CN114910197A - Detection device and detection method for tissue working load - Google Patents

Abstract

The invention discloses a detection device and a detection method for tissue working load, which comprises the following steps: an implantation unit having one end connected to the tissue to position the detection device; a measurement unit for detecting a working load of the tissue; the measuring unit is detachably arranged at the other end of the implantation unit, and the other end of the measuring unit is opposite to one end, connected with the tissue, of the implantation unit; wherein the working load of the tissue is transferred to the measurement unit by the implant unit and is acquired by the measurement unit. The method can realize the measurement of the tissue workload under the intervention condition, so that the acquired data is close to reality; provides real and reliable experimental data for the design of the implantation instrument. And the design and manufacturing cost of the detection device is reduced, and meanwhile, the device is convenient for operators to use.

Description

Detection device and detection method for tissue working load

Technical Field

The invention relates to the technical field of medical instruments, in particular to a device and a method for detecting tissue working load.

Background

In the field of tissue repair, the morphology of the tissue being repaired is typically altered by the force of an implantation instrument to achieve the goal of repair. In practice, the implant devices are often subjected to varying loads by tissue contraction and/or relaxation, and it takes months to 1 year for the implant devices to completely endothelialize and integrate with the tissue in vivo. However, until then, the implantation instrument has been subjected to the working load of the tissue or organ. For example, in the case of heart valve repair, it is required that the implant device can withstand 4000 million alternating loads without failure for 1 year, and even the implant device is required to meet 10 hundred million alternating loads without failure in some industry standards. Thus, the reliable design of the implantation instrument is of particular importance. How to accurately obtain the stress condition of the implanted device, such as the parameters of the force magnitude, the frequency and the like, is very important for designing the implanted device. However, in the prior art, there are only a few detecting devices and corresponding detecting methods capable of directly and truly measuring the stress condition of the flexible tissue after the instrument acts on the interior of the flexible tissue. There is also a lack of detection devices or methods that can simulate the force conditions experienced by the device after it has been introduced into tissue. The main reasons for this phenomenon are that the flexible tissue has a narrow internal space and a large measurement difficulty, and the existing measurement instrument cannot be arranged at a target measurement point and cannot truly and directly reflect the working load of the flexible tissue, so that the measurement error is too large.

Disclosure of Invention

In order to overcome the problems, the invention provides a device and a method for detecting the tissue working load. The flexible tissue target point location detection device can be effectively compatible with the existing implantation instrument, so that the detection device can directly reach the target point location of the flexible tissue, the load data of the tissue can be accurately measured, and an accurate design basis is provided for the implantation instrument.

To achieve the above object, according to an aspect of an embodiment of the present invention, there is provided a tissue work load detecting apparatus including:

an implantation unit having one end connected to the tissue to position the detection device;

a measurement unit for detecting a working load of the tissue;

the measuring unit is detachably arranged at the other end of the implantation unit, and the other end of the measuring unit is opposite to one end, connected with the tissue, of the implantation unit; wherein,

the working load of the tissue is transmitted to the measuring unit by the implant unit and is acquired by the measuring unit.

Optionally, the implant unit comprises a stop;

the measuring unit comprises a measuring substrate;

the detection device also comprises a stop component;

wherein, measure the base member joint between backstop portion and the subassembly of ending to gather the tissue work load who transmits to the measuring unit through backstop portion.

Optionally, the stopping portion is a rotating arm base, the implantation unit further includes a clamping arm base, and a connecting portion is disposed on one side of the clamping arm base, which is close to the measurement unit; wherein,

the connecting part penetrates through the rotating arm base and then is detachably connected with the stop component.

Optionally, a sawtooth feature is arranged on the outer peripheral side of the connecting part, and the stop assembly comprises a stop clamping piece;

and the stop clamping piece is clamped and connected with the sawtooth features and then the measuring unit is clamped and connected between the rotating arm base and the stop clamping piece.

Optionally, the measuring substrate includes a base portion, a detecting portion and a conducting wire;

the base body part is sleeved on the connecting part, the detection part is arranged on the base body part, and the detection part is connected with the lead.

Optionally, the implantation unit further comprises a clamping arm and a rotating arm;

one end of the clamping arm is pivoted on the clamping arm base;

one end of the rotating arm is pivoted in the middle of the clamping arm, and the other end of the rotating arm is pivoted on the rotating arm base.

