Systems and methods for acute incision preservation and manipulation - Patents.com

Abstract

Various types of incision control devices secure tissue surrounding and / or adjacent to a 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 unintended trauma, dilation, contraction, or migration of the incision during a surgical procedure. They can also serve the beneficial purpose of allowing immediate communication between lumens prior to the complete creation of a permanent anastomosis. In some embodiments, magnetic compression anastomosis devices and / or other devices can be deployed through a channel in the incision control device, such as for deployment within the distal lumen.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 435,724, entitled "SYSTEMS AND METHODS FOR PRESERVING AND MANIPULATING OF ACUTE OTOMIES," filed December 28, 2022, and U.S. Provisional Patent Application No. 63 / 419,509, entitled "SYSTEMS AND METHODS FOR PRESERVING AND MANIPULATING OF ACUTE OTOMIES," filed October 26, 2022, each of which is incorporated by reference herein in its entirety.

[0002] The present invention relates to devices and methods for preserving, manipulating, and capturing acute incisions, and in particular to the intraoperative capture of acute incisions between two or more compression anastomosis devices.

[0003] Background technology Bypasses or detours in the gastrointestinal (GI), cardiovascular, or urinary systems are traditionally created by cutting holes in tissue (i.e., acute incisions) in two locations and then joining the holes with sutures or staples. The bypass or detour is typically positioned to route fluids (e.g., secretions, blood, nutrients) between healthier parts of the system while bypassing diseased or dysfunctional tissue, or to shorten the overall path of the luminal system. This procedure is typically invasive and exposes patients to risks such as bleeding, infection, pain, and adverse reactions to anesthesia. Additionally, bypasses or detours created with sutures or staples can be complicated by postoperative leakage and adhesions. Leaks can lead to infection or sepsis, while adhesions can lead to complications such as intestinal strangulation and obstruction. Traditional bypass procedures can be completed using endoscopes, laparoscopes, or robots, but joining the holes cut in the tissue can be time-consuming. Furthermore, such procedures require specialized expertise and equipment that is not available in many surgical facilities.

[0004] 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 pair of magnets can be delivered to the tissues to be joined. Due to the strong compression, the tissue trapped between the coupling or magnets is cut off from its blood supply. Under these conditions, the tissue necrotizes and degenerates, while new tissue grows around the compression point, e.g., on the edges of the coupling. Over time, the coupling can be removed, leaving a healed anastomosis between the tissues.

[0005] Current practice for accessing internal lumens / organs to deliver compression couplings or magnets often requires the creation of acute incisions. Once the desired surgery is complete, these acute incisions require subsequent closure procedures. This adds a procedural step, increases procedure time, and requires effort on the part of the physician to preserve the incision against tearing / dilatation due to intraoperative manipulation. This also adds risk for the patient in the form of uncontrolled tearing / dilatation of the incision due to manipulation, which can result in acute or even chronic anastomotic leakage. Additionally, compression anastomoses can take up to two weeks to develop, which may prevent the immediate positive effects of the procedure and limit the types of procedures that can be performed using compression anastomosis devices.

[0006] Thus, there remains a need for devices and methods that reduce the need for an incision closure step and create immediate communication between the lumens prior to the complete creation of a permanent anastomosis.

[0007] Summary of the Invention According to one embodiment of the present invention, the dissection control device comprises distal and proximal flanges separated and connected by a central channel, the distal and proximal flanges configured to compress to fit the dissection control device within a working channel of an access or delivery device in a delivery configuration and to expand on either side of the incision to secure the incision upon delivery from the working channel in a fully deployed configuration.

[0008] In various alternative embodiments, each flange may comprise a shape memory material, such as nitinol shape memory material or a spring material. Each flange may comprise an internal framework and an external cover surrounding some or all of the internal framework. The external cover may comprise a biocompatible material or a flexible material, such as plastic, rubber, urethane, or polymer, which may be formed on or above the internal framework, such as by injection molding. Alternatively, the distal flange, proximal flange, and channel may be formed as a unitary device. The flanges may be expandable. The device may include one or more magnets, for example, located within the distal flange, within the proximal flange, and / or located around the central channel. At least one of the flanges may be shaped or configured to aid in positioning the magnetic compression anastomosis device around the dissection control device, such as by being tapered. The flanges may have the same configuration or different configurations. The proximal flange may be shaped or configured to mate with the proximal flange of another dissection control device. The dissection control device may be a two-piece device comprising a distal half including a distal flange and a proximal half including a proximal flange, the distal and proximal halves configured to interlock and form a central channel, in which case the device may include a locking mechanism for approximating the distal and proximal halves and / or preventing separation after the distal and proximal halves have been approximated. The dissection control device may include at least one connecting member to assist in mating the device with another dissection control device. In various alternative embodiments, each flange may include one or more loops or lobes.

[0009] Additional embodiments may be disclosed and claimed.

[0010] Those skilled in the art will more fully appreciate the advantages of various embodiments of the present invention from the following Description of Exemplary Embodiments, discussed with reference to the drawings summarized immediately below. [Brief explanation of the drawings]

