CN117547717A - Urinary catheter - Google Patents

Abstract

The present invention provides a urinary catheter comprising a tube assembly and a basket assembly, the tube assembly comprising a main tube having a longitudinal axis and comprising a proximal end and a distal end opposite each other; a basket assembly located at a distal end of the main tube and including a head end and a tail end and a plurality of ridges connecting the head end and the tail end, the plurality of ridges extending from the tail end toward the head end and converging at the head end; wherein there is a gap between two adjacent ridges to allow liquid to pass through the gap into the main tube. The basket assembly also includes a cage-like support member and a cage-like shaped member positioned inboard of and attached to the cage-like support member. The catheter provided by the invention is provided with the basket structure, has good urination effect, has small contact area with the bladder neck, is small in sense of compression, does not cause local necrosis, and is short in head end of the basket assembly and not easy to stab the bladder.

Description

Urinary catheter

Technical Field

The embodiment of the disclosure relates to the field of medical instruments, in particular to a catheter.

Background

A urinary catheter is a conduit that is inserted into the bladder from the urethra in order to drain urine. The catheter is generally balloon-type, and after the catheter is inserted into the bladder of a patient, a balloon is arranged near the head end of the catheter, and the balloon can be fixed in the bladder after being inflated, so that the catheter is left in the bladder and is not easy to fall out, and the drainage tube is connected with the urine bag to collect urine. Urinary catheters are generally divided into three categories: single-cavity urinary catheter, double-cavity urinary catheter and three-cavity urinary catheter. The single-cavity catheter is generally balloon-free, has only one channel, is not easy to fix and has short retention time. The double-cavity catheter has two cavities, one is a water injection cavity and the other is a liquid drainage cavity. The double-cavity catheter can be fixed and is mainly used for indwelling catheterization. The three-cavity catheter has three cavities: the water injection cavity, the medicine injection cavity and the liquid drainage cavity are mainly used for short-term indwelling catheterization, intravesical medicine liquid instillation, flushing, drainage and the like.

However, the existing balloon catheter has the defects that after the catheter is inserted into the bladder of a patient, the front end part of the catheter body, which is positioned on the balloon, is too long, the front end part of the catheter body, which is positioned on the balloon, is easy to stab the bladder when the patient moves, pain and even bladder bleeding are caused to the patient, and bladder inflammation is easy to cause after a long time, so that the body health of the patient is affected. In addition, the balloon catheter is frequently subjected to accidents such as catheter slippage caused by balloon rupture, liquid in the balloon not being discharged, urine drainage disorder caused by the fact that the balloon cannot be centered, and the like in clinical use. In addition, because the contact area of the balloon and the bladder is large, the neck mucosa of the bladder is continuously pressed, and ischemia or necrosis can be caused. If the balloon is left for a long time, the balloon wall calcium salt deposition also easily forms a calculus balloon with the balloon as the center, and once the calculus balloon is formed, the operation treatment is also needed, thus seriously affecting the health of patients.

Disclosure of Invention

The embodiment of the invention provides a catheter, which aims to solve at least one problem in the balloon catheter.

According to an embodiment of the invention, there is provided a catheter comprising: a tube assembly and a basket assembly; the tube assembly includes a main tube having a longitudinal axis and including proximal and distal ends opposite each other; the basket assembly is located at the distal end of the main pipe and includes a head end and a tail end and a plurality of ridges connecting the head end and the tail end, the plurality of ridges extending from the tail end toward the head end and converging at the head end; wherein a gap is provided between two adjacent ridges to allow liquid to pass through the gap into the main pipe; wherein, the basket assembly further comprises: a cage-like support member located inside the cage-like support member and attached to the cage-like shaped member; the cage-shaped supporting member includes a plurality of supporting ribs, and the cage-shaped shaping member includes a plurality of shaping pipes, which are in one-to-one correspondence with the plurality of supporting ribs and are connected to each other to constitute a part of the ridge portion.

In at least some embodiments, the basket assembly is configured to have an expanded state and a collapsed state and is configured to: the basket assembly being in the expanded state when no external force is applied, wherein a plurality of the ridges are bent radially outwardly of the basket assembly to assume a cage shape; the basket assembly is in the collapsed state when an external force is applied, wherein a plurality of the ridges extend generally along the longitudinal axis to be cylindrical.

In at least some embodiments, the shaping tube is configured to be filled with a first fluid and to change its morphology by an external force generated by the first fluid, thereby changing the morphology of the cage-shaped shaping member and the cage-shaped support member.

In at least some embodiments, the basket assembly is configured to: when the shaping pipe is filled with the first fluid, the cage-shaped shaping component is contracted inwards along the radial direction under the action of external force generated by the first fluid, so that the cage-shaped supporting component is contracted inwards along the radial direction, and the basket assembly is changed from the expanded state to the folded state; after the first fluid is discharged from the shaping tube, the cage-shaped shaping member flexes outwardly in the radial direction by virtue of its own generated restoring force to flex the cage-shaped support member outwardly in the radial direction, and the basket assembly returns from the collapsed condition to the expanded condition.

In at least some embodiments, the first fluid comprises at least one of a gas and a liquid.

