Medical device

Abstract

The present disclosure relates to a medical device for repairing a patient's heart valve. The medical device includes an engaging member and a pair of blades disposed on both sides of the engaging member in the thickness direction. The engaging member includes: an extending portion that extends along the length direction and one end of which is connected to the pair of blades; and an acting portion that is connected to the other end of the extending portion and has a width greater than that of the extending portion. According to the medical device provided by the present disclosure, the engaging member has an acting portion with a larger width provided at one end of the extending portion. This structure improves the acting range of the engaging member, such that only one medical device can effectively improve the regurgitation condition of patients with a larger heart. Therefore, for patients with a larger heart, using the medical device provided by the present disclosure can reduce the surgical cost and the surgical difficulty.

Description

Technical Field

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

[0002] The heart valve refers to the valve between the atrium and the ventricle or between the ventricle and the artery. The valve plays a key role in the never-ending blood circulation activity of the heart. After the blood flows through, the valve will close, thus preventing blood from flowing back. Several structural factors may affect the proper closure of the heart valve, thus causing blood reflux. Taking the mitral valve as an example, if the mitral valve cannot close properly, it will cause blood to flow from the left ventricle through the mitral valve to the left atrium during systole, thereby damaging the patient's health.

[0003] A medical device for repairing the heart valve has a clip-like structure. This medical device improves the valve insufficiency by clamping on a pair of leaflets of the valve. Specifically, this medical device includes an engaging member and a pair of blades located on opposite sides in the thickness direction of the engaging member. After this medical device is implanted into the patient's heart, one leaflet of the valve is clamped between the engaging member and one blade, and the other leaflet of the valve is clamped between the engaging member and the other blade. Taking the mitral valve as an example, when the left ventricle is in diastole, the valves on both sides of the medical device open to form a double orifice for the leaflets, and blood can flow from the left atrium into the left ventricle; when the left ventricle is in systole, the valve closes to close the double orifice, thus preventing the blood in the left ventricle from flowing back to the left atrium.

[0004] However, due to the differences in the structures of the hearts of different patients, for some patients (such as those with larger hearts) with more severe valve insufficiency, using only one medical device cannot effectively improve the blood reflux situation of the heart. At this time, multiple medical devices need to be used, that is, multiple "clips" are clamped at different positions on a pair of leaflets, which increases the treatment cost and the surgical difficulty. It may also cause stenosis of the valve due to more difficult opening during ventricular diastole and valve opening, hindering the atrial blood flow into the ventricle during diastole and causing problems with ventricular filling. Summary of the Invention

[0005] In view of this, the present disclosure provides a medical device for repairing a patient's heart valve to reduce the surgical cost and the surgical difficulty.

[0006] The medical device provided by the present disclosure includes an engaging member and a pair of blades disposed on both sides of the engaging member in the thickness direction. The engaging member includes: an extension portion extending along the length direction and having one end connected to the pair of blades; and an acting portion connected to the other end of the extension portion and having a width greater than the width of the extension portion.

[0007] According to the medical device provided by the present disclosure, the engaging member has an acting portion with a relatively large width provided at one end of the extending portion. This structure improves the acting range of the engaging member for valvular insufficiency, enabling a single medical device to more effectively improve the regurgitation condition of the patient, including those patients with a relatively large heart who currently require more than one device for treatment. Therefore, the medical device provided by the present disclosure can be applied to more patients, while also reducing the surgical cost, lowering the surgical difficulty, and reducing complications.

[0008] In a possible implementation, the width of the acting portion is adjustable.

[0009] Since the acting portion has an adjustable width, during or after the surgery, the width of the acting portion can be adjusted according to the actual condition of the patient's heart, achieving "precision" treatment, so that the acting portion can better match the patient's heart structure, and further enabling the medical device to more effectively improve the regurgitation condition.

[0010] In a possible implementation, the medical device further includes: a control unit; and an adjustment mechanism configured to adjust the width of the acting portion under the control of the control unit.

[0011] Considering that the patient's condition is constantly evolving. When the patient's condition develops (or recovers) to a certain extent, the initial width of the acting portion 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 acting portion can be adjusted by controlling the adjustment mechanism through the control unit, so that the width of the acting portion can be re-matched to the patient's condition. Thus, if the medical device provided by the present disclosure is adopted, when the patient's condition changes, there is no need or the need to postpone as much as possible the way of replacing and / or adding / replacing the medical device through a second surgery or adjusting the width of the acting portion through a second interventional surgery to adapt to the patient's condition. Therefore, adopting the medical device provided by the present disclosure can reduce the economic burden on the patient and reduce the harm to the patient's health.

[0012] In a possible implementation, the medical device further includes a communication unit configured to receive control instructions, and the control unit is configured to control the adjustment mechanism based on the control instructions to adjust the width of the acting portion.

