A tether adjuster and methods of using same

Abstract

This invention provides a tether adjuster and its method of use. The tether adjuster includes a housing, a clamping mechanism, and a tension adjusting mechanism. The clamping mechanism is connected to the distal end of the housing and is capable of clamping an apical pad. The apical pad is used to connect to the proximal end of the tether, and the distal end of the tether is connected to a heart valve prosthesis. The clamping mechanism includes a first driving part and a jaw. The jaw includes two clamping arms symmetrically arranged circumferentially on the housing. The first driving part is connected to the two clamping arms respectively and is used to drive the distal ends of the two clamping arms to move in a direction of mutual approach to open the jaw, or to drive the distal ends of the two clamping arms to move in a direction of mutual approach to close the jaw. The tension adjusting mechanism is connected to the housing and to the proximal end of the tether, and is used to drive the proximal end of the tether to move relative to the heart valve prosthesis to adjust the tension of the tether. When adjusting the tension of the tether using the tether adjuster, two symmetrically arranged clamping arms are used to clamp the apical pad, so that the apical pad is subjected to symmetrical and balanced clamping force, maintaining the stability of the apical pad. This allows the operator to manipulate the tension adjustment mechanism to move the proximal end of the tether and thus adjust the tension of the tether.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a tethered adjuster and its usage method. Background Technology

[0002] Heart valve prostheses are used to replace diseased or failed native valves. There are generally two methods of anchoring implanted heart valve prostheses: intracardiac anchoring and extracardiac anchoring. Extracardiac anchoring refers to the process where a tether attached to the heart valve prosthesis passes through the apex of the heart and extends to the outside of the heart. A apical pad is then used to secure the portion of the tether outside the heart to the outer ventricular wall. This restraint force of the tether prevents the heart valve prosthesis from being pushed into the atrium during cardiac systole.

[0003] The tension of the tether determines the fixation effect of the heart valve prosthesis. Specifically, if the tether tension is too low, the heart valve prosthesis cannot be pulled towards the apex of the heart, causing it to move towards the atrium during ventricular systole under the impact of blood flow, leading to a gap between the prosthesis and the original valve, resulting in paravalvular leakage. If the tether tension is too high, it causes excessive compression of the myocardium, hindering the heart's pumping function and potentially causing myocardial damage and heart failure. In existing technologies, a tether adjuster is typically used to adjust the tether tension. During adjustment, it is necessary to ensure a secure connection between the apical pad and the tether adjuster to guarantee a smooth adjustment operation. Summary of the Invention

[0004] The purpose of this invention is to provide a tether adjuster and its method of use, which can stably connect to the apical pad and prevent detachment during use.

[0005] To achieve the above objectives, the present invention provides a tether adjuster, comprising:

[0006] case;

[0007] A clamping mechanism, connected to the distal end of the housing, is capable of clamping an apical pad; the apical pad is used to connect to the proximal end of a tether, the distal end of which is connected to a heart valve prosthesis; the clamping mechanism includes a first drive unit and a jaw, the jaw comprising two clamping arms symmetrically arranged circumferentially on the housing; the first drive unit is respectively connected to the two clamping arms and is used to drive the distal ends of the two clamping arms to move in a direction away from each other to open the jaw, or to drive the distal ends of the two clamping arms to move in a direction close to each other to close the jaw; and,

[0008] A tension adjustment mechanism, connected to the housing and to the proximal end of the tether, is used to drive the proximal end of the tether to move relative to the heart valve prosthesis in order to adjust the tension of the tether.

[0009] Optionally, the first drive unit includes a fixed rod, a gripper seat, a second movable rod, and a connecting rod;

[0010] The fixed rod is connected to the distal end of the housing and remains relatively stationary with respect to the housing; the gripper seat is connected to the distal end of the fixed rod and is also rotatably connected to the middle of each gripper arm; the second movable rod is located between the housing and the gripper seat, the second movable rod is sleeved on a portion of the outer surface of the fixed rod, and is configured to move along the axial direction of the fixed rod; the connecting rod is rotatably connected to the gripper arm and the second movable rod respectively;

[0011] The clamping mechanism is configured such that when the second movable rod moves from the distal end to the proximal end, the second movable rod drives the distal ends of the two clamping arms to move away from each other via the connecting rod; and when the second movable rod moves from the proximal end to the distal end, the second movable rod drives the distal ends of the two clamping arms to move closer to each other via the connecting rod.

[0012] Optionally, the number of connecting rods is two, the two connecting rods are arranged opposite each other in the circumferential direction of the second movable rod, and correspond one-to-one with the two clamping arms; the proximal end of each connecting rod is rotatably connected to the second movable rod, and the distal end of each connecting rod is rotatably connected to the proximal end of a corresponding clamping arm; and / or,

[0013] The first drive unit further includes a third elastic element, which is sleeved on a portion of the outer surface of the fixed rod and located between the housing and the second movable rod; the third elastic element is configured to store elastic potential energy when the second movable rod moves from the distal end to the proximal end under the action of an external force, and to release the elastic potential energy when the external force is removed, thereby driving the second movable rod to move from the proximal end to the distal end.

[0014] Optionally, the apical pad includes a second hub, on which a mating hole is provided;

[0015] The first drive unit has a third channel extending through the housing along its axial direction; the tether adjuster further includes a second drive unit, the second drive unit including an engagement rod partially disposed in the third channel, and the proximal end of the engagement rod disposed on the housing; the engagement rod is also configured to be axially movable along the housing, and allows the distal end of the engagement rod to extend out of the third channel and into the engagement hole to connect with the second hub; the engagement rod is also configured to be rotatable in a predetermined direction, and drive the second hub connected to the engagement rod to rotate in the predetermined direction, so that the apical pad is connected to the tether; the engagement rod has a fourth channel extending through its axial direction for the tether to pass through.

[0016] Optionally, the housing has an inner cavity, and the proximal end of the connecting rod is disposed in the inner cavity; the second driving part further includes a second knob, a fourth elastic element, and a second locking element; the second knob is partially located in the inner cavity and sleeved on the outer surface of the proximal end of the connecting rod, and remains relatively stationary with the connecting rod; an abutment portion is formed on the inner wall of the housing, and the abutment portion is located on the proximal end side of the second knob; the fourth elastic element is disposed between the abutment portion and the second knob; the second locking element is used to selectively connect or disconnect with the second knob, when the second locking element is connected with the second knob, it prevents the second knob and the connecting rod from moving in the direction from the proximal end to the distal end, and the second knob squeezes the fourth elastic element, so that the fourth elastic element stores elastic potential energy, when the second locking element is disconnected from the second knob, the fourth elastic element releases elastic potential energy and drives the second knob and the connecting rod to move in the direction from the proximal end to the distal end.

[0017] Optionally, the tension adjustment mechanism includes a movable adjustment member; the movable adjustment member is for connection to the proximal end of the tether and is configured to move axially along the housing to drive the proximal end of the tether to move synchronously to adjust the tension of the tether.

[0018] Optionally, the tension adjustment mechanism further includes a first operating member, which is rotatably connected to the proximal end of the housing and has an engaging portion; the movable adjustment member further includes a first movable rod, which has an external thread on its outer side.

[0019] The external thread on the first movable rod selectively engages or disengages with the engagement part. When the external thread on the first movable rod engages with the engagement part, the first operating member can rotate under the action of external force and drive the first movable rod to move along the axial direction of the housing through helical transmission. When the external thread on the first movable rod disengages from the engagement part, the first movable rod can move along the axial direction of the housing under the action of external force.

[0020] Optionally, the first operating member is provided with a first channel extending through the axial direction of the housing; a portion of the inner wall of the first channel is provided with internal threads; the engaging portion includes the internal threads;

[0021] The distal end of the first movable rod is disposed on the housing, and the proximal end of the first movable rod passes through the first channel.