In at least some embodiments, the cage-shaped shaping member further comprises a shaping annular top portion at the head end, a shaping annular bottom portion at the tail end, and a first draft tube connecting the shaping annular bottom portions, a plurality of the shaping tubes being connected between the shaping annular top portion and the shaping annular bottom portion; the tube assembly further includes a first branch tube including a proximal end and a distal end opposite each other, the distal end being connected to the first draft tube, the proximal end communicating to the exterior of the main tube to deliver the first fluid from the exterior through the first draft tube into a plurality of the profiled tubes.

In at least some embodiments, the first branch tube includes a distal opening disposed at a distal end thereof, the main tube includes a lumen and a tube wall surrounding the lumen, the distal opening is located in the tube wall and is not in communication with the lumen, and the first drainage tube is configured to be inserted into the distal opening of the first branch tube.

In at least some embodiments, the basket assembly further comprises a tip at the head end, the distal ends of the support ribs and the shaped piece annular top configured to be inserted into the tip.

In at least some embodiments, the material of the cage support member comprises a shape memory material.

In at least some embodiments, the basket assembly further comprises: the washing component is positioned on the outer side of the cage-shaped supporting component and is attached to the cage-shaped supporting component, the washing component comprises a plurality of washing pipes, the washing pipes are in one-to-one correspondence with the supporting ribs and are mutually connected, a liquid outlet hole for spraying second fluid is formed in the distal end of each washing pipe, and the washing pipes, the shaping pipes and the supporting ribs form a part of the ridge part.

In at least some embodiments, the flushing component further comprises a flushing piece annular bottom at the tail end and a second draft tube connected to the flushing piece annular bottom, a plurality of the flushing tubes being connected to the flushing piece annular bottom; the tube assembly further includes a second branch tube including a proximal end and a distal end opposite each other, the distal end being connected to the second drain tube, the proximal end being in communication with the exterior of the main tube for delivering the second fluid from the exterior through the second drain tube into a plurality of the flushing tubes.

In at least some embodiments, the second branch tube includes a distal opening disposed at a distal end thereof, the distal opening being located on an outer wall of a tube wall of the main tube, the second drainage tube being configured to be inserted into the distal opening of the second branch tube.

In at least some embodiments, the length of the flush tube is set to be shorter than the length of the support rib such that the liquid outlet aperture is located in a middle section of the support rib.

In at least some embodiments, the main tube further comprises a distal opening disposed at a distal end thereof and an end receiving cavity proximate the distal opening, the end receiving cavity being connected to the inner lumen of the main tube and configured to receive the support annular base of the cage-like support member and the shaping annular base of the cage-like shaping member.

In at least some embodiments, the end receiving cavity comprises an inner side and an outer side opposite each other in the radial direction, the flushing piece annular bottom being located on the outer side, the support piece annular bottom and the shaping piece annular bottom being located on the inner side.

In at least some embodiments, the basket assembly has at least one of the following arrangements: the cage-shaped supporting parts are arranged into an integrated structure; the cage-shaped shaping parts are arranged into an integral structure; the flushing part is arranged as an integral structure.

The catheter provided by the embodiment of the invention can be used for temporary catheterization, indwelling catheterization, postoperative hemostasis by compression of the bladder, intravesical liquid medicine instillation and bladder irrigation, the basket structure has good urination effect, the contact area with the bladder neck is small, the compression feeling is small, local necrosis is not caused, and the head end of the basket assembly is short and is not easy to stab the bladder. In addition, through adopting cage-shaped supporting part and cage-shaped fixed part to form the basket subassembly, not only can provide the necessary holding power of basket subassembly, be convenient for change the form of basket subassembly moreover, make catheter more simple and convenient, scientific, reasonable when using, clinical adaptability, affinity are stronger.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly described below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure, not to limit the present disclosure.

FIG. 1 is a schematic illustration of a three-lumen urinary catheter in accordance with an embodiment of the present disclosure;

FIG. 2 is a schematic view of the internal structure of main pipes and branch pipes according to an embodiment of the present disclosure;

FIG. 3 is a schematic illustration of the expanded and collapsed states of the basket assembly of FIG. 1;

FIG. 4 is a schematic structural view of a support member of an embodiment of the present disclosure;

FIG. 5 is a schematic structural view of a shaped component of an embodiment of the present disclosure;

FIG. 6 is a schematic structural view of a flushing component of an embodiment of the disclosure;

FIG. 7 is a schematic partial cross-sectional view of the ridge of FIG. 3;

FIG. 8 is a schematic cross-sectional view of the aft end of a basket assembly according to an embodiment of the present disclosure.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present disclosure more apparent, the technical solutions of the embodiments of the present disclosure will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present disclosure. It will be apparent that the described embodiments are some, but not all, of the embodiments of the present disclosure. All other embodiments, which can be made by one of ordinary skill in the art without the need for inventive faculty, are within the scope of the present disclosure, based on the described embodiments of the present disclosure.

Unless defined otherwise, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this disclosure belongs. The terms "first," "second," and the like in the description and in the claims, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, is intended to mean that elements or items that are present in front of "comprising" or "comprising" are included in the word "comprising" or "comprising", and equivalents thereof, without excluding other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to denote relative positional relationships, which may also change accordingly when the absolute position of the object to be described changes.

