Implant for magnetic compression anastomosis

Abstract

An implant for forming a magnetic compression anastomosis in a patient, the implant having a first low profile configuration for insertion into the patient, and being deployable to a second operational configuration for forming an anastomosis, the implant comprising at least one pliable polymeric body (20, 30), 20 ') and a plurality of magnetic elements (30) at least partially embedded within the polymer body, the polymer body being flexible to allow the polymer body to transition between a first state in a first form of the implant and a second state in a second form of the implant, The plurality of polymer bodies may be joined by connecting elements (24).

Description

Technical Field

[0001] The present invention relates to an implant, a method of making an implant, and a method of delivering an implant for creating an anastomosis in a patient's body, particularly in the digestive system, optionally connecting two portions of the gastrointestinal tract. Background Art

[0002] An anastomosis is considered a connection or opening between two normally separate structures and is a natural occurrence in the human body, such as in the circulatory system, or may be created surgically by a trained physician. This may be the case, for example, in gastrointestinal surgeries to promote weight loss in obese patients, such as the Roux-en-Y gastric bypass.

[0003] Although the anastomosis can be created surgically by suturing or stapling, performing the same technique laparoscopically or endoscopically remains technically challenging because access is considerably restricted.

[0004] Implants and devices have been proposed to help avoid these complications. Magnetic compression anastomosis is a technique that involves the use of magnets introduced on either side of adjacent body cavity walls. The magnetic attraction forces the tissue walls together, both joining the tissues and creating interconnected holes at the junction.

[0005] In EP 2849655, an implantable device for performing magnetic compression anastomosis is proposed, which provides an exoskeleton and magnetic segments. The exoskeleton is made of a memory shape alloy and is intended to guide the self-assembly of the magnetic segments. WO 2016 / 183039 also describes different examples of self-opening magnetic rings, which spontaneously open to form a ring when delivered. One example includes a spherical ball magnet inside an extruded or molded tube.

[0006] It is desirable to improve existing anastomotic techniques, particularly by achieving anastomosis through magnetic compression. Summary of the invention

[0007] A first aspect of the present invention provides an implant for forming a magnetic compression anastomosis in a patient. The implant has a first low-profile configuration for insertion into the patient and a second operative configuration for forming an anastomosis. The implant includes a plurality of magnetic elements.

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

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

[0010] (a) The implant may include at least one polymer body in which a plurality of magnetic elements are at least partially embedded. The polymer body may be at least partially pliable and / or bendable and / or flexible to allow the polymer body to transition 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 substantially straight shape. Additionally or alternatively, in some embodiments, at least in the second state, the polymer body has an at least partially annular shape.

[0012] As used herein, the term "annular" refers to a shape that generally surrounds a central region, whether the shape is circular, curved, curvilinear, or a polygon consisting of linear edges or line segments. An at least partially annular shape is a shape that at least partially surrounds a central region, even if the shape is not a completely closed shape, or is closed by a non-polymer material.

[0013] At least partially embedding the magnetic elements may help reduce the risk of accidental dislodging of the magnetic elements from the implant. Magnetic elements may be difficult to securely attach in a biocompatible manner, especially to non-polymer materials such as shape memory alloys. Loose magnetic elements are undesirable because they may cause internal injuries and in any case they reduce the magnetic compressive force that needs to be concentrated on the target side for the formation of the anastomosis.

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

[0015] Providing such a polymer body can achieve a soft, atraumatic implant and can therefore help avoid patient discomfort. It can also reduce the risk of damaging surrounding tissue. In addition, the use of a polymer body can increase the pliability and / or flexibility and / or bendability of the implant. This can facilitate changing the shape of the implant to adapt to the anatomical structure in which the implant is located, and / or allow the implant to be more easily expelled from the body through the intestine after anastomosis.

[0016] The polymer host may also be resistant to the internal parameters of the gastrointestinal tract. For example, the polymer host may be more resistant to the acidic environment of the stomach than, for example, a shape memory alloy.

