CN116269276A

CN116269276A - Implantable sensor and sensor system

Info

Publication number: CN116269276A
Application number: CN202310373970.5A
Authority: CN
Inventors: 任凯炳; 朱泽荀; 姚瑶; 李俊菲; 罗七一
Original assignee: Minimally Invasive Investment Holdings Ltd
Current assignee: Minimally Invasive Investment Holdings Ltd
Priority date: 2023-04-06
Filing date: 2023-04-06
Publication date: 2023-06-23

Abstract

The present invention relates to an implantable sensor and a sensor system. The implantable sensor is used for implanting heart to monitor intracardiac pressure and comprises a sensor main body and a fixer, wherein the sensor main body comprises a packaging shell and a pressure measurement module, a part of structure of the pressure measurement module is exposed outside the packaging shell to form a strain part, the strain part deforms along with external pressure change, the pressure measurement module converts the deformation into self-signal change, the fixer comprises an elastic clamping part, a connecting piece and a bottom frame which are sequentially connected, at least one of the elastic clamping part and the bottom frame is rotatably connected with the connecting piece, the bottom frame is fixedly connected with the packaging shell, and the sensor main body is matched with the elastic clamping part through the bottom frame to jointly clamp a preset partition. So configured, increased stability and reliability of implantation in vivo, reduced interference with hemodynamics and reduced risk of thrombosis, in particular, effective protection of the sensor body by the chassis, and reduced risk of rupture of the sensor body.

Description

Implantable sensor and sensor system

Technical Field

The invention relates to the field of medical instruments, in particular to an implantable sensor and a sensor system for heart failure monitoring.

Background

Heart Failure (HF) is abbreviated as heart failure, which refers to a syndrome of heart circulatory disturbance caused by venous blood stasis and insufficient arterial blood perfusion due to insufficient venous blood flow out of the heart due to dysfunction of the systolic function and/or diastolic function of the heart. Heart failure is a severe manifestation or advanced stage of various heart diseases, with mortality and readmission rates remaining high. The prevalence of heart failure in developed countries is 1.5% -2.0%, and the prevalence of people aged 70% or more is 10% or more. However, the aging population of China aggravates, the occurrence of chronic diseases such as coronary heart disease, hypertension, diabetes, obesity and the like is in an ascending trend, and the life cycle of heart disease patients is prolonged due to the improvement of medical level, so that the heart failure prevalence rate of China is in a continuous ascending trend.

Acute decompensation in heart failure patients can lead to dyspnea, edema, and fatigue, which are the most common symptoms leading to admission to heart failure. Currently, prophylaxis and admission judgment for such patients relies mainly on frequent evaluations, but the rate of heart failure hospitalization remains high. In the process of stabilizing heart failure from hemodynamics to acute decompensation, the heart failure patient generally first generates filling pressure rise 20-30 days before worsening to the need of hospitalization, then changes the thoracic impedance (10-20 days before hospitalization), and finally generates symptoms such as edema (fluid retention), dyspnea and the like which need of hospitalization. Therefore, the heart pressure (such as left atrial pressure and pulmonary artery pressure) and the like are monitored, a time window can be provided for advanced medical intervention of heart failure patients, and the purposes of improving congestion symptoms, reducing hospitalization or shortening hospitalization time are achieved by controlling the left atrial pressure or the pulmonary artery pressure. Compared with pulmonary arterial pressure monitoring, heart failure monitoring by Left Atrial Pressure (LAP) is more direct and reliable, because: about 90% of patients admitted to the hospital for heart failure have pulmonary congestion associated with elevated left atrial pressure; in cases of increased pulmonary resistance, the estimation of left heart filling pressure by pulmonary arterial pressure may be unreliable, which occurs in more than 50% of patients with advanced heart failure; direct endocardial pressure information may enhance sensitivity to detect other pathological entities such as mitral regurgitation, myocardial ischemia, and atrial arrhythmias. However, the existing sensor has the problem of instability under the impact of blood flow after being conveyed to a preset position, and has the risk of being difficult to fall off due to the fact that the clamping is not firm, and stability and reliability are reduced.

It should be noted that the information disclosed in the background section of the present invention is only for enhancement of understanding of the general background of the present invention and should not be taken as an admission or any form of suggestion that this information forms the prior art already known to those skilled in the art.

Disclosure of Invention

Aiming at least one technical problem in the prior art, the invention provides an implantable sensor and a sensor system, which can realize pressure monitoring, increase stability and reliability when being implanted into a body, reduce interference on blood flow dynamics and reduce thrombosis risk.

To achieve the above object, the present invention provides an implantable sensor for implanting in a heart to monitor intracardiac pressure, comprising a sensor body and a holder;

the sensor main body comprises a packaging shell and a pressure measurement module, part of the structure of the pressure measurement module is exposed outside the packaging shell to form a strain part, the strain part can deform along with external pressure change, and the pressure measurement module can convert the deformation into change of own signals;

the fixer comprises an elastic clamping part, a connecting piece and a bottom frame which are sequentially connected, wherein at least one of the elastic clamping part and the bottom frame is rotatably connected with the connecting piece, the bottom frame is connected with the packaging shell outside the packaging shell, the bottom frame and the strain part are arranged on two opposite sides of the packaging shell, and the sensor main body is matched with the elastic clamping part to jointly clamp the preset partition through the bottom frame.

In one embodiment, the implantable sensor further comprises a braking device disposed on the connector, the implantable sensor configured to: the sensor body and the underframe are released from the sheath tube and then rotate to a preset position, the preset position controls the strain part to be placed facing the pressure source, and the braking device controls the sensor body and the underframe to be kept in the preset position.

In one embodiment, the brake device can abut against the bottom of the chassis after the sensor body is rotated to a preset orientation with the chassis.

In one embodiment, the connecting piece and the braking device are arranged at an included angle, one end of the connecting piece is rotatably connected with the bottom frame, the other end of the connecting piece is fixedly connected with the elastic clamping part, and the braking device is arranged on the side face of the connecting piece.

In one embodiment, the chassis has an accommodating space, and the package housing is at least partially accommodated in the accommodating space.

In one embodiment, the chassis and the package case are fixedly connected through a plurality of fixing wires, the fixing wires penetrate through the chassis and the package case in the width direction of the chassis, and two ends of the fixing wires are fixedly connected with two sides of the chassis in the width direction.

In one embodiment, the chassis further comprises a frame body, a bottom and a rotating part, wherein the frame body, the bottom and the rotating part are sequentially connected, the bottom is hollow or not hollow, the rotating part is rotatably connected with the elastic clamping part through a rotating shaft, and the rotating shaft is fixedly connected with the elastic clamping part.

In one embodiment, the absolute value of the difference between the dimension of the receiving space and the outer dimension of the sensor body is 0.05mm-0.20mm, and/or the thickness of the chassis is 0.05mm-0.50mm.

In one embodiment, the elastic clamping part comprises a plurality of elastic rings wound by elastic wires, or the elastic clamping part is an elastic disc woven by braided wires.

In one embodiment, a coating is provided on the elastic disc.

In one embodiment, the maximum dimension of the resilient clamping portion in a direction parallel to the predetermined partition is greater than the dimension of the chassis in a direction parallel to the predetermined partition, and/or the partial dimension of the resilient clamping portion in a direction parallel to the predetermined partition is less than the dimension of the chassis in a direction parallel to the predetermined partition.

In one embodiment, the maximum profile of the resilient clip portion beyond the sensor body is at least partially within a highly radiating region of the sensor body, the sensor body being vertically disposed from a predetermined partition.