Embodiments of the present disclosure provide a urinary catheter. The catheter includes a tube assembly and a basket assembly; the tube assembly includes a main tube having a longitudinal axis and including proximal and distal ends opposite each other; the basket assembly is located at the distal end of the main pipe and includes a head end and a tail end and a plurality of ridges connecting the head end and the tail end, the plurality of ridges extending from the tail end toward the head end and converging at the head end; wherein a gap is provided between two adjacent ridges to allow liquid to pass through the gap into the main pipe; wherein the basket assembly further comprises: a cage-like support member positioned inside the cage-like support member and attached to the cage-like shaping member; the cage-like support member includes a plurality of support ribs and the cage-like shaping member includes a plurality of shaping tubes that are in one-to-one correspondence with the plurality of support ribs and are interconnected to form a portion of the spine.

In the presently disclosed embodiments, the terms "proximal," "proximal" and "distal" refer to a side proximal to an operator or healthcare worker, and the terms "distal" and "distal" refer to a side distal from the operator or healthcare worker. "plurality" means two or more. The term "tube" includes, but is not limited to, hollow tubes having a circular cross-sectional shape, but may also include hollow tubes having other cross-sectional shapes. The term "liquid" includes, but is not limited to, urine or blood, and the like.

The present disclosure is illustrated by the following specific examples. Detailed descriptions of known functions and known components may be omitted for the sake of clarity and conciseness in the following description of the embodiments of the present disclosure. When any element of an embodiment of the present disclosure appears in more than one drawing, the element may be referred to by the same reference numeral in each drawing.

Fig. 1 is a schematic structural view of a three-lumen urinary catheter in accordance with an embodiment of the present disclosure. Fig. 2 is a schematic view of the internal structure of main pipes and branch pipes according to an embodiment of the present disclosure. Fig. 3 is a schematic view of the basket assembly of fig. 1 in an expanded and collapsed state, and also in an enlarged schematic view of region a of fig. 1.

For example, as shown in fig. 1 to 3, a urinary catheter 1 provided according to an embodiment of the disclosure comprises a tube assembly 10 and a basket assembly 20, wherein the tube assembly 10 comprises a main tube 11 and a first branch tube 12 and a second branch tube 13 connected to the main tube 11. The main pipe 11, the first branch pipe 12 and the second branch pipe 13 may be flexible pipes, for example, made of latex, silica gel, polyvinyl chloride (PVC) or polyurethane. The main tube 11 has an inner cavity (also referred to as a drainage cavity) for drainage, which has a large diameter, for draining urine in the bladder. The main tube 11 has a longitudinal axis Z and comprises a proximal end 11A and a distal end 11B opposite to each other. In the embodiment of the present disclosure, the "longitudinal axis Z" is a virtual axis, and does not actually exist, and since the main pipe 11 is bendable, the longitudinal axis Z of the main pipe 11 may also be equivalent to the extending direction of the main pipe 11. The first branch 12 is used to inject a first fluid (e.g., a gas or liquid) into the cage shaped member 22 (see fig. 5) to control the expansion or collapsing of the basket assembly 20. The second branch pipe 13 is used to inject a second fluid (e.g., a flushing liquid) into the flushing part 23 (see fig. 6) to flush the bladder. The first branch pipe 12 and the second branch pipe 13 and their related structures will be described in detail later.

For example, basket assembly 20 is located at distal end 11B of main tube 11. The main tube 11 may include a distal opening P11B at the distal end 11B and a proximal opening P11A at the proximal end 11A, with the basket assembly 20 operatively connected to the distal opening P11B. Basket assembly 20 includes a head end 20A and a tail end 20B opposite each other and a plurality of ridges 200 connecting head end 20A and tail end 20B, the plurality of ridges 200 extending from tail end 20B toward head end 20A and converging at head end 20A, e.g., at a central location of head end 20A.

For example, the basket assembly 20 has (a) an expanded state and (b) a collapsed state, and is transitionable between the two states. Since the basket assembly 20 is in the expanded state in the natural state (i.e., when no external force is applied), the plurality of ridges 200 flex outwardly in the radial direction R to assume a cage shape. When an external force is applied, the basket assembly 20 is in a collapsed state, at which time the plurality of ridges 200 extend generally along the longitudinal axis Z to be cylindrical. When the catheter 1 is used, firstly, the basket assembly 20 is folded inwards to a folded state by applying external force to form a column shape, and the column-shaped basket assembly 20 is easy to insert into the urethra; when the basket assembly 20 reaches the target location in the bladder, the external force is removed and the basket assembly 20 returns to the expanded state to form a cage, at which point the basket assembly 20 is secured in the bladder. The catheter 1 can be left in the bladder for a long period of time, or can be pulled out of the bladder after use. When the catheter 1 needs to be pulled out, the basket assembly 20 can be folded inwards to form a column shape again by applying external force, so that the catheter can be pulled out from the bladder smoothly. As can be seen, in the presently disclosed embodiments, the expandable and contractible basket assembly 20 provides for ease of insertion and removal of the urinary catheter.

