WO2023226874A1

WO2023226874A1 - Implantable control device

Info

Publication number: WO2023226874A1
Application number: PCT/CN2023/095063
Authority: WO
Inventors: 张子涵; 陈佳; 薛文俊; 刘智勇
Original assignee: 上海康路联医疗科技有限公司
Priority date: 2022-05-23
Filing date: 2023-05-18
Publication date: 2023-11-30
Also published as: CN218165445U

Abstract

The present application discloses an implantable control device, comprising a flexible channel holding member, a flexible channel interference unit, a closed interference space, and a control unit. The flexible channel holding member is configured for securing the control device to a flexible channel. The closed interference space comprises the flexible channel interference unit. The flexible channel interference unit is arranged on the flexible channel holding member. The control unit is connected with the interference space to control the switch of the interference space between a protrusion state and a contraction state. In the protrusion state, the interference space is in contact with the flexible channel and can thus hold the flexible channel together with the flexible channel holding member, so as to displace the flexible channel for liquid control. The present application can reduce the onset of diseases due to mechanical faults, and avoid long-term compression of the flexible channel.

Description

an implantable control device

This application claims priority to the Chinese patent application submitted to the China Patent Office on May 23, 2022, with the application number: 202221359474.1 and the application title "An implantable control device", the entire content of which is incorporated into this application by reference. .

Technical field

The utility model relates to the technical field of medical devices, and in particular to an implantable control device.

Background technique

Surgical options for patients with mild or moderate stress urinary incontinence include an implantable sling technology. This type of device usually consists of a urethral restraint device and a urethral fixation device. In practical applications, due to the excessive size of the fluid sac, there is a problem during the operation. It is difficult to ideally adjust the elasticity of the urethral restraint device, which may cause the urethra to be too tight and cause difficulty in urination (urinary retention). At the same time, due to the complex fixation method and cumbersome surgical steps, puncture of the pubic area is required during the operation to remove the sling. It is fixed on the urethra, and the operation time is long, which leads to large surgical trauma, numbness or pain in the perineum and scrotum, and perineal wound infection. And relevant literature shows that the durability of this implantable sling technology will be reduced to about 85% after it is implanted for more than three years, and will decrease every year in the future, which may lead to the patient’s implantation being Shortly after inserting this sling, another repair surgery is required. For the patient, the surgical trauma will increase and the probability of complications will also increase.

Surgical options for patients with severe stress urinary incontinence include an implanted artificial sphincter technology. Such devices usually consist of a urethral restraint device, a switch device, a connecting device, etc. In practical applications, there is a tightness adjustment due to intraoperative urethral restraints. It is difficult to idealize and may cause the urethra to be restrained too tightly, causing difficulty in urination (urinary retention). If the urethral restraint device is loose, urine leakage problems (urinary incontinence) will still occur. This product has the characteristics of circumferentially wrapping the urethra, which can prevent urination for a long time. Compression of the urethra can easily lead to complications such as insufficient urethral blood supply, urethral atrophy, infection, and urethral erosion, which can lead to complications such as product mechanical failure. The biggest problem with this type of device is the high level of mechanical failure. 60% of patients require secondary repair surgery. The average service life of this product is about 7 years.

Utility model content

The purpose of the utility model is to solve the problem of urinary control for patients with urinary incontinence. The utility model provides an implantable control device, which can reduce the incidence rate caused by mechanical failure and avoid long-term compression of the urethra.

In order to solve the above technical problems, an embodiment of the present invention discloses an implantable control device, which includes: a flexible channel restraint assembly, a flexible channel interference element, a closed interference space, and a control member; wherein, the flexible channel restraint assembly is When the control device is fixed on the flexible channel; the closed interference space includes the flexible channel interference element, the flexible channel interference element is provided in the flexible channel restraint component, the control member and the interference space Connected to control the interference space to switch between a raised state and a contracted state; wherein, in the raised state, the interference space can contact the flexible channel and jointly fix the flexible channel with the flexible channel binding assembly channel to cause displacement of the flexible channel to control liquid.

Using the above technical solution, fluid control for male urinary incontinence patients can be achieved by causing displacement and bending of the flexible channel. The fluid-type flexible channel interference element can reduce the incidence rate caused by mechanical failure; the multi-point contact method causes the displacement of a section of the flexible channel to avoid long-term compression of the flexible channel. It can effectively reduce surgical trauma and reduce the contact area between the implant material and the flexible channel, thereby reducing the probability of atrophy or infection of the flexible channel.

According to another specific embodiment of the present invention, the embodiment of the present invention discloses an implantable control device. In the raised state, the interference space causes the flexible channel to generate displacement for liquid drainage and liquid control.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device. In the raised state, the interference space causes the flexible channel to generate displacement for liquid control; in the In the contracted state or in the process of the interference space switching from the raised state to the contracted state, the interference space causes the flexible channel to displace for liquid discharge.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device. The flexible channel restraint assembly includes a connecting base plate. An interference cavity is provided inside the connecting base plate. The flexible channel restraint assembly includes an interference cavity. The channel interference element includes a layer of flexible material covering the outside of the connection bottom plate and forming the closed interference space with the interference cavity. The flexible material is used to contact the flexible channel.

According to another specific embodiment of the present invention, an embodiment of the present invention discloses an implantable control device. The bottom of the interference cavity is provided with a soft material, and the soft material is lined with an interlayer.

