CN113081132B

CN113081132B - Quantitative stability evaluation system of left auricle occluder

Info

Publication number: CN113081132B
Application number: CN202110379414.XA
Authority: CN
Inventors: 储慧民; 刘天宇
Original assignee: Shanghai Zuoxin Medical Technology Co ltd
Current assignee: Chu Huimin
Priority date: 2021-04-08
Filing date: 2021-04-08
Publication date: 2022-08-02
Anticipated expiration: 2041-04-08
Also published as: CN113081132A

Abstract

The left auricle occluder is implanted into a body through a push rod and comprises a traction module and a stability evaluation module, wherein the traction module comprises a traction part, a force evaluation part and a fixed connecting part which are sequentially connected, the far end of the fixed connecting part is connected with the left auricle occluder, the near end of the fixed connecting part is connected with the traction part, the force evaluation part is used for displaying the quantitative value of the traction force of the traction part, the stability evaluation module is connected with the traction part, and the stability evaluation module is used for evaluating the stable state of the left auricle occluder. The quantitative stability evaluation system can perform traction inspection, and can help an operator to accurately control traction test force after successfully implanting the left atrial appendage occluder, so that operation risks are avoided.

Description

Quantitative stability evaluation system of left auricle occluder

Technical Field

The invention relates to the field of medical equipment, in particular to a quantitative stability evaluation system of a left atrial appendage occluder in a left atrial appendage occlusion operation for treating atrial fibrillation.

Background

Atrial fibrillation (atrial fibrillation) is the most common persistent arrhythmia at risk of inducing ischemic stroke, and therefore, prevention of atrial fibrillation is of great importance. In recent years, it has been shown that plugging the left atrial appendage is effective in preventing the risk of ischemic stroke due to atrial fibrillation.

Common left atrial appendage occluders can be divided into two categories, one being plug style occluders, represented by Watchman, and the other being cap style occluders, represented by lamb, both of which require pull-up verification, i.e. verification of successful anchoring of the occluder to the atrial appendage prior to release. The main test method at present is to directly pull the occluder by an operator, and the test method completely depends on experience and hand feeling of the operator to test whether the occluder is successfully anchored on the auricle, which easily causes the following two problems:

1. when the traction force of an operator on the plugging device is too large, the anchoring hook of the plugging device is easy to pull the auricle, so that the inner wall of the auricle is scratched, pericardial effusion is generated, and the auricle can be torn in serious cases to cause serious medical accidents.

2. When the art person is not enough to the plugging device pulling force, can't effectively discern whether anchoring of plugging device anchoring hook is firm, if the plugging device is not anchored firmly this moment, and the art person has accomplished the release of plugging device, then can lead to the plugging device to release the back, the apparatus has the risk of droing, leads to the operation failure to need carry out the operation of opening the chest.

3. The frameworks of the two types of occluders are made of nickel titanium materials, mainly utilize the self-expansion characteristic of the nickel titanium materials, but have time effect due to the expansion process of the nickel titanium materials. This just requires the art person to wait for a period of time after the occluder releases, waits to carry out the traction test again after the occluder stabilizes, but in the actual operation, because the time that the art person waited for is different, sometimes the art person can forget to need waiting time even, promptly after the occluder releases, the art person can carry out the traction test immediately, and the occluder at this moment is not stable yet, can lead to the apparatus after the traction to drop, causes the operation to fail.

Disclosure of Invention

The invention aims to provide a quantitative and stable evaluation system of a left atrial appendage occluder, which can meet the requirement of traction test and can judge the magnitude of the traction force provided by an operator so as to quantitatively evaluate the traction force, thereby avoiding the operation risk caused by inaccurate traction force and avoiding the operation risk when the waiting time after the left atrial appendage occluder is released is too short.

In order to solve the technical problems, the invention provides a quantitative stability evaluation system of a left atrial appendage occluder, which is implanted into a body through a push rod, and is characterized by comprising a traction module and a stability evaluation module, wherein the traction module comprises a traction part, a force evaluation part and a fixed connecting part which are sequentially connected, the far end of the fixed connecting part is connected with the left atrial appendage occluder, the near end of the fixed connecting part is connected with the traction part, the force evaluation part is used for displaying a quantitative value of the traction force of the traction part, the stability evaluation module is connected with the traction part, and the stability evaluation module is used for evaluating the stable state of the left atrial appendage occluder

Optionally, the force evaluating part includes a force quantifier and an elastic device, and the force quantifier displays a quantified value by deformation of the elastic device.

Furthermore, the force quantizer comprises an inner cylinder and an outer cylinder, the inner cylinder is in clearance fit with the inner cylinder, the near end of the inner cylinder is connected with the far end of the elastic device, the far end of the inner cylinder is connected with the fixed connecting part, and the near end of the outer cylinder is connected with the near end of the elastic device.

Further, the near-end of inner tube is provided with first parallel key, the distal end of inner tube is provided with the backstop piece, the urceolus is provided with first parallel key groove on its extending direction's lateral wall, first parallel key position in the first parallel key groove, just when the urceolus slides along its extending direction, first parallel key is in follow in the first parallel key groove the extending direction of first parallel key groove slides, the backstop piece with the distal end of urceolus is mutually supported, and will the urceolus is injectd in on one side that the inner tube is close to its near-end.

Furthermore, the first flat key is provided with an indicating mark, scale marks are arranged on two sides of the first flat key groove, and when the outer cylinder slides, the indicating mark indicates that the position of the scale marks is the force required by the deformation of the elastic device.

Furthermore, the strength quantizer comprises a sensor and a digital display module, the sensor is used for sampling the deformation of the elastic device, and the digital display module is used for processing the sampling signal of the sensor and displaying the strength of the force.

Optionally, the force evaluating part comprises a force quantifier and a pulling device, and the force quantifier is used for displaying the pulling force of the pulling device to a quantified value.

Further, the pulling device comprises a connecting inner cylinder and a pulling sleeve, the connecting inner cylinder is connected to the near end of the fixed connecting portion, and the pulling sleeve is sleeved at the near end of the connecting inner cylinder.

Further, the force quantizer is fixed in the traction sleeve and connected with the connecting inner barrel.

