CN116602802B

CN116602802B - Implant and implant system

Info

Publication number: CN116602802B
Application number: CN202310901178.2A
Authority: CN
Inventors: 葛书晨; 王励; 李博
Original assignee: Heyuan Medical Device Shanghai Co ltd
Current assignee: Heyuan Medical Device Shanghai Co ltd
Priority date: 2023-07-21
Filing date: 2023-07-21
Publication date: 2023-10-20
Anticipated expiration: 2043-07-21
Also published as: CN116602802A

Abstract

The present disclosure provides an implant and an implant system. The implant includes a stent, a wireless sensor, and a connector. The stent is used for being arranged at a target site to improve the physiological function of organisms. The bracket comprises a main body formed by a plurality of elastic curve sections and at least one joint section, wherein the joint section is arranged in a preset area of the main body and is connected with a part of at least one elastic curve section; the wireless sensor comprises a detection element and a wireless signal transmission element, wherein the detection element is used for acquiring a target physiological parameter, and the wireless signal transmission element is used for transmitting the target physiological parameter acquired by the detection element to the outside of the organism; the connecting piece is used for connecting the wireless sensor and the bracket; the connecting member includes a first connecting portion and a second connecting portion connected to each other, the first connecting portion connecting the wireless sensor, the second connecting portion connecting the joint section, so that the wireless sensor is attached to the outer peripheral surface of the bracket in a predetermined area.

Description

Implant and implant system

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to an implant and an implant system.

Background

Heart Failure (Heart Failure) is a clinical syndrome caused by ventricular filling and ejection dysfunction. Heart failure is mainly manifested by dyspnea, fatigue, fluid retention (pulmonary congestion, systemic congestion, peripheral edema), and the like. Heart failure can be divided into three categories, heart failure with a reduced ejection fraction, heart failure with a slightly reduced ejection fraction, and heart failure with a retained ejection fraction. Epidemiological investigation of heart failure in China revealed that the weighted heart failure prevalence was 1.3% and approximately 1370 ten thousand in residents over 35 years old in China. Of these, 52.7% of patients were heart failure with reduced ejection fraction, 23.9% of patients were heart failure with slightly reduced ejection fraction, and 23.4% of patients were heart failure with retained ejection fraction. In chronic heart failure patients with retained and reduced ejection fraction, sustained left atrial pressure elevation is the leading cause of pulmonary congestion, and 90% of heart failure patients are therefore admitted to treatment.

Atrial bypass is a means of improving left atrial hypertension by creating holes in the atrial septum to direct blood flow from the left atrium to the right atrium, thereby reducing left atrial burden. Atrial bypass is divided into implant bypass and non-implant bypass. Implant distraction requires the implant to be secured in an artificially created atrial septum to keep the holes from closing. Room space pore-forming and implant fixation are currently commonly performed by vascular interventional means. The specific process is that the instrument or the shunt is contained in the catheter, and the instrument or the shunt is delivered to the heart lesion site along with the catheter through the artery or the vein of the human body for operation. Because of the limited diameter of the vessel, the corresponding catheter diameter is limited, and therefore, the shunt needs to be maintained in a compressed state within the catheter, and then automatically or passively expanded to a predetermined size after being withdrawn from the catheter when delivered to the target site.

In addition to the shunt described above for heart failure patients, there are other stent-like implants suitable for placement in the heart or blood vessels for cardiovascular disease patients, such as those in which an occluder is required to perform cardiovascular function, and vascular stenting patients may be implanted with vascular stents. However, in addition to the treatment of the associated symptoms by the implant, monitoring of the patient's cardiovascular hemodynamic parameters is also significant. For example, pressure monitoring of the atria is also an important health management tool for heart failure patients, in addition to surgical treatment. However, how to combine pressure monitoring devices with these stent-like implants is a great technical difficulty in the art. The applicant has found that if the pressure monitoring device is mounted within a stent, since the stent is typically a mesh structure woven from metal wires or cut from tubing, the mesh structure may interfere with or even shield the wireless signal transmission of the pressure monitoring device. If the pressure monitoring device is axially arranged at the proximal end or the distal end of the stent, the pressure monitoring device can increase the overall structural length and prevent the normal flow of blood flow, thereby affecting the size of the stent port and generating the risk of long-term stenosis.

Disclosure of Invention

Accordingly, the present disclosure provides an implant and implant system that address at least some of the above issues.

In a first aspect, the present disclosure provides an implant for implantation at a target site within a living being, comprising a stent, a wireless sensor, and a connector. The stent is used for being arranged at a target position to improve the physiological function of a living body, the stent comprises a main body formed by a plurality of elastic curve sections, the plurality of elastic curve sections comprise at least one joint section, and the joint section is arranged at a preset area of the main body and is connected with a part of at least one elastic curve section; the wireless sensor comprises a detection element and a wireless signal transmission element, wherein the detection element is used for acquiring a target physiological parameter, and the wireless signal transmission element is used for transmitting the target physiological parameter acquired by the detection element to the outside of the organism; the connecting piece is used for connecting the wireless sensor and the bracket; the connecting member includes a first connecting portion and a second connecting portion connected to each other, the first connecting portion connecting the wireless sensor, the second connecting portion connecting the joint section, so that the wireless sensor is attached to the outer peripheral surface of the bracket in a predetermined area.

In one possible implementation, the second connection portion includes a clamped portion, and the engagement section is inserted into the second connection portion to clamp the clamped portion; the engagement section is integrally formed with the portion of at least one of the elastic curved sections, the engagement section forcing the clamped portion against the outer peripheral surface of the main body by its own elastic force, and/or the engagement section forcing the clamped portion against the outer peripheral surface of the main body by an adhesive.

In combination with the above possible implementation, in another possible implementation, the bracket is disposed side by side with the wireless sensor.

In combination with the possible implementation manner described above, in another possible implementation manner, the second connection portion includes a sheet portion having an edge portion forming a clamped portion, and the joint section is connected to the sheet portion in the form of a clamped edge portion.

In combination with the above possible implementation manner, in another possible implementation manner, the edge portion is located at an edge region of the sheet portion or at an edge region of an opening formed on the sheet portion.

With reference to the foregoing possible implementation manner, in another possible implementation manner, the connection piece is an annular sleeve, a part of the annular sleeve is a first connection portion, and another part of the annular sleeve is a second connection portion; the edge portion of the sheet portion is formed by an edge portion of the annular sleeve, or the annular sleeve is provided with an opening, and the edge portion of the sheet portion is formed by an edge portion of the opening.

In combination with the foregoing possible implementation manner, in another possible implementation manner, the annular sleeve at least partially overlaps the wireless signal transmission element in an axial direction, the annular sleeve is a non-metal sleeve, a cross section of the non-metal sleeve is a closed structure or a non-closed structure, or the annular sleeve is a metal sleeve, and a cross section of the metal sleeve is a non-closed structure.

