WO2024088354A1

WO2024088354A1 - Medical treatment device

Info

Publication number: WO2024088354A1
Application number: PCT/CN2023/126908
Authority: WO
Inventors: 王励
Original assignee: 合源医疗器械(上海)有限公司
Priority date: 2022-10-27
Filing date: 2023-10-26
Publication date: 2024-05-02
Also published as: CN117982259A

Abstract

The present disclosure relates to a medical treatment device used for repairing heart valves of patients. The medical treatment device comprises: a pad, which is configured to be positioned between a plurality of leaflets of a valve and to periodically open and close the valve by means of cooperation with the plurality of leaflets, and which comprises an adjustment mechanism; and a control unit, configured to control the adjustment mechanism to adjust the size of the pad. When the condition of a patient changes, the medical treatment device provided by the present disclosure can re-match the pad with the condition of the patient just by means of enabling the control unit to control the adjustment mechanism to adjust the size of the pad. Hence, by means of using the medical treatment device provided by the present disclosure, a reoperation to replace a pad is not needed when the condition of a patient changes. Therefore, using the medical treatment device provided by the present disclosure can lower economic burdens of patients and reduce damage to the health of patients.

Description

Medical Devices

Technical Field

The present disclosure relates to the technical field of medical instruments, and in particular, to a medical device for repairing a valve of a patient.

Background technique

Heart valves are valves between the atria and ventricles or between the ventricles and arteries. They play a key role in the heart's never-ending blood circulation. After blood has flowed through them, the valves close to prevent blood from flowing back.

Several structural factors can affect the proper closure of heart valves, causing blood regurgitation. For example, if the mitral valve does not close properly, blood can flow from the left ventricle through the mitral valve to the left atrium during systole, which can harm the patient's health.

A medical device for repairing a heart valve includes a cushion that can be surgically delivered between the leaflets of a patient's valve. When the valve is closed, the cushion fills the gaps between the leaflets, thereby improving the closure of the valve.

The patient's condition is constantly evolving. When the patient's condition develops to a certain extent, the cushion initially implanted in the valve may no longer match the patient's condition. For example, if the condition worsens, when the valve is closed, the cushion will no longer be able to fully fill the gap between the leaflets, and regurgitation will reappear. For another example, if the condition improves (for example, the ventricle begins to become smaller), when the valve opens, the cushion may cause the effective area for blood flow through the valve to decrease, leading to stenosis.

If the above situation occurs, another surgery is required to replace the pad originally implanted in the patient's body with a pad that matches the patient's current condition. However, another surgery will increase the patient's financial burden and damage the patient's health.

Summary of the invention

In view of this, the present disclosure provides a medical device for repairing a patient's heart valve, so as to reduce the patient's economic burden and reduce damage to the patient's health.

The present disclosure provides a medical device which is suitable for being implanted in a patient's body to repair the patient's valve. The medical device includes a pad and a control unit. The pad is configured to be located between a plurality of leaflets of a valve and to periodically open and close the valve by cooperating with the plurality of leaflets, and the pad includes an adjustment mechanism. The control unit is configured to control the adjustment mechanism to adjust the size of the pad.

According to the medical device provided by the present disclosure, when the patient's condition changes, only the control The unit controls the adjustment mechanism to adjust the size of the pad, so that the pad can be re-matched to the patient's condition. It can be seen that if the medical device provided by the present disclosure is used, when the patient's condition changes, there is no need for reoperation to replace the pad. Therefore, the use of the medical device provided by the present disclosure can avoid or reduce reoperation, thereby achieving better treatment effects while reducing the patient's economic burden and reducing damage to the patient's health, such as the risk of reoperation.

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 size of the pad based on the control instruction.

After implanting the medical device of the present disclosure, the patient can undergo regular reexaminations to confirm changes in the condition. When it is detected that the size of the pad 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 size of the pad, thereby matching the pad with the patient's condition again.

In a possible implementation, the communication unit is configured to establish a wireless communication connection with a control device located outside the patient's body.

In a 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 size of the cushion based on the physiological information.

Since there is a sensor for sensing physiological information reflecting the patient's condition, the control unit can control the adjustment mechanism to adjust the size of the pad according to the physiological information, so that the pad can always match the patient's condition. The medical device provided by this implementation can reduce the number of re-examinations of the patient after implantation, and/or can detect problems early and make appropriate adjustments (especially for patients with poor compliance with regular follow-up), so that the patient can receive better treatment, while reducing the patient's economic burden and time cost.

In one possible implementation, the communication unit is configured to send physiological information to the external device and receive control instructions generated by the external device according to the physiological information, and the control unit is configured to control the adjustment mechanism to adjust the size of the pad based on the control instructions. In this way, the complexity and power consumption of the medical device can be reduced.

In a possible implementation, the medical device further includes a wake-up unit configured to wake up the control unit based on a preset schedule.

