Implant and implant system
By designing an implant system consisting of a stent formed by elastic curve segments and a wireless sensor, the problem of combining pressure monitoring devices and stent-type implants in the existing technology is solved, effectively monitoring atrial pressure and avoiding interference with blood flow. Adverse effects.
Patent Information
- Application Number
- CN202311281029.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-07-21
- Publication Date
- 2025-01-21
AI Technical Summary
It is difficult for the prior art to effectively combine pressure monitoring devices with stent implants, especially in patients with cardiovascular diseases. There are technical difficulties in how to monitor atrial pressure and combine stent treatment.
An implant was designed, including a stent formed by multiple elastic curve segments and a wireless sensor. The wireless sensor was connected to the stent through a connector to ensure that the wireless sensor was on the periphery of the stent and tightly connected to avoid affecting the shunt ability of the stent.
It achieves effective monitoring of atrial pressure without affecting the shunt capacity of the stent, and reduces the volume of the implant in the cavity and the contact area with the anchor point to avoid adverse effects on blood flow.
Smart Images
Figure CN119326565A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of interventional medical devices, and in particular, to an implant and an implant system. Background Art
[0002] Heart failure is a clinical syndrome caused by abnormal ventricular filling and ejection function. The main manifestations of heart failure are dyspnea, fatigue and fluid retention (pulmonary congestion, systemic congestion and peripheral edema). Heart failure can be divided into three categories, namely heart failure with reduced ejection fraction, heart failure with mildly reduced ejection fraction and heart failure with preserved ejection fraction. According to the 2012-2015 China Heart Failure Epidemiological Survey, the weighted heart failure prevalence rate among Chinese residents aged 35 and above was 1.3%, or about 13.7 million. Among them, 52.7% of patients had heart failure with reduced ejection fraction, 23.9% of patients had heart failure with mildly reduced ejection fraction, and 23.4% of patients had heart failure with preserved ejection fraction. In patients with chronic heart failure with preserved ejection fraction and reduced ejection fraction, persistent left atrial pressure increase is the main cause of pulmonary congestion, and 90% of heart failure patients are hospitalized for this reason.
[0003] Atrial shunt surgery is a means of improving left atrial hypertension. It guides the blood flow from the left atrium to the right atrium by making a hole in the atrial septum, thereby reducing the load on the left atrium. Atrial shunt surgery is divided into implant shunt and non-implant shunt. Implant shunt requires the implant to be fixed in the artificially formed atrial septum hole to keep the hole open. Currently, atrial septum puncture and implant fixation are generally performed through vascular intervention. The specific process is to accommodate the device or shunt in the catheter, and send the device or shunt with the catheter through the human artery or vein to the site of the heart disease for operation. Due to the limited diameter of the blood vessel, the corresponding catheter diameter is also limited, so the shunt needs to be kept in a compressed state in the catheter first, and then automatically or passively expand to a predetermined size after it is removed from the catheter when it reaches the target site.
[0004] In addition to the shunts suitable for patients with heart failure mentioned above, there are other stent-type implants suitable for setting in the heart or blood vessels for patients with cardiovascular diseases. For example, some patients need to set occluders in the heart or blood vessels to improve cardiovascular function, and patients with vascular stenosis may need to implant vascular stents. However, in addition to treating related symptoms through implants, it is also very meaningful to monitor the hemodynamic parameters of the patient's cardiovascular system. For example, for patients with heart failure, in addition to surgical treatment, atrial pressure monitoring is also an important health management method. However, how to combine the pressure monitoring device with these stent-type implants is a major technical difficulty in this field. The applicant found that if the pressure monitoring device is installed in the stent, since the stent is usually a mesh structure made of metal wire weaving or pipe cutting, the mesh structure will interfere with or even shield the wireless signal transmission of the pressure monitoring device. If the pressure monitoring device is set axially at the proximal or distal end of the stent, the pressure monitoring device will increase the length of the overall structure, hinder the normal flow of blood, affect the size of the stent port, and produce the risk of long-term stenosis. Summary of the invention
[0005] In view of this, the present disclosure provides an implant and an implant system to at least partially solve the above problems.
[0006] In a first aspect, the present disclosure provides an implant for implantation in a target site in a living body, comprising a stent for being arranged at the target site to improve the physiological function of the living body, the stent comprising a main body formed by a plurality of elastic curve segments, the main body being used for shunting; the stent also comprises a clamping arm group, the clamping arm group comprising at least a first clamping arm and a second clamping arm, the first clamping arm and the second clamping arm being distributed at intervals along the axial direction of the main body on the periphery of the main body, the first clamping arm and the second clamping arm each forming a cantilever protruding from the periphery of the main body.
[0007] In a possible implementation, the first clamping arm and / or the second clamping arm are formed by bending an elastic metal wire, and / or the first clamping arm and / or the second clamping arm have a U-shaped or V-shaped structure formed by the elastic metal wire extending radially a predetermined distance and then folding back.
[0008] In combination with the above possible implementations, in another possible implementation, the main body is a cylinder, and the cylinder is formed by a plurality of elastic curve segments extending in a ring and / or spiral form, or the cylinder is formed by a plurality of elastic curve segments extending in a wave-like manner in the axial direction and simultaneously extending in the circumferential direction.
[0009] In combination with the above possible implementations, in another possible implementation, the elastic curve segment is an elastic metal wire, the elastic metal wire constituting the first clamping arm and / or the second clamping arm and the elastic metal wire of the cylinder to which the base of the first clamping arm and / or the second clamping arm is attached are the same elastic metal wire, and / or the first clamping arm and / or the second clamping arm have a predetermined distance from the ends of the cylinders respectively adjacent to each other.
[0010] In combination with the above possible implementations, in another possible implementation, the free end of the first clamping arm overlaps with the free end of the second clamping arm in axial projection, and the fixed end of the first clamping arm and the fixed end of the second clamping arm are staggered in axial projection.
[0011] In combination with the above possible implementation methods, in another possible implementation method, the main body is divided into an upper tube and a lower tube, the number of the first clamping arms and the second clamping arms are both 2 or more, the first clamping arms are evenly distributed on the surface of the upper tube, and the second clamping arms are evenly distributed on the surface of the lower tube.
[0012] In combination with the above possible implementations, in another possible implementation, the bracket also includes a coating, which is applied inside and / or outside the main body, and the main body is divided into an upper tube and a lower tube, and the upper tube and the lower tube are coaxially distributed and connected by the coating.
[0013] In combination with the above possible implementations, in another possible implementation, the elastic curve segment of the upper tube extends upward in a spiral form in the circumferential direction in an initial stage, and extends in a ring form in the last circle, and the elastic curve segment of the lower tube extends in a ring form in the circumferential direction in an initial stage, and extends upward in a spiral form after one circle.