In combination with the above possible implementation manner, in another possible implementation manner, the annular sleeve completely covers the wireless sensor in the axial direction, and the detecting element is exposed at the end face of the wireless sensor, and is used for detecting the pressure.

In combination with the possible implementation manner described above, in another possible implementation manner, the elastic curved segment forms the body by extending in the circumferential direction and in the axial direction, and the elastic curved segment comprises at least a wave segment, a portion of which forms the engagement segment.

In combination with the possible implementations described above, in another possible implementation, the predetermined trough and/or crest portions of the wave segments form the engagement segments.

In combination with the foregoing possible implementation manner, in another possible implementation manner, the joint section includes a first joint section and a second joint section, and the second connection portion includes a clamped portion, and the first joint section and the second joint section clamp the clamped portion from two opposite directions, respectively.

In combination with the foregoing possible implementation manner, in another possible implementation manner, the elastic curve section forms the main body by extending in a circumferential direction and an axial direction, and the elastic curve section includes at least a wave section, a predetermined portion of the wave section has a detour section, the detour section is broken in the middle and forms a first joint section and a second joint section, the first joint section and the second joint section include bent and folded ends, and the bent and folded ends of the first joint section and the second joint section are respectively nested with each other.

With reference to the foregoing possible implementation manner, in another possible implementation manner, the connection piece is an annular sleeve, a part of the annular sleeve is a first connection portion, and another part of the annular sleeve is a second connection portion; the annular sleeve is provided with a first opening and a second opening which have a preset interval in the axial direction, and the first joint section and the second joint section are respectively inserted between the annular sleeve and the wireless sensor through the first opening and the second opening.

In combination with the above possible implementation manner, in another possible implementation manner, the stent is an atrial shunt, the main body is a cylinder for shunt, and the cylinder is formed by extending the elastic curve section in a ring-shaped and/or spiral form.

In combination with the possible implementation manner described above, in another possible implementation manner, the cylinder is a mesh structure formed by elastic curved sections, and the cylinder is configured to be elastically deformable in a radial direction and to keep the circumference unchanged.

In combination with the above possible implementation manner, in another possible implementation manner, the cylinder is configured to be capable of being resiliently compressed in the first radial direction in the limited space, and/or the cylinder is configured to have a C-shape in cross-section when compressed in the first radial direction in the limited space.

In combination with the foregoing possible implementation manner, in another possible implementation manner, the wireless sensor is parallel to the main body, and/or the wireless sensor is connected with the main body in an circumscribed manner.

In combination with the foregoing possible implementation manner, in another possible implementation manner, the support further includes a clamping arm set, where the clamping arm set includes at least a first clamping arm and a second clamping arm, the first clamping arm and the second clamping arm are distributed at the periphery of the main body along an axial direction of the main body at intervals, and the first clamping arm and the second clamping arm respectively form a cantilever protruding from the periphery of the main body.

In combination with the foregoing possible implementation manner, in another possible implementation manner, the first clamping arm and/or the second clamping arm are formed by bending a resilient wire, and/or the first clamping arm and/or the second clamping arm have a U-shaped or V-shaped structure formed by folding the resilient wire after extending a predetermined distance in a radial direction.

In combination with the possible implementation manner, in another possible implementation manner, the elastic wire forming the first clamping arm and/or the second clamping arm and the elastic wire forming the cylinder body to which the base of the first clamping arm and/or the second clamping arm is attached are the same elastic wire, and/or the first clamping arm and/or the second clamping arm have a predetermined distance from the end of the cylinder body respectively adjacent.

In combination with the foregoing possible implementation manner, in another possible implementation manner, the free end of the first clamping arm overlaps the free end of the second clamping arm in an axial projection, and the fixed end of the first clamping arm and the fixed end of the second clamping arm are staggered in the axial projection.

In combination with the foregoing possible implementation manner, in another possible implementation manner, the stent further includes a cover film, the cover film is applied to the inside and/or the outside of the main body, and the cover film has a notch exposing the joint section when the cover film is applied to the outside of the main body.

In combination with the above possible implementation manner, in another possible implementation manner, the connecting piece is made of a high polymer material, and the wireless sensor and the bracket are fixed through a thermal shrinkage process.

In a second aspect, an implant system is provided that includes a delivery catheter and an implant. The implant of any one of the first aspects is in a compressed state when the implant is disposed within a catheter, the stent is compressed into a configuration having a C-shaped cross-section, the outer surface of the compressed stent at least partially encloses the wireless sensor, and the implant is capable of protruding from the catheter.

In a possible implementation, the implant further comprises a signal receiving device for receiving a signal of the wireless sensor in the implant.

The present disclosure provides implants for implantation at a target site within a living being. The implant includes a stent, a wireless sensor, and a connector. A stent for attachment to a target site to improve a physiological function of a living being, the stent comprising a body formed of a plurality of elastic curve segments, at least one engagement segment disposed in a predetermined region of the body and connected to a portion of at least one of the elastic curve segments; the wireless sensor comprises a detection element and a wireless signal transmission element, wherein the detection element is used for acquiring a target physiological parameter, and the wireless signal transmission element is used for transmitting the target physiological parameter acquired by the detection element to the outside of the organism; the connecting piece is used for connecting the wireless sensor and the bracket; the connecting member includes a first connecting portion and a second connecting portion connected to each other, the first connecting portion connecting the wireless sensor, the second connecting portion connecting the joint section, so that the wireless sensor is attached to the outer peripheral surface of the bracket in a predetermined area. The wireless sensor is arranged on the periphery of the bracket, so that the bracket cannot shield wireless signals. Further, the wireless sensor is fixed to the surface of the bracket through the cooperation of the joint section connected with the elastic curve section and the connecting piece, and the connecting structure is simple, reliable and compact.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings that are required to be used in the embodiments will be briefly described below.

It is appreciated that the following drawings depict only certain embodiments of the disclosure and are not to be considered limiting of its scope.

It should also be understood that the same or similar reference numerals are used throughout the drawings to designate the same or similar elements.

It should also be understood that the drawings are merely schematic and that the dimensions and proportions of the elements in the drawings are not necessarily accurate.

Fig. 1 is a schematic diagram of a structure of a target site in an organism according to an embodiment of the disclosure.

Fig. 2 is a schematic structural view of an implant according to an embodiment of the present disclosure.

Fig. 3 is a schematic view of the implant of fig. 2 after the wireless sensor has been obscured.

Fig. 4 is an enlarged partial schematic view of the attachment member to the bracket of fig. 2.

Fig. 5 is an end elevation view of the implant of fig. 1.

Fig. 6 is a schematic view of a compressed state of an implant positioned in a delivery tube according to an embodiment of the present disclosure.

