CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to, and the benefit of, U.S. Provisional Application No. 62/679,782, filed on June 2, 2018, the content of which is incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The invention relates to deployable magnetic compression devices, and, more

particularly, to systems, devices, and methods for the deployment and positioning of magnetic compression devices at a desired site so as to improve the accuracy of anastomoses creation between tissues, organs, or the like.

BACKGROUND

Bypasses of the gastroenterological (GI), cardiovascular, or urological systems are typically formed by cutting holes in tissues at two locations and joining the holes with sutures or staples. A bypass is typically placed to route fluids (e.g., blood, nutrients) between healthier portions of the system, while bypassing diseases or malfunctioning tissues. The procedure is typically invasive, and subjects a patient to risks such as bleeding, infection, pain, and adverse reaction to anesthesia. Additionally, a bypass created with sutures or staples can be complicated by post-operative leaks and adhesions. Leaks may result in infection or sepsis, while adhesions can result in complications such as bowel strangulation and obstruction. While traditional bypass procedures can be completed with an endoscope, laparoscope, or robot, it can be time consuming to join the holes cut into the tissues. Furthermore, such procedures require specialized expertise and equipment that is not available at many surgical facilities.

As an alternative to sutures or staples, surgeons can use mechanical couplings or magnets to create a compressive anastomosis between tissues. For example, compressive couplings or paired magnets can be delivered to tissues to be joined. Because of the strong compression, the tissue trapped between the couplings or magnets is cut off from its blood supply. Under these conditions, the tissue becomes necrotic and degenerates, and at the same time, new tissue grows around points of compression, e.g., on the edges of the coupling. With time, the coupling can be removed, leaving a healed anastomosis between the tissues.

Nonetheless, the difficulty of placing the magnets or couplings limits the locations that compressive anastomosis can be used. In most cases, the magnets or couplings have to be delivered as two separate assemblies, requiring either an open surgical field or a bulky delivery device. For example, existing magnetic compression devices are limited to structures small enough to be deployed with a delivery conduit e.g., an endoscopic instrument channel or laparoscopic port. When these smaller structures are used, the formed anastomosis is small and suffers from short-term patency. Furthermore, placement of the magnets or couplings can be imprecise, which can lead to anastomosis formation in locations that is undesirable or inaccurate.

Thus, there still remains a clinical need for reliable devices and minimally-invasive procedures that facilitate compression anastomosis formation between tissues in the human body.

SUMMARY

The invention provides improved devices and techniques for minimally-invasive formation of anastomoses within the body, e.g., the gastrointestinal tract. Such devices and techniques facilitate faster and less-expensive treatments for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatments for diseases such as cancers, such as stomach or colon cancer.

More specifically, the invention provides a controller for providing improved deployment and positioning of magnetic compression devices at a desired target site so as to create anastomoses between tissues. The controller is configured to be used in the placement and manipulation / positioning of magnetic compression devices that include one or more guide elements, such as sutures or wires, used for the positioning and/or manipulation of the devices once delivered to the target tissue, to achieve optimal placement and anastomosis formation.

For example, in the embodiments described herein, at least one of a pair of self assembling magnetic anastomosis devices (which are configured to couple together by way of magnetic attraction to thereby capture intervening tissue therebetween, which will subsequently necrose, causing an anastomosis to form) includes one or more guide elements coupled thereto. Each guide element may include a distal end coupled to a respective portion of the anastomosis device, and a proximal end that can be manipulated (i.e., increased or decreased tension) to thereby manipulate the positioning and orientation of the anastomosis device once it has self- assembled into the pre-determined shape (i.e., a polygon). By way of an access device, such as an endoscope, laparoscope, catheter, trocar, or other access device, a first magnetic anastomosis device can be delivered to the target tissue site, generally via a delivery needle or the like. A surgeon or other trained medical professional may advance the access device within a hollow body of the patient and position the access device at a desired anatomical location for formation of the anastomosis based on either a visual depiction of the location of the target site as provided by an imaging modality providing a medical imaging procedure (e.g., ultrasound (US), wavelength detection, X-ray-based imaging, illumination, computed tomography (CT), radiography, and fluoroscopy, or a combination thereof). For example, if the hollow body is a bowel of the patient, the first portion may be a distal portion of the bowel and the second portion may be a proximal portion of the bowel. The bowel includes any segment of the alimentary canal extending from the pyloric sphincter of the stomach to the anus. In some embodiments, an anastomosis is formed to bypass diseased, mal-formed, or dysfunctional tissues. In some embodiments, an anastomosis is formed to alter the“normal” digestive process in an effort to diminish or prevent other diseases, such as diabetes, hypertension, autoimmune, or

musculoskeletal disease. It should be noted that the system may be used for the formation of an anastomosis between a first portion of tissue of the hollow body at the target site and an adjacent tissue of a second hollow body (e.g., portal between the stomach and the gallbladder or the duodenum and the gallbladder, etc.).

The access device is configured to provide access between first and second portions of target tissue(s) of the hollow body and further deliver and position the first and second implantable magnetic anastomosis devices relative to the first and second portions of tissue or adjacent tissue for the formation of an anastomosis between tissues at the target site. The first and second implantable magnetic anastomosis devices are configured to be magnetically attracted to one another through a defined tissue area of the combined thickness of a wall of the tissues at the target site and exert compressive forces on the defined area to form the

anastomosis.

