Medical device

Abstract

The present disclosure relates to a medical device for repairing a heart valve of a patient. The medical device comprises a pad configured to be located between a pair of leaflets of the valve and to cause the valve to periodically open and close by cooperating with the pair of leaflets, and comprising an adjusting mechanism; and a control unit configured to control the adjusting mechanism to adjust a size of the pad. According to the medical device provided by the present disclosure, when the condition of the patient changes, only the size of the pad needs to be adjusted by controlling the adjusting mechanism through the control unit, so that the pad can be matched to the condition of the patient again. Therefore, if the medical device provided by the present disclosure is used, when the condition of the patient changes, the pad does not need to be replaced by surgery again. Therefore, the medical device provided by the present disclosure can reduce the economic burden of the patient and reduce the damage to the health of the patient.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and more specifically to a medical device for repairing a patient's valve. Background Technology

[0002] Heart valves are the valves between the atria and ventricles of the heart, or between the ventricles and arteries. Valves play a crucial role in the heart's ceaseless circulation of blood. After blood has flowed through, the valves close, preventing backflow.

[0003] Several structural factors can affect the proper closure of heart valves, leading to blood regurgitation. For example, if the mitral valve fails to close properly, blood can flow from the left ventricle through the mitral valve into the left atrium during systole, potentially harming the patient's health.

[0004] A medical device for repairing heart valves includes a pad that can be surgically delivered between the leaflets of a patient's valve. When the valve closes, the pad fills the gap between the leaflets, thereby improving valve closure.

[0005] A patient's condition is constantly evolving. As the condition progresses, the pads initially implanted at the valve may no longer be a good fit. For example, if the condition worsens, the pads may no longer be able to adequately fill the gaps between the leaflets when the valve closes, causing regurgitation to recur. Conversely, if the condition improves (e.g., the ventricles begin to shrink), the pads may reduce the effective area for blood flow through the valve when it opens, potentially leading to stenosis.

[0006] If the above situation occurs, a second surgery will be required to replace the original implant with a pad that is matched to the patient's current condition. However, a second surgery would increase the patient's financial burden and harm their health. Summary of the Invention

[0007] In view of this, the present disclosure provides a medical device for repairing a patient's heart valve, thereby reducing the patient's financial burden and minimizing harm to the patient's health.

[0008] The medical device disclosed herein includes a pad and a control unit. The pad is configured to be located between a pair of leaflets of a valve and to periodically open and close the valve by cooperating with the pair 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.

[0009] According to the medical device disclosed herein, when a patient's condition changes, the size of the pad can be adjusted simply by controlling the adjustment mechanism via the control unit, allowing the pad to be refitted to the patient's condition. Therefore, if the medical device disclosed herein is used, there is no need for a second surgery to replace the pad when the patient's condition changes. Thus, using the medical device disclosed herein can avoid or reduce the need for repeat surgeries, thereby achieving better treatment results while reducing the patient's financial burden and minimizing harm to the patient's health, such as the risk of repeat surgery.

[0010] In one possible implementation, the medical device further includes a communication unit configured to receive control commands, and the control unit configured to control the adjustment mechanism based on the control commands to adjust the size of the pad.

[0011] After the medical device of this disclosure is implanted, patients can undergo regular follow-up examinations to monitor changes in their condition. When it is detected that the size of the pad no longer matches the patient's condition, the doctor can send a control command to the communication unit of the medical device implanted in the patient's body via an external control device. Upon receiving the control command, the control unit can control the adjustment mechanism to appropriately adjust the size of the pad, thereby restoring the fit between the pad and the patient's condition.

[0012] In one possible implementation, the medical device further includes a sensor configured to sense the patient's physiological information, and a control unit configured to control an adjustment mechanism based on the physiological information to adjust the size of the pad.

[0013] Because it has sensors that detect physiological information reflecting the patient's condition, the control unit can adjust the size of the adjustment pad based on this information, ensuring that the pad always matches the patient's condition. Medical devices implemented in this way can reduce the number of follow-up examinations required after implantation and / or allow for early detection and appropriate adjustments (especially for patients with poor adherence to regular follow-ups), thereby providing better treatment while reducing the patient's financial burden and time costs.

[0014] In one possible implementation, the communication unit is configured to send physiological information to an external device and receive control commands generated by the external device based on the physiological information. The control unit is configured to control the adjustment mechanism based on the control commands to adjust the size of the pad. This approach reduces the complexity and power consumption of the medical device.

[0015] In one possible implementation, the medical device also includes a wake-up unit configured to wake up the control unit based on a preset schedule.