[0014] In combination with the above possible implementations, in another possible implementation, the plurality of elastic curve segments include at least one joining segment, the joining segment is arranged in a predetermined area of the main body and connected to a portion of at least one of the elastic curve segments; the implant also includes a wireless sensor and a connector. The wireless sensor includes a detection element and a wireless signal transmission element, the detection element is used to obtain the target physiological parameters, and the wireless signal transmission element is used to transmit the target physiological parameters obtained by the detection element to the outside of the biological body; the connector is used to connect the wireless sensor and the bracket; the connector includes a first connecting portion and a second connecting portion connected to each other, the first connecting portion is connected to the wireless sensor, and the second connecting portion is connected to the joining segment, so that the wireless sensor is attached to the outer peripheral surface of the bracket in the predetermined area.
[0015] In combination with the above possible implementation methods, in another possible implementation method, the second connecting part includes a clamped part, and the joining section is inserted into the second connecting part or between the second connecting part and the sensor to clamp the clamped part; the joining section is integrally formed with the part of at least one elastic curve segment, and the joining section forces the clamped part to be attached to the outer peripheral surface of the main body through its own elastic force, and / or the joining section makes the clamped part attached to the outer peripheral surface of the main body through an adhesive.
[0016] In combination with the foregoing possible implementation manner, in another possible implementation manner, in another possible implementation manner, the bracket and the wireless sensor are arranged side by side.
[0017] In combination with the above possible implementations, in another possible implementation, in another possible implementation, the second connecting portion includes a sheet portion, the sheet portion has an edge portion, the edge portion forms a clamped portion, the joining section is connected to the sheet portion in the form of a clamping edge portion, and the edge portion is located in the edge area of the sheet portion or in the edge area of an opening formed on the sheet portion.
[0018] In combination with the above possible implementations, in another possible implementation, in another possible implementation, the connecting member is an annular sleeve, a part of the annular sleeve is a first connecting part, and another part of the annular sleeve is a second connecting part; the edge portion of the sheet portion is formed by the 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 the edge portion of the opening.
[0019] In combination with the above possible implementations, in another possible implementation, the annular sleeve at least partially overlaps with the wireless signal transmission element in the axial direction, the annular sleeve is a non-metallic sleeve, and the cross-section of the non-metallic sleeve is a closed structure or a non-closed structure, or the annular sleeve is a metal sleeve, and the cross-section of the metal sleeve is a non-closed structure.
[0020] In combination with the above possible implementations, in another possible implementation, the annular sleeve completely covers the wireless sensor in the axial direction, and a detection element is exposed on the end face of the wireless sensor, and the detection element is used to detect pressure.
[0021] In combination with the above possible implementations, in another possible implementation, the elastic curve segment forms a main body by extending in the circumferential direction and the axial direction, and the elastic curve segment includes at least a wave segment, and a part of the wave segment forms a joining segment.
[0022] In combination with the above possible implementation manner, in another possible implementation manner, a predetermined trough portion and / or a peak portion of the wave segment forms a joining segment.
[0023] In combination with the above possible implementations, in another possible implementation, the joining section includes a first joining section and a second joining section, the second connecting portion includes a clamped portion, and the first joining section and the second joining section clamp the clamped portion from two opposite directions respectively.
[0024] In combination with the above possible implementations, in another possible implementation, the elastic curve segment forms the main body by extending circumferentially and axially, and the elastic curve segment at least includes a wave segment, a predetermined portion of the wave segment has a detour segment, the detour segment is disconnected in the middle and forms a first joining segment and a second joining segment, the first joining segment and the second joining segment include bent and folded ends, and the bent and folded ends of the first joining segment and the second joining segment are respectively nested in each other.
[0025] In combination with the above possible implementations, in another possible implementation, the connecting piece is an annular sleeve, a part of the annular sleeve is a first connection part, and the other part of the annular sleeve is a second connection part; the annular sleeve is provided with a first opening and a second opening with a predetermined spacing in the axial direction, and the joining section includes a first joining section and a second joining section, and the first joining section and the second joining section are respectively inserted between the annular sleeve and the wireless sensor through the first opening and the second opening and are nested with each other.
[0026] In combination with the above possible implementations, in another possible implementation, the stent is an atrial shunt, the main body is a cylinder, the cylinder is configured to be able to deform resiliently in the radial direction while keeping the circumference unchanged, the cylinder is configured to be able to be resiliently compressed along a first radial direction within a confined space, and / or the cylinder is configured to have a C-shaped cross-sectional shape when compressed along a first radial direction within a confined space.
[0027] In combination with the above possible implementation manner, in another possible implementation manner, the wireless sensor is parallel to the main body, and / or the wireless sensor is circumferentially connected to the main body.
[0028] In combination with the above possible implementation manner, in another possible implementation manner, the connector is made of a polymer material, and the wireless sensor and the bracket are fixed together by a heat shrink process.
[0029] In combination with the above possible implementations, in another possible implementation, the diameter of the middle part of the bracket is smaller than the diameter of the two ends; or, the upper section of the bracket is trumpet-shaped and the lower section is straight-cylindrical; or, the diameter of one end of the bracket is larger than the diameter of the other end, and the diameter in the axial direction changes linearly; or, the diameters at both ends of the bracket are different from the diameter of the middle part, and the centers of the two ends are not coaxial with the center of the middle part; or, the bracket is Z-shaped as a whole.
[0030] In a second aspect, an implant system is provided, comprising a delivery catheter and an implant. The implant is any implant comprising a wireless sensor in the first aspect, and when the implant is disposed in the catheter, the implant is in a compressed state, the stent is compressed into a structure with a C-shaped cross section, the outer surface of the compressed stent at least partially surrounds the wireless sensor, and the implant can extend from the catheter.
[0031] The implant provided by the present disclosure is used to be implanted in a target part in a living body. The implant includes a stent, a wireless sensor and a connector. The stent is used to connect to the target part to improve the physiological function of the living body, and the stent includes a main body formed by a plurality of elastic curve segments; the stent also includes a clamping arm group, and the clamping arm group includes at least a first clamping arm and a second clamping arm, and the first clamping arm and the second clamping arm are distributed on the periphery of the main body along the axial direction of the main body, and the first clamping arm and the second clamping arm each form a cantilever protruding from the periphery of the main body. The clamping arm design of the implant provided by the present disclosure is different from the waist-shaped or flange-shaped anchoring design in the prior art, which can effectively reduce the volume of the implant in the cavity and the contact area with the anchoring point to avoid adverse effects on blood flow, and can firmly anchor the main body in the target part. BRIEF DESCRIPTION OF THE DRAWINGS
[0032] In order to more clearly illustrate the technical solution of the embodiment of the present disclosure, the following briefly introduces the drawings required for use in the embodiment.
[0033] It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and should not be viewed as limiting the scope.
[0034] It should also be understood that the same or similar reference numerals are used in the drawings to represent the same or similar elements.
[0035] It should also be understood that the drawings are merely schematic and that the sizes and proportions of elements in the drawings are not necessarily accurate.
[0036] Figure 1 It is a schematic structural diagram of a target site in a living body according to an embodiment of the present disclosure.
[0037] Figure 2 Schematic diagram of the structure of an implant according to an embodiment of the present disclosure.