According to another specific embodiment of the present invention, an embodiment of the present invention discloses an implantable control device, and the interlayer includes a polyester woven mesh.

According to another specific embodiment of the present invention, an embodiment of the present invention discloses an implantable control device, the flexible material includes a biocompatible material.

According to another specific embodiment of the present invention, the embodiment of the present invention discloses an implantable control device, and the biocompatible material includes any one of silicone, PET, and PU.

According to another specific embodiment of the present invention, an embodiment of the present invention discloses an implantable control device, and the biocompatible material includes TPU.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device. The control member is used to apply an external force to the interference space to control the bulge state and the state of the interference space. When switching between contraction states, the external force acts indirectly on the flexible channel through the interference space, causing the flexible channel to generate displacement.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device, the magnitude of the external force is proportional to the bulge degree of the interference space.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device, the bulge degree is the distance from the highest point of the interference space to the connecting bottom plate of the flexible channel restraint assembly. .

According to another specific embodiment of the present invention, an embodiment of the present invention discloses an implantable control device, which applies the external force to the interference space by injecting fluid into the interference space.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device. The implantable control device further includes a connecting piece, and both ends of the connecting piece are connected to the control piece respectively. It is connected to the interference space for transmitting fluid.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device. The control part includes: an injection interface; the injection interface is connected to the connecting piece for connecting the The fluid is injected into the interference space through the connecting piece, causing the interference space to switch from the contracted state to the raised state.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device. The control member further includes a switch, a first channel and a second channel; and the switch includes: a storage device. Liquid bladder and hydraulic pump, the switch can be switched between the first position and the second position, the liquid storage bladder is used to store the fluid and is connected to the hydraulic pump; the first channel includes a first one-way valve, in the first position, the fluid in the reservoir bag flows into the interference space through the first one-way valve through the hydraulic pump; the second channel includes a second one-way valve, In the second position, the fluid in the interference space flows back to the reservoir via the second one-way valve through the hydraulic pump.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device. A hydraulic rod is provided in the interference space, and the hydraulic rod presses the interference space to achieve The external force is applied to the interference space.

According to another specific embodiment of the present invention, an embodiment of the present invention discloses an implantable control device, and the number of the enclosed interference spaces includes multiple.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device. Along the extending direction of the flexible channel, the connecting bottom plate is provided with at least two flexible channel fixing elements. The flexible channel fixing element is used to be fixed on the flexible channel.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device, the flexible channel restraint assembly includes a connecting bottom plate, the flexible channel fixing element includes a hook structure, and the hook structure It includes a hook end and a fixed end, the fixed end of the hook structure is fixed on the connecting bottom plate, and the hook end of the hook structure is used to hang on the flexible channel.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device, the flexible channel restraint assembly includes a connecting bottom plate, the flexible channel fixing element includes a loop rope structure, and the loop The rope structure includes an open end and a fixed end. The fixed end of the loop rope structure is fixed to the connecting bottom plate. The open end of the loop rope structure is used to be wound across the flexible channel and sewn to be fixed to the connecting bottom plate.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device, the flexible channel restraint assembly includes a connecting bottom plate, the flexible channel fixing element includes a columnar structure, and the columnar structure It includes a vertical section and a curved section, the vertical section is perpendicular to the connecting base plate, the curved section includes a plane facing the connecting base plate, and the plane is used to contact the flexible channel.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device, which includes two rows of flexible channel fixing elements along the extending direction of the flexible channel, and each row includes two columnar structures. .

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device, the flexible channel restraint assembly further includes a suture ear, and the suture ear is provided on the connecting base plate, It is used to position the connecting bottom plate on the tissue surrounding the flexible channel, and to limit the displacement of the connecting bottom plate relative to the tissue surrounding the flexible channel.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device, the flexible channel fixing element includes a flexible channel contact surface and a non-contact surface; the flexible channel non-contact surface The forming material includes any one of peek, ptfe, pe and pom, used to maintain the shape of the flexible channel fixing element; the forming material of the flexible channel contact surface includes any one of silica gel and polyurethane, used to reduce the Erosion of the flexible channel.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device. The connecting piece is an inelastic, non-deformable connecting channel made of silicone material.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device. The flexible channel restraint assembly includes a connecting bottom plate, and the connecting bottom plate is provided in a cavity, and the display Flexible communication The channel interference element includes a cavity that forms the closed interference space, and the cavity is placed in the cavity of the connecting base plate.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device. The connecting bottom plate further includes a pipeline. Along the extending direction of the flexible channel, the pipeline is provided on the Attach one side of the base plate.

According to another specific embodiment of the present utility model, an embodiment of the present utility model discloses an implantable control device. The implantable control device includes a connecting piece. One end of the connecting piece passes through the pipeline and is connected to the pipe. The interference space in the cavity is connected, and the other end of the connecting piece is connected to the control piece for transmitting fluid.

According to another specific embodiment of the present utility model, the embodiment of the present utility model discloses an implantable control device. Along the extension direction of the flexible channel, the cavity is provided with a control panel perpendicular to the extension direction of the flexible channel. A first L-shaped groove and a second L-shaped groove; a third L-shaped groove and a fourth L-shaped groove perpendicular to the extension direction of the flexible channel are provided outside the flexible channel interference element. The flexible channel restraint component is combined with the flexible channel interference element; the first L-shaped groove inside the cavity is fit with the third L-shaped groove outside the flexible channel interference element, and the third L-shaped groove inside the cavity is The two L-shaped grooves fit with the fourth L-shaped groove outside the flexible channel interference element.