Optionally, the number of the clamping arms and the number of the rotating arms are two, and the two clamping arms and the two rotating arms move oppositely to clamp the tissue.

Optionally, the clamping arm and the rotating arm are provided with barbs on the side facing the tissue.

Optionally, a buckle is arranged at an end of the connecting portion away from the clamping unit, and the connecting portion is detachably connected with the base tube through the buckle.

Optionally, the clamping assembly further comprises a stop conveying rod, a buckle is arranged at an end part of the stop clamping piece far away from the implantation unit, and the stop clamping piece is detachably connected with the stop conveying rod through the buckle;

the stop clamping piece and the stop conveying rod are sleeved on the base pipe; an inner core rod penetrates through the base tube.

Optionally, the implantation unit includes anchor portion and anchor, connects through acting as go-between anchor portion and the anchor, the anchor as end position subassembly, the tip of keeping away from anchor portion and anchor on the acting as go-between is provided with the fastener of acting as go-between, the fastener of acting as stop portion.

Optionally, the measuring substrate includes a base portion, a detecting portion and a conducting wire;

the base body part is sleeved on the pull wire and clamped between the stopping part and the stopping component, the detection part is arranged on the base body part, and the detection part is connected with the lead.

According to another aspect of the embodiments of the present invention, there is provided a method for detecting a tissue working load, using the detection device of any one of the first aspect,

the detection method comprises the following steps of,

operating an implantation unit of the detection device to connect one end thereof to the tissue;

the working load of the tissue is detected by the measuring unit.

According to still another aspect of embodiments of the present invention, there is provided a method for detecting a tissue working load, using the detection apparatus according to any one of the first aspect,

the detection method comprises the following steps of,

operating the implantation unit of the detection device to connect one end thereof with the tissue;

acquiring the load of a stopping part detected by a measuring unit, and acquiring the posture of the implanted unit in an interventional state;

the working load of the tissue is calculated from the load of the stop and the attitude of the implanted unit.

Optionally, the calculating the workload of the organization includes: the workload is calculated by the following formula:

wherein F is the working loadFm is the load of the stop part, alpha is the included angle between the two clamping arms, and beta is the included angle between the clamping arm and the rotating arm.

The technical scheme of the invention has the following advantages or beneficial effects:

(1) by connecting the measurement unit to the implantation unit, namely integrating a customized measurement unit such as a force value sensor on the implantation instrument, the measurement of the tissue workload under the intervention condition can be realized, so that the acquired data is close to reality; provides real and reliable experimental data for the design of the implantation instrument.

(2) Through with the measuring unit centre gripping between backstop portion and end position subassembly, reach through mechanism conversion, change into the effort between the rigid structure with the work load that flexible tissue produced that is difficult to characterize and test for the scheme that measures tissue work load through the measuring unit can effectively be implemented. The problem of unable direct measurement organize work load among the prior art is solved.

(3) Through simple and repeatable detection device and detection method, a clinical data source is provided for the design and check of the implantation instrument.

(4) Through adopting the modularized design thought, make things convenient for the measuring unit integration on current apparatus, effectively reduced detection device's design and manufacturing cost, also make things convenient for operating personnel to use simultaneously, reduced user's study cost.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:

FIG. 1 is a schematic view of an assembled state of a detecting device according to an embodiment of the present invention;

fig. 2 is a schematic view of an explosive structure of an assembled state of a detection apparatus according to an embodiment of the present invention;

FIG. 3 is a schematic view showing an installation state of a clamp arm base of the detecting device according to the embodiment of the present invention;

FIG. 4 is a schematic structural diagram of a measuring unit of the detecting device according to the embodiment of the present invention;

FIG. 5 is a schematic view of another perspective of a measurement unit of a detection apparatus according to an embodiment of the present invention;

FIG. 6 is a schematic diagram of a deformation of a base body of a detecting unit according to an embodiment of the present invention;

FIG. 7 is a schematic view of a stop dog of the detection apparatus according to an embodiment of the present invention;

FIG. 8 is a schematic view of the force applied to a sensing device according to an embodiment of the invention;

FIG. 9 is a schematic diagram of the measurement principle of a detection device according to an embodiment of the present invention;

FIG. 10 is a schematic view of another measurement principle of a detection device according to an embodiment of the present invention;

FIG. 11 is a graph showing the measurement results of a detection apparatus according to an embodiment of the present invention;

FIG. 12 is a diagram illustrating a mapping relationship between a closing angle of a detecting device and a coefficient C according to an embodiment of the present invention;

FIG. 13 is a graphical representation of a workload measurement for a detection arrangement according to an embodiment of the invention;

FIG. 14 is a schematic view of another measurement principle of a detection device according to an embodiment of the present invention;

FIG. 15 is a schematic diagram of the measurement principle of the split-type detecting device according to the embodiment of the present invention;

FIG. 16 is a diagram illustrating still another detection result of the detection apparatus according to the embodiment of the present invention.

