CN117982259A

CN117982259A - Medical device

Info

Publication number: CN117982259A
Application number: CN202211327896.5A
Authority: CN
Inventors: 王励
Original assignee: Heyuan Medical Device Shanghai Co ltd
Current assignee: Heyuan Medical Device Shanghai Co ltd
Priority date: 2022-10-27
Filing date: 2022-10-27
Publication date: 2024-05-07
Also published as: WO2024088354A1

Abstract

The present disclosure relates to a medical device for repairing a heart valve of a patient. The medical device includes: a pad configured to be positioned between and to periodically open and close the valve by engaging the pair of leaflets of the valve, and comprising an adjustment mechanism; and a control unit configured to control the adjustment mechanism to adjust the size of the pad. According to the medical device provided by the disclosure, after the illness state of a patient changes, the size of the cushion is adjusted by controlling the adjusting mechanism through the control unit, so that the cushion can be matched with the illness state of the patient again. It can be seen that with the medical device provided by the present disclosure, there is no need to replace the pad with a surgical procedure again after the patient's condition changes. Thus, 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.

Description

Medical device

Technical Field

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

Background

A heart valve refers to a valve between the atrium and ventricle or between the ventricle and artery. Valves play a critical role in the blood circulation activity that the heart never stops. After blood flow, the valve closes, thereby preventing reflux of blood.

Several structural factors may affect proper closure of the heart valve, thereby inducing regurgitation of blood. Taking the mitral valve as an example, if the mitral valve fails to close properly, blood can flow from the left ventricle through the mitral valve to the left atrium during systole, thereby compromising the patient's health.

A medical device for repairing a heart valve includes a pad that can be surgically delivered between the leaflets of the valve of a patient. When the valve is closed, the pad can fill the gaps between the leaflets, thereby improving the closing of the valve.

The condition of the patient is continuously developed. When the patient's condition has progressed to some extent, the pad initially implanted at the valve may no longer match the patient's condition. For example, if the condition deteriorates, the pad will no longer adequately fill the gaps between the leaflets when the valve closes, and regurgitation may occur again. As another example, if the condition is improved (e.g., the ventricle begins to become smaller), the pad may cause a decrease in the effective area of blood flow through the valve when the valve is open, thereby causing stenosis.

If this occurs, the procedure needs to be performed again, replacing the pad originally implanted in the patient with a pad that matches the current condition of the patient. However, re-surgery can burden the patient's economy and compromise the patient's health.

Disclosure of Invention

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

The medical device provided by the present disclosure includes a pad and a control unit. The pad is configured to be positioned between and to periodically open and close the valve by engaging the pair of leaflets of the valve, 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 disclosure, after the illness state of a patient changes, the size of the cushion is adjusted by controlling the adjusting mechanism through the control unit, so that the cushion can be matched with the illness state of the patient again. It can be seen that with the medical device provided by the present disclosure, there is no need to replace the pad with a surgical procedure again after the patient's condition changes. Accordingly, the medical device provided by the present disclosure can avoid or reduce re-surgery, thereby reducing the economic burden on the patient and reducing the risk of damage to the patient's health, such as re-surgery, while achieving better therapeutic results.

In one possible implementation, the medical device further comprises a communication unit configured to receive the control instruction, the control unit being configured to control the adjustment mechanism to adjust the size of the pad based on the control instruction.

After implantation of the medical device of the present disclosure, the patient may be periodically retested to confirm the change in condition. When it is detected that the size of the pad no longer matches the condition of the patient, the physician may send control instructions to the communication unit of the medical device implanted in the patient via the control unit located outside the body. After receiving the control instruction, the control unit can control the adjusting mechanism according to the control instruction, so that the adjusting mechanism can properly adjust the size of the cushion, and the cushion is matched with the illness state of the patient again.

In one possible implementation, the medical device further comprises a sensor configured to sense physiological information of the patient, the control unit being configured to control the adjustment mechanism to adjust the size of the pad based on the physiological information.