Furthermore, the force quantizer comprises a force sensor module, a signal processing printed board and a display part, wherein the force sensor module is fixed in the traction sleeve and connected with the connecting inner cylinder, the force sensor module is electrically connected with the signal processing printed board, and the signal processing printed board is electrically connected with the display part;

the force sensor module is used for collecting force value information of the traction sleeve, converting the force value information into an electric signal and transmitting the electric signal to the signal processing printed board, and the signal processing printed board is used for displaying the force value information in a numerical value form through the display part.

Further, the stability evaluation module comprises a time calculation unit; the time calculation unit comprises at least one of a positive timing module, a negative timing module or a time setting module.

Optionally, the fixed connection portion includes a locking clamp spring and a clamp assembly, the locking clamp spring is installed at a distal end of the inner cylinder, an end portion of the push rod is installed in the locking clamp spring, and the clamp assembly is located at the end portion of the push rod and outside the locking clamp spring and used for fixing the push rod; the locking clamp spring is made of thin-wall metal elastic materials, is in a barrel shape and is provided with two oppositely arranged openings.

Furthermore, the two openings are respectively a clamping end and a connecting end of the locking clamp spring, the clamping end clamps the end part of the push rod, and the connecting end is installed at the far end of the force evaluation part.

Furthermore, at least one hollowed-out groove is formed in the side walls of the clamping end and the connecting end, the hollowed-out groove penetrates through the side wall of the locking clamp spring in the thickness direction of the locking clamp spring, and the hollowed-out grooves are adjacent to each other and are arranged at intervals and not communicated with each other.

Furthermore, the number of the hollow-out grooves of the clamping end is larger than that of the connecting end.

Furthermore, the clamping end clamps the end part of the push rod with the diameter of 10 mm-16 mm.

Further, the clamp assembly comprises a clamping piece and a tightening piece, and the tightening piece locks the clamping piece on the outer side of the locking clamp spring in the operation process.

Further, the chucking spare includes clamp, root round pin axle and bolt pin axle, first end and the second end that has relative setting on the lateral wall of clamp, root round pin axle sets up the first end of clamp, just root round pin axle with the clamp is articulated, it fixes through bolt pin axle the second end of clamp to twist the spare.

Further, it includes bolt, handle and lock post to screw up the piece, the handle is connected the one end of lock post, the screw rod of bolt has the external screw thread, the lock post have with external screw thread assorted internal thread, the screw rod pass through bolt pin axle with hole threaded connection between the clamp the lock post to locking or release the tip of chucking spare and push rod.

Compared with the prior art, the invention has the beneficial effects that:

the left auricle occluder comprises a traction module and a stability evaluation module, wherein the traction module comprises a traction part, a force evaluation part and a fixed connecting part which are sequentially connected, the far end of the fixed connecting part is connected with the left auricle occluder, the near end of the fixed connecting part is connected with the traction part, the force evaluation part is used for displaying the quantitative value of the traction force of the traction part, the stability evaluation module is connected with the traction part, and the stability evaluation module is used for evaluating the stable state of the left auricle occluder. The quantitative stability evaluation system can perform traction test, and can help an operator to accurately control traction test force after successfully implanting the left atrial appendage occluder, thereby avoiding operation risk.

Furthermore, the clamping end clamps the end part of the push rod with the diameter of 10 mm-16 mm, so that the fixed connecting part can clamp the end heads of the occluders with different diameters, and the universality of the quantitative stability evaluation system is realized. Fixed connection portion includes locking jump ring and clamp subassembly, the locking jump ring is installed the distal end of strength evaluation portion, the tip of push rod is installed in the locking jump ring, the clamp subassembly is located the tip of push rod and the outside of locking jump ring, and be used for fixing the push rod makes fixed connection portion's simple structure, convenient operation.

Drawings

Fig. 1 is a schematic perspective view of a quantitative stability evaluation system of a left atrial appendage occluder according to an embodiment of the present invention;

fig. 2 is an exploded schematic view of a traction module according to an embodiment of the present invention;

FIG. 3 is a schematic structural diagram of an inner barrel according to an embodiment of the present invention;

fig. 4 is a schematic structural diagram of an end cap according to an embodiment of the present invention;

fig. 5 is a schematic structural diagram of a locking clamp spring according to a first embodiment of the present invention;

FIG. 6 is a schematic structural view of a clip assembly according to an embodiment of the present invention;

fig. 7 is a schematic perspective view of a quantitative stability evaluation system of a left atrial appendage occluder according to a second embodiment of the present invention;

fig. 8 is an exploded schematic view of a stability assessment module according to a second embodiment of the present invention;

fig. 9 is a schematic perspective view of a quantitative stability evaluation system of a left atrial appendage occluder according to a third embodiment of the present invention;

fig. 10 is an exploded schematic view of a quantitative stability assessment system according to a third embodiment of the present invention.

Description of reference numerals:

1-the end of a push rod; 2-a traction module; 3-a stability assessment module;

100-a pulling part; 110-an end cap; 111-a first lifting lug;

200-an elastic device;

300-a force quantizer; 310-an inner cylinder; 311-first flat key; 312-a stop block; 313-a second flat bond; 320-outer cylinder; 321-a first flat keyway; 330-connecting the inner cylinder; 331-a first inner barrel; 332-a second inner barrel; 340-a pulling sleeve; 341-card slot; 350-a force sensor module; 360-signal processing printed board;

400-fixed connection; 410-locking a clamp spring; 411-a second flat keyway; 412-a hollow out; 413-limit stop; 420-a clip assembly; 421-clamp; 4211-a first sub-clip; 4212-second sub-clip; 422-root pin shaft; 423-bolt pin; 4241-bolt; 4242-a handle; 4243-lock cylinder; 4251-a first hole; 4252-second hole;

500-a time calculation unit; 510-a timing module; 511-control the printed board; 512-a battery; 513-a button cap; 520-timing adjustment means; 530-a display component; 540-time early warning component;

600-a timer cartridge; 611-grooves; 612-pores;

700-a second end cap; 710-an extension; 720-a second lifting lug; 730-tab.

