The present invention relates to the technical field of medical instruments and, in particular, to a release device, system and method, and a therapeutic apparatus.
Intracranial aneurysm is a common vascular disease that threatens middle-aged and elderly people. The aneurysm ruptures in patients due to high blood pressure. If no timely and effective therapeutic is given, it will be life-threatening. The traditional therapeutic method for intracranial aneurysm is mainly to clip the aneurysm by surgical operation, but it has the disadvantages of large trauma and high patient mortality.
In recent years, with the rapid development of interventional therapy technology, more and more patients with intracranial aneurysm choose interventional therapy. A commonly used interventional therapeutic method for intracranial aneurysm is to use a coil for embolization. The coil is connected to a push rod. The doctor pushes the push rod to deliver the coil to the diseased site where the intracranial aneurysm is located, and pushes the coil into the lumen of the aneurysm. After the coil is in place, the coil needs to be separated from the push rod, which requires a release process to be performed. The release process is carried out in the patient’s body, and the doctor cannot observe the progress of the release. As a result, it is difficult for the doctor to determine the relase state. Therefore, it is eager to develop a release device capable of determining whether the coil has been completely released.
An object of the present invention is to provide a release device, a relase system, a release method, and a therapeutic device, so as to improve the success rate in the release of the medical implant and improve the patient’s use experience.
In order to achieve the above object, the present invention provides a release device, applied to a release system, the release device comprising a power supply assembly, a current detector, a first timer and a control unit; wherein,
Optionally, the release device further comprises a second timer that is in communication with the control unit, and configured to detect a release time duration;
wherein the control unit is configured to calculate the power consumption according to the current of the release circuit and the release time duration.
Optionally, the control unit pre-stores a first predetermined timing and a first power consumption threshold, and the release device comprises a first release mode and a second release mode, wherein the control unit further pre-stores a first predetermined current value for the first release mode and a second predetermined current value for the second release mode, and the second predetermined current value is greater than the first predetermined current value;
wherein the control unit is further configured to acquire an initial power consumption that refers to a power consumption of the release circuit during a time period from a beginning of the release process to the first predetermined timing, and determine that the first release mode or the second release mode is to be excuted for the release process according to the initial power consumption and the first power consumption threshold.
Optionally, when the initial power consumption is less than the first power consumption threshold, the control unit is configured to execute the first release mode; the control unit further pre-stores a second predetermined timing and a third predetermined timing both for the first release mode, and the third predetermined timing is after the second predetermined timing;
Optionally, the control unit pre-stores a second power consumption threshold and a first predetermined time duration, wherein the power consumption of the release circuit in the time period from beginning of the release process to the third predetermined timing is a second power consumption;
Optionally, when the initial power consumption is greater than or equal to the first power consumption threshold, the control unit is configured to perform the release process in the second release mode;
Optionally, the control unit pre-stores a third power consumption threshold and a second predetermined time duration;
Optionally, the control unit further pre-stores a fifth predetermined timing and a fourth power consumption threshold, the fifth predetermined timing is after the fourth predetermined timing, and the fourth power consumption threshold is greater than the third power consumption threshold;
when the second accumulated time duration is greater than or equal to the second predetermined time duration, the control unit is configured to determine whether the third power consumption is greater than or equal to the fourth power consumption threshold, if so, determine that the release process is successful, and if not, control the power supply assembly to continue supplying power to the release circuit until the fifth predetermined timing is reached, and determine that the release process is successful at the fifth predetermined timing.
Optionally, the release device further comprises a third release mode, and the control unit further pre-stores a reference range of power consumption;
after the release process is suspended, the control device is further configured to determine whether the stored power consumption is within the reference range of power consumption, if yes, execute the third release mode, and if not, determine that the release process is terminated.
