Use method of artificial sphincter

Abstract

The invention provides an artificial sphincter using method which comprises the steps that S1, a retractable element implanted into the body of a patient is used for controlling the retractable element through a remote controller by the patient so that the initial tightness degree of the retractable element can reach A; s2, the patient can select a urination mode, a common mode, a sleep mode and a movement mode according to own conditions; s3, the patient can switch to a common mode through the remote controller; s4, the patient can switch to the sleep mode through the remote controller. According to the retractable element, a patient can adjust the initial tightness degree of the retractable element through a remote controller, and therefore it is guaranteed that the patient obtains a comfortable state; in addition, the retractable element has multiple modes, such as a common mode, a urine mode, a sleep mode and a motion mode, the patient can select the corresponding modes according to the actual situation, the functionality of the retractable element is increased, and different scene requirements of the patient are better met.

Description

Technical Field

[0001] The present invention relates to the technical field of artificial sphincters, and in particular to a method for using an artificial sphincter. Background Art

[0002] Due to physiological dysfunction, accidents, illness, or surgery, some patients may experience urinary sphincter damage or dysfunction. This condition can lead to an inability to control urination. Some patients are able to restore urinary sphincter function through continuous muscle exercises, gradually regaining normal control; however, others continue to experience urinary incontinence, which can impair their quality of life.

[0003] For example, patent publication number CN111757715A discloses an artificial contractile structure and a medical device including such an artificial contractile structure. The artificial contractile device includes at least one contractile element, the contractile element comprising a flexible strip extending in a longitudinal direction and a closure member, the closure member being configured to form the contractile element into a closed loop around a hollow human organ, the closure member being located at a first end of the flexible strip. The contractile element is adapted to contract the hollow human organ, such that the contractile element can be in either a rest position or an activated position.

[0004] The above patent implants a flexible strip and a closure member of a contractile element into the human body, and uses electric control to control the contraction and expansion of the flexible strip and the closure member, thereby achieving the purpose of having an artificial sphincter.

[0005] However, since the diameter of the urethra of each patient is different, the flexible strip and the closure member in the initial position need to be adaptively adjusted to the urethra of each patient.

[0006] In addition, the artificial sphincter in the prior art cannot perform adaptive adjustments to the patient under different external factors and has a relatively single function.

[0007] Based on this, the applicant proposes a method for using an artificial sphincter to solve the above technical problems. Summary of the Invention

[0008] The problem solved by the present invention is that since the urethra diameter of each patient is different, the flexible strip and closure in the initial position need to be adaptively adjusted to the urethra of each patient. The artificial sphincter in the existing technology cannot be adaptively adjusted to the patient under different external factors and has a relatively single function.

[0009] To solve the above problems, the present invention provides a method for using an artificial sphincter, comprising a contractile element implanted in a patient's body, the contractile element being arranged around the patient's urethra, and an external remote controller being used to control the operation of the contractile element. S1: The patient controls the contractile element through the remote controller to adjust the initial tightness of the contractile element to A, so that the patient can achieve a comfortable state; S2: The patient can select urination mode, normal mode, sleep mode, and exercise mode according to their own situation; and can select any of S3-S5 according to actual situation; S3: The patient can switch to normal mode through the remote controller; Mode, in the normal mode, the tightness of the contractile element is A, and the patient is reminded to switch to the urination mode after every T1 time; S4: the patient can switch to the sleep mode through the remote control, in the sleep mode, the tightness of the contractile element is B, and the patient is reminded to switch to the urination mode after every T1 time, and it will automatically switch to the normal mode after an interval of T2 time; S5: the patient can switch to the exercise mode through the remote control, in the exercise mode, the tightness of the contractile element is C, and it will automatically switch back to the normal mode after every T3 time.

[0010] Compared with the existing technology, for the retractable element in this application, the patient can adjust the initial tightness of the retractable element through the remote control, thereby ensuring that the patient is in a more comfortable state; in addition, the retractable element in this application also has multiple modes, such as normal mode, urination mode, sleep mode and exercise mode. The patient can choose the corresponding mode according to the actual situation, which increases the functionality of the retractable element and better meets the different scenario needs of the patient.

[0011] In this embodiment, the contractile element is connected to a driving source, which is built into the patient's body. The remote control is in communication with the driving source and is provided with a first operating part for the patient to switch modes.