Detailed Description

A quantitative stability assessment system of the left atrial appendage occluder of the present invention will be described in further detail below. The present invention will now be described in more detail with reference to the accompanying drawings, in which preferred embodiments of the invention are shown, it being understood that one skilled in the art may modify the invention herein described while still achieving the advantageous effects of the invention. Accordingly, the following description should be construed as broadly as possible to those skilled in the art and not as limiting the invention.

In the interest of clarity, not all features of an actual implementation are described. In the following description, well-known functions or constructions are not described in detail since they would obscure the invention in unnecessary detail. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific details must be set forth in order to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art.

In order to make the objects and features of the present invention more comprehensible, embodiments of the present invention are described in detail below with reference to the accompanying drawings. It is to be noted that the drawings are in a very simplified form and are all used in a non-precise ratio for the purpose of facilitating and distinctly aiding in the description of the embodiments of the invention. As used herein, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The terms "inner", "outer", and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Herein, the terms "distal" and "proximal" refer to the relative orientation, relative position, and direction of elements or actions relative to one another from the perspective of a clinician using the medical device, although "distal" and "proximal" are not intended to be limiting, but rather "distal" generally refers to the end of the medical device that is first introduced into a patient, and "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation.

Example one

Fig. 1 is a schematic perspective view of a quantitative stability evaluation system of a left atrial appendage occluder provided in this embodiment. Fig. 2 is an exploded schematic view of the traction module provided in this embodiment.

As shown in fig. 1-2, the present embodiment provides a quantitative stability evaluation system for left atrial appendage occluder, which is used for the pull test of the operator after successfully implanting the left atrial appendage occluder, specifically, for example, the pull test before releasing the left atrial appendage occluder in the left atrial appendage occlusion operation for treating atrial fibrillation. Wherein, the left auricle occluder is implanted into the body through a push rod. The distal end of the quantitative stability assessment system fixes the end 1 of the push rod of the left atrial appendage occluder, and the operator pulls the proximal end of the quantitative stability assessment system, so that whether the occluder is successfully anchored to the atrial appendage before release can be verified (i.e. a pull test is performed), and the effectiveness of the pull test is ensured.

The quantitative stability evaluation system comprises a traction module 2, wherein the traction module 2 comprises a traction part 100, a force evaluation part and a fixed connection part 400 which are sequentially connected, and the force evaluation part comprises an elastic device 200 and a force quantizer 300. The force quantizer 300 displays a quantized value by deformation of the elastic device 200. Wherein the traction part 100, the elastic device 200, the force quantifier 300 and the fixed connection part 400 are connected in sequence, the fixed connection part 400 fixes the left atrial appendage occluder 1, and an operator indirectly pulls the left atrial appendage occluder 1 through the traction part to check whether the occluder is successfully anchored to the atrial appendage before being released.

Fig. 4 is a schematic structural diagram of an end cap according to an embodiment of the present invention. As shown in fig. 4, the pulling part 100 is connected to the proximal end of the elastic means 200. The pulling part 100 includes, for example, a first lifting lug 111, and the proximal end of the elastic device 200 is connected to the first lifting lug 111. Specifically, the quantitative stability evaluation system may further include a first end cap 110, where the first end cap 110 has two end faces disposed opposite to each other, the first lifting lug 111 is disposed on one of the end faces, and a pulling ring 730 is disposed on the other end face, pulling the pulling ring 730 may deform the elastic device 200 to generate a pulling force, and a proximal end of the elastic device 200 is connected to the first lifting lug 111. When pulling the pulling part 100, the operator can pull the pulling part 100 to stretch or compress the elastic device 200. The elastic means 200 may be a spring.

The force quantizer 300 is connected to the distal end of the elastic device 200, and can measure the magnitude of the pulling force provided by the operator when the operator pulls the pulling part 100 (the elastic device 200 is elastically deformed), so as to help the operator to accurately control the pulling test force after the operator successfully implants the left atrial appendage occluder, thereby avoiding the surgical risk.

In this embodiment, the force quantifier 300 may be a force quantifier displaying scales, and the force quantifier 300 converts the stretching amount or the shrinking amount of the elastic device 200 into the magnitude of the pulling force and displays the scales. Fig. 3 is a schematic structural diagram of an inner barrel according to an embodiment of the present invention. As shown in fig. 3, the force quantifier 300 includes, for example, an inner cylinder 310 and an outer cylinder 320, the inner cylinder 310 is clearance-fitted inside the outer cylinder 320 (i.e. the outer cylinder 320 is sleeved outside the inner cylinder 310, and a clearance is provided between the inner cylinder 310 and the outer cylinder 320), so that the inner cylinder 310 can slide in the outer cylinder 320 along the extending direction thereof, the proximal end of the outer cylinder 320 is connected to the proximal end of the elastic device 200, and the proximal end of the inner cylinder 310 is connected to the distal end of the elastic device 200. The outer cylinder 320 is cylindrical and has two openings disposed opposite to each other. The inner cylinder 310 is, for example, cylindrical, and preferably, the inner cylinder 310 is, for example, a barrel shape and has two openings to reduce the weight of the inner cylinder 310. The length of the outer cylinder 320 is the sum of the length of the inner cylinder 310 and the length of the elastic device 200 when the elastic device 200 is not elastically deformed, that is, when the elastic device 200 is not elastically deformed, the elastic device 200 and the inner cylinder 310 are both located in the outer cylinder 320. The proximal end of the outer cylinder 320 is connected to the other end face, in detail, the first end cap 110 has an annular extending surface at an edge position of the other end face, an outer thread is provided on an outer wall of the extending surface, an inner thread matched with the outer thread is provided on an inner wall of the proximal end of the outer cylinder 320, and the outer cylinder 320 is screwed on the extending surface.