Optionally, the control unit pre-stores a third predetermined current value, a sixth predetermined timing and a fifth power consumption threshold;
in the third release mode, the control unit is configured to: acquire a fourth power consumption that refers to the power consumption of the release circuit in a time period from the beginning of the third release mode to the sixth predetermined timing; determine whether the fourth power consumption is greater than or equal to the fifth power consumption threshold; determine whether a comparison current is less than the third predetermined current value, the comparison current refers to the current of the release circuit at a timing for comparison, the timing for comparison refers to a timing when the power consumption of the release circuit in the third release mode is greater than the fifth power consumption threshold; determine whether the timing for comparison is before the sixth predetermined timing; determine whether the third accumulated time duration is greater than or equal to the third predetermined time duration, the third accumulated time duration is an accumulated time duration over which the current of the release circuit is less than the third predetermined current value in the time period from the beginning of the third release mode to the sixth predetermined timing, if the third accumulated time duration is greater than or equal to the third predetermined time duration, it is determined that the release process is successful.
Optionally, in the third release mode, the control unit is further configured to determine that the release process is terminated when the fourth power consumption is less than the fifth power consumption threshold, or when the comparison current is greater than the third predetermined current value.
Optionally, the release device further comprises a display element that is in communication with the control unit, and configured to display a release state of the release system.
Optionally, the power supply assembly comprises a constant current source and a current driver, wherein the constant current source and the current driver are both connected to the control unit, and the constant current source is configured to supply power to the release circuit through the current driver.
In order to achieve the above object, the present invention also provides a release system, comprising a push rod and the above release device, wherein the push rod is configured to connect with the power supply assembly of the release device, and the power supply assembly is configured to supply power to positive and negative electrodes of the push rod to form the release circuit.
Optionally, the power supply assembly has a positive electrode and a negative electrode, and the push rod comprises a first electrical conductor and a second electrical conductor, wherein the first electrical conductor is connected to the negative electrode of the power supply assembly, the second electrical conductor comprises a conductive area and a release area that are connected to each other, wherein the conductive area is connected to the positive electrode of the power supply assembly, and the release area is configured to connect with the first electrical conductor through an electrolyte, wherein the power supply assembly is configured to supply power to the push rod to break the release area.
In order to achieve the above object, the present invention also provides a therapeutic device, comprising a medical implant and the above release system, the medical implant is configurd to connect with the release system, and can be release from the release system in a predetermined condition.
In order to achieve the above object, the present invention also provides a release method, comprising steps of:
Optionally, the release process performed by the release system is determined to be successful when the power consumption reaches a predetermined power consumption threshold, and when the accumulated time duration reaches a predetermined time duration.
Optionally, the release method further comprises:
Optionally, the predetermined current value is set according to a detection result of the present power consumption of the release circuit;
Optionally, the release method further comprises a first release mode and a second release mode;
Optionally, the release method further comprises a third release mode;
Optionally, in Step S1, the first release mode or the second release mode is selected for the release process to be performed for the first time according to:
Optionally, the first predetermined current value, a second predetermined timing, a third predetermined timing, a second power consumption threshold and a first predetermined time duration are pre-stored for the first release mode, wherein the third predetermined timing is after the second predetermined timing; wherein the first release mode is excuted through:
Optionally, when the release process is determined to be not successful in Step S24, the release method further comprises:
Step S25: acquiring and storing a second power consumption that refers to the power consumption of the release circuit in the time period from the beginning of the release process to the third predetermined timing, and stopping supplying power to the release circuit to suspend the release process.
Optionally, the second predetermined current value, a fourth predetermined timing, a fifth predetermined timing, a third power consumption threshold, a fourth power consumption threshold, and a second predetermined time duration are pre-stored for the second release mode, wherein the fifth predetermined timing is after the fourth predetermined timing, and the fourth power consumption threshold is greater than the third power consumption threshold;
Optionally, when it is determined that the release process is not successful in Step S35, the release method further comprises:
Step S36: supplying power to the release circuit until the fifth predetermined timing is reached, and determining that the release process is successful at the fifth predetermined timing.
Optionally, it is to be determined whether the stored power consumption is within a reference range of power consumption; if not, it is determined that the release process is terminated, and if so, it is determined that the third release mode is to be excuted.
