A test tool for implantable electrode lead

Abstract

The present application discloses a test fixture for an implantable electrode wire, comprising a slide rail and a head end slider, an intermediate slider and a tail end slider sequentially arranged on the slide rail; a head end clamping device for fixing the electrode wire is provided on the head end slider, and a tail end clamping device for fixing the electrode wire is provided on the intermediate slider; a tension sensor for measuring the tension on the electrode wire is rigidly connected between the intermediate slider and the tail end slider, and the tension sensor is electrically connected to a control box for measuring the obtained tension value. When the tension value displayed by the control box reaches the required tension value or the moving distance of the tail end slider reaches the required stretching length, the tail end slider is locked on the slide rail and kept for the required time to observe whether the electrode wire is broken or the electrical insulation layer is broken, so as to know whether the electrode wire under test can withstand the tension after implantation, which fills the gap of the implantable electrode wire tension test fixture and has the advantages of simple structure and easy operation.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a testing tool for an implantable electrode lead. Background Art

[0002] An implantable cardiac pacemaker is an electronic therapeutic device that is implanted in the patient's body for a long time. It emits electric pulses powered by a battery through a pulse generator, and through the conduction of electrode wires, it stimulates the myocardium that the electrodes contact, causing the heart to be excited and contracted, thereby achieving the purpose of treating heart dysfunction caused by certain arrhythmias. A pacing electrode wire is a medical implant electrode wire that is connected to an electrical stimulation medical device such as a pacemaker or defibrillator at one end, and directly connected to the heart or other part that needs to be stimulated at the other end. The electrical signal emitted by the electrical stimulation medical device is transmitted to the heart structure to be stimulated through the electrode wire.

[0003] Implantable electrode leads generally include an electrode head, an electrode lead body, and a connector. The electrode head is the non-insulated end of the implantable electrode lead that directly contacts the heart, and the connector is the other non-insulated end of the electrode lead that connects to electrical stimulation medical devices such as pacemakers and defibrillators.

[0004] Implantable electrode leads should be able to withstand the tension that may be generated after implantation to ensure that they can function stably and reliably in the human body for a long time after being implanted. Therefore, implantable electrode leads need to be tension tested before being put into use, but there is currently no testing tooling for implantable electrode leads.

[0005] Application Contents

[0006] Therefore, the technical problem to be solved by the present application is to overcome the defect in the prior art of lacking a tension test tool for implantable electrode wires, thereby providing a test tool for implantable electrode wires.

[0007] To solve the above technical problems, the technical solution of this application is as follows:

[0008] A test tool for an implantable electrode lead, comprising:

[0009] Slide rails;

[0010] A head end slider is arranged at the head end of the slide rail, and the head end slider is provided with a head end locking member for locking the head end slider on the slide rail, and a head end pressing device for fixing the head end of the electrode wire;

[0011] A tail end slider, slidably disposed at the tail end of the slide rail, the tail end slider being provided with a tail end locking member for locking the tail end slider on the slide rail;

[0012] An intermediate slider is slidably disposed on the slide rail between the head end slider and the tail end slider, and a tail end clamping device for fixing the tail end of the electrode wire is disposed on the intermediate slider;

[0013] A tension sensor, rigidly connected between the middle slider and the tail slider, for measuring the tension value exerted on the electrode wire;

[0014] The control box is electrically connected to the tension sensor and is used to display the tension value measured by the tension sensor.

[0015] Furthermore, the slide rail includes a plurality of sub-slide rails arranged in sequence, and two adjacent sub-slide rails are hingedly connected on the same side of the slide rail; the slide rail has a straight line arrangement state in which the plurality of sub-slide rails are arranged along the same straight line and a curved arrangement state in which the plurality of sub-slide rails are bent in the same direction.

[0016] Furthermore, when the slide rails are in the curved arrangement state, the curved shape formed by the multiple sections of the sub-slide rails is the same as the curved shape of the electrode wire to be tested when it is implanted in a human body.

[0017] Furthermore, the sub-slide rail is provided with a guide mechanism for guiding the direction of the electrode wire.

[0018] Furthermore, the slide rail is provided with a scale.

