A delivery system to deliver and position a ring-shaped implant in a body lumen

Abstract

A system for delivering an anastomosis ring is described. The system comprises an access sheath comprising a lumen, a delivery device to deliver a magnetic ring-shaped implant along the lumen of the access sheath and through a hole in a body lumen, a magnetic element (e.g. a securing magnet), and a securing magnet holder to deliver the securing magnet along the lumen of the access sheath. The securing magnet is detachably attachable to the securing magnet holder and configured to magnetically couple with the magnetic ring-shaped implant across a wall of the body lumen. The system allows a magnetic ring-shaped implant such as a compression anastomosis ring to be delivered via the access sheath into a body lumen (e.g. a colon) through a hole (e.g. a cut end or a side hole), articulated into position inside the body lumen surrounding (or aligned with) the hole, and then secured in position using the securing magnet.

Description

[0001] TITLE

[0002] A delivery system to deliver and position a ring-shaped implant in a body lumen

[0003] Technical Field

[0004] The present disclosure relates to a delivery system to deliver and position a ringshaped implant in a body lumen. Also disclosed is a system comprising a ringshaped implant such as an anastomosis ring and a delivery system for the ringshaped implant.

[0005] Technical Background

[0006] Colorectal cancer is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women across the world. There were over 1.9 million new cases in 2020 globally. The global burden of colorectal cancer is expected to increase by 60%, to over 2.2 million new cases and 1.1 million annual deaths, by the year 2030. This growth is expected as a product of environmental changes, such as more sedentary lifestyle, greater obesity, processed food, alcohol, and meat consumption, and greater overall longevity.

[0007] A surgical anastomosis is done when a surgeon removes a diseased part of an intestine, colon or blood vessel and then reconnects the healthy ends. One of the most serious complications of anastomosis is anastomotic leakage which occurs in up to 20% of patients undergoing anterior resection. Anastomotic leakage causes faecal material to enter the bowel cavity leading to serious complications such as peritonitis or septic shock. An anastomotic leakage is not easily detectable and leads to extended hospital stays, readmission, reoperations or even death. In the UK, the 2019 National Bowel Cancer Audit showed that 8% of patients whounderwent colorectal surgery had an unplanned return to theatre (URTT) with 50% of these occurring within the first 7 days post-operatively. Mortality in patients with URTT is 8% compared to 2% in those who do not return to theatre.

[0008] One 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 and a healing process which eventually joins the two bowel ends. 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 (for e.g., needing a purse suturing to secure 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 0.5-1 cm 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, and less scarring with laparoscopic surgery. In the UK, 61% of patients had laparoscopic procedures in 2019, an increase from 48% in 2014. Endoscopes are also used widely in colorectal surgery for various applications from illumination, imaging of the interior of the body or to perform minimally invasive surgical procedures which can include air insufflation, irrigation, aspiration or gripping and cutting of tissue. To introduce the equipment required for the respective intervention, the endoscope has several channels.

[0010] WO2022171349A1 describes a compression anastomosis system comprising compression anastomosis implant rings. Each ring is comprised of a flexible silicone outer body ring, which encompasses a series of tissue anchors that encase magnetic elements. These magnetic elements exert an attraction force which bringsthe implant ring pair together to form a compression anastomosis. This tissue anchors grip the tissue and prevent the ring from migrating once positioned within the tubular Gl tract. Positioning the rings in a body lumen is challenging, especially when it is delivered in laparoscopic procedure. In addition, the implant ring needs to be oriented and gripped to the lumen during the deployment phase of the delivery to prevent the ring from migrating from the lumen or moving away from an idealised or desired position during this phase.

[0011] Minimally invasive delivery systems for anastomosis rings are described in the literature. The system generally comprise an access sheath, and a delivery arm disposed inside the access sheath which is required to hold and deliver the anastomosis ring through the access sheath into a body lumen. Once inside the body lumen, the ring has to be deployed, correctly positioned, and then released from the delivery arm. Example of delivery systems for anastomosis rings are described in US2023 / 255624, US2024 / 041461 and WO2025 / 186472. While these systems perform some of the functions required, there remains a need for a delivery system that not only delivers and deploys an anastomosis ring, but also can secure the deployed ring in position and optionally allow for further repositioning of the anastomosis ring while it is secured.

[0012] It is an object of the invention to overcome at least one of the above-referenced problems.

[0013] Summary of the Disclosure

[0014] In one aspect, these objects are addressed by a system comprising an access sheath comprising a lumen, a delivery device to deliver a magnetic ring-shaped implant along the lumen of the access sheath and through a hole in a body lumen, a magnetic element (e.g. a securing magnet), and a securing magnet holder to deliver the securing magnet along the lumen of the access sheath. The securing magnet is detachably attachable to the securing magnet holder and configured to magnetically couple with the magnetic ring-shaped implant across a wall of thebody lumen. The system allows a magnetic ring shaped implant such as a compression anastomosis ring to be delivered via the access sheath into a body lumen (e.g. a colon) through a hole (e.g. a cut end or a side hole), articulated into position inside the body lumen surrounding (or aligned with) the hole, and then secured in position using the securing magnet which is delivered through (the same or a different) access sheath and positioned outside the body lumen adjacent to the hole where it magnetically couples with the magnetic ring-shaped implant across the wall of the body lumen, retaining the magnetic ring-shaped implant in the correct position inside the body lumen surrounding the hole in the wall of the body lumen. The system also enables further articulation or re-positioning of the ringshaped implant using a gripping element which can grasp the securing magnet and adjust the position of the ring-shaped magnet by moving the securing magnet. These objects are addressed by providing a delivery system fora ring-shaped implant such as an anastomosis ring. The delivery system includes an access sheath and a delivery arm with a distal head axially movable relative to the access sheath. The distal head narrows (e.g. tapers inwardly) from its distal end to its proximal end, allowing the ring to be mounted on a proximal part during delivery. A distal part of the head is bigger than the deployed ring thus preventing the distal head passing through the implant. The access sheath with the delivery arm and ring stowed inside (both in a contracted configuration) is advanced towards and into an incision in the body lumen or into a body lumen end. Once the distal end of the access sheath is positioned inside the body lumen, the access sheath is retracted relative to the delivery arm to deploy the distal head and ring inside the body lumen, or the delivery arm and distal head are advanced relative to the access sheath, with the deployed ring mounted on the deployed distal head. The distal head is then retracted proximally causing the deployed ring to ride up the distal head until the implant is gripped on the distal head. This also results in the implant being pulled proximally towards the incision from inside the body lumen until it abuts the wall of the body lumen surrounding the incision. A distal head having a conical distal part has been found to be beneficial for this operation. A bulbous distal part of the distal head provides an atraumatic head on the delivery system. A whisk-type structure or an inflatable type structure or an expandable structure isideal for providing these features. The use of the delivery system to deliver an anastomosis ring in this matter is illustrated in Figures 1 to 8.

[0015] In one aspect the disclosure relates to a system to deliver and position a ring shaped implant comprising a magnet (hereafter “magnetic ring-shaped implant”) inside a body lumen, comprising:

[0016] a delivery device to deliver the magnetic ring-shaped implant through a hole in a body lumen;

[0017] a securing magnet; and

[0018] a securing magnet holder to hold (or releasably couple with) the securing magnet to deliver the securing magnet to the body lumen.

