CN111068167A

CN111068167A - Four-chamber three-bag prostate expansion catheter assembly

Info

Publication number: CN111068167A
Application number: CN201911354905.8A
Authority: CN
Inventors: 张一平; 邵钦蓉; 周文; 刘炳辉; 王裕权
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-12-25
Filing date: 2019-12-25
Publication date: 2020-04-28

Abstract

The invention provides a four-chamber three-bag prostate expansion catheter assembly (100), which comprises a catheter (10) and a latex sleeve (30), wherein the catheter (10) comprises three communicating pipes, and a first liquid outlet (17), a second liquid outlet (18) and a third liquid outlet (19) are arranged on the wall surface of the conduit (10), one end of each of the three communicating pipes (16) is respectively communicated with the first liquid outlet (17), the second liquid outlet (18) and the third liquid outlet (19), the latex sleeve (30) is combined with the catheter (10) so that an outer cavity (51), an inner cavity (52) and an auxiliary cavity (53) which are mutually isolated are formed between the latex sleeve (30) and the catheter (10), the inner cavity (52), the outer cavity (51) and the auxiliary cavity (53) are respectively communicated with the first liquid outlet (17), the second liquid outlet (18) and the third liquid outlet (19). The four-cavity three-sac prostate expansion catheter assembly can effectively treat the hyperplasia of prostate.

Description

Four-chamber three-bag prostate expansion catheter assembly

Technical Field

The invention relates to the technical field of medical instruments, in particular to a four-cavity three-bag prostate expansion catheter assembly.

Background

In the middle-aged and elderly people, the phenomenon of suffering from prostatic hyperplasia is very common, and with the change of aging of the global population, the senile disease also tends to increase greatly. Pathological analysis of prostate hyperplasia was: the male external urethra is tightly wrapped with a layer of fine soft tissue, the soft tissue is the prostate, the fine degree of the soft tissue changes with age and becomes gradually loose, so that the thickness of the prostate layer is thickened, the thickened soft tissue cannot expand outwards and only develops inwards due to the fact that the periphery of the prostate layer is wrapped by body tissues, and the urethra is gradually compressed after the prostate is thickened to a certain degree. The urethra at this location will therefore become constricted by the hyperplasia of the prostate gland, thereby affecting urination and even creating problems with difficulty in urination. In severe cases, it may cause the patient to have no urination for many days, which is very painful.

The better measure for treating the disease at the present stage is still an operation treatment method for decades ago, although the traditional treatment method can solve the pain of the patient, the cost is high, the patient needs to bear the pain of the operation in the treatment process, a large amount of Chinese and western medicines are needed for anesthesia, inflammation diminishing, pain relieving, healing promotion and the like, and the problems of long treatment period and the like exist. Patients can also choose to go to hospital for catheterization to relieve pain, but too many catheterization times can promote inflammation of the inner wall of the urethra, and most patients eventually have to choose surgery to remove the prostate.

Disclosure of Invention

The object of the present invention is to overcome at least partly the drawbacks of the prior art and to provide a medical device for treating a prostate proliferative disorder or at least relieving pain in a patient suffering from prostate hyperplasia.

It is also an object of the present invention to provide a four-lumen three-balloon prostate dilation catheter assembly that is effective in treating prostate hyperplasia.

The invention also aims to provide a four-cavity three-sac prostate expansion catheter component which has simple structure and convenient operation and is used for treating the prostatic hyperplasia diseases.

To achieve one of the above objects or purposes, the technical solution of the present invention is as follows:

a four-cavity three-bag prostate expansion catheter assembly comprises a catheter and a latex sleeve,

the conduit comprises a first communicating pipe, a second communicating pipe and a third communicating pipe, a first liquid outlet, a second liquid outlet and a third liquid outlet are arranged on the wall surface of the conduit, one end of each of the first communicating pipe, the second communicating pipe and the third communicating pipe is respectively communicated with the first liquid outlet, the second liquid outlet and the third liquid outlet,

the latex sleeve is combined with the catheter, so that an outer cavity, an inner cavity and an auxiliary cavity which are mutually isolated are formed between the latex sleeve and the catheter, the outer cavity surrounds the inner cavity, and the inner cavity, the outer cavity and the auxiliary cavity are respectively communicated with the first liquid outlet, the second liquid outlet and the third liquid outlet.

According to a preferred embodiment of the present invention, the combination of the latex sleeve and the catheter forms a first connection node, a second connection node, and a third connection node, the outer lumen and the inner lumen being located between the first connection node and the second connection node, and the auxiliary lumen being located between the second connection node and the third connection node.

According to a preferred embodiment of the present invention, the first, second and third connection joints are respectively composed of an interlining and an adhesive.

According to a preferred embodiment of the present invention, the wall thickness of the portion of the latex cannula forming the outer lumen, the inner lumen and the auxiliary lumen is thinner than the wall thickness of the other portion of the latex cannula.

According to a preferred embodiment of the present invention, at least a portion of each of the first communication pipe, the second communication pipe, and the third communication pipe is located inside the duct, and the other end of each of the first communication pipe, the second communication pipe, and the third communication pipe extends outside the duct through the wall surface of the duct.