By having a sensor for sensing physiological information reflecting the condition of the patient, the control unit is enabled to control the adjustment mechanism to adjust the size of the pad according to the physiological information so that the pad can always be matched to the condition of the patient. The medical device provided by the implementation can reduce the number of rechecks of patients after implantation, and/or can discover problems early and adjust the problems appropriately (particularly for patients with poor compliance with periodic follow-up), so that the patients can be better treated, and the economic burden and time cost of the patients can be reduced.

In one possible implementation, the communication unit is configured to send physiological information to the extracorporeal device and receive control instructions generated by the extracorporeal device in accordance with the physiological information, the control unit being 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 one possible implementation, the medical device further comprises a wake-up unit configured to wake-up the control unit based on a preset schedule.

Considering that the patient's condition is generally slow to develop, it is not necessary to frequently adjust the size of the pad. In such an implementation, the control unit, sensor, communication unit, etc. may be in a sleep state most of the time, and after a preset point in time is reached, the wake-up unit may wake up one or more of them. Therefore, the energy consumption can be reduced, and the purpose of energy conservation is achieved.

In an alternative implementation, the wake-up unit is also configured to wake-up the control unit in response to the physiological information reaching a preset condition.

In one possible implementation, the device further comprises an energy supply unit configured to supply energy to the control unit and the adjustment mechanism.

In one possible implementation, the adjustment mechanism is configured to adjust the thickness of the pad, i.e. the size of the pad that can be adjusted to its thickness, under the control of the control unit.

In one possible implementation, the pad comprises a pair of body members stacked in a thickness direction of the pad, each body member having opposite free ends and connection ends, the connection ends of the pair of body members being pivotably connected, the adjustment mechanism being configured to adjust the thickness of the pad by adjusting the opening of the pair of body members under the control of the control unit.

In this way, the adjustment mechanism is able to adjust the thickness of the pad under the control of the control unit. The implementation mode has the advantages of simplicity in implementation, compactness in structure, high reliability and the like.

In one possible implementation, the adjustment mechanism includes a driving member and a slider slidably disposed between and abutting the pair of body members, the driving member being configured to adjust the opening degree of the pair of body members by driving the slider to slide under the control of the control unit.

In this way, the adjustment mechanism is able to adjust the opening of the pair of body members, and thus the thickness of the pad, under the control of the control unit. The implementation mode has the advantages of simplicity in implementation, compactness in structure, high reliability and the like.

In one possible implementation, the pad has a pair of apposition surfaces configured to face a pair of leaflets, respectively, and each apposition surface periodically apposes and separates from the leaflet it faces as the pair of leaflets moves.

In this implementation, the pad does not affect or affects less the movement of a pair of leaflets, each of which is capable of retaining its original physiological function. That is, in this implementation, a pair of leaflets can move toward and away from each other naturally and periodically as the cardiac cycle changes. Therefore, with the medical device according to this embodiment, the structure and function of the leaflet can be less adversely affected.

In one possible implementation, the pair of leaflets includes a first leaflet and a second leaflet, the pad is configured to follow the second leaflet movement, the pad has a first apposition surface and a second apposition surface, the second apposition surface is configured to face and remain apposed with the second leaflet, the first apposition surface is configured to face the first leaflet, and the first apposition surface is configured to periodically appose and separate from the first leaflet with the pad following the second leaflet movement.

That is, in such an implementation, a pair of leaflets can both naturally, periodically move relative to each other and away from each other as the cardiac cycle changes. Therefore, with the medical device according to this embodiment, the structure and function of the leaflet can be less adversely affected.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings that are required to be used in the embodiments will be briefly described below.

It is to be understood that the following drawings illustrate only certain embodiments of the present disclosure and are therefore not to be considered limiting of its scope, for the person of ordinary skill in the art may admit to other equally relevant drawings without inventive effort.

It should be understood that the same or similar reference numerals are used throughout the drawings to designate the same or similar elements (components or portions thereof).

It should be understood that the figures are merely schematic and that the dimensions and proportions of the elements (components or portions thereof) in the figures are not necessarily accurate.

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

Fig. 2A and 2B are schematic structural views showing pads, control systems, sensors, and the like of the medical device in fig. 1.

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

Fig. 5 is a schematic structural view of at least a portion of a medical device according to another embodiment of the present disclosure.

Fig. 6 is a schematic structural view of at least a portion of a medical device according to another embodiment of the present disclosure.

