Systems and methods for retaining and manipulating acute incisions

Abstract

Various types of incision control devices secure the periphery and / or adjacent tissue of a target incision site and maintain the size of the incision by a single wall of a blood vessel, organ or lumen within the body. This may reduce, among other things, unintentional trauma, dilation, contraction, or movement of the incision during the surgical procedure. They may also be used for the beneficial purpose of allowing immediate communication between lumens prior to complete formation of a permanent anastomosis. In some embodiments, magnetic compression stapling devices and / or other devices may be deployed through a channel of an incision control device, such as for deployment in a distal lumen.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 435,724, filed on December 28, 2022, entitled “SYSTEMS AND METHODS FOR PRESERVING AND MANIPULATING OF ACUTE OTOMIES,” and U.S. Provisional Patent Application No. 63 / 419,509, filed on October 26, 2022, entitled “SYSTEMS AND METHODS FOR PRESERVING AND MANIPULATING OF ACUTE OTOMIES,” each of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates to devices and methods for preserving, manipulating and capturing acute incisions, and more particularly to devices and methods for intraoperatively capturing acute incisions between two or more compression stapling devices. Background Art

[0004] The bypass or diversion of the gastrointestinal (GI) system, cardiovascular system or urinary system is usually formed by cutting a hole (that is, an acute incision) in the tissue at two positions and connecting the holes with sutures or nails. Usually a bypass or diversion is placed to guide liquid (for example, secretions, blood, nutrients) between the healthier parts of the system, while bypassing lesions or dysfunctional tissues or shortening the overall path of the luminal system. This operation is usually invasive and causes the patient to suffer risks such as hemorrhage, infection, pain and adverse reactions to anesthesia. In addition, the bypass or diversion produced with sutures or nails can become complicated due to postoperative leakage and adhesion. Leakage can lead to infection or sepsis, and adhesion can lead to complications such as intestinal strangulation and obstruction. Although traditional bypass surgery can be completed with endoscopes, laparoscopes or robots, connecting the holes cut into the tissue may be time consuming. In addition, this type of operation requires unavailable specialized techniques and equipment at many surgical facilities.

[0005] As an alternative to sutures or staples, surgeons can use mechanical couplings or magnets to create a compression anastomosis between tissues. For example, a compression coupling or a paired magnet can be delivered to the tissue to be connected. Due to strong compression, the tissue trapped between the couplings or magnets is cut off from its blood supply. Under these conditions, the tissue becomes necrotic and degenerates, while new tissue grows around the compression point, such as on the edge of the coupling. Over time, the coupling can be removed, leaving a healed anastomosis between the tissues.

[0006] Current practices for accessing internal lumens / organs to deliver compression couplings or magnets often require the creation of an acute incision. These acute incisions require subsequent closure surgery after the desired procedure is completed. This adds additional steps to the procedure, increases operative time, and requires the surgeon to diligently maintain the incision to prevent tearing / dilation due to intraoperative manipulation. This also increases the risk to the patient of uncontrolled tearing / dilation of the incision due to manipulation, leading to acute or even chronic anastomotic leakage. Additionally, compression anastomosis can take up to two weeks to form, which prevents the procedure from having an immediate positive effect and may limit the types of procedures that can be performed using compression anastomotic devices.

[0007] Therefore, there remains a need for devices and methods that reduce the need for an incision closure step and create immediate communication between lumens prior to full formation of a permanent anastomosis. Summary of the Invention

[0008] According to one embodiment of the present invention, the incision control device includes a distal flange and a proximal flange separated and connected by a central channel, wherein the distal flange and the proximal flange are configured to compress to adapt the incision control device in a delivery configuration within a working channel of an access device or a delivery device, and to expand on opposite sides of the incision to secure the incision in a fully expanded configuration after being delivered from the working channel.

[0009] In various alternative embodiments, each flange may include a shape memory material, such as nitinol shape memory material or a spring material. Each flange may include an inner frame and some or all of an outer covering surrounding the inner frame, wherein the outer covering may include a biocompatible material and may include a flexible material such as plastic, rubber, polyurethane or polymer that is formed on or above the inner frame by injection molding. Alternatively, the distal flange, the proximal flange and the channel may be formed as an integral device. The flange may be inflatable. The device may include, for example, one or more magnets located in the distal flange, in the proximal flange and / or around the central channel. At least one of the flanges may be shaped or configured to help position the magnetic compression stapling device around the incision control device, for example, in a conical shape. The flanges may have the same configuration or may have different configurations. The proximal flange may be shaped or configured to cooperate with the proximal flange of another incision control device. The incision control device can be a two-piece device comprising: a distal half-section comprising the distal flange and a proximal half-section comprising the proximal flange, wherein the distal half-section and the proximal half-section are configured to interlock to form the central channel, in which case the device can include a locking mechanism for pulling the distal half-section and the proximal half-section together and / or preventing the distal half-section and the proximal half-section from separating after being pulled together. The incision control device can include at least one connecting member to help the device mate with another incision control device. In various alternative embodiments, each flange can include one or more rings or lobes.

[0010] Additional embodiments may be disclosed and claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Those skilled in the art will more fully appreciate the advantages of the various embodiments of the present invention from the following "Detailed Description" discussed with reference to the accompanying drawings summarized immediately below.

[0012] Figure 1 An exemplary device for controlling an acute incision is schematically shown.

[0013] Figures 2A to 2I The surgical steps for creating, controlling, and healing an acute incision are schematically illustrated.

[0014] Figure 3 A silicone grommet is shown schematically, identifying the intraluminal and extraluminal flanges and how the grommet sits transmurally in the tissue.

[0015] Figure 4 A Nitinol tube / wire hybrid grommet is schematically shown.

[0016] Figure 5 A Nitinol tube / wire hybrid grommet is schematically shown.

[0017] Figure 6A and Figure 6B A Nitinol tube / wire hybrid grommet is schematically shown.

[0018] Figure 7A and Figure 7B A Nitinol wire array clamp is schematically shown.

[0019] Figure 8 An expandable grommet is shown schematically.

[0020] Figure 9 The apparatus for controlling the incision is schematically shown.

[0021] Figure 10 The apparatus for controlling the incision is schematically shown.

[0022] Figure 11 The apparatus for controlling the incision is schematically shown.

[0023] Figure 12 A spring clamping element for securing the cutout is shown schematically.

[0024] Figure 13A and Figure 13B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0025] Figure 14A and Figure 14B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0026] Figure 15A and Figure 15B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0027] Figure 16A and Figure 16B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0028] Figure 17A and Figure 17B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0029] Figure 18A and Figure 18B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0030] Figure 19A and Figure 19BSchematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0031] Figure 20A and Figure 20B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0032] Figure 21A and Figure 21B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0033] Figure 22A and Figure 22B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0034] Figure 23A and Figure 23B Schematic diagram showing a perspective view of a Nitinol tube device used to secure an incision.

[0035] Figure 24A and Figure 24B Schematic diagram showing a perspective view of a Nitinol tube / wire hybrid device used to secure an incision.

[0036] Figure 25A and Figure 25B Schematic diagram showing a perspective view of a Nitinol tube / wire hybrid device used to secure an incision.

[0037] Figure 26 Schematic diagram showing a view of a Nitinol tube / wire hybrid device used to secure an incision.

[0038] Figure 27A and Figure 27B A perspective view of a ratchet securing device for securing a cutout is schematically shown.

[0039] Figure 28A and Figure 28B A perspective view of a ring-shaped fixing device for fixing an incision is schematically shown.