According to a preferred embodiment of the present invention, the at least a portion of the first communication pipe, the second communication pipe, and the third communication pipe is embedded in a wall surface of the duct.

According to a preferred embodiment of the present invention, the interior of the duct assembly is hollow, one end of the duct assembly has an opening port, the other end has an insertion head, a communication port is provided on the insertion head, and the opening port communicates with the communication port.

According to a preferred embodiment of the invention, the central axis of the insertion head is inclined with respect to the central axis of the main body of the catheter assembly.

According to a preferred embodiment of the invention the angle between the central axis of the insertion head and the central axis of the main body of the catheter assembly is 10-20 degrees.

According to a preferred embodiment of the invention, the catheter assembly further comprises a catheter adapter arranged at an end of the catheter assembly remote from the insertion head.

The four-cavity three-bag prostate expansion catheter assembly can effectively treat prostate hyperplasia diseases and relieve pain of patients with prostate hyperplasia, has a simple structure and convenient operation, does not need operations in the whole treatment process, avoids the pain of skin cutting by a scalpel, does not need a large amount of Chinese and Western medicines for anesthesia, inflammation diminishing, pain relieving, healing promotion and the like, has a relatively simple treatment environment, does not need a hospitalization rehabilitation process after treatment, can be discharged immediately after clinical treatment, and is very simple and convenient to operate in the whole treatment process. According to the evaluation of clinical test doctors, the design is simple, efficient and beneficial to doctors and patients.

Drawings

FIG. 1 is a schematic view of a prostate dilation catheter according to an embodiment of the present invention;

FIG. 2 is a cross-sectional view of the prostatic dilation catheter of FIG. 1 taken along section B-B;

FIG. 3 is a cross-sectional view of the prostatic dilation catheter of FIG. 1 along section A-A;

FIG. 4 is a schematic view of a latex cannula according to an embodiment of the invention;

FIG. 5 is a partial top view of the condom tube of FIG. 4 taken along direction C;

FIG. 6 is a cross-sectional view of the condom tube of FIG. 4 along section D-D;

FIG. 7 is a schematic view of an inner bladder section of a latex sleeve according to an embodiment of the invention;

FIG. 8 illustrates an outer bladder section of a latex sleeve according to an embodiment of the invention;

FIG. 9 is a schematic view of a four-lumen, three-balloon prostate dilation catheter assembly according to an embodiment of the present invention; and

figure 10 is a cross-sectional view of the four-lumen, three-balloon prostate dilation catheter assembly of figure 9 taken along section E-E.

Detailed Description

Exemplary embodiments of the present invention will hereinafter be described in detail with reference to the accompanying drawings, wherein like or similar reference numerals denote like or similar elements. Furthermore, in the following detailed description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the embodiments of the disclosure. It may be evident, however, that one or more embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in schematic form in order to simplify the drawing.

To solve the problems mentioned in the background section, designers have conducted various investigations and researches to design a four-chamber three-balloon prostate dilatation catheter assembly, which is a medical device for treating prostatic hyperplasia diseases by non-operative physical therapy. The medical instrument is a very simple clinical medical instrument, the operation is not needed in the whole treatment process, the skin is prevented from being cut by a scalpel, a large amount of Chinese and western medicines are not needed for anesthesia, inflammation diminishing, pain relieving, healing promotion and the like, the treatment environment is relatively simple, the process of hospitalization and rehabilitation is not needed after treatment, the patient can be discharged immediately after clinical treatment, and the whole treatment process is very simple and convenient to operate. According to the evaluation of clinical test doctors, the design is simple, efficient and beneficial to doctors and patients.

The four-cavity three-bag prostate expansion catheter assembly mainly comprises a prostate expansion catheter and a latex casing pipe, wherein the latex casing pipe is sleeved on the catheter, a cavity is formed between the latex casing pipe and the catheter, the cavity is communicated with the outside through a communicating pipe, and the latex casing pipe can expand when liquid is introduced into the cavity by means of the elasticity of the latex casing pipe. In the treatment process, the catheter assembly is firstly inserted into the urethra of a patient, and after the catheter assembly is positioned, liquid is introduced into the cavity to expand the latex sleeve, so that the prostate layer is extruded, the urethra is unobstructed, and the treatment purpose is achieved. The catheter, the latex cannula and the catheter assembly will be described separately with reference to the drawings, and the treatment principle thereof will be described in detail.

Figures 1-3 illustrate a prostate dilation catheter according to an embodiment of the present invention. As shown in fig. 1, the prostate dilatation catheter 10 includes a catheter adapter 11, a longitudinal extension 12 and a catheter head 13, the longitudinal extension 12 and the catheter head 13 being integrally formed, i.e. they are integrally formed, from the same material, by the same machining process, the catheter adapter 11 being arranged at the end of the longitudinal extension 12 remote from the catheter head 13. The catheter 10 may be integrally extruded from PVC plastic. The conduit 10 further includes a first communicating pipe 14, a second communicating pipe 15 and a third communicating pipe 16, wherein a first liquid outlet 17, a second liquid outlet 18 and a third liquid outlet 19 are disposed on a wall surface of the longitudinal extending portion 12, at least a portion of each of the first communicating pipe 14, the second communicating pipe 15 and the third communicating pipe 16 is located inside the longitudinal extending portion 12, one end of each of the first communicating pipe 14, the second communicating pipe 15 and the third communicating pipe 16 is respectively communicated with the first liquid outlet 17, the second liquid outlet 18 and the third liquid outlet 19, and the other end of each of the first communicating pipe 14, the second communicating pipe 15 and the third communicating pipe 16 respectively penetrates through the wall surface of the longitudinal extending portion 12 and extends to the outside of the longitudinal extending portion 12. It should be noted that the first communication pipe 14, the second communication pipe 15, and the third communication pipe 16 may extend from an opening port 23, which will be described later, toward the trailing end instead of penetrating through the wall surface of the longitudinally extending portion 12. The first, second and third communicating