[0019] Furthermore, the slide rail is provided with two oppositely arranged convex guide rail surfaces, and opposite sides of the head end slider, the middle slider and the tail end slider are provided with concave guide rail surfaces, and the two concave guide rail surfaces and the two convex guide rail surfaces are embedded in a one-to-one correspondence.

[0020] Furthermore, the side surfaces of the head end slider and the tail end slider are both provided with connection holes, and the head end locking piece and the tail end locking piece are both assembled on the corresponding connection holes.

[0021] Furthermore, the head end clamping device and the tail end clamping device are clamping devices with the same structure, and the clamping device comprises:

[0022] A base, fixed on the head end slider or the middle slider, the upper end surface of the base is provided with a lower arc groove, and the base is also provided with a plurality of guide rods, and the plurality of guide rods extend in a direction away from the slide rail;

[0023] A lower pressure cover, on which a lower through hole is provided for the guide rod to pass through, and an upper arc groove is provided on the lower end surface of the lower pressure cover facing the base corresponding to the position of the lower arc groove;

[0024] A threaded rod is fixed to the lower gland and extends in a direction away from the slide rail.

[0025] An upper gland, on which an upper through hole is provided for the threaded rod to pass through, and a concave hole is also provided on a side of the upper gland facing the lower gland, and the upper end of the guide rod abuts against the concave hole;

[0026] A spring, sleeved on the guide rod and elastically supported between the lower pressure cover and the upper pressure cover;

[0027] The tightening nut is located on a side of the upper pressure cover facing away from the lower pressure cover and is threadably matched with the threaded rod through a nut hole thereon.

[0028] Furthermore, buffer pads are provided in both the lower arc-shaped groove and the upper arc-shaped groove.

[0029] Furthermore, a control unit is provided in the control box, the tension sensor is electrically connected to the control unit, the control unit is also electrically connected to a display drive circuit, a switch circuit and a power supply, and the display drive circuit is electrically connected to a display screen.

[0030] Furthermore, an ohmmeter is included, wherein two test leads of the ohmmeter are electrically connected to the connector ring and the ring electrode of the electrode lead respectively, and are used to measure the resistance of the electrode lead.

[0031] The technical solution of this application has the following advantages:

[0032] 1. The test tooling for implantable electrode wire provided in the present application, when testing the tension of the implantable electrode wire, fix the head end of the electrode wire on the head end clamping device on the head end slider, and fix the tail end of the electrode wire on the tail end clamping device of the middle slider, and then use the head end locking piece to lock the head end slider on the slide rail. At this time, the electrode wire is in a straightened but not stretched state, and the tail end slider is moved to the end away from the head end slider. Since the tail end slider, the tension sensor and the middle slider are rigidly connected, the distance moved by the tail end slider is the stretching length of the electrode wire, and the tension value detected by the tension sensor is the tension value exerted on the electrode wire. When the tension value displayed by the control box reaches the required tension value or the moving distance of the tail end slider reaches the required stretching length, the tail end slider is locked on the slide rail by the tail end locking piece, and maintained for the required time to observe whether the electrode wire is broken or the electrical insulation layer is broken, so as to know whether the electrode wire under test can withstand the tension after implantation, thereby filling the gap in the tension test tooling for implantable electrode wires, and having the advantages of simple structure and easy operation.

[0033] 2. The test tooling for implantable electrode wires provided in the present application is such that, since the electrode wire is actually in a bent state after being implanted in the human body, measuring the tension exerted on the electrode wire in the bent state is more in line with the tension exerted on the electrode wire when in use. The slide rail is composed of multiple sections of sub-slide rails, and two adjacent sections of sub-slide rails are hingedly connected on the same side of the slide rail. Such an arrangement allows various required angles to be formed between the sections of the sub-slide rails to simulate the tension exerted on the electrode wire in a bent state during actual use, so that the tension test result of the electrode wire is more in line with the actual situation of the electrode wire after implantation, thereby improving the reliability of the tension test result of the electrode wire and meeting the needs of tension testing of the electrode wire under various conditions.

[0034] 3. The test fixture for the implantable electrode lead provided in the present application has a guide mechanism on the sub-slide rail, which facilitates guiding the direction of the electrode lead at the junction of the two sub-slide rails, is beneficial for the electrode lead to remain in a stretched state during testing, and allows the electrode lead to extend in the direction of the scale line on the guide rail.

