Compression anastomosis system and its use

Abstract

The compression anastomosis system includes corresponding first and second compression ring devices 1, 40, 50, 60, 70, 80, 90, each configured for adjustment from an elongated delivery configuration suitable for passage of minimally invasive surgical instruments to a deployed radially expanded configuration dimensioned to circumferentially abut an inner wall of a body lumen. The compression rings include connecting elements 20, 41, 56, 57 for connecting the rings to one another in a face-to-face compression anastomosis configuration, and each compression ring device includes a radially outwardly facing surface 10 having tissue anchors 12, 58 configured to secure the ring to a wall of the body lumen when the rings are deployed in the body lumen. A method of forming a compression anastomosis in a body lumen, such as the colon, is also described.

Description

[Technical Field]

[0001] The present invention relates to a compression anastomosis system, particularly a compression anastomosis system for performing a colonic anastomosis by minimally invasive surgery. The present invention also provides a method for performing a compression anastomosis in a subject, particularly a method for performing a colonic anastomosis by minimally invasive surgery. [Background technology]

[0002] Colorectal cancer is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women worldwide. There were more than 1.9 million new cases worldwide in 2020. The global burden of colorectal cancer is projected to increase by 60%, reaching more than 2.2 million new cases and 1.1 million deaths per year by 2030. This increase is projected to be the product of environmental changes such as more sedentary lifestyles, increased obesity, processed food, alcohol, and meat consumption, and greater overall longevity.

[0003] Surgical anastomosis is performed when a surgeon removes a diseased section of the intestine, colon, or blood vessel and then reconnects healthy ends. One of the most serious problems with anastomosis is anastomotic leakage, which occurs in up to 20% of patients who undergo anterior rectal resection. Anastomotic leakage allows fecal material to enter the abdominal cavity, leading to serious problems such as peritonitis or septic shock. Anastomotic leakage is not easily detectable and can lead to longer hospital stays, readmissions, reoperations, or even death. In the UK, the 2019 National Colorectal Cancer Report showed that 8% of patients who underwent colorectal surgery had an unplanned return to theatre (URTT), and 50% of these occurred within the first 7 days after surgery. The mortality rate for patients with URTT is 8%, compared with 2% for patients who do not return to the operating room.

[0004] Creating a healthy and safe anastomosis requires adequate perfusion, the absence of tension at the anastomosis site, and the absence of efferent obstruction and mesenteric volvulus. Currently, surgical anastomosis is primarily performed using sewing or stapling techniques. Surgical anastomoses can be configured in many ways. These include end-to-end, side-to-side, side-to-end, and end-to-side. Stapling devices can be circular (used to perform end-to-end anastomosis) and linear (used for side-to-side anastomosis). A literature review comparing stapled and hand-sewn anastomoses in colon and rectal surgery found no statistical difference in surgical outcomes between these two methods. Many surgeons base the decision to perform stapled or hand-sewn anastomosis on personal preference and experience. Colorectal surgeons believe that stapled anastomoses have the advantages of lower complication rates and shorter operative times compared to hand-sewn anastomoses. However, numerous adverse events associated with surgical staplers have been reported. The FDA found that it received over 41,000 individual medical device reports from January 1, 2011, to March 31, 2018, including 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions (https: / / www.fda.gov / medical-devices / letters-health-care-providers / safe-use-surgical-staplers-and-staples-letter-health-care-providers). These adverse events have led some surgeons to prefer performing handsewn anastomoses.

[0005] Another technique for creating an anastomosis consists of compression anastomosis, in which the intestinal ends are held together using a device that applies a constant compressive force. This leads to tissue necrosis and a healing process that ultimately joins the two intestinal ends. Various compression anastomosis devices have been developed, but these have not achieved widespread adoption in clinical practice. The main limitations of compression anastomosis devices are that they are difficult to use (e.g., because they require purse-string sutures to secure them in place) and that they were designed for open surgery, while surgical approaches are shifting toward minimally invasive techniques. Despite these limitations, compression anastomosis healing has been associated with less foreign body reaction, scarring, and inflammation compared to stapled anastomosis in large animal models.

[0006] Laparoscopic surgery is a minimally invasive procedure performed using multiple small 0.5-1 cm incision ports. A tubular instrument called a trocar is then used at each port. Laparoscopic instruments are then passed through the trocar. Compared to traditional open surgery, patients often experience less pain, a shorter recovery, and less scarring with laparoscopic surgery. In the UK, 61% of patients underwent laparoscopic procedures in 2019, up from 48% in 2014. Endoscopes are also widely used in colorectal surgery for a variety of purposes, from illumination and intracorporeal imaging to minimally invasive surgical procedures, which can include insufflation, irrigation, suction, gripping, and tissue cutting. Endoscopes have multiple channels for introducing the instruments required for each intervention.

[0007] U.S. Patent Application Publication No. 2008 / 0015617 describes a compression anastomosis ring (CAR) assembly having a first portion having an anvil ring and a second portion having a bottom ring positioned substantially parallel to and spaced from the anvil ring, the anvil ring and the bottom ring adapted to abut in the presence of a closure force applied across them. This device is not suitable for use in minimally invasive surgery.

[0008] U.S. Patent Application Publication No. 2002 / 0082625 describes a surgical fastener for performing an anastomosis having a pair of rings and a protrusion on one of the rings configured to lock the rings together in a compression anastomosis arrangement, the protrusion being configured to pierce tissue in a body lumen. The device is not suitable for use in minimally invasive procedures.

[0009] U.S. Patent Application Publication No. 2018 / 0271531 describes a self-opening magnetic compression anastomosis device having a pair of magnetic rings, each magnetic ring adjustable from a delivery configuration to a deployed ring configuration, and the use of the device to perform side-to-side anastomosis.

[0010] Compression anastomosis devices are described in US Patent Application Publication No. 2016 / 324523, US Patent No. 9320524, Chinese Patent No. 104921772 and Chinese Patent No. 107874801. None of the prior art documents describes a compression anastomosis device suitable for performing end-to-end colonic anastomosis by minimally invasive surgery. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] U.S. Patent Application Publication No. 2008 / 0015617 [Patent Document 2] U.S. Patent Application Publication No. 2002 / 0082625 [Patent Document 3] U.S. Patent Application Publication No. 2018 / 0271531 [Patent Document 4] U.S. Patent Application Publication No. 2016 / 324523 [Patent Document 5] U.S. Patent No. 9,320,524 [Patent Document 6] Chinese Patent No. 104921772 [Patent Document 7] Chinese Patent No. 107874801 [Non-patent literature]

[0012] [Non-Patent Document 1] https: / / www.fda.gov / medical-devices / letters-health-care-providers / safe-use-surgical-staplers-and-staples-letter-health-care-providers [Non-patent document 2] Prakasam et al. (Biodegradable Materials and Metallic Implants-A Review, J Funct Biomater.2017 Dec;8(4):44) [Non-patent document 3] Kawaii et al. (https: / / doi.org / 10.1002 / 3527600035.bpol9012) [Non-patent document 4] https: / / www.chemistryworld.com / news / drug-release-polymer-triggered-by-ultrasound / 4863.article [Non-patent document 5] https: / / en.wikipedia.org / wiki / Poly(N-isopropylacrylamide and Walker et al. (NPG Asia Materials, 9, e350 (2017)) [Non-patent document 6] Schmidt et al. (Macromolecular Rapid Communications, 2006) Summary of the Invention [Problem to be solved by the invention]

[0013] The object of the present invention is to overcome at least one of the above-mentioned problems. [Means for solving the problem]

[0014] Applicant has solved the problems of the prior art by providing a minimally invasive, biocompatible device for the creation of compression anastomoses that can significantly reduce anastomotic leakage. The device remains in place until the body's natural healing and tissue repair processes are complete. Once the device is fully or partially resorbed, it is spontaneously eliminated along with the fecal mass through the colon. The device is configured for use in any body lumen and is particularly suitable for use in the digestive tract, including the esophagus, small intestine, and large intestine (colon).

[0015] In a first aspect, the present invention provides a compression anastomosis system having corresponding first and second compression ring devices, each configured for adjustment from a contracted (e.g., elongated delivery) configuration suitable for passage through the lumen of a minimally invasive surgical instrument, such as a trocar, catheter, or endoscope, to a deployed, radially expanded configuration dimensioned to circumferentially abut the interior wall of a body lumen. At least one of the rings generally has a connecting element for connecting the rings to each other in the face-to-face compression anastomosis configuration. Additional connecting elements configured to connect with the connecting elements of the rings may be used. Each compression ring device typically has a tissue anchor disposed on a radially outward-facing surface of the ring and configured to secure the ring to the wall of the body lumen when the ring is deployed in the body lumen. The anchor may be disposed on the top and / or side of the ring.

[0016] In a second, related aspect, the present invention provides a compression ring device configured for adjustment from a contracted (e.g., elongated delivery) configuration suitable for passage through the lumen of a surgical instrument such as a trocar, catheter, or endoscope, to a deployed, radially expanded configuration sized to circumferentially abut the interior wall of a body lumen, the ring device having connecting elements for connecting the ring to a corresponding adjacent ring in a face-to-face compression anastomosis configuration, the ring device having tissue anchors typically disposed on a radially outwardly facing surface of the ring and configured to secure the ring to the wall of the body lumen when the ring is deployed in the body lumen. The anchors may be disposed on the top and / or sides of the ring.

[0017] One or both of the rings, or one or more portions thereof, may be biodegradable, allowing the or each ring to be absorbed, broken down into smaller portions, or adapted to an open ring shape. In another embodiment, the or each ring is configured to lose stiffness over time within the body or in response to an external stimulus, making the ring more flexible and easier to pass through a body lumen.

[0018] In any embodiment, the or each ring has a locking mechanism for locking the ring in the deployed configuration.

[0019] In all embodiments, the locking mechanism is self-locking.

[0020] In all embodiments, the or each compression ring, when in the elongated delivery configuration, is sized to pass through a lumen of a surgical instrument having a diameter of up to 15 mm.

[0021] In all embodiments, the device is completely or almost completely biodegradable.