With continued reference to fig. 1-2, the extension direction of the outer cylinder 320 is the same as the extension direction of the inner cylinder 310, the opening of the inner cylinder 310 is located at the distal end thereof, the bottom opposite to the opening is located at the proximal end thereof, and the distal end of the elastic device 200 is connected to the proximal end of the inner cylinder 310. The inner barrel 310 has a stopper 312 on an outer wall near a distal end thereof, the stopper 312 being convex, the stop block 312 may be a ring-shaped continuous protrusion, or may be a ring-shaped protrusion formed by a plurality of protruding columns, which is fitted with an end surface at the distal end of the outer cylinder 320 to prevent the operator from physically shocking the elastic means and the fixed connection 400 when the inner cylinder 310 is completely inserted into the interior of the outer cylinder 320 when the quantitative stability assessment system is pulled to release the quantitative stability assessment system, and at the same time, the limit of the maximum value of the pulling force (namely the pulling threshold value) is provided with a threshold early warning function, the control of the maximum elongation of the elastic device is realized, the limit of the pulling force is finally realized, thereby avoided not enough the unable effective discernment anchoring hook that leads to of pulling force whether anchor firm and pulling force too big impaired problem of auricle inner wall that leads to.

The inner cylinder 310 has an indication mark thereon, in this embodiment, the inner cylinder 310 has a first flat key 311 thereon, the upper surface of the first flat key 311 has an indication mark thereon, the outer cylinder 320 has an elongated first flat key groove 321 at a position corresponding to the first flat key 311, the first flat key 311 is located in the first flat key groove 321, and the first flat key 311 can slide in the first flat key groove 321 when the outer cylinder 320 slides along the inner cylinder 310 in the extending direction thereof. The two sides of the first flat key slot 321 are provided with scale marks according to the range requirement, so as to read the pulling force and help the surgeon to accurately apply the pulling force.

In other embodiments, the force quantizer 300 may also be a force quantizer 300 displaying numbers, where the force quantizer 300 includes a sensor for sampling a signal of deformation of the elastic device and a digital display module for processing the sampled signal of the sensor and displaying a magnitude of the force. The force quantizer 300 is, for example, configured to acquire a force generated by deformation of the elastic device 200 by using a pressure sensor or a tension sensor, process and display a sensor sampling signal through a digital display module, where the digital display module sets a tension threshold, and when a pulling force exceeds the threshold tension, the display screen flashes to alarm for a maximum tension.

Fig. 5 is a schematic structural diagram of a locking clamp spring according to an embodiment of the present invention. Fig. 6 is a schematic structural diagram of a clip assembly according to an embodiment of the present invention. As shown in fig. 5 and 6, the fixing connection 400 is used to fix the end 1 of the push rod. Fixed connection portion 400 includes locking jump ring 410 and clamp subassembly 420, locking jump ring 410 is installed the distal end of inner tube 310, the tip 1 of push rod is installed in locking jump ring 410, the clamp subassembly is located the tip 1 of push rod and the outside of locking jump ring, in order to fix the left atrial appendage occluder.

As shown in fig. 5, the locking clamp spring 410 is made of a thin-wall metal elastic material, the locking clamp spring 410 is in a cylindrical shape and has two openings which are oppositely arranged, and the two openings are respectively a clamping end and a connecting end of the locking clamp spring 410. In order to further increase the elasticity of the locking clamp spring 410, at least one hollow groove 412 is formed in the side walls of the clamping end and the connecting end, the hollow groove 412 penetrates through the side wall of the locking clamp spring 410 along the thickness direction of the locking clamp spring 410, and the adjacent hollow grooves 412 are arranged at intervals and are not communicated with each other. The number of the hollow grooves 412 of the clamping end is larger than that of the hollow grooves 412 of the connecting end, that is, the number of the hollow grooves 412 arranged on the clamping end is more as much as possible, for example, 4 hollow grooves are arranged, so that the clamping end can deform more easily, the clamping end can move along the radial direction of the end portion 1 of the push rod when clamping the end portion 1 of the push rod, meanwhile, the end heads of the end portions 1 of the push rod with different diameters can be clamped, a quantitative stability evaluation system can clamp the end portions 1 of the push rod with different diameters, and the clamping end can clamp the end head of the end portion 1 of the push rod with the diameter of 10 mm-14 mm, for example, so that certain universality is realized. The number of the hollow-out grooves 412 arranged on the connecting end is as small as possible, for example, two hollow-out grooves are arranged, so that the connecting end is not greatly deformed and is only deformed during assembly, and after the assembly is completed, the connecting end has enough radial supporting force, so that the connecting end has enough deformation resistance and can be assembled. Still be provided with at least one spacing tang 413 on the outer wall of exposed core, it is used for realizing the axial positioning of clamp subassembly, in order to prevent the clamp subassembly drops. The thickness direction of the locking clamp spring 410 is the radial direction of the locking clamp spring 410.

In this embodiment, at least two second flat key slots 411 are further formed on the side wall of the connection end of the locking clip 410, a second flat key 313 matched with the second flat key slots is arranged on the inner wall of the distal end of the inner cylinder 310, when the locking clip 410 is installed on the inner cylinder 310, the second flat key 313 is located in the second flat key slots 411, and the second flat key 313 is matched with the second flat key slots 411, so that the locking clip 410 is assembled with the inner cylinder 310.

In other embodiments, at least two first through holes are further formed in the side wall of the connection end of the locking clip spring 410, a second through hole matched with the first through hole is formed in the side wall of the distal end of the inner cylinder 310, when the locking clip spring 410 is installed on the inner cylinder 310, the first through hole and the second through hole are overlapped, and the locking clip spring 410 and the inner cylinder 310 are fixed in the first through hole and the second through hole through screws.

Hoop assembly 420 installs on locking jump ring 410's the exposed core, through hoop assembly 420's tight degree of clamp provides the clamp and presss from both sides tight the radial load of the tip 1 of push rod makes locking jump ring 410's exposed core can radially tighten up and relax to realize the tip 1 clamping and the release of push rod.

Clamp assembly 420 can include chucking spare and screw up the piece, in the art, screw up the piece will chucking spare locking is in on the outside of locking jump ring 410, can conveniently realize that the art person adjusts the clamping force degree of push rod end in the operation process, ensures that the centre gripping is reliable.

As shown in fig. 6, the clamping member includes, for example, a clamp 421, a root pin 422 and a bolt pin 423, the clamp 421 is a cylinder and has two openings oppositely disposed, the sidewall of the clamp 421 has a first end and a second end oppositely disposed, the root pin 422 is disposed at the first end of the clamp, the root pin 422 is hinged to the clamp 421, and the tightening member is fixed at the second end of the clamp 421 through the bolt pin 423.