[0022] Optionally, the first operating element includes a first knob, a first button, and a first elastic element; the first knob is rotatably connected to the proximal end of the housing, and the first knob is provided with a first receiving groove, the extending direction of the first receiving groove intersecting the axial direction of the housing; the first button is partially disposed in the first receiving groove; the first elastic element is disposed in the first receiving groove and is located between the bottom of the first receiving groove and the first button;

[0023] The first channel passes through the first knob and the first button, and the inner wall surface of the portion of the first channel located on the first button includes a first region and a second region that are circumferentially opposite to each other in the first channel. The first region is closer to the first elastic element than the second region. The first region is provided with the internal thread, and the second region is smooth.

[0024] When the first button is subjected to an external force pointing from the second region to the first region, the first button moves in the direction from the second region to the first region, causing the external thread on the first movable rod to disengage from the internal thread on the first region, and causing the first elastic element to store elastic potential energy; when the external force is removed, the first elastic element releases the elastic potential energy, and drives the first button to move in the direction from the first region to the second region, causing the internal thread on the first region to engage with the external thread on the first movable rod.

[0025] Optionally, the tension adjustment mechanism further includes a force monitoring element; the movable adjustment element includes a contact portion located at the distal end of the force monitoring element, and the contact portion is used to contact the force monitoring element to apply a target force that characterizes the tension of the tether to the force monitoring element, and the force monitoring element is also used to monitor the target force.

[0026] Optionally, the contact portion includes a boss connected to the outer surface of the first movable rod; or,

[0027] The contact portion includes a boss and a second elastic element. The boss is connected to the outer surface of the first movable rod, and the second elastic element is sleeved on the outer periphery of the first movable rod and located between the boss and the force monitoring element.

[0028] Optionally, the housing has an inner cavity, in which the distal end of the first movable rod, the contact portion, and the force monitoring element are all disposed;

[0029] The housing is also provided with a transparent window, which is positioned corresponding to the force monitoring element; a scale is provided at the transparent window, and the contact portion is visible to the outside through the transparent window; and / or,

[0030] The inner wall of the housing is also provided with a guide groove extending along the axial direction of the housing, and the boss is partially disposed in the guide groove.

[0031] Optionally, the movable adjustment member is provided with a second channel that passes through the first movable rod and the fixed seat along the axial direction of the housing, and the second channel is used for the tether to pass through; the movable adjustment member also includes a fixed seat and a first locking member; the fixed seat is connected to the proximal end of the first movable rod; the first locking member is disposed on the fixed seat and is used to fix the portion of the tether that passes through the fixed seat;

[0032] The fixing base is provided with a locking hole, the extension direction of the locking hole intersects with the second channel, and the locking hole communicates with the second channel; the first locking member partially passes through the locking hole and extends into the second channel; or,

[0033] The fixing seat includes a seat body and a plurality of first clamping pieces. The seat body is connected to the proximal end of the first movable rod. The plurality of first clamping pieces are disposed on the proximal end face of the seat body and are arranged at intervals around the second channel. The first locking member includes a first hub, which is threadedly engaged with the seat body and used to compress the first clamping pieces, so that all the first clamping pieces together clamp the tether.

[0034] To achieve the above objectives, the present invention also provides a method of using the tether adjuster as described above, wherein the distal end of the tether is connected to a heart valve prosthesis and the proximal end passes through the apical spacer, and the method of use includes:

[0035] Manipulate the first drive unit to drive the gripper to open, and arrange the distal ends of the two gripper arms symmetrically on opposite sides of the circumferential apical pad.

[0036] Manipulate the first drive unit to drive the gripper to close, so that the two gripper arms hold the apical pad;

[0037] Adjust the tether to straighten it and connect the proximal end of the tether to the tension adjustment mechanism; and,

[0038] Manipulate the tension adjustment mechanism to drive the proximal end of the tether to move.

[0039] Compared with the prior art, the tether adjuster and its method of use of the present invention have the following advantages:

[0040] The aforementioned tether adjuster includes a housing, a clamping mechanism, and a tension adjusting mechanism. The clamping mechanism is connected to the distal end of the housing and is capable of clamping an apical pad. The apical pad is used to connect to the proximal end of the tether, and the distal end of the tether is connected to a heart valve prosthesis. The clamping mechanism includes a first drive unit and a jaw. The jaw includes two clamping arms symmetrically arranged circumferentially on the housing. The first drive unit is connected to the two clamping arms respectively and is used to drive the distal ends of the two clamping arms to move in a direction of mutual approach to open the jaw, or to drive the distal ends of the two clamping arms to move in a direction of mutual approach to close the jaw. The tension adjusting mechanism is connected to the housing and to the proximal end of the tether, and is used to drive the proximal end of the tether to move relative to the heart valve prosthesis to adjust the tension of the tether. When adjusting the tension of the tether using the tether adjuster, two symmetrically arranged clamping arms are used to clamp the apical pad, so that the apical pad is subjected to symmetrical and balanced clamping force, maintaining the stability of the apical pad. This allows the operator to manipulate the tension adjustment mechanism to move the proximal end of the tether and thus adjust the tension of the tether. Attached Figure Description

[0041] The accompanying drawings are provided to better understand the invention and are not intended to unduly limit the scope of the invention. Wherein:

[0042] Figure 1 This is a schematic diagram of the existing technology for anchoring heart valve prostheses using tethers and apical pads;

[0043] Figure 2 This is a schematic diagram of the tether adjuster provided by the present invention according to an embodiment;

[0044] Figure 3 yes Figure 2 The figure shows a cross-sectional view of the tether adjuster (AA section), where the second elastic element is not shown.

[0045] Figure 4 yes Figure 3 Enlarged diagram of point B in the diagram;

[0046] Figure 5 This is a schematic diagram of the tether adjuster provided according to an embodiment of the present invention. Figure 4 Observation position and Figure 2 different;

[0047] Figure 6 yes Figure 5 The diagram shows a CC cross-sectional view of the tether adjuster, in which the second knob is connected to the second locking element, and the second elastic element is also shown.

[0048] Figure 7 yes Figure 6 Enlarged diagram of point D in the diagram;

[0049] Figure 8 This is a partial structural schematic diagram of a tether adjuster provided according to an embodiment of the present invention. The figure shows a fixing base and a first locking member, and the first locking member includes a first hub.

[0050] Figure 9 This is a schematic diagram of the overall structure of the apical pad in the existing technology;

[0051] Figure 10 yes Figure 9 The longitudinal sectional view of the apical pad shown also shows part of the tether threaded through the junctional channel;

[0052] Figure 11 yes Figure 9 A transverse cross-sectional view of the apical pad shown;

[0053] Figure 12 yes Figure 9 The diagram shown illustrates the explosion of the apical cushion.

[0054] Figure 13 This is a partial cross-sectional view of a tether adjuster provided according to an embodiment of the present invention;

[0055] Figure 14 This is a schematic diagram of the application scenario of the tether adjuster provided by the present invention according to an embodiment. In the figure, the gripper of the clamping mechanism is open but has not yet clamped the apex pad.

[0056] Figure 15 This is a schematic diagram of the application scenario of the tether adjuster provided by the present invention according to an embodiment. In the figure, the clamping mechanism clamps the apical pad, and the movable adjusting member moves from the distal end to the proximal end until the boss of the contact part contacts the force monitoring element, and the connecting rod is inserted into the connecting hole of the apical pad.

[0057] Figure 16 yes Figure 15 The tether adjuster and apical pad shown are cross-sectional views.

[0058] Figure 17 This is a schematic diagram of an application scenario of the tethered adjuster provided by the present invention according to an embodiment. The gripper of the clamping mechanism in the figure opens to release the apical pad.