[0017] The use of a polymer body may also enable economical manufacturing of the implant. For example, the material cost of a polymer may be considerably cheaper than that of a shape memory alloy. In addition, a polymer body may be easier to produce, so the implant may be produced more quickly.

[0018] (c) The implant may comprise at least two bodies (e.g., a first and a second body) in which the magnetic element is at least partially mounted or embedded, and wherein the bodies are connected to each other, optionally via a connecting element that is integral and / or integrally attached to the first and second bodies. The connecting element may extend from an end of at least one of the bodies, optionally between the ends of the first and second bodies.

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

[0020] (d) The connecting element may be flexible. Optionally, whether or not the connecting element is flexible, the connecting element may be reinforced by magnetic elements within the body (e.g., a polymer body) and disposed at opposite ends of the connecting element. The magnetic elements may be selected so as to exert a repulsive magnetic force between the connecting portions of the bodies. The repulsive force may provide or enhance the longitudinal column strength of the connecting element so that a thrust force can be transferred from one body to another.

[0021] (e) at least one polymer body can be molded into a generally straight shape and / or can be elastically deformed from a generally straight shape and / or can be elastically biased into a generally straight shape. In addition or alternatively, at least one polymer body can be molded into an at least partially annular shape and / or can be elastically deformed from an at least partially annular shape and / or can be elastically biased into an at least partially annular shape.

[0022] When at least one first polymer body has an at least partially annular shape, the body can be self-biased into the annular shape when deployed in vivo, and this can also be used to guide the second body into a matching annular shape through magnetic coupling between the bodies. For example, the second body can have a generally straight configuration and can bend or conform to the annular shape, which is at least partially due to the magnetic coupling with the first body.

[0023] When at least one polymeric body has a generally straight shape, this may aid in controllability of the body when deployed from a constraining sheath, as the straight shape itself is less prone to popping out of the constraints of the sheath.

[0024] (f) The polymer body may be generally solid except for the region occupied by the magnetic element. Alternatively, the polymer body may have open spaces, such as cavities, that are not occupied by the magnetic element. For example, the polymer body may be tubular.

[0025] (g) The polymer body may have a first end and a second end that are spaced apart from each other in a first state of the polymer body and are adjacent to each other in a second state of the polymer body.

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

[0027] The positioning element or system may be self-regulating so that it operates independently of manual input or control by an operator. For example, the positioning element may be resilient so that it applies a resilient bias to affect positioning during and / or after deployment. The resilient bias may, for example, increase during deployment.

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

[0029] Additionally or alternatively, a positioning system element or system can be used to guide the polymer to transition from the first state to the second state during deployment. For example, a filament can extend from one end of the polymer body to the other end such that tension in the filament pulls one end toward the other end to form at least a partial loop. For example, the filament can pass through a hole in a connecting element (if provided).

[0030] (i) at least one, preferably a majority, optionally substantially all of the magnetic elements may be non-spherical magnetic elements. In particular, in the case where the element is a magnet, the use of non-spherical elements may provide significant advantages in enabling the element to be positively aligned in a magnetic direction relative to the polymer body, and thereby relative to other magnetic elements in the same body and / or within the implant. The non-spherical shape may have one or more lobes and / or sides and / or edges and / or corners that may form a bond or fixed position engagement with adjacent or surrounding polymeric materials. In addition to facilitating assembly, such engagement may also maintain the magnetic alignment of the element during use, and resist any tendency for the element alignment to creep during use, compared to a spherical magnetic element that may roll or rotate in its position to orient toward the lowest energy magnetic orientation.

[0031] In some embodiments, the magnetic element can have a form selected from one or more of the following: roughly cylindrical; roughly rectangular; roughly elongated; roughly polygonal; roughly trapezoidal, roughly disc-shaped; roughly flat; a form having at least one roughly flat face, optionally having multiple flat faces; a form having an exterior that is substantially completely defined by flat faces.

