Implants for magnetic compression anastomosis

Abstract

An implant for use in creating a magnetic compression anastomosis in a patient, the implant having a first low-profile configuration for insertion in the patient and expandable to a second operative configuration for use in creating the anastomosis, the implant comprising at least one pliable polymer body (20, 20') and a plurality of magnetic elements (30) at least partially embedded within the polymer body, the polymer body being pliable such that the polymer body can be transitioned between a first state in the first configuration of the implant and a second state in the second configuration of the implant. The plurality of polymer bodies may be coupled by a connecting element (24).

Description

[Technical field]

[0001] The present invention relates to implants, methods of making implants, and methods of delivering implants for use in forming an anastomosis within a patient's body, particularly the digestive system, optionally joining two sites along the digestive tract. [Background technology]

[0002] An anastomosis is considered to be a connection or opening between two normally separate structures and may occur naturally in the human body, such as in the circulatory system, or may be surgically created by a trained practitioner, as may be the case, for example, in procedures of the gastrointestinal tract to promote weight loss in obese patients, such as the Roux-en-Y procedure.

[0003] Although anastomoses can be created surgically by suturing or stapling, laparoscopic or endoscopic performance of this same technique remains technically challenging due to the significant limited access.

[0004] Implants and devices have been proposed to help circumvent such challenges. The creation of a magnetic compression anastomosis is one technique that involves the use of magnets introduced into either side of the walls of adjacent body lumens. The magnetic attraction presses the tissue walls together, joining the tissues and forming a mutually communicating opening at the junction.

[0005] In EP 2849655, an implant device for performing magnetic compression anastomosis is proposed, providing an exoskeleton and magnetic segments. The exoskeleton is made of a shape memory alloy and is designed to direct the self-organization of the magnetic segments. WO 2016 / 183039 also describes various examples of self-opening magnetic rings that spontaneously open to form a ring shape upon delivery. One example is a spherical ball magnet in an extruded or molded tube. Summary of the Invention [Problem to be solved by the invention]

[0006] It would be desirable to improve upon existing techniques, particularly for creating anastomoses by magnetic compression. [Means for solving the problem]

[0007] A first aspect of the invention provides an implant for use in creating a magnetic compression anastomosis in a patient, the implant having a first low profile configuration for insertion in the patient and a second operative configuration for use in creating the anastomosis, the implant comprising a plurality of magnetic elements.

[0008] As used herein, the term "magnetic" refers to an element that behaves like a magnet or that can be attracted by a magnet. In some embodiments, the magnetic element can be any suitable element that can generate a magnetic field, such as, for example, a magnet. Additionally or alternatively, the magnetic element can be any suitable element that can be attracted by a magnet, such as, for example, a ferromagnetic element.

[0009] The implant may further include any one, or any combination of, the following features, all of which are optional.

[0010] (a) The implant may comprise at least one polymer body having a plurality of magnetic elements at least partially embedded therein, and the polymer body may be at least partially soft and / or bendable and / or flexible such that the polymer body can be transitioned between a first state in a first configuration of the implant and a second state in a second configuration of the implant.

[0011] In some embodiments, at least in the first state, the polymer body has a generally straight shape. Additionally or alternatively, in some embodiments, at least in the second state, the polymer body has an at least partially looped shape.

[0012] As used herein, the term "loop shape" means a shape that generally encloses a central region, regardless of whether the shape is circular, curved, curvilinear, or a polygon containing straight sides or segments. An at least partially loop shape is a shape that at least partially encloses a central region, even if the shape is not a completely closed shape or is closed by a non-polymeric material.

[0013] At least partially embedding the magnetic element can help reduce the risk of undesired detachment of the magnetic element from the implant. Magnetic elements can be difficult to attach securely in a biocompatible manner, especially to non-polymeric materials such as shape memory alloys. Loose magnetic elements are undesirable because they can cause visceral damage and, in any case, reduce the magnetic compression force that is desired to be concentrated on the target side for the creation of the anastomosis.

[0014] (b) The polymer body, if provided, may be made of any suitable polymer capable of providing an at least partially flexible body. For example, the polymer body may be made of silicone.

