CN116211535A

CN116211535A - Biological opening and closing device and working method thereof

Info

Publication number: CN116211535A
Application number: CN202310418584.3A
Authority: CN
Inventors: 刘谋都
Original assignee: Suzhou Huaqi Medical Technology Co ltd
Current assignee: Suzhou Huaqi Medical Technology Co ltd
Priority date: 2023-04-19
Filing date: 2023-04-19
Publication date: 2023-06-06

Abstract

The application discloses biological open-close device and working method thereof for can keep the support frame body of the prostate functional urethra support of human physiology urination reaction, biological open-close device outside border be installed in support frame body is last to form first open-ended tip border, biological open-close device is set up when receiving predetermined size fluid pressure, can form at least one intercommunication mouth that can open and shut in the middle part, biological open-close device includes at least 3 lamella polymer flexible diaphragm, wherein every the diaphragm all has an edge portion, two side shoulder and with a portion that ends that is opposite to the edge portion, wherein at least 3 lamella polymer flexible diaphragm is by arranging side in first opening, wherein every the edge portion of diaphragm is used for being fixed on support frame body, adjacent two the side shoulder of diaphragm is fixed each other, all the portion that ends of diaphragm is encircleed and is formed a communicating mouth that can open and shut.

Description

Biological opening and closing device and working method thereof

Technical Field

The invention relates to the field of medical instruments, in particular to a biological opening and closing device and a working method thereof.

Background

Prostate diseases are common in many areas of the world, especially in China, where men, after entering a certain age group, may have a tendency to fibrosis and be accompanied by an increase in volume. The enlarged volume of the prostate will press the patient's urethra, thereby reducing the cross-sectional diameter of the patient's pressed urethra and preventing the patient from urinating normally.

After enlargement of the prostate of a patient, there are generally two methods for medical solutions in order to ensure that the patient can urinate normally, one of them being: surgical excision of the enlarged prostate; and secondly, the urethra of the patient is strutted through the urethra support so that the urethra of the patient can have a cross-sectional diameter of a preset size.

The enlarged prostate gland of surgical excision is gradually abandoned because of irreversible physiological effects on the patient, such as loss of sexual function. While the urinary tract of a patient can be ensured to be urinated by the way of expanding the urinary tract of the patient through the urinary tract stent, the urine in the urinary bladder of the patient can directly flow out due to the fact that the traditional urinary tract stent cannot be contracted after being implanted into the urinary tract of the patient. Therefore, the subsequently improved urethral support is generally provided with a structure capable of preventing urine from flowing out, and when a patient needs to drain, the patient can drain urine only by manually opening the structure capable of preventing urine from flowing out.

A prostatic urethra stent system capable of autonomous urination disclosed in CN207821957U and a prostatic urethra stent used by the same, and a prostatic stent capable of autonomous urination disclosed in CN 211750302U.

While the urethral stents disclosed in the prior art are capable of allowing a user to patient and preventing urination, the urethral stents of the prior art do not allow the patient to retain the physiological urination response of the human body. It is well known that the nervous system of the human body controls the physiological response of the human body, as does the physiological urination response of the human body. While the nervous system of the human body follows the principle of feeding and discharging, that is, when the human body has the intention of urination, the human body urinates, and if the human body urinates directly without awareness of urination, the nervous reflex system of the human body controlling urination will deteriorate, even be lost, over time.

In the prior art, most of urination brackets are compulsory urination, namely, if a structure for preventing urine from flowing out is opened, no matter whether a patient has urination consciousness or not, the urination will be performed, so that the normal physiological urination reaction of the human body can be destroyed.

In addition, in order to ensure a stable supporting effect of the urethral stent, the urethral stent is generally made of a metal material in the prior art. The urethra is an important channel for discharging liquid in the human body, so that the pH value of the liquid discharged through the urethra is greatly influenced by eating habits of the human body. In other words, sometimes, the liquid discharged from the human urethra has high acidity, and sometimes, the liquid discharged from the human urethra has high alkalinity, and when the metal stent exists in the urethra with relatively complex pH value for a long time, the structure and plasticity of the metal stent are affected, so that the service life of the metal stent is necessarily reduced, and the stability of the metal stent for expanding the urethra is affected.