Detailed Description

The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure. It will be apparent that the described embodiments are only some, but not all, of the embodiments of the present disclosure.

Fig. 1 is a schematic structural view of a medical device 10 according to an embodiment of the present disclosure. Fig. 1 shows a state in which the medical device 10 is placed at a heart valve of a patient.

In fig. 1 (and other figures of the present disclosure), a heart valve is positioned between the first chamber and the second chamber for allowing blood flow from the first chamber into the second chamber and preventing the opposite flow. The heart valve includes a pair of mated leaflets FL, SL. For ease of description, the leaflet FL will hereinafter be referred to as a first leaflet and the leaflet SL will be referred to as a second leaflet.

For a healthy heart, the pair of leaflets FL, SL can naturally coapt and separate with the cardiac cycle to periodically close and open the valve, allowing blood to flow from the first chamber into the second chamber and preventing the opposite flow. However, for a patient with valve insufficiency, when valve closure is required, the pair of leaflets FL, SL do not achieve proper coaptation, with a gap between them, so that blood flow can flow from the second chamber into the first chamber through the valve, causing regurgitation.

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 the 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 devices provided by the present disclosure are not limited to use on mitral valves, but may be used on other heart valves as well.

Referring to fig. 1, a medical device 10 includes a pad 11. When the medical device 10 is positioned in the heart of a patient, the pad 11 is positioned between the pair of leaflets FL, SL. Pad 11 is configured to cooperate with a pair of leaflets FL, SL to periodically open and close the valve. Specifically, when the valve is closed, the pad 11 may reduce or fill the gap that exists between the pair of leaflets FL, SL when the closure is not tight enough, or when the closure is occurring, so that the valve is properly closed.

As one example, the pad 11 has a pair of opposed faces 11a,11b. When the medical device 10 is placed in the heart of a patient, the pair of opposing faces 11a,11b respectively face the pair of leaflets FL, SL. For convenience of description, the mating face 11a will be hereinafter referred to as a first mating face, and the mating face 11b will be hereinafter referred to as a second mating face. With a change in the cardiac cycle, each of the pair of apposition surfaces 11a,11b periodically apposes (coaptation) and separates from its facing leaflet, thereby allowing the valve to periodically open and close. For example, the coaptation length (coaptation length) of each coaptation surface and its corresponding leaflet can be 6 to 12 millimeters.

Specifically, when the second chamber is relaxed, the pair of leaflets FL, SL move apart such that gaps are formed between the pair of leaflets FL, SL and the pair of opposed faces 11a,11b, respectively; at this point, the valve is open and blood flow is allowed to flow from the first chamber into the second chamber through these gaps. When the second chamber contracts, the pair of leaflets FL, SL move toward each other so that the pair of leaflets FL, SL respectively coapt with the pair of opposed faces 11a,11 b; at this point, the valve is closed and blood flow from the second chamber to the first chamber is prevented.

It is noted that in the present disclosure, when the leaflet is engaged with the coaptation surface, the leaflet can be in contact engagement with the coaptation surface to prevent blood flow there between.

In such an implementation, the pad does not affect or affects less the movement of a pair of leaflets, each of which can more fully retain its original anatomical and/or physiological function. That is, in such an implementation, as the cardiac cycle changes, a pair of leaflets are able to move toward and away from each other naturally, periodically, depending on their own structure. Thus, with the medical device according to this implementation, adverse effects on the structure and function of the leaflet can be avoided or reduced.

Consider that the condition of a patient is evolving. After a period of time following implantation, the pad may no longer match the patient's condition and may not achieve the desired therapeutic effect or even cause adverse reactions. If this occurs, the procedure needs to be performed again to replace the pad originally implanted in the patient with a pad that matches the patient's current condition. However, re-surgery can increase the economic burden on the patient and present a certain risk, possibly even compromising the patient's health.

Fig. 2A and 2B are schematic structural views showing the pad 11, the control system 12, the sensor 13, and the like of the medical device 10.

Referring to fig. 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 such 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 such that the adjustment mechanism adjusts the thickness of the pad 11.