In one embodiment, the implantable sensor further comprises a non-return device, at least one of the chassis and the elastic clamping portion is provided with the non-return device, the sensor body and the chassis can only rotate in a preset direction when the sensor body and the chassis are released from the sheath, so that the strain is placed facing the pressure source, and the non-return device is used for controlling the sensor body and the chassis to rotate only in the preset direction.

To achieve the above object, the present invention also provides a sensor system including a conveyor including a sheath and a push rod having a delivery state loaded in the sheath and a deployment state after being released from the sheath, and an implantable sensor of any one of the above, the push rod penetrating the sheath and being capable of being pushed in the sheath, a distal end of the push rod being adapted to be releasably connected with the elastic clamping portion.

In summary, the implantable sensor provided by the invention is used for implanting a heart to monitor intracardiac pressure, and comprises a sensor main body and a fixer; the sensor main body comprises a packaging shell and a pressure measurement module, part of the structure of the pressure measurement module is exposed outside the packaging shell to form a strain part, the strain part can deform along with external pressure change, and the pressure measurement module can convert the deformation into change of own signals; the fixer comprises an elastic clamping part, a connecting piece and a bottom frame which are sequentially connected, wherein at least one of the elastic clamping part and the bottom frame is rotatably connected with the connecting piece, the bottom frame is connected with the packaging shell outside the packaging shell, the bottom frame and the strain part are arranged on two opposite sides of the packaging shell, and the sensor main body is matched with the elastic clamping part to jointly clamp the preset partition through the bottom frame.

So configured, firstly, the sensor can realize wireless and passive measurement of pressure in the heart through the pressure measurement module, the stability and reliability of pressure measurement are increased, and the measurement process is not easily affected by endothelialization, secondly, the sensor can be fixed in the heart through the fixer, meanwhile, the sensor can not have obvious protrusion in an atrium or a ventricle, the interference to blood flow dynamics and the thrombosis risk are reduced, and particularly, when the sensor is fixed, the sensor main body can be effectively protected through the underframe, and the rupture risk of the sensor main body is reduced.

Because the sensor system provided by the invention and the implantable sensor provided by the invention belong to the same inventive concept, the sensor system provided by the invention has all the advantages of the implantable sensor provided by the invention, and the beneficial effects of the sensor system provided by the invention are not repeated here.

Drawings

Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention. Wherein:

FIG. 1 is a schematic diagram of an implantable sensor according to an embodiment of the present invention;

FIG. 2 is a schematic view of a sensor body of an implantable sensor according to an embodiment of the present invention;

FIG. 3a is a schematic view showing a structure of a holder in an implantable sensor according to a first embodiment of the present invention;

FIG. 3b is a schematic view showing another holder of the implantable sensor according to the first embodiment of the present invention;

FIG. 4 is a schematic view of a chassis in a holder according to a first embodiment of the present invention;

FIG. 5 is a schematic view of a chassis coupled to a sensor body according to a first embodiment of the present invention;

FIG. 6 is a schematic structural view of a connector according to a first embodiment of the present invention;

FIG. 7 is a schematic view of a first embodiment of the present invention wherein a connector is coupled to a chassis and the chassis is coupled to a sensor body;

FIG. 8a is a schematic view illustrating the dimensions of the resilient clip portion and the chassis according to a first embodiment of the present invention;

FIG. 8b is a schematic view of the position of the elastic clamping portion relative to the sensor body when opened according to the first embodiment of the present invention;

FIG. 9a is a view of an implantable sensor according to a first embodiment of the present invention when the sensor is fixed to an atrial septum;

FIG. 9b is a view of the implantable sensor of the comparative example as secured to the atrial septum;

FIG. 10a is a schematic view of an implantable sensor according to a first embodiment of the present invention as delivered in a sheath;

FIG. 10b is a schematic view of the sensor body and chassis of the implantable sensor according to the first embodiment of the present invention after being pushed out of the sheath;

FIG. 11 is a schematic view of the oversteer of the sensor body of the comparative example with the chassis pushed out of the sheath;

fig. 12 is a schematic structural view of a connecting member with a brake device according to a first embodiment of the present invention;

FIG. 13 is a schematic view of the sensor body with the chassis pushed out of the sheath for braking according to the first embodiment of the present invention;

FIG. 14 is a schematic diagram of an implantable sensor according to a second embodiment of the present invention;

fig. 15 is a schematic structural diagram of a connector according to a second embodiment of the present invention;

FIG. 16 is a schematic view of a resilient disc according to a second embodiment of the present invention;

FIG. 17a is a schematic view of an implantable sensor according to a second embodiment of the present invention as delivered in a sheath;

FIG. 17b is a schematic view of the sensor body of the second embodiment of the present invention, together with the chassis, being turned after being pushed out of the sheath and the elastic disc being opened after being pushed out of the sheath;

FIG. 17c is a schematic view of the resilient disc of the second embodiment of the present invention being re-housed in the sheath and the sensor body remaining turned with the chassis;

FIG. 17d is a schematic view of a chassis of a second embodiment of the present invention positioned adjacent to the atrial septum on the left atrial side;

fig. 17e is a schematic view of the elastic disc of the second embodiment of the present invention being re-released to allow the implantable sensor to be secured to the atrial septum.

In the accompanying drawings:

100-an implantable sensor; 200-a holder; 210-an elastic grip; 211-an elastic ring; 212-elastic yarn; 210 a-an excess portion; 213-elastic disc; 2131-a woven mesh body; 2132-a proximal sleeve; 2133-plug; 220. 220' -connecting piece; 221-notch; 222-connector mounting holes; 223-clamping mounting holes; 230-a chassis; 231-fixing holes; 232-a frame body; 233-bottom; 234-a rotating part; 235-chassis rotation mounting holes; 240-fixing wires; 250-rotating shaft; 260-braking means; 400-a sensor body; 401—a sensing surface; 410-a pressure measurement module; 411—pressure capacitance; 4111-deformation pole; 4113-a first substrate; 4114-first electrode; 4112-base; 4115-a second substrate; 4116-second electrode; 412-an inductor; 430-packaging the shell; 431-first side; 432-second side; 433-mounting groove; 300-conveyor; 310-sheath; 330-pushing rod; w-width direction; the overall height of the structure formed by the H-sensor body and the underframe; w0-width of the chassis; l0-the length of the chassis; w1-width of the elastic clamping portion; l1-length of the elastic clamping portion.

Detailed Description

The invention will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" means two or more, and the meaning of "a number" means a number not limited. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art that the invention may be practiced without one or more of these details. In other instances, well-known features have not been described in detail in order to avoid obscuring the invention.

In the following description, for ease of description, "axial," "circumferential," and "radial," are used, as are "proximal," "proximal," and "distal"; "axial" refers to the direction along the central axis of the sheath, with the implantable sensor being substantially parallel to the central axis of the sheath when within the sheath; "circumferential" refers to a direction about the central axis of the sheath; "radial" refers to a direction perpendicular to the central axis of the sheath, such as along the diameter of the sheath; "proximal" and "proximal" refer to the end of the implantable sensor that is proximal to the operator when delivered in the sheath; "distal" and "distal" refer to the ends of the implantable sensor that are distal to the operator when delivered in the sheath. The terms "distal", "proximal" and "distal" in this document do not refer to the ends of the structure, but rather to the relative positions.

As background technology, V-LAP is the first implantable wireless left atrial pressure monitoring system, and its implantable left atrial pressure sensor adopts passive design, which increases the life and reliability of the sensor, but adopts an end sensing mode, so that there is a significant bulge on one side of the left atrium, which increases the interference to hemodynamics and the risk of thrombosis, and also needs to avoid endothelialization of the sensing site after implantation. In addition, the presence of complex integrated circuits within the sensor can affect the reliability and stability of the implanted device.