[0011] [Figure 1] 1A and 1B illustrate schematic diagrams of an exemplary device for controlling an acute incision. [Figure 2A] 1 illustrates a schematic of the treatment steps for acute incision creation, control, and healing. [Figure 2B] 1 illustrates a schematic of the treatment steps for acute incision creation, control, and healing. [Figure 2C] 1 illustrates a schematic of the treatment steps for acute incision creation, control, and healing. [Figure 2D] 1 illustrates a schematic of the treatment steps for the creation, control, and healing of an acute incision. [Figure 2E] 1 illustrates a schematic of the treatment steps for the creation, control, and healing of an acute incision. [Figure 2F] 1 illustrates a schematic of the treatment steps for the creation, control, and healing of an acute incision. [Figure 2G] 1 illustrates a schematic of the treatment steps for acute incision creation, control, and healing. [Figure 2H] 1 illustrates a schematic of the treatment steps for acute incision creation, control, and healing. [Figure 2I] 1 illustrates a schematic of the treatment steps for acute incision creation, control, and healing. [Figure 3] 10A-B show a schematic of a silicone grommet identifying the intraluminal and extraluminal flanges and how the grommet seats transmurally within tissue. [Figure 4] 1A and 1B illustrate schematic diagrams of a nitinol tubing / wire hybrid grommet. [Figure 5] 1A and 1B illustrate schematic diagrams of a nitinol tubing / wire hybrid grommet. [Figure 6A] 1A and 1B illustrate schematic diagrams of a nitinol tubing / wire hybrid grommet. [Figure 6B] 1A and 1B illustrate schematic diagrams of a nitinol tubing / wire hybrid grommet. [Figure 7A] 1 shows a schematic representation of a nitinol wire array clamp. [Figure 7B] 1 shows a schematic representation of a nitinol wire array clamp. [Figure 8] 1 shows a schematic representation of an inflatable grommet. [Figure 9] 1 shows a schematic representation of a device for controlling an incision. [Figure 10] 1 shows a schematic representation of a device for controlling an incision. [Figure 11] 1 shows a schematic representation of a device for controlling an incision. [Figure 12] 10A and 10B show schematic views of a spring-loaded clamping element for securing the incision. [Figure 13A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 13B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 14A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 14B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 15A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 15B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 16A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 16B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 17A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 17B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 18A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 18B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 19A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 19B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 20A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 20B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 21A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 21B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 22A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 22B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 23A] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 23B] 1A and 1B are schematic perspective views of a nitinol tubing device for securing an incision; [Figure 24A] 1A and 1B show schematic perspective views of a nitinol tubing / wire hybrid device for securing an incision. [Figure 24B] 1A and 1B show schematic perspective views of a nitinol tubing / wire hybrid device for securing an incision. [Figure 25A] 1A and 1B show schematic perspective views of a nitinol tubing / wire hybrid device for securing an incision. [Figure 25B] 1A and 1B show schematic perspective views of a nitinol tubing / wire hybrid device for securing an incision. [Figure 26] 10A-10C show schematic diagrams of a nitinol tubing / wire hybrid device for securing an incision. [Figure 27A] 1 shows a perspective view of a ratchet locking device for locking an incision. [Figure 27B]1 shows a perspective view of a ratchet locking device for locking an incision. [Figure 28A] 1 shows a perspective view of a circular fixation device for fixing an incision. [Figure 28B] 1 shows a perspective view of a circular fixation device for fixing an incision. [Figure 29A] 10A-10C show schematic diagrams of a stent-type nitinol array device for securing an incision. [Figure 29B] 10A-10C show schematic diagrams of a stent-type nitinol array device for securing an incision. [Figure 30A] 10A-10C show schematic diagrams of a stent-type nitinol array device for securing an incision. [Figure 30B] 10A-10C show schematic diagrams of a stent-type nitinol array device for securing an incision. [Figure 31A] 10A and 10B show schematic diagrams of a stent-type nitinol array helical wire device for securing an incision. [Figure 31B] 10A and 10B show schematic diagrams of a stent-type nitinol array helical wire device for securing an incision. [Figure 32A] 10A-10C illustrate diagrammatically an inflatable grommet device for securing an incision. [Figure 32B] 10A-10C illustrate diagrammatically an inflatable grommet device for securing an incision. [Figure 33A] 1 shows a schematic representation of a two-part suture clamping device for securing an incision. [Figure 33B] 1 shows a schematic representation of a two-part suture clamping device for securing an incision. [Figure 34A] 10A and 10B show diagrammatically a snap locking device for securing the incision. [Figure 34B] 10A and 10B show diagrammatically a snap locking device for securing the incision. [Figure 35A] 10A and 10B show schematic diagrams of a sliding arm incision clip for securing an incision. [Figure 35B] 10A and 10B show schematic diagrams of a sliding arm incision clip for securing an incision. [Figure 36]10A-10C illustrate a schematic representation of a foam grommet device for securing an incision. [Figure 37] 10A and 10B illustrate diagrammatically a clip-securing grommet incision clip device for securing an incision. [Figure 38] 10A-10C illustrate diagrammatically a coil compression grommet device for securing an incision. [Figure 39A] 1A and 1B show schematic perspective views of an incision clip device for securing an incision; [Figure 39B] 1A and 1B show schematic perspective views of an incision clip device for securing an incision; [Figure 40A] 10A and 10B show a schematic illustration of the concept of a coiled wire for securing an incision. [Figure 40B] 10A and 10B show a schematic illustration of the concept of a coiled wire for securing an incision. [Figure 40C] 10A and 10B show a schematic illustration of the concept of a coiled wire for securing an incision. [Figure 40D] 10A and 10B show a schematic illustration of the concept of a coiled wire for securing an incision. [Figure 41] 10A and 10B show schematic diagrams of adhesive reinforcement devices for securing incisions; [Figure 42A] 10A and 10B show schematic diagrams of an incision clip patch for securing an incision. [Figure 42B] 10A and 10B show schematic diagrams of an incision clip patch for securing an incision. [Figure 43A] 10A and 10B show schematic diagrams of an incision clip puncture patch for securing an incision. [Figure 43B] 10A and 10B show schematic diagrams of an incision clip puncture patch for securing an incision. [Figure 44] 10A and 10B show schematic diagrams of a crimped wire incision clip for securing an incision. [Figure 45A] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45B]10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45C] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45D] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45E] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45F] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45G] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45H] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45I] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45J]10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45K] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45L] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45M] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45N] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 45O] 10A-10C illustrate schematic diagrams of the formation of a duodenal incision for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using an incision control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 46A] 10A-10C illustrate schematic diagrams of the formation of an ileotomy for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 46B] 10A-10C illustrate schematic diagrams of the formation of an ileotomy for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 46C]10A-10C illustrate schematic diagrams of the formation of an ileotomy for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 46D] 10A-10C illustrate schematic diagrams of the formation of an ileotomy for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 46E] 10A-10C illustrate schematic diagrams of the formation of an ileotomy for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 46F] 10A-10C illustrate schematic diagrams of the formation of an ileotomy for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 46G] 10A-10C illustrate schematic diagrams of the formation of an ileotomy for a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47A] 10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47B] 10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47C] 10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47D]10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47E] 10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47F] 10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47G] 10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47H] 10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments. [Figure 47I] 10A-10C illustrate schematic diagrams of the formation of an anastomosis for a single anastomosis duodenoileostomy (SADI) with intracorporeal anastomosis (EIA) using a dissection control device and a self-assembling magnetic compression anastomosis device, according to certain embodiments.

[0012] MODE FOR CARRYING OUT THE INVENTION It should be noted that the above-described figures and the elements depicted therein are not necessarily drawn to consistent or any scale. Unless the context suggests otherwise, like elements are designated by like numerals. The drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein.

[0013] Exemplary embodiments of the present invention include systems and methods for preserving and manipulating acute incisions. Various embodiments enable intraoperative capture of the incision between two or more devices to create a compression anastomosis. The embodiments described herein may reduce or eliminate the need for an acute incision closure step, reducing the risk of anastomotic leakage. Certain embodiments of the present invention include various types of incision control devices that secure surrounding and / or adjacent tissue around a 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 unintended trauma, dilation, contraction, or migration of the incision during a surgical procedure. They may also serve the beneficial purpose of allowing immediate communication between lumens prior to the complete creation of a permanent anastomosis. In some embodiments, magnetic compression anastomosis devices and / or other devices can be deployed through a channel in the incision control device, such as for deployment within a distal lumen.

[0014] As used herein, distal and proximal are relative to the access device handle. As used herein, particularly with respect to an access or delivery device for deploying a magnetic compression anastomosis device or a dissection control device, the terms "distal" and "proximal" generally refer to such access or delivery device, e.g., "distal" being further from the access or delivery device than "proximal." In some situations, the terms "distal" and "proximal" may refer to the lumen, e.g., "distal" being generally within the lumen and "proximal" being generally outside the lumen.

[0015] It should be noted that although certain embodiments are described herein with reference to nitinol shape memory material, the embodiments are not limited to nitinol, and instead other shape memory materials, including, but not limited to, materials that can act as springs, may be used in various alternative embodiments.

[0016] 1-3 illustrate an exemplary dissection control device according to certain embodiments. Like many of the dissection control devices described herein, the dissection control device shown in FIGS. 1-3 is a dual-flange device (referred to herein as a grommet). As shown in FIGS. 1 and 3, the grommet device may include a distal flange and a proximal flange connected by a channel of smaller diameter than the flanges. A central channel between the flanges connects the flanges while 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 passage through the grommet. Grommets are typically, but not necessarily, annular.