Description of the drawings

Figure 1 shows a perspective view of an implantable control device according to an embodiment of the present invention.

Figure 2 shows a schematic diagram of the interference flexible channel of the implantable control device according to the embodiment of the present invention.

Figure 3a shows a side view of the interference space raised state of the implantable control device according to the embodiment of the present invention.

Figure 3b shows a side view of the interference space contracted state of the implantable control device according to the embodiment of the present invention.

Figure 4 shows a cross-sectional view of an implantable control device according to an embodiment of the present invention.

Figure 5 shows a perspective view of the implantable control device according to the embodiment of the present invention, in which the control element is a switch.

Figure 6 shows a schematic diagram of the control component of the implantable control device according to the embodiment of the present invention.

Figure 7 shows a cross-sectional view of the implantable control device according to the embodiment of the present invention, where the control component is a hydraulic rod.

FIG. 8 shows a perspective view of an implantable control device with multiple interference elements according to an embodiment of the present invention.

Figure 9 shows a perspective view of the flexible channel fixing element of the implantable control device in a hook structure according to the embodiment of the present invention.

Figure 10 shows a perspective view of the flexible channel fixing element of the implantable control device in the form of a loop rope structure according to the embodiment of the present invention.

Figure 11 shows a perspective view of the flexible channel fixing element of the implantable control device according to the embodiment of the present invention, which is a positioning post.

Figure 12a shows a perspective view of the flexible channel restraint assembly of the implantable control device according to the embodiment of the present invention.

Figure 12b shows a cross-sectional view of the flexible channel restraint assembly of the implantable control device according to the embodiment of the present invention.

Figure 13 shows a perspective view of the flexible channel interference element of the implantable control device according to the embodiment of the present invention.

Figure 14 shows a combined perspective view of the implantable control device according to the embodiment of the present invention.

Detailed ways

The implementation of the present invention is described below with specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. Although the description of the present utility model will be introduced in conjunction with the preferred embodiments, this does not mean that the features of the utility model are limited to this embodiment. On the contrary, the purpose of introducing the utility model in conjunction with the embodiments is to cover other options or modifications that may be extended based on the claims of the utility model. In order to provide a thorough understanding of the present invention, the following description contains many specific details. The invention may also be implemented without these details. Furthermore, some specific details will be omitted from the description in order to avoid confusing or obscuring the focus of the present invention. It should be noted that, as long as there is no conflict, the embodiments and features of the embodiments of the present invention can be combined with each other.

It should be noted that in this specification, similar reference numerals and letters represent similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be referenced in subsequent drawings. for further definition and explanation.

In the description of this embodiment, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "bottom", etc. is based on the orientation or positional relationship shown in the drawings, or The orientation or positional relationship in which the utility model product is customarily placed during use is only for the convenience of describing the utility model and simplifying the description, and does not indicate or imply that the device or component referred to must have a specific orientation, be constructed in a specific orientation, and operation, therefore it cannot be construed as a limitation of the present invention.

The terms "first", "second", etc. are used for descriptive purposes only and are not to be understood as indicating or implying relative importance.

In the description of this embodiment, it should also be noted that, unless otherwise clearly stated and limited, the terms "set", "connected" and "connected" should be understood in a broad sense. For example, it can be a fixed connection or a fixed connection. Detachable connection, or integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two components. For those of ordinary skill in the art, the specific meanings of the above terms in this embodiment can be understood in specific situations.

In order to make the purpose, technical solutions and advantages of the present utility model clearer, the embodiments of the present utility model will be further described in detail below with reference to the accompanying drawings.

Referring to Figure 1 , this application provides an implantable control device, including: a flexible channel restraint component 101, a flexible channel interference element 102, and a control member 103. 2, the flexible channel binding assembly 101 is used to fix the control device on the flexible channel 201. Continuing to refer to Figure 1, the flexible channel interference element 102 is provided on the flexible channel restraint component 101, And form a closed interference space 1021 with the flexible channel binding assembly 101. Furthermore, referring to Figures 3a and 3b, the interference space 1021 can be switched between a raised state (as shown in Figure 3a) and a contracted state (as shown in Figure 3b). When the interference space 1021 is in the contracted state, the flexible channel binding assembly 101 The flexible channel 201 is attached to the connecting bottom plate 1013 described later; when the interference space 1021 is in a raised state, the flexible channel 201 between the flexible channel binding components 101 is separated from the connecting bottom plate 1013 described later. Illustratively, the cross-section of the interference cavity 1022 is a polygon; however, the application is not limited thereto, and may also be a circle or other shapes.

Continuing to refer to Figures 1 and 2, the control member 103 is connected to the interference space 1021 and can control the interference space 1021 to switch between a raised state (shown in Figure 3a) and a contracted state (shown in Figure 3b). Specifically, the flexible channel binding assembly 101 cooperates with the interference space 1021 in two states to fix the flexible channel 201 and displace the flexible channel 201 in a multi-point contact method.

