Medical device

Abstract

A medical device (20) for repairing a heart valve of a patient, comprising a coaptation member (21) and a pair of blades (22) arranged at two sides of the coaptation member (21) in the thickness direction. The coaptation member (21) comprises: an extension part (212) extending in the length direction and having one end connected to the pair of blades (22); and an acting part (211) connected to the other end of the extension part (212) and having a width greater than the width of the extension part (212). The configuration that the coaptation member (21) has an acting part (211) provided at one end of the extension part (212) and having a greater width improves the range of action of the coaptation member (21), such that only one medical device (20) is required to effectively improve the regurgitation condition of a patient with a large heart. Therefore, for a patient with a large heart, the use of the medical device (20) can reduce the cost and difficulty of surgery.

Description

medical devices Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and in particular, to a medical device for repairing a valve of a patient. Background Art

[0002] Heart valves are the valves between the atria and ventricles, or between the ventricles and arteries. They play a critical role in the heart's constant circulation of blood. After blood has flowed through them, the valves close, preventing reverse flow. Several structural factors can affect the proper closure of heart valves, leading to reverse flow. For example, if the mitral valve doesn't close properly, blood can flow from the left ventricle through the mitral valve into the left atrium during systole, potentially harming the patient's health.

[0003] A medical device for repairing heart valves has a structure similar to a clip. This medical device improves valve insufficiency by clamping onto a pair of leaflets of the valve. Specifically, this medical device includes a coupling member and a pair of paddles located on opposite sides of the coupling member in the thickness direction. After this medical device is implanted into the patient's heart, one leaflet of the valve is clamped between the coupling member and one paddle, and the other leaflet of the valve is clamped between the coupling member and the other paddle. Taking the mitral valve as an example, when the left ventricle relaxes, the pair of leaflets on both sides of the valve of the medical device open to form double holes, allowing blood to flow from the left atrium into the left ventricle; when the left ventricle contracts, the valve closes to close the double holes, thereby preventing blood from the left ventricle from flowing back into the left atrium.

[0004] However, due to differences in heart structure between patients, some patients (e.g., those with larger hearts) experience more severe valvular insufficiency, and a single medical device alone cannot effectively improve heart regurgitation. In such cases, multiple medical devices are required, requiring multiple "clips" to be placed at different locations on a pair of leaflets. This increases treatment costs and surgical difficulty. Furthermore, the multiple "clips" may cause incomplete valvular opening during ventricular diastole, leading to valvular "stenosis," which can hinder diastolic atrial blood flow into the ventricles and cause ventricular filling problems.

[0005] Summary of the Invention

[0006] In view of this, the present disclosure provides a medical device for repairing a patient's heart valve, so as to reduce surgical costs and ease surgical difficulty.

[0007] The medical device provided by the present disclosure includes a mating part and a pair of paddles arranged on both sides of the mating part in the thickness direction. The mating part includes: an extension part, which extends along the length direction and has one end connected to the pair of paddles; and an action part, which is connected to the other end of the extension part and has a width greater than the width of the extension part.

[0008] The medical device provided herein features a widened active portion at one end of the extended portion. This design increases the effective range of the device for valvular insufficiency, allowing a single medical device to more effectively improve regurgitation in patients, including those who currently require more than one device, such as those with larger hearts. Consequently, the medical device provided herein can be applied to a wider range of patients while also reducing surgical costs, difficulty, and complications.

[0009] In a possible implementation, the width of the active portion is adjustable.

[0010] Since the active part has an adjustable width, the width of the active part can be adjusted according to the actual condition of the patient's heart during or after the operation to achieve "precise" treatment, so that the active part can better match the patient's heart structure, and the medical device can more effectively improve the reflux condition.

[0011] In one possible implementation, the medical device further includes: a control unit; and an adjustment mechanism configured to adjust the width of the active portion under the control of the control unit.

[0012] Considering that the patient's condition is constantly developing. When the patient's condition develops (or recovers) to a certain extent, the initial width of the active part may no longer match the patient's condition. According to the medical device provided by the present disclosure, when the patient's condition changes, the width of the active part can be adjusted by controlling the adjustment mechanism through the control unit, so that the width of the active part can be re-matched with the patient's condition. It can be seen that if the medical device provided by the present disclosure is adopted, when the patient's condition changes, there is no need or as much as possible to postpone the replacement and / or addition / replacement of the medical device through re-operation or the adjustment of the width of the active part through re-intervention surgery to adapt to the patient's condition. Therefore, the use of the medical device provided by the present disclosure can reduce the economic burden on patients and reduce damage to their health.

[0013] In a possible implementation, the medical device further includes a communication unit configured to receive a control instruction, and the control unit is configured to control the adjustment mechanism to adjust the width of the action portion based on the control instruction.

[0014] After implantation of the medical device disclosed herein, the patient can undergo regular reexaminations to confirm changes in their condition. When a problem with the patient's transvalvular hemodynamics is detected, such as when the width of the device's active portion no longer matches the patient's condition, the doctor can send a control instruction to the communication unit of the medical device implanted in the patient's body via a control device located outside the body. After receiving the control instruction, the control unit can control the adjustment mechanism according to the control instruction, so that the adjustment mechanism appropriately adjusts the width of the active portion, thereby making the width of the active portion match the patient's condition again.