The clip 421 includes a first sub clip 4211 and a second sub clip 4212, the first sub clip 4211 and the second sub clip 4212 each have a semi-circular cross section, and the first sub-hoop 4211 and the second sub-hoop 4212 are spliced to form the hoop 421 in a cylindrical shape, the first 4211 and second 4212 sub-ferrules at the first end articulate the first 4211 and second 4212 sub-ferrules by a stub pin 422, the bolt pin 423 is secured to the second sub ferrule 4212 on the second end, so that a first hole 4251 perpendicular to the axial direction of the second sub-hoop 4212 is formed between the bolt pin 423 and the second sub-hoop 4212, a second hole 4252 overlapping with the first hole 4251 is formed at the other connecting end of the first sub-hoop 4211, the screw passes through the first and second holes 4251, 4252 to lock the other connection ends of the first and second sub-ferrules 4211, 4212. The second bore 4252 has an opening in a direction facing away from the first partial clip 4211, which allows the fastener to be easily removed from or mounted on the fastener.

The tightening member includes, for example, a bolt 4241 and a tightening knob, the tightening knob includes a handle 4242 and a lock cylinder 4243, the lock cylinder 4243 has an internal thread, the screw of the bolt 4241 has, for example, an external thread matching the internal thread, and the bolt 4241 passes through the second hole 4252 and the first hole 4251 and is screwed in the lock cylinder 4243. The grip 4242 is, for example, a handle; or may be formed in a cylindrical shape with both ends opened, so that a bolt is inserted into the knob 4242 and is rotated to easily screw the bolt 4241 into the lock cylinder 4243. The width of the first and second holes 4251 and 4252 (i.e., the length parallel to the radial direction of the yoke 4212) is slightly larger than the diameter of the bolt, so that the bolt can pass through the first and second holes 4251 and 4252. The tightening piece realizes clamping of the end head in a mode of screwing the hoop and the bolt, and is simple in structure and convenient to operate.

The pulling member 100 of the pulling test device of this embodiment is connected to the first lifting lug 111 of the end cap 110, the proximal end of the elastic member 200 is connected to the second lifting lug 112 of the end cap 110, the distal end of the elastic member 200 is connected to the proximal end of the inner cylinder 310, the outer cylinder 320 is in clearance fit with the outside of the inner cylinder 310, the proximal end of the outer cylinder 320 is in threaded connection with the end cap 110, the locking clamp spring 410 is installed at the distal end of the inner cylinder 310, the connecting end of the locking clamp spring 410 is located at the outside of the distal end of the inner cylinder 310, the clamping member is sleeved at the outside of the clamping end of the locking clamp spring 410, and the clamp spring 421 of the clamping member is in a relaxed state, that is, the clamping member is not tightened, so that the clamping end of the locking clamp spring 410 can be easily put into the end 1 of clamping left atrial appendage occluder with different diameters, the end part 1 of the left atrial appendage occluder with the required diameter is installed at the clamping end of the locking clamp spring 410, the tightening piece is tightened, the traction piece 100 is pulled to carry out traction inspection, the outer cylinder 320 moves towards the direction of an operator along with the traction piece in the traction inspection process, the specific numerical value of the traction force provided by the operator is indicated by the indication mark in the moving process, the uncertainty caused by the experience and the hand feeling of the operator is avoided, the reasonable threshold value is set for the traction device, various problems caused by overlarge and undersize of the traction force of the operator can be effectively avoided, and the reliability, the safety and the stability of the traction test are improved.

Example two

Fig. 7 is a schematic perspective view of a quantitative stability evaluation system of the left atrial appendage occluder provided in this embodiment. Fig. 8 is an exploded schematic view of the stability assessment module provided in this embodiment. As shown in fig. 7 and 8, compared to the first embodiment, the present embodiment is different in that the quantitative stability assessment system further includes a stability assessment module 3, the stability assessment module 3 is connected to the pulling part 100, and the stability assessment module 3 is used for assessing the stable state of the left atrial appendage occluder.

In this embodiment, the quantitative stability assessment system may further include a first end cover 110, where the first end cover 110 has two end faces that are opposite to each other, a first lifting lug 111 is disposed on one of the end faces, and the stability assessment module 3 is connected to the other end face of the first end cover 110.

In other embodiments, the quantitative stability assessment system does not include a first end cap, the first ear 111 is directly disposed on the end surface of the stability assessment module facing the elastic device, and the proximal end of the elastic device is connected to the first ear 111, so that when the traction part 100 is pulled, an operator can stretch or compress the elastic device 200 by pulling the traction part 100. The elastic means 200 may be a spring.

The stability assessment module 3 may contain a time calculation unit 500, a timer cartridge 600 and a second end cap 700. The time counting unit 500 is disposed on the timer cartridge 600, and the timer cartridge 600 has two openings oppositely disposed, one of the openings is connected to the first end cap 110, and the other opening is connected to the second end cap 700. Specifically, the timer cartridge 600 is cylindrical, and has a distal opening connected to the first end cap 110 and a proximal opening connected to the second end cap 700. The timer barrel 600 has a receiving space therein, a part of the time counting unit 500 is disposed in the receiving space of the timer barrel 600, and a part of the time counting unit 500 is embedded on a sidewall of the timer barrel 600. The axial direction of the timer cylinder 600 is the same as the axial direction of the inner cylinder and the outer cylinder.

The side wall of the timer cylinder 600 has a groove 611, the groove 611 is used for placing a part of the time counting unit 500, the groove 611 may penetrate through the outer wall and the inner wall of the timer cylinder 600, or only penetrate through the outer wall of the timer cylinder 600, and a plurality of holes are provided in the groove 611, the holes penetrate through the bottom wall of the groove and the inner wall of the timer cylinder 600, and the holes are used for passing through a part of the wires electrically connected inside the time counting unit 500. The shape of the groove 611 may be circular, square, oval, polygonal, etc. The timer barrel 600 also has a honeycomb-shaped fine hole 612 and a plurality of circular holes (e.g., three) on the sidewall.