[0015] Providing such a polymer body can allow for a soft, atraumatic implant, thus helping to avoid discomfort for the patient and reducing the risk of damage to the surrounding tissue. Furthermore, the use of a polymer body can increase the softness and / or flexibility and / or bendability of the implant. This can facilitate changing the configuration of the implant to fit the anatomy of the body where the implant is placed, and / or allow easier passage of the implant out of the body through the intestinal pathway after the anastomosis has been created.

[0016] Additionally, the polymer body may be able to withstand the internal parameters of the digestive tract, for example, the polymer body may be more resistant to the acidic environment in the stomach than, for example, a shape memory alloy.

[0017] Additionally, the use of a polymer body may allow for economical manufacture of the implant: compared to shape memory alloys, for example, the material costs of polymers may be relatively low. Additionally, polymer bodies may be easier to manufacture, thus allowing for faster manufacture of the implant.

[0018] (c) The implant may comprise at least two (e.g., first and second) bodies within which the magnetic element is at least partially attached or embedded, the bodies being optionally integral with and / or connected to one another by a connecting element that is integrally attached to both the first and second bodies and that may extend from an end of at least one body and may optionally extend between the ends of both the first and second bodies.

[0019] At least one body may be a polymeric body, and optionally both the first and second bodies are polymeric bodies. Additionally or alternatively, at least one body may be flexible, and optionally both the first and second bodies may be flexible.

[0020] (d) The connecting element may be flexible. Optionally, whether the connecting element is flexible or not, the connecting element may be reinforced by magnetic elements within the body (e.g., polymer body) disposed at both ends of the connecting element. The magnetic elements may be selected such that a repulsive magnetic force is applied between the connected portions of the body. The repulsive force may provide or enhance the longitudinal column strength of the connecting element and may enable the transfer of compressive forces from one body to another.

[0021] (e) at least one polymer body may be molded into a generally linear shape and / or may be elastically deformable from and / or may be elastically biased towards a generally linear shape. Additionally or alternatively, at least one polymer body may be molded into an at least partial loop shape and / or may be elastically deformable from and / or may be elastically biased towards an at least partial loop shape.

[0022] Where at least a first polymer body has at least a partial loop shape, the body may self-bias into a loop shape when deployed within the body, which may be used to induce a second body into a conforming loop shape via magnetic coupling between the bodies. For example, the second body may have a generally linear configuration and bendable or conformable into a loop shape due at least in part to magnetic coupling with the first body.

[0023] When at least one polymeric body has a generally linear shape, this can aid in controllability when the body is deployed from the constraining sheath, since a linear shape may be less prone to ejecting itself from the constraining sheath.

[0024] (f) The polymer body may be generally solid except for the area occupied by the magnetic elements. Alternatively, the polymer body may have open space, e.g., cavities, that are not occupied by the magnetic elements. For example, the polymer body may be tubular.

[0025] (g) The polymer body may have first and second ends that are spaced apart from one another in the first state of the polymer body and adjacent to one another in the second state of the polymer body.

[0026] (h) The implant may comprise a positioning element or system for facilitating positioning of the at least one polymeric body. For example, the positioning element may comprise a filament or tether attached to or integrated within the implant (e.g., attached to or integrated within the polymeric body of the implant).

[0027] The positioning element or system may be self-adjusting such that it can function independent of manual input or control by an operator. For example, the positioning element may be elastic to apply an elastic bias to affect positioning during and / or after deployment. The elastic bias may be increased, for example, during deployment.

[0028] Optionally, a positioning element or system may function to maintain the position of the first polymer body while the second polymer body is positioned. For example, a filament or tether may extend from a location on the polymer body that is spaced between the ends of the body and / or spaced from the connecting element (if provided).

[0029] Additionally or alternatively, the positioning system element or system may function to direct the transition of the polymer body from a first state to a second state upon deployment. For example, the filament may extend from one end of the polymer body to an opposite end such that tension in the filament pulls one end toward the other end to form at least a partial loop shape. The filament may pass through, for example, an opening in the connecting element (if provided).