In the bulging state, the interference space 1021 can contact the flexible channel 201 and jointly fix the flexible channel 201 with the flexible channel binding assembly 101. The interference space 1021 generates bulging deformation in the direction in which the flexible channel 201 extends (as shown in the X direction in Figure 2). A multi-point contact method is used to provide pressure to the flexible channel 201, so that part of the flexible channel 201 located between the flexible channel binding components 101 is displaced by a certain distance (for example, the distance shown as h in Figure 3a) to control the liquid. Reduce the morbidity caused by mechanical failure and avoid long-term and large-area compression of flexible channels.

In some possible implementations, referring to Figure 3a, for patients with mild or moderate stress urinary incontinence, the doctor operates the control 103 to make the interference space 1021 in a raised state, and the interference space 1021 in the raised state applies pressure to the flexible channel 201 , part of the flexible channel 201 is in contact with the highest point of the bulge in the interference space 1021 (shown as point a in Figure 3a), and at the same time, the flexible channel 201 is displaced along the force direction (shown in the Y direction in Figure 2), and part of the flexible channel 201 is in contact with The connecting bottom plate 1013 is separated, and the flexible channel restraint assembly 101 fixes the flexible channel 201 with the control device. The flexible channel restraint assembly 101 generates pressure to the flexible channel 201 opposite to the displacement direction (shown in the direction a in Figure 2). The flexible channel binding component 101 and the interference space 1021 cooperate to cause the flexible channel 201 to displace a certain distance (the distance shown as h in Figure 3a) through multi-point contact for liquid drainage and liquid control.

For example, for patients with mild or moderate stress urinary incontinence, after the control device is implanted in the human body, the interference space 1021 of the present invention continues to maintain a raised state, except that the doctor needs to replenish fluids.

In some possible implementations, with reference to Figures 1 and 3a, for patients with severe stress urinary incontinence, the patient operates the control 103 to make the interference space 1021 in a raised state, and the interference space 1021 in the raised state cooperates with the flexible channel restraint assembly 101 Through multi-point contact, the displacement of a certain distance (the distance shown as h in Figure 3a) of the flexible channel 201 is controlled to prevent urine from being discharged through the flexible channel 201.

Referring to Figures 1 and 3b, the patient operates the control 103 to make the interference space 1021 in a contracted state or the interference space 1021 During the process of switching from the bulging state to the contracted state, the pressure exerted by the interference space 1021 on the flexible channel 201 disappears or gradually decreases, and the force that causes the flexible channel 201 to be displaced under pressure disappears or gradually decreases, so that the flexible channel 201 changes from a bulging state to a contracted state. A certain distance of the state displacement (distance shown as h in Figure 3a) returns to the original position of the flexible channel 201, that is, the extension direction of the flexible channel (shown in the X direction in Figure 2) for liquid drainage.

Illustratively, the flexible channel 201 can be discharged by returning to its original position; but the application is not limited thereto. When the interference space 1021 is in the process of switching from a raised state to a contracted state, the flexible channel 201 is subject to the pressure exerted by the interference space 1021 The liquid discharge behavior can be performed when the flexible channel 201 is displaced back to the original flexible channel direction (shown in the X direction in Figure 2).

It should be noted that when the interference space 1021 is in a contracted state, the flexible channel 201 is attached to the connecting bottom plate 1013, and the flexible channel 201 is in its original position, that is, the flexible channel extends along the length direction (as shown in the X direction in Figure 2). When the interference space 1021 is in a raised state, the interference space 1021 exerts pressure on the flexible channel 201, and part of the flexible channel 201 contacts the highest raised point of the interference space 1021 (shown as point a in Figure 3a). At the same time, the flexible channel 201 is generated along the force-bearing direction. Displacement (as shown in the Y direction in Figure 2), part of the flexible channel 201 is separated from the connecting bottom plate 1013.

In some possible implementations, referring to FIG. 1 , the flexible channel restraint assembly 101 includes a connecting bottom plate 1013. For example, the material of the connecting bottom plate 1013 is silicone; but the application is not limited thereto, and can also be other biocompatible materials. , such as polyurethane, etc.; referring to Figure 4, an interference cavity 1022 is provided inside the connection bottom plate 1013. The flexible channel interference element 102 is covered by a layer of flexible material outside the connection bottom plate 1013 and forms a closed interference space with the interference cavity 1022. The flexible material is used to contact the flexible channel 201. The flexible material switches between the bulging and shrinking states under the control of the control member 103, so that the flexible channel 201 is displaced to control and drain the liquid. Flexible materials can reduce erosion of flexible channels and reduce postoperative morbidity for patients. Illustratively, the flexible material is silica gel; however, the application is not limited thereto, and may also be other biocompatible materials, such as a mixture of one or more of PET, PU, and TPU, or a polymer.

In some possible implementations, referring to FIG. 4 , the bottom of the interference cavity 1022 is made of soft material, and the soft material is lined with an interlayer 1023 . The interlayer 1023 can be used to reduce the pressure caused by the interference space 1021 in the bulging state on the connection bottom plate 1013 . The deformation amount of the deformation; for example, the lining interlayer 1023 is a polyester woven mesh; but the application is not limited to this, and can also be other materials that can effectively reduce the deformation amount of the connecting bottom plate 1013.

In some possible implementations, referring to Figures 3a and 3b, the control member 103 is connected to the interference space 1021, and controls the application of an external force to the interference space 1021 to switch the interference space 1021 from a contracted state to a raised state, and controls the interference space. The external force received by 1021 disappears, causing the interference space 1021 to switch from a bulging state to a contracted state. As the external force increases, the interference space 1021 bulges higher, and as the external force decreases, the bulge decreases until the external force is applied. The external force in the interference space 1021 disappears, and its bulging degree is reduced to the minimum and reaches a contracted state.

