阅读说明：本技术 植入式柔性磁控膀胱挤压装置 (Implanted flexible magnetic control bladder extrusion device ) 是由 凌青 刘继红 王少刚 臧剑锋 王佳鑫 吴清扬 凌乐 羊佑舟 杨甲申 于 2021-08-18 设计创作，主要内容包括：本发明公开了一种植入式柔性磁控膀胱挤压装置,该装置包括用于包裹膀胱的柔性磁控包裹体,所述柔性磁控包裹体包括柔性无磁基体和铁磁复合体,所述铁磁复合体设置在柔性无磁基体的外表面；所述柔性无磁基体由有机硅胶、聚二甲基硅氧烷树脂及亮光剂通过热塑固化制得；所述铁磁复合体由有机硅胶、聚二甲基硅氧烷树脂及磁颗粒通过热塑固化制得。本发明的植入式柔性磁控膀胱挤压装置能够解决膀胱活动低下/逼尿肌收缩无力等导致的排尿困难。手术植入该挤压装置后,可以在不接任何额外管道的情况下,通过外磁场施加的磁力的大力矩,实现正常排尿的功能。(The invention discloses an implanted flexible magnetic control bladder extrusion device which comprises a flexible magnetic control inclusion for wrapping a bladder, wherein the flexible magnetic control inclusion comprises a flexible non-magnetic base body and a ferromagnetic complex body, and the ferromagnetic complex body is arranged on the outer surface of the flexible non-magnetic base body; the flexible non-magnetic substrate is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and a brightening agent; the ferromagnetic complex is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and magnetic particles. The implanted flexible magnetic control bladder squeezing device can solve the difficult urination caused by low bladder activity/weak detrusor contraction and the like. After the extrusion device is implanted into the operation, the function of normal urination can be realized through the large moment of the magnetic force exerted by the external magnetic field under the condition of not connecting any extra external pipeline.)

1. An implanted flexible magnetic control bladder extrusion device is characterized in that: the bladder-wrapping flexible magnetic control wrapping body comprises a flexible magnetic control wrapping body (1) used for wrapping a bladder, wherein the flexible magnetic control wrapping body (1) comprises a flexible non-magnetic base body (1.1) and a ferromagnetic complex body (1.2), and the ferromagnetic complex body (1.2) is arranged on the outer surface of the flexible non-magnetic base body (1.1);

the flexible non-magnetic substrate (1.1) is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and a brightening agent; the ferromagnetic complex (1.2) is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and magnetic particles.

2. The implantable flexible magnetically controlled bladder compression device of claim 1, wherein: the volume ratio of the organic silica gel to the polydimethylsiloxane resin in the flexible non-magnetic matrix (1.1) is (4-10): 1; the brightening agent accounts for 2-4% of the flexible non-magnetic matrix by weight;

the volume ratio of the organic silica gel to the polydimethylsiloxane resin in the ferromagnetic complex (1.2) is (4-10): 1; the volume fraction of the magnetic particles in the ferromagnetic composite body (1.2) is 20-65%.

3. The implantable flexible magnetically controlled bladder compression device of claim 2, wherein: the magnetic particles are any one or combination of more of NdFeB, Fe and FeC; the magnetic particles are uniformly magnetized in a pulse magnetic field with the magnetic induction intensity of 3-10T.

4. The implantable flexible magnetically controlled bladder compression device according to claim 1, 2 or 3, wherein: the flexible magnetic control inclusion (1) is provided with a urethra coating body (2) along the extension direction of the urethra; the material of the urethra coating body (2) is the same as that of the flexible non-magnetic base body (1.1).