[0019] In any embodiment, the securing magnet is detachably attachable to the securing magnet holder and configured to magnetically couple with the magnetic ringshaped implant across wall of the body lumen.

[0020] Also described is a system to deliver and position a magnetic ring-shaped implant inside a body lumen, comprising:

[0021] an access sheath comprising a lumen;

[0022] a delivery device to deliver the ring-shaped implant along the lumen of the access sheath and through a hole in a body lumen;

[0023] a securing magnet; and

[0024] a securing magnet holder to deliver the securing magnet along the lumen of the access sheath.In any embodiment, the securing magnet is detachably attachable to the securing magnet holder and configured to magnetically couple with the magnetic ringshaped implant across a wall of the body lumen.

[0025] In any embodiment, the securing magnet has a longitudinal aspect and a magnetic orientation disposed along the longitudinal aspect (axially magnetized).

[0026] In any embodiment, the securing magnet comprises a grasping part configured for engagement with a grasping tool. The grasping part may comprises, for example:

[0027] a section of the securing magnet that is shaped for ease of gripping (e.g. a narrowed section or a widened section, or formations that mate with corresponding formations on the gripping tool);

[0028] a section of the securing magnet that has a surface comprising a material configured to provide better grip between the surface and the gripping tool (e.g. rubber or silicone);

[0029] a section of the surface comprising formations for improved grip with a gripping tool (e.g. ridges, projections, detents, etc);

[0030] In any embodiment, the securing magnet comprises a distal magnet part and a grasping part, typically a proximal grasping part.

[0031] In any embodiment, the grasping part is deformable, ideally resiliently deformable.

[0032] In any embodiment, the securing magnet holder is configured for detachable (releasable) magnetic coupling with the securing magnet.

[0033] In any embodiment, a first magnetic coupling strength between the securing magnet and the ring shaped implant is greater than a second magnetic couplingstrength defined between the coupling magnet and the coupling magnet holder. This allows passive release of the coupling magnet.

[0034] In any embodiment, the securing magnet holder comprises an elongated body with a distal end configured to couple with the securing magnet.

[0035] In any embodiment, the securing magnet holder comprises at least two securing magnets.

[0036] In any embodiment, the securing magnet holder comprises an elongated body having a lumen (or socket), a securing magnet disposed in the lumen (or socket), and typically a conveying module configured to deliver the securing magnet from the lumen (or socket) to a distal end of the elongated body.

[0037] In any embodiment, the securing magnet is diametrically magnetized. An example is a cylindrical securing magnet where its magnetic poles are aligned across its diameter.

[0038] In any embodiment, the securing magnet is magnetized at each end. An example is a cylindrical securing magnet where its magnetic poles are aligned at each end.

[0039] In any embodiment, the system comprises at least one magnetic ring shaped implant.

[0040] In any embodiment, the (or each) magnetic ring-shaped implant comprises a magnetic endoskeleton.

[0041] In any embodiment, the (or each) magnetic ring shaped implant is compressible into a low-profile delivery configuration.In any embodiment, the securing magnet comprises an elongated body having a distal end comprising a first magnet or magnetic pole configured to magnetically couple with the magnetic ring shaped implant and a proximal end configured to couple with a distal end of the securing magnet holder.

[0042] In any embodiment, the proximal end is configured to magnetically couple with the distal end of the securing magnet holder.

[0043] In any embodiment, the proximal end is configured to mechanically couple with the distal end of the securing magnet holder.

[0044] In any embodiment, the securing magnet (typically a proximal end of the securing magnet) is configured to couple with the distal end of the securing magnet holder by a friction fit.

[0045] In any embodiment, the securing magnet holder comprises a user-operable actuator adjustable between a coupling condition in which the actuator secures the securing magnet to the securing magnet holder and a release condition in which the actuator releases the securing magnet from the securing magnet holder.

[0046] In any embodiment, the system comprises a first magnetic ring-shaped implant and a second magnetic ring-shaped implant, wherein the first magnetic ring-shaped implant and second magnetic ring-shaped implant are configured to magnetically couple together in a face-to-face configuration.

[0047] In any embodiment, a magnetic coupling strength between the first magnetic ringshaped implant and the second magnetic ring-shaped implant is greater than a magnetic coupling strength between first magnetic ring shaped implant and the securing magnet.

[0048] In any embodiment, a distal end of the holder comprises a socket configured to passively hold the at least one securing magnet.Also described is a system to deliver and position a magnetic ring-shaped implant”) inside a body lumen, comprising:

[0049] a delivery device to deliver the magnetic ring-shaped implant through a hole in a body lumen;

[0050] a securing magnet; and

[0051] a securing magnet holder to hold (or releasably couple with) the securing magnet to deliver the securing magnet to the body lumen.

[0052] wherein the securing magnet is configured to magnetically couple with the magnetic ring-shaped implant across wall of the body lumen and a proximal end of the securing magnet is configured to couple with the distal end of the securing magnet holder by a friction fit.

[0053] Also described is a method of delivering and positioning a first magnetic ringshaped implant inside a body lumen, comprising the steps of:

[0054] mounting the first magnetic ring-shaped implant on a delivery device;

[0055] using the delivery device, delivering the first magnetic ring-shaped implant through a hole (side hole or end hole) in a body lumen;

[0056] delivering a securing magnet to a position adjacent to (or overlapping) the hole in the body lumen;

[0057] allowing the securing magnet to magnetically couple with the first magnetic ring-shaped implant through the wall of the body lumen adjacent (or at a periphery of) the hole in the body lumen;releasing the first magnetic ring-shaped implant from the delivery device; and

[0058] optionally, withdrawing the delivery device.

[0059] In any embodiment, the method comprises adjusting the position of the delivery device to orient and position the first magnetic ring-shaped implant such that the first magnetic rings-shaped implant is disposed around the hole in the body lumen. Generally, this is performed prior to the securing magnet magnetically coupling to the first magnetic ring shaped implant.

[0060] In any embodiment, the method comprises gripping the securing magnet disposed outside the body lumen with a gripping element and adjusting a position of the first magnetic ring-shaped implant disposed inside the body lumen by articulating the position of the securing magnet with the gripping element.

[0061] In any embodiment, the method comprises delivering the securing magnet through the access sheath using a securing magnet holder which is axially adjustable relative to the access sheath.

[0062] The step of releasing the first magnetic ring-shaped implant from the delivery device is usually only performed after the securing magnet has magnetically coupled with the magnet of the implant.

[0063] Also described in a method of forming a compression anastomosis in a subject comprising:

[0064] delivering and positioning a first magnetic ring-shaped implant inside a first part of a body lumen of the subject according to a method of the disclosure;delivering and positioning a second magnetic ring-shaped implant inside a second part of the body lumen of the subject according to a method of the disclosure; and

[0065] magnetically coupling the rings together in a face-to-face orientation to form a compression anastomosis in the body lumen.

[0066] In any embodiment, the method comprises uncoupling and withdrawing the coupling magnets after the compression anastomosis has been formed.

[0067] In another aspect, there is provided a delivery system to deliver and position a ringshaped implant (hereafter “implant”) inside a body lumen, the delivery system comprising:

[0068] an access sheath having a lumen;

[0069] an implant delivery arm disposed in the lumen of the access sheath and axially movable relative to the access sheath; and

[0070] an implant positioning head disposed on a distal end of the delivery arm for movement therewith configured for adjustment between a contracted delivery configuration dimensioned to fit within the lumen of the access sheath and a deployed radially expanded configuration configured to grip an inner periphery of the ring-shaped implant.