[0032] (i) At least in one state of the polymer body, such as the first state and / or the second state, the magnetic elements may be at least partially spaced apart from each other laterally along the polymer body. The magnetic elements may be spaced apart by intermediate polymer material of the polymer body.

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

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

[0035] (1) In addition to or as an alternative to the above, at least some, optionally a majority, optionally substantially all of the magnetic elements can be arranged so that the magnetic poles are aligned substantially perpendicularly with respect to the longitudinal and / or circumferential 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 relative to the longitudinal and / or circumferential directions of the implant and / or polymer body (if provided). For example, adjacent magnetic elements may be arranged with opposite magnetic orientations.

[0037] (n) The implant can be configured in such a way that compression of the implant against internal tissue can induce tissue necrosis at the target site, thereby producing anastomosis of the internal tissue.

[0038] Forming anastomosis by magnetic compression can reduce the risk of complications that typically occur after anastomosis. For example, magnetic compression of tissue can promote fusion of one or more tissues after tissue necrosis, thereby reducing the risk of anastomotic leakage.

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

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

[0041] Having at least a partially elongated polymer body may facilitate insertion of the implant into the patient. It may facilitate changes in the configuration of the implant to form an anastomosis.

[0042] Having at least a partially soft polymer body can allow the implant to conform to contractions, such as in the gastrointestinal tract. This can help reduce patient discomfort. A softer implant can further help ease expulsion of the implant after the anastomosis is complete.

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

[0044] Covering the magnetic element can avoid direct contact between 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 to the patient. This can further secure the magnetic element relative to the polymer body and can prevent the magnetic element from falling out of the polymer body. This can prevent injuries caused by magnets falling out of the patient's body.

[0045] Additionally or alternatively, at least one of the polymer bodies may include an outer sheath.

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

[0047] The outer sheath may also help secure the magnetic element relative to the polymer body within the one or more cavities, thereby reducing the risk of injury to the patient.

[0048] In some embodiments, the implant may include at least two polymer bodies for forming an anastomosis within a patient. A magnetic element of a first polymer body may magnetically attract a magnetic element of at least a second polymer body.

[0049] Providing at least two polymer bodies with multiple magnetic elements can allow for stronger magnetic compression of internal tissue. It can also promote even distribution of compression forces along the contour of the implant. These properties can enable better anastomosis of tissue.

[0050] In some embodiments, at least one first polymer body can be positioned within a first tissue, and at least one second polymer body can be positioned within a second tissue to conform to multiple tissues. Optionally, the first tissue and the second tissue can be at least partially adjacent to each other, for example, the first tissue can be a stomach, and the second tissue can be an intestinal tract.

[0051] In some embodiments, at least two polymer bodies can be configured to at least partially overlap each other due to magnetic attraction.

[0052] The stacking of at least two polymer bodies can facilitate compression of internal tissue to form anastomosis in a patient. It can facilitate uniform compression of internal tissue, thus facilitating formation of anastomosis.

[0053] Additionally or alternatively, at least two polymer bodies are optionally connected to each other via a connection element that is integral with and / or integrally attached to each polymer body.

[0054] The ends of at least two polymer bodies connected by a connecting element may include one or more magnetic elements.

[0055] If provided, the magnetic elements located at the connecting 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 connecting the at least two polymer bodies. This may help to avoid deformation of the implant.

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

[0058] Compressing at least two portions of the internal tissue may cause necrosis of the two portions of tissue in which the implant is located, thereby possibly forming an anastomosis between the two portions of tissue. For example, this may help connect two portions of tissue that were not previously connected, or may help bypass a portion of the tissue.

[0059] Additionally or alternatively, the implant may be at least partially linear in the first configuration and at least partially annular in the second configuration.