[0012] The technical effect after adopting this technical solution is that the contractile element is driven by a driving source. The driving source preferably adopts a motor and decelerates through a deceleration structure, thereby driving the contractile element to contract and expand through the transmission structure. Since the driving source needs to be implanted in the human body together with the contractile element, the specifications of the driving source are relatively small. The driving source and the remote control are connected by wireless, Bluetooth and other communication means, so that the patient can switch modes when operating the first operating part, reflecting the characteristics of multifunctionality.

[0013] In this embodiment, the remote controller can control the operation of the driving source only when the remote controller is within a preset range of the driving source.

[0014] The technical effect of adopting this technical solution is that in order to ensure that the remote control cannot control the driving source due to reasons such as accidental touch by other people after exceeding the preset range, the patient can only control the driving source by operating the remote control when the remote control is within the preset range of the driving source, thereby ensuring the safety of the patient's control.

[0015] In this embodiment, the contractile element includes: a flexible strip and a closing piece, the closing piece is located at the first end of the flexible strip; a reinforcing element is provided on the flexible strip; the contractile element also includes: a flexible transmission device, the flexible transmission device includes a tensioning element, the tensioning element is anchored to a first anchoring point on the flexible strip at the first end, and the tensioning element is provided with a second anchoring point on the flexible strip; wherein, when the remote control controls the contractile element to contract, the distance between the first anchoring point and the second anchoring point is shortened and drives the flexible strip to contract, and when the controller controls the contractile element to reset, the distance between the first anchoring point and the second anchoring point is extended and drives the flexible strip to extend.

[0016] The technical effect after adopting this technical solution is that the contractile element specifically includes a flexible strip and a closing piece, and a circle is formed around the urethra by the flexible strip and the closing piece. The specific flexible transmission device includes a tensioning element, which is provided with a first anchor point and a second anchor point. The distance between the first anchor point and the second anchor point is controlled by a driving source to realize the contraction and extension of the flexible strip, thereby corresponding to the controller controlling the contraction and resetting of the contractile element, and the silk thread between the first anchor point and the second anchor point is stretched and contracted to fit the urethra more closely, without causing damage, squeezing, etc. to the urethra, making the patient more comfortable and without a sense of tight restraint.

[0017] In this embodiment, the closure member is provided with a plurality of grooves for the first anchoring point and the reinforcing element to enter. When the first anchoring point and the reinforcing element enter the grooves at different positions, different tightening degrees may correspond.

[0018] The technical effect of adopting this technical solution is that, since the urethra diameter of each patient is different, the flexible strip and closure in the initial position need to be adaptively adjusted to the urethra of each patient, that is, the patient can enter the grooves in different positions through the first anchor point and the reinforcing element, thereby corresponding to the urethra diameter of different patients.

[0019] In this embodiment, the tightness B of the contractile element in step S4 is less than the tightness A of the contractile element in step S3 and less than the tightness C of the contractile element in step S5, wherein C>A>B, and the greater the tightness, the tighter the contractile element contracts.

[0020] The technical effect after adopting this technical solution is that, in addition, in order to reflect the tightness of the contractile element in different modes, C>A>B, when in normal mode, the tightness A of the contractile element is the initial tightness, and when in sleep mode, the probability of accidental urinary leakage of the patient is significantly reduced, and the tightness B of the contractile element can be looser than in normal mode to ensure the comfort of the patient; and when in exercise mode, the body movement is accompanied by increased abdominal pressure, resulting in an increased probability of accidental urinary leakage, and the tightness C of the contractile element indicates a tighter contraction, so that the patient is less likely to leak urine.

[0021] In this embodiment, T1 in step S3 ≥ T2 in step S4 > T3 in step S5.

[0022] The technical effects of this solution are as follows: in normal mode, the patient is reminded every T1 time interval, using a voice announcement on the remote control to remind the patient to switch to urination mode to urinate, thus ensuring that the patient urinates at regular intervals; in sleep mode, the system automatically switches to normal mode after an interval of T2 time interval, ensuring switching between sleep mode and normal mode. In exercise mode, the system automatically switches to normal mode at a smaller interval of T3 time interval.

[0023] This embodiment also includes a safety mode. In this safety mode, if the system detects an operational anomaly or the battery level in the drive source is low, it automatically enters the safety mode. In this safety mode, the retractable element does not retract, and the degree of retraction cannot be adjusted via the remote control.

[0024] The technical effect after adopting this technical solution is that in the safety mode, the system puts the retractable element into a pause state, that is, the retractable element does not shrink and the degree of shrinkage cannot be adjusted by the remote control until the safety mode is exited.