[0071] In any embodiment, the implant positioning head comprises a distal section that cannot fit through the deployed implant and a proximal part that tapers inwardly towards the delivery arm.

[0072] In any embodiment, the implant positioning head or a section thereof tapers inwardly towards the delivery arm.In any embodiment, the implant positioning head in the deployed configuration comprises a conical section.

[0073] In any embodiment, the implant positioning head in the deployed configuration is cylindrical (or comprises a cylindrical section).

[0074] In any embodiment, the cylindrical implant positioning head comprises an annular circumferential recess dimensioned to receive the ring-shaped implant upon deployment of the implant positioning head.

[0075] In any embodiment, the proximal part of the implant positioning head has a conical configuration.

[0076] In any embodiment, the distal part of the implant positioning head has an atraumatic configuration. In any embodiment, the distal part has a bulbous configuration.

[0077] In any embodiment, the implant positioning head is or comprises an inflatable structure. The inflatable structure is generally disposed on a distal end of the delivery arm. The inflatable structure may be fluidically connected to an inflation device by an inflation lumen disposed in the delivery arm.

[0078] In any embodiment, the implant position head comprises a wireframe structure, such as a mesh cage or stent.

[0079] In any embodiment, the implant position head comprises a foam or polymer structure.

[0080] In any embodiment, the implant position head comprises an umbrella type structure.In any embodiment, the implant positioning head is formed from a plurality of wire loops formed into a whisk-type structure. As used here, the term “whisk-type structure” refers to a structure of the cooking implement used to whisk cream and sauces having an elongated proximal handle, a conical intermediate section and a bulbous distal head formed from a plurality of wire loops.

[0081] In any embodiment, the implant positioning head is formed from two wire loops formed into a whisk-type structure. The loops are typically disposed orthogonally to each other and share a common longitudinal axis.

[0082] In any embodiment, the distal part of the implant positioning head has a maximum diameter in the deployed configuration of 0.1 to 8 cm.

[0083] In any embodiment, the proximal part of the implant positioning head tapers inwardly from a diameter of 0.1 to 8.1 cm at a distal end to 0.1 to 2 cm at a proximal end.

[0084] In any embodiment, the delivery system comprises a deployment sheath disposed in the lumen of the access sheath and axially movable relative to the access sheath, wherein the implant positioning head is disposed within the deployment sheath, wherein the implant position head and deployment sheath are axially movable relative to each other for deployment and recapture of the implant position head.

[0085] In any embodiment, a distal tip of the access sheath is bevelled.

[0086] In any embodiment, a distal tip of the access heath comprises a cauterising element.

[0087] In any embodiment, the delivery system comprises a magnetic element and a magnetic element delivery arm disposed in the lumen or external to the lumen of the access sheath and axially movable relative to the access sheath, wherein themagnetic element is detachably attached to a distal end of the magnetic element delivery arm.

[0088] In any embodiment, the ring-shaped implant comprises a magnet (or magnetic or magnetisable body) configured to magnetically couple with the magnetic element.

[0089] In any embodiment, the ring-shaped implant comprises a magnetic endoskeleton.

[0090] In any embodiment, the magnetic element comprises an elongated body having a distal end comprising a magnet configured to magnetically couple with the ring shaped implant and a proximal end configured to magnetically couple with the distal end of the magnetic element.

[0091] In any embodiment, the distal end magnet is configured to magnetically couple with the ring shaped implant across the wall of the body lumen with a first magnetic force and the proximal end magnet is configured to magnetically couple with the distal end of the magnetic element delivery arm with a second magnetic force that is less than the first magnetic force. Thus, once the magnetic element magnetically couples with the ring-shaped implant, the delivery arm can be retracted to release the magnetic element from its delivery arm leaving it outside the body lumen and magnetically coupled to the implant positioned inside the body lumen. A user can then articulate the magnetic element to position the implant.

[0092] In any embodiment, the distal end magnet is configured to magnetically couple with the ring shaped implant across the wall of the body lumen with a first magnetic force and the distal end of the magnetic element delivery arm is configured to couple with the proximal end of the magnetic delivery via an releasable interlocking section. Thus, once the magnetic element magnetically couples with the ringshaped implant, the magnetic delivery arm can be adjusted to release the distal end of the magnetic element delivery arm to release the magnetic element from its delivery arm leaving it outside the body lumen and magnetically coupled to theimplant positioned inside the body lumen. A user can then articulate the magnetic element to position the implant.

[0093] Also described is an anastomosis system (hereafter “system”) comprising a delivery system as described herein and a ring-shaped implant (hereafter “ring”). The ring is typically adjustable (typically self-adjustable) from an elongated delivery orientation dimensioned to fit within the lumen of the access sheath to a deployed ring-shaped configuration. Suitably, the distal part of the implant positioning head when deployed has a diameter that is greater than an inner diameter of the ring such that the proximal part of the implant positioning head can be retracted through a centre of the deployed ring until it grips and orients the ring orthogonally to a longitudinal axis of the implant positioning head.

[0094] In any embodiment, the ring comprises a fastening arm configured to extend through the incision and press against an external part of the wall of the body lumen adjacent the incision to fasten the external part of the wall of the body lumen to the ring when the ring is disposed inside the body lumen surrounding the incision.

[0095] In any embodiment, the fastening arm is adjustable from a U-shaped configuration to an at least partially straightened configuration, and is biassed into the U-shaped configuration.

[0096] In any embodiment, the system comprises a first tether disposed in a lumen of the access sheath that is axially adjustable relative to the access sheath and comprises a distal end detachably attached to a distal part of the fastening arm.

[0097] In any embodiment, the ring comprises a fastening arm attached to opposite sides of the ring and in which the system optionally comprises a first tether for each fastening arm.In any embodiment, the fastening element comprises an open coil having a first end attached to the implant and a second end detachably attached to a second tether disposed in a lumen of the access sheath, wherein the second tether is axially adjustable relative to the access sheath

[0098] In any embodiment, the open coil comprises about one turn.

[0099] In any embodiment, the ring is an anastomosis ring, typically a compression anastomosis ring.

[0100] In any embodiment, the ring comprises a magnet or magnetisable material.

[0101] In any embodiment, the anastomosis ring is square and in which the implant positioning head in the deployed configuration comprises a whisk structure comprising two wire loops.

[0102] Also described is an anastomosis ring comprising a ring-shaped tubular exoskeleton formed of a shape-set alloy (typically Nitinol) and a plurality of magnets disposed inside the exoskeleton.

[0103] In any embodiment, the ring-shaped tubular exoskeleton comprises four straight sections and transition sections connecting adjacent straight sections.

[0104] In any embodiment, the transition sections are curved. In any embodiment, the transition sections are L-shaped.

[0105] In any embodiment, at least two of the transition sections are configured to deform to allow compression of the anastomosis ring into a flattened configuration.

[0106] In any embodiment, the ring-shaped tubular exoskeleton comprises a single tube of shape set alloy that is shape set into a ring and joined at its ends. In any embodiment, the ring has features formed by laser cutting and machining.In any embodiment, the ring-shaped tubular exoskeleton comprises a plurality of modular tubes that are joined together end-to-end.