[0016] Considering that patients' conditions typically progress slowly, frequent adjustments to the pad size are unnecessary. In this implementation, the control unit, sensors, and communication unit can remain in a dormant state most of the time, and a wake-up unit can activate one or more of them at a preset time. This reduces energy consumption and achieves energy saving.

[0017] In an alternative implementation, the wake-up unit is also configured to wake up the control unit in response to physiological information reaching a preset condition.

[0018] In one possible implementation, it also includes a power supply unit configured to supply power to the control unit and the regulating mechanism.

[0019] In one possible implementation, the adjustment mechanism is configured to adjust the thickness of the pad under the control of the control unit, i.e., the pad can be adjusted to the size of its thickness.

[0020] In one possible implementation, the pad includes a pair of body members stacked in the thickness direction of the pad, each body member having an opposing free end and a connecting end, the connecting ends of the pair of body members being pivotally connected, and an adjustment mechanism configured to adjust the thickness of the pad by adjusting the opening of the pair of body members under the control of a control unit.

[0021] In this way, the adjustment mechanism can adjust the thickness of the pad under the control of the control unit. This method has many advantages, such as being relatively simple to implement, having a compact structure, and offering superior reliability.

[0022] In one possible implementation, the adjustment mechanism includes a drive and a slider, the slider being slidably positioned between and abutting against a pair of main bodies, and the drive being configured to adjust the opening of the pair of main bodies by driving the slider to slide under the control of a control unit.

[0023] In this way, the adjustment mechanism can adjust the opening of a pair of main components under the control of the control unit, thereby adjusting the thickness of the pad. This method has many advantages, such as being relatively simple to implement, having a compact structure, and being highly reliable.

[0024] In one possible implementation, the pad has a pair of mating surfaces configured to face a pair of leaflets respectively, and each mating surface periodically mates and separates from the leaflet it faces as the pair of leaflets move.

[0025] In this implementation, the pad does not affect or minimally affects the movement of the lobules, allowing each lobule to maintain its original physiological function. That is, in this implementation, the lobules can naturally and periodically move towards and away from each other with the changes in the cardiac cycle. Therefore, medical devices using this implementation can have fewer adverse effects on the structure and function of the lobules.

[0026] In one possible implementation, a pair of leaflets includes a first leaflet and a second leaflet, a pad is configured to follow the movement of the second leaflet, the pad has a first mating surface and a second mating surface, the second mating surface is configured to face the second leaflet and remain in mating with the second leaflet, the first mating surface is configured to face the first leaflet, and the first mating surface is configured to periodically mate and separate with the first leaflet as the pad follows the movement of the second leaflet.

[0027] In other words, in this implementation, both lobules can naturally and periodically move relative to each other and separate as the cardiac cycle changes. Therefore, medical devices using this implementation can have fewer adverse effects on the structure and function of the lobules. Attached Figure Description

[0028] To more clearly illustrate the technical solutions of the embodiments of this disclosure, the accompanying drawings used in the embodiments will be briefly described below.

[0029] It should be understood that the following figures only illustrate certain embodiments of this disclosure and should not be considered as a limitation of the scope. For those skilled in the art, other related figures can be obtained from these figures without any creative effort.

[0030] It should be understood that the same or similar reference numerals are used in the accompanying drawings to denote the same or similar elements (components or components).

[0031] It should be understood that the accompanying drawings are only schematic, and the dimensions and scale of the elements (components or parts) in the drawings are not necessarily precise.

[0032] Figure 1 This is a schematic diagram of the structure of a medical device according to an embodiment of the present disclosure.

[0033] Figure 2A and Figure 2B It shows Figure 1 A schematic diagram of the structure of the medical device, including the pad, control system, and sensors.

[0034] Figure 3A and Figure 3B This is a schematic diagram of at least a portion of the pad of a medical device according to another embodiment of the present disclosure.

[0035] Figure 4 This is a schematic diagram of at least a portion of the structure of a medical device according to another embodiment of the present disclosure.

[0036] Figure 5 This is a schematic diagram of at least a portion of the structure of a medical device according to another embodiment of the present disclosure.

[0037] Figure 6 This 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 Implementation

[0038] The technical solutions of the embodiments of this disclosure will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them.

[0039] Figure 1 This is a schematic diagram of the structure of a medical device 10 according to an embodiment of the present disclosure. Figure 1 The image shows the medical device 10 placed on the patient's heart valve.

[0040] exist Figure 1 (And other figures in this disclosure) show a heart valve located between a first chamber and a second chamber, which allows blood flow from the first chamber to the second chamber and prevents flow in the opposite direction. The heart valve comprises a pair of matching leaflets FL, SL. For ease of description, leaflet FL will be referred to hereinafter as the first leaflet and leaflet SL as the second leaflet.

