CN114145882A - A prostatic urethral stent system with thermal ablation function - Google Patents

Abstract

The invention relates to the field of medical instruments for urinary systems, in particular to a prostatic urethra bracket system. The system consists of three parts, namely a bracket system, a conveying system and a control system. The support comprises six subparts of a support main body, a thermal ablation coil, a temperature sensor, a lead, a support base and a connecting rope. The bracket body is wound with a thermal ablation coil, and the control system is connected with the thermal ablation coil through a lead. By changing the current parameters flowing into the coil, the control system can control the temperature of the stent, thereby playing a role in inducing the necrosis of the cells of the lesion tissue. The invention combines the thermal ablation technology, solves the defects of slow effect and easy relapse of the traditional stent, and simultaneously avoids the problem of secondary blockage caused by edema after the thermal ablation operation due to the support of the stent. And because the overall effect time of the present invention is longer relative to conventional thermal ablation procedures, the thermal ablation temperature can be set lower relative to conventional thermal ablation procedures, which also reduces the problem of post-operative edema.

Description

Prostate urethra support system with heat ablation function

Technical Field

The invention relates to the field of medical instruments for urinary systems, in particular to a prostate stent system with a heat ablation function.

Background

Benign Prostatic Hyperplasia (BPH), commonly known as prostatic hypertrophy, is one of the common diseases in middle-aged and elderly men. About half of men older than 60 have symptoms of benign prostatic hyperplasia to varying degrees, and in the population of older men 70, 80 years, this figure is up to 90%. Patients with BPH may press the urethra due to hyperplasia and hypertrophy of the prostate, causing difficulty in urination, frequent and unsmooth urination, interruption of urine, or poor urine flow. Urinary stones, bladder tightening, urinary tract infections, and even kidney damage may also occur with increased disease.

For treating benign prostatic hyperplasia, a medicament treatment or an operation treatment mode is usually adopted, the medicament treatment is usually not obvious in curative effect, the operation is divided into two categories of resection and thermal ablation, the resection operation is usually at risk of losing sexual function, and the thermal ablation operation also has the problem of secondary blockage caused by postoperative edema. In addition to surgery, prostate stents are also commonly used clinically for treatment. The prostate stent is made of memory alloy material, and the stent is assembled in vitro and is unfolded into a working state by energization or self-expansion after being delivered to a diseased part of a patient. The traditional prostate stent leads to ischemia by pressing local tissues or remodels the urethral passage by physical support, and the traditional stent has the defects of slow effect, easy relapse after being taken out and the like. .

Disclosure of Invention

To solve the problem, the invention provides a prostate stent system with a thermal ablation function, which consists of three parts, namely a stent system, a conveying system and a control system.

The bracket system part consists of six sub-parts, namely a bracket main body, a thermal ablation coil, a temperature sensor, a lead, a bracket base and a connecting rope.

The main body of the bracket is divided into four parts, namely a head section, a middle supporting section, a rear section and a fixed compression bar, wherein the middle supporting section and the rear section are formed by mutually winding a plurality of adjacent elastic closed wires into a twist shape, the head section of the bracket is a connecting part between the head ends of the two middle supporting sections, and the head section of the bracket is composed of the parts of the elastic wires which are not wound.

The number of the middle supporting sections is at least 3, when the number of the middle supporting sections is 3, the middle supporting sections are distributed in 5 points, 7 points and 12 points, and the shape of the bracket main body changes along with the change of the number of the middle supporting sections.

The elastic closure wire may be made of nitinol or other elastic metallic material.

The fixing pressure rod is of an arc-shaped structure, has elasticity, can play a role of fixing the support and prevents displacement.

The heat-melting coil is a conductive coil wound on the support section in the middle of the bracket, and the outside of the coil is coated with insulating materials, so that the bracket can be prevented from being connected with current passing through the coil. One coil or a plurality of coils may be wound around one central support section and the coils may be laid over the entire or only a portion of the central support section.