[0017] 2A-2I illustrate a method of controlling an incision, such as during the creation of a permanent anastomosis, using an incision control device of the type shown in FIG. 1. Generally speaking, the procedure for controlling the incision and anastomosis formation may be completed endoscopically, laparoscopically, robotically, by open field surgery, or a combination thereof.

[0018] An incision is made in the organ and / or intestine as shown in Figure 2 A. After the incision is made, an access device is cannulated through the incision to advance the tissue distally into the organ / intestine lumen.

[0019] The grommet device is compressed within the working channel of the access device in the delivery configuration, with the distal flange toward the distal end of the access device and the proximal flange toward the proximal end of the access device. The access device can house the grommet within a rigid tube, such as a cannula, or via a flexible tube, such as a catheter or endoscope. The grommet, in some embodiments, may be housed within the working channel of a secondary delivery device within the access device. The secondary delivery device can move proximally, distally, and rotationally within the access device. The secondary delivery device may store the grommet prior to deployment of the grommet into the patient's body.

[0020] The access device, in some embodiments, may include a pusher device in addition to or instead of a secondary delivery device to deploy the grommet into the patient's lumen. The pusher may include a monolithically formed push rod or wire, cable, or articulating mechanism that advances the grommet from the access device. The pusher may be rigid, semi-rigid, or flexible.

[0021] The medical professional advances the access device into the distal lumen, deploying the distal flange of the device while the proximal flange remains inside the access device. The distal flange may be deployed by retracting the access device, advancing a secondary delivery device, and / or advancing a pusher. After the distal flange is deployed within the lumen, distal to the incision, the distal flange expands to a deployed configuration.

[0022] The medical professional retracts the access device from the lumen into the body cavity. The medical professional then retracts the access device, retracts a secondary delivery device, and / or advances the pusher to deploy the proximal flange proximal to the tissue surrounding the incision. Upon deployment from the access device, the proximal flange expands to a deployed configuration. As shown in FIG. 2B, the grommet is then in a fully deployed configuration, with the distal flange engaging the distal side of the tissue surrounding the incision in the lumen and the proximal flange engaging the proximal side of the tissue surrounding the incision.

[0023] In some embodiments, a medical professional can endoscopically insert an access device into a lumen. From inside the lumen, the medical professional advances the access device through a tissue wall and into the body cavity. The distal flange may be deployed by retracting the access device, advancing a secondary delivery device, and / or advancing a pusher. After the distal flange is deployed into the body cavity distal to the incision, the distal flange expands to the deployed configuration.

[0024] The medical professional retracts the access device from the body cavity into the lumen. The medical professional then retracts the access device, retracts the secondary delivery device, and / or advances the pusher to deploy the proximal flange proximal to the tissue surrounding the incision. Upon deployment from the access device, the proximal flange expands to a deployed configuration. As shown in FIG. 2B, the grommet is then in a fully deployed configuration, with the distal flange engaging the distal side of the tissue surrounding the incision in the body cavity and the proximal flange engaging the proximal side of the tissue surrounding the incision in the lumen.

[0025] In the fully deployed configuration, as shown in FIG. 2B, the grommets allow for incision control, reduced tissue expansion / tear surrounding the incision, and a channel for immediate fluid flow through the incision.

[0026] After the grommet is deployed within the incision, the medical professional can advance an access device through the incision for further surgical procedures, as shown in FIG. 2C. For example, in creating an anastomosis, the medical professional may deploy a magnetic compression anastomosis device or other device through the grommet and into the lumen of the patient's organ / intestine at the target anastomosis site. Additionally or alternatively, the medical professional may deploy a magnetic compression anastomosis device or other device into the lumen prior to deployment of the grommet. FIG. 2D shows a magnetic compression anastomosis device deployed within 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 out of the lumen.

[0027] The methods and steps described above and depicted in Figures 2A-2D may be repeated one or more times at another target anastomosis site in another organ / intestine / lumen of the patient. A medical professional may then approximate the incisions at one or more target sites. The incisions may be manipulated, for example, endoscopically, laparoscopically, robotically, or in open-field surgery. The medical professional may manipulate the incisions using sutures attached to a magnetic compression anastomosis device, for example, as shown in Figure 2E.

[0028] After the magnetic compression anastomosis devices are brought into proximity with each other, they interlock due to attractive magnetic forces, compressing the tissue between them to form the anastomosis, as shown in Figure 2F. As shown in Figure 2G, the channels in the grommets allow immediate patency and fluid passage between the lumens before complete creation of the anastomosis.

[0029] The magnetic compression anastomosis device compresses and necrotizes the tissue between them. As the tissue necroses, the grommets may fall off the target site and naturally pass from the patient, as shown in Figure 2H. After complete formation of the anastomosis, the magnetic compression anastomosis device also falls away from the target site and naturally passes from the patient, leaving behind a fully formed anastomosis, as shown in Figure 2I.

[0030] The compression anastomosis devices described herein may include articulating magnetic compression anastomosis devices, which may be self-assembling. For example, magnetic anastomosis devices of certain embodiments generally comprise magnetic segments that can assume a delivery configuration and a deployed configuration. The delivery configuration is typically linear so that the device can be delivered to tissue using an endoscope or similar device, through a laparoscopic "keyhole" incision, or via a natural pathway, e.g., delivery via the esophagus. Additionally, the delivery configuration typically has some flexibility so that the device can be guided through various curves within the body. Once the device is delivered, it will assume a deployed configuration of a desired shape and size by automatically transforming from the delivery configuration to the deployed configuration. The self-transformation from the delivery configuration to the deployed configuration is directed by a coupling structure that moves the magnetic segments in a desired manner without intervention.

[0031] Generally, a magnetic anastomosis procedure involves positioning first and second magnetic structures adjacent to first and second portions of tissue, respectively, thus bringing the tissues together. When the two devices are brought into proximity, the magnetic structures interlock, bringing the tissues together. Over time, an anastomosis of the size and shape of the device will form, and the device will fall away from the tissue. In particular, the tissue surrounded by the device will be allowed to necrotize and decompose, providing an opening between the tissues.

[0032] FIG. 3 depicts a side view of the exemplary grommet incision control device of FIG. 1. 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 flanges. As shown in FIG. 3, the grommet is deployed across the incision with one flange engaging the interior lumen of the tissue and the other flange engaging the exterior lumen of the tissue. The inner diameter channel allows for immediate patency and fluid passage through the incision. Additionally, this passage allows for deployment of a compression anastomosis device within the lumen distal to the incision, as shown in FIG. 3.