Fig. 7 is a schematic cross-sectional view of the delivery tube and implant of fig. 6.

Fig. 8 is a schematic view of a delivery tube containing an implant as it reaches a target site.

Fig. 9 is a schematic view of an implant with one end and some gripping arms extending from the delivery tube.

Fig. 10 is a schematic view of the delivery tube retracted with the gripping arms of the implant reaching the atrial septum surface.

Fig. 11 is a schematic view with the delivery tube removed to allow the implant to be mounted to a target site.

Fig. 12 is a schematic structural view of an implant according to another embodiment of the present disclosure.

Fig. 13 is another angular view of the implant of fig. 12.

Fig. 14 is an enlarged view of the connection structure of the connector of fig. 12 with the engagement section of the body.

Fig. 15 is a schematic view of the body and the covering membrane of the implant of fig. 12.

Fig. 16 is a schematic view of the structure of a wireless sensor, a connector and an engagement section in an implant according to another embodiment of the present disclosure.

Fig. 17 is a schematic view of the structure of a wireless sensor, a connector and an engagement section in an implant according to another embodiment of the present disclosure.

Fig. 18 is a schematic view of the structure of a wireless sensor, a connector and an engagement section in an implant according to another embodiment of the present disclosure.

Fig. 19 is a schematic view of the structure of a wireless sensor, a connector and an engagement section in an implant according to another embodiment of the present disclosure.

Fig. 20 is a schematic view of the structure of the wireless sensor, the connector and the joint section in an alternative embodiment.

FIG. 21 is a schematic view of an alternative embodiment of a connector structure.

Fig. 22a is a schematic longitudinal cross-sectional shape of a stent in an alternative embodiment.

Fig. 22b is a schematic longitudinal cross-sectional shape of a stent in another alternative embodiment.

Fig. 22c is a schematic longitudinal cross-sectional view of another alternative embodiment of a stent.

Fig. 22d is a schematic longitudinal cross-sectional view of another alternative embodiment of a stent.

Fig. 22e is a schematic longitudinal cross-sectional shape of a stent in another alternative embodiment.

Detailed Description

Embodiments of the present disclosure are exemplarily described below with reference to the accompanying drawings. It should be understood that the implementations of the present disclosure may be varied and should not be construed as limited to the embodiments set forth herein, which are presented only to provide a more thorough and complete understanding of the present disclosure.

It should be understood that the term "include" and variations thereof as used in this disclosure are intended to be open-ended, i.e., including, but not limited to. The term "according to" is based, at least in part, on.

It should be understood that, although the terms "first" or "second," etc. may be used in this disclosure to describe various elements, these elements are not limited by these terms, these terms are merely used to distinguish one element from another element.

Embodiments of the present disclosure provide an implant for implantation in a living organism to improve a physiological function of the living organism while acquiring a target physiological parameter. The implant includes a stent, a wireless sensor, and a connector. The stent is used for being arranged at a target site to improve the physiological function of organisms. The stent can be a net-shaped structure body such as a shunt, an occluder or a vascular stent. The stent comprises at least a main body formed of a plurality of elastic curvilinear segments. The "elastic curve segment" refers to a wire segment which has elasticity and is curved as a whole, but the partial area of the "elastic curve segment" can still be in a straight line shape, and a plurality of elastic curve segments can also be formed by the same wire or a plurality of different wires, such as metal wires, for example, the invention is not limited to this. The wireless sensor comprises a detection element and a wireless signal transmission element which are electrically connected. The detection element is used for obtaining the target physiological parameter. The wireless signal transmission element is used for transmitting the target physiological parameter obtained by the detection element to the outside of the organism. The connecting piece is used for connecting the wireless sensor and the bracket, and enables the wireless sensor to be arranged outside the bracket and to be abutted against the outer peripheral surface of the bracket. By means of the arrangement, the support cannot influence signal transmission of the wireless sensor, the wireless sensor cannot influence port sizes at two ends of the support, and particularly when the support is a shunt, shunt capacity of the support cannot be influenced.

The bracket can be fixed with the wireless sensor in various modes such as pressure welding, bonding, suture connection, welding and the like. In this embodiment, the bracket and the wireless sensor are fixed by a specially designed connecting piece, the connecting piece includes a first connecting portion and a second connecting portion which are connected to each other, the first connecting portion is connected to the wireless sensor, and the second connecting portion is connected to the elastic curve section of the bracket. Specifically, the bracket further comprises at least one joint section which is arranged in a preset area of the main body and is connected with a part of at least one elastic curve section, the joint section is inserted into the second connecting part to enable the connecting piece to be attached to the surface of the bracket in the preset area, and the wireless sensor is kept at the periphery of the bracket through the connecting piece and is arranged approximately side by side with the bracket. The wireless sensor is fixed to the surface of the bracket through the cooperation of the joint section connected with the elastic curve section and the connecting piece, the connecting structure is simple, reliable and compact, the elastic curve section is a part of the bracket, other structures are not required to be additionally arranged for connection with the connecting piece, the radial size of the implant is not remarkably increased, and the risk of thrombus generation is further reduced.

Fig. 1 is a schematic structural view of an in-vivo target site m1 according to an embodiment of the present disclosure. Specifically, the target site m1 is a hole located on the atrial septum m2 between the left atrium and the right atrium. The hole may be an patent foramen ovale or an artificial hole. For some heart failure patients, the hole can reduce left atrium pressure and relieve heart failure symptoms. The stent provided by the embodiments of the present disclosure is a shunt that may be disposed in the hole to maintain the shape of the hole, directing blood flow from the left atrium to the right atrium. Preferably, the wireless sensor is disposed at an intermediate position of the outer peripheral surface of the shunt, so that when the implant in the present embodiment is disposed on the atrial septum m2, the wireless sensor is disposed in the target site m1 together with the stent and is abutted against the target site. Further, two detection elements may be provided at both ends of the wireless sensor, thereby simultaneously acquiring pressures of the left atrium and the right atrium.

Referring to fig. 2 to 5, fig. 2 to 5 are schematic structural views of an implant according to an embodiment of the present disclosure. The implant in this embodiment includes a stent 100 and a wireless sensor 200. Fig. 2 is a schematic structural view of an implant according to an embodiment of the present disclosure. Fig. 3 is a schematic view of the implant of fig. 2 after the implant conceals the wireless sensor 200. Fig. 4 is an enlarged partial view of the connection of the connector 300 and the bracket 100 in fig. 2. Fig. 5 is an end elevation view of the implant of fig. 1.