Optionally, a third predetermined current value, a sixth predetermined timing, a fifth power consumption threshold and a third predetermined time duration are pre-stored for the third release mode; the third release mode is excuted through:
Optionally, when it is determined that the fourth power consumption is greater than or equal to the fifth power consumption threshold in Step S42, it is directed to Step S43 and Step S44.
Compared with the prior art, the release device, system and method, and therapeutic device of the present invention have the following advantages:
The release device is applied to a release system, and includes a power supply assembly, a current detector, a first timer and a control unit. The power supply assembly is configured to connect with a push rod, and supply power to the positive and negative electrodes of the push rod. When the power supply assembly supplies power to the positive and negative electrodes of the push rod, the release system forms a release circuit. The current detector is configured to detect the current of the release circuit. The first timer is configured to detect the accumulated time duration over which the current is smaller than a predetermined current value. The control unit is in communication with the current detector and the first timer, and is configured to acquire the power consumption of the release circuit, and determine whether the release process of the release system is successful according to the power consumption and the accumulated time duration. The power consumption of the release circuit and the accumulated time duration over which the current of the release circuit are less than a predetermined current value are used for determining whether the release process is successful, which effectively reduces the misjudgment caused by the unstable current in the release circuit and improves the judgment accuracy.
The release device includes a first release mode and a second release mode, and an appropriate release mode and judgment criterion are selected according to the actual situation, which further improves the accuracy of the operator’s judgment on the release state.
The release device further includes a third release mode. After the process release performed for the first time in the first release mode or the second release mode fails, if the power consumption of the release circuit satisfies a predetermined condition, the release device can automatically activate the third release mode to perform the release process for the second time. This improves the success rate of release, and improve the patient’s experience of use.
Objectives, advantages and features of the present invention will become more apparent upon reading the following more detailed description of the present invention, which is set forth by way of particular embodiments with reference to the accompanying drawings. Note that the figures are provided in a very simplified form not necessarily drawn to exact scale and for the only purpose of facilitating easy and clear despription of the embodiments.
As used herein, the singular forms “a”, “an” and “the” include plural referents, unless the context clearly dictates otherwise. As used herein and in the appended claims, the term “or” is generally employed in the sense of “and/or”, “plurality” of “two or more”, and “several” of “one or more”, unless the context clearly dictates otherwise. As used herein, unless otherwise expressly specified and defined, the terms “mounting”, “coupling” and “connection” should be interpreted in a broad sense. For example, a connection may be a fixed, detachable or integral connection, or a mechanical or electrical connection, or a direct or indirect connection with one or more intervening media, or an internal communication or interaction between two components. Those of ordinary skill in the art can understand the specific meanings of the above-mentioned terms herein, depending on their context. The same or similar reference numerals in the drawings represent the same or similar parts.
An object of the present invention is to provide a release device, which is applied to a release system that is configured to connect with a medical implant and to send the medical implant to a predetermined position in a patient’s body. The medical implant includes, but is not limited to, coils. As shown in
Generally, as the release process progresses, the current of the release circuit S changes in real time. The release device 100 according to the embodiment of the present invention is configured to calculate the power consumption of the release circuit S based on the current of the release circuit S. The first timer 130 is configured to detect the accumulated time duration over which the current of the release circuit S is less than a predetermined current. The power consumption and the accumulated time duration are used together for determining the release state of the release system, so that the possibility of misjudgment due to the instable current can be reduced. Specifically, when the power consumption reaches the predetermined power consumption threshold, and the accumulated time duration reaches the predetermined time duration, it can be determined that the release process of the release system is successful. In this embodiment, the control unit 140 is implemented as a programmable control unit known to those skilled in the art, such as a PLC controller, a computer, and the like.
Optionally, the release device 100 further includes a second timer 150 that is in communication with the control unit 140, and configured to detect the release time duration of the release circuit S (that is, the time duration over which the power supply assembly outputs current to the release circuit S). The control unit 140 is configured to calculate the power consumption according to the current of the release circuit S and the release time duration, which for example is an integral of the current of the release circuit S with respect to the release time duration.