[0035] 4. The test fixture for implantable electrode wires provided in the present application has scales set on the slide rails, which can facilitate the test personnel to observe the stretched length in real time when the electrode wire is stretched, and compare it with the specific tension value on the control box in real time to determine the required stretching length; and avoid the potential risk of confusion due to difficulty in distinguishing electrode wires of different length specifications during testing.

[0036] 5. The test fixture for the implantable electrode lead provided in the present application adopts a one-to-one matching mode between the concave guide surface and the convex guide surface for the slide rail and the slider, which enables the slider to slide on the slide rail with low resistance, thereby reducing the influence of sliding friction resistance on the tensile test value.

[0037] 6. The test fixture for the implantable electrode lead provided in the present application has a clamping device that adopts a structural design in which a base and a lower pressure cover are pressed together, and a lower arc-shaped groove is provided on the base, and an upper arc-shaped groove is provided on the lower pressure cover. The lower arc-shaped groove and the upper arc-shaped groove cooperate to clamp the electrode lead, and the static friction force of the clamping device on the electrode lead is controlled by adjusting the spring compression amount by tightening the nut. It can be suitable for electrode leads of different outer diameters, and the required fixing pressure can also be adjusted.

[0038] 7. The test fixture for the implantable electrode lead provided in the present application, the buffer pad can ensure that the lower pressure cover and the base can provide static friction to the electrode lead without contacting each other, and can be applicable to the testing of electrode leads with different outer diameter specifications.

[0039] 8. The test fixture for the implantable electrode lead provided in the present application uses an external ohmmeter to test the electrical performance of the electrode lead during the stretching process. If failure occurs during the tension stretching stage, the stretched length of the electrode lead or the stretching length retention time that caused the failure can be discovered and determined in real time. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0041] Figure 1 is a schematic diagram of the structure of the electrode wire;

[0042] Figure 2 This is a schematic diagram of the overall structure of the test tooling in the embodiment of the present application;

[0043] Figure 3 It is a schematic diagram of the structure when multiple sections of slide rails of the test fixture are arranged in a curve;

[0044] Figure 4 This is a schematic diagram of the structure of the slider in the embodiment of the present application;

[0045] Figure 5 This is a schematic diagram of the structure of the clamping device in the embodiment of the present application;

[0046] Figure 6 This is a control principle diagram of the control box in the embodiment of the present application;

[0047] Figure 7 This is a diagram showing an application example of the test tooling in the embodiment of the present application during the mechanical force test of the electrode conductor;

[0048] Figure 8 A schematic diagram of the fixing effect of the electrode tip in the embodiment of the present application;

[0049] Fig. 9 This is another example diagram of the test tool in the process of testing the mechanical force of the electrode wire in the embodiment of the present application;

[0050] Fig.10 This is an example diagram of the electrode wire in actual use.

[0051] Description of reference numerals: 10, test tool;

[0052] 100, electrode wire; 110, connector; 111, connector needle; 112, connector ring; 120, electrode wire body; 130, electrode head; 131, electrode ring; 132, spiral head; 200, slide rail; 210, one-stage slide rail; 220, two-stage slide rail; 230, three-stage slide rail; 240, four-stage slide rail; 250, guide shaft; 260, hinge; 201, scale; 310, head end slider; 320, middle slider; 330, tail end slider; 301, concave guide rail surface; 302, connecting hole; 303, locking hole; 410, head end clamping device; 420, tail end clamping device; 40, clamping device; 41, Base; 411, lower arc-shaped groove; 42, guide rod; 43, lower pressure cover; 431, upper arc-shaped groove; 44, threaded rod; 45, upper pressure cover; 451, upper through hole; 452, concave hole; 46, spring; 47, tightening nut; 471, nut hole; 48, buffer pad; 510, head end locking piece; 520, tail end locking piece; 600, tension sensor; 610, signal line; 700, control box; 710, MCU; 720, display drive circuit; 730, switch circuit; 740, lithium battery; 750, display screen; 800, ohmmeter; 810, test lead; 900, heart; 910, right atrium; 920, right ventricle. DETAILED DESCRIPTION

[0053] The technical solution of the present application will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present application.