To solve such problems, the present invention provides an implantable sensor that avoids the use of an end sensing approach while employing a wireless and passive design, because the end sensing has an elongated extension shape to sense external pressure, and the non-end sensing approach can reduce the protrusion height of the sensor when in the atrium or heart, thereby reducing the interference to hemodynamics and the risk of thrombosis, while being less susceptible to endothelialization; meanwhile, no integrated circuit exists, so that the stability and the reliability of the implant are improved.

The present application is further described below with reference to the drawings and preferred embodiments, and the following embodiments and features of the embodiments may be mutually complementary or combined without conflict. In the following description, the left atrial pressure monitoring is illustrated schematically, where the implantable sensor is fixed to the atrial septum, but one skilled in the art will be able to modify the following description for pressure monitoring of other atria or ventricles, with appropriate modifications in detail.

As shown in fig. 1 and 2, embodiments of the present invention provide an implantable sensor 100 that enables passive and wireless monitoring of left atrial pressure. The implantable sensor 100 includes a holder 200 and a sensor body 400. The sensor body 400 includes a pressure measurement module 410 and a package housing 430. Part of the structure of the pressure measurement module 410 is exposed outside the package housing 430 to form a strain portion, the strain portion can deform along with the external pressure change, and the pressure measurement module 410 can convert the deformation of the strain portion into a change of a signal thereof, wherein the signal is mainly a wireless signal.

The pressure measurement module 410 is sealed between the strain portion and the package housing 430 (including in the package housing 430) except for the portion exposed outside of the package housing 430. The package housing 430 is used to seal and support the pressure measurement module 410 (corresponding to an LC tank circuit). The holder 200 is used to fix the implantable sensor 100 to the interatrial septum (AS), and after fixing, the Left Atrial Pressure (LAP) can be stably monitored in the heart. It is appreciated that when implantable sensor 100 monitors ventricular pressure, implantable sensor 100 is fixed to the Ventricular Septum (VS). Here, the room space and the room space are both predetermined partitions.

In a particular embodiment, the pressure measurement module 410 includes a pressure capacitor 411 and an inductor 412. A portion of the substrate of the pressure capacitor 411 is exposed outside the package case 430 to form the above-mentioned strain portion. The pressure capacitor 411 is located at one side of the package housing 430 to sense the blood pressure value in the left atrium, and the capacitance value of the pressure capacitor 411 may be changed along with the change of the left atrial pressure. The inductance coil 412 is located inside the package body 430, and can realize wireless detection of capacitance change. The inductance coil 412 and the pressure capacitor 411 are connected in parallel to form an LC oscillating circuit, so as to convert the change of the capacitance value of the pressure capacitor 411 into the change of the resonant frequency of the LC oscillating circuit, thereby realizing wireless reading of the blood pressure value.

As shown in fig. 2, the pressure capacitor 411 is composed of a deformation electrode 4111 and a base electrode 4112; the deformed electrode 4111 is composed of a first substrate 4113 and a first electrode 4114; the first electrode 4114 is directly connected to the first substrate 4113, and the first electrode 4114 is sealed between the first substrate 4113 and the package housing 430; the base 4112 is composed of a second substrate 4115 and a second electrode 4116; the second electrode 4116 is directly connected to the second substrate 4115 and is disposed opposite to the first electrode 4114. Only the first substrate 4113 is exposed outside the package body 430 to form a strain portion, and at this time, the first substrate 4113 is also used as a cover plate of the package body 430 to seal the side surface of the package body 430, so as to prevent the first electrode 4114, the second electrode 4116, the second substrate 4115 and the inductor coil 412 from being exposed outside. The inductor coil 412 is wound on the second substrate 4115.

In more detail, the package case 430 has a first side 431 for mounting the holder 200, and the package case 430 further has a second side 432 disposed opposite to the first side 431. The first substrate 4113 is disposed on the second side 432 of the package housing 430. Preferably, the package housing 430 is provided with a mounting groove 433 at the second side 432, and the second substrate 4115 is directly disposed in the mounting groove 433. The second substrate 4115 is integrally or monolithically formed with the package housing 430, or the second substrate 4115 is separately formed from the package housing 430.

The connection between the inductance coil 412 and the electrodes in the pressure capacitor 411 depends on the number of electrodes. In the illustrated embodiment, the number of the first electrodes 4114 is one, the number of the second electrodes 4116 is two, and the two second electrodes 4116 share one first electrode 4114, so as to form a one-to-two arrangement mode, and at this time, two ends of the inductance coil 412 are respectively connected with the terminals of the two second electrodes 4116, so as to form two LC oscillating circuits with series capacitors connected in parallel with one inductance coil 412. In other embodiments, the number of first electrodes 4114 and second electrodes 4116 is one, forming a one-to-one arrangement, where one end of inductor 412 is electrically connected to the terminal of first electrode 4114 and the other end is electrically connected to the terminal of second electrode 4116, thereby forming an LC tank circuit with a capacitor and an inductor 412 connected in parallel.

It will be appreciated that after the implantable sensor 100 is implanted in the body, the first substrate 4113 is disposed facing the left atrium, and the first substrate 4113 is deformed under the action of the atrial pressure, so that the plate distance between the first electrode 4114 and the second electrode 4116 is changed, thereby changing the capacitance value of the pressure capacitor 411, and further changing the resonant frequency of the LC oscillating circuit. The inductance coil 412 is connected in parallel with the pressure capacitance 411, and serves as both a resonant element and a transmission antenna during measurement. When the inductance coil of the external reader is close to the human body, the inductance coil 412 in the implanted sensor 100 transmits energy and signals in a near field coupling mode, and the signals read by the external reader are processed to determine the resonance frequency, and then the blood pressure value is determined according to the resonance frequency, so that the passive and wireless measurement of the left atrial pressure is realized.

Measurement of the resonant frequency of the implantable sensor 100 can be accomplished by known methods as would be recognized by those skilled in the art, including time domain methods, frequency sweep methods, and the like. The resonance frequency f, the inductance value L and the capacitance value C satisfy the following relationship:

wherein:

in the above formula: l is an inductance value; c is the capacitance value; pi takes a value of 3.14; p is cardiac pressure; c (p) represents the relationship of capacitance value as the left atrium pressure changes, and the correspondence between capacitance value and pressure value is known and can be calibrated in advance. In the measuring process, the inductance value L is kept constant, so that K is a determined constant, the change of the capacitance value C can be calculated by measuring the change of the resonant frequency f, and the left atrium pressure is further determined according to the change of the capacitance value C.

Referring to fig. 3a to 3b, fig. 4 to 7, fig. 8a to 8b, fig. 9a to 9b, fig. 10a to 10b, fig. 12 to 16, fig. 17a to 17e, the implantable sensor 100 according to the embodiment of the present invention will be described in more detail with reference to fig. 1 and 2.