[0022] In all embodiments, one or more portions of the device are biodegradable such that the portions of the device biodegrade during use to cause the device to break down into smaller portions sized for passage through a body lumen (e.g., the colon and anus).

[0023] In any embodiment, a first portion of the compression ring device is configured to biodegrade more rapidly than a second portion of the compression ring device, such that the first portion of the device biodegrades during use to break down the compression ring device into a second portion sized for passage through the intestine and anus. The first portion (or a particular region of the first portion) may be configured for radio frequency assisted pyrolysis.

[0024] In all embodiments, the device is configured for adjustment of the orientation of the tissue anchor upon deployment of the compression ring device from a first orientation to a second tissue-gripping orientation.

[0025] In all embodiments, the anchors are located on the top and / or sides of the ring.

[0026] In all embodiments, the anchors are located on either side of the ring.

[0027] In all embodiments, the anchor elements extend radially from the ring surface or at an angle relative to a radial vector.

[0028] In all embodiments, the rings are configured such that, upon deployment, the angle of the anchor elements relative to the longitudinal axis of the body lumen decreases or increases.

[0029] In all embodiments, the anchors on the proximal side of the outer surface of the ring are angled outward (i.e., toward the open end of the body lumen) and the anchors on the distal side of the outer surface of the ring are angled inward (away from the open end of the body lumen).

[0030] In all embodiments, the tissue anchors comprise a plurality of arrays (typically linear arrays) of anchors circumferentially spaced about the radially outwardly facing surface of the compression ring.

[0031] In any embodiment, one or more of the anchor arrays includes a plurality of anchors (eg, 2, 3, or 4 or more) disposed laterally across the radially outwardly facing surface.

[0032] In any embodiment, the tissue anchor comprises: Barb (spine or barb) is.

[0033] In any embodiment, the or each compression ring device comprises an inflatable ring configured to deploy the compression ring upon inflation.

[0034] In all embodiments, the expandable ring is configured such that the radially outer surface of the expandable ring changes profile from a first profile to a more convex profile upon deployment, causing the tissue anchors on the radially outer surface to evert the wall of the body lumen around the distal face of the ring. The distal face of the ring is the surface that faces the corresponding compression ring during use. This feature helps ensure that the everted tissue on each ring is held in place in the abutting position when the rings are coupled together.

[0035] In any embodiment, the or each compression ring device ideally includes an elongate inflation conduit which is detachable from the inflatable ring.

[0036] In any embodiment, the or each compression ring device comprises a reinforcing element coupled to the expandable ring.

[0037] In all embodiments, the reinforcing element is annular.

[0038] In all embodiments, the reinforcing element is coupled to the expandable ring along the radially inner circumference of the expandable ring.

[0039] In all embodiments, the expandable ring is molded to the reinforcing element.

[0040] In all embodiments, the reinforcing elements are coupled to the inflatable ring along the lateral (transverse) periphery of the inflatable balloon.

[0041] In all embodiments, the annular reinforcing element has a radially inner base portion and a radially outwardly depending sidewall that defines an annular trough sized to receive an inflatable balloon. See, e.g., Figure 40.

[0042] In all embodiments, the trough has a concave cross section, see for example Figure 40.

[0043] In all embodiments, the annular reinforcing element comprises a plurality of substantially rigid segments pivotally connected to one another.

[0044] In all embodiments, the plurality of substantially rigid segments includes a first set of rigid segments coupled to one another to form first and second sections of a ring adjustable from a straight configuration to a curved configuration, and a second set of rigid segments that are curved and configured to connect ends of the first and second sections to form the ring.

[0045] In all embodiments, the reinforcing element comprises an elongated strain-limiting element (such as a wire, filament, or thread) wrapped around at least a portion of the inflatable ring, configured to prevent or limit expansion of the ring (i.e., prevent or limit changes in the cross-sectional area of ​​the inflatable ring) while allowing the ring to unfold. The element may form a coil around the ring. The element may be embedded in the wall of the ring (e.g., the ring may be molded in situ with the element).

[0046] In all embodiments, the reinforcing element comprises annular reinforcing elements coupled to one or two opposite sides of the expandable ring.

[0047] In all embodiments, the inflatable ring has a circular, semicircular, or elliptical cross section.

[0048] In all embodiments, the inflatable ring has, in cross section, a flat inner base portion and a convex upper portion.

[0049] In all embodiments, the wall of the inflatable ring forming the flat inner base portion is thicker than the wall of the inflatable ring forming the convex upper portion.

[0050] In all embodiments, the inflatable ring has a plurality of first portions separated by one or more weakened second portions, which may be structurally weakened or may comprise a material configured to biodegrade more rapidly than the material of the first portions, and which are positioned on the ring such that degradation of the weakened second portions results in separation of the ring into a plurality of first portions small enough to pass along the intestine and exit through the anus.

[0051] In all embodiments, the compression ring device is biased into the elongated delivery configuration. This may be achieved by the design of the linkage between the segments forming the ring. If the ring comprises an inflatable ring, expansion of the ring biases the ring into the radially expanded, deployed configuration.

[0052] In any embodiment, the first and / or second compression rings each include a plurality of rigid links hingedly connected to one another to form an annulus.

[0053] In all embodiments, the rigid links include alternating first and second links hingedly joined to each other at their ends, with the first links having two spaced apart arms and the second links having a single central arm, each end of the single central arm being positioned between the two spaced apart arms of an adjacent first link and hingedly connected to the two spaced apart arms by a hinge element such as a pin.

[0054] In all embodiments, the system includes a deployment mechanism operable to adjust the compression ring from an elongated delivery configuration to a radially expanded deployed configuration.

[0055] In all embodiments, the compression ring in the deployed configuration is oval.

[0056] In all embodiments, the compression ring in the deployed configuration is circular.

[0057] In any embodiment, all or some of the tissue anchors are biodegradable, in which case biodegradation of the anchors releases the ring, which can be passed along a body lumen without the need for the ring to degrade.

[0058] In all embodiments, the compression ring includes a damping mechanism configured to prevent further radial expansion of the compression ring once deployed to a desired deployed configuration.

[0059] In all embodiments, the braking mechanism includes a braking element disposed on the single arm and configured to abut one of the two spaced arms when one of the two spaced arms is pivoted to a position aligned with the single arm.

[0060] In all embodiments, one of the spaced arms has a detent sized to receive a braking element.

[0061] In all embodiments, the compression ring includes a locking mechanism for locking the links in a desired deployed configuration. In all embodiments, the locking mechanism is a self-locking mechanism. In all embodiments, the locking mechanism includes one or more structures on a sidewall of the central arm and corresponding structures on a sidewall of one of the spaced arms, the structures configured to engage when the ring is fully deployed. In all embodiments, the structures are sized for friction fit engagement.

[0062] In all embodiments, each ring has a connecting element for connecting the rings together in a compression anastomosis configuration.

[0063] In any embodiment the or each coupling element is magnetic.

[0064] In all embodiments, each ring has a magnetic coupling element (one ring may have a magnetic coupling element of one polarity, and the other ring may have a magnetic coupling element of the opposite polarity).

[0065] In all embodiments, the coupling elements on the first and second rings are sized to fit together, for example, one magnetic element may be convex and the other may be concave.

[0066] In all embodiments, the unitizing element includes a latching mechanism. One ring may include an axially extending arm, and the second ring may include a structure (e.g., an annular lip) configured to receive the arm in a locking arrangement.

[0067] In embodiments where the or each ring has an annular reinforcing element, the unitizing element may be disposed on the reinforcing element.

[0068] In any embodiment, the or each ring has a removable cover disposed on a proximal or distal surface of the ring configured to prevent material in the body lumen from passing through the ring when the ring is deployed. The cover may be a film material, a nonwoven material, or a mesh of material.

[0069] In all embodiments, the cover has gripping elements that allow the cover to be grasped and removed from the ring after the ring has been deployed.

[0070] In all embodiments, the compression ring has a width of 1 to 10 mm, preferably 2 to 5 mm or 3 to 4 mm.

[0071] In all embodiments, the compression ring has a diameter of between 20 and 80 mm, depending on the body lumen with which the compression ring is used, or, if used with the colon, the particular section of the colon.

[0072] In all embodiments, the ring or portions thereof comprise a biodegradable material. Details of such materials are known to those skilled in the art and include naturally occurring polymers such as chitosan, hyaluronic acid, collagen, fibrin, and silk, or their derivatives, as well as synthetic polymers such as polyglycolic acid (PGA), polylactic acid (PLA), poly-beta-hydroxybutyrate (PHB), polylactic-co-glycolic acid (PLGA), poly-ε-caprolactone (PCL), or biodegradable polyethers (e.g., polyethylene glycol, polypropylene glycol, polytetramethylene glycol). Biodegradable polymers are described in Prakasam et al. (Biodegradable Materials and Metallic Implants—A Review, J Funct Biomater. 2017 Dec;8(4):44). Biodegradable polyethers are described in Kawaii et al. (https: / / doi.org / 10.1002 / 3527600035.bpol9012).

[0073] In all embodiments, the systems of the present invention include one or more body lumen clamps. Typically, the clamps are passive clamps. In all embodiments, the clamps may include magnets configured to maintain the proximal anastomotic compression rings in a desired position in the body lumen during deployment.

[0074] In another aspect, the present invention provides the use of a compression anastomosis system of the present invention to perform a compression anastomosis of a body lumen in a subject.

[0075] In all embodiments, the compression anastomosis is an end-to-end compression anastomosis of a body lumen.

[0076] In all embodiments, the compression anastomosis is a colonic compression anastomosis. Other suitable body lumens include the vasculature and the urethra.

[0077] In any embodiment, the subject has colon cancer and the compression anastomosis is performed after a section of the colon containing cancerous or suspected cancerous tissue has been resected.

[0078] In any embodiment, the or each anastomotic ring comprises: an annular hollow tube biased into a ring shape and elastically deformable; a plurality of ring segments arranged in a ring; The anastomotic ring is configured to be elastically deformed into an elongated delivery configuration suitable for passage through a tubular surgical instrument, such as a trocar, catheter, or endoscope, and to self-deploy upon release from the surgical instrument into a radially expanded configuration suitable for fully or at least partially circumferentially abutting the inner wall of a body lumen.

