CN111068167B - Four-cavity three-bag prostate expanding catheter assembly - Google Patents
Four-cavity three-bag prostate expanding catheter assembly Download PDFInfo
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- CN111068167B CN111068167B CN201911354905.8A CN201911354905A CN111068167B CN 111068167 B CN111068167 B CN 111068167B CN 201911354905 A CN201911354905 A CN 201911354905A CN 111068167 B CN111068167 B CN 111068167B
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- 210000002307 prostate Anatomy 0.000 title abstract description 33
- 239000007788 liquid Substances 0.000 claims abstract description 97
- 239000004816 latex Substances 0.000 claims abstract description 70
- 229920000126 latex Polymers 0.000 claims abstract description 70
- 238000004891 communication Methods 0.000 claims description 53
- 238000003780 insertion Methods 0.000 claims description 24
- 230000037431 insertion Effects 0.000 claims description 24
- 239000000853 adhesive Substances 0.000 claims description 4
- 230000001070 adhesive effect Effects 0.000 claims description 4
- 230000008859 change Effects 0.000 claims description 2
- 206010004446 Benign prostatic hyperplasia Diseases 0.000 abstract description 11
- 208000004403 Prostatic Hyperplasia Diseases 0.000 abstract description 10
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 7
- 201000010099 disease Diseases 0.000 abstract description 4
- 210000003932 urinary bladder Anatomy 0.000 description 34
- 238000000034 method Methods 0.000 description 19
- 210000003708 urethra Anatomy 0.000 description 19
- 230000008878 coupling Effects 0.000 description 14
- 238000010168 coupling process Methods 0.000 description 14
- 238000005859 coupling reaction Methods 0.000 description 14
- 230000008569 process Effects 0.000 description 14
- 239000010410 layer Substances 0.000 description 9
- 230000036407 pain Effects 0.000 description 9
- 206010061218 Inflammation Diseases 0.000 description 8
- 238000013461 design Methods 0.000 description 8
- 210000002700 urine Anatomy 0.000 description 7
- 230000010339 dilation Effects 0.000 description 6
- 239000004744 fabric Substances 0.000 description 6
- 230000004054 inflammatory process Effects 0.000 description 6
- 230000009471 action Effects 0.000 description 5
- 238000001125 extrusion Methods 0.000 description 4
- 230000000149 penetrating effect Effects 0.000 description 4
- 210000004872 soft tissue Anatomy 0.000 description 4
- 206010002091 Anaesthesia Diseases 0.000 description 3
- 230000037005 anaesthesia Effects 0.000 description 3
- 239000002775 capsule Substances 0.000 description 3
- 229940126678 chinese medicines Drugs 0.000 description 3
- 239000012530 fluid Substances 0.000 description 3
- 230000035876 healing Effects 0.000 description 3
- 238000005304 joining Methods 0.000 description 3
- 230000027939 micturition Effects 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 229940126673 western medicines Drugs 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000023597 hemostasis Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 239000012790 adhesive layer Substances 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 229940124599 anti-inflammatory drug Drugs 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000009172 bursting Effects 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000003467 diminishing effect Effects 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000003754 machining Methods 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 238000010827 pathological analysis Methods 0.000 description 1
- 238000000554 physical therapy Methods 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000000452 restraining effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 238000011272 standard treatment Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
- A61M25/10181—Means for forcing inflation fluid into the balloon
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Child & Adolescent Psychology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention provides a four-cavity three-sac prostate expanding catheter assembly (100), which comprises a catheter (10) and a latex sleeve (30), wherein the catheter (10) comprises three communicating pipes, a first liquid outlet (17), a second liquid outlet (18) and a third liquid outlet (19) are arranged on the wall surface of the catheter (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), an outer cavity (51), an inner cavity (52) and an auxiliary cavity (53) which are isolated from each other are formed between the latex sleeve (30) and the catheter (10), 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). The four-cavity three-bag prostate expanding catheter assembly can effectively treat the diseases of prostatic hyperplasia.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a four-cavity three-sac prostate expanding catheter assembly.
Background
In middle-aged and elderly people, the phenomenon of prostatic hyperplasia diseases is very common, and the senile diseases have a greatly increasing trend along with the aging change of the global population. The pathological analysis of the prostatic hyperplasia is as follows: the periphery of male external urethra is tightly wrapped with a layer of fine soft tissue, and this layer of soft tissue is the prostate, and as the age increases, the fine degree of this layer of soft tissue changes, and is gradually loose, so that the thickness of the prostate layer also thickens, and because the periphery of the prostate layer is wrapped by body tissue, the thickened soft tissue body can not expand outwards, can only develop inwards, and after this the prostate thickens to a certain extent, the urethra begins to be pressed gradually. The urethra in this position will therefore become stenosed due to hyperplasia of the prostate, thereby affecting urination and even creating a difficult urination problem. In severe cases, patients may not urinate for many days, which is very painful.
The treatment of the disease is still a surgical treatment method for decades, and the traditional treatment method can solve the pain of patients, but has the problems of high cost, operation bearing of the patients in the treatment process, the need of using a large amount of Chinese and western medicines for anesthesia, inflammation diminishing, pain relieving, healing promotion and the like, and the long treatment period and the like. Patients can also choose to go to hospital for catheterization to relieve pain, but excessive times of catheterization can promote the formation of inflammation on the inner wall of the urethra, and most patients finally have to choose surgery to resect the prostate.