[0040] Figure 29A and Figure 29B A schematic diagram shows a stent-type nitinol array device used to secure an incision.

[0041] Figure 30A and Figure 30B A schematic diagram shows a stent-type nitinol array device used to secure an incision.

[0042] Figure 31A and Figure 31B A schematic diagram shows a stent-type nitinol array helical device used to secure an incision.

[0043] Figure 32A and Figure 32B An expandable grommet device for securing an incision is schematically shown.

[0044] Figure 33A and Figure 33B A two-piece suture-holding device for securing an incision is schematically shown.

[0045] Figure 34A and Figure 34B A snap lock device for securing the cutout is schematically shown.

[0046] Figure 35A and Figure 35B A sliding arm notch clip for securing the notch is schematically shown.

[0047] Figure 36 A foam grommet device for securing the cutout is schematically shown.

[0048] Figure 37 A grommet cutout clip device for securing a cutout clip is schematically shown.

[0049] Figure 38 A coil compression grommet device for securing a cutout is schematically shown.

[0050] Figure 39A and Figure 39B A perspective view of an incision clip device for securing an incision is schematically shown.

[0051] Figures 40A to 40D The helix concept for securing the cutout is schematically shown.

[0052] Figure 41 An adhesive reinforcement device for securing the cutout is schematically shown.

[0053] Figure 42A and Figure 42B An incision clip patch for securing an incision is schematically shown.

[0054] Figure 43A and Figure 43B The incision clip puncture patch used to fix the incision is schematically shown.

[0055] Figure 44 A slit clip in the form of a crimp wire for securing the slit is shown schematically.

[0056] Figures 45A to 45O Schematic illustration of forming a duodenal incision for a single-stomosis duodenoileostomy (SADI) with endoscopic intraluminal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression stapling device, according to certain embodiments.

[0057] Figures 46A to 46G Schematic illustration of forming an ileotomy for a single-stomosis duodenoileostomy (SADI) with endoscopic intraluminal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression stapling device, according to certain embodiments.

[0058] Figures 47A to 47I Schematic illustration of forming an anastomosis for a single-stapled duodenoileostomy (SADI) with endoscopic intraluminal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression stapling device, according to certain embodiments.

[0059] It should be noted that the aforementioned figures and the elements depicted therein are not necessarily drawn to a consistent scale or any proportion. Unless the context indicates otherwise, like elements are indicated by like numbers. The accompanying drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. DETAILED DESCRIPTION

[0060] Exemplary embodiments of the present invention include systems and methods for maintaining and manipulating acute incisions. Various embodiments allow for intraoperative capture of an incision between two or more devices to produce a compression anastomosis. The embodiments described herein can reduce or eliminate the need for a closure step for the acute incision, thereby reducing the risk of anastomotic leakage. Certain embodiments of the present invention include various types of incision control devices that secure the periphery and / or adjacent tissues of the target incision site and maintain the size of the incision through a single wall of a vessel, organ, or lumen within the body. Among other things, this can reduce unintentional trauma, expansion, contraction, or movement of the incision during surgery. They can also be used for the beneficial purpose of allowing immediate communication between lumens before a permanent anastomosis is fully formed. In some embodiments, a magnetic compression anastomosis device and / or other device can be deployed through a channel of the incision control device, for example for deployment in a distal lumen.

[0061] As used herein, distal and proximal shall refer to an access device handle. As used herein, particularly with respect to an access or delivery device for deploying a magnetic compression stapling device or an incision control device, the terms "distal" and "proximal" are generally relative to such an access or delivery device, e.g., where "distal" is further from the access or delivery device than "proximal." In some cases, the terms "distal" and "proximal" may be relative to a lumen, e.g., where "distal" is generally within the lumen and "proximal" is generally outside the lumen.

[0062] It should be noted that certain embodiments are described herein with reference to Nitinol shape memory material, but it should be noted that the embodiments are not limited to Nitinol, and other shape memory materials may be used in various alternative embodiments, including but not limited to materials that may function as springs.

[0063] Figures 1 to 3 An exemplary incision control device according to certain embodiments is shown. As with many of the incision control devices described herein, Figures 1 to 3 The cut control device shown in FIG is a double flange type device (referred to herein as a grommet). Figure 1 and Figure 3 As shown, the grommet device can include a distal flange and a proximal flange connected by a channel having a smaller diameter than the flange. A central channel between the flanges connects the flanges, simultaneously capturing and controlling the size of the incision. The flanges engage the tissue surrounding the incision, while the central channel connecting the flanges allows fluid to pass through the grommet. The grommet is typically (though not necessarily) annular in shape.

[0064] Figures 2A to 2I The use of (e.g. during the formation of a permanent anastomosis) Figure 1 Methods of controlling incisions with incision control devices of the type shown. Generally speaking, procedures for controlling incision and stapling formation can be performed endoscopically, laparoscopically, robotically, through open surgery, or a combination thereof.

[0065] like Figure 2A As shown, an incision is formed in the organ and / or intestine. After the incision is formed, an access device is cannulated through the incision to allow the distal side of the tissue to enter the organ / intestinal cavity.

[0066] The grommet device is compressed within the working channel of the access device in a delivery configuration with the distal flange facing the distal end of the access device and the proximal flange facing the proximal end of the access device. The access device can house the grommet within a rigid tube such as a cannula, or can house the grommet through a flexible tube such as a catheter or endoscope. In some embodiments, the grommet can be housed within the working channel of an auxiliary delivery device within the access device. The auxiliary delivery device can be moved proximally, distally, and rotationally within the access device. The auxiliary delivery device can house the grommet before it is deployed into the patient.

[0067] In some embodiments, in addition to or in lieu of the auxiliary delivery device, the access device may include a pusher device for deploying the grommet into the patient's lumen. The pusher may include an integrally formed push rod or a wire, cable, or articulated mechanism to advance the grommet from the access device. The pusher may be rigid, semi-rigid, or flexible.

[0068] The medical professional advances the access device into the distal lumen and deploys the device's distal flange, with the proximal flange remaining within the access device. The distal flange can be deployed by retracting the access device, advancing the assistive delivery device, and / or advancing the pusher. After the distal flange is deployed into the lumen, it expands to its deployed configuration on the distal side of the incision.

[0069] The medical professional pulls the access device back from the lumen into the body cavity. The medical professional then pulls back the access device, pulls back the auxiliary delivery device, and / or advances the pusher to deploy the proximal flange proximally on the tissue surrounding the incision. When deployed from the access device, the proximal flange expands to the deployed configuration. Figure 2B As shown, the grommet is then in a fully expanded configuration, with the distal flange engaging the distal side of tissue surrounding the incision within the lumen and the proximal flange engaging the proximal side of tissue surrounding the incision.

[0070] In some embodiments, a medical professional can insert an access device into the lumen through an endoscope. From within the lumen, the medical professional advances the access device through the tissue wall and into the body cavity. The distal flange can be deployed by retracting the access device, advancing the auxiliary delivery device, and / or advancing the pusher. After the distal flange is deployed into the body cavity, it expands to the deployed configuration on the distal side of the incision.

[0071] The medical professional pulls the access device back into the lumen from the body cavity. The medical professional then pulls back the access device, pulls back the auxiliary delivery device, and / or advances the pusher to deploy the proximal flange proximally on the tissue surrounding the incision. When deployed from the access device, the proximal flange expands to the deployed configuration. Figure 2B As shown, the grommet is then in a fully deployed configuration, with the distal flange engaging the tissue distal to the incision within the body lumen and the proximal flange engaging the tissue proximal to the incision within the lumen.