[0041] In a healthy heart, the pair of leaflets (FL, SL) naturally align and separate during the cardiac cycle to periodically close and open the valve, allowing blood to flow from the first chamber to the second chamber and preventing reverse flow. However, in patients with valvular regurgitation, when valve closure is required, the pair of leaflets (FL, SL) cannot align properly, resulting in a gap that allows blood to flow through the valve from the second chamber to the first chamber, causing regurgitation.

[0042] It should be noted that, Figure 1 The valve in (and other accompanying drawings of this disclosure) can be the mitral valve. Correspondingly, the first chamber can be the left atrium, the second chamber can be the left ventricle, and one of the pair of leaflets FL and SL can be the anterior leaflet and the other can be the posterior leaflet. It should be understood that the medical device provided in this disclosure is not limited to use on the mitral valve, but can also be used on other heart valves.

[0043] See Figure 1The medical device 10 includes a pad 11. When the medical device 10 is placed in a patient's heart, the pad 11 is located between a pair of leaflets FL, SL. The pad 11 is configured to cooperate with the pair of leaflets FL, SL to periodically open and close the valve. Specifically, when the valve closes, the pad 11 can reduce or fill any gaps between the pair of leaflets FL, SL that are not tightly closed, or that exist during closure, thereby ensuring proper valve closure.

[0044] As an example, pad 11 has a pair of occlusive surfaces 11a, 11b. When the medical device 10 is placed in a patient's heart, the pair of occlusive surfaces 11a, 11b face a pair of leaflets FL, SL, respectively. For ease of description, occlusive surface 11a will be referred to as the first occlusive surface, and occlusive surface 11b as the second occlusive surface. With the changes in the cardiac cycle, each of the pair of occlusive surfaces 11a, 11b periodically occludes and separates from the leaflet it faces, thereby causing the valve to periodically open and close. For example, the occlusive length of each occlusive surface and its corresponding leaflet can be 6 to 12 millimeters.

[0045] Specifically, when the second chamber relaxes, the pair of leaflets FL and SL move apart, creating gaps between the leaflets FL and SL and the occlusal surfaces 11a and 11b. At this time, the valve opens, allowing blood to flow from the first chamber into the second chamber through these gaps. When the second chamber contracts, the pair of leaflets FL and SL move towards each other, aligning with the occlusal surfaces 11a and 11b. At this time, the valve closes, blocking blood flow from the second chamber to the first chamber.

[0046] It should be noted that, in this disclosure, when the leaflet and the occlusal surface come into contact, the leaflet and the occlusal surface can make contact and cooperate to prevent blood flow between them.

[0047] In this implementation, the pad does not affect or minimally affects the movement of the lobules, allowing each lobule to more fully maintain its original anatomical and / or physiological functions. In other words, in this implementation, with changes in the cardiac cycle, each lobule can naturally and periodically move towards and away from each other according to its own structure. Therefore, medical devices using this implementation can avoid or minimize adverse effects on the structure and function of the lobules.

[0048] Considering that a patient's condition is constantly evolving, the implant may no longer be a good match for the patient's condition after a period of time, potentially failing to achieve the expected therapeutic effect or even causing adverse reactions. If this occurs, a second surgery is required to replace the original implant with a new one that is more suitable for the patient's current condition. However, this second surgery increases the patient's financial burden and carries certain risks, potentially even harming their health.

[0049] Figure 2A and Figure 2B This is a schematic diagram showing the structure of the medical device 10, including the pad 11, control system 12, and sensor 13.

[0050] See Figure 2A and Figure 2B The medical device 10 may also include a control system 12, which 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.

[0051] In this way, when a patient's condition changes, the size of the pad can be adjusted simply by controlling the adjustment mechanism via the control unit, allowing the pad to be refitted to the patient's condition. Since there is no need for further surgery to replace the pad as the patient's condition progresses, this medical device reduces the financial burden on patients and minimizes harm to their health.

[0052] In this disclosure, the adjustable dimensions of the pad can be the dimensions of the pad in various dimensions, and are 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.

[0053] The thickness of the pad can refer to its dimension along the direction from one occlusal surface to the other. Alternatively, a pair of occlusal surfaces can be located on opposite sides of the pad's thickness. In other words, when the pad is installed at the patient's valve, a pair of leaflets are located on opposite sides of the pad's thickness.

[0054] The height of the pad can refer to its dimension in the direction from the first chamber to the second chamber when the pad is installed at the valve. The width of the pad can refer to its dimension in the direction perpendicular to both the height and thickness directions.