[0025] In this embodiment, the remote controller is provided with a first operating portion for setting the user to enter a normal mode, a sports mode, and a sleep mode; and a second operating portion for setting the user to enter a urination mode.

[0026] The technical effect after adopting this technical solution is that the above-mentioned normal mode, exercise mode, sleep mode and urination mode are entered respectively through the above-mentioned first operating part and the second operating part, so as to achieve the purpose of patient safety and multi-functional use of the remote control to control the retractable structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 Schematic diagram of various modes of using a method of an artificial sphincter according to the present invention;

[0028] Figure 2Schematic diagram of the structure of the remote control in the present invention;

[0029] Figure 3 is a schematic diagram of the collapsible structure of the present invention;

[0030] Figure 4 for Figure 3 Schematic cross-section diagram of ;

[0031] Figure 5 for Figure 4 A magnified schematic diagram of point A in the middle;

[0032] Figure 6 for Figure 4 Enlarged schematic diagram of point A in the middle.

[0033] Explanation of the accompanying drawings: 1. remote control; 2. flexible strip; 3. closing piece; 4. reinforcing element; 5. first anchoring point; 6. second anchoring point; 7. groove; 8. first operating part; 9. second operating part; 10. third operating part. DETAILED DESCRIPTION

[0034] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0035] The present application relates to a method for using an artificial sphincter, such as Figure 1-6 As shown,

[0036] The invention comprises a contractile element implanted in the patient's body, wherein the contractile element is arranged around the patient's urethra, and an external remote controller 1 is used to control the operation of the contractile element. S1: the patient controls the contractile element through the remote controller 1 to adjust the initial tightness of the contractile element to A so that the patient can achieve a comfortable state; S2: the patient can select urination mode, normal mode, sleep mode and exercise mode according to his or her own situation; and select any of S3-S5 according to actual situation; S3: the patient can switch to normal mode through the remote controller 1, in which the tightness of the contractile element is A, and the patient is reminded to switch to urination mode after every T1 time; S4: the patient can switch to sleep mode through the remote controller 1, in which the tightness of the contractile element is B, and the patient is reminded to switch to urination mode after every T1 time, and the contractile element will automatically switch to normal mode after an interval of T2 time; S5: the patient can switch to exercise mode through the remote controller 1, in which the tightness of the contractile element is C, and the contractile element will automatically switch back to normal mode after every T3 time.

[0037] The physician implants the contractile element into the patient's body through laparoscopic surgery, where it forms a constriction loop around the patient's urethra. Over time or due to environmental factors within the patient's body, the contractile element may become inconsistent with the initial constriction loop created by the physician. In this case, the patient can use remote control 1 to adjust the tightness of the contractile element to A for a more comfortable position.

[0038] During the patient's daily use of the contractile element, the urethra may present different states due to external environmental factors. For example, in sleep mode, the probability of urine leakage is very low, and the contractile element is relaxed at this time; while in exercise mode, the probability of urine leakage is significantly increased, and the contractile element is tightened to prevent the patient from leaking urine. New modes can also be added according to life scenarios. For example, the exercise mode can be subdivided into high-intensity exercise, low-intensity exercise, etc. The degree of increase in abdominal pressure caused by the physical exercise is also different, resulting in different increases in the probability of accidental urine leakage. Corresponding settings can be made in the remote control 1 to meet the needs of daily work and life. For example, in normal mode, according to the patient's work environment, if the patient is a white-collar worker who needs to sit for a long time to work at a computer, the remote control 1 can be set to remind the patient to stand up after a period of time to ensure that the contractile structure, urethra, etc. do not always remain in the patient's sedentary state.

[0039] To meet the patient's daily needs, daily life is broadly divided into normal modes. Normal mode is work mode, requiring only regular urination intervals. Remote control 1 sends voice reminders to the patient, prompting the patient to switch to urination mode. Sleep mode: Since the human body is in a resting state in this mode, the probability of urine discharge from the urethra and bladder is not very high. In this case, switching to sleep mode via remote control 1 causes the contractile structure to relax the urethra. Exercise mode also significantly increases the probability of urine leakage, and the contractile element tightens to prevent leakage.

[0040] Further optimized, in this embodiment, the contractile element is connected to a driving source, the driving source is built into the patient's body, the remote control 1 is communicatively connected to the driving source, and the remote control 1 is provided with a first operating part 8, which is used for the patient to switch modes.