Considering that the patient's condition usually develops slowly, it is not necessary to adjust the size of the pad frequently. In this implementation, the control unit, the sensor, the communication unit, etc. can be in a dormant state most of the time, and the awakening unit can wake up one or more of them after reaching a preset time point. In this way, energy consumption can be reduced and the purpose of energy saving can be achieved.

In an alternative implementation, the wake-up unit is also configured to respond to the physiological information reaching The control unit is woken up by a preset condition.

In a possible implementation, the device further includes a power supply unit, which is configured to supply power to the control unit and the adjustment mechanism.

In a possible implementation, the adjustment mechanism is configured to adjust the thickness of the pad under the control of the control unit, that is, the adjustable dimension of the pad is its thickness.

In one possible implementation, the pad includes a pair of main body members, which are stacked in the thickness direction of the pad, each main body member has a relative free end and a connecting end, the connecting ends of the pair of main body members are pivotally connected, and the adjustment mechanism is configured to adjust the thickness of the pad by adjusting the opening of the pair of main body members under the control of the control unit.

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

In one possible implementation, the adjustment mechanism includes a driving member and a slider, the slider can be slidably placed between a pair of main members and abut against the pair of main members, and the driving member is configured to adjust the opening of the pair of main members by driving the slider to slide under the control of the control unit.

In this way, the adjustment mechanism can adjust the opening of the pair of main parts under the control of the control unit, thereby adjusting the thickness of the pad. This implementation has many advantages such as simple implementation, compact structure and good reliability.

In a possible implementation, the dimension is the width of the pad.

In one possible implementation, the pad includes a pair of shells; one end of one shell in the width direction is mounted on one end of the other shell in the width direction, and the two shells cooperate to define an internal space; the adjustment mechanism is configured to adjust the overlap of the pair of shells under the control of the control unit, thereby adjusting the width of the pad.

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.

In a possible implementation, the pad has a plurality of apposition surfaces, which are configured to face the plurality of leaflets respectively, and as the plurality of leaflets move, each apposition surface periodically appositions to and separates from the leaflet it faces.

In this implementation, the pad will not affect or will have little effect on the movement of the multiple leaflets, and the multiple leaflets can maintain their original physiological functions. That is, in this implementation, as the cardiac cycle changes, the multiple leaflets can naturally and periodically move toward and away from each other. Therefore, the use of a medical device according to this implementation can have less adverse effects on the structure and function of the leaflets.

In one possible implementation, the plurality of leaflets include a first leaflet and a second leaflet, the pad is configured to follow the movement of the second leaflet, the pad has a first apposition surface and a second apposition surface, the second apposition surface is configured to face the second leaflet and remain apposition with the second leaflet, the first apposition surface is configured to face the first leaflet, and the first apposition surface is configured to periodically apposition and apposition with the first leaflet as the pad follows the movement of the second leaflet. Separation.

In a possible implementation, the medical device further includes a support member connected to the pad so as to position the pad between the plurality of leaflets, and the pad is connected to the support member in a manner such that it can follow the movement of the second leaflet.

That is, in this implementation, as the cardiac cycle changes, the multiple leaflets can move relative to and apart from each other naturally and periodically. Therefore, using a medical device according to this implementation can have less adverse effects on the structure and function of the leaflets.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings required for use in the embodiments are briefly introduced below.

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

It should be understood that the same or similar reference numerals are used in the drawings to indicate the same or similar elements.

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.

FIG. 1 is a schematic structural diagram of a medical device according to an embodiment of the present disclosure.

2A and 2B are schematic structural diagrams showing a pad, a control system, a sensor, etc. of the medical device in FIG. 1 .

3A and 3B are schematic structural diagrams of at least a portion of a pad of a medical device according to another embodiment of the present disclosure.

FIG. 4 is a schematic diagram of at least a portion of a medical device according to another embodiment of the present disclosure.

FIG. 5 is a schematic diagram of at least a portion of the structure of a medical device according to another embodiment of the present disclosure.

FIG. 6 is a schematic diagram of at least a portion of the structure of a medical device according to another embodiment of the present disclosure.

Detailed ways

The following will be combined with the 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, not all of the embodiments. The multiple referred to in the present disclosure includes two and more than two.

Fig. 1 is a schematic diagram of the structure of a medical device 10 according to an embodiment of the present disclosure. Fig. 1 shows a state where the medical device 10 is placed at a heart valve of a patient. The medical device 10 provided by the present disclosure (as well as other medical devices provided by the present disclosure) is suitable for being implanted in a patient's body to repair the patient's valve.

In FIG. 1 (and other figures of the present disclosure), the heart valve is located between the first chamber and the second chamber, and is used to allow blood flow from the first chamber to flow into the second chamber and prevent reverse flow. The heart valve includes a pair of leaflets FL, SL that match each other. For ease of description, the leaflet FL is hereinafter referred to as the first leaflet. leaf, and leaflet SL is called the second leaflet.