In addition, the existing urethral stent needs to remain in the urethra of the human body for a long period of time after being implanted into the human body to prop open the inner wall of the urethra. In other words, the existing urethral stents are required to closely fit the inner wall of the human urethra. The urethral cells of the human body are stimulated to be easy to proliferate after being pressed, so that after the stent is implanted into the urethra of the human body for a preset time, new cells are proliferated at the contact part of the urethral stent and the inner wall of the urethra, and the stimulated cells are eliminated.

However, after a certain period of use, the stent needs to be removed from the urethra of the human body for replacement or maintenance, and once the stent is wrapped by cells on the inner wall of the urethra, the removal of the stent is plagued.

Disclosure of Invention

An advantage of the present invention is to provide a bio-switch and a method of operating the same, wherein the bio-switch can be fitted with a prostate functional urethral stent that can preserve the physiological urination response of the human body, while preserving the physiological urination response of the patient, preventing the user from leaking urine and allowing the user to urinate autonomously.

Another advantage of the present invention is to provide a bio-switch and a method of operating the same, wherein the bio-switch is capable of responding to a change in a urination response of a user and is better suited for the user.

Another advantage of the present invention is to provide a bio-switch and a method of operating the same, in which the bio-switch can greatly reduce a user's foreign body sensation.

Another advantage of the present invention is to provide a bio-switch and a method of operating the same, in which the bio-switch can rapidly respond to a user's urination reaction and urination and rapidly block the user's urethra after urination from the outside, thereby effectively preventing urinary tract infection of the user.

To achieve at least one of the above advantages, an advantage of the present invention is to provide a bio-opener for a prostatic functional urethral stent capable of retaining physiological urination reaction of a human body, the supporting frame having a first opening, a second opening and a communication channel communicating the first opening and the second opening, the bio-opener having an outer edge mounted on the supporting frame to form an end edge of the first opening, the bio-opener being provided to form at least one communication opening openable and closable in a middle portion when subjected to a predetermined magnitude of fluid pressure, the bio-opener comprising at least 3-flap polymeric flexible membranes, wherein each of the membranes has an edge portion, two side shoulders and a communication stop portion opposite to the edge portion, wherein at least 3-flap polymeric flexible membranes are arranged side by side on the first opening, wherein the edge portion of each of the membranes is to be fixed on the supporting frame, the communication stop portions of two adjacent side shoulders are fixed to each other, and all the communication membranes are formed around the communication opening.

According to one embodiment of the invention, the predetermined magnitude of fluid pressure is set to 300 milliliters, 5 centimeters of water, 10 millimeter diameter evacuated tubes, 3 pounds of force.

According to an embodiment of the invention, the biological shutter comprises a 4-flap or 5-flap polymer flexible membrane.

According to an embodiment of the invention, each of the diaphragms is held obliquely in the communication passage.

According to an embodiment of the present invention, when the bio-opener keeps the communication port closed, an extending direction of the support frame body is taken as an axial direction, wherein an included angle between each of the membrane pieces and the axial direction is set to 15 ° to 20 °.

According to an embodiment of the invention, wherein each lobe of the membrane is set at an angle of 18 ° to the axial direction.

According to an embodiment of the invention, the edge portion of each of the diaphragms has a head portion and a tail portion, wherein when the bioswitch is in an open state forming the communication port, a cross-sectional diameter of the edge portion gradually decreases from the head portion toward the tail portion, and the head portion of the edge portion of one of the adjacent two diaphragms corresponds to the tail portion of the edge portion of the other diaphragm.

According to an embodiment of the invention, the tail of the edge portion of one of the adjacent two membranes is retracted from the head of the edge portion of the other membrane into the edge portion of the other membrane when the bioswitch is in the closed state, and the tail of the edge portion of one of the adjacent two membranes is removed from the head of the edge portion of the other membrane when the bioswitch is in the open state.