[0041] In this embodiment, the driving source is a driving source corresponding to that disclosed in patent publication number CN111757715A, or any of patent documents WO13091730, WO13093074, or WO12000681, or any other convenient driving source. The remote control 1 and the driving source can be connected wirelessly or via Bluetooth. The remote control 1 is provided with a first operating unit 8, which can be a button-type, knob-type, touch-type, or any other conveniently operated switch. Preferably, the first operating unit 8 is a button-type and can be provided with up, down, left, and right directional keys. The patient can select a corresponding mode based on the information displayed on the display screen of the remote control 1. Further optimization is that the remote control 1 can only control the operation of the driving source when it is within a preset range of the driving source.

[0042] To ensure that the remote control 1 does not control the driving source due to accidental contact by another person, etc., if it exceeds the preset range, the patient can only control the driving source when the remote control 1 is within the preset range of the driving source, thereby ensuring patient control safety. Preferably, the preset range is such that when the remote control 1 is close to the surface of the driving source, the distance does not exceed 5 cm, thereby ensuring the accuracy of the commands issued by the remote control 1.

[0043] Further optimization, the contractile element includes: a flexible strip 2 and a closing piece 3, the closing piece 3 is located at the first end of the flexible strip 2; a reinforcing element 4 is provided on the flexible strip 2; the contractile element also includes: a flexible transmission device, the flexible transmission device includes a tensioning element, the tensioning element is anchored to a first anchoring point 5 on the flexible strip 2 at the first end, and the tensioning element is provided with a second anchoring point 6 on the flexible strip 2; wherein, when the remote control 1 controls the contractile element to contract, the distance between the first anchoring point 5 and the second anchoring point 6 is shortened and drives the flexible strip 2 to contract, and when the controller controls the contractile element to reset, the distance between the first anchoring point 5 and the second anchoring point 6 is extended and drives the flexible strip 2 to extend.

[0044] The specific structure of the contractile element can be referred to patent publication number CN111757715A. Figure 4 、 Figure 5 and Figure 6 As shown in the figure, the first anchor point 5 is set on the left side, and the second anchor point 6 is set on the right side. The first anchor point 5 and the second anchor point 6 are connected by a silk thread. When the contractile element contracts, the distance between the first anchor point 5 and the second anchor point 6 shortens, which drives the flexible strip 2 to contract, thereby suspending urination in the patient's urethra and controlling the patient's urination. When the controller controls the contractile element to return to its original position, the distance between the first anchor point 5 and the second anchor point 6 increases, driving the flexible strip 2 to extend, thereby resetting the patient's urethra.

[0045] As a further optimization, the closing member 3 is provided with a plurality of grooves 7 for the first anchoring point 5 and the reinforcing element 4 to enter. When the first anchoring point 5 and the reinforcing element 4 enter the grooves 7 at different positions, different tightening degrees can be corresponded.

[0046] like Figure 5 As described above, three grooves 7 at different positions are provided on the closure member 3. When the first anchor point 5 and the reinforcing element 4 enter the grooves 7 at different positions, they correspond to the urethra diameters of different patients, so that in the initial state, the patient can reach a more comfortable state and will not be restricted by the excessive tightening of the contractile element.

[0047] Further optimization is performed, the tightness B of the contractile element in step S4 is less than the tightness A of the contractile element in step S3 and less than the tightness C of the contractile element in step S5, wherein C>A>B, and the greater the tightness, the tighter the contractile element contracts.

[0048] In addition, to reflect the tightness of the contractile element in different modes, C>A>B, when in normal mode, the tightness A of the contractile element is the initial tightness. When in sleep mode, the patient's urination frequency is significantly reduced, and the tightness B of the contractile element can be looser than in normal mode to ensure the patient's comfort. When in exercise mode, the probability of urinary leakage is also significantly increased, and the tightness C of the contractile element represents a tighter tightness to prevent the patient from leaking urine. The above tightness is compared based on the initial tightness, that is, the initial tightness A=1, and the value range of the tightness B of the contractile element is 0.5-1; the value range of the tightness C of the contractile element is 1-1.5.

[0049] Further optimization is performed, T1 in step S3 ≥ T2 in step S4 > T3 in step S5.

[0050] In normal mode, the patient is reminded every T1 time, and the reminder can be made by voice broadcasting of remote control 1, reminding the patient to switch the mode to urination mode to urinate, thus ensuring that the patient urinates at regular time intervals; while in the patient's sleep mode, it automatically switches to normal mode after an interval of T2 time, ensuring the switching between sleep mode and normal mode. When the patient is in exercise mode, it automatically switches to normal mode at a smaller interval of T3 time. Among them, the value range of T1 time is 4h~10h, the value range of T2 time is 4h~10h, which is obtained from the urination interval required for normal human metabolism, and the value range of T3 time is 1-3h.