The implant includes a stent 100, a wireless sensor 200, and a connector 300. The bracket 100 and the wireless sensor 200 are arranged side by side, and the connector 300 connects the two together. It should be understood that the "side-by-side arrangement" of the present invention is not limited to a parallel arrangement, and includes the stand 100 and the wireless sensor may also be in a positional relationship (but not a vertical positional relationship) having a predetermined angle. Of course, it is preferable that the bracket 100 and the wireless sensor 200 are disposed in parallel, and as shown in fig. 5, when the main body of the bracket is in a cylindrical structure and the wireless sensor 200 is also in a cylindrical structure, the wireless sensor 200 and the bracket 100 take on an circumscribed form under the action of the joint section and the connector. By such design, the implant can have smaller radial dimension in the conveying process, and is convenient to be pressed and held in the conveying device.

In the present embodiment, the stent 100 includes a main body 110, a first clamping arm 112, a second clamping arm 113, and a cover 120. The main body 110 is a tubular structure formed by braiding metal wires, and is substantially cylindrical. The coating 120 is applied to the inner surface of the main body 110. The first clamping arm 112 and the second clamping arm 113 extend radially outwardly from the surface of the body 110 to form a cantilevered structure. The first clamping arm 112 and the second clamping arm 113 form at least one clamping arm set for being distributed on both sides of the atrial septum m2 to clamp the atrial septum m2. The main body 110, the first clamping arm 112 and the second clamping arm 113 are formed by winding and bending the elastic curve section 101. Specifically, the main body 110 is divided into an upper stage cylinder and a lower stage cylinder. The number of the first clamp arms 112 and the second clamp arms 113 is 3. The 3 first clamping arms 112 are uniformly distributed on the surface of the upper section cylinder. The 3 second clamping arms 113 are uniformly distributed on the surface of the lower section cylinder. Part of the elastic curve section 101 extends in a wavy manner in the axial direction and simultaneously extends in the circumferential direction to form a net-shaped cylinder; the other part of the elastic curve section 101 extends outwards from the surface of the net-shaped cylinder in the radial direction and then folds back to the surface of the cylinder to form a U-shaped clamping arm.

In some alternative embodiments, the body 110 may also be cut from metal. The number of each of the first clamp arm 112 and the second clamp arm 113 may be greater than 3 or less than 3, for example, 2, as long as the clamping function can be achieved. The elastic curve segment 101 may take other forms, as well, and the invention is not limited in this regard.

Further, 3 first clamping arms 112 and 3 second clamping arms 113 form three clamping arm groups. The first clamping arm 112 and the second clamping arm 113 of each clamping arm group are axially spaced apart. The first clamping arm 112 has a predetermined distance from a first end (upper end in fig. 2) of the body 110. The second clamping arm 113 has a predetermined distance from the second end (lower end in fig. 2) of the body 110. The free ends of the first clamping arm 112 and the second clamping arm 113 overlap in axial projection, and the fixed ends of the first clamping arm 112 and the second clamping arm 113 are staggered in axial projection, so that a larger clamping area (the area of a clamping area formed by the first clamping arm 112 and the second clamping arm 113 together) is realized, and a better clamping effect is obtained. The fixed end of the first clamping arm 112 and the fixed end of the second clamping arm 113 are ends of the first clamping arm 112 and the second clamping arm 113 connected with the main body 110. The upper section cylinder and the lower section cylinder are coaxially distributed and can be connected through a covering film 120 and/or an elastic curve section. The elastic curve section of the lower section cylinder extends in a circumferential direction in an annular form at the initial stage, and extends upwards in a spiral form after one turn. The elastic curve section of the upper section cylinder extends upwards in a spiral form in the circumferential direction at the initial stage, and the last circle extends in an annular form. In the above embodiment, the axial distance of the clamp arm was 3mm. The axial distance may be selected in the range of greater than 0mm and less than or equal to 3mm. In the above embodiment, the elastic wire constituting the clamp arm and the elastic wire of the cylinder body to which the clamp arm base is attached are the same elastic wire. In some alternative embodiments, the clamping arms may be separate U-shaped or V-shaped pieces welded to the resilient curved sections of the barrel.

The design of the clamping arm in this embodiment is different from the anchoring design of the kidney-shaped or flange plate structure in the prior art, so that the volume of the shunt device in the cavity and the contact area with the anchoring point can be effectively reduced, adverse effects on blood flow are avoided, and the main body can be stably anchored in the target part.

In this embodiment, the length of the covering film 120 is equal to the sum of the lengths of the upper section cylinder and the lower end cylinder, and since the covering film 120 has a cylindrical structure with a certain strength, the strength of the main body 110 and the connection strength between the upper section cylinder and the lower end cylinder can be enhanced when the covering film is laid on the inner/outer surface of the main body 110, and the predetermined shape of the elastic curve section can be maintained, so that the shape of the main body 110 is maintained. The coating 120 makes the inner cavity of the cylinder smooth, prevents hyperplasia of septum from blocking the cylinder cavity, and keeps the cylinder cavity smooth. The material of the covering film 120 may be a polymer material or a biological material, and is not limited to terylene, polytetrafluoroethylene, animal pericardium, and the like. The surface of the cover film 120 may be provided with a coating to improve surface finish to improve long-term patency. In some alternative embodiments, the cover 120 may also be disposed on the outer surface of the body 110. In other alternative embodiments, both the inner and outer surfaces of the body 110 may be provided with a layer of coating 120. Another benefit of the cover 120 is that it creates an insulating effect that can isolate the body 110 from the wireless sensor 200 to some extent, avoiding signal interference. The cover film 120 and the main body 110 may be connected by hot pressing or sewing. In order to more clearly distinguish the cover film 120 from the main body 110, the thickness dimension of the cover film 120 is intentionally enlarged and the cover film 120 is drawn on the inner surface of the main body 110, with the actual thickness being smaller than the illustrated dimension.

It will be appreciated by those skilled in the art that although in the present embodiment the bracket 100 is connected to the wireless sensor 200 via the connector 300, in other embodiments the bracket 100 may be used as a separate shunt.

In this embodiment, the joint section includes a first joint section and a second joint section, which are respectively integrally formed with respective portions of the two elastic curve sections, in other words, the first joint section is formed by a natural extension of a portion of the elastic curve section, and the second joint section is formed by a natural extension of a portion of the other elastic curve section. Referring to fig. 3 and 4, in the middle of the main body 110, a first engagement section 114 is formed at an initial section (upper side) of the elastic curve section of the lower section cylinder, and a second engagement section 115 is formed at an end section (lower side) of the elastic curve section of the upper section cylinder.

Referring to fig. 2, the wireless sensor 200 includes a detecting element 210 and a wireless signal transmitting element 220. The detection element 210 may be a pressure detection element, which may measure, for example, the pressure of the blood flow. A sensing element 210 is provided at one end of the wireless sensor 200 for monitoring the pressure of the left atrium. The wireless signal transmission element 220 is used for transmitting the signal collected by the detection element 210 to the outside of the human body in the form of electromagnetic waves. The detection element 210 and the wireless signal transmission element 220 are packaged as one body by a sealing structure. In other embodiments, two detection elements 210 may also be provided at both ends of the wireless sensor 200, thereby detecting the pressure of the left atrium and the right atrium, and a wireless signal transmission element 220 is provided between the two detection elements 210.