According to another aspect of the present invention, there is provided a method of operating a bio-switch, the method comprising:

responding to urination reaction of a user, after at least one biological opening and closing device arranged on a first opening and/or a second opening of the support frame body is subjected to fluid pressure with a preset size, the biological opening and closing device forms at least one communication port together with a communication channel formed between the first opening and the second opening of the support frame body, so that urine in the bladder of the user is discharged through the communication channel;

after the user finishes urination and the urination reaction disappears, the biological opening and closing device automatically closes the communication port.

Drawings

Fig. 1 shows a perspective view of the prostate functional urethral stent that can preserve the physiological urination response of the human body according to the first embodiment of the invention.

Fig. 2 is a schematic view showing the prostate functional urethral stent capable of retaining physiological urination response of a human body in the opened state of the bio-switch according to the first embodiment of the invention.

Fig. 3 shows a schematic view of the prostate functional urethral stent capable of retaining physiological urination response of a human body in a closed state according to the first embodiment of the invention.

Fig. 4 shows a schematic view of the prostate functional urethral stent of the first embodiment of the invention in an angle that preserves the physiological urination response of the human body.

Fig. 5 shows an enlarged schematic view of the structure of the prostate functional urethral stent section capable of retaining the physiological urination response of the human body according to the first embodiment of the invention.

Fig. 6 is an enlarged view showing another part of the structure of the functional prostatic urethral stent capable of retaining physiological urination response of human body according to the first embodiment of the invention.

Fig. 7 shows a schematic view of the prostate functional urethral stent that can preserve the physiological urination response of the human body according to the first embodiment of the invention in one scenario.

Fig. 8 shows a schematic view of the prostate functional urethral stent that can preserve the physiological urination response of the human body according to the first embodiment of the invention in another scenario.

Fig. 9 is a perspective view showing that the prostate functional urethral stent capable of retaining physiological urination response of human body according to the second embodiment of the invention comprises a 3-flap polymer telescoping membrane.

Fig. 10 is a perspective view showing that the prostate functional urethral stent capable of retaining physiological urination response of human body according to the third embodiment of the invention comprises 4-flap polymer telescoping membrane.

Detailed Description

The following description is presented to enable one of ordinary skill in the art to make and use the invention. The preferred embodiments in the following description are by way of example only and other obvious variations will occur to those skilled in the art. The basic principles of the invention defined in the following description may be applied to other embodiments, variations, modifications, equivalents, and other technical solutions without departing from the spirit and scope of the invention.

It will be appreciated by those skilled in the art that in the present disclosure, the terms "longitudinal," "transverse," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," etc. refer to an orientation or positional relationship based on that shown in the drawings, which is merely for convenience of description and to simplify the description, and do not indicate or imply that the apparatus or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore the above terms should not be construed as limiting the present invention.

It will be understood that the terms "a" and "an" should be interpreted as referring to "at least one" or "one or more," i.e., in one embodiment, the number of elements may be one, while in another embodiment, the number of elements may be plural, and the term "a" should not be interpreted as limiting the number.

Referring to fig. 1 to 8, a prostate functional urethral stent capable of retaining a physiological urination reaction of a human body, which can be used to prop open the urethra of a patient and can maintain the physiological urination reaction of the human body, according to a preferred embodiment of the present invention will be described in detail below.

Specifically, the prostate functional urethral stent capable of retaining the physiological urination reaction of the human body comprises a supporting frame body 10 and at least one biological opening and closing device 20. The supporting frame 10 has a first opening 101, a second opening 102, and a communication channel 103 for communicating the first opening 101 and the second opening 102, wherein at least one bio-switch 20 is disposed in the communication channel 103 to close or open the first opening 101 and the second opening 102. As an example, one of the bioswitches 20 is provided to the first opening 101 of the communication channel 103.