Optionally, the release device 100 may further include a display element 160 that is in communication with the control unit 140, and configured to display the release state of the release system, for example display that the release process is successful, the release process is suspended, the release process is terminated, etc. The display element 160 may be a buzzer alarm, a display screen, an LED light and other components.
Optionally, the power supply assembly 110 preferably includes a constant current source 111 and a current driver 112. The constant current source 111 may be a DC constant current source, and the constant current source 111 is configured to supply power directly to the current detector 120, the first timer 130, the control unit 140, the second timer, and the display element 160. The control unit 140 controls the supply of a constant direct current to the release circuit S by controlling power-on and power-off of the current driver 112. The constant direct current may be in the range of 1.2-3.0 mA, preferably 1.8 mA.
During the release of the implant, the releasing device 100 performs a release process at least once. Specifically, the release device 100 includes a first release mode and a second release mode. The control unit 140 may select the first release mode or the second release mode for performing the releae process for the first time according to the actual situation of the release system 10. Specifically, it is determined whether the first release mode or the second release mode is to be selected to perform the release process for the first time according to the determination whether the power consumption of the release circuit S reaches a first power consumption threshold. If the power consumption of the release circuit S is less than the first power consumption threshold, the first release mode is selected. If the power consumption of the current release circuit S is greater than or equal to the first power consumption threshold, the second release mode is selected. Please see
The release device 100 further includes a third release mode configured to perform the release process for the second time.
As shown in
The process of Step S1 is specifically as follows: Step S11: acquiring, at the control unit, an initial power consumption, which refers to the power consumption of the release circuit during the time period from the beginning of the release process to the first predetermined timing.
Step S12: determining, at the control unit, whether the initial power consumption is less than the first power consumption threshold; if so, it is determined to select the first release mode for the release process to be performed for the first time; if not, it is detertmined to select the second release mode to perform the release process for the first time.
The control unit 140 of the release device can detect and distinguish the current environment of the release circuit S, and select different release modes (i.e., the first release mode or the second release mode) according to the current environment. This effectively avoids the “one-size-fits-all” standard for detection of release state, improves the accuracy of judgment, and reduces misjudgment.
The specific processes of the first release mode, the second release mode and the third release mode will be described in detail below with reference to
As shown in
Preferably, the control unit is configured to control the power supply assembly to stop supplying power to the release circuit at the third predetermined timing. That is, the release process is preferably to be suspended at the third predetermined timing.
In the first release mode, the current supplied from the power supply assembly to the release circuit is small, so the power consumption of the release circuit increases slowly. The control unit determines whether the first power consumption reaches the second power consumption threshold at a timing between the second predetermined timing and the thrid predetermined timing. In this way, the workload of the control unit can be reduced.
As shown in
The control unit determines whether the third release mode to be excuted according to the second power consumption or the third power consumption. That is, if the release device selects the first release mode for the release process to be performed for the first time, the control unit determines whether the second power consumption is within the reference range of power consumption; if so, it is determined to execute the third release mode, if not, it is determined that release process is terminated. If the release device selects the second release mode for the release process to be performed for the first time, the control unit determines whether the third power consumption is within the reference range of power consumption; if so, it is determined to execute the third release mode, if not, it is determined that the release process is terminated.
The control unit is configured to determine whether the release process is to be performed for the second time according to the power consumption of the release circuit when the release process performed for the first time is suspended, which can reduce the unnecessary suffering of the patient. This is because if the power consumption of the release circuit is less than the minimum value of the reference range of power consumption when the release process performed for the first time is suspended, it means that the current of the release circuit is small, which may be due to poor release environment or short-circuiting of the release circuit; if the power consumption of the relase circuit is greater than the maximum value of the reference range of power consumption when release process performed for the first time is suspended, it means that the current of the release circuit is large, and a short circuit may have occurred. The existence of these problems will cause the release system to fail to complete the release process, thereby eliminating the need for a release process to be perfomed for the second time.