For a healthy heart, a pair of leaflets FL, SL can naturally apposition and separation with the cardiac cycle to periodically close and open the valve, thereby allowing blood to flow from the first chamber into the second chamber and preventing the reverse flow. However, for patients with valvular regurgitation, when the valve needs to be closed, a pair of leaflets FL, SL cannot achieve proper apposition, and there is a gap between them, allowing blood to flow from the second chamber into the first chamber through the valve, causing reflux.

It should be noted that the valve in FIG. 1 (and other figures of the present disclosure) may be a mitral valve. Correspondingly, the first chamber may be the left atrium, the second chamber may be the left ventricle, one of a pair of leaflets FL, SL may be the anterior leaflet, and the other may be the posterior leaflet. It should be understood that the medical device provided by the present disclosure is not limited to application on the mitral valve, but may also be applied to other heart valves. For example, on the tricuspid valve. When the medical device provided by the present disclosure is applied to the tricuspid valve, it may be located between the three leaflets of the tricuspid valve.

1 , the medical device 10 includes a cushion 11. When the medical device 10 is placed in the heart of a patient, the cushion 11 is located between a pair of leaflets FL, SL. The cushion 11 is configured to cooperate with the pair of leaflets FL, SL to periodically open and close the valve. Specifically, when the valve is closed, the cushion 11 can reduce or fill the gap between the pair of leaflets FL, SL that is not tightly closed or exists when closed, so that the valve is properly closed.

As an example, the pad 11 has a pair of coaptation surfaces 11a, 11b. When the medical device 10 is placed in the patient's heart, the pair of coaptation surfaces 11a, 11b face a pair of leaflets FL, SL respectively. For ease of description, the coaptation surface 11a is referred to as the first coaptation surface, and the coaptation surface 11b is referred to as the second coaptation surface. As the cardiac cycle changes, each of the pair of coaptation surfaces 11a, 11b periodically coapts and separates with the leaflet it faces, so that the valve periodically opens and closes. For example, the coaptation length of each coaptation surface and its corresponding leaflet can be 6 to 12 mm.

Specifically, when the second chamber is diastolic, the pair of leaflets FL and SL move away from each other, so that gaps are formed between the pair of leaflets FL and SL and the pair of apposition surfaces 11a and 11b, respectively; at this time, the valve is open, and blood flows from the first chamber to the second chamber through these gaps. When the second chamber is contracted, the pair of leaflets FL and SL move toward each other, so that the pair of leaflets FL and SL apposition to the pair of apposition surfaces 11a and 11b, respectively; at this time, the valve is closed, and blood flow from the second chamber to the first chamber is blocked.

It should be noted that, in the present disclosure, when the leaflet and the apposition surface are appositioned, the leaflet and the apposition surface may contact and cooperate to prevent blood from flowing between the two.

In this implementation, the pad will not affect or less affect the movement of the pair of leaflets, and the pair of leaflets can more fully maintain their original anatomical and/or physiological functions. That is, in this implementation, as the cardiac cycle changes, the pair of leaflets can naturally and periodically move toward and away from each other according to their own structures. Therefore, using a medical device according to this implementation can avoid or lessen adverse effects on the structure and function of the leaflets.

Considering that the patient's condition is constantly evolving. After a period of time after implantation, the pad may no longer match the patient's condition and may not achieve the expected treatment effect or even cause adverse reactions. If this happens, another surgery is required to replace the pad originally implanted in the patient's body with a pad that matches the patient's current condition. However, another surgery will increase the patient's financial burden and have certain risks, and may even damage the patient's health.

2A and 2B are schematic diagrams showing the structure of the pad 11, the control system 12, the sensor 13, etc. of the medical device 10. As part of the medical device 10, the pad 11, the control system 12, and the sensor 13 may all be implanted into the patient's body.

2A and 2B , the medical device 10 may further include a control system 12, the control system 12 may include a control unit 121, and the pad 11 may include an adjustment mechanism. The control unit 121 is configured to control the adjustment mechanism so that the adjustment mechanism adjusts the size of the pad 11. In one example, the control unit 121 may be configured to control the adjustment mechanism so that the adjustment mechanism adjusts the thickness of the pad 11.

In this way, when the patient's condition changes, the control unit only needs to control the adjustment mechanism to adjust the size of the pad to match the patient's condition again. Since there is no need to undergo surgery again to replace the pad after the patient's condition progresses, the use of this medical device can reduce the patient's financial burden and reduce damage to the patient's health.

In the present disclosure, the adjustable size of the pad can be the size of the pad in various dimensions, and is not limited to the thickness of the pad. For example, in some embodiments, the adjustment mechanism can also adjust one or more of the thickness, height or width of the pad under the control of the control unit.