Upon delivery and deployment of the first magnetic anastomosis device at the target tissue site, the one or more guide elements may generally extend from the anastomosis device.

As previously described, the system further includes a controller configured to keep one or more guide elements taught during delivery and self-assembly of an anastomosis device consistent with the present disclosure. For example, once the first magnetic anastomosis device has been delivered to a tissue, it is beneficial to be able to manipulate the location and/or orientation of the device. While the device could be manipulated with conventional tools such as forceps, the controller is configured to manipulate the positioning and orientation of the deployed device via the one or more guide elements. The controller generally comprises one or more control members, each being directly coupled to a proximal end of a respective one of the one or more guide elements coupled to the anastomosis device. Each control member is configured to separately control an amount of tension applied to the respective guide element coupled thereto so as to allow for the magnetic compression anastomosis device to be manipulated in both an unassembled state and an assembled state. Accordingly, the controller is configured to provide a user or operator with handheld control over one or more guide elements coupled to separate respective magnetic segments of the anastomosis device, which, in turn, results in a high degree of precision when positioning the anastomosis device and adjusting the orientation of the anastomosis device, which is particularly useful when attempting to locate and secure the anastomosis device to the target site and/or mate the anastomosis device to a corresponding anastomosis device. The application of tension generally eliminates slack during self-closing or self-opening, keeps the guide elements out of the way of visualization or other procedures, and further stabilizes the device during transition from delivery state to deployed state.

The controller may have a number of different embodiments and may provide a number of different features. For example, in some embodiments, the controller may be configured to allow for automatic tensioning upon the guide elements during the deployment of the

anastomosis device (i.e., during the self-assembly process of the device) so as to prevent or reduce the likelihood of the guide elements from becoming tangled with one another. For example, in some embodiments, the controller may include constant force spring arrangements for providing automatic tensioning. Alternatively, in some embodiments, the controller may include a timed mechanical system for providing automatic tensioning. In all embodiments, the automatic tensioning feature may be controlled by the operator (i.e., activated and deactivated) to thereby allow for either automatic tensioning, locking of the tensioning at a desired tension level, and manual control over the amount of tension to be applied. For example, while each control member may be coupled to the constant force spring assembly, each control member may be individually manipulated and further transition between locked and unlocked states (in both automatic spring mode and manual mode), thereby allowing an operator to utilize the automatic tensioning feature when desired or to override the automatic tensioning feature and manually adjust any given guide element.

Accordingly, the controller allows a user to hold a given anastomosis device tightly for certain portions of the procedure, and also allow the device to move freely under gravity or magnetic attraction while maintaining a degree of tension on one or more of the guide elements or sutures. This flexibility makes it easier to successfully mate with a complementary magnetic device, and it allows for adjustment of a deployed device when successful placement is not achieved, thereby ensuring a high degree of precision and improved placement of anastomosis devices at the intended target site) to achieve optimal placement and anastomosis formation.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the claimed subject matter will be apparent from the following detailed description of embodiments consistent therewith, which description should be considered with reference to the accompanying drawings.

FIG. 1 is a schematic illustration of an anastomosis formation system consistent with the present disclosure.

FIG. 2 shows several potential anatomical targets for anastomosis formation, where arrow A is stomach to small intestine, arrow B is small intestine to large intestine, arrow C is small intestine to small intestine, arrow D is large intestine to large intestine, and arrow E is stomach to large intestine.

FIG. 3 shows an exemplary magnetic anastomosis device delivered through an endoscope instrument channel such that the individual magnet segments self-assemble into a larger magnetic structure— in this particular case, an octagon.

FIG. 4A depicts two magnetic anastomosis devices attracting each other through tissue. As shown, the devices each comprise eight magnetic segments, however alternate configurations are possible. Once the two devices mate, the tissue that is trapped between the devices will necrose, causing an anastomosis to form. Alternatively, the tissue bound by the devices may be perforated after the devices mate to create an immediate anastomosis. FIG. 4B shows the two magnetic anastomosis devices coupled together by magnetic attraction, capturing the intervening tissue. In some instances, the endoscope can be used to cut through the circumscribed tissue.

FIG. 5A shows the needle delivering a first magnetic device into a first portion of the hollow body at the target site.

FIG. 5B shows subsequent deployment to of a second magnetic device into a second portion of the hollow body adjacent to the target site.

FIG. 6A shows endoscopic ultrasound guided needle delivery of a magnet assembly into the gallbladder which then couples with a second magnet assembly in the stomach or duodenum as shown in FIG. 6B.

FIG. 7 illustrates a single guide element for deploying and manipulating a magnetic anastomosis device.

FIGS. 8A, 8B, 8C, 8D, 8E, and 8F each depict the deployment of the self-closing magnetic anastomosis device with a plurality of guide elements.

FIG. 9 is a perspective view of one embodiment of a linear controller utilizing a constant force spring assembly for providing automatic tensioning features.

FIG. 10 is a perspective view of one embodiment of a rotary controller utilizing a constant force spring assembly for providing automatic tensioning features.

FIG. 11 is a perspective view of one embodiment of a clockwork controller utilizing a timed mechanical system for providing automatic tensioning features.

