CN114145882A

CN114145882A - Prostate urethra support system with heat ablation function

Info

Publication number: CN114145882A
Application number: CN202111636883.1A
Authority: CN
Inventors: 陆安俊; 孙杰; 徐梦婷; 唐世豪
Original assignee: Shanghai Xinghuo Medical Technology Co ltd
Current assignee: Shanghai Xinghuo Medical Technology Co ltd
Priority date: 2021-12-29
Filing date: 2021-12-29
Publication date: 2022-03-08

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 the stand 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, a thermal ablation coil 2, a stent base 3, a lead wire 4, a connecting rope 5 and a temperature sensor 6 (shown in figure 6). The main body of the bracket consists of a head section 11, a middle supporting section 12, a rear section 13 and a fixed compression bar 14. The main body 1 of the bracket is twisted into a twist shape by a plurality of elastic closed wires except the fixed 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 three middle supporting sections 12, and the three middle supporting sections 12 are distributed at 5 points, 7 points and 12 points to form a trihedron-like configuration. The head section 11 of the stent body is a connecting portion between the head ends of the two middle support sections 12, and the structure is composed of the unwound portions of the wires. The fixing compression bar 14 is of an arc-shaped structure, has elasticity, and can play a role of a fixing support to prevent displacement. The rear end 13 of the bracket main body and the rear end of the fixed compression bar 14 are bound and fixed in the bracket base 3 through the head end of the connecting rope 5. The other end of the fixed back connecting rope 5 passes through the support base 3 and then passes through the axial hole of the pushing sheath 7, and finally, a knot is tied at the tail end of the connecting rope 5 to prevent the pushing sheath 7 from moving.

As shown in fig. 1, a thermal ablation coil 2 is wound on each of the central 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 to branch wires 41 of the wires 4. The heat ablation coils 2 are connected in series or in parallel. Each of the thermal ablation coils 2 may be individually connected to the control system 8 without being interconnected.

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

As shown in FIG. 1, the wires 4 connecting the thermal ablation coil 2 and the temperature sensor 6 are passed through the support base 3 and then connected to the control system 8.

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

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

The product delivery system is composed of a push sheath 7 in fig. 1 and a sheath 9 in fig. 2. The sheath 9 is composed of a sheath tube body 91 and an operation 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. The wires 4 are connected at one end to a control system 8 and at the other end to wires 41 connected to the thermal ablation coil 2 and the temperature 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 pushing sheath 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 pushing sheath 7 is rotated to enable the bracket fixing pressure rod 14 to be aligned with the middle lobe of the prostate of the patient, the pushing sheath 7 is slowly pulled outwards to enable the bracket to be retracted to the prostate, and when the bracket fixing pressure 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 pushing sheath 7 is cut off, the pushing sheath 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 the heat ablation coil 2, the temperature 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 connecting string 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

1. A prostate urethra support system with a heat ablation function is composed of a support system, a conveying system and a control system, and is characterized in that the support system is composed of six sub-parts including a support main body, a heat ablation coil, a temperature sensor, a lead, a support base and a connecting rope.

2. The prostatic urethra stent system with thermal ablation function as claimed in claim 1, wherein the stent body is divided into four parts, a head section, a middle support section, a back section and a fixing pressure rod, wherein the support section and the back section are formed by winding a plurality of adjacent elastic closed wires into a twist shape, the head section of the stent is a connecting part between the head ends of the two middle support sections, and the head section of the stent is formed by the non-wound parts of the elastic wires.

3. The prostatic urethra stent system with thermal ablation function as claimed in claim 2, wherein the number of the middle support segments is at least 3, the middle support segments are distributed at 5 points, 7 points and 12 points when the number of the middle support segments is 3, and the shape of the stent body changes with the number of the middle support segments.

4. The prostatic urethra stent system with thermal ablation function as claimed in claim 2, wherein the fixing pressure rod is of an arc-shaped structure and is elastic.

5. The prostatic urethra stent system with thermal ablation function as claimed in claim 1, wherein the thermal ablation coil is a conductive coil wound around the middle support section of the stent, and the coil is coated with an insulating material to prevent the stent from passing current through the coil.

6. The prostatic urethral stent system with thermal ablation function as claimed in claim 5, wherein a coil or coils can be wound on one central support section, and the coil can be spread over the whole or only part of the central support section.

7. The prostatic urethra stent system with thermal ablation function as claimed in claim 5, wherein the thermal ablation coils are connected with wires at head and tail parts, different coils are connected with each other through wires, the coils can be connected in series or in parallel or independently, and each coil is separately connected with the control system through wires.

8. The prostatic urethra stent system with thermal ablation function of claim 1, wherein the temperature sensor is placed at the seam between the thermal ablation coil and the middle support section of the stent.

9. The prostatic urethra bracket system with thermal ablation function as claimed in claim 1, wherein the bracket base is a long barrel-shaped structure with three cavities, the smaller through cavity at the upper part is a wire cavity for connecting wires of the thermal ablation washer and the temperature sensor, the front cavity at the lower part is a circular connecting cavity, the rear cavity at the other side below the bracket base is a non-circular control cavity, a partition board is arranged between the cavities at the two sides below the bracket base for limiting, and a circular hole is arranged at the center of the partition board for allowing the connecting rope to pass through.

10. The prostatic urethra stent system with thermal ablation function as claimed in claim 1, wherein the delivery system part comprises a push sheath and a sheath, the push sheath is made of hard elastic material and is integrally cylindrical with an axial hole for the connection rope to pass through, and the shape of the front end of the push sheath is matched with the shape of the non-circular control cavity at the back section of the stent base.