[0038] Figure 3 yes Figure 2 Schematic diagram of the structure of the implant after the wireless sensor is hidden.
[0039] Figure 4 yes Figure 2 A partially enlarged schematic diagram of the connection method between the middle connecting piece and the bracket.
[0040] Figure 5 yes Figure 1 End view of the implant.
[0041] Figure 6 Schematic diagram of a compressed state of an implant in a delivery tube according to an embodiment of the present disclosure.
[0042] Figure 7 yes Figure 6 Schematic diagram of the cross-section of the delivery tube and implant.
[0043] Figure 8 is a schematic diagram of the delivery tube containing the implant when it reaches the target site.
[0044] Fig. 9 A diagram of an implant with one end extending from a delivery tube and some clamping arms.
[0045] Fig.10 is a schematic diagram of the delivery tube being withdrawn so that the clamping arms of the implant reach the surface of the atrial septum.
[0046] Fig.11 It is a schematic diagram of the implant being installed at the target site after the delivery tube is removed.
[0047] Fig.12 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.
[0048] Fig.13 yes Fig.12 Another angle view of the implant.
[0049] Fig.14 yes Fig.12 An enlarged view of the connection structure between the middle connecting piece and the middle joint section of the main body.
[0050] Fig.15 yes Fig.12 Schematic diagram of the structure of the implant body and the membrane.
[0051] Fig.16 It is a schematic structural diagram of a wireless sensor, a connector and a joint section in an implant according to another embodiment of the present disclosure.
[0052] Fig.17 It is a schematic structural diagram of a wireless sensor, a connector and a joint section in an implant according to another embodiment of the present disclosure.
[0053] Fig.18 It is a schematic structural diagram of a wireless sensor, a connector and a joint section in an implant according to another embodiment of the present disclosure.
[0054] Fig.19 It is a schematic structural diagram of a wireless sensor, a connector and a joint section in an implant according to another embodiment of the present disclosure.
[0055] Fig. 20 The present invention is a schematic diagram of the structure of a wireless sensor, a connector and a joint section in an optional implementation manner.
[0056] Fig.21 The figure is a schematic diagram of the structure of the connector in an optional implementation manner.
[0057] Fig.22a The figure is a schematic diagram of the longitudinal cross-sectional shape of the bracket in an optional implementation manner.
[0058] Figure 22b It is a schematic diagram of the longitudinal cross-sectional shape of the bracket in another optional implementation manner.
[0059] Fig.22c It is a schematic diagram of the longitudinal cross-sectional shape of the bracket in another optional implementation manner.
[0060] Fig.22d It is a schematic diagram of the longitudinal cross-sectional shape of the bracket in another optional implementation manner.
[0061] Fig.22e It is a schematic diagram of the longitudinal cross-sectional shape of the bracket in another optional implementation manner. DETAILED DESCRIPTION
[0062] The following is an exemplary description of the embodiments of the present disclosure in conjunction with the accompanying drawings. It should be understood that the present disclosure can be implemented in a variety of ways and should not be construed as being limited to the embodiments described here. The embodiments described here are only for a more thorough and complete understanding of the present disclosure.
[0063] It should be understood that the term “including” and its variations used in the present disclosure are open inclusions, ie, “including but not limited to.” The term “based on” means “at least in part based on.”
[0064] It should be understood that although the terms “first” or “second” etc. may be used in the present disclosure to describe various elements, these elements are not limited by these terms, and these terms are only used to distinguish one element from another.
[0065] The embodiment of the present disclosure provides an implant for implantation in a living body to improve the physiological function of the living body and obtain target physiological parameters at the same time. The implant includes a stent, a wireless sensor and a connector. The stent is used to be arranged at a target site to improve the physiological function of the living body. The stent can be a mesh structure such as a shunt, an occluder or a vascular stent. The stent at least includes a main body formed by a plurality of elastic curve segments. The "elastic curve segment" here refers to a wire segment that is elastic and presents a curve as a whole, but can still present a straight line shape in a local area of the "elastic curve segment". The plurality of elastic curve segments can also be formed by the same wire or a plurality of different wires, such as braided metal wires, and the present invention does not limit this. The wireless sensor includes an electrically connected detection element and a wireless signal transmission element. The detection element is used to obtain the target physiological parameters. The wireless signal transmission element is used to transmit the target physiological parameters obtained by the detection element to the outside of the living body. The connector is used to connect the wireless sensor and the stent, and the wireless sensor is arranged outside the stent and abuts against the outer peripheral surface of the stent. By such arrangement, the bracket will not affect the signal transmission of the wireless sensor, and the wireless sensor will not affect the port size at both ends of the bracket. In particular, when the bracket is a diverter, the diversion capacity of the bracket will not be affected.
[0066] The stent can be fixed to the wireless sensor by various methods such as crimping, bonding, suturing, welding, etc. In the present embodiment, the stent and the wireless sensor are fixed by a specially designed connector, which includes a first connecting portion and a second connecting portion connected to each other, the first connecting portion connecting the wireless sensor, and the second connecting portion connecting the elastic curve segment of the stent. Specifically, the stent also includes at least one engaging segment, which is arranged in a predetermined area of the main body and connected to a part of at least one of the elastic curve segments, the engaging segment is inserted into the second connecting portion so that the connecting member is attached to the surface of the stent in the predetermined area, and the wireless sensor is maintained at the periphery of the stent by the connecting member and is arranged roughly side by side with the stent. The wireless sensor is fixed to the surface of the stent by cooperating with the engaging segment connected to the elastic curve segment and the connecting member. The connection structure is simple, reliable and compact, and the elastic curve segment itself is a part of the stent, and no other structure needs to be additionally arranged to connect with the connecting member, which will not significantly increase the radial size of the implant and further reduce the risk of thrombosis.
[0067] Figure 1It is a structural schematic diagram of a target part m1 in a biological body according to an embodiment of the present disclosure. Specifically, the target part m1 is a hole on the atrial septum m2 between the left atrium and the right atrium. The hole can be an unclosed foramen ovale or an artificial hole. For some patients with heart failure, the hole can reduce the pressure in the left atrium and relieve the symptoms of heart failure. The stent provided in the embodiment of the present disclosure is a shunt, and the shunt can be arranged in the hole to maintain the shape of the hole and guide the blood to flow from the left atrium to the right atrium. Preferably, the wireless sensor is arranged in the middle position of the outer peripheral surface of the shunt, so that when the implant in this embodiment is arranged on the atrial septum m2, the wireless sensor and the stent are arranged together in the target part m1 and abut against the target part. Furthermore, two detection elements can be arranged at both ends of the wireless sensor to simultaneously obtain the pressure of the left atrium and the right atrium.
[0068] refer to Figures 2 to 5 , Figures 2 to 5 FIG. 1 is a schematic diagram of the structure of an implant according to an embodiment of the present disclosure. In this embodiment, the implant includes a stent 100 and a wireless sensor 200 . Figure 2 Schematic diagram of the structure of an implant according to an embodiment of the present disclosure. Figure 3 yes Figure 2 A schematic diagram of the structure of the implant after the wireless sensor 200 is hidden. Figure 4 yes Figure 2 A partially enlarged schematic diagram of the connection between the middle connecting member 300 and the bracket 100. Figure 5 yes Figure 1 End view of the implant.