[0033] In various embodiments, the dissection control device includes an internal framework and an external cover that surrounds some or all of the internal framework. Generally speaking, the internal framework and / or the external cover may include flexible portions (e.g., portions associated with the flanges) that allow the dissection control device to be compressed within the delivery device but also allow the dissection control device flanges to automatically expand or deploy when deployed from the delivery device. Thus, for example, the internal framework 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 cover may be made from any suitable material (e.g., plastic, rubber, urethane, polymer, etc.) and formed using any suitable technique (e.g., lamination, injection molding, etc.). The internal framework and / or the external cover are made to include a biocompatible material. It should be understood that various alternative dissection control devices are described herein, and that some embodiments depict configurations that may be used alone and / or with an external cover (e.g., some embodiments depict configurations that may be an internal framework upon which or over which an external cover may be formed). It should also be understood that some embodiments may be formed without an internal framework. For example, certain devices (e.g., as shown in FIGS. 1 and 32A / B) may be formed as a one-piece device (e.g., injection molded) with flanges that are sufficiently flexible for storage within a delivery device and expansion upon deployment.

[0034] In various embodiments, magnets may be incorporated into the grommet (e.g., into one or both of the flanges and / or around the central channel section), combining the grommet and magnetic compression anastomosis device into a single device. One or more magnets may be incorporated into the distal and / or proximal flanges, or the entire grommet. This would allow the grommet to control the incision while also acting as a magnetic compression anastomosis device.

[0035] 4 depicts an exemplary embodiment of a grommet-type incision control device. The grommet depicted in FIG. 4 comprises a semi-rigid or rigid conduit that acts as an open channel to facilitate deployment and alignment of surgical tools and fluid passage through the incision. The grommet may be constructed from nitinol, stainless steel, or other biocompatible materials.

[0036] FIG. 5 depicts a nitinol tubing or wire hybrid grommet. The nitinol wires or tubes may be attached to a central tube section and clamp the periphery of the tissue surrounding the incision from both sides. The central tube section preserves shape and size, reducing tissue tearing surrounding the incision while allowing the passage of fluids and surgical tools through the incision. The central tube section may be made of any suitable material (e.g., nitinol, stainless steel, etc.). To deliver this device into a patient, the device would be housed within a delivery device, such as an endoscope, laparoscope, or catheter, with the top set of nitinol wires / tubes extending upward and the bottom set of nitinol wires / tubes extending downward. Note that the embodiments shown in FIGS. 5-6B, 13A-19B, and 21A-25B may be delivered to a patient in this manner.

[0037] 6A-6B depict another exemplary nitinol tubing or wire hybrid grommet. The grommet may include two or more bent wire loops attached to a tubing section. FIGS. 6A-6B depict a wire hybrid grommet including four bent wire loops. The wire loops may be constructed from nitinol, stainless steel, or other biocompatible materials. The bent wire loops clamp the tissue surrounding the incision, fixing the size and shape of the incision and reducing tissue tearing. The tubing sections allow for the passage of fluids or surgical tools through the incision. The embodiment shown in FIGS. 6A-6B depicts an internal framework covered by an external covering, as described above.

[0038] 7A-7B depict a nitinol wire stent array grommet. The nitinol wire stent array clamps the tissue surrounding the incision site, securing the incision and reducing tissue deformation around the incision. As depicted in FIG. 7B, the flanges of the nitinol wire stent array engage the distal and proximal sides of the tissue, respectively, while the tubular section passes through the incision, allowing immediate patency and fluid passage before complete formation of a permanent anastomosis. The tubular section also maintains the diameter of the incision because the flanges reduce tearing and expansion of the tissue surrounding the incision during the surgical procedure.

[0039] 8 depicts an exemplary embodiment of an expandable grommet. The expandable grommet is contracted to a delivery configuration within an access device. After deployment into the lumen distal to the incision, the distal flange of the grommet is expanded to a deployed diameter. The proximal flange is then deployed proximal to the incision and expanded to the deployed diameter. Once expanded to the deployed configuration, the expandable grommet secures the incision and reduces tissue tearing around the incision site.

[0040] 13A-13B depict perspective views of an exemplary nitinol tubing / wire hybrid grommet for securing acute incisions. This device is similar to the device shown in FIG. 5, but includes a central open ring section rather than a central tube section to which nitinol wires or tubes are attached, forming a nitinol wire or tubing array that clamps the periphery of the tissue surrounding the incision site from both sides. The array has curved tube or wire sections for clamping the tissue, while the hollow central section allows for immediate patency through the incision and fluid passageway prior to complete formation of a permanent anastomosis. The central section also maintains the diameter of the incision because the nitinol wire / tubing reduces tearing and dilation of the tissue surrounding the incision during the surgical procedure. The central open ring section can be made of any suitable material, such as nitinol, stainless steel, etc. This device can be delivered by storing the device within a delivery device, as described above with reference to FIG. 5.

[0041] 14A-14B depict a two-piece nitinol tubing / wire hybrid grommet. A nitinol wire can be attached to the central section to clamp the periphery of the tissue surrounding the incision. The two halves of the nitinol tubing / wire array grommet are stored within a delivery device in a delivery configuration. A medical professional advances the delivery device through the created incision and retracts the delivery device, deploying the distal half of the nitinol tubing / wire array grommet to the deployed configuration. The medical professional may then pull the delivery device further back, deploying the proximal half of the grommet to the deployed configuration. The outer arms of the two halves clamp the tissue surrounding the created incision, while the central portion allows the passage of fluids and surgical tools through the incision. This preserves 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 depicted in Figures 14A-14B, the two halves have corresponding mating elements (in this embodiment, aligning corresponding arms of the two halves) to better ensure that the two halves join in the desired configuration.

[0042] 15A-15B depict an exemplary two-piece nitinol tubing / wire grommet. The nitinol wire can be attached to the center section to clamp the periphery of the tissue surrounding the incision. The center section preserves shape and size, allowing the passage of fluids and surgical tools through the incision while 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. As depicted in FIGS. 15A-15B, the two halves have corresponding mating elements (in this embodiment, matching corresponding arms of the two halves) to better ensure that the two halves join in the desired configuration.

[0043] 16A-16B depict perspective views of an exemplary two-piece nitinol tubing / wire array grommet. The nitinol tubing / wire arms may be attached to the circumference of the grommet's central section. The arms grip the tissue surrounding the made incision, while the central section allows for the immediate passage of fluids and other materials, such as surgical tools, through the incision prior to the creation of a permanent anastomosis. This secures the tissue surrounding the incision site and reduces tearing, dilation, or migration of the incision site.

[0044] 17A-17B depict another embodiment of a two-piece nitinol tubing / wire array grommet. Nitinol tubing / wire arms may be attached to the circumference of the grommet's central section. The arms grip the tissue surrounding the made incision, while the central section allows for the immediate passage of fluids and other materials, such as surgical tools, through the incision prior to the creation of a permanent anastomosis. This secures the tissue surrounding the incision site and reduces tearing, dilation, or migration of the incision site.

[0045] 18A-18B depict perspective views of another embodiment of a two-piece nitinol tubing / wire array grommet. The grommet may comprise two or more bent wire loops attached to a tubing section. FIGS. 18A-18B depict a wire hybrid grommet comprising eight bent wire loops. The wire loops may be constructed from nitinol, stainless steel, or other biocompatible materials. The bent wire loops clamp the tissue surrounding the incision, fixing the size and shape of the incision and reducing tissue tearing. The tubing section allows for the passage of fluids or surgical tools through the incision.