[0015] In one possible implementation, the medical device further includes a sensor configured to sense physiological information of the patient, and the control unit is configured to control the adjustment mechanism to adjust the width of the action portion based on the physiological information.

[0016] Because the control unit includes a sensor for sensing physiological information reflecting the patient's condition, it can control the adjustment mechanism to adjust the width of the active portion based on this physiological information, so that the active portion can better and more timely match the patient's condition. The medical device provided by this implementation can reduce the number of follow-up examinations required by patients after implantation, thereby reducing the patient's financial burden and time costs, while also achieving more accurate, timely, and effective treatment.

[0017] In one possible implementation, the control system further includes a wake-up unit configured to wake up one or more of the control unit, the communication unit, and the sensor based on a preset schedule.

[0018] In one possible implementation, the action portion includes a pair of shells, the pair of shells including a first shell and a second shell, wherein the first shell is arranged on the outside of the second shell, and the adjustment mechanism is configured to adjust the overlap between the first shell and the second shell under the control of the control unit, thereby adjusting the width of the pad.

[0019] In one possible implementation, the adjustment mechanism includes a drive unit, a pair of gears and a screw; the pair of gears includes a first gear and a second gear that are meshed with each other, the drive unit is used to drive the first gear to rotate, thereby driving the second gear to rotate, and the second gear is meshed with the screw and is used to drive the screw to rotate; the screw drives the first shell and the second shell to move relative to each other, thereby adjusting the overlap between the first shell and the second shell.

[0020] In one possible implementation, the medical device also includes a force-applying member, the action portion includes a pair of shells, the pair of shells includes a first shell and a second shell, wherein the first shell is arranged on the outside of the second shell, and the force-applying member is used to adjust the overlap between the first shell and the second shell, thereby adjusting the width of the pad.

[0021] In a possible implementation, a pair of lugs is provided on the outer surface of the second shell, and a pair of fixing grooves is provided on the inner surface of the first shell. The pair of fixing grooves respectively cooperate with the pair of lugs so that the action portion has an adjustable width.

[0022] In a possible implementation, the action portion is curved in a manner of convexly facing one side in the thickness direction. The action portion having such a structure can better match the shape of a pair of leaflets, thereby being able to more effectively improve the regurgitation condition.

[0023] In a possible implementation, a projection of the engaging member in the thickness direction is T-shaped, and the acting portion is arranged to be perpendicular to the extending portion.

[0024] In one possible implementation, each paddle includes a main body extending longitudinally and connected to the mating member at one end; and a clamping seat disposed at the other end of the main body and having a greater width than the main body. This configuration can increase the range of action of the medical device, thereby improving its effectiveness and further improving reflux.

[0025] In one possible implementation, the active portion and the clamping seat portion of each blade are curved to convexly face the same side in the thickness direction. A medical device with such a structure can better match the shape of a pair of leaflets, thereby more effectively improving reflux.

[0026] In a possible implementation, the ratio of the width of the active portion to the width of the extended portion ranges from 1.25 to 5.5. In particular, the ratio of the width of the active portion to the width of the extended portion ranges from 2 to 4.

[0027] In a possible implementation, the ratio of the width of the clamping seat portion to the width of the main body portion ranges from 1.25 to 5.5. In particular, the ratio of the width of the clamping seat portion to the width of the main body portion ranges from 2 to 4.

[0028] In a possible implementation, a projection of the blade in the thickness direction is T-shaped, and the clamping seat portion has a structure matching the action portion.

[0029] BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the embodiments.

[0031] It should be understood that the following drawings only illustrate certain embodiments of the present disclosure, but not all.

[0032] It should be understood that the same or similar reference numerals are used throughout the drawings to identify the same or similar elements.

[0033] It should be understood that the drawings are merely schematic and that the sizes and proportions of elements in the drawings are not necessarily accurate.

[0034] 1A and 1B illustrate a healthy heart valve viewed from the first chamber side, wherein the heart valve is open in FIG. 1A and properly closed in FIG. 1B .

[0035] FIG. 2 shows a malfunctioning heart valve that fails to close properly, as viewed from the first chamber side.

[0036] FIG3 is a schematic structural diagram of a medical device according to related art.

[0037] FIG. 4 shows the medical device shown in FIG. 3 installed at a heart valve of a patient.

[0038] 5A and 5B illustrate the medical device shown in FIG. 3 mounted on a patient's heart valve as viewed from the first chamber side, wherein in FIG. 5A a pair of leaflets form double holes on both sides of the medical device, and in FIG. 5B a pair of leaflets are properly apposed.

[0039] 6 illustrates the medical device shown in FIG. 3 mounted on a heart valve of a patient, viewed from the first chamber side, wherein a pair of leaflets fail to properly appose.

[0040] FIG7 is a schematic structural diagram of a medical device according to an embodiment of the present disclosure.

[0041] FIG8 is a schematic structural diagram of the medical device shown in FIG7 viewed from another direction.

[0042] FIG9 is a schematic structural diagram of the medical device shown in FIG7 viewed from another direction.