[0069] The implant includes a support 100, a wireless sensor 200 and a connector 300. The support 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" in the present invention is not limited to parallel arrangement, including that the support 100 and the wireless sensor can also be in a positional relationship with a predetermined angle (but not a vertical positional relationship). Of course, preferably, the support 100 and the wireless sensor 200 are arranged in parallel, and as Figure 5 As shown, when the main body of the stent is a cylindrical structure and the wireless sensor 200 is also a cylindrical structure, under the action of the joint section and the connector, the wireless sensor 200 and the stent 100 present an externally cut shape. Such a design can make the implant have a smaller radial size during the delivery process, so that it is easy to be pressed and gripped in the delivery device.
[0070] In this embodiment, the stent 100 includes a main body 110, a first clamping arm 112, a second clamping arm 113 and a coating 120. The main body 110 is a tubular structure woven from metal wires, which is roughly 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 outward from the surface of the main body 110 to form a cantilever structure. The first clamping arm 112 and the second clamping arm 113 form at least one clamping arm group, which are used to be 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 all formed by winding and bending the elastic curve segment 101. Specifically, the main body 110 is divided into an upper tube and a lower tube. The number of the first clamping arm 112 and the second clamping arm 113 is 3. The three first clamping arms 112 are evenly distributed on the surface of the upper tube. The three second clamping arms 113 are evenly distributed on the surface of the lower cylinder. Part of the elastic curve segment 101 extends in a wave-like manner in the axial direction and extends in the circumferential direction to form a mesh cylinder; another part of the elastic curve segment 101 extends radially outward from the surface of the mesh cylinder and then folds back to the cylinder surface to form a U-shaped clamping arm.
[0071] In some optional embodiments, the main body 110 may also be cut from metal. The number of the first clamping arm 112 and the second clamping 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 also present other forms, which are not limited by the present invention.
[0072] Furthermore, the three first clamping arms 112 and the three 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 spaced apart in the axial direction. The first clamping arm 112 is connected to the first end ( Figure 2 The second clamping arm 113 and the second end ( Figure 2The first clamping arm 112 and the second clamping arm 113 have a predetermined spacing. The free end of the first clamping arm 112 overlaps with the free end of the second clamping arm 113 in the axial projection, and the fixed end of the first clamping arm 112 and the fixed end of the second clamping arm 113 are staggered in the axial projection, so as to achieve a larger clamping area (the area of the clamping area formed by the first clamping arm 112 and the second clamping arm 113), and obtain a better clamping effect. Among them, the fixed end of the first clamping arm 112 and the fixed end of the second clamping arm 113 are the ends of the first clamping arm 112 and the second clamping arm 113 connected to the main body 110. The upper section tube and the lower section tube are coaxially distributed, and the two can be connected by a coating 120 and / or an elastic curve segment. The elastic curve segment of the lower section tube extends in a circular form in the circumferential direction in the initial stage, and extends upward in a spiral form after one circle. The elastic curve segment of the upper section tube extends upward in a spiral form in the circumferential direction in the initial stage, and extends in a circular form in the last circle. In the above embodiment, the axial distance of the clamping arm is 3mm. The optional range of the axial distance is greater than 0 mm and less than or equal to 3 mm. In the above embodiment, the elastic metal wire constituting the clamping arm and the elastic metal wire of the cylinder to which the base of the clamping arm is attached are the same elastic metal wire. In some optional embodiments, the clamping arm can be a separate U-shaped or V-shaped part, which is welded to the elastic curve section of the cylinder by welding.
[0073] The clamping arm design in this embodiment is different from the waist-shaped or flange-shaped anchoring design in the prior art. It can effectively reduce the volume of the shunt device in the cavity and the contact area with the anchoring point to avoid adverse effects on blood flow, and can firmly anchor the main body in the target area.
[0074] In this embodiment, the length of the coating 120 is equal to the sum of the lengths of the upper tube and the lower tube. Since the coating 120 is a tubular structure with a certain strength, it can also strengthen the strength of the main body 110 and the connection strength between the upper tube and the lower tube when it is laid on the inner / outer surface of the main body 110, and at the same time, it can maintain the preset shape of the elastic curve segment, thereby maintaining the shape of the main body 110. The coating 120 makes the inner cavity of the tube smooth, prevents the proliferation of atrial septal tissue from blocking the tube cavity, and maintains the smoothness of the tube cavity. The material of the coating 120 can be a polymer material or a biomaterial, not limited to polyester, polytetrafluoroethylene, animal pericardium, etc. The surface of the coating 120 can be provided with a coating to improve the surface finish, so as to improve the long-term patency rate. In some optional embodiments, the coating 120 can also be provided on the outer surface of the main body 110. In other optional embodiments, a layer of coating 120 can be provided on the inner and outer surfaces of the main body 110. Another beneficial effect of the coating 120 is to produce an insulating effect, which can isolate the main body 110 and the wireless sensor 200 to a certain extent to avoid signal interference. The film 120 and the main body 110 can be connected by heat pressing or sewing. In order to more clearly distinguish the film 120 from the main body 110, the thickness of the film 120 is deliberately enlarged and the film 120 is drawn on the inner surface of the main body 110. The actual thickness is smaller than the illustrated size.
[0075] Those skilled in the art can understand 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 can also be used as an independent diverter.
[0076] In this embodiment, the joint segment includes a first joint segment and a second joint segment, which are respectively formed integrally with a portion of the two elastic curve segments. In other words, the first joint segment is formed by a natural extension of a portion of the elastic curve segment, and the second joint segment is formed by a natural extension of a portion of the other elastic curve segment. Figure 3 and Figure 4 In the middle of the main body 110 , the initial section (upper part) of the elastic curve section of the lower tube forms a first joining section 114 , and the terminal section (lower part) of the elastic curve section of the upper tube forms a second joining section 115 .
[0077] Please refer to Figure 2, the wireless sensor 200 includes a detection element 210 and a wireless signal transmission element 220. The detection element 210 can be a pressure detection element, which can measure, for example, the pressure of blood flow. The detection element 210 is arranged at one end of the wireless sensor 200 to monitor the pressure of the left atrium. The wireless signal transmission element 220 is used to transmit 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 a whole by a sealing structure. In other embodiments, two detection elements 210 can also be arranged at the two ends of the wireless sensor 200 to detect the pressure of the left atrium and the right atrium, and the wireless signal transmission element 220 is arranged between the two detection elements 210.