The head and the tail of the thermal ablation coil are connected with wires, different coils are connected with each other through the wires, and the coils can be connected in series or in parallel; or independent of each other, each coil is separately connected with the control system through a lead.

The temperature sensor is placed at a crack between the thermal ablation coil and the support section in the middle of the support, and plays a role in detecting the temperature of the support.

The connecting rope winds and ties the rear section of the bracket and the rear section of the fixing pressure rod together.

The support base is of a long barrel-shaped structure and is provided with three cavities, the smaller through cavity above the support base is a wire cavity and is used for a wire for connecting the heat ablation coil and the temperature sensor, the front-section cavity below the support base is a circular connecting cavity, the rear-section cavity below the support base on the other side is a non-circular control cavity, a partition plate is arranged between the cavities on the two sides below the support base and plays a limiting role, and a circular hole is formed in the center of the partition plate and is used for allowing the connection rope to pass through.

The conveying system part consists of a pushing sheath and a sheath.

The pushing sheath is made of hard elastic materials and is integrally of a cylindrical structure with an axial hole, the hole can be penetrated by a connecting rope, and the shape of the front end of the pushing sheath is matched with the shape of the non-circular control cavity at the rear section of the bracket base.

The sheath consists of an operation base and a sheath tube, wherein the operation base plays a role in convenient operation and is connected with the sheath tube. The protective sleeve is a high polymer material pipe and plays a role in compressing the bracket and storing.

The control system is a power supply control system, is connected with the lead and plays a role in detecting the temperature of the bracket and controlling the temperature of the bracket. The control system is detachably connected with the lead.

The invention has the following effective benefits: the invention combines the traditional stent and the thermal ablation technology, and solves the defects of slow effect and easy relapse of the traditional stent. Meanwhile, due to the support of the bracket, the problem of secondary blockage caused by edema after a thermal ablation operation is avoided. And because the device can be placed in a human body for a relatively long time, the temperature for thermal ablation is set lower than that of the traditional thermal ablation operation, and the problem of postoperative edema is also reduced.

Drawings

FIG. 1 is a schematic view of the stand and control system of the present invention.

Fig. 2 is a schematic view of the sheath structure of the delivery system.

Fig. 3 is a partial cross-sectional view of fig. 1.

Fig. 4 is a cross-sectional view of fig. 2.

Fig. 5 is a left side view of thestand base 3 and stand portion of fig. 1.

Fig. 6 is an enlarged view of a portion a of fig. 3.

Fig. 7 is an enlarged view of the portion b in fig. 3.

FIG. 8 is a cross-sectional view of a pedestal of the stand.

Fig. 9 is a left side view of the completed structure of fig. 8.

Fig. 10 is a right side view of the completed structure of fig. 8.

Fig. 11 is a schematic view of the structure of the stent in the sheath.

Detailed Description

The invention is composed of three major parts, namely a bracket system, a conveying system and a control system, and the invention is further explained according to the attached drawings of the specification:

as shown in figure 1, the stent system consists of six components, namely a stent main body 1, athermal ablation coil 2, astent base 3, alead wire 4, a connectingrope 5 and a temperature sensor 6 (shown in figure 6). The main body of the bracket consists of ahead section 11, amiddle supporting section 12, arear section 13 and afixed compression bar 14. The main body 1 of the bracket is twisted into a twist shape by a plurality of elastic closed wires except thefixed compression bar 14, and the main body of the bracket is a hollow frame three-dimensional structure. The main body of the bracket shown in the embodiment is threemiddle supporting sections 12, and the threemiddle supporting sections 12 are distributed at 5 points, 7 points and 12 points to form a trihedron-like configuration. Thehead section 11 of the stent body is a connecting portion between the head ends of the twomiddle support sections 12, and the structure is composed of the unwound portions of the wires. Thefixing compression bar 14 is of an arc-shaped structure, has elasticity, and can play a role of a fixing support to prevent displacement. Therear end 13 of the bracket main body and the rear end of thefixed compression bar 14 are bound and fixed in thebracket base 3 through the head end of the connectingrope 5. The other end of the fixedback connecting rope 5 passes through thesupport base 3 and then passes through the axial hole of the pushingsheath 7, and finally, a knot is tied at the tail end of the connectingrope 5 to prevent the pushingsheath 7 from moving.