The thickness of the cushion may refer to the dimension of the cushion from one apposition surface to another apposition surface. In other words, a pair of apposition surfaces may be located on both sides of the cushion in the thickness direction. That is, when the cushion is installed at the patient's valve, a pair of leaflets are located on both sides of the cushion in the thickness direction.

The height of the cushion may refer to the dimension of the cushion in the direction from the first chamber to the second chamber when the cushion is installed at the valve. The width of the cushion may refer to the dimension of the cushion in a direction perpendicular to the height direction and the thickness direction.

For ease of understanding, in the drawings of the present disclosure, arrow X is used to indicate the thickness direction of the pad, arrow Y is used to indicate the width direction of the pad, and arrow Z is used to indicate the height direction of the pad.

There are many ways to adjust the thickness of the pad, and this disclosure does not specifically limit this.

As an example, referring to FIGS. 1 to 2B , the pad 11 includes a pair of main body members 111, 112. The main body members 111, 112 are stacked in the thickness direction of the pad 11. Each main body member has a relative free end and a connecting end, that is, the main body member 111 has a free end 111a and a connecting end 111b, and the main body member 112 has a free end 112a and a connecting end 112b. The connecting ends 111b, 112b of the main body members 111, 112 are pivotally connected. The adjustment mechanism is configured to adjust the opening between the main body members 111, 112 under the control of the control unit 121, thereby adjusting the thickness of the pad 11.

The opening between the main members 111, 112 can be defined by the angle (acute angle) between the two. In FIG2A, the angle _α1 between the main members 111, 112 is small, the opening between the main members 111, 112 is small, and the thickness of the pad 11 is also small. In FIG2B, the angle _α2 between the main members 111, 112 is large, the opening between the main members 111, 112 is large, and the thickness of the pad 11 is also large.

It is understood that in other examples, the thickness of the pad can also be adjusted in other ways. For example, in some embodiments, the pad 11 can include a pair of plates stacked in thickness, and the adjustment mechanism can adjust the thickness of the pad by adjusting the spacing between the pair of plates.

There are many ways to implement the adjustment mechanism, and this disclosure does not specifically limit this.

As an example, the adjustment mechanism may include a driving member 113 and a slider 114. The slider 114 is slidably disposed between the main members 111, 112 and abuts against the main members 111, 112. The driving member 113 is configured to adjust the opening between the main members 111, 112 by driving the slider 114 to slide. Specifically, the adjustment mechanism is configured (under the control of the control unit 121): to expand the opening of the main members 111, 112 by driving the slider 114 to move toward the connecting ends 111b, 112b of the main members 111, 112; and to reduce the opening of the main members 111, 112 by driving the slider 114 to move toward the free ends 111a, 112a of the main members 111, 112.

It is understood that in other examples, the adjustment mechanism can be implemented in other ways. For example, in some embodiments, the adjustment mechanism can include a cam disposed between a pair of main members, and the driving member can adjust the opening between the pair of main members by driving the cam to rotate.

There are many ways to drive the slider, and this disclosure does not specifically limit this.

As an example, referring to FIG. 2A and FIG. 2B , the driving member 113 may be a motor 113 , and the adjustment mechanism further includes a pair of meshing bevel gears 115 , 116 and a lead screw 117 , and the lead screw 117 passes through a threaded hole provided in the slider 114 . The bevel gear 115 is mounted on the output of the motor 113 , and the bevel gear 116 is mounted on the lead screw 117 .

When the motor 113 rotates under the control of the control unit 121, the power is transmitted to the lead screw 117 through the bevel gears 115 and 116, so that the lead screw 117 rotates. As the lead screw 117 rotates, the lead screw 117 drives the slider 114 to slide between the main parts 111 and 112, thereby adjusting the opening between the main parts 111 and 112, and further adjusting the thickness of the pad 11.

In this way, the slider can be driven to slide between the pair of main parts, thereby adjusting the opening of the pair of main parts, and then adjusting the thickness of the pad. This implementation method has many advantages such as simple implementation, compact structure and good reliability.

It is understood that in other examples, the slider may be driven by other means. For example, in some embodiments, the slider may be a magnetic member, and the driving member may be an electromagnetic member, so that the slider is driven to slide by electromagnetic force.

In one example, referring to FIG. 2A and FIG. 2B , the main body 111 is provided with a receiving groove 111c, and the motor 113 is received in the receiving groove 111c to avoid taking up extra space, which is conducive to reducing the overall size of the pad 11. In one example, the main body 111 is also provided with a narrow and long guide groove 111d, and a part of the slider 114 extends into the guide groove 111d, so that the guide groove 111d can guide the slider 114 to slide along a preset track. In one example, the main body 111 is also provided with a boss 111e, and the boss 111e is provided with a through hole for the screw 117 to pass through so as to support the screw 117. In one example, the screw 117 is provided with a shoulder 117a, and the shoulder 117a is located on the side of the boss 111e away from the slider 114 and abuts against the boss 111e to limit the screw 117.