FIG. 12 is a top plan view of a linear controller utilizing a constant force spring assembly for providing automatic tensioning features.

FIG. 13 is a perspective view of the linear controller of FIG. 12.

FIG. 14 is a top plan view of the linear controller of FIG. 12 illustrating the control members in a locked position.

FIG. 15 is an enlarged view of the locks in engagement with corresponding portions (i.e., tabs) of each control member, thereby holding the control members in a locked position

FIG. 16 is a top plan view of the linear controller of FIG. 12 illustrating the control members in an unlocked position in which automatic tension is applied as a result of the constant force spring assembly. FIG. 17 is an enlarged view of the locks disengaged from corresponding portions (i.e., tabs) of the control members, thereby allowing the control members to transition to a position based on the automatic tension.

FIG. 18 is a top plan view of the linear controller of FIG. 12 illustrating the two-part construction of each control member, in which a first portion of each control member, which is under the influence of the constant force spring assembly, is in a locked position, and a second portion of each control member can be moved independently of the first portion to thereby allow for manual adjustment to tension upon the corresponding guide element.

FIG. 19 is an enlarged view of the locks engaged with the first portion of each control member, thereby holding the first portion in a locked position.

FIG. 20 is a side view, partly in section, of the controller of FIG. 12 illustrating the lock or latch mechanism configured to engage the first portion of the control member and further illustrating the second portion of the control member that is configured to independently move relative to the first portion regardless of whether the first portion is in a locked or unlocked position.

FIGS. 21 and 22 illustrate a single lock configured to engage each of the control members simultaneously as well as a spring loader mechanism allowing for a user to manually activate or disable the spring force.

FIGS. 23 and 24 are top and side views of another embodiment of a linear controller consistent with the present disclosure.

FIG. 25 is a top view of the linear controller of FIG. 23 and FIG. 26 is a side view, partly in section, of the linear controller of FIG. 23 illustrating a soft spring release component.

FIGS. 27 and 28 are sectional views of the linear controller of FIG. 23 illustrating internal workings of the controller.

FIG. 29 is a back view of the linear controller of FIG. 23 illustrating a spring

disengagement component.

FIGS. 30 and 31 are top views of the linear controller of FIG. 23 illustrating a pull tab member allowing for retraction to occur.

FIGS. 32 and 33 are perspective views of one embodiment of a rotary controller utilizing a constant force spring assembly for providing automatic tensioning features. FIG. 34 is a side view of the rotary controller of FIG. 32 illustrating dimensions of the controller.

FIG. 35 illustrates mounting of the rotary controller of FIG. 32 to a scope.

FIGS. 36, 37, 38, 39, and 40 are perspective views of various variants of the rotary controller of FIG. 32.

FIGS. 41, 42, and 43 are perspective front and rear views of one embodiment of a clockwork controller utilizing a timed mechanical system for providing automatic tensioning features.

FIGS. 44 and 45 are side views, partly in section, of the clockwork controller of FIG. 41, illustrating the inner workings of the controller and FIG. 46 is a perspective view of the inner workings within the controller cover.

FIG. 47 illustrates a linear controller coupled to a scope by way of an adapter for mounting the controller to the scope.

FIG. 48 is a perspective view of one embodiment of a mounting member for mounting a controller consistent with the present disclosure to a scope.

FIGS. 49 and 50 illustrate coupling of the mounting member of FIG. 48 to a scope.

FIG. 51 illustrates another embodiment of a mount for coupling a controller consistent with the present disclosure to a scope.

FIG. 52A is a side view, partly in section, and FIG. 52B is a side view illustrating one embodiment of a cutting assembly including a sliding cutter for cutting the one or more guide elements once the magnetic anastomosis device is in place.

FIG. 53A is a side view, partly in section, and FIG. 53B is a side view illustrating one embodiment of a cutting assembly including a rotating cutter for cutting the one or more guide elements once the magnetic anastomosis device is in place.

FIG. 54A is a side view and FIG. 54B is a side view partly in section, illustrating another embodiment of a cutting assembly including a rotating cutter for cutting the one or more guide elements once the magnetic anastomosis device is in place.

For a thorough understanding of the present disclosure, reference should be made to the following detailed description, including the appended claims, in connection with the above- described drawings. Although the present disclosure is described in connection with exemplary embodiments, the disclosure is not intended to be limited to the specific forms set forth herein. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient.

DETAILED DESCRIPTION

The invention provides a system for providing improved placement and positioning / manipulation of magnetic compression devices at a desired target site so as to create anastomoses between tissues. The system generally includes an access device configured to be provided within a hollow body of a patient and assist in the formation of an anastomosis at a target site (a desired anatomical location) within the hollow body for formation of an anastomosis between a first portion of tissue of the hollow body at the target site and a second portion of tissue of the hollow body. The access device is configured to provide access to the first and second portions of tissue of the hollow body and further deliver and position first and second implantable magnetic anastomosis devices relative to the first and second portions of tissue or adjacent tissue for the formation of an anastomosis between tissues at the target site. The first and second implantable magnetic anastomosis devices are configured to be magnetically attracted to one another through a defined tissue area of the combined thickness of a wall of the tissues at the target site and exert compressive forces on the defined area to form the anastomosis.