For example, in the expanded state of the basket assembly 20, there is a void GP between adjacent two of the ridges 200 through which urine in the bladder may pass into the main tube 11 (as indicated by the arrow in fig. 3) and drain from the main tube 11 to the outside of the patient. Of the four ridges 200 in fig. 3, every adjacent two ridges 200 have a gap GP therebetween, thereby achieving rapid drainage of urine. It should be noted that, the four ridges 200 are illustrated as an example in the embodiment of the present disclosure, and in other embodiments, the ridges 200 may be two, three or more than five, which is not limited in the embodiment of the present disclosure. When four ridges 200 are used, it is preferable to provide a basket assembly with a good support force while ensuring a rapid removal of urine.

Compared with the front end of the balloon catheter is an inflatable balloon, the basket assembly of the embodiment of the disclosure has the following advantages: 1) The contact area with the bladder wall is small, the pressing sense is small, and thus ischemia or necrosis is not easy to cause. 2) The urine guiding hole in the air sac type catheter is usually arranged at the upper part of the air sac, so that the urine at the lower part of the air sac is not very beneficial to discharge and the urine discharging effect is affected; the basket assembly is in a cage-shaped open structure when urinating, urine at the upper part or the lower part of the bladder can enter the main pipe through a larger gap (namely a gap) of the basket assembly, so that the urethral catheterization effect is greatly improved; 3) Since urine flows out of the slit, the distal end (i.e., the head end 20A) of the catheter 1 does not need to be provided with a urine guiding hole, and only the end-side ends of the plurality of ridges 200 can be covered and fixed, so that the length of the head end 20A is shorter than that of the balloon type catheter with urine, and the urinary bladder is not easy to be poked, and bleeding, cystitis and other problems are caused.

Fig. 4 is a schematic structural view of a support member according to an embodiment of the present disclosure. Fig. 5 is a schematic structural view of a shaped member of an embodiment of the present disclosure. Fig. 6 is a schematic structural view of a flushing component of an embodiment of the disclosure. Fig. 7 is a schematic partial cross-sectional view of the ridge of fig. 3, and also a schematic cross-sectional view of region B of fig. 3.

For example, as shown in fig. 7, the basket assembly 20 further includes a cage-like supporting member 21 and a cage-like shaped member 22, the cage-like supporting member 21 including an inner side 21N and an outer side 21W opposite to each other in a radial direction of the basket assembly 20, the cage-like shaped member 22 being located at the inner side 21N of the cage-like supporting member 21 and attached to the cage-like supporting member 21. As shown in fig. 3 to 5, the cage-like support member 21 includes a plurality of support ribs 210 (for example, four shown in the drawings), the cage-like shaping member 22 includes a plurality of shaping pipes 220 (for example, four shown in the drawings), and the plurality of shaping pipes 220 are in one-to-one correspondence with the plurality of support ribs 210 and are connected to each other such that the shaping pipes 220 and the support ribs 210 constitute a part of the ridge 200. For example, each of the shaped tubes 220 may be adhered to the inner side 21N of its corresponding support rib 210 with an adhesive (e.g., glue). By providing the cage-like support members 21 and the cage-like shaping members 22, not only can the necessary support force for the basket assembly 20 be provided, but also changes in the morphology of the basket assembly 20 can be facilitated.

In the embodiment of the present disclosure, the cage-shaped supporting member 21 and the cage-shaped shaping member 22 are shaped like a lantern under the condition of no stress (i.e., in a natural state), and form changes together under the condition of stress. Since the shaping pipe 220 is a hollow pipe, the forms of the cage-like shaped member 22 and the cage-like supporting member 21 can be changed by filling the first fluid LT1 therein and by an external force generated by the first fluid LT 1. The first fluid LT1 includes at least one of a gas and a liquid. For example, by injecting a liquid or gas into the shaping tube 220 to form a column of water or gas, the four shaping tubes 220 are stretched into a straight shape by the force of the column of water or gas, and the four support ribs 210 are further stretched into a straight shape, and the basket assembly 20 is in a contracted state, at which time the urinary catheter can be inserted into the bladder. When the urinary bladder is reached, the liquid or gas in the shaping tubes 220 can be released, and the four shaping tubes 220 are restored to a curved shape by their own restoring force, so that the four supporting ribs 210 are restored to a curved shape, and the basket assembly 20 is in an expanded state, so that the urinary catheter can be fixed in the urinary bladder for a long time. It can be seen that by filling or draining fluid in the shaped tube 220, the basket assembly 20 can be controlled to switch between an expanded state and a contracted state, facilitating handling and use of the catheter.

Thus, when the shaping tube 220 is filled with the first fluid LT1, the cage-like shaped member 22 contracts radially inwardly R under the external force generated by the first fluid LT1 to cause the cage-like support member 21 to contract radially inwardly R, and the basket assembly 20 transitions from the expanded state to the collapsed state. After the first fluid LT1 is discharged from the shaping tube 220, the cage-like shaping member 22 is bent outwardly in the radial direction R by its own generated restoring force to outwardly bend the cage-like support member 21 in the radial direction R, and the basket assembly 20 returns to the expanded state from the collapsed state.