[0046] 19A-19B depict perspective views of another embodiment of a two-piece nitinol tubing / wire array grommet. The grommet may comprise two or more bent wire loops attached to a tubing section. FIGS. 19A-19B depict a wire hybrid grommet comprising 16 bent wire loops. The wire loops may be constructed from nitinol, stainless steel, or other biocompatible materials. The bent wire loops clamp the tissue surrounding the incision, fixing the size and shape of the incision and reducing tissue tearing. The tubing section allows for the passage of fluids or surgical tools through the incision.

[0047] 20A-20B depict perspective views of another embodiment of a nitinol tubing / wire array grommet. The grommet in FIGS. 20A-20B may include two or more bent wire loops. FIGS. 20A-20B depict a grommet with 16 wire loops, eight in the distal half and eight in the proximal half of the grommet. The wire loops may be constructed from nitinol, stainless steel, or other biocompatible materials. The bent wire loops clamp the tissue surrounding the incision so that the periphery of the loop is perpendicular to the tissue surface. This secures the size and shape of the incision and reduces tissue tearing. The central section of the grommet allows for the passage of fluids or surgical tools through the incision.

[0048] 21A-21B depict one embodiment of a nitinol tubing / wire array grommet comprising wire half loops. The grommet of FIGS. 21A-21B comprises 16 wire half loops, eight on the proximal half of the device and eight on the distal half of the device, and comprises a hollow central section. The grommet device is stored within a delivery device in a delivery configuration. A medical professional advances the delivery device through a created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal half of the grommet on the distal side of the tissue surrounding the incision to the deployed configuration. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the proximal half of the grommet device on the proximal side of the tissue surrounding the incision to the deployed configuration. Once in the deployed configuration, the half loops of the distal half are adjacent to the half loops of the proximal half of the device and grip the tissue surrounding the incision. This fixes the size and shape of the incision and reduces tissue tearing. The central section of the grommet allows for the passage of fluids or surgical tools through the incision.

[0049] 22A-22B depict perspective views of another embodiment of a nitinol tubing / wire array grommet. The grommet in FIGS. 22A-22B may include two or more bent wire loops. FIGS. 22A-22B depict a grommet with eight wire loops, four in the distal half and four in the proximal half of the grommet. The wire loops may be constructed from nitinol, stainless steel, or other biocompatible materials. The bent wire loops clamp the tissue surrounding the incision so that the periphery of the loop is perpendicular to the tissue surface. This secures the size and shape of the incision and reduces tissue tearing. The central section of the grommet allows for the passage of fluids or surgical tools through the incision.

[0050] 23A-23B depict perspective views of another embodiment of a nitinol tubing / wire array grommet. The grommet in FIGS. 23A-23B may include two or more bent wire loops. FIGS. 23A-23B depict a grommet with eight wire loops, four in the distal half and four in the proximal half of the grommet. The wire loops may be constructed from nitinol, stainless steel, or other biocompatible materials. The bent wire loops clamp the tissue surrounding the incision so that the periphery of the loop is perpendicular to the tissue surface. This secures the size and shape of the incision and reduces tissue tearing. The central section of the grommet allows for the passage of fluids or surgical tools through the incision.

[0051] FIGS. 24A-24B and 25A-25B depict one embodiment of a nitinol tubing / wire hybrid grommet. The grommet may comprise two or more wire loops encased in a biocompatible material, creating a distal flange and a proximal flange. The flanges may be continuous, as shown in FIGS. 25A-25B, or may comprise a cutout section, as shown in FIGS. 24A-24B. There may be a hollow central section connecting the two flanges. The grommet device is stored within a delivery device in a delivery configuration. A medical professional advances the delivery device through the created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal flange of the grommet into the distal side of the tissue surrounding the incision to the deployed configuration. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the proximal flange of the grommet device within the proximal side of the tissue surrounding the incision to the deployed configuration. When in the deployed configuration, the flanges grip 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 for the passage of fluids or surgical tools through the incision. The embodiment shown in Figures 24A-24B and 25A-25B depicts an internal framework covered by an outer covering, as described above.

[0052] FIG. 26 depicts a triple-sleeved hoop device for securing tissue surrounding a created incision. The incision sleeve includes a small, central hoop and two larger hoops, one on each side, parallel to the central hoop. The smaller hoops provide a working channel / conduit centered over the incision for fluids and / or surgical tools to pass through the incision. The larger hoops tension the sleeve, preventing the device from being pulled out of the incision. The sleeved hoop is stored within a delivery device in a delivery configuration. A medical professional advances the delivery device through the created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal, larger hoop of the triple-sleeved hoop into the tissue surrounding the incision in a deployed configuration. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the proximal, larger hoop of the triple-sleeved hoop within the proximal side of the tissue surrounding the incision to the deployed configuration. In the deployed configuration, the larger hoop grips the tissue surrounding the incision. This fixes the size and shape of the incision and reduces tissue tearing. The central hoop allows the passage of fluids or surgical tools through the incision.

[0053] 27A-27B depict a ratchet incision fixation device. The exemplary embodiment includes a distal ratchet member and a proximal ratchet member connected by a central ratchet. The ratchet fixation device is stored within the delivery device in a delivery configuration. A medical professional advances the delivery device through a created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal ratchet member on the distal side of the tissue surrounding the incision to the deployed configuration. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the proximal ratchet member on the proximal side of the tissue surrounding the incision to the 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. When moved closer together, the ratchet members clamp the tissue surrounding the incision, securing the incision and reducing tissue damage. It should be noted that the dissection fixation device may include alternative mechanisms, e.g., screw mechanisms, locking mechanisms, etc., for drawing the two members toward one another and / or preventing the two members from moving away from one another after they have been approximated. For convenience, the ratchet mechanism or alternative mechanisms will be referred to herein as locking mechanisms. Generally speaking, any of the two-part dissection control devices with distal and proximal flanges described herein can be configured to include a locking mechanism for interlocking with another dissection control device.

[0054] 28A-28B depict a circular incision fixation device. The circular fixation device may be made of nitinol, stainless steel, or other biocompatible materials. As shown in FIG. 28A, the fixation device may include two circular hoops parallel to one another and connected by one or more central supports. The circular fixation device is stored within the delivery device in a delivery configuration. A medical professional advances the delivery device through the created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal hoop into the distal side of the tissue surrounding the incision to the deployed configuration. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the proximal hoop within the proximal side of the tissue surrounding the incision to the deployed configuration. Once in the deployed configuration, the hoops connected by the central support grip the incision. This fixes the size and shape of the incision and reduces tissue tearing. The central opening in the hoop allows for the immediate passage of fluids and other materials through the incision prior to permanent anastomosis formation.

[0055] 29A-29B depict a stent-type nitinol array. In one embodiment of the device, split nitinol tubing creates arms that can clamp the tissue surrounding the incision site. The arms are positioned around a hollow central portion of the device. The stent-type nitinol array is stored within the delivery device in a delivery configuration. A medical professional advances the delivery device through the created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal arms of the device into a deployed configuration into the distal side of the tissue surrounding the incision. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the proximal arms of the device into a deployed configuration at the proximal side of the tissue surrounding the incision. Once in the deployed configuration, the arms grip the tissue surrounding the incision. This fixes the size and shape of the incision and reduces tissue tearing. The central portion of the device allows the passage of fluids or surgical instruments through the incision.