Specifically, the external force acts on the interference space 1021, causing the interference space 1021 to bulge. The bulge of the interference space 1021 generates pressure on the flexible channel 201, so that the external force indirectly acts on the flexible channel 201, causing the flexible channel 201 to displace. The bulge degree of the interference space 1021 refers to the distance from the highest point of the interference space 1021 (shown as point a in Figure 3a) to the connecting bottom plate of the flexible channel restraint assembly 101 (shown as point b in Figure 3a), that is, the bulge height (such as (shown as h in Figure 3a).

It should be noted that the closed interference space 1021 is bulged by external force, and the interference space 1021 causes the flexible channel 201 to be displaced by the indirect action of external force, so that the control device has fewer mechanical parts, a low failure rate, and a long service life. Compared with rigid materials, the interference space 1021 formed by flexible materials can reduce the foreign body sensation and pain after implantation in the patient's body, and can effectively reduce the impact of secondary repair surgery on the patient.

In some possible implementations, referring to FIG. 1 , when applying an external force to the interference space 1021 by injecting fluid into the interference space 1021 , the implantable control device further includes a connecting piece 104 . For example, the connecting piece 104 forms The material is silica gel; however, the application is not limited to this and can also be other inelastic, non-deformable biocompatible materials. The connecting piece 104 is an inelastic, non-deformable connecting channel, its two ends are respectively connected to the control piece 103 and the interference space 1021 in the connecting bottom plate 1013, and are used to transmit the fluid controlled by the control piece 103.

In some possible implementations, referring to Figure 1, the control member 103 includes an injection interface 1031. The injection interface 1031 is lined with a peek tube for increasing strength and is connected to the connector 104 for injecting fluid into the interference space through the connector 104. 1021, switching the interference space 1021 from a contracted state to a raised state; this embodiment is suitable for patients with mild or moderate stress urinary incontinence. After implantation in the human body, in addition to the need to replenish fluid, the raised state of the interference space 1013 will not occur. Change.

In some possible implementations, referring to FIGS. 5 and 6 , the control member 103 further includes a switch 1032 , a first channel 1033 and a second channel 1034 . The switch 1032 includes: a liquid reservoir 1035 and a hydraulic pump 1036. The switch 1032 can be switched between the first position and the second position. After the control device is implanted in the human body, the patient needs to press the hydraulic switch 1032 to make the switch 1032 in the second position. The second channel is connected to the liquid storage bag, so that the bulge height of the interference space 1021 is reduced to drain the liquid. After the fluid drainage is completed, the patient presses the hydraulic switch 1032 again to return the switch 1032 to the first position, allowing the first channel to communicate with the fluid reservoir, causing the interference space 1021 to bulge again to achieve fluid control.

The fluid storage bag 1035 is used to store fluid and is connected to the hydraulic pump 1036. The first channel 1034 includes a first one-way valve 1038. When the switch is in the first position, the fluid reservoir 1035 and the hydraulic pump 1036 are connected to the first channel 1034, and the fluid in the fluid reservoir 1035 passes through the first one-way valve through the hydraulic pump 1036. The valve 1038 flows into the interference space 1021, causing the interference space 1021 to bulge due to external force. The second channel 1033 includes a second one-way valve 1037. When the switch is in the second position, the liquid reservoir 1035 and The hydraulic pump 1036 is connected to the second channel 1033, and the fluid in the interference space 1021 flows back to the fluid storage bag 1035 through the second one-way valve 1037 through the hydraulic pump 1036, causing the interference space 1021 to shrink.

In some possible implementations, referring to Figure 7, the control member 103 is a hydraulic rod 1039, which is located inside the interference space 1021. The hydraulic rod 1039 presses the interference space 1021 and applies an external force to the interference space 1021 to make it in a raised state. and contraction state to achieve liquid control.

In some possible implementations, referring to FIG. 8 , the number of closed interference spaces 1021 formed by covering the flexible channel interference elements 102 on the connecting bottom plate 1013 includes multiple, and the multiple interference spaces 1021 are along the extension direction of the flexible channel (such as (shown in the

In some possible implementations, referring to Figure 2, along the extension direction of the flexible channel 201 (shown in the X direction in Figure 2), the connection bottom plate is provided with at least two flexible channel fixing elements. For example, Figure 2 Two flexible channel fixing elements are shown in , the first flexible channel fixing element 1011 and the second flexible channel fixing element 1012 are used to fix the control device on the flexible channel 201; but the application is not limited to this, the number of flexible channel fixing elements Can be multiple.

In some possible implementations, referring to Figure 9, the flexible channel restraint assembly 101 includes a connecting bottom plate 1013, the first flexible channel fixing element 1011 and the second flexible channel fixing element 1012 include a hook structure, the hook structure includes a fixed end 1111 and The hook end 1112, the fixed end 1111 of the hook structure is fixed on the connecting bottom plate 1013, and the hook end 1112 of the hook structure is used to hang on the flexible channel 201; for example, the hook end 1112 of the first flexible channel fixing element 1011 The bending direction is opposite to the bending direction of the hook end 1112 of the second flexible channel fixing element 1012 to achieve a better fixing effect, so that the flexible channel can be firmly positioned on the connecting bottom plate 1013 and not easily displaced; however, this application is not limited to Therefore, the bending direction of the hook end 1112 of the first flexible channel fixing element 1011 and the bending direction of the hook end 1112 of the second flexible channel fixing element 1012 can also be designed to have the same bending direction.