The system further includes a controller for providing improved deployment and positioning of magnetic compression devices at a desired target site so as to create anastomoses between tissues. The controller is configured to be used in the placement and manipulation / positioning of magnetic compression devices that include one or more guide elements, such as sutures or wires, used for the positioning and/or manipulation of the devices once delivered to the target tissue, to achieve optimal placement and anastomosis formation. For example, in the embodiments described herein, at least one of a pair of self-assembling magnetic anastomosis devices (which are configured to couple together by way of magnetic attraction to thereby capture intervening tissue therebetween, which will subsequently necrose, causing an

anastomosis to form) includes one or more guide elements coupled thereto. Each guide element may include a distal end coupled to a respective portion of the anastomosis device, and a proximal end that can be manipulated (i.e., increased or decreased tension) to thereby manipulate the positioning and orientation of the anastomosis device once it has self-assembled into the predetermined shape (i.e., a polygon). Upon delivery and deployment of the first magnetic anastomosis device at the target tissue site, the one or more guide elements may generally extend from the anastomosis device.

As previously described, the system further includes a controller configured to keep one or more guide elements taught during delivery and self-assembly of an anastomosis device consistent with the present disclosure. For example, once the first magnetic anastomosis device has been delivered to a tissue, it is beneficial to be able to manipulate the location and/or orientation of the device. While the device could be manipulated with conventional tools such as forceps, the controller is configured to manipulate the positioning and orientation of the deployed device via the one or more guide elements. The controller generally comprises one or more control members, each being directly coupled to a proximal end of a respective one of the one or more guide elements coupled to the anastomosis device. Each control member is configured to separately control an amount of tension applied to the respective guide element coupled thereto so as to allow for the magnetic compression anastomosis device to be manipulated in both an unassembled state and an assembled state. Accordingly, the controller is configured to provide a user or operator with handheld control over one or more guide elements coupled to separate respective magnetic segments of the anastomosis device, which, in turn, results in a high degree of precision when positioning the anastomosis device and adjusting the orientation of the anastomosis device, which is particularly useful when attempting to locate and secure the anastomosis device to the target site and/or mate the anastomosis device to a corresponding anastomosis device. The application of tension generally eliminates slack during self-closing or self-opening, keeps the guide elements out of the way of visualization or other procedures, and further stabilizes the device during transition from delivery state to deployed state.

Accordingly, the controller allows a user to hold a given anastomosis device tightly for certain portions of the procedure, and also allow the device to move freely under gravity or magnetic attraction while maintaining a degree of tension on one or more of the guide elements or sutures. This flexibility makes it easier to successfully mate with a complementary magnetic device, and it allows for adjustment of a deployed device when successful placement is not achieved, thereby ensuring a high degree of precision and improved placement of anastomosis devices at the intended target site) to achieve optimal placement and anastomosis formation.

FIG. 1 is a schematic illustration of an anastomosis formation system 10 for providing improved placement of magnetic anastomosis devices at a desired site so as to improve the accuracy of anastomoses creation between tissues within a patient 12. The system 10 generally includes an access device 14, a tension controller (embodiments 100, 200, or 300), magnetic anastomosis devices 16, and an imaging modality 18.

The access device 14 may generally include a scope, including, but not limited to, an endoscope, laparoscope, catheter, trocar, or other delivery device. For most applications described herein, the access device 14 is an endoscope, including a delivery needle configured to deliver the magnetic anastomosis devices 16. Accordingly, the system 10 of the present disclosure relies on a single endoscope 14 for the delivery of the two magnetic devices 16. As will be described in greater detail herein, a surgeon may advance the endoscope 14 within a hollow body of the patient 12 and position the endoscope 14 at the desired anatomical location for formation of the anastomosis based on a visual depiction of the location of the target site as provided by the imaging modality 18. For example, the imaging modality 18 may include a display in which an image, or other visual depiction, is displayed to the surgeon illustrating a target site when performing a medical imaging procedure, including, but not limited to, ultrasound (US), wavelength detection, X-ray-based imaging, illumination, computed tomography (CT), radiography, and fluoroscopy, or a combination thereof. The surgeon may then rely on such a visual depiction when advancing the endoscope through the hollow body so as to position the access device 14 at a portion of tissue adjacent to the other portion of tissue at the target site, thereby ensuring the placement of the magnetic devices 16 is accurate.

It should be noted that the hollow body through which the access device 14 may pass includes, but is not limited to, the stomach, gallbladder, pancreas, duodenum, small intestine, large intestine, bowel, vasculature, including veins and arteries, or the like.

In some embodiments, the self-assembling magnetic devices are used to create a bypass in the gastrointestinal tract. Such bypasses can be used for the treatment of a cancerous obstruction, weight loss or bariatrics, or even treatment of diabetes and metabolic disease (i.e. metabolic surgery). FIG. 2 illustrates the variety of gastrointestinal anastomotic targets that may be addressed with the devices of the invention, such targets include stomach to small intestine (A), stomach to large intestine (E), small intestine to small intestine (C), small intestine to large intestine (B), and large intestine to large intestine (D). Accordingly, the invention provides improved devices and techniques for minimally-invasive formation of anastomoses within the body, e.g., the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatments for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatments for diseases such as cancers, such as stomach or colon cancer.