As a possible implementation, referring to FIG. 2A and FIG. 2B , the pad 11 may include a cover 118, which partially or completely wraps a pair of main body members 111, 112. The cover 118 may define the outer surface of the pad 11. A pair of mating surfaces 11a, 11b of the pad 11 is provided by the cover 118. In other words, the pair of mating surfaces 11a, 11b are part of the outer surface of the cover 118. In some embodiments, the cover 118 may be made of a material with better biocompatibility and have a smooth outer surface, thereby reducing the adverse effects of the pad 11 on the health of the patient.

The control unit may spontaneously control the size of the adjustment mechanism and the adjustment pad according to the patient's condition, or may be controlled by instructions from a doctor or the patient to control the size of the adjustment mechanism and the adjustment pad, and the present disclosure does not make any specific limitation on this.

As an example, referring to FIG. 2A and FIG. 2B , the control system 12 may further include a communication unit 122. The communication unit 122 is configured to communicate with a control device located outside the patient's body in a wireless manner. For example, the communication unit 122 may communicate with the external control device in the following manners, but is not limited to: Bluetooth, cellular network, Wi-Fi, electromagnetic field, radio frequency communication, or ultrasonic communication, etc.

The doctor (or patient) can send a control instruction to the communication unit 122 by operating the control device. The communication unit 122 is configured to receive the control instruction and send the control instruction to the control unit 121. After receiving the control instruction, the control unit 121 is configured to control the adjustment mechanism to adjust the size of the pad 11 based on the control instruction.

As another example, referring to FIG. 2A and FIG. 2B , the medical device 10 may further include a sensor 13, which is communicatively connected to the control unit 121. The sensor 13 is configured to sense physiological information of the patient, The sensed physiological information is sent to the control unit 121 , so that the control unit 121 controls the adjustment mechanism to adjust the size of the pad 11 based on the physiological information.

Exemplarily, the physiological information may include, but is not limited to, 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 heart 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.

Since there is a sensor for sensing physiological information reflecting the patient's condition, the control unit can control the adjustment mechanism to adjust the size of the pad according to the physiological information, so that the pad can always match the patient's condition. The medical device provided by this implementation method can not only reduce the number of surgeries while improving the efficacy, but also reduce the number of re-examinations of patients after implantation, thereby reducing the economic burden and time cost of patients.

It can be 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 make any specific limitation on this.

There are many ways to implement the sensor, and this disclosure does not specifically limit this.

As an example, referring to FIG1 , the sensor 13 may include a hemodynamic sensor, such as a pressure sensor or an accelerometer. The sensor 13 may be attached to the outer surface of the pad 11 to sense physiological information that can reflect the blood flow state at the valve. In other words, the physiological information sensed by the sensor 13 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 121 can appropriately adjust the size of the pad 11 according to the physiological information, so that the size of the pad 11 is more matched with the patient's current condition.

It should be noted that in other examples, the sensor is attached to the pad, but is located in the first chamber or the second chamber and focuses on the hemodynamic information of the chamber.

It should be noted that in other examples, the sensor may not be attached to the pad. For example, in some embodiments, the sensor may also be installed on the leaflet. In another example, in some embodiments, the sensor may also be installed on other components of the medical device, such as a support.

In addition, it should be noted that in some embodiments, the medical device provided by the present disclosure may also include multiple sensors, which may be arranged in different positions, such as one in the first chamber and another in the second chamber, so as to more accurately determine the patient's condition. Alternatively, a sensor may have two or more receptors to sense, for example, hemodynamic information in different chambers or different parts of the same chamber.

In an alternative implementation, the communication unit 122 may be configured to send physiological information to the external device and receive control instructions generated by the external device according to the physiological information, and the control unit 121 may be configured to control the adjustment mechanism to adjust the size of the pad 11 based on the control instructions. In this way, it is possible to reduce The complexity and power consumption of the medical device 10.

In order to reduce energy consumption, in one example, referring to FIG. 2A and FIG. 2B , the control system 12 may further include a wake-up unit 123 , which is configured to wake up one or more of the control unit 121 , the communication unit 122 and the sensor 13 based on a preset schedule.

Considering that the patient's condition usually progresses slowly, it is not necessary to adjust the size of the pad frequently. In this implementation, the control unit, the sensor, the communication unit, etc. can be in a dormant state most of the time, and the awakening unit can wake up one or more of them after reaching a preset time point. In this way, energy consumption can be reduced and the purpose of energy saving can be achieved.

As an example, the preset schedule may include multiple cycles, each cycle including a sleep phase and a wake-up phase. When in the sleep phase, other units that need energy consumption except the wake-up unit 123 may be in a dormant state to reduce energy consumption. After the wake-up phase begins, the wake-up unit 123 may wake up some or all of the units that need energy consumption.