[0055] For ease of understanding, in the accompanying drawings of this 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.

[0056] There are various ways to adjust the thickness of the pad, and this disclosure does not specifically limit this method.

[0057] As an example, see Figures 1 to 2B The pad 11 includes a pair of main body members 111 and 112. The main body members 111 and 112 are stacked in the thickness direction of the pad 11. Each main body member has opposing free ends and connecting ends; that is, main body member 111 has a free end 111a and a connecting end 111b, and main body member 112 has a free end 112a and a connecting end 112b. The connecting ends 111b and 112b of the main body members 111 and 112 are pivotally connected. An adjustment mechanism is configured to adjust the opening between the main body members 111 and 112 under the control of a control unit 121, thereby adjusting the thickness of the pad 11.

[0058] The opening between main components 111 and 112 can be defined by the angle (acute angle) between them. Figure 2A In this configuration, the included angle α1 between main components 111 and 112 is relatively small, the opening between main components 111 and 112 is relatively small, and the thickness of pad 11 is also relatively small. Figure 2B In the middle, the included angle α2 between the main body parts 111 and 112 is relatively large, the opening between the main body parts 111 and 112 is relatively large, and the thickness of the pad 11 is also relatively large.

[0059] In this way, the adjustment mechanism can adjust the thickness of the pad under the control of the control unit. This method has many advantages, such as being relatively simple to implement, having a compact structure, and offering superior reliability.

[0060] It is understood that the thickness of the pad can be adjusted in other ways in other examples. For example, in some embodiments, the pad 11 may include a pair of plates stacked in thickness manner, and the adjustment mechanism can adjust the thickness of the pad by adjusting the spacing between the pair of plates.

[0061] There are various ways to implement a regulating mechanism, and this disclosure does not make any specific limitations on this.

[0062] As an example, the adjustment mechanism may include a drive member 113 and a slider 114. The slider 114 is slidably positioned between and abuts against the main bodies 111 and 112. The drive member 113 is configured to adjust the opening between the main bodies 111 and 112 by driving the slider 114 to slide. Specifically, the adjustment mechanism is configured (under the control of the control unit 121) to: increase the opening of the main bodies 111 and 112 by driving the slider 114 toward the connecting ends 111b and 112b of the main bodies 111 and 112; and to decrease the opening of the main bodies 111 and 112 by driving the slider 114 toward the free ends 111a and 112a of the main bodies 111 and 112.

[0063] In this way, the adjustment mechanism can adjust the opening of a pair of main components under the control of the control unit, thereby adjusting the thickness of the pad. This method has many advantages, such as being relatively simple to implement, having a compact structure, and being highly reliable.

[0064] It is understood 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 main body members, and a drive member may adjust the opening between the pair of main body members by driving the cam to rotate.

[0065] There are various ways to drive the slider, and this disclosure does not specifically limit them.

[0066] As an example, see Figure 2A and Figure 2B The driving component 113 can be a motor 113. The adjusting mechanism also includes a pair of meshing bevel gears 115 and 116 and a lead screw 117, with the lead screw 117 passing through a threaded hole 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.

[0067] When the motor 113 rotates under the control of the control unit 121, the power is transmitted to the lead screw 117 via the bevel gears 115 and 116, causing the lead screw 117 to rotate. As the lead screw 117 rotates, it drives the slider 114 to slide between the main body parts 111 and 112, thereby adjusting the opening between the main body parts 111 and 112, and thus adjusting the thickness of the pad 11.

[0068] In this way, the slider can be driven to slide between a pair of main components, thereby adjusting the opening of the pair of main components and thus adjusting the thickness of the pad. This implementation method has many advantages, such as being relatively simple to implement, having a relatively compact structure, and being highly reliable.

[0069] It is understandable that in other examples, the slider can be driven in other ways. For example, in some embodiments, the slider can be a magnetic component and the driving component can be an electromagnetic component, thereby driving the slider to slide by electromagnetic force.

[0070] In one example, see Figure 2A and Figure 2BThe main body 111 is provided with a receiving groove 111c, in which the motor 113 is housed to avoid occupying additional space, which helps to reduce the overall size of the pad 11. In one example, the main body 111 is also provided with an elongated guide groove 111d, into which a portion of the slider 114 extends, so that the guide groove 111d can guide the slider 114 to slide along a preset trajectory. In one example, the main body 111 is also provided with a boss 111e, which has a through hole for the lead screw 117 to pass through in order to support the lead screw 117. In one example, the lead screw 117 is provided with a shoulder 117a, which is located on the side of the boss 111e away from the slider 114 and abuts against the boss 111e to limit the movement of the lead screw 117.