[0054] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0055] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0056] In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0057] An embodiment of the present application provides a testing tool suitable for an implantable electrode lead.

[0058] like Figure 1 An electrode lead shown in the figure, the electrode lead 100 includes a connector 110, an electrode lead body 120 and an electrode head 130. The connector 110 is mainly composed of a connector needle 111 and a connector ring 112. After the electrode lead 100 is implanted, the connector 110 is connected to the pulse generator; the electrode head 130 is mainly composed of an electrode ring 131 and a spiral head 132. After the electrode lead 100 is implanted, the electrode head 130 contacts the target muscle in the heart. The electrode lead body 120 has a multi-layer structure inside, which can conduct electrical signals between the connector ring 112 and the electrode ring 131, and between the connector needle 111 and the spiral head 132.

[0059] Figure 2 and Figure 3 Two schematic diagrams of the appearance of the test tool 10 for the implantable electrode lead are shown respectively; Figure 2As shown, the electrode wire test fixture 10 includes a slide rail 200, a head end slider 310, an intermediate slider 320, a tail end slider 330, a head end clamping device 410, a tail end clamping device 420, a head end locking member 510, a tail end locking member 520, a tension sensor 600 and a control box 700. Among them, the head end slider 310, the intermediate slider 320 and the tail end slider 330 are all embedded in the slide rail 200; the intermediate slider 320 and the tail end slider 330 are all slidably set on the slide rail 200, and the head end slider 310 can be slidably set on the slide rail 200, and can also be fixedly set on the slide rail 200. The head end clamping device 410 and the head end locking member 510 are arranged on the head end slider 310, the head end clamping device 410 is used to fix the head end of the electrode wire, and the head end locking member 510 is used to lock the head end slider 310 on the slide rail 200; the tail end clamping device 420 is arranged on the middle slider 320, and is used to fix the tail end of the electrode wire; the tail end locking member 520 is arranged on the tail end slider 330, and is used to lock the tail end slider 330 on the slide rail 200. The tension sensor 600 is rigidly connected between the middle slider 320 and the tail end slider 330, and is used to measure the tension value of the electrode wire; the control box 700 is electrically connected to the tension sensor 600, and is used to display the tension value measured by the tension sensor 600.

[0060] Further, the slide rail 200 includes multiple sections of sub-slide rails arranged in sequence, and two adjacent sections of sub-slide rails are hingedly connected on the same side of the slide rail; the slide rail 200 has a linear arrangement state in which multiple sections of sub-slide rails are arranged along the same straight line and a curved arrangement state in which multiple sections of sub-slide rails are bent in the same direction; when the slide rail 200 is in the curved arrangement state, the curved shape formed by the multiple sections of sub-slide rails is the same as the curved shape when the electrode wire to be tested is implanted in the human body. In some embodiments of this embodiment, the slide rail 200 is composed of 4 sections of sub-slide rails connected by hinges 260. The required angles can be adjusted in the horizontal direction between the first section of the sub-slide rail 210 and the second section of the sub-slide rail 220, the second section of the sub-slide rail 220 and the third section of the sub-slide rail 230, and the third section of the sub-slide rail 230 and the fourth section of the sub-slide rail 240, so that the slide rail 200 as a whole forms the required curvature in the same direction. It can be understood here that the number of sub-slide rails can be adaptively selected according to needs, and the length of each section of the sub-slide rail can also be selected according to actual needs.

[0061] Furthermore, the length of the slide rail 200 is greater than the length of the electrode wire, for example, it can be set to 1000mm, which can meet the test requirements of conventional electrode wires. A scale 201 is provided on the slide rail 200, and the scale 201 starts from 0mm at one end of the slide rail 200 to the other end of the slide rail 200. The accuracy of the scale 201 is 1mm, which can be used to evaluate the specific positions of the head end slider 310, the middle slider 320 and the tail end slider 330 on the slide rail 200. The slide rail 200 is composed of 4 sections of sub-slide rails connected by hinges 260. The required angles can be adjusted in the horizontal direction between the first section of the sub-slide rail 210 and the second section of the sub-slide rail 220, the second section of the sub-slide rail 220 and the third section of the sub-slide rail 230, and the third section of the sub-slide rail 230 and the fourth section of the sub-slide rail 240, so that the slide rail 200 as a whole forms the required curvature in the same direction.