[0078] Please refer to Figure 3 and Figure 4 In this embodiment, the connecting member 300 is an annular sleeve, and a partial section of the annular sleeve slightly protrudes outward to form a second connecting portion 320, and the other parts except the second connecting portion 320 are the first connecting portion 310. The outward protrusion of the second connecting portion 320 can be formed by the pulling of the bracket 100 and the wireless sensor 200 after the connecting member 300 connects the bracket 100 and the wireless sensor 200, or it can be a permanent protrusion set during manufacturing. The first connecting portion 310 is arranged around the middle of the wireless sensor 200. The second connecting portion 320 is a thin sheet structure as a whole, including a sheet portion 321. The sheet portion 321 is roughly rectangular. The sheet portion 321 has two parallel edges, namely an upper edge and a lower edge perpendicular to the axis of the annular sleeve. The upper edge and at least a portion of the area adjacent to it form an edge portion 322, and the lower edge and at least a portion of the area adjacent to it form another edge portion 322. The two edge portions 322 are used to be clamped by the first engaging section 114 and the second engaging section 115 , that is, the two edge portions 322 form a clamped portion 323 .
[0079] In this embodiment, the width (dimension in the axial direction) of the annular sleeve is small, while the length of the first engaging section 114 and the second engaging section 115 is large, so the first engaging section 114 and the second engaging section 115 each clamp two edge portions 322, that is, the first engaging section 114 and the second engaging section 115 clamp the entire axial direction area of the sheet portion 321. In some optional embodiments, the axial dimension of the sheet portion 321 is large, and / or the length of the first engaging section 114 and / or the second engaging section 115 is small, the first engaging section 114 can only clamp the edge portion 322 corresponding to the lower edge, and the second engaging section 115 only clamps the edge portion 322 corresponding to the upper edge. Relative to the overall size of the connector, the height of the protrusion of the second connecting portion 320 is very small. In some optional embodiments, the first connecting portion can also be a complete cylindrical structure, and the second connecting portion 320 can be regarded as being arranged to fit the outer contour of the first connecting portion 310, so that the radial dimensions of the second connecting portion 320 and the first connecting portion 310 will not increase significantly. The bonding referred to here may be that the two adjacent surfaces are in contact with each other (but can be separated by external force, such as being separated by the insertion of the joining section), or that the two adjacent surfaces have a very small distance so that the first joining section can be inserted.
[0080] Through the above connection method, the second connection part 320 of the connector 300 is clamped between the first joint section 114, the second joint section 115 and the coating 120, which is equivalent to pressing the second connection part 320 on the surface of the main body 110; the bracket 100 and the wireless sensor 200 are connected together in parallel and circumferential. In addition, the first joint section 114 and the second joint section 115 are also clamped between the wireless sensor 200 and the second connection part 320. Such a connection is simple and reliable, which is convenient for the assembly and connection of small components such as shunts. In addition, the free ends of the first joint section 114 and the second joint section 115 point in opposite directions, which can also prevent the second connection part 320 from falling off in the axial direction. The connection method in which the joint section on the surface of the bracket 100 clamps the sheet structure on the surface of the wireless sensor 200 has a very small radial size, so it can allow the wireless sensor 200 to be tightly connected to the bracket 100 without causing the radial size of the implant to be too large.
[0081] The shape of the connector 300 is not limited to the structure described in the above embodiment, as long as the first connector 310 can be fixedly connected to the wireless sensor 200, the second connector 320 is arranged in contact with the surface of the first connector 310 and can be clamped by the joint section of the main body 110. Therefore, the first connector 310 can also be a ring-shaped structure with an opening, which can clamp the wireless sensor 200; or a closed or open box-shaped structure adapted to the shape of the wireless sensor 200, which can accommodate the wireless sensor 200; or a structure adapted to the connected part 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 slot, a thread or an adhesive surface); and the second connector 320 can be an arched structure or a cantilever structure that can be clamped by the joint section.
[0082] Preferably, the connector 300 is a sleeve, a part of which is the first connecting portion, and the other part is the second connecting portion. When the connector 300 and the wireless signal transmission element 220 overlap at least partially in the axial direction, the connector 300 is a non-metallic sleeve, and the cross section of the non-metallic sleeve is a closed structure (for example, an O-shaped structure) or an unclosed structure (for example, a C-shaped structure), so that the connector 300 itself can be prevented from affecting the signal transmission; or the annular sleeve is a metal sleeve, and the cross section of the metal sleeve is an unclosed structure, which can also avoid the connector 300 itself from affecting the signal transmission; when the connector 300 and the wireless signal transmission element 220 do not overlap at all in the axial direction, there is no restriction on the material of the connector 300.
[0083] refer to Fig.11 , which shows the implant when installed in the target part. The target part m1 is a hole connecting the left atrium and the right atrium. The implant is inserted into the hole as a whole, and is clamped on the atrial septum tissue by the first clamping arm 112 and the second clamping arm 113 to prevent the implant from axially falling out of the target part m1. The detection element 210 is located in the left atrium and can detect the blood pressure of the left atrium. When the left atrium contracts, in addition to entering the left ventricle, a part of the blood flow therein will enter the right atrium through the lumen of the stent 100. The wireless sensor 200 is arranged side by side on the outside of the stent 100, so the wireless sensor 200 will not hinder the blood flow in the lumen or at both ends of the stent 100; and the stent 100 does not surround the wireless sensor 200, so it will not hinder the transmission of wireless signals. The wireless sensor 200 can be installed in the atrial septum hole side by side with the stent 100, and will not occupy too much atrial space like the traditional axial series connection method. The connector 300 is tightly connected to the joint section of the stent 100, so that the stent 100 and the wireless sensor 200 are tightly against each other, which can not only enhance the connection strength between the two, but also reduce the radial size of the two, which is beneficial to the operation of transvascular interventional implantation.
[0084] refer to Figure 6 and Figure 7 . Figure 7 FIG. 4 is a schematic diagram of a compressed state of the implant according to the aforementioned embodiment when it is located in a delivery tube. Figure 8 for Figure 7 Schematic diagram of the cross section of the delivery tube and the implant. The support 100 of the implant is formed by an elastic curve segment 101, so that the whole can be deformed under external compression and restore its original shape after the external force is removed. The implant and the delivery tube used for interventional surgery form an implant system.
[0085] In the implant, the elastic curve segment forms the main body of the stent 100, so that the stent 100 is elastic as a whole. When the wireless sensor 200 applies pressure to the stent 100 along the center line of the wireless sensor 200 and the stent 100, the stent 100 can be compressed, that is, the stent 100 is resiliently deformed along the first radial direction in the restricted space (the radial dimension in the force direction is reduced, and the radial dimension perpendicular to the force direction is enlarged, and the "first radial direction" here refers to the radial direction consistent with the force direction), and the wireless sensor 200 can be partially embedded in the recessed area of the stent 100. After the external force disappears, the stent 100 will return to its original shape and restore its positional relationship with the wireless sensor 200. In the process of placing the implant into the delivery tube 400, the wall of the delivery tube 400 exerts pressure on the stent 100 and the wireless sensor 200 in the direction along the center line connecting the wireless sensor 200 and the stent 100 and in the direction perpendicular to the direction, so that the stent 100 is compressed into a C-shaped cross section along the first radial direction, and the wireless sensor 200 is partially embedded in the recessed part of the stent 100. In addition, the first clamping arm 112 and the second clamping arm 113 are pressed down along the longitudinal section to approach the surface of the stent 100, that is, the free ends of the first clamping arm 112 and the second clamping arm 113 are respectively approached to the extension direction of the two ends of the stent 100. After the implant is placed in the delivery tube 400, the overall radial dimension is compressed; because the form of its compression deformation is that the cylinder is flattened, and the circumference of the cylinder remains unchanged. Instead of achieving radial dimension reduction by axial elongation, the axial dimension of the implant does not change significantly. An implant of shorter length is more conducive to the bending of the delivery tube 400 and the convenience of the implantation process.