Disclosure of Invention
The present invention aims to at least partially overcome the drawbacks of the prior art and to provide a medical device for treating a benign prostatic hyperplasia disorder or at least alleviating pain in a patient suffering from a benign prostatic hyperplasia.
The invention also aims to provide a four-cavity three-sac prostate expanding catheter assembly for effectively treating the benign prostatic hyperplasia.
The invention also aims to provide the four-cavity three-sac prostate expanding catheter assembly for treating the benign prostatic hyperplasia diseases, which has a simple structure and is convenient to operate.
In order 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 expanding catheter assembly comprises a catheter and a latex sleeve,
The catheter 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 catheter, 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 isolated from each other 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 invention, the combination of the latex sleeve and the catheter forms a first connection, a second connection and a third connection, the outer lumen and the inner lumen being located between the first connection and the second connection, and the auxiliary lumen being located between the second connection and the third connection.
According to a preferred embodiment of the invention, the first, second and third connection junctions are respectively composed of a backing and an adhesive.
According to a preferred embodiment of the invention, the wall thickness of the portion of the latex sleeve used to form the outer lumen, the inner lumen and the auxiliary lumen is thinner than the wall thickness of the other portions of the latex sleeve.
According to a preferred embodiment of the present invention, at least a part of each of the first communication pipe, the second communication pipe, and the third communication pipe is located inside the duct, and the other ends of each of the first communication pipe, the second communication pipe, and the third communication pipe extend outside the duct through the wall surface of the duct, respectively.
According to a preferred embodiment of the invention, the at least a part of the first communication tube, the second communication tube and the third communication tube are embedded in the wall surface of the conduit.
According to a preferred embodiment of the present invention, the interior of the catheter assembly is hollow, one end of the catheter assembly has an open port, the other end has an insertion head, a communication port is provided on the insertion head, and the open 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 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 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, which is arranged at the end of the catheter assembly remote from the insertion head.
The four-cavity three-sac prostate expanding catheter assembly can effectively treat the diseases of prostatic hyperplasia, relieves pain of patients with prostatic hyperplasia, has a simple structure and convenient operation, does not need to perform operation in the whole treatment process, avoids the skin cutting by a scalpel, does not need a large amount of Chinese and western medicines for anesthesia, anti-inflammation, pain relieving, healing promotion and the like, has relatively simple treatment environment, does not need the process of hospitalization and rehabilitation after treatment, can be discharged when in clinical treatment, and has very simple and convenient operation in the whole treatment process. Proved by clinical trial doctors, the method is a simple, efficient and ingenious design which is beneficial to doctors and patients.
Drawings
Fig. 1 is a schematic view of a prostate dilation catheter in accordance with an embodiment of the present invention;
FIG. 2 is a cross-sectional view of the prostate dilation catheter of FIG. 1 taken along section B-B;
FIG. 3 is a cross-sectional view of the prostate dilation catheter of FIG. 1 taken along section A-A;
FIG. 4 is a schematic view of a latex sleeve according to an embodiment of the invention;
FIG. 5 is a partial top view of the latex sleeve of FIG. 4 in the direction C;
FIG. 6 is a cross-sectional view of the latex sleeve of FIG. 4 taken along section D-D;
FIG. 7 is a schematic view of an inner balloon segment of a latex sleeve according to an embodiment of the invention;
FIG. 8 illustrates an outer balloon segment of a latex sleeve according to one embodiment of the invention;
fig. 9 is a schematic view of a four-lumen three-balloon prostate dilation catheter assembly in accordance with an embodiment of the present invention; and
Fig. 10 is a cross-sectional view of the four-lumen, three-balloon prostate-dilation catheter assembly of fig. 9 taken along section E-E.
Detailed Description
Exemplary embodiments of the present invention are described in detail below with reference to the attached drawing figures, wherein the same or similar reference numerals denote the same 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 present 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 the drawings in order to simplify the drawings.
In order to solve the problems in the background art, the designer designs a medical apparatus for treating the benign prostatic hyperplasia by a non-operative physical therapy method, namely a four-cavity three-sac prostate expanding catheter assembly through various aspects of investigation and research. The medical device is a very simple clinical medical instrument, no operation is needed in the whole treatment process, the skin is prevented from being cut by a scalpel, a large number of Chinese and western medicines are not needed for anesthesia, anti-inflammation, pain relieving, healing promotion and the like, the treatment environment is relatively simple, the hospitalization and rehabilitation process is not needed after treatment, the patient can be discharged after clinical treatment, and the whole treatment process is very simple and convenient to operate. Proved by clinical trial doctors, the method is a simple, efficient and ingenious design which is beneficial to doctors and patients.