Thus, after the illness state of the patient changes, the size of the cushion is adjusted by controlling the adjusting mechanism through the control unit, so that the cushion can be matched with the illness state of the patient again. The use of such a medical device can reduce the economic burden on the patient and reduce the harm to the patient's health, since there is no need to perform a re-operation to replace the pad after the patient's condition has progressed.

In the present disclosure, the size of the pad that can be adjusted 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 may also adjust one or more of the thickness, height, or width of the pad under the control of the control unit.

The thickness of a pad may refer to the dimension of the pad in the direction from one mating surface to the other. Alternatively, a pair of opposed faces may be located on both sides in the thickness direction of the pad, respectively. That is, when the pad is mounted to the valve of the patient, a pair of leaflets are located on both sides of the pad in the thickness direction, respectively.

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

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

There are various ways of adjusting the thickness of the pad, which the present disclosure does not specifically limit.

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

The opening between the body parts 111,112 may be defined by the angle (acute angle) formed between the two. In fig. 2A, the angle α ₁ between the body parts 111,112 is small, the opening between the body parts 111,112 is small, and the thickness of the pad 11 is also small. In fig. 2B, the angle α ₂ between the body parts 111,112 is large, the opening between the body parts 111,112 is large, and the thickness of the pad 11 is also large.

It will be appreciated that in other examples, the thickness of the pad may be adjusted in other ways. For example, in some embodiments, pad 11 may comprise a pair of plates stacked in a thickness manner, and the adjustment mechanism may adjust the thickness of the pad by adjusting the spacing of the pair of plates.

There are a variety of implementations of the adjustment mechanism, which the present disclosure does not specifically limit.

As one example, the adjustment mechanism may include a drive member 113 and a slider 114. A slider 114 is slidably disposed between the body members 111,112 and abuts the body members 111, 112. The driving member 113 is configured to adjust the opening degree between the body members 111,112 by sliding the driving slider 114. Specifically, the adjustment mechanism is configured (under the control of the control unit 121): expanding the opening of the body members 111,112 by driving the slider 114 toward the connection ends 111b,112b of the body members 111, 112; the opening of the body members 111,112 is reduced by driving the slider 114 toward the free ends 111a,112a of the body members 111, 112.

It will be appreciated that in other examples, the adjustment mechanism may be implemented in other ways. For example, in some embodiments, the adjustment mechanism may include a cam disposed between a pair of body members, and the drive member may adjust the opening between the pair of body members by driving the cam to rotate.

There are various ways of driving the slider, which the present disclosure does not specifically limit.

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

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

In this way, the slider can be driven to slide between the pair of body members, thereby adjusting the opening degree of the pair of body members and thus the thickness of the pad. The implementation mode has the advantages of simplicity in implementation, compactness in structure, high reliability and the like.

It will be appreciated that in other examples, the slider may be driven in other ways as well. 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 2B, the body member 111 is provided with a receiving groove 111c, and the motor 113 is received in the receiving groove 111c to avoid taking up additional space, which is advantageous in reducing the overall size of the pad 11. In one example, the body member 111 is further provided with an elongated guide groove 111d, and a portion of the slider 114 is inserted into the guide groove 111d, so that the guide groove 111d can guide the slider 114 to slide along a predetermined trajectory. In one example, the body member 111 is further provided with a boss 111e, and the boss 111e is provided with a through hole through which the screw 117 passes to support the screw 117. In one example, the screw 117 is provided with a shoulder 117a, the shoulder 117a being located on the side of the boss 111e facing away from the slider 114 and abutting the boss 111e to limit the screw 117.

As one possible implementation, referring to fig. 2A and 2B, the pad 11 may include a cover 118, the cover 118 partially or fully surrounding the pair of body members 111,112. The cover 118 may define an outer surface of the pad 11. A pair of opposed faces 11a,11b of pad 11 are provided by a cover 118. Alternatively, the pair of opposed faces 11a,11b are part of the outer surface of the cover 118. In some embodiments, the cover 118 may be made of a biocompatible material and have a smooth outer surface to reduce adverse effects of the pad 11 on the patient's health.

The control unit may control the size of the adjustment mechanism adjustment pad spontaneously according to the condition of the patient, or may be controlled by instructions from a doctor or the patient to control the size of the adjustment mechanism adjustment pad, which is not particularly limited in this disclosure.