[0079] In all embodiments, one or more of the ring segments comprises a magnetic or magnetizable material to provide a coupling element for coupling the two rings together.

[0080] In any embodiment, one side of the or each ring segment has magnetic or magnetizable material of a first polarity and the opposite side of the ring segment has magnetic or magnetizable material of a second polarity.

[0081] In all embodiments, the annular hollow tube comprises an elastically deformable polymeric material.

[0082] In all embodiments, the annular hollow tube, or one or more portions thereof, is biodegradable.

[0083] In all embodiments, the annular hollow tube, or one or more portions thereof, comprises a material configured to lose stiffness over a predetermined period of time in vivo, such that the annular hollow tube and anastomotic ring lose stiffness after the predetermined period of time in vivo and are compressed in the body lumen to facilitate movement along the body lumen, such as in the case of a mammalian digestive tract, whereby the ring may be passed through the colon and anus.

[0084] In all embodiments, one or more of the ring segments has an inner core and an outer sheath.

[0085] In all embodiments, the inner core comprises a magnetic or magnetizable material.

[0086] In all embodiments, the outer sheath includes a tissue anchor. In all embodiments, the tissue anchor and the annular hollow tube are configured such that, upon assembly of the anastomotic ring, the tissue anchor protrudes through the annular hollow tube to provide a tissue anchor on the outer surface of the ring.

[0087] In all embodiments, the tissue anchors include first anchors located distally (e.g., rearward) of the outer diameter of the ring. These anchors aid in inserting the ring into the lumen. The anchors prevent the ring from falling back into the lumen.

[0088] In all embodiments, the tissue anchors include second anchors located proximal (e.g., anterior) to the outer diameter of the ring. These anchors help prevent the ring from falling forward in the lumen. The anchors also provide additional fixation when connected to another ring to grasp tissue and hold the ring in place. In all embodiments, the second anchor of one ring is configured to interlock with the second anchor of the corresponding ring when the two rings are joined together to form a compression anastomosis.

[0089] In all embodiments, the tissue anchors include a third anchor located proximally on the inner diameter of the ring, which is designed to grip the everted tissue and, when connected to the other ring, to prevent the tissue from escaping the grip of the ring when the device is under pressure.

[0090] In all embodiments, the outer sheath is configured to block magnetic forces on one side of the inner core, such that the side of the ring facing the corresponding ring has a greater magnetic force than the opposite side of the ring. This may be achieved, for example, by selectively blocking one side of the inner core. For example, the outer sheath may extend only partially around the inner core, e.g., covering one side of the inner core and not covering (or only partially covering) the opposite side of the inner core.

[0091] In all embodiments, the outer sheath is biodegradable.

[0092] In all embodiments, the or each inner core of a ring segment is a cylindrical element.

[0093] In all embodiments, the tissue anchor is biodegradable.

[0094] In all embodiments, the annular hollow tube has a central strut element that assists in deployment of the tube into an O-shape and is configured to collapse when the annular hollow tube is compressed into the delivery configuration. In all embodiments, the central element is cross-shaped. In all embodiments, the central strut element is configured to collapse when the ring is in the contracted delivery configuration.

[0095] In all embodiments, the anastomotic ring includes a coil element helically wound around all or a portion of the ring. In all embodiments, the tissue anchor is disposed on the helical coil.

[0096] In all embodiments, the anastomotic ring includes a sleeve wrapped around all or part of the ring, and in all embodiments, the tissue anchor is disposed on the sleeve.

[0097] In any embodiment, the or each anastomotic ring is configured to be adjustable between an open ring configuration and a closed ring configuration, such that the ring comprises a flexible elongate element (an open ring) with opposing ends configured to join together to form a closed ring, such that the ring can be delivered through a laparoscopic medical device in the elongate configuration and the ends can be joined together to form the ring configuration inside the body.

[0098] In all embodiments, the flexible elongate element has multiple segments connected to one another. Adjacent segments may be hingedly connected to one another to allow adjustment of the ring between an elongate open ring configuration (delivery configuration) and a closed ring-shaped configuration (deployed configuration). In all embodiments, the ring includes a magnet and the flexible elongate element extends through the magnet.

[0099] In all embodiments, the flexible elongate element is biased into a ring shape so that it forms a ring shape when released from a delivery device, such as a laparoscopic instrument.

[0100] In all embodiments, the ring has a hollow lumen configured to accommodate the actuating filament.

[0101] In all embodiments, the rings when deployed have an annular groove that extends completely or partially around the inner circumference of the ring when deployed, and this groove may function as a connecting element to connect corresponding rings together.

[0102] In all embodiments, the compression anastomosis system includes a connecting insert configured to connect to a connecting element of a corresponding ring to connect the rings together.

[0103] In all embodiments, the coupling insert comprises a frame having a first coupling structure configured to couple with a connecting element of a first ring and a second coupling structure configured to couple with a connecting element of a second ring.

[0104] In all embodiments, the rings each have an annular groove that extends completely or partially around the inner circumference of the ring when deployed, and a first coupling structure is configured to engage the annular groove of one ring and a second coupling structure is configured to engage the annular groove of the second ring to hold the rings in a face-to-face compression anastomosis configuration.

[0105] In all embodiments, the frame is radially expandable from a radially contracted delivery configuration to a radially expanded deployed configuration.

[0106] In all embodiments, the frame has a plurality of support segments arranged around a central axis, with connecting structures disposed on the support segments, and a plurality of elastically deformable struts connecting adjacent support segments, allowing movement of the support segments radially inward and outward relative to the central axis. The frame is elastically biased to a delivery configuration in which the support segments are arranged around the central axis. The frame typically has four support segments spaced equally around the circumference of the frame when deployed. The or each support segment has a support member with spaced-apart connecting structures (connecting structures for connecting to the connecting elements of a first ring and connecting to the support structures of a second ring). In all embodiments, each elastically deformable strut comprises a curved strut. In all embodiments, each support segment is connected to an adjacent support segment by two elastically deformable struts.

[0107] In all embodiments, all or part of the coupling insert is biodegradable.

[0108] In any embodiment, the or each ring comprises a material configured to change its structural properties in response to a stimulus to make the or each ring less rigid and more suitable for passage along a body lumen.

[0109] In any embodiment, the stimulus is the environment of a body lumen, and the material is configured to become less rigid in the environment of the body lumen over a predetermined period of time. For example, the material may be configured to change structural properties over a predetermined period of time as a result of the pH, temperature, or water content of the body lumen. The predetermined period of time may be, for example, 2 to 10 weeks.

[0110] In all embodiments, the stimulus is an external stimulus, such as an acoustic, electrical or electromagnetic stimulus.

[0111] In another aspect, the present invention provides a method of performing a compression anastomosis of a body lumen in a subject, comprising: providing first and second compression anastomosis rings, each configured for adjustment from an elongated delivery configuration suitable for passage through a tubular surgical instrument, such as a trocar, catheter, or endoscope, to a deployed, radially expanded configuration dimensioned to circumferentially abut an interior wall of a body lumen; inserting a first compression ring into a body lumen at a first position; inserting a second compression ring into the body lumen at a second location axially spaced from the first location; deploying the compression rings to a radially expanded deployed configuration such that each deployed ring circumferentially abuts an interior wall of the body lumen; ablating a section of the body lumen between the first and second locations in the body lumen; and connecting the first and second compression anastomosis rings together using a connecting element on each ring to form a compression anastomosis.

[0112] In all embodiments, the method employs the compression anastomosis system of the present invention.

[0113] In all embodiments, the procedure is performed internally by minimally invasive surgery.

[0114] In all embodiments, a portion of the body lumen is removed from the body and the method steps are performed extracorporeally.

[0115] In all embodiments, the body lumen is the digestive tract of the subject.

[0116] In all embodiments, the body lumen is the colon of the subject.

[0117] In any embodiment, the or each compression ring is inserted into the body lumen through an opening in the side wall of the body lumen.

[0118] In embodiments where the body lumen is the intestine (eg, the colon), the or each compression ring may be inserted through the rectum.

[0119] In any embodiment, the section of the body lumen is excised after the compression ring is inserted into the body lumen and deployed.

[0120] In all embodiments, the section of the body lumen to be resected is clamped at each end by a clamp prior to resection of the section of the body lumen.

[0121] In all embodiments, a section of the body lumen is excised prior to insertion of the compression ring into the body lumen.

[0122] In any embodiment, the method comprises: constricting the body lumen with a clamp in a first position; constricting the body lumen with a clamp at a second location spaced from the first location; and cutting the body lumen at two spaced locations between the two clamps to excise a section of the body lumen.

[0123] In this embodiment, resection of the section of the body lumen leaves open ends at the proximal and distal portions of the body lumen, and a first compression ring is inserted into the open end at the distal portion of the body lumen and a second compression ring is inserted into the open end at the proximal portion of the body lumen.

[0124] In any embodiment, the method preferably includes the step of clamping the distal and proximal ends of the section of the body lumen to be excised prior to excision of the section of the body lumen.

[0125] In any embodiment, the method comprises: advancing a first compression anastomosis ring in an elongated delivery configuration through a tubular surgical instrument into a body lumen in a minimally invasive manner; positioning a first compression anastomosis ring within the body lumen adjacent the first open end of the body lumen and laterally across the body lumen; deploying a first compression anastomosis ring within the body lumen such that the deployed ring circumferentially abuts an interior wall of the body lumen; advancing the second compression anastomosis ring in an elongated delivery configuration through a tubular surgical instrument into a body lumen in a minimally invasive manner; positioning a second compression anastomosis ring within the second open end of the body lumen and laterally across the second open end of the body lumen; deploying a second compression anastomotic ring within the body lumen such that the deployed ring circumferentially abuts an interior wall of the body lumen; and connecting the first and second compression anastomosis rings together using a connecting element to form a compression anastomosis.

[0126] In any embodiment, the method includes positioning the compression anastomosis ring within the body lumen, within 1-5 cm or within 1-3 cm of the open end, transversely across the body lumen.

[0127] In all embodiments, the compression anastomosis ring is configured such that the radially outer surface of the ring changes profile upon deployment from a first profile to a more convex profile, causing the tissue anchors at the radially outer surface to evert the wall of the body lumen around the distal face of the ring (i.e., distal to the open end of the body lumen).