For example, the cage-shaped shaping member 22 further includes a shaping annular top 221 at the head end 20A and a shaping annular bottom 222 at the tail end 20B, with four shaping tubes 220 connected between the shaping annular top 221 and the shaping annular bottom 222, respectively. For example, in order to allow the first fluid LT1 to flow into the plurality of shaping pipes 220 at the same time, the shaping ring-shaped bottom 222 is hollow, and the lower portion of the hollow shaping ring-shaped bottom 222 is connected to the first drainage pipe 224 and the upper portion is connected to the four shaping pipes 220 at the same time. Thus, when the first fluid LT1 flows in through the first draft tube 224, the shape-defining piece annular bottom 222 can simultaneously deliver the first fluid LT1 into the four shape-defining pipes 220, so that the four shape-defining pipes 220 can be deformed simultaneously; when the first fluid LT1 is discharged from the four forming tubes 220, it may also flow synchronously through the hollow forming member annular bottom 222 into the first draft tube 224 and out the proximal end 12A of the first branch tube 12.

Referring to fig. 2 and 5, for example, the cage-shaped member 22 further includes a first draft tube 224 connected to the annular bottom 222 of the shaping member. The first branch pipe 12 includes a proximal end 12A and a distal end 12B opposite to each other, the proximal end 12A being communicated to the outside of the main pipe 11, and the distal end 12B being connected to the first drainage tube 224. In this way, it is convenient for the healthcare worker to inject the first fluid LT1 into the first branch tube 12 and deliver it to the four shaping tubes 220 via the first drainage tube 224. For example, main tube 11 includes a lumen 110 and a tube wall 112 surrounding lumen 110, first branch tube 12 includes a distal opening P12B disposed at its distal end 12B and a proximal opening P12A disposed at its proximal end 12A, with distal opening P12B being located in tube wall 112 and not in communication with lumen 110, and first drain tube 224 is insertable into distal opening P12B. Thus, on the premise of not increasing the diameter of the main pipe 11, two independent channels are respectively arranged for urine and first fluid, so that mutual interference is avoided.

Referring to fig. 4, for example, each support rib 210 includes a proximal end 210A and a distal end 210B opposite each other in the direction of extension thereof, the proximal end 210A being connected to a support annular base 212 (to be described in detail later), the distal end 210B extending substantially along a longitudinal axis Z. Referring to fig. 1, 3-5, basket assembly 20 further includes a head 24 (see fig. 3) at head end 20B, a plurality of distal ends 210B of a plurality of support ribs 210 and a shape-forming annular top 221 of cage-shaped member 22 are configured to be inserted into head 24, thereby securing plurality of distal ends 210B and shape-forming annular top 221. In this way, even if basket assembly 20 expands or contracts, distal end 210B and shape-forming member annular top 221 move only in longitudinal axis Z and do not change position radially, avoiding hitting the bladder inner wall due to radial movement. The maximum dimension d1 of the tip 24 along the longitudinal axis Z is 5-12 mm. Through the arrangement, under the condition that quick catheterization of the basket assembly is ensured, the length of the end head 24 (namely the head end of the basket assembly) is reduced, and bleeding and the like caused by stamping the inner wall of the bladder are not easy to occur. The basket assembly 20 has a maximum dimension d2 in the radial direction R of 15-35 mm, which allows a more stable fixation of the catheter 1 in the bladder.

FIG. 8 is a schematic cross-sectional view of the aft end of the basket assembly of an embodiment of the present disclosure, such as the cross-sectional view of FIG. 3 taken along line a-a. For simplicity of illustration, the first draft tube and the second draft tube are not shown in FIG. 8. Referring to fig. 3, 4 and 8, for example, the cage support member 21 further includes a support annular base 212 at the trailing end 20B, the support annular base 212 being connected to the plurality of support ribs 210 and configured to be inserted into the distal opening P11B of the main tube 11. In this way, a connection between the cage-like support member 21 and the main pipe 11 can be achieved. Referring to fig. 5 and 8, the shape annular base 222 of the cage shape shaping member 22 may be configured to be inserted into the support annular base 212 to reduce the footprint of the shape annular base 222. For example, the outer diameter dimension of the shaped piece annular bottom 222 is smaller than the inner diameter dimension of the support piece annular bottom 212. In practice, the support annular base 212 and the former annular base 222 may be fixed together and then inserted together into the distal opening P11B of the main tube 11. Further, in order to provide sufficient accommodation space for the support annular bottom 212 and the former annular bottom 222, the main tube 11 is provided with an end receiving cavity 114 at a section near the distal end opening P11B, which end receiving cavity 114 is adapted to receive or accommodate the support annular bottom 212 and the former annular bottom 222. The end receiving chamber 114 is connected to the inner chamber 110 so that fluid in the bladder is smoothly drained from the inner chamber 112 while accommodating the support member annular base 212 and the shaping member annular base 222. For example, the outer diameter dimension of the support annular bottom 212 is smaller than the inner diameter dimension of the receiving cavity 114 to facilitate insertion of the support annular bottom 212 into the distal opening P11B of the main tube 11. In the disclosed embodiments, various connection methods may be used between the shaped member annular bottom 222, the support member annular bottom 212, and the main pipe 11, including but not limited to adhesive, screw, or snap connection, etc., which are not limited in this disclosure. When an adhesive means (e.g., glue) is used, the manufacturing process can be simplified, and is thus preferable.