Detailed Description

Exemplary embodiments of the present invention are described below with reference to the accompanying drawings, in which various details of embodiments of the invention are included to assist understanding, and which are to be considered as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.

To solve at least one problem of the background art, according to an aspect of an embodiment of the present invention, there is provided a tissue workload detecting apparatus including: an implantation unit having one end connected to the tissue to position the detection device; a measurement unit for detecting a working load of the tissue; the measuring unit is detachably arranged at the other end of the implantation unit, and the other end of the measuring unit is opposite to one end, connected with the tissue, of the implantation unit; wherein the working load of the tissue is transferred to the measurement unit by the implant unit and is acquired by the measurement unit.

The tissue working load measuring device provided in one embodiment of the invention can be used for measuring loads of various human tissues, particularly for measuring periodic loads to which a heart valve repair device is subjected in an implanted state. The load is a periodic force generated by the contraction and/or relaxation process of the heart tissue on the interventional instrument. More importantly, the detection device has the characteristic of modular design, and the measurement unit can be integrated on the implantation instrument only by slightly modifying the existing implantation instrument, so that the structural design complexity of the detection device is simplified, the production cost is reduced, and the detection device is convenient for operators to use. Specifically, the detection device comprises an implantation unit and a measurement unit; wherein, implant the unit and be used for connecting the tissue, realize the fixed to detection device. The implant unit may be a compact implant device as shown in fig. 1-2 or a split implant device as shown in fig. 15. The connection structure may include various ways, such as clamping, screw anchoring, etc., which are only examples and do not limit the scope of the present invention. After the connection is completed, the working load of the tissue can be detected by the measuring unit. Because the measuring unit and the implanting unit are integrated, the detecting device can be transported to a target tissue by adopting the existing conveying system, so that the accurate measuring effect of real-time sampling and real reflection of the stress condition is achieved. The measuring unit is close to the target to be measured, the measurement is more visual, and the authenticity of data is guaranteed. Specifically, the measuring unit is detachably arranged at the other end of the implantation unit, and the other end is opposite to the end, connected with the tissue, of the implantation unit; the working load of the tissue is transmitted to the measuring unit by the implant unit and is acquired by the measuring unit. It can be understood that the detachable design of the measurement unit in this embodiment fully embodies the modular design concept, and the design makes the measurement unit versatile, and it can be adapted to different types of implant units to accomplish various measurement purposes. Furthermore, the implantation unit transmits the working load of the tissue to the measurement unit, so that the parameters of the load size, the frequency and the like of the tissue can be measured really, and accurate design parameters are provided for the structural design of the implantation instrument.

Preferably, the implant unit comprises a stop; the measuring unit comprises a measuring substrate; the detection device also comprises astop component 5; wherein, measure the base member joint between backstop portion and the subassembly of ending to gather the tissue work load who transmits to the measuring unit through backstop portion.