tubes

14, 15, 16 may be constructed as pvc plastic tubes with an outer diameter of 2 mm and an inner diameter of 1 mm, and the outer end of each communicating tube is connected with a control valve on the output tube of the medical fluid flow pump, which is not shown in the figures because the control valve belongs to a fluid flow pump instrument system.

Preferably, the at least a portion of the first communication pipe 14, the second communication pipe 15, and the third communication pipe 16 is embedded in the wall surface of the longitudinal extension portion 12, so that the first communication pipe 14, the second communication pipe 15, and the third communication pipe 16 can be directly fixed using the wall surface of the longitudinal extension portion 12 without an additional fixing means, and the first communication pipe 14, the second communication pipe 15, and the third communication pipe 16 can be isolated from the hollow interior of the catheter, avoiding contamination by urine and the like in the hollow interior. Further, the first communication pipe 14, the second communication pipe 15, and the third communication pipe 16 extend in parallel with each other, and are not twisted together.

In the embodiment of fig. 1, the longitudinally extending portion 12, the tube head 13, the first communication tube 14, the second communication tube 15, and the third communication tube 16 constitute an integral structure, but alternatively, they may be separately manufactured and then assembled together. Clearly, the integral construction has particular advantages in that it saves machining and assembly steps and is more reliable.

As shown in fig. 1, the longitudinal positions of the first liquid outlet 17, the second liquid outlet 18, and the third liquid outlet 19 on the wall surface of the longitudinal extension portion 12 are different two by two, and the circumferential positions of the first liquid outlet 17, the second liquid outlet 18, and the third liquid outlet 19 on the wall surface of the longitudinal extension portion 12 are different two by two. In one example, the first liquid outlet 17, the second liquid outlet 18 and the third liquid outlet 19 are uniformly distributed on the wall surface of the longitudinal extension 12 along the circumference of the longitudinal extension 12, that is, the circumferential angle of the first liquid outlet 17 and the second liquid outlet 18 on the wall surface of the longitudinal extension 12 is 120 degrees, the circumferential angle of the first liquid outlet 17 and the third liquid outlet 19 on the wall surface of the longitudinal extension 12 is 120 degrees, and the circumferential angle of the second liquid outlet 18 and the third liquid outlet 19 on the wall surface of the longitudinal extension 12 is 120 degrees. In the embodiment of fig. 1, the circumferential angle of the first liquid outlet 17 and the second liquid outlet 18 on the wall surface of the longitudinal extension portion 12 is 90 degrees, the circumferential angle of the second liquid outlet 18 and the third liquid outlet 19 on the wall surface of the longitudinal extension portion 12 is 90 degrees, and the circumferential angle of the first liquid outlet 17 and the third liquid outlet 19 on the wall surface of the longitudinal extension portion 12 is 180 degrees. The first outlet orifice 17 is spaced from the second outlet orifice 18 by 3-10 cm in the longitudinal direction of the longitudinal extension 12, and the second outlet orifice 18 is spaced from the third outlet orifice 19 by 8-20 cm in the longitudinal direction of the longitudinal extension 12.

In order to drain urine in the bladder or supply medical fluid into the body, the catheter 10 is designed to: the interior of the longitudinal extension 12 is hollow, one end of the longitudinal extension 12 remote from the conduit head 13 has an open port 23, the conduit 10 further comprises at least one fourth liquid outlet 20, the fourth liquid outlet 20 is disposed on the conduit head 13, and the conduit head 13 comprises a hollow 21 in the center of the conduit head 13, such that the fourth liquid outlet 20 communicates with the open port 23 through the hollow 21. Thus, when using the catheter assembly of the present invention, urine that has accumulated in the bladder and cannot be discharged can be discharged through the fourth liquid outlet 20.

Advantageously, said at least one fourth liquid outlet 20 comprises a liquid outlet provided on the tip of the conduit head 13 and a liquid outlet provided on the side wall of the conduit head 13. The catheter head 13 has a stepped outer contour and the end of the catheter head 13 remote from the longitudinal extension 12 has an arcuate contour, which facilitates insertion of the catheter.

In order to prevent the curved guide portion of the front end of the catheter from entering into the bladder after penetrating into the urethra, the central axis of the catheter head 13 of the front end is inclined relative to the central axis of the longitudinal extension 12, specifically, the included angle between the central axis of the catheter head 13 and the central axis of the longitudinal extension 12 is 10-20 degrees, and preferably, the included angle between the central axis of the catheter head 13 and the central axis of the longitudinal extension 12 is 15 degrees.