For example, if the hollow body through which the access device 14 may pass is a bowel of the patient, the first portion may be a distal portion of the bowel and the second portion may be a proximal portion of the bowel. The bowel includes any segment of the alimentary canal extending from the pyloric sphincter of the stomach to the anus. In some embodiments, an anastomosis is formed to bypass diseased, mal-formed, or dysfunctional tissues. In some embodiments, an anastomosis is formed to alter the“normal” digestive process in an effort to diminish or prevent other diseases, such as diabetes, hypertension, autoimmune, or

musculoskeletal disease. It should be noted that the system may be used for the formation of an anastomosis between a first portion of tissue of the hollow body at the target site and an adjacent tissue of a second hollow body (e.g., portal between the stomach and the gallbladder, the duodenum and the gallbladder, stomach to small intestine, small intestine to large intestine, stomach to large intestine, etc.).

In an endoscopic procedure, the self-assembling magnetic devices can be delivered using a single endoscope 14. Deployment of a magnetic device 16 is generally illustrated in FIG. 3. As shown, exemplary magnetic anastomosis devices 16 may be delivered through an endoscope 14 such that individual magnet segments self-assemble into a larger magnetic structure— in this particular case, an octagon. When used with the techniques described herein, the devices 16 allow for the delivery of a larger magnetic structures than would otherwise be possible via a small delivery conduit, such as in a standard endoscope, if the devices were deployed as a completed assembly. Larger magnet structures, in turn, allow for the creation of larger anastomoses that are more robust, and achieve greater surgical success. Because the magnetic devices are radiopaque and echogenic, the devices can be positioned using fluoroscopy, direct visualization (trans-illumination or tissue indentation), and ultrasound, e.g., endoscopic ultrasound. The devices 16 can also be ornamented with radiopaque paint or other markers to help identify the polarity of the devices during placement.

The magnetic anastomosis devices 16 of the invention generally comprise magnetic segments that can assume a delivery conformation and a deployed configuration. The delivery configuration is typically linear so that the device can be delivered to a tissue via a laparoscopic “keyhole” incision or with delivery via a natural pathway, e.g., via the esophagus, with an endoscope 14 or similar device. Additionally, the delivery conformation is typically somewhat flexible so that the device can be guided through various curves in the body. Once the device is delivered, the device will assume a deployed configuration of the desired shape and size by converting from the delivery configuration to the deployed configuration automatically. The self conversion from the delivery configuration to the deployment configuration is directed by coupling structures that cause the magnetic segments to move in the desired way without intervention. Exemplary self-assembling magnetic anastomosis devices 16, such as self-closing, self-opening, and the like, are described in U.S. Patent No. 8,870,898, U.S. Patent No. 8,870,899, U.S. Patent No. 9,763,664, and U.S. Patent Application No. 14/805,916, filed July 22, 2015, the contents of each of which are incorporated by reference herein in their entirety.

In general, as shown in FIG. 4A, a magnetic anastomosis procedure involves placing a first and a second magnetic structures l6a, l6b adjacent to first and second portions 20, 24 of tissues 22, 26, respectively, thus causing the tissues 22 and 26 to come together. Once the two devices l6a, l6b are brought into proximity, the magnetic structures l6a, l6b mate and bring the tissues 22, 26 together. With time, an anastomosis of the size and shape of the devices l6a, l6b will form and the devices will fall away from the tissue. In particular, the tissues 22, 26 circumscribed by the devices will be allowed to necrose and degrade, providing an opening between the tissues.

Alternatively, because the mated devices l6a and l6b create enough compressive force to stop the blood flow to the tissues 22, 26 trapped between the devices, a surgeon may create an anastomosis by making an incision in the tissues 22, 26 circumscribed by the devices, as shown in FIG. 4B.

In yet another embodiment, as will be described in greater detail herein, a surgeon may first cut into, or pierce, the tissues 22, 26, and then deliver device l6a into a portion of the hollow body so as to place device l6a around the incision on tissue 22. The surgeon may then place device l6b into portion 24 of the hollow body so as to deliver device l6b around the incision on tissue 26, and then allow the devices l6a and l6b to couple to one another, so that the devices l6a, l6b circumscribe the incision. As before, once the devices l6a, l6b mate, the blood flow to the incision is quickly cut off. While the figures and structures of the disclosure are primarily concerned with annular or polygonal structures, it is to be understood that the delivery and construction techniques described herein can be used to make a variety of deployable magnetic structures. For example, self-assembling magnets can re-assemble into a polygonal structure such as a circle, ellipse, square, hexagon, octagon, decagon, or other geometric structure creating a closed loop. The devices may additionally include handles, suture loops, barbs, and protrusions, as needed to achieve the desired performance and to make delivery (and removal) easier.

As previously described, the self-assembling magnetic anastomosis devices can be delivered to the target site via the access device 14. For example, as shown in FIG. 5A, the access device 14 may include a delivery needle 28 (e.g., an aspiration needle) used to deliver the first magnetic anastomosis device l6a into the lower small intestine (through the puncture), which is then followed by deployment to of a second magnetic device l6b into the upper small intestine at a location on the tissue adjacent to the target site (shown in FIG. 5B). It should be noted that the delivery can be guided with fluoroscopy or endoscopic ultrasound. Following self- assembly, these small intestine magnetic devices l6a, l6b couple to one another (e.g., magnetically attracted to one another) through a defined tissue area of the combined thickness of a wall of the tissues at the target site and exert compressive forces on the defined area to form the anastomosis.