The four-cavity three-bag prostate expanding catheter assembly mainly comprises a prostate expanding catheter and a latex sleeve, wherein the latex sleeve is sleeved on the catheter, a cavity is formed between the latex sleeve and the catheter, the cavity is communicated with the outside through a communicating pipe, and the latex sleeve can expand when liquid is introduced into the cavity by means of elasticity of the latex sleeve. In the treatment process, firstly, the catheter component is inserted into the urethra of a patient, after the catheter component is positioned, liquid is introduced into the cavity to expand the emulsion sleeve, so that the prostate layer is extruded, the urethra is unobstructed, and the treatment purpose is achieved. The catheter, latex sleeve, catheter assembly are each described below with reference to the accompanying drawings, and the treatment principles thereof are described in detail.
Figures 1-3 illustrate a prostate dilation catheter in accordance with an embodiment of the present invention. As shown in fig. 1, the prostate-dilating catheter 10 comprises a catheter hub 11, a longitudinal extension 12 and a catheter head 13, the longitudinal extension 12 and the catheter head 13 being integrally provided, i.e. they are integrally formed of the same material by the same process, the catheter hub 11 being provided 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 catheter 10 further includes a first communicating tube 14, a second communicating tube 15, and a third communicating tube 16, where a first liquid outlet 17, a second liquid outlet 18, and a third liquid outlet 19 are provided on a wall surface of the longitudinally extending portion 12, at least a portion of each of the first communicating tube 14, the second communicating tube 15, and the third communicating tube 16 is located inside the longitudinally extending portion 12, 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, and the other end of each of the first communicating tube 14, the second communicating tube 15, and the third communicating tube 16 respectively penetrates out of the wall surface of the longitudinally extending portion 12 to the outside of the longitudinally 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 to the trailing end from an opening port 23 to be described later, instead of penetrating from the wall surface of the longitudinally extending portion 12. The first communication tube 14, the second communication tube 15 and the third communication tube 16 may be constructed as pvc plastic tubes having an outer diameter of 2mm and an inner diameter of 1mm, and the outer ends of the respective communication tubes are connected to control valves on the output tube of the medical fluid pump, which are not shown in the drawings because they are fluid pump instrument systems.
Preferably, the at least a portion of the first, second and third communication pipes 14, 15 and 16 are embedded in the wall surface of the longitudinal extension 12, so that the first, second and third communication pipes 14, 15 and 16 can be directly fixed with the wall surface of the longitudinal extension 12 without additional fixing means, and the first, second and third communication pipes 14, 15 and 16 can be isolated from the hollow interior of the catheter, from being contaminated by urine or 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 entangled.
In the embodiment of fig. 1, the longitudinal extension 12, the catheter head 13, the first communication tube 14, the second communication tube 15 and the third communication tube 16 constitute a unitary structure, alternatively they may also be manufactured separately and then assembled together. Clearly, the integrally formed structure has particular advantages in that it allows for a saving in machining and assembly processes and a higher reliability.
As shown in fig. 1, the longitudinal positions of the first, second and third liquid outlets 17, 18 and 19 on the wall surface of the longitudinally extending portion 12 are different from each other, and the circumferential positions of the first, second and third liquid outlets 17, 18 and 19 on the wall surface of the longitudinally extending portion 12 are different from each other. In one example, the first, second and third liquid outlets 17, 18 and 19 are uniformly distributed on the wall surface of the longitudinally extending portion 12 along the circumference of the longitudinally extending portion 12, that is, the circumferential angles of the first and second liquid outlets 17, 18 on the wall surface of the longitudinally extending portion 12 are 120 degrees, the circumferential angles of the first and third liquid outlets 17, 19 on the wall surface of the longitudinally extending portion 12 are 120 degrees, and the circumferential angles of the second and third liquid outlets 18, 19 on the wall surface of the longitudinally extending portion 12 are 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 longitudinally extending 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 longitudinally extending 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 longitudinally extending portion 12 is 180 degrees. The first 17 and second 18 liquid outlets are spaced between 3-10 cm in the longitudinal direction of the longitudinal extension 12 and the second 18 and third 19 liquid outlets are spaced between 8-20 cm in the longitudinal direction of the longitudinal extension 12.
To drain urine within the bladder or supply medical fluid into the body, catheter 10 is designed to: the inside of the longitudinal extension 12 is hollow, the end of the longitudinal extension 12 remote from the catheter head 13 has an open port 23, the catheter 10 further comprises at least one fourth liquid outlet 20, the fourth liquid outlet 20 is disposed on the catheter head 13, and the catheter head 13 comprises a hollow portion 21 at the center of the catheter head 13, such that the fourth liquid outlet 20 communicates with the open port 23 through the hollow portion 21. Thus, when the catheter assembly of the present invention is used, urine that is not excreted in the bladder by backlog can be guided out through the fourth liquid outlet 20.
Advantageously, the at least one fourth outlet 20 comprises a outlet provided on the tip of the catheter head 13 and a outlet provided on a side wall of the catheter head 13. The catheter head 13 has a stepped outer profile and the end of the catheter head 13 remote from the longitudinal extension 12 has an arcuate profile, which facilitates insertion of the catheter.