[0107] In any embodiment, a first face of the ring-shaped tubular exoskeleton of the ringshaped tubular exoskeleton comprises a plurality of upstanding projections, in which each upstanding projection typically comprises a tab which is cut out of a wall of the exoskeleton and bent away from the surface of the exoskeleton to form an upstanding projection.

[0108] In any embodiment, a second face of the ring-shaped exoskeleton comprises a plurality of recesses dimensioned to receive a plurality of corresponding tabs formed on a matching anastomosis ring. In any embodiment, the upstanding projections and recesses are configured to fasten together.

[0109] In any embodiment, the first face and / or the second face comprises a plurality of tabs and a plurality of recesses.

[0110] Also described is a kit comprising a first and second matching anastomosis rings, each of the matching anastomosis rings being an anastomosis ring as described herein, in which a face of the ring-shaped exoskeleton of the first ring comprises a plurality of upstanding projections, and in which a face of the ring-shaped exoskeleton of the second ring comprises a plurality of recesses corresponding to plurality of upstanding projections of the first ring, wherein the rings are configured to couple together in a face-to-face relationship by the plurality of projections engaging the plurality of respective recesses.

[0111] In any embodiment, each upstanding projection comprises a tab which is cut out of a wall of the exoskeleton and bent away from the surface of the exoskeleton to form an upstanding projection.Also described is an anastomosis ring comprising a ring-shaped sheath having an annular lumen enclosing an endoskeleton ring formed from a plurality of magnets arranged end-to-end, in which the anastomosis ring has more than four sides and in which each side of the anastomosis ring comprises a corresponding magnet. The anastomosis ring may have six or eight sides, for example.

[0112] In any embodiment, the anastomosis ring has eight sides and a corresponding magnet for each side.

[0113] In any embodiment, each magnet is cylindrical.

[0114] In any embodiment, the eight sides comprise four first sides of equal length and four second sides of equal length arranged in a alternating configuration, optionally in which the first sides are longer than the second sides.

[0115] In any embodiment, the eight magnets comprise four first magnets of equal length and four second magnets of equal length arranged in ring in an alternating configuration, in which the first magnets are longer than the second magnets, and in which ends of each of the first or second magnets are bevelled.

[0116] In any embodiment, each magnet is separated from an adjacent magnet by a gap that tapers inwardly from an outer periphery of the endoskeleton towards an inner periphery of the endoskeleton.

[0117] In any embodiment, one or more of the magnets comprises a sleeve comprising two rows of barbs that pierce through the sheath.

[0118] Also described is an anastomosis ring comprising an ring-shaped sheath having an annular lumen and enclosing an endoskeleton ring formed from a plurality of magnets, in which opposed ends of each magnet comprise joint formations to allow the ends interlock or abut end-to-end in a ring configuration.In any embodiment, the joint formations are selected from shoulder joints and / or mitre joints.

[0119] In any embodiment, the sheath comprises silicone.

[0120] Other aspects and preferred embodiments of the invention are defined and described in the other claims set out below.

[0121] Brief Description of the Figures

[0122] Figure 1 is a rear perspective view of a delivery system of the disclosure with a ring-shaped implant in a deployed configuration mounted on a proximal section of a deployed implant positioning head in a gripping configuration.

[0123] Figure 2 is a side elevation view of the delivery system and ring-shaped implant of Figure 1.

[0124] Figure 3 is a front perspective view of a delivery system and ring-shaped implant of Figure 1.

[0125] Figures to 4 to 7 are a front and rear perspective views of a delivery system and ring-shaped implant during re-sheathing of the delivery head inside a delivery sheath, which occurs after the implant has been positioned against an inside wall of the body lumen surrounding an incision (not shown). Re-sheathing of the delivery head causes the delivery head to contract radially allowing the delivery head to be retracted fully through the deployed implant (and out of the body lumen through the incision leaving the implant anchored to the inside wall of the body lumen surrounding the incision). The delivery head can be re-sheathed ora deployment sheath can be advanced over the delivery head.Figure 8 is a side elevation view of a delivery system with a ring-shaped implant mounted thereon in a contracted delivery configuration inside an access sheath.

[0126] Figure 9 is a sectional view of a delivery system and ring-shaped implant of Figure 8.

[0127] Figure 10 is a sectional view of a distal end of the access sheath entering a body lumen through an incision.

[0128] Figure 11 is a sectional view of access sheath fully advanced into the body lumen and the start of the retraction of the access sheath or the advancement of the implant positioning head to effect deployment of the implant positioning head inside the body lumen.

[0129] Figure 12 is a sectional view of the access sheath fully retracted out of the body lumen and the implant positioning head fully deployed inside the body lumen such that it grips the implant and positions it facing and surrounding the incision.

[0130] Figure 13 is a view from outside the body lumen.

[0131] Figures 14 and 15 illustrate a ring shaped implant with fastening arms in an untensioned folded configuration (Fig. 14) and a tensioned partially unfolded configuration.

[0132] Figure 16 illustrates a body lumen with an implant delivered and positioned and the implant positioning head in a partially contracted configuration being retracted and pulling out the fastening arms.

[0133] Figure 17 illustrates the implant positioned head further retracted into the access sheath where the fastening arms are released and spring back into their folded configuration to implant to the wall of the body lumen.Figures 18 and 19 illustrate two sections of a body lumen, each having an anastomosis implant anchored inside (only one is shown), before and after the implants are connected together to form a side-to-side anastomosis.

[0134] Figures 20 to 22 illustrate another embodiment of the ring shaped implant with fastening arms in which delivery device comprises a tether attached to a distal end of the respective fastening arms that is axially adjustable to pull the fastening arms out through the incision and then release the arms which spring back into a fastening position shown.

[0135] Figures 23 and 24 illustrate another embodiment of the ring shaped implant with fastening arms in which the distal end of the arms are attached together by a tether (Fig. 23) which can be cut to release the arms which then spring back into the fastening position (Fig. 24).

[0136] Figures 25 to 32 illustrate a ring shaped implant with a fastening coil.

[0137] Figures 33 to 41 A illustrate a delivery system and implant according to an alternative embodiment of the disclosure in which the implant positioning head has radial arms configured to grip the deployed implant.

[0138] Figure 41 B illustrates a compression anastomosis ring according to one embodiment of the disclosure showing eights magnets disposed inside a lumen of transparent silicone sheath having four long sides and four short sides.

[0139] Figure 42 is an illustration of the anastomosis ring of Figure 41 A with the silicone sheath removed.

[0140] Figure 43 is a top plan view of the anastomosis ring of Figure 42A showing the magnets arranged in a ring with a small wedge-shaped spacing between their respective ends.Figures 44 to 46 illustrates a compression anastomosis ring according to another embodiment of the disclosure having four magnets disposed inside a lumen of transparent silicone sheath having four sides and rounded corner sections, in which the magnets have a shoulder at each end to form a shoulder joint with an adjacent magnet.

[0141] Figure 47 illustrates a compression anastomosis ring according to another embodiment of the disclosure that is the same as the ring of Figure 44 but in which the ends of each magnet are bevelled to form a mitre joint with an adjacent magnet.

[0142] Figures 48 and 49 illustrate a compression anastomosis ring according to another embodiment of the disclosure comprising a ring formed from an elongated tube of shape-set alloy material that is machined or laser cut. The ring has projections in the form of cut-out tabs on one side and recesses on an opposite side. An inside face at each corner comprises a plurality of parallel cut-outs to facilitate the ring being contracted during use into an elongated configuration.