The time calculating unit 500 includes a timing module 510, a timing adjusting part 520, a display part 530 and a time early warning part 540. The timing module 510 is, for example, at least one of a forward timing module, a backward timing module or a time setting module. The timer module 510 includes a control printed board 511, a battery 512, and a button cap 513, wherein the control printed board 511 is connected to the battery 512, and the battery 512 supplies power (i.e., voltage and current) to the control printed board 511. The control printed board 511 may be mounted on the inner wall of the timer barrel 600 by screws, and is used for performing signal control and signal processing on the timing module 510 to implement setting of timing, countdown or time. The button cap 513 is fixed to the control printed board 511 and is disposed opposite to the plurality of circular holes, and the button cap 513 can perform count-up, count-down or time setting by pressing. In this embodiment, the button cap 513 includes three, for example, which are disposed in the accommodating space of the timer drum 600 and respectively face three circular holes disposed on the side wall of the timer drum 600.

The timing adjusting member 520 is used for adjusting a timing function, and the timing adjusting member 520 includes, for example, three buttons, which are respectively covered on the three button caps 513 and respectively fixed in three circular holes of the timer barrel 600, and are partially exposed outside an outer wall of the timer barrel 600. When the button is pressed, a button cap 513 located under the button is pressed. Three of the buttons are, for example, M, S, T/P, respectively, where the M button can adjust minutes, the S button can adjust seconds, the T/P button controls start and end, and holding the M and S buttons simultaneously clears the timer.

The display component 530 is used for displaying the current timing time, for example, a display screen, and the display component 530 is electrically connected to the timing module 510. The shape of the display part 530 may be a circle, an ellipse, a square, a polygon, etc., which is disposed in a groove on the outer wall of the timer barrel 600, and when the groove 611 only penetrates the outer wall of the timer barrel 600 and there are a plurality of holes in the groove 611, the wires of the display part are electrically connected with the timing module 510 through the holes.

The time early warning component 540 is, for example, a speaker, the time early warning component 540 is electrically connected to the timing module 510 and is used for reminding the end of timing, and the time early warning component 540 is located in the accommodating space of the timer barrel 600 and is opposite to the honeycomb-shaped pores 612 so as to transmit sound through the pores.

Second end cap 700 is including the relative first terminal surface and the second terminal surface that sets up, extension 710 has on the first terminal surface of second end cap 700, the extending direction of extension 710 with the thickness direction of second end cap 700 and the axial of a time-recorder section of thick bamboo 600 are the same, and this extension 710 is the ring form, the internal diameter of extension 710 is greater than the diameter of battery 512 and is less than the diameter of the internal diameter of a time-recorder section of thick bamboo 600 makes the negative pole of battery 512 can be located in the extension, extension 710 can overlap the inside of a time-recorder section of thick bamboo 600. The first end surface of the second end cap 700 has a metal thin layer thereon so that the negative electrode of the battery 512 can be located in the extension, and the negative electrode is connected to the metal thin layer, and the positive electrode of the battery 512 is connected to the control printed board 511, so that the battery can be normally supplied with power. The second end face of the second end cap 700 has a second lifting lug 720, the second lifting lug 720 is further connected with a pulling ring 730, and the operator pulls the pulling part 100 by pulling the pulling ring 730 along the axis of the outer cylinder.

The drawing part 100 of the drawing test device of the embodiment is connected to one end of the timer barrel 600, the other end of the timer barrel 600 is connected to the second lifting lug 720 of the second end cap 700, the time calculation unit 500 is arranged on the timer barrel 600 to start countdown after the stopper is released, and after the countdown is finished, the drawing device sends out a click sound to remind an operator that a drawing test can be carried out. The distal end of the elastic device 200 is connected to the proximal end of the inner cylinder 310, the outer cylinder 320 is in clearance fit with the outside of the inner cylinder 310, the proximal end of the outer cylinder 320 is in threaded connection with the first end cover 110, the locking clamp spring 410 is installed at the distal end of the inner cylinder 310, the connecting end of the locking clamp spring 410 is located at the outside of the distal end of the inner cylinder 310, the clamping member is sleeved at the outside of the clamping end of the locking clamp spring 410, and the clamp spring 421 of the clamping member is in a relaxed state, that is, the clamping member is not tightened, so that the clamping end of the locking clamp spring 410 can be easily put into the end 1 of clamping push rods with different diameters, and when in operation, the end 1 of the push rod with a required diameter is installed at the clamping end of the locking clamp spring 410, and the tightening member is tightened and is subjected to traction inspection through the traction part 100, in the traction test process, the outer cylinder 320 moves towards the direction of an operator along with the traction part, and indicates the specific value of the traction force provided by the marker indication operator in the moving process, so that the uncertainty caused by the experience and the hand feeling of the operator is avoided, a reasonable threshold value is set for the traction device, various problems caused by overlarge and undersize tension force when the operator performs traction can be effectively avoided, and the reliability, the safety and the stability of the traction test are improved.

EXAMPLE III

Fig. 9 is a schematic perspective view of a quantitative stability evaluation system of the left atrial appendage occluder provided in this embodiment. Fig. 10 is an exploded schematic view of the quantitative stability assessment system provided in this embodiment. As shown in fig. 9 and 10, compared with the first embodiment, the traction module 2 of the quantitative stability assessment system of the present embodiment is a digital traction module. Specifically, the traction module 2 still includes a traction portion 100, a strength evaluation portion and a fixed connection portion 400 that are connected in sequence, and the traction portion 100 and the strength evaluation portion are different from those in the first embodiment.