[0013] After implanting the medical device of the present disclosure, the patient can undergo regular reexaminations to confirm the changes in the condition. When it is detected that there are problems with the patient's transvalvular hemodynamics, for example, when the width of the functional part of the device 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 through 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 functional part, and further makes the width of the functional part match the patient's condition again.

[0014] In a possible implementation, the medical device further includes a sensor configured to sense the physiological information of the patient, and the control unit is configured to control the adjustment mechanism to adjust the width of the functional part based on the physiological information.

[0015] Due to the sensor for sensing the physiological information reflecting the patient's condition, the control unit can control the adjustment mechanism to adjust the width of the functional part according to the physiological information, so that the functional part can better and timely match the patient's condition. The medical device provided by this implementation method can reduce the number of reexaminations of the patient after implanting the medical device, thereby reducing the economic burden and time cost of the patient, and at the same time achieving more accurate, timely, and effective treatment.

[0016] In a possible implementation, the functional part is bent in a way that protrudes towards one side in the thickness direction. The functional part with this structure can better match the shape of a pair of leaflets, thereby being able to more effectively improve the regurgitation situation.

[0017] In a possible implementation, each blade includes: a main body portion extending along the length direction and having one end connected to the mating member; and a clamping seat portion provided at the other end of the main body portion and having a width greater than the width of the main body portion. This structure can increase the action range of the medical device, thereby improving the effectiveness of the medical device, and further being able to better improve the regurgitation situation.

[0018] In a possible implementation, the functional part and the clamping seat portion of each blade are bent in a way that protrudes towards the same side in the thickness direction. The medical device with this structure can better match the shape of a pair of leaflets, thereby being able to more effectively improve the regurgitation situation.

[0019] In a possible implementation, the value range of the ratio of the width of the functional part to the width of the extension part is from 1.25 to 5.5. In particular, the value range of the ratio of the width of the functional part to the width of the extension part is from 2 to 4.

[0020] In a possible implementation, 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. In particular, the value range of the ratio of the width of the clamping seat part to the width of the main body part is from 2 to 4. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings required for use in the embodiments will be briefly introduced below.

[0022] It should be understood that the following drawings only show some embodiments of the present disclosure, and therefore should not be regarded as limiting the scope. For those of ordinary skill in the art, without creative efforts, other related drawings can also be obtained based on these drawings.

[0023] It should be understood that the same or similar reference numerals are used in the drawings to represent the same or similar elements (components or parts).

[0024] It should be understood that the drawings are only schematic, and the sizes and proportions of the elements (components or parts) in the drawings are not necessarily accurate.

[0025] Figure 1A and Figure 1B shows a healthy heart valve viewed from the first chamber side, where the heart valve is open in Figure 1A and the heart valve is properly closed in Figure 1B the center.

[0026] Figure 2 shows a malfunctioning heart valve that fails to close properly, viewed from the first chamber side.

[0027] Figure 3 is a schematic structural diagram of a medical device according to the related art.

[0028] Figure 4 shows the medical device as shown in Figure 3 installed at the heart valve of a patient.

[0029] Figure 5A and Figure 5B show the medical device as shown in Figure 3 installed at the heart valve of a patient, viewed from the first chamber side, where a pair of leaflets form double holes on both sides of the medical device in Figure 5A and the pair of leaflets are properly opposed in Figure 5B the center.

[0030] Figure 6 shows the medical device as shown in Figure 3 installed at the heart valve of a patient, viewed from the first chamber side, where a pair of leaflets fail to oppose properly.

[0031] Figure 7 is a schematic structural diagram of a medical device according to an embodiment of the present disclosure.

[0032] Figure 8 is a schematic structural diagram of the medical device shown in Figure 7 as viewed from another viewing direction.

[0033] Figure 9 is a schematic structural diagram of the medical device shown in Figure 7 as viewed from another viewing direction.

[0034] Figure 10 is Figure 7 a schematic structural diagram of at least a part of the engaging member of the medical device in

[0035] Figure 11 shows the medical device shown in Figure 7 installed at a patient's heart valve.

[0036] Figure 12 shows the medical device shown in Figure 7 installed at a patient's heart valve as viewed from the first chamber side, where a pair of leaflets are properly engaged.

[0037] Figure 13A and Figure 13B are schematic structural diagrams showing an adjustment mechanism, a control system, a sensor, and an acting part of an engaging member of a medical device according to another embodiment of the present disclosure.

[0038] Figure 14 is an exploded schematic diagram of an acting part of an engaging member of a medical device according to another embodiment of the present disclosure.

[0039] Figure 15 is Figure 14 a partial cross-sectional view of a housing of the acting part shown in

[0040] Figure 16 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.

[0041] Figure 17 is a schematic structural diagram of the medical device shown in Figure 16 as viewed from another viewing direction.