Example 1

As shown in fig. 3a, the fastener 200 according to the first embodiment of the present invention includes an elastic clamping portion 210, a connecting member 220, and a bottom frame 230 connected in sequence. At least one of the elastic clamping portion 210 and the bottom chassis 230 is rotatably connected with the connection member 220. In the present embodiment, the elastic clamping portion 210 is fixedly connected to the connecting member 220, and the connecting member 220 is rotatably connected to the chassis 230, but is not limited thereto. The chassis 230 is coupled to the package case 430 at the outside of the package case 430, specifically, the chassis 230 is mounted at the first side 431 of the package case 430, the chassis 230 and the strain portion are disposed at opposite sides of the package case 430, that is, the chassis 230 and the first substrate 4113 are disposed at opposite sides of the package case 430 in the height direction, and finally, the chassis 230 and the elastic clamping portion 210 cooperate to clamp the room space (AS) together, in such a manner that the sensor is stably fixed on the room space. In one embodiment, the connector 220 is rotatably coupled to the chassis 230 via a shaft 250. At least one of the connecting member 220 and the bottom frame 230 is rotatably connected with the rotating shaft 250, in this embodiment, the connecting member 220 is fixedly connected with the rotating shaft 250, and the bottom frame 230 is rotatably connected with the rotating shaft 250. Accordingly, the chassis 230 and the elastic clamping portion 210 may be relatively rotated, that is, the chassis 230 together with the sensor body 400 may be rotated with respect to the elastic clamping portion 210.

The elastic clamping part 210 and the sensor main body 400 can relatively rotate, so that the whole sensor can be conveyed through the sheath tube 310, the sensor main body 400 and the bottom frame 230 are conveniently separated from the sheath tube 310 in advance to be positioned and released in the left atrium, further, the pressure measuring module 410 realizes wireless and passive measurement of the left atrial pressure in the left atrium, the stability and the reliability are good, and the measuring process is not easily affected by endothelialization. After the releasing position of the sensor body 400 is clear, the holder 200 is released again, and finally, the sensor is firmly fixed on the room space. After fixation, the sensor body 400, together with the chassis 230, is not significantly bulged in the left atrium as a whole, reducing the risk of hemodynamic disturbances and thrombosis. In particular, the effective protection of the sensor body 400 by the chassis 230 reduces the risk of breakage of the sensor body 400 when clamped.

The main reason why the sensor body 400 is easily broken is that the package housing 430 is often made of brittle materials with good insulation properties such as glass, quartz, and quartz glass, and is easily broken by force.

AS shown in fig. 9b, in the comparative embodiment, if the chassis 230 is not provided, the elastic clamping portion 210 and the encapsulation body 430 directly clamp the space (AS), and in this clamped state, the encapsulation body 430 is easily broken by direct stress, and also the relative friction between the connection member 220 and the encapsulation body 430 during implantation or after implantation during heart beat causes the encapsulation body 430 to be broken. To solve this problem, the chassis 230 is added to the package body 430, which has a better protection effect on the package body 430 and increases the stability of the sensor.

AS shown in fig. 9a, when the implantable sensor 100 is fixed on the space (AS), the elastic clamping portion 210 is disposed on one side of the Right Atrium (RA) and the sensor body 400 is disposed on one side of the Left Atrium (LA) together with the chassis 230 along with the space (AS), and the chassis 230 directly abuts on the space (AS), and the space (AS) is directly clamped by the chassis 230 and the elastic clamping portion 210, so that the breakage caused by the direct stress of the package housing 430 in the clamped state after implantation can be reduced, and the breakage of the package housing 430 caused by the relative friction between the connection member 220 and the package housing 430 during implantation or after implantation during heart beat can be avoided.

In addition to the above effects, the implantable sensor 100 provided by the present invention does not have a separate deployment of fixation and pressure monitoring, and the structure is simplified, thereby further improving the safety and reliability of implantation. It should also be appreciated that the procedure requires penetration over the Atrial Septum (AS) to form a puncture through which the sheath 310 may pass, and that the connector 220 also requires deployment in the puncture after fixation.

As shown in fig. 5, in various embodiments, the overall height H of the structure of the sensor body 400 along with the chassis 230 may be reduced to 1.6 mm-2.7 mm, and thus, the risk of thrombosis may be greatly reduced with little impact on left intra-atrial hemodynamics. Here, the height of the sensor body 400 is perpendicular to the room space (AS).

It should be noted that there are various ways to connect the chassis 230 and the package cover 430, and at least one of them may be selected to perform. The following is an exemplary illustration.

As shown in fig. 3a, 4 to 5, in one embodiment, the chassis 230 and the package case 430 are fixedly connected by the fixing wires 240. The number of the fixing wires 240 is a plurality of at least two fixing wires 240. The fixing wire 240 passes through the chassis 230 and the package case 430 in the width direction W of the chassis 230, and finally, both ends of the fixing wire 240 are directly fixed to both sides of the chassis 230 in the width direction W. In the present embodiment, the width direction of the chassis 230 coincides with the width direction of the package case 430, where the widths are parallel to the room space (AS).

Further, two pairs of fixing holes 231 are provided on the bottom frame 230, four fixing holes 231 are distributed at four corners of the bottom frame 230, the two pairs of fixing holes 231 are configured in one-to-one correspondence with the two fixing wires 240, and each fixing wire 240 only needs to pass through a corresponding pair of fixing holes 231. Here, although four fixing holes 231 are mentioned, this is not meant to be limiting, and one skilled in the art should recognize that the number of fixing holes 231 may be increased to 6 or 8, etc., depending on the shape and size of the bottom chassis 230.

The diameter of the fixing hole 231 is slightly larger than that of the fixing wire 240, and further, the diameter of the fixing hole 231 is 0.05mm-0.10mm larger than that of the fixing wire 240, so that difficulty in installing the fixing wire 240 is reduced, and connection strength of two ends of the fixing wire 240 can be achieved. If the diameter of the fixing hole 231 is smaller than that of the fixing wire 240, the fixing wire 240 is difficult to pass through the fixing hole 231; if the diameter of the fixing hole 231 is much larger than that of the fixing wire 240, the connection strength of both ends of the fixing wire 240 is reduced. Preferably, the diameter of the fixing hole 231 is 0.2mm-0.5mm. The initial length of the fixing wire 240 is much longer than the distance of the pair of fixing holes 231 connected thereto. The both ends of the fixing wire 240 are preferably welded and fixed. Here, the fixing wire 240 has a simple structure and convenient assembly, and can reduce the stress of the package housing 430, thereby further reducing the risk of cracking the package housing 430.

As shown in fig. 5, when the chassis 230 is connected to the package case 430, the fixing wire 240 passes through the fixing hole 231 of one side of the chassis 230 in the width direction W, then passes through the package case 430, then passes through the fixing hole 231 of the other side of the chassis 230, and finally, the both ends of the fixing wire 240 are welded and fixed to the chassis 230. The above steps are repeated, and the other fixing wire 240 is inserted into the other pair of fixing holes 231, so that the fixing between the package body 430 and the bottom chassis 230 can be completed. The fixing wire 240 is mostly made of metal materials, such as nickel-titanium alloy wires, 316 stainless steel wires, titanium alloy wires, etc. Preferably, the material of the fixing wire 240 is similar or identical to that of the bottom chassis 230, which is advantageous for improving the welding strength between the fixing wire 240 and the bottom chassis 230.

The structure of the elastic clamping portion 210 is not particularly limited, and the elastic clamping portion can be folded when being conveyed, can be automatically opened after being separated from the sheath 310, is not easy to fall off after being clamped, and can be firmly connected.

