CN114910197B - Detection device and detection method for tissue workload - Google Patents
Detection device and detection method for tissue workload Download PDFInfo
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- CN114910197B CN114910197B CN202210490460.1A CN202210490460A CN114910197B CN 114910197 B CN114910197 B CN 114910197B CN 202210490460 A CN202210490460 A CN 202210490460A CN 114910197 B CN114910197 B CN 114910197B
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- 238000005259 measurement Methods 0.000 claims abstract description 37
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
- G01L1/00—Measuring force or stress, in general
- G01L1/16—Measuring force or stress, in general using properties of piezoelectric devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2472—Devices for testing
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
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- Prostheses (AREA)
Abstract
The invention discloses a detection device and a detection method for tissue workload, comprising the following steps: an implantation unit having one end connected to the tissue to position the detection device; a measurement unit for detecting a workload of the tissue; the measuring unit is detachably arranged at the other end of the implantation unit, and the other end is opposite to one end of the implantation unit connected with the tissue; wherein, the work load of the tissue is transferred to the measuring unit through the implantation unit and is collected by the measuring unit. The method can realize tissue workload measurement of interventional conditions, so that acquired data is close to reality; the experimental data of reality and reliability are provided for the design of the implantation instrument. And the design and manufacturing cost of the detection device are reduced, and the device is convenient for operators to use.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a device and a method for detecting tissue workload.
Background
In the field of tissue repair, the morphology of the tissue to be repaired is generally changed by the force of an implantation instrument to achieve the purpose of repair. In practice, the implant devices are often subjected to varying loads by tissue contraction and/or relaxation, and the implant devices take months to 1 year in the body to fully endothelialise and integrate with the tissue. But until now the implantation instrument has been subjected to the working load of the tissue or organ. Taking heart valve repair as an example, it is required that the implant device can withstand 4000 tens of thousands of alternating loads for 1 year without failure, and it is even required in some industry standards that the implant device satisfies 4 hundred million alternating loads for 10 years without failure. Thus, the reliability design of the implantation instrument is particularly important. How to accurately obtain the stress condition of the implanted instrument, such as the parameters of force, frequency and the like, is very important to design the implanted instrument. However, in the prior art, there are a detection device and a corresponding detection method capable of directly and truly measuring the stress condition after the mechanical action is performed inside the flexible tissue. There is also a lack of detection devices or methods that can simulate the stress conditions of the instrument after it has been introduced into tissue. The main reasons for the phenomenon are that the internal space of the flexible tissue is narrow, the measurement difficulty is high, the existing measuring instrument cannot be arranged at a target measuring point, and the working load of the flexible tissue cannot be truly and directly reflected, so that the measurement error is overlarge.
Disclosure of Invention
In order to overcome the problems, the invention provides a device and a method for detecting tissue workload. The device can be effectively compatible with the existing implantation instrument, so that the detection device can directly reach the target point position 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 detection apparatus for an organization workload, including:
an implantation unit having one end connected to the tissue to position the detection device;
a measurement unit for detecting a workload of the tissue;
the measuring unit is detachably arranged at the other end of the implantation unit, and the other end is opposite to one end of the implantation unit connected with the tissue; wherein,,
the working load of the tissue is transferred to and collected by the measuring unit through the implanting unit.
Optionally, the implant unit includes a stop;
the measuring unit comprises a measuring matrix;
the detection device also comprises a stop component;
the measuring base body is clamped between the stop part and the stop component so as to collect tissue working load transmitted to the measuring unit through the stop part.
Optionally, the stop part is a rotating arm base, the implantation unit further comprises a clamping arm base, and a connecting part is arranged 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, the outer peripheral side of the connecting part is provided with a sawtooth feature, and the stop component comprises a stop clamp;
the stop clamping piece is clamped and connected with the saw tooth feature, and then the measuring unit is clamped between the rotating arm base and the stop clamping piece.
Optionally, the measuring matrix comprises a matrix part, a detection part and a wire;
the base body part is sleeved on the connecting part, the detecting part is arranged on the base body part, and the detecting 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 at the middle part of the clamping arm, and the other end of the rotating arm is pivoted on the rotating arm base.
Optionally, the two clamping arms and the two rotating arms are respectively moved in opposite directions to clamp tissues.
Optionally, the clamping arm and the rotating arm are provided with barbs on one side facing the tissue.