Referring to fig. 3-7, for example, basket assembly 20 further includes a flush member 23 located on an outer side 21W of cage-like support member 21 and attached to cage-like support member 21, flush member 23 including a plurality of flush tubes 230 (e.g., four as shown in the figures), plurality of flush tubes 230 being in one-to-one correspondence with and interconnected with a plurality of support ribs 210 such that flush tubes 230, shaped tubes 220 and support ribs 210 form a portion of ridge 200. For example, each flush tube 230 may be adhered to the outer side 21W of its corresponding support rib 210 with an adhesive (e.g., glue). The irrigation tube 230 includes a proximal end 230A and a distal end 230B opposite each other, wherein the proximal end 230A is connected to an irrigation annular bottom 232 (described in detail later), and the distal end 230B is provided with an outlet opening 231 for injecting a second fluid LT2 for irrigation of the bladder interior. For example, the second fluid includes, but is not limited to, physiological saline or a therapeutic drug. By providing the flushing means 23, the catheter 1 can be provided with an additional function of flushing the bladder. Because the flushing pipe 230 is attached to the outer side 21W of the support rib 210, it is possible to avoid occupying more space without affecting the normal operation of the support rib 210 and the shaping pipe 220, which is advantageous for miniaturization of the basket assembly.

The cage-like support member 21 and the cage-like shaping member 22 are collapsed inwardly prior to insertion of the urinary catheter 1 into the urethra. Because the washpipe 230 and the support ribs 210 are connected to each other, the four washpipes 230 are also drawn inwardly, and the basket assembly 20 is in a column shape. After the basket assembly 20 reaches the target position of the urinary bladder, the cage-shaped supporting members 21 and the cage-shaped shaping members 22 are bent outwards, the four flushing pipes 230 are driven to be opened outwards, and the basket assembly is in an expanded state, so that the urinary catheter 1 can not only urinate, but also flush the urinary bladder. It can be seen that the flushing part 23 can be opened or closed together with the cage-like supporting part 21 and the cage-like shaping part 22, and the operation of the basket assembly is simplified on the premise of having a flushing function.

For example, for injecting the second fluid LT2 in the second branch pipe 13 into the flushing part 23, the flushing part 23 further comprises a flushing piece annular bottom 232 at the tail end 20B and a second drainage tube 234 connecting the flushing piece annular bottom 232, a plurality of flushing pipes 230 being connected to the flushing piece annular bottom 232, for example a proximal end 230A of the flushing pipe 230 being arranged hollow with the flushing piece annular bottom 232. In this way, the second fluid LT2 provided by the second branch 13 may flow through the second draft tube 234 and the rinse member annular base 232 into the four rinse tubes 230.

Referring to fig. 1 and 6, the second branch pipe 13 includes a proximal end 13A and a distal end 13B opposite to each other, the distal end 13B being connected to the second drainage tube 234, the proximal end 13A being communicated to the outside of the main pipe 11 to convey the second fluid LT2 from the outside through the second drainage tube 234 into the plurality of flushing pipes 230. For example, referring to fig. 1 and 6, the second branch pipe 13 includes a proximal end opening P13A provided at a proximal end 13A thereof and a distal end opening P13B provided at a distal end 13B thereof, the distal end opening P13B being located on an outer wall of the pipe wall 112 of the main pipe 11, and the second drainage tube 234 being located outside the main pipe 11 and configured to be inserted into the distal end opening P13B of the second branch pipe 13. Thus, in use of the flushing member 23, the second fluid LT2 injected into the second branch tube 13 from the proximal opening P13A may flow from the distal opening P13B into the second draft tube 234, through the second draft tube 234 and the flushing member annular bottom 232 into the plurality of flushing tubes 230, and finally out the outlet openings 231. It will be appreciated that the washed blood may be mixed with urine and expelled through the lumen 110 of the main tube 11.

For example, the length of the washout tube 230 is set to be shorter than the length of the support rib 210 so that the outlet holes are located at the middle section of the support rib (e.g., the position shown in fig. 3), that is, at the maximum dimension of the basket assembly in the radial direction R, thereby further increasing the washout range and washout area of the plurality of outlet holes and greatly increasing the bladder washout effect. For example, the length of the wash pipe 230 is set to 1/3 to 1/2 of the length of the support rib 210, thereby further securing the liquid outlet hole in the middle position.

Referring to fig. 6 and 8, for example, the end receiving chamber 114 includes an inner side 114N and an outer side 114W opposite each other in the radial direction R, the flushing ring-shaped bottom 232 is located at the outer side 114W, and the support ring-shaped bottom 212 and the shaping ring-shaped bottom 222 are located at the inner side 114N. Since the flush tube 230 is located outside of the support rib 210, the flush member annular bottom 232 is also outside of the support member annular bottom 212. Compared with the support member annular bottom 231, the shaping member annular bottom 232 and the flushing member annular bottom 232 are all arranged on the inner side 114N of the end receiving cavity 114, the space occupied in the end receiving cavity 114 can be reduced by arranging the flushing member annular bottom 232 on the outer side 114W of the end receiving cavity 114, and the inner cavity 11 is further ensured to have a larger urethral catheterization space. In the disclosed embodiment, the flushing member annular bottom 232 and the main pipe 11 may be connected by various manners, including but not limited to adhesion, screw connection or clamping connection, etc., which are not limited in this disclosure. When an adhesive means (e.g., glue) is used, the manufacturing process can be simplified, and is thus preferable.