[0071] As one possible implementation, see Figure 2A and Figure 2B The pad 11 may include a cover 118 that partially or completely encloses a pair of 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 are provided by the cover 118. Alternatively, 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 biocompatible material and have a smooth outer surface, thereby reducing the adverse effects of the pad 11 on the patient's health.

[0072] The control unit can spontaneously control the size of the adjustment pad of the adjustment mechanism according to the patient's condition, or it can be controlled by instructions from the doctor or the patient to control the size of the adjustment pad of the adjustment mechanism. This disclosure does not make any specific limitations in this regard.

[0073] As an example, see Figure 2A and Figure 2B The control system 12 may also include a communication unit 122. The communication unit 122 is configured to wirelessly communicate with a control device located outside the patient's body. For example, the communication unit 122 may, but is not limited to, communicate with the external control device via Bluetooth, cellular network, Wi-Fi, electromagnetic field, radio frequency communication, or ultrasound communication, etc.

[0074] A doctor (or patient) can send control commands to the communication unit 122 by operating the control device. The communication unit 122 is configured to receive the control commands and send them to the control unit 121. Upon receiving the control commands, the control unit 121 is configured to control the adjustment mechanism to adjust the size of the pad 11 based on the control commands.

[0075] After the medical device of this disclosure is implanted, patients can undergo regular follow-up examinations to monitor changes in their condition. When it is detected that the size of the pad no longer matches the patient's condition, the doctor can send a control command to the communication unit of the medical device implanted in the patient's body via an external control device. Upon receiving the control command, the control unit can control the adjustment mechanism to appropriately adjust the size of the pad, thereby restoring the fit between the pad and the patient's condition.

[0076] As another example, see Figure 2A and Figure 2B The medical device 10 may also include a sensor 13, which is communicatively connected to the control unit 121. The sensor 13 is configured to sense the patient's physiological information and send the sensed physiological information 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.

[0077] For example, the physiological information may include, but is not limited to, one or more of the following: blood pressure information, blood flow rate information, blood pH information, blood temperature information, blood oxygen information, electrocardiogram information, heart sound information, cardiac acceleration information, and cardiac contractility information in the patient's heart. Correspondingly, the sensor in this disclosure may be a sensor capable of sensing one or more of the above-mentioned information.

[0078] Because it has sensors that detect physiological information reflecting the patient's condition, the control unit can adjust the size of the pad in the adjustment mechanism based on this physiological information, so that the pad can always match the patient's condition. Medical devices implemented in this way not only improve treatment efficacy while reducing surgery, but also reduce the number of follow-up examinations after implantation, thereby reducing the patient's financial burden and time costs.

[0079] It is understood that in some embodiments, the medical device provided in this disclosure may include only one of the communication unit and the sensor, or it may include both the communication unit and the sensor. This disclosure does not specifically limit it in this regard.

[0080] There are many ways to implement sensors, and this disclosure does not specifically limit them.

[0081] As an example, see Figure 1The 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 reflecting the blood flow status at the valve. That is, the physiological information sensed by the sensor 13 reflects the blood flow status at the valve, indicating whether regurgitation or stenosis is present. Thus, the control unit 121 can appropriately adjust the size of the pad 11 based on this physiological information, making the size of the pad 11 more suitable for the patient's current condition.

[0082] It should be noted that in other examples, the sensor is attached to the pad but located in the first or second chamber and focuses on the hemodynamic information of the chamber.

[0083] 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 be mounted on the leaflet. Also, in some embodiments, the sensor may be mounted on other components of the medical device, such as a support.

[0084] Furthermore, it should be noted that in some embodiments, the medical device provided in this disclosure may also include multiple sensors, which may be arranged in different locations, such as one in a first chamber and another in a second chamber, thereby enabling a more accurate determination of the patient's condition. Alternatively, a single sensor may have two or more receptors to sense hemodynamic information, for example, in different chambers or different locations within the same chamber.

[0085] In an alternative implementation, the communication unit 122 can be configured to send physiological information to an external device and receive control commands generated by the external device based on the physiological information. The control unit 121 can be configured to control the adjustment mechanism based on the control commands to adjust the size of the pad 11. In this way, the complexity and power consumption of the medical device 10 can be reduced.

[0086] To reduce energy consumption, in one example, see Figure 2A and Figure 2B The control system 12 may also 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.

[0087] Considering that patients' conditions typically progress slowly, frequent adjustments to the pad size are unnecessary. In this implementation, the control unit, sensors, and communication unit can remain in a dormant state most of the time, and a wake-up unit can activate one or more of them at a preset time. This reduces energy consumption and achieves energy saving.