[0030] (i) At least one, preferably a majority, and optionally substantially all, of the magnetic elements may be non-spherical magnetic elements. Particularly when the elements are magnets, the use of non-spherical elements may provide significant advantages in that the elements may be actively aligned to a particular magnetic orientation relative to the polymer body and thus relative to other magnetic elements within the same body and / or implant. The non-spherical shape may have one or more lobes and / or sides and / or edges and / or corners that may form a keyed or position-locking engagement with adjacent or surrounding polymeric material. In addition to aiding in assembly, such engagement may also maintain the magnetic alignment of the elements during use, resisting the tendency of the alignment of the elements to creep during use, as compared to spherical magnetic elements that may have a tendency to roll or rotate within their seat toward a minimum energy magnetic orientation.

[0031] In some embodiments, the magnetic element may have a configuration selected from one or more of the following: generally cylindrical; generally oval; generally elongated; generally polygonal; generally trapezoidal, generally disc-shaped; generally flat; a configuration having at least one generally flat surface, optionally multiple flat surfaces; a configuration whose exterior is substantially entirely defined by flat surfaces.

[0032] (j) The magnetic elements may be at least partially spaced apart laterally from one another along the polymer body in at least one state of the polymer body, e.g., the first state and / or the second state, and the magnetic elements may be spaced apart by intervening polymer material of the polymer body.

[0033] (k) At least some of the magnetic elements, at least in the first configuration, and optionally in both the first and second configurations, may be arranged to avoid mutual attraction with laterally adjacent magnetic elements.

[0034] In some embodiments, there may be exceptions at both ends of the same polymer body (if provided) where the magnetic elements are configured to attract the ends into end-to-end engagement with each other to form at least a partial loop shape.

[0035] (l) Additionally or alternatively to any of the above, at least some, and optionally most, and optionally substantially all, of the magnetic elements may be arranged such that their magnetic poles are aligned generally perpendicular to the longitudinal direction and / or loop direction of the implant and / or polymer body (if provided).

[0036] (m) Additionally or alternatively, in some embodiments, the magnetic elements are arranged with alternating magnetic poles aligned relative to the longitudinal and / or loop direction of the implant and / or polymer body (if present). For example, adjacent magnetic elements may be arranged with opposite magnetic orientations.

[0037] (n) The implant may be configured to create an anastomosis of internal tissue by inducing tissue necrosis at a target site through compression of the internal tissue by the implant.

[0038] The creation of anastomoses by magnetic compression may make it possible to reduce the risk of complications that usually occur after anastomosis. For example, magnetic compression of tissues may promote the fusion of one or more tissues after tissue necrosis, thus reducing the risk of anastomotic leakage.

[0039] The first, low profile configuration for insertion in a patient can facilitate delivery of the implant in the patient. The low profile can be smaller than the operating configuration and can be inserted using smaller instruments, thus helping to reduce the invasiveness of the procedure.

[0040] Additionally or alternatively to any of the above, the polymer body may be at least partially elongated and / or at least partially flexible.

[0041] Having an at least partially elongated polymer body can help facilitate insertion of the implant in a patient. It can facilitate changing the configuration of the implant to create an anastomosis.

[0042] Having an at least partially compliant polymer body can allow the implant to conform to, for example, the contractions of the digestive tract, which can help reduce discomfort for the patient. A softer implant can further help facilitate easier expulsion of the implant after the anastomosis is completed.

[0043] In some embodiments, substantially all surfaces of the magnetic element may be at least partially covered by the polymer body.

[0044] Covering the magnetic element can avoid direct contact between the internal tissue and the magnetic element by providing a softer layer between the internal tissue and the magnetic element. This can also help reduce discomfort or irritation in the patient. This can further secure the magnetic element to the polymer body and avoid the magnetic element falling off the polymer body. This can prevent injury due to the magnet coming loose inside the patient's body.

[0045] Additionally or alternatively, the at least one polymeric body may further comprise an outer sheath.

[0046] The outer sheath can reduce friction or irritation between the implant and internal tissue.