[0043] FIG. 10 is a schematic structural diagram of at least a portion of the engaging member of the medical device in FIG. 7 .

[0044] FIG. 11 shows the medical device shown in FIG. 7 installed at a heart valve of a patient.

[0045] 12 shows the medical device shown in FIG. 7 installed at a patient's heart valve as viewed from the first chamber side, with the pair of leaflets properly apposed.

[0046] 13A and 13B are schematic structural diagrams showing an adjustment mechanism, a control system, a sensor, and an action portion of an engaging member of a medical device according to another embodiment of the present disclosure.

[0047] FIG. 14 is an exploded schematic diagram of an active portion of an engaging member of a medical device according to another embodiment of the present disclosure.

[0048] FIG15 is a partial cross-sectional view of the housing of the action portion shown in FIG14 .

[0049] FIG16 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.

[0050] FIG17 is a schematic structural diagram of the medical device shown in FIG16 viewed from another direction.

[0051] FIG18 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.

[0052] FIG19 is a schematic structural diagram of the medical device shown in FIG18 viewed from another direction.

[0053] FIG. 20 is a schematic diagram of at least a portion of the paddle of the medical device of FIG. 18 . DETAILED DESCRIPTION

[0054] The following will be combined with the accompanying drawings in the embodiments of the present disclosure to exemplarily describe the technical solutions in the embodiments of the present disclosure. Obviously, the described embodiments are only part of the embodiments of the present disclosure, rather than all the embodiments.

[0055] Heart valves are the valves between the atria and ventricles, or between the ventricles and arteries. They play a crucial role, like valves, in the heart's constant blood circulation. After blood has flowed through them, the valves close, preventing backflow.

[0056] Taking the valve located between the first and second chambers as an example, see Figures 1A and 1B. This valve includes a pair of leaflets FL and SL. As shown in Figure 1A, when the second chamber is in diastole, the pair of leaflets FL and SL separate from each other, opening the valve and allowing blood to flow from the first chamber into the second chamber. As shown in Figure 1B, in a healthy valve, when the second chamber is in systole, the pair of leaflets FL and SL properly appose to properly close the valve, preventing blood from flowing back from the second chamber into the first chamber.

[0057] For example, in the present disclosure, the first chamber may be referred to as the left atrium, the second chamber may be referred to as the left ventricle, and the valve therebetween may be referred to as the mitral valve.

[0058] Several structural factors can affect heart valve closure, leading to blood regurgitation. As shown in Figure 2, in a dysfunctional heart valve, when the second chamber is in systole, the pair of leaflets FL and SL fail to properly appose, leaving a gap G between them. This prevents the valve from closing properly, allowing blood to flow from the second chamber into the first chamber through gap G (i.e., causing regurgitation), which can harm the patient's health.

[0059] 3 , a medical device 10 includes a mating member 11 and a pair of paddles 12. The paddles 12 are located on opposite sides of the mating member 11 in the thickness direction. That is, the direction from one paddle 12 to the other paddle 12 can be considered the thickness direction of the medical device 10.

[0060] It should be noted that in the drawings of the present disclosure, arrows T+ and T- are respectively used to indicate the opposite sides in the thickness direction of the medical device; arrows L+ and L- are respectively used to indicate the opposite sides in the length direction of the medical device; and arrows W+ and W- are respectively used to indicate the opposite sides in the width direction of the medical device.

[0061] 4 , when the medical device 10 is implanted in the valve, the pair of paddles 12 are respectively configured to grasp the pair of leaflets FL, SL to hold the apposition member 11 between the pair of leaflets FL, SL, thereby repairing the valve function.

[0062] Specifically, as shown in Figure 5A , when the second chamber is in diastole, the pair of leaflets FL and SL form dual orifices on either side of the medical device 10 (i.e., on either side of the apposition member 11); the valve opens, allowing blood to flow from the first chamber into the second chamber. As shown in Figure 5B , when the second chamber is in systole, the pair of leaflets FL and SL properly appose on either side of the apposition member 11; the valve closes properly, preventing blood backflow.

[0063] However, due to structural differences in heart valves between patients (e.g., some patients have larger hearts), a single medical device 10 cannot effectively eliminate regurgitation, resulting in residual regurgitation, which can still lead to high atrial pressure, low aortic ejection volume, and corresponding symptoms. As shown in FIG6 , for such patients, when the second chamber contracts, the apposition of the pair of leaflets FL and SL on either side of the apposition member 11 cannot completely eliminate the existing gap G, but instead forms two residual gaps G1 and G2 on either side of the apposition member 11. At this point, blood may flow back from the second chamber to the first chamber through gaps G1 and G2.

[0064] For such patients, multiple medical devices 10 are typically placed on their heart valves, either spaced apart or in contact. However, the use of multiple medical devices 10 not only significantly increases treatment costs but also greatly increases surgical difficulty. Simultaneous use of multiple devices 10 may also excessively constrain the valve, affecting its ability to open during diastole, resulting in an insufficient opening (stenosis), and thus impairing blood flow from the atria into the ventricles.