For example, a sleep stage can be 6 months to 12 months, and a wake-up stage can be 3 days to 7 days. The duration and start time of each stage can be set. The doctor can set the preset schedule to match the patient's reexamination plan, that is, set the preset schedule to: when the patient needs a reexamination, the medical device 10 is just in the wake-up stage. In this way, after the doctor examines the patient's condition, he can send a control instruction to the communication unit 122 through the external control device to adjust the size of the pad 11 to match the patient's condition after the reexamination.

In an alternative implementation, the awakening unit 123 is also configured to awaken the control unit 121 in response to the physiological information reaching a preset condition. For example, when the physiological information includes blood pressure, the preset condition may be: the blood pressure is greater than or less than a preset threshold.

Referring again to FIG. 2A and FIG. 2B , the control system 12 may further include a power supply unit 124 for supplying power to one or more of the control unit 121 , the communication unit 122 , the wake-up unit 123 , and the sensor 13 .

There are many ways to implement the energy supply unit 124, and the present disclosure does not specifically limit this. For example, in some embodiments, the energy supply unit 124 can be a battery. For another example, in some embodiments, the energy supply unit 124 can be an induction coil, and the doctor or patient can charge the energy supply unit through an external device. For another example, in some embodiments, the energy supply unit 124 can also be an ultrasonic transducer to convert ultrasonic waves sent by an external device into electrical energy. In some embodiments, the energy supply unit 124 can also be a device that can convert kinetic energy into electrical energy.

For the purpose of simplifying the structure, in some implementations, part or all of the control system 12 may be located inside the pad 11. Of course, in some embodiments, the control system 12 may also be located entirely outside the pad 11. This disclosure does not specifically limit this.

There are many ways to position the pad between a pair of leaflets, and this disclosure is not particularly limited thereto.

As an example, referring to FIG. 1 , the medical device 10 may further include a support member 14. When the medical device 10 is placed in the patient's heart, the support member 14 is located in the first chamber and connected to the pad 11, so that the pad 11 is positioned between a pair of leaflets SL, FL. By placing the support member 14 in the first chamber, the pad 11 can be reliably positioned between the pair of leaflets FL, SL. In one example, the pad 11 can be rigidly connected to the support member 14 to always keep the pad 11 in a suitable position to prevent the position of the pad 11 from changing under the influence of blood flow or leaflets FL, SL. If the pad 11 cannot be maintained in a suitable position, it cannot be guaranteed that the pair of leaflets FL, SL can be well aligned with the pair of aligning surfaces 11a, 11b every time the valve is closed.

There are many ways to implement the support member, and this disclosure does not specifically limit this.

As an example, referring to FIG. 1 , the support member 14 may be ring-shaped. When the medical device 10 is installed in the patient's heart, the support member 14 may be placed at the heart's valve annulus. In some embodiments, the support member 14 may have a mesh structure. During delivery, the support member 14 may be folded to reduce its volume; after the support member 14 is delivered to the target location, it may be unfolded again.

It is understood that the implementation of the support member is not limited to the above, as long as the pad can be positioned between a pair of leaflets of the valve. For example, in some embodiments, the support member may also be semi-annular.

It should be understood that, although in the above embodiments, the adjustment mechanism is used to adjust the thickness of the pad, in other embodiments, the adjustment mechanism may also be used to adjust the size of the pad in other dimensions. A possible alternative implementation is given below.

3A and 3B are schematic diagrams of at least a portion of the structure of a pad 21 provided in another embodiment.

3A and 3B , the pad 21 includes a pair of shells 211 and 212. One end of the shell 212 is sleeved on one end of the shell 211, and the two cooperate to define an internal space 21a. The adjustment mechanism is configured to adjust the overlap of the pair of shells 211 and 212 under the control of the control unit, thereby adjusting the width of the pad 21.

3A, the overlap _d1 of the pair of shells 211, 212 is small, and the width _w1 of the pad 21 is large. When the pad 21 is in the state of FIG3B, the overlap _d2 of the pair of shells 211, 212 is large, and the width _w2 of the pad 21 is small.

In some embodiments, the pad 21 may further include an expandable and contractible membrane layer (not shown) covering the pair of shells 211 , 212 . The membrane layer may have a smooth outer surface to prevent or reduce the growth of epidermal cells and the like on the outside of the pad 21 .

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

As an example, referring to FIG. 3A and FIG. 3B , the adjustment mechanism may include a motor 213, a pair of meshing gears 214, 215, a shaft 216 supporting the gear 215, and a rack 217 meshing with the gear 215. The gear 214 is mounted on the output shaft of the motor 213, the shaft 216 is fixed to the housing 211, and one end of the rack 217 is fixed to the housing 211. The motor 213 can rotate under the control of the control unit, thereby driving the rack 217 to move, thereby changing the overlap of the pair of shells 211,212.

It is understandable that the mat and the pair of leaflets are not limited to the above implementation. A possible alternative implementation is given below.