[0072] In the fully expanded configuration, such as Figure 2B As shown, the grommet allows for control of the incision, reduced tissue expansion / tearing around the incision, and a channel for immediate fluid flow through the incision.

[0073] After the grommet is deployed within the incision, the medical professional can advance the device through the incision to perform further surgical procedures, such as Figure 2C For example, during the formation of the anastomosis, the medical professional can deploy the magnetic compression anastomotic device or other device through the grommet into the lumen of the patient's organ / intestine at the target anastomotic site. Additionally or alternatively, the medical professional can deploy the magnetic compression anastomotic device or other device into the lumen before deploying the grommet. Figure 2DThe magnetic compression anastomosis device is shown deployed in the lumen behind the grommet. Regardless of whether the magnetic compression anastomosis device is deployed before or after the grommet, the diameter of the magnetic compression anastomosis device is generally larger than the diameter of the grommet and therefore cannot pass through the grommet to exit the lumen.

[0074] As mentioned above and Figures 2A to 2D The methods and steps described in the can be repeated one or more times at another target anastomosis site in another organ / intestine / lumen of the patient. The medical professional can then make the incisions at one or more target sites close to each other. The incisions can be manipulated, for example, endoscopically, laparoscopically, robotically, or in open surgery. Figure 2E As shown, a medical professional can manipulate the incision, for example, using sutures attached to a magnetic compression stapling device.

[0075] After the magnetic compression anastomosis devices are brought close to each other, they are fitted together due to the attractive magnetic force, as shown in FIG. Figure 2F As shown, the tissues between them are compressed to form an anastomosis. Figure 2G As shown, the channel within the grommet allows for immediate patency and fluid passage between the lumens prior to full formation of the anastomosis.

[0076] The magnetic compression anastomosis device compresses the tissue therebetween and causes the tissue therebetween to become necrotic. When the tissue becomes necrotic, the grommet may fall off from the target site and be naturally discharged from the patient, such as Figure 2H After the anastomosis is completely formed, the magnetic compression anastomosis device also falls off from the target site and is naturally discharged from the patient, as shown in FIG. Figure 2I As shown, a fully formed anastomosis is left.

[0077] The compression stapling devices described herein may include articulated magnetic compression stapling devices that may be self-assembling. For example, certain embodiments of the magnetic stapling devices typically include magnetic segments that can assume a delivery configuration and a deployment configuration. The delivery configuration is typically linear so that the device can be delivered to the tissue via a laparoscopic "keyhole" incision or delivered to the tissue via a natural route (e.g., via the esophagus) using an endoscope or similar device. In addition, the delivery configuration is typically slightly flexible so that the device can be guided through various bends in the body. Once the device is delivered, the device will assume the deployment configuration of the desired shape and size by automatically converting from the delivery configuration to the deployment configuration. The self-conversion from the delivery configuration to the deployment configuration is guided by a coupling structure that causes the magnetic segments to move in the desired manner without intervention.

[0078] Typically, a magnetic anastomosis procedure involves placing first and second magnetic structures adjacent to first and second portions of tissue, respectively, to bring the tissues together. Once the two devices are brought into close proximity, the magnetic structures engage and bring the tissues together. Over time, the size and shape of the devices become compatible, and the devices fall away from the tissue. Specifically, the tissue enclosed by the devices is allowed to necrotize and degrade, creating an opening between the tissues.

[0079] Figure 3 Depicts Figure 1 A side view of an exemplary grommet cutout control device. The exemplary grommet has a proximal flange and a distal flange connected by a channel therebetween. The diameter of the channel is smaller than the diameter of the flange. Figure 3 As shown, the grommet is deployed across the incision with one flange engaging the intraluminal side of the tissue and the other flange engaging the extraluminal side of the tissue. The inner diameter channel allows for immediate patency and fluid flow through the incision. Additionally, as Figure 3 As shown, the channel allows the compression anastomotic device to be deployed within the lumen distal to the incision.

[0080] In various embodiments, the incision control device includes an internal frame and an external covering that surrounds some or all of the internal frame. Generally speaking, the internal frame and / or the external covering may include a flexible portion (e.g., a portion associated with the flange) that allows the incision control device to be compressed within the delivery device and allows the incision control device flange to automatically expand or unfold when deployed from the delivery device. Thus, for example, the internal frame may include or be formed from a shape memory material (e.g., nitinol or other shape memory material such as a spring material) and the external covering may be made from any suitable material (e.g., plastic, rubber, polyurethane, polymer, etc.) and may be formed using any suitable technique (e.g., lamination, injection molding, etc.). The internal frame and / or external covering may be made to include a biocompatible material. Various alternative incision control devices are described herein, and it should be understood that some embodiments depict configurations that can be used alone and / or in combination with an external covering (e.g., some embodiments depict configurations that can be an internal frame on or over which an external covering can be formed). It should also be understood that some embodiments may be formed without an internal frame. For example, certain devices (e.g., such as Figure 1 and Figure 32A / Figure 32B The delivery device (shown) can be formed as a one-piece device (e.g., an injection molded one-piece device) having a flange that is flexible enough to be stored in the delivery device and expand when deployed.

[0081] In various embodiments, magnets may be incorporated into the grommet (e.g., in one or both of the flanges and / or around the central channel section), thereby combining the grommet and magnetic compression stapling device into a single device. One or more magnets may be incorporated into the distal flange and / or the proximal flange or the entire grommet. This would allow the grommet to control the incision while also functioning as a magnetic compression stapling device.

[0082] Figure 4 An exemplary embodiment of a grommet-type incision control device is depicted. Figure 4 The grommet depicted in comprises a semi-rigid or rigid conduit that acts as an open channel to facilitate deployment and alignment of surgical tools and passage of fluids through an incision. The grommet may be constructed of nitinol, stainless steel, or other biocompatible materials.

[0083] Figure 5 A Nitinol tube or wire hybrid grommet is depicted. Nitinol wires or tubes can be attached to the central tube segment to clamp the perimeter of the tissue surrounding the incision from both sides. The central tube segment allows fluids and surgical tools to pass through the incision while maintaining shape and size and reducing tearing of the tissue surrounding the incision. The central tube segment can be made of any suitable material, such as Nitinol, stainless steel, etc. In order to deliver the device to the patient, the device would be stored inside a delivery device such as an endoscope, laparoscope, catheter, etc., with the top set of Nitinol wires / tubes extending upward and the bottom set of Nitinol wires / tubes extending downward. Note that Figures 5 to 6B 、 Figures 13A to 19B 、 Figures 21A to 25B The embodiment shown in can be delivered to a patient in this manner.

[0084] Figure 6A and Figure 6B Another exemplary Nitinol tubing or wire hybrid grommet is depicted. The grommet may include two or more curved wire loops attached to a tube segment. Figures 6A to 6B Depicted is a wire hybrid grommet comprising four curved wire loops. The wire loops can be constructed from nitinol, stainless steel, or other biocompatible materials. The curved wire loops clamp the tissue around the incision, securing the size and shape of the incision and reducing tissue tearing. The tubing section allows fluids or surgical tools to pass through the incision. Figure 6A and Figure 6B The illustrated embodiment depicts an inner frame covered by an outer covering, as described above.

[0085] 7A to 7B Depicted is a nitinol wire stent array grommet. The nitinol wire stent array clamps the tissue around the incision site, securing the incision and reducing deformation of the tissue around the incision site. Figure 7BAs depicted, the flanges of the nitinol wire stent array engage the distal and proximal sides of the tissue, respectively, while the tube segment passes through the incision, allowing for immediate patency and fluid passage before the permanent anastomosis is fully formed. The tube segment also maintains the diameter of the incision while the flanges reduce tearing and expansion of the tissue surrounding the incision during surgery.