5. The implantable flexible magnetically controlled bladder compression device of claim 4, wherein: the urethra coating body (2) comprises a first half stem pipe (2.1), a second half stem pipe (2.2), a first stem pipe extending part (2.3) and a second stem pipe extending part (2.4), and the first half stem pipe (2.1) and the second half stem pipe (2.2) are formed in an extending mode along the axial direction of the urethra;

the first and second stalk canal extensions (2.3, 2.4) are arranged on both sides of the first or second half-stalk canal (2.1, 2.2) and formed in a way of extending along the circumferential direction of the urethra; the first (2.3) and second (2.4) stem extension are butted for wrapping the urethra;

the first and second stalk extension parts (2.3, 2.4) are sewed by medical suture after being wrapped on the urethra.

6. The implantable flexible magnetically controlled bladder compression device according to claim 1, 2 or 3, wherein: an incision (3) is formed in the flexible magnetic control inclusion (1), the incision (3) is used for conveying the bladder into the flexible magnetic control inclusion (1), and at least one end of the incision (3) is provided with a ureter hole (4); the bladder is sewn through medical suture after being sent into the flexible magnetic control inclusion body (1) through the incision (3).

7. The implantable flexible magnetically controlled bladder compression device according to claim 1, 2 or 3, wherein: the flexible non-magnetic substrate (1.1) is provided with a front-surface extrusion part (1.11) and a back-surface positioning part (1.12), the front-surface extrusion part (1.11) of the flexible non-magnetic substrate (1.1) is close to the peritoneum, and the back-surface positioning part (1.12) of the flexible magnetic control inclusion body (1) is close to the pubis;

the ferromagnetic complex (1.2) comprises a plurality of first magnetic strips (1.21), and the first magnetic strips (1.21) are arranged on the front surface extrusion part (1.11) of the flexible non-magnetic base body (1.1) at intervals.

8. The implantable flexible magnetically controlled bladder compression device of claim 7, wherein: the ferromagnetic complex (1.2) further comprises a plurality of second magnetic strips (1.22), and the second magnetic strips (1.22) are arranged on two sides of the back positioning part (1.12) of the flexible nonmagnetic matrix (1.1) at intervals.

9. The implantable flexible magnetically controlled bladder compression device of claim 1, wherein: the flexible magnetic control inclusion body fixing device is characterized by further comprising a fixing assembly, wherein the fixing assembly comprises a plurality of operation net belts (5) used for fixing the flexible magnetic control inclusion body (1).

10. The implantable flexible magnetically controlled bladder compression device of claim 9, wherein: one end of the operation mesh belt (5) is embedded into the flexible magnetic control inclusion body (1) and fixed with the flexible magnetic control inclusion body, and the other end of the operation mesh belt (5) is fixed by penetrating through the fascia at the pelvic floor at two sides, so that the flexible magnetic control inclusion body (1) is stably sleeved on the bladder.

Technical Field

The invention belongs to the technical field of medical devices, and particularly relates to an implanted flexible magnetic control bladder extrusion device.

Background

The rapid development of soft robots for biomedical applications aims to improve medical conditions and provide novel therapeutic tools, such as surgical instruments, body simulation and drug delivery. As an active system with high compliance and biocompatibility, the soft body robot has a wide prospect in assisting the movement of organs and even reconstructing the organs. There have been attempts to use soft robots in prosthetic aids to address various diseased muscles, such as the myocardium, hand muscles, and sphincters.

Low bladder activity (UAB) is characterized by prolonged urination time and difficulty in urination due to muscle weakness (DU), leading to serious complications and even death. The incidence of UAB is high due to aging, nervous system diseases, trauma or diabetes, wherein male is 9-48%, and female is 12-45% for old people over 70 years old. Nerve-based therapies, represented by neuromodulation (SNM), have shown potential for treating UAB and OAB (overactive bladder). However, a complete micturition reflex arc is essential to achieve the clinical efficacy of SNM. This indicates that the device is not suitable for patients with sacral or pudendal nerve injury and dysfunction of the detrusor muscle itself.

Unlike current treatment approaches, increasing the force of detrusor contraction is the most direct and fundamental solution to voiding the bladder. Attempts have been made to restore detrusor contractile capacity through regenerative medical strategies (e.g., muscle transplantation and stem cell injection). However, these methods only partially restore the urine storage function of the bladder, and the risk-to-benefit ratio remains to be further evaluated in a wider range of UAB/DU patients.