In one example, the wall of the longitudinal extension 12 is provided with an outwardly projecting annular flange 22. The annular flange can be used for positioning the joint point of the catheter and the latex casing pipe, and the annular flange can enhance the joint force of the latex casing pipe and the catheter, and the joint area of the latex casing pipe and the catheter is increased, so that the sealing between the catheter and the latex casing pipe is ensured, and the reliability is improved. Specifically, three annular flanges 22 are provided on the wall surface of the longitudinal extension portion 12, the three annular flanges 22 are provided at different longitudinal positions on the wall surface of the longitudinal extension portion 12, the first liquid outlet 17 and the second liquid outlet 18 are located between the first annular flange and the second annular flange, and the third liquid outlet 19 is located between the second annular flange and the third annular flange.

In order to increase the strength of the catheter and to prevent the catheter from breaking under the action of external forces after insertion into the urethra or under the pressure of the inner and outer balloons, a plurality of reinforcing ribs are provided on the inner surface of the wall surface of the longitudinal extension 12 between the first annular flange and the second annular flange, said reinforcing ribs being distributed circumferentially along the inner surface of the wall surface of the longitudinal extension 12 or, alternatively, longitudinally along the inner surface of the wall surface of the longitudinal extension 12.

A marking line is provided on a wall surface of the longitudinally extending portion 12 at an end remote from the catheter head 13, the marking line being opposed to the inclined catheter head 13 to mark the direction of inclination of the catheter head 13. By marking the line, the operator can know in which direction the catheter head 13 is deflected, facilitating insertion and removal of the catheter.

Fig. 4 to 6 show a latex cannula according to an embodiment of the present invention, in a catheter assembly in which the latex cannula is fitted over a catheter, which is configured to have three balloon sections, the latex cannula 30 includes a grip section 31, a first coupling section 32, an outer balloon section 33, a second coupling section 39, an auxiliary outer balloon section 34, a third coupling section 40, and a cannula head 35 in the backward-forward direction. The gripping section 31, the outer bladder section 33, the auxiliary outer bladder section 34, the cannula head 35, the first coupling section 32, the second coupling section 39 and the third coupling section 40 constitute an integral structure. An auxiliary outer bladder section 34 is arranged between the outer bladder section 33 and the casing head 35, wherein the latex casing 30 further comprises an inner bladder section 36, the inner bladder section 36 is arranged inside the outer bladder section 33, and the length of the inner bladder section 36 is smaller than the length of the outer bladder section 33. The inner bladder section 36, the outer bladder section 33, and the auxiliary outer bladder section 34 are adapted to expand outwardly under the pressure of the fluid, thereby compressing the treatment site. The inner balloon section 36, the outer balloon section 33, and the auxiliary outer balloon section 34 are inflatable on the premise that they need to be bonded to the wall surface of the catheter 10 to form a relatively closed cavity (with respect to which, will be described later), and therefore, the latex sheath 30 further includes a first bonding section 32, a second bonding section 39, and a third bonding section 40 for bonding with the prostate-dilating catheter 10, wherein the first bonding section 32 is disposed between the grip section 31 and the outer balloon section 33, the second bonding section 39 is disposed between the outer balloon section 33 and the auxiliary outer balloon section 34, and the third bonding section 40 is disposed between the auxiliary outer balloon section 34 and the sheath head 35. With respect to the bonding of the inner balloon section 36 to the wall of the catheter 10, additional bonding sections may be employed, for example, additional bonding sections may be provided at both ends of the inner balloon section 36, with the additional bonding sections bonding the inner balloon section 36 to the wall of the catheter, thereby forming a relatively closed cavity between the inner balloon section 36 and the catheter 10. The latex sleeve employs a white latex material, which has good elasticity, in consideration of the expandability of the sleeve.

It should be noted that, since the inner balloon section 36 is disposed inside the outer balloon section 33 and is shorter than the outer balloon section 33, in order not to affect the combination of the outer balloon section 33 and the catheter, i.e., the combination is performed by the first combining section 32 and the second combining section 39, the outer balloon section 33 seems to surround the inner balloon section 36 and the additional combining sections at both ends of the inner balloon section 36, and both the outer balloon section 33 and the inner balloon section 36 are combined with the catheter to form a closed space, and the space between the inner balloon section 36 and the catheter 10 and the space between the outer balloon section 33 and the inner balloon section 36 are working chambers. Fig. 7 shows additional bonded segments at both ends of the inner bladder segment 36.

The first liquid outlet 17 of the conduit 10 corresponds to the inner bag section 36, the second liquid outlet 18 corresponds to the part of the outer bag section 33 except for the inner bag section 36, and the third liquid outlet 19 corresponds to the auxiliary outer bag section 34, i.e., liquid can pass through the first communication pipe 14, the second communication pipe 15 and the third communication pipe 16, and then enter the inner bag section 36, the outer bag section 33 and the auxiliary outer bag section 34 through the first liquid outlet 17, the second liquid outlet 18 and the third liquid outlet 19, see fig. 9.