[0047] The outer sheath may further contribute to securing the magnetic elements in the one or more cavities to the polymer body, thus reducing the risk of injury to the patient.

[0048] In some embodiments, an implant can include at least two polymer bodies for creating an anastomosis in a patient, wherein a magnetic element of a first polymer body can magnetically attract a magnetic element of at least a second polymer body.

[0049] Providing multiple magnetic elements on at least two polymer bodies may allow for stronger magnetic compression of internal tissue and may promote even distribution of the compression force along the contour of the implant. These features may allow for better anastomosis of tissue.

[0050] In some embodiments, at least a first polymer body can be disposed within a first tissue and at least a second polymer body can be disposed within a second tissue to anastomose multiple tissues. Optionally, the first tissue and the second tissue can be at least partially adjacent to one another, for example, the first tissue can be the stomach and the second tissue can be the intestine.

[0051] In some embodiments, at least two polymer bodies may be configured to at least partially overlap one another by magnetic attraction.

[0052] The overlap of the at least two polymer bodies can facilitate compression of the internal tissue to create an anastomosis in the patient. This can promote even compression of the internal tissue, thus aiding in the creation of the anastomosis.

[0053] Additionally or alternatively, the at least two polymer bodies are optionally connected to one another by a connecting element integral with and / or attached to each polymer body.

[0054] At least two ends of the polymer body connected by a connecting element may comprise one or more magnetic elements.

[0055] If provided, the magnetic elements located at the connected ends of the at least two polymer bodies may magnetically repel each other.

[0056] The magnetic repulsion between the two polymer bodies may help to strengthen the connecting element joining the at least two polymer bodies, which may help to avoid deformation of the implant.

[0057] In some embodiments, a change in configuration of the implant from a first configuration to a second configuration can compress at least two portions of the internal tissue to create an anastomosis of the internal tissues.

[0058] Compressing at least two portions of an internal tissue can induce necrosis of the two portions of tissue in which the implant is placed, thus creating an anastomosis between the two tissues, which can be useful, for example, to connect two portions of tissue that were previously unconnected, or to bypass a portion of tissue.

[0059] Additionally or alternatively, the implant may be at least partially straight in the first configuration and at least partially loop-shaped in the second configuration.

[0060] A loop shape is contemplated to be any at least partially curved and / or bent at least partially closed shape. For example, but by no means exclusively, the implant may have a circular or polygonal shape.

[0061] The implant may be easier to insert in a patient due to its at least partially straight configuration, and the at least partially straight configuration for insertion may allow for the use of smaller instruments for delivery of the implant, which may help provide easier and less invasive insertion of the implant in a patient.

[0062] In some embodiments, the loop shape of the implant may be at least partially closed by magnetic attraction of a plurality of magnetic elements at the ends of the polymer body.

[0063] Additionally or alternatively, the magnetic elements at the ends of the two polymer bodies may be arranged to resist the attractive forces between each other to aid in proper assembly of the polymer bodies in an at least partially closed loop-shaped configuration.

[0064] The at least partially loop-shaped second configuration may help provide an even distribution of compressive magnetic force, which may avoid uneven compression of tissue and allow for more rapid anastomosis of tissue.

[0065] Connecting the first and second ends of the polymer body can help to anchor the second configuration and can help prevent the polymer body from reverting to the first configuration.

[0066] In some embodiments, the implant, and optionally at least one polymeric body of the implant, may have one or more grooves. The one or more grooves may be at least partially circumferential about the implant.

[0067] The grooves can increase the flexibility of the implant, which can facilitate adjustment of the implant from a first configuration to a second configuration, which can reduce the risk of tearing or damage to the implant when changing configuration.

[0068] The implant may further comprise at least one positioning system for adjusting a configuration of the at least one polymer body. Optionally, the positioning system may be configured to be attached to the one or more polymer bodies. Optionally, the positioning system may at least partially surround at least a portion of the one or more polymer bodies.

[0069] The positioning system may be any suitable means for adjusting the implant from a first configuration to a second configuration.