Fig. 4 is a schematic diagram of at least a portion of the structure of a medical device 30 according to another embodiment of the present disclosure. Fig. 4 shows a state where the medical device 30 is placed at a heart valve of a patient.

The medical device 30 has many identical or similar elements to the medical device 10. For the purpose of brevity, the relevant description is appropriately omitted. It is understood that the elements of the medical device 10 and the medical device 30 can be combined with each other without any contradiction.

Referring to FIG. 4 , the medical device 30 includes a pad 31 having a first apposition surface 31a and a second apposition surface 31b. When the medical device 30 is implanted in the heart valve of the patient, the pad 31 is placed between a pair of leaflets FL and SL. The pad 31 is configured to follow the movement of the second leaflet SL, the second apposition surface 31b is configured to face the second leaflet SL and remain apposition with the second leaflet SL, the first apposition surface 31a is configured to face the first leaflet FL, and the first apposition surface 31a is configured to periodically apposition and separation with the first leaflet FL as the pad 31 follows the movement of the second leaflet SL. That is, as the cardiac cycle changes, the second apposition surface 11b always remains apposition with the second leaflet SL, while the first apposition surface 11a periodically appositions and separations with the first leaflet FL.

In this implementation, the pad will not affect or will have little effect on the movement of the pair of leaflets, and the pair of leaflets can maintain their original physiological functions. That is, in this implementation, as the cardiac cycle changes, the pair of leaflets can naturally and periodically move relative to and apart from each other. Therefore, the use of a medical device according to this implementation can have less adverse effects on the structure and function of the leaflets.

There are many ways to position the pad between a pair of leaflets and make the pad follow the movement of the second leaflet, which is not specifically limited in the present disclosure. Several possible implementations are given below.

As an example, referring back to FIG. 4 , the medical device 30 may further include a support member 34. When the medical device 30 is placed in the patient's heart, the support member 34 is located in the first chamber, and the pad 31 is connected to the support member 34 in a manner that can follow the movement of the second leaflet SL. For example, the pad 31 may be hinged to the support member 34 so that the pad 31 can follow the movement of the second leaflet SL. For another example, the pad 31 may be connected to the support member by a flexible member (or portion) so that the pad 31 can follow the movement of the second leaflet SL.

The pad can be reliably positioned between the first leaflet and the second leaflet by the support member placed in the first chamber. The pad is connected to the support member in a manner that it can follow the movement of the second leaflet, and it can be ensured that the pad follows the movement of the second leaflet along with the movement of the second leaflet, so that the first apposition surface is periodically appositioned and separated from the first leaflet.

Fig. 5 is a schematic diagram of at least a portion of the structure of a medical device 40 according to another embodiment of the present disclosure. Fig. 5 shows a state where the medical device 40 is placed at a heart valve of a patient.

The medical device 40 has many identical or similar elements to the medical devices 10 and 30. For the purpose of brevity, the relevant description is appropriately omitted. It is understood that the elements of the medical device 40 and the medical devices 10 and 30 can be combined with each other without any contradiction.

As another example, referring to FIG. 5 , the medical device 40 may include a pin 45 in addition to the pad 41. When the medical device 40 is placed in the patient's heart, the pin 45 may penetrate the second leaflet SL and attach the pad 41 to the second leaflet SL, so that the pad 41 is located between a pair of leaflets FL, SL and follows the movement of the second leaflet SL. In this way, as the cardiac cycle changes, the second apposition surface 41b facing the second leaflet SL can maintain apposition with the second leaflet SL, and the first apposition surface 41a facing the first leaflet FL can periodically apposition and separation with the first leaflet FL as the pad 41 follows the movement of the second leaflet SL.

It should be noted that the medical device may include only one nail or multiple nails, which is not specifically limited in the present disclosure. The nail may be formed integrally with the pad, or the two may be two independent components, which is not specifically limited in the present disclosure.

Fig. 6 is a schematic diagram of at least a portion of the structure of a medical device 50 according to another embodiment of the present disclosure. Fig. 5 shows a state where the medical device 50 is placed at a heart valve of a patient.

The medical device 50 has many identical or similar elements to the medical devices 10, 30, and 40. For the purpose of brevity, the relevant description is appropriately omitted. It is understood that the elements of the medical device 40 and the medical devices 10, 30, and 40 can be combined with each other without any contradiction.

6 , the medical device 50 includes a cushion 51 and a support member 54 . The cushion 51 has a first apposition surface 51 a and a second apposition surface 51 b . The first apposition surface 51 a and the second apposition surface 51 b are configured to face the first leaflet FL and the second leaflet SL, respectively.

When the medical device 50 is implanted in the patient's heart, the cushion 51 is rigidly connected to the support member 54 (i.e., the two are connected in a manner that they cannot move relative to each other), so that the cushion 51 is maintained at a preset position between a pair of leaflets FL, SL and the second apposition surface 51b is maintained in apposition with the second leaflet SL. The preset position is configured so that the first apposition surface 51 can periodically apposition and separation with the first leaflet FL as the first leaflet FL moves.