In some possible implementations, referring to Figure 10, the flexible channel restraint assembly 101 includes a connecting bottom plate 1013, the first flexible channel fixing element 1011 and the second flexible channel fixing element 1012 include a loop rope structure, and the loop rope structure includes an open end 1113 and The fixed end 1114 of the loop rope structure is fixed on the connecting bottom plate 1013. The open end 1113 of the loop rope structure is used to be wound across the flexible channel 201 and sewn to be fixed to the connecting bottom plate 1013.

In some possible implementations, referring to Figure 11, the flexible channel restraint assembly 101 includes a connecting bottom plate 1013, and the flexible channel fixing element 1011 includes a columnar structure, including two along the extension direction of the flexible channel (as shown in the X direction in Figure 11). Rows of flexible channel fixing elements, each row including two columnar structures, the columnar structure including a vertical section 1115 and a curved section 1116, along the flexible channel extension direction (shown in the X direction in Figure 11) the vertical section 1115 is relative to the flexible channel 201 Both axial sides are perpendicular to the connecting bottom plate 1013. The curved section 1116 includes a plane 1117 facing the connecting bottom plate 1013. The plane is used for Contact the flexible channel 201 and limit the displacement of the flexible channel 201 relative to the connecting bottom plate 1013.

It should be noted that in order to reduce the degree of loosening of the flexible channel during the operation, thereby avoiding damage to the flexible channel 201, the flexible channel fixing element 1011 with a columnar structure is used, which is conducive to fixing the relative relationship between the base plate 1013 and the flexible channel, and at the same time reduces Damage to flexible channel 201. In actual surgery, the difficulty lies in operating the flexible channel 201. Improper operation may cause damage to the flexible channel, bleeding of the flexible channel, and stenosis of the flexible channel.

In some possible embodiments, referring to Figure 1, the flexible channel restraint assembly 101 also includes a suture ear 1014. The suture ear 1014 is provided around the connecting bottom plate 1013 and is used to position the connecting bottom plate 1013 to the tissue surrounding the flexible channel to prevent control. The device rotates, shifts, etc. within the body, reducing surgical time and surgical trauma through simple fixation.

In some possible implementations, the flexible channel fixing element includes a flexible channel contact surface and a non-contact surface; the internal structure of the flexible channel non-contact surface is used to maintain the shape of the flexible channel fixing element and form pressure resistance with the flexible channel interference element 102; Illustratively, the material of the non-contact surface of the flexible channel of the present invention includes biocompatible materials such as peek, ptfe, pe, and pom. The flexible channel contact surface is used to reduce erosion of the flexible channel tissue and reduce postoperative morbidity; exemplarily, the materials forming the flexible channel contact surface of the present invention include soft materials such as silicone and polyurethane.

It should be noted that under the premise that the flexible channel 201 can be effectively compressed and the flexible channel 201 is displaced for liquid control by using a multi-point contact method combined with the interference space 1021, the structural width should be reduced as much as possible to reduce The contact area between the implant material and the flexible channel 201 is reduced, thereby reducing the probability of atrophy or infection of the flexible channel.

In some possible implementations, the flexible channel restraint assembly 101 and the flexible channel interference element 102 can be separated from each other. The flexible channel interference element 102 includes a chamber 1024 that forms a closed interference space 1021 .

Referring to Figure 12a, the connecting bottom plate 1013 of the flexible channel restraint assembly 101 contains a cavity 1015, and toward the rear along the extension direction of the flexible channel (as shown in the direction a in Figure 12a), the connecting bottom plate 1013 is provided with a circular pipe 1016. Referring to Figures 12a and 12b, along the extension direction of the flexible channel (shown in the X direction in Figure 12b), the cavity 1015 is provided with a first L-shaped interior perpendicular to the extension direction of the flexible channel (shown in the Y direction in Figure 12a) groove 1515 and the second L-shaped groove 1215. The first L-shaped groove 1515 includes a connected first surface 1525 and a second surface 1535 along the extension direction of the flexible channel (shown in the X direction in Figure 12b), and the second L-shaped groove 1215 extends along the direction of the flexible channel (shown in the (shown in the X direction) includes a first surface 1225 and a second surface 1235 that are connected.

Referring to Figure 13, the flexible channel interference element 102 is provided with a third L-shaped groove 1315 perpendicular to the extension direction of the flexible channel (shown in the Y direction in Figure 13) outside the flexible channel extension direction (shown in the X direction in Figure 13). and fourth L-shaped groove 1415. The third L-shaped groove 1315 includes connected The fourth L-shaped groove 1415 includes the connected first surface 1425 and the second surface 1435 along the extension direction of the flexible channel (shown in the X direction in Figure 13). Along the rearward direction of the extension direction of the flexible channel (shown in the direction a in Figure 13), the connector 104 communicates with the cavity 1024 of the flexible channel interference element 102. The structure shown in Figure 13 is entirely accommodated in the above-mentioned cavity 1015 of the connecting bottom plate 1013.