[0086] For reference Figures 8 to 10 , which shows the surgical procedure of implanting a shunt at a target site via an interventional catheter. Figure 8 4 is a schematic diagram showing when the delivery tube 400 containing the implant reaches the target site m1. Fig. 9 It is a schematic diagram of an implant extending one end from a delivery tube 400 and a first clamping arm 112 .
[0087] Fig.10It is a schematic diagram when the delivery tube 400 is withdrawn to allow the first clamping arm 112 of the implant to reach the surface of the atrial septum m2. Fig.11 It is a schematic diagram when the delivery tube 400 is removed and the implant is installed in the target site m1.
[0088] One end of the delivery tube 400 containing the implant enters the right atrium through the thicker blood vessels of the human body, and enters the left atrium through the hole of the atrial septum m2. At this position, one end of the implant is extended from the end of the delivery tube 400 by withdrawing the delivery tube or pushing the implant outward, and the first clamping arm 112 is unfolded into a cantilever state. After the first clamping arm 112 is unfolded, the overall radial size of the implant is greater than the diameter of the hole on the atrial septum m2. The delivery tube is withdrawn again, and the implant moves with the catheter until the first clamping arm 112 contacts the atrial septum m2. The delivery tube 400 is further withdrawn, and due to the obstruction of the atrial septum m2, the implant will remain in this position and will not be withdrawn with the delivery tube 400. After the implant is completely separated from the delivery tube 400, the second clamping arm 113 will also be unfolded, and the second clamping arm 113 and the first clamping arm 112 will keep the stent 100 and the wireless sensor 200 in the hole of the atrial septum m2. The stent 100 returns to its original shape in the radial direction, and its lumen allows blood flow from the left atrium to enter the right atrium. After the stent 100 is in place, the detection 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 transmission element 220.
[0089] refer to Figures 12 to 15 . Fig.12 is a schematic structural diagram of an implant according to another embodiment of the present disclosure. Fig.13 yes Fig.12 Another angle view of the implant. Fig.14 yes Fig.12 An enlarged view of the connection structure between the middle connecting piece and the joint section. Fig.15 yes Fig.12 Schematic diagram of the structure of the main body of the implant in the present embodiment. The implant in this embodiment has a substantially identical structure to the implant in the previous embodiment, such as the first clamping arm 112a, the second clamping arm 113a and the coating are identical to the first clamping arm 112, the second clamping arm 113 and the coating 120. The main difference between the two is the structure of the connecting piece and the structure of the corresponding joint section on the main body. In order to facilitate the description of the structure of the connecting piece, the sensor is omitted from the schematic diagram of this embodiment.
[0090] In this embodiment, the elastic curve segment 101a extends in the circumferential and axial directions to form the main body of the bracket 100a, and the elastic curve segment is curved in a wave shape as a whole, including multiple wave segments 102a. Among them, the trough 114a of a wave segment 102a in the middle of the bracket 100a forms a first joint segment, and the peak 115a of another wave segment 102a in the middle of the bracket 100a forms a second joint segment. The trough 114a and the peak 115a have a larger area clamped in the axial and circumferential directions, and their strength and clamping force are greater, which can form a more stable connection.
[0091] The connecting member 300a is an annular sleeve with two ends connected. The width (axial dimension) of the annular sleeve in this embodiment is greater than Figure 2 The width of the annular sleeve in the illustrated embodiment. The annular sleeve includes two parts, one part is a sleeve body with a semi-open two-thirds circular ring cross section, which forms the first connecting portion 310a; the other part is a sleeve body with a semi-open, roughly rectangular cross section, which forms the second connecting portion 320a. Of course, in other embodiments, a diaphragm can also be provided at the junction of the two to divide the sleeve body into two cavities. The first connecting portion 310a is arranged around the wireless sensor. The second connecting portion 320a is used for clamping the first joining section 114a (trough portion) and the second joining section 115a (peak portion). The second connecting portion 320a is a roughly rectangular thin film sheet, which is pressed against the surface of the main body 100a by the first joining section 114a (trough portion) and the second joining section 115a (peak portion). The second connecting portion 320a can also be further bonded or sutured to the coating 120a to strengthen the connection strength.
[0092] refer to Fig.16 , Fig.16 1 is a schematic diagram of the structure of the connector 300b and the joint section 114b in the implant according to another embodiment of the present disclosure. In order to more clearly express the connection relationship between the connector and the joint section, only the sensor 200b, the connector 300b and the partial elastic curve section structure in the bracket are shown in this embodiment, and other structures are omitted. The connector 300b is an annular sleeve, which is formed by a polymer material. The upper edge and the lower edge of a part of the annular sleeve and the area therebetween form a clamped portion, and in this embodiment, the clamped portion is the second connecting portion. The other part of the annular sleeve is the first connecting portion, which is fixed around the middle of the sensor 200b. The joint section 114b in the bracket is an inverted V-shaped structure formed by bending the elastic curve section, which is inserted between the second connecting portion and the sensor 200b from the lower edge of the second connecting portion. The length of the joint section 114b is greater than the axial dimension of the connector 300b, so one end of the joint section 114b extends from between the connector 300b and the sensor 200b.
[0093] refer to Fig.17 , Fig.17The structure of the sensor 200b, the connecting member 300b and the joint section 114b shown in FIG. Fig.16 The structure shown in is basically the same, except that the top end and two base ends of the joint segment 114b are sutured to the covering film of the diverter stent through a suture structure 600 (not shown).
[0094] refer to Fig.18 , Fig.18 It is a structural schematic diagram of a connector and a joint section in an implant according to another embodiment of the present disclosure. In this embodiment, the sensor 200c is clamped by a connector 300c, and the connector 300c is connected to the first joint section 114c and the second joint section 115c. Specifically, two slit-shaped openings 324c are provided on the second connecting portion of the connector 300c, and the two openings 324c are parallel to the edge of the connector 300c and have a predetermined distance in the axial direction. The first joint section 114c is a trough portion, and the second joint section 115c is a crest portion, and the two are arranged oppositely. The first joint section 114c and the second joint section 115c are inserted between the connector 300c and the sensor 200c from the two openings 324c. The respective edges of the two openings 324c and the area between the two are the clamped portions.