[0065] In view of the above situation, an embodiment of the present disclosure provides a medical device 20. Referring to Figures 7 to 11, the medical device 20 includes a coupling 21 and a pair of paddles 22. The pair of paddles 22 are located on opposite sides of the coupling 21 in the thickness direction. After the medical device 20 is implanted at the valve, the pair of paddles 22 are configured to maintain the coupling 21 between the pair of leaflets FL, SL. In one example, each paddle 22 can have a structure similar to a clip to clamp on the corresponding leaflet, thereby positioning the coupling 21 between the pair of leaflets FL, SL. In another example, each paddle 22 can cooperate with the coupling 21 to clamp the corresponding leaflet between the two, thereby positioning the coupling 2111 between the pair of leaflets FL, SL. It should be understood that the specific implementation of the pair of paddles 22 can refer to the relevant technology, and for the purpose of brevity, it will not be repeated here.

[0066] The engaging member 21 includes an operating portion 211 and an extending portion 212. The extending portion 212 extends along the length of the medical device 20. The extending portion 212 has two opposing ends in the lengthwise direction. One end is connected to the pair of paddles 22 (directly or via an intermediate member), and the other end is connected to the operating portion 211. The width W1 of the operating portion 211 is configured to be greater than the width W2 of the extending portion 212.

[0067] In this disclosure, the width of an element may refer to its dimension in the width direction. Furthermore, in certain embodiments of this disclosure, the width direction, thickness direction, and length direction may be perpendicular to each other. Furthermore, in certain embodiments of this disclosure, the width of an element may refer to its maximum width; in other embodiments of this disclosure, the width of an element may refer to its average width.

[0068] As shown in Figure 12 , after implantation into the valve, the boundaries of the pair of leaflets FL and SL extend in a direction close to the width of the active portion 211. Due to the greater width of the active portion 211, this configuration increases the range of action of the apposition member 21. Comparing Figures 6 and 12 , it can be seen that for larger hearts, if medical device 20 is used, only one medical device 20 is required to properly close the pair of leaflets FL and SL during contraction of the second chamber, effectively preventing or mitigating regurgitation.

[0069] The medical device provided herein includes a wide, active portion at one end of the extended portion. This design increases the active range of the device, allowing a single medical device to effectively improve reflux in patients with larger hearts. Therefore, for patients with larger hearts, the medical device provided herein can reduce surgical costs and difficulty, while achieving better treatment outcomes.

[0070] It should be noted that in the present disclosure, the width W1 of the action portion 211 is not slightly larger than the width W2 of the extension portion 212, but is significantly larger than the width W2 of the extension portion 212. In this way, the medical device 20 can play the role of multiple traditional medical devices in a larger heart. For example, the ratio of the width W1 of the action portion 211 to the width W2 of the extension portion 212 ranges from 1.25 to 5.5. In particular, the ratio of the width W1 of the action portion 211 to the width W2 of the extension portion 212 ranges from 2 to 4. As shown in Figures 7 to 10, preferably, the extension direction of the action portion 211 is consistent with the width direction, while the extension direction of the extension portion 212 is consistent with the length direction. The projection of the mating member 21 in the thickness direction is roughly T-shaped, and the action portion 211 is arranged to be perpendicular to the extension portion 212 and has a roughly cylindrical structure.

[0071] Considering that the structures of heart valves vary among patients, and that the structure of the heart valves of the same patient may also change as the condition progresses, in some embodiments, the engaging member of the medical device provided herein may be configured to have an adjustable width. Since the width of the active portion is adjustable, the width of the active portion can be adjusted during or after surgery based on the patient's actual heart condition, thereby enabling the active portion to better match the patient's heart structure, and thus enabling the medical device to more effectively improve regurgitation.

[0072] The following describes a medical device with an active portion having an adjustable width by way of example with reference to the accompanying drawings.

[0073] As a possible implementation, referring to Figures 13A and 13B, a medical device according to another embodiment of the present disclosure may include, in addition to a pair of blades and a pair of blades, a control system 33 and an adjustment mechanism. The configuration of the pair of blades and the pair of blades of the medical device provided in this embodiment can be referred to the above embodiment. For the purpose of brevity, they will not be described here in detail. The control system 33 may include a control unit 331. The adjustment mechanism may be configured to adjust the width of the active portion 311 of the pair of blades under the control of the control unit 331.

[0074] Considering that the patient's condition is constantly developing. When the patient's condition develops to a certain extent, the initial width of the active part may no longer match the patient's condition. According to the medical device provided by the present disclosure, when the patient's condition changes, it is only necessary to control the adjustment mechanism through the control unit to adjust the width of the active part, so that the width of the active part can be re-matched with the patient's condition. It can be seen that if the medical device provided by the present disclosure is adopted, when the patient's condition changes, there is no need to replace the medical device through another surgery or adjust the width of the active part through another surgery to adapt to the patient's condition. Therefore, the use of the medical device provided by the present disclosure can reduce the economic burden on patients and reduce damage to their health.

[0075] There are various ways to adjust the width of the active portion, which are not specifically limited in this disclosure. As an example, referring again to Figures 13A and 13B , the active portion 311 includes a pair of shells: a first shell 3111 and a second shell 3112. The first shell 3111 is sleeved over the second shell 3112, and the two shells cooperate to define an internal space 311a. In certain embodiments, the first shell 3111 can be connected to an extension of the mating member.