In the embodiment shown in fig. 1, the detecting device (or called measuring unit) 4 is connected to thetissue 1, including but not limited to myocardial tissue, via the clamping unit (or called clamping unit, clamp) 3. It should be noted that the main structure of the holdingunit 3 according to one embodiment of the present invention is the same as or slightly adjustable to the main structure of the conventional implantation instrument, or is obtained by modifying the conventional implantation instrument, i.e. the corresponding interface is only required to be arranged on the implantation instrument to connect with the measurement unit to form the detection device. Illustratively, the clamping unit clamps the tissue at the clampingpart 111 by means of butt clamping. Taking a myocardial tissue as an example, the myocardial tissue reciprocates in thediastolic direction 21 or the systolic direction in a normal operating state, and the workingload 22 thereof acts on the graspingunit 3 through thenip portion 111 on the tissue. In order to really and accurately collect the acting force of the tissue motion process on the clamping unit, in one embodiment of the invention, a rotating arm base is arranged at one end, far away from the tissue, of the clamping unit. Accordingly, the measuringbase 41 of the measuring unit is clamped between the base of the swivel arm and the stop assembly by the stop assembly. It will be appreciated that the measurement base is provided with a force sensing unit to measure the working load of the tissue. For example, the force sensing unit may be a strain gauge attached to the surface of the measurement substrate, and the other end of the strain gauge transmits the measured signal to the signal collecting unit through thewire 42. Specifically, because the measurement substrate is clamped between the rotating arm base and the stop assembly, the actingforce 23 generated by the contraction or relaxation motion of the tissue is transmitted to the rotating arm base and causes the rotating arm base to move, thereby deforming the measurement base to generate a signal on the strain gauge. The characteristics of the working load generated by the normal physiological activities of the tissues on the clamping unit can be obtained through the collection of signals and data processing. Finally, real and reliable experimental data are provided for the design of the implantation instrument. It should be noted that, the structure and the operation principle of the detection device described above are described by taking a compact instrument as an example, and a corresponding split-type instrument can also be provided with the measurement unit of the present invention, and achieve the same detection function, which will be described in detail later.

Optionally, the stopping portion is a rotating arm base, the implantation unit further includes a clamping arm base, and a connecting portion is disposed on one side of the clamping arm base, which is close to the measurement unit; the connecting part penetrates through the rotating arm base and then is detachably connected with the stop assembly.

In the embodiment shown in fig. 2 and 3, the gripper unit further comprises agripper arm base 33, the right end of which is provided with a connection. In practice, the connecting part is detachably connected with thebase pipe 35, and the clamping arm base is pushed to be far away from or close to therotating arm base 34 by controlling the forward and backward movement of the base pipe, so that the opening and closing states of the clamping unit are controlled, and finally the clamping force is adjusted. Preferably, the axis of the rotating arm base is provided with a through hole, and the connecting part passes through the through hole of the rotating arm base and then is detachably connected with the stop assembly. As shown in fig. 3, the connecting portion may be provided with saw-tooth features 331, and the saw-tooth features may be provided in a plurality of sets spaced apart from each other in the circumferential direction of the connecting portion. Correspondingly, the stop assembly can be provided with a buckle. Preferably, the number of the buckles is two, and the buckles are arranged oppositely. When the measuring tool is used, the measuring base body is sleeved on the connecting portion, then the stop assembly is rotated to enable the buckle to be located at the interval of the sawtooth features, and then the buckle is pushed to move forwards to a preset position. In the moving process, the buckle is not in contact with the sawtooth features, and the buckle is rotated again after the target position is reached, so that the buckle is in contact with the sawtooth features and clamped in the tooth grooves, and then the measuring base body is fixed between the rotating arm base and the stopping assembly. Of course, by properly configuring the shape of the clip, the clip can be directly aligned with the serrated feature and pushed forward along the serrated feature and reach a predetermined position. Further, when the measuring base body needs to be disassembled, the buckle of the stop assembly can be rotated to the interval of the sawtooth feature, and the stop assembly is pulled reversely to be far away from the clamping unit so as to solve the constraint effect on the measuring base body.

Optionally, a sawtooth feature is arranged on the outer periphery of the connecting part, and the stop assembly comprises astop fastener 51; and the stop clamping piece is clamped and connected with the sawtooth features and then the measuring unit is clamped and connected between the rotating arm base and the stop clamping piece.

Optionally, the measuring substrate includes a base portion, a detecting portion and a conducting wire; the base body is sleeved on the connecting part, the detection part is arranged on the base body, and the detection part is connected with the lead.

In the embodiment shown in fig. 4 to 5, the measuring base includes a base portion, a detectingportion 411, and alead wire 42. The detection part includes but is not limited to a strain gauge, which can be attached to the surface of the base part. The base body part is preferably U-shaped, and the middle part of the U-shaped is provided with a throughhole 412; one of two arms of the U-shaped structure abuts against the rotating arm base, and the other arm abuts against the clamping component; when the base of the rotating arm moves back and forth, the working load of the tissue can be transferred to the measuring unit through the arm of the U-shaped structure. As shown in fig. 6, when the tissue is relaxed, the working load is transmitted to the base of the rotating arm and the pressing base part is deformed, i.e., changed from the solid line position to the broken line position in the figure, and when the tissue is contracted, the base part is changed from the broken line position to the solid line position in fig. 6 by the restoring action of its own elastic force. The deformation process will cause the detectingportion 411 to deform accordingly and generate a measuring signal, which is collected through theconducting wire 42. It will be appreciated that changes in the magnitude of the tissue workload will cause differences in the deformation of the base portion and the deformation of the sensing portion, thereby measuring changes in the tissue workload accurately in real time. The stress condition of each part is shown in fig. 8, in the figure, a is a connection point between arotating arm 32 and a clampingarm 31, α is an included angle between the clamping arms, β is an included angle between the clamping arm and the rotating arm, F is a working load of the tissue acting on the connection point a, and Fm is a load applied to the measuring unit.