[0095] refer to Fig.19 , Fig.19 FIG. 2 is a schematic diagram of the structure of the connector and the joint section in an implant according to another embodiment of the present disclosure. Fig.17 The corresponding structure shown in FIG. 1 is the same as that shown in FIG. 1 , except that the first engaging section 114d and the second engaging section 115d are different. Figure 3 The structure of the joint section shown is similar, but different from the joint section of a single rod, in this embodiment, the elastic curve section is disconnected at the wave section, and the end of the elastic curve section extends in its length direction and folds back to form a U-shaped joint section. And the first joint section 114d and the second joint section 114d formed by the two ends folding back overlap in the length direction and embed into each other in the radial direction. The specific manufacturing process can be that two metal wires are bent and embedded together, or a part of the detour section is set on the same metal wire during the winding process, and the middle part of the detour section is cut off or a section is cut off, so that the detour section forms two joint sections with a U-shaped structure.
[0096] refer to Fig. 20 , Fig. 20 It is a schematic diagram of the structure of the connecting member 300d and the joint section in an optional implementation manner. Fig. 20 The connection method shown in Fig.19The connection method shown in is similar to that shown in FIG. 1 , except that the first engaging segment 114d and the second engaging segment 115d are not inserted between the connecting member 300d and the sensor 200d from the edge of the connecting member 300d, but are inserted from two openings 324d provided in the connecting member 300d. Both openings 324d are rectangular and have a predetermined distance in the axial direction. Fig.19 In the connection method shown, the first joining section 114d and the second joining section 115d located below the connecting member 300d cannot be connected to the coating on the bracket, so the strength of the bracket at this location will be weak. By providing an opening 324d on the connecting member 300d, the length of the first joining section 114d and the second joining section 114d covered by the connecting member 300d can be reduced, so that the joining section has more areas that can be connected to the coating, avoiding a significant weakening of the strength of the bracket at this location. In addition, since the first joining section 114d and the second joining section 114d are U-shaped bending structures, they have a larger area to clamp the connecting member 300d, and the connection strength between the connecting member and the connecting member can also be further improved. In some optional embodiments, a viscose connection can be further provided between the first joining section 114d and the second joining section 114d and the connecting member 300d.
[0097] refer to Fig.21 , which shows a schematic diagram of the structure of a connecting member 30 in an optional embodiment. The connecting member 30 includes a first connecting portion 31 and a second connecting portion 32. The structure of the connecting member 30 in this embodiment is similar to Figure 2 The structure of the connector 300 shown in the figure is basically the same, except that its axial dimension is larger, so that it can completely surround the wireless sensor in the axial direction. This arrangement can make the implant surface smoother as a whole, reduce holes or gaps, and reduce the chance of thrombosis. Preferably, the connector 30 is made of a polymer material, which can not only prevent itself from affecting signal transmission, but also protect the wireless sensor and prevent the stent from damaging the wireless sensor during transportation.
[0098] In order to better connect the wireless sensor to the bracket, the connectors in the above embodiments can be made of heat shrinkable materials. After the connector is connected to the connector through the joint section, the joint section is firmly connected between the connector and the wireless sensor through the heat shrink process, thereby realizing a stable connection between the wireless sensor and the bracket. In the above embodiments, the joint section and the elastic curve section are integrally formed as an example, but those skilled in the art can understand that in other embodiments of the present invention, the joint section can also be made of a material different from the elastic curve section, such as the elastic curve section is a metal wire, the joint section is a hard plastic tube or a stainless steel sheet, etc., and the joint section and the elastic curve section are fixedly connected (for example, welded), which can also achieve the purpose of the present invention. However, from the convenience of the processing technology and the use effect, the preferred method of integrally forming the joint section and the elastic curve section is not only simple, reliable and compact in connection structure; and the elastic curve section itself is a part of the bracket, and no additional structure is required to be connected to the connector, which will not significantly increase the radial size of the implant, and can also completely avoid the safety problems caused by the connection firmness or smoothness of the additional joint section and the elastic curve section.
[0099] refer to Figures 22a to 22e , which shows some optional embodiments of the bracket.
[0100] Fig.22a The figure is a schematic diagram of the longitudinal cross-section shape of a stent in an optional embodiment. In this embodiment, the diameter of the middle portion of the stent is smaller than the diameter of the two ends, forming an X-shaped longitudinal cross-section shape. Figure 22b Schematic diagram of the longitudinal section shape of the bracket in another optional embodiment. In this embodiment, the upper section of the bracket is trumpet-shaped, and the lower section is straight-cylindrical, forming a Y-shaped longitudinal section shape. Fig.22c Schematic diagram of the longitudinal cross-section shape of the stent in another optional embodiment. In this embodiment, the diameter of one end of the stent is greater than the diameter of the other end, and the diameter of the cylinder changes linearly in the axial direction, forming a V-shaped longitudinal cross-section shape. Fig.22d It is a schematic diagram of the longitudinal cross-sectional shape of the bracket in another optional implementation. In this implementation, the diameter at both ends of the bracket is different from the diameter in the middle, and the centers of the two ends are not coaxial with the center of the middle, and the bracket has a K-shaped longitudinal cross-sectional shape. Fig.22e It is a schematic diagram of the longitudinal cross-sectional shape of the bracket in another optional implementation manner. In this implementation manner, the bracket is Z-shaped as a whole.
[0101] The present disclosure also provides an implant system. The implant system includes a delivery catheter and an implant. The delivery catheter is used to accommodate the compressed implant and deliver the implant to the target site through an artificial or natural chamber / pipeline. The implant may include a stent and a wireless sensor. The stent may be a shunt for atrial shunt surgery as described in the aforementioned embodiment, or may be an occluder or a vascular stent. The implant is in a compressed state in the delivery catheter. Specifically, the stent is compressed into 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. When the delivery catheter delivers the implant to the target site, the implant can be pushed out of the catheter through the inner catheter.
[0102] In some optional embodiments, the implant system further includes a signal receiving device, which is used to receive signals from wireless sensors in the implant so that medical personnel can track changes in physiological parameters of the organism in real time.
[0103] The above is only a specific embodiment of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any person skilled in the art who is familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present disclosure, which should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.
Claims
1. An implant for implantation into a target site in a living body, characterized in that: include: A stent is used to be arranged at a target site to improve the physiological function of the organism, the stent includes a main body formed by a plurality of elastic curve segments, the main body is used for shunting; the stent also includes a clamping arm group, the clamping arm group includes at least a first clamping arm and a second clamping arm, the first clamping arm and the second clamping arm are distributed on the periphery of the main body at intervals along the axial direction of the main body, and the first clamping arm and the second clamping arm each form a cantilever protruding from the periphery of the main body.
2. The implant according to claim 1, characterized in that The first clamping arm and / or the second clamping arm are formed by bending an elastic metal wire, and / or the first clamping arm and / or the second clamping arm have a U-shaped or V-shaped structure formed by the elastic metal wire extending radially for a predetermined distance and then folding back.
3. The implant according to claim 1, characterized in that The main body is a cylinder, and the cylinder is formed by a plurality of elastic curve segments extending in a ring and / or spiral form, or the cylinder is formed by a plurality of elastic curve segments extending in a wave-like manner in the axial direction and extending in the circumferential direction at the same time.