[0076] The adjustment mechanism is configured to adjust the overlap between the first shell 3111 and the second shell 3112 under the control of the control unit, thereby adjusting the width of the pad 311. When the pad 311 is in the state shown in FIG. 13A, the overlap between the first shell 3111 and the second shell 3112 is D. 1a Small, the width W of the action portion 311 1a When the action portion 311 is in the state shown in FIG13B, the overlap degree D between the first shell 3111 and the second shell 3112 is larger. 1b Larger, the width W of the action portion 311 1b Smaller.

[0077] In this way, the adjustment mechanism can adjust the width of the pad under the control of the control unit. This implementation has many advantages such as simple implementation, compact structure and good reliability.

[0078] There are many ways to adjust the overlap of a pair of shells, and this disclosure does not specifically limit this.

[0079] As an example, referring again to Figures 13A and 13B , the adjustment mechanism may include a drive unit 341, a pair of gears, and a lead screw 344. A first boss 3113 is provided on the inner wall of the first shell 3111, and a second boss 3114 is provided on the inner wall of the second shell 3112. The first boss 3113 has a through hole, and the second boss 3114 has a threaded hole.

[0080] The pair of gears includes a first gear 342 and a second gear 343. The drive unit 341 is used to drive the first gear 342 to rotate. For example, the drive unit 341 can be a motor, and the first gear 342 can be mounted on its output shaft. The second gear 343 is mounted on a lead screw 344 and meshes with the first gear 342. The lead screw 344 passes through the through hole of the first boss 3113 and is supported in a rotatable and non-sliding manner by components such as bearings and retaining rings. The lead screw 344 passes through the threaded hole of the second boss 3114 and has external threads that mate with the threaded hole.

[0081] When the width of the operating portion 311 needs to be adjusted, the control unit 331 can control the operation of the drive unit 341. As the drive unit 341 moves, torque is transmitted to the lead screw 344 via the first gear 342 and the second gear 343. As the lead screw 344 rotates, it causes the first shell 3111 and the second shell 3112 to move relative to each other, changing the overlap between the two, thereby changing the width of the operating portion 311.

[0082] In one example, referring to FIG13A and FIG13B , the control system 33 may further include a communication unit 332. The communication unit 332 is configured to wirelessly communicate with a control device located inside or outside the patient's body. For example, the communication unit 332 may communicate with the external control device via, but is not limited to, Bluetooth, a cellular network, Wi-Fi, radio frequency communication, or ultrasonic communication.

[0083] The doctor (or patient) can operate the control device to send a control instruction to the communication unit 332. The communication unit 332 is configured to receive the control instruction and send the control instruction to the control unit 341. After receiving the control instruction, the control unit 341 is configured to control the adjustment mechanism based on the control instruction to adjust the width of the action part 311.

[0084] After implantation of the disclosed medical device, patients can undergo regular reexaminations to confirm changes in their condition. If the doctor detects that the width of the active portion no longer matches the patient's condition, they can use a control device located internally or externally to send a control instruction to the communication unit of the implanted medical device. Upon receiving this control instruction, the control unit can control the adjustment mechanism accordingly, causing it to appropriately adjust the width of the active portion, thereby re-adapting the pad to the patient's condition.

[0085] In another example, referring again to FIG13A and FIG13B , the medical device may further include a sensor 35, which is communicatively connected to the control unit 341. The sensor 35 is configured to sense physiological information of the patient and transmit the sensed physiological information to the control unit 341, so that the control unit 341 controls the adjustment mechanism based on the physiological information to adjust the width of the active portion 311.

[0086] For example, the physiological information may include, but is not limited to, one or more of the following: blood pressure information, blood flow rate information, blood pH information, blood temperature information, blood oxygenation information, electrocardiogram information, heart sound information, cardiac acceleration information, and cardiac contractility information in the patient's heart. Correspondingly, the sensor in the present disclosure may be a sensor capable of sensing one or more of the above information.

[0087] Because the sensor is used to detect physiological information reflecting the patient's condition, the control unit can control the adjustment mechanism to adjust the width of the active portion based on this physiological information, so that the width of the active portion is always consistent with the patient's condition. The medical device provided by this implementation can reduce the number of follow-up examinations required by patients after implantation, thereby reducing the patient's financial burden and time costs.

[0088] It is understood that in certain embodiments, the medical device provided by the present disclosure may include only one of the communication unit and the sensor, or may include both the communication unit and the sensor, and the present disclosure does not specifically limit this. In certain embodiments, the sensor used in the present disclosure may be part of the medical device provided by the present disclosure, or may be part of another medical device, and the present disclosure does not specifically limit this.

[0089] There are many ways to implement the sensor, and this disclosure does not specifically limit this. As an example, the sensor may include a hemodynamic sensor, such as a pressure sensor or an accelerometer. The sensor can be attached to the top of the counterpart to sense physiological information that can reflect the blood flow state at the valve. In other words, the physiological information sensed by the sensor can reflect the blood flow state at the valve, that is, it can reflect whether there is a regurgitation phenomenon or a stenosis phenomenon. In this way, the control unit can appropriately adjust the width of the active part according to the physiological information, so that the width of the active part is more in line with the patient's current condition.