At present, the urinary bladder urination dysfunction caused by DU cannot be solved by adopting methods such as medicines, electrical stimulation, operation, body nerve reflex treatment and the like or by adopting auxiliary urination measures such as abdominal pressure, drainage, diversion and the like, and is one of the well-recognized problems in the medical field. How to effectively solve the difficult urination caused by detrusor contraction disorder is a problem which needs to be solved urgently by the technical personnel in the field at present.

Several solutions for directly pressing the bladder based on a contact type hydraulic system directly implanted by a soft robot are proposed in the prior art, and are named as Endoskeleton/artificial detrusor muscle. These intravesical pressure maintenance system driving forces are mainly derived from thermally responsive gels or shape memory alloys, intended to encapsulate the bladder and physically contract in response to stimuli. Previous research results show that the mechanical strategies effectively increase the intravesical pressure and improve the problem of low bladder power. Despite the encouraging results, existing artificial detrusor muscles provide limited hydraulic pressure, far from human muscle levels, due to the relatively inefficient operation of the excitation source. In addition, current soft bladder assisted robotic systems do not enable reliable long-term functionality due to lack of realistic medical design and optimization of biological safety.

Disclosure of Invention

The invention aims to provide an implanted flexible magnetic control bladder extrusion device which can solve the difficult urination caused by UAB/DU, and can realize the function of normal urination by the large moment of magnetic force exerted by an external magnetic field under the condition of not connecting any extra external pipeline after the extrusion device is implanted through operation.

In order to achieve the aim, the invention designs an implanted flexible magnetically controlled bladder extrusion device, which comprises a flexible magnetically controlled inclusion body used for wrapping a bladder; the flexible magnetic control inclusion comprises a flexible non-magnetic base body and a ferromagnetic complex, and the ferromagnetic complex is arranged on the outer surface of the flexible non-magnetic base body;

the flexible non-magnetic substrate is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and a brightening agent; the ferromagnetic complex is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and magnetic particles.

Further, the volume ratio of the organic silica gel to the polydimethylsiloxane resin in the flexible non-magnetic matrix is (4-10): 1; the brightening agent accounts for 2-4% of the flexible non-magnetic matrix by weight;

the volume ratio of the organic silica gel to the polydimethylsiloxane resin in the ferromagnetic complex is (4-10): 1; the volume fraction of the magnetic particles in the ferromagnetic composite body is 20-65%.

Further, the magnetic particles are any one or combination of NdFeB, Fe and FeC; the magnetic particles are uniformly magnetized in a pulse magnetic field with the magnetic induction intensity of 3-10T.

Further, the flexible magnetic control inclusion body is provided with a urethra coating body along the urethra extending direction; the material of the urethra coating body is the same as that of the flexible non-magnetic base body.

Further, the urethra coating body comprises a first half stem pipe, a second half stem pipe, a first stem pipe extending part and a second stem pipe extending part, and the first half stem pipe and the second half stem pipe are formed by extending along the axial direction of the urethra;

the first and second stalk tube extensions are disposed on both sides of the first or second half-stalk tube and formed to extend in a circumferential direction of the urethra; the first and second stem extension portions are butted and then used for wrapping the urethra;

the first and second stalk extension portions are wrapped around the urethra and then sutured together with a medical suture.

Furthermore, an incision is arranged on the flexible magnetic control inclusion body and used for conveying the bladder into the flexible magnetic control inclusion body, and at least one end of the incision is provided with a ureter hole; the bladder is sewn through medical suture after being sent into the flexible magnetic control inclusion body through the incision.

Furthermore, the flexible non-magnetic base body is provided with a front-surface extrusion part and a back-surface positioning part, the front-surface extrusion part of the flexible non-magnetic base body is close to the peritoneum, and the back-surface positioning part of the flexible magnetic control inclusion body is close to the pubic bone;

the ferromagnetic complex comprises a plurality of first magnetic strips, and the first magnetic strips are arranged at the front side extrusion part of the flexible nonmagnetic matrix at intervals.