As shown in fig. 1, athermal ablation coil 2 is wound on each of thecentral support sections 12 of the stent body, and the coil is coated with an insulating material on the outside to prevent branch current from flowing into the stent, and both ends of the coil are connected tobranch wires 41 of thewires 4. Theheat ablation coils 2 are connected in series or in parallel. Each of thethermal ablation coils 2 may be individually connected to the control system 8 without being interconnected.

As shown in figure 6, atemperature sensor 6 is placed between thethermal ablation coil 2 and thecentral support section 12, thetemperature sensor 6 being able to detect the effect of the temperature of the stent body when thethermal ablation coil 2 is heated.

As shown in FIG. 1, thewires 4 connecting thethermal ablation coil 2 and thetemperature sensor 6 are passed through thesupport base 3 and then connected to the control system 8.

As shown in fig. 8, 9 and 10, thebracket base 3 is composed of a smaller through cavity at the upper part, which is awire cavity 31, acircular connecting cavity 32 at the front section at the lower part, and anon-circular control cavity 33 at the rear section at the lower part, a partition board is arranged between thecavity 32 and thecavity 33, and a circular hole is arranged at the center of the partition board for the connectingrope 5 to pass through. Thewire cavity 31 is used for passing the wire of the thermal ablation coil and the temperature sensor. Thecavity 32 is used for fixing the bracketrear section 13 bound with the connectingrope 5 and the rear section of thefixed compression bar 14 together. Thecavity 33 is used for connecting with the pushingsheath 7, and the pushingsheath 7 contains an axial hole in the center. The shape of thecavity 33 is consistent with the shape of the front end structure of thepush sheath 7, and the cavity is of a non-circular structure. The bracket can integrally rotate along with the pushing sheath by rotating the pushingsheath 7.

As shown in fig. 3, after the connectingrope 5 binds therear section 13 of the bracket and the fixingcompression bar 14, the other end of the connecting rope passes through the hole of the partition plate between thecavity 32 and thecavity 33 and passes through the central axial hole of thepush sheath 7, a knot is tied at the tail part of thepush sheath 7, the diameter of the knot is larger than that of the hole of thepush sheath 7, and the knot can prevent thepush sheath 7 from falling out of thecavity 33 of thebracket base 3.

The product delivery system is composed of apush sheath 7 in fig. 1 and a sheath 9 in fig. 2. The sheath 9 is composed of asheath tube body 91 and anoperation base 92. Before use of the product, the stent is collapsed into a sheath tube 91 (as shown in fig. 11).

The product control system 8 is a power supply control system, is composed of circuit components, and has the functions of detecting the temperature of the bracket and controlling the temperature of the bracket. Thewires 4 are connected at one end to a control system 8 and at the other end towires 41 connected to thethermal ablation coil 2 and thetemperature sensor 6, respectively (as shown in figure 1).