It is noted that the auxiliary outer bladder section 34 functions as a positioning member, as will be described later. The reason why the prostate is pressed by one of the outer balloon section 33 and the inner balloon section 36 is that the outer balloon section 33 is long, and if the outer balloon section 33 is separately arranged, the deformation of the outer balloon section 33 is not easy to control, and the inner balloon section 36 can restrict and restrict the deformation of the outer balloon section 33, so that the expanded outer contour is more cylindrical, and the prostate tissue can be extruded conveniently. The length of the inner bladder section 36 is about 1/3 the length of the outer bladder section 33. In actual use, the inner bag section 36 or the outer bag section 33 can be inflated independently by controlling the first communication pipe 14 and the second communication pipe 15. When the device is used for local treatment, the inner balloon section 36 can be inflated independently, when the treatment range is larger, the outer balloon section 33 can be inflated independently, and the inner balloon section 36 and the outer balloon section 33 can be inflated simultaneously.

The latex cannula 30 further includes at least one opening 37, the opening 37 being disposed on the cannula head 35, the at least one opening 37 including an opening 37 disposed on a tip of the cannula head 35 and an opening 37 disposed on a sidewall of the cannula head 35. The opening 37 in the cannula head 35 is located opposite the fourth liquid outlet 20 in the catheter head 13.

Advantageously, a plurality of arc-like projections 38 are provided on the outer surface of the outer bladder section 33, see fig. 6. The design is mainly applied to positioning, extruding and hemostasis when bleeding or inflammation occurs on the local part of the inner wall of the urethra.

An interlining is disposed between the first and

third coupling sections

32 and 40 on the inner surface of the latex sleeve 30, and an interlining is disposed between the inner and

outer bladder sections

36 and 33. The lining cloth is used for restraining and containing the three bag sections and preventing the three bag sections from expanding and bursting. The lining cloth is provided with preset folds, the lining cloth retracts along the folds in the contraction state of the bag section, and the folds of the lining cloth are unfolded to adapt to the shape of the bag section when the bag section is pressed and expanded.

The latex casing pipe utilizes the principle that the thickness and the thickness of the rubber layer of each part on the whole colloid casing pipe are different and the expansion coefficient is also different, so that a whole casing pipe can form a front outer sac and a rear outer sac very conveniently, the difficulty of assembling multiple sacs on one catheter simultaneously is solved, and the treatment scheme is realized. Specifically, the wall thickness of the inner bladder section 36, the outer bladder section 33, and the auxiliary outer bladder section 34 are each smaller than the wall thickness of any of the first bonding section 32, the second bonding section 39, and the third bonding section 40. The inner bladder section 36, the outer bladder section 33, and the auxiliary outer bladder section 34 may have the same wall thickness, the first, second, and third joining

sections

32, 39, and 40 may have the same wall thickness, and the wall thickness of the first, second, and third joining

sections

32, 39, and 40 may be equal to the wall thickness of the grip section 31. Optionally, the wall thickness of the inner bladder section 36 is less than the wall thickness of the outer bladder section 33.

It is particularly preferred that the wall thickness of the outer bladder section 33 varies along the longitudinal length such that the wall thickness of the outer bladder section 33 undergoes at least a decrease, an increase, a decrease, an increase change along the longitudinal length. Fig. 8 shows a specific example of an outer bladder section 33, in which the outer bladder section 33 has two thicknesses, and the two thicknesses are alternately arranged. The purpose of this is: if the outer balloon section 33 has a uniform thickness, it forms a contour similar to a sphere when it is inflated under pressure, and when the outer balloon section 33 has a thickness as shown in fig. 8, it forms a contour more similar to a cylinder when it is inflated, the pressure of the cylindrical outer contour surface to the prostate tissue is a surface pressure, and the pressure of the spherical outer contour surface to the prostate tissue is a point pressure, obviously such a design makes the pressure more uniform, and thus the treatment effect is better.

Similarly, the inner balloon section 36 may adopt the same arrangement, and the auxiliary outer balloon section 34 need not adopt this arrangement since the main function of the auxiliary outer balloon section 34 is to position the catheter assembly, which is more easily positioned by the spherical outer profile when inflated.

Advantageously, from the cannula head 35 to the end of the gripping section 31, graduation marks are provided on the outer surface of the latex cannula 30 for marking the depth of insertion of the latex cannula 30.

The cannula head 35 has a stepped outer contour and the end of the cannula head 35 remote from the gripping section 31 has an arcuate contour such that the shape of the cannula head 35 matches the shape of the catheter head 13. The central axis of the cannula head 35 is inclined with respect to the central axis of the holding section 31, specifically, the included angle between the central axis of the cannula head 35 and the central axis of the holding section 31 is 10 to 20 degrees, and preferably, the included angle between the central axis of the cannula head 35 and the central axis of the holding section 31 is 15 degrees.

The first, second, and

third coupling sections

32, 39, and 40 correspond one-to-one to the first, second, and third annular flanges.

In the same manner as the design of the marker line on the catheter 10, the holding section 31 may be provided with a marker line which faces the inclined cannula head 35 and which, when the latex cannula 30 is assembled to the catheter 10, faces the inclined catheter head 13 to mark the inclination direction of the cannula head 35. In order to facilitate the operator to know the position of the liquid outlet, a marking pattern is provided on both the outer bag section 33 and the auxiliary outer bag section 34 for marking the position of the liquid outlet on the catheter 10. Specifically, two marking patterns are provided on the outer bag section 33 for marking the positions of the first liquid outlet 17 and the second liquid outlet 18, respectively, and one marking pattern is provided on the auxiliary outer bag section 34 for marking the position of the third liquid outlet 19. The marking patterns on the outer bladder section 33 and the auxiliary outer bladder section 34 differ two by two in the longitudinal position on the latex sleeve 30, and the marking patterns on the outer bladder section 33 and the auxiliary outer bladder section 34 differ two by two in the circumferential position on the outer surface of the latex sleeve 30. The marking patterns on the outer bladder section 33 and the auxiliary outer bladder section 34 are evenly distributed along the circumference of the latex sleeve 30 on the outer surface of the latex sleeve 30, i.e., the circumferential angle of the two marking patterns on the outer surface of the latex sleeve 30 is 120 degrees.

Figures 9-10 are schematic views of a four-lumen, three-balloon prostate dilation catheter assembly according to an embodiment of the present invention. It should be noted that the catheter assembly is a combination of a catheter and a latex casing, and for simplifying the drawing, the boundary between the catheter and the latex casing is not shown in the drawing because they are actually tightly combined together, the white area in fig. 9 is understood as the catheter, and the shaded area is understood as the cross section of the latex casing, and in addition, the first communicating pipe 14, the second communicating pipe 15 and the third communicating pipe 16 are illustrated as examples in the drawing, which do not protrude from the wall surface of the longitudinal extension portion 12, that is, they extend to the tail end and protrude from the open port 23.

As shown in the figures, the four-chamber three-cell prostate expansion catheter assembly 100 includes a catheter 10 and a latex sleeve 30, the catheter 10 includes a first communicating tube 14, a second communicating tube 15 and a third communicating tube 16, and a first liquid outlet 17, a second liquid outlet 18 and a third liquid outlet 19 are provided on a wall surface of the catheter 10, one end of each of the first communicating tube 14, the second communicating tube 15 and the third communicating tube 16 is respectively communicated with the first liquid outlet 17, the second liquid outlet 18 and the third liquid outlet 19, wherein the latex sleeve 30 is combined with the catheter 10, such that an outer chamber 51, an inner chamber 52 and an auxiliary chamber 53 which are isolated from each other are formed between the latex sleeve 30 and the catheter 10, the outer chamber 51 surrounds the inner chamber 52, and the inner chamber 52, the outer chamber 51 and the auxiliary chamber 53 are respectively communicated with the first liquid outlet 17, the second liquid outlet 18 and the third liquid outlet. The four-lumen three-balloon prostate dilation catheter assembly of the present invention refers to the outer lumen, the inner lumen, the auxiliary lumen and the lumen formed inside the catheter head.

The latex sleeve 30 and the catheter 10 are joined to form a first connection junction 54, a second connection junction 55, and a third connection junction 56, the outer lumen 51 and the inner lumen 52 being located between the first connection junction 54 and the second connection junction 55, and the auxiliary lumen 53 being located between the second connection junction 55 and the third connection junction 56. That is, the first annular flange of the catheter 10 is joined to the first bonded section 32 of the latex sleeve 30 to form a first connection 54, the second annular flange of the catheter 10 is joined to the second bonded section 39 of the latex sleeve 30 to form a second connection 55, and the third annular flange of the catheter 10 is joined to the third bonded section 40 of the latex sleeve 30 to form a third connection 56.

The first connecting joint 54, the second connecting joint 55 and the third connecting joint 56 are respectively composed of lining cloth and adhesive, and the lining cloth and the adhesive are combined to facilitate the fastening performance and the sealing performance of the combination.

As previously mentioned, the portions of the latex cannula 30 that are used to form the outer lumen 51, the inner lumen 52 and the auxiliary lumen 53 have a thinner wall thickness than the other portions of the latex cannula 30.

As an alternative example of the embodiment of fig. 9, at least a portion of each of the first communication pipe 14, the second communication pipe 15, and the third communication pipe 16 is located inside the duct 10, and the other ends of each of the first communication pipe 14, the second communication pipe 15, and the third communication pipe 16 respectively penetrate through the wall surface of the duct 10 to extend to the outside of the duct 10. The at least a portion of the first communication pipe 14, the second communication pipe 15, and the third communication pipe 16 is embedded in the wall surface of the duct 10.

The interior of the duct assembly 100 is hollow, one end of the duct assembly 100 has an opening port 23, the other end has an insertion head, a communication port is provided on the insertion head, and the opening port 23 communicates with the communication port. The insertion heads correspond to the catheter head 13 of the catheter 10 and the cannula head 35 of the latex cannula 30 as a combined product of the two. Accordingly, the communication ports thereon correspond to the fourth liquid outlet 20 and the opening 37.

The central axis of the insertion head is inclined with respect to the central axis of the main body of the catheter assembly 100, in particular, the angle between the central axis of the insertion head and the central axis of the main body of the catheter assembly 100 is 10-20 degrees, and preferably, the angle between the central axis of the insertion head and the central axis of the main body of the catheter assembly 100 is 15 degrees. The catheter assembly 100 further comprises a catheter adapter 11, the catheter adapter 11 being arranged at an end of the catheter assembly 100 remote from the insertion head.

The working principle of the four-lumen three-balloon prostate dilation catheter assembly 100 is described below.

The prostate expansion catheter assembly 100 is formed by combining a catheter 10 and a latex sleeve 30, the outer cavity 51, the inner cavity 52 and the auxiliary cavity 53 which are isolated from each other are formed by combining the two, when the catheter assembly 100 is used for treatment, an elastic clamp can be used in a matching way, and the working principle is as follows:

first, the catheter assembly 100 is pushed into the bladder through the urethral orifice to push the slightly curved semicircular insertion head, so that the urine which cannot be discharged from the bladder is accumulated, and the urine is discharged from the opening port 23 to the outside of the body along the hollow part 21 connected through the opening 37 at the center of the front semicircular head and the fourth liquid outlet 20, thereby relieving the urine pressure of the bladder of the patient. Then, liquid flow with certain standard pressure is injected through other first communicating pipes 14, second communicating pipes 15 and third communicating pipes 16, the liquid flow with certain pressure is sent into the inner cavity 52, the outer cavity 51 and the auxiliary cavity 53 through the corresponding first liquid outlet 17, second liquid outlet 18 and third liquid outlet 19, so that the cavities respectively expand in different degrees under the action of the liquid flow pressure, at the moment, the urethra is gradually converted into an outward expansion state from a state of being contracted by the enlargement and compression of the prostate, the process enables the loosened prostate layer to start to slowly recover to an original fine tissue state under the action of certain external pressure formed by the expansion of the inner cavity 52 and the outer cavity 51, and meanwhile, the urethra is prevented from being compressed by the prostate, and the smooth state of the urethra is recovered. The whole process is a simple physical process, and does not need any medicine or other auxiliary measures. Therefore, the four-cavity three-sac prostate expansion catheter assembly has the advantages of simple treatment principle, uncomplicated treatment instruments, very convenient clinical operation for medical care personnel, no pain for patients, no need of paying high operation cost, no need of long time process for hospitalization operation and rehabilitation, and capability of discharging the patients after only 1-2 hours of outpatient operation for medical care personnel.

Brief description of the operational procedure and method of operation:

1) before the catheter component penetrates into the urethral orifice, a layer of lubricant is coated on the outer surface of the insertion head part with the curved semicircular shape, so that pain caused by friction between the inner wall of the urethra and the catheter component is prevented;

2) after the catheter assembly penetrates into the urethra and the inserting head with the front end bent into a semicircular shape completely enters the bladder, the control switch at the outer end of the opening port is opened so as to facilitate the urination outside the body and control the entering depth of the catheter assembly;

3) after the urine is discharged, injecting pressure liquid flow for calibration into the inner cavity, the outer cavity and the auxiliary cavity, and sequentially performing according to a specified program, firstly injecting pressure liquid flow with standard dosage into the auxiliary cavity 53 arranged near the top end, closing a control valve at an input port of the third communicating pipe 16, expanding the auxiliary cavity under the action of the pressure liquid flow for calibration, and then pumping the catheter assembly outwards until the expanded auxiliary cavity is clamped at the joint of the bladder and the urethra, wherein the whole catheter assembly is in the optimal position to finish positioning;

4) in order to prevent the catheter assembly from being accurately positioned and possibly generating displacement in the inner and outer directions at any time to influence the treatment effect, the catheter is required to be clamped by the elastic clamp along the end part of the tortoise head immediately after positioning, so that the catheter assembly is prevented from sliding inwards, the catheter cannot move outwards at the moment because the auxiliary cavity is positioned in the bladder, but the catheter may move inwards, and then the clamp is used for carrying out reverse secondary positioning, so that the auxiliary cavity blocks the bladder outlet due to expansion, the catheter assembly cannot slide outwards, and meanwhile, the catheter assembly cannot slide inwards under the limiting action of the elastic clamp. Thereby ensuring that the inner cavity and the outer cavity are in the optimal positions in the whole treatment process;

5) finally, calibrated pressure liquid flows with different standard dosages are respectively injected into the inner cavity and the outer cavity through the first communicating pipe 14 and the second communicating pipe 15, relevant control valves are closed, and the pressure is stabilized for one standard treatment period;

6) after one treatment course is finished, all the control valves are released, pressure liquid flow in each cavity is discharged, the catheter assembly is drawn out, the whole treatment course is completely finished, generally, the patient can be completely recovered without three treatment courses, and the whole course only needs outpatient operation without hospitalization.

The invention adopts the bladder inner cavity positioning technology of the front end latex elastic auxiliary cavity, applies the treatment technical principle that the inner cavity and the outer cavity are expanded under the action of liquid flow with calibrated pressure and then extrude prostate tissues around the urethra, adopts the elastic clamp external positioning measure, penetrates three communicating pipes in the catheter main body and respectively injects liquid flow with calibrated pressure to successively expand the inner cavity and the outer cavity so as to realize the medical effect, and the latex sleeve pipe uses the principle that the thickness and the thickness of the rubber layer of each part on the whole colloid sleeve pipe are different and the expansion coefficient is also different, so that the integral sleeve pipe is very simple and convenient to form a front outer bag and a rear outer bag, thereby solving the difficulty of simultaneously assembling a plurality of bags on one catheter and realizing the treatment scheme. In order to prevent the arc-shaped guide part at the front end of the catheter from entering into a branch road by mistake after penetrating into the urethra and before entering into the bladder, the design that the central axis of the guide head at the front end and the central axis of the catheter main body form a 15-degree bending included angle is specially designed; the outer surface of the latex sleeve is provided with a row of arc-shaped bulges with the width of 10mm and the height of 5mm, and the design is mainly applied to positioning, extruding and hemostasis when bleeding or inflammation occurs on the local part of the inner wall of the urethra; in addition, if inflammation occurs in the inner cavity of the bladder or the inner wall of the urethra, the treatment can be performed by injecting normal saline into the hollow part of the head part of the catheter to flush or injecting related anti-inflammatory drugs.