[0143] Figures 50 to 52 illustrate how the rings join together face-to-face to form a compression anastomosis.

[0144] Figures 53 to 55 illustrate how the ring is formed after the tube has been shape set into the ring shape.

[0145] Figures 56 to 63 illustrate a delivery system and implant according to an alternative embodiment of the disclosure in which the implant positioning head is inflatable and has a tapered shape when deployed.

[0146] Figures 64 to 70 illustrate a delivery system and implant according to an alternative embodiment of the disclosure in which the implant positioning head is inflatable and has a cylindrical shape.Figures 71 to 75 illustrate a delivery system and implant according to an alternative embodiment of the disclosure in which the implant positioning head is inflatable, has a cylindrical shape when deployed comprising a wastyed section dimensioned to receive the implant upon deployment.

[0147] Figures 76 to 100 illustrate a delivery system and implant according to an alternative embodiment of the disclosure in which the system comprises a magnetic element and associated delivery arm in which the magnetic element is magnetically coupled to the implant through the wall of the body lumen surrounding the incision and can be used to articulate the implant by articulation of the magnetic element.

[0148] Detailed Description of the Invention

[0149] 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.

[0150] Definitions and general preferences

[0151] 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:

[0152] 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.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.

[0153] As used herein, the term “ring-shaped 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.

[0154] 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 selfdeploys into the radially expanded deployed configuration.

[0155] “Delivery device” as used herein refers to a delivery device suitable for delivery of a compression anastomosis ring into a body lumen (e.g. a colon) of a subject. Some examples of delivery devices are described herein, and others are described in theliterature, see for example US2023 / 255624, US2024 / 041461 and WO2025 / 186472. Generally, these device comprise an access sheath suitable for minimally invasive use, and a delivery device for the ring-shaped implant which is configured to hold the ring-shaped implant during advancement through the access sheath and into the body lumen, and aid in positioning the ring-shaped implant prior to release.

[0156] The systems of the disclosure are typically minimally invasive. As used herein, the term “minimally invasive” means that the systems are suitable for delivering a ringshaped implant (such as a compressible anastomosis ring) by means of endoscopic or laparoscopic surgery. The systems of the disclosure are primarily for use in minimally invasive delivery of a compressible anastomosis ring, but it may also be used for delivery during open surgery.

[0157] Exemplification

[0158] 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.

[0159] Referring to the drawings, and initially to Figures 1 to 7, there is illustrated a delivery system according to the disclosure, indicated generally by the reference numeral 1, and an implant ring indicated generally by the reference numeral 2. In this embodiment, the implant ring is a compression anastomosis ring such as that described below or in WO2022171349A1. The implant ring has an outer silicone or rubber or polyurethane sheath containing a number of elongated magnets, and a number of rows of barbs projecting from an obverse face of the implant ring. The purpose of the barbs is to anchor the implant ring to a wall of a body lumen after the implant ring has been delivered into the body lumen.The delivery system 1 comprises an access sheath 3 that is suitable for laparoscopic delivery of the implant ring 2 and comprises a bevelled tip 4 and a central elongated lumen, and a delivery arm 5 extending along the lumen and having a distal end 6. A proximal end of the access sheath and delivery arm are attached to a handle (not shown), the details of which are provided below. An implant positioning head 7 is disposed at the distal end 6 of the delivery arm 5. The delivery arm 5 and implant positioning head 7 are axially movable along the lumen of the access sheath from a delivery position in which the implant positioning head 7 is disposed inside the access sheath to a deployed configuration in which the implant position head is advanced distally of the tip 4 of the access sheath 3. A top surface 8 of the access sheath 3 comprises a plurality of markers 9 that can be imaged in-vivo using a suitable imaging machine. The implant positioning head 7 is radially adjustable from a contracted delivery and / or removal configuration (shown in Figures 8 to 11) where it can fit inside the lumen 3 of the access sheath 3 to a deployed radially expanded configuration shown in Figures 1 to 4.

[0160] In this embodiment, the implant positioning head 7 has a whisk-type structure and formed from two wire loops 10A and 10B. In the deployed configuration, the head 7 has a proximal conical section 11 and a bulb-shaped distal section 14. A proximal end 12 of the conical section 11 is coupled to the distal end 6 of the delivery arm 5. A distal end 13 of the conical section 11 transitions into the bulb-shaped distal section 14. The implant positioning head is dimensioned such that the proximal end 12 of the conical section 11 is narrower that a centre 15 of the implant ring 2 (to allow the ring to be mounted on a proximal end of the conical section) and such that the distal end 13 of the conical section 11 is too broad to pass through the centre 15 of the ring 2. Providing an implant positioning head having a conical section upon which the ring is mounted helps centre, position and fully deploy an implant ring when the implant positioning head 7 is retracted relative to the implant ring (such as when the device is used to deliver an implant into a body lumen). This process is described in more details below.In the embodiment shown, the implant positioning head 7 has a length of 1 - 6 cm, the conical section 11 has a length of 0.6 - 6 cm and a diameter that decreases from 0.3 cm distally to 2- 6 cm proximally. The bulb-shaped distal section has a length of 2 -6 cm and a diameter of 0.6 - 6 cm. The implant ring has an inner diameter of 1 - 6 cm and an outer diameter of 1.8 - 8 cm.

[0161] Figures 1 to 3 show the implant positioning head 7 fully deployed with the implant ring 2 gripped by a mid-section of the deployed conical section 11. In use, this serves to centre and position the ring to correctly abut an inside wall of a body lumen surrounding an incision or to correctly position the ring in the open end of a body lumen. Figures 4 to 7 show the implant positioning head 7 being retracted into the access sheath 3 which causes head 7 to radially contract to release the implant ring 2. This procedure is performed after the implant ring 2 has been anchored to the wall of the body lumen. The delivery head can also be contracted by advancing an additional tubular member (not shown) over the delivery arm 5 and the proximal conical section 11 of the implant positioning head 7.

[0162] Figures 8 and 9 illustrate the delivery system 1 and ring implant 2 stowed in the access sheath 3 in a radially contracted configuration during delivery of the ring implant to a body lumen.

[0163] In use, and referring to Figures 10 to 12, the delivery system 1 is inserted into a subject’s body and advanced through an incision 20 in a body lumen 21. The incision may be made in advance, or it may be made by a cauterising element or bipolar cutting element formed on the tip 4 of the access sheath 3 which is operably connected to a controller on a handle. Once the tip 4 is inside the body lumen 21 , the delivery arm 5 is advanced distally through the access sheath 3 to deploy the implant positioning head 7 and implant ring 2 inside the body lumen. Once fully deployed, the ring 2 is gripped by the conical section 11 of the head 7 as shown in Figure 12. The delivery device may then be retracted which pulls the deployed implant 2 into contact with an inside wall 23 of the body lumen surrounding the incision, where the barbs partially anchor the ring 2 in position. Once this has beenachieved, the access sheath may be advanced along the conical section 11 of the head 7 which causes the head 7 to radially contract, whereupon it may be retracted through the centre 15 of the deployed ring 2, leaving the ring 2 in-situ inside the body lumen, anchored to the inside wall of the body lumen. The delivery head can also be contracted by advancing an additional tubular member (not shown) over the delivery arm 5 and the proximal conical section 11 of the implant positioning head 7, which causes the head 7 to radially contract, whereupon it may be retracted through the centre 15 of the deployed ring 2, leaving the ring 2 in-situ inside the body lumen, anchored to the inside wall of the body lumen.