Referring to fig. 3 and 4, in the present embodiment, the connecting member 300 is an annular sleeve, and a partial section of the annular sleeve protrudes slightly outwards to form the second connecting portion 320, and the other parts except the second connecting portion 320 are the first connecting portion 310. The second connection part 320 may be formed by being pulled by the bracket 100 and the wireless sensor 200 after the connection member 300 connects them, or may be a permanent protrusion provided at the time of manufacturing. The first connection portion 310 is wound around the middle of the wireless sensor 200. The second connecting portion 320 is integrally formed in a sheet structure, and includes a sheet portion 321. The sheet portion 321 is substantially rectangular. The sheet portion 321 has two parallel edges, an upper edge and a lower edge perpendicular to the axis of the annular sleeve. The upper edge and at least part of the area adjacent thereto form one edge portion 322 and the lower edge and at least part of the area adjacent thereto form another edge portion 322. The two edge portions 322 are intended to be clamped by the first joint section 114 and the second joint section 115, i.e. the two edge portions 322 form a clamped portion 323.

In this embodiment, the width (dimension in the axial direction) of the annular sleeve is small, and the lengths of the first joint section 114 and the second joint section 115 are large, so that the first joint section 114 and the second joint section 115 each hold two edge portions 322, that is, the first joint section 114 and the second joint section 115 hold the entire axial direction region of the sheet portion 321. In some alternative embodiments, the axial dimension of the sheet portion 321 is larger and/or the length of the first engagement section 114 and/or the second engagement section 115 is smaller, the first engagement section 114 may grip only the lower edge-corresponding edge portion 322 and the second engagement section 115 may grip only the upper edge-corresponding edge portion 322. The second connection part 320 protrudes to a small height with respect to the overall size of the connection member. In some alternative embodiments, the first connecting portion may also be a complete cylindrical structure, and the second connecting portion 320 may be regarded as being disposed in a manner conforming to the outer contour of the first connecting portion 310, so that the dimensions of the second connecting portion 320 and the first connecting portion 310 in the radial direction do not significantly increase. The bonding referred to herein may be such that two adjacent surfaces are in contact with each other (but may be separated by an external force, such as by insertion of a joint), or may be such that two adjacent surfaces have a small distance to allow insertion of a first joint.

By the above connection, the second connection portion 320 of the connector 300 is clamped between the first joint section 114, the second joint section 115 and the cover film 120, which corresponds to pressing the second connection portion 320 against the surface of the main body 110; the cradle 100 is connected together in parallel and circumscribed with the wireless sensor 200. Also, the first joint section 114 and the second joint section 115 are also sandwiched between the wireless sensor 200 and the second connection portion 320. The connection is simple and reliable, and the assembly connection of tiny components such as the shunt is facilitated. And the first joint section 114 and the free end of the second joint section 115 are directed in opposite directions, and the second connection part 320 is prevented from falling off in the axial direction. The engagement section of the surface of the bracket 100 clamps the connection mode of the sheet structure of the surface of the wireless sensor 200, and the size of the connection structure in the radial direction is small, so that the wireless sensor 200 can be allowed to be tightly connected with the bracket 100, and the radial dimension of the whole implant is not excessively large.

The shape of the connector 300 is not limited to the configuration described in the foregoing embodiment, as long as the first connector 310 can be fixedly connected to the wireless sensor 200, and the second connector 320 can be provided so as to be bonded to the surface of the first connector 310 and can be held by the joint section of the main body 110. Thus, the first connection portion 310 may also be an annular structure with an opening, which may pinch the wireless sensor 200; or a closed or non-closed box-like structure adapted to the shape of the wireless sensor 200, which can house the wireless sensor 200; or a structure for adapting to the connected portion of the wireless sensor 200, such as a structure with a buckle, a thread, or an adhesive surface (of course, the wireless sensor itself needs to be provided with a corresponding matching structure such as a clamping groove, a thread, or an adhesive surface); and the second connection portion 320 may be an arch structure or a cantilever structure, etc., which can be clamped by the joint section.

Preferably, the connecting member 300 is a sleeve, and one part thereof is a first connecting portion and the other part thereof is a second connecting portion. When the connection member 300 and the wireless signal transmission element 220 at least partially overlap in the axial direction, the connection member 300 is a non-metal sleeve, and the cross section of the non-metal sleeve is a closed structure (e.g., an O-shaped structure) or an unsealed structure (e.g., a C-shaped structure), so that the influence of the connection member 300 on signal transmission itself can be avoided; or the annular sleeve is a metal sleeve, the cross section of the metal sleeve is of a non-closed structure, and the influence of the connecting piece 300 on signal transmission can be avoided; when the connector 300 and the wireless signal transmission element 220 are not overlapped in the axial direction, the material of the connector 300 is not limited.

Referring to fig. 11, the implant is shown mounted to a target site. The target site m1 is a hole communicating the left atrium and the right atrium. The implant is integrally inserted into the hole and is clamped on the septum primum tissue by the first clamping arm 112 and the second clamping arm 113 to prevent the implant from axially coming out of the target site m1. The detecting element 210 is located in the left atrium, and is capable of detecting the blood pressure of the left atrium. When the left atrium contracts, there is a portion of the blood flow that passes through the lumen of the stent 100 into the right atrium in addition to entering the left ventricle. The wireless sensors 200 are arranged side by side outside the stent 100, so that the wireless sensors 200 do not obstruct blood flow in the lumen or at both ends of the stent 100; the stent 100 does not surround the wireless sensor 200 and therefore does not impede wireless signal transmission, and the wireless sensor 200 can be mounted side-by-side with the stent 100 in the atrial septum, without taking up too much atrial space as in the conventional axial series approach. The connector 300, by being tightly connected with the engagement section of the stent 100, enables the stent 100 and the wireless sensor 200 to tightly abut against each other, not only can enhance the connection strength of the two, but also can reduce the radial dimension of the two, thereby facilitating the operation of transvascular interventional implantation.

Reference is made to fig. 6 and 7. Fig. 7 is a schematic view of the implant according to the previous embodiment in a compressed state in a delivery tube. Fig. 8 is a schematic cross-sectional view of the delivery tube and implant of fig. 7. The stent 100 of the implant is formed of a resilient curved section 101 so that the whole can be deformed under compression by an external force and restored to its original shape after the external force is removed. The implant forms an implant system with the delivery tube for the interventional procedure.