[0042] Figure 18 is a schematic structural diagram of a medical device according to another embodiment of the present disclosure.

[0043] Figure 19 is a schematic structural diagram of the medical device shown in Figure 18 as viewed from another viewing direction.

[0044] Figure 20 Yes Figure 18 Schematic diagram of at least part of the structure of the blade of the medical device in Detailed implementation mode

[0045] Next, the technical solutions in the embodiments of the present disclosure will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present disclosure. Obviously, the described embodiments are only a part of the embodiments of the present disclosure, rather than all the embodiments.

[0046] The heart valve refers to the valve between the atrium and the ventricle or between the ventricle and the artery. The valve plays a key role similar to a valve in the never-ending blood circulation activity of the heart. After the blood flows through, the valve will close, thereby preventing blood from flowing back.

[0047] Taking the valve located between the first chamber and the second chamber as an example, see Figure 1A and Figure 1B , this valve includes a pair of leaflets FL, SL. As Figure 1A shown, when the second chamber is in diastole, the pair of leaflets FL, SL are separated from each other to open the valve, and blood flow can flow from the first chamber into the second chamber. As Figure 1B shown, for a healthy valve, when the second chamber is in systole, the pair of leaflets FL, SL are properly opposed to properly close the valve and prevent blood flow from returning from the second chamber to the first chamber.

[0048] Exemplarily, in the present disclosure, the first chamber may refer to the left atrium, the second chamber may refer to the left ventricle, and the valve between the two may refer to the mitral valve.

[0049] Several structural factors may affect the proper closure of the heart valve, thereby causing blood reflux. As Figure 2 shown, for a dysfunctional heart valve, when the second chamber is in systole, the pair of leaflets FL, SL cannot be properly opposed, and there is a gap G between them. This will cause the valve to not close properly, and blood flow can flow from the second chamber into the first chamber through the gap G (that is, cause reflux), thereby damaging the health of the patient.

[0050] See Figure 3 , a medical device 10 includes an opposed member 11 and a pair of blades 12. The pair of blades 12 are respectively located on opposite sides of the opposed member 11 in the thickness direction. That is to say, the direction from one blade 12 to the other blade 12 can be regarded as the thickness direction of the medical device 10.

[0051] It should be noted that in the accompanying drawings of the present disclosure, arrow T+ and arrow T- are respectively used to indicate the opposite sides in the thickness direction of the medical device; arrow L+ and arrow L- are respectively used to indicate the opposite sides in the length direction of the medical device; arrow W+ and arrow W- are respectively used to indicate the opposite sides in the width direction of the medical device.

[0052] See Figure 4 , after the medical device 10 is implanted at the valve, a pair of paddles 12 are respectively configured to grasp a pair of leaflets FL, SL to hold the occluder 11 between the pair of leaflets FL, SL, thereby repairing the function of the valve.

[0053] Specifically, as Figure 5A shown, when the second chamber is in diastole, a pair of leaflets FL, SL form double holes on both sides of the medical device 10 (i.e., both sides of the occluder 11); at this time, the valve opens and blood flow can flow from the first chamber into the second chamber. As Figure 5B shown, when the second chamber is in systole, a pair of leaflets FL, SL are properly opposed on both sides of the occluder 11; at this time, the valve is properly closed, thereby preventing blood flow from regurgitating.

[0054] However, due to the structural differences in the heart valves of different patients (for example, some patients have larger hearts), using a single medical device 10 cannot effectively eliminate regurgitation, there will be residual regurgitation, and it will still cause too high atrial pressure in the patient, less aortic ejection volume, and corresponding symptoms. As Figure 6 shown, for such patients, when the second chamber contracts, the opposition of a pair of leaflets FL, SL on both sides of the occluder 11 cannot completely eliminate the existing gap G, and two remaining gaps G1, G2 will be formed on both sides of the occluder 11; at this time, blood flow may flow back from the second chamber to the first chamber through the gaps G1, G2.

[0055] For such patients, it is usually necessary to arrange multiple medical devices 10 on their heart valves at intervals or in contact. However, using multiple medical devices 10 will not only significantly increase the treatment cost, but also greatly increase the surgical difficulty. Using multiple devices 10 at the same time may also cause excessive restraint on the valve, affecting its opening during diastole, resulting in an insufficiently large opening (stenosis), thereby affecting the flow of atrial blood into the ventricle.

[0056] In view of the above situation, an embodiment of the present disclosure provides a medical device 20. See Figures 7 to 11, the medical device 20 includes an engagement member 21 and a pair of blades 22. The pair of blades 22 are located on opposite sides of the engagement member 21 in the thickness direction. After the medical device 20 is implanted at the valve, the pair of blades 22 are configured to hold the engagement member 21 between a pair of leaflets FL, SL. In one example, each blade 22 may have a clip-like configuration to clamp onto the corresponding leaflet, thereby positioning the engagement member 21 between the pair of leaflets FL, SL. In another example, each blade 22 may cooperate with the engagement member 21 to clamp the corresponding leaflet therebetween, thereby positioning the engagement member 21 between the pair of leaflets FL, SL. It should be understood that the specific implementation of the pair of blades 22 can be referred to the related art, and for the sake of brevity, it will not be elaborated here.