In order to prevent the arc-shaped guiding portion of the catheter tip from being erroneously turned into the fork after penetrating into the urethra and before entering into the urinary bladder, the central axis of the catheter head 13 of the tip is specifically designed to be inclined with respect to the central axis of the longitudinal extension 12, in particular, the angle between the central axis of the catheter head 13 and the central axis of the longitudinal extension 12 is 10-20 degrees, preferably, the 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 of the catheter and the latex sleeve, and can enhance the bonding force of the latex sleeve and the catheter, because the bonding area of the catheter and the latex sleeve is increased, the sealing between the catheter and the latex sleeve is ensured, and the reliability is improved. Specifically, three annular flanges 22 are provided on the wall surface of the longitudinal extension 12, the three annular flanges 22 being provided at different longitudinal positions on the wall surface of the longitudinal extension 12, the first and second liquid outlets 17, 18 being located between the first and second annular flanges, and the third liquid outlet 19 being located between the second and third annular flanges.
In order to increase the strength of the catheter, however, to prevent the catheter from breaking under the action of external forces after insertion into the urethra or by the extrusion of the inner and outer balloons, a plurality of stiffening ribs are provided on the inner surface of the wall of the longitudinal extension 12 between the first annular flange and the second annular flange, said stiffening ribs being circumferentially distributed along the inner surface of the wall of the longitudinal extension 12 or, alternatively, said stiffening ribs being longitudinally distributed along the inner surface of the wall of the longitudinal extension 12.
A marking line is provided on a wall surface of the end of the longitudinal extension 12 remote from the catheter head 13, the marking line being opposite to the inclined catheter head 13 to mark the inclined direction of the catheter head 13. By marking the wire, the operator can know in which direction the catheter head 13 is deflected, facilitating insertion and extraction of the catheter.
Fig. 4-6 illustrate a latex sleeve according to an embodiment of the invention, in a catheter assembly, the latex sleeve being sleeved over a catheter, which is configured with three balloon segments, the latex sleeve 30 comprising, in a back-to-front direction, a grip segment 31, a first coupling segment 32, an outer balloon segment 33, a second coupling segment 39, an auxiliary outer balloon segment 34, a third coupling segment 40 and a sleeve head 35. The grip section 31, the outer bladder section 33, the auxiliary outer bladder section 34, the sleeve head 35, the first coupling section 32, the second coupling section 39 and the third coupling section 40 constitute a unitary structure. An auxiliary outer balloon segment 34 is arranged between the outer balloon segment 33 and the sleeve head 35, wherein the latex sleeve 30 further comprises an inner balloon segment 36, the inner balloon segment 36 is arranged inside the outer balloon segment 33, and the length of the inner balloon segment 36 is smaller than the length of the outer balloon segment 33. The inner bag section 36, the outer bag section 33, the auxiliary outer bag section 34 are adapted to expand outwardly under the influence of the liquid pressure, thereby compressing the treatment site. The inner and outer balloon sections 36, 33, 34 are capable of inflation provided that they are required to form a relatively airtight cavity (as to which will be described later) in combination with the wall surface of the catheter 10, and therefore, the latex sleeve 30 further includes a first coupling section 32, a second coupling section 39 and a third coupling section 40 for coupling with the prostate-dilation catheter 10, wherein the first coupling section 32 is disposed between the grip section 31 and the outer balloon section 33, the second coupling section 39 is disposed between the outer balloon section 33 and the auxiliary outer balloon section 34, and the third coupling section 40 is disposed between the auxiliary outer balloon section 34 and the sleeve head 35. With respect to the bonding of the inner balloon segment 36 to the wall of the catheter 10, additional bonding segments may be employed, such as additional bonding segments disposed at either end of the inner balloon segment 36, with the inner balloon segment 36 being bonded to the wall of the catheter using the additional bonding segments, such that a relatively airtight cavity is formed between the inner balloon segment 36 and the catheter 10. The latex sleeve is made of white latex material with good elasticity in consideration of the expansibility of the sleeve.
It should be noted that, since the inner bag section 36 is disposed inside the outer bag section 33 and is shorter than the outer bag section 33, in order not to affect the bonding of the outer bag section 33 to the catheter, that is, bonding by the first bonding section 32 and the second bonding section 39, the outer bag section 33 appears to enclose the inner bag section 36 and the additional bonding sections at both ends of the inner bag section 36, and the outer bag section 33, the inner bag section 36 are bonded to the catheter to form a closed space, and the space between the inner bag section 36 and the catheter 10 and the space between the outer bag section 33 and the inner bag section 36 are working chambers. Fig. 7 shows additional bonding segments at both ends of the inner bladder segment 36.
The first liquid outlet 17 of the catheter 10 corresponds to the inner bag section 36, the second liquid outlet 18 corresponds to a portion of the outer bag section 33 other than the inner bag section 36, and the third liquid outlet 19 corresponds to the auxiliary outer bag section 34, i.e. liquid can enter the inner bag section 36, the outer bag section 33 and the auxiliary outer bag section 34 through the first communication pipe 14, the second communication pipe 15 and the third communication pipe 16, and then through the first liquid outlet 17, the second liquid outlet 18 and the third liquid outlet 19, see fig. 9.