[0060] A ring is considered to be any at least partially curvilinear 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 is at least partially linear, which may make it easier to insert into a patient. The implant is at least partially linear, which may allow the implant to be delivered using smaller instruments. This helps make the implant easier and less invasive to insert into a patient.

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

[0063] Additionally or alternatively, the magnetic elements at the ends of the two polymer bodies may be arranged to oppose attractive forces therebetween to assist in properly assembling the polymer bodies into the at least partially closed annular configuration.

[0064] The at least partially annular second shape can help provide an evenly distributed magnetic compressive force, which can avoid uneven compression of tissue and achieve faster tissue anastomosis.

[0065] Connecting the first end and the second end of the polymer body can help secure the second configuration and can help prevent the polymer body from returning to the first configuration.

[0066] In some embodiments, the implant (optionally, at least one polymer body of the implant) may have one or more grooves. The one or more grooves may be at least partially circumferential relative to the implant.

[0067] The grooves may increase the flexibility of the implant. This may facilitate adjustment of the implant from a first configuration to a second configuration. This may reduce the risk of tearing or damaging the implant when changing configuration.

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

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

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

[0071] In some embodiments, the positioning system may be at least partially elastic.The positioning system may be elastically stretchable from a non-stretched configuration to a stretched configuration.

[0072] Additionally or alternatively, the positioning system may self-adjust from a stretched position to a relaxed position to change the configuration of the implant.

[0073] Optionally, the positioning system may 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 operative configuration.

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

[0075] Including a self-adjusting positioning system may help reduce the number of instruments needed to position the implant. It may also help maintain the position of the first polymer body while the second polymer body is delivered, thus potentially helping to make the procedure easier for the physician.

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

[0077] The method may comprise the step of moulding at least one polymer body.

[0078] In some embodiments, the polymer body may be molded into an at least partially linear shape, but is not limited thereto.

[0079] Molding the implant into an at least partially linear shape can facilitate loading of the implant into a delivery device.

[0080] Additionally or alternatively, the polymer body may be molded to be at least partially annular.

[0081] Molding the polymer body into at least a partial ring shape allows the implant to return to the ring shape when delivered to the target site. This can allow the positioning system to be abandoned, thereby helping to reduce costs or make the surgical procedure less complicated.

[0082] In some embodiments, the polymer body may be molded in a manner to provide one or more cavities.

[0083] Additionally or alternatively, a step of integrating one or more magnetic elements into the polymer body may be provided.

[0084] In some embodiments, the magnetic element may be placed in one or more cavities of a pre-molded polymer body. The cavities may be formed according to the shape of the mold.

[0085] Once the polymer body is formed, the magnetic components can be placed.

[0086] In some embodiments, the cavity may be created by molding a polymer body around one or more magnetic elements within a mold.

[0087] Molding the polymer body around the magnetic element may help secure the element relative to the implant and may further help prevent the magnetic element from falling out.

[0088] Further additionally or alternatively, the method may comprise the step of adding an additional layer to the polymer body to secure the one or more magnetic elements.

[0089] In some embodiments, additional layers may be molded onto and / or placed around the pre-molded polymer body.

[0090] The additional layer can help secure the multiple magnetic elements to the polymer body. This can help prevent the magnetic elements from accidentally falling out and can improve the safety of the implant.

[0091] In a third aspect, the present invention provides a method of delivering an implant, optionally for delivering an implant as described above.

[0092] The method includes the steps of inserting an implant into a patient, optionally inserting the implant in a first low-profile configuration.

[0093] The method may provide the step of deploying the implant within the patient.

[0094] In some embodiments, a first polymer body can be placed on a first side of the tissue, optionally positioned using a positioning system.

[0095] Furthermore, if provided, at least a second polymer body may be delivered to a second side of the tissue, or a second tissue, optionally in close proximity to the location of the first polymer body.