[0164] The implant positioning head 7 may be formed of stainless steel or nitinol wire or other elastically deformable wires in a whisk type arrangement, that allows a range of deformation from an expanded configuration to a contracted configuration.

[0165] The implant positioning head 7 may be formed of an inflatable structure, that allows the implant positioning head to change shape from an expanded configuration to a contracted configuration.

[0166] The implant positioning head 7 may be formed of stent based structure, that allows a range of deformation from an expanded configuration to a contracted configuration.

[0167] The implant positioning head 7 may be formed of expandable foam or porous material, that allows a range of deformation from an expanded configuration to a contracted configuration.

[0168] The implant positioning head 7 may be formed of an umbrella type structure, that allows a range of deformation from an expanded configuration to a contracted configuration.

[0169] Although not described, the delivery device may include a deployment and resheathing mechanism. The mechanism may be provided by a deployment sheathmounted in the lumen of the access sheath and axially movable relative to the delivery arm and the access sheath. The deployment sheath and implant positioning head may be configured for relative movement therebetween from a delivery configuration in which all or part of the conical section of the implant positioning head is retracted into the deployment sheath and a deployed configuration in which the conical section is fully deployed out of the deployment sheath. In another embodiment, instead of a sheath, a recapture sleeve may be provided in the access sheath which is configured for axial movement along the distal part of the conical section to radially contract the conical section before recapture of the conical section inside the access sheath.

[0170] Figures 14 to 17 illustrate an embodiment of an anastomosis ring according to the disclosure, indicated generally by the reference numeral 30, and in which parts described with reference to the previous embodiments are assigned the same reference numerals. The anastomosis ring 30 has an outer silicone sheath 31 containing a number of elongated magnets (not shown), and a number of rows of barbs 32 projecting from an obverse face 33 of the implant ring. The purpose of the barbs is to anchor the implant ring to a wall of a body lumen after the implant ring has been delivered into the body lumen. The obverse face 33 of the ring 30 is the face that when delivered abuts the wall on the body lumen, and the opposed face (facing an inside of the body lumen) is the reverse face 34. In this embedment, the ring 30 has two fastening arms 35 mounted to the reverse face 34 of the ring 30 on opposite sides of the ring. Each arm 35 is generally U-shaped and has a proximal arm part 36 that extends radially towards the centre of the ring and distal arm part 37 connected by a curved transition section 38, and a tissue gripping pad 39 disposed on a free end of the distal arm part 37. The arms 34 are biassed into the U-shaped configuration shown in Figure 14 and can be pulled into the tensioned configuration shown in Figure 15. In use, when the ring 30 has been delivered and implanted into the inside of the body lumen surrounding the incision as described above, the implant position head is then retracted through the centre of the ring. During this movement, the wires of the implant position head snag the distal arm parts 37 and pull them through the incision (Figure 16) and further retraction of thehead causes the distal arm parts to be released whereupon they spring-back into contact with tissue of the wall of the body lumen thereby fastening the ring to the wall of the body lumen (Figure 17).

[0171] Figures 18 and 19 illustrate a side-by-side compression anastomosis formed between two sections of a human bowel using anastomosis rings and a delivery device of this disclosure.

[0172] Figures 20 to 22 illustrate an alternative embodiment of a compression anastomosis ring according to the disclosure, which is similar to the embodiment of Figures 14 to 17, and in which parts described with reference to the embodiment of Figures 14 to 17 are assigned the same reference numerals. In this embodiment, the delivery device 1 comprises two tethers 40 that extend through the lumen of the access sheath 3, each of which is detachably attached at its distal end to the distal arms part 37 of a fastening arm 35. The tethers are used to control the arms during positioning and anchoring of the ring inside the body lumen. For example, after the ring 30 has been deployed inside the body lumen, the tethers can be pulled to pull the distal arm parts 37 out of the incision and then released to allow the distal arm parts 37 spring-back into the fastening position. The tethers may then be cut or released.

[0173] In another embodiment illustrated with reference to Figures 23 and 24, the distal arm parts 37 are connected together in an extended, tensioned, configuration by a short tether 42 during delivery and deployment in the body lumen. The short tether 42 may be cut after the ring 30 has been positioned and anchored, thus releasing the distal arm parts 37 which spring-back into the fastening position.

[0174] Figures 25 to 32 illustrate an anastomosis ring according to an alternative embodiment of the disclosure, indicated generally by the reference numeral 50, and configured for delivery and positioning using the delivery device described with reference to the previous embodiments and in which parts described with reference to the previous embodiments are assigned the same reference numerals. In thisembodiment, instead of fastening arms, the ring 50 comprises a fastening coil comprising a single open coil 52 with a first coil end 53 attached to the obverse face 33 of the ring 50 or the first coil end 53 is attached to a suitable place on the ring. The coil 52 has an untensioned diameter that is greater than the inner diameter, and smaller than the outer diameter, of the ring 50 and is configured to lie flush against the obverse face of the ring when relaxed. The delivery device 1 comprises a tether 54 extending through the lumen of the access sheath 3 having a distal end attached to a second coil end 55. The tether is axially movable relative to the access sheath. In use, and referring to Figures 28 to 31 , once the ring 50 has been positioned and partially anchored to the inside wall of the body lumen, the tether 54 is pulled which uncoils the open coil pulling it out of the body lumen through the incision. This is performed while the implant positioning head 7 is gripping the ring 50 and holding it against the inside of the wall of the body lumen.

[0175] The coil and / or tethering arms may include gripping elements (for example, barbs) to allow more stable engagement with tissue.

[0176] Figures 33 to 41 illustrate a delivery system according to an alternative embodiment of the disclosure, indicated generally by the reference numeral 60, being used with an anastomosis ring 50 described with reference to the previous embodiments and in which parts described with reference to the previous embodiments are assigned the same reference numerals. In this embodiment, the bulb-shaped distal section 14 of the implant positioning head 7 when deployed has a diameter that is smaller than an inner diameter of the deployed ring 50, and has four wings 51 that extend radially outwardly of the bulb-shaped distal section 14 and function to engage and grip the ring 50 when the implant positioning head 7 is deployed. Once the head 7 has gripped the ring, it is retracted proximally to bring the obverse face of the ring into contact with the wall of the body lumen as described previously. The head 7 is then re-sheathed in the access sheath as illustrated with reference to Figures 36 to 38. The deployment of the fastening coil is performed as described with reference to the previous embodiment.Referring to Figures 41 to 43, an anastomosis ring according to an embodiment of the disclosure is described, indicated generally by the reference numeral 70, in which parts described with reference to the previous embodiments are assigned the same reference numerals. The ring 70 comprises an outer silicone sheath 71 having an inner lumen and four long sides 72 arranged in a square and four angled corner side 73. The ring 70 comprises an endoskeleton 74 disposed in the lumen of the sheath formed from a ring of eight magnets arranged end-to end as illustrated in Figure 43 including four long magnets 75 corresponding to the long sides 72 and four short magnets 76 corresponding to the angled corner sides 73. The long magnets 75 have square ends 77 and the short magnets 76 have bevelled ends 78. The magnets are arranged end-to end with the ends spaced from each other by a gap 81 that tapers outwardly from an inner periphery 79 of the ring towards an outer periphery 80 of the ring. This gap allows the ring to be compressed into an elongated configuration for delivery inside an access sheath. The ring 70 also includes four sleeves 82, each configured to embrace a long magnet 75 and having two rows of barbs 83 projecting upwardly away from an obverse face of the ring. These barbs help with anchoring the ring to an inner wall of the body lumen around the incision.