Optionally, the tip that clamping unit was kept away from to connecting portion is provided with the buckle, connecting portion pass through the buckle and be connected with the base pipe can be dismantled.
Optionally, 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 is arranged in the base pipe in a penetrating mode.
Optionally, the implant unit includes anchor portion and anchor, connects through the acting as the stay wire between anchor portion and the anchor, the anchor as the position subassembly that ends that keep away from anchor portion and anchor on the acting as the stay wire locker, the stay wire locker as the backstop portion.
Optionally, the measuring matrix comprises a matrix part, a detection part and a wire;
the base body part is sleeved on the stay wire and clamped between the stop part and the stop 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 an embodiment of the present invention, there is provided a method of detecting a tissue workload, using the detection device according to any one of the first aspects,
the method of detection may include the steps of,
operating an implantation unit of the detection device to connect one end of the implantation unit to tissue;
the working load of the tissue is detected by the measuring unit.
According to a further aspect of embodiments of the present invention, there is provided a method of detecting tissue workload, using the detection device of any one of the first aspects,
the method of detection may include the steps of,
operating an implantation unit of the detection device to connect one end of the implantation unit to tissue;
collecting the load of the stop part detected by the measuring unit, and acquiring the posture of the implanted unit in the intervention state;
the working load of the tissue is calculated by the load of the stop and the pose of the implant unit.
Optionally, the workload of the computing organization includes: the workload is calculated by the following formula:
wherein F is the working load, fm 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 arms 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, i.e. integrating a customized measurement unit, such as a force sensor, to the implantation instrument, tissue workload measurement of the interventional condition can be achieved, such that the acquired data is close to reality; the experimental data of reality and reliability are provided for the design of the implantation instrument.
(2) By clamping the measuring unit between the stop part and the stop component, the working load generated by flexible tissues which are difficult to characterize and test is converted into acting force between rigid structures through mechanism conversion, so that the scheme of measuring the working load of the tissues through the measuring unit can be effectively implemented. The problem that the tissue workload cannot be directly measured in the prior art is solved.
(3) The simple and repeatable detection device and the detection method provide clinical data sources for the design and check of the implantation instrument.
(4) Through adopting modularized design thinking, make things convenient for 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 detection 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 detecting device according to an embodiment of the present invention;
FIG. 3 is a schematic view showing an installation state of a clamp arm base of a detecting device according to an embodiment of the present invention;
fig. 4 is a schematic structural view of a measuring unit of the detecting device according to the embodiment of the present invention;
FIG. 5 is a schematic diagram of another view of a measurement unit of a detection device according to an embodiment of the present invention;
FIG. 6 is a schematic representation of a deformation of a substrate of a detection device according to an embodiment of the present invention;
FIG. 7 is a schematic view of a stop clip of a detection device according to an embodiment of the present invention;
FIG. 8 is a schematic illustration of the force applied by a detection device according to an embodiment of the present 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 diagram of another measurement principle of a detection device according to an embodiment of the present invention;
FIG. 11 is a schematic diagram of measurement results of a detection device according to an embodiment of the present invention;
FIG. 12 is a schematic diagram showing 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 schematic diagram of the workload measurement results of a detection device according to an embodiment of the present invention;
FIG. 14 is a schematic diagram of another measurement principle of a detection device according to an embodiment of the present invention;
fig. 15 is a schematic view of a measurement principle of a split type detecting device according to an embodiment of the present invention;
fig. 16 is a schematic diagram of still another detection result of the detection apparatus according to the embodiment of the present invention.
Detailed Description
Exemplary embodiments of the present invention will now be described with reference to the accompanying drawings, in which various details of the embodiments of the present invention are included to facilitate understanding, and are to be considered 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 in the background art, according to an aspect of an embodiment of the present invention, there is provided a detection apparatus for an organization workload, including: an implantation unit having one end connected to the tissue to position the detection device; a measurement unit for detecting a workload of the tissue; the measuring unit is detachably arranged at the other end of the implantation unit, and the other end is opposite to one end of the implantation unit connected with the tissue; wherein, the work load of the tissue is transferred to the measuring unit through the implantation unit and is collected by the measuring unit.