The implantation and recovery operation mode of the product is as follows:

the patient's prostate is examined by ultrasound or other examination equipment for size and a correspondingly sized stent model is selected. The rigid cystoscope is inserted into an endoscope sheath larger than 17F and pushed into the urethra of a patient to the entrance of the bladder, the endoscope sheath is kept still, and the cystoscope is pulled out of the endoscope sheath. The sheath 9 loaded with the stent is inserted into the cystoscope sheath, and then the pushingsheath 7 is pushed to push the stent into the cystoscope sheath and slowly push the stent into the bladder of a patient, so that the stent can be automatically unfolded in the bladder of the patient. At this point the stent is held stationary, the sheath 9 is pulled out, and the cystoscope is reinserted to the bladder entrance to view the stent angle. The pushingsheath 7 is rotated to enable the bracket fixingpressure rod 14 to be aligned with the middle lobe of the prostate of the patient, the pushingsheath 7 is slowly pulled outwards to enable the bracket to be retracted to the prostate, and when the bracket fixingpressure rod 14 just abuts against the outer wall of the bladder opening, the bracket reaches the placed specified position. At the moment, a knot at the tail end of the pushingsheath 7 is cut off, the pushingsheath 7 is pulled out from the urethra, a switch of the control system 8 is turned on, the control system 8 enables the temperature of the coil-wrapped stent to be increased through the electromagnetic induction effect by changing parameters such as the current size, the frequency and the direction of theheat ablation coil 2, thetemperature sensor 6 monitors the temperature condition of the stent in time to automatically adjust the heating mode, the stent is maintained in a corresponding working temperature range, and the pathological change tissue cells of a patient are induced to be necrotic through the heat effect. The stent implantation process is completed.

The bracket placed at the prostate of the patient can forcedly prop open the hyperplasia tissue of the prostate of the patient, so that the hyperplasia tissue generates ischemia, and the condition of the hyperplasia of the prostate can be relieved after 5-7 days of implantation treatment by matching with the effect of thermal ablation.

When the product is retrieved after implantation has expired, the connectingstring 5 is passed through the sheath, again using an endoscopic sheath larger than 17F, and the sheath is pushed along the urethra of the patient up to the prostate. The connecting cord is pulled outwardly to retract the stent within the endoscope sheath. And finally, the stent and the endoscope sheath are pulled out from the patient body together, and then the recovery is finished.

The above description is only a typical example of the present invention, and is not intended to limit the present invention, and all examples modified and extended based on the present invention are within the scope of the present invention.

Claims (10)