As an example, referring to fig. 2A and 2B, control system 12 may also include a communication unit 122. The communication unit 122 is configured to be communicatively connected to a control device located outside the patient's body by wireless means. For example, the communication unit 122 may be, but is not limited to, communicatively connected with an external control device by: bluetooth, cellular network, wi-Fi, electromagnetic field, radio communication, or ultrasonic communication, etc.

The doctor (or patient) can send control instructions to the communication unit 122 by operating the control means. The communication unit 122 is configured to receive the control instruction and transmit the control instruction to the control unit 121. Upon 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 2B, the medical device 10 may further include a sensor 13, the sensor 13 being communicatively connected to the control unit 121. The sensor 13 is configured to sense physiological information of the patient and transmit the sensed physiological information to the control unit 121, such that the control unit 121 controls the adjustment mechanism to adjust the size of the pad 11 based on the physiological information.

Illustratively, 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, electrocardiographic 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 information described above.

By having a sensor for sensing physiological information reflecting the condition of the patient, the control unit is enabled to control the adjustment mechanism to adjust the size of the pad according to the physiological information so that the pad can always be matched to the condition of the patient. The medical device provided by the implementation mode not only can improve the curative effect while reducing the operation, but also can reduce the number of rechecks of the patient after implantation, thereby reducing the economic burden and time cost of the patient.

It will be appreciated 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, as the present disclosure is not limited in detail.

There are various implementations of the sensor, which the present disclosure does not specifically limit.

As an example, referring to fig. 1, the sensor 13 may comprise a hemodynamic sensor, such as a pressure sensor or an accelerometer. A sensor 13 may be attached to the outer surface of the pad 11 to sense physiological information that can be representative of the state of blood flow at the valve. That is, the physiological information sensed by the sensor 13 can represent the blood flow state at the valve, i.e., whether or not 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 current condition of the patient.

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 while focusing on the hemodynamic information of the chambers.

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 mounted on the leaflet. As another example, in certain embodiments, the sensor may also be mounted on other components of the medical device, such as a support.

Furthermore, it should be noted that in some embodiments, the medical device provided by the present disclosure may also include multiple sensors, which may be disposed at different locations, such as one in the first chamber and another in the second chamber, to enable a more accurate determination of the patient's condition. It is also possible that one sensor has two or more receptors to sense e.g. hemodynamic information of 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 extracorporeal device and receive control instructions generated by the extracorporeal 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, the complexity and power consumption of the medical device 10 can be reduced.

For reasons of reduced power consumption, in one example, referring to fig. 2A and 2B, the control system 12 may further comprise a wake-up unit 123, the wake-up unit 123 being 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.

As one example, the preset schedule may include a plurality of cycles, each cycle including a sleep stage and a wake stage. While in the sleep stage, other units requiring power consumption other than the wake-up unit 123 may be in a sleep state to reduce power consumption. After the wake-up phase begins, the wake-up unit 123 may wake up some or all of the units that require power consumption.

For example, one sleep stage may be 6 months to 12 months and one wake-up stage may be 3 days to 7 days. The duration and start time of each phase may be set. The doctor can set the preset schedule to match the review plan of the patient, i.e., set the preset schedule to: when the patient requires a review, the medical device 10 is just in the wake-up phase. Thus, after the doctor has checked the condition of the patient, the external control device may send control instructions to the communication unit 122 to adjust the size of the pad 11 to match the condition of the patient after the re-examination.

In an alternative implementation, the wake-up unit 123 is also configured to wake-up 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 back to fig. 2A and 2B, the control system 12 may further comprise an energy supply unit 124, the energy supply unit 124 being configured to supply energy to one or more of the control unit 121, the communication unit 122, the wake-up unit 123 and the sensor 13.

There are various implementations of the power supply unit 124, which the present disclosure does not specifically limit. For example, in some embodiments, the power supply unit 124 may be a battery. As another example, in some embodiments, the energy supply unit 124 may be an induction coil that the physician or patient may energize by an external device. As another example, in some embodiments, the energy supply unit 124 may also be an ultrasonic transducer to convert ultrasonic waves transmitted by an external device into electrical energy. In some embodiments, the energy supply unit 124 may also be a device capable of converting kinetic energy into electrical energy.