[0057] The engagement member 21 includes an acting portion 211 and an extending portion 212. The extending portion 212 extends along the length direction (of the medical device 20). The extending portion 212 has opposite ends in the length direction, one end of which is connected to the pair of blades 22 (directly or through an intermediate member), and the other end of which is connected to the acting portion 211. The width W1 of the acting portion 211 is configured to be greater than the width W2 of the extending portion 212.

[0058] In the present disclosure, the width of a certain element may refer to its dimension in the width direction. In addition, in some embodiments of the present disclosure, the width direction, the thickness direction, and the length direction may be perpendicular to each other in pairs. In addition, in some embodiments of the present disclosure, the width of a certain element may refer to its maximum width; in other embodiments of the present disclosure, the width of a certain element may also refer to its average width.

[0059] See Figure 12 , after being implanted at the valve, the extending direction of the boundary of the pair of leaflets FL, SL is close to the width direction of the acting portion 211. Due to the acting portion 211 having a larger width, this configuration improves the acting range of the engagement member 21. Comparing Figure 6 and Figure 12 it can be known that for a larger heart, if the medical device 20 is adopted, only one medical device 20 is required to enable the pair of leaflets FL, SL to close properly during the contraction of the second chamber, thereby effectively avoiding or reducing the regurgitation phenomenon.

[0060] According to the medical device provided by the present disclosure, the engagement member has an acting portion with a larger width provided at one end of the extending portion. This configuration improves the acting range of the engagement member, such that only one medical device can effectively improve the regurgitation condition of patients with a larger heart. Therefore, for patients with a larger heart, for example, adopting the medical device provided by the present disclosure can reduce the surgical cost and the surgical difficulty, while achieving a better treatment effect.

[0061] It should be noted that in the present disclosure, the width W1 of the acting portion 211 is not slightly greater than the width W2 of the extending portion 212, but is significantly greater than the width W2 of the extending portion 212, so that the medical device 20 can play the role of multiple traditional medical devices in a larger heart. For example, the value range of the ratio of the width W1 of the acting portion 211 to the width W2 of the extending portion 212 is from 1.25 to 5.5. In particular, the value range of the ratio of the width W1 of the acting portion 211 to the width W2 of the extending portion 212 is from 2 to 4.

[0062] Considering that the structures of the heart valves of different patients vary, and the structure of the heart valves of the same patient also changes with the development of the disease. Therefore, in some embodiments, the mating member of the medical device provided in the present disclosure can be configured to have an adjustable width. Since the acting portion has an adjustable width, it is possible to adjust the width of the acting portion according to the actual condition of the patient's heart during or after the operation, so that the acting portion can better match the structure of the patient's heart, and further enable the medical device to more effectively improve the regurgitation condition.

[0063] The following will give an example of a medical device with an acting portion having an adjustable width in conjunction with the accompanying drawings.

[0064] As a possible implementation, refer to Figure 13A and Figure 13B , the medical device according to another embodiment of the present disclosure may further include a control system 33 and an adjustment mechanism in addition to the mating member and a pair of blades. The structures of the mating member and the pair of blades of the medical device provided in this embodiment can refer to the above embodiments. For the sake of brevity, they will not be described in detail here. The control system 33 may include a control unit 331. The adjustment mechanism may be configured to adjust the width of the acting portion 311 of the mating member under the control of the control unit 331.

[0065] Considering that the patient's condition is constantly developing. When the patient's condition develops to a certain extent, the initial width of the acting portion may no longer match the patient's condition. According to the medical device provided in 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 acting portion, so that the width of the acting portion can be re-matched to the patient's condition. It can be seen that if the medical device provided in the present disclosure is adopted, when the patient's condition changes, there is no need to replace the medical device through a second operation or adjust the width of the acting portion through a second operation to adapt to the patient's condition. Therefore, adopting the medical device provided in the present disclosure can reduce the economic burden on the patient and reduce the damage to the patient's health.

[0066] There are various ways to adjust the width of the acting portion, and the present disclosure does not make specific limitations on this. As an example, refer back to Figure 13A, 13B, the acting part 311 includes a pair of shells 3111, 3112. The shell 3111 is sleeved outside the shell 3112, and the two cooperate to define an internal space 311a. In some embodiments, the shell 3111 can be connected to the extension part of the mating part.