The tissue working load measuring device provided in one embodiment of the present invention may be used to measure loads of various body tissues, particularly for measuring cyclic loads to which a heart valve repair instrument is subjected in an implanted state. The load is the periodic force of the heart tissue contraction and/or relaxation process on the interventional instrument. More importantly, the detection device has the characteristic of modularized design, and the measurement unit can be integrated on the implantation instrument only by slightly modifying the existing implantation instrument, so that the design complexity of the detection device structure 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; the implantation unit is used for connecting tissues to fix the 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 described connection structure may comprise various modes, such as clamping, screw anchoring, etc., and the above is only an example, and does not limit the scope of the technical solution of the present invention. After the connection is completed, the work load of the tissue can be detected by the measuring unit. Because the measuring unit and the implantation unit are integrated together, the detection device can be transported to the target tissue by adopting the existing conveying system, so as to achieve the effect of real-time sampling and truly reflect the accurate measurement of the stress condition. The measuring unit is close to the target to be measured, the measurement is more visual, and the authenticity of the data is ensured. Specifically, the measuring unit is detachably arranged at the other end of the implantation unit, and the other end is opposite to the end of the implantation unit connected with the tissue; the working load of the tissue is transferred to and collected by the measuring unit through the implanting unit. It will be appreciated that the embodiment fully embodies the modular design concept of the measurement unit in a detachable manner, which allows the measurement unit to be universal, and to be adapted to different types of implant units for a variety of measurement purposes. Furthermore, the working load of the tissue is transmitted to the measuring unit through the implanting unit, and parameters such as the load size and the frequency of the tissue can be truly measured, so that accurate design parameters are provided for the structural design of the implanting apparatus.
Preferably, the implant unit comprises a stop; the measuring unit comprises a measuring matrix; the detection device also comprises a stop assembly 5; the measuring base body is clamped between the stop part and the stop component so as to collect tissue working load transmitted to the measuring unit through the stop part.
In the embodiment shown in fig. 1, the detection device (or referred to as measurement unit) 4 is connected to tissue 1, including but not limited to myocardial tissue, via a clamping unit (or referred to as clamping unit, clamp) 3. It should be noted that the main structure of the clamping unit 3 according to one embodiment of the present invention is the same as or slightly adjustable to that of a conventionally used implantation instrument, or is obtained by modifying a conventional implantation instrument, i.e. only a corresponding interface is provided on the implantation instrument to connect with the measuring unit, forming the detection device. Illustratively, the clamping unit is clamped at the clamping portion 111 of the tissue by means of a butt clamp. Taking myocardial tissue as an example, it will reciprocate in the diastole direction 21 or the systole direction under normal operation, and its working load 22 will then act on the clamping unit 3 via the clamping portion 111 on the tissue. In order to truly 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 of the clamping unit far away from the tissue. Correspondingly, the measuring base 41 of the measuring unit is clamped between the swivel arm base and the stop assembly by the stop assembly. It will be appreciated that the measuring matrix 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 transmits the measured signal to the signal collecting unit via the wire 42. Specifically, since the measurement matrix is clamped between the rotating arm base and the stop assembly, the force 23 generated by the systolic or diastolic movement of the tissue is transferred 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 workload generated by the normal physiological activities of the tissue on the clamping unit can be obtained through the collection of the signals and the data processing. And finally, providing real and reliable experimental data for the design of the implantation instrument. It should be noted that, the structure and the working principle of the detection device described above are described by taking a compact apparatus as an example, and the corresponding split apparatus may also be provided with the measurement unit of the present invention and achieve the same detection function, which will be described later.
Optionally, the stop part is a rotating arm base, the implantation unit further comprises a clamping arm base, and a connecting part is arranged 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 clamping unit further comprises a clamping arm base 33, the right end of which is provided with a connection. In practice, the connecting portion is detachably connected to the base tube 35, and the front-back movement of the base tube is controlled to push the clamping arm base away from or close to the rotating arm base 34, so as to control the opening and closing and the folding state of the clamping unit, and finally achieve the effect of adjusting the clamping force. Preferably, the axis of the rotating arm base is provided with a through hole, and the connecting part penetrates through the through hole of the rotating arm base and then is detachably connected with the stop component. As shown in fig. 3, the connection portion may be provided with saw tooth features 331, where multiple groups of saw tooth features may be disposed in a circumferential direction of the connection portion, and the multiple groups are spaced apart from each other. 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 device is used, the measuring base body is sleeved on the connecting part, and then the stop component is rotated to enable the buckle to be located at the interval of the sawtooth feature and then push the buckle to move forwards to a preset position. In the moving process, the buckle is not contacted with the sawtooth feature, and the buckle is rotated again to be contacted with the sawtooth feature and clamped in the tooth slot after reaching the target position, so that the measuring matrix is fixed between the rotating arm base and the stop component. Of course, by properly shaping the buckle, the buckle can be aligned directly with the saw tooth feature and pushed to advance along the saw tooth feature and reach the predetermined position. Further, when the measuring matrix needs to be disassembled, the buckle of the stop component can be rotated to the interval of the sawtooth features, and the stop component is reversely pulled away from the clamping unit so as to solve the constraint effect on the measuring matrix.