In the implant, the elastic curve segments form the body of the stent 100, such that the stent 100 is elastic in its entirety. When the wireless sensor 200 is pressed against the holder 100 in the direction of the central line between the wireless sensor 200 and the holder 100, the holder 100 may be compressed, i.e., the holder 100 may be elastically deformed in the first radial direction within the restricted space (the radial dimension in the direction of the application of force decreases, the radial dimension perpendicular to the direction of the application of force increases, and the "first radial direction" herein refers to the radial direction coincident with the direction of the application of force), and the wireless sensor 200 may be partially embedded in the recessed region of the holder 100. After the external force is removed, the bracket 100 will recover its original shape and the positional relationship with the wireless sensor 200 will be recovered. During the process of placing the implant into the delivery tube 400, the wall of the delivery tube 400 applies pressure to the stent 100 and the wireless sensor 200 in both the direction along the line connecting the wireless sensor 200 to the center of the stent 100 and the direction perpendicular thereto, so that the stent 100 is compressed in the first radial direction into a state in which the cross section is C-shaped, and the wireless sensor 200 is partially embedded in the concave portion of the stent 100. The first clamp arm 112 and the second clamp arm 113 are pressed down along the longitudinal section to be close to the surface of the bracket 100, that is, the free ends of the first clamp arm 112 and the second clamp arm 113 are respectively close to each other in the extending direction of the both ends of the bracket 100. The radial overall size of the implant after placement into delivery tube 400 is compressed; because the compression deformation form is that the cylinder is flattened, the circumference of the cylinder is unchanged. Rather than by axial elongation, the radial dimension reduction is achieved so that the axial dimension of the implant does not change significantly. Shorter length implants may facilitate bending of delivery tube 400 and facilitate the implantation process.

Referring also to fig. 8-10, a surgical procedure for implanting a shunt into a target site via an interventional catheter is illustrated. Fig. 8 is a schematic view of the implant-containing delivery tube 400 as it reaches the target site m 1. Fig. 9 is a schematic view of the implant with one end and first clamping arm 112 extended from delivery tube 400. Fig. 10 is a schematic view of the delivery tube 400 retracted to allow the first clamping arm 112 of the implant to reach the surface of the interatrial septum m 2. Fig. 11 is a schematic view with the delivery tube 400 removed to allow the implant to be mounted to the target site m 1.

One end of the delivery tube 400 containing the implant is passed through the thicker blood vessel of the human body into the right atrium and through the hole in the atrial septum m2 into the left atrium. In this position, one end of the implant is extended from the end of the delivery tube 400 by retracting the delivery tube or pushing the implant outward, and the first clamping arm 112 is deployed in a cantilevered state. After deployment of the first clamping arm 112, the overall radial dimension of the implant is greater than the diameter of the hole in the atrial septum m 2. The delivery tube is then withdrawn and the implant is moved with the catheter until the first clamping arm 112 contacts the atrial septum m 2. Continuing to retract the delivery tube 400 again, the implant will remain in this position without retracting with the delivery tube 400 due to the obstruction of the atrial septum m 2. After the implant is completely detached from the delivery tube 400, the second clamp arm 113 is also deployed, and the second clamp arm 113 and the first clamp arm 112 retain the stent 100 and the wireless sensor 200 in the hole of the atrial septum m 2. And the stent 100 resumes its original shape radially with its lumen available for blood flow from the left atrium into the right atrium. After the bracket 100 is in place, the detecting element 210 of the wireless sensor 200 can monitor the blood pressure of the left atrium in real time and transmit the relevant information to an external receiving device through the wireless signal transmitting element 220.

Refer to fig. 12 to 15. Fig. 12 is a schematic structural view of an implant according to another embodiment of the present disclosure. Fig. 13 is another angular view of the implant of fig. 12. Fig. 14 is an enlarged view of the connection structure of the connection member and the joint section of fig. 12. Fig. 15 is a schematic structural view of the body of the implant of fig. 12. The implant in this embodiment is substantially identical in structure to the implant in the previous embodiments, such as the first clamping arm 112a, the second clamping arm 113a, and the cover film are identical in construction to the first clamping arm 112, the second clamping arm 113, and the cover film 120, with the primary differences in the structure of the connector and the structure of the engagement section on the corresponding body. The sensor is omitted from the schematic diagram of the present embodiment for convenience in explaining the structure of the connector.

In this embodiment, the elastic curve segment 101a extends in the circumferential direction and the axial direction to form the main body of the stent 100a, and the elastic curve segment is entirely wavy and includes a plurality of wavy segments 102a. Wherein the trough portion 114a of one wave segment 102a in the middle of the bracket 100a forms a first engagement segment and the crest portion 115a of another wave segment 102a in the middle of the bracket 100a forms a second engagement segment. The areas of the valley portions 114a and the peak portions 115a clamped in the axial direction and the circumferential direction are larger, the strength and the clamping force are larger, and a more stable connection can be formed.

The connecting member 300a is a ring-shaped sleeve member having both ends penetrating. The width (axial dimension) of the annular sleeve in this embodiment is greater than the width of the annular sleeve in the embodiment shown in fig. 2. The annular sleeve comprises two parts, one part is a sleeve body with a half-open two-thirds circular ring in section, and the sleeve body forms a first connecting part 310a; the other part is a substantially rectangular sleeve body having a semi-open cross section, which forms the second connecting portion 320a. Of course, in other embodiments, a septum may be provided at the junction between the two to divide the housing into two chambers. The first connection portion 310a is disposed around the wireless sensor. The second connection portion 320a is used for clamping the first joint segment 114a (the valley portion) and the second joint segment 115a (the peak portion). The second connection portion 320a is a substantially rectangular piece of film that is pressed against the surface of the main body 100a by the first engagement section 114a (valley portion) and the second engagement section 115a (peak portion). The second connection portion 320a may be further bonded or sewn to the cover film 120a to enhance the connection strength.

Referring to fig. 16, fig. 16 is a schematic structural view of a connector 300b and a joint segment 114b in an implant according to another embodiment of the present disclosure. To more clearly express the connection relationship of the connection member and the joint section, only a part of the elastic curve section structures in the sensor 200b, the connection member 300b and the bracket are shown in the present embodiment, and other structures are omitted. The connector 300b is an annular sleeve formed of a polymer material. The upper and lower edges of a portion of the annular sleeve and the area therebetween form a clamped portion, in this embodiment a second connection portion. Another part of the annular set is a first connection, which is fixed around the middle of the sensor 200 b. The engagement section 114b in the bracket is an inverted V-shaped structure formed by bending an elastic curved section, which is interposed between the second connection portion and the sensor 200b from the lower edge of the second connection portion. The length of the engagement section 114b is greater than the axial dimension of the connector 300b, so that one end of the engagement section 114b extends from between the connector 300b and the sensor 200 b.