[0088] As an example, a preset schedule may include multiple cycles, each cycle comprising a sleep phase and a wake-up phase. During the sleep phase, other energy-consuming units besides wake-up unit 123 may be in a dormant state to reduce energy consumption. Upon the start of the wake-up phase, wake-up unit 123 may wake up some or all of the energy-consuming units.

[0089] For example, a sleep phase can last from 6 to 12 months, and a wake-up phase can last from 3 to 7 days. The duration and start time of each phase can be set. Doctors can set a preset schedule to match the patient's follow-up examination plan, that is, the preset schedule is set so that when the patient needs a follow-up examination, the medical device 10 is exactly in the wake-up phase. In this way, after the doctor has examined the patient's condition, he can send a control command to the communication unit 122 through an external control device to adjust the size of the pad 11 to match the patient's condition after the follow-up examination.

[0090] In an alternative implementation, the wake-up unit 123 is also configured to wake up the control unit 121 in response to physiological information reaching a preset condition. For example, when the physiological information includes blood pressure, the preset condition may be: blood pressure greater than or less than a preset threshold.

[0091] See again Figure 2A and Figure 2B The control system 12 may also include a power supply unit 124, which is used to supply power to one or more of the control unit 121, communication unit 122, wake-up unit 123 and sensor 13.

[0092] There are various ways to implement the power supply unit 124, and this disclosure does not specifically limit it. For example, in some embodiments, the power supply unit 124 can be a battery. In other embodiments, the power supply unit 124 can be an induction coil, which can be charged by a doctor or patient through an external device. In still other embodiments, the power supply unit 124 can also be an ultrasonic transducer to convert ultrasonic waves transmitted by an external device into electrical energy. In some embodiments, the power supply unit 124 can also be a device capable of converting kinetic energy into electrical energy.

[0093] For the purpose of simplifying the structure, in some embodiments, 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.

[0094] There are various ways to position the pad between a pair of leaflets, and this disclosure does not specifically limit this method.

[0095] As an example, see Figure 1The medical device 10 may further include a support 14. When the medical device 10 is placed in a patient's heart, the support 14 is located in a first chamber and connected to the pad 11, thereby positioning the pad 11 between a pair of leaflets SL, FL. The support 14, positioned in the first chamber, reliably positions the pad 11 between the pair of leaflets FL, SL. In one example, the pad 11 may be rigidly connected to the support 14 to always hold the pad 11 in a proper position, preventing changes in position due to blood flow or the influence of the leaflets FL, SL. If the pad 11 cannot be held in a proper position, it cannot be guaranteed that the pair of leaflets FL, SL will properly align with the pair of occlusal surfaces 11a, 11b each time the valve closes.

[0096] There are various ways to implement the support component, and this disclosure does not make any specific limitation on it.

[0097] As an example, see Figure 1 The support 14 may be annular. When the medical device 10 is implanted in a patient's heart, the support 14 may be positioned at the valve annulus of the heart. In some embodiments, the support 14 may have a mesh structure. During delivery, the support 14 may be folded to reduce its volume; after delivery to the target location, it may be unfolded.

[0098] It is understood that the support can be implemented in ways not limited to those described above, as long as it can position the pad between the leaflets of the valve. For example, in some embodiments, the support may also be semi-circular.

[0099] It should be understood that although the adjustment mechanism is used to adjust the thickness of the pad in the above embodiments, it can also be used to adjust the dimensions of the pad in other dimensions in other embodiments. A possible alternative implementation is given below.

[0100] Figure 3A and Figure 3B This is a schematic diagram of at least a portion of the structure of the pad 21 provided in another embodiment.

[0101] See Figure 3A and Figure 3B The pad 21 includes a pair of shells 211 and 212. One end of shell 212 is fitted onto one end of shell 211, and the two together define an internal space 21a. An adjustment mechanism is configured to adjust the overlap of the pair of shells 211 and 212 under the control of a control unit, thereby adjusting the width of the pad 21.

[0102] When pad 21 is in Figure 3A In the state of [condition], the overlap d1 of the pair of shells 211 and 212 is small, and the width w1 of pad 21 is large. When pad 21 is in [condition]... Figure 3BIn the state of being in the middle, the overlap d2 of the pair of shells 211 and 212 is large, and the width w2 of pad 21 is small.

[0103] In this way, the adjustment mechanism can adjust the width of the pad under the control of the control unit. This implementation method has many advantages, such as being relatively simple to implement, having a compact structure, and being highly reliable.