Furthermore, the ferromagnetic complex further comprises a plurality of second magnetic strips, and the plurality of second magnetic strips are arranged on two sides of the back positioning part of the flexible nonmagnetic matrix at intervals.

Still further, the implanted flexible magnetically controlled bladder pressing device further comprises a fixing assembly, and the fixing assembly comprises a plurality of surgical mesh belts for fixing the flexible magnetically controlled inclusion.

Furthermore, one end of the operation mesh belt is embedded into the flexible magnetic control inclusion body and fixed with the flexible magnetic control inclusion body, and the other end of the operation mesh belt is fixed by penetrating through the pelvic floor fascia on two sides, so that the flexible magnetic control inclusion body is stably sleeved on the bladder.

Compared with the prior art, the invention has the following advantages:

firstly, the implanted flexible magnetic control bladder extrusion device can play a role of an artificial detrusor, and when the device is used, the flexible magnetic control bladder extrusion device is sleeved on a bladder with weak detrusor contraction, so that the bladder is extruded and emptied in a contact manner;

secondly, the implanted flexible magnetic control bladder extrusion device arranges the ferromagnetic complexes into a flexible non-magnetic matrix frame conformal with the filled bladder, thereby forming a flexible magnetic response bladder pump. At the same time, each magnetic particle is uniformly magnetized, so that the magnetic particles press the filled bladder under the gradient magnetic field generated by the permanent magnet to resist the resistance of the sphincter, and then the urination function of the disabled bladder is reconstructed.

Thirdly, the implanted flexible magnetic control bladder extrusion device has the design of a flexible non-magnetic substrate, so that the flexible magnetic control bladder extrusion device has good biocompatibility. And ferromagnetic composites have a higher modulus and higher density than natural human organs.

Fourthly, after the flexible magnetic control bladder squeezing device is implanted through an operation, the normal urination function can be realized through the large moment of the magnetic force exerted by the external magnetic field under the condition of not connecting any extra external pipeline. The control of the magnetic field does not bring additional harm to the body of the patient, and can provide larger moment; the implantation part is made of light and thin soft materials without redundant parts, and is directly fixed on the outer surface of the bladder in a surgical suture mode, so that the phenomenon of sliding and foreign body sensation generation cannot occur, and discomfort is caused.

Fifthly, the adopted flexible non-magnetic substrate is a high polymer material with good biocompatibility, and the health of a user is not influenced; due to the structural design of the centripetal movement tendency and the flexibility of the magnetic domain distribution design of the hard magnetic particles, the requirements of different patients can be met, and the effect of completely emptying urine is achieved; because the implanted extrusion device does not need to be supplied with energy internally, the implanted extrusion device can be permanently placed in a patient body after an operation, so that the implanted extrusion device can be used for the whole life after being implanted once, the economic burden of a patient is reduced, and the risk of a secondary operation is reduced.

Drawings

FIG. 1 is a schematic structural view of an implantable flexible magnetically controlled bladder compression device;

FIG. 2 is another schematic view of the implanted flexible magnetically controlled bladder compression device shown in FIG. 1;

FIG. 3 is a partial structural view of the incision suture of the implanted flexible magnetically controlled bladder compression device of the present invention;

FIG. 4 is a partial structure diagram of the suture of the urethral capsule of the implanted flexible magnetic control bladder squeezing device of the invention;

FIG. 5 is a schematic view of the placement of an implantable flexible magnetically controlled bladder compression device within a living being;

FIG. 6 is a schematic view of the urination state of an implanted flexible magnetically controlled bladder pressing device under the action of an external magnetic field;

in the figure: the urethral catheter comprises a flexible magnetic control inclusion 1 (a flexible non-magnetic base body 1.1, a front extrusion part 1.11, a back positioning part 1.12, a ferromagnetic complex 1.2, a first magnetic strip 1.21 and a second magnetic strip 1.22), a urethral coating 2 (a first half stem tube 2.1, a second half stem tube 2.2, a first stem tube extension part 2.3 and a second stem tube extension part 2.4), an incision 3, a ureter hole 4, a surgical mesh belt 5, a bladder 6, a urethra 7, a ureter 8, a peritoneum 9, a pubic bone 10, a sphincter 11 and an external magnetic field 12.