[0177] Referring to Figures 44 to 47, an anastomosis ring according to an alternative embodiment of the disclosure is described, indicated generally by the reference numeral 90, and in which parts described with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the ring 90 is square and has a square outer sheath 91 and a square endoskeleton ring 92 comprising four magnets 93 arranged end to end. Ends of the magnets are shaped to form a joint with an adjacent magnets. In Figures 44 to 46, the ends comprise shoulders 94 that are configured to form shoulder joints. In Figure 47, the magnets have bevelled ends 95 that are configured to form mitre joints and are spaced from each other by a small gap 96.

[0178] Referring to Figures 47 to 55, an anastomosis ring according to an alternative embodiment of the disclosure is described. In this embodiment, the ring, indicatedgenerally by the reference numeral 100, comprises a tubular exoskeleton 101 formed of Nitinol and in this embodiment having a circular profile, In the embodiments illustrated, the ring 100 has a generally square shape and is assembled into a ring from four straights side sections 102 and four curved corner sections 103. An inner periphery of the corner sections has a series of laser cut slits 104 that enables the corner section to partially straighten when it is compressed into an elongated delivery configuration. The ring 101 also includes a series of cut out tabs 106 and a series of recesses 107 dimensioned to receive the cut-out tabs of another ring to fasten the two rings together. In the ring illustrated in Figure 48, one face (underside) of the ring comprises four cut-out tabs 106 and an opposite face (upper side) has four recesses 107. In the ring illustrated in Figure 49, the upper face of the ring comprises four cut-out tabs 106 and four recesses 107, each straight section 102 comprising one cut-out tab 106 and one recess 107.

[0179] Figures 50 to 52 illustrates two rings of Figure 49 (100A and 100B), arranged such that their upper faces with the tabs and recesses are facing each other, brought together so that the cut-out tabs 106 of one ring engage the recesses 107 of the second ring coupling the two rings together.

[0180] Referring to Figures 53 to 55, the ring 100 may be formed from a single elongated tube which is shape set into the ring shape with a connecting section 109 having free ends 110 and 111 configured to engage to form a closed ring. In the embodiment shown, the corner section 103A, and adjacent straight section 102A each have an elongated slot 113 that allows the respective sections to be shape set into the configuration shown in Figure 55 and then adjusted into a closed ring configuration shown in Figure 53 by coupling free ends 110 and 111 together. In another embodiment, the ring may for formed as modular shape set tubular sections (for example, straight and curved corner sections) that are connected together to form an assembled ring.

[0181] Figures 56 to 63 illustrate a delivery system according to an alternative embodiment of the disclosure, indicated generally by the reference numeral 120, being usedwith an implant ring 2 described with reference to the previous embodiments and in which parts described with reference to the previous embodiments are assigned the same reference numerals. In this embodiment, the implant position head is an inflatable body 121 attached to the distal end 6 of the delivery arm 5 configured to inflate from a low profile delivery configuration to a radially expanded configuration comprising a distal section 122 and a proximal dome-shaped section 123 that tapers inwardly in a distal to proximal direction. A plunger 124 is disposed on the delivery arm proximally of the inflatable body 121 and is axially adjustable relative to the delivery arm 5. The function of the plunger is to prevent any proximal axial movement of the implant during delivery and also to urge the implant towards the mouth of the access sheath (see Figs 60 and 61). Although not illustrated, the plunger 124 is mounted on a delivery tube 125 which is coaxially mounted on the delivery arm 5. In use, the implant ring 2 is mounted on the delivery arm 5 proximal of the inflatable body 121 (Fig. 56). The access sheath 3 is advanced towards and across the incision in the body lumen (Fig. 57). The delivery arm 5 is then advanced relative to the access sheath 3 (Fig. 58) and the inflatable body 121 is then inflated (Fig. 59) such that a proximal end of the inflatable body is disposed adjacent the distal end of the access sheath 3. The plunger 124 is then advanced relative to the delivery arm 5 and access sheath 3 to urge the ring implant 2 into the body lumen (Fig. 60) whereupon the ring self-deploys on a proximal end of the inflatable body 121 (Fig. 61). With the inflatable body 121 now gripping the deployed ring 2, and the ring 2 thereby centered with respect to the delivery arm 5, the delivery arm 5 can be retracted to bring the ring 2 into contact with the wall of the body lumen around the incision (Figs 62 and 63). Once in position, the inflatable body 121 can be deflated thereby releasing its grip on the ring allowing the body 121 and arm 5 to be retracted back inside the access sheath.

[0182] Figures 64 to 70 illustrate a delivery system according to an alternative embodiment of the disclosure, indicated generally by the reference numeral 130, being used with an implant ring 2 described with reference to the previous embodiments and in which parts described with reference to the previous embodiments are assigned the same reference numerals. In this embodiment, the implant position head whendeployed is a cylindrical inflatable body 131 which does not have an inwardly tapering section but is dimensioned to grip an inner periphery of the implant ring when deployed. The cylindrical body is usually dimensioned such that it can fit through the incision of the body wall thus allowing a ring that is mounted on the cylindrical body to be brought into contact with the wall of the body lumen irrespective of where along the cylindrical body the ring is mounted. The use of this embodiment is substantially identical to that described previously with reference to Figures 56 to 63.

[0183] Figures 71 to 75 illustrate a delivery system according to an alternative embodiment of the disclosure, indicated generally by the reference numeral 140, being used with an implant ring 2 described with reference to the previous embodiments and in which parts described with reference to the previous embodiments are assigned the same reference numerals. In this embodiment, the implant position head is a cylindrical inflatable body 141 that is identical to the inflatable body of the previous embodiment except that it has a circumferential recess 142 dimensioned to receive the ring-shaped implant 2 in a snug, embracing configuration. This helps keep the ring is position and centered on the delivery arm 5 during positioning of the ring. The use of this embodiment is substantially identical to that described previously with reference to Figures 56 to 63.

[0184] In the embodiments illustrated with reference to Figures 56 to 75, the implant positioning head is inflatable and has a number of different shapes, all of which are configured to grip an inner periphery of the implant ring when deployed and typically center the implant ring on the delivery arm. It will however be appreciated that the inflatable bodies 121, 131 and 141 could be replaced with non-inflatable implant positioning heads that are adjustable (preferably self-adjustable) for a contracted delivery configuration and to a deployed radially expanded configuration.