As will be appreciated by those skilled in the art, in one embodiment, one of the bioswitches 20 is disposed in the second opening 102. In yet another embodiment, the first opening 101 and the second opening 102 may be provided with one of the bioswitches 20, respectively. In other embodiments, the bio-switch 20 may be disposed at other locations than the first and

second openings

101 and 102.

In order to enable those skilled in the art to understand the embodiments of the present invention, at least one embodiment of the present application will be described with reference to the bio-switch 20 being disposed in the first opening 101, wherein the first opening 101 is close to and faces the bladder of the user after the prostate functional urethral stent capable of retaining the physiological urination reaction of the human body is placed in the urethra of the human body.

The bioswitch 20 is provided in the communication passage 103 so as to be capable of communicating the first opening 101 and the second opening 102 when subjected to a predetermined magnitude of fluid pressure, and blocking the first opening 101 and the second opening 102 when subjected to a magnitude of fluid pressure lower than the predetermined magnitude.

In particular, in one embodiment, the outer edge of the bioswitch 20 is mounted on the support body 10 forming an end edge of the first opening 101. The bio-switch 20 is provided so that at least one communication port 201 is formed in the middle portion to be openable and closable when a predetermined amount of fluid pressure is applied thereto.

Thus, after the prostate functional urethral stent capable of retaining the physiological urination reaction of the human body is implanted in the urethra of the patient, when the communication port 201 is formed at the middle portion of the bio-switch 20, the urethra of the user can be communicated with the communication channel 103 of the supporting frame body 10 through the communication port 201, thereby allowing the user to urinate. In particular, in the process that the urine of the user gradually remains and accumulates in the bladder of the user, the fluid pressure formed by the urine of the user gradually increases, and when the fluid pressure formed by the urine of the user is greater than the maximum pressure that the bio-switch 20 can be kept to close the communication port 201, the communication port 201 is opened, so that the urine of the user bladder can be discharged from the user's urethra through the communication port 201, the communication channel 103 of the support frame 10 and the second opening 102 in sequence.

When the urine of the user gradually remains and accumulates in the bladder of the user and the fluid pressure of the accumulated urine is smaller than the maximum pressure that the bio-switch 20 can receive to keep the communication port 201 closed, most parts of the urethra, bladder, etc. of the user are isolated from the outside by the bio-switch 20 because the communication port 201 is closed. Thus, external bacteria, dust, viruses and other dirt can be effectively prevented from entering the urethra of the user, and the urethra of the user can be effectively prevented from being disturbed.

Preferably, the predetermined magnitude of fluid pressure is set to 300 milliliters, 5 centimeters of water, 10 millimeter diameter evacuated tubes, 3 pounds of force. Experiments have shown that most people produce urine by conscious urination at pressures in the urethra that are close to: 300 ml, 5 cm water column, 10 mm diameter evacuated tube, 3 lbs. force. Thus, when the user intentionally urinates, the pressure of the fluid in the bladder is controlled, and when the pressure of the fluid in the user's bladder is greater than the predetermined magnitude of the fluid pressure, the bio-switch 20 may automatically form the communication port 201. And when the user disappears, the bio-switch 20 may automatically close the communication port 201.

It is worth mentioning that in one embodiment, the communication port 201 is implemented as a macroscopic opening; in a variant embodiment, however, the communication port 201 may be embodied as an invisible opening allowing the passage of the fluid, i.e. a channel similar to the permeable membrane permeable to the fluid. In order for those skilled in the art to understand the present invention, at least one embodiment of the present invention is described only by taking an example in which the communication port 201 is implemented as a macroscopic opening, and those skilled in the art will understand that this is not limiting to the present invention.

As will be appreciated by those skilled in the art, since the human body can consciously control the pressure of the fluid in the own bladder, even if the original pressure of the fluid in the user's bladder is greater than the predetermined magnitude of the fluid pressure, the pressure of the fluid in the user's bladder finally given to the bio-switch 20 is less than the predetermined magnitude of the fluid pressure due to the subconscious control of the user, the bio-switch 20 is still in the closed state, i.e., the communication port 201 is closed.