[0056] 30A-30B depict an alternative embodiment of a stent-type nitinol array fixation device. This embodiment can include nitinol tubing that deforms upon deployment to clamp the tissue surrounding the incision. The device may include two or more nitinol tubes around the circumference of a hollow central region. The stent-type nitinol array is stored within the delivery device in a delivery configuration. A medical professional advances the delivery device through the created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal nitinol tubes into the distal side of the tissue, where they transform to the deployed configuration. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the proximal nitinol tubes into the proximal side of the tissue, where they transform to the deployed configuration. Once in the deployed configuration, the tubes grip the tissue surrounding the incision. This fixes the size and shape of the incision and reduces tissue tearing. The central section allows fluids and / or surgical tools to pass immediately through the incision.

[0057] 31A-31B depict a helical stent-type nitinol array fixation device. 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 within a delivery device in a delivery configuration. A medical professional advances the delivery device through a created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal helical wire array distally to the deployed configuration. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the proximal helical array into the proximal side of the tissue to the deployed configuration. Once in the deployed configuration, the array grips the tissue surrounding the incision.

[0058] 32A-32B depict one embodiment of an inflatable grommet for securing tissue surrounding an incision site. The grommet can include a distal flange and a proximal flange connected by a hollow central portion. The inflatable grommet can be stored within a delivery device in a contracted delivery configuration. A medical professional advances the delivery device through a created incision. Once distal to the incision, the medical professional retracts the delivery device, deploying the distal flange of the inflatable grommet into the distal side of the incision. The medical professional may further retract the delivery device through the proximal side of the incision, deploying the inflatable proximal flange into the proximal side of the tissue. The grommet can then be inflated to the deployed configuration. Once inflated, the flanges clamp the tissue surrounding the incision, and the hollow central portion allows for the immediate passage of fluids and other materials through the incision.

[0059] 33A-33B depict one embodiment of a two-piece suture clamp. The clamp may include two washers made of stainless steel or another biocompatible material aligned parallel or substantially parallel to one another. The washers may be connected by one or more connecting members that are perpendicular to the washers but parallel to the other connecting members. A distal washer is attached to the connecting member. The washer can be translated along the connecting member toward or away from the other washers. A medical professional positions the distal washer distal to the created incision, and the connecting member is 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 interlocked washers clamp the tissue surrounding the incision site, securing the tissue and preserving the incision. A central opening in the washer allows fluids and other materials to readily pass through the incision. Generally speaking, any of the two-part dissection control devices with distal and proximal flanges described herein can be configured to include one or more connecting members to assist in mating with another dissection control device.

[0060] 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.

[0061] 34A-34B depict a snap-lock dissection clip, which can be considered another type of locking mechanism as described above. The dissection clip may include a distal washer and a proximal washer. The distal washer and / or the proximal washer may have a snap configured to mate with the inner circumference of the opposing washer. A medical professional positions the distal washer distal to the incision and the proximal washer proximal to the incision. The medical professional then brings the washers closer together and slides the snap into the inner circumference of the opposing washer, attaching the washer across the incision. This secures the tissue surrounding the incision site, reducing trauma to the tissue while maintaining the incision. Generally speaking, any of the two-part dissection control devices with distal and proximal flanges described herein can be configured to include a snap-lock mechanism for interlocking with another dissection control device.

[0062] 35A-35B depict one embodiment of a sliding-arm dissecting clip. The dissecting clip comprises a hollow central support tube and four or more sliding arms, two or more of which are proximal arms and two or more of which are distal arms. As shown in FIG. 35A, the sliding arms are in a delivery configuration for storage within a delivery device. The arms are curved to complement the outer circumference of the hollow central support tube. A medical professional advances the delivery device into the incision so that the distal arms are positioned distal to the incision and the proximal arms are positioned proximal to the incision. The medical professional may then deploy the arms of the sliding-arm dissecting clip to a deployed configuration, as shown in FIG. 35B. The sliding arms protrude from the hollow central support tube and clamp the tissue surrounding the incision. Note that the arms may be deployed in any order.

[0063] FIG. 36 depicts one embodiment of a foam grommet for securing tissue surrounding an incision. The foam grommet is stored within a delivery device in a compressed delivery configuration. A medical professional advances the delivery device through the incision distal to the tissue. The medical professional then retracts 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 retracts 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, as depicted in FIG. 36. The expanded foam grommet includes distal and proximal flanges that together clamp and secure the tissue surrounding the incision.

[0064] 37 depicts one embodiment of a clip-securing grommet. The clip-securing grommet can include one or more clips attached to the inner periphery of a hollow grommet. One side of the grommet is sutured around the incision, and the tissue surrounding the incision is secured to the grommet with clips. The clips secure the tissue surrounding the incision, reducing tissue trauma and migration and preserving the incision.

[0065] 38 depicts one embodiment of a coil compression grommet. The grommet is stored within a delivery device in a compressed delivery configuration. A medical professional advances the delivery device distally through the incision into the tissue. The medical professional then retracts 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 retracts 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 grommet is then secured with a coil to preserve the incision and secure the tissue surrounding the incision.

[0066] 40A-40D depict an exemplary embodiment of a coiled wire incision fixation device. A single length of nitinol, stainless steel, or other biocompatible material may be coiled and deployed around the incision site to secure tissue. The coiled layers clamp the tissue between them, securing the tissue and reducing trauma or tissue migration to secure the incision. The hollow center of the coil allows for the immediate passage of fluids and other materials through the incision prior to the creation of a permanent anastomosis.

[0067] Figure 41 depicts one embodiment of an incision reinforced with adhesive. After the incision is created, the tissue surrounding the incision is coated with adhesive to reduce tearing and / or stretching of the incision site. The adhesive on the tissue holds the center of the incision site open, preserving the integrity of the incision site while allowing the passage of fluids and other materials through the incision.

[0068] 42A-42B depict one embodiment of a patch for securing an incision. After the incision is created, the incision site is supported by a patch adhered to the tissue surrounding the incision site. The patch has an annular shape, allowing the passage of fluids and other materials through the patch and the incision.

[0069] 43A-43B depict one embodiment of a puncture patch for securing an incision. After the incision is created, the incision site is supported by a patch that is mechanically adhered to the tissue surrounding the incision site. The patch may include spikes or other protrusions that can puncture the tissue surrounding the incision site, securing the patch to the tissue and preserving the incision.

[0070] FIG. 44 depicts one embodiment of a crimped wire dissection clip. The crimped wire dissection clip is stored in a ring-shaped delivery configuration within a delivery device. The crimped wire dissection clip may be deployed prior to or after the creation of an incision. Upon delivery, the crimped wire dissection clip is clipped into the deployed configuration. The crimp clamps the tissue surrounding the incision site, securing the tissue and supporting the incision. The ring shape of the clip allows for the immediate passage of fluids or other materials through the clip and the incision.

[0071] The fixation elements described above may be positioned on the target anatomical structure prior to incision creation or after incision creation by adhering, clamping, and / or encapsulating the anatomical structure to serve as guides for tool placement to create and access the incision. The elements may be delivered to the target anatomical structure by a tool or surgeon and may remain in the body after completion of the procedure or may be removed from the body prior to completion of the surgery. The devices described herein allow for control of the incision site, reducing tissue tearing, incision extension, and unintended trauma to the site.