It should be noted that the auxiliary outer bag section 34 functions as a positioning device, which will be described later. The pressing of the prostate can be realized by one of the outer bag section 33 and the inner bag section 36, and the reason why the outer bag section 33 and the inner bag section 36 are divided is that the outer bag section 33 is longer, if the outer bag section 33 is independently arranged, the deformation of the outer bag section 33 is not easy to control, and the deformation of the outer bag section 33 can be restrained and restricted by the inner bag section 36, so that the outer outline formed by expansion of the outer bag section is more cylindrical, and the extrusion of the prostate tissue is facilitated. The length of the inner bladder segment 36 is about 1/3 of the length of the outer bladder segment 33. In actual use, the inner bag section 36 or the outer bag section 33 may be inflated alone by controlling the first communication pipe 14 and the second communication pipe 15. When used locally for treatment, the inner balloon segment 36 may be inflated separately, and when the treatment is over a large range, the outer balloon segment 33 may be inflated separately, or both the inner and outer balloon segments 36, 33 may be inflated simultaneously.
The latex sleeve 30 further comprises at least one opening 37, said opening 37 being provided on the sleeve head 35, said at least one opening 37 comprising an opening 37 provided on the tip of the sleeve head 35 and an opening 37 provided on the side wall of the sleeve head 35. The opening 37 in the cannula head 35 is located opposite the fourth outlet 20 in the catheter head 13.
Advantageously, a plurality of arcuate projections 38 are provided on the outer surface of the outer bladder segment 33, see fig. 6. The design is mainly applied to the positioning extrusion hemostasis when bleeding or inflammation occurs on the part of the inner wall of the urethra.
A backing is disposed on the inner surface of the latex sleeve 30 between the first bonding segment 32 and the third bonding segment 40, and a backing is disposed between the inner bladder segment 36 and the outer bladder segment 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 is retracted along the folds in the shrinkage 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 compressed and expanded.
The latex sleeve uses the principle that the thickness and the thickness of the adhesive layers at all parts of the whole latex sleeve are different and the expansion coefficients are also different, so that the whole sleeve is very simple and convenient to form the front outer capsule and the rear outer capsule, the difficulty of simultaneously assembling multiple capsules on one catheter is solved, and the treatment scheme is realized. Specifically, the wall thickness of the inner bladder segment 36, the outer bladder segment 33, and the auxiliary outer bladder segment 34 is less than the wall thickness of any of the first, second, and third bonding segments 32, 39, 40. The inner bladder segment 36, the outer bladder segment 33, and the auxiliary outer bladder segment 34 may have the same wall thickness, the first, second, and third bonding segments 32, 39, and 40 may have the same wall thickness, and the wall thickness of the first, second, and third bonding segments 32, 39, and 40 may be equal to the wall thickness of the grip segment 31. Optionally, the wall thickness of the inner bladder segment 36 is less than the wall thickness of the outer bladder segment 33.
It is particularly preferred that the wall thickness of the outer bladder segment 33 varies along the longitudinal length such that the wall thickness of the outer bladder segment 33 undergoes at least a decrease, an increase, a decrease, an increase variation along the longitudinal length. Fig. 8 shows a specific example of an outer bag section 33, wherein the outer bag section 33 has two thicknesses, which are arranged at intervals. The purpose of this is: if the outer balloon segment 33 has a uniform thickness, it will form a contour resembling a sphere when inflated under pressure, whereas when the outer balloon segment 33 has a thickness as shown in fig. 8, it will form a contour more closely resembling a cylinder, the cylindrical outer contour surface being at a face pressure against the prostate tissue and the spherical outer contour surface being at a point pressure against the prostate tissue, it will be apparent that this design will result in a more uniform pressure and thus better therapeutic effect.
Similarly, the inner bladder segment 36 may be provided in the same arrangement, and the auxiliary outer bladder segment 34 need not be provided because the primary function of the auxiliary outer bladder segment 34 is to locate the catheter assembly, which is more easily located by the spherical outer profile when inflated.
Advantageously, graduations are provided on the outer surface of the latex sleeve 30, starting from the sleeve head 35 to the end of the gripping section 31, for marking the depth of insertion of the latex sleeve 30.
The sleeve head 35 has a stepped outer profile and the end of the sleeve head 35 remote from the grip section 31 has an arcuate profile such that the shape of the sleeve head 35 matches the shape of the catheter head 13. The central axis of the sleeve head 35 is inclined with respect to the central axis of the grip section 31, in particular, the angle between the central axis of the sleeve head 35 and the central axis of the grip section 31 is 10-20 degrees, preferably, the angle between the central axis of the sleeve head 35 and the central axis of the grip section 31 is 15 degrees.
The first, second and third coupling segments 32, 39 and 40 are in one-to-one correspondence with the first, second and third annular flanges.
In the same way as the design of the marking wire on the catheter 10, it is also possible to provide the gripping section 31 with a marking wire opposite the inclined cannula head 35, which marking wire in the assembled state of the latex cannula 30 on the catheter 10 is opposite the inclined catheter head 13, to mark the inclined direction of the cannula head 35. For the convenience of the operator to know the location of the liquid outlet, marking patterns are provided on both the outer bag section 33 and the auxiliary outer bag section 34 for marking the location 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 and second liquid outlets 17 and 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 bag section 33 and the auxiliary outer bag section 34 differ from each other in the longitudinal position on the latex sleeve 30, and the marking patterns on the outer bag section 33 and the auxiliary outer bag section 34 differ from each other in the circumferential position on the outer surface of the latex sleeve 30. The marking patterns on the outer bag section 33 and the auxiliary outer bag section 34 are uniformly distributed on the outer surface of the latex sleeve 30 along the circumference of the latex sleeve 30, i.e., the circumferential angle of every two marking patterns on the outer surface of the latex sleeve 30 is 120 degrees.