It can be further understood by those skilled in the art that, unlike the prior art, since the opening and closing of the bio-switch 20 is the engagement and control of the urination consciousness of the user, the prostate functional urethral stent provided with the bio-switch 20, which can retain the physiological urination reaction of the human body, can continuously train the urination consciousness of the user when being used by the user, so that the prostate functional urethral stent, which can retain the physiological urination reaction of the human body, can not only control the on-off of the urethra and the bladder of the user, but also retain the normal urination consciousness of the user. In the prior art, as in the technical schemes disclosed in CN207821957U or CN211750302U, the on-off of the urethra and the bladder of the user are controlled manually by the user, and the user's urination consciousness is not needed or not involved and controlled, and in long term, the urination consciousness of the user is lost, thus causing other problems.

In one example, the bio-switch 20 is implemented as a flexible elastic membrane.

Preferably, the bio-switch 20 comprises at least 3-flap polymeric flexible membranes 21, wherein each membrane 21 has an edge portion 211, two side shoulder portions 212 and a stop portion 213 opposite to the edge portion 211, wherein at least 3-flap polymeric flexible membranes 21 are arranged side by side at the first opening 101, wherein the edge portion 211 of each membrane 21 is fixed on the support frame body 10. Furthermore, the side shoulders 212 of two adjacent diaphragms 21 are fixed to each other. The communication ports 201 are formed so as to be openable and closable around the stopper portions 213 of all the diaphragms 21.

Referring to fig. 1 and 9 and fig. 10, in one embodiment, the bio-breaker 20 includes at least 3 flaps of the polymeric telescoping membrane 21. In one embodiment, the bio-switch 20 includes at least 4 flaps of the polymeric telescoping membrane 21. In yet another embodiment, the bio-switch 20 includes at least 5 flaps of the polymeric telescoping membrane 21. That is, the bioswitch 20 includes at least 3 petals. In order to enable those skilled in the art to understand the present invention, at least one embodiment of the present invention is described by taking the bio-switch 20 including the 5-piece polymeric flexible membrane 21 as an example, but this is not a limitation of the present invention.

It should be noted that, when the bio-switch 20 is in the closed state, the side shoulder 212 and the through-stop 213 of each membrane 21 contact each other to close the communication port 201. And when the bio-switch 20 is in an open state, i.e., the bio-switch 20 is formed with the communication port 201, the communication port 201 is opened, and at this time, the diaphragm 21 receives a pressure greater than the predetermined magnitude of fluid pressure. It should be noted that, since the diaphragm 21 has stretchability, the larger the pressure applied to the diaphragm 21, the larger the size of the communication port 201 is formed, and thus, the user can be made to urinate promptly, which can also respond to the awareness of urination of the user. That is, as the user's awareness of urination becomes stronger, the pressure corresponding to the impact of the diaphragm 21 is greater, and accordingly, the size of the communication port 201 opened is greater, thereby enabling the user to urinate faster. Conversely, when the user's awareness of urination is weaker, the pressure corresponding to the impact of the diaphragm 21 is smaller, and accordingly, the size of the communication port 201 opened is larger, thereby enabling the user to urinate slowly.

That is, by providing the bio-switch 20 as the polymer flexible membrane 21 of at least three flaps, not only is it advantageous for the exercise of the user's awareness of urination, but also it is possible to respond to the change of the user's awareness of urination.

Preferably, the polymer flexible membrane 21 is made of titanium alloy, pyrolytic carbon fiber film, or the like.

Also preferably, each of the diaphragm 21 is held obliquely at the first opening 101, and the stopper 213 of the diaphragm 21 in the state of being held obliquely is located closer to the second opening 102, that is, each of the diaphragm 21 is inclined so as to extend into the communication passage 103 formed in the support body 10.