[0096] Further additionally or alternatively, the step of adjusting the configuration of the implant may be included. Optionally, the implant is adjusted to a second configuration (adjusting the implant to an at least partially annular configuration) to conform to the tissue.

[0097] In some embodiments, at least one polymer body of the implant can self-adjust to the second configuration under the influence of magnetic attraction of a previously positioned first polymer body.

[0098] Providing an implant that is at least partially self-adjustable to an operative configuration can make the surgical procedure easier and can reduce the need for additional instrumentation to change the configuration of the implant. This can also reduce the complexity of the surgery.

[0099] Although certain features and ideas have been emphasized in the foregoing description and in the appended claims, protection is desired to any novel feature or idea described herein and / or shown in the drawings whether or not emphasized. BRIEF DESCRIPTION OF THE DRAWINGS

[0100] Figure 1 is a schematic side view of a first embodiment of a low-profile implant for forming a magnetic anastomosis in a patient.

[0101] Figure 2 yes Figure 1 Schematic perspective view of an implant in a deployed configuration for forming a magnetic anastomosis in a patient.

[0102] Figure 3 is a schematic exploded side view of a second embodiment of an implant for forming a magnetic anastomosis in a patient.

[0103] Figure 4 is a schematic side view of a third embodiment of a low-profile implant for forming a magnetic anastomosis in a patient.

[0104] Figure 5 is a schematic perspective view of a third embodiment of an implant for forming a magnetic anastomosis in a patient in a partially deployed configuration.

[0105] Figure 6 is a schematic perspective view of a fourth embodiment of an implant in its molded configuration.

[0106] Figure 7 is a schematic perspective view showing annular first and second bodies for forming a magnetic compression anastomosis.

[0107] Figure 8 is a perspective view of a mold suitable for molding a polymer body of an implant in a spaced arrangement.

[0108] Fig. 9 yes Figure 8 A plan view of the mold.

[0109] Fig.10 yes Figure 8 A schematic side view of the mold in an assembled relationship. DETAILED DESCRIPTION

[0110] In the drawings, the same reference numerals are used to represent the same or equivalent features in different embodiments and examples. Unless otherwise specified, the description of features in one embodiment may also apply to the same or equivalent features in another embodiment or example. Features may also be interchanged in the embodiments as needed.

[0111] refer to Figure 1 and 2 , a first embodiment of an implant 10 is shown, which is configured to form a magnetic compression anastomosis in a patient. The implant 10 includes a polymer body 20 having a plurality of cavities 22 configured to accommodate a plurality of magnetic elements 30. Figure 1 In FIG. 1 , a mixture of magnetic elements 30 and open cavities 22 is schematically shown so that the arrangement of the cavities can be seen.

[0112] The magnetic element 30 may be a magnet, or 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 the magnetic element to lock in place, and / or to allow a predetermined magnetic orientation, and / or to prevent changes in orientation during use, for example, due to rotation of the ball in the socket.

[0113] The implant 10 has a first low-profile configuration 20a for insertion into a patient, wherein the implant 10 is at least partially linear (see Figure 1 ). The implant 10 is also configured to be deployable into a second operative configuration 20b, wherein the implant is at least partially annular (see Figure 2 ).

[0114] The polymer body 20 of the implant has a first end (eg, end) 21a and a second end (eg, end) 21b. The polymer body 20 is at least partially flexible to facilitate changing from a first configuration 20a to a second configuration 20b.

[0115] In the second operational configuration 20 b , the first end 21 a of the polymer body 20 is positioned at least partially closer to the second end 21 b of the polymer body 20 .

[0116] The first end 21a and the second end 21b of the polymer body 20 are configured to be connected to each other, optionally by magnetic attraction. Magnetic elements 30a and 30b may be arranged at the ends 21a and 22b.

[0117] The implant 10 may further include a plurality of grooves 25. The grooves 25 are provided on the outer peripheral surface to improve flexibility so as to bend the polymer body 20 into a ring shape.