Preferably, the clamping unit comprises a clamping arm and a rotating arm; one end of the clamping arm is pivoted on the clamping arm base; one end of the rotating arm is pivoted in the middle of the clamping arm, and the other end of the rotating arm is pivoted on the rotating arm base. In order to fully utilize the existing implantation instrument and reduce the detection cost of the tissue working load, the implantation unit body of the detection device in the embodiment shown in fig. 2 to 3 adopts the structure of a conventional implantation instrument. However, in order to increase the versatility of the measuring unit described in the present invention, the structure of the gripping arm base of the implant unit needs to be optimized to be compatible with the measuring unit. On the basis, the clamping arms and the rotating arms are arranged in the clamping unit to anchor or clamp the tissue, so that the anchoring stability of the tissue is enhanced. Specifically, centre gripping arm and swinging boom all adopt the mode of butt clamp, the one end pin joint respectively of centre gripping arm and swinging boom on the centre gripping arm base and the swinging boom base, and the other end pin joint of swinging boom is at the middle part of centre gripping arm. During the use, throughbase pipe 35 control centre gripping arm base for the back-and-forth movement of swinging boom base, can synchronous control centre gripping arm and swinging boom expansion or shrink to make things convenient for operating personnel to use.

Preferably, the number of the clamping arms and the number of the rotating arms are two, and the two clamping arms and the two rotating arms move oppositely to clamp tissues.

Preferably, the clamping arm and the rotating arm are provided with barbs on the sides facing the tissues. The arrangement of the barb structure increases the stability of anchoring tissues of the clamping unit. It will be understood by those skilled in the art that the length, number and distribution of the barbs can be flexibly adjusted according to the needs, and are not limited herein.

Preferably, the end of the connecting part remote from the clamping unit is provided with asnap 332 by which the connecting part is detachably connected with thebase tube 35. In the embodiment shown in fig. 3, in order to facilitate the control of the opening and closing angles of the clamping arm and the rotating arm and the control of the apparatus by an operator, the detection device is further provided with a base tube, and the butt joint positions of the base tube and the connecting part can be respectively provided with a buckle, so that the base tube and the connecting part are connected through a buckle structure. And after the implantation operation is completed, the buckle can be unlocked, and the base tube is withdrawn.

Preferably, the clamping assembly further comprises a stop conveying rod, a buckle is arranged at the end part of the stop clamping piece far away from the clamping unit, and the stop clamping piece is detachably connected with the stop conveying rod through the buckle; the stop clamping piece and the stop conveying rod are sleeved on the base pipe; an inner core rod penetrates through the base tube. In the embodiment shown in fig. 2 and 7, the detent assembly comprises astop conveying rod 52 and astop detent 51, and abuckle 521 is arranged at the end part connected between the two, and the connection or the disconnection between the two is realized through the buckle. The further part of the stop catch facing theserrated feature 331 is provided with at least one pair ofcatches 511. Furthermore, in order to conveniently install and operate the instrument, in one embodiment of the invention, a multilayer nested structure is adopted among the tubular parts, and the tubular parts and the buckle parts are designed in a tubular mode, so that the design and manufacturing difficulty is reduced, and the production cost is effectively reduced. Specifically, the stop clamping piece and the stop conveying rod are sleeved on the base pipe, so that the stop clamping piece and the stop conveying rod can slide relative to the base pipe. Further, acore rod 36 is inserted into the base tube. During the use, can get up base pipe and connecting portion through the buckle joint earlier to wear to establish in base pipe and connecting portion with the inner core pole, utilize the limiting displacement of inner core pole outer wall to prevent the buckle unblock between base pipe and the connecting portion. When the buckle needs to be unlocked, the limiting function can be released only by pulling out the inner core rod. After the installation of completion base pipe and connecting portion, can establish the measuring unit cover on the connecting portion, then establish the position fastener and the position conveying rod cover that end that the buckle is connected on the base pipe to carry to sawtooth characteristic department along the base pipe forward. Due to the limiting effect of the base pipe and the outer wall of the connecting part, the stop clamping piece is connected with the buckle between the stop conveying rods to keep a locking state.