Before executing the third release mode, preferably the control unit 140 clears the previously stored power consumption (i.e., the second power consumption or the third power consumption), so that the power consumption calculated by the control unit after the third relase mode is excuted is actually the power consumption of the release circuit in the third relase mode. As shown in
In Step S42, if the fourth power consumption is less than the fifth power consumption threshold, the control unit can determine that the first release mode is terminated, and further determine that the release process is terminated. In Step S45, if the timing for comparison is after the sixth predetermined timing, it means that the current of the release circuit has not decreased to the third predetermined current value before the sixth predetermined timing, and the control unit determines that the second release mode is terminated, and further determines that the release process is terminated.
In another embodiment, the order of Step S44 and Step S45 in
In addition, in the third release mode, the current output by the constant current source 111 to the release circuit may be in a range of 1.2-3.0 mA, for example, 1.8 mA.
Based on the aforementioned release device, an embodiment of the present invention further provides a release system. As shown in
In detail, the power supply assembly 110 has a positive electrode and a negative electrode. The push rod 200 includes a first electrical conductor 210 and a second electrical conductor 220. The proximal end of the first electrical conductor 210 is connected to the negative electrode of the power supply assembly 110. The second conductor 220 includes a conductive area 221 and a release area 222 that are connected to each other. The proximal end of the conductive area 221 is connected to the positive electrode of the power supply assembly 110. In this way, the proximal end of the first electrical conductor 210 is formed as the negative electrode of the push rod 200, and the proximal end of the conductive area 221 of the second electrical conductor 220 is formed as the positive electrode of the push rod 200. The release area 222 is disposed at the distal end of the conductive area 221, and is connected to the second end through an electrolyte such as body fluid to form the release circuit S. It can be understood that the “proximal end” and “distal end” mentioned here refer to relative orientations, relative positions and directions of elements relative to each other from the perspective of the doctor operating the medical instruments. Although the “proximal end” and the “distal end” are not restrictive, the “proximal end” generally refers to the end of the medical device that is close to the doctor during normal operation, while the “distal end” generally refers to the end that enters the patient’s body first.
In an exemplary embodiment, the first electrical conductor 210 and the second electrical conductor 220 are arranged one sleeved over another. In detail, please continue to refer to
Please continue to refer to
When a doctor uses the therapeutic device for interventional treatment, such as embolization treatment for intracranial aneurysm, the medical implant 300 can be sent into the lumen where the intracranial aneurysm locates by the push rod 200, and then the release device 100, the push rod 200 and the body fluid together form a release circuit S, to which the power supply assembly 110 of the release device 100 supplies power so as to break the release area 222 to complete the relase of the medical implant 300. The medical implant 300 may be a coil or a stent. The therapeutic device provided in this embodiment adopts a self-loop structure, so that there is no need to insert conductive needles or place electrodes on the patient’s body, thereby reducing the suffering of the patient.
Further, an embodiment of the present invention also provides a release method including the following steps:
Whether the release process is successful can be determined according to whether the power consumption reaches a predetermined power consumption threshold and whether the accumulated time dration reaches the predetermined time duration; if both so, it is determined that the release process of the release system is successful. Preferably, it is to be determined in advance whether the power consumption reaches a predetermined power consumption threshold; if so, it is then to be determined whether the accumulated time duration has reached the predetermined time duration.
Preferably, the predetermined current value is set according to the detection result about the present power consumption of the release circuit. When the power consumption is less than the first power consumption threshold, the first predetermined current value is set. When the power consumption is greater than or equal to the first power consumption threshold, the second predetermined current value is set. The first predetermined current value is less than the second predetermined current value. This method distinguishes between high-current environments and low-current environments, and adopts different judgment standards and different judgment steps for different current environments, which is more flexible and accurate. In an embodiment, the power consumption of the release circuit is acquired, a first predetermined current value is set when the power consumption is less than a first power consumption threshold, and a second predetermined current value is set when the power consumption is greater than or equal to the first power consumption threshold. The first predetermined current value is less than the second predetermined current value. The release environments are distinguished into a low-current environment and a high-current environment. A first predetermined current value is set in the low-current environment. Whether the release process is successful can be determined according to whether the present power consumption of the release circuit reaches a predetermined power consumption threshold and whether the accumulated time dration over which the current of the release circuit is less than or equal to the first predetermined current value reaches the predetermined time duration; if both so, it is determined that the release process of the release system is successful. A second predetermined current value (greater than the first predetermined current value in the low-current environment) is set in the high-current environment. Whether the release process is successful can be determined according to whether the present power consumption of the release circuit reaches a predetermined power consumption threshold and whether the accumulated time dration over which the current of the release circuit is less than or equal to the second predetermined current value reaches the predetermined time duration; if both so, it is determined that the release process of the release system is successful.