For purposes of simplifying the structure, in some implementations, some or all of the control system 12 may be located inside the pad 11. Of course, in some embodiments, control system 12 may also be located entirely outside of pad 11. The present disclosure is not particularly limited thereto.

There are a variety of ways to position the pad between a pair of leaflets, which the present disclosure does not specifically limit.

As an example, referring to fig. 1, the medical device 10 may further include the medical device 10 and may further include a support 14. When the medical device 10 is positioned in the patient's heart, the support 14 is positioned within the first chamber and connected to the pad 11, thereby positioning the pad 11 between the pair of leaflets SL, FL. By the support 14 placed in the first chamber, the pad 11 can be reliably positioned between the pair of leaflets FL, SL. In one example, pad 11 may be rigidly connected to support 14 to maintain pad 11 in a proper position throughout, avoiding a change in position of pad 11 under the influence of blood flow or leaflets FL, SL. If pad 11 is not held in place, it is not guaranteed that each time the valve is closed, the pair of leaflets FL, SL will be properly coaptated with the pair of abutment surfaces 11a,11 b.

There are a variety of implementations of the support, which the present disclosure does not specifically limit.

As an example, referring to fig. 1, the support 14 may be annular. When the medical device 10 is installed in a patient's heart, the support 14 may be positioned at the annulus of the heart. In some embodiments, the support 14 may have a grid configuration. During delivery, the support 14 may be folded first to reduce its volume; after the support 14 is delivered to the target site, it may be deployed again.

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

It should be appreciated that while 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. In the following, one possible alternative implementation is given.

Fig. 3A and 3B are schematic structural views of at least part of a pad 21 provided in another embodiment.

Referring to fig. 3A and 3B, the pad 21 includes a pair of housings 211,212. One end of the housing 212 is fitted over one end of the housing 211, and both cooperatively define the inner space 21a. The adjustment mechanism is configured to adjust the degree of overlap of the pair of housings 211,212 under the control of the control unit, thereby adjusting the width of the pad 21.

When the pad 21 is in the state in fig. 3A, the overlapping degree d ₁ of the pair of cases 211,212 is small, and the width w ₁ of the pad 21 is large. When the pad 21 is in the state in fig. 3B, the overlapping degree d ₂ of the pair of cases 211,212 is large, and the width w ₂ of the pad 21 is small.

Thus, the adjusting mechanism can adjust the width of the pad under the control of the control unit. The implementation mode has the advantages of simplicity in implementation, compactness in structure, high reliability and the like.

In some embodiments, pad 21 may also include an expandable and contractible membrane layer (not shown) that encases a pair of shells 211, 212. The membrane layer may have a smooth outer surface to avoid or reduce the appearance of neoplasms such as epidermal cells on the exterior of the pad 21.

There are various ways of adjusting the degree of overlap of a pair of shells, which the present disclosure does not specifically limit.

As an example, referring to fig. 3A and 3B, the adjustment mechanism may include a motor 213, a pair of meshed gears 214,215, a shaft 216 supporting the gear 215, and a rack 217 meshed 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 212. The motor 213 can be rotated under the control of the control unit to drive the rack 217 to move, thereby changing the degree of overlap of the pair of housings 211, 212.

It will be appreciated that the manner in which the pad mates with the pair of leaflets is not limited to the above-described implementation. In the following, one possible alternative implementation is given.

Fig. 4 is a schematic structural view of at least a portion of a medical device 30 according to another embodiment of the present disclosure. Fig. 4 shows the state in which the medical device 30 is placed at a heart valve of a patient.

Medical device 30 has many of the same or similar elements as medical device 10. For the sake of brevity, the related description is appropriately omitted. It is understood that the elements of medical device 10 and medical device 30 may be combined with one another without contradiction.