Optionally, the outer peripheral side of the connecting portion is provided with a sawtooth feature, and the stop assembly includes a stop clip 51; the stop clamping piece is clamped and connected with the saw tooth feature, and then the measuring unit is clamped between the rotating arm base and the stop clamping piece.
Optionally, the measuring matrix comprises a matrix part, a detection part and a wire; the base body part is sleeved on the connecting part, the detecting part is arranged on the base body part, and the detecting part is connected with the lead.
In the embodiment shown in fig. 4-5, the measurement matrix includes a matrix portion, a detection portion 411, and wires 42. The sensing portion includes, but is not limited to, a strain gauge that can be attached to a surface of the base portion. The base body part is preferably U-shaped, and a through hole 412 is formed in the middle of the U-shape; one of the two arms of the U-shaped structure is abutted against the rotating arm base, and the other arm is abutted against the clamping component; when the rotating arm base 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 transferred to the rotary arm base and then the base portion is pushed to deform, namely, the position changes from the solid line position to the broken line position in the figure, and when the tissue is contracted, the base portion changes from the broken line position to the solid line position in fig. 6 under the recovery action of the self elastic force. The deformation process will deform the detecting portion 411 and generate a measurement signal, and the signal is collected by the wire 42. It will be appreciated that a change in the magnitude of the tissue workload will cause a difference in the deformation of the base portion and a difference in the deformation of the sensing portion, thereby accurately measuring the change in tissue workload in real time. The stress condition of each component is shown in fig. 8, in which a is a connection point between the rotating arm 32 and the clamping arm 31, α is an included angle between the clamping arm, 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 at the middle part 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 workload, the implantation unit body of the detection device in the embodiment shown in fig. 2 to 3 adopts the structure of the conventional implantation instrument. However, in order to increase the versatility of the measuring unit described in the present invention, the structure of the clamping arm base of the implant unit needs to be optimized so that it is compatible with the measuring unit. On the basis, the tissue is anchored or clamped by arranging the clamping arm and the rotating arm in the clamping unit, so that the anchoring stability of the tissue is enhanced. Specifically, the clamping arm and the rotating arm are in a butt clamping mode, one ends of the clamping arm and the rotating arm are respectively pivoted on the clamping arm base and the rotating arm base, and the other ends of the rotating arm are pivoted at the middle part of the clamping arm. When the clamping arm base is used, the base pipe 35 controls the clamping arm base to move back and forth relative to the rotating arm base, so that the clamping arm and the rotating arm can be synchronously controlled to expand or contract, and the clamping arm base is convenient for operators to use.
Preferably, the two clamping arms and the two rotating arms are respectively used for clamping tissues by moving in opposite directions.
Preferably, the clamping arm and the rotating arm are provided with barbs on the side facing the tissue. The provision of the barb structure increases the stability of the gripping unit to anchor tissue. It will be appreciated by those skilled in the art that the length, number and distribution of the barbs may be flexibly adjusted as desired and are not specifically limited herein.
Preferably, the end of the connecting portion, which is far away from the clamping unit, is provided with a buckle 332, and the connecting portion is detachably connected with the base tube 35 through the buckle. In order to control the opening and closing angles of the clamping arm and the rotating arm conveniently, and control the apparatus conveniently, as shown in the embodiment of fig. 3, the invention further provides a base pipe in the detection device, and the base pipe and the connecting part can be respectively provided with a buckle at the butt joint position, so that the base pipe and the connecting part are connected through a buckle structure. And, after the implantation operation is completed, the clasp may be unlocked, withdrawing the base tube.