Fig. 9-10 are schematic illustrations of a four-lumen three-balloon prostate dilation catheter assembly in accordance with an embodiment of the present invention. It should be noted that the catheter assembly is a combination of a catheter and a latex sleeve, and the demarcation of the catheter and the latex sleeve is not shown in the drawings for simplicity of the drawing, because they are actually tightly combined together, the white area in fig. 9 may be understood as a catheter, the hatched area as a section of the latex sleeve, and further, the first communication tube 14, the second communication tube 15, and the third communication tube 16 shown in the drawing take the example of not penetrating the wall surface of the longitudinal extension 12, that is, they extend toward the tail end and protrude from the open port 23.
As shown in the drawing, the four-chamber three-balloon prostate-dilating catheter assembly 100 comprises a catheter 10 and a latex sleeve 30, wherein the catheter 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 catheter 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, the latex sleeve 30 is combined with the catheter 10, so 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 19. The four chambers of the four-chamber three-bag prostate expanding catheter assembly of the invention refer to the outer chamber, the inner chamber, the auxiliary chamber and the chamber formed inside the head of the catheter.
The combination of the latex sleeve 30 and the catheter 10 forms a first connection 54, a second connection 55 and a third connection 56, the outer lumen 51 and the inner lumen 52 being located between the first connection 54 and the second connection 55, and the auxiliary lumen 53 being located between the second connection 55 and the third connection 56. That is, the first annular flange of the catheter 10 is joined to the first joining section 32 of the latex sleeve 30 to form a first joint 54, the second annular flange of the catheter 10 is joined to the second joining section 39 of the latex sleeve 30 to form a second joint 55, and the third annular flange of the catheter 10 is joined to the third joining section 40 of the latex sleeve 30 to form a third joint 56.
The first connection 54, the second connection 55 and the third connection 56 are respectively composed of lining cloth and adhesive, and the combination of the lining cloth and the adhesive is adopted to be favorable for the combination of tightness and tightness.
As described above, the wall thickness of the portion of the latex sleeve 30 used to form the outer lumen 51, the inner lumen 52 and the auxiliary lumen 53 is thinner than the wall thickness of the other portions of the latex sleeve 30.
As an alternative to the embodiment of fig. 9, 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 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 extend outside the duct 10 through the wall surface of the duct 10, respectively. The at least a portion of the first communication tube 14, the second communication tube 15, and the third communication tube 16 are embedded in the wall surface of the conduit 10.
The inside of the catheter assembly 100 is hollow, one end of the catheter assembly 100 is provided with an open port 23, the other end is provided with an insertion head, a communication port is arranged on the insertion head, and the open port 23 is communicated with the communication port. The insertion head corresponds to the catheter head 13 of the catheter 10 and the cannula head 35 of the latex cannula 30, being the product of the combination 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 body of the catheter assembly 100, in particular, the angle between the central axis of the insertion head and the central axis of the body of the catheter assembly 100 is 10-20 degrees, preferably, the angle between the central axis of the insertion head and the central axis of the body of the catheter assembly 100 is 15 degrees. The catheter assembly 100 further comprises a catheter adapter 11, which catheter adapter 11 is arranged at the end of the catheter assembly 100 remote from the insertion head.
The principle of operation of the four-lumen three-balloon prostate-dilation catheter assembly 100 is described below.
The prostate-dilating catheter assembly 100 is formed by combining a catheter 10 and a latex sleeve 30, and the combination of the two forms an outer cavity 51, an inner cavity 52 and an auxiliary cavity 53 which are isolated from each other, and when the catheter assembly 100 is used for treatment, the prostate-dilating catheter assembly 100 can be matched with an elastic clamp for use, and the working principle is as follows:
First, the catheter assembly 100 is pushed into the bladder through the urethral meatus with a slightly curved semicircular insertion head, at this time, urine which cannot be discharged from the bladder is accumulated, and the urine is discharged from the open port 23 through the opening 37 at the center of the semicircular head and the fourth liquid outlet 20 along the connected hollow portion 21, thereby relieving the pressure of the urine in the bladder of the patient. Then, the liquid flow with certain standard pressure is injected through the other first communicating pipe 14, the second communicating pipe 15 and the third communicating pipe 16, and 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, the second liquid outlet 18 and the third liquid outlet 19, so that the cavities are respectively expanded to different degrees under the action of the liquid flow pressure, at the moment, the urethra is gradually converted into an outward expanded state from the state of being compressed and contracted by the original prostate, the loose prostate layer begins to be slowly restored to the 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 the urethra is simultaneously removed from being compressed by the prostate, so that the urethra is restored to the original smooth state. The whole process is a simple physical process, and no medicine or other auxiliary measures are needed. The four-cavity three-sac prostate expanding catheter assembly has the advantages that the treatment principle is very simple, the treatment instrument is not complex, the clinical operation of medical staff is very convenient, no pain is caused to patients, the high operation cost is not required to be paid, the long time process required by hospitalization and rehabilitation is not required, and the outpatient operation of the medical staff can be carried out only by 1-2 hours.