Referring to fig. 17, the structure of the sensor 200b, the connector 300b and the joint section 114b shown in fig. 17 is substantially the same as that shown in fig. 16, except that the tip and both base ends of the joint section 114b are sewn to the cover film of the shunt holder (not shown) by a sewing structure 600.

Referring to fig. 18, fig. 18 is a schematic view of the structure of a connector and a joint section in an implant according to another embodiment of the present disclosure. In this embodiment, sensor 200c is captured by connector 300c, and connector 300c is coupled to first coupling segment 114c and second coupling segment 115 c. Specifically, the second connection portion of the connection member 300c is provided with two slit-shaped openings 324c, and the two openings 324c are parallel to the edge of the connection member 300c and have a predetermined distance in the axial direction. The first engaging section 114c is a trough portion, and the second engaging section 115c is a crest portion, which are disposed opposite to each other. The first joint section 114c and the second joint section 115c are inserted from the two openings 324c between the connector 300c and the sensor 200 c. The respective edges of the two openings 324c and the area therebetween are clamped portions.

Referring to fig. 19, fig. 19 is a schematic view of the structure of a connector and a joint section in an implant according to another embodiment of the present disclosure. The sensor 200d and the connector 300d in this embodiment are identical to the corresponding structure shown in fig. 17, except that the first joint section 114d and the second joint section 115d are different. The first joint section 114d and the second joint section 115d in this embodiment are similar in structure to the joint section shown in fig. 3, but are different from the joint section of a single rod in that in this embodiment, the ends of the elastic curve sections are extended in the length direction thereof and folded back to form a U-shaped joint section by causing the elastic curve sections to be broken at the wavy sections. And the first joint section 114d and the second joint section 114d formed by folding back the both ends overlap in the length direction and are embedded in each other in the radial direction. The specific manufacturing process can be that two metal wires are respectively bent and then embedded together, or that a part of detour section is arranged on the same metal wire in the winding process, and the middle part of the detour section is cut or one section is cut off, so that the detour section forms two joint sections with U-shaped structures.

Referring to fig. 20, fig. 20 is a schematic view of the structure of a connector 300d and a joint according to an alternative embodiment. The connection shown in fig. 20 is similar to that shown in fig. 19, except that the first engagement section 114d and the second engagement section 115d are not inserted from the edge of the connector 300d between the connector 300d and the sensor 200d, but are inserted from two openings 324d provided in the connector 300 d. Both openings 324d are rectangular, and have a predetermined distance in the axial direction. In the connection shown in fig. 19, the first joint section 114d and the second joint section 115d located below the connection 300d cannot be connected to the coating film on the stent, so that the strength of the stent is weak there. By providing the opening 324d in the connector 300d, the length of the first and second joint segments 114d, 114d covered by the connector 300d may be reduced, thereby allowing more area of the joint segments to be connected to the cover, avoiding significant weakening of the stent at that location. In addition, since the first joint section 114d and the second joint section 114d have U-shaped bent structures, they have a larger area to clamp the connecting member 300d, and the connection strength with the connecting member can be further improved. In some alternative embodiments, an adhesive connection may be further provided between the first and second engagement sections 114d, 114d and the connector 300 d.

Referring to fig. 21, a schematic structural view of an alternative embodiment of the connector 30 is shown. The connection member 30 includes a first connection portion 31 and a second connection portion 32. The structure of the connector 30 in this embodiment is substantially identical to the structure of the connector 300 shown in fig. 2, except that it has a larger axial dimension so as to completely axially surround the wireless sensor. This arrangement allows for a smoother overall implant surface, reduces holes or gaps, and reduces the chance of thrombosis. Preferably, the connecting piece 30 is made of a high polymer material, so that not only can the influence on signal transmission be prevented, but also the wireless sensor can be protected, and the damage of the bracket to the wireless sensor in the conveying process can be avoided.

In order to better connect the wireless sensor with the bracket, the connecting piece in the embodiments can be made of heat-shrinkable material, and after the connecting piece is connected with the connecting piece through the joint section, the joint section is firmly fixed between the connecting piece and the wireless sensor through a heat shrinkage process, so that the wireless sensor is firmly connected with the bracket. In the above embodiments, the joining section and the elastic curve section are integrally formed, but it will be understood by those skilled in the art that in other alternative embodiments, the joining section may be made of a material different from the elastic curve section, for example, the elastic curve section is a metal wire, the joining section is a rigid plastic tube or a stainless steel sheet, and the joining section is fixedly connected (e.g., welded) to the elastic curve section. However, from the convenience and use effect of the processing technology, the mode of integrally forming the joint section and the elastic curve section is preferable, so that the connecting structure is simple, reliable and compact; the elastic curve section is a part of the bracket, other structures are not required to be additionally arranged for connection with the connecting piece, the radial dimension of the implant is not obviously increased, and the safety problem caused by the connection firmness or smoothness of the additional joint section and the elastic curve section can be completely avoided.

Referring to fig. 22 a-22 e, some alternative embodiments of the stent are shown.

Fig. 22a is a schematic longitudinal cross-sectional shape of a stent in an alternative embodiment. In this embodiment, the diameter of the middle portion of the stent is smaller than the diameters of both ends, forming an X-shaped longitudinal cross-sectional shape. Fig. 22b is a schematic longitudinal cross-sectional shape of a stent in another alternative embodiment. In this embodiment, the upper section of the bracket is horn-shaped, and the lower section is straight cylindrical, forming a Y-shaped longitudinal cross-section. Fig. 22c is a schematic longitudinal cross-sectional view of another alternative embodiment of a stent. In this embodiment, the diameter of one end of the bracket is larger than the diameter of the other end, and the diameter of the cylinder in the axial direction is linearly changed to form a V-shaped longitudinal cross-sectional shape. Fig. 22d is a schematic view of a longitudinal cross-sectional shape of a stent in another alternative embodiment in which the stent has a different diameter at both ends than at the middle and the centers of both ends are not coaxial with the center of the middle, the stent having a K-shaped longitudinal cross-sectional shape. Fig. 22e is a schematic longitudinal cross-sectional view of a stent in another alternative embodiment, in which the stent is generally Z-shaped.

The present disclosure also provides an implant system. The implant system includes a delivery catheter and an implant. The delivery catheter is used to receive the compressed implant and deliver the implant to the target site via a manual or natural lumen/conduit. The implant may include a stent, which may be a shunt as in the previous embodiments for atrial bypass, or an occluder or vascular stent, and a wireless sensor. The implant is in a compressed state within the delivery catheter. In particular, the stent is compressed to have a C-shaped cross-section, and the outer surface of the compressed stent at least partially surrounds the sensor, thereby reducing the diameter of the implant. As the delivery catheter delivers the implant to the target site, the implant may be pushed out of the catheter through the inner catheter.