Detailed Description

The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. The described embodiments are only some embodiments of the invention, not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

An implantable flexible magnetically controlled bladder squeezing device as shown in fig. 1 and 2 comprises a flexible magnetically controlled inclusion 1 for wrapping a bladder 6, wherein the flexible magnetically controlled inclusion 1 is provided with a urethra coating body 2 along the extension direction of a urethra 7; the flexible magnetic control inclusion 1 is provided with an incision 3, the incision 3 is used for conveying the bladder into the flexible magnetic control inclusion 1, and at least one end of the incision 3 is provided with a ureter hole 4 for a ureter 8 to pass through. The flexible magnetic control inclusion 1 comprises a flexible non-magnetic base body 1.1 and a ferromagnetic complex 1.2, and the ferromagnetic complex 1.2 is arranged on the outer surface of the flexible non-magnetic base body 1.1. The flexible non-magnetic substrate is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and a brightening agent; the ferromagnetic complex is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and magnetic particles. The volume ratio of the organic silica gel to the polydimethylsiloxane resin in the flexible non-magnetic matrix is (4-10): 1; the brightening agent accounts for 2-4% of the flexible non-magnetic matrix by weight; the volume ratio of the organic silica gel to the polydimethylsiloxane resin in the ferromagnetic complex is (4-10): 1; the volume fraction of the magnetic particles in the ferromagnetic composite body is 20-65%. The magnetic particles are any one or combination of more of NdFeB, Fe and FeC; the magnetic particles are uniformly magnetized in a pulse magnetic field with the magnetic induction intensity of 3-10T.

In the technical scheme, the flexible non-magnetic base body 1.1 is provided with a front-surface extrusion part 1.11 and a back-surface positioning part 1.12, the front-surface extrusion part 1.11 of the flexible non-magnetic base body 1.1 is close to the peritoneum 9, and the back-surface positioning part 1.12 of the flexible magnetic control inclusion body 1 is close to the pubis 10; the ferromagnetic complex 1.2 comprises a plurality of first magnetic strips 1.21, and the plurality of first magnetic strips 1.21 are arranged at intervals on the front surface extrusion part 1.11 of the flexible nonmagnetic matrix 1.1. The ferromagnetic complex 1.2 further comprises a plurality of second magnetic strips 1.22, and the plurality of second magnetic strips 1.22 are arranged at two sides of the back positioning part 1.12 of the flexible nonmagnetic matrix 1.1 at intervals.

As shown in fig. 2, the urethral coating 2 includes a first half stem tube 2.1 and a second half stem tube 2.2, and the first half stem tube 2.1 and the second half stem tube 2.2 are formed to extend axially along the urethra. The urethral coating 2 further comprises a first 2.3 and a second 2.4 stalk extension; a first 2.3 and a second 2.4 stem extension are provided on both sides of the first 2.1 or second 2.2 half-stem in a circumferentially extending formation of the urethra; the first 2.3 and second 2.4 stem extensions are docked for wrapping around the urethra. The incision 3 is sewed by medical suture after the bladder is sent into the flexible magnetic control inclusion body 1. The first 2.3 and second 2.4 stalk extensions are sutured with medical sutures after wrapping around the urethra.

In the above technical solution, the implanted flexible magnetically controlled bladder squeezing device of this embodiment further includes a fixing component, and the fixing component includes a plurality of surgical mesh belts 5 for fixing the flexible magnetically controlled inclusion 1. One end of the operation net belt 5 is embedded into the flexible magnetic control inclusion 1 and fixed with the flexible magnetic control inclusion, and the other end of the operation net belt 5 is fixed by penetrating through the fascia at the pelvic floor at two sides, so that the flexible magnetic control inclusion 1 is stably sleeved on the bladder.