[0067] The adjusting mechanism is configured to adjust the overlapping degree of the pair of shells 3111, 3112 under the control of the control unit, so as to adjust the width of the acting part 311. When the acting part 311 is in Figure 13A the state shown in, the overlapping degree D of the pair of shells 3111, 3112 1a is smaller, and the width W of the acting part 311 1a is larger. When the acting part 311 is in Figure 13B the state shown in, the overlapping degree D of the pair of shells 3111, 3112 1b is larger, and the width W of the acting part 311 1b is smaller.

[0068] In this way, the adjusting mechanism can adjust the width of the acting part under the control of the control unit. This implementation method has many advantages such as simple implementation, relatively compact structure, and high reliability.

[0069] There are various ways to adjust the overlapping degree of a pair of shells, and the present disclosure does not make specific limitations on this.

[0070] As an example, referring back to Figure 13A and Figure 13B , the adjusting mechanism can include a driving unit 341, a pair of gears 342, 343 and a lead screw 344. A boss 3113 is provided on the inner wall of the shell 3111, a boss 3114 is provided on the inner wall of the shell 3112, a through hole is provided on the boss 3113, and a threaded hole is provided on the boss 3114.

[0071] The driving unit 341 is used to drive the gear 342 to rotate. For example, the driving unit 341 can be a motor, and the gear 342 can be installed on its output shaft. The gear 343 is installed on the lead screw 344 and meshes with the gear 342. The lead screw 344 passes through the through hole of the boss 3113 and is supported in a manner that it can rotate and cannot slide axially through components such as bearings and retaining rings. The lead screw 344 passes through the threaded hole of the boss 3114 and has an external thread that mates with the threaded hole.

[0072] When it is necessary to adjust the width of the acting part 311, the control unit 331 can control the driving unit 341 to operate. As the driving unit 341 moves, the torque is transmitted to the lead screw 344 through the pair of gears 342, 343. As the lead screw 344 rotates, it causes the pair of shells 3111, 3112 to move relative to each other to change their overlapping degree, and further change the width of the acting part 311.

[0073] In one example, referring toFigure 13A and Figure 13B ,The control system 33 may further include a communication unit 332. The communication unit 332 is configured to communicate wirelessly with a control device located inside or outside the patient. For example, the communication unit 332 may, but is not limited to, communicate with an external control device in the following ways: Bluetooth, cellular network, Wi-Fi, radio frequency communication, or ultrasonic communication, etc.

[0074] A doctor (or patient) can send a control instruction to the communication unit 332 by operating the control device. 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 acting part 311.

[0075] After implanting the medical device of the present disclosure, the patient can undergo a re-examination regularly to confirm the change of the condition. When it is detected that the width of the acting part 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 through a control device located inside or 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 acting part, and further makes the acting part match the patient's condition again.

[0076] In another example, referring back to Figure 13A and Figure 13B ,the medical device may further include a sensor 35, and the sensor 35 is communicatively connected to the control unit 341. The sensor 35 is configured to sense the physiological information of the patient and send 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 acting part 311.

[0077] Exemplarily, the physiological information may, but is not limited to, include one or more of blood pressure information, blood flow rate information, blood pH information, blood temperature information, blood oxygen information, electrocardiogram information, heart sound information, heart 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.

[0078] Due to having a sensor for sensing the physiological information reflecting the patient's condition, the control unit can control the adjustment mechanism to adjust the width of the acting part according to the physiological information, so that the width of the acting part can always match the patient's condition. The medical device provided by this implementation method can reduce the number of re-examinations after implantation of the patient, thereby reducing the economic burden and time cost of the patient.

[0079] It can be understood that in some 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. The present disclosure does not make specific limitations thereto. In some embodiments, the sensor used in the present disclosure may be a part of the medical device provided by the present disclosure, or may be a part of other medical devices. The present disclosure does not make specific limitations thereto.

[0080] There are various implementation manners of the sensor, and the present disclosure does not make specific limitations thereto. As an example, the sensor may include a hemodynamic sensor. For example, a pressure sensor or an accelerometer. The sensor may be attached to the top of the engagement member to sense physiological information that can reflect the blood flow state at the valve. That is to say, 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 acting portion according to the physiological information, so that the width of the acting portion is more matched with the current condition of the patient.

[0081] It should be noted that in other examples, the sensor may not be attached to the engagement member. For example, in some embodiments, the sensor may also be installed on the leaflet or the extension portion. Also, for example, in some embodiments, the sensor may also be installed on other components of the medical device.

[0082] In addition, it should be noted that in some embodiments, the medical device provided by the present disclosure may also include multiple sensors, and the multiple sensors may be arranged at different positions, so as to more accurately determine the condition of the patient.

[0083] For the consideration of reducing energy consumption, in one example, referring back to Figure 13A and Figure 13B , the control system 33 may further include a wake-up unit 333, and the wake-up unit 333 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.