Referring to fig. 4, the medical device 30 includes a pad 31, the pad 31 having a first apposition surface 31a and a second apposition surface 31b. After the medical device 30 is implanted at the heart valve of the patient, the pad 31 is positioned between the pair of leaflets FL, SL. The pad 31 is configured to follow the movement of the second leaflet SL, the second coaptation surface 31b is configured to face and remain coaptation with the second leaflet SL, the first coaptation surface 31a is configured to face the first leaflet FL, and the first coaptation surface 31a is configured to periodically coapt and separate from the first leaflet FL with the pad 31 following the movement of the second leaflet SL. That is, the second coaptation surface 11b remains coaptated with the second leaflet SL throughout as the cardiac cycle changes, while the first coaptation surface 11a periodically coapts and separates from the first leaflet FL.

In this implementation, the pad does not affect or affects less the movement of a pair of leaflets, each of which is capable of retaining its original physiological function. That is, in such an implementation, a pair of leaflets can both naturally, periodically move relative to each other and away from each other as the cardiac cycle changes. Therefore, with the medical device according to this embodiment, the structure and function of the leaflet can be less adversely affected.

There are a variety of ways to position the pad between a pair of leaflets and allow the pad to follow the movement of the second leaflet, which is not specifically limited by this disclosure. Several possible implementations are given below.

As one example, referring back to fig. 4, the medical device 30 may also include a pad support 34. When the medical device 30 is placed in the heart of a patient, the support 34 is located within the first chamber and the pad 31 is connected to the support 34 in a manner that is capable of following the movement of the second leaflet SL. For example, the pad 31 may be hinged with the support 34 to enable the pad 31 to follow the second leaflet SL movement. As another example, the pad 31 may be connected to the support by a flexible member (or portion) to enable the pad 31 to follow the second leaflet SL movement.

By means of the support placed in the first chamber, the pad can be reliably positioned between the first leaflet and the second leaflet. The pad is connected with the support in a manner capable of following the movement of the second leaflet, and can ensure that the pad follows the movement of the second leaflet, so that the first coaptation surface and the first leaflet are periodically coaptated and separated.

Fig. 5 is a schematic structural view of at least a portion of a medical device 40 according to another embodiment of the present disclosure. Fig. 5 shows the state in which the medical device 40 is placed at the heart valve of the patient.

The medical device 40 has many of the same or similar elements as the medical devices 10, 30. For the sake of brevity, the related description is appropriately omitted. It will be appreciated that the elements of the medical device 40 and the medical devices 10,30 may be combined with one another without contradiction.

As another example, referring to fig. 5, medical device 40 may include staples 45 in addition to pads 41. When the medical device 40 is positioned in the patient's heart, the staples 45 may penetrate the second leaflet SL to attach the pad 41 to the second leaflet SL such that the pad 31 is positioned between the pair of leaflets FL, SL and follows the movement of the second leaflet SL. In this way, with a change in the cardiac cycle, the second coaptation surface 41b facing the second leaflet SL can remain coaptated with the second leaflet SL, and the first coaptation surface 41a facing the first leaflet FL can be periodically coaptated and separated from the first leaflet FL with the movement of the pad 41 following the second leaflet SL.

It should be noted that the medical device may include only one nail or may include a plurality of nails, which is not particularly limited in this disclosure. The peg may be integrally formed with the pad, or may be two separate pieces, and the embodiments of the present disclosure are not particularly limited.

Fig. 6 is a schematic structural view of at least a portion of a medical device 50 according to another embodiment of the present disclosure. Fig. 5 shows the medical device 50 in a state of being placed at a heart valve of a patient.

The medical device 50 has many of the same or similar elements as the medical devices 10,30, 40. For the sake of brevity, the related description is appropriately omitted. It is understood that the elements of the medical device 40 and the medical devices 10,30,40 may be combined with one another without contradiction.

Referring to fig. 6, the medical device 50 includes a pad 51 and a support 54, the pad 51 having a first apposition surface 51a and a second apposition surface 51b, the first apposition surface 51a and the second apposition surface 51b being configured to face the first leaflet FL and the second leaflet SL, respectively.

After the medical device 50 is implanted in the patient's heart, the pad 51 is rigidly connected (i.e., non-relatively movably connected) to the support 54 such that the pad 51 is held in a predetermined position between the pair of leaflets FL, SL and the second apposition surface 51b remains apposed with the second leaflet SL. The preset position is configured to enable the first coaptation surface 51 to periodically coapt and separate from the first leaflet FL as the first leaflet FL moves.