In order to more clearly illustrate the structure of the implanted flexible magnetically controlled bladder squeezing device of the present invention, the following description is provided.

In the natural bladder, the complex process of urination is innervated and accomplished by coordinated movement of the detrusor and sphincter 11. UAB patients undergo a series of morphological and urodynamic changes due to reduced detrusor contractility compared to normal bladder. Unlike other visceral structures, urination is voluntarily controlled and dependent on learning behavior.

When the bladder 6 is full of urine, the relevant information is transmitted to the higher-level micturition center of the brain through afferent nerves and ascending fibers along the spinal cord, and the human body can feel the sense of urination. Subsequently, a signal relating to urination is transmitted through the spinal cord to the sacral medullary lower urinary center, the detrusor muscle under sacral innervation contracts, and the sphincter 11 relaxes, causing urination. Inspired by the working mode of the natural bladder 6, we propose an implanted flexible magnetically controlled bladder compression device consisting of a magnetically responsive chamber that compresses the bladder 6 under the action of an external magnetic field. The magnetically controlled bladder compression device is composed of a polymer embedded with uniformly magnetized ferromagnetic particles. Due to the embedded permanent magnetic particles and their interaction, the ferromagnetic particulate polymer has a higher modulus and a higher density than natural human organs. The implanted flexible magnetic control bladder extrusion device optimizes the mechanical property of ferromagnetic materials, optimizes the light structure of the artificial bladder and is very important for eliminating the influence of physiological activities.

As shown in fig. 5 and 6, the device design takes into full consideration the bladder 6 and surrounding anatomy and voiding function in order to integrally conform to the bladder 6. Referring to the attached drawings 1 and 2, the implanted flexible magnetic control bladder extrusion device provided by the invention is a flexible magnetic control inclusion 1 formed by combining a flexible non-magnetic substrate 1.1 and a ferromagnetic complex 1.2; the implanted flexible magnetic control bladder extrusion device is adapted to the shape of the inflated bladder 6, and a movable cavity wrapping the bladder 6 is arranged in the implanted flexible magnetic control bladder extrusion device.

The flexible non-magnetic matrix 1.1 and the ferromagnetic composite body are both sheet materials with the thickness not exceeding 4mm, and the capacity of the flexible magnetic control inclusion body 1 is about 500 ml so as to meet the requirement of storing urine during storage, and ensure that the bladder 6 can store enough volume without increasing the internal pressure of the bladder 6; the internal pressures of the natural bladder 6 with and without water injection were compared by experiments, thereby verifying that the storage capacity of the natural bladder 6 is not affected by the non-operation state of the compressing device. The flexible magnetic control inclusion 1 provides enough space for the bladder 6 to be inflated, and can press the bladder 6 under the gradient field of the applied external magnetic field 12.

The flexible non-magnetic substrate 1.1 is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and a brightening agent, wherein the volume ratio of the organic silica gel to the polydimethylsiloxane resin is 4-10: 1, the weight percentage of the brightening agent to the flexible non-magnetic matrix 1.1 is 2-4%. The organic silica gel is platinum curing silica gel Ecoflex 00-30 which is a two-component material, and the volume ratio of the component A to the component B of the platinum curing silica gel Ecoflex 00-30 is 1: 1. Polydimethylsiloxane resin PDMS resin is model number Sylgard 184. The volume ratio of the organic silica gel to the polydimethylsiloxane resin is 9: 1, the weight percentage of the brightening agent to the flexible non-magnetic matrix 1.1 is 2.5%.