Preferably, when the bio-switch 20 keeps the communication port 201 closed, the extending direction of the support body 10 is taken as an axial direction, wherein an angle θ between each of the diaphragms 21 and the axial direction is set to 15 ° to 20 °, preferably 18 °.

By in vitro experimental conditions: 300 ml, 5 cm water column, 10 mm diameter evacuated tube. The basal force surface for bladder contraction upon pressurization with 3 pounds of external force, i.e., physiological urination:

(1) When the angle between each diaphragm 21 and the axial direction is set to 90 °,3 pounds of external force is applied, and 5 cm of water column cannot form the communication port 201. Only a drip-like drip is formed.

(2) When the included angle between each piece of membrane 21 and the axial direction is set to be 10 degrees, 3 pounds of external force is applied, the 5 cm water column closer can open to the far end of the urethra for about 30 degrees, the 300 milliliter water volume is emptied for about 4-5 minutes, and the communication port 201 is closed rapidly for about 3-4 seconds.

(3) When the included angle between each piece of membrane 21 and the axial direction is set to be 20 degrees, 3 pounds of external force is applied, the 5 cm water column closer can open to the far end of the urethra for about 60 degrees, the 300 milliliter water volume emptying time is about 65-75 seconds, and the communication port 201 is closed rapidly for about 5-6 seconds.

(4) When the included angle between each piece of membrane 21 and the axial direction is set to be 30 degrees, 3 pounds of external force is applied, the 5 cm water column closer can open to the far end of the urethra for about 75 degrees, the 300 milliliter water volume emptying time is about 55-60 seconds, the communication port 201 is closed slowly, and the time is about 15-16 seconds. There is a risk of retrograde urinary tract infection.

That is, when the angle between each of the diaphragm 21 and the axial direction is set to 15 ° to 20 °, not only the time for urination by the user but also the rapid closing of the communication port 201 can be ensured.

Further, the edge portion 211 of each of the diaphragms 21 has a head portion 2111 and a tail portion 2112, wherein when the bioswitch 20 is in the open state forming the communication port 201, the cross-sectional diameter of the edge portion 211 gradually decreases from the head portion 2111 toward the tail portion 2112, and the head portion 211 of the edge portion 211 of one of the adjacent two diaphragms 21 corresponds to the tail portion 212 of the edge portion 211 of the other diaphragm 21.

It should be noted that, by such an arrangement, the contact area between the outer wall of the bio-switch 20 and the urethra of the user can be reduced, thereby reducing the foreign body sensation of the user. In addition, since each of the diaphragms 21 has stretchability, and the cross-sectional diameter of the rim portion 211 is gradually reduced from the head portion 2111 to the tail portion 2112 when the bio-switch 20 is in the opened state in which the communication port 201 is formed, it is possible to increase the speed in which the communication port 201 is formed and the communication port 201 is closed, thereby enabling a user to urinate more quickly and isolate the user's urethra after urination is completed more quickly.

Preferably, when the bioswitch 20 is in the closed state, the tail portion 2112 of the edge portion 211 of one of the adjacent two membranes 21 contracts to merge from the head portion 2111 of the edge portion 211 of the other membrane 21 into the edge portion 211 of the other membrane 21. While the bio-switch 20 is in the open state, the tail portion 2112 of the edge portion 211 of the adjacent two of the membranes 21 is moved out of the head portion 2111 of the edge portion 211 of the other membrane 21.

It will be appreciated that such a design is effective to increase the speed of forming the communication port 201 and closing the communication port 201.

Preferably, the support body 10 is embodied in a memory alloy, preferably NiTi memory alloy.

It will be appreciated by those skilled in the art that NiTi memory alloys have excellent biocompatibility and corrosion resistance, while having exceptional memory properties and superelasticity. The shape of the inner support under ice water is changed within a certain range at 0-10 ℃, the prostate functional urethral support capable of retaining human physiological urination reaction is sent into a narrow area of the user's body urethra through an imbedding device, the prostate functional urethral support capable of retaining human physiological urination reaction can be restored to the original shape at body temperature immediately, and the generated radial expansion tension acts on the inner wall of the urethra, so that the narrow is expanded.