[0051] Further optimization also includes a safety mode. In the safety mode, the system detects abnormal operation or low battery power in the driving source and automatically enters the safety mode. In the safety mode, the retractable element does not retract and the degree of retraction cannot be adjusted by the remote control.

[0052] In the safety mode, the system puts the retractable element into a paused state, that is, the retractable element does not retract and the degree of retraction cannot be adjusted by the remote control until the safety mode is exited.

[0053] Further optimized, the remote controller 1 is provided with a first operating part 8 for setting the normal mode, exercise mode and sleep mode; and a second operating part 9 is used for setting the urination mode.

[0054] The normal mode, exercise mode, sleep mode and urination mode are entered respectively through the first operating part 8 and the second operating part 9, thereby achieving the purpose of patient safety and multi-functional use of the remote controller 1 to control the retractable structure.

[0055] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be based on the scope defined by the claims.

Claims

1. A method for using an artificial sphincter, comprising implanting a contractile element into a patient's body, the contractile element being arranged around the patient's urethra, and an external remote controller (1) for controlling the operation of the contractile element, characterized in that: S1: The patient controls the contractile element through the remote controller (1) to adjust the initial tightness of the contractile element to A, so that the patient can achieve a comfortable state; S2: Patients can choose urination mode, normal mode, sleep mode and exercise mode according to their own conditions; and choose any of S3-S5 according to actual conditions; S3: The patient can switch to the normal mode through the remote control (1). In the normal mode, the tightness of the contractile element is set to A, and the patient is reminded to switch to the urination mode every T1 time. S4: The patient can switch to the sleep mode through the remote control (1). In the sleep mode, the tightness of the contractile element is set to B, and the patient is reminded to switch to the urination mode after a time interval T1, and automatically switches to the normal mode after a time interval T2; S5: The patient can switch to the exercise mode through the remote controller (1), in which the tightness of the contractile element is set to C, and the contractile element will automatically switch back to the normal mode after a time interval of T3.

2. The method for using an artificial sphincter according to claim 1, wherein: The contractile element is connected to a driving source, which is built into the patient's body. The remote controller (1) is in communication with the driving source. The remote controller (1) is provided with a first operating part (8), which is used for the patient to switch modes.

3. The method for using an artificial sphincter according to claim 1, wherein: The remote controller (1) can only control the operation of the driving source when the remote controller (1) is within a preset range of the driving source.

4. The method for using an artificial sphincter according to claim 1, wherein: The contractile element comprises: a flexible strip (2) and a closing element (3), wherein the closing element (3) is located at a first end of the flexible strip (2); a reinforcing element (4) is provided on the flexible strip (2); The contractile element further comprises a flexible transmission device comprising a tensioning element anchored at a first end to a first anchoring point (5) on the flexible strip (2), the tensioning element being provided with a second anchoring point (6) on the flexible strip (2); When the remote controller (1) controls the contractile element to contract, the distance between the first anchor point (5) and the second anchor point (6) shortens and drives the flexible strip (2) to contract; when the controller controls the contractile element to reset, the distance between the first anchor point (5) and the second anchor point (6) lengthens and drives the flexible strip (2) to lengthen.

5. The method for using an artificial sphincter according to claim 4, wherein: The closure member (3) is provided with a plurality of grooves (7) for the first anchoring point (5) and the reinforcing element (4) to enter. When the first anchoring point (5) and the reinforcing element (4) enter the grooves (7) at different positions, different tightening degrees can be achieved.

6. The method for using an artificial sphincter according to claim 1, wherein: The tightness B of the contractile element in step S4 is less than the tightness A of the contractile element in step S3 and less than the tightness C of the contractile element in step S5, wherein C>A>B, and the greater the tightness, the tighter the contractile element contracts.

7. The method for using an artificial sphincter according to claim 1, wherein: T1 in step S3 ≥ T2 in step S4 > T3 in step S5.

8. The method for using an artificial sphincter according to claim 2, wherein: There is also a safety mode. In the safety mode, the system automatically enters the safety mode when it detects abnormal operation or low battery power in the driving source. In the safety mode, the retractable element does not retract and the degree of retraction cannot be adjusted by the remote control.

9. The method for using an artificial sphincter according to claim 1, wherein: The remote controller (1) is provided with a first operating part (8) for setting the normal mode, exercise mode and sleep mode; and a second operating part (9) for setting the urination mode.

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