[0070] Additionally or alternatively, the positioning system may have a first at least partially extended configuration and a second unextended configuration, and may be configured to change from the extended configuration to the second relaxed configuration, and optionally, a change in the configuration of the positioning system may cause a change in the configuration of the implant.

[0071] In some embodiments, the positioning system may be at least partially elastic: The positioning system may elastically stretch from an unstretched configuration to an stretched configuration.

[0072] Additionally or alternatively, the positioning system may be self-adjusting from an extended position to a relaxed position to change the configuration of the implant.

[0073] Optionally, the positioning system can be in a first configuration when the implant is in the low-profile configuration and in a second configuration when the implant is in the operational configuration.

[0074] In some embodiments, the positioning system may be further configured to maintain a position of the first polymer body relative to the tissue while the second polymer body is adjusted to the operating configuration under magnetic attraction with the first polymer body.

[0075] Having a self-adjusting positioning system can help reduce the number of tools required to position the implant, and can also help maintain the position of the first polymer body as the second polymer body is delivered, thus making the procedure easier for the practitioner.

[0076] In a second aspect, the present invention provides a method of manufacturing an implant for performing an anastomosis in a patient, optionally providing a method for producing an implant according to any of the preceding claims.

[0077] The method may include molding at least one polymer body. In some embodiments, the polymer body may be, but is not limited to, molded into an at least partially linear shape.

[0078] Molding the implant into an at least partially straight shape can facilitate loading of the implant within a delivery device.

[0079] Additionally or alternatively, the polymer body may be molded into at least a partial loop shape.

[0080] Molding the polymer body into at least a partial loop shape may allow the implant to return to a loop shape when delivered to the target site, which may allow for the elimination of a positioning system and thus help reduce costs or allow for a less complicated procedure.

[0081] The polymer body, in some embodiments, may be molded in such a way that it includes one or more cavities.

[0082] Additionally or alternatively, a step may be provided in which one or more magnetic elements are integrated into the polymer body.

[0083] In some embodiments, the magnetic element may be disposed within one or more cavities in a pre-formed polymer body. The cavities may be created due to the shape of the mold.

[0084] This allows the magnetic elements to be positioned once the polymer body is molded. In some embodiments, the cavity may be produced by molding a polymer body around one or more magnetic elements disposed in a mold.

[0085] Molding a polymer body around the magnetic element can help secure the element to the implant and can further help prevent the magnetic element from becoming dislodged.

[0086] Additionally or alternatively, the method may include adding an additional layer to the polymer body for securing one or more magnetic elements.

[0087] In some embodiments, the additional layers may be molded onto and / or disposed around a pre-formed polymer body.

[0088] The additional layer can help secure the multiple magnetic elements to the polymer body, which can help avoid undesired separation of the magnetic elements and improve the safety of the implant.

[0089] In a third aspect, the present invention provides a method of delivering an implant, optionally as described above.

[0090] The method includes the step of inserting an implant into a patient, optionally including the step of inserting the implant in a first, low-profile configuration.

[0091] The method can provide a step for deploying the implant in the patient. In some embodiments, a first polymer body may be positioned on a first side of tissue, optionally by using a positioning system.

[0092] Additionally, if provided, at least a second polymer body may be delivered to a second side of the tissue or to a second tissue, optionally adjacent to the location of the first polymer body.

[0093] Additionally or alternatively, steps may be included for adjusting the configuration of the implant. Optionally, the implant may be adjusted to a second configuration for anastomosing tissue, where the implant may be adjusted to an at least partially loop-shaped configuration.

[0094] In some embodiments, at least one polymer body of the implant can self-adjust to a second configuration under a magnetically attractive force from a first polymer body already in place.

[0095] Providing an implant that can at least partially self-adjust to an operational configuration can allow for easier procedures and can reduce the need for additional instruments to change the configuration of the implant, which may also reduce the complexity of the procedure.