Preferably, the clamping assembly further comprises a stop conveying rod, a buckle is arranged at the end part of the stop clamping piece, which is 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 is arranged in the base pipe in a penetrating mode. In the embodiment shown in fig. 2 and 7, the clamping assembly comprises a stop conveying rod 52 and a stop clamping piece 51, wherein a buckle 521 is arranged at the connecting end between the stop conveying rod and the stop clamping piece, and the connection or the disassembly between the stop conveying rod and the stop clamping piece is realized through the buckle. The portion of the further stop catch facing the saw tooth feature 331 is provided with at least one pair of catches 511. Furthermore, in order to facilitate installation and operation of the apparatus, in one embodiment of the invention, a multi-layer nested structure is adopted among the tubular parts, and as the tubular structures, the buckles and other design modes are adopted, the design and manufacturing difficulties are 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 relatively to the base pipe. Further, an inner core rod 36 is provided inside the base pipe. When the inner core rod is used, the base pipe and the connecting part can be clamped together through the buckle, the inner core rod is arranged in the base pipe and the connecting part in a penetrating mode, and the buckle unlocking between the base pipe and the connecting part is prevented by utilizing the limiting function of the outer wall of the inner core rod. When the buckle needs to be unlocked, the limiting effect can be relieved only by pulling away the inner core rod. After the installation of the base pipe and the connecting part is completed, the measuring unit can be sleeved on the connecting part, and then the stop clamping piece and the stop conveying rod connected by the buckle are sleeved on the base pipe and conveyed to the sawtooth feature part forwards along the base pipe. The locking state is maintained by the clamping connection between the stop clamping piece and the stop conveying rod due to the limiting effect of the outer walls of the base pipe and the connecting part.
Preferably, the implant unit comprises an anchor part and an anchor, the anchor part and the anchor are connected through a stay wire, the anchor is used as a stop component, a stay wire locker is arranged at the end part, far away from the anchor part and the anchor, of the stay wire, and the stay wire locker is used as the stop part.
In the embodiment of the split instrument shown in fig. 15, the implant unit is of split design and comprises an anchor portion 9 and an anchor 11, which are connected by a pull wire 10. Wherein the anchoring position of the anchoring portion is remote from the fixed position of the anchor 11. In this embodiment, the anchor is used as a stop assembly, and the end of the wire remote from the anchor and the anchor is provided with a wire locker 122, which acts as the stop. Under normal working conditions, the load of the tissue is transmitted to the anchor 11 through the anchor part 9 and the stay wire 10 in sequence. In this embodiment, the end of the pull wire close to the anchor is fixed at the anchor 11 by a pull wire locker. Based on the installation characteristics of the implantation instrument, the invention effectively utilizes the force transmission characteristics between structures to clamp the measuring unit between the stay wire locker and the anchor, and effectively collects the working load of tissues.
Preferably, similar to the previous embodiments, in the embodiment shown in fig. 15, the measuring base also includes a base portion, a detecting portion, and a wire; the base body part is sleeved on the stay wire and clamped between the stop part and the stop 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 validity and accuracy of the detection device shown in the embodiment of the invention, the invention further designs an experimental scheme. The described scheme may also be used to collect the workload of other organizations. The protocol is shown in fig. 9, where a sensing device is implanted in the heart to measure the tissue workload experienced by the implantation instrument used for valve repair. Wherein, the detection device is implanted into a target tissue, such as the heart tricuspid valve, through the superior vena cava 12 by a delivery system, and a wire of the detection device is connected with a force value collector 6 arranged outside the body. The force generated by the periodic contraction or relaxation of heart tissue on the clamping device is exclusively transmitted to the measuring matrix through the rotating arm base, so that the periodic shape change of the detecting part is caused, for example, the periodic deformation of the strain gauge is caused to change the self resistance value, and the change of the electric signal generated by the change is measured by the force value collector. Thereby obtaining data such as the acting force of the tissue on the implantation instrument and the frequency.
In addition to verifying or using the instrument of the present invention in an interventional state to measure tissue workload, the instrument of the present invention may also be used in an ex vivo state. In the pulsatile flow ex vivo test as shown in fig. 10, tissue workload was measured by building a pulsatile flow platform. The motor pump 77 is connected to the heart by tubing to provide cardiac power thereto, for example, to simulate the beating 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 change of the working load and the pressure respectively so as to verify the accuracy of the detection device. For example, the pressure sensor 7 is arranged in the heart in the vicinity of the clamping unit, and the pressure and the working load in the tissue change synchronously when the heart contracts or expands. When the pressure P is maximum, the ventricle is in a contracted state, the valve leaflet is closed, the annulus contracts, the clamping force of the clamping unit clamped on the valve annulus is minimum, whereas when the valve annulus expands to the maximum (when the orifice is opened, the valve annulus expands to the maximum, the corresponding pressure P is minimum), the clamping force is also maximum. To facilitate observation of the working state of the heart, an endoscope 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 trauma to the tissue.