Preferably, the implant unit comprises an anchoring portion and an anchor, the anchoring portion and the anchor are connected through a pull wire, the anchor serves as a stop component, a pull wire locker is arranged at the end portion, far away from the anchoring portion and the anchor, of the pull wire, and the pull wire locker serves as a stopping portion.

In the embodiment of the split-type instrument shown in fig. 15, the implant unit is of a split design and includes an anchoring portion 9 and ananchor 11 connected by apull wire 10. Wherein the anchoring position of the anchoring portion is distant from the fixing position of theanchor 11. In this embodiment, the anchor is used as a stop component, and a pull-wire locker 122 is arranged on the end of the pull wire far away from the anchor part and the anchor, and the pull-wire locker is used as the stop part. Under the normal working condition of the tissue, the load of the tissue is transmitted to theanchor 11 through the anchoring part 9 and thepull wire 10 in sequence. In this embodiment, the end of the puller wire near the anchor secures the end of the puller wire at theanchor 11 by the puller wire locker. Based on the installation characteristic of the implantation instrument, the measuring unit is clamped between the pull-line locker and the anchor by effectively utilizing the force transmission characteristic between structures, and the working load of the tissue is effectively collected.

Preferably, similar to the previous embodiment, in the embodiment shown in fig. 15, the measuring base also includes a base portion, a detecting portion and a conducting wire; the base body part is sleeved on the pull wire and clamped between the stopping part and the stopping component, the detection part is arranged on the base body part, and the detection part is connected with the lead.

Preferably, in order to test the effectiveness and accuracy of the detection device shown in the embodiment of the invention, the invention further designs an experimental scheme. The described scheme can also be used to collect the workload of other tissues. The experimental protocol is shown in fig. 9, where a test device is implanted in the heart to measure the tissue work load on an implantation instrument used for valve repair. Wherein, the detection device is implanted into a target tissue, such as a posterior valve of a cardiac tricuspid valve, through asuperior vena cava 12 by a delivery system, and a lead of the detection device is connected with aforce value collector 6 arranged outside the body. The force generated by the periodical contraction or relaxation of the heart tissue on the clamping device is transmitted to the measuring base body through the rotating arm base, so that the periodical shape change of the detection part is caused, for example, the periodical deformation of the strain gauge is caused to change the resistance value of the strain gauge, and the change of the electric signal generated by the change is measured by the force value collector. Thereby obtaining the data of the acting force and the frequency of the tissue to the implantation instrument.

In addition to validating or using the instrument of the invention to measure tissue workload during an interventional procedure, the instrument of the invention may also be used ex vivo. In the pulsatile flow ex vivo test, as shown in fig. 10, the tissue working load was measured by building up a pulsatile flow platform. Themotor pump 77 is connected to the heart via a conduit to provide cardiac power to the heart, for example, to simulate the pulsation of a pig heart with water as a medium. The detection device and the pressure sensor can be implanted simultaneously during measurement, and the two measurement devices are implanted to monitor the changes of the working load and the pressure respectively so as to verify the accuracy of the detection device. For example, thepressure sensor 7 is provided in the heart in the vicinity of the clamp unit, and when the heart contracts or expands, the pressure in the tissue and the working load change in synchronization. When the pressure P is maximum, the ventricle is in a contraction state, the valve leaflets close, the valve ring contracts, the clamping force of the clamping unit clamped on the valve ring is minimum, and when the valve ring expands to the maximum (when the valve orifice is opened, the valve ring expands to the maximum, the corresponding pressure P is minimum), the clamping force is also maximum. In order to facilitate the observation of the working state of the heart, anendoscope 101 is further installed in the embodiment shown in fig. 10 to observe the opening and closing of the valve annulus. It will be appreciated by those skilled in the art that in vivo tissue experiments, the endoscope may be replaced with an ultrasound device to reduce tissue trauma.