[0072] As mentioned above, in some embodiments, a magnetic compression anastomosis device and / or other devices can be deployed through a channel in the dissection control device, such as for deployment within the distal lumen. The following is an exemplary anastomosis procedure using a dissection control device of the type described above to support the incision and deliver a magnetic compression anastomosis device, particularly in the context of a single anastomotic duodenoileostomy (SADI) with intracorporeal anastomosis (EIA).

[0073] FIG. 45A is a schematic diagram showing relevant gastrointestinal anatomical structures for an exemplary procedure.

[0074] Figure 45B is a schematic diagram showing the gastrointestinal anatomy upon completion of the procedure, i.e., with a sleeve gastrectomy of the stomach (e.g., reducing the stomach size to approximately 100-150 milliliters) and a single anastomosis connecting the duodenum (e.g., approximately 3 centimeters beyond the stomach, thereby preserving the pyloric valve) to the ileum (e.g., approximately 3 meters from the large intestine).

[0075] FIG. 45C is a schematic diagram showing the portion of the duodenum where the anastomosis is formed.

[0076] FIG. 45D is a schematic diagram showing an incision made in the duodenum using, for example, an electrocautery device.

[0077] FIG. 45E is a schematic diagram showing insertion of a delivery device through an incision into the duodenum for delivery of the incision control device.

[0078] FIG. 45F is a schematic diagram showing a delivery device with a dissection control device from within the duodenum.

[0079] 45G is a schematic diagram illustrating deployment of the distal flange of the dissection control device within the duodenum, such as by retracting the delivery device and / or advancing a pusher device within the delivery device. Note that this particular dissection control device includes an internal framework and an external covering.

[0080] FIG. 45H is a schematic diagram showing retraction of the delivery device in preparation for delivery of the proximal flange of the dissection control device.

[0081] FIG. 45I is a schematic diagram showing delivery of the proximal flange of the incision control device to the exterior of the duodenum such that the incision is not controlled from both the interior and exterior of the duodenum.

[0082] With the incision controlled in this manner, one or more devices, such as a magnetic compression anastomosis device, can be placed into the duodenum through channels in the incision control device.

[0083] 45J is a schematic diagram showing an instrument inserted into the duodenum through a channel of the dissection control device. In this example, the instrument is a delivery device for delivering a self-assembling magnetic compression anastomosis device.

[0084] Figure 45K is a schematic diagram showing an instrument in the duodenum delivering a self-assembling magnetic compression anastomosis device. In this image, the magnetic compression anastomosis device is partially deployed. The sutures used to manipulate the magnetic compression anastomosis device can be seen.

[0085] Figure 45L is a schematic diagram showing the fully deployed and fully assembled self-assembled magnetic compression anastomosis device within the duodenum. The sutures used to manipulate the magnetic compression anastomosis device can be seen.

[0086] FIG. 45M is a schematic diagram showing the instrument being retracted from the duodenum to leave the magnetic compression anastomosis device and sutures fully deployed.

[0087] 45N is a schematic diagram showing the magnetic compression anastomosis device being manipulated into position around the dissection control device using sutures against the interior surface of the duodenum surrounding the incision and dissection control device. In this embodiment, the flange of the dissection control device is shaped or otherwise configured to aid in positioning the magnetic compression anastomosis device around the dissection control device, for example, a tapered configuration.

[0088] FIG. 45O is a schematic diagram showing the completed duodenal incision from the outer surface of the duodenum.

[0089] A similar procedure can be performed on the ileum either before or after making the incision in the duodenum.

[0090] FIG. 46A is a schematic diagram showing an incision made in the ileum using, for example, an electrocautery device.

[0091] FIG. 46B is a schematic diagram showing insertion of a delivery device through the incision and into the ileum for delivery of the incision control device.

[0092] FIG. 46C is a schematic diagram showing retraction of the delivery device from the ileum after deployment of the distal flange of the dissection control device within the ileum.

[0093] FIG. 46D is a schematic diagram showing the proximal flange of the dissection control device delivered to the exterior surface of the ileum.

[0094] 46E is a schematic diagram showing an instrument inserted through a channel of the dissection control device into the ileum. In this example, the instrument is a delivery device for delivering a self-assembling magnetic compression anastomosis device.

[0095] 46F is a schematic diagram showing the instrument after delivery of the magnetic compression anastomosis device in the ileum. The sutures used to manipulate the magnetic compression anastomosis device can be seen.

[0096] Figure 46G is a schematic diagram showing retraction of the instrument from the incision to leave a fully deployed and fully assembled self-assembling magnetic compression anastomosis device within the ileum. The sutures used to manipulate the magnetic compression anastomosis device can be seen.

[0097] With the incisions fully formed and controlled in both the duodenum and ileum, as depicted schematically in FIG. 47A, and the magnetic compression anastomosis device fully deployed within the duodenum and ileum, the two incisions can be brought together, as depicted schematically in FIG. 47B, until they are in contact and aligned via the incision control device and magnetic compression anastomosis device, as depicted schematically in FIG. 47C. Sutures can be used to position the magnetic compression anastomosis device. FIG. 47D is a schematic diagram showing the incision control device and magnetic compression anastomosis device positioned to allow immediate fluid communication from the duodenum to the ileum through the incisions, as depicted schematically in FIG. 47E, even before the anastomosis is formed. Typically, after about 1-7 days, the duodenal and ileal tissues surrounding the incisions will degrade to the point where the incision control device will remove and pass through the ileum, leaving only the magnetic compression anastomosis device in place, as depicted schematically in FIG. 47F and FIG. 47G. Typically, after about 10-14 days, the anastomosis will be fully formed and the magnetic compression anastomosis device will be removed and passed through the ileum, leaving behind a fully formed anastomosis, as depicted schematically in Figures 47H and 47I.

[0098] 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, e.g., the distal flange positioned within the lumen may be shaped or otherwise configured to aid in positioning the magnetic compression anastomosis device, while the proximal flange positioned outside the lumen may be shaped or otherwise configured to aid in mating of the two incisions, as depicted schematically in Figures 47C-47D (e.g., the distal flange may be tapered, while the proximal flange may be flatter to aid in mating of the two incisions). In this regard, the proximal flange may be shaped or configured to mate with another proximal flange, e.g., having interlocking ridge and / or recess features.

[0099] It should be noted that any two-part dissection control device may include a ratchet mechanism (e.g., as depicted diagrammatically in Figures 27A-27B) or other connection mechanism to help maintain the connection between the two halves.

[0100] The flanges of the dissection control device may have any number of loops or lobes; for example, the device shown in FIG. 1 includes a single loop or lobe, the device shown in FIG. 45G includes two loops or lobes per flange, the device shown in FIG. 6A includes four loops or lobes per flange, the device shown in FIG. 5 includes eight loops or lobes per flange, the device shown in FIG. 14A includes 16 loops or lobes per flange, etc. The devices can have any number of loops or lobes per flange, e.g., 1, 2, 3, 4, etc. Note that the flanges can have the same number and configuration of loops or lobes or can have different numbers and / or configurations of loops or lobes. For example, the distal flange can have multiple loops or lobes (e.g., to facilitate delivery of the dissection control device and placement of the magnetic compression anastomosis device) and the proximal flange can have a single loop or lobe (e.g., to facilitate mating with the proximal flange of another dissection control device).