[0090] It should be noted that in other examples, the sensor may not be attached to the apposition member. For example, in some embodiments, the sensor may be mounted on the leaflet or the extension. In another example, in some embodiments, the sensor may be mounted on other components of the medical device.

[0091] In addition, it should be noted that, in certain embodiments, the medical device provided by the present disclosure may also include multiple sensors, and the multiple sensors may be arranged in different positions, so as to more accurately determine the patient's condition.

[0092] In order to reduce energy consumption, in one example, referring again to Figures 13A and 13B, the control system 33 may also include a wake-up unit 333, which is configured to wake up one or more of the control unit 341, the communication unit 332 and the sensor 35 based on a preset schedule.

[0093] Considering that a patient's condition typically progresses slowly, frequent adjustment of the width of the active portion is unnecessary. In this implementation, the control unit, sensor, and communication unit can remain dormant for most of the time. After a preset time point, the wake-up unit can wake one or more of them up. This reduces energy consumption and achieves energy conservation.

[0094] As an example, the preset schedule may include multiple cycles, each cycle including a sleep phase and a wake-up phase. During the sleep phase, units requiring energy consumption other than the wake-up unit 333 may be in a dormant state to reduce energy consumption. After the wake-up phase begins, the wake-up unit 333 may wake up some or all of the units requiring energy consumption.

[0095] For example, a sleep phase can last from 6 months to 12 months, and a wake-up phase can last from 3 days to 7 days. The duration and start time of each phase can be set. The doctor can set the preset schedule to match the patient's reexamination plan, that is, set the preset schedule so that when the patient needs a reexamination, the medical device 10 is in the wake-up phase. In this way, after the doctor has examined the patient's condition, he can send a control instruction to the communication unit 332 through an external control device to adjust the width of the action portion 311 to match the patient's condition after the reexamination. Of course, the doctor can also wake up the medical device and put it into operation through an external device.

[0096] In one example, referring again to FIG. 13A and FIG. 13B , the control system 33 may further include a power supply unit 334 configured to supply power to one or more of the control unit 341 , the communication unit 332 , the wake-up unit 333 , and the sensor 35 .

[0097] The energy supply unit 334 can be implemented in a variety of ways, and this disclosure does not specifically limit this. For example, in some embodiments, the energy supply unit 334 can be a battery. In another example, in some embodiments, the energy supply unit 334 can be an induction coil, and the doctor or patient can charge the energy supply unit through an external device. In another example, in some embodiments, the energy supply unit 334 can also be an ultrasonic transducer to convert ultrasonic waves transmitted by an external device into electrical energy.

[0098] For the purpose of simplifying the structure, in some implementations, part or all of the control system 33 may be located inside the active portion 311. Of course, in some embodiments, the control system 33 may also be located entirely outside the active portion 311. This disclosure does not specifically limit this.

[0099] The method of adjusting the width of the action portion is not limited to being achieved by the control unit and the adjustment mechanism. In other embodiments, the action portion can be configured to be manually adjustable by the doctor during surgery. A possible implementation is given below.

[0100] Referring to Figure 14 , in this embodiment, the engaging member 411 of the medical device comprises a pair of shells, namely a first shell 4111 and a second shell 4112. In certain embodiments, the shells 4111 may be fixedly connected to the extending portion of the engaging member. It should be noted that the configuration of the engaging member and the pair of paddles of the medical device provided in this embodiment can be referenced to the medical device 10 provided in the aforementioned embodiment. For the sake of brevity, this description will not be repeated here.

[0101] The first shell 4111 is sleeved outside the second shell 4112. In this embodiment, the medical device further includes a force-applying member 43 that applies a force toward the first shell 4111 and the second shell 4112, away from each other. For example, the force-applying member 43 may be a compression spring 43 disposed within a cavity cooperatively defined by the first shell 4111 and the second shell 4112, with both ends of the compression spring 43 respectively abutting against the inner surfaces of the first shell 4111 and the second shell 4112 in terms of width.

[0102] A pair of lugs 4112a are provided on the outer surface of the second shell 4112, and a pair of fixing grooves are provided on the inner surface of the first shell 4111. The pair of fixing grooves are respectively matched with the pair of lugs 4112a (that is, the pair of lugs 4112a are respectively inserted into the pair of fixing grooves) so that the action part 411 has an adjustable width.

[0103] Specifically, referring to Figure 15 , each fixing slot includes a trunk 4111a extending along the width direction and a plurality of branches spaced apart in the width direction and intersecting the trunk 4111a. Each branch includes a connecting section 4111b and a tail section 4111c. One end of the connecting section 4111b connects to the trunk 4111a and the other end connects to the tail section 4111c. One end of the tail section 4111c connects to the connecting section 4111b and the other end extends along the width direction toward the side where the housing 4112 is located.