[0104] In some embodiments, the pad 21 may further include an expandable and contractible membrane layer (not shown) covering a pair of shells 211, 212. The membrane layer may have a smooth outer surface to avoid or reduce the growth of epidermal cells and other growths on the exterior of the pad 21.

[0105] There are various ways to adjust the overlap of a pair of shells, and this disclosure does not specifically limit them.

[0106] As an example, see Figure 3A and Figure 3B The adjustment mechanism may include a motor 213, a pair of meshing gears 214 and 215, a shaft 216 supporting the gears 215, and a rack 217 meshing with the gears 215. The gears 214 are 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 rotate under the control of the control unit, thereby driving the rack 217 to move, thus changing the overlap between the pair of housings 211 and 212.

[0107] It is understandable that the way the pad and the pair of leaflets are paired is not limited to the above implementation. Below, a possible alternative implementation is given.

[0108] Figure 4 This 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. Figure 4 The image shows the medical device 30 placed on the patient's heart valve.

[0109] Medical device 30 and medical device 10 share many similar or identical elements. For the sake of brevity, relevant descriptions are omitted. It is understood that, without contradiction, elements of medical device 10 and medical device 30 can be combined.

[0110] See Figure 4The medical device 30 includes a pad 31 having a first mating surface 31a and a second mating surface 31b. When the medical device 30 is implanted into a patient's heart valve, the pad 31 is positioned between a pair of leaflets FL and SL. The pad 31 is configured to follow the movement of the second leaflet SL, the second mating surface 31b is configured to face and remain mated with the second leaflet SL, and the first mating surface 31a is configured to face the first leaflet FL, and the first mating surface 31a is configured to periodically mate and separate from the first leaflet FL as the pad 31 moves with the second leaflet SL. That is, with changes in the cardiac cycle, the second mating surface 31b always remains mated with the second leaflet SL, while the first mating surface 31a periodically mates and separates from the first leaflet FL.

[0111] In this implementation, the pad does not affect or minimally affects the movement of the lobules, allowing each lobule to maintain its original physiological function. That is, in this implementation, the lobules can naturally and periodically move relative to and away from each other with the changes in the cardiac cycle. Therefore, medical devices using this implementation can have fewer adverse effects on the structure and function of the lobules.

[0112] There are several ways to position the pad between a pair of leaflets and make the pad follow the movement of the second leaflet, and this disclosure does not specifically limit this. Several possible implementations are given below.

[0113] As an example, see again Figure 4 The medical device 30 may also include a pad support 34. When the medical device 30 is placed in a patient's heart, the support 34 is located within a first chamber, and the pad 31 is connected to the support 34 in a manner that allows it to follow the movement of the second leaflet SL. For example, the pad 31 may be hinged to the support 34 to allow the pad 31 to follow the movement of the second leaflet SL. Alternatively, the pad 31 may be connected to the support via a flexible member (or portion) to allow the pad 31 to follow the movement of the second leaflet SL.

[0114] The pad can be reliably positioned between the first and second leaflets by means of a support member placed in the first chamber. The pad is connected to the support member in a manner that allows it to follow the movement of the second leaflet, ensuring that the pad moves with the second leaflet, thereby enabling the first mating surface to periodically mate and separate from the first leaflet.

[0115] Figure 5 This 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. Figure 5 The image shows the medical device 40 placed on the patient's heart valve.

[0116] Medical device 40 shares many similar or identical elements with medical devices 10 and 30. For the sake of brevity, relevant descriptions are omitted. It is understood that, without contradiction, elements of medical device 40 and medical devices 10 and 30 can be combined.

[0117] As another example, see Figure 5 In addition to the pad 41, the medical device 40 may also include a nail 45. When the medical device 40 is placed in the patient's heart, the nail 45 can penetrate the second lobule SL to attach the pad 41 to the second lobule SL, so that the pad 41 is located between a pair of lobes FL,SL and moves with the second lobule SL. In this way, with the change of the cardiac cycle, the second occlusal surface 41b facing the second lobule SL can remain occlusal with the second lobule SL, and the first occlusal surface 41a facing the first lobule FL can periodically occlude and separate from the first lobule FL as the pad 41 moves with the second lobule SL.

[0118] It should be noted that the medical device may include only one nail or multiple nails, and this disclosure does not specifically limit this. The nail may be integrally formed with the pad, or the two may be two independent components, and this disclosure also does not specifically limit the embodiments therein.

[0119] Figure 6 This 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. Figure 5 The image shows the medical device 50 placed on the patient's heart valve.