[0118] In use, the implant 10 is delivered to the body in a first configuration and deployed in a second configuration to form at least a partial ring, preferably a complete ring. The implant 10 is positioned on one side of the target tissue to be anastomosed. A corresponding paired or complementary implant is delivered to the other side of the tissue, and the magnetic attraction between the implants compresses the tissue.

[0119] The polymer body may have a natural (eg, molded) shape, and the polymer body may be self-biased to that shape. The natural shape may be the first configuration, or the second configuration, or an intermediate shape between the first and second configurations.

[0120] See also Figure 3 , a second embodiment of the implant includes a first polymer body 20 and a second polymer body 20'. The implant is shown in a first low profile configuration suitable for insertion into a patient. The two polymer bodies 20 and 20' are connected by a connecting element 24. Compared to the implant in the first embodiment, which is only provided as a single or separate ring, in the second embodiment, the implant provides a first and a second ring to fit at opposite sides of the tissue wall to be formed with magnetic compression anastomosis.

[0121] The implant also includes a plurality of magnetic elements 30 (see Figure 3 ). The magnetic element 30 is configured to be at least partially embedded in the polymer body 20. Figure 3 , the line segments within each magnetic element schematically represent the distinction between magnetic poles. For example, for most magnetic elements 30, the magnetic poles are arranged approximately perpendicularly relative to the longitudinal axis and / or the direction of the ring. Wherein the magnetic elements 30 are all magnets, in the first mode, the magnetic orientation is opposite to the orientation required for magnetic attraction. When the implant is transformed into the second operating mode, the plane of one polymer body can be folded over to cover the other polymer body, and a set of magnets can be turned upside down and aligned for magnetic attraction.

[0122] Optionally, the magnetic element 30 is located in one or more cavities 22 of the implant 10. The cavity 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 end may allow the magnetic element to be roughly flush with the surface of the polymer body. In the illustrated form, the cavity is typically open only at one end. For example, the cavity 22 of the first polymer body 20 opens in one direction (e.g., downward in the example shown), while the cavity 22 of the second polymer body 20' opens in the opposite direction (e.g., upward in the example shown). When the implant is transformed into the second operating mode, the plane of one polymer body can be folded to lie against the other polymer body, so that the paired ends (e.g., open ends) of the cavity 22 face each other.

[0123] The connecting element 24 is at least partially flexible. The connecting element 24 is configured to connect the first end 21a of the first polymer body 20 to the first end 21a' of the second polymer body 20'. The flexibility allows one polymer body to fold up to lie against the other polymer body when the device is transformed from its first low-profile configuration for delivery to its second operational configuration for implantation.

[0124] The connecting element 24 is reinforced by a plurality of magnetic elements 30a and 30b, which are located at the first end 21a of the first polymer body 20 and the first end 21a' of the second polymer body 20' (see Figure 3 ). The magnetic elements at the first ends 21a and 21a' are arranged to avoid attracting each other, preferably to repel each other. This can increase the effective column strength of the implant on the flexible connecting element.

[0125] Figure 3 The implant shown also includes 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 can be made of a heat-shrinkable polymer, such as a tubular film, which can be heat-shrunk around the polymer body. The sheath can be used to further lock the magnetic element in the polymer body. In the illustrated form, two sheaths are provided, one for each polymer body, so as not to affect the foldability of the connecting element.

[0126] like Figure 4As shown, 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 polymer body 20; 20'. In use, the positioning system 40 can be used to assist in positioning one of the polymer bodies, such as the most distal polymer body, against a tissue surface on the side of the tissue wall opposite to the rest of the delivery system. The delivery system may include an elastic filament that biases the polymer body when the filament is elastically stretched with the deployment of the implant.

[0127] Figure 5 and Figure 6 Alternative embodiments of implants are depicted, comprising a first polymer body 20 and a second polymer body 20 ′. They also show an alternative embodiment of a positioning system 40 . The positioning system 40 is attached to the first (eg distal) polymer body 20 .