As shown in fig. 3a and 3b, in one embodiment, the elastic clamping portion 210 includes a plurality of elastic rings 211 wound from an elastic wire 212. The number of elastic rings 211 is two or more, however in other embodiments the elastic rings 211 may be one. The plurality of elastic rings 211 are more stable when clamped than a single elastic ring 211. The elastic ring 211 adapts to various room spaces or compartments while maintaining a certain flexibility and elasticity. Preferably, the elastic wire 212 is made of nickel-titanium alloy with shape memory capability. Considering that the elastic wire 212 is too thin, the stability of clamping may be lowered, and when the elastic wire 212 is too thick, it is easy to increase the transport size and increase the weight of the entire sensor. For this problem, the elastic wire 212 having a diameter of 0.05mm to 0.80mm is preferably used, and more preferably, the elastic wire 212 has a diameter of 0.20mm to 0.40mm. In some embodiments, as shown in fig. 3a, the elastic clamping portion 210 includes 2 elastic rings 211 symmetrically distributed, wherein the elastic rings 211 respectively correspond to two ends of the sensor body 400 along the length direction, and clamp the predetermined partition together. In some embodiments, AS shown in fig. 3b, the elastic clamping portion 210 includes 4 elastic rings 211, wherein two elastic rings 211 respectively correspond to two ends of the sensor body 400 in the length direction, and the other two elastic rings 211 respectively correspond to two ends of the sensor body 400 in the width direction, where the length is parallel to the room space (AS).

In addition, the chassis 230 mainly adopts a frame structure, especially a hollowed-out frame, so as to reduce the weight and reduce the signal interference, but at the same time, the strength can be ensured. Specifically, the chassis 230 has an accommodating space, and the package case 430 is at least partially accommodated in the accommodating space.

As shown in fig. 4, in one embodiment, the bottom chassis 230 includes a frame body 232, a bottom 233, and a rotating part 234, which are sequentially connected. The bottom 233 is hollowed out or not hollowed out. Further, a fixing hole 231 is provided on the frame body 232. If the bottom 233 is hollowed out, the hollowed-out shape corresponds to the outer contour shape of the package housing 430, and in this embodiment, the package housing 430 is a cuboid, and correspondingly, the hollowed-out shape of the bottom 233 is a rectangle. The frame body 232 is wrapped around the outside of the package case 430. The frame body 232 does not wrap around the entire sensor body 400, and at least the first substrate 4113 needs to be exposed. The bottom 233 is disposed at a side of the bottom chassis 230 facing away from the package case 430, and mounts the rotating part 234. Further, the rotating portion 234 is rotatably connected to the elastic clamping portion 210 through a rotating shaft 250, the rotating portion 234 is provided with a chassis rotation mounting hole 235, and the rotating shaft 250 rotatably passes through the chassis rotation mounting hole 235. The bottom chassis 230 is integrally or integrally formed or is assembled after being formed separately. The diameter of the chassis rotation mounting hole 235 is slightly larger than the outer diameter of the rotating shaft 250, and further, the diameter of the chassis rotation mounting hole 235 is 0.05mm-0.30mm larger than the outer diameter of the rotating shaft 250, so that the rotating shaft 250 can be conveniently inserted into the chassis rotation mounting hole 235, and meanwhile connection tightness can be guaranteed.

The size of the receiving space (i.e., hollowed-out) of the chassis 230 may be slightly larger or slightly smaller than the outer dimension of the sensor body 400. The outer profile dimensions of the sensor body 400 include the length and width of the sensor body 400, specifically, the length of the receiving space is slightly greater than or slightly less than the length of the sensor body 400, and the width of the receiving space is slightly greater than or slightly less than the width of the sensor body 400.

In this embodiment, the sensor body 400 has a rectangular structure as a whole, and correspondingly, the hollow of the chassis 230 is rectangular. Preferably, the hollowed-out dimension of the underframe 230 is different from the outline dimension of the sensor main body 400 by 0.05mm-0.20mm; if the dimensional differences are too large, the assembly is too loose or too tight, which may affect the connection strength, and too tight, which may increase the assembly difficulty and increase the risk of damaging the sensor body 400. Preferably, the thickness of the chassis 230 is 0.05mm to 0.50mm, and the too thin thickness may reduce the strength of the chassis 230, resulting in breakage of the chassis 230, falling off of the sensor, etc., and if too thick thickness may increase the diameter of the sheath 310 during sensor transportation, reducing the transportation performance. More preferably, the chassis 230 has a thickness of 0.05mm to 0.30mm. The thickness of the bottom chassis 230 refers to the plate thickness of the frame body 232.

In some embodiments, the chassis 230 is made of a metal material, preferably pure titanium, titanium alloy, 316 stainless steel, cobalt chrome alloy, etc., which can ensure connection strength and have good biocompatibility. In other embodiments, the chassis 230 is made of a polymer material with good mechanical properties, where the polymer material should ensure the connection strength, and of course has good biocompatibility, mainly referred to as a hard polymer material.

As shown in fig. 6, in one embodiment, the connection member 220 is provided with a notch 221 for receiving the rotating part 234 of the bottom chassis 230, the notch 221 is provided with connection member mounting holes 222 in the mounting direction of the rotation shaft 250, and two connection member mounting holes 222 are distributed at both ends of the notch 221. The rotation shaft 250 passes through the two connector mounting holes 222 and forms a fixed connection with the connector 220. Preferably, the diameter of the connector mounting hole 222 is slightly larger than the outer diameter of the rotating shaft 250, and more preferably, the diameter of the connector mounting hole 222 is 0.05mm-0.10mm larger than the outer diameter of the rotating shaft 250. It can be appreciated that if the diameter of the connector mounting hole 222 is smaller than the outer diameter of the rotating shaft 250, the rotating shaft 250 cannot pass through the connector mounting hole 222; if the diameter of the connector mounting hole 222 is much larger than that of the rotation shaft 250, the connection strength of both ends of the rotation shaft 250 is reduced. Preferably, the connector mounting holes 222 have a diameter of 0.2mm to 0.5mm.

The connection means 220 may be connected to the elastic clamping portion 210 in various manners, and at least one of the manners may be selected, such as welding, riveting, interference fitting, etc. For example, the connecting member 220 is further provided with a clamping mounting hole 223 for fixing the elastic wire 212. In this embodiment, the elastic wires 212 are wound to form elastic rings 211, each elastic ring 211 is formed by winding one elastic wire 212, and two ends of each elastic wire 212 are respectively embedded into two clamping mounting holes 223 to fix and form the elastic rings 211. The depth of the clip mounting hole 223 should ensure the coupling strength and avoid the increase in the size of the coupling member 220. Preferably, the clip mounting holes 223 have a depth of 0.5mm-3.0mm. In this embodiment, the elastic wire 212 is inserted into the clamp mounting hole 223 and is fixedly connected with the connecting member 220 by a suitable manner.

Preferably, the initial length of the shaft 250 is substantially greater than the distance between the two connector mounting holes 222. As shown in fig. 7, when the connector 220 is connected to the chassis 230, the rotating shaft 250 passes through the connector mounting hole 222 on one side of the connector 220, then passes through the chassis rotation mounting hole 235 on the chassis 230, finally passes through the connector mounting hole 222 on the other side of the connector 220, and then the two ends of the rotating shaft 250 are welded and fixed to the connector 220. The shaft 250 is preferably made of a metallic material such as nickel-titanium alloy, 316 stainless steel, titanium alloy, etc. Preferably, the material of the rotating shaft 250 is similar or identical to that of the connecting member 220, which is advantageous for improving the connection strength.

As shown in fig. 8a, the dimension (including length and width) of the elastic clamping portion 210 in the direction parallel to the predetermined partition may be greater than, less than, or equal to the dimension (including length and width) of the chassis 230 in the direction parallel to the predetermined partition, preferably, the dimension (mainly referred to as the maximum dimension) of the elastic clamping portion 210 in the direction parallel to the predetermined partition is greater than the dimension of the chassis 230 in the direction parallel to the predetermined partition, so as to increase the stability of the implantable sensor 100 when clamped on the atrial septum. Preferably, the elastic clamping portion 210 has a smaller partial outer dimension (mainly width) in the direction parallel to the predetermined interruption than the outer dimension of the chassis 230 in the direction parallel to the predetermined interruption, which enables the elastic clamping portion 210 itself to prevent erroneous steering of the sensor body 400, which would result in implantation failure if erroneous steering occurs.