4. The implant according to claim 3, characterized in that The elastic curve segment is an elastic metal wire, and the elastic metal wire constituting the first clamping arm and / or the second clamping arm and the elastic metal wire of the cylinder to which the base of the first clamping arm and / or the second clamping arm is attached are the same elastic metal wire, and / or the first clamping arm and / or the second clamping arm have a predetermined distance from the end of the cylinder respectively adjacent to each other.
5. The implant according to claim 1, characterized in that The free end of the first clamping arm overlaps with the free end of the second clamping arm in axial projection, and the fixed end of the first clamping arm and the fixed end of the second clamping arm are staggered in axial projection.
6. The implant according to claim 1, characterized in that The main body is divided into an upper tube and a lower tube, the number of the first clamping arms and the number of the second clamping arms are both 2 or more, the first clamping arms are evenly distributed on the surface of the upper tube, and the second clamping arms are evenly distributed on the surface of the lower tube.
7. The implant according to claim 1, characterized in that The bracket also includes a coating, which is applied inside and / or outside the main body. The main body is divided into an upper tube and a lower tube. The upper tube and the lower tube are coaxially distributed and connected by the coating.
8. The implant according to claim 7, characterized in that The elastic curve section of the upper tube extends upward in a spiral form in the circumferential direction in the initial stage and extends in a ring form in the last circle. The elastic curve section of the lower tube extends in a ring form in the initial stage and extends upward in a spiral form after one circle.
9. The implant according to claim 1, characterized in that The plurality of elastic curve segments include at least one engagement segment, the engagement segment being disposed in a predetermined area of the body and connected to a portion of at least one of the elastic curve segments; the implant further includes: A wireless sensor, comprising a detection element and a wireless signal transmission element, wherein the detection element is used to obtain a target physiological parameter, and the wireless signal transmission element is used to transmit the target physiological parameter obtained by the detection element to the outside of a biological body; and A connector for connecting the wireless sensor and the bracket; the connector includes a first connecting portion and a second connecting portion connected to each other, the first connecting portion is connected to the wireless sensor, and the second connecting portion is connected to the joining section, so that the wireless sensor is attached to the outer peripheral surface of the bracket in the predetermined area.
10. The implant according to claim 9, characterized in that The second connecting portion includes a clamped portion, and the engaging section is inserted into the second connecting portion or between the second connecting portion and the sensor to clamp the clamped portion; and The joining section is integrally formed with a portion of at least one of the elastic curve sections, and the joining section forces the clamped portion to abut against the outer circumferential surface of the main body through its own elastic force, and / or the joining section forces the clamped portion to abut against the outer circumferential surface of the main body through an adhesive.
11. The implant according to claim 9, characterized in that The bracket and the wireless sensor are arranged side by side.
12. The implant according to claim 10, characterized in that The second connecting portion includes a sheet portion, the sheet portion has an edge portion, the edge portion forms the clamped portion, and the joining section is connected to the sheet portion in the form of clamping the edge portion; the edge portion is located in the edge area of the sheet portion or in the edge area of an opening formed on the sheet portion.
13. The implant according to claim 12, characterized in that The connecting piece is an annular sleeve, a part of the annular sleeve is the first connecting part, and the other part of the annular sleeve is the second connecting part; the edge part of the sheet part is formed by the edge part of the annular sleeve, or the annular sleeve is provided with the opening, and the edge part of the sheet part is formed by the edge part of the opening.
14. The implant according to claim 13, characterized in that The annular sleeve at least partially overlaps with the wireless signal transmission element in the axial direction; the annular sleeve is a non-metallic sleeve, and the cross-section of the non-metallic sleeve is a closed structure or a non-closed structure, or the annular sleeve is a metal sleeve, and the cross-section of the metal sleeve is a non-closed structure.
15. The implant according to claim 13, characterized in that The annular sleeve completely covers the wireless sensor in the axial direction, and the detection element is exposed at the end surface of the wireless sensor, and the detection element is used to detect pressure.
16. The implant according to claim 9, characterized in that The elastic curved section forms the main body by extending in the circumferential direction and the axial direction, and the elastic curved section at least includes a wave section, a part of which forms the joining section.
17. The implant according to claim 16, characterized in that The predetermined trough portion and / or the peak portion of the wave segment forms the joining segment.
18. The implant according to claim 9, characterized in that The engaging section includes a first engaging section and a second engaging section, the second connecting portion includes a clamped portion, and the first engaging section and the second engaging section clamp the clamped portion from two opposite directions respectively.
19. The implant according to claim 18, characterized in that The plurality of elastic curve segments are formed into the main body by extending in the circumferential and axial directions, and the plurality of elastic curve segments at least include a wave segment, a predetermined portion of the wave segment has a detour segment, the detour segment is disconnected in the middle and forms a first joining segment and a second joining segment, the first joining segment and the second joining segment include bent and folded ends, and the bent and folded ends of the first joining segment and the second joining segment are respectively nested with each other.
20. The implant according to claim 9, characterized in that The connecting piece is an annular sleeve, a part of which is the first connecting part, and the other part of which is the second connecting part; the annular sleeve is provided with a first opening and a second opening having a predetermined spacing in the axial direction, and the joining section includes a first joining section and a second joining section, and the first joining section and the second joining section are respectively inserted between the annular sleeve and the wireless sensor through the first opening and the second opening and are nested with each other.
21. The implant according to any one of claims 1 to 20, characterized in that The stent is an atrial shunt, the main body is a cylinder, the cylinder is configured to be able to deform resiliently in the radial direction while keeping the circumference unchanged, the cylinder is configured to be able to be resiliently compressed along a first radial direction within a confined space, and / or the cylinder is configured to have a C-shaped cross-sectional shape when compressed along a first radial direction within a confined space.
22. The implant according to claim 9, characterized in that The wireless sensor is parallel to the main body, and / or the wireless sensor is circumferentially connected to the main body.
23. The implant according to claim 9, characterized in that The connecting piece is made of polymer material, and the wireless sensor and the bracket are fixed by a heat shrinking process.
24. The implant according to claim 1, characterized in that The diameter of the middle part of the bracket is smaller than the diameter of the two ends; or, the upper part of the bracket is trumpet-shaped and the lower part is straight-cylindrical; or, the diameter of one end of the bracket is larger than the diameter of the other end, and the diameter in the axial direction changes linearly; or, the diameters of the two ends of the bracket are different from the diameter of the middle part, and the centers of the two ends are not coaxial with the center of the middle part; or, the bracket is Z-shaped as a whole.
25. An implant system, comprising a delivery catheter and an implant, characterized in that: The implant is the implant described in any one of claims 9 to 24. When the implant is arranged in the catheter, it is in a compressed state, the bracket is compressed into a structure with a C-shaped cross-section, and the outer surface of the compressed bracket at least partially surrounds the wireless sensor, and the implant can extend from the catheter.