Although embodiments of the present invention have been shown and described, it would be appreciated by those skilled in the art that changes may be made in these embodiments without departing from the principles and spirit of the invention. The scope of applicability of the present invention is defined by the appended claims and their equivalents.

List of reference numerals:

100 catheter assembly

10 catheter

11 pipe joint

12 longitudinal extension

13 catheter head

14 first communicating pipe

15 second communicating pipe

16 third communicating pipe

17 first liquid outlet

18 second liquid outlet

19 third liquid outlet

20 fourth liquid outlet

21 hollow part

22 annular flange

23 open port

30 emulsion casing

31 grip segment

32 first joining section

33 outer bladder segment

34 auxiliary outer bladder segment

35 casing head

36 inner bag section

37 opening

38 arc-shaped protrusion

39 second joining section

40 third joining section

51 outer cavity

52 inner cavity

53 auxiliary chamber

54 first connection

55 second connecting knot

56 third connecting node.

Claims

1. A four-lumen, three-balloon prostate dilation catheter assembly (100) comprising a catheter (10) and a latex cannula (30), characterized by:

the conduit (10) comprises a first communicating pipe (14), a second communicating pipe (15) and a third communicating pipe (16), a first liquid outlet (17), a second liquid outlet (18) and a third liquid outlet (19) are arranged on the wall surface of the conduit (10), one end of each of the first communicating pipe (14), the second communicating pipe (15) and the third communicating pipe (16) is respectively communicated with the first liquid outlet (17), the second liquid outlet (18) and the third liquid outlet (19),

wherein the latex sleeve (30) is combined with the catheter (10) to form an outer cavity (51), an inner cavity (52) and an auxiliary cavity (53) which are isolated from each other between the latex sleeve (30) and the catheter (10), the outer cavity (51) surrounds the inner cavity (52), and the inner cavity (52), the outer cavity (51) and the auxiliary cavity (53) are respectively communicated with the first liquid outlet (17), the second liquid outlet (18) and the third liquid outlet (19).

2. The four-lumen, three-balloon prostate dilation catheter assembly (100) of claim 1, wherein:

the combination of the latex sleeve (30) and the catheter (10) forms a first connection junction (54), a second connection junction (55) and a third connection junction (56), the outer lumen (51) and the inner lumen (52) are located between the first connection junction (54) and the second connection junction (55), and the auxiliary lumen (53) is located between the second connection junction (55) and the third connection junction (56).

3. The four-lumen, three-balloon prostate dilation catheter assembly (100) of claim 2, wherein:

the first connecting joint (54), the second connecting joint (55) and the third connecting joint (56) are respectively composed of lining cloth and adhesive.

4. The four-lumen, three-balloon prostate dilation catheter assembly (100) of claim 3, wherein:

the wall thickness of the part of the latex sleeve (30) for forming the outer cavity (51), the inner cavity (52) and the auxiliary cavity (53) is thinner than that of the other part of the latex sleeve (30).

5. The four-lumen, three-balloon prostate dilation catheter assembly (100) of claim 4, wherein:

at least a part of each of the first communication pipe (14), the second communication pipe (15) and the third communication pipe (16) is located inside the conduit (10), and the other end of each of the first communication pipe (14), the second communication pipe (15) and the third communication pipe (16) penetrates through the wall surface of the conduit (10) and extends to the outside of the conduit (10).

6. The four-lumen, three-balloon prostate dilation catheter assembly (100) of claim 5, wherein:

the at least a part of the first communication pipe (14), the second communication pipe (15), and the third communication pipe (16) is embedded in a wall surface of the duct (10).

7. The four-lumen, three-balloon prostate dilation catheter assembly (100) of claim 6, wherein:

the interior of the catheter assembly (100) is hollow, one end of the catheter assembly (100) is provided with an opening port (23), the other end of the catheter assembly is provided with an insertion head, a communication port is formed in the insertion head, and the opening port (23) is communicated with the communication port.

8. The four-lumen, three-balloon prostate dilation catheter assembly (100) of claim 7, wherein:

the central axis of the insertion head is inclined with respect to the central axis of the main body of the catheter assembly (100).

9. The four-lumen, three-balloon prostate dilation catheter assembly (100) of claim 8, wherein:

the angle between the central axis of the insertion head and the central axis of the main body of the catheter assembly (100) is 10-20 degrees.

10. The four-chambered, three-balloon prostate dilation catheter assembly (100) according to any one of claims 1-9, wherein:

the catheter assembly (100) further comprises a catheter adapter (11), the catheter adapter (11) being arranged at an end of the catheter assembly (100) remote from the insertion head.