Translated fromChinese

1.一种带热消融功能的前列腺尿道支架系统，由支架系统、输送系统与控制系统三大部分组成，其特征在于支架系统由支架主体、热消融线圈、温度感应器、导线、支架底座和连接绳六个子部分组成。1. a prostatic urethral stent system with thermal ablation function, consisting of three major parts of a stent system, a delivery system and a control system, is characterized in that the stent system is composed of a stent main body, a thermal ablation coil, a temperature sensor, a wire, a stent base and The connecting rope consists of six subsections.2.根据权利要求1所述一种带热消融功能的前列腺尿道支架系统，其特征还在于支架主体分为头段、中部支撑段、后段、固定压杆四个部分，其中部支撑段与后段由相邻的数根弹性封闭线材相互缠绕成麻花状而成，支架的头段为两个中部支撑段头端之间的连接部分，支架的头段由上述弹性线材的不缠绕的部分组成。2. A prostatic urethral stent system with thermal ablation function according to claim 1, characterized in that the stent main body is divided into four parts: a head section, a middle support section, a rear section and a fixed pressure rod, wherein the middle support section is divided into four parts. The rear section is formed by intertwining several adjacent elastic closed wires into a twist shape, the head section of the bracket is the connecting part between the head ends of the two middle support sections, and the head section of the bracket is formed by the above-mentioned elastic wire. composition.3.根据权利要求2所述一种带热消融功能的前列腺尿道支架系统，其特征还在于中部支撑段数量最少为3个，当中部支撑段为3个时其呈5点、7点、12点分布，支架主体的形状随着中部支撑段数量的变化而变化。3. A prostatic urethral stent system with thermal ablation function according to claim 2, characterized in that the number of the middle support section is at least 3, and when the middle support section is 3, it is 5 o'clock, 7 o'clock, 12 o'clock. Point distribution, the shape of the stent body changes with the number of middle support segments.4.根据权利要求2所述一种带热消融功能的前列腺尿道支架系统，其特征还在于固定压杆呈弧状结构，有弹性。4 . The prostatic urethral stent system with thermal ablation function according to claim 2 , further characterized in that the fixed pressure rod has an arc-shaped structure and is elastic. 5 .5.根据权利要求1所述一种带热消融功能的前列腺尿道支架系统，其特征还在于热消融线圈为缠绕在支架中部支撑段的导电线圈，该线圈外部涂有绝缘材料，可防止支架接入通过线圈电流。5. A prostatic urethral stent system with thermal ablation function according to claim 1, characterized in that the thermal ablation coil is a conductive coil wound around the support section in the middle of the stent, and the outer part of the coil is coated with insulating material, which can prevent the stent from being connected. into the current through the coil.6.根据权利要求5所述一种带热消融功能的前列腺尿道支架系统，其特征还在于一个中部支撑段上可缠绕一个线圈或多个线圈，线圈可铺满整个或仅覆盖部分中部支撑段。6. A prostatic urethral stent system with thermal ablation function according to claim 5, characterized in that a middle support section can be wound with a coil or a plurality of coils, and the coil can be covered all over or only cover part of the middle support section .7.根据权利要求5所述一种带热消融功能的前列腺尿道支架系统，其特征还在于热消融线圈头尾部与导线相连，不同的线圈之间通过导线相互连接，线圈之间可为串联也可为并联连接，也可彼此之间互相独立，每个线圈单独通过导线与控制系统相连。7. A prostatic urethral stent system with thermal ablation function according to claim 5, characterized in that the head and tail of the thermal ablation coils are connected with wires, different coils are connected to each other by wires, and the coils can be connected in series or in series. It can be connected in parallel or independent of each other, and each coil is connected to the control system through a wire alone.8.根据权利要求1所述一种带热消融功能的前列腺尿道支架系统，其特征还在于温度感应器放置于热消融线圈与支架中部支撑段之间的夹缝处。8 . The prostatic urethral stent system with thermal ablation function according to claim 1 , wherein the temperature sensor is placed at the crevice between the thermal ablation coil and the middle support section of the stent. 9 .9.根据权利要求1所述一种带热消融功能的前列腺尿道支架系统，其特征还在于支架底座为长桶状结构，有三个腔体，上方较小的贯通腔体为导线腔体，用于通过连接热消融垫圈和温度感应器的导线，下方的前段腔体为圆形连接腔体，支架底座下方另一侧后段腔体为非圆形控制腔体，下方两侧腔体之间有一隔板，起到限位的作用，隔板中心有圆形孔洞用于穿过连接绳。9. A prostatic urethral stent system with thermal ablation function according to claim 1, characterized in that the stent base is a long barrel-shaped structure with three cavities, and the smaller through-cavity above is a lead cavity, which is used for Because of the wire connecting the thermal ablation washer and the temperature sensor, the lower front cavity is a circular connection cavity, the rear cavity on the other side of the bracket base is a non-circular control cavity, and the lower cavity between the two sides is a non-circular control cavity. There is a partition to limit the position, and there is a circular hole in the center of the partition for passing the connecting rope.10.根据权利要求1所述一种带热消融功能的前列腺尿道支架系统，其特征还在于输送系统部分由推送鞘、护套两个部分组成，推送鞘为硬质弹性材料制成，整体为带有一轴向孔洞的圆柱形结构，孔洞可供连接绳穿过，推送鞘前端形状与支架底座的后段非圆形控制腔体形状相吻合。10. A kind of prostatic urethral stent system with thermal ablation function according to claim 1 is further characterized in that the delivery system is partially composed of a push sheath and a sheath, and the push sheath is made of a hard elastic material, and the whole is It has a cylindrical structure with an axial hole through which the connecting rope can pass, and the shape of the front end of the push sheath matches the shape of the rear non-circular control cavity of the support base.

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