78 penetrate tissue. The penetrating element 86 can be located anywhere on the hood 78, but as shown, the penetrating element 86 extends around a perimeter of the hood 78. The penetrating element 86 as shown is in the form of a paddle that does not necessarily cut tissue but rather merely extends outward from an outer surface of the hood 78. The paddle can have a generally planer, elongate configuration, and in use it can be configured to penetrate tissue with or without the tissue having a previously formed cut or slit therein, e.g., formed with a cutting instrument inserted through the dissector 74. For example, the paddle can be rotated to spread open an elongate cut made through tissue. A person skilled in the art will appreciate that the penetrating element 86 can be formed integrally with the hood 78 such that the hood 78 and the penetrating element 86 are formed as a single piece of material, or it can be separate from and mated to the hood 78.
In use, the dissector 76 can be introduced to a surgical site in any way appreciated by a person skilled in the art, e.g., advanced through a trocar or access device, advanced via a working channel of a scoping device, etc. Advancing the hood 78 through tissue desired for dissection can dissect the tissue by, e.g., separating tissue layers and/or creating an incision, thereby allowing the hood 78 and/or at least a portion of the shaft 76 to be advanced through the tissue. The hood 78 can be manually and/or mechanically rotatable around a central axial axis 78x of the hood 78 to help the hood 78 penetrate tissue by, e.g., rotating a proximal handle of the dissector 74, as will be appreciated by a person skilled in the art.
As mentioned above, the surgeon can use a surgical instrument such as a scoping device to visualize the posterior of the stomach 40. Such visualization can help in determining a starting location 88 for a transection of the stomach 40, as illustrated in
Transection of the stomach 40 can begin substantially at the starting location 88. In an exemplary embodiment illustrated in
As will be appreciated by a person skilled in the art, the opening 96 can be formed in any way using any surgical device, e.g., a cutting instrument, a dissector, a transector, etc.. In an exemplary embodiment illustrated in
The transector(s) can be rigid, flexible, or a combination thereof. In an exemplary embodiment, referring to transector 98 by way of non-limiting example, the transector 98 includes at least one flexible joint 104 along its elongate shaft 100, preferably in a distal portion thereof as illustrated that articulates to allow pitch and/or yaw displacement of the shaft 100 distal to the flexible joint 104. The flexible joint 104 can be articulated in any way, passively and/or actively, such as by actuating a control mechanism at the transector's handle 102. The flexible joint 104 can be configured in any way, as discussed above. One embodiment of a transector 98′ including a single flexible joint 104′ at a distal end of the transector's elongate shaft 100′ is illustrated in
At any time prior to transecting the stomach 40, the surgeon can manipulate the stomach 40 to form a gastric tube or stomach sleeve in the stomach 40. In an exemplary embodiment, the stomach sleeve can be formed after creation of the tunnel 72 under the stomach 40 and the opening 96 through the stomach 40, although the sleeve can be formed before or after creation of the tunnel 72 or the opening 96. As illustrated in
The sizer 110 can be adjusted in the stomach 40 to place the sizer 110 in a sizing position that generally indicates the size and position of the stomach sleeve following at least partial transection of the stomach 40. In an exemplary embodiment, the sizer 110 in the sizing position extends along a lesser curvature 40c of the stomach 40 and into the pylorus 92 of the stomach 40 so at least a distal-most end 110a of the sizer 110 extends to the pyloric sphincter or valve of the pylorus 92. The sizer 110 can be adjusted in the patient 10 in any way, as will be appreciated by a person skilled in the art. In an exemplary embodiment, the sizer 110 can be adjusted in the stomach 40 using a flexible and/or rigid grasper inserted into the stomach 40 through an abdominal access hole. The grasper can include an end effector having two opposed, movable jaws configured to grasp and move the sizer 110 once the sizer 110 has been adequately advanced into the patient 10 for the grasper to access it. A scoping device inserted into the stomach 40 can have a light located thereon which can help the surgeon find and grasp the sizer 110 with the grasper and to locate the pyloric valve. If the sizer 110 is advanced into the stomach 40 before the starting location 88 for the transection is determined and/or before the opening 96 is created at the starting location 88, the sizer's positioning along the lesser curvature 40c can assist in such determining and/or creating.