[0101] Below is a description of several alternative types of incision control devices that generally operate by clamping around the incision borders.

[0102] Figures 9-12 schematically illustrate various views of a clamping device for acute incision control. The clamp functions by anchoring the tissue adjacent to the incision site, reinforcing the tissue and distributing applied forces during subsequent surgical procedures to the device rather than the tissue. This prevents expansion or contraction of the incision site. As shown in Figures 9-10, the device contains a rigid or semi-rigid conduit that facilitates deployment and alignment of surgical tools and acts as an open channel to maintain fluid passage through the tissue wall. The clamping device may also include features for securing a compression anastomosis device to the tool, allowing for single-handed operation and control of the tissue and compression anastomosis device.

[0103] The clamping device can be deployed endoscopically, laparoscopically, robotically, or in open-field surgery. After creation of an acute incision, the clamp is grasped onto the tissue surrounding the incision site. This allows for control of the diameter of the incision and reduces tissue tearing and expansion around the incision site.

[0104] The clamp may also include features for securing the compression anastomosis device to a tool, allowing for single-handed operation and control of the tissue and compression anastomosis device.

[0105] The fenestrated design of various embodiments allows the clamp to grasp and support the tissue surrounding the incision site while maintaining an open channel for tool passage during the surgical procedure. In some embodiments, the clamp may remain in place after the magnets are engaged, providing a channel for fluid passage prior to completion of the permanent anastomosis.

[0106] Exemplary embodiments of the clamping device may be removed by the medical professional prior to the end of the procedure, leaving behind the incision or anastomosis created.

[0107] The device of the present invention can be used to facilitate alignment of an incision to an interlocking surgical site for creating an anastomosis.

[0108] As shown in Figure 11, the clamping device may include a flexible member or moving hinge point that allows the tissue to be clamped proximally before it is clamped distally, allowing for adjustment of the tissue between the proximal and distal ends of the grasping element.

[0109] 12 depicts an exemplary embodiment of a spring-loaded clamping device or dissection clip. The dissection clip can be deployed around an incision site to secure tissue. The dissection clip includes a fenestrated design to allow passage of fluid through the incision. The dissection clip clamps the tissue around the incision site, reducing tearing, dilation, or migration of the incision site.

[0110] 39A-39B depict one embodiment of a spring-loaded clamp dissection clip. The dissection clip can be deployed around an incision site to secure tissue. The dissection clip includes a fenestrated design to allow the passage of fluid through the incision. The dissection clip clamps the tissue around the incision site, reducing tearing, dilation, or migration of the incision site.

[0111] While various inventive embodiments have been described and illustrated herein, those skilled in the art will readily envision a variety of other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application in which the teachings of the present invention are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. Accordingly, the above-described embodiments are presented by way of example only, and it should be understood that, within the scope of the appended claims and their equivalents, inventive embodiments may be practiced otherwise than as specifically described and claimed. The inventive embodiments of the present disclosure are directed 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 inventive scope of the present disclosure, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.

[0112] Various inventive concepts may be embodied as one or more methods, examples of which are provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, while shown as sequential actions in the exemplary embodiments, embodiments may be constructed in which actions are performed in an order different from that illustrated, which may include performing some actions simultaneously.

[0113] All definitions 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.

[0114] The indefinite articles "a" and "an," as used in the specification and claims, unless expressly indicated otherwise, should be understood to mean "at least one."

[0115] The term "and / or," as used in the specification and claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements present conjunctively in some cases and disjunctively in other cases. Multiple elements listed with "and / or" should be construed in the same manner, i.e., "one or more" of the elements so conjoined. Other elements, whether related or unrelated to those elements specifically identified, may optionally be present other than the elements specifically identified by the "and / or" clause. Thus, as a non-limiting example, a reference to "A and / or B," when used in conjunction with open-ended language such as "comprising," can refer in one embodiment to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements), etc.

[0116] As used in this specification and the 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" shall be interpreted as inclusive, i.e., including at least one of, but also including more than one of, several elements or a list of elements, and optionally including additional unlisted items. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," shall refer to the inclusion of exactly one element of several elements or a list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e., "one or the other, but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of."

[0117] As used in this specification and claims, the phrase "at least one," when referring to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combinations of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in 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") can refer in one embodiment to at least one A, optionally including more than one, with no B (and optionally including elements other than B); in another embodiment to at least one B, optionally including more than one, with no A (and optionally including elements other than A); in yet another embodiment to at least one A, optionally including more than one, and at least one B (and optionally including other elements), optionally including more than one, etc.

[0118] As used in this specification and claims, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like, shall be understood to be open-ended, i.e., to mean including but not limited to. 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.

[0119] While the foregoing description discloses various exemplary embodiments of the present invention, it will be apparent to those skilled in the art that various modifications can be made which achieve several of the advantages of the present invention without departing from the true scope of the invention. Any reference to the "invention" is intended to refer to exemplary embodiments of the invention and should not be construed as referring to all embodiments of the invention unless the context requires otherwise. The described embodiments are to be considered in all respects only as illustrative and not restrictive.

Claims

1. 1. A dissection control device comprising: a distal flange and a proximal flange separated and connected by a central channel, the distal flange and the proximal flange configured to compress to fit the dissection control device within a working channel of an access or delivery device in a delivery configuration and to expand on either side of the incision to secure the incision upon delivery from the working channel in a fully deployed configuration; Incision control device.

2. The device of claim 1 , wherein each flange comprises a shape memory material.

3. The device of claim 2 , wherein the shape memory material comprises a nitinol shape memory material.

4. The device of claim 2 , wherein the shape memory material comprises a spring material.

5. The device of claim 1 , wherein each flange comprises an internal framework and an external cover that encloses some or all of the internal framework.

6. The device of claim 5 , wherein the outer cover comprises a biocompatible material.

7. The device of claim 5 , wherein the outer cover comprises a flexible material.

8. The device of claim 7 , wherein the flexible material comprises at least one of a plastic, a rubber, a urethane, or a polymer.

9. The device of claim 5 , wherein the outer cover is injection molded onto the inner framework.

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

11. The device of claim 1 , wherein the flange is expandable.

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

13. The device of claim 12 , wherein the at least one magnet is located within the distal flange.

14. The device of claim 12 , wherein the at least one magnet is located within the proximal flange.

15. The device of claim 12 , wherein the at least one magnet is positioned about the central channel.

16. The device of claim 1 , wherein at least one of the flanges is shaped or configured to aid in positioning a magnetic compression anastomosis device around the dissection control device.

17. The device of claim 16 , wherein at least one of the flanges is tapered.

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

19. The device of claim 1 , wherein the flanges have different configurations.

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

21. 10. The device of claim 1, wherein the dissection control device is a two-part device comprising a distal half including the distal flange and a proximal half including the proximal flange, the distal half and the proximal half being configured to interlock and form the central channel.

22. 22. The device of claim 21, further comprising a locking mechanism for at least one of approximating the distal and proximal halves or preventing the distal and proximal halves from separating after they have been approximated.

23. 22. The device of claim 21, further comprising at least one connecting member for assisting in mating the device with another dissection control device.

24. The device of claim 1 , wherein at least one flange comprises a single loop or lobe.

25. The device of claim 1 , wherein at least one flange includes a plurality of loops or lobes.

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