Taking the data collected by one pulsating flow test as an example, fig. 11 shows waveforms of the collected pressure P and force Fm (or called the stop load) at the same time, where the waveforms of the two are similar and the periods are substantially the same, which effectively proves the accuracy of the measurement of the instrument of the present invention. It should be noted that Fm measured in fig. 11 is a value of a force directly measured by the detection unit, and is not a work load. Therefore, a numerical solution is required to obtain the true workload. In the force analysis diagram shown in fig. 8, Fm and the working load F have a conversion relationship, and the strong equilibrium relationship under the corresponding closing angle (i.e., the included angle between the two clamping arms) α is as follows:

under the corresponding closing angle alpha, the two are in positive correlation, and the coefficients are recorded as follows:

the coefficient C is related to the closing angle α, and the correspondence is shown in fig. 12. For example, when the closing angle is 58 °, C may be found to be 0.182, and Fm shown in fig. 11 may be converted into a waveform diagram of the working load F in the cardiac cycle, as shown in fig. 13. As can be seen from the above description, the force value (i.e. the working load) of the clamping device (or called clamping unit or clamping instrument) 3 acting on the annulus tissue fluctuates in a range of 2.02N to 2.52N during the periodic contraction or expansion of the tissue. The force value can be used as input data of instrument design and fatigue verification, so that powerful experimental support is provided for designers, and the designed implantation instrument can meet the requirements of safety and reliability.

It should be noted that the above experimental procedure requires a value of α. This value is usually calculated by controlling the distance between the base of the rotation arm and the base of the gripper arm, but can of course also be obtained experimentally. Fig. 14 shows a test flow of two test environments, which shows how to obtain the value of α in the intervention situation, and finally obtain the clamping force F (or referred to as the working load).

Fig. 15 and 16 are schematic views showing the measurement of the workload of an implantation instrument used in another interventional annulus repair technique. This example demonstrates the force value (or referred to as the working load) of the posterior mitral valve over time as a function of the cardiac cycle tested on live animals. The implantation instrument is of a split structure and is anchored at theposterior valve annulus 8 of the mitral valve, and the implantation instrument comprises an anchoring part 9 and ananchor 11; wherein the anchoring part 9 is anchored on the back valve, theanchor 11 is anchored on the atrial septum, the anchor and the anchoring part are connected through astay wire 10, and one end of thestay wire 10 far away from the anchor and the anchoring part is provided with astay wire locker 122. Thelead 42 exits the body through theinferior vena cava 13. In this type, the posterior flap is pulled toward theanchor 11 by thepull wire 10 and the annulus anchor 9, and after the pull wire is locked by thepull wire locker 122, the measurement unit is held between thepull wire locker 122 and theanchor 11 and receives a working load. When the heart works, the stress of the measuring unit fluctuates and is transmitted into theforce value collector 6 through thelead 42, and fig. 16 is the waveform of the force value of the tensile force in 10s collected in one experiment.

It should be noted that, in the tests of the above embodiments, the magnitude of the force value is related to the environment of the heart of the subject, and in addition, the force value obtained by the test is different according to the degree of the heart beating, the amount of the clamped tissue and the pulling degree of the pulling wire, and the specific application needs to customize the test conditions and parameters according to the needs. However, the detection device and the detection method provided by the invention have repeatability and can be suitable for various implantation instruments. The user checks or calibrates the detection part before testing, and the accuracy of the test data can be ensured.

In another aspect, the present invention provides a method of detecting a tissue working load using the detection device of any one of the first aspect of the present invention, the method comprising operating an implantation unit of the detection device to attach a tissue at one end thereof; the working load of the tissue is detected by the measuring unit.

In a further aspect of the invention, there is provided a method of detecting a tissue working load using any of the detection devices described in the first aspect of the invention having a rotatable arm base, the method comprising operating an implantation unit of the detection device to attach one end thereof to a tissue; acquiring the load of a stopping part detected by a measuring unit, and acquiring the posture of the implanted unit in an interventional state; the working load of the tissue is calculated from the load of the stop and the attitude of the implanted unit.

Preferably, said calculating the workload of the organization comprises: the workload is calculated by the following formula:

f is a working load, Fm is a load of the stop part, alpha is an included angle between the two clamping arms, and beta is an included angle between the clamping arm and the rotating arm.