[0062] Optionally, the scale range on the first-stage slide rail 210 is 0-150mm, the scale range on the second-stage slide rail 220 is 150-300mm, the scale range on the third-stage slide rail 230 is 300-450mm, and the scale range on the fourth-stage slide rail 240 is 450-1000mm. Further, the ends of the first-stage slide rail 210, the second-stage slide rail 220 and the third-stage slide rail 230 are all equipped with a guide mechanism, which is specifically a guide shaft 250, which can provide a guiding function. Optionally, the material of the slide rail 200 is aluminum alloy or other light metal materials.

[0063] Figure 4 FIG. 3 is a schematic diagram of the appearance of the tail end slider 330. The structures of the head end slider 310, the middle slider 320 and the tail end slider 330 are basically the same. Figure 4 Taking the middle and tail end slider 330 as an example, the specific structure of each slider is described in detail. Figure 2 and Figure 4 As shown, the tail end slider 330 can move linearly along the track on the slide rail 160, and a tail end locking piece 520 is set on the side of the tail end slider 330. The tail end locking piece 520 can be axially rotated to lock the tail end slider 330 on the slide rail 200.

[0064] The head end slider 310 is disposed at one end of the slide rail 200 close to the 0 scale, one end of the tension sensor 600 is rigidly connected to the middle slider 320 through a connecting shaft, and the other end of the tension sensor 600 is rigidly connected to the tail end slider 330 through another connecting shaft. The control box 700 is disposed just above the tail end slider 330, and the control box 700 is connected to the tension sensor 600 through a signal line 610. The tension sensor 600 transmits the tension signal during the test to the control box 700 through the signal line 610, and the control box 700 analyzes and processes the tension signal after receiving it and displays the tension value.

[0065] like Figure 2 , Figure 3 and Figure 4 As shown, the tail end slider 330 is provided with two left and right concave guide surfaces 301, and the slide rail 200 is provided with two convex guide surfaces. The concave guide surfaces 301 and the convex guide surfaces are interlocked with each other, and the surfaces are smoothed so that the slider 330 can slide on the slide rail 200 with low resistance. Furthermore, lubricant is added to the slide rail 200 to further reduce the friction coefficient. The front end of the tail end slider 330 is provided with a connecting hole 115 for assembling the connecting shaft; the side of the tail end slider 330 is provided with a locking hole 303, which can be equipped with a tail end locking piece 520. Axially rotating the tail end locking piece 520 can fix the tail end slider 330 to prevent it from moving. The structure of the head end slider 310 and the middle slider 320 is the same as that of the tail end slider 330, which will not be repeated here.

[0066] The head end clamping device 410 and the tail end clamping device 420 are clamping devices 40 with the same structure. Figure 5 It is a three-dimensional schematic diagram of the clamping device 40. The clamping device 40 includes a base 41, a lower pressure cover 43, a threaded rod 44, an upper pressure cover 45, a spring 46 and a tightening nut 47. The base 41 is fixed on the head end slider 310 or the middle slider 320, and a lower arc groove 411 is provided on the upper end surface of the base 41. Two guide rods 42 are also provided on the base 41, and the two guide rods 42 extend on the base 41 in the direction away from the slide rail. A lower through hole for the guide rod 42 to pass through is provided on the lower pressure cover 43, and an upper arc groove 431 corresponding to the position of the lower arc groove 411 is provided on the lower end surface of the lower pressure cover 43 facing the base 41. The threaded rod 44 is fixed on the lower pressure cover 43 and extends in the direction away from the slide rail. The upper cover 45 is provided with an upper through hole 451 for the threaded rod 44 to pass through, and the upper cover 45 is also provided with a concave hole 452 on the side facing the lower cover 43, and the upper end of the guide rod 42 abuts against the concave hole 452. The spring 46 is sleeved on the guide rod 42 and elastically supported between the lower cover 43 and the upper cover 46. The tightening nut 47 is located on the side of the upper cover 45 facing away from the lower cover 43, and is threadedly engaged with the threaded rod 44 through the nut hole 471 thereon.