[0128] Compared to the previous embodiment, the main difference 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 annular shape, and when deployed from the delivery catheter, the polymer body will automatically self-bias into this shape (for example, on the side of the tissue opposite to the rest of the delivery catheter). This can help to properly deploy the first polymer body on 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 degree). This can avoid assisting in the fine control of the deployment of the second polymer body from the delivery catheter, and reduce any tendency of the second polymer body 20' to self-pop out of the delivery catheter when the implant is close to being fully deployed. Due to the magnetic attraction with the first body 20, the second polymer body 20' can adopt the same shape as the first polymer body 20 when it is gradually deployed from the delivery catheter.

[0129] Figure 6 The implant in FIG. 1 also shows a plurality of magnetic elements 30 embedded in the first polymer body 20 and the second polymer body 20'. The first polymer body has been deployed to an operational configuration, while the second polymer is in a low profile configuration. The implant has magnetic elements embedded in the first polymer body 20 and the second polymer body 20'. Figure 6 The magnetic element in the embodiment shown is cylindrical.

[0130] Figure 7 In some alternative embodiments, the implant has a plurality of trapezoidal magnetic elements embedded in a respective polymer body 20, 20'. This embodiment may include any of the features described above.

[0131] Figures 8 to 10 Illustrated are molds 50a and 50b for molding the polymeric bodies 20 and 20' of the implant 10. In the illustrated form, the molds are shown as being of a generally straight, elongated configuration.

[0132] It should be understood that the foregoing description is only illustrative of the present invention and does not limit the scope of protection.

Claims

1. An implant for forming a magnetic compression anastomosis in a patient's body, the implant having a first low-profile form for insertion into the patient's body and being deployable into a second operational form for forming the anastomosis, the implant comprising at least one polymer body and a plurality of magnetic elements at least partially embedded in the polymer body, the polymer body being flexible to allow the polymer body to transition between a first state of the first form of the implant and a second state of the second form of the implant.

2. An implant according to any one of the preceding claims, wherein at least one polymer body is at least partially elongated and at least partially flexible.

3. The implant of claim 2, wherein the magnetic elements disposed at opposite ends of the polymer body are configured to hold the polymer body in a ring shape by magnetic attraction.

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

5. An implant according to any one of the preceding claims, wherein at least one polymer body further comprises an outer sheath.

6. An implant according to any of the preceding claims, wherein at least one, optionally a plurality, optionally a majority, optionally substantially all of the magnetic elements are non-spherical.

7. An implant according to any of the preceding claims, wherein the implant comprises at least two polymer bodies for forming an anastomosis in a patient's body, each polymer body having a plurality of magnetic elements so that the magnetic elements of a polymer body generate an attractive force relative to the magnetic elements of another polymer body.

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

9. An implant according to claim 6 or 7, wherein at least two polymer bodies are connected to each other, optionally by a connecting element that is integral with and / or integrally attached to each polymer body.

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

11. An implant according to any one of claims 6 to 8, wherein at least one polymer body is biased in its first configuration and at least one polymer body is biased in its second configuration.

12. An implant according to any one of the preceding claims, wherein the implant is at least partially linear in a first configuration and at least partially annular in a second configuration.

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

14. An implant according to any of the preceding claims, wherein the implant further comprises at least one positioning system for adjusting the shape of the at least one polymer body, optionally wherein the positioning system comprises an elastic element for biasing the polymer body by means of stretching of the elastic element.

15. A method of making an implant for performing an anastomosis in a patient, optionally for making an implant according to any one of the preceding claims, wherein the method comprises one or more of the following steps, performed in any order: (i) molding at least one polymer body; (ii) integrating one or more magnetic elements into at least one polymer body; (iii) Adding additional layers to the polymer body to secure one or more magnetic elements.

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