Taking data collected from a single pulsatile flow test as an example, fig. 11 shows waveforms of the collected pressure P and force value Fm (or referred to as the stop load) at the same time, the waveforms are similar and the period is substantially the same, which effectively demonstrates the accuracy of the instrument measurement of the present invention. Note that Fm measured in fig. 11 is a value of force directly measured by the detection unit, and is not a work load. Therefore, a numerical solution is required to obtain a true workload. In the force analysis chart shown in fig. 8, fm has a conversion relationship with the working load F, and a forceful 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 coefficient is recorded:
the coefficient C is related to the closing angle α, and its correspondence is shown in fig. 12. For example, when the closing angle is 58 °, c=0.182 can be obtained, and Fm shown in fig. 11 can be further converted into a waveform diagram of the working load F under the cardiac cycle, specifically shown in fig. 13. From the above description, it follows that the value of the force (i.e. the working load) exerted by the clamp (or gripping unit or gripping instrument) 3 on the tissue during periodic contraction or expansion of the valve annulus tissue fluctuates in the range of 2.02N to 2.52N. The force value can be used as input data for instrument design and fatigue verification, so that a powerful experimental support is provided for a designer, and the designed implantation instrument is ensured to meet the requirements of safety and reliability.
It should be noted that the above experimental procedure requires the value of α. This value is usually calculated by controlling the distance between the base of the swivel arm and the base of the clamping arm, although it can also be obtained experimentally. Fig. 14 is a test flow of two test environments, which shows how the value of a is obtained in case of intervention and finally the clamping force F (or called working load) is obtained.
As shown in fig. 15 and 16, is a schematic representation of the measurement of the working load of an implantation instrument employed in another interventional annulus repair technique. This example demonstrates the fluctuation of force values (or referred to as workload) over time of the mitral valve postvalve following a cardiac cycle tested on a living animal. The implantation instrument is of a split structure and is anchored at the position of the mitral valve posterior valve annulus 8, and the instrument comprises an anchoring part 9 and an anchor 11; wherein the anchoring part 9 is anchored on the back valve, the anchor 11 is anchored on the atrial septum, the anchor and the anchoring part are connected through a stay wire 10, and a stay wire locker 122 is arranged at one end of the stay wire 10 far away from the anchor and the anchoring part. The lead 42 is led out of the body through the inferior vena cava 13. In this operative mode, the posterior valve is pulled towards the anchor 11 by the pull wire 10 and the annulus anchor 9, and after the pull wire is locked by the pull wire locker 122, the measuring unit is clamped between the pull wire locker 122 and the anchor 11 and is subjected to the working load. When the heart works, the stress of the measuring unit also fluctuates, and is transmitted into the force value collector 6 through the lead 42, and fig. 16 is a waveform of the force value of the 10s internal pulling force collected in one experiment.
In the test of each embodiment, the force value is related to the environment of the heart of the tested object, and the degree of the heart beating, the amount of the clamping tissue and the degree of the pulling wire pulling are different, so that the force value obtained by the test is different, and the test conditions and parameters are required to be customized according to the specific application. 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, so that the accuracy of the test data can be ensured.
In another aspect, the present invention provides a method for detecting a tissue workload using the detecting device according to any one of the first aspects of the present invention, the detecting method comprising operating an implanting unit of the detecting device such that one end thereof is connected to a tissue; the working load of the tissue is detected by the measuring unit.
In a further aspect the invention provides a method of detecting tissue workload using any of the detection devices described in the first aspect of the invention with a rotating arm base, the method comprising operating an implant unit of the detection device with one end connected to tissue; collecting the load of the stop part detected by the measuring unit, and acquiring the posture of the implanted unit in the intervention state; the working load of the tissue is calculated by the load of the stop and the pose of the implant unit.
Preferably, the workload of the computing organization includes: the workload is calculated by the following formula:
wherein F is the working load, fm 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 arms and the rotating arm.
The above embodiments do not limit the scope of the present invention. It will be apparent to those skilled in the art that various modifications, combinations, sub-combinations and alternatives can occur depending upon design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the scope of the present invention.