The above-described embodiments should not be construed as limiting the scope of the invention. Those skilled in the art will appreciate that various modifications, combinations, sub-combinations, and substitutions can occur, depending on design requirements and other factors. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (15)

1. A device for detecting tissue working load, comprising:

an implantation unit having one end connected to the tissue to position the detection device;

a measurement unit for detecting a working load of the tissue;

the method is characterized in that:

the measuring unit is detachably arranged at the other end of the implantation unit, and the other end of the measuring unit is opposite to one end, connected with the tissue, of the implantation unit; wherein,

the working load of the tissue is transmitted to the measuring unit by the implant unit and is acquired by the measuring unit.

2. The apparatus for detecting tissue workload according to claim 1,

the implant unit comprises a stop;

the measuring unit comprises a measuring substrate;

the detection device also comprises a stop component;

wherein, measure the base member joint between backstop portion and the subassembly of ending to gather the tissue work load who transmits to the measuring unit through backstop portion.

3. The apparatus for detecting tissue workload according to claim 2,

the stopping part is a rotating arm base, the implantation unit further comprises a clamping arm base, and a connecting part is arranged on one side, close to the measurement unit, of the clamping arm base; wherein,

the connecting part penetrates through the rotating arm base and then is detachably connected with the stop component.

4. The apparatus for detecting tissue workload according to claim 3,

the peripheral side of the connecting part is provided with a sawtooth feature, and the stop assembly comprises a stop fastener;

and the stop clamping piece is clamped and connected with the sawtooth features and then the measuring unit is clamped and connected between the rotating arm base and the stop clamping piece.

5. A tissue workload detection device according to any one of claims 3 to 4,

the measuring basal body comprises a basal body part, a detecting part and a lead;

the base body is sleeved on the connecting part, the detection part is arranged on the base body, and the detection part is connected with the lead.

6. A tissue workload detection device according to any one of claims 3 to 4,

the implantation unit also comprises a clamping arm and a rotating arm;

one end of the clamping arm is pivoted on the clamping arm base;

one end of the rotating arm is pivoted in the middle of the clamping arm, and the other end of the rotating arm is pivoted on the rotating arm base.

7. The apparatus for detecting tissue workload according to claim 6,

the tissue clamping device is characterized in that the number of the clamping arms and the number of the rotating arms are two, and the two clamping arms and the two rotating arms move oppositely to clamp tissues.

8. The tissue workload detection device of claim 7,

the clamping arm and one side of the rotating arm facing to the tissue are provided with barbs.

9. The apparatus for detecting tissue workload according to claims 3 to 4,

the end part of the connecting part, which is far away from the clamping unit, is provided with a buckle, and the connecting part is detachably connected with the base pipe through the buckle.

10. The apparatus for detecting tissue workload according to claim 9,

the clamping assembly further comprises a stop conveying rod, a buckle is arranged at the end part of the stop clamping piece far away from the implantation unit, and the stop clamping piece is detachably connected with the stop conveying rod through the buckle;

the stop clamping piece and the stop conveying rod are sleeved on the base pipe; an inner core rod penetrates through the base tube.

11. The apparatus for detecting tissue workload according to claim 2,

implant the unit and include anchor portion and anchor, connect through acting as go-between anchor portion and the anchor, the anchor as end position subassembly, the tip of keeping away from anchor portion and anchor on the acting as go-between is provided with the locker of acting as go-between, the locker of acting as stop portion.

12. The apparatus for detecting tissue workload according to claim 11,

the measuring basal body comprises a basal body part, a detecting part and a lead;

the base body part is sleeved on the pull wire and clamped between the stopping part and the stopping component, the detection part is arranged on the base body part, and the detection part is connected with the lead.

13. A method of detecting a tissue working load using the detecting device according to any one of claims 1 to 12,

the method is characterized in that: the detection method comprises the following steps of,

operating the implantation unit of the detection device to connect one end thereof with the tissue;

the working load of the tissue is detected by the measuring unit.

14. A method of detecting a tissue working load using the detecting device according to any one of claims 6 to 10,

the method is characterized in that: the detection method comprises the following steps of,

operating the implantation unit of the detection device to connect one end thereof with the tissue;

acquiring the load of a stopping part detected by a measuring unit, and acquiring the posture of the implanted unit in an interventional state;

the working load of the tissue is calculated from the load of the stop and the attitude of the implanted unit.

15. The method of detecting tissue workload according to claim 14,

the computing of the workload of the organization comprises:

the workload is calculated by the following formula:

whereinF is a working load, Fm is a load of the stop part, alpha is an included angle between the two clamping arms, and beta is an included angle between the clamping arm and the rotating arm.

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