In this implementation, since the pad 51 is maintained at a preset position between a pair of leaflets FL, SL and the second mate surface 51b remains mate with the second leaflet SL, the pad 51 blocks the movement of the second leaflet SL and the second leaflet SL loses its original physiological function.

Compared with the aforementioned implementation, if a medical device according to this implementation is used, it may cause adverse effects on the structure and function of the second leaflet after a long period of use.

It should be understood that the term “including” and its variations used in the present disclosure are open inclusions, ie, “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.”

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), but these elements are not limited by these terms, and these terms are only used to distinguish one element from another.

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. In order to avoid unnecessary repetition, the present disclosure will not further describe various possible combinations.

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 "one" or "an" used to describe a component or part is not intended to exclude other components or parts.

The above is only a specific embodiment of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any changes or substitutions that can be imagined by any technician familiar with the technical field within the technical scope disclosed in the present disclosure should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims

A medical device, which is suitable for being implanted in a patient's body to repair a valve of the patient, is characterized in that the medical device comprises:

a cushion configured to be located between the plurality of leaflets of the valve and to cause the valve to open and close periodically by cooperating with the plurality of leaflets, and comprising an adjustment mechanism; and

A control unit is configured to control the adjustment mechanism to adjust the size of the pad.
The medical device according to claim 1 is characterized in that it also includes a communication unit, wherein the communication unit is configured to receive a control instruction, and the control unit is configured to control the adjustment mechanism to adjust the size of the pad based on the control instruction.
The medical device according to claim 2 is characterized in that the communication unit is configured to communicate with a control device located outside the patient's body via a wireless manner.
The medical device according to claim 1, further comprising a sensor, wherein the sensor is configured to sense physiological information of the patient, and the control unit is configured to control the adjustment mechanism to adjust the size of the pad based on the physiological information.
The medical device according to claim 1 is characterized in that it also includes a sensor and a communication unit, the sensor is configured to sense physiological information of the patient, the communication unit is configured to send the physiological information to an external device and receive a control instruction generated by the external device according to the physiological information, and the control unit is configured to control the adjustment mechanism based on the control instruction to adjust the size of the pad.
The medical device according to claim 1 is characterized in that it also includes a wake-up unit, which is configured to wake up the control unit based on a preset schedule.
The medical device according to claim 1 is characterized in that it also includes a wake-up unit and a sensing unit, the sensing unit is configured to sense the physiological information of the patient, and the wake-up unit is configured to wake up the control unit in response to the physiological information reaching a preset condition.
The medical device according to claim 1 is characterized in that it also includes a power supply unit, which is configured to supply power to the control unit and the adjustment mechanism.
The medical device of claim 1, wherein the dimension is a thickness of the pad.
The medical device according to claim 9 is characterized in that the pad includes a pair of main body members, the pair of main body members are stacked in the thickness direction of the pad, each main body member has a relative free end and a connecting end, the connecting ends of the pair of main body members are pivotally connected, and the adjustment mechanism is configured to adjust the thickness of the pad by adjusting the opening of the pair of main body members under the control of the control unit.
The medical device according to claim 10 is characterized in that the adjustment mechanism includes a driving member and a slider, the slider is slidably disposed between the pair of main body members and abuts against the pair of main body members, and the driving member is configured to adjust the opening of the pair of main body members by driving the slider to slide under the control of the control unit.
The medical device of claim 1, wherein the dimension is the width of the pad.
The medical device according to claim 12 is characterized in that the pad comprises a pair of shells; one end of one shell in the width direction is mounted on one end of the other shell in the width direction, and the two shells cooperate to define an internal space; the adjustment mechanism is configured to adjust the overlap of the pair of shells under the control of the control unit, thereby adjusting the width of the pad.
The medical device according to any one of claims 1 to 13 is characterized in that the pad has a plurality of mate surfaces, the plurality of mate surfaces are configured to face the plurality of leaflets respectively, and as the plurality of leaflets move, each mate surface periodically mates with and separates from the leaflet it faces.
The medical device according to any one of claims 1 to 13 is characterized in that the multiple leaflets include a first leaflet and a second leaflet, the pad is configured to follow the movement of the second leaflet, the pad has a first mate surface and a second mate surface, the second mate surface is configured to face the second leaflet and remain mate with the second leaflet, the first mate surface is configured to face the first leaflet, and the first mate surface is configured to periodically mate with and separate from the first leaflet as the pad follows the movement of the second leaflet.
The medical device according to claim 15 is characterized in that the medical device also includes a support member, which is connected to the pad so as to position the pad between the multiple leaflets, and the pad is connected to the support member in a manner that can follow the movement of the second leaflet.