[0084] Considering that the condition of the patient usually develops slowly, it is not necessary to frequently adjust the width of the acting portion. In this implementation manner, the control unit, the sensor, the communication unit, etc. can be in a sleep state most of the time, and after reaching the preset time point, the wake-up unit can wake up one or more of them. In this way, energy consumption can be reduced to achieve the purpose of energy saving.

[0085] As an example, the preset schedule may include multiple cycles, and each cycle includes a sleep phase and a wake-up phase. When in the sleep phase, other energy-consuming units except the wake-up unit 333 may be in a sleep state to reduce energy consumption. After the start of the wake-up phase, the wake-up unit 333 can wake up some or all of the energy-consuming units.

[0086] For example, a sleep phase can be from 6 months to 12 months, and a wake-up phase can be 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 exactly in the wake-up phase. In this way, after the doctor examines the patient's condition, a control instruction can be sent to the communication unit 332 through the external control device to adjust the width of the acting part 311 to match the patient's condition after the reexamination. Of course, the doctor can also wake up the medical device through an external device and implement its operation.

[0087] In one example, referring back to Figure 13A and Figure 13B , the control system 33 may further include a power supply unit 334 for powering one or more of the control unit 341, the communication unit 332, the wake-up unit 333, and the sensor 35.

[0088] There are various ways to implement the power supply unit 334, and the present disclosure does not make specific limitations thereto. For example, in some embodiments, the power supply unit 334 can be a battery. In another example, in some embodiments, the power supply unit 334 can be an induction coil, and the doctor or the patient can charge the power supply unit through an external device. In yet another example, in some embodiments, the power supply unit 334 can also be an ultrasonic transducer to convert the ultrasonic wave sent by an external device into electrical energy.

[0089] For the purpose of simplifying the structure, in some implementations, part or all of the control system 33 can be located inside the acting part 311. Of course, in some embodiments, the control system 33 can also be entirely located outside the acting part 311. The present disclosure does not make specific limitations thereto.

[0090] The method of adjusting the width of the acting part is not limited to being implemented through the control unit and the adjustment mechanism. In other embodiments, the acting part can be configured to be adjustable in width manually by the doctor during the operation. A possible implementation is given below.

[0091] Referring to Figure 14 , in this embodiment, the acting part 411 of the mating part of the medical device includes a pair of shells 4111, 4112. In some embodiments, the shell 4111 can be fixedly connected to the extension part of the mating part. It should be noted that the structure of the mating part and the pair of blades of the medical device provided in this embodiment can refer to the medical device 10 provided in the above embodiment. For the sake of brevity, it will not be elaborated here.

[0092] The housing 4111 is sleeved outside the housing 4112. In this embodiment, the medical device further includes a force applying member 43, and the force applying member 43 applies a force to the housings 4111 and 4112 in a direction away from each other. For example, the force applying member 43 can be a compression spring 43, and the compression spring 43 is disposed in the cavity jointly defined by the housings 4111 and 4112, and both ends respectively abut against the ends of the inner surfaces of the housings 4111 and 4112 in the width direction.

[0093] A pair of lugs 4112a are provided on the outer surface of the housing 4112, and a pair of fixing grooves are provided on the inner surface of the housing 4111. The pair of fixing grooves are respectively engaged 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 acting portion 411 has an adjustable width.

[0094] Specifically, referring to Figure 15 , each fixing groove includes a main body 4111a extending in the width direction and a plurality of branches spaced apart in the width direction and intersecting with the main body 4111a. Each branch includes a connecting section 4111b and a tail section 4111c. One end of the connecting section 4111b is connected to the main body 4111a, and the other end is connected to the tail section 4111c. One end of the tail section 4111c is connected to the connecting section 4111b, and the other end extends in the width direction towards the side where the housing 4112 is located.

[0095] Under normal conditions, the lug 4112a is located at the tail section 4111c of a branch. Under the action of the force applying member 43, the lug 4112a will not come out of the tail section 4111c. When it is necessary to adjust the width of the acting portion 411, a doctor can manually adjust the width of the acting portion 411 (for example, by a surgical instrument). Specifically, the acting portion 411 can be compressed first so that the lug 4112a moves from the tail section 4111c to the connecting section 4111b; then, the pair of housings 4111 and 4112 can be caused to rotate relative to each other so that the lug 4112a moves from the connecting section 4111b to the main body 4111a; then, the pair of housings 4111 and 4112 can be caused to move relative to each other in the width direction and rotate relative to each other to move the lug 4112a into the tail section 4111c of another branch. In this way, the width of the acting portion 411 can be manually changed.