[0086] Figure 8 An exemplary embodiment of an expandable grommet is depicted. The expandable grommet is in a deflated state in a delivery configuration within an access device. After deployment into the distal lumen of an incision, the distal flange of the grommet expands to the deployed diameter. The proximal flange is then deployed proximally to the incision and expanded to the deployed diameter. Once expanded into the deployed configuration, the expandable grommet secures the incision and reduces tearing of tissue surrounding the incision site.

[0087] Figure 13A and Figure 13B Depicted is a perspective view of an exemplary nitinol tube / wire hybrid grommet for securing acute incisions. This device is similar to Figure 5 The device is as shown, but includes a central open ring segment instead of a central tube segment to which the Nitinol wires or tubes are attached, thereby forming an array of Nitinol wires or tubes that clamp the perimeter of the tissue around the incision site from both sides. The array has curved tube or wire segments to clamp the tissue, while the hollow central segment allows immediate patency through the incision and fluid passage prior to full formation of the permanent anastomosis. The central segment also maintains the diameter of the incision while the Nitinol wires / tubes reduce tearing and expansion of the tissue surrounding the incision during surgery. The central open ring segment can be made of any suitable material (e.g., Nitinol, stainless steel, etc.). The device can be delivered by storing the device in a delivery device, as described above with reference to Figure 5 described.

[0088] Figure 14A and Figure 14B A two-piece Nitinol tube / wire hybrid grommet is depicted. The Nitinol wire can be attached to the central section to clamp the perimeter of the tissue surrounding the incision. The two halves of the Nitinol tube / wire array grommet are stored in a delivery configuration in a delivery device. The medical professional advances the delivery device through the created incision and pulls back on the delivery device to deploy the distal half of the Nitinol tube / wire array grommet into the deployed configuration. The medical professional can then pull back on the delivery device further to deploy the proximal half of the grommet into the deployed configuration. The outer arms of the two halves clamp the perimeter tissue of the created incision while the central section allows fluids and surgical tools to pass through the incision. This maintains shape and size and reduces tearing of the tissue surrounding the incision. The two halves of the array grommet can be held together mechanically, magnetically, and / or by other mechanisms. As Figure 14A and Figure 14BAs depicted, the two halves have corresponding mating elements to better ensure that the two halves are joined in the desired configuration (in this embodiment, this aligns the corresponding arms of the two halves).

[0089] Figure 15A and Figure 15B An exemplary two-piece Nitinol tube / wire grommet is depicted. The Nitinol wire can be attached to the center segment to clamp the perimeter of the tissue surrounding the incision. The center segment allows fluids and surgical tools to pass through the incision while maintaining shape and size and reducing tearing of the tissue surrounding the incision. The two halves of the array grommet can be held together mechanically, magnetically, and / or by other mechanisms. Figure 15A and Figure 15B As depicted, the two halves have corresponding mating elements to better ensure that the two halves are joined in the desired configuration (in this embodiment, this aligns the corresponding arms of the two halves).

[0090] Figure 16A and Figure 16B A perspective view of an exemplary two-piece Nitinol tube / wire array grommet is depicted. Nitinol tube / wire arms can be attached to the circumference of the grommet's central section. These arms clasp the tissue surrounding the created incision, while the central section allows fluids and other materials (such as surgical tools) to pass through the incision immediately before creating a permanent anastomosis. This secures the tissue surrounding the incision site, reducing tearing, expansion, or movement at the incision site.

[0091] Figure 17A and Figure 17B Another embodiment of a two-piece nitinol tube / wire array grommet is depicted. Nitinol tube / wire arms can be attached to the circumference of the grommet's central section. The arms clasp the tissue surrounding the created incision, while the central section allows fluids and other materials (such as surgical tools) to pass through the incision immediately before creating a permanent stapling. This stabilizes the tissue surrounding the incision site, reducing tearing, expansion, or movement at the incision site.

[0092] Figure 18A and Figure 18B Depicted is a perspective view of another embodiment of a two-piece Nitinol tube / wire array grommet. The grommet may include two or more curved wire loops attached to a tube segment. Figure 18A and Figure 18B Depicted is a wire hybrid grommet comprising eight curved wire loops. The wire loops can be constructed from nitinol, stainless steel, or other biocompatible materials. The curved wire loops grip the tissue surrounding the incision, ensuring the size and shape of the incision and minimizing tissue tearing. A tube segment allows fluids or surgical tools to pass through the incision.

[0093] Figure 19A and Figure 19BDepicted is a perspective view of another embodiment of a two-piece Nitinol tube / wire array grommet. The grommet may include two or more curved wire loops attached to a tube segment. Figure 19A and Figure 19B Depicted is a wire hybrid grommet comprising sixteen curved wire loops. The wire loops can be constructed from nitinol, stainless steel, or other biocompatible materials. The curved wire loops clamp the tissue around the incision, securing the size and shape of the incision and reducing tissue tearing. A tube segment allows fluids or surgical tools to pass through the incision.

[0094] Figure 20A and Figure 20B Depicted is a perspective view of another embodiment of a Nitinol tube / wire array grommet. Figure 20A and Figure 20B The grommet may include two or more bent wire loops. Figure 20A and Figure 20B A grommet is depicted, comprising sixteen wire loops: eight on the distal half of the grommet and eight on the proximal half. The wire loops can be constructed of nitinol, stainless steel, or other biocompatible materials. The curved wire loops clamp the tissue around the incision, with the circumference of the loops perpendicular to the tissue surface. This stabilizes the size and shape of the incision and reduces tissue tearing. The center section of the grommet allows fluids or surgical tools to pass through the incision.

[0095] Figure 21A and Figure 21B An embodiment of a Nitinol tube / wire array grommet comprising wire half-rings is depicted. Figure 21A and Figure 21B The grommet comprises sixteen wire half-loops: eight on the proximal half of the device, eight on the distal half, and a hollow central section. The grommet device is stored in the delivery device in a delivery configuration. The medical professional advances the delivery device through the created incision. Once on the distal side of the incision, the medical professional pulls back on the delivery device to deploy the distal half of the grommet, located on the distal side of the tissue surrounding the incision, into the deployed configuration. The medical professional can further pull the delivery device back toward the proximal side of the incision to deploy the proximal half of the grommet device, located on the proximal side of the tissue surrounding the incision, into the deployed configuration. Once in the deployed configuration, the distal half-loops approach the proximal half-loops of the device to clasp the tissue surrounding the incision. This secures the size and shape of the incision and reduces tissue tearing. The central section of the grommet allows fluids or surgical tools to pass through the incision.

[0096] Figure 22A and Figure 22B Depicted is a perspective view of another embodiment of a Nitinol tube / wire array grommet. Figure 22A and Figure 22B The grommet may include two or more bent wire loops. Figure 22A and Figure 22BA grommet is depicted, comprising eight wire loops: four on the distal half of the grommet and four on the proximal half. The wire loops can be constructed of nitinol, stainless steel, or other biocompatible materials. The curved wire loops clamp the tissue around the incision, with the circumference of the loops perpendicular to the tissue surface. This stabilizes the size and shape of the incision and reduces tissue tearing. The center section of the grommet allows fluids or surgical tools to pass through the incision.