In the present embodiment, the outer dimension of the elastic clamping portion 210 in the direction parallel to the predetermined partition includes a length L1 and a width W1, and the outer dimension of the chassis 230 in the direction parallel to the predetermined partition includes a length L0 and a width W0. The width W1 of the elastic clamping portion 210 may be greater than, less than, or equal to the width W0 of the chassis 230, and the length L1 of the elastic clamping portion 210 may be greater than, less than, or equal to the length L0 of the chassis 230. As shown in fig. 8a, the width W1 of the elastic clamping portion 210 is greater than the width W0 of the chassis 230, and/or the length L1 of the elastic clamping portion 210 is greater than the length L0 of the chassis 230. Further, the width of the elastic clamping portion 210 at a partial position may be smaller than that of the bottom chassis 230, which enables the elastic clamping portion 210 itself to prevent erroneous steering of the sensor body 400.

Referring to fig. 8b, implantable sensor 100 is shown in a natural state, which is understood to be an extended state in which it is not implanted in the body and no external forces are applied. In a natural state, the elastic clamping portion 210 is completely opened, and the sensor body 400 is disposed opposite to the elastic clamping portion 210 along with the bottom chassis 230, and at this time, an excess portion 210a of the elastic clamping portion 210, which exceeds the sensor body 400, may be located within a high radiation area of the sensor body 400. Of course, not limited thereto, the protruding portion 210a of the elastic clamping portion 210 having the largest outline beyond the sensor body 400 may be located outside the high radiation area of the sensor body 400. It is also understood that the distance of the excess portion 210a of the resilient clip portion 210 from the sensing surface 401 of the sensor body 400 may be greater than, less than, or equal to the distance of the bottom portion 233 of the chassis 230 from the sensing surface 401.

In an embodiment, the distance of the protruding portion 210a of the elastic clamping portion 210 from the sensing surface 401 is greater than the distance of the bottom portion 233 from the sensing surface 401, such that the protruding portion 210a is located outside the highly radiating area of the sensor body 400, i.e. the protruding portion 210a does not extend beyond the bottom portion 233. In another embodiment, the distance of the excess portion 210a of the resilient clamping portion 210 from the sensing surface 401 is smaller than the distance of the bottom portion 233 from the sensing surface 401, such that the excess portion 210a is located within the highly radiating area of the sensor body 400, i.e. the excess portion 210a extends beyond the bottom portion 233. Alternatively, the distance between the protruding portion 210a of the elastic clamping portion 210 and the sensing surface 401 is substantially equal to the distance between the bottom portion 233 and the sensing surface 401, so that the protruding portion 210a and the bottom portion 233 are at the same height. Preferably, the maximum profile of the resilient clamping portion 210 exceeds the outer profile 210a of the sensor body 400 in the highly radiating region of the sensor body 400, thereby increasing the clamping force of the implantable sensor 100 on the Atrial Septum (AS) and making the clamping more secure and stable.

As shown in fig. 9a, the elastic clamping portion 210 is preferably opened to avoid tissue near the puncture (not labeled) to reduce damage to human tissue during clamping. At this time, the portion of the elastic clamping portion 210 near the connection member 220 is recessed in a direction away from the sensor body 400, and the portion of the elastic clamping portion 210 away from the connection member 220 is closer to the sensor body 400 than the middle recessed area and abuts on the atrial septum. However, in other embodiments, the resilient clip portion 210 does not form a recessed area but is entirely nearly in one plane, such as the resilient clip portion 210 in fig. 9 b.

Referring next to fig. 10a and 10b and fig. 13, the present embodiment also provides a sensor system comprising a conveyor 300 and an implantable sensor 100. Wherein the transporter 300 comprises a sheath 310 and a push rod 330. Implantable sensor 100 has a delivery state in which it is delivered within sheath 310 and a deployed state after it is detached from sheath 310, and is switchable between the delivery state and the deployed state. The push rod 330 penetrates the sheath 310 and can be pushed within the sheath 310 to release and retrieve the implantable sensor 100. The distal end of the push rod 330 is adapted to be releasably coupled to the resilient clip portion 210 to restrain the resilient clip portion 210 in the collapsed state. It should be noted that the size of implantable sensor 100 should be as small as possible to avoid increasing the size of sheath 310 during delivery within sheath 310.

As shown in fig. 10a, when delivered through the sheath 310, the elastic clamping portion 210 may be folded with respect to the sensor body 400 and the chassis 230 such that the elastic clamping portion 210 and the sensor body 400 are substantially in a parallel arrangement, and have a small radial dimension, so as to be conveniently delivered through the sheath 310.

As shown in fig. 10b, when deployed, the sensor body 400 and the chassis 230 are released first, so that the sensor body 400 and the chassis 230 are rotated to a preset orientation almost perpendicular to the axial direction of the sheath 310 after being detached from the sheath 310, and the preset orientation controls the strain to be placed facing the pressure source. The "pressure source" herein refers to blood in the left atrium, that is, only the first substrate 4113 can contact the blood to sense the left atrium pressure.

In this embodiment, the sensor body 400, along with the chassis 230, can only be rotated in a predetermined direction when released from the sheath 310, such that the strain is placed facing the pressure source. In fig. 10a and 10b, the direction indicated by arrow A1 is the correct steering (i.e., the predetermined direction), and vice versa. In other words, the implantable sensor 100 of the present embodiment itself can prevent erroneous steering at the time of sheath 310. There are various ways of preventing the erroneous steering, and at least one of them may be selected to be performed. The following is an exemplary illustration.

At least one of the packing case 430 and the elastic clamping portion 210 is provided with a ratcheting means which can control the sensor body 400 to rotate only in a predetermined direction when the release sheath 310 is released, the ratcheting means being provided on a rotation path opposite to the predetermined direction, and the packing case 430 and the elastic clamping portion 210 being capable of being abutted by the ratcheting means.

As described with reference to the clockwise direction in fig. 10b, when the sensor body 400 is separated from the sheath 310 by the connection of the chassis 230, the sensor body 400 can rotate clockwise in the counterclockwise rotation path because the chassis 230 is blocked by the non-return device and cannot rotate counterclockwise in the clockwise rotation path. The backstop device may be implemented in various ways, for example, the backstop device may be directly disposed on the elastic clamping portion 210, so that the chassis 230 may abut against the backstop device of the elastic clamping portion 210 in the longitudinal direction on a rotation path opposite to the predetermined direction, or the backstop device may be directly disposed on the chassis 230, so that the chassis 230 may abut against the elastic clamping portion 210 by the backstop device of the longitudinal direction on a rotation path opposite to the predetermined direction, or the backstop device may be disposed in the width direction, so that the chassis 230 may abut against the backstop device of the elastic clamping portion 210 in the width direction on a rotation path opposite to the predetermined direction. In practice, the non-return means may be grooves or protrusions, the grooves corresponding to a reduced size and the protrusions corresponding to an increased size, both of which are convenient for the chassis 230 and the elastic clamping portion 210 to abut by the non-return means.