[0096] The medical device 50 according to another embodiment of the present disclosure is shown in Figure 16 and Figure 17 As Figure 16 and Figure 17As shown, the medical device 50 is substantially the same as the medical device 20 in the foregoing embodiment. The medical device 50 includes an engaging member 51 and a pair of blades 52. The pair of blades 52 are respectively disposed on opposite sides of the engaging member 51 in the thickness direction. The engaging member 51 includes an acting portion 511 and an extending portion 512. The extending portion 512 extends in the length direction, one end of which in the length direction is connected to the pair of blades 52, and the other end is connected to the acting portion 511.

[0097] In this embodiment, the acting portion 511 is configured to bend in a manner that protrudes toward one side (i.e., the T+ side) in the thickness direction. Considering that the sizes of the pair of leaflets FL, SL are usually not exactly the same, as Figure 1B shown, when the pair of leaflets FL, SL are engaged, the boundary between them usually bends in a manner that protrudes toward one side, that is, substantially in a C shape. When the medical device 50 is implanted at the valve of a patient, the pair of leaflets FL, SL are respectively located on opposite sides of the acting portion 511 in the thickness direction. The acting portion 511 is configured to bend in a manner that protrudes toward one side in the thickness direction. This configuration of the acting portion 511 is conducive to adapting to (or matching) the shape of the pair of leaflets FL, SL, thereby facilitating the proper engagement of the pair of leaflets FL, SL. If the acting portion does not match the shape of the pair of leaflets FL, SL, when the pair of leaflets FL, SL are engaged, the acting portion may affect the engagement of the pair of leaflets FL, SL, making the engagement of the pair of leaflets FL, SL not tight enough, thus causing regurgitation.

[0098] The medical device 60 according to another embodiment of the present disclosure is shown in Figure 18 and Figure 19 As shown in Figure 18 and Figure 19 shown, the medical device 60 is substantially the same as the medical device 20 in the foregoing embodiment. The medical device 60 includes an engaging member 61 and a pair of blades 62. The pair of blades 62 are respectively disposed on opposite sides of the engaging member 61 in the thickness direction. The engaging member 61 includes an acting portion 611 and an extending portion 612. The extending portion 612 extends in the length direction, one end of which in the length direction is connected to the pair of blades 62, and the other end is connected to the acting portion 611.

[0099] In this embodiment, refer to Figure 20, each blade 62 includes a clamping seat portion 621 and a main body portion 622. The main body portion 622 extends along 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 at the valve of a patient, the clamping seat portion 621 of each blade 62 and the acting portion 611 of the mating member 61 and / or the main body portion of 62 and the extending portion of the mating member 61 clamp a leaflet between them. Since both the clamping seat portion 621 and the acting portion 611 have relatively large widths, the cooperation between the two can further increase the acting range of the medical device, thereby improving the effectiveness of the medical device, and further being able to better improve the regurgitation condition.

[0100] It should be noted that in the present disclosure, the width W3 of the clamping seat portion 621 is not slightly greater than the width W4 of the main body portion 622, but is significantly greater than the width W4 of the main body portion 622, so that the medical device 60 can play the role of multiple traditional medical devices in a relatively large heart. For example, the value range of the ratio of the width W3 of the clamping seat portion 621 to the width W4 of the main body portion 622 is from 1.25 to 5.5. In particular, the value range of the ratio of the width W3 of the clamping seat portion 621 to the width W4 of the main body portion 622 is from 2 to 4.

[0101] Refer again to Figure 19 , the acting portion 611 of the mating member 61 and the clamping seat portion 621 of each blade 62 are configured to bend in a manner that protrudes toward the same side in the thickness direction (i.e., the T+ side). The medical device 60 having such a configuration can better match the shape of a pair of leaflets FL, SL, and thus can more effectively improve the regurgitation condition.

[0102] It should be understood that in other embodiments, the acting portion of the mating member and the clamping seat portion of each blade may also extend straight in the width direction without bending.

[0103] It should be understood that the medical device according to the present disclosure is not limited to being applied to 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 particularly, the medical device according to the present disclosure can also be applied to a pair of cooperating leaflets of the tricuspid valve.

[0104] It should be understood that the term "comprising" and its variations used in the present disclosure are open-ended, 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".

[0105] It should be understood that although terms such as "first" or "second" may be used in this disclosure to describe various elements (such as a first chamber and a second chamber), these elements are not limited by these terms, and these terms are only used to distinguish one element from another.

[0106] It should be noted that the various specific technical features (elements) described in the above specific embodiments can be combined in any suitable manner without contradiction. To avoid unnecessary repetition, this disclosure will not separately describe various possible combination methods.

[0107] 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 multiple separate components and / or parts. The disclosure of "a" or "an" used to describe a component or part does not mean to exclude other components or parts.

[0108] As described above, the above are only the specific embodiments of this disclosure, but the protection scope of this disclosure is not limited thereto. Any person skilled in the art within the technical scope disclosed by this disclosure can think of changes or substitutions, which should all be covered within the protection scope of this disclosure. Therefore, the protection scope of this disclosure should be subject to the protection scope of the claims.