[0185] Figures 76 to 100 illustrate a delivery system according to an alternative embodiment of the disclosure, indicated generally by the reference numeral 150, inwhich parts described with reference to previous embodiments are assigned the same reference numerals. In this embodiment, the system 150, which is substantially identical to that described with reference to Figures 1 to 13, comprises a magnetic positioning element which in this embodiment is provided by a short positioning rod 151 and a magnetic element delivery arm 152 disposed in the lumen of the access sheath 3 for axial movement relative to the sheath. The positioning rod 151 is detachably attached to a distal end of the arm 152. The distal arm may be provided by a steerable catheter. A distal end of the positioning rod 151 comprises a permanent magnet 156 (Fig. 82) configured to produce a sufficiently strong magnetic field to allow it to securely couple with the implant ring 2 disposed inside the body lumen across the wall of the body lumen. The implant ring may comprise one or magnets or magnetisable material, to allow it magnetically couple with the permanent magnet 156. In one embodiment, the ring 2 comprises an endoskeleton formed by a ring of permanents magnets (as described above). The proximal end 157 of the positioning rod 151 may also include a permanent magnet (proximal magnet) configured to couple with a magnet disposed in the distal end of the arm 152. The proximal magnet may be configured to produce a weaker magnetic field that the permanent (distal) magnet 156 (thus ensuring that the delivery arm 152 detaches from the rod 151 when the delivery arm is retracted, as opposed to detaching from the implant ring 2). In other embodiments, the distal end 153 of the arm 152 may comprises a user-controllable electromagnet, ora mechanical detachable coupling.

[0186] The magnetic positioning element which in this embodiment is provided by a short positioning rod 151 and a magnetic element delivery arm 152 can be detachable from each other. Detachment methods may include one or a combination of: a screw type arrangement, a magnet arrangement, releasable clasps such as those used in the delivery of nitinol transcatheter heart valve replacement devices, interlocking elements that are connected by an outer tube or an inner connecting wire, releasable sheaths, plastically deformable joints or elastically deformable joints, or sliding tubes.In use, the implant ring 2 is delivered into the body lumen and is mounted on the deployed implant positioning head 7, and then the system is retracted to bring the implant 2 into contact with the wall of the body lumen inside the body lumen and the access sheath is positioned outside the body lumen, as described previously (Fig. 76). The delivery arm 152 for the magnetic element 151 is then advanced out of the access sheath 2 and directed towards the wall of the body lumen surrounding the incision (Figs 76-80- perspective view, and Figs 83 side sectional view). Once in the vicinity of the wall, the permanent magnet 156 on the positioning rod 151 will couple with the implant 2 across the wall of the body lumen with a strong magnetic force (Figs. 81 and 85). The delivery arm 152 may then be retracted which detaches the positioning rod 151 from the delivery arm 152, leaving the positioning rod 151 disposed outside the body lumen and magnetically coupled to the implant 2 disposed inside the body lumen (Figs 86-90). The implant position body 7 may then be re-sheathed and retracted back into the access sheath 3 (Figs 91-93) leaving the positioning rod disposed outside the body lumen attached to the implant ring 2 and keeping the ring 2 concentric with the incision (Fig. 94). Using grippers 159, a user can then grip and articulate the positioning rod 151 to adjust the position of the implant 2 inside the body lumen (Fig. 95). This procedure may be repeated to deliver and position a corresponding ring-shaped implant in a different section of the body lumen, and then the two positioning rods 151 may be articulated to bring implants rings together enabling them to couple together before the positioning rods are detached and removed (Figs 96 to 100).)

[0187] Equivalents

[0188] 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.

Claims

1. CLAIMS:

1. A system to deliver and position a magnetic ring-shaped implant inside a body lumen, comprising:an access sheath comprising a lumen;a delivery device to deliver the ring-shaped implant along the lumen of the access sheath and through a hole in a body lumen;a securing magnet; anda securing magnet holder releasably coupled to the securing magnet to deliver the securing magnet along the lumen of the access sheath,wherein the securing magnet is detachably attachable to the securing magnet holder and configured to magnetically couple with the magnetic ring-shaped implant across a wall of the body lumen.

2. A system according to claim 1 , in which the securing magnet has a longitudinal aspect and a magnetic orientation disposed along the longitudinal aspect (axially magnetized).

3. A system according to claim 1 or 2, in which the securing magnet comprises a grasping part configured for engagement with a grasping tool.

4. A system according to claim 1 or 2, in which the securing magnet comprises a distal magnet part and a proximal grasping part.

5. A system according to claim 3 or 4, in which the grasping part is resiliently deformable.

6. A system according to any preceding claim, in which the securing magnet holder is configured for detachable magnetic coupling with the securing magnet.

7. A system according to any preceding claim, in which a first magnetic coupling strength between the securing magnet and the ring shaped implant is greater than a second magnetic coupling strength defined between the coupling magnet and the coupling magnet holder.

8. A system according to any preceding claim, in which the securing magnet holder comprises an elongated body with a distal end configured to couple with the securing magnet.

9. A system according to any preceding claim, in which the securing magnet holder comprises at least two securing magnets.

10. A system according to any preceding claim, in which the securing magnet holder comprises an elongated body having a lumen, a securing magnet disposed in the lumen, and a conveying module configured to deliver the securing magnet from the lumen to a distal end of the elongated body.

11. A system according to any of claims 1 and 3 to 10, wherein the securing magnet is diametrically magnetized.

12. A system according to any preceding claim, comprising a magnetic ring shaped implant.

13. A system according to claim 12, in which the magnetic ring-shaped implant comprises a magnetic endoskeleton.

14. A system according to claim 12 or 13, in which the magnetic ring shaped implant is compressible into a low-profile delivery configuration.

15. A system according to claim 1 , in which the securing magnet comprises an elongated body having a distal end comprising a first magnet or magnetic pole configured to magnetically couple with the magnetic ring shaped implant and a proximal end configured to couple with a distal end of the securing magnet holder.

16. A system according to claim 15, in which the proximal end is configured to magnetically couple with the distal end of the securing magnet holder.

17. A system according to claim 15, in which the proximal end is configured to mechanically couple with the distal end of the securing magnet holder.

18. A system according to claim 17, in which the securing magnet holder comprises a user-operable actuator adjustable between a coupling condition in which the actuator secures the securing magnet to the securing magnet holder and a release condition in which the actuator releases the securing magnet from the securing magnet holder.

19. A system according to any preceding claim, comprising a first magnetic ringshaped implant and a second magnetic ring-shaped implant, wherein the first magnetic ring-shaped implant and second magnetic ring-shaped implant are configured to magnetically couple together in a face-to-face configuration.

20. A system according to claim 19, in which a magnetic coupling strength between the first magnetic ring-shaped implant and the second magnetic ring-shaped implant is greater than a magnetic coupling strength between first magnetic ring shaped implant and the securing magnet.

21. A system to deliver and position a magnetic ring-shaped implant inside a body lumen, comprising:a delivery device to deliver the magnetic ring-shaped implant through a hole in a body lumen;a securing magnet; anda securing magnet holder to deliver the securing magnet to the body lumen,wherein the securing magnet is detachably attachable to the securing magnet holder and configured to magnetically couple with the magnetic ring-shaped implant across wall of the body lumen.

22. A system to deliver and position a magnetic ring-shaped implant inside a body lumen, comprising:an access sheath comprising a lumen;a delivery device to deliver the ring-shaped implant along the lumen of the access sheath and through a hole in a body lumen;a securing magnet; anda securing magnet holder to deliver the securing magnet to the body lumen.wherein the securing magnet is configured to magnetically couple with the magnetic ring-shaped implant across wall of the body lumen and a proximal end of the securing magnet is configured to couple with the distal end of the securing magnet holder by a friction fit.

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