Claims (14)
1. A device for detecting tissue workload, comprising:
an implantation unit having one end connected to the tissue to position the detection device;
a measurement unit for detecting a workload 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 is opposite to one end of the implantation unit connected with the tissue; wherein,,
the working load of the tissue is transmitted to the measuring unit through the implanting unit and is collected by the measuring unit;
the implant unit includes a stop;
the measuring unit comprises a measuring matrix;
the detection device also comprises a stop component;
the measuring base body is clamped between the stop part and the stop component so as to collect tissue working load transmitted to the measuring unit through the stop part.
2. The apparatus for detecting tissue workload according to claim 1, wherein,
the stop 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 measuring 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.
3. The apparatus for detecting tissue workload according to claim 2, wherein,
the periphery of the connecting part is provided with sawtooth characteristics, and the stop component comprises a stop clamping piece;
the stop clamping piece is clamped and connected with the saw tooth feature, and then the measuring unit is clamped between the rotating arm base and the stop clamping piece.
4. A device for detecting tissue workload according to any one of the claims 2 to 3, wherein,
the measuring matrix comprises a matrix part, a detection part and a wire;
the base body part is sleeved on the connecting part, the detecting part is arranged on the base body part, and the detecting part is connected with the lead.
5. A device for detecting tissue workload according to any one of the claims 2 to 3, wherein,
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 at the middle part of the clamping arm, and the other end of the rotating arm is pivoted on the rotating arm base.
6. The apparatus for detecting tissue workload according to claim 5, wherein,
the clamping arms and the rotating arms are two, and the clamping arms and the rotating arms move in opposite directions to clamp tissues.
7. The apparatus for detecting tissue workload according to claim 6, wherein,
the clamping arm and the rotating arm are provided with barbs on one side facing the tissue.
8. The apparatus for detecting tissue workload according to claim 3, wherein,
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.
9. The apparatus for detecting tissue workload according to claim 8, wherein,
the stop assembly further comprises a stop conveying rod, a buckle is arranged at the end part of the stop clamping piece, which is 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 is arranged in the base pipe in a penetrating mode.
10. The apparatus for detecting tissue workload according to claim 1, wherein,
the implant unit comprises an anchoring portion and an anchor, the anchoring portion is connected with the anchor through a stay wire, the anchor is used as a stop component, a stay wire locker is arranged at the end portion, far away from the anchoring portion and the anchor, of the stay wire, and the stay wire locker is used as the stop portion.
11. The apparatus for detecting tissue workload according to claim 10, wherein,
the measuring matrix comprises a matrix part, a detection part and a wire;
the base body part is sleeved on the stay wire and clamped between the stop part and the stop component, the detection part is arranged on the base body part, and the detection part is connected with the lead.
12. A method for detecting tissue workload, which uses the detecting device according to any one of claims 1 to 11,
the method is characterized in that: the method of detection may include the steps of,
operating an implantation unit of the detection device to connect one end of the implantation unit to tissue;
the working load of the tissue is detected by the measuring unit.
13. A method for detecting tissue workload, which uses the detecting device according to any one of claims 5 to 9,
the method is characterized in that: the method of detection may include the steps of,
operating an implantation unit of the detection device to connect one end of the implantation unit to tissue;
collecting the load of the stop part detected by the measuring unit, and acquiring the posture of the implanted unit in the intervention state;
the working load of the tissue is calculated by the load of the stop and the pose of the implant unit.
14. The method of claim 13, wherein,
the workload of the computing organization comprises:
the workload is calculated by the following formula:
the method comprises the steps of carrying out a first treatment on the surface of the Wherein F is the working load, fm 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 arms and the rotating arm.
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| US6821297B2 (en) * | 2000-02-02 | 2004-11-23 | Robert V. Snyders | Artificial heart valve, implantation instrument and method therefor |
| US7635329B2 (en) * | 2004-09-27 | 2009-12-22 | Evalve, Inc. | Methods and devices for tissue grasping and assessment |
| US11185413B2 (en) * | 2016-07-13 | 2021-11-30 | Medfree, Inc. | Tissue grasping devices and related methods |
| WO2020092251A1 (en) * | 2018-10-30 | 2020-05-07 | Edwards Lifesciences Corporation | Valve diameter and force monitoring of a prosthetic heart valve |
| WO2021098371A1 (en) * | 2019-11-19 | 2021-05-27 | 杭州德晋医疗科技有限公司 | Independently controllable valve clamping system |
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