Brief description of the operational flow and method of operation:
1) Before the catheter component penetrates into the urethral meatus, a layer of lubricant is coated on the outer surface of the bent semicircular insertion head to prevent pain formed after friction between the inner wall of the urethra and the catheter component;
2) After the catheter component penetrates into the urethra, the front end of the semicircular bent insertion head completely enters the bladder, and a control switch at the outer end of the open port is opened, so that urination outside the body is facilitated, and the entering depth of the catheter component is controlled;
3) After the urine is discharged, the inner cavity, the outer cavity and the auxiliary cavity are filled with the calibrated pressure liquid flow, the standard pressure liquid flow is needed to be sequentially filled into the auxiliary cavity 53 near the top end, the control valve at the input port of the third communicating pipe 16 is closed, the auxiliary cavity is expanded under the action of the calibrated pressure liquid flow, the catheter assembly is immediately pumped outwards until the expanded auxiliary cavity is clamped at the joint of the bladder and the urethra, and the whole catheter assembly is at the optimal position to finish positioning;
4) In order to prevent the catheter assembly from being accurately positioned, the catheter assembly is required to be immediately clamped along the glans end by using the elastic clamp after being positioned so as to prevent the catheter assembly from sliding inwards, and the catheter cannot move outwards at the moment because the auxiliary cavity is positioned inwards in the bladder, but can move inwards, so that the clamp is used for carrying out reverse secondary positioning at the moment, and the auxiliary cavity is clamped at the outlet of the bladder due to expansion, so that the catheter assembly cannot slide outwards, and meanwhile, the catheter assembly cannot slide inwards under the limiting action of the elastic clamp. Thereby realizing the best position of the inner cavity and the outer cavity in the whole treatment process;
5) Finally, respectively injecting the calibrated pressure liquid flows with different standard dosages into the inner cavity and the outer cavity through the first communicating pipe 14 and the second communicating pipe 15, closing the related control valves, and stabilizing the pressure for keeping the time of a standard treatment course;
6) And after the treatment course is finished, all the control valves are released, the pressure liquid flow in each cavity is discharged, the catheter assembly is extracted, the whole treatment course is finished completely, the patient can recover completely without more than three treatment courses, and the whole treatment course only needs outpatient operation without hospitalization.
The invention adopts bladder inner cavity positioning technology of front latex elastic auxiliary cavity, applies the treatment technology principle that the inner cavity and the outer cavity form expansion under the action of liquid flow of the calibration pressure and then squeeze the prostatic tissue around the urethra, adopts elastic clip outer positioning measure, penetrates three communicating pipes in the catheter main body and respectively injects the liquid flow of the calibration pressure to make the inner cavity and the outer cavity expand in order to realize medical effect, and the latex sleeve uses the principle that the thickness and the thickness of the glue layer of each part on the whole colloid sleeve are different and the expansion coefficient is also different, so that the whole sleeve can form the front and the rear outer bags very simply, and solves the difficulty of simultaneously assembling multiple bags on one catheter, thus realizing the treatment scheme. In order to prevent the arc-shaped guiding part at the front end of the catheter from being wrongly put into a turnout after penetrating into the urethra and before entering into the bladder, the design that the central axis of the guiding head at the front end and the central axis of the catheter body form a 15-degree bending included angle is specially designed; the outer surface of the latex sleeve is designed with a row of arc-shaped protrusions with the width of 10mm and the height of 5mm, and the design is mainly applied to positioning extrusion hemostasis when bleeding or inflammation occurs on the 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, physiological saline can be injected into the hollow part of the catheter head to flush or relevant anti-inflammatory drugs can be injected to treat the inflammation.
Although embodiments of the present invention have been shown and described, it will 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 equivalents thereof.
List of reference numerals:
100. Catheter assembly
10. Catheter tube
11. Catheter adapter
12. Longitudinal extension
13. Catheter head
14. First communication pipe
15. Second communicating pipe
16. Third communicating pipe
17. A first liquid outlet
18. A second liquid outlet
19. Third liquid outlet
20. Fourth liquid outlet
21. Hollow part
22. Annular flange
23. Open port
30. Latex sleeve
31. Holding section
32. First combined section
33. Outer bag section
34. Auxiliary outer bag section
35. Sleeve head
36. Inner bag section
37. An opening
38. Arc-shaped protrusion
39. Second combined section
40. Third combined section
51. External cavity
52. Inner cavity
53. Auxiliary cavity
54. First connection link
55. Second connecting knot
56. And a third connection.
Claims (10)
1. A four-lumen three-balloon prostate-dilation catheter assembly (100) comprising a catheter (10) and a latex sleeve (30), characterized in that:
the conduit (10) comprises a conduit joint (11), a longitudinal extension part (12), a conduit head part (13), a first communicating pipe (14), a second communicating pipe (15) and a third communicating pipe (16), wherein the conduit joint (11) is arranged at one end of the longitudinal extension part far away from the conduit head part (13), a first liquid outlet (17), a second liquid outlet (18), a third liquid outlet (19) and a fourth liquid outlet (20) 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), three sections of annular flanges (22) are arranged on the wall surface of the longitudinal extension part, and are arranged at different longitudinal positions on the wall surface of the longitudinal extension part,
Wherein the latex sleeve (30) is combined with the catheter (10), three sections of annular flanges are used for respectively positioning the combining points of the catheter and the latex sleeve, the latex sleeve comprises a holding section (31), a first combining section (32), an outer bag section (33), an inner bag section (36) arranged on the inner side of the outer bag section, a second combining section (39), an auxiliary outer bag section (34), a third combining section (40) and a sleeve head (35) along the direction from back to front, so that an outer cavity (51), an inner cavity (52), an auxiliary cavity (53) and a cavity formed in the catheter head are formed between the latex sleeve (30) and the catheter (10), the outer cavity (51) surrounds the inner cavity (52), the outer cavity (51) and the auxiliary cavity (53) are respectively communicated with a first liquid outlet (17), a second liquid outlet (18) and a third liquid outlet (19), the latex sleeve further comprises an opening (37) arranged on the tip end of the sleeve head and an opening (37) arranged on the side wall of the sleeve head, the fourth liquid outlet (20) is communicated with the opening (37),
The wall thickness of the outer balloon segment undergoes at least a decrease, increase, decrease, increase change along the longitudinal length to have two different thicknesses that are spaced apart such that the profile formed upon inflation of the outer balloon segment approximates a cylinder with the pressure of the cylindrical outer profile surface against the prostatic tissue being the face pressure.
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 (54), a second connection (55) and a third connection (56), the outer cavity (51) and the inner cavity (52) are located between the first connection (54) and the second connection (55), and the auxiliary cavity (53) is located between the second connection (55) and the third connection (56).
3. The four-lumen three-balloon prostate-dilation catheter assembly (100) of claim 2, wherein:
The first, second and third connection (54, 55, 56) are respectively composed of a backing and an adhesive.
4. A four-lumen three-balloon prostate-dilation catheter assembly (100) as recited in claim 3, wherein:
The wall thickness of the portion of the latex sleeve (30) used for forming the outer cavity (51), the inner cavity (52) and the auxiliary cavity (53) is thinner than the wall thickness of the other portions 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 communicating pipe (14), the second communicating pipe (15) and the third communicating pipe (16) is positioned inside the catheter (10), and the other ends of each of the first communicating pipe (14), the second communicating pipe (15) and the third communicating pipe (16) respectively penetrate through the wall surface of the catheter (10) and extend to the outside of the catheter (10).
6. The four-lumen three-balloon prostate-dilation catheter assembly (100) of claim 5, wherein:
the at least a portion of the first communication tube (14), the second communication tube (15) and the third communication tube (16) are embedded in the wall surface of the conduit (10).
7. The four-lumen three-balloon prostate-dilation catheter assembly (100) of claim 6, wherein:
The inside of the catheter assembly (100) is hollow, one end of the catheter assembly (100) is provided with an open port (23), the other end of the catheter assembly is provided with an insertion head, a communication port is arranged on the insertion head, and the open 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 body of the catheter assembly (100).
9. The four-lumen three-balloon prostate-dilation catheter assembly (100) of claim 8, wherein:
the included angle between the central axis of the insertion head and the central axis of the body of the catheter assembly (100) is 10-20 degrees.
10. The four-lumen three-balloon prostate-dilation catheter assembly (100) of 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.
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CN2204172Y (en) * | 1994-07-22 | 1995-08-02 | 青岛市第四人民医院 | Four-cavity three-bag prostate diffusion catheter |
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US10064539B2 (en) * | 2014-04-21 | 2018-09-04 | Nanjing Shuangwei Biotechnology Co., Ltd. | Inspection positioning prostatic capsule expansion catheter |
CN105079950A (en) * | 2015-09-21 | 2015-11-25 | 北京优尼康通医疗科技有限公司 | Novel prostate dilation catheter |
US10201689B1 (en) * | 2017-08-07 | 2019-02-12 | Advanced Dilation Strategies, LLC | Urethral balloon dilator catheter |
CN109847175A (en) * | 2019-01-30 | 2019-06-07 | 沈阳泰伦药业有限公司 | The double capsules of disposable five chamber visual superslide prostate dilator entirely |
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CN2304401Y (en) * | 1997-08-22 | 1999-01-20 | 黄卫东 | Two pocket and three chamber instrument for perfusion and drainage of prostate |
CN108236755A (en) * | 2018-01-22 | 2018-07-03 | 黄正 | Three capsule of multi-cavity positioning capsula prostatica expands and tissue splits and shifts conduit |
CN108577934A (en) * | 2018-05-21 | 2018-09-28 | 沈阳泰伦药业有限公司 | Disposable three-cavity and double-caspula superslide prostate dilator |
CN211724353U (en) * | 2019-12-25 | 2020-10-23 | 邵钦蓉 | Four-chamber three-bag prostate expansion catheter assembly |
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