[0059] [The annotations in the attached figures are explained below]:

[0060] 100-Heart valve prosthesis, 200-Tether, 300-Apical pad, 310-Base, 311-Gathering groove, 320-Clamping element, 321-Second clip, 330-Second hub, 331-Gathering hole;

[0061] 1000 - Housing, 1100 - Inner cavity, 1110 - First chamber, 1120 - Second chamber, 1130 - Third chamber, 1001 - Transparent window, 1002 - Scale, 1003 - Abutment part, 2000 - Clamping mechanism, 2100 - First drive part, 2110 - Fixed rod, 2111 - Fixed rod body, 2112 - Limiting block, 2120 - Gripper seat, 2130 - Second movable rod, 2131 - Second receiving groove, 2140 - Connecting rod, 2150 - Third elastic element, 2200 - Gripper, 2210 - Gripper arm, 2211 - Protrusion, 3000 - Tension adjustment mechanism, 3100 - Movable adjustment element, 3110 - Contact part, 3111 - Boss, 3112 - Second elastic element, 3120 - First movable rod 3121 - External thread, 3130 - Fixed base, 3131 - Base body, 3132 - First clamping piece, 3140 - First locking element, 3101 - Second channel, 3200 - Force monitoring element, 3300 - First operating element, 3301 - First channel, 3310 - First knob, 3311 - First receiving groove, 3320 - First button, 3330 - First elastic element, 4000 - Second drive part, 4100 - Engaging rod, 4101 - Fourth channel, 4200 - Second knob, 4210 - Slot, 4300 - Connecting pin, 4400 - Fourth elastic element, 4500 - Second locking element, 4510 - Elastic engagement part, 4520 - Snap fastener, 4521 - Mating bevel, 4530 - Second operating element, 4600 - Radial limiting part Detailed Implementation

[0062] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show components related to the present invention and are not drawn according to the actual number, shape, and size of components in the actual implementation. In the actual implementation, the type, quantity, and proportion of each component can be arbitrarily changed, and the component layout may also be more complex.

[0063] Furthermore, while each embodiment described below possesses one or more technical features, this does not imply that users of the present invention must simultaneously implement all technical features in any embodiment, or can only separately implement some or all technical features in different embodiments. In other words, provided it is feasible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility in implementing the present invention.

[0064] As used herein, the singular forms “a,” “an,” and “the” include plural objects, and the plural form “multiple” includes two or more objects, unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or,” unless otherwise expressly indicated, and the terms “installed,” “connected,” and “linked” should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection. Connections can be mechanical or electrical. Connections can be direct or indirect through an intermediate medium, and can be internal communication between two elements or an interaction between two elements. Relational terms such as “first,” “second,” etc., are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly specify the number of indicated technical features. It should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Those skilled in the art can understand the specific meaning of the above terms in the present invention according to the specific circumstances.

[0065] The terms “proximal” and “distal” in this article are based on the relative positions and orientations of the various parts and components of a medical device. Although not restrictive, “proximal” usually refers to the end of the medical device that is closer to the operator during normal use, while “distal” is the end of the medical device that is axially opposite to “proximal” and is closer to the patient’s body (in contact with or inside the body).

[0066] Figure 1 This diagram illustrates an application scenario of a prior art heart valve prosthesis 100. For example... Figure 1As shown, the heart valve prosthesis 100 is implanted in the heart and replaces a native valve, such as the native mitral valve. A tether 200 is connected distally to the heart valve prosthesis 100, and proximally extended from the apex of the heart to the outside of the heart and is secured by an apical pad 300. After the apical pad 300 is connected to the tether 200, it rests against the outer ventricular wall. With appropriate tension in the tether 200, the heart valve prosthesis 100 is effectively anchored by the tether 200, preventing displacement and paravalvular leak due to compression into the atrium during cardiac systole, and also preventing excessive compression of the myocardium.

[0067] The purpose of this invention is to provide a tether adjuster and its usage method, which can be effectively connected to the apical pad 300, thereby enabling smooth tension adjustment of the tether 200.

[0068] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar parts.

[0069] Figures 2 to 7 A schematic diagram of the tether adjuster is shown. Figures 2 to 7 As shown, the tether adjuster includes a housing 1000, a clamping mechanism 2000, and a tension adjusting mechanism 3000. The clamping mechanism 2000 is connected to the distal end of the housing 1000 and is capable of clamping the apical pad 300. The tension adjusting mechanism 3000 is connected to the housing 1000 and to the proximal end of the tether 200, and is used to drive the proximal end of the tether 200 to move relative to the heart valve prosthesis 100 to adjust the tension of the tether 200.

[0070] In this embodiment of the invention, the clamping mechanism 2000 includes a first driving part 2100 and a gripper 2200. The gripper 2200 is connected to the first driving part 2100 and opens or closes under the drive of the first driving part 2100. Specifically, the gripper 2200 includes two gripping arms 2210, which are symmetrically arranged circumferentially on the housing 1000. The first driving part 2100 is movably connected to the proximal end and the middle part of each gripping arm 2210, and drives the distal ends of the two gripping arms 2210 to move in directions that are moving away from or towards each other. When the distal ends of the two gripping arms 2210 move in directions that are moving away from each other, the gripper 2200 opens; when the distal ends of the two gripping arms 2210 move in directions that are moving towards each other, the gripper 2200 closes. Therefore, when the clamping jaws 2200 of the clamping mechanism 2000 clamp the apical pad 300, the two clamping arms 3310 can provide symmetrical and balanced clamping forces to the apical pad 300, so as to stably clamp the apical pad 300, thereby enabling the tension adjustment of the tether 200 to be carried out smoothly.

[0071] Therefore, the method of using the tether adjuster includes at least the following steps:

[0072] First, the first drive unit 2100 is manipulated to open the gripper 2200 and to make the distal ends of the two gripper arms 2210 symmetrically distributed on opposite circumferential sides of the apical pad 300.

[0073] Subsequently, the first drive unit 2100 is manipulated to drive the gripper 2200 to close, and the clamping mechanism 2000 is used to clamp the apical pad 300.

[0074] Then, adjust the tether 200 to straighten it, and connect the tether 200 to the tension adjustment mechanism 3000 while the tether 200 is straight.

[0075] Then, the tension adjustment mechanism 3000 is manipulated to drive the proximal end of the tether 200 to move relative to the heart valve prosthesis 100, thereby adjusting the tension of the tether 200.

[0076] The tension adjustment mechanism 3000 includes a movable adjustment member 3100, which is used to connect to the proximal end of the tether 200 and is configured to move along the axial direction of the housing 1000 to drive the proximal end of the tether 200 to move synchronously to adjust the tension of the tether 200.

[0077] Furthermore, the tension adjustment mechanism 3000 also includes a force monitoring element 3200. The movable adjustment member 3100 is used to connect to the proximal end of the tether 200 and includes a contact portion 3110. The contact portion 3110 is located on the distal side of the force monitoring element 3200, and the contact portion 3110 is used to contact the force monitoring element 3200 to apply a target force to the force monitoring element 3200, the target force being capable of characterizing the tension of the tether 200. The force monitoring element 3200 also monitors the target force to indirectly monitor the tension of the tether 200. Therefore, the aforementioned "manipulating the tension adjustment mechanism 3000 to drive the proximal end of the tether 200 to move relative to the heart valve prosthesis 100" refers to manipulating the movable adjustment member 3100 to move axially along the housing 1000 until the contact portion 3110 contacts the force monitoring element 3200 to generate the target force, and keeping the target force within a predetermined range. At this point, connecting the tether 200 to the apical pad 300 allows the tension of the tether 200 to be maintained within a suitable range, thereby effectively anchoring the heart valve prosthesis 100. The advantage of providing the contact portion 3110 and the force monitoring element 3200 is that the tension of the tether 200 can be directly monitored using the tension adjustment mechanism 3000, eliminating the need for external tension monitoring equipment. This also simplifies the surgical procedure by eliminating the need for fluid channel purging, pressure value calibration, and additional connection to an electrocardiogram monitor when using external tension monitoring equipment.

[0078] It should be noted that the force monitoring element 3200 used in the embodiments of the present invention may include any suitable force sensor in the prior art.

[0079] The following is a detailed description of the structure of each component of the tether adjuster. It should be noted that the structures described below are merely optional, not mandatory, configurations of the tether adjuster, and should not be construed as unduly limiting the scope of protection of this invention.