[0104] Normally, the lug 4112a is located at the tail section 4111c of one branch. Under the action of the force-applying member 43, the lug 4112a does not dislodge from the tail section 4111c. When the width of the operating portion 411 needs to be adjusted, the surgeon can manually adjust the width of the operating portion 411 (e.g., using a surgical instrument). Specifically, the operating portion 411 can be compressed to move the lug 4112a from the tail section 4111c into the connecting section 4111b. Next, the pair of shells 4111 and 4112 can be caused to rotate relative to each other, moving the lug 4112a from the connecting section 4111b into the trunk 4111a. Next, the pair of shells 4111 and 4112 can be caused to move and rotate relative to each other along the width direction, moving the lug 4112a into the tail section 4111c of the other branch. In this way, the width of the operating portion 411 can be manually changed.

[0105] A medical device 50 according to another embodiment of the present disclosure is shown in Figures 16 and 17. As shown in Figures 16 and 17, the medical device 50 is substantially the same as the medical device 20 in the aforementioned embodiment. The medical device 50 includes a mating member 51 and a pair of paddles 52. The pair of paddles 52 are disposed on opposite sides of the mating member 51 in the thickness direction. The mating member 51 includes an action portion 511 and an extension portion 512. The extension portion 512 extends in the length direction, and one end thereof in the length direction is connected to the pair of paddles 52, and the other end is connected to the action portion 511.

[0106] In this embodiment, the action portion 511 is configured to bend in a manner that bulges toward one side in the thickness direction (i.e., the T+ side). Considering that the sizes of a pair of leaflets FL, SL are generally not exactly the same, as shown in FIG1B , when the pair of leaflets FL, SL are in apposition, the boundary between them is generally curved in a manner that bulges toward one side, i.e., roughly C-shaped. When the medical device 50 is implanted in the patient's valve, the pair of leaflets FL, SL are located on opposite sides of the action portion 511 in the thickness direction. The action portion 511 is configured to bend in a manner that bulges toward one side in the thickness direction. This configuration of the action portion 511 facilitates adaptation to (or matching) the shape of the pair of leaflets FL, SL, thereby facilitating proper apposition of the pair of leaflets FL, SL. If the action portion does not match the shape of the pair of leaflets FL, SL, then when the pair of leaflets FL, SL are in apposition, the action portion may affect the apposition of the pair of leaflets FL, SL, resulting in insufficient apposition of the pair of leaflets FL, SL, thereby causing regurgitation.

[0107] A medical device 60 according to another embodiment of the present disclosure is shown in Figures 18 and 19. As shown in Figures 18 and 19, the medical device 60 is substantially the same as the medical device 20 in the aforementioned embodiment. The medical device 60 includes a mating member 61 and a pair of paddles 62. The pair of paddles 62 are disposed on opposite sides of the mating member 61 in the thickness direction. The mating member 61 includes an action portion 611 and an extension portion 612. The extension portion 612 extends in the length direction, with one end thereof being connected to the pair of paddles 62 in the length direction and the other end being connected to the action portion 611.

[0108] In this embodiment, referring to FIG20 , each paddle 62 includes a clamping seat portion 621 and a main body portion 622. The main body portion 622 extends in the length direction. One end of the main body portion 622 in the length direction is connected to the mating member 612, and the other end is connected to the clamping seat portion 621. The width W3 of the clamping seat portion 621 is greater than the width W4 of the main body portion 622. After the medical device 60 is implanted in the patient's valve, the clamping seat portion 621 of each paddle 62 and the action portion 611 of the mating member 61 and / or the main body portion of each paddle 62 and the extension portion 612 of the mating member 61 clamp a leaflet therebetween. Since both the clamping seat portion 621 and the action portion 611 have a large width, the cooperation between the two can further increase the range of action of the medical device, thereby improving the effectiveness of the medical device, and further improving the reflux situation.

[0109] It should be noted that in the present disclosure, the width W3 of the clamping seat portion 621 is not slightly larger than the width W4 of the main body portion 622, but is significantly larger than the width W4 of the main body portion 622. In this way, the medical device 60 can play the role of multiple traditional medical devices in a larger heart. For example, the ratio of the width W3 of the clamping seat portion 621 to the width W4 of the main body portion 622 ranges from 1.25 to 5.5. In particular, the ratio of the width W3 of the clamping seat portion 621 to the width W4 of the main body portion 622 ranges from 2 to 4. Therefore, as shown in Figures 18 to 20, the projection of the paddle 62 in the thickness direction is T-shaped. Preferably, the clamping seat portion 621 has a structure that matches the action portion 611. For example, when the action portion 611 is a roughly cylindrical structure, the clamping seat portion 621 has a curved surface structure and its concave surface faces the outer surface of the action portion 611.

[0110] Referring again to FIG19 , the active portion 611 of the engaging member 61 and the clamping seat portion 621 of each paddle 62 are configured to be curved so as to convexly face the same side (i.e., the T+ side) in the thickness direction. The medical device 60 having this configuration can better match the shape of the pair of leaflets FL and SL, thereby more effectively improving regurgitation.

[0111] It should be understood that in other embodiments, the action portion of the engaging member and the clamping seat portion of each blade may also extend straight in the width direction without being bent.