Preferably, the support frame 10 is provided in a cylindrical shape, more preferably in a cylindrical shape. More preferably, the supporting body 10 is implemented in a mesh structure, so that a contact area between the supporting body 10 and the urethra of the user can be effectively reduced, thereby greatly reducing the foreign body sensation of the user. In addition, the supporting body 10 provided in the mesh structure also has better shape recovery performance, and particularly when the supporting body 10 is implemented to be made of a memory alloy, the supporting body 10 of the mesh structure can be quickly recovered to a shape expanding the urethra of the user.

Preferably, the outer wall of the supporting frame body 10 is provided with a drug coating 30, wherein the drug coating 30 is formed of a drug for delaying the excessive proliferation of endothelial cells of urinary tract, such as embedded paclitaxel/rapamycin-anticancer drugs.

It should be noted that, after the prostate functional urethral stent capable of retaining the physiological urination reaction of the human body is implanted into the human body, the stent needs to be retained in the urethra of the human body for a long time for expanding the inner wall of the urethra of the user. In other words, the supporting frame body 10 of the prostate functional urethral stent which can retain the physiological urination reaction of the human body is required to be closely adhered to the inner wall of the urethra of the human body. After the human urethral cells are pressed, the human urethral cells are stimulated to be easy to proliferate, so that after the prostate functional urethral stent capable of retaining the physiological urination reaction of the human body is implanted into the human urethra for a preset time, new cells are proliferated in the contact part of the urethral stent and the inner wall of the urethra, thereby eliminating the stimulation.

And because the outer wall of the supporting frame body 10 is provided with the drug coating 30, the overgrowth of the endothelial cells of the urethra can be effectively delayed, and the service cycle of the prostate functional urethral stent capable of retaining the physiological urination reaction of the human body can be prolonged.

Preferably, the outer wall of the supporting frame body 10 has at least one embedding groove 104, wherein the embedding groove 104 is embedded with a drug for delaying the overgrowth of endothelial cells of urethra, such as paclitaxel/rapamycin-anticancer drug. Preferably, after embedding, the interval between the drug for delaying the excessive proliferation of endothelial cells of urethra, such as paclitaxel/rapamycin-anticancer drug, and the urethra of the user is at least not smaller than the interval between the outer wall of the supporting frame body 10 and the urethra of the user, so that it is ensured that the drug embedded in the embedding groove 104 can directly contact with the urethral cells of the user after the supporting frame body 10 is implanted into the urethra of the user.

Preferably, the inner wall of the supporting frame body 10 is provided with a corrosion-resistant layer 40. Preferably, the corrosion-resistant layer 40 is formed of a polymer film resistant to acid and alkali corrosion.

As can be appreciated by those skilled in the art, since the urethra is an important channel for the human body to drain fluid from the body, the ph of the fluid drained by the urethra is greatly affected by the eating habits of the human body. In other words, sometimes the liquid discharged from the human urethra is more acidic, and sometimes the liquid discharged from the human urethra is more basic. The existing urethral stent needs to prop open the urethra of the human body and needs to have larger plasticity, so that the existing urethral stent mostly adopts a metal stent, and when the metal stent exists in the urethra with relatively complex pH value for a long time, the structure and the plasticity of the metal stent are affected, and thus, the service life of the metal stent is necessarily reduced.

And after the inner wall of the supporting frame body 10 is provided with the corrosion-resistant layer 40, the corrosion of urine to the supporting frame body 10 can be effectively delayed or even prevented, so that the supporting frame body 10 has a longer service life.