FIG. 6A shows endoscopic ultrasound guided needle delivery of a magnet assembly into the gallbladder which then couples with a second magnet assembly in the stomach or duodenum as shown in FIG. 6B. Accordingly, the described procedures may also be used with procedures that remove or block the bypassed tissues. For example, endoscopic ultrasound (EUS) can be used to facilitate guided transgastric or transduodenal access into the gallbladder for placement of a self-assembling magnetic anastomosis device. Once gallbladder access is obtained, various strategies can be employed to maintain a patent portal between the stomach and the gallbladder or the duodenum and the gallbladder. In another embodiment, gallstones can be endoscopically retrieved and fluid drained. For example, using the described methods, an anastomosis can be created between the gallbladder and the stomach. Once the gallbladder is accessed in a transgastric or transduodenal fashion, the gallstones can be removed. Furthermore, the gallbladder mucosa can be ablated using any number of modalities, including but not limited to argon plasma coagulation (APC), photodynamic therapy (PDT), sclerosant (e.g. ethanolamine or ethanol).

As previously described, the securement apparatus 100 provides improved placement and securement of magnetic compression devices at a desired target site so as to create anastomoses between tissues. The securement apparatus 100 is configured to be used in the placement and securement of magnetic compression devices that include one or more guide elements, such as sutures or wires, used for the positioning and/or manipulation of the devices once delivered to the target tissue, to achieve optimal placement and anastomosis formation.

FIG. 7 illustrates a single guide element 30 for deploying and manipulating a magnetic anastomosis device 16. For example, once the self-assembling magnetic device has been delivered to a tissue, it is beneficial to be able to manipulate the location of the device 16. While the device 16 can be manipulated with conventional tools such as forceps, it is often simpler to manipulate the location of the deployed device 16 with a guide element 30, such as a suture or wire. As shown in FIGS.7 and 8A-8F, a variety of attachment points can be used to provide control over the location and deployment of a self-assembling magnetic anastomosis device 16. For example, as shown in FIG. 7, the guide element 30 may be coupled to a single distal segment such that, upon self-assembly, the single distal segment results in an attachment point that provides translational freedom of movement. It is also notable that the configuration shown in FIG. 7 also allows a closing force to be applied to the distal-most segment. That is, in the event that one or more segments should become entangled with tissue, or otherwise prevented from self-assembling, a proximal pulling force with the guide element 30 can help the device 16 to complete self-assembly. Once self-assembly is completed, the device 16 can be positioned with the guide element 30 to be mated with another device (not shown) to form an anastomosis, as described above. While it is not shown in FIG. 7, it is envisioned that additional structures, such as a solid pusher or a guide tube can be used to deploy the device 16 in the desired location.

The guide element 30 can be fabricated from a variety of materials to achieve the desired mechanical properties and bio-compatibility. The guide element 30 may be constructed from metal, e.g., wire, e.g., stainless steel wire, or nickel alloy wire. The guide element may be constructed from natural fibers, such as cotton or an animal product. The guide element may be constructed from polymers, such as biodegradable polymers, such as polymers including repeating lactic acid, lactone, or glycolic acid units, such as polylactic acid (PLA). The guide element may also be constructed from high-tensile strength polymers, such as Tyvek™ (high density polyethylene fibers) or Kevlar™ (para-aramid fibers). In an embodiment, guide element 30 is constructed from biodegradable suture, such as VICRYL™ (polyglactin 910) suture available from Ethicon Corp., Somerville, N.J.

In some embodiments, a magnetic anastomosis device 16 may include multiple guide elements 30. For example, as shown in FIGS. 8 A, 8B, 8C, 8D, 8E, and 8F, a variety of attachment points can be used to provide control over the location and deployment of a self assembling magnetic anastomosis device 16. As shown, four guide elements 30(l)-30(4) may be coupled to four separate segments of the device 16, respectively. Each guide element may include a distal end coupled to a respective portion of the anastomosis device, and a proximal end that can be manipulated (i.e., increased or decreased tension) to thereby manipulate the positioning and orientation of the anastomosis device once it has self-assembled into the predetermined shape (i.e., a polygon). For example, as shown, guide element 30(1) is coupled to the most distal end segment, guide elements 30(2) and 30(3) are coupled to middle segments (segments between the most distal end segment and most proximal end segment), and guide element 30(4) is coupled to the most proximal end segment.

FIG. 9 is a perspective view of one embodiment of a linear controller 100 utilizing a constant force spring assembly for providing automatic tensioning features. FIG. 10 is a perspective view of one embodiment of a rotary controller 200 utilizing a constant force spring assembly for providing automatic tensioning features. FIG. 11 is a perspective view of one embodiment of a clockwork controller 300 utilizing a timed mechanical system for providing automatic tensioning features. Each of the controllers 100, 200, 300 is configured to improve deployment and positioning of magnetic compression devices at a desired target site so as to create anastomoses between tissues. The controllers are configured to be used in the placement and manipulation / positioning of magnetic compression devices 16 that include one or more guide elements 30, such as sutures or wires, used for the positioning and/or manipulation of the devices 16 once delivered to the target tissue, to achieve optimal placement and anastomosis formation.