[0112] It should be understood that the medical device according to the present disclosure is not limited to application at the mitral valve. Obviously, the medical device according to the present disclosure can also be applied to other heart valves. For example, the medical device according to the present disclosure can also be applied to the tricuspid valve. More specifically, the medical device according to the present disclosure can also be applied to a pair of cooperating leaflets of the tricuspid valve.

[0113] It should be understood that the term “including” and its variations used in the present disclosure are open inclusions, that is, “including but not limited to.” The term “one embodiment” means “at least one embodiment,” and the term “another embodiment” means “at least one additional embodiment.”

[0114] It should be understood that although the terms "first" or "second" etc. may be used in the present disclosure to describe various elements (such as a first chamber and a second chamber), these elements are not limited by these terms. These terms are only used to distinguish one element from another.

[0115] It should be noted that the various specific technical features (elements) described in the above specific embodiments can be combined in any appropriate manner without contradiction. In order to avoid unnecessary repetition, the present disclosure will not further describe various possible combinations.

[0116] It should be understood that multiple components and / or parts can be provided by a single integrated component or part. Alternatively, a single integrated component or part can be divided into separate multiple components and / or parts. The disclosure "a" or "an" used to describe a component or part does not mean to exclude other components or parts.

[0117] The above description is merely a specific embodiment of the present disclosure, but the scope of protection of the present disclosure is not limited thereto. Any changes or substitutions that can be conceived by a person skilled in the art within the technical scope disclosed in this disclosure should be included in the scope of protection of the present disclosure. Therefore, the scope of protection of the present disclosure should be based on the scope of protection of the claims.

Claims

1. A medical device for repairing a valve of a patient, characterized in that, it includes an engaging member and a pair of blades respectively disposed on both sides of the engaging member in the thickness direction, and the engaging member includes: an extension portion extending along the length direction and having one end connected to the pair of blades; and a working portion connected to the other end of the extension portion and having a width greater than that of the extension portion.

2. The medical device according to claim 1, characterized in that, the width of the working portion is adjustable.

3. The medical device according to claim 2, characterized in that, it further includes: a control unit; and an adjusting mechanism configured to adjust the width of the working portion under the control of the control unit.

4. The medical device according to claim 3, characterized in that, it further includes a communication unit configured to receive a control instruction, and the control unit is configured to control the adjusting mechanism based on the control instruction to adjust the width of the working portion.

5. The medical device according to claim 3, characterized in that, it further includes a sensor configured to sense physiological information of the patient, and the control unit is configured to control the adjusting mechanism to adjust the width of the working portion based on the physiological information.

6. The medical device according to claim 5, characterized in that, the control system further includes a wake-up unit configured to wake up one or more of the control unit, the communication unit, and the sensor based on a preset schedule.

7. The medical device according to claim 2, characterized in that, the working portion includes a pair of shells, the pair of shells includes a first shell and a second shell, wherein the first shell is sleeved outside the second shell, and the adjusting mechanism is configured to adjust the overlapping degree of the first shell and the second shell under the control of the control unit, so as to adjust the width of the pad.

8. The medical device according to claim 7, characterized in that, the adjusting mechanism includes a driving unit, a pair of gears, and a lead screw; the pair of gears includes a first gear and a second gear that mesh with each other, the driving unit is used to drive the first gear to rotate, thereby driving the second gear to rotate, and the second gear meshes with the lead screw and is used to drive the lead screw to rotate; the lead screw drives the first shell and the second shell to move relative to each other, so as to adjust the overlapping degree of the first shell and the second shell.

9. The medical device according to claim 2, characterized in that, it further includes a force-applying member, the working portion includes a pair of shells, the pair of shells includes a first shell and a second shell, wherein the first shell is sleeved outside the second shell, and the force-applying member is used to adjust the overlapping degree of the first shell and the second shell, so as to adjust the width of the pad.

10. The medical device according to claim 9, characterized in that, a pair of lugs are provided on the outer surface of the second shell, and a pair of fixing grooves are provided on the inner surface of the first shell, and the pair of fixing grooves are respectively matched with the pair of lugs, so that the working portion has an adjustable width.

11. The medical device according to claim 1, characterized in that, The acting part is bent in a manner of protruding towards one side in the thickness direction.

12. The medical device according to claim 1, wherein, the projection of the engaging part in the thickness direction is T-shaped, and the acting part is arranged perpendicular to the extending part.

13. The medical device according to any one of claims 1 to 12, wherein, the value range of the ratio of the width of the acting part to the width of the extending part is from 1.25 to 5.

5.

14. The medical device according to claim 1, wherein, each blade includes: a main body part extending along the length direction and connected to the engaging part at one end; and a clamping seat part provided at the other end of the main body part and having a width greater than the width of the main body part.

15. The medical device according to claim 14, wherein, the acting part and the clamping seat part of each blade are bent in a manner of protruding towards the same side in the thickness direction.

16. The medical device according to claim 14, wherein, the value range of the ratio of the width of the clamping seat part to the width of the main body part is from 1.25 to 5.

5.

17. The medical device according to claim 14, wherein, the projection of the blade in the thickness direction is T-shaped, and the clamping seat part has a structure matching the acting part.

Images