Referring to Figures 12a to 14, the control device of the present invention is in the working state, and the flexible channel restraint component 101 and the flexible channel interference element 102 are combined with each other. The chamber 1024 of the flexible channel interference element 102 is placed inside the cavity 1015 of the connecting bottom plate 1013. Along the extending direction of the flexible channel (shown in the X direction in Figure 14), the first surface 1525 of the first L-shaped groove 1515 and the second The surface 1535 is respectively fitted with the first surface 1325 and the second surface 1335 of the third L-shaped groove 1315; the first surface 1225 and the second surface 1235 of the second L-shaped groove 1215 are respectively fitted with the third surface of the fourth L-shaped groove 1415. The first surface 1425 and the second surface 1435 are attached to each other.

That is, the first L-shaped groove 1515 of the cavity 1015 and the third L-shaped groove 1315 outside the flexible channel interference element 102 overlap; the second L-shaped groove 1215 of the cavity 1015 and the third L-shaped groove 1315 outside the flexible channel interference element 102 overlap. Four L-shaped grooves 1415 overlap together. When the interference space 1021 is in a raised state, the L-shaped grooves interact with each other to limit the position, preventing the flexible channel interference element 102 from sliding out of the above-mentioned cavity 1015 connected to the bottom plate 1013 when it is switched to the contracted state.

Referring to Figures 5 and 14, along the direction in which the flexible channel extends toward the rear (as shown in direction a in Figure 14), one end of the connector 104 passes through the circular pipe 1016 to communicate with the flexible channel interference element 102 in the cavity 1015. The other end of the member 104 is connected to the control member 103 for transmitting liquid. The control part 103 is connected to the interference space 1021 through the connection part 104, and controls the transmission of liquid to the interference space 1021 to switch the interference space 1021 from a contracted state to a raised state, and controls the liquid in the interference space 1021 to flow back to the control part through the connection part 104. 103. Switch the interference space 1021 from a raised state to a contracted state. The interference space 1021 bulges more as the internal liquid increases, and the bulge decreases as the internal liquid decreases, until all the liquid in the interference space 1021 flows back to the control member 103 , and the bulge is reduced to a minimum and reaches a contracted state. Referring to FIG. 2 , the flexible channel restraint component 101 and the flexible channel interference element 102 cooperate to displace the flexible channel 201 through multi-point contact to perform liquid drainage and liquid control.

During the processing of the control device of this embodiment, the flexible channel restraint component 101 and the flexible channel interference element 102 are processed separately and then assembled, which can reduce the processing difficulty and improve production efficiency.

The flexible channel of the utility model includes the urethra and the esophageal cardia, and the control device of the utility model is suitable for treating organ dysfunction in humans or animals. For example, it is used to treat problems caused by urinary incontinence, obesity and type 2 diabetes.

When the control device of the present invention is used to control the flow of stomach contents of a patient, the flexible channel interference element 102 displaces part of the flexible channel 201 tissue of the patient's esophageal cardia to affect the flow of stomach contents and produce fullness. Sensation, thereby achieving the effect of limiting the patient's food intake at each meal.

When the control device of the present invention is used to control the flow of urine through the patient's urethra, the flexible channel interference element 102 displaces part of the flexible channel 201 of the patient's urethra to affect the flow of urine in the urethra, thereby enabling the patient to urinate. and urinary control.

Although the present invention has been illustrated and described with reference to certain preferred embodiments of the present invention, those of ordinary skill in the art will understand that the above content is a further detailed description of the present invention in conjunction with specific embodiments. , it cannot be concluded that the specific implementation of the present utility model is limited to these descriptions. Those skilled in the art can make various changes in form and details, including making several simple deductions or substitutions, without departing from the spirit and scope of the present invention.

Claims

An implantable control device, characterized by comprising: a flexible channel restraint component, a flexible channel interference element, a closed interference space, and a control member; wherein,

The flexible channel binding assembly is used to fix the control device on the flexible channel;

The enclosed interference space includes the flexible channel interference element, the flexible channel interference element is provided in the flexible channel binding assembly, and the control member is connected to the interference space to control the interference space in a raised state and Switch between contraction states; where,

In the raised state, the interference space can contact the flexible channel and fix the flexible channel together with the flexible channel binding component to cause displacement of the flexible channel for liquid control.
The implantable control device according to claim 1, wherein in the raised state, the interference space causes the flexible channel to displace for liquid drainage and liquid control.
The implantable control device according to claim 1, characterized in that, in the raised state, the interference space causes the flexible channel to generate displacement for fluid control; in the contracted state or the interference space, the interference space is caused by the displacement of the flexible channel. During the process of switching from the bulging state to the contracted state, the interference space causes the flexible channel to displace for liquid discharge.
The implantable control device according to claim 1, wherein the flexible channel restraint assembly includes a connecting base plate, an interference cavity is provided inside the connecting base plate, and the flexible channel interference element includes a layer of coating device. A flexible material is provided outside the connection bottom plate and forms the closed interference space with the interference cavity, and the flexible material is used to contact the flexible channel.
The implantable control device according to claim 4, wherein a soft material is provided at the bottom of the interference cavity, and the soft material is lined with an interlayer.
The implantable control device of claim 5, wherein the interlayer includes polyester woven mesh.
The implantable control device of claim 4, wherein the flexible material includes a biocompatible material.
The implantable control device according to claim 7, wherein the biocompatible material includes any one of silicone, PET, and PU.
The implantable control device of claim 7, wherein the biocompatible material includes TPU.
The implantable control device according to any one of claims 1 to 9, characterized in that the control member is used to apply an external force to the interference space to control the interference space between a raised state and a contracted state. switch.
The implantable control device according to claim 10, wherein the magnitude of the external force is proportional to the bulge of the interference space.
The implantable control device according to claim 11, wherein the protrusion degree is the distance from the highest point of the interference space to the connecting bottom plate of the flexible channel restraint assembly.
The implantable control device according to claim 10, wherein the external force is applied to the interference space by injecting fluid into the interference space.
The implantable control device according to claim 13, characterized in that the implantable control device further includes a connecting piece, and both ends of the connecting piece are respectively connected to the control piece and the interference space for transfer fluid.
The implantable control device according to claim 14, characterized in that the control part includes: an injection interface; the injection interface is connected to the connecting piece and is used to inject the fluid into the connecting piece through the connecting piece. The interference space switches the interference space from the contracted state to the raised state.
The implantable control device according to claim 14, wherein the control member further includes a switch, a first channel and a second channel; and,