Upon delivery and deployment of the first magnetic anastomosis device l6a at the target tissue site, the one or more guide elements 30 may generally extend from the anastomosis device 16. The controllers are configured to keep one or more guide elements 30 taught during delivery and self-assembly of an anastomosis device 16. For example, once the first magnetic anastomosis device l6a has been delivered to a tissue, it is beneficial to be able to manipulate the location and/or orientation of the device l6a. While the device l6a could be manipulated with conventional tools such as forceps, the controller 100, 200, 300 is configured to manipulate the positioning and orientation of the deployed device l6a via the one or more guide elements 30. The controller 100, 200, 300 generally comprises one or more control members, each being directly coupled to a proximal end of a respective one of the one or more guide elements 30 coupled to the anastomosis device l6a.

Each control member is configured to separately control an amount of tension applied to the respective guide element coupled thereto so as to allow for the magnetic compression anastomosis device to be manipulated in both an unassembled state and an assembled state. Accordingly, the controller is configured to provide a user or operator with handheld control over one or more guide elements coupled to separate respective magnetic segments of the anastomosis device, which, in turn, results in a high degree of precision when positioning the anastomosis device and adjusting the orientation of the anastomosis device, which is particularly useful when attempting to locate and secure the anastomosis device to the target site and/or mate the anastomosis device to a corresponding anastomosis device. The application of tension generally eliminates slack during self-closing or self-opening, keeps the guide elements out of the way of visualization or other procedures, and further stabilizes the device during transition from delivery state to deployed state.

As will be described in greater detail herein, the controllers may have a number of different embodiments and may provide a number of different features. For example, in some embodiments, the controller may be configured to allow for automatic tensioning upon the guide elements during the deployment of the anastomosis device (i.e., during the self-assembly process of the device) so as to prevent or reduce the likelihood of the guide elements from becoming tangled with one another. For example, in some embodiments, the controller may include constant force spring arrangements for providing automatic tensioning. Alternatively, in some embodiments, the controller may include a timed mechanical system for providing automatic tensioning. In all embodiments, the automatic tensioning feature may be controlled by the operator (i.e., activated and deactivated) to thereby allow for either automatic tensioning, locking of the tensioning at a desired tension level, and manual control over the amount of tension to be applied. For example, while each control member may be coupled to the constant force spring assembly, each control member may be individually manipulated and further transition between locked and unlocked states (in both automatic spring mode and manual mode), thereby allowing an operator to utilize the automatic tensioning feature when desired or to override the automatic tensioning feature and manually adjust any given guide element.

Accordingly, the controller allows a user to hold a given anastomosis device tightly for certain portions of the procedure, and also allow the device to move freely under gravity or magnetic attraction while maintaining a degree of tension on one or more of the guide elements or sutures. This flexibility makes it easier to successfully mate with a complementary magnetic device, and it allows for adjustment of a deployed device when successful placement is not achieved, thereby ensuring a high degree of precision and improved placement of anastomosis devices at the intended target site) to achieve optimal placement and anastomosis formation.

To simplify the procedure automatically tensioning the sutures during magnet deployment would be ideal. Two ideas came out of the brainstorm, constant force springs or a multi stage timed mechanical system. FIG. 12 is a top plan view of a linear controller 100 utilizing a constant force spring assembly for providing automatic tensioning features. FIG. 13 is a perspective view of the linear controller 100.

FIG. 14 is a top plan view of the linear controller 100 illustrating the control members in a locked position and FIG. 15 is an enlarged view of the locks in engagement with corresponding portions (i.e., tabs) of each control member, thereby holding the control members in a locked position.

FIG. 16 is a top plan view of the linear controller 100 illustrating the control members in an unlocked position in which automatic tension is applied as a result of the constant force spring assembly and FIG. 17 is an enlarged view of the locks disengaged from corresponding portions (i.e., tabs) of the control members, thereby allowing the control members to transition to a position based on the automatic tension.

FIG. 18 is a top plan view of the linear controller of 100 illustrating the two-part construction of each control member, in which a first portion of each control member, which is under the influence of the constant force spring assembly, is in a locked position, and a second portion of each control member can be moved independently of the first portion to thereby allow for manual adjustment to tension upon the corresponding guide element. FIG. 19 is an enlarged view of the locks engaged with the first portion of each control member, thereby holding the first portion in a locked position.

FIG. 20 is a side view, partly in section, of the controller 100 illustrating the lock or latch mechanism configured to engage the first portion of the control member and further illustrating the second portion of the control member that is configured to independently move relative to the first portion regardless of whether the first portion is in a locked or unlocked position.

FIGS. 21 and 22 illustrate a single lock configured to engage each of the control members simultaneously as well as a spring loader mechanism allowing for a user to manually activate or disable the spring force.

FIGS. 23 and 24 are top and side views of another embodiment of a linear controller lOOa consistent with the present disclosure. As will be described in greater detail herein, the controller lOOa includes separate suture channels to reduce tangling, a soft spring release, an easy spring release, a easy-to-use spring disengagement, it is compact, and it includes friction features to manage manual controls.

FIG. 25 is a top view of the linear controller lOOa and FIG. 26 is a side view, partly in section, of the linear controller lOOa illustrating a soft spring release component. By staging the positions of the control members (which generally slide along tracks of the controller), no single component has to travel more than .25 inches when the spring tension is released. A small coil spring also acts as a buffer between the spring driven components staged start points and the parts they contact.