Claims

1. A medical device for repairing a patient's valve, characterized in that, Comprising an engaging member and a pair of blades disposed on both sides of the engaging member in the thickness direction, The engaging member includes: An extension portion extending along the length direction and connected to the pair of blades at one end in the length direction; and An acting portion connected to the other end of the extension portion in the length direction and having a dimension in the width direction greater than that of the extension portion in the width direction; Each blade includes: A main body portion connected to the engaging member at one end in the length direction; and A clamping seat portion connected to the other end of the main body portion and having a dimension in the width direction greater than that of the main body portion in the width direction, and the clamping seat portion has a dimension in the width direction comparable to that of the acting portion so as to be able to cooperate to clamp the leaflets of the valve between the two.

2. The medical device according to claim 1, wherein The width of the acting portion is adjustable.

3. The medical device according to claim 2, wherein It further includes: A control unit; And An adjusting mechanism configured to adjust the width of the acting 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 control instructions, and the control unit is configured to control the adjusting mechanism based on the control instructions to adjust the width of the acting portion.

5. The medical device according to claim 4, wherein It further includes a sensor and a wake-up unit, the sensor is configured to sense the physiological information of the patient, and the control unit is configured to control the adjusting mechanism to adjust the width of the acting portion based on the physiological information; The wake-up unit is configured to wake up one or more of the control unit, the communication unit and the sensor based on a preset schedule.

6. The medical device according to claim 1, wherein, The acting portion is bent in a manner of protruding towards one side in the thickness direction.

7. The medical device according to any one of claims 1 to 6, characterized in that, The value range of the ratio of the width of the acting portion to the width of the extension portion is from 1.25 to 5.

5.

8. The medical device according to claim 1, wherein The acting portion and the clamping seat portion of each blade are bent in a manner of protruding towards the same side in the thickness direction.

9. The medical device according to claim 1, wherein The value range of the ratio of the width of the clamping seat portion to the width of the main body portion is from 1.25 to 5.

5.

10. The medical device according to claim 1, characterized in that, The value range of the ratio of the width of the acting portion to the width of the extension portion is from 2 to 4.

11. The medical device according to claim 1, wherein The value range of the ratio of the width of the clamping seat portion to the width of the main body portion is from 2 to 4.

12. The medical device according to claim 3, characterized in that, The acting 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, thereby adjusting the width of the acting portion.

13. The medical device according to claim 2, wherein, It further includes a force applying member, the acting 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, thereby adjusting the width of the acting portion.

14. A medical device for repairing a patient's valve, characterized in that, Comprising an engaging member and a pair of blades disposed on both sides of the engaging member in the thickness direction, The engaging member includes: An extension portion extending along the length direction and connected to the pair of blades at one end in the length direction; and An acting portion connected to the other end of the extension portion in the length direction and having a dimension in the width direction greater than that of the extension portion in the width direction; Each blade includes: A main body portion, connected to the mating member at one end in the length direction; and A clamping seat portion, connected to the other end of the main body portion, and having a dimension in the width direction greater than that of the main body portion in the width direction, so as to be able to cooperate with the acting portion to clamp the leaflet of the valve between the two, wherein, the value range of the ratio of the width of the acting portion to the width of the extension portion is from 1.25 to 5.5, and the value range of the ratio of the width of the clamping seat portion to the width of the main body portion is from 1.25 to 5.

5.

15. The medical device according to claim 14, characterized in that, The width of the acting portion is adjustable.

16. The medical device according to claim 15, characterized in that, It further includes: A control unit; And An adjusting mechanism, configured to adjust the width of the acting portion under the control of the control unit.

17. The medical device according to claim 16, characterized in that, It further includes a communication unit, the communication unit is 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 acting portion.

18. The medical device according to claim 17, wherein It further includes a sensor and a wake-up unit, the sensor is configured to sense the physiological information of the patient, and the control unit is configured to control the adjusting mechanism to adjust the width of the acting portion based on the physiological information; The wake-up unit is configured to wake up one or more of the control unit, the communication unit and the sensor based on a preset schedule.

19. The medical device according to claim 14, characterized in that, The acting portion is bent in a manner of protruding to one side in the thickness direction.

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

21. The medical device according to claim 14, characterized in that, The value range of the ratio of the width of the acting portion to the width of the extension portion is from 2 to 4.

22. The medical device according to claim 14, characterized in that, The value range of the ratio of the width of the clamping seat portion to the width of the main body portion is from 2 to 4.

23. The medical device according to claim 16, wherein, The acting 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 acting portion.

24. The medical device according to claim 15, wherein, It further includes a force applying member, the acting 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 acting portion.

25. The medical device according to claim 14, wherein, The clamping seat portion has a dimension in the width direction equivalent to that of the acting portion.

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