[0128] In all embodiments, the method includes adjusting the orientation of tissue anchors on the body lumen-facing surface of the ring during deployment of the ring.

[0129] In any embodiment, the method includes adjusting the shape of the body lumen-facing surface of the ring during deployment of the ring.

[0130] In all embodiments, the method includes positioning a compression anastomosis ring within a body lumen and diametrically across the body lumen.

[0131] In any embodiment, the or each compression ring comprises an inflatable ring, and the deploying step comprises inflating the ring.

[0132] In all embodiments, the inflatable fluid is inflated using a fluid conduit fluidly connected to the ring, and the method includes the step of detaching the fluid conduit from the ring after deployment of the ring.

[0133] In all embodiments, the inflation fluid is a liquid, such as deionized water or saline.

[0134] In all embodiments, one or both of the rings are configured for adjustment from an open ring configuration to a closed ring configuration.

[0135] In all embodiments, one or both of the rings are delivered in an open ring configuration and adjust to a closed ring configuration in vivo.

[0136] In any embodiment, the or each open ring is delivered through a minimally invasive medical device in an open, elongated configuration, typically along an actuating filament.

[0137] In any embodiment, the method comprises joining the ends of the or each ring together in vivo to form a closed ring.

[0138] In any embodiment, the or each ring is configured to self-adjust to a ring shape when released from a restraint, such as a minimally invasive medical device.

[0139] In any embodiment, the or each ring end is configured to self-mate with one another, which may be achieved, for example, by open ring ends having magnetic elements configured to guide the ends into mating relationship.

[0140] In all embodiments, the step of coupling the compression anastomosis rings together includes providing a coupling insert and coupling a first ring to the coupling insert and a second ring to the coupling insert such that the two rings are coupled to each other to form the compression anastomosis.

[0141] In all embodiments, the method includes minimally invasively advancing a coupling insert in a radially contracted delivery configuration through a minimally invasive medical device into a body lumen, and deploying the coupling insert from the minimally invasive medical device into the body lumen, whereby the coupling insert radially expands into the coupling configuration and connects each ring to the coupling insert.

[0142] In all embodiments, a first ring is deployed within a first cut end of a body lumen, a second ring is placed within a second cut end of the body lumen, a joining insert is attached to the first ring within the first cut end of the body lumen, and then the second ring is attached to the joining insert to abut the cut ends of the body lumens to form a compression anastomosis.

[0143] Other aspects and preferred embodiments of the invention are defined and described in the remaining claims set forth below. [Brief explanation of the drawings]

[0144] [Figure 1] FIG. 1 is a perspective view of a compression ring device according to one embodiment of the present invention shown in an elongated delivery configuration. [Figure 2] FIG. 2 is a side view of the compression ring device of FIG. 1. [Figure 3] FIG. 2 is a plan view of the compression ring device of FIG. 1. [Figure 4] FIG. 2 is a perspective, partial cross-sectional view of the compression ring device of FIG. 1. [Figure 5] FIG. 2 is a cross-sectional end view of the compression ring device of FIG. 1. [Figure 6] FIG. 2 is a perspective view of the compression ring device of FIG. 1 shown in a deployed radially expanded configuration. [Figure 7] FIG. 7 is a front view of the compression ring device of FIG. [Figure 8] FIG. 7 is a side view of the compression ring device of FIG. 6. [Figure 9] FIG. 8 is a cross-sectional view taken along line AA in FIG. 7. [Figure 10] FIG. 1 is a cross-sectional view of a compression ring device when the ring is in a delivery configuration. [Figure 11] FIG. 1 is a cross-sectional view of a compression ring device when the ring is in a deployed radially expanded configuration. [Figure 12] FIG. 10 is a cross-sectional view of a compression ring device showing the latch arms that form part of the coupling mechanism. [Figure 13] FIG. 10 is a partial cross-sectional perspective view showing how the latch on one ring engages a shoulder on an adjacent ring. [Figure 14] FIG. 1 is a cross-sectional view showing the latch arm and coupling mechanism. [Figure 15]10A-10C are cross-sectional views showing how the coupling mechanism can couple the rings in a slightly spaced apart configuration. [Figure 16] 10A-10C are cross-sectional views showing how a coupling mechanism can couple rings in an abutting configuration. [Figure 17A] FIG. 1 shows a section of colon with a tumor and a passive clamp attached to the colon distal to the tumor. [Figure 17B] FIG. 1 shows a passive clamp attached to and clamping the colon. [Figure 18] FIG. 10 shows a second passive clamp attached to the colon distal to the tumor and spaced apart from the first clamp. [Figure 19] FIG. 1 shows the colon being cut between the clamps. [Figure 20] FIG. 1 shows a distal section of the colon with a clamp attached. [Figure 21] FIG. 1 shows a delivery device approaching the open end of the distal colon. [Figure 22] FIG. 10 shows a first compression ring in an elongated delivery configuration being advanced from the open end of a delivery device. [Figure 23] FIG. 10 shows the first compression ring after delivery adjacent the open end of the distal colon. [Figure 24] FIG. 10 shows a first compression ring being advanced into the open end of the distal colon. [Figure 25] FIG. 1 shows a ring positioned within and diametrically across the colon. [Figure 26] FIG. 1 shows a partially sectioned colon showing the fixation barbs on the surface of the ring. [Figure 27] FIG. 10 shows the ring after it has been deployed into a radially expanded configuration, showing how the severed end of the distal colon everts around the ring. [Figure 28] FIG. 10 shows the deployed ring with the balloon inflation conduit removed and retracted. [Figure 29]1 illustrates a distal colon with a deployed compression ring and a proximal section of the colon with a corresponding compression ring in a deployed configuration, the proximal section being prepared in the same manner as the distal colon. [Figure 30] The cut ends of the colon are butted together and the compression rings are joined together by engaging the latching arms of one ring with the other, resulting in the everted colon sections being compressed together around the distal ends of the rings. [Figure 31] FIG. 10 illustrates the formation of a compression anastomosis. [Figure 32] FIG. 10 is a side view showing compression rings deployed at the ends of two sections of the colon. [Figure 33] FIG. 10 shows the rings being joined together, resulting in the tissue at the ends of the two sections being pressed together. [Figure 34] FIG. 10 is a diagram showing the formation of an anastomosis. [Figure 35] Subsequent biodegradation of the weakened section of the ring allows the section of the ring to pass along the colon and be expelled through the anus. [Figure 36] FIG. 1 illustrates a compression ring device according to another embodiment of the present invention shown in a deployed, radially expanded configuration. [Figure 37] FIG. 37 shows a detail of the compression ring device of FIG. 36. [Figure 38] FIG. 37 is a front view of the compression ring device of FIG. 36. [Figure 39] FIG. 37 is a side view of the compression ring device of FIG. 36. [Figure 40] FIG. 37 is a side view of the compression ring device of FIG. 36 with the reinforcing element and inflatable balloon separated. [Figure 41] FIG. 37 is a perspective view of the compression ring device of FIG. 36 with the reinforcing element and inflatable balloon separated. [Figure 42] FIG. 1 is a side view of two compression ring devices aligned prior to engagement. [Figure 43]FIG. 10 is a side view of the two rings after engagement. [Figure 44] FIG. 37 is a perspective view of the compression device of FIG. 36 in an elongated delivery configuration. [Figure 45] FIG. 45 is a side view of the compression device of FIG. 44. [Figure 46] FIG. 45 is a plan view of the compression device of FIG. 44. [Figure 47] FIG. 45 is an end view of the compression device of FIG. 44, including a balloon inflation fluid conduit. [Figure 48] FIG. 45 is a perspective view of the compression device of FIG. 44, including a balloon inflation fluid conduit. [Figure 49] FIG. 10 is a perspective view of a compression ring device according to an alternative embodiment of the present invention in a radially retracted delivery configuration. [Figure 50] FIG. 50 is a perspective view of the compression ring device of FIG. 49. [Figure 51A] FIG. 50 is a plan view of the compression ring device of FIG. 49. [Figure 51B] FIG. 50 is a side view of the compression ring device of FIG. 49. [Figure 52] FIG. 50 is a perspective view of the compression ring device of FIG. 49 in a partially deployed, radially expanded configuration. [Figure 53] FIG. 50 is a perspective view of the compression ring device of FIG. 49 in a fully deployed, radially expanded configuration. [Figure 54] FIG. 54 is a detailed view of the body lumen-facing surface of the compression ring device of FIG. 53, showing the tissue fixation barbs. [Figure 55] FIG. 54 is a side view of the compression ring device of FIG. 53. [Figure 56] FIG. 54 is a detailed view of the compression ring device of FIG. 53 showing the braking mechanism. [Figure 57] FIG. 54 is another detailed view of the compression ring device of FIG. 53 showing the braking mechanism. [Figure 58] FIG. 54 is a detailed side view of the compression ring device of FIG. 53 showing one example of a coupling formation, in this case alternating concave and convex magnetic formations. [Figure 59]FIG. 59 is a detailed view of the two compression ring devices of FIG. 58 combined with concave and convex magnetic formations. [Figure 60] FIG. 60 is a perspective view of a compression ring similar to the embodiment of FIGS. 58 and 59, but having an alternative coupling element, in this case a latching arm. [Figure 61] FIG. 60 is a perspective view of the two compression ring devices of FIG. 59 aligned prior to engagement. [Figure 62] FIG. 10 is a perspective view of two rings after engagement. [Figure 63] A detailed perspective view of two compression ring devices prior to bonding. [Figure 64] A detailed perspective view of two compression ring devices after bonding. [Figure 65] 10 is a perspective view of another embodiment of a compression ring device according to the present invention having a face covering film in an elongated delivery configuration. FIG. [Figure 66] FIG. 66 is a perspective view of the compression ring device of FIG. 65 in a deployed, radially expanded configuration. [Figure 67] FIG. 66 is a perspective view showing the removal of the face covering film from the compression ring device of FIG. 65. [Figure 68] FIG. 66 is a perspective view showing the removal of the face covering film from the compression ring device of FIG. 65. [Figure 69] FIG. 10 is a perspective view of another embodiment of a compression ring device according to the present invention. [Figure 70] FIG. 70 is a perspective view of an end of the compression ring device of FIG. 69; [Figure 71] FIG. 70 is a longitudinal cross-sectional view of the compression ring device of FIG. 69. [Figure 72] FIG. 70 is a front view of the compression ring device of FIG. 69. [Figure 73] FIG. 70 is a side view of the compression ring device of FIG. 69. [Figure 74] FIG. 70 is a detailed longitudinal cross-sectional view of the compression ring device of FIG. 69. [Figure 75] FIG. 70 is a cross-sectional view of the compression ring device of FIG. 69. [Figure 76]FIG. 70 is a side view of the compression ring device of FIG. 69. [Figure 77] FIG. 70 is a perspective view showing two compression ring devices of FIG. 69 joined together in a compression anastomosis configuration. [Figure 78] FIG. 70 is a perspective view showing the compression ring device of FIG. 69 broken into segments due to biodegradation of weakened sections of the ring. [Figure 79] FIG. 1 is a diagram of a passive clamp for use with the devices and systems of the present invention. [Figure 80] FIG. 1 is a diagram of a passive clamp for use with the devices and systems of the present invention. [Figure 81] FIG. 1 is a diagram of a passive clamp for use with the devices and systems of the present invention. [Figure 82] FIG. 1 is a diagram of a passive clamp for use with the devices and systems of the present invention. [Figure 83] 10A-10C show a compression anastomosis ring according to an alternative embodiment of the present invention. [Figure 84A] FIG. 84 shows an inner core magnetic element forming part of the compression anastomotic ring of FIG. 83. [Figure 84B] FIG. 84 shows an outer sheath forming part of the compression anastomotic ring of FIG. 83. [Figure 84C] 84 shows an annular hollow tube forming part of the compression anastomotic ring of FIG. 83. FIG. [Figure 85] FIG. 84 is an exploded view of the components of the compression anastomotic ring of FIG. 83. [Figure 86] FIG. 84 shows the compression anastomotic ring of FIG. 83 in a flat delivery configuration. [Figure 87A] FIG. 84 is an end profile view of the compression anastomotic ring of FIG. 83. [Figure 87B] FIG. 84 is an end profile view of the compression anastomotic ring of FIG. 83. [Figure 88] FIG. 84 is a side view of the compression anastomotic ring of FIG. 83 in a flattened delivery configuration. [Figure 89]84 is a cross-sectional view of the compression anastomosis ring of FIG. 83 showing the outer sheath partially surrounding the magnetic inner core and the placement of anchors extending through the annular hollow tube. [Figure 90] FIG. 1 shows an anastomotic compression ring with one side exhibiting a strong north pole force (N+++) and the other side exhibiting a weak south pole force (S+). [Figure 91A] FIG. 84 is a side view of the compression anastomotic ring of FIG. 83. [Figure 91B] FIG. 84 is a side view of the two compression anastomosis rings of FIG. 83 joined together in a compression anastomosis forming configuration. [Figure 92] FIG. 1 shows two anastomotic compression rings with the ring-facing side of the first ring exhibiting a strong north pole force (N+++) and the ring-facing side of the second ring exhibiting a strong south pole force (S+++). [Figure 93] FIG. 93 is a perspective view of the two rings of FIG. 92 after they have been magnetically coupled. [Figure 94A] FIG. 93 is an end view of the two rings of FIG. 92 after they have been magnetically coupled. [Figure 94B] FIG. 93 is an end view of the two rings of FIG. 92 after they have been magnetically coupled. [Figure 95] FIG. 93 is a side view of the two rings of FIG. 92 after they have been magnetically coupled. [Figure 96A] FIG. 1 is a side view of a ring segment forming part of a compression anastomotic ring of the present invention. [Figure 96B] FIG. 1 is an end view of a ring segment forming part of a compression anastomosis ring of the present invention. [Figure 96C] FIG. 1 is a perspective view of a ring segment forming part of a compression anastomotic ring of the present invention. [Figure 97A] FIG. 10 is a perspective view of an alternative ring segment forming part of the compression anastomotic ring of the present invention. [Figure 97B] FIG. 10 is an end view of an alternative ring segment forming part of the compression anastomotic ring of the present invention. [Figure 97C] FIG. 10 is a side view of an alternative ring segment forming part of the compression anastomotic ring of the present invention. [Figure 98]FIG. 98 is a perspective view of two compression anastomotic rings with ring segments of FIG. [Figure 99A] 98 is a diagram of two compression anastomosis rings having the ring segments of FIG. 97 in a compression anastomosis formation configuration. [Figure 99B] 98 is a diagram of two compression anastomosis rings having the ring segments of FIG. 97 in a compression anastomosis formation configuration. [Figure 100] FIG. 10 is an exploded view of a compression anastomosis ring according to an alternative embodiment of the present invention. [Figure 101] FIG. 10 is an exploded view of a compression anastomosis ring according to an alternative embodiment of the present invention. [Figure 102] FIG. 10 is an exploded view of a compression anastomosis ring according to an alternative embodiment of the present invention. [Figure 103A] FIG. 10 is an exploded view of a compression anastomosis ring according to an alternative embodiment of the present invention. [Figure 103B] FIG. 10 is an exploded view of a compression anastomosis ring according to an alternative embodiment of the present invention. [Figure 104] FIG. 84 illustrates the use of a compression anastomosis system having two compression anastomosis rings of FIG. 83 to form a compression anastomosis of a severed colon. [Figure 105] FIG. 10 is a side view of a compression anastomosis ring according to an alternative embodiment of the present invention, shown in an open ring configuration, in which the ring is configured for delivery and adjustment from a closed ring deployment configuration. [Figure 106] FIG. 106 is a perspective view of the compression anastomotic ring of FIG. 105. [Figure 107] (A) shows an elongated laparoscopic surgical device including the compression anastomosis ring of FIG. 105 in an open ring configuration positioned within the central lumen of the device; (B) and (C) show the ring partially advanced from the device along the actuating filament; and (D) shows the ring fully advanced from the device. [Figure 108] FIG. 106 shows the compression anastomosis ring of FIG. 105 deployed in a closed ring configuration. [Figure 109] FIG. 1 is a perspective view of a coupling insert forming part of a compression anastomosis system according to one embodiment of the present invention. [Figure 110] 109A shows the compression anastomotic ring of FIG. 105 attached to one side of the docking insert of FIG. 109. [Figure 111A] 109 shows two compression anastomosis rings of FIG. 105 attached to the connecting insert of FIG. 109. [Figure 111B] 109 shows two compression anastomosis rings of FIG. 105 attached to the connecting insert of FIG. 109. [Figure 111C] 109 shows two compression anastomosis rings of FIG. 105 attached to the connecting insert of FIG. 109. [Figure 112A] 109 shows the first compression anastomotic ring of FIG. 105 attached to one side of the connecting insert and deployed at a first open cut end of the colon, and the second compression anastomotic ring of FIG. 105 (not shown) deployed at a second open cut end of the colon. [Figure 112B] 112B shows the compression anastomosis formed when the second compression anastomosis ring of FIG. 112A is attached to the second side of the unitization element. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0145] All publications, patents, patent applications, and other references mentioned in this specification are incorporated herein by reference in their entirety for all purposes as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference and the contents of which were set forth in full.