The ferromagnetic complex is prepared by thermoplastic curing of organic silica gel, polydimethylsiloxane resin and magnetic particles, and the volume ratio of the organic silica gel to the polydimethylsiloxane resin is 4-10: 1, as a preferred embodiment, the organic silica gel is platinum-gold cured silica gel Ecoflex 00-30 which is a two-component material, and the volume ratio of the component A to the component B of the platinum-gold cured silica gel Ecoflex 00-30 is 1: 1. The model of polydimethylsiloxane resin PDMS resin is Sylgard 184; the volume ratio of the organic silica gel to the polydimethylsiloxane resin is 9: 1. the volume fraction of the magnetic particles in the ferromagnetic composite body is 55-65%.

The magnetic particles are any one or combination of more of NdFeB, Fe and FeC; the magnetic particles are uniformly magnetized in a pulse magnetic field with the magnetic induction intensity of 3-10T. The flexible non-magnetic substrate 1.1 and the ferromagnetic complex are combined into a flexible magnetic control inclusion 1 in a thermoplastic curing mode.

An incision 3 is formed at the position of the flexible magnetic control inclusion 1 corresponding to the position of the bladder 6 connected with the urethra and the ureter, and the bladder 6 is sent into the movable cavity of the flexible magnetic control inclusion 1 from the incision 3 through an operation; two ureter holes 4 are formed in the position, corresponding to the ureter 8, of the flexible magnetic control inclusion 1, and the two ureter holes 4 are located at two ends of the cut 3.

The flexible magnetic control inclusion 1 is extended with a urethra inclusion 2 corresponding to the urethra, the material of the urethra inclusion 2 is the same as that of the flexible non-magnetic matrix 1.1, and the length of the urethra inclusion 2 can be designed to be equal to that of the urethra. The design of the urethra coating body 2 can prevent the bladder 6 from sliding out of the movable cavity of the flexible magnetic control inclusion body 1, and meanwhile, the flexible magnetic control inclusion body 1 can be conveniently fixed on the pelvis.

The urethral coating body 2 includes: a first half stem tube 2.1, a second half stem tube 2.2, a first stem tube extension 2.3 and a second stem tube extension 2.4, the first half stem tube 2.1 and the second half stem tube 2.2 are formed by extending a flexible non-magnetic substrate 1.1 axially along the urethra; the first half stem pipe 2.1 and the second half stem pipe 2.2 are butted to form a stem pipe capable of wrapping the urethra; the first and second stem tube extensions 2.3, 2.4 are formed by the first half-stem tube 2.1 extending in the circumferential direction of the urethra, or the first and second stem tube extensions 2.3, 2.4 are formed by the second half-stem tube 2.2 extending in the circumferential direction of the urethra, and the first and second stem tube extensions 2.3, 2.4 can wrap the stem tube after being butted.

As shown in fig. 3 and 4, after the bladder 6 is placed in the active cavity of the flexible magnetic control inclusion body 1, the incision 3 between the ureteral orifice 4 and the urethra inclusion body 2 is sewed through a medical suture; the first and second stalk canal extensions 2.3 and 2.4 are sutured by medical suture, so that the flexible magnetic control inclusion 1 can wrap and fix the bladder 6.

The flexible magnetic control inclusion 1 is divided into a front extrusion part and a back positioning part, the front extrusion part is close to the peritoneum 9 of the organism, and the back positioning part is close to the pubis 10 of the organism; the ferromagnetic composite body comprises a plurality of first magnetic strips 1.21, and the plurality of first magnetic strips 1.21 are arranged in the front pressing part at intervals side by side. In the urination process, the front-surface extrusion part is close to the back-surface positioning part under the action of the external magnetic field 12 to form a pressing effect, and the function of a detrusor is achieved.

The ferromagnetic complex body further comprises a plurality of second magnetic strips 1.22, and the plurality of second magnetic strips 1.22 are distributed on two sides of the back positioning part at intervals side by side. The back positioning part of the flexible magnetic control inclusion 1 is provided with a plurality of second magnetic strips 1.22, the back positioning part is tightly attached to the pubis 10 under the action of the external magnetic field 12, free sliding of the front extrusion part of the flexible magnetic control inclusion 1 in the pressing process can be effectively prevented, and the stability of the action of extruding the bladder 6 is guaranteed.