In another embodiment, in the release method, the release process under a low-current environment and the release process under a high-current environment are respectively defined as a first release mode and a second release mode (the names of the two can also be interchanged). The release process under the first release mode or the second release mode is to be performed for the first time. The release method includes the following steps:
In another embodiment, referring to
If the release system fails to perform the release process for the first time and the release process is suspended, the control unit will store the power consumption of the release circuit at a predetermined timing, and determine whether the third release mode is to be excuted so that the release process is to be performed for the second time according to the power consumption of the release circuit at the predetermined timing.
In another specific embodiment, in Step S1, the first release mode or the second release mode is selected for the release process to be performed for the first time based on following steps:
In another embodiment, referring to
In this embodiment, the first predetermined current value, the second predetermined timing, the third predetermined timing, the second power consumption threshold and the first predetermined time duration are pre-stored for the first release mode. The third predetermined timing is after the second predetermined timing.
In another embodiment, when it is determined that the release process is not successful in Step S24, the release method further includes:
Step S25: acquiring and storing a second power consumption, which refers to the power consumption of the release circuit in the time period from the beginning of the release process to the third predetermined timing, and stopping supplying power to the release circuit to suspend the release process.
In one embodiment, referring to
In this embodiment, the second predetermined current value, the fourth predetermined timing, a fifth predetermined timing, the third power consumption threshold, the fourth power consumption threshold and the second predetermined time duration are pre-stored for the second release mode. The fifth predetermined timing is after the fourth predetermined timing, and the fourth power consumption threshold is greater than the third power consumption threshold.
In another embodiment, when it is determined that the release process is not successful in Step S35, the release method further includes:
Step S36: supplying power to the release circuit until the fifth predetermined timing is reached, and determining that the release process is successful at the fifth predetermined timing.
In another preferred embodiment, a reference range of power consumption is also pre-stored according to the release method. It is to be determined whether the stored power consumption is within the reference range of power consumption; if not, it is determined that the release process is terminated, and if so, it is determined that the third release mode is to be executed. This embodiment is an alternative solution provided on the basis that the release process is not successful in both the first release mode and the second release mode, and the release process can be preformed in the third release mode.
In one embodiment, referring to
In this embodiment, the third predetermined current value, the sixth predetermined timing, the fifth power consumption threshold and a third predetermined time duration are pre-stored.
In another embodiment, referring to
In another embodiment, the order of Step S44 and Step S45 in
The present invention provides at least one of the following beneficial effects:
1) In the general procedure, a detection and a determination on the current environments are performed (in Step S12 as shown in
2) In the general procedure, if the release process performed for the first time is not successful and the power consumption satisfies certain conditions, the release process is automatically performed for the second time (in the third release mode), which effectively improves the user experience.
3) In each release mode, the condition for determining the success of the release process includes the Td index, that is, the accumulated time duration for the current to reach the critical current value, which can effectively reduce the misjudgment caused by the instability of the circuit current and further improve the accuracy.
4) The release circuit in the push rod adopts a self-loop structure, and thus there is no need to insert conductive needles or place electrodes on the human body, which reduces the suffering of the patient.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and variations can be made in the present invention by those skilled in the art without departing from the spirit and scope of the invention. Thus, provided that these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.
Number | Date | Country | Kind |
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202010506601.5 | Jun 2020 | CN | national |
Filing Document | Filing Date | Country | Kind |
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PCT/CN2021/108016 | 7/23/2021 | WO |