[0097] Figure 23A and Figure 23B Depicted is a perspective view of another embodiment of a Nitinol tube / wire array grommet. Figure 23A and Figure 23B The grommet may include two or more bent wire loops. Figure 23A and Figure 23B A grommet is depicted, comprising eight wire loops: four on the distal half and four on the proximal half. The wire loops can be constructed of nitinol, stainless steel, or other biocompatible materials. The curved wire loops clamp the tissue around the incision, with the circumference of the loops perpendicular to the tissue surface. This ensures the correct size and shape of the incision and reduces tissue tearing. The center section of the grommet allows fluids or surgical tools to pass through the incision.

[0098] Figure 24A and Figure 24B as well as Figure 25A and Figure 25B An embodiment of a Nitinol tube / wire hybrid grommet is depicted. The grommet may include two or more wire loops encased in a biocompatible material, forming a distal flange and a proximal flange. The flange may be continuous, such as Figure 25A and Figure 25B As shown, or may include Figure 24A and Figure 24B The cutaway section shown. There may be a hollow center section connecting the two flanges. The grommet device is stored in the delivery device in a delivery configuration. The medical professional advances the delivery device through the formed incision. Once on the distal side of the incision, the medical professional pulls back the delivery device to deploy the distal flange of the grommet into the distal side of the tissue surrounding the incision, into the deployed configuration. The medical professional can further pull the delivery device back to the proximal side of the incision to deploy the proximal flange of the grommet device in the proximal side of the tissue surrounding the incision into the deployed configuration. Once in the deployed configuration, the flanges clasp the tissue surrounding the incision. This fixes the size and shape of the incision and reduces tissue tearing. The center section of the grommet allows fluid or surgical tools to pass through the incision. Figure 24A and Figure 24B as well as Figure 25A and Figure 25B The embodiment shown in depicts an inner frame covered by an outer covering, as described above.

[0099] Figure 26A three-hoop device for securing tissue around a created incision is depicted. The incision sleeve includes a small central hoop with two larger hoop rings running parallel to the central hoop, one on each side. The small hoop provides a working path / conduit centered on the incision for fluids and / or surgical tools to pass through the incision. The larger hoop tensions the sleeve and prevents the device from being pulled out of the incision. The hoop rings are stored in a delivery device in a delivery configuration. A medical professional advances the delivery device through the created incision. Once on the distal side of the incision, the medical professional pulls back the delivery device to deploy the larger distal hoop of the three hoop rings into the distal tissue surrounding the incision, into the deployed configuration. The medical professional can further pull the delivery device back to the proximal side of the incision to deploy the larger proximal hoop of the three hoop rings proximal to the tissue surrounding the incision into the deployed configuration. Once in the deployed configuration, the larger hoop secures the tissue surrounding the incision. This secures the size and shape of the incision and reduces tissue tearing. The central hoop allows fluids or surgical tools to pass through the incision.

[0100] Figure 27A and Figure 27B A ratchet incision fixation device is depicted. An exemplary embodiment includes a distal ratchet member and a proximal ratchet member connected by a central ratchet. The ratchet fixation device is stored in a delivery device in a delivery configuration. A medical professional advances the delivery device through the created incision. Once on the distal side of the incision, the medical professional pulls back the delivery device to deploy the distal ratchet member, located on the distal side of the tissue surrounding the incision, into an deployed configuration. The medical professional can further pull the delivery device back to the proximal side of the incision to deploy the proximal ratchet member, located on the proximal side of the tissue surrounding the incision, into an deployed configuration. Once in the deployed configuration, the medical professional can ratchet the two ratchet members toward each other. The central ratchet only allows the ratchet members to move closer together, not further apart. Once in close proximity, the ratchet members clamp the tissue surrounding the incision, thereby securing the incision and reducing tissue damage. It should be noted that the incision fixation device may include alternative mechanisms for pulling the two members toward each other and / or preventing the two members from moving apart after close proximity, such as a screw mechanism, a locking mechanism, etc. For convenience, the ratchet mechanism or alternative mechanism is referred to herein as a locking mechanism.In general, any of the two-piece incision control devices having distal and proximal flanges described herein can be configured to include a locking mechanism to interlock with another incision control device.

[0101] Figure 28A and Figure 28B A circular incision fixation device is depicted. The circular fixation device can be made of nitinol, stainless steel or other biocompatible materials. Figure 28AAs shown, the fixation device can include two annular rings parallel to each other and connected by one or more central supports. The annular fixation device is stored in the delivery device in a delivery configuration. The medical professional advances the delivery device through the formed incision. Once on the distal side of the incision, the medical professional pulls back the delivery device to deploy the distal ring into the distal tissue surrounding the incision, into the deployed configuration. The medical professional can further pull the delivery device back to the proximal side of the incision to deploy the proximal ring into the proximal tissue surrounding the incision into the deployed configuration. Once in the deployed configuration, the rings connected by the central support secure the incision. This secures the size and shape of the incision and reduces tissue tearing. The central opening of the rings allows fluids and other materials to pass through the incision immediately before the permanent anastomosis is formed.

[0102] Figure 29A and Figure 29B A stent-type nitinol array is depicted. In one embodiment of the device, separate nitinol tubes create arms that can clamp tissue around the incision site. The arms are positioned around the circumference of the hollow center portion of the device. The stent-type nitinol array is stored in a delivery device in a delivery configuration. The medical professional advances the delivery device through the created incision. Once on the distal side of the incision, the medical professional pulls back on the delivery device to deploy the distal arms of the device into the distal tissue surrounding the incision, into the deployed configuration. The medical professional can further pull the delivery device back to the proximal side of the incision to deploy the proximal arms of the device into the proximal tissue surrounding the incision, into the deployed configuration. Once in the deployed configuration, the arms clasp the tissue surrounding the incision. This secures the size and shape of the incision and reduces tissue tearing. The central section of the device allows fluid or surgical tools to pass through the incision.

[0103] Figure 30A and Figure 30B An alternative embodiment of a stent-type nitinol array fixation device is depicted. This embodiment may include nitinol tubes that deform when deployed to clamp tissue around the incision. The device may include two or more nitinol tubes surrounding the circumference of a hollow central region. The stent-type nitinol array is stored in a delivery device in a delivery configuration. The medical professional advances the delivery device through the incision formed. Once on the distal side of the incision, the medical professional pulls back on the delivery device to deploy the distal nitinol tubes into the distal side of the tissue, where they deform into the deployed configuration. The medical professional can pull the delivery device further back to the proximal side of the incision to deploy the proximal nitinol tubes into the proximal side of the tissue, where they deform into the deployed configuration. Once in the deployed configuration, the tubes clasp the tissue around the incision. This secures the size and shape of the incision and reduces tissue tearing. The central section allows fluid and / or surgical tools to pass through the incision immediately.

[0104] Figure 31A and Figure 31B A helical stent-type nitinol array fixation device is depicted. A single length of nitinol, stainless steel, or other biocompatible material is coiled into two parallel or substantially parallel helical arrays connected by a central connecting member. The stent-type nitinol array is stored in a delivery device in a delivery configuration. The medical professional advances the delivery device through the formed incision. Once on the distal side of the incision, the medical professional pulls back the delivery device to deploy the distal helical array distally into the deployed configuration. The medical professional can further pull the delivery device proximal to the incision to deploy the proximal helical array proximal to the tissue into the deployed configuration. Once in the deployed configuration, the array clasps the tissue surrounding the incision.