[0080] like Figures 2 to 7 As shown, for ease of gripping by the operator, the housing 1000 is preferably a hollow structure with an inner cavity 1100, and the clamping mechanism 2000 is partially disposed within the inner cavity 1100, as is the tension adjusting mechanism 3000. In this way, when using the tether adjuster, the operator can grip the housing 1000.

[0081] From the perspective of ease of assembly, it is further preferred that the housing 1000 be an assembled structure, including two sub-housings (not shown in the figure) facing each other in the circumferential direction. That is, the two sub-housings are spliced ​​together to form the housing 1000, and the splicing surfaces of the two sub-housings are parallel to the axial direction of the housing 1000. It can be understood that when assembling the tether adjuster, the clamping mechanism 2000, the tension adjusting mechanism 3000, and other components (such as the second drive unit 4000 mentioned later) are first assembled onto one of the sub-housings, and then the two sub-housings are spliced ​​together.

[0082] Please refer to Figures 2 to 7 The first drive unit 2100 may be partially located in the inner cavity 1100 and may include a fixed rod 2110, a gripper seat 2120, a second movable rod 2130 and a connecting rod 2140.

[0083] The fixing rod 2110 is connected to the distal end of the housing 1000 and remains relatively stationary with respect to the housing 1000. Optionally, the inner cavity 1100 includes a first chamber 1110 located at the distal end of the housing 1000, and both the proximal and distal walls of the first chamber 1110 are formed as limiting surfaces. The fixing rod 2110 includes a fixing rod body 2111 and a limiting block 2112, the limiting block 2112 being connected to the proximal outer surface of the fixing rod body 2111. The limiting block 2112 is disposed within the first chamber 1110, and the proximal end face of the limiting block 2112 abuts against the proximal wall of the first chamber 1110, and the distal end face of the limiting block 2112 abuts against the distal wall of the first chamber 1110. The distal end of the fixing rod 2110 passes through the distal end of the housing 1000 and extends to the outside of the housing 1000.

[0084] The gripper seat 2120 is connected to the distal end of the fixing rod 2110 and is rotatably connected to the middle of each gripper arm 2210.

[0085] The second movable rod 2130 is located at the distal end of the housing 1000 and at the proximal end of the gripper seat 2120. The second movable rod 2130 has a fifth channel (not shown) extending axially through it, and the second movable rod 2130 is sleeved on a portion of the outer surface of the fixed rod 2110 through the fifth channel. The second movable rod 2130 is also configured to move axially along the fixed rod 2110.

[0086] The connecting rod 2140 is rotatably connected to the proximal end of the clamping arm 2210 and the distal end of the second movable rod 2130, respectively.

[0087] Thus, when the second movable rod 2130 moves relative to the fixed rod 2110 in a direction from distal to proximal, the second movable rod 2130 can drive the distal ends of the two clamping arms 2110 to move in a direction away from each other via the connecting rod 2140, thereby opening the clamp 2200; conversely, when the second movable rod 2130 moves relative to the fixed rod 2110 in a direction from proximal to distal, the second movable rod 2130 can drive the two clamping arms 2210 to move in a direction close to each other via the connecting rod 2140, thereby closing the clamp 2200.

[0088] Therefore, the operation of clamping the apical pad 300 using the clamping mechanism 2000 is as follows: First, control the second movable rod 2130 to move relative to the fixed rod 2110 in a distal to proximal direction, so that the gripper 2200 opens. Then, position the distal ends of the two gripping arms 2210 on both sides of the circumference of the apical pad 300. Subsequently, move the second movable rod 2130 relative to the fixed rod 2110 in a proximal to distal direction, so that the gripper 2200 clamps the apical pad. The operation of releasing the apical pad 300 using the clamping mechanism 2000 is as follows: Control the second movable rod 2130 to move relative to the fixed rod 2110 in a distal to proximal direction, so that the gripper 2200 opens. Then, move the system adjuster to move the gripper 2200 away from the apical pad 300.

[0089] In an exemplary embodiment, there are two connecting rods 2140, arranged circumferentially opposite each other on the second movable rod 2130, and corresponding one-to-one with the two clamping arms 2210. The proximal end of each connecting rod 2140 is rotatably connected to the distal end of the second movable rod 2130, and the distal end of each connecting rod 2140 is rotatably connected to the proximal end of the corresponding clamping arm 2210. It should be understood that there may be more than two connecting rods 2140, as long as a portion of the connecting rods 2140 connect one clamping arm 2210 to the second movable rod 2130, and another portion of the connecting rods 2140 connect the other clamping arm 2210 to the second movable rod 2130.

[0090] Preferably, the first driving part 2100 further includes a third elastic element 2150, which is sleeved on a portion of the outer surface of the fixed rod 2110 and located between the housing 1000 and the second movable rod 2130. Specifically, as Figure 4As shown, the proximal end of the second movable rod 2130 is further provided with a second receiving groove 2131 surrounding the fifth channel of the fixed rod 2110, and the second receiving groove 2131 penetrates the proximal end face of the second movable rod 2130. The third elastic member 2150 is partially located within the second receiving groove 2131. Furthermore, when the second movable rod 2130 moves relative to the fixed rod 2110 in a direction from distal to proximal, the second movable rod 2130 applies pressure to the third elastic member 2150, causing the third elastic member 2150 to be compressed and store elastic potential energy. When the third elastic member 2150 releases its elastic potential energy, the third elastic member 2150 can drive the second movable rod 2130 to move relative to the fixed rod 2110 in a direction from proximal to distal. Thus, when it is necessary to open the gripper 2200, the operator can apply an external force from the distal end to the proximal end to the second movable lever 2130, and when it is necessary to close the gripper 2200, the operator only needs to stop applying the external force from the distal end to the proximal end to the second movable lever 2130.

[0091] Please refer to this carefully. Figure 2 , Figure 3 , Figure 5 and Figure 6 The movable adjustment member 3100 includes a first movable rod 3120, a fixed seat 3130, and a first locking member 3140. The inner cavity 1100 includes a second chamber 1120, which is located proximal to the first chamber 1110 and communicates with it. The distal end of the first movable rod 3120 passes through the second chamber 1120, and the proximal end of the first movable rod 3120 is located outside the proximal end of the housing 1000, and the first movable rod 3120 is movable along the axial direction of the housing 1000. The fixed seat 3210 is connected to the proximal end of the first movable rod 3120 and remains relatively stationary with respect to the first movable rod 3120. The movable adjustment member 3100 also has a second channel 3101 that passes through the first movable rod 3120 and the first fixed seat 3130 along the axial direction of the housing 1000, and the tether 200 partially passes through the second channel 3101. The first locking member 3140 is disposed on the fixed base 3130 and is used to fix the portion of the tether 200 that passes through the fixed base 3130, so as to lock the proximal portion of the tether 200 and achieve the purpose of connecting the proximal end of the tether 200 with the movable adjusting member 3100.

[0092] Optionally, the fixing base 3130 is provided with a locking hole (not shown in the figure), the extending direction of which intersects with the second channel 3101, preferably perpendicular to it, and the locking hole communicates with the second channel 3101. The first locking member 3140 partially passes through the locking hole and extends into the second channel 3101. In some embodiments, the first locking member 3140 presses against the tether 200 to jointly compress the tether 200 with the hole wall of the second channel 3101, thereby locking the portion of the tether 200 located within the fixing base 3130. In other embodiments, the first locking member 3140 partially passes through the tether 200 and nails the tether 200 to lock the portion of the tether 200 within the fixing base 3130. It is understood that the locking hole is preferably a threaded hole, and the first locking member is a screw.