[0067] Specifically, the two guide rods 42 cooperate with the two lower through holes on the lower pressure cover 43. The diameter of the guide rod 42 is slightly smaller than the lower through hole, so that the guide rod 42 can slide axially in the lower through hole. One end of the spring 46 abuts against the upper surface of the lower pressure cover 43, and the other end abuts against the concave hole 452 of the upper pressure cover 45, and the other end of the guide rod 42 also abuts against the concave hole 452. When the upper pressure cover 45 is pressed downward, the spring 46 contracts, so that the lower pressure cover 43 is pressed downward along the axial direction of the guide rod 42, and cooperates with the base 42, thereby fixing the electrode wire. The upper through hole 451 of the upper pressure cover 45 at the upper end of the threaded rod 44 is screwed and matched with the nut hole 471. The nut hole 471 is a through hole, and the threaded rod 44 can completely penetrate the nut hole 471, so that the tightening nut 47 can move axially along the threaded rod 44. When the tightening nut 47 is axially rotated, the adjustable tightening nut 47 moves axially upward or downward along the threaded rod 44, thereby driving the upper gland 45 to move axially upward or downward to control the contraction or rebound of the spring 46. The spring 46 can be changed and replaced according to actual needs to obtain a suitable elastic force.

[0068] Buffer pads 48 are provided in the lower arc groove 411 and the upper arc groove 431. The buffer pads 48 are specifically silicone pads. Silicone has a certain elasticity, which can prevent damage to the electrode wire body when the lower pressure cover 43 and the base 41 are pressed together. Moreover, the silicone material has a strong friction coefficient. The silicone pad can provide a strong static friction force when pressing the electrode wire body. The required static friction force can be obtained by adjusting the spacing between the lower pressure cover 43 and the base 41 to match electrode wires of different outer diameters. Therefore, it can be suitable for fixing electrode wires of different models and specifications.

[0069] Figure 6 FIG. 7 is a schematic diagram of the principle of the control box 700. Figure 6 As shown, a control unit is provided in the control box 700, the tension sensor 600 is electrically connected to the control unit, the control unit is also electrically connected to a display drive circuit 720, a switch circuit 730 and a power supply, and the display drive circuit 720 is electrically connected to a display screen 750. Specifically, the control unit is an MCU 710, and the power supply is a lithium battery 740. The lithium battery 740 provides power to the MCU 710 and the display screen 750, and the switch circuit 730 can control the opening and closing of the control box 700. The circuit principles of the tension sensor 600, MCU 710, display screen drive circuit 720, display screen 750, and switch circuit 730 in this application are all prior art, and those skilled in the art can clearly understand them, so they will not be described in detail here.

[0070] Figure 7 This is an application example of the test tooling of the implantable electrode lead in the present application in the process of mechanical force testing of the electrode lead. This test phase is the process of applying a tension load to the electrode lead during the mechanical force testing of the electrode lead. Figure 8Figure 1 is a schematic diagram of fixing the electrode lead tip. Figure 7 and Figure 8 As shown, the two ends of the electrode wire 5 are fixed to the head end clamping device 410 and the tail end clamping device 420 respectively. The head end slider 310 is fixed to the head end of the slide rail 200 by axially rotating the head end locking member 510 on the head end slider 310. The length of the electrode wire of the measured section is measured by the scale 201 on the slide rail 200, and the required stretching distance is determined. At this time, the electrode wire 110 is in a straightened but not stretched state, and the tail end slider 330 is rigidly connected to the middle slider 320 through the tension sensor 600 and the connecting shaft, so the distance moved by the tail end slider 330 to the other end is the stretched length of the electrode wire 100. Move the tail end slider 330 to the other end to stretch the electrode wire 100, and observe the tension value on the control box 700, based on the first reaching the required tension value or the required stretching length, and lock the tail end slider 330 through the tail end locking member 520, and keep it for the required time. Furthermore, the electrical performance of the electrode wire 100 can be tested using the ohmmeter 800 when the electrode wire 100 is stretched. The specific method is: the two test wires 810 of the ohmmeter 800 are respectively connected to the connector ring 112 and the ring electrode 131 of the electrode wire 110, and the resistance change of the electrode wire 100 is observed in real time when the electrode wire 110 is stretched, so as to detect the electrical performance change of the electrode wire 100 when it is stretched in more detail.