In order to make the efficiency and effect of preventing the wrong turning better, in other embodiments, the passive non-return device is replaced by an active non-return device, and the active non-return device has elasticity and is respectively connected with the chassis 230 and the connecting piece 220; the active non-return device is elastically deformed when an external force is applied thereto, and pushes the bottom frame 230 to rotate in a predetermined direction together with the sensor body 400 by its own elastic force after the external force is released. In more detail, the active backstop is forced to elastically deform as the sensor is delivered in the sheath 310; when the sensor body 400 is separated from the sheath 310 together with the chassis 230, the active backstop is released together with the chassis 230, so that the active backstop releases the elastic force and pushes the sensor body 400 to rotate together with the chassis 230 in a predetermined direction.

In order to rotate the sensor body 400 only in a predetermined direction during the detachment of the chassis 230 from the sheath 310, the backstop may be omitted, and the sensor body 400 may be prevented from being erroneously steered by means of the asymmetry of the rotation radius of the sensor body 400. For example, the connection member 220 is connected to both sides of the bottom chassis 230 in the width direction W, and a connection point between the connection member 220 and the sides of the bottom chassis 230 is spaced from the bottom 233 of the bottom chassis 230 by a distance smaller than a distance from the top of the sensor body 400 (the top is the sensing surface of the first substrate 4113) such that a first radius of rotation when the sensor body 400 is rotated in a predetermined direction together with the bottom chassis 230 is smaller than a second radius of rotation when rotated in a direction opposite to the predetermined direction. That is, the backstop function is achieved by the distance from the connection point to the distal end face of the push rod 330, so that the distal end face of the push rod 330 can block the erroneous steering of the sensor body 400 when it is detached from the sheath 310.

In this embodiment, the elastic clamping portion 210 is configured as a passive non-return device, so that the elastic clamping portion 210 prevents the sensor body 400 and the chassis 230 from rotating in a direction opposite to a predetermined direction when the release sheath 310 is released by its own structure (including shape and size). Because of the blocking effect of the elastic clamping portion 210 on the sensor body 400, the sensor body 400 together with the chassis 230 can only rotate in the direction of arrow A1 after being pushed out of the sheath 310.

As shown in fig. 10a, in the delivery state, the elastic grip 210 is restrained by the distal end of the push rod 330 and arranged along the axial extension of the sheath 310, while the sensor body 400 is arranged along the axial extension of the sheath 310 after rotation of the chassis 230 with respect to the elastic grip 210, and such that the bottom 233 of the chassis 230 partially rests on the elastic grip 210. It should be understood that, the pushing rod 330 constrains the elastic clamping portion 210, so that the elastic clamping portion 210 does not interfere with the release and positioning of the sensor body 400, and the elastic clamping portion 210 can be smoothly transported and released through the sheath 310, and the sequential release of the sensor body 400 and the elastic clamping portion 210 is achieved. Further, AS shown in fig. 10b, when the sensor body 400 and the chassis 230 are released from the sheath 310, they are not rotated in the wrong direction, and normally, after the rotation, the strain part is directed to the left atrium, and the chassis 230 is directed to the Atrial Septum (AS).

It has further been found that oversteer may occur even without an erroneous steering after the sensor body 400 is pushed out of the sheath 310 along with the chassis 230, and implantation failure may occur if oversteer occurs. Because the sensor body 400 is pushed out of the sheath 310 together with the chassis 230, the sensor body 400 is first turned by gravity as shown in fig. 10b, but the sensor body 400 is not stably positioned, and sometimes oversteer as shown in fig. 11 occurs, which may cause implantation failure. To address this problem, the present invention further improves the sensor configuration by adding a brake 260 to the connector 220, see in particular fig. 12.

As shown in fig. 12, the brake 260 may control the sensor body 400 to remain in the above-described predetermined orientation along with the chassis 230, further reducing the risk of implant failure. However, there are various ways of preventing oversteer, and at least one of them may be selected to perform. The following is an exemplary illustration.

In some embodiments, the brake 260 is a non-resilient structure that passively controls the sensor body 400 to remain in the preset orientation described above in conjunction with the chassis 230.

In other embodiments, the brake 260 is a resilient structure that actively controls the sensor body 400 to remain in the predetermined orientation described above in conjunction with the chassis 230.

As shown in fig. 12, in the present embodiment, the braking device 260 passively controls the sensor body 400 and the chassis 230 to maintain the above-mentioned preset orientation, at this time, the connecting member 220 and the braking device 260 are disposed at an included angle, one end of the connecting member 220 is rotatably connected with the chassis 230 (corresponding to the position of the connecting member mounting hole 222), the other end of the connecting member 220 is fixedly connected with the elastic clamping portion 210 (corresponding to the position of the clamping mounting hole 223), and the braking device 260 is only required to be disposed on the side surface of the connecting member 220 and can abut against the bottom 233 of the chassis 230 at the preset orientation.

After the brake 260 is provided, as shown in fig. 13, when the sensor body 400 is rotated with the chassis 230 until the strain portion is perpendicular to the axial direction of the sheath 310, the brake 260 acts so that the sensor body 400 is kept stable with the chassis 230 in this state. Then, the sheath 310 and the pushing rod 330 are withdrawn simultaneously, so that the bottom frame 230 is tightly attached to the left atrium side of the atrial septum, and then the pushing rod 330 is withdrawn to release the elastic clamping portion 210, so that the elastic clamping portion 210 is clamped on the right atrium side of the atrial septum, and finally the implantable sensor 100 is fixed on the atrial septum.

In this embodiment, the connecting member 220 and the braking device 260 are integrally formed, and after the sensor body 400 is pushed out of the sheath 310 together with the chassis 230 to be turned, the connecting member 220 is connected to the elastic clamping portion 210 in the axial direction parallel to the sheath 310, and the braking device 260 blocks the chassis 230 in the axial direction perpendicular to the sheath 310.

However, those skilled in the art will recognize that the manner of preventing oversteer is not limited to the cases listed in the above embodiments.

< example two >

Referring next to fig. 1, fig. 14 to 16, and fig. 17a to 17e, and in combination with fig. 2, an implantable passive sensor 100 according to a second embodiment of the present invention has substantially the same structure as the implantable passive sensor 100 according to the above embodiment, and the same parts will not be described again, but only the differences will be described below.

As shown in fig. 1 and 14, in the holder 200 according to the second embodiment of the present invention, the elastic clamping portion 210 is an elastic disc 213 woven by a woven wire, and another connecting member 220' is used instead of the connecting member 220 in the above embodiment. Compared with the elastic ring 211, the elastic plate 213 has better blocking effect on the puncture hole on the atrial septum after implantation, can reduce or even avoid atrial bypass, and has better anti-falling effect, because the elastic plate 213 is relatively slower when being released and unfolded, can be slowly opened and attached to the atrial septum, and has small release impact.

As shown in fig. 14 and 15, the link 220' rotatably connects the elastic tray 213 to the bottom chassis 230. Specifically, the link 220 'is provided with a clip mounting hole 223 in addition to the notch 221 accommodating the rotating portion 234 and the link mounting hole 222, and further, the link 220' is also provided with a brake 260. The function of the notch 221, the connector mounting hole 222 and the detent 260 are similar to the previous embodiments and will not be described in detail. The spring plate 213 has opposite proximal and distal ends. The proximal end of the elastic disc 213 is adapted to be releasably connected to the distal end of the push rod 330, and the distal end of the elastic disc 213 is fixedly connected to the connector 220', specifically, the distal end of the elastic disc 213 is fixed in the clamping mounting hole 223.

As shown in fig. 16, in the present embodiment, the elastic disc 213 includes a knitted net main body 2131, and the knitted net main body 2131 may be a single knitted net or a cage-like knitted net. The main body 2131 of the woven mesh is provided with a proximal connection portion at a proximal end and a distal connection portion at a distal end, the proximal connection portion being detachably connected to the distal end of the push rod 330, the distal connection portion being fixedly connected to the connection member 220'.