[0093] Alternatively, such as Figure 8 As shown, the fixing seat 3130 includes a seat body 3131 and a plurality of first clamping pieces 3132. The seat body 3131 is connected to the proximal end of the first movable rod 3120, and the plurality of first clamping pieces 3132 are connected to the proximal end of the seat body 3131, and the plurality of first clamping pieces 3132 are arranged at intervals around the second channel 3101. The first locking member 3140 includes a first hub, which is threadedly engaged with the seat body 3131 and used to compress the first clamping pieces 3132, so that all the first clamping pieces 3132 together clamp the tether 200.

[0094] Please return to the reference. Figure 3 and Figure 6 The contact portion 3110 includes at least a boss 3111, which is connected to the outer surface of the first movable rod 3120. In practical application of the tether adjuster, it is desirable that the force monitoring element 3200 only monitors the target force, and not generate a force due to accidental contact with the force monitoring element 3200 by the operator, thus preventing the force monitoring element 3200 from also monitoring the force applied by the operator, thereby avoiding interference with the tension monitoring of the tether 200. Therefore, it is preferable that both the contact portion 3110 and the force monitoring element 3200 are disposed in the second chamber 1120. In this way, since the operator only holds the housing 1000 and does not touch the components inside the second chamber 1120, accidental contact with the force monitoring element 3200 can be avoided.

[0095] For further information, please continue to refer to [link / reference]. Figure 3 and Figure 6 and combined Figure 2 and Figure 5The tension adjustment mechanism 3000 includes a first operating member 3300, which is rotatably disposed on the proximal exterior of the housing 1000. The first operating member 3300 has an engaging portion (not shown in the figure), and the outer surface of the first movable rod 3120 has an external thread 3121. The external thread 3121 on the first movable rod 3120 selectively engages with the engaging portion. When the external thread 3121 on the first movable rod 3120 engages with the engaging portion, the first operating member 3300 can rotate under the action of an external force, and drive the first movable rod 3120 to move axially along the housing 1000 through helical transmission. When the external thread 3121 on the first movable rod 3120 is disengaged from the engaging portion, the first movable rod 3120 can directly move axially along the housing 1000 under the action of an external force.

[0096] Those skilled in the art should understand that when the first movable rod 3120 can move directly along the axial direction of the housing 1000 under the action of an external force, the movement speed of the first movable rod 3120 can be relatively fast. However, when the first operating member 3300 drives the first movable rod 3120 to move along the axial direction of the housing 1000 through a screw drive, the movement speed of the first movable rod 3120 can be relatively slow, which facilitates the operator to precisely control the movement speed and movement distance of the first movable rod 3120. In other words, the movement adjustment of the first movable rod 3120 along the axial direction of the housing 1000 can be divided into two modes: coarse adjustment and fine adjustment. Thus, in the initial adjustment phase, the operator can disengage the external thread 3121 on the first movable rod 3120 from the engagement portion on the first operating member 3300, so as to directly apply external force to the first movable rod 3120 to quickly drive the first movable rod 3120 to move axially along the housing 1000, thereby achieving coarse adjustment of the position of the first movable rod 3120 relative to the housing 1000. Meanwhile, the boss 3111 is near or has already contacted the force monitoring element 3200. Then, the external thread 3121 on the first movable rod 3120 engages with the meshing part on the first operating member 3300. An external force is then applied to the first knob 3110 to rotate it, causing the first movable rod 3120 to move slowly along the axial direction of the housing 1000. This allows for precise adjustment of the position of the first movable rod 3120 relative to the housing 1000, thereby precisely adjusting the target force applied by the contact part 3110 to the force monitoring element 3200. Furthermore, even if the first movable rod 3120 moves slightly further from the distal end to the proximal end, resulting in slightly higher tension on the tether 200, the operator can use the first knob 3110 to move the first movable rod 3120 a suitable distance from the proximal end to the distal end until the tension on the tether 200 is appropriate. In other words, the configuration of the movable adjusting member 3100 offers advantages such as convenient adjustment, high flexibility, and a high tolerance for error. It can be understood that when the first movable rod 3120 moves along the axial direction of the housing 1000, the movable adjusting member 3100 also moves along the axial direction of the housing 1000.

[0097] In one specific embodiment, the first actuating member 3300 is provided with a first channel 3301 extending axially through the housing 1000, and a portion of the inner wall of the first channel 3301 is provided with an internal thread (not shown in the figure). The engaging portion includes the internal thread. The proximal end of the first movable rod 3120 also passes through the first channel 3301, and the external thread 3121 on the first movable rod 3120 selectively engages or disengages with the internal thread on the first channel 3301.

[0098] Furthermore, the first operating element 3300 includes a first knob 3310, a first button 3320, and a first elastic element 3330. The first knob 3310 is rotatably connected to the proximal exterior of the housing 1000, and the first knob 3310 has a first receiving groove 3311, the extending direction of which intersects the axial direction of the housing 1000, preferably perpendicular to it. A portion of the first button 3310 is located within the first receiving groove 3311, and another portion is located outside the first knob 3310. The first elastic element 3330 is disposed within the first receiving groove 3311, and is located between the bottom of the first receiving groove 3311 and the first button 3320.

[0099] The first channel 3301 passes through the first knob 3310 and the first button 3320. That is, a portion of the first channel 3301 is located on the first knob 3310, and another portion is located on the first button 3320. The inner wall surface of the portion of the first channel 3301 located on the first button 3320 is divided into a first region and a second region (not shown in the figure). The first region and the second region are opposite each other in the circumferential direction of the first channel 3301, and the first region is closer to the first elastic element 3330 than the second region. The first region has the internal thread, and the second region is a smooth curved surface.

[0100] When the first operating member 3300 is in its natural state, the first elastic member 3330 applies a supporting force to the first button 3320 along the first region pointing towards the second region, causing the internal thread on the first region to engage with the external thread 3121 on the first movable rod 3120. When the operator applies an external force to the first button 3320 along the second region pointing towards the first region, the first button 3320 moves in the direction from the second region to the first region, causing the first region to separate from the first movable rod 3120, thereby disengaging the internal thread on the first region from the external thread 3121 on the first movable rod 3120. At the same time, the first button 3320 also compresses the first elastic member 3330, causing the first elastic member 3330 to deform and store elastic potential energy. When the operator stops applying external force along the second region to the first region to the first button 3320, the first elastic element 3330 releases its elastic potential energy and drives the first button 3320 to move along the direction from the first region to the second region until the internal thread on the first region re-engages with the external thread 3121 on the first movable rod 3120. At this point, the first operating element 3300 returns to its natural state. That is, the natural state refers to the state when the internal thread on the first region engages with the external thread 3121 on the first movable rod 3120.

[0101] Optionally, such as Figure 2As shown, in some embodiments, a transparent window 1001 is formed on the housing 1000, and the position of the transparent window 1001 matches the position of the force monitoring element 3200. Specifically, the contact portion 3110, specifically the boss 3111, is visible to the outside through the transparent window 1001. In some embodiments, the matching of the position of the transparent window 1001 with the force monitoring element 3200 means that the force monitoring element 3200 is visible to the outside through the transparent window 1001. That is, the operator can directly observe the relative positional relationship between the force monitoring element 3200 and the boss 3111 from the transparent window 1001, and thus determine whether the boss 3111 is adjacent to the force monitoring element 3200. In other embodiments, the matching of the position of the transparent window 1001 with the force monitoring element 3200 means that the transparent window 1001 is located at a predetermined position on the distal side of the force monitoring element 3200. Correspondingly, a scale 1002 is also provided at the transparent window 1001. The scale 1002 has multiple graduation lines arranged at intervals along the axial direction of the housing 1000, and the distance between each graduation line and the force monitoring element 3200 is known. In this way, the operator can determine whether the boss 3111 is close to the force monitoring element 3200 by observing the graduation line at the location of the boss 3111.