[0146] Definitions and General Precedence As used herein, unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meaning that the term may have in the art.

[0147] Unless otherwise required by context, the use of the singular herein should be read to include the plural and vice versa. The term "a" or "an" when used in reference to an entity should be read to refer to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein.

[0148] As used herein, the term "comprise" or variations thereof, such as "comprises" or "comprising," should be read to indicate the inclusion of any enumerated integer (e.g., feature, element, characteristic, property, method / process step, or limitation) or group of integers (e.g., feature, element, characteristic, property, method / process step, or limitation), but not the exclusion of any other integer or group of integers. Thus, as used herein, the term "comprising" is inclusive or open-ended and does not exclude additional, unenumerated integers or method / process steps.

[0149] As used herein, the term "disease" is used to define any abnormal condition that impairs physiological function and is associated with specific symptoms. The term is used broadly to encompass any disease, ill-health, abnormality, lesion, illness, condition, or syndrome in which physiological function is impaired, regardless of the nature of the etiology (or whether an etiological basis for the illness has actually been established). Thus, the term encompasses conditions resulting from infection, trauma, injury, surgery, radioactive ablation, aging, poisoning, or nutritional deficiency.

[0150] As used herein, the term "treatment" or "treating" refers to an intervention (e.g., the administration of PFA treatment to a subject) that cures, ameliorates, or reduces the symptoms of a disease or eliminates its cause (or reduces the effects of its cause), in which case the term is used interchangeably with the term "therapy."

[0151] Additionally, the terms "treatment" or "treating" refer to an intervention (e.g., administration of PFA therapy to a subject) that prevents or delays the onset or progression of, and reduces the incidence of (or eliminates) the disease in, the treated population. In this context, the term treatment is used synonymously with the term "prophylaxis."

[0152] In the context of treatment and effective amounts as defined above, the term subject (which shall be read to include, where the context permits, "individual," "animal," "patient," or "mammal") defines any subject, particularly a mammalian subject, for whom treatment is indicated. Mammalian subjects include, but are not limited to, humans, livestock, farm animals, zoo animals, sport animals, and pet animals, such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, camels, bison, cattle, and dairy cows; primates, such as apes, monkeys, orangutans, and chimpanzees; canines, such as dogs and wolves; felines, such as cats, lions, and tigers; equines, such as horses, donkeys, and zebras; food animals, such as dairy cows, pigs, and sheep; ungulates, such as deer and giraffes; and rodents, such as mice, rats, hamsters, and guinea pigs. In a preferred embodiment, the subject is a human. As used herein, the term "equine" refers to mammals of the family Equidae, which includes horses, donkeys, asses, kiangs, and zebras.

[0153] As used herein, the term "compression ring" is understood to mean a compression ring that can be used in forming a compression anastomosis. The ring generally has spikes, hooks, or BarbThe ring has an outer surface (the surface facing the body lumen) having a tissue anchor or surface texture such as a tubular or tubular ridge. The ring is generally adjustable from a contracted configuration (e.g., an elongated delivery configuration suitable for implantation into the body using minimally invasive surgical instruments) to a radially expanded configuration typically sized to have a diameter about the same as or slightly larger or smaller than the diameter of the body lumen into which the ring is to be deployed. The ring generally has a locking mechanism, preferably a self-locking mechanism, to lock the ring in the deployed configuration. The ring may be fully or partially biodegradable. The ring may include weakened section(s) configured to degrade, causing the ring to break down in the body lumen into smaller sections or to open the ring. The weakened section(s) may be mechanically weaker (e.g., a thin connecting element) or may be formed from a material configured to biodegrade more quickly than other portions of the ring. The compression ring may include an inflatable ring. The ring may be biased into the elongated delivery configuration. The ring may be formed from segments that may be connected to one another (e.g., hingedly connected to one another) or attached to connecting elements, such as wire elements. The segments may be unconnected. The segments may be attached to an annular tubular element, which may be biodegradable. The segments may be magnetic. Each segment may be attached to a sheath. An anchor may be provided on the sheath. The segments may be configured to penetrate the annular tubular element to provide tissue anchors on a surface of the ring. The ring may be adjustable from an open ring configuration to a closed ring configuration, whereby the ring may be delivered via minimally invasive surgical instruments in the open ring configuration and then deployed to the closed ring configuration in vivo. The ring may be configured to be biased to the closed ring configuration. The rings may have connecting elements configured to connect to one another to close the rings. The connecting elements may be biodegradable. The rings may be configured to self-assemble into the closed ring configuration. The rings may have connecting elements configured to connect to connecting elements of an adjustment ring. The connecting element may be configured to connect to the connecting insert.

[0154] "A material configured to change its structural properties in response to a stimulus to render the or each ring less rigid and suitable for passage along a body lumen" refers to a material that loses its rigidity in response to a stimulus. The stimulus may be the environment of the body lumen. For example, if the body lumen is the digestive tract, the material may be configured to become less rigid over a predetermined period of time as a result of an environmental cue such as pH, temperature, or humidity. The material may be configured to become less rigid over a defined period of time, e.g., 2 to 10 weeks. The material may be configured to change its structural properties in response to an external stimulus, e.g., acoustic (e.g., ultrasound), electrical (e.g., RF energy), or electromagnetic (laser, UV light) stimulus. The ring or a portion of the ring may be formed from a material. In any embodiment, the material is a polymer, e.g., a shape-memory polymer or a temperature-responsive polymer. One example of a material configured to change its structural properties is a shape-memory polymer, e.g., a crosslinked P(MMA-BA) copolymer (P = poly, MMA = methyl methacrylate, BA = butyl acrylate), which changes its shape in response to ultrasound (https: / / www.chemistryworld.com / news / drug-release-polymer-triggered-by-ultrasound / 4863.article). Another example is a temperature-responsive polymer (e.g., poly(N-isopropylacrylamide) (PNIPAm)) that can be activated by RF energy to trigger a change in state (https: / / en.wikipedia.org / wiki / Poly(N-isopropylacrylamide) and Walker et al. (NPG Asia Materials, 9, e350 (2017)). Another example is the polymer responsive to electromagnetic fields described in Schmidt et al. (Macromolecular Rapid Communications, 2006).

[0155] A "connection insert" is a connection device configured to connect with a connection element of a first ring and a connection element of a second ring, such that the first and second rings abut one another and form a compression anastomosis when connected to the connection insert. The connection insert is typically configured for delivery through a minimally invasive surgical instrument or medical device. The connection insert, or one or more portions thereof, is generally biodegradable.

[0156] As used herein, the term "expandable ring" refers to an annular balloon that can be inflated by pumping a fluid, such as a liquid or gas (or a mixture thereof), into the balloon, causing the compression ring to change shape from a stored (e.g., elongated delivery) configuration to a radially expanded, deployed configuration. The expandable ring may have an outer surface (the surface facing the body lumen) configured to change profile upon deployment, for example, from a first profile to a more convex profile.

[0157] As used herein, the term "biodegradable" as applied to a material or ring means that the material can be completely or partially degraded within the body. Suitable biodegradable materials for forming implants and for use within the body are described in the literature and include natural-based polymers such as chitosan, hyaluronic acid, collagen, fibrin, and silk, or their derivatives, and synthetic polymers such as polyglycolic acid (PGA), polylactic acid (PLA), poly-beta-hydroxybutyrate (PHB), polylactic-co-glycolic acid (PLGA), poly-ε-caprolactone (PCL), or biodegradable polyethers (polyethylene glycol, polypropylene glycol, polytetramethylene glycol, etc.). Biodegradable polymers are described in Prakasam et al. (Biodegradable Materials and Metallic Implants—A Review, J Funct Biomater. 2017 Dec;8(4):44). Biodegradable polyethers are described in Kawaii et al. (https: / / doi.org / 10.1002 / 3527600035.bpol9012). One or more portions of the ring may be biodegradable. The term also includes materials configured to change properties (e.g., lose structural rigidity) as a result of an environmental stimulus (e.g., conditions in a body lumen) or an external stimulus, such as acoustic, electrical, or electromagnetic (e.g., UV light or laser) stimulus.

[0158] As used herein, the term "body lumen" is understood to mean an elongated cavity such as the digestive tract (e.g., esophagus, ileum, colon) or arteries, veins, lymphatic vessels, urethra, ureters, sinuses, ear canals, nasal cavities, bronchi).

[0159] As used herein, the terms "minimally invasive surgical instrument" or "laparoscopic instrument" are understood to mean a surgical instrument that can be inserted into the body through a small incision and that contains a lumen through which a surgical instrument or medical device can be inserted. The lumen is generally up to 15 mm in diameter. Examples include catheters, trocars, endoscopes, and laparoscopic devices.

[0160] As used herein, the term "fluid" is understood to mean a gas, a liquid, or a mixture thereof. In a preferred embodiment, the fluid is a liquid, such as saline or deionized water.

[0161] As used herein, the term "removable cover" is understood to mean a thin layer of material that covers the surface of the compression ring. The material may be a film or a nonwoven material.

[0162] As used herein, the term "end-to-end anastomosis" is understood to mean an anastomosis formed between the severed ends of a body lumen, for example, the severed ends of the colon. The systems and methods of the present invention may also be applied to side-to-end or side-to-side anastomoses.

[0163] As used herein, the term "weakened section" is understood to mean a portion of the ring that is mechanically weakened (e.g., a thin wall) or a portion of the ring that is formed from a material configured to biodegrade more quickly than the rest of the ring.

[0164] As used herein, the term "elongate strain-limiting element" means a wire, thread, or filament that is flexible and has the required tensile strength to restrict the shape of the expandable ring to a desired configuration.

[0165] Example The present invention will now be described with reference to specific examples. These are merely exemplary and for illustrative purposes only. They are not intended to limit in any way the scope of the claimed features or the invention described. These examples constitute the best modes presently contemplated for carrying out the invention.

[0166] Referring now to the drawings, and initially to FIGS. 1-9, a compression ring device in accordance with the present invention is shown and generally designated by the reference numeral 1. In FIGS. 1-5, compression ring device 1 is shown in an elongated delivery configuration suitable for delivery through a trocar having a 10 mm diameter, and in FIGS. 6-9, compression ring device 1 is shown in a deployed, radially expanded configuration. Compression ring device 1 has an inflatable ring 2 attached to an annular, reinforced housing 3 for the inflatable ring. Housing 3 has a base 4 and a sidewall 5 depending from the base, with base 4 and sidewall 5 together defining an annular trough sized to receive inflatable ring 3. Referring to FIG. 5, radially outwardly facing wall 6 of base 4 has a concave profile, and radially inwardly facing wall 7 has a stepped profile.

[0167] The outer surface 10 of the expandable ring 2 has tissue fixation grooves 14 circumferentially disposed along the outer surface 10 . Barb The inflatable ring has a plurality of spaced arrays 11 of 12. Each array 11 has six spaced arrays 11 spaced across the outer surface 10 of the inflatable ring. Barb As shown in FIG. 5, the outer surface of the expandable ring is convex, with three proximal Barb 12 are angled outward (i.e., toward one end of the body lumen) and the three distal ends of the outer surface 10 of the ring. Barb is angled inward (towards the opposite end of the body lumen). Barb is integrally formed with the inflatable balloon and may be formed from the same polymer as the inflatable ring. The inflatable ring 2 also has a fluid port 18 configured to removably engage an inflation conduit.

[0168] 2, the housing 3 includes a first set 15A of rigid segments having a plurality of substantially rigid segments hingedly connected to one another at their ends, connected to form first and second sections 16, 17 of a ring that is adjustable from a straight to a curved configuration, and a second set 15B of rigid segments configured to connect the ends of the first and second sections to form the curved, annular housing 3. Thus, the housing is adjustable from the elongated configuration shown in FIG. 2 to the circular, radially deployed configuration shown in FIG.

[0169] 10 and 11, the expandable ring 2 is shown in cross section before (FIG. 10) and after (FIG. 11) inflation. When the expandable ring is inflated, the shape of the outer surface 10 and Barb It can be seen that the outer surface 10 is designed to change its orientation, i.e., the outer surface 10 becomes more convex, which Barb Change the direction of Barb The expandable ring grasps tissue in the body lumen and everts the tissue around the top and sides of the expandable ring.

[0170] Referring to FIGS. 12-16, a coupling element for coupling two aligned rings together is shown, comprising a series of latching arms 20 attached to the side of the housing 3 and extending axially away from the housing. Each latching arm 20 has a sloped head 21. The radially inward-facing wall 7 of the housing base has a stepped profile with a step 22. In use, when two compression rings are aligned and positioned and butted together, the sloped heads 21 of the arms 20 catch on the step, locking the rings together. Each compression ring may include multiple latching arms and steps, as shown in FIGS. 12-14. In the embodiment shown in FIGS. 15 and 16, the wall 7 of each ring has two steps 7A and 7B, which allow the rings to be locked together in a slightly spaced or abutting configuration.

[0171] Use of the device in a procedure for performing an end-to-end compression anastomosis of the colon will now be described with reference to Figures 17-35. Figures 17A and 17B show a section of colon 29 containing a tumor 30 and a passive clamp 31 attached to the colon distal to the tumor and constricting the colon. Figure 18 shows a second passive clamp 32 attached to the colon distal to the tumor and spaced approximately 6 cm from the first clamp. Figure 19 shows the colon being cut between the clamps to sever the colon, and Figure 20 shows a healthy section of colon 33A distal to the cut, with an open end 34. 21-25 show the delivery device 36 approaching the open end 34 of the colon, with the first compression ring 1 in the elongated delivery configuration being advanced from the open end of the delivery device and delivered adjacent the open end of the distal colon, and then advanced into the open end 34 of the colon and positioned diametrically across the colon, approximately 1-4 cm from the severed open end. FIG. 26 shows the partially excised colon, with the surface of the ring engaging the colon tissue at the open end 34 of the colon. Barb This shows:

[0172] An appropriate compression ring is selected by the surgeon based on imaging or observation of the colon before the procedure is performed. The ring should have a diameter approximately the same as the colon or slightly larger or smaller when deployed so that most of the outer surface of the ring abuts the inner wall of the colon when the ring is deployed.

[0173] Figure 27 shows the ring 1 after it has been deployed into its radially expanded configuration, showing how the open end 34 of the colon 33A wraps around the distal face of the ring. The balloon inflation conduit 38 is then detached from the inflatable ring and retracted through the delivery device (Figure 28).

[0174] 17-28 are then performed on the section of colon proximal to the tumor to provide a section of healthy colon proximal to the tumor with an open end, with the resected section of colon containing the tumor clamped at both ends to prevent the release of fecal material into the abdomen. The resected section of colon may then be removed and a corresponding compression ring positioned within the open end of the colon and deployed as described above.

[0175] Figure 29 shows a first section 33A of a healthy colon with a deployed compression ring and a second section 33B of a healthy colon with a corresponding compression ring (not shown) in the deployed configuration. Figure 30 shows that the cut ends of the colon are butted together and the compression rings are joined (as described above) by engaging the latching arms of one ring with the other ring, so that the sections of colon everted around the rings are compressed together to form a compression anastomosis, as shown in Figure 31.

[0176] 32-35 are side views showing that the compression ring 1 is deployed at the ends of two sections of the colon (FIG. 32), and as the rings are joined, the tissue 34 at the ends of the two sections 33A, 33B is compressed together (FIG. 33), forming an anastomosis 39 (FIG. 34), and subsequent biodegradation of the weakened sections of the ring allows the sections of the ring to pass along the colon and be expelled through the anus (FIG. 35).

[0177] 36-47, an alternative embodiment of a compression ring, generally designated by reference numeral 40, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, the compression ring has the same overall structure as the compression ring device 1 previously described with reference to FIGS. 1-9, but the linking element includes a series of magnets 41 of a first polarity in one ring and corresponding magnets 42 of opposite polarity in a second ring. As illustrated, the magnets are positioned on the sidewall of the housing 3 at every other segment 15A. Use of this embodiment is the same as the previous embodiment, except that the rings are joined in a compression anastomosis configuration by the magnets.

[0178] 49-59, an alternative embodiment of a compression ring, generally designated by the reference numeral 50, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, the compression ring 50 has a plurality of stiff, alternating first and second links hingedly connected to one another end-to-end, thereby forming an annulus that can be adjusted to a low-profile configuration and then deployed to a radially expanded configuration. In the illustrated embodiment, the compression ring device has four first links 51 connected to one another in an end-to-end arrangement by four second links 52. Each first link 51 has two spaced-apart arms 51A and 51B, and each second link 52 has a single central arm, the ends 52A, 52B of which are positioned between and abut the two spaced-apart arms 51A, 51B of the adjacent first link and are pivotally connected to the two spaced-apart arms by a pin 53. Each arm is curved, with the arms of the first link being longer than the second, central arm. The curvature and length of the arms are configured so that when the device is articulated into the deployed configuration, the ring has an elliptical shape defined by the four first links arranged in end-to-end relationship. The upper surfaces of the spaced arms 51A, 51B form tissue-engaging Barb58. The ring 50 also has a damping mechanism for limiting pivoting of the first and second links relative to one another during deployment once the oval shape is formed. The damping mechanism includes a stop structure 54 centrally located on the upper portion of the central arm 52 that projects laterally into the path of one of the first link arms 51A, 51B to prevent further pivoting of the first link arm when the first link arm is longitudinally aligned with the second central arm. The first link arm has a detent 55 positioned and dimensioned to receive the stop structure 54. The detent may be dimensioned to snap-engage with the stop structure 54 and function as a locking mechanism for rigidly holding the ring once the desired oval, deployed shape is achieved. Other types of locking mechanisms may also be provided, such as a structure on the side wall of the central arm and a corresponding structure on the side wall of one of the arms 51A, 51B configured to engage when the ring is fully deployed to lock the ring in the fully deployed position. The braking mechanism is shown in FIGS.

[0179] The unitizing elements provided on the rings 50 include magnets, specifically a series of magnets 56 of a first polarity on one side of the ring and corresponding magnets 57 of the opposite polarity on the second ring. As shown in Figures 58 and 59, in the illustrated embodiment, the magnets 56 on one ring include concave magnets 56A and convex magnets 56B, with corresponding convex magnets 57A and concave magnets 57B on the other ring. Use of this embodiment is the same as the previous embodiment.

[0180] 60-64, an alternative embodiment of a compression ring generally designated by the reference numeral 60 is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, which is similar to the embodiment described with reference to FIGS. 48-57, the connection element has latching arms 20 as previously described, which are attached to one of the first link arms and are configured to hook behind the axially inner wall 61 of the first link arm of the adjacent ring. This is shown in FIGS. 63 and 64. Use of this embodiment is the same as the previous embodiment.

[0181] Referring to FIGS. 65-68, an alternative embodiment of a compression ring, generally designated by reference numeral 70, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, similar to the embodiment described with reference to FIGS. 1-9, ring device 70 includes a cover member 71 attached to the periphery of the ring, covering the surface of the ring when the ring is in the delivery and deployed configuration, and functioning to occlude the body lumen when the ring device is deployed to prevent passage of material from the body lumen when the body lumen is severed. The cover may comprise a film, e.g., a biodegradable polymer film, and may include gripping tabs 72 to facilitate removal of the film with a gripping device. Use of this embodiment is the same as the previous embodiment, except that the rings are coupled to each other in the compression anastomosis configuration by magnets.

[0182] Referring to FIGS. 69-77, an alternative embodiment of a compression ring, generally designated by reference numeral 80, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, ring 80 includes an expandable ring 81 and a reinforcing element in the form of a wire 82 that is wound around a portion of the ring to allow the ring, upon inflation, to radially expand from the elongated delivery configuration (shown in FIGS. 69-71) to the deployed configuration shown in FIGS. 72 and 73 without excessively changing the cross-sectional area of ​​the ring. In the illustrated embodiment, the wire is embedded in the ring wall in a coiled configuration. The expandable ring has a base wall 84 that is thicker than the side walls 85. The expandable ring 81 includes partitions 86 that define ring segments 87, each partition 86 having an opening 88 to allow fluid communication between the ring segments 87.

[0183] Referring to FIG. 78, an alternative embodiment of a compression ring, generally designated by reference numeral 90, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, the ring includes an inflatable ring 91 having chambers 92 defined by dividing walls 93 having small apertures 94 that provide fluid communication between the chambers. The dividing walls are formed from a material that is more easily degraded in the body, thereby providing weakened sections that biodegrade first, resulting in the ring device breaking down into multiple segments. The weakened sections can be positioned around the ring in locations that ensure the resulting segments are small enough to pass through the colon and anus.

[0184] Referring to FIGS. 79-82, a passive clamp suitable for clamping a body lumen, such as the colon, is shown and generally designated by the reference numeral 100. Clamp 100 has a first arm 101 and a second arm 102 connected by a hinge 103 and a locking structure 104 at the distal end of each arm for locking the clamp in a clamped position. Each arm has a clamping surface with a series of tissue-gripping structures (in this embodiment, rectangular teeth 105). The teeth on each clamping surface are staggered so that they do not engage. The clamp is configured so that the teeth on opposing clamping arms are sufficiently separated so that the teeth do not interlock when the clamp is in the clamped configuration. The tissue-gripping elements may take the form of wedges, pins, or a hydrogel-like material. The clamp is a passive clamp because it does not damage tissue and is placed over the intestine in an area that will not release fecal material into the surgical cavity. It is also contemplated that the clamp may help reduce bleeding.

[0185] Referring to FIGS. 83-96, an alternative embodiment of a compression ring, generally designated by reference numeral 110, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, the compression ring 110 includes an annular hollow tube 111 and a plurality of ring segments 112 disposed within the ring. In this embodiment, the ring segments are not connected to one another. The annular hollow tube is formed from a polymeric biodegradable material and is elastically deformable to allow the ring to be radially compressed into a flat, elongated configuration (FIGS. 86 and 88) during delivery in a minimally invasive surgical instrument and to self-expand into a ring shape (FIG. 83) upon release from the surgical instrument and deployment at the target location. The tube in this embodiment is formed from a biodegradable material that degrades over time within the body. It will be appreciated that only a portion of the tube may be biodegradable to allow the tube to break down into smaller pieces, or indeed to change the tube from a closed ring shape to an open ring shape (the tube elongates into a shape that allows the ring segments to be released and passed through the colon and anus).

[0186] The annular hollow tube 111 is biased into the X-shape shown in FIG. 83 but has X-shaped spoke elements 118 formed from an elastically deformable material that can be compressed in a scissor fashion during compression of the ring into the delivery configuration shown in FIG. 88.

[0187] Each ring segment 112 has a cylindrical inner core 113 and an outer sheath 114. The inner core comprises a magnetic material that functions as a connecting element configured to connect one compression anastomosis ring to an adjacent corresponding ring. In this embodiment, the inner core is diametrically magnetized so that one side exhibits a north pole (north pole side 115) and the opposite side exhibits a south pole (south pole side 116). The inner core 113 is arranged in a ring so that one side of the ring exhibits multiple north poles and the opposite side of the ring exhibits multiple south poles. This connects the rings together. Referring to FIGS. 89 and 96, the outer sheath 114 has a polymer jacket that covers each end of the inner core and extends approximately 75% of the circumference of the tubular inner core, exposing the north pole side 115 and covering the south pole side 116 of the inner core 113. This acts to weaken the magnetic force on the south pole side 116 compared to the north pole side 115. In use, referring to FIG. 92, a pair of ring segments are configured such that one side of the first ring exhibits a strong north pole (N+++) and the ring segments of the second ring are configured such that one side of the second ring exhibits a strong north pole (S+++).

[0188] Tissue anchors for the compression ring 110 are provided by anchors 117 integrally formed with the outer sheath 114. When the ring 110 is assembled, the anchors 117 protrude through the annular hollow tube 111 to provide anchors to the tube surface. Referring to FIGS. 87 and 89, the anchors include an array of first anchors 117A and second anchors 117B disposed on the top surface 119 of the inner sheath, and a third array of anchors 117C extending from the bottom surface 120 of the inner sheath. Each array of anchors includes two rows of anchors extending longitudinally along the outer sheath. The first array of anchors 117A extends upwardly and laterally from the sheath, while the second array of anchors 117B extends laterally in a direction generally opposite that of the first array of anchors. The third array of anchors 117C extends downwardly away from the sheath. When assembled to the annular tube 111, the first and third arrays of anchors 117A and 117C extend laterally from one side of the assembled ring (the side facing the corresponding ring), and the third array of anchors 117B extends laterally inward (away from the corresponding ring).

[0189] The second array of anchors 117B aids in inserting the rings into the lumen and prevents them from falling backward into the lumen. The first array of anchors 117A aids in preventing the rings from falling forward in the lumen. They also add fixation when connected to another ring to grip tissue and hold the ring in place. The third array of anchors 117C is designed to grip everted tissue and, when connected to another ring, grip everted tissue and prevent tissue from escaping the grip of the rings when the device is under pressure.

[0190] 92-95 show two compression rings 110A and 110B joined together in a compression anastomosis configuration, with one row of each of the first and third arrays of anchors protruding into the annular canal of the opposing ring. The rings are joined together by the magnetic forces of the inner cores of the respective rings.

[0191] 97-99, an alternative embodiment of a compression ring, generally designated by the reference numeral 120, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, an outer sheath 121 has anchors 122 protruding from one side 123 of the outer sheath. When the anastomotic ring 120 is assembled, the anchors 120 protrude laterally from the side of the ring and are oriented to penetrate directly into the opposing ring. This tissue-gripping structure forms an interlocking grip on the tissue. The spikes are oriented to intersect with each other.

[0192] 100-102, an alternative embodiment of a compression ring, generally designated by reference numeral 130, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, cylindrical inner cores 113 are connected in series by typically flexible threads 131. The threads 131 may be provided by multiple connecting threads 131A, each connecting thread connecting one end of one inner core to the end of a second inner core. Alternatively, the inner cores may have a through hole 133 and may be attached to a single thread loop 134, as shown in FIG. 101. In FIG. 102, the inner cores are not connected, but the outer sheaths are connected in series by threads 135.

[0193] 103, an alternative embodiment of a compression ring generally designated by reference numeral 140 is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, the ring has a helical coil 141 wound around an annular hollow tube 111. The coil 141 is configured to be anchored to tissue in a body lumen. Barb It has 142 types of anchors. Barb are positioned at the diametrically outer and lateral portions of the coil.

[0194] FIG. 104 illustrates the use of compression rings of the present invention to form a compression anastomosis. A first compression ring 110 is deployed within a first open end of the colon, and a second compression ring (not shown) is deployed within a second open end of the colon. In this position, the free end of the colon wraps around the exposed surface of each ring, where it is gripped by the anchor. The two rings are then butted together and magnetically coupled to form the compression anastomosis. This is left in place for several weeks to allow the severed ends of the colon to heal and heal, allowing the annular hollow tube of each ring to biodegrade, releasing the ring segments, which then naturally pass through the colon and anus.

[0195] 105-112, an alternative embodiment of a compression ring, generally designated by reference numeral 150, is described, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, ring 150 is configured to adjust from an open ring (FIGS. 105-107) to a closed ring (FIGS. 108-110). Ring 150 is formed from ring segments 151 hingedly connected to one another in series, and is adjustable from an elongated open ring configuration suitable for delivery via laparoscopic surgical instruments to an unfolded, closed ring configuration. Ring 150 has end segments 153 configured to couple to one another; in the illustrated embodiment, one end segment 153A has latching arms 154, and the other end segment 153B has latching structure (not shown) configured to couple with latching arms 154. It will be appreciated that the ring can be closed using other coupling arrangements, including magnetic coupling elements. In this embodiment, the ring is configured to self-deploy when released from the delivery configuration to the ring-like configuration shown in Figure 105. Delivery of the ring 150 from a laparoscopic surgical instrument 157 along an actuation filament is shown in Figure 107.

[0196] 108, the unitizing element is provided on the ring in the form of an annular groove provided on the inner periphery of the ring when deployed. Each ring segment 151 has a groove portion 160A located on the inner surface of the segment such that when the ring is deployed, the groove portions 160A align to form the annular groove.

[0197] 109, a coupling insert 165 is shown having a frame 166 configured to expand radially about the Z-axis, a first series of coupling structures 166 disposed along a first circumference of the frame, and a second series of coupling structures 167 disposed along a second circumference of the frame parallel to and spaced from the first circumference. The frame has four supports 168 spaced around the circumference of the frame, the supports connected in series about the Z-axis by elastically deformable curved support struts 169, and each support 168 is connected to an adjacent support 168 by two support struts 169.

[0198] The joining insert 165 is shown in an expanded configuration in Figure 109. Figure 110 shows how a first ring 150A is joined to one side of the joining insert 165, with circumferentially arranged joining structures 166 engaging the annular groove 160 of ring 150A. Figure 111 shows how a second ring 150B is joined to the opposite side of the joining insert 165, with circumferentially arranged joining structures 167 engaging the annular groove 160 of ring 150B, abutting the two rings in a compression anastomosis-forming configuration. Figure 112 illustrates the use of this embodiment to form a compression anastomosis of the colon.

[0199] equivalent The foregoing description details presently preferred embodiments of the invention. It is anticipated that many modifications and variations in its practice will occur to those skilled in the art upon consideration of these descriptions. Such modifications and variations are intended to be encompassed within the scope of the claims appended hereto.

Claims

1. A compression anastomosis system, comprising corresponding first and second compression ring devices (1, 40, 50, 60, 70, 80, 90), each compression ring device configured for adjustment from an elongated delivery configuration adapted for passage through a lumen of a minimally invasive surgical instrument to a deployed, radially expanded configuration; the first and second compression ring devices have magnetic coupling elements (20, 41, 56, 57) configured to couple the rings together in a face-to-face compression anastomosis configuration, wherein in the face-to-face compression anastomosis configuration, a first side of the first compression ring device faces and couples to a second side of the second compression ring device, thereby compressing tissue between the first side and the second side; the first side of the first compression ring device and the second side of the second compression ring device each have a plurality of barbs configured to secure the first and second compression ring devices to a wall of a body lumen.

2. 10. The compression anastomosis system of claim 1, wherein all or a portion of each compression ring device is configured to biodegrade in vivo.

3. 10. The compression anastomosis system of claim 1, wherein one or more portions of the or each compression ring device are configured to biodegrade in vivo to break down the or each compression ring device into multiple smaller portions.

4. 4. The compression anastomosis system of claim 1, wherein the compression ring is sized to pass through a lumen of 15 mm or less in diameter in the elongated delivery configuration and to circumferentially abut an inner wall of a body lumen in the deployed closed ring configuration.

5. A compression anastomosis system as described in claim 1, wherein the first and second compression ring devices each have an inflatable ring (2), and expansion of the inflatable annular ring deploys the compression ring devices into the radially expanded deployed configuration so as to circumferentially abut the inner wall of the body cavity.

6. 6. The compression anastomosis system according to claim 1, wherein the uniting element comprises a magnet (56) of one polarity disposed on a side of the first compression ring device and a corresponding magnet (57) of a second polarity disposed on a side of the second compression ring device.

7. the or each anastomotic ring: an annular tube that is biased into a ring shape and is elastically deformable; a plurality of ring segments disposed within the annular pipe; and 7. The compression anastomosis system of claim 1, wherein the anastomosis ring is elastically deformable into an elongated delivery configuration suitable for delivery within a minimally invasive surgical instrument, and is configured to self-deploy upon release from the surgical instrument into a radially expanded configuration suitable for fully or at least partially circumferentially abutting an inner wall of a body lumen.

8. The compression anastomosis system of claim 7, wherein one or more of the ring segments comprises a magnetic or magnetizable material, thereby providing the joining element for joining two rings together.

9. The compression anastomosis system according to claim 7 or 8, wherein the annular tube comprises an elastically deformable polymer material.

10. 10. The compression anastomosis system according to claim 7, wherein one or more of the ring segments comprises an inner core and an outer sheath, the inner core comprising the magnetic or magnetizable material.

11. 11. The compression anastomosis system of claim 10, wherein the outer sheath has the barbs, and the barbs and the annular tube are configured such that, when the anastomotic ring is assembled, the barbs protrude through the annular tube to provide barbs on the sides of the ring.

12. A compression anastomosis system as described in any one of claims 1 to 11, wherein each compression ring device has a central spoke element configured to assist in the deployment of the compression ring device and to fold when the compression ring device is compressed into a delivery configuration.

13. A compression anastomosis system as described in any one of claims 1 to 12, wherein the barb has an outer anchor positioned proximal to the outer diameter of the ring and an inner anchor positioned proximal to the inner diameter of the ring, and the outer anchor of one ring is configured to engage with the outer anchor of the corresponding ring when the two rings are joined together to form a compression anastomosis.

14. The compression anastomosis system of claim 10 , wherein the outer sheath is configured to block magnetic forces on one side of the inner core.

15. A compression anastomosis system as described in claim 1, wherein the or each anastomosis ring is configured to be adjustable between an open ring configuration and a closed ring configuration.

Images