The implanted flexible magnetically controlled bladder squeezing device of the embodiment further comprises fixing components, wherein the fixing components are 3 pairs of operation mesh belts which are respectively arranged on the flexible magnetically controlled inclusion body 1; one end of each operation net belt is embedded into a flexible non-magnetic matrix 1.1 and fixed into a whole through physical bonding, and the other end of each operation net belt is fixed on the organism by penetrating through pelvic floor fascia on two sides of the organism, so that the flexible magnetic control inclusion 1 is stably sleeved on the bladder 6 of the organism.

One end of each operation mesh belt is embedded into the flexible non-magnetic matrix 1.1 to form physical combination, and the obtained adhesion force is represented by tensile force in a tensile test of the materials of the operation mesh belts and the flexible non-magnetic matrix 1.1. The measurements show that the fracture occurs in the flexible non-magnetic matrix 1.1 material part instead of the surgical mesh tape or the composite part of both, which indicates that the physical bond is sufficiently strong and that the strength of the combination of the surgical mesh tape and the flexible non-magnetic matrix 1.1 is determined by the flexible non-magnetic matrix 1.1 material itself. A simplified finite element model is constructed by using ABAQUS to research stress distribution and damage, and simulation result analysis is as follows: at the junction between the surgical mesh and the flexible non-magnetic matrix 1.1, some stress concentration zones were present, where the maximum stress was at least 10 times lower than the failure stress of the flexible non-magnetic matrix 1.1, so finite element analysis results showed that the stress distribution was still within the safe range of failure.

The implanted flexible magnetic control bladder extrusion device can play a role of an artificial detrusor through a ferromagnetic complex composed of organic silica gel, polydimethylsiloxane resin and magnetic particles, so that a flexible magnetic response bladder pump can perform contact extrusion to empty a bladder 6; the ferromagnetic complexes are arranged in a frame of a flexible non-magnetic matrix 1.1 conformal to the filled bladder to form a flexible magnetic control inclusion 1, and each magnetic particle is uniformly magnetized, so that the filled bladder 6 is pressed under a gradient magnetic field generated by an external applied magnetic field permanent magnet to resist the resistance of a sphincter, and then the urination function of the disabled bladder 6 is reconstructed. The externally applied magnetic field is lower than the magnetization field intensity of the hard magnetic particles, and can be a natural magnet or an electromagnet, and when the externally applied magnetic field is placed at a set position, the squeezing device squeezes the bladder 6 to urinate. The flexible non-magnetic matrix 1.1 is designed, so that the flexible magnetic control bladder extrusion device has good biocompatibility, and compared with natural human organs, the ferromagnetic complex has higher modulus and higher density.

After the patient is implanted with the flexible magnetic control bladder squeezing device through an operation, the normal urination function can be realized through the large moment of the magnetic force exerted by the external magnetic field 12 under the condition of not connecting any extra external pipeline. The control of the magnetic field does not bring additional harm to the body of the patient, and can provide larger torque; meanwhile, the implanted part is made of light and thin soft material, has no redundant parts, is directly sleeved on the outer surface of the bladder 6 through sewing, and cannot generate foreign body sensation and slide to cause discomfort; the adopted flexible non-magnetic matrix 1.1 is a high polymer material with good biocompatibility, and the health of a user is not influenced; due to the structural design of the centripetal movement tendency and the flexibility of the magnetic domain distribution design of the hard magnetic particles, the requirements of different patients can be met, and the effect of completely emptying urine is achieved; because the implanted extrusion device does not need to be internally powered, the implanted extrusion device can be permanently placed in a patient body after an operation, so that the implanted extrusion device can be used for the whole life after one-time implantation, and the economic burden and the operation risk of a patient are reduced.

The above description is only an embodiment of the present invention, and it should be noted that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the protection scope of the present invention, and the rest that is not described in detail is the prior art.