[0071] Fig. 9 This is another application example of the test fixture for implantable electrode leads in the present application in the process of mechanical force testing of electrode leads. Fig. 9 As shown, the first sub-slide rail 210, the second sub-slide rail 220, the third sub-slide rail 230 and the fourth sub-slide rail 240 are bent to a certain angle under the action of the hinge 260. The electrode wire 100 is fixed to the tooling by the head end clamping device 410 and the tail end clamping device 420, and the electrode wire body 120 is assembled between the guide shafts 250, so that the electrode wire 100 is bent into a corresponding curvature. When the tail end slider 330 is pulled to move toward the distal end, the electrode wire 100 is stretched in a bent state, so that the mechanical force tensile performance of the electrode wire 100 in a bent state can be measured.

[0072] Fig.10 This is an actual application scenario of the electrode wire 100. The electrode wire 100 is implanted in the heart 900 through the right atrium 910 and the right ventricle 920, respectively, to emit electrical stimulation to the right ventricle 920 to achieve the purpose of pacing. Fig.10 As shown, the electrode wire 100 is irregularly curved during clinical application. When the heart 900 beats, the electrode wire 100 also bends under the action of mechanical force. Fig. 9The test example in the embodiment can simulate the tensile force that the electrode lead 100 is subjected to during actual use.

[0073] The test fixture for implantable electrode leads provided in the embodiment of the present application is suitable for tension testing of electrode leads of cardiac pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy defibrillators (CRT-D), and cardiac resynchronization therapy pacemakers (CRT-P). This application is to solve the problem that the current electrode lead technology field lacks relevant tension testing fixtures. The electrode lead parts are small and delicate. Although there are standard fixed test requirements, no corresponding test methods and fixtures are provided. This application aims to fill the gap in the mechanical force testing fixture for electrode leads.

[0074] In summary, the test tool for implantable electrode lead provided in the embodiment of the present application has the following beneficial effects:

[0075] First, conventional test fixtures are usually only applicable to products of a single specification and model, and cannot be used for the assembly and testing process of electrode wires of different models and specifications. The test fixture of the present application adopts a design in which the lower pressure cover 43 and the base 41 are pressed together, and the lower pressure cover 43 and the base 41 are respectively provided with arc grooves and silicone pads. The buffering effect of the silicone pad ensures that the lower pressure cover 43 and the base 41 can provide static friction to the electrode wire body without contacting each other, which can be applied to the testing of electrode wires of different outer diameters.

[0076] Secondly, the slide rail 200 of the electrode wire testing tool of the present application is provided with scale lines, which can optimize the length testing and clamping positioning operation of the electrode wire, facilitate the operation of the tester, and can perform real-time observation of the stretched length during the test; and avoid the potential risk of confusion due to the difficulty in distinguishing electrode wires of different length specifications during testing.

[0077] Third, the electrode wire test tool of the present application is easy to operate and can realize other extended tests besides the tension load function required by the standard. For example, during the test, when the electrode wire is stretched, the electrical performance of the electrode wire in the stretching process can be tested by an external ohmmeter 800. If the electrode wire fails to meet the standards during the tension stretching stage, the stretched length of the electrode wire or the stretching length retention time that caused the failure can be found and determined in real time.

[0078] Fourthly, the electrode conductor testing tool of the present application can realize the synchronous observation of the stretching length and the stretching force value of the electrode conductor through a simple design, and can maintain the stretching state by using a simple locking member.

[0079] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection created by this application.