In accordance with another aspect of the present invention, a method of operating a bio-switch according to a preferred embodiment of the present invention is described in detail below, wherein the bio-switch is used in a prostate functional urethral stent that retains a physiological urination response of a human, wherein the method of operating the bio-switch comprises:

s1001, responding to the urination reaction of the user, forming at least one communication port 201 together with the communication channel 103 formed between the first opening 101 and the second opening 102 of the supporting frame body 10 by the biological shutter 20 after receiving the predetermined magnitude of fluid pressure by at least one of the biological shutters 20 disposed on the first opening 101 and the second opening 102 of the supporting frame body 10, for discharging urine in the bladder of the user through the communication channel 103;

s1002, the bio-switch 20 automatically closes the communication port 201 after the user finishes urination and the urination reaction disappears.

In one embodiment, the bio-switch 20 is configured as at least three flaps of the polymeric telescoping membrane 21.

It will be appreciated by persons skilled in the art that the embodiments of the invention described above and shown in the drawings are by way of example only and are not limiting. The advantages of the present invention have been fully and effectively realized. The functional and structural principles of the present invention have been shown and described in the examples and embodiments of the invention may be modified or practiced without departing from the principles described.

Claims

1. A biological opening and closing device for a support frame body of a prostate functional urethral support capable of retaining human physiological urination reaction, the support frame body is provided with a first opening, a second opening and a communication channel for communicating the first opening and the second opening, the biological opening and closing device is characterized in that the outer edge of the biological opening and closing device is arranged on the support frame body to form an end edge of the first opening, the biological opening and closing device is arranged on the support frame body, when the biological opening and closing device is subjected to fluid pressure with a preset size, at least one communication opening capable of being opened and closed can be formed in the middle, the biological opening and closing device comprises at least 3 pieces of high-molecular telescopic membranes, each membrane is provided with an edge part, two side shoulder parts and a stopping part opposite to the edge part, wherein at least 3 pieces of high-molecular telescopic membranes are arranged on the first opening in a side-by-side mode, the edge part of each membrane is used for being fixed on the support frame body, the side shoulder parts of two adjacent membranes are mutually fixed, and all the stopping parts surround to form a communication opening and closing membrane capable of opening and closing.

2. The prostatic functional urethral stent of claim 1 or 2, wherein the predetermined magnitude of fluid pressure is set to 300 milliliters, 5 centimeters of water, 10 millimeters of diameter evacuation tube, 3 pounds of force.

3. The prostatic functional urethral stent capable of retaining physiological urination response of a human according to claim 2, wherein the biological opening and closing device comprises 4-flap or 5-flap polymer flexible membrane.

4. The prostatic functional urethral stent of claim 1, wherein each of the membrane elements is held in the communication channel at an incline.

5. The prostate functional urethral stent capable of retaining physiological urination reaction of human body according to claim 4, wherein when the biological opening-closing device keeps the communication port closed, the extending direction of the supporting frame body is taken as an axial direction, and the included angle between each diaphragm and the axial direction is set to be 15-20 degrees.

6. The prostatic functional urethral stent of claim 5, wherein each flap of the membrane is disposed at an angle of 18 ° to the axial direction.

7. The prostatic functional urethral stent of claim 1, wherein the edge portion of each of the membranes has a head portion and a tail portion, wherein the cross-sectional diameter of the edge portion gradually decreases from the head portion toward the tail portion when the bio-switch is in an open state forming the communication port, and the head portion of the edge portion of one of the adjacent two membranes corresponds to the tail portion of the edge portion of the other membrane.

8. The prostatic functional urethral stent of claim 1, wherein when the bioswitch is in a closed state, the tail of the edge portion of one of the adjacent two membranes contracts to merge into the edge portion of the other membrane from the head of the edge portion of the other membrane, and when the bioswitch is in an open state, the tail of the edge portion of one of the adjacent two membranes moves out of the head of the edge portion of the other membrane.

9. The method of operating a bioswitch according to any one of claims 1-8, wherein the method of operating a bioswitch comprises:

10. The method of claim 9, wherein the extending direction of the supporting frame body is taken as an axial direction when the bio-switch keeps the communication port closed, and wherein an included angle between each diaphragm and the axial direction is set to 15 ° to 20 °.