[0102] In alternative embodiments, such as Figure 6 As shown, the contact portion 3110 further includes a second elastic element 3112, which provides feedback to the operator when the boss 3111 approaches the force monitoring element 3200. Specifically, the second elastic element 3112 is sleeved on the outer periphery of the first movable rod 3120 and located between the force monitoring element 3200 and the boss 3111. When the distance between the boss 3111 and the force monitoring element 3200 is large, the operator can smoothly control the first movable rod 3110 to move smoothly along the axial direction of the housing 1000 from the distal end to the proximal end. When the protrusion 3111 approaches the force monitoring unit 3200, the two axial ends of the second elastic element 3112 contact the protrusion 3111 and the force monitoring element 3200 respectively, and are compressed by the protrusion 3111 and the force monitoring element 3200 to store elastic potential energy. In other words, when the protrusion 3111 approaches the force monitoring unit 3200, the operator can feel resistance when manipulating the first movable rod 3120 from the distal end to the proximal end, and this resistance can provide feedback to the operator. Optionally, the distal end of the second elastic element 3112 is connected to the protrusion 3111.

[0103] In practice, the tether adjuster includes at least one of the transparent window 1001 and the second elastic member 3112. That is, when the housing 1000 includes the transparent window 1001, the contact portion 3110 may not include the second elastic member 3112; or, when the contact portion 3110 includes the second elastic member 3112, the housing 1000 may not include the transparent window 1001. Alternatively, when the housing 1000 includes the transparent window 1001, the contact portion 3110 may also include the second elastic member 3112.

[0104] Additionally, it should be noted that when the contact portion 3110 includes the second elastic element 3112, the second elastic element 3112 can also act as a buffer between the boss 3111 and the force monitoring element 3200. It can disengage the external thread 3121 on the first movable rod 3120 from the internal thread on the first channel 3301, and prevent the boss 3111 from suddenly impacting the force monitoring element 3200 and causing damage to the force monitoring element 3200 when the operator manipulates the first movable rod 3120 to move from the distal end to the proximal end at a relatively fast speed.

[0105] Optionally, the inner wall of the housing 1000 is further provided with a guide groove (not shown in the figure) extending axially along the housing 1000, and the boss 3111 is partially disposed in the guide groove. The movement of the first movable rod 3120 is guided by the cooperation between the guide groove and the boss 3111, ensuring that the first movable rod 3120 moves along the axial direction of the housing 1000.

[0106] Furthermore, the tether adjuster may also include a display module (not shown in the figure), which is communicatively connected to the force monitoring element 3200 and configured to receive and display the target force so that the operator can promptly obtain the value of the target force.

[0107] Optionally, the display module may be disposed at any suitable location on the housing 1000. Alternatively, the display module may be a component independent of the housing 1000.

[0108] As mentioned above, when the value of the target force is within a predetermined range, the tension of the tether 200 is considered appropriate, allowing the tether 200 to connect with the apical pad 300. The predetermined range is determined based on actual conditions, and the specific method for determining this range is well-known to those skilled in the art.

[0109] Furthermore, the present invention does not impose any particular limitation on the connection method between the apical pad 300 and the tether 200, as long as the two can be effectively connected.

[0110] Figures 9 to 12 A schematic diagram of an existing apical cushion 300 is shown. Figures 9 to 12 As shown, the apical pad 300 includes a base 310, a second hub 320, and a clamping member 330, which is disposed between the base 310 and the second hub 320. The apical pad 300 has an engagement channel (not shown) penetrating the base 310, the clamping member 320, and the second hub 330, for the passage of the tether 200. The base 310 also has an engagement groove 311 extending circumferentially therearound, which engages with the distal end of the clamping arm 3210 of the clamping mechanism 2000, thereby clamping the apical pad 300. The clamping member 320 includes a plurality of second clamping pieces 321, which are spaced circumferentially along the engagement channel. The second hub 330 is threadedly engaged with the base 310. When the second hub 330 rotates in a predetermined direction, the second hub 330 and the base 310 together compress all the second clamping pieces 321, causing all the second clamping pieces 321 to clamp the tether 200, thus connecting the tether 200 to the apical pad 300. The predetermined direction is either counterclockwise or clockwise.

[0111] It should be noted that each of the clamping arms 2210 has a protrusion 2211 at its distal end, the protrusions 2211 of the two clamping arms 2210 are arranged opposite to each other, and each protrusion 2211 is used to at least partially engage with the engagement groove 321.

[0112] against Figures 9 to 12 The apical pad 300 shown includes a tether adjuster that further includes a second drive unit 4000, which is detachably connected to the second hub 330 and, when connected to the second hub 330, drives the second hub 330 to rotate in the predetermined direction.

[0113] Specifically, the second hub 330 is provided with a mating hole 331, which is part of the mating channel. Please refer to the reference. Figures 3 to 7 and combined Figure 13The first drive unit 2100 has a third channel (not shown in the figure) extending axially through the housing 1000, which actually passes through the fixing rod 2110. The second drive unit 4000 includes a connecting rod 4100, which partially passes through the third channel, and the proximal end of the connecting rod 4100 is disposed on the housing 1000, specifically in the third chamber 1130 of the inner cavity 1100. The third chamber 1130 is located between the first chamber 1110 and the second chamber 1120, and communicates with both the first chamber 1110 and the second chamber 1120. The connecting rod 4100 has a fourth channel 4101 extending axially through the housing 1000, which communicates with the second channel 3101. The tether 200 first passes through the fourth channel 4101, and then through the second channel 3101.

[0114] The engaging rod 4100 is configured to move axially along the housing 1000, and allows its distal end to extend out of the third channel and into the engaging hole 331 on the second hub 330. That is, the distal end of the engaging rod 4100 can engage with the engaging hole 331 to connect the engaging rod 4100 to the second hub 330. The engaging rod 4100 is also configured to rotate about its own axis in the predetermined direction to drive the second hub 330, to which the distal end of the engaging rod 4100 is connected, to rotate in the predetermined direction.

[0115] Optionally, the second drive unit 4000 further includes a second knob 4200, which is sleeved on the proximal outer surface of the engaging rod 4100 and remains relatively stationary with respect to the engaging rod 4100. A portion of the second knob 4200 is located in the third chamber 1130, and another portion is located outside the housing 1000. In use, the operator applies force to the second knob 4200 to rotate the engaging rod 4100 in the predetermined direction.

[0116] It should be noted that the connection method between the second knob 4200 and the connecting rod 4100 is not limited in this embodiment of the invention. In an optional implementation, the second drive unit 4000 further includes two connecting pins 4300, which are disposed on the proximal outer surface of the connecting rod 4100 and arranged opposite to each other in the circumferential direction of the connecting rod 4100. The second knob 4200 includes two sub-knobs (not shown in the figure), each sub-knob being approximately semi-circular in shape, and each sub-knob having a third receiving groove. Each sub-knob is arranged corresponding to one connecting pin 4300, and each third receiving groove accommodates the corresponding connecting pin 4300. The two sub-knobs are connected by screws.

[0117] In some embodiments, the operator can apply a proximal-to-distal force to the second knob 4200 to drive the engagement rod 4100 in a proximal-to-distal direction until the distal end of the engagement rod 4100 is inserted into the engagement hole 331. When it is necessary to disengage the distal end of the engagement rod 4100 from the engagement hole 331, the operator can apply a distal-to-proximal force to the second knob 4200 to drive the engagement rod 4100 in a distal-to-proximal direction. However, this method of operation is prone to misoperation, such as accidentally inserting the distal end of the engagement rod 4100 into the engagement hole 331.

[0118] Therefore, preferably, the second drive unit 4000 further includes a fourth elastic element 4400 and a second locking element 4500. The third chamber 1130 has an abutment portion 1003 on its cavity wall, located on the proximal side of the second knob 4200. The fourth elastic element 4400 is disposed between the abutment portion 1003 and the second knob 4200, and is sleeved on the proximal outer surface of the connecting rod 4100. The axial ends of the fourth elastic element 4400 abut against the proximal end face of the second knob 4200 and the distal end face of the abutment portion 1003, respectively. The second locking member 4500 is used to selectively connect or disconnect from the second knob 4200. When the second locking member 4500 is connected to the second knob 4200, it prevents the second knob 4200 and the engaging rod 4100 from moving from the proximal end to the distal end. At the same time, the second knob 4200 compresses the fourth elastic member 4400 and stores elastic potential energy in the fourth elastic member 4400. When the second locking member 4500 is disconnected from the second knob 4200, the fourth elastic member 4400 releases its elastic potential energy and drives the second knob 4200 and the engaging rod 4100 to move from the proximal end to the distal end.