[0096] Although emphasis has been placed above and in the appended claims to certain features and ideas, protection is claimed for every novel feature or idea described in this specification and / or shown in the drawings, whether or not emphasis is placed on it. [Brief description of the drawings]

[0097] [Figure 1] 1 is a schematic side view of a first embodiment of an implant for use in creating a magnetic anastomosis in a patient, the implant being in a low-profile configuration. [Diagram 2]2 is a schematic perspective view of the implant of FIG. 1 for use in creating a magnetic anastomosis in a patient, the implant being in a deployed configuration; [Diagram 3] FIG. 1 is a schematic exploded side view of a second embodiment of an implant for use in creating a magnetic anastomosis in a patient. [Figure 4] 1 is a schematic side view of a third embodiment of an implant for use in creating a magnetic anastomosis in a patient, the implant being in a low profile configuration. FIG. [Diagram 5] FIG. 13 is a schematic perspective view of a third embodiment of an implant for use in creating a magnetic anastomosis in a patient, the implant being in a partially deployed configuration. [Figure 6] FIG. 13 is a schematic perspective view of a fourth embodiment of an implant in a molded configuration. [Figure 7] FIG. 1 is a schematic perspective view showing first and second bodies in the shape of a loop for forming a magnetic compression anastomosis. [Figure 8] FIG. 2 is a perspective view of mold tools suitable for molding the polymer body of the implant, the mold tools being spaced apart. [Figure 9] FIG. 9 is a plan view of the mold tool of FIG. 8. [Figure 10] FIG. 9 is a schematic side view of the mold tool of FIG. 8 in an assembled state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0098] In the figures, the same reference numbers are used to indicate identical or equivalent features among different embodiments and examples. Unless otherwise stated, a description of a feature in one embodiment may also apply to the same or equivalent feature in another embodiment or example. Furthermore, features may be interchanged between embodiments as desired.

[0099] 1 and 2, there is shown a first embodiment of an implant 10 configured for use in creating a magnetic compression anastomosis in a patient. The implant 10 comprises a polymer body 20 having a plurality of cavities 22 configured to house a plurality of magnetic elements 30. In FIG. 1, the mixture of magnetic elements 30 and open cavities 22 is shown diagrammatically so that the arrangement of the cavities can be seen.

[0100] The magnetic element 30 may be a magnet, an element that behaves like a magnet, or an element that can be attracted by a magnet. The magnetic element 30 may have any suitable shape. A non-spherical shape may be preferred to allow a fixed position of the magnetic element and / or to allow a predetermined magnetic orientation and / or to prevent the orientation from changing during use due to, for example, a ball rotating in its seat.

[0101] The implant 10 has a first, low-profile configuration 20a for insertion into a patient in which the implant 10 is at least partially straight (see FIG. 1), and is further configured to be deployed into a second, operational configuration 20b in which the implant is at least partially loop-shaped (see FIG. 2).

[0102] The polymer body 20 of the implant has a first end (e.g., end) 21 a and a second end (e.g., end) 21 b. The polymer body 20 is at least partially flexible to facilitate changing from the first configuration 20 a and the second configuration 20 b.

[0103] In the second, operational configuration 20b, the first end 21a of the polymer body 20 is positioned at least partially adjacent to the second end 21b of the polymer body 20.

[0104] The first and second ends 21a and 21b of the polymer body 20 are configured to be connected to one another, optionally by magnetic attraction. Magnetic elements 30a and 30b may be disposed at the ends 21a and 22b.

[0105] The implant 10 optionally further comprises a plurality of grooves 25. The grooves 25 are located on the circumferential surface and enhance the flexibility of the polymer body 20 to bend into a loop shape.

[0106] In use, the implant 10 is delivered into the body in a first configuration and expanded to a second configuration to form at least a partial loop, and preferably a complete loop. The implant 10 is placed on one side of the target tissue where an anastomosis is to be formed. A corresponding matching or complementary implant is delivered to the other side of the tissue, and the magnetic attraction between the implants compresses the tissue.

[0107] The polymer body may have a natural (e.g., molded) shape into which the polymer body is self-biased. The natural shape may be the first configuration, or the second configuration, or an intermediate shape between the first configuration and the second configuration.