In this implementation, since the pad 51 is held at a predetermined position between the pair of leaflets FL, SL and the second coaptation surface 51b remains coaptated with the second leaflet SL, the pad 51 will block movement of the second leaflet SL, which loses its original physiological function.

If a medical device according to such an implementation is used, the structure and function of the second leaflet may be adversely affected after a longer period of use than in the previous implementation.

It should be understood that the term "include" and variations thereof as used in this disclosure are intended to be open-ended, i.e., including, but not limited to. The term "one embodiment" means "at least one embodiment," and the term "another embodiment" means "at least one other embodiment.

It should be understood that although the terms "first" or "second," etc. may be used in this disclosure to describe various elements (e.g., a first chamber and a second chamber), these elements are not limited by these terms, which are merely used to distinguish one element from another element.

The specific features (elements) described in the foregoing embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, the disclosure does not further describe various possible combinations.

It should be understood that multiple components and/or portions can be provided by a single integrated component or portion. Alternatively, a single integrated component or part may be separated into separate multiple components and/or parts. The disclosure of "a" or "an" to describe a component or section is not intended to exclude other components or sections.

The foregoing is merely a specific embodiment of the disclosure, but the protection scope of the disclosure is not limited thereto, and any person skilled in the art will recognize that changes and substitutions are within the technical scope of the disclosure. Therefore, the protection scope of the present disclosure shall be subject to the protection scope of the claims.

Claims

1. A medical device for repairing a valve of a patient, comprising:

A pad configured to be positioned between and to periodically open and close the valve by engaging a pair of leaflets of the valve, and comprising an adjustment mechanism; and

And a control unit configured to control the adjustment mechanism to adjust the size of the pad.

2. The medical device of claim 1, further comprising a communication unit configured to receive control instructions, the control unit configured to control the adjustment mechanism to adjust the size of the pad based on the control instructions.

3. The medical device of claim 1, further comprising a sensor configured to sense physiological information of the patient, the control unit configured to control the adjustment mechanism to adjust the size of the pad based on the physiological information.

4. The medical apparatus of claim 1, further comprising a sensor configured to sense physiological information of the patient and a communication unit configured to send the physiological information to an extracorporeal device and receive control instructions generated by the extracorporeal device according to the physiological information, the control unit configured to control the adjustment mechanism to adjust the size of the pad based on the control instructions.

5. The medical device of claim 1, further comprising a wake-up unit configured to wake-up the control unit based on a preset schedule.

6. The medical device of claim 1, further comprising a wake-up unit configured to sense physiological information of the patient and a sensing unit configured to wake-up the control unit in response to the physiological information reaching a preset condition.

7. The medical device of claim 1, further comprising an energy supply unit configured to power the control unit and the adjustment mechanism.

8. The medical device of claim 1, wherein the dimension is a thickness of the pad.

9. The medical device of claim 8, wherein the pad comprises a pair of body members stacked in a thickness direction of the pad, each body member having opposite free ends and a connection end, the connection ends of the pair of body members being pivotably connected, the adjustment mechanism being configured to adjust the thickness of the pad by adjusting an opening of the pair of body members under control of the control unit.

10. The medical device of claim 9, wherein the adjustment mechanism comprises a drive member and a slider slidably disposed between and against the pair of body members, the drive member being configured to adjust the opening of the pair of body members by driving the slider to slide under the control of the control unit.

11. The medical device of any one of claims 1-10, wherein the pad has a pair of opposing faces configured to respectively face the pair of leaflets, and each of the opposing faces periodically coaptates and separates from the leaflet with which it faces as the pair of leaflets moves.

12. The medical device of any one of claims 1-10, wherein the pair of leaflets comprises a first leaflet and a second leaflet, the pad is configured to follow the second leaflet motion, the pad has a first apposition surface and a second apposition surface, the second apposition surface is configured to face and remain apposed with the second leaflet, the first apposition surface is configured to face the first leaflet, and the first apposition surface is configured to periodically appose and separate from the first leaflet as the pad follows the second leaflet motion.