[0119] That is, only when the connection between the second knob 4200 and the second locking member 4500 is released can the second knob 4200 and the connecting rod 4100 be driven to move from the proximal end to the distal end, thus avoiding the situation where the distal end of the connecting rod 4100 is mistakenly inserted into the connecting hole 331 due to operator misoperation.

[0120] Optionally, the second drive unit 4000 further includes a radial limiting part 4600, which is connected to the proximal end face of the second knob 4200 and surrounds the proximal outer side of the engaging rod 4100. The fourth elastic member 4400 is located inside the radial limiting part 4600. By providing the radial limiting part 4600, it can be ensured that the fourth elastic member 4400 can be compressed by the second knob 4200 and store elastic potential energy when the second locking member 4500 is connected to the second knob 4200.

[0121] The connection method between the second knob 4200 and the second locking member 4500 in this embodiment of the invention is not limited, as long as it can easily achieve connection or disconnection. In an optional embodiment, the second knob 4200 and the second locking member 4500 are snap-fit ​​connected. For details, please refer to... Figure 7The second knob 4200 has a slot 4210 at its proximal end, the opening of which faces the engaging rod 4100. The second locking member 4500 includes an elastic engagement portion 4510 and a latch 4520. The elastic engagement portion 4510 is disposed in the third chamber 1130, and its proximal end is connected to the housing 1000. The latch 4520 is connected to the distal end of the elastic engagement portion 4510 and is located on the side of the elastic engagement portion 4510 away from the engaging rod 4100. The elastic engagement portion 4510 is deformable to allow the latch 4520 to engage with the slot 4210 to connect the second locking member 4500 to the second knob 4200, or to allow the latch 4520 to disengage from the slot 4210 to disengage the second locking member 4500 from the second knob 4200. Additionally, the latch 4530 is provided with a mating ramp 4531 for contacting the second knob 4200. The distance from the mating ramp 4521 to the engaging rod 4100 increases from the distal end to the proximal end. During the movement of the second knob 4200 from the distal end to the proximal end, when the proximal end of the second knob 4200 contacts the mating ramp 4521, the second knob 4200 applies force to the second locking member 4500 through the mating ramp 4521, thereby pushing the latch 4520 and the distal end of the elastic engagement portion 4510 to move closer to the engaging rod 4100. It can be understood that when the distal end of the elastic engagement portion 4510 moves closer to the engaging rod 4100, the elastic engagement member 4510 stores elastic potential energy.

[0122] Optionally, the second locking member 4500 further includes a second operating member 4530, a portion of which is located in the third chamber 1130 and connected to the resilient engagement portion 4510, and another portion of which extends to the outside of the housing 1000 to receive external force from the operator.

[0123] Thus, when it is necessary to disconnect the connection between the second knob 4200 and the second locking member 4500, the operator applies an external force to the second operating member 4530 along the radial direction of the housing 1000 and pointing towards the axis of the housing 1000, driving the distal end of the elastic engagement portion 4510 to move closer to the engagement rod 4100, thereby causing the buckle 4520 to disengage from the slot 4210. When it is necessary to connect the second knob 4200 and the second locking member 4500, the operator applies an external force to the second knob 4200 from the distal end to the proximal end to drive the second knob 4200 to move in the direction from the distal end to the proximal end. After the second knob 4200 contacts the mating inclined surface 4521, the second knob 4200 drives the latch 4520 to move in the direction close to the connecting rod 4100, and causes the elastic engagement portion 4510 to deform and store elastic potential energy until the second knob 4200 separates from the mating inclined surface 4521. At this time, the elastic engagement portion 4510 releases elastic potential energy and drives the latch 4520 to move in the direction away from the connecting rod 4100 until the latch 4520 is engaged in the slot 4210.

[0124] Figures 14 to 17 This diagram illustrates an application scenario of the tether adjuster, with the apical pad shown in the diagram being... Figures 9 to 12 The apical pad shown. Next, combine... Figures 14 to 17 The following describes the operating procedure for using the tether adjuster in conjunction with the apical pad 300 to anchor the heart valve prosthesis 100, specifically including the following steps:

[0125] First, the proximal end of the tether 300 is passed through the engagement channel.

[0126] Next, the proximal end of the tether 300 passes sequentially through the fourth channel 4101 and the second channel 3101, and extends out from the proximal end of the movable adjustment member 3100.

[0127] Next, the operator applies an external force from distal to proximal to the second movable lever 2120, causing the gripper 2200 to open and the two gripping arms 2210 to be in a circumferentially symmetrical position on the apical pad 300, with the protrusion 2211 of each gripping arm 2210 aligned with the engagement groove 311 on the base 310.

[0128] Next, the operator releases the external force applied to the second movable rod 2120, causing the gripper 2200 to close and each of the protrusions 2211 to at least partially engage with the engagement groove 311 to clamp the base 310.

[0129] Next, the tether 300 is straightened, and the proximal end of the tether 300 is connected to the movable adjustment member 3100 by the cooperation of the first locking member 3140 and the fixed base 3130.

[0130] Next, the operator applies an external force to the first button 3320 along the second region pointing towards the first region, causing the external thread 3121 on the first movable rod 3120 to disengage from the internal thread on the first channel 3301, and applies an external force along the distal end to the proximal end to the first movable rod 3120 to drive the first movable rod 3120 to move rapidly along the distal end to the proximal end until the boss 3111 approaches the force monitoring element 3200.

[0131] Next, the external force applied to the first button 3320 is removed, causing the external thread 3121 on the first movable rod 3120 to engage with the internal thread on the first channel 3301.

[0132] Next, the operator applies an external force to the first knob 3310 to drive the first knob 3310 to rotate, and drive the first movable rod 3120 to move along the axial direction of the housing 1000 until the contact portion 3110 contacts the force monitoring element 3200, and the target force is within the predetermined range.

[0133] Next, the operator applies external force to the second actuating member 4530 to disengage the second locking member 4500 from the second knob 4200.

[0134] After the second locking member 4500 is disconnected from the second knob 4200, the fourth elastic member 4400 releases its elastic potential energy and drives the second knob 4200 and the engagement rod 4100 to move from the proximal end to the distal end until the distal end of the engagement rod 4100 is inserted into the engagement hole 331 on the second hub 330.

[0135] Next, the operator applies external force to the second knob 4200 to drive the connecting rod 4100 to rotate in the predetermined direction, thereby driving the second hub 330 to rotate in the predetermined direction, so that the second hub 330 engages with the base 310 and squeezes all the second clamps 321, thereby connecting the tether 200 with the apical pad 300.

[0136] Next, the operator applies external force to the second knob 4200, causing the second knob 4200 to drive the connecting rod 4100 to move from the distal end to the proximal end until the second knob 4200 is reconnected to the second locking member 4500.

[0137] Next, the operator cancels the external force applied to the second knob 4200.

[0138] Next, the operator applies an external force from distal to proximal to the second movable lever 2120, causing the gripper 2200 to open and the tether adjuster to move away from the apical pad 300 in a distal to proximal direction.

[0139] Finally, the operator can cut the tether 200 at the position between the apical pad 300 and the tether adjuster.

[0140] In summary, the clamping and tension adjustment functions of the tether adjuster provided in this embodiment of the invention are independent of each other and do not interfere with each other. It has the advantages of simple and convenient operation and short operation time, and can effectively improve the success rate of surgery.

[0141] While the present invention has been disclosed above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if such modifications and variations fall within the scope of the claims and their equivalents, the present invention also intends to include such modifications and variations.