With the patient's stomach 40 prepared as desired, e.g., tissue attached to the stomach 40 dissected, stomach sleeve sized, transection starting location determined, etc., the stomach 164 can be transected between its lesser and greater curvatures 40c, 90. As discussed above, the stomach 40 can be transected in any way appreciated by a person skilled in the art, but in an exemplary embodiment a transector can be used to cut and secure the stomach 40 beginning at the opening 96. In one embodiment illustrated in
In an exemplary embodiment, the transactor 116 can be inserted through the opening 96, and it can be used to cut and secure the stomach 40 along a transection “line” 122 in a direction from the antrum 40a to the angle of His 40b, using the sizer 110 as a guide until the angle of His 40b is breached. The transection “line” 122 can generally include an opening in the stomach 40 that is closed or sealed using one or more securing elements, e.g., two rows of staples on either side of the opening as illustrated in
The transection can be visualized using at least one scoping device inserted through any opening, as discussed herein. For non-limiting example only, the surgeon can visualize above and/or underneath the stomach 40 using, e.g., the laparoscope 38 inserted through the multiple port access device 16 in the abdominal access hole 12, to determine if a desired path of transection is clear or readily cleared of tissue and/or other debris. The surgeon can place one or more draining devices in the stomach fundus following the transection, e.g., along a greater curvature of the stomach sleeve formed by the transection. If used, the sizer 110 can be removed from the stomach 40 at any time during the surgical procedure, but in an exemplary embodiment it is removed from the patient 10 by retracting it through the patient's mouth 112 after the stomach 40 has been transected and inspected via scoping device visualization for any uncorrected and potentially dangerous irregularities, e.g., improperly bent staples, improperly placed staples, untied sutures, etc.
The surgeon can optionally secure the transected stomach, e.g., along the stapled or otherwise secured cut edge of the fundus, using any one or more supplemental securing elements in any combination to help better secure the transection and/or reduce bleeding. The supplemental securing elements are preferably biocompatible and can optionally be bioabsorbable such that the supplemental securing elements can dissolve in the patient 10 over time as the transection heals. Non-limiting embodiments of a surgical stapler than can apply staples with bioabsorbable pledgets can be found in previously filed U.S. Patent Application No. [Atty. Docket No. END5966], which is hereby incorporated by reference in its entirety.
At the conclusion of a gastroplasty, any access holes formed in a patient can be closed in any way and in any order as will be appreciated by a person skilled in the art, such as by suturing the openings.
The patient 10 can optionally be provided with a drug and/or device that suppresses appetite that can work in conjunction with the stomach sleeve to help the patient 10 lose weight. Such a drug or device can be provided to the patient 10 at the end of the gastroplasty and/or in a subsequent surgical procedure. A non-limiting embodiment of an implantable appetite suppressant device is available from Duocore, Inc. of Ramat-Hasharon, Israel.
A gastroplasty procedure described herein can optionally be combined with one or more other surgical procedures. For non-limiting example, the gastroplasty can be combined with a transoral minimally invasive surgical procedure, non-limiting examples of which, e.g., creating a gastroenteroanastomosis or enteroenteroanastomosis, can be found in U.S. Patent Application No. 2006/0271075 filed May 18, 2006 and entitled “Double Loop Gastric Bypass Procedure,” which is hereby incorporated by reference in its entirety. As another non-limiting example, the gastroplasty can be performed as a first stage of a two stage surgical procedure where a second stage, e.g., a duodenal switch, a Roux-en-Y procedure, etc., can be performed immediately after the gastroplasty or in a subsequent surgical procedure.
A person skilled in the art will appreciate that the present invention has application in conventional endoscopic and open surgical instrumentation as well application in robotic-assisted surgery.
The devices disclosed herein can also be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
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.
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.