Claims

1. A test tool for an implantable electrode lead, characterized in that: include: Slide rail (200); A head end slider (310) is arranged at the head end of the slide rail (200), and the head end slider (310) is provided with a head end locking member (510) for locking the head end slider (310) on the slide rail (200), and a head end pressing device (410) for fixing the head end of the electrode wire; A tail end slider (330) is slidably disposed at the tail end of the slide rail (200), and a tail end locking member (520) is provided on the tail end slider (330) for locking the tail end slider (330) on the slide rail (200); An intermediate slider (320) is slidably disposed on the slide rail (200) between the head end slider (310) and the tail end slider (330), and a tail end clamping device (420) for fixing the tail end of the electrode wire is provided on the intermediate slider (320); A tension sensor (600) is rigidly connected between the middle slider (320) and the tail slider (330) and is used to measure the tension value applied to the electrode wire; A control box (700) is electrically connected to the tension sensor (600) and is used to display the tension value measured by the tension sensor (600); The slide rail (200) comprises a plurality of sub-slide rails arranged in sequence, and two adjacent sub-slide rails are hingedly connected on the same side of the slide rail (200); the slide rail (200) has a straight line arrangement state in which the plurality of sub-slide rails are arranged along the same straight line, and a curved arrangement state in which the plurality of sub-slide rails are bent in the same direction; When the slide rail (200) is in the curved arrangement state, the curved shape formed by the multiple sections of the sub-slide rails is the same as the curved shape of the electrode wire to be tested when it is implanted in a human body.

2. The test tool for implantable electrode lead according to claim 1, characterized in that: The sub-slide rail is provided with a guiding mechanism for guiding the direction of the electrode wire.

3. The test tool for implantable electrode lead according to claim 1, characterized in that: The slide rail (200) is provided with a scale (201).

4. The test tool for implantable electrode lead according to claim 1, characterized in that: The slide rail (200) is provided with two convex guide rail surfaces that are arranged opposite to each other, and the opposite sides of the head end slider (310), the middle slider (320), and the tail end slider (330) are provided with concave guide rail surfaces (301), and the two concave guide rail surfaces (301) are chiseled with the two convex guide rail surfaces in a one-to-one correspondence.

5. The test tool for implantable electrode lead according to claim 1, characterized in that: The side surfaces of the head end slider (310) and the tail end slider (330) are both provided with connection holes (302), and the head end locking piece (510) and the tail end locking piece (520) are both assembled on the corresponding connection holes (302).

6. The test tool for implantable electrode lead according to claim 1, characterized in that: The head end clamping device (410) and the tail end clamping device (420) are clamping devices (40) with the same structure, and the clamping device (40) comprises: A base (41) is fixed on the head end slider (310) or the middle slider (320), the upper end surface of the base (41) is provided with a lower arc groove (411), and the base (41) is also provided with a plurality of guide rods (42), and the plurality of guide rods (42) extend in a direction away from the slide rail (200); A lower pressure cover (43) is provided with a lower through hole for the guide rod (42) to pass through, and an upper arc-shaped groove (431) is provided on the lower end surface of the lower pressure cover (43) facing the base (41) and is arranged corresponding to the position of the lower arc-shaped groove (411); A threaded rod (44) is fixed on the lower pressure cover (43) and extends in a direction away from the slide rail (200). An upper pressure cover (45) is provided with an upper through hole (451) for the threaded rod (44) to pass through, and a concave hole (452) is also provided on the side of the upper pressure cover (45) facing the lower pressure cover (43), and the upper end of the guide rod (42) abuts against the concave hole (452); A spring (46) is sleeved on the guide rod (42) and elastically supported between the lower pressure cover (43) and the upper pressure cover (45); The tightening nut (47) is located on the side of the upper pressure cover (45) facing away from the lower pressure cover (43), and is threadably engaged with the threaded rod (44) through the nut hole (471) thereon.

7. The test tool for implantable electrode lead according to claim 6, characterized in that: Buffer pads (48) are provided in both the lower arc-shaped groove (411) and the upper arc-shaped groove (431).

8. The test tool for implantable electrode lead according to claim 1, characterized in that: The control box (700) is provided with a control unit, the tension sensor (600) is electrically connected to the control unit, the control unit is also electrically connected to a display drive circuit (720), a switch circuit (730) and a power supply, and the display drive circuit (720) is electrically connected to a display screen (750).

9. The test tool for implantable electrode lead according to claim 1, characterized in that: An ohmmeter (800) is also included, wherein two test leads (810) of the ohmmeter (800) are respectively electrically connected to the connector ring and the ring electrode of the electrode lead and are used to measure the resistance of the electrode lead.

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