The switch includes: a liquid storage bag and a hydraulic pump. The switch can be switched between a first position and a second position. The liquid storage bag is used to store the fluid and is connected to the hydraulic pump; the first The passage includes a first one-way valve, and in the first position, the fluid in the fluid reservoir flows into the interference space through the first one-way valve through the hydraulic pump;

The second passage includes a second one-way valve, and in the second position, the fluid in the interference space flows back to the reservoir via the hydraulic pump through the second one-way valve.
The implantable control device according to claim 10, wherein a hydraulic rod is provided in the interference space, and the hydraulic rod presses the interference space to apply the external force to the interference space. .
The implantable control device according to any one of claims 1 to 9 and 11 to 17, wherein the number of the enclosed interference spaces includes multiple.
The implantable control device according to any one of claims 1 to 9 and 11 to 17, wherein the connecting base plate is provided with at least two flexible channel fixing elements along the extending direction of the flexible channel, so The flexible channel fixing element is used to be fixed on the flexible channel.
The implantable control device according to claim 19, characterized in that:

The flexible channel restraint assembly includes a connecting base plate, the flexible channel fixing element includes a hook structure, the hook structure includes a hook end and a fixed end, the fixed end of the hook structure is fixed to the connecting base plate, and the hook The hook end of the structure is used to hang on the flexible channel.
The implantable control device according to claim 19, characterized in that:

The flexible channel restraint assembly includes a connecting base plate, the flexible channel fixing element includes a loop rope structure, the loop rope structure includes an open end and a fixed end, the fixed end of the loop rope structure is fixed to the connecting base plate, the Loop rope structure The open end is used to be wrapped across the flexible channel and sewn to be fixed to the connecting base plate.
The implantable control device according to claim 19, characterized in that:

The flexible channel restraint assembly includes a connecting base plate, the flexible channel fixing element includes a columnar structure, the columnar structure includes a vertical section and a curved section, the vertical section is perpendicular to the connecting base plate, and the curved section includes a The plane of the connecting bottom plate is used to contact the flexible channel.
The implantable control device according to claim 22, characterized in that, along the extending direction of the flexible channel, there are two rows of flexible channel fixing elements, and each row includes two columnar structures.
The implantable control device according to claim 1, wherein the flexible channel restraint assembly further includes a suture ear, the suture ear is provided on the connecting base plate and is used to position the connecting base plate on The tissue surrounding the flexible channel is used to limit the displacement of the connecting bottom plate relative to the tissue surrounding the flexible channel.
The implantable control device according to any one of claims 20 to 22, wherein the flexible channel fixation element includes a flexible channel contact surface and a non-contact surface;

The material forming the non-contact surface of the flexible channel includes any one of peek, ptfe, pe and pom, which is used to maintain the shape of the flexible channel fixing element;

The material forming the contact surface of the flexible channel includes any one of silicone and polyurethane, which is used to reduce erosion of the flexible channel.
The implantable control device according to claim 14, wherein the connecting piece is an inelastic, non-deformable connecting channel made of silicone material.
The implantable control device according to claim 1, wherein the flexible channel restraint assembly includes a connecting base plate, a cavity is provided in the connecting base plate, and the flexible channel interference element includes a chamber, the chamber The closed interference space is formed, and the chamber is placed in the cavity connecting the bottom plate.
The implantable control device according to claim 27, wherein the connecting base plate further includes a pipe, and the pipe is provided on one side of the connecting base plate along the extending direction of the flexible channel.
The implantable control device according to claim 28, characterized in that the implantable control device includes a connecting piece, one end of the connecting piece passes through the pipeline and is connected to the interference space in the cavity. The other end of the connecting piece is connected to the control piece for transmitting fluid.
The implantable control device according to claim 27, wherein along the extension direction of the flexible channel, a first L-shaped groove and a second L-shaped groove perpendicular to the extension direction of the flexible channel are provided inside the cavity. groove; the flexible channel interference element is provided with a third L-shaped groove and a fourth L-shaped groove perpendicular to the extension direction of the flexible channel;

The flexible channel restraint component is combined with the flexible channel interference element; the first L-shaped groove inside the cavity and The third L-shaped groove outside the flexible channel interference element is fitted, and the second L-shaped groove inside the cavity is fitted with the fourth L-shaped groove outside the flexible channel interference element.