FIGS. 27 and 28 are sectional views of the linear controller lOOa illustrating internal workings of the controller. As shown in FIG. 27, a separate channel has been introduced for just the sutures. This feature, as well as the staged starting points, helps keep the sutures from ever being excessively loose and should prevent tangling. As shown in FIG. 28, spring loaded ball bearings drag against the channel walls.

FIG. 29 is a back view of the linear controller lOOa illustrating a spring disengagement component. As shown, a sliding lever re-latches all the springs after deployment de-tensioning the sutures. In the rare case that tension is needed again the release lever on the back can be used. These can be integrated into one feature on the side but this arrangement will keep accidental spring release to a minimum. FIGS. 30 and 31 are top views of the linear controller of lOOa illustrating a pull tab member allowing for retraction to occur. In order to keep the controller small (saves about 3 inches), an extra pull tab was needed to facilitate the extra travel required for the first suture during retraction. When the regular manual slides are at maximum travel the little green tab pops out of the top automatically.

FIGS. 32 and 33 are perspective views of one embodiment of a rotary controller 200 utilizing a constant force spring assembly for providing automatic tensioning features. The spool layout of the rotary controller 200 is very compact and constant force springs would provide independent tension to each suture. FIG. 34 is a side view of the rotary controller 200 illustrating dimensions of the controller. FIG. 35 illustrates mounting of the rotary controller 200 to a scope.

FIGS. 36, 37, 38, 39, and40 are perspective views of various variants of the rotary controller 200. FIG. 36 illustrates a smaller spool 200a that rotates more than 360 degrees. FIG. 37 illustrates an individual spool option 200b, further provided for in the different embodiments of FIGS. 38, 39, and 40 and the respective embodiments 200c. For example, each suture could have its own dial or input, wherein such dials could be potentially arrays in different formats, as illustrated in FIGS. 38, 39, and 40.

FIGS. 41, 42, and 43 are perspective front and rear views of one embodiment of a clockwork controller 300 utilizing a timed mechanical system for providing automatic tensioning features. FIGS. 44 and 45 are side views, partly in section, of the clockwork controller 300, illustrating the inner workings of the controller and FIG. 46 is a perspective view of the inner workings (illustrating the controller cover removed).

FIG. 47 illustrates a linear controller coupled to a scope by way of an adapter for mounting the controller to the scope. It is important to minimize the amount of hands required for a procedure to take place. Accordingly, an adapter for mounting the controller to an endoscope would greatly improve the ease with which a procedure can be performed.

FIG. 48 is a perspective view of one embodiment of a mounting member for mounting a controller consistent with the present disclosure to a scope. FIGS. 49 and 50 illustrate coupling of the mounting member to a scope. As illustrated, the mounting member is adjustable and can be mounted directly to the endoscope.

FIG. 51 illustrates another embodiment of a mount for coupling a controller consistent with the present disclosure to a scope. The design illustrated in FIG. 51 allows for any length of catheter, as the service loop accommodates any slack. The quick-connects allow for the controller to be off of the scope when needed (i.e., during loading of a magnetic anastomosis device into the access device for delivery), but quickly allows for the controller to be attached to the scope so a user can access the controller while operating the scope. The mount further includes a seal between the mount and the scope, as well as in the mount' port where the catheter enters. The seal prevents air and fluid from pushing up and out of the scope.

FIG. 52A is a side view, partly in section, and FIG. 52B is a side view illustrating one embodiment of a cutting assembly including a sliding cutter for cutting the one or more guide elements once the magnetic anastomosis device is in place.

FIG. 53A is a side view, partly in section, and FIG. 53B is a side view illustrating one embodiment of a cutting assembly including a rotating cutter for cutting the one or more guide elements once the magnetic anastomosis device is in place.

FIG. 54A is a side view and FIG. 54B is a side view partly in section, illustrating another embodiment of a cutting assembly including a rotating cutter for cutting the one or more guide elements once the magnetic anastomosis device is in place. The pairing of a rotating cutter with a shearing edge would reduce chances of jamming while still allowing increased pressure to be applied.

It should be noted that, alternatively, or in addition, to the mechanical means of cutting the guide elements (sutures), the cutting assembly may include a heating element positioned on an end of the access device (i.e., catheter) and configured to melt through the sutures.

Accordingly, the controller of the present disclosure provides for improved deployment and positioning of magnetic compression devices at a desired target site so as to create anastomoses between tissues. The controller is configured to be used in the placement and manipulation / positioning of magnetic compression devices that include one or more guide elements, such as sutures or wires, used for the positioning and/or manipulation of the devices once delivered to the target tissue, to achieve optimal placement and anastomosis formation. The controller allows a user to hold a given anastomosis device tightly for certain portions of the procedure, and also allow the device to move freely under gravity or magnetic attraction while maintaining a degree of tension on one or more of the guide elements or sutures. This flexibility makes it easier to successfully mate with a complementary magnetic device, and it allows for adjustment of a deployed device when successful placement is not achieved, thereby ensuring a high degree of precision and improved placement of anastomosis devices at the intended target site) to achieve optimal placement and anastomosis formation.

Incorporation by Reference

References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.

Equivalents

The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Scope of the invention is thus indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein