A delivery system and method for delivery of an implant to a body lumen

Abstract

A delivery system to deliver an annular implant to a body lumen and stabilise the annular implant during deployment and positioning in the body lumen is described. The delivery system comprises a delivery arm, a first tethering element comprising a first tethering arm to releasably tether a first part of the self-expansible implant to the delivery arm, and optionally a second tethering element comprising a second tethering arm to releasably tether a second part of the self-expansible implant to the delivery arm. The delivery system comprises a coupling module actuatable to untether the first tethering arm and optional second tethering arm to release the implant from the delivery arm in-vivo. The annular implant may be an anastomosis ring or a gastrointestinal tract window. A method of using the delivery system to deliver an annular implant to a body lumen and stabilise the annular implant during deployment and positioning in the body lumen is described.

Description

[0001] TITLE

[0002] A delivery system and method for delivery of an implant to a body lumen

[0003] Technical Field

[0004] The present invention relates to a delivery system and method for delivery of an implant to a body lumen such as a gastrointestinal tract. In particular, the invention relates to a delivery system and method for minimally invasive delivery of self-expansible compression anastomosis ring in the gastrointestinal tract.

[0005] Background

[0006] An anastomosis is done when a surgeon removes a diseased tube in the body or does not remove any tissue but connects two tubes together in the body. Examples of this include connecting tubes in the gastrointestinal tract, urology system and cardiovascular systems. The anastomosis is sometimes done following the removal of a diseased portion of tissue, or to bypass a diseased or malfunctioning tissue. In addition, in bariatric surgery a bypass of a portion of the stomach and / or the intestine to treat obesity or diabetes involves the creation of an anastomosis. One of the most serious complications associated with an anastomosis creation is anastomotic leakage, which occurs in up to 20% of patients undergoing certain procedures. Anastomotic leakage leads to serious complications such as peritonitis or septic shock. An anastomotic leak is not easily detectable and leads to extended hospital stays, readmission, reoperations or even death.

[0007] Creating a healthy and safe anastomosis requires adequate perfusion, freedom from tension at the anastomotic site, and absence of distal obstruction and mesenteric twisting. Currently the creation of a surgical anastomosis is mainly done using a sewing or stapling technique. A surgical anastomosis can be configured in numerous ways. These include end to end, side to side, side to end, and end to side. The stapling devices can be circular (used to perform end-to-end anastomoses) and linear stapling devices (used for side-to-side anastomoses).

[0008] A literature review comparing hand-sewn with stapled anastomoses in colon and rectal surgery have not found statistical differences in the surgical outcomes between these two methods. Another technique for creating an anastomosis consists of compression anastomosis in which the bowel ends are kept together using a device applying a consistent compression force. This leads to tissue necrosis action and a healing process which eventually allows the two bowel ends to be joined. Various compression anastomosis devices have been developed however they have not achieved a wide adoption in clinical practice. The main limitations of the compression anastomosis devices have been the fact that they are difficult to use (e.g., some devices need additional purse suturing to secure the device in place) and were designed for an open surgery while the surgery practice is moving towards minimally invasive techniques. Despite the limitations, compression anastomotic healing was associated with less foreign body reactions, scarring, and inflammation as compared with stapled anastomoses in a large animal model.

[0009] Laparoscopic surgery is a minimally invasive surgery that is performed using several small 0.3-2.5cm incision ports. At each port, a tubular instrument called a trocar is used. The laparoscopic instruments are then passed through the trocars. Compared to traditional open surgery, patients often experience less pain, a shorter recovery, better outcomes, and less scarring with laparoscopic surgery.

[0010] WO2022 / 171349 describes a compression anastomosis system comprising matching first and second compression ring devices, each compression ring device configured for adjustment from a contracted (e.g., elongated delivery) configuration suitable for passing through a lumen of a minimally invasive surgical instrument such as a trocar, catheter or endoscope to a deployed radially expanded configuration. At least one of the rings generally comprises coupling elements for coupling the rings together in a face-to-face compression anastomosis configuration. An additional coupling element may be employed that is configured to couple with the coupling elements of the rings. Each compression ring device typically comprises tissue anchors disposed on a radially outward facing surface of the ring and configured to anchor the ring to the wall of the body lumen when the ring is deployed in the body lumen. The anchors may be disposed on a top and / or side of the ring.

[0011] US 2023 / 063969 A1 describes medical devices (e.g., anastomotic devices, drainage stents, etc.) and systems to establish and / or maintain a controlled periodic or intermittent flow or access passage from or between the stomach or duodenal wall into the peritoneal cavity. The devices typically have an elongate tubular body comprising a proximal portion, a distal portion, and a length therebetween, the elongate tubular body defining a lumen along the length and having an unexpanded and an expanded configuration; and a flexible member disposed around a saddle region.

[0012] Delivery devices for magnetic anastomosis devices are described in US 2023 / 0389924 A1 , US 17 / 108,840 and US 11 ,832,820 B2.

[0013] It is an object of the invention to provide a system for delivery, deployment and / or positioning of a compression anastomosis system which addresses at least one of the problems of the prior art.

[0014] Described herein is a delivery system for an annular implant such as an anastomosis ring (which is delivered in a ring configuration or a linear configuration)that can be used for example for endoscopic or laparoscopic delivery or robotic delivery of the implant allowing the orientation of the implant to be controlled and stabilised during deployment and positioning in the body lumen. The delivery system employs a delivery arm and at least one tethering element comprising a tethering arm to tether the annular implant at one point (e.g. tether at least a distal part or a proximal part of the annular ring ortether a side of the annular ring, or any combination thereof) to the delivery arm, thus positionally stabilising the ring relative to the delivery arm during delivery and deployment. A coupling element allows uncoupling of the tethering arm in-vivo to release the annular implant from the delivery arm in vivo. In one embodiment, the delivery arm comprises at least two tethering elements (each comprising a tethering arm) to tether the annular ring at two points (e.g. tether a distal part and proximal part of the ring to the delivery arm), thereby improving the control and stability of the annular ring during delivery and deployments. In this embodiment, the coupling element is configured for uncoupling the two tethering elements independently, where the provision of first and second tethering elements that are independently releasable allows the ring to be uncoupled in an iterative process, which provides for greater control and stability, while also allowing the surgeon to choose whether to release the distal end of the ring or the proximal end of the ring first, or both together depending on the clinical circumstances and target body lumen. Broadly, there is described a delivery system for delivery of an implant (e.g. an annular implant such as an anastomosis ring) to a body lumen, the delivery system comprising: a delivery arm; at least a first tethering element comprising a first tethering arm to releasably tether a first part of the implant to the delivery arm; and a coupling module actuatable to untether the at least first tethering arm to release the implant from the delivery arm.

[0015] In any embodiment, the system is configured for tethering a distal end of the implant to the delivery arm with the first tethering element.

[0016] In any embodiment, the system is configured for tethering a proximal end of the implant to the delivery arm with the first tethering element.

[0017] In any embodiment, the delivery system comprises a second tethering element comprising a second tethering arm to releasably tether a second part of the implant to the delivery arm.

[0018] In any embodiment, the tethering arms are configured to tether spaced apart first and second parts of the implant to the delivery arm (e.g. a distal part and a proximal part of the implant, or one side and an opposite side of the implant, or a combination thereof).

[0019] Typically, the coupling module is configured to untether the first tethering arm and second tethering arm independently of each other (e.g. the first tethering arm can be uncoupled prior to the second tethering arm, or vice versa).

[0020] In any embodiment, the implant is a gastrointestinal implant.

[0021] In any embodiment, the implant is an annular implant.

[0022] In any embodiment, the annular ring is configured for delivery in a ring configuration or in a linear (open ring) configuration. In the latter case, the open ring linear implant may be configured to self-assemble into a closed ring configuration upon deployment.

[0023] In any embodiment, the implant is self-expansible from a compressed delivery configuration into a deployed expanded configuration. In any embodiment, the implant is self-assembling from a minimal delivery configuration into a deployed expanded configuration.

[0024] In any embodiment, the delivery system is for minimally invasive delivery of the implant, and the delivery arm is configured for axial movement along a lumen of a minimally invasive access conduit. In this embodiment, the access sheath generally has a cross-sectional profile that is smaller than the profile of the deployed implant, such that the implant has to be compressed into a delivery configuration before it is sheathed within the access sheath.

[0025] In any embodiment, the implant is an anastomosis ring.

[0026] In any embodiment, the anastomosis ring is a magnetic anastomosis ring.

[0027] In any embodiment, the anastomosis ring is a compression anastomosis ring.

[0028] In any embodiment, the coupling module is configured to release the first tethering arm and second tethering arm sequentially.

[0029] In any embodiment, the first tethering element tethers a proximal part of the implant to the delivery arm and the second tethering element tethers a distal part of the implant to the delivery arm.

[0030] In any embodiment, the first tethering element tethers a left part of the implant to the delivery arm and the second tethering element tethers a right part of the implant to the delivery arm.

[0031] In any embodiment, the first tethering element tethers a section of the implant to the delivery arm and the second tethering element tethers a different section of the implant to the delivery arm.

[0032] In any embodiment, the coupling module is configured to release the first tethering element before the second tethering element.

[0033] In any embodiment, the coupling module comprises a first coupling rod that is axially movable relative to the delivery arm from an advanced position in which the coupling rod is coupled to a distal end of at least one of the first tethering arm and second tethering arm to a retracted position in which the coupling rod is uncoupled to the distal end of at least one of the first tethering arm and second tethering arm.

[0034] In any embodiment, the delivery arm comprises a sidewall defining a delivery arm lumen and a window in the sidewall dimensioned to receive a distal end of at least one of the first tethering arm and second tethering arm, wherein the coupling element is mounted within, and for axial movement along, the delivery arm lumen.

[0035] In any embodiment, the sidewall of the delivery shaft comprises a distal window and a proximal window. The distal window can therefore receive a distal end of the tethering arm of one of the tethering elements and the proximal window can receive a distal end of the tethering arm of another of the tethering elements

[0036] In any embodiment the first coupling rod is configured for axial movement along the delivery arm lumen between (a) a first coupling configuration in which the distal end of the first coupling rod is disposed adjacent to the distal window and the first coupling rod is coupled to the distal end of the first tethering arm and second tethering arm, (b) a second coupling configuration in which the distal end of the first locking rod is disposed adjacent to the proximal window and coupled to the second tethering arm, and (c) the retracted release configuration.

[0037] In any embodiment, the coupling element comprises a second locking rod disposed within the delivery arm lumen configured for axial movement along the delivery arm lumen between a coupling configuration and a release configuration, in which a distal end of the second locking rod is configured to engage the distal end of the first tethering arm or second tethering arm.

[0038] In any embodiment, the first locking rod is configured for axial movement along the delivery arm lumen between a coupling configuration in which the distal end of the first locking rod is disposed adjacent to the proximal window in the sidewall and coupled to the distal end of the first tethering arm and the release configuration in which the distal end of the first locking rod is disposed proximally of the proximal window in the sidewall and is uncoupled from the distal end of the first tethering arm, and in which the second locking rod is configured for axial movement along the delivery arm lumen between a coupling configuration in which the distal end of the second locking rod is disposed adjacent to the distal window in the sidewall and coupled to the distal end of the second tethering arm and a release configuration in which the distal end of the second locking rod is disposed proximally of the distal window in the sidewall and is uncoupled from the distal end of the first tethering arm.

[0039] In any embodiment, the second locking rod has a proximal section disposed adjacent and parallel to the first locking rod, a distal section disposed distally of the first locking rod and optionally co-axial with the first locking rod part, and a transition section connecting the proximal section and the distal section.

[0040] In any embodiment, the or each tethering arm is flexible.

[0041] The tethering elements may be independent of each other and configured to couple to the delivery arm, as illustrated in Figures 58 to 70, or they may form part of a tethering body, for example a flexible cover for the annular implant, as illustrated in Figures 1 to 37.

[0042] In any embodiment, the first tethering element and second tethering element are associated with the delivery arm, for example releasably attached to the delivery arm.

[0043] In any embodiment, the first tethering element and second tethering element are disposed on a distal end of the delivery arm in a spaced-apart configuration.

[0044] In any embodiment, the first tethering element is disposed on the distal end of the delivery arm proximally of the proximal window and the second tethering element is disposed on the distal end of the delivery arm distally of the distal window.

[0045] In any embodiment, the first tethering element is slidably mounted to the delivery arm.

[0046] In any embodiment, the first tethering element and / or second tethering element comprise stabilising element configured to abut a surface of the implant and stabilise the implant during deployment.

[0047] In any embodiment, the stabilising element comprises a formation configured to receive part of the implant in a nested relationship. In any embodiment, the formation is a plate having a concave cross-sectional profile.

[0048] In any embodiment, the first tethering element and / or second tethering element comprise a coupling part to couple to the delivery arm.

[0049] In any embodiment, the coupling part of the tethering element comprises a sleeve configured embracing the delivery arm.

[0050] In one embodiment, the tethering arm of the first tethering element is mounted to a proximal side of the first stabilising element and the tethering arm of the second tethering element is mounted to a distal side of the second stabilising element.

[0051] In another embodiment, the tethering arm of the first tethering element is mounted to a distal side of the first stabilising element and the tethering arm of the second tethering element is mounted to a proximal side of the second stabilising element. This embodiment is suitably employed when the delivery system comprises a push rod actuatable to assist detaching the first tethering element from the implant.

[0052] In any embodiment, the delivery system comprises a flexible cover for the implant configured to abut a surface of the implant (e.g. a top or bottom surface), wherein the first tethering element and second tethering element are attached to or integrally formed with the flexible cover.

[0053] In any embodiment, the tethering arms extend radially outwardly or inwardly of the flexible cover.

[0054] In any embodiment, the flexible cover is partially or fully annular.

[0055] In any embodiment, the flexible cover comprises a central hub configured for mounting on the delivery arm, an annular part configured to cover all or part of the surface of the implant, and flexible spokes connecting the central hub and annular part.

[0056] In any embodiment, the flexible cover comprises at least three, four, five, or six tethering elements integrally formed with the flexible cover and disposed at spaced-apart intervals around a periphery of the flexible cover. In any embodiment, each tethering arm has a distal end comprising a formation such as a loop configured to engage a coupling rod.

[0057] In any embodiment, the tethering arms comprise a first lateral tethering arm disposed on a first side of the flexible cover and a second lateral tethering arm disposed on a second side of the flexible cover.

[0058] In any embodiment, the tethering arms comprise lateral tethering arms disposed on a proximal side of the cover and lateral tethering arms disposed on a distal side of the cover.

[0059] In any embodiment, the tethering arms comprise a distal tethering arm extending from a distal end of the flexible cover and a proximal tethering arm extending from a proximal end of the flexible cover.

[0060] In any embodiment, the delivery system comprises a grasping arm, typically configured for axial movement along a minimally invasive access conduit.

[0061] In any embodiment, the delivery system comprises at least one pull wire extending along the delivery arm lumen and having a distal end coupled to the flexible cover.

[0062] In any embodiment, the delivery system comprises a first pull wire having a distal end coupled to a first side of the flexible cover, a second pull wire having a distal end coupled to a second side of the flexible cover, and a third pull wire having a distal end coupled to a proximal end of the flexible cover,

[0063] In any embodiment, the flexible cover comprises a silicone material. Other suitable materials include a shape memory material such as Nitinol or other flexible biocompatible materials e.g. polyurethane.

[0064] In any embodiment, an upper surface of a distal end of the flexible cover is coupled to delivery arm.

[0065] In any embodiment, the distal end of the flexible cover and a distal tip of the delivery are configured for coupling together. In any embodiment, the distal end of the flexible cover and the distal tip of the delivery comprise mutually engageable formations for coupling together.

[0066] In any embodiment, the distal end of the flexible cover comprises a socket formation configured to receive and couple with a distal tip of the delivery arm. Other coupling mechanisms will be apparent to a person skilled in the art.

[0067] In any embodiment, the delivery system comprises a minimally invasive access conduit for the delivery arm.

[0068] In any embodiment, the delivery system comprises a minimally invasive access conduit for the grasping arm.

[0069] In any embodiment, the access conduit is selected from a catheter, introducer or a trocar.

[0070] In any embodiment, the delivery system comprises a push rod arm disposed adjacent to the delivery arm and configured for axial movement relative to the delivery arm, in which a distal end of the push rod is associated with (e.g. abuts or is attached to) the first tethering element. Advancing the push rod helps de-couple the proximal end of the implant from the first tethering element.

[0071] In another aspect, there is provided a cover for an annular ring, for example a cover for an anastomosis ring of the type having an upper ring surface comprising anchoring barbs, the cover comprising a flexible ring of resiliently deformable material having a circumcentre and a convex cross-sectional profile configured to conform to an upper aspect of the annular ring, and comprising a plurality of tethering arms extending radially outwardly from an outer periphery of the flexible ring or radially inwardly from an inner periphery of the flexible ring.

[0072] In any embodiment, the tethering arms are flexible.

[0073] In any embodiment, each tethering arm has a distal end comprising a formation such as a loop configured to engage a coupling rod of a delivery arm. In any embodiment, the flexible ring has a proximal end, a distal end, a first side section, a second side section, an upper surface and a lower surface.

[0074] In any embodiment, the upper surface of the distal end of the flexible ring comprises a socket configured to receive a distal end of the delivery arm,

[0075] In any embodiment, the plurality of flexible tethering arms comprise a first lateral tethering arm extending from a first side section of the flexible ring and a second lateral tethering arm extending from a second side section of the flexible ring.

[0076] In any embodiment, the plurality of flexible tethering arms comprise a proximal tethering arm extending from a proximal end of the flexible arm.

[0077] In any embodiment, the plurality of flexible tethering arms comprise a distal tethering arm extending from a distal end of the flexible arm.

[0078] In any embodiment, the plurality of flexible tethering arms comprise two lateral tethering arms extending from a first side section of the flexible ring and two lateral tethering arms extending from a second side section of the flexible ring.

[0079] In any embodiment, the anastomosis ring has a diameter of X and each tethering arm has a length of Y, wherein a ratio of X:Y is 10:2 to 10:8, preferably 10:2 to 10:6, more preferably 10:3 to 10:5.

[0080] In any embodiment, the anastomosis ring when employed for gastrointestinal applications has a diameter of 1-20cm, 1-15cm, 1-12cm, 5-20cm, 5-15cm, 10-15cm, 15-20cm.

[0081] In any embodiment, the or each flexible tethering arm has a length that is greater than a circumference of the anastomosis ring, for example at least 1.2, 1.4, 1.6 or 2.0 times greater.

[0082] In any embodiment, the flexible ring and / or tethering arms are formed from a flexible resiliently deformable material, for example silicone.

[0083] In another aspect, there is provided an annular ring and a coverforthe annular ring according to the invention. In any embodiment, the annular ring is an anastomosis ring having a plurality of barbs on an upper or lower surface thereof, wherein the cover is configured to abut the surface of the anastomosis ring bearing the plurality of barbs.

[0084] In another aspect, there is provided a method of delivering an annular ring to a body lumen (e.g. a section of the gastrointestinal tract) of a subject using a delivery system of the disclosure, comprising the steps of: tethering the annular ring to a distal end of the delivery arm with the tethering element by: inserting a distal end of an access sheath into body lumen of a subject; inserting the delivery arm of the delivery system with the annular implant tethered thereto into a proximal end of the access sheath; advancing the delivery arm through the access sheath until the distal end of the delivery arm with the annular implant tethered thereto is exposed distally of the distal end of the access sheath; actuating the coupling element to uncouple the tethering element from the delivery arm; and retracting the delivery arm through the access sheath to leave the implant positioned within the body lumen.

[0085] In another aspect, there is provided a method of delivering an annular ring to a body lumen (e.g. a section of the gastrointestinal tract) of a subject using a delivery system of the disclosure, comprising the steps of: attaching a distal end of the annular ring to the delivery arm with the second tethering element; attaching a proximal end of the annular ring to the delivery arm with the first tethering element; inserting a distal end of an access sheath into body lumen of a subject; inserting the delivery arm of the delivery system with the annular ring tethered thereto into a proximal end of the access sheath; advancing the delivery arm through the access sheath until the distal end of the delivery arm with the annular ring tethered thereto is exposed distally of the distal end of the access sheath; actuating the coupling element to uncouple one of the first or second tethering elements from the delivery arm; actuating the coupling element to uncouple another of the first or second tethering elements from the delivery arm; and retracting the delivery arm through the access sheath to leave the annular ring positioned within the body lumen.

[0086] In any embodiment, the first (proximal) tethering element is uncoupled prior to the second (distal) tethering element.

[0087] In any embodiment, the tethering step comprises looping the tethering arm of the (or each) tethering element around a circumference of the annular ring and coupling a distal end of the tethering arm to the coupling element.

[0088] In any embodiment, the (or each) tethering arm is looped around an external periphery of the annular ring and up through a centre of the annular ring.

[0089] In any embodiment, the distal end of the tethering arm comprises an aperture and the coupling step comprises advancing a coupling rod of the delivery arm through the aperture.

[0090] In any embodiment, the steps of tethering the annular ring to the delivery arm comprises looping a tethering arm of the first (proximal) tethering element around a proximal section of the annular implant, inserting the distal end of the tethering arm into the proximal window in the delivery arm, and advancing the coupling rod distally into engagement with the distal end of the tethering arm.

[0091] In any embodiment, the steps of tethering the implant to the delivery arm comprises looping a tethering arm of the second (distal) tethering element around a distal section of the annular implant, inserting the distal end of the tethering arm into the distal window in the delivery arm, and further advancing the coupling rod distally into engagement with the distal end of the tethering arm.

[0092] In any embodiment, the steps of tethering the implant to the delivery arm comprises looping a tethering arm of the first (proximal) tethering element around a proximal section of the annular implant, inserting the distal end of the tethering arm into the proximal window in the delivery arm, advancing the first coupling rod distally into engagement with the distal end of the tethering arm, looping a tethering arm of the second (distal) tethering element around a distal section of the annular implant, inserting the distal end of the tethering arm into the distal window in the delivery arm, and advancing the second coupling rod distally into engagement with the distal end of the tethering arm.

[0093] In any embodiment, the annular implant is a compressible and self-expansible annular implant, in which the method comprises a step of compressing the tethered implant into a compressed (typically elongated) configuration prior to the step of inserting the delivery arm of the delivery system with the implant tethered thereto into the proximal end of the access sheath. The annular ring can be pulled into the access sheath at the distal end when it is being loaded / assembled prior to delivery to the patient.

[0094] In any embodiment, the access sheath is dimensioned to retain the compressible and self- expansible implant in the compressed elongated configuration prior to deployment.

[0095] In any embodiment, the method comprises a step of actuating the push rod after the first tethering element has been uncoupled to help detach the proximal end of the ring from first tethering element.

[0096] In any embodiment, the first and second tethering elements are incorporated into a flexible cover for the compressible and self-expansible annular implant, in which the method comprises mounting the flexible cover on top of the compressible anastomosis ring before tethering the annular implant to the delivery arm using the tethering elements of the flexible cover.

[0097] In any embodiment, the annular implant is configured to self-assemble from a linear (open ring) configuration to an annular (closed ring) configuration in-vivo, in which the method comprises tethering the annular implant in the linear configuration to the delivery arm, delivering the implant through the access sheath to the body lumen in the linear configuration (whereby the dimensions of the access sheath constrains the annular implant in the linear (open ring) configuration, deploying the implant out of the end of the access sheath whereby the implant self-assembles into the annular (closed ring) configuration, and the uncoupling the first and second tethering elements to release the annular ring from the delivery arm.

[0098] In another aspect, there is provided a method of performing a compression anastomosis in a subject comprising the steps of: delivering a first magnetic compression anastomosis ring to first section of a gastrointestinal tract in the subject according to a method of the disclosure; delivering a second magnetic compression anastomosis ring to second section of the gastrointestinal tract according to a method of the disclosure; and bringing the first and second magnetic compression anastomosis rings into proximity of each other, whereby they are magnetically brought together to form an anastomosis.

[0099] In any embodiment, the step of bringing the first and second magnetic compression anastomosis rings into proximity of each other employs a minimally invasive grasping tool.

[0100] Other aspects and preferred embodiments of the invention are defined and described in the other claims set out below.

[0101] Brief Description of the Figures

[0102] Figure 1 illustrates a compressible anastomosis ring and a delivery system according to a first embodiment of the disclosure.

[0103] Figure 2 illustrates a cover forming part of the delivery system mounted on a top of the compressible anastomosis ring with a delivery arm of the delivery system showing in sectional view illustrating the coupling mechanism (e.g. the first locking rod) in a retracted release configuration.

[0104] Figure 3 illustrates the coupling element, namely the first locking rod, advanced distally along the lumen of the delivery arm to a first coupling configuration where it engages a distal end of three proximal tethering arms thus tethering the proximal end of the flexible cover to the compressible anastomosis ring.

[0105] Figure 4 illustrates the first locking rod advanced distally to a second coupling configuration where it engages a distal end of three distal tethering arms thus tethering the distal end of the flexible cover to the compressible anastomosis ring.

[0106] Figures 5 to 11 illustrate the coupling of the compressible anastomosis ring to the delivery system. Figures 12 and 13 illustrate the compressible anastomosis ring loaded on to the delivery system and compressed into an elongated delivery configuration prior to being sheathed within an access conduit (e.g. a laparoscopic tool).

[0107] Figures 14 to 20 illustrate the use of the delivery system of Figures 1 to 13 in the deployment of the compressible anastomosis ring, in which the delivery arm is advanced distally out of a distal end of the access conduit (Figure 14), the first locking rod (not shown) is moved proximally to release the distal tethering arms (Figure 15), with the distal tethering arms released the distal end of the anastomosis ring falls away from the flexible cover with the proximal end of the anastomosis ring still retained (Figures 16 to 18), the first locking rod (not shown) is then moved proximally to release the proximal tethering arms (Figure 19), thus releasing the anastomosis ring from the flexible cover and delivery arm (Figure 20).

[0108] Figures 21 to 27 illustrate a second embodiment of the delivery system of the disclosure in which the coupling mechanism comprises a first locking rod and a second locking rod that are movable independently of each other axially along the lumen of the delivery arm. Specifically:

[0109] Figure 21A shows the delivery system with the compressible anastomosis ring retained in contact with the flexible cover and all tethering arms coupled to the delivery arm;

[0110] Figure 21 B is a perspective sectional view through the delivery system and anastomosis ring showing the first locking rod and second locking rod in coupling configurations;

[0111] Figure 22 is a side elevational sectional view through the delivery system and anastomosis ring showing the first locking rod and second locking rod in distally advanced coupling configurations;

[0112] Figure 23 shows the first locking rod retracted proximally into a release configuration thus releasing the proximal tethering arms which spring back away from the delivery rod releasing the proximal end of the flexible cover from anastomosis ring;

[0113] Figure 24 shows a first embodiment of a compression element forming part of the delivery arm and configured to assist detaching the flexible cover from the anastomosis ring when the tethering arms have been released. In this embodiment, the compression element takes the form of a compression rod that is external to the sidewall of the delivery arm having a distal end attached to a top of the proximal part of the flexible cover;

[0114] Figures 25 and 26 show the compression element advanced distally to push the proximal end of the flexible cover off the proximal end of the anastomosis ring; and Figure 27 shows the second locking rod retracted proximally into a release configuration thus releasing the distal tethering arms which spring back away from the delivery arm fully releasing the flexible cover from anastomosis ring.

[0115] Figures 28 to 37 illustrate a third embodiment of the delivery system which is similar to the delivery system of Figures 21 to 27 insofar as the delivery arm comprises a first locking rod and a second locking rod, but in which the compression element comprises three pull wires threaded along the lumen of the delivery rod having distal ends attached to the top of the flexible cover:

[0116] Figure 28 to 20 show the delivery system attached to the anastomosis ring with all tethering arms coupled to the delivery arm via the locking rods, and three pull wires projecting out of a distal tip of the delivery arm and attached to the proximal end, and opposed sides, of the top of the flexible cover;

[0117] Figure 31 shows the proximal tethering arms released;

[0118] Figure 32 shows the pull wires in a partially retracted configuration where they have displaced the proximal end of the flexible cover from the anastomosis ring and pulled it distally;

[0119] Figure 33 shows a grasping arm that is independent from the delivery arm grasping a proximal end of the anastomosis ring and holding it in position;

[0120] Figure 34 shows the distal tethering arms released;

[0121] Figure 35 shows the anastomosis ring being held static while the delivery arm is advanced distally to push the flexible cover off the anastomosis ring; and

[0122] Figures 36 and 37 show the delivery system detached from the anastomosis ring.

[0123] Figures 38 to 57 illustrate the use of the delivery system to deliver compressible anastomosis rings to a colon of a subject by minimally invasive surgery.

[0124] Figures 58 to 64 illustrate a delivery system according to a further embodiment of the disclosure in which the first and second tethering elements are independent of each other and configured for attachment to the delivery arm.

[0125] Figures 65 to 68 illustrate a delivery system according to a further embodiment of the disclosure in which the first and second tethering elements are independent of each other and configured for attachment to the delivery arm and including a push rod configured to assist with release of the implant by pushing the first tethering element by pushing distally along the delivery arm.

[0126] Figures 69 and 70 illustrate a variation of the delivery system of Figures 65 to 68 in which the tethering arms extend radially inwardly in a relaxed configuration (Fig. 70). Figures 71 to 79 illustrate a delivery system according to the disclosure for a selfforming compression anastomosis ring that is delivered in an elongated (open ring) configuration and that self-forms into a closed ring upon deployment from the distal end of the access sheath.

[0127] Figures 80 to 82 illustrate a delivery system according to the disclosure for delivering and deploying a compression anastomosis ring in a body lumen concentric to the body lumen.

[0128] Figures 83 to 85 illustrate a delivery system according to a further embodiment of the disclosure that include one tethering element for tethering the distal end of the annular implant to the delivery arm.

[0129] Figures 86 to 91 illustrate a delivery system according to a further embodiment of the disclosure that is similar to the embodiment shown in Figures 21 to 28 but in which the compression element (rod) is separate to the delivery arm and mounted within the access sheath for axial movement relative to the access sheath.

[0130] Detailed Description of the Invention

[0131] All publications, patents, patent applications and other references mentioned herein are hereby incorporated by reference in their entireties for all purposes as if each individual publication, patent or patent application were specifically and individually indicated to be incorporated by reference and the content thereof recited in full.

[0132] Definitions and

[0133] Where used herein and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings the terms might enjoy in the art:

[0134] Unless otherwise required by context, the use herein of the singular is to be read to include the plural and vice versa. The term "a" or "an" used in relation to an entity is to be read to refer to one or more of that entity. As such, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein.

[0135] As used herein, the term "comprise," or variations thereof such as "comprises" or "comprising," are to be read to indicate the inclusion of any recited integer (e.g. a feature, element, characteristic, property, method / process step or limitation) or group of integers (e.g. features, element, characteristics, properties, method / process steps or limitations) 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, unrecited integers or method / process steps.

[0136] As used herein, the term “annular implant” refers to an implant having a ring shape or configured to self-form into a ring shape. Examples are anastomosis rings. In a preferred embodiment, the annular implant is an anastomosis ring, such as a self-forming or compression anastomosis ring, and ideally a magnetic compression anastomosis ring. The anastomosis ring may be of the type that is delivered in a closed ring configuration, or an anastomosis ring that is delivered in a linear elongated open ring configuration (Figs 71-79)

[0137] As used herein, the term “compressible anastomosis ring” refers to an anastomosis ring that is adjustable between a deployed radially expanded configuration and a compressed (usually elongated) delivery configuration. They are described in WO2022 / 171349, specifically the anastomosis ring described in Figures 85 to 86 which is comprised of ring segments contained within an annular housing providing flexibility to the ring. Generally, the compressible anastomosis ring is biased into the deployed configuration such that the ring can be compressed into an elongated delivery configuration, inserted into an access conduit such as a trocar where it is retained in the elongated configuration due to the size of the lumen of the access conduit, and when advanced out of the end of the access conduit the ring self-deploys into the radially expanded deployed configuration.

[0138] As used herein, the term “minimally invasive” as applied to the delivery system of the disclosure means that the delivery system is suitable for delivering a compressible anastomosis ring by means of endoscopic or laparoscopic surgery. The delivery system of the invention is primarily for use in minimally invasive delivery of a compressible anastomosis ring, but it may also be used for delivery during open surgery.

[0139] As used herein, the term “access conduit” refers to a conduit having a central lumen dimensioned to receive surgical instruments used in minimally invasive surgery. Examples of access conduits include trocars, laparoscopic catheters and introducer sheaths. The delivery system of the disclosure may include one or more access conduits, for example one for a delivery system and one for a grasping arm. As used herein the term “delivery arm” refers to an elongated shaft that is generally straight but may also be curved or cranked intermediate its end. A proximal end of the arm is generally attached to a handle. The distal end of the arm includes a coupling element to couple the arm to one or more tethering arms. The arm may optionally be telescopically extendable. The arm may optionally be designed with some flexibility. The arm generally has a sidewall defining a central lumen that generally extends the length of the delivery arm. The arm may include one or more coupling rods that are mounted within the central lumen and configured for movement into and out of engagement with a distal end of one or more tethering arms. Typically, the coupling rod(s) is / are configured for axial movement along the lumen. The sidewall of a distal end of the arm may include one or more windows the purpose of which is to allow a distal end of a tethering arm be inserted into the central lumen where it can couple with a locking rod. The delivery arm may also include a push rod that is actuatable to assist detaching a tethering element from the anastomosis ring. The push rod typically has a distal end attached to or abutting a proximal side of a tethering element, or it may comprise one or more pull wires threaded through the central lumen of the delivery arm having a distal end attached to a top surface of the flexible cover (for example, the top surface of a proximal end of the flexible cover). Retracting the pull wires distally through the central lumen of the delivery arm pulls the flexible cover off the anastomosis ring.

[0140] As used herein, the term “tethering element” refers to a part of the system comprising a tethering arm for use in tethering the annular ring to the delivery arm. Two main embodiments are described below, a first embodiment in which the delivery system comprises a flexible cover that sits on top (or bottom) of the annular ring and comprises the first and second tethering elements (e.g. distal and proximal tethering arms) - this embodiment is described with reference to Figures 1 to 57 and 80 to 82 - and a second embodiment described with reference to Figures 58 to 79 in which the first and second tethering elements are independent of each other, are configured for mounting to the delivery arm and each include a tethering arm to tether the ring to the delivery arm. The or each tethering arm is preferably flexible (but could be hingable) and are ideally formed from a resiliently deformable material such as silicone.

[0141] As used herein, the term “flexible cover” refers to a cover for all or part of a surface of the annular ring, for example a top or bottom surface. The cover is generally shaped to receive a top (or bottom) surface of the annular ring in a closely fitting arrangement. The cover is usually annular with a central aperture but may also be circular. The ring usually has a convex cross-sectional profile to allow the top of the ring and the cover nest together. The cover is generally flexible to allow it remain attached to the anastomosis ring when the ring is compressed into an elongated delivery configuration. An outer (or inner) circumference of the annular cover comprises one or more tethering arms that typically extend outwardly, typically radially outwardly, from the circumference of the cover. A tethering arm may be attached to a distal end, proximal end, and opposed sides, of the ring. Typically, the flexible cover comprises 4 to 8, and more preferably 6, tethering arms. Typically, the flexible cover is attached to a distal end of the delivery arm. For example, a top surface of the flexible cover may include an annular fitting configured to mate with a distal tip of the delivery arm. Typically, the flexible cover and / or flexible tethering arms comprise a silicone.

[0142] The invention will now be described with reference to specific Examples. These are merely exemplary and for illustrative purposes only: they are not intended to be limiting in any way to the scope of the monopoly claimed or to the invention described. These examples constitute the best mode currently contemplated for practicing the invention.

[0143] Referring to the drawings, and initially to Figures 1 to 12, there is illustrated a delivery system according to a first embodiment of the disclosure, indicated generally by the reference numeral 1. The delivery system in this embodiment is for delivering a compressible anastomosis ring 2 to a lumen of a body lumen such as an intestine or bowel. The anastomosis ring 2 is illustrated in Figure 1 and comprises a top surface 3 comprising anchoring barbs 4, an annular housing 5 and four ring segments 6 disposed within the annular sleeve. The anchoring barbs 4 are formed on sleeves 7 which embrace each ring segment 6 and the barbs project through the annular housing 5 to be exposed proud of the top surface 3 of the ring 2. The compressible anastomosis ring 2 can be manually compressed from the deployed ring shaped configuration shown in Figure 1 to a compressed elongated delivery configuration shown in Figure 12. Once external compression forces are released, the anastomosis ring is configured to self-deploy into the radially-expanded deployed configuration illustrated in Figure 1. A compression anastomosis ring substantially similar to the anastomosis ring 2 is described in more detail in WO2022 / 171349, in particular with reference to Figures 85-86. The delivery system 1 comprises a delivery arm 10 having a distal end 11 and a flexible cover 12 for the anastomosis ring 2 incorporating a first tethering element and a second tethering element.

[0144] The flexible cover 12 has a central aperture 8, a distal end 14, a proximal end 15, a first side 16 and a second side 17, and a convex cross-sectional profile dimensioned to allow the top surface 3 of the anastomosis ring 2 nest within the flexible cover 12. An outer circumference of the flexible cover 12 comprises six flexible tethering arms 13 extending radially outwardly from an outer circumference of the ring, including a first tethering element comprising a proximal flexible tethering arm 13B extending radially outwardly from the proximal end 15 of the ring 2, a second tethering element comprising a distal flexible tethering arm 13A extending from a distal end 14, first distal and proximal lateral tethering arms 13C and 13D extending from the first side 16, and second distal and proximal lateral tethering arms 13E and 13F extending from the second side 17. Each flexible tethering arm has a length of about X cm and a distal (free) end comprising a loop section 18. The top surface 3 of the distal end 14 of the flexible cover 12 comprises an upstanding ring 19 dimensioned to receive a distal tip 20 of the delivery arm 10 to attach the delivery arm 10 to the flexible sleeve 12 during use.

[0145] The delivery arm 10 comprises a rigid shaft with a sidewall 22 defining a central lumen 23 that extends axially along the length of the delivery arm, and a coupling mechanism to couple the distal end of each tethering arm to the delivery arm. In this embodiment, the coupling mechanism comprises a locking rod 24 with a distal end 25 mounted within the central lumen for axial movement along the central lumen. The delivery arm 10 also includes a handle which is not shown but which comprises actuation means for the locking rod 24. The sidewall

[0146] 22 of the distal end 11 of the delivery arm 10 comprises a distal window 26 and a proximal window 27. Each window is dimensioned to receive the loop sections of three flexible tethering arms. The locking rod 24 is configured for axial movement along the central lumen

[0147] 23 between a release configuration illustrated in Figure 2 where the distal end 25 of the locking rod 24 is disposed proximally of the proximal window 27, a first coupling configuration illustrated in Figure 3 where the distal end 25 of the locking rod 24 is disposed adjacent to the proximal window 27 and is threaded through the loop sections of the proximal tethering arms 13B, 13D and 13F, and a second coupling configuration illustrated in Figure 4 where the distal end 25 of the locking rod 24 is disposed adjacent to the distal window 27 and is also threaded through the loop sections of the distal tethering arms 13A, 13C and 13E. In this embodiment, the delivery system also comprises an access conduit, specifically a trocar 30 having a distal end 31 and central lumen 32 configured to receive the delivery system 1 attached to the anastomosis ring 2 is a compressed elongated delivery configuration and retain the anastomosis ring in the elongated delivery configuration until deployment out of the distal end 31 of the trocar 30.

[0148] Assembly of the delivery system is illustrated in Figures 1 to 12. In a first step, with reference to Figure 1 , the delivery arm 10 is advanced through the trocar 30 until the distal end 11 is exposed proud on the distal end 31. The flexible cover 12 is then positioned under the distal end of the delivery arm and the distal tip 20 of the delivery arm 10 is inserted into the upstanding ring 19 to securely attach the cover sleeve to the delivery arm. The anastomosis ring 2 is then positioned under the flexible cover 12 with the top surface 3 of the ring uppermost, and raised until it nests within the flexible cover and is held in position as illustrated in Figure 5. At this stage of assembly, the locking rod 24 is the fully retracted release position.

[0149] Referring to Figures 3 and 6, the three proximal tethering arms 13B, 13D and 13F. are folded around the outer circumference of the ring and threaded through the central aperture 8 and the loop section 18 of each tethering arm is inserted into the proximal window 27. Once the three loop sections 18 are aligned in the central lumen of the delivery arm the locking rod 24 is adjusted from the release configuration into the first coupling configuration where the distal end of the locking rod extends through the three loop sections, coupling the three proximal tethering arms to the delivery arm and retaining the proximal end of the flexible cover in position covering the top surface of the anastomosis ring.

[0150] Referring to Figures 4 and 10, the three distal tethering arms 13A, 13C and 13E are folded around the outer circumference of the ring and threaded through the central aperture 8 of the ring before the loop section 18 of each tethering arm is inserted into the distal window 26. Once the three loop sections 18 are aligned in the central lumen of the delivery arm the locking rod 24 is further advanced distally from the first coupling configuration (Figure 3) to the second coupling configuration (Figure 4) where the distal end of the locking rod extends through the three loop sections of the distal tethering arms, coupling the three distal tethering arms to the delivery arm and securely retaining the flexible cover in position covering the top surface of the anastomosis ring. Referring to Figure 12, the anastomosis ring 2 is then manually compressed into an elongated delivery configuration before the delivery arm 10 is manually retracted proximally relative to the trocar 30 to sheath the flexible cover and anastomosis ring inside the trocar as shown in Figure 14.

[0151] Figures 14 to 20 illustrate the deployment of the anastomosis ring by the delivery system 10. In a first step, the delivery arm 10 is advanced distally until the distal end 11 comprising the anastomosis ring 2 and flexible cover 12 is exposed proud of the distal end of the trocar. Once free of the restraining forces of the trocar, the anastomosis ring will self-deploy into the radially expanded deployed configuration shown in the Figure 14. The locking rod 24 is then retracted proximally from the second coupling configuration (Figure 4) to the first coupling configuration (Figure 3) releasing the distal arms 13A, 13C and 13E which spring back into a radially outward configuration shown in Figure 15. Once the distal tethering arms are released, the distal end of the ring will fall away from the flexible cover as shown in Figures 16 to 19. The locking rod 24 is then retracted proximally from the first coupling configuration (Figure 3) to the release configuration (Figure 2) releasing the proximal arms 13B, 13D and 13F which spring back into a radially outward configuration shown in Figure 20. The anastomosis ring is then fully released from the flexible cover, which remains attached to the distal end of the delivery arm to facilitate the removal of the flexible cover along with the delivery arm.

[0152] Referring to Figures 21 to 27, an alternative embodiment of the delivery system of the disclosure, indicated generally by the reference numeral 40, is described in which parts described with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the coupling system comprises two locking rods mounted for axial movement along the central lumen 23 of the delivery arm 10, namely a first locking rod 41 and a second locking rod 43. The first locking rod 41 has a distal end 42 and is axially adjustable between a coupling configuration shown in Figure 22 in which the distal end 42 is disposed adjacent to the proximal window 27 in the sidewall 22 of the delivery arm 10, to a release configuration shown in Figure 23 in which the distal end 42 is disposed proximally of the proximal window 27 in the sidewall 22 of the delivery arm 10. The second locking rod 3 has a distal end 44 and is axially adjustable between a coupling configuration shown in Figures 22 and 23 in which the distal end 44 is disposed adjacent to the distal window 26 in the sidewall 22 of the delivery arm 10, to a release configuration shown in Figure 27 in which the distal end 44 is disposed proximally of the distal window 2. The first locking rod 41 is a straight rod. The second locking rod 43 has a straight proximal section 45 having a first longitudinal axis, a straight distal section 46 having a second longitudinal axis that is parallel to and laterally offset with the first longitudinal axis, and a transition section 47. The straight proximal section 45 is disposed above and co-parallel with the first locking rod 41 and the straight distal section 46 is disposed distally of and co-axial with the first locking rod 41 .

[0153] The delivery system 40 also includes a compression mechanism to urge the detachment of the proximal end of the flexible cover from the proximal end of the anastomosis ring. In this embodiment, the compression system comprises a compression arm 48 having a distal end 49 that is attached to the proximal end 15 of the flexible 12. The compression arm 48 is associated with the delivery arm (in this case it has a curved profile configured to match the curvature of one side of the delivery arm and nests against the delivery arm). The compression arm is thus mounted to the delivery arm 10 and axially movable relative to the delivery arm from a delivery configuration shown in Figure 24 to a distally advanced release configuration shown in Figure 26. The purpose of the compression arm is to urge the proximal end of the flexible cover 12 distally off the anastomosis ring during the deployment process.

[0154] The assembly of the delivery system is substantially the same as that described with reference to the first embodiment, with the exception that the first locking rod is first actuated to couple the proximal tethering arms to the delivery arm and the second locking rod is then actuated to couple the distal tethering arms. The deployment of the anastomosis ring comprises a first step of retracting the first locking rod to first release the proximal tethering arms (which is not possible when only one locking rod is employed), a second step of advancing the compression rod distally to dislodge the proximal end of the flexible cover from the proximal end of the anastomosis ring, and a third step of retracting the second locking rod to release the distal tethering arms to fully detach the anastomosis ring from the flexible cover and delivery arm.

[0155] Referring to Figures 28 to 37, an alternative embodiment of the delivery system of the disclosure, indicated generally by the reference numeral 50, is described in which parts described with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the coupling system comprises three pull wires 51 , 52 and 53 that are threaded through the central lumen of the delivery 10 and have distal ends 51A, 51B and 51C attached to the proximal end 15, first side 16 and second side 17 of the flexible cover. Although not shown, the proximal ends of each pull wire is attached to the retraction mechanism actuatable to pull the pull wires proximally. The delivery system 50 also includes a grasping arm 55 having remotely actuatable jaws 56 configured to grasp the anastomosis ring during use and a second trocar (not shown) for minimally invasive delivery of the grasping arm. In use, the delivery system 50 and retained anastomosis ring 2 is delivered through the trocar 30 into a body lumen, the first locking rod is adjusted from the coupling configuration to the release configuration to release the proximal tethering arms, the pull wires are then retracted to detach the proximal end of the cover from the anastomosis ring, the grasping arm is then used to hold the proximal end of the anastomosis ring in position, the second locking rod is then moved into the release configuration to release the distal arms, and the pull wires are retracted further to fully detach the anastomosis ring from the flexible cover and delivery arm.

[0156] Figures 38 to 57 illustrate the use of the delivery system of one embodiment of the invention to deliver compression anastomosis rings to the colon of a subject.

[0157] 1 . An enterotomy or lumen is made in the intestine. The hole smaller or the same size of the delivery tool tip (Figure 38)

[0158] 2. The delivery tool tip is placed through the hole / enterotomy. The placement of the tip can be measured / validated via labelling’s and / or colours along the shaft. (Figures 39 and 40)

[0159] 3. Once the user is happy with the positioning of the delivery tool the user plunges the implant out of the tip of the delivery tool. (Figure 41)

[0160] 4. The user plunges the implant out of the tip of the delivery tool. Once the whole implant has exited the delivery tool tip its opens and returns to its original ring configuration (Figures 42 and 43)

[0161] 5. The user then manipulates the delivery tool and the retractable arm to position the ring circumcentre to the lumen / hole it entered (Figure 44)

[0162] 6. For this particular embodiment there is a mechanism which is attached to the retaining element from the side closest to the delivery device as shown below. When this mechanism is activated it pushes the retaining member away from the implant in stages. (Figures 24 to 26) 7. The ring is positioned around the lumen / enterotomy. (Figure 45)

[0163] 8. The first step of the detachment process is started. The back retaining arms of the retaining member are released. Once released the arms will refrain from hugging the ring and will retract to their original position. (Figure 46)

[0164] 9. Once the back arms have been released the retaining member compression arm pushes the back end of the cover away from the implant, revealing the implant tissue gripping features (Figure 47)

[0165] 10. Once the tissue gripping features have been exposed it is important to move the ring into position in line with the lumen / opening (Figure 48)

[0166] 11. Once in position it is advised to anchor the implant into position using a grasper or clip. The user places the grasper / clip over the exposed area of the ring and adjacent tissue, holding it in position temporarily (Figure 49)

[0167] 12. One the grasper / clip is in place the user activates the second stage of detachment. The user detaches the front arms of the retaining member. Hence the ring detaches from the cover (Figure 50)

[0168] 13. The user pulls away the retaining member and delivery device from the lumen / enterotomy. (Figures 51 to 53)

[0169] 14. Repeat the steps for the second implant.

[0170] 15. With the grasper / clip still attached to each ring the user must bring the implants and tissue segments together. The magnetic elements will aid with alignment and when in close proximity to each other will connect. (Figures 54 to 56)

[0171] 16. The user must then remove the grasper / clips to ensure full circumferential compression. (Figure 57). The delivery system illustrated in Figures 1 to 57 incorporated first and second tethering elements as integral elements of a flexible cover which in use was placed on top of the ring and then used to tether the ring to the deliver arm. An alternative embodiment of the system will now be described with reference to Figures 58 to 79 in which the first and second tethering elements are not integrated into a single body, but are independent of each other and configured for mounting to the delivery arm and incorporate tethering arms configured to loop around a section of an implant. The coupling mechanism for the embodiments of Figures 58 to 79 is essentially the same as that described with reference to Figures 1 to 57 and will not be described in any detail. Figures 83 to 85 below describe an embodiment of the delivery system of the disclosure having one tethering element configured for mounting to the delivery arm and incorporating one tethering arm configured to loop around a distal section of the annular implant.

[0172] Referring initially to Figures 58 to 64, an alternative embodiment of the delivery system of the disclosure is described in which parts described with reference to the previous embodiments are assigned the same reference numerals. In the embodiment, the delivery system, indicated generally by the reference numeral 60, is shown in use delivering a compression anastomosis ring 2 inside a body lumen. In this embodiment, the system 60 does not include a flexible cover, and includes a first tethering element 61 and second tethering element 62 that are independent of each other and configured for mounting on the delivery arm 2. In more detail, each of the first and second tethering elements 61 , 62 include a coupling ring 63 disposed on top of a stabilising plate 64, with a flexible tethering arm 13 attached to each stabilising plate. The entire element may be formed from silicone or another suitable material such as Nitinol. To assist in stabilising the ring during deployment, the stabilising plate 64 has a half-pipe curvature that corresponds to the curvature on the top of the proximal end 65 of the ring 2 allowing the stabilising plate 64 nest on top of the ring 2. The stabilising plate has a longitudinal axis X that is orthogonal to a central axis Y of the coupling ring 63. This helps securely tether the ring to the delivery system and keep it stable during deployment allowing for more accurate positioning of the ring in-vivo. As illustrated best in Figure 62, the distal tethering arm 13A extends radially outwardly from a distal side of the stabilising plate 64 of the second tethering element 62 and in a tethered configuration is looped around the bottom of the ring and up through the ring and into the distal window where it couples with a coupling rod, as described previously. The proximal tethering arm 13B extends radially outwardly from a proximal side of the stabilising plate 64 of the first tethering element 61 and in a tethered configuration is looped around the bottom of the ring and up through the ring and into the proximal window where it couples with a coupling rod, as described previously.

[0173] The assembly and deployment of the delivery system and uncoupling (release) of the ring is substantially as described previously and involves tethering the ring to the delivery arm using the tethering elements which are spaced apart on the delivery arm with the first tethering element positioned on the arm just proximally of the proximal window and the second tethering element positioned on the arm just distally of the distal window. The ring is then placed under the delivery arm and adjusted until the distal and proximal ends of the ring are nested in the curved stabilising plates. Once in this position, the tethering arms 13A and 13B are looped around an outside of the ring, up through a centre of the ring, and then into the distal and proximal windows as described previously. The coupling mechanism is then actuated to couple the end of the arms to the delivery arm and thereby couple the ring to the delivery system. The delivery system and ring are shown in a fully coupled configuration in Figures 58 and 59.

[0174] Referring to Figures 60 to 64, the coupling mechanism is actuated to release the proximal tethering arm (Figs. 60 and 61), and subsequently the distal tethering arm (Fig. 62 and 63), whereupon the ring is uncoupled from the delivery arm and tethering elements and released from the delivery system (Fig. 64).

[0175] Referring to Figures 65 to 68, an alternative embodiment of the delivery system of the disclosure is described in which parts described with reference to the previous embodiments are assigned the same reference numerals. In the embodiment, the delivery system, indicated generally by the reference numeral 70, is substantially identical to that described with reference to Figures 60 to 64 with the exception that the delivery arm comprises a push rod 48 having a distal end 49 that abuts the first tethering element 61 . During uncoupling of the ring from the delivery system, after uncoupling of the proximal tethering arm and prior to uncoupling of the distal tethering arm, the rod is advanced distally to push the first tethering element 61 distally along the delivery arm 2 and away from the proximal end of the ring 2, as illustrated in Figure 66. The distal tethering arm is then uncoupled (Fig. 67) to release the ring 2 from the delivery arm 10 (Fig. 68).

[0176] Referring initially to Figures 69 and 70, an alternative embodiment of the delivery system 70 of the disclosure is described in which parts described with reference to the previous embodiments are assigned the same reference numerals. In this embodiment, the delivery system is substantially identical to that described with reference to Figures 65 to 68 with the exception that the proximal tethering arm 13B extends from a distal side of the stabilising plate 64 of the first tethering element 61 , the distal tethering arm 13A extends from a proximal side of the stabilising plate 64 of the second tethering element 62, and the distal window 26 and proximal window 27 are further spaced apart as illustrated in Figure 69. The use of this embodiment is the same as that described with reference to Figures.

[0177] Figures 71 to 79 illustrate the use of a delivery system of the disclosure to deliver, stabilise and position a self-forming compression anastomosis ring 81 comprising a string of ring segments 83 including a distal segment 83A and a proximal ring segment 83B that include magnetic elements (not shown) configured to attach the segments together to close the ring. The delivery system, indicated generally by the reference numeral 80, is substantially identical to that described with reference to Figures 65 to 68 with the exception that the proximal tethering arm 13B extends from a proximal side of the stabilising plate 64 of the first tethering element 61 , the distal tethering arm 13A extends from a proximal side of the stabilising plate 64 of the second tethering element 62. The ring 81 , is tethered to the delivery arm 10 in an open-ring elongated configuration, and advanced into the access sheath. Once the distal end of the access sheath is positioned inside a target body lumen, the deliver arm is advanced along the access sheath to advance the ring 81 proud of the end of the access sheath (Fig. 71). As the distal segments of the ring are advanced out of the sheath, they begin to self-form into a ring shape (Fig. 72). Figures 73 and 74 illustrate the deliver arm extending out of the access sheath until the first tethering element 61 and second tethering element 62 are both exposed proud of the distal end of the sheath (Fig. 76). The string of segments continues to self-form into a ring shape until facing ends of the distal and proximal segments are in close proximity to each other (Fig. 76). The ends of the distal and proximal segments join together to close the ring (Fig. 77). At this stage, it is noted that the distal and proximal segments 83A, 83B are aligned with the stabilising plates 64 of the tethering elements 61 , 62 allowing them to nest together thus stabilising the closed ring relative to the delivery arm. The first tethering element 61 is then uncoupled and the second tethering element is subsequently uncoupled to release the ring from the delivery system.

[0178] The embodiments described above are predominantly configured to deliver and deploy an annular implant in a body lumen in a flat orientation. When the implant is an anastomosis ring, this delivery orientation is suitable for forming a side-to-side, or side-to-end anastomosis. Figures 80 to 82 illustrate a delivery system according to an alternative embodiment of the disclosure, indicated generally by the reference numeral 90, suitable for delivering and stably positioning an anastomosis ring in an orientation that is concentric to the body lumen, and therefore suitable for forming an end-to-end anastomosis. The delivery system 90 comprises a delivery arm 10 suitable for advancement through an access sheath, and a flexible cover 12 for the anastomosis ring 2 having an annular part 91 comprising a plurality of tethering arms 13 extending radially outwardly of an outer periphery of the annular part as described previously with reference to Figures 1 to 20. In this embodiment, the flexible cover 12 comprises a central hub 93 with a lumen configured to receive the delivery arm 2, and a plurality of flexible radial spokes 94 connecting the central hub 93 with an inner periphery of the annular part 91. The distal ends of the tethering arms are coupled to the delivery arm by means of an axially movable coupling rod (not shown) disposed within the delivery arm as described previously. The distal end of the delivery arm includes a stabilisation element 95 having a piercing tip 96 and four stabilisation wings 97 disposed around a circumference of the piercing element and hingedly movable from a delivery configuration where the wings extend proximally parallel to the delivery arm to a deployed configuration shown in Figs 80-82 where the wings extend radially outwardly. The delivery system is configured to adjust the relative axial position of the stabilisation element and the anastomosis ring to allow the stabilisation element to be moved to a position that is flush against the deployed ring to keep the ring stable during the positioning of the ring. The system may include a second stabilising element (not shown) mounted to the delivery arm proximally of the anastomosis ring, which is adjustable to stabilise the anastomosis ring from the proximal side.

[0179] Referring to Figures 83 to 85, an alternative embodiment of the delivery system of the disclosure is described in which parts described with reference to the previous embodiments are assigned the same reference numerals. In the embodiment, the delivery system, indicated generally by the reference numeral 100, is shown in use delivering a compression anastomosis ring 2 inside a body lumen. The delivery system 100 of this embodiment is similar to that shown in Figures 58 to 64 but has only one tethering element 101 , the details of which are described previously with reference to Figures 58-64, which tethers the distal end of the compression anastomosis ring 2 to the distal end of the delivery arm 10. The use of this embodiment is substantially similar to that described with reference to the embodiment of Figures 58 to 64 with the exception that uncoupling of the ring from the delivery arm requires only one tethering arm to be untethered. Referring to Figures 86 to 91 , an alternative embodiment of the delivery system of the disclosure is described in which parts described with reference to the previous embodiments are assigned the same reference numerals. In the embodiment, the delivery system, indicated generally by the reference numeral 110, is shown in use delivering a compression anastomosis ring 2 inside a body lumen. The delivery system 110 of this embodiment is similar to that shown in Figures 21-27 but has a compression rod 111 that is not associated with (or mounted to) the delivery arm 2 but is mounted within the access sheath 30 for axial movement relative to the access sheath. A distal end 112 of the compression rod 111 is coupled to a proximal end of the flexible cover 12, and a distal end of the delivery arm 10 is coupled to the distal end of the flexible cover 12. In use, similar to the embodiment of Figures 21-27, the delivery arm is advanced distally out of the distal end of the access sheath whereupon the anastomosis ring deploys into a ring shape (Figure 86), the first locking rod (not shown) is then retracted to release the tethering arms on the distal end of the flexible cover, including tethering arm 13D (Figure 87), and the compression rod 111 is then advanced distally to urge the distal end of the flexible cover distally and away from the distal end of the anastomosis ring, while the coupling between the distal end of the delivery arm 10 and the distal end of the flexible cover 12 retains the distal end of the flexible cover static (Figures 88 and 89). The tethering arms on the distal end of the flexible cover 13A, 13E and 13C are then released by retraction of the second locking rod (not shown) thus fully releasing the anastomosis ring 2 from the delivery arm 10 (Figures 90 and 91).

[0180] The foregoing description details presently preferred embodiments of the present invention. Numerous modifications and variations in practice thereof are expected to occur to those skilled in the art upon consideration of these descriptions. Those modifications and variations are intended to be encompassed within the claims appended hereto. Reference Numerals

[0181] Delivery system 1 , 40, 50, 60, 70, 80, 90, 100, 110

[0182] Compressible anastomosis ring 2

[0183] Top surface of ring 3

[0184] Anchoring barbs 4

[0185] Annular housing of ring 5

[0186] Ring segments 6 Sleeves for ring segments 7

[0187] Delivery arm 10 having a distal end 11

[0188] Flexible cover 12

[0189] Central aperture 8 of cover

[0190] Distal end (of flexible cover) 14

[0191] Proximal end 15

[0192] First side 16

[0193] Second side 17

[0194] Flexible tethering arms 13

[0195] Distal flexible tethering arm 13A

[0196] Proximal flexible tethering arm 13B

[0197] First distal and proximal lateral tethering arms 13C and 13D

[0198] Second distal and proximal lateral tethering arms 13E and 13F

[0199] Loop section 18

[0200] Upstanding ring 19

[0201] Distal tip 20

[0202] Sidewall of delivery arm 22

[0203] Central lumen 23

[0204] Locking rod 24

[0205] Distal end 25

[0206] Distal window 26

[0207] Proximal window 27.

[0208] Trocar 30 having a distal end 31 and central lumen 32

[0209] First locking rod 41 with distal end 42

[0210] Second locking rod 43 with distal end 44

[0211] Straight proximal section 45

[0212] Straight distal section 46

[0213] Transition section 47 Pust (compression) rod 48 having a distal end 49

[0214] Pull wires 51 , 52 and 53

[0215] Distal ends 51 A, 51 B and 51 C

[0216] Grasping arm 55

[0217] Remotely actuatable jaws 56

[0218] First tethering element 61

[0219] Second tethering element 62

[0220] Coupling ring 63

[0221] Stabilising plate 64

[0222] Proximal end 65 of ring 2

[0223] Self- forming compression anastomosis ring 81

[0224] Ring segments 83

[0225] Distal segment 83A

[0226] Proximal segment 83B

[0227] Annular part of flexible cover 91

[0228] Central hub 93

[0229] Radial spokes 94

[0230] Stabilisation element 95

[0231] Piercing tip 96

[0232] Stabilisation wings 97

[0233] Single tethering element 101

[0234] Compression rod 111 with distal end 112

Claims

CLAIMS:

1. A delivery system to deliver of an annular implant to a body lumen, the delivery system comprising: a delivery arm; a first tethering element comprising a first tethering arm to releasably tether a first part of the annular implant to the delivery arm; a second tethering element comprising a second tethering arm to releasably tether a second part of the annular implant to the delivery arm; and a coupling module actuatable to untether the first tethering arm and second tethering arm to release the annular implant from the delivery arm.

2. A delivery system according to Claim 1 , in which the first tethering element is configured to releasably tether a distal part of the annular implant to the delivery arm and the second tethering element is configured to releasably tether a proximal part of the annular implant to the delivery arm.

3. A delivery system according to Claim 1 or 2, in which the coupling module is configured to release the first tethering arm and second tethering arm sequentially.

4. A delivery system according to any preceding Claim, for minimally invasive delivery of the annular implant, in which the delivery arm with annular implant tethered thereto is configured for axial movement along a lumen of a minimally invasive access conduit.

5. A delivery system according to any preceding Claim, in which the coupling module comprises a first coupling rod that is axially movable relative to the delivery arm from an advanced position in which the first coupling rod is coupled to a distal end of at least one of the first and second tethering arms to a retracted position in which the first coupling rod is uncoupled to the distal end of at least one of the first tethering arm and second tethering arm.

6. A delivery system as claimed in Claim 5, in which the delivery arm comprises a sidewall defining a delivery arm lumen and a window in the sidewall dimensioned to receive the distal end of at least one of the first tethering arm and second tethering arm, wherein the coupling element is mounted within, and for axial movement along, the delivery arm lumen.

7. A delivery system as claimed in Claim 6, in which the sidewall of the delivery shaft comprises a distal window and a proximal window.

8. A delivery system according to Claim 7, in which the first coupling rod is configured for axial movement along the delivery arm lumen between a first coupling configuration in which the distal end of the first coupling rod is disposed adjacent to the distal window and the first coupling rod is coupled to the distal end of the first tethering arm and second tethering arm, a second coupling configuration in which the distal end of the first coupling rod is disposed adjacent to the proximal window and coupled to the second tethering arm, and the release configuration.

9. A delivery system as claimed in any of Claims 5 to 8, in which the coupling element comprises a second coupling rod disposed within the delivery arm lumen and configured for axial movement along the delivery arm lumen between a coupling configuration and a release configuration, in which a distal end of the second coupling rod is configured to engage the distal end of the tethering arm.

10. A delivery system according to any preceding Claim, in which the annular implant is a compressible ring or configured to self-form into a ring when released from the delivery arm.

11. A delivery system according to any preceding Claim, in which the first tethering element and second tethering element are independent of each other and configured to couple to a distal end of the delivery arm in an axially spaced-apart configuration.

12. A delivery system according to Claim 11 , in which the first tethering element and second tethering element each comprise a coupling part to couple to the delivery arm and a stabilisation element configured to abut a surface of the implant and stabilise the annular implant in position during deployment.

13. A delivery system according to any of Claims 1 to 10, comprising a flexible cover for the annular implant configured to abut a top or bottom surface of the annular implant, wherein the flexible cover comprises the first tethering element and second tethering element.

14. A delivery system according to Claim 13, in which the tethering arms extend radially outwardly of the flexible cover.

15. A delivery system according to Claim 13 or 14, in which the flexible cover comprises an annular part, a central hub with a lumen configured for mounting on the delivery arm, and flexible spokes connecting the annular part and the central hub.

Images