[0105] Figure 32A and Figure 32B An embodiment of an expandable grommet for securing tissue around an incision site is depicted. The grommet may include a distal flange and a proximal flange connected by a hollow center section. The expandable grommet may be stored in a delivery device in a collapsed delivery configuration. The medical professional advances the delivery device through the formed incision. Once on the distal side of the incision, the medical professional pulls back the delivery device to deploy the distal flange of the expandable grommet into the distal side of the incision. The medical professional can further pull the delivery device back to the proximal side of the incision to deploy the proximal flange of the expandable grommet into the proximal side of the tissue. The grommet can then be expanded into the expanded configuration. Once expanded, the flanges clamp the tissue around the incision, and the hollow center section allows fluids and other materials to pass through the incision immediately.

[0106] Figure 33A and Figure 33B An embodiment of a two-piece suture clamp is depicted. The clamp may include two washers made of stainless steel or another biocompatible material, aligned parallel or substantially parallel to each other. The washers may be connected by one or more connecting members perpendicular to the washers but parallel to the other connecting members. A distal washer is attached to the connecting member. The washer can translate along the connecting member toward or away from the other washer. A medical professional positions the distal washer distal to the created incision, with the connecting member positioned through the incision. The medical professional then slides the proximal washer onto the connecting member and translates the proximal washer toward the distal washer. The mating washers clamp the tissue around the incision site, securing the tissue and maintaining the incision. The central opening of the washers allows fluids and other materials to pass through the incision immediately. Generally speaking, any of the two-piece incision control devices having distal and proximal flanges described herein can be configured to include one or more connecting members to facilitate mating with another incision control device.

[0107] In an alternative embodiment, the proximal washer is attached to the connecting member and the distal washer translates along the connecting member toward the proximal washer.

[0108] Figure 34A and Figure 34B A snap-lock incision clip is depicted, which can be considered another type of locking mechanism as described above. The incision clip can include a distal washer and a proximal washer. The distal washer and / or the proximal washer can have a snap that is configured to mate with the inner circumference of the opposing washer. The medical professional positions the distal washer on the distal side of the incision and the proximal washer on the proximal side of the incision. The medical professional then brings the washers closer to each other and slides the snap into the inner circumference of the opposing washer, thereby attaching the washers across the incision. This secures the tissue around the incision site and reduces trauma to the tissue while maintaining the incision. In general, any of the two-piece incision control devices described herein having a distal flange and a proximal flange can be configured to include a snap-lock mechanism to interlock with another incision control device.

[0109] Figure 35A and Figure 35B An embodiment of a sliding arm incision clamp is depicted. The incision clamp includes a hollow central support tube and four or more sliding arms, wherein two or more sliding arms are proximal arms and two or more sliding arms are distal arms. Figure 35A As shown, the sliding arms are in a delivery configuration for storage in the delivery device. The arms are curved to complement the outer circumference of the hollow center support tube. The medical professional advances the delivery device into the incision so that the distal arms are positioned on the distal side of the incision and the proximal arms are positioned on the proximal side of the incision. The medical professional can then deploy the arms of the sliding arm incision clamp into the deployed configuration, as shown in FIG. Figure 35B As shown. The sliding arms protrude from the hollow center support tube and clamp the tissue around the incision. Note that the arms can be deployed in any order.

[0110] Figure 36 An embodiment of a foam grommet for securing tissue around an incision is depicted. The foam grommet is stored in a compressed delivery configuration in a delivery device. A medical professional advances the delivery device distally through the incision to the tissue. The medical professional then pulls back on the delivery device, thereby deploying the distal end of the grommet into the distal lumen. The distal end of the grommet expands to the deployed configuration. The medical professional then pulls back on the delivery device, thereby deploying the proximal end of the grommet into the proximal lumen. The proximal end of the grommet expands to the deployed configuration, as Figure 36 The expanded foam grommet includes a distal flange and a proximal flange that together clamp and secure the tissue surrounding the incision.

[0111] Figure 37An embodiment of a clip-secured grommet is depicted. The clip-secured grommet may include one or more clips on the inner circumference of a hollow grommet. A single grommet is sutured around the incision, and the tissue surrounding the incision is secured to the grommet with a clip. The clip secures the tissue surrounding the incision, reducing tissue trauma and movement to protect the incision.

[0112] Figure 38 An embodiment of a coil-compressed grommet is depicted. The grommet is stored in a delivery device in a compressed delivery configuration. A medical professional advances the delivery device through an incision to the distal side of the tissue. The medical professional then pulls back on the delivery device, deploying the distal end of the grommet into the distal lumen. The distal end of the grommet expands to the deployed configuration. The medical professional then pulls back on the delivery device, deploying the proximal end of the grommet into the proximal lumen. The proximal end of the grommet expands to the deployed configuration. The coil is then used to secure the grommet to maintain the incision and stabilize the surrounding tissue.

[0113] Figures 40A to 40D An exemplary embodiment of a helical incision fixation device is depicted. A single length of nitinol, stainless steel, or other biocompatible material can be coiled into a helix around the incision site and deployed to secure the tissue. The coiled layers clamp the tissue between them, securing it and reducing trauma or movement, thereby securing the incision. The hollow center of the helix allows fluids and other materials to pass through the incision immediately before forming a permanent anastomosis.

[0114] Figure 41 An embodiment of an adhesive-enhanced incision is depicted. After the incision is formed, the tissue surrounding the incision is coated with an adhesive to reduce tearing and / or stretching at the incision site. The adhesive on the tissue leaves the center of the incision site open, allowing fluids and other materials to pass through the incision while maintaining the integrity of the incision site.

[0115] Figure 42A and Figure 42B An embodiment of a patch for fixing an incision is depicted. After the incision is formed, the incision site is supported by the patch attached to the tissue surrounding the incision site. The patch has an annular shape that allows fluids and other materials to pass through the patch and the incision.

[0116] Figure 43A and Figure 43B Described is the embodiment of the puncture patch for fixing incision.After forming incision, the incision site is supported by the patch that mechanically adheres to the tissue around the incision site.The patch may include nails or other protrusions that can pierce the tissue around the incision site to fix the patch to the tissue, thereby maintaining the incision.

[0117] Figure 44An embodiment of a crimped incision clip is depicted. The crimped incision clip is stored in a delivery device in a circular delivery configuration. The crimped incision clip can be deployed before or after the incision is made. During delivery, the crimped incision is clamped into the deployed configuration. The crimp clamp secures the tissue surrounding the incision site, securing it and supporting the incision. The clip's circular shape allows for immediate passage of fluids or other materials through the clip and incision.

[0118] The fixation element can be positioned on the target anatomical structure before forming an incision to serve as a guide for tool placement to form and approach the incision, or can be positioned on the target anatomical structure after forming the incision by adhering, clamping and / or encapsulating the anatomical structure. The element can be delivered to the target anatomical structure by the tool or the surgeon and can remain in the body after the operation is completed or be removed from the body before the operation is completed. The devices described herein allow for control of the incision site, reducing tissue tearing, expansion of the incision, and accidental trauma to the site.

[0119] As described above, in some embodiments, a magnetic compression anastomotic device and / or other device can be deployed through a channel of an incision control device, for example, for deployment in a distal lumen. The following is an exemplary anastomotic procedure using an incision control device of the type described above to support the incision and deliver a magnetic compression anastomotic device, particularly in the context of a single-stab duodenoileostomy (SADI) with an endoscopic intraluminal anastomosis (EIA).

[0120] Figure 45A is a schematic diagram showing relevant gastrointestinal anatomy for an exemplary procedure.