In one embodiment, the distal connection portion includes a distal sleeve (not shown) that is secured in the clamping mounting hole 233 and is fixedly connected by welding, bonding, crimping, riveting, or the like. In one embodiment, the proximal connection includes a proximal sleeve 2132 and a plug 2133, the proximal sleeve 2132 being secured to the plug 2133, the plug 2133 being adapted to releasably connect with the distal end of the push rod 330. The proximal sleeve 2132 and the distal sleeve are made of a metallic material, including but not limited to steel sleeves. The role of the proximal sleeve 2132 and the distal sleeve also includes constraining the braiding filaments at the proximal and distal ends of the braided mesh body 2131. The connection of the connection 220' to the chassis 230 is substantially the same as in the first embodiment and will not be described in detail.

Further, the bolt head 2133 is in threaded connection with the distal end of the pushing rod 330, for example, the bolt head 2133 has female threads, the distal end of the pushing rod 330 has male threads, and the male threads and the female threads are matched to form threaded connection, so that the conveying is convenient. The pin head 2133 and the proximal sleeve 2132 may be fixedly attached by laser welding or the like. Optionally, the main body 2131 of the knitted net is knitted by nickel-titanium alloy wires, the diameter of the nickel-titanium alloy wires is 0.02mm-0.20mm, and the number of the knitted wires is 12-144.

The elastic disk 213 may be provided with a coating or a coating may be removed. Preferably, the elastic disc 213 is provided with a coating to further enhance its occluding properties and reduce the incidence of inter-atrial bypass. The coating is provided on the inside of the elastic disc 213 facing the atrial septum or the outside facing away from the atrial septum, or the coating is provided on both the inside and the outside of the elastic disc 213.

Fig. 17a to 17e are schematic views illustrating a state in which the implantable sensor 100 according to the second embodiment is delivered through the sheath 310.

As shown in fig. 17a, the implantable sensor 100 is entirely conveyed in the sheath 310, and at this time, the elastic disk 213 is restrained by the pushing rod 330 to be stretched, and the radial dimension is small. As shown in fig. 17b, the distal end of the sheath 310 is positioned in the Left Atrium (LA) by the puncture, after both the sensor body 400 and the elastic disc 213 are pushed out of the sheath 310, the elastic disc 213 is opened and the sensor body 400 is turned. If the release position is not appropriate, the flexible disk 213 may be reintroduced into the sheath 310, see in particular fig. 17c. As shown in fig. 17c, in the left atrium, the flexible disk 213 is retracted back into the sheath 310, and the sensor body 400 remains deflected in the left atrium. Here, since the brake 260 is added to the connector 220', when the sensor body 400 rotates to the strain side facing the left atrium, the brake 260 acts so that the sensor body 400 is kept stable in this state. As shown in fig. 17d, the sheath 310 and implantable sensor 100 are retracted as a unit until the chassis 230 is snugly positioned against the left atrial side of the atrial septum. AS shown in fig. 17e, sheath 310 alone is withdrawn, and spring plate 213 is re-released, clamping implantable sensor 100 to the Atrial Septum (AS).

Compared with the prior art, the implantable sensor provided by the invention has at least the following beneficial effects:

(1) The implanted sensor has no battery and no integrated circuit, so that the stability and reliability of the sensor are improved, and the sensor is hardly affected by endothelialization.

(2) The sensor as a whole can be delivered through the sheath and after removal of the sheath can be turned to the correct orientation and stably fixed to the predetermined partition without the sensor protruding significantly from the heart, thus reducing the risk of disturbance of the hemodynamics and thrombosis.

(3) When the sensor is fixed, the setting of chassis has reduced the sensor main part risk of breaking, has played better guard action to the sensor.

(4) The sensor itself prevents false steering and oversteer during sheath ejection, reducing the risk of implant failure.

However, it should be noted that the implantable passive pressure sensor provided by the present invention is suitable for monitoring the pressure of any atrium and ventricle, and is not limited to the left atrium.

It should be noted that several modifications and additions will be possible to those skilled in the art without departing from the method of the invention, which modifications and additions should also be considered as within the scope of the invention. Equivalent embodiments of the present invention will be apparent to those skilled in the art having the benefit of the teachings disclosed herein, when made with the changes, modifications, and variations to the invention; meanwhile, any equivalent changes, modifications and evolution of the above embodiments according to the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. An implantable sensor for monitoring intra-cardiac pressure for implantation in a heart, comprising a sensor body and a holder;

2. The implantable sensor of claim 1, further comprising a braking device disposed on the connector, the implantable sensor configured to: the sensor body and the underframe are released from the sheath tube and then rotate to a preset position, the preset position controls the strain part to be placed facing the pressure source, and the braking device controls the sensor body and the underframe to be kept in the preset position.

3. The implantable sensor according to claim 2, wherein the brake is capable of abutting against a bottom of the chassis after the sensor body is rotated to a predetermined orientation with the chassis.

4. An implantable sensor according to claim 3, wherein the connecting member is disposed at an angle to the braking device, one end of the connecting member is rotatably connected to the chassis, the other end of the connecting member is fixedly connected to the elastic clamping portion, and the braking device is disposed on a side surface of the connecting member.

5. The implantable sensor according to claim 1, wherein the chassis has a receiving space, and the package housing is at least partially received in the receiving space.

6. The implantable sensor according to claim 5, wherein the chassis and the package case are fixedly connected by a plurality of fixing wires, the fixing wires penetrate through the chassis and the package case in a width direction of the chassis, and both ends of the fixing wires are fixedly connected with both sides of the chassis in the width direction.

7. The implantable sensor of claim 5, wherein the chassis further comprises a frame body, a bottom and a rotating part connected in sequence, the bottom is hollow or not hollow, the rotating part is rotatably connected with the elastic clamping part through a rotating shaft, and the rotating shaft is fixedly connected with the elastic clamping part.

8. The implantable sensor according to claim 5, wherein the absolute value of the difference between the size of the receiving space and the outer dimension of the sensor body is 0.05mm-0.20mm, and/or the thickness of the chassis is 0.05mm-0.50mm.

9. The implantable sensor according to claim 1, wherein the elastic clamping portion comprises a plurality of elastic rings wound with elastic filaments, or wherein the elastic clamping portion is an elastic disc woven with braided filaments.

10. An implantable sensor according to claim 1, wherein the maximum dimension of the resilient clamping portion in a direction parallel to the predetermined partition is greater than the dimension of the chassis in a direction parallel to the predetermined partition and/or the partial dimension of the resilient clamping portion in a direction parallel to the predetermined partition is less than the dimension of the chassis in a direction parallel to the predetermined partition.

11. The implantable sensor according to claim 10, wherein the portion of the elastic grip having its largest outline beyond the sensor body is located at least partially within a highly radiating area of the sensor body, the sensor body being vertically oriented to a predetermined partition.

12. The implantable sensor according to claim 1, further comprising a backstop device, at least one of the chassis and the resilient clamping portion being provided with the backstop device, the sensor body together with the chassis being rotatable only in a predetermined direction upon release from the sheath such that the strain is placed facing the pressure source, the backstop device being adapted to control rotation of the sensor body together with the chassis only in the predetermined direction.

13. A sensor system comprising a transporter and an implantable sensor according to any one of claims 1-12, the transporter comprising a sheath and a pusher bar, the implantable sensor having a transport state loaded in the sheath and a deployed state after removal from the sheath, the pusher bar penetrating the sheath and being capable of being pushed in the sheath, a distal end of the pusher bar being adapted to be releasably connected to the resilient clip.