[0108] 3, a second embodiment of the implant comprises a first polymer body 20 and a second polymer body 20'. The implant is shown in a first, low profile configuration adapted for insertion into a patient. The two polymer bodies 20 and 20' are connected by a connecting element 24. In contrast to the first embodiment, in which the implant provides only a single or individual loop shape, in the second embodiment, the implant provides both a first loop shape and a second loop shape that fit on either side of the tissue wall where the magnetic compression anastomosis is to be formed.

[0109] The implant further comprises a plurality of magnetic elements 30 (see FIG. 3). The magnetic elements 30 are configured to be at least partially embedded within the polymer body 20. In FIG. 3, the lines within each magnetic element show the division between the magnetic poles in a schematic manner. For example, for most of the magnetic elements 30, the magnetic poles are aligned generally perpendicular to the longitudinal axis and / or the direction of the loop. If the magnetic elements 30 are all magnets, in the first configuration, the magnetic orientation is opposite to the orientation desired for magnetic attraction. When the implant transitions to the second operational configuration, the plane of one polymer body can be folded over the other polymer body, turning one set of magnets upside down and aligned for magnetic attraction.

[0110] Optionally, the magnetic element 30 is disposed in one or more cavities 22 of the implant 10. The cavities 22 may have at least one open end, and / or at least one closed end, and / or at least one partially open end. The closer the magnetic element 30 is to the surface, the stronger the magnetic interaction. In some designs, the open ends may present the magnetic element approximately flush with the surface of the polymer body. In the illustrated configuration, the cavities are generally open at only one end. For example, the cavity 22 of the first polymer body 20 is open in one direction (e.g., downward in the illustrated example) and the cavity 22 of the second polymer body 20' is open in the opposite direction (e.g., upward in the illustrated example). When the implant transitions to the second operating configuration, the plane of one polymer body may be folded over the other polymer body, with the matching ends (e.g., open ends) of the cavities 22 facing each other.

[0111] The connecting element 24 is at least partially flexible. The connecting element 24 is configured to connect a first end 21 a of the first polymer body 20 to a first end 21 a′ of the second polymer body 20′. The flexibility allows one polymer body to fold over the other polymer body as the device transitions from a first low-profile configuration for delivery to a second operational configuration for implantation.

[0112] The connecting element 24 is reinforced by a plurality of magnetic elements 30a and 30b disposed at a first end 21a of the first polymer body 20 and a first end 21a' of the second polymer body 20' (see FIG. 3). The magnetic elements at the first ends 21a and 21a' are positioned to avoid attraction between each other, and preferably to repel each other, which can increase the effective column strength of the implant across the flexible connecting element.

[0113] The implant shown in Fig. 3 further comprises at least one sheath 23, optionally two sheaths. Optionally, the sheath 23 is configured to cover at least one polymer body 20, 20' of the implant 10. The sheath may be made of a heat shrinkable polymer, for example a tubular film, that can be heat shrunk around the polymer body. The sheath may further serve to fix the magnetic element trapped within the polymer body. In the illustrated embodiment, two sheaths are provided, one for each polymer body, so as not to impede the possibility of folding the connection element.

[0114] As seen in FIG. 4, the implant 10 has a positioning system 40 in the form of at least one filament or tether. The positioning system is connected to at least one of the polymer bodies 20, 20′. In use, the positioning system 40 can function to assist in positioning one of the polymer bodies, such as the most distal polymer body, against a tissue surface of the tissue wall opposite the remainder of the delivery system. The delivery system can include an elastic filament that biases the polymer body as the filament elastically extends with deployment of the implant.

[0115] 5 and 6 show another embodiment of an implant comprising a first polymer body 20 and a second polymer body 20'. Also shown is another embodiment of a positioning system 40. The positioning system 40 is attached to the first (e.g., distal) polymer body 20.

[0116] The main difference compared to the previous embodiment is that the first and second polymer bodies are molded into different shapes. The first polymer body 20 is molded to have a natural curved or looped shape that automatically self-biases the polymer body when deployed from the delivery catheter (e.g., to the opposite side of the tissue relative to the remainder of the delivery catheter). This can aid in precise deployment of the first polymer body to the distal side of the tissue. The second polymer body 20' is molded to have a natural straight shape (or at least a less curved shape). This can aid in precise control of the deployment of the second polymer body from the delivery catheter and reduce the tendency of the second polymer body 20' to exit the delivery catheter on its own when the implant reaches near full deployment. As the second polymer body 20' is gradually deployed from the delivery catheter, it can assume the same shape as the first polymer body 20 due to magnetic attraction with the first polymer body 20.