In some alternative embodiments, the implant system further comprises a signal receiving device for receiving a signal from a wireless sensor in the implant for a healthcare worker to track changes in a physiological parameter of the living being in real time.

The foregoing is merely specific embodiments of the disclosure, but the protection scope of the disclosure is not limited thereto, and any person skilled in the art can easily think about changes or substitutions within the technical scope of the disclosure, and it is intended to cover the scope of the disclosure. Therefore, the protection scope of the present disclosure shall be subject to the protection scope of the claims.

Claims

1. An implant for implantation at a target site within a living being, comprising:

a stent for placement at a target site to improve a physiological function of the living being, the stent comprising a body formed of a plurality of elastic curve segments and at least one engagement segment disposed at a predetermined region of the body and connected to a portion of at least one of the elastic curve segments;

the wireless sensor comprises a detection element and a wireless signal transmission element, wherein the detection element is used for acquiring a target physiological parameter, and the wireless signal transmission element is used for transmitting the target physiological parameter acquired by the detection element to the outside of a living body; and

The connecting piece is used for connecting the wireless sensor and the bracket; the connecting piece comprises a first connecting part and a second connecting part which are connected, the first connecting part is connected with the wireless sensor, and the second connecting part is connected with the joint section, so that the wireless sensor is attached to the outer peripheral surface of the bracket in the preset area;

wherein the second connecting portion includes a sheet portion having an edge portion forming a clamped portion, and the joint section is connected to the sheet portion in such a manner as to clamp the edge portion.

2. The implant of claim 1, wherein the engagement section is inserted into the second connection portion to grip the gripped portion; and

the engagement section is integrally formed with the portion of at least one of the elastic curved sections, the engagement section urges the clamped portion against the outer peripheral surface of the main body by its own elastic force, and/or the engagement section urges the clamped portion against the outer peripheral surface of the main body by an adhesive.

3. The implant of claim 2, wherein the bracket is disposed side-by-side with the wireless sensor.

4. The implant of claim 1, wherein the edge portion is located at an edge region of the sheet portion or at an edge region of an opening formed in the sheet portion.

5. The implant of claim 1, wherein the connector is an annular sleeve, a portion of the annular sleeve being the first connector and another portion of the annular sleeve being the second connector; the edge portion of the sheet portion is formed by an edge portion of the annular sleeve, or the annular sleeve is provided with an opening, and the edge portion of the sheet portion is formed by an edge portion of the opening.

6. The implant of claim 5, wherein the annular sleeve at least partially overlaps the wireless signal transmission element in an axial direction; the annular sleeve is a nonmetallic sleeve, the cross section of the nonmetallic sleeve is of a closed structure or a non-closed structure, or the annular sleeve is a metallic sleeve, and the cross section of the metallic sleeve is of a non-closed structure.

7. The implant of claim 5, wherein the annular sleeve axially completely covers the wireless sensor, and the sensing element is exposed at an end face of the wireless sensor, the sensing element for sensing pressure.

8. The implant of claim 1, wherein the elastic curvilinear segment forms the body by extending in a circumferential and axial direction, and the elastic curvilinear segment comprises at least a wave segment, a portion of which forms the engagement segment.

9. Implant according to claim 8, characterized in that predetermined wave trough portions and/or wave crest portions of the wave segments form the engagement segments.

10. The implant of claim 1, wherein the engagement section comprises a first engagement section and a second engagement section, the second connection portion comprising a clamped portion, the first engagement section and the second engagement section clamping the clamped portion from two opposite directions, respectively.

11. The implant of claim 10, wherein the resilient curvilinear segment forms the body by extending circumferentially and axially, and wherein the resilient curvilinear segment comprises at least a wave segment, a predetermined portion of the wave segment having a detour segment, the detour segment being split intermediate and forming a first engagement segment and a second engagement segment, the first engagement segment and the second engagement segment comprising curved and folded ends, the curved and folded ends of the first engagement segment and the second engagement segment each being nested within one another.

12. The implant of claim 11, wherein the connector is an annular sleeve, a portion of the annular sleeve being the first connector and another portion of the annular sleeve being the second connector; the annular sleeve is provided with a first opening and a second opening which have a preset interval in the axial direction, and the first joint section and the second joint section are respectively inserted between the annular sleeve and the wireless sensor through the first opening and the second opening.

13. The implant of any one of claims 1-12, wherein the scaffold is an atrial shunt and the body is a barrel for shunt, the barrel being formed by the elastic curved segments extending in an annular and/or helical fashion.

14. The implant of claim 13, wherein the barrel is a mesh formed by the resilient curvilinear segments, the barrel being configured to resiliently deform in a radial direction and maintain a constant circumference.

15. Implant according to claim 13, characterized in that the cylinder is arranged to be resiliently compressible in the first radial direction in the confined space and/or that the cylinder is arranged to have a C-shaped cross-sectional shape when compressed in the first radial direction in the confined space.

16. Implant according to claim 13, characterized in that the wireless sensor is parallel to the body and/or that the wireless sensor is connected circumscribed to the body.

17. The implant of claim 13, wherein the support further comprises a set of clamping arms including at least a first clamping arm and a second clamping arm, the first clamping arm and the second clamping arm being spaced apart along the axial direction of the body at the outer periphery of the body, the first clamping arm and the second clamping arm each forming a cantilever protruding from the outer periphery of the body.

18. Implant according to claim 17, characterized in that the first and/or second clamping arms are formed by bending a resilient wire and/or that the first and/or second clamping arms have a U-or V-shaped structure formed by bending back a resilient wire after extending a predetermined distance radially.

19. Implant according to claim 18, characterized in that the elastic wire constituting the first and/or second clamping arm is the same elastic wire as the elastic wire of the cylinder to which the base of the first and/or second clamping arm is attached and/or that the first and/or second clamping arm is at a predetermined distance from the end of the cylinder respectively adjacent.

20. The implant of claim 17, wherein the free ends of the first and second clamp arms overlap in axial projection and the fixed ends of the first and second clamp arms are offset in axial projection.

21. The implant of claim 1, wherein the stent further comprises a cover applied to the interior and/or exterior of the body, the cover having a notch exposing the engagement section when the cover is applied to the exterior of the body.

22. The implant of claim 1, wherein the connector is made of a polymeric material and secures the wireless sensor and the bracket by a heat shrink process.

23. An implant system comprising a delivery catheter and an implant, wherein the implant is as claimed in any one of claims 1 to 22, in a compressed state when the implant is disposed within the catheter, the stent is compressed into a C-shaped cross-section configuration, the outer surface of the compressed stent at least partially surrounding the wireless sensor, and the implant is capable of protruding from the catheter.

24. The implant system of claim 23, further comprising signal receiving means for receiving signals of a wireless sensor in the implant.