The force evaluation part comprises a force quantizer and a pulling device, and the force quantizer is used for displaying the quantized value of the pulling force of the pulling device. The pulling means includes a connecting inner cylinder 330 and a pulling sleeve 340, the connecting inner cylinder 330 is connected to the proximal end of the fixed connecting portion 400, the connecting inner cylinder 330 is, for example, a solid cylinder and is composed of a first inner cylinder 331 and a second inner cylinder 332, the first inner cylinder 331 has a larger diameter than the second inner cylinder 332, the first inner cylinder 331 is axially disposed at the distal end of the second inner cylinder 332, and the connecting portion 400 is axially connected to the distal end of the first inner cylinder 331. The pulling sleeve 340 is a hollow cylinder, that is, the pulling sleeve 340 has an accommodating space along the axial direction, the accommodating space is penetrated through at both ends of the pulling sleeve 340 along the axial direction, the pulling sleeve 340 is disposed at the proximal end of the second inner cylinder 332 and sleeved outside the second inner cylinder 332, the diameter of the second inner cylinder 332 is smaller than the inner diameter of the pulling sleeve 340, and the diameter of the first inner cylinder 331 is larger than the inner diameter of the pulling sleeve 340, so that the pulling sleeve 340 can abut against the end face of the proximal end of the first inner cylinder 331. The connection inner cylinder 330 and the left atrial appendage occluder 1 connected to the connection portion 400 are pulled by pulling the pulling sleeve 340. The pulling device may further include a first end cap 110, the proximal end of the pulling sleeve 340 is connected to the end surface of the first end cap 110 opposite to the first end cap, and may also be directly connected to the end surface of the stability assessment module facing the pulling part 100, and the first end cap 110 has a hole penetrating through both end surfaces thereof, so that the strength assessment part may be electrically connected to the stability assessment module.

The strength evaluation part comprises a force sensor module 350, a signal processing printed board 360 and a display part, the force sensor module 350 is electrically connected with the signal processing printed board 360, the signal processing printed board 360 is electrically connected with the display part, the force sensor module 350 collects force value information when in use and converts the force value information into an electric signal to be transmitted to the signal processing printed board 360, and the signal processing printed board 360 passes through the force value to display the force value through the display part, so that the display part can display the force value instantly.

The signal processing printed board 360 is fixed the near-end of force sensor module 350, force sensor module 350 passes through threaded connection on the terminal surface of the near-end of second inner tube 332, it is specific, threaded hole has on the terminal surface of the near-end of second inner tube 332, the internal thread has in the threaded hole, the distal end of force sensor module 350 is fixed on a screw rod, the screw rod have with internal thread assorted external screw thread, force sensor module 350 passes through screw rod threaded connection in the threaded hole of second inner tube 332, signal processing printed board 360 passes through the fix with screw the near-end of force sensor module 350, simultaneously, force sensor module 350 and signal processing printed board 360 electricity are connected.

The force sensor module 350 and the signal processing printed board 360 are disposed in the accommodating space of the pulling sleeve 340, and the inner wall of the pulling sleeve 340 has two fastening grooves 341 disposed along the axial direction of the pulling sleeve 340, for example, the two fastening grooves 341 are disposed on the inner wall of the pulling sleeve 340 in an opposite manner. The force sensor module 350 and the signal processing printed board 360 are fixed in the slot 341 by screws, so that the pulling sleeve 340 pulls the connection inner cylinder 330 by the force sensor module 350 and the signal processing printed board 360 fixed in the slot 341.

The display part of the strength evaluation part may be disposed on the pulling sleeve 340, and meanwhile, a corresponding operation interface (i.e., a button) is configured, but in order to simplify the structure and save space, preferably, in this embodiment, the display part of the strength evaluation part is integrated with the display part of the stability evaluation module 3, so that the signal processing printed board is electrically connected with the timing module 510, the number of buttons needs to be expanded, the number of corresponding button caps needs to be increased, and the button caps provide signal control and switching, and exchange signals with the control printed board of the time calculation unit 500. The button cap comprises a switch button, an SW button, a ZR button, an SET button, M, S, T/P, a-solidup and a T-shirt button, wherein when the switch button is in an off state, the power supply is switched on through the switch button, the display screen is lightened, the display part defaults to simultaneously display a force value and time, and the power supply is switched off by pressing the switch button for a long time; the SW button can switch (enlarge) the display state of the display part (individual force value display/individual time counting display/simultaneous force value and time counting, and the force value and time counting are displayed simultaneously by default every time the power is turned on); the ZR button is a force value zero clearing button, the SET button is an early warning threshold setting button, and the size of a preset threshold can be adjusted through the tangle-solidup and xxx buttons; the M button can adjust minutes, the S button is used for adjusting seconds, and the T/P button controls the start and the end.

The time early warning component 540 is electrically connected with the timing module 510, is used for reminding the timing completion, and is also connected with the signal processing printed board for alarming when the force value exceeds a threshold value.

The tractive portion 100 of the tractive testing arrangement of this embodiment is connected the one end of a time-recorder section of thick bamboo 600, the tractive cover barrel cover of tractive portion 100 is established on the second inner tube of connecting the inner tube, and the distal end of the first inner tube of connecting the inner tube is installed locking jump ring 410, the force sensor module sets up in the telescopic accommodation space of tractive, and threaded connection is on the terminal surface of the near-end of second inner tube, and signal processing printed board is fixed the near-end of force sensor module, just signal processing printed board is fixed in two draw-in grooves of the telescopic inner wall of tractive. When the traction sleeve is pulled, the force sensor module collects force value information, converts the force value information into an electric signal and transmits the electric signal to the signal processing printed board, and the signal processing printed board displays the force value through the display part.

In summary, the present invention provides a quantitative stability evaluation system for a left atrial appendage occluder, wherein the left atrial appendage occluder is implanted in a body through a push rod, the system includes a traction module and a stability evaluation module, the traction module includes a traction portion, a force evaluation portion and a fixed connection portion, the traction portion, the force evaluation portion and the fixed connection portion are sequentially connected, a distal end of the fixed connection portion is connected to the left atrial appendage occluder, a proximal end of the fixed connection portion is connected to the traction portion, the force evaluation portion is used for displaying a quantitative value of a traction force of the traction portion, the stability evaluation module is connected to the traction portion, and the stability evaluation module is used for evaluating a stable state of the left atrial appendage occluder. The quantitative stability evaluation system can perform traction inspection and simultaneously help an operator to accurately control the traction test force after successfully implanting the left atrial appendage occluder, thereby avoiding the operation risk.

Furthermore, the clamping ends clamp the end portions of the pushing rods with the diameters of 10 mm-16 mm, so that the fixed connecting portions can clamp the ends of the occluders with different diameters, and the universality of the quantitative stability evaluation system is realized. Fixed connection portion includes locking jump ring and clamp subassembly, the locking jump ring is installed the distal end of strength evaluation portion, the tip of push rod is installed in the locking jump ring, the clamp subassembly is located the tip of push rod and the outside of locking jump ring, and be used for fixing the push rod makes fixed connection portion's simple structure, convenient operation.