In the embodiment of the present disclosure, at least one of the cage-like supporting member 21, the cage-like shaped member 22 and the flushing member 23 is provided as a unitary structure. In some embodiments, the cage support members 21 may be provided as a unitary structure. For example, the support rib 210 and the support annular bottom 212 in fig. 4 are an integral structure made of the same material, and the cage-like support member 21 is formed by heat treatment, bonding, thereby simplifying the manufacturing process of the cage-like support member 21 and improving the firmness of the cage-like support member 21. In some embodiments, the cage shaped members 22 may be provided as a unitary structure. For example, the shaping tube 220, the shaping ring-shaped top 221, the shaping ring-shaped bottom 222, and the first draft tube 224 in fig. 5 are a unitary structure made of the same material, and the cage-shaped member 22 is formed by cutting, heat treatment, bonding, thereby simplifying the manufacturing process of the cage-shaped member 22 and improving the firmness of the cage-shaped member 22. In some embodiments, the flush member 23 may be provided as a unitary structure. For example, in fig. 6, the flushing pipe 230, the flushing member annular bottom 232 and the second drain pipe 234 are of a unitary structure made of the same material, and the flushing member 23 is formed by bending, bonding, thereby simplifying the manufacturing process of the flushing member 23 and improving the firmness of the flushing member 23.

In the disclosed embodiment, the material of at least one of the cage-like support member 21 and the tip 24 includes a shape memory material, including but not limited to medical nickel-titanium alloy, which provides the cage-like support member 21 and the tip 24 with low cost, light weight, high deformation (up to 800%) and good chemical stability and biocompatibility. For example, the material of the cage support member 21 may comprise a shape memory material, or the material of both the cage support member 21 and the tip 24 may comprise a shape memory material.

The embodiments of the present disclosure described above illustrate a three-lumen urinary catheter having a basket assembly, where the three lumens are: an inflation/liquid chamber in the first branch pipe, a flushing chamber in the second branch pipe and a drainage chamber of the main pipe; it will be appreciated that in other embodiments of the present disclosure, a two-lumen urinary catheter with a basket assembly may also be provided, wherein the two lumens are the inflation/fluid lumen in the first leg and the drainage lumen of the main tube. That is, the urinary catheter may have only a main tube and a first branch tube.

In the above-mentioned embodiments of the present disclosure, the urinary catheter has a collapsible basket assembly, and when the urinary catheter needs to enter the urethra, gas or liquid is filled from the first branch tube, and after the shaping tube is filled with gas or liquid, the basket assembly is forced to stretch into a cylinder-like body, so as to smoothly pass through the urethra and reach the bladder. When the target position is reached, gas or liquid is discharged from the shaping pipe, the basket assembly is restored to a cage-shaped structure, the four ridge parts are clamped on the bladder neck to enable urination, and urine can enter the main pipe from the gaps of the basket assembly, so that the urine guiding effect is greatly improved. Physiological saline or medicine can be injected into the bladder through the second branch pipe in the middle of catheterization, and the washing pipe can carry out omnibearing washing treatment on the bladder. After the urethral catheterization is finished, gas or liquid is filled into the first branch pipe again, so that the basket assembly is changed into a column like a column, and the urethral catheter can be pulled out smoothly. It can be seen that the catheter provided by the embodiments of the present disclosure has the following advantages: 1) The basket assembly has a cage-shaped open structure, so that the urination effect is better; 2) The contact area between the basket structure and the bladder wall is small, the compression feeling is small, and local necrosis is not easy to cause; 3) The length of the end head is short, the bladder in the middle part is not easy to be poked, and the problems of bleeding, cystitis and the like are caused; 4) The liquid outlet is positioned at the outer side of the basket assembly, so that the bladder washing effect is better; 5) Through adopting cage-shaped supporting part and cage-shaped fixed part to form the basket assembly, not only can provide the necessary holding power of basket assembly, be convenient for change the form of basket assembly moreover, make the catheter more simple and convenient, scientific, reasonable when using, clinical adaptability, affinity are stronger.

In this context, the following points need to be noted:

(1) The drawings of the embodiments of the present disclosure relate only to the structures related to the embodiments of the present disclosure, and other structures may refer to the general design.

(2) The embodiments of the present disclosure and features in the embodiments may be combined with each other to arrive at a new embodiment without conflict.

(3) The foregoing is merely exemplary embodiments of the present disclosure and is not intended to limit the scope of the disclosure, which is defined by the appended claims.