[0120] Medical device 50 shares many similar or identical elements with medical devices 10, 30, and 40. For the sake of brevity, relevant descriptions are omitted. It is understood that, without contradiction, elements of medical device 40 and medical devices 10, 30, and 40 can be combined.

[0121] See Figure 6 The medical device 50 includes a pad 51 and a support 54. The pad 51 has a first mating surface 51a and a second mating surface 51b, which are configured to face the first leaflet FL and the second leaflet SL, respectively.

[0122] After the medical device 50 is implanted into the patient's heart, the pad 51 is rigidly connected to the support 54 (i.e., the two are connected in a manner that prevents relative movement), thereby holding the pad 51 in a predetermined position between a pair of leaflets FL, SL and keeping the second mating surface 51b in contact with the second leaflet SL. This predetermined position is configured such that the first mating surface 51 can periodically mate and separate from the first leaflet FL as the first leaflet FL moves.

[0123] In this implementation, since the pad 51 is held at a preset position between a pair of leaflets FL,SL and the second mating surface 51b is mated with the second leaflet SL, the pad 51 will block the movement of the second leaflet SL, and the second leaflet SL will lose its original physiological function.

[0124] Compared to the aforementioned implementation method, if a medical device based on this implementation method is used, it may have adverse effects on the structure and function of the second lobule after a long period of use.

[0125] It should be understood that the term "comprising" and its variations as used in this disclosure are open-ended, meaning "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".

[0126] It should be understood that although terms such as “first” or “second” may be used in this disclosure to describe various elements (such as the first chamber and the second chamber), these elements are not limited by these terms, which are only used to distinguish one element from another.

[0127] 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, this disclosure will not describe the various possible combinations separately.

[0128] It should be understood that multiple components and / or parts can be provided by a single integrated component or part. Alternatively, a single integrated component or part can be divided into multiple separate components and / or parts. The use of the public designation "a" or "an" to describe a component or part does not imply the exclusion of other components or parts.

[0129] The above description is merely a specific embodiment of this disclosure, but the scope of protection of this disclosure is not limited thereto. Any variations or substitutions that can be conceived by those skilled in the art within the scope of the technology disclosed in this disclosure should be included within the scope of protection of this disclosure. Therefore, the scope of protection of this disclosure should be determined by the scope of the claims.

Claims

1. A medical device for repairing a patient's valve, characterized in that, include: A pad is configured to be located between a pair of leaflets of the valve and to periodically open and close the valve by cooperating with the pair of leaflets, and includes an adjustment mechanism; A sensor configured to sense the patient's physiological information; as well as The control unit is configured to control the adjustment mechanism based on the physiological information to adjust the size of the pad; wherein... The pad includes a pair of main body members stacked in the thickness direction of the pad, each main body member having an opposing free end and a connecting end, the connecting ends of the pair of main body members being pivotally connected, and the adjustment mechanism being 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 pad also includes a cover partially or completely enclosing the pair of main body members, the cover having a smooth outer surface; the adjustment mechanism includes a drive member and a slider, the slider being slidably positioned between and abutting against the pair of main body members, the drive member being 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 drive member is a motor, one of the main body members having a receiving groove on its inner side, the motor being received in the receiving groove.

2. The medical device according to claim 1, characterized in that, It also includes a communication unit configured to receive control commands, and the control unit configured to control the adjustment mechanism based on the control commands to adjust the size of the pad.

3. The medical device according to claim 1, characterized in that, It also includes a communication unit configured to send the physiological information to an external device and receive control commands generated by the external device based on the physiological information, and the control unit configured to control the adjustment mechanism based on the control commands to adjust the size of the pad.

4. The medical device according to claim 1, characterized in that, It also includes a wake-up unit configured to wake up the control unit based on a preset schedule.

5. The medical device according to claim 1, characterized in that, It also includes a wake-up unit configured to wake up the control unit in response to the physiological information reaching a preset condition.

6. The medical device according to claim 1, characterized in that, It also includes a power supply unit configured to supply power to the control unit and the regulating mechanism.

7. The medical device according to any one of claims 1 to 6, characterized in that, The pad has a pair of mating surfaces configured to face the pair of leaflets respectively, and each mating surface periodically mates and separates from the leaflet it faces as the pair of leaflets move.

8. The medical device according to any one of claims 1 to 6, characterized in that, The pair of leaflets includes a first leaflet and a second leaflet. The pad is configured to follow the movement of the second leaflet. The pad has a first mating surface and a second mating surface. The second mating surface is configured to face the second leaflet and remain in mating with the second leaflet. The first mating surface is configured to face the first leaflet and is configured to periodically mate and separate from the first leaflet as the pad follows the movement of the second leaflet.

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