[0121] Figure 45B is a schematic diagram showing the gastrointestinal anatomy upon completion of a sleeve gastrectomy of the stomach (e.g., reducing the size of the stomach to approximately 100 ml-150 ml) and a single anastomosis connecting the duodenum (e.g., approximately 3 cm beyond the stomach, thereby preserving the pyloric valve) to the ileum (e.g., approximately 3 meters from the large intestine).

[0122] Figure 45C is a schematic diagram showing the portion of the duodenum where the anastomosis will be formed.

[0123] Figure 45D is a schematic diagram showing an incision made in the duodenum, for example, using an electrocautery device.

[0124] Figure 45E is a schematic diagram showing the insertion of a delivery device through an incision into the duodenum to deliver an incision control device.

[0125] Figure 45F is a schematic diagram showing a delivery device with an incision control device from within the duodenum.

[0126] Figure 45G is a schematic diagram illustrating deployment of the distal flange of the incision control device within the duodenum, such as by retracting the delivery device and / or advancing a pusher device within the delivery device. Note here that this particular incision control device includes an inner frame and an outer covering.

[0127] Figure 45H is a schematic diagram illustrating the retraction of the delivery device in preparation for delivery of the proximal flange of the incision control device.

[0128] Figure 45I is a schematic diagram showing the delivery of the proximal flange of the incision control device outside the duodenum so that the incision is not controlled from the inside and outside of the duodenum.

[0129] With the incision so controlled, one or more devices, such as a magnetic compression stapling device, can be placed within the duodenum through a passage in the incision control device.

[0130] Figure 45J is a schematic diagram showing an instrument being inserted into the duodenum through a channel of an incision control device. In this example, the instrument is a delivery device for delivering a self-assembling magnetic compression stapling device.

[0131] Figure 45K Schematic diagram of an apparatus for delivering a self-assembling magnetic compression stapling device within the duodenum. In this image, the magnetic compression stapling device is partially deployed. The sutures used to manipulate the magnetic compression stapling device can be seen.

[0132] Figure 45L Schematic diagram showing the self-assembling magnetic compression anastomotic device fully deployed and fully assembled in the duodenum. The sutures used to manipulate the magnetic compression anastomotic device can be seen.

[0133] Figure 45M is a schematic diagram showing the instrument being retracted from the duodenum to leave behind a fully deployed magnetic compression anastomotic device and sutures.

[0134] Figure 45N is a schematic diagram illustrating a magnetic compression stapling device being manipulated into position around an incision control device using sutures, against the incision and the inner surface of the duodenum around the incision control device. In this embodiment, the flange of the incision control device is shaped or otherwise configured to facilitate positioning of the magnetic compression stapling device around the incision control device, such as in a tapered configuration.

[0135] Figure 45O is a schematic diagram showing a duodenal incision made from the outer surface of the duodenum.

[0136] A similar procedure can be performed on the ileum before or after the incision is made in the duodenum.

[0137] Figure 46A Schematic diagram showing an incision made in the ileum, for example, using an electrocautery device.

[0138] Figure 46B is a schematic diagram showing the insertion of a delivery device through an incision into the ileum to deliver an incision control device.

[0139] Figure 46C Schematic diagram showing the retraction of the delivery device from the ileum after deployment of the distal flange of the incision control device in the ileum.

[0140] Figure 46D Schematic diagram showing the proximal flange of an incision control device being delivered to the outer surface of the ileum.

[0141] Figure 46E Schematic diagram showing an instrument being inserted into the ileum through a channel of an incision control device. In this example, the instrument is a delivery device for delivering a self-assembling magnetic compression anastomosis device.

[0142] Figure 46F Schematic diagram showing the apparatus after delivery of the magnetic compression anastomosis device in the ileum. The sutures used to manipulate the magnetic compression anastomosis device can be seen.

[0143] Figure 46G Schematic diagram showing the instrument being retracted from the incision to allow the self-assembling magnetic compression anastomotic device to be fully deployed and assembled within the ileum. The sutures used to manipulate the magnetic compression anastomotic device can be seen.

[0144] With the incisions fully formed and controlled in both the duodenum and ileum, and with the magnetic compression anastomosis device fully deployed within the duodenum and ileum, as Figure 47A As schematically depicted in , the two incisions can be brought together, e.g. Figure 47B Until they are in contact and aligned via the incision control device and the magnetic compression anastomosis device, as schematically depicted in Figure 47C Sutures can be used to position the magnetic compression anastomosis device. Figure 47D is a schematic diagram showing an incision control device and a magnetic compression anastomosis device positioned to allow immediate fluid communication from the duodenum through the incision to the ileum even before the anastomosis is formed, as shown Figure 47E Typically after about 1 to 7 days, the tissue of the duodenum and ileum surrounding the incision will degrade to the point where the incision control device will dislodge and pass through the ileum leaving only the magnetic compression anastomosis device in place, as shown. Figure 47F and Figure 47GTypically after about 10 to 14 days, the anastomosis will be fully formed and the magnetic compression anastomotic device will be removed and passed through the ileum to leave a fully formed anastomosis, as shown in FIG. Figure 47H and Figure 47I Schematically depicted in .

[0145] It should be noted that in various alternative embodiments, the proximal and distal flanges may be of the same configuration or may be of different configurations, for example, the distal flange positioned within the lumen may be shaped or otherwise configured to assist in positioning the magnetic compression anastomosis device, while the proximal flange positioned outside the lumen may be shaped or otherwise configured to assist in attaching the magnetic compression anastomosis device. Figures 47C to 47D (e.g., the distal flange may be tapered, while the proximal flange may be flatter to assist in mating the two cutouts.) In this regard, the proximal flange may be shaped or configured to mate with the other proximal flange, for example, with interlocking raised and / or recessed features.

[0146] It should be noted that any two-piece cut control device may include a ratchet mechanism (e.g., Figure 27A and Figure 27B ) or other connecting mechanism to help maintain the connection between the two halves.

[0147] It should be noted that the flange of the notch control device may have any number of rings or lobes, e.g. Figure 1 The device shown comprises a single ring or lobe, Figure 45G Each flange of the device shown comprises two rings or lobes, Figure 6A Each flange of the device shown comprises four rings or lobes, Figure 5 The device shown comprises eight rings or lobes per flange, Figure 14A The device shown includes 16 rings or lobes per flange, etc., and each flange of the device can have any number of rings or lobes, such as 1, 2, 3, 4, etc. It should be noted that the flanges can have the same number and configuration of rings or lobes, or can have different numbers and / or configurations of rings or lobes. For example, the distal flange can have multiple rings or lobes (e.g., to facilitate delivery of an incision control device and placement of a magnetic compression stapling device), and the proximal flange can have a single ring or lobes (e.g., to facilitate mating with the proximal flange of another incision control device).

[0148] The following is a description of some alternative types of incision control devices, which generally operate by clamping around the boundaries of the incision.

[0149] Figures 9 to 12Schematic diagram of various views of a clamp-type device used to control acute incisions. The clamp works by anchoring the perimeter of tissue near the incision site to strengthen the tissue and distribute the forces applied during subsequent surgical procedures to the device rather than the tissue. This prevents expansion or contraction of the incision site. Figure 9 and Figure 10 As shown, the device includes a rigid or semi-rigid conduit that acts as an open channel to facilitate deployment and alignment of surgical tools and maintain fluid passage through the tissue wall. The clamping device may also include features to secure the compression stapling device to the tool, thereby allowing single-handed manipulation and control of the tissue and compression stapling device.

[0150] The clamp device can be deployed endoscopically, laparoscopically, robotically, or during open surgery. After an acute incision is made, the clamp is clamped onto the tissue surrounding the incision site. This allows for control of the incision diameter and reduces tearing and expansion of the tissue surrounding the incision site.