Claims (16)

1. A urinary catheter, comprising:

a tube assembly comprising a main tube having a longitudinal axis and comprising a proximal end and a distal end opposite each other; and

a basket assembly located at a distal end of the main pipe and including a head end and a tail end and a plurality of ridges connecting the head end and the tail end, the plurality of ridges extending from the tail end toward the head end and converging at the head end; wherein a gap is provided between two adjacent ridges to allow liquid to pass through the gap into the main pipe;

wherein the basket assembly further comprises a cage-like support member and a cage-like shaping member located inboard of and attached to the cage-like support member; the cage-shaped supporting member includes a plurality of supporting ribs, and the cage-shaped shaping member includes a plurality of shaping pipes, which are in one-to-one correspondence with the plurality of supporting ribs and are connected to each other to constitute a part of the ridge portion.

2. The urinary catheter of claim 1, wherein the basket assembly is configured to have an expanded state and a collapsed state and is configured to: the basket assembly being in the expanded state when no external force is applied, wherein a plurality of the ridges are bent radially outwardly of the basket assembly to assume a cage shape; the basket assembly is in the collapsed state when an external force is applied, wherein a plurality of the ridges extend generally along the longitudinal axis to be cylindrical.

3. The urinary catheter according to claim 2, wherein the shaping tube is configured to be filled with a first fluid and to change its morphology by external forces generated by the first fluid, thereby changing the morphology of the cage-shaped shaping member and the cage-shaped support member.

4. The urinary catheter of claim 3, wherein the basket assembly is configured to:

when the shaping pipe is filled with the first fluid, the cage-shaped shaping component is contracted inwards along the radial direction under the action of external force generated by the first fluid, so that the cage-shaped supporting component is contracted inwards along the radial direction, and the basket assembly is changed from the expanded state to the folded state;

after the first fluid is discharged from the shaping tube, the cage-shaped shaping member flexes outwardly in the radial direction by virtue of its own generated restoring force to flex the cage-shaped support member outwardly in the radial direction, and the basket assembly returns from the collapsed condition to the expanded condition.

5. The urinary catheter of claim 3, wherein the first fluid comprises at least one of a gas and a liquid.

6. The urinary catheter of claim 1, wherein,

the cage-shaped shaping part further comprises a shaping piece annular top part positioned at the head end, a shaping piece annular bottom part positioned at the tail end and a first drainage tube connected with the shaping piece annular bottom part, and a plurality of shaping tubes are connected between the shaping piece annular top part and the shaping piece annular bottom part;

the tube assembly further includes a first branch tube including a proximal end and a distal end opposite each other, the distal end being connected to the first draft tube, the proximal end communicating to the exterior of the main tube to deliver a first fluid from the exterior through the first draft tube into a plurality of the profiled tubes.

7. The urinary catheter according to claim 6, wherein the first branch tube includes a distal opening disposed at a distal end thereof, the main tube including a lumen and a tube wall surrounding the lumen, the distal opening being located in the tube wall and not in communication with the lumen, the first drainage tube being configured to be inserted into the distal opening of the first branch tube.

8. The urinary catheter of claim 6, wherein the basket assembly further comprises a tip at the head end, the distal ends of the support ribs and the shaped piece annular top being configured to be inserted into the tip.

9. The urinary catheter according to claim 1, wherein the material of the cage-like support member comprises a shape memory material.

10. The urinary catheter according to any one of claims 1 to 9, wherein the basket assembly further comprises: the washing component is positioned on the outer side of the cage-shaped supporting component and is attached to the cage-shaped supporting component, the washing component comprises a plurality of washing pipes, the washing pipes are in one-to-one correspondence with the supporting ribs and are mutually connected, a liquid outlet hole for spraying second fluid is formed in the distal end of each washing pipe, and the washing pipes, the shaping pipes and the supporting ribs form a part of the ridge part.

11. The urinary catheter of claim 10, wherein,

the flushing component further comprises a flushing piece annular bottom positioned at the tail end and a second drainage tube connected with the flushing piece annular bottom, and a plurality of flushing tubes are connected with the flushing piece annular bottom;

the tube assembly further includes a second branch tube including a proximal end and a distal end opposite each other, the distal end being connected to the second drain tube, the proximal end being in communication with the exterior of the main tube for delivering the second fluid from the exterior through the second drain tube into a plurality of the flushing tubes.

12. The urinary catheter according to claim 11, wherein the second branch tube includes a distal opening disposed at a distal end thereof, the distal opening being located on an outer wall of the tube wall of the main tube, the second drainage tube being configured to be inserted into the distal opening of the second branch tube.

13. The urinary catheter according to claim 10, wherein the length of the flushing tube is arranged to be shorter than the length of the support ribs such that the exit opening is located in the middle section of the support ribs.

14. The urinary catheter of claim 10, wherein,

the main tube further includes a distal opening disposed at a distal end thereof and an end receiving cavity proximate the distal opening, the end receiving cavity being connected with the inner lumen of the main tube and configured to receive the support annular base of the cage-like support member and the shaping annular base of the cage-like shaping member.

15. The urinary catheter according to claim 14, wherein the end-receiving cavity comprises an inner side and an outer side radially opposite each other, the flushing member annular bottom being located on the outer side, the support member annular bottom and the shaping member annular bottom being located on the inner side.

16. The urinary catheter of claim 10, wherein the basket assembly has at least one of the following settings:

the cage-shaped supporting parts are arranged into an integrated structure;

the cage-shaped shaping parts are arranged into an integral structure;

the flushing part is arranged as an integral structure.