[0117] The implant of Figure 6 further illustrates a plurality of magnetic elements 30 embedded within a first polymer body 20 and a second polymer body 20'. The first polymer body is deployed in an operational configuration and the second polymer body is in a low-profile configuration. The implant has magnetic elements embedded within the first polymer body 20 and the second polymer body 20'. The magnetic elements of the embodiment illustrated by Figure 6 are cylindrical.

[0118] 7, in some alternative embodiments, the implant has a plurality of trapezoidal magnetic elements embedded within each polymer body 20, 20'. This embodiment can include any of the features described above.

[0119] Figures 8-10 show shaping tools 50a and 50b for shaping the polymeric bodies 20 and 20' of the implant 10. In the illustrated form, the shaping tools are shown in a generally straight, elongated configuration.

[0120] It will be understood that the above description is merely illustrative of some examples of the invention and does not limit the scope of protection.

Claims

1. 1. An implant for use in creating a magnetic compression anastomosis in a patient, comprising: having a first low-profile configuration for insertion in a patient and deployable to a second operative configuration for use in creating an anastomosis; 1. An implant comprising: at least one polymer body and a plurality of magnetic elements at least partially embedded within the polymer body, the polymer body being flexible such that the polymer body can be transitioned between a first state in the first configuration of the implant and a second state in the second configuration of the implant.

2. 10. An implant according to any preceding claim, wherein at least one polymeric body is at least partially elongated and at least partially flexible.

3. The implant of claim 2 , wherein magnetic elements disposed on opposite ends of the polymer body are configured to attract each other to hold the polymer body in a loop shape by magnetic attraction.

4. 10. An implant according to any preceding claim, wherein substantially all faces of the magnetic element are at least partially covered by the polymer body.

5. 10. The implant of any preceding claim, wherein the at least one polymeric body further comprises an outer sheath.

6. 10. An implant according to any preceding claim, wherein at least one, optionally a plurality, optionally a majority, optionally substantially all of said magnetic elements are non-spherical in shape.

7. 10. An implant according to any preceding claim, comprising at least two polymer bodies for creating an anastomosis in a patient, each polymer body having a plurality of magnetic elements such that the magnetic elements of one polymer body create an attractive force for the magnetic elements of another polymer body.

8. The implant of claim 6 , wherein the at least two polymer bodies are configured to overlap one another under the magnetic attraction of the magnetic element.

9. 8. The implant of claim 6 or 7, wherein the at least two polymer bodies are optionally connected to each other by a connecting element integral with and / or attached to each polymer body.

10. 10. The implant of claim 9, wherein in the first configuration of the implant, a magnetic element of a first one of the polymer bodies is configured to repel a magnetic element of a second one of the polymer bodies, the magnetic elements being disposed at opposite ends of the connecting element.

11. The implant of any of claims 6 to 8, wherein at least one polymer body is biased to a first configuration and at least one polymer body is biased to a second configuration.

12. 10. The implant of any preceding claim, wherein the implant is at least partially straight in a first configuration and at least partially loop-shaped in a second configuration.

13. 13. The implant of claim 12, wherein at least one polymer body is biased to a first configuration and at least one polymer body is biased to a second configuration.

14. 10. The implant of any preceding claim, further comprising at least one positioning system for adjusting a configuration of the at least one polymer body, optionally comprising an elastic element for biasing the polymer body by elongation of the elastic element.

15. 10. A method for manufacturing an implant for performing an anastomosis in a patient, optionally comprising a method for producing an implant according to any of the preceding claims, the method comprising: (i) forming at least one polymer body; (ii) integrating one or more magnetic elements into said at least one polymer body; and (iii) adding an additional layer to the polymer body to secure the one or more magnetic elements; in any order.

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