[0151] The clamp may also include features to secure the compression stapling device to the tool, thereby allowing single-handed manipulation and control of the tissue and the compression stapling device.

[0152] The apertured design of various embodiments allows the clamp to grasp and support tissue surrounding the incision site while maintaining an open channel for tool passage during surgery. In some embodiments, after the magnets are engaged, the clamp can remain in place to provide a channel for fluid passage before completing a permanent anastomosis.

[0153] Exemplary embodiments of the clamp-type device may be removed by the medical professional before the procedure is complete, leaving behind the incision or formed stoma.

[0154] The apparatus of the present invention may be used to facilitate alignment of an incision with a mating surgical site to form an anastomosis.

[0155] like Figure 11 As shown, the clamping device may include a flexible member or a mobile hinge point that allows the tissue to be clamped proximally before being clamped distally. This allows the tissue to be adjusted between the proximal and distal ends of the grasping element.

[0156] Figure 12 An exemplary embodiment of a spring-loaded clamping device, or incision clip, is depicted. The incision clip can be deployed around an incision site to secure tissue. The incision clip includes a perforated design to allow fluid to pass through the incision. The incision clip clamps tissue around the incision site, thereby reducing tearing, expansion, or movement of the incision site.

[0157] Figure 39A and Figure 39BAn embodiment of a spring-loaded incision clip is depicted. The incision clip can be deployed around an incision site to secure tissue. The incision clip includes a perforated design to allow fluid to pass through the incision. The incision clip clamps the tissue around the incision site, thereby reducing tearing, expansion, or movement of the incision site.

[0158] Although various inventive embodiments have been described and exemplified herein, a person of ordinary skill in the art will readily conceive of various other means and / or structures for performing the functions and / or obtaining the results and / or one or more advantages described herein, and each of these variations and / or modifications is considered to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications in which the teachings of the present invention are used. Those skilled in the art will recognize or be able to determine, using only routine experimentation, many equivalents to the specific inventive embodiments described herein. Therefore, it should be understood that the foregoing embodiments are presented by way of example only, and that within the scope of the appended claims and their equivalents, embodiments of the present invention may be practiced in a manner other than as specifically described and claimed. The inventive embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the invention of the present disclosure if they are not inconsistent with each other.

[0159] Various inventive concepts can be embodied as one or more methods, examples of which have been provided. The actions performed as part of a method can be ordered in any suitable manner. Thus, embodiments can be constructed in which actions are performed in an order different from that illustrated, which can include performing some actions simultaneously, even though shown as sequential actions in an illustrative embodiment.

[0160] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0161] Unless clearly indicated to the contrary, the indefinite articles "a" and "an" as used herein in the specification and claims should be understood to mean "at least one."

[0162] As used herein in the specification and claims, the phrase "and / or" should be understood to mean "either or both" of the elements so combined, i.e., elements that are present in combination in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so combined. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, when used in conjunction with open language such as "comprising," a reference to "A and / or B" may, in one embodiment, refer only to A (optionally including elements in addition to B); in another embodiment, to B (optionally including elements in addition to A); in yet another embodiment, to both A and B (optionally including other elements); and so on.

[0163] As used herein in the specification and claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as inclusive, that is, including at least one (but also including more than one) of a plurality of elements or a list of elements, and optionally, additional unlisted items. Only terms that clearly indicate the opposite, such as "only one" or "exactly one", or when used in the claims, "consisting of..." will refer to including exactly one element in a plurality of elements or a list of elements. Generally, the term "or" as used herein will only be interpreted to indicate an exclusive alternative (i.e., "one or the other but not both") when preceded by an exclusive term, such as "either", "one", "only one" or "exactly one". When used in the claims, "consisting essentially of..." should have its ordinary meaning used in the field of patent law.

[0164] As used herein in the specification and claims, the phrase "at least one" with respect to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, but does not necessarily include at least one of each element specifically listed within the list of elements, and does not exclude any combination of elements in the list of elements. This definition also allows for elements to optionally be present other than those specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B," or equivalently, "at least one of A and / or B") may refer, in one embodiment, to at least one, optionally including more than one A, wherein B is absent (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one B, wherein A is absent (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one A, and at least one, optionally including more than one B (and optionally including other elements); and so on.

[0165] As used herein in the specification and claims, all transitional phrases such as "comprise," "include," "carry," "have," "contain," "involving," "maintaining," "consisting of," and the like are to be construed as open-ended, i.e., meaning including, but not limited to, "consisting of." Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0166] Although the above discussion discloses various exemplary embodiments of the present invention, it should be apparent that those skilled in the art can make various modifications that will achieve some of the advantages of the present invention without departing from the true scope of the present invention. Any reference to the "present invention" is intended to refer to exemplary embodiments of the present invention and should not be construed as referring to all embodiments of the present invention unless the context otherwise requires. The described embodiments are to be considered in all respects only as illustrative and not restrictive.

Claims

1. An incision control device, comprising: A distal flange and a proximal flange, the distal flange and the proximal flange being separated and connected by a central channel, wherein the distal flange and the proximal flange are configured to compress to fit the incision control device in a delivery configuration within a working channel of an access device or a delivery device, and to expand on opposite sides of the incision to secure the incision in a fully deployed configuration after being delivered from the working channel.

2. The device according to claim 1, wherein Each flange includes a shape memory material.

3. The device according to claim 2, wherein The shape memory material includes Nitinol shape memory material.

4. The device according to claim 2, wherein The shape memory material includes a spring material.

5. The device according to claim 1, wherein Each flange includes an inner frame and an outer covering surrounding some or all of the inner frame.

6. The device according to claim 5, wherein The outer covering comprises a biocompatible material.

7. The device according to claim 5, wherein The outer covering comprises a flexible material.

8. The device according to claim 7, wherein The flexible material includes at least one of plastic, rubber, polyurethane or polymer.

9. The device according to claim 5, wherein The outer covering is injection molded onto the inner frame.

10. The device according to claim 1, wherein The distal flange, the proximal flange and the channel are formed as a unitary device.

11. The device according to claim 1, wherein The flange is expandable.

12. The device of claim 1, further comprising at least one magnet.

13. The device according to claim 12, wherein The at least one magnet is located in the distal flange.

14. The device according to claim 12, wherein The at least one magnet is located in the proximal flange.

15. The device according to claim 12, wherein The at least one magnet is positioned around the central channel.

16. The device according to claim 1, wherein At least one of the flanges is shaped or configured to assist in positioning the magnetic compression stapling device around the incision control device.

17. The device according to claim 16, wherein At least one of the flanges is tapered.

18. The device according to claim 1, wherein The flanges have the same configuration.

19. The device according to claim 1, wherein The flanges have different configurations.

20. The device according to claim 1, wherein The proximal flange is shaped or configured to mate with a proximal flange of another incision control device.

21. The device according to claim 1, wherein The cut control device is a two-piece device comprising a distal half-section including the distal flange and a proximal half-section including the proximal flange, wherein the distal half-section and the proximal half-section are configured to interlock to form the central channel.

22. The device of claim 21, further comprising a locking mechanism for at least one of approximating the distal and proximal half-sections or preventing separation of the distal and proximal half-sections after approximation.

23. The device of claim 21, further comprising at least one connecting member to facilitate mating of the device with another incision control device.

24. The apparatus according to claim 1, wherein At least one flange comprises a single ring or lobe.

25. The apparatus according to claim 1, wherein At least one flange includes a plurality of rings or lobes.

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