Claims

1. A tether adjuster, characterized in that, include: case; A clamping mechanism is connected to the distal end of the housing and is capable of clamping the apical pad; the apical pad is used to connect to the proximal end of a tether, and the distal end of the tether is connected to a heart valve prosthesis; the clamping mechanism includes a first drive unit and a jaw, the jaw including two clamping arms symmetrically arranged in the circumferential direction of the housing; the first drive unit is respectively connected to the two clamping arms and is used to drive the distal ends of the two clamping arms to move in a direction away from each other to open the jaw, or to drive the distal ends of the two clamping arms to move in a direction close to each other to close the jaw; as well as, A tension adjustment mechanism, connected to the housing, includes a movable adjustment member and a force monitoring element. The movable adjustment member is for connecting to the proximal end of the tether and includes a first movable rod configured to move axially along the housing to synchronously move the proximal end of the tether to adjust the tension of the tether. The movable adjustment member includes a contact portion located on the distal side of the force monitoring element and includes a boss connected to the outer surface of the first movable rod, which is used to contact the force monitoring element to apply a target force characterizing the tension of the tether. The force monitoring element is also used to monitor the target force. The contact portion includes a second elastic element, which is sleeved on the outer periphery of the first movable rod and located between the boss and the force monitoring element; and / or, the housing has an inner cavity in which the distal end of the first movable rod, the contact portion, and the force monitoring element are all disposed; the housing is also provided with a transparent window, which is disposed corresponding to the force monitoring element; a scale is provided at the transparent window, and the boss is visible to the outside through the transparent window.

2. The tether adjuster according to claim 1, characterized in that, The first drive unit includes a fixed rod, a gripper seat, a second movable rod, and a connecting rod; The fixed rod is connected to the distal end of the housing and remains relatively stationary with respect to the housing; the gripper seat is connected to the distal end of the fixed rod and is also rotatably connected to the middle of each gripper arm; the second movable rod is located between the housing and the gripper seat, the second movable rod is sleeved on a portion of the outer surface of the fixed rod, and is configured to move along the axial direction of the fixed rod; the connecting rod is rotatably connected to the gripper arm and the second movable rod respectively; The clamping mechanism is configured such that when the second movable rod moves from the distal end to the proximal end, the second movable rod drives the distal ends of the two clamping arms to move away from each other via the connecting rod; and when the second movable rod moves from the proximal end to the distal end, the second movable rod drives the distal ends of the two clamping arms to move closer to each other via the connecting rod.

3. The tether adjuster according to claim 2, characterized in that, The number of the connecting rods is two, and the two connecting rods are arranged opposite each other in the circumferential direction of the second movable rod and correspond one-to-one with the two clamping arms; the proximal end of each connecting rod is rotatably connected to the second movable rod, and the distal end of each connecting rod is rotatably connected to the proximal end of the corresponding clamping arm. And / or, The first drive unit further includes a third elastic element, which is sleeved on a portion of the outer surface of the fixed rod and located between the housing and the second movable rod; the third elastic element is configured to store elastic potential energy when the second movable rod moves from the distal end to the proximal end under the action of an external force, and to release the elastic potential energy when the external force is removed, thereby driving the second movable rod to move from the proximal end to the distal end.

4. The tether adjuster according to claim 1, characterized in that, The apical pad includes a second hub, on which a mating hole is provided; The first drive unit has a third channel extending through the housing along its axial direction; the tether adjuster further includes a second drive unit, the second drive unit including an engagement rod partially disposed in the third channel, with the proximal end of the engagement rod disposed on the housing; the engagement rod is also configured to be axially movable along the housing to allow the distal end of the engagement rod to extend out of the third channel and into the engagement hole to connect with the second hub; the engagement rod is also configured to be rotatable in a predetermined direction and to drive the second hub connected to the engagement rod to rotate in the predetermined direction, so that the apical pad is connected to the tether; the engagement rod has a fourth channel extending through its axial direction for the tether to pass through.

5. The tether adjuster according to claim 4, characterized in that, The housing has an inner cavity, and the proximal end of the connecting rod is disposed in the inner cavity; the second driving part further includes a second knob, a fourth elastic element, and a second locking element; the second knob is partially located in the inner cavity and sleeved on the outer surface of the proximal end of the connecting rod, and remains relatively stationary with the connecting rod; an abutment portion is formed on the inner wall of the housing, and the abutment portion is located on the proximal end side of the second knob; the fourth elastic element is disposed between the abutment portion and the second knob; the second locking element is used to selectively connect or disconnect with the second knob. When the second locking element is connected with the second knob, it prevents the second knob and the connecting rod from moving from the proximal end to the distal end, and the second knob compresses the fourth elastic element, causing the fourth elastic element to store elastic potential energy. When the second locking element is disconnected from the second knob, the fourth elastic element releases the elastic potential energy and drives the second knob and the connecting rod to move from the proximal end to the distal end.

6. The tether adjuster according to claim 1, characterized in that, The tension adjustment mechanism further includes a first operating member, which is rotatably connected to the proximal end of the housing and has an engaging portion; the outer side of the first movable rod is provided with an external thread. The external thread on the first movable rod selectively engages or disengages with the engagement part. When the external thread on the first movable rod engages with the engagement part, the first operating member can rotate under the action of external force and drive the first movable rod to move along the axial direction of the housing through helical transmission. When the external thread on the first movable rod disengages from the engagement part, the first movable rod can move along the axial direction of the housing under the action of external force.

7. The tether adjuster according to claim 6, characterized in that, The first operating member is provided with a first channel extending through the axial direction of the housing; a portion of the inner wall of the first channel is provided with internal threads; the engaging portion includes the internal threads; The distal end of the first movable rod is disposed on the housing, and the proximal end of the first movable rod passes through the first channel.

8. The tether adjuster according to claim 7, characterized in that, The first operating element includes a first knob, a first button, and a first elastic element; the first knob is rotatably connected to the proximal end of the housing, and the first knob is provided with a first receiving groove, the extending direction of the first receiving groove intersecting the axial direction of the housing; the first button is partially disposed in the first receiving groove; the first elastic element is disposed in the first receiving groove and is located between the bottom of the first receiving groove and the first button. The first channel extends through the first knob and the first button, and the inner wall surface of the portion of the first channel located on the first button includes a first region and a second region that are circumferentially opposite to each other in the first channel. The first region is closer to the first elastic element than the second region. The first region is provided with the internal thread, and the second region is smooth. When the first button is subjected to an external force pointing from the second region to the first region, the first button moves in the direction from the second region to the first region, causing the external thread on the first movable rod to disengage from the internal thread on the first region, and causing the first elastic element to store elastic potential energy; when the external force is removed, the first elastic element releases the elastic potential energy, and drives the first button to move in the direction from the first region to the second region, causing the internal thread on the first region to engage with the external thread on the first movable rod.

9. The tether adjuster according to claim 1, characterized in that, The inner wall of the housing is also provided with a guide groove extending along the axial direction of the housing, and the boss is partially disposed in the guide groove.

10. The tether adjuster according to claim 7, characterized in that, The movable adjustment component further includes a fixed base and a first locking component; the fixed base is connected to the proximal end of the first movable rod; the movable adjustment component is provided with a second channel that passes through the first movable rod and the fixed base along the axial direction of the housing, the second channel being used for the tether to pass through; the first locking component is disposed on the fixed base and is used to fix the portion of the tether that passes through the fixed base; The fixing base is provided with a locking hole, the extension direction of the locking hole intersects with the second channel, and the locking hole communicates with the second channel; the first locking member partially passes through the locking hole and extends into the second channel; or, The fixing seat includes a seat body and a plurality of first clamping pieces. The seat body is connected to the proximal end of the first movable rod. The plurality of first clamping pieces are disposed on the proximal end face of the seat body and are arranged at intervals around the second channel. The first locking member includes a first hub, which is threadedly engaged with the seat body and used to compress the first clamping pieces, so that all the first clamping pieces together clamp the tether.

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