In addition, it should be noted that the description of the terms "first", "second", and the like in the specification is only used for distinguishing each component, element, step, and the like in the specification, and is not used for representing a logical relationship or a sequential relationship between each component, element, step, and the like, unless otherwise specified or indicated.

It is to be understood that while the present invention has been described in conjunction with the preferred embodiments thereof, it is not intended to limit the invention to those embodiments. It will be apparent to those skilled in the art from this disclosure that many changes and modifications can be made, or equivalents modified, in the embodiments of the invention without departing from the scope of the invention. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention are still within the scope of the protection of the technical solution of the present invention, unless the contents of the technical solution of the present invention are departed.

Claims

1. The utility model provides a system for quantitatively and stably evaluating left atrial appendage occluder, left atrial appendage occluder passes through the push rod and implants internally, its characterized in that, including traction module and stable evaluation module, traction module is including tractive portion, strength evaluation portion and the fixed connection portion that connect gradually, left atrial appendage occluder is connected to the distal end of fixed connection portion, the near-end of fixed connection portion is connected tractive portion, strength evaluation portion is used for showing the pulling force's of tractive portion quantization value, stable evaluation module with tractive portion connects, stable evaluation module is used for assessing the steady state of left atrial appendage occluder.

2. The quantitative stability assessment system according to claim 1, wherein the force evaluation section comprises a force quantifier and an elastic device, the force quantifier displaying a quantified value by deformation of the elastic device.

3. The quantitative stability assessment system according to claim 2, wherein the force quantifier comprises an inner cylinder and an outer cylinder, the inner cylinder being a clearance fit inside the outer cylinder, a proximal end of the inner cylinder being connected to the distal end of the elastic means, a distal end of the inner cylinder being connected to the fixed connection, and a proximal end of the outer cylinder being connected to the proximal end of the elastic means.

4. The quantitative stability assessment system according to claim 3, wherein the proximal end of the inner cylinder is provided with a first flat key, the distal end of the inner cylinder is provided with a stopper, the outer cylinder is provided with a first flat key groove on a side wall in the extending direction thereof, the first flat key is located in the first flat key groove, and when the outer cylinder slides in the extending direction thereof, the first flat key slides in the first flat key groove in the extending direction of the first flat key groove, the stopper is engaged with the distal end of the outer cylinder, and the outer cylinder is defined on a side of the inner cylinder near the proximal end thereof.

5. The quantitative stability assessment system according to claim 4, wherein the first flat key has an indication mark thereon, and the first flat key has scale marks on both sides thereof, and the indication mark indicates the magnitude of the force required for deformation of the elastic means at the positions of the scale marks when the outer cylinder slides.

6. The quantitative stability assessment system according to claim 2, wherein the force quantifier comprises a sensor for signal sampling of the deformation of the elastic device and a digital display module for processing the sampled signal of the sensor and displaying the magnitude of the force.

7. The quantitative stability assessment system according to claim 1, wherein the force assessment section comprises a force quantifier and a pulling device, the force quantifier being configured to display a pulling force of the pulling device as a quantified value thereof.

8. The quantitative stability assessment system according to claim 7, wherein the pulling means comprises a connection inner barrel connected to the proximal end of the fixed connection portion and a pulling sleeve sleeved on the proximal end of the connection inner barrel.

9. The quantitative stability assessment system of claim 8, wherein the force quantifier is secured within the pull sleeve and is coupled to the inner connector barrel.

10. The quantitative stability assessment system according to claim 9, wherein the force quantifier comprises a force sensor module, a signal processing printed board and a display part, the force sensor module is fixed in the traction sleeve and connected with the connection inner cylinder, the force sensor module is electrically connected with the signal processing printed board, and the signal processing printed board is electrically connected with the display part;

11. The quantitative stability assessment system of claim 1, wherein the stability assessment module comprises a time calculation unit comprising at least one of a count-up module, a count-down module, or a time setting module.

12. The quantitative stability assessment system according to claim 3, wherein the fixing connection part comprises a locking snap spring installed at a distal end of the inner cylinder, an end portion of the push rod installed in the locking snap spring, and a clip assembly located at the end portion of the push rod and outside the locking snap spring and fixing the push rod; the locking clamp spring is made of thin-wall metal elastic materials, is in a barrel shape and is provided with two oppositely arranged openings.

13. The quantitative stability assessment system according to claim 12, wherein the two openings are a clamping end and a connecting end of the locking clamp spring, the clamping end clamps the end of the pushing rod, and the connecting end is installed at a distal end of the force evaluation portion.

14. The quantitative stability assessment system according to claim 13, wherein the side walls of the clamping end and the connecting end are respectively provided with at least one hollowed-out groove, the hollowed-out grooves penetrate through the side walls of the locking clamp spring along the thickness direction of the locking clamp spring, and the adjacent hollowed-out grooves are arranged at intervals and are not communicated with each other.

15. The quantitative stability assessment system according to claim 14, wherein the number of hollowed-out grooves of the clamping end is greater than the number of hollowed-out grooves of the connecting end.

16. The quantitative stability assessment system of claim 15, wherein the clamping end clamps an end of a push rod having a diameter of 10mm to 16 mm.

17. The quantitative stability assessment system of claim 12, wherein the collar assembly comprises a clamp and a tightening member, the tightening member locking the clamp to the outside of the locking circlip during surgery.

18. The quantitative stability assessment system of claim 17, wherein the clamping member comprises a clamp, a root pin and a bolt pin, the clamp having a sidewall with a first end and a second end disposed opposite to each other, the root pin disposed at the first end of the clamp, the root pin hinged to the clamp, the tightening member secured to the second end of the clamp by the bolt pin.

19. The quantitative stability assessment system of claim 17, wherein the tightening member comprises a bolt, a handle and a lock post, the handle is connected to one end of the lock post, a shank of the bolt has an external thread, the lock post has an internal thread matching the external thread, the shank is threadedly connected to the lock post through a hole between a bolt pin and the clamp to lock or release the tightening member and the end of the push rod.