CN114288527A

CN114288527A - Nephrostomy tube fixing device and nephrostomy tube kit

Info

Publication number: CN114288527A
Application number: CN202111555057.4A
Authority: CN
Inventors: 程跃; 王卫红
Original assignee: Ningbo First Hospital
Current assignee: Ningbo First Hospital
Priority date: 2021-07-14
Filing date: 2021-12-17
Publication date: 2022-04-08

Abstract

The invention discloses a nephrostomy tube fixing device and a nephrostomy tube kit, wherein the urinary system postoperative indwelling tube fixing device comprises a fixing chassis and a fixing component, the fixing chassis is suitable for being fixed on the surface of a human body, the fixing component is arranged on the fixing chassis to form a tube penetrating channel, and the tube penetrating channel is suitable for penetrating through a nephrostomy tube so as to be convenient for fixing the nephrostomy tube in a preset position of the body in an encircling manner through the fixing component.

Description

Nephrostomy tube fixing device and nephrostomy tube kit

Technical Field

The invention relates to the field of medical appliance articles, in particular to a nephrostomy tube fixing device and a nephrostomy tube kit.

Background

The nephrostomy drainage operation is an operation for draining urine, pus, blood and the like and facilitating the formation of a sinus by puncturing or cutting the parenchyma of the kidney and delivering a catheter into a renal pelvis. In nephrostomy drainage it is often necessary to use a nephrostomy tube which is placed in the nephrostomy passage for a predetermined time to aid drainage.

After completion of the placement of the nephrostomy tube, the patient needs to be carried for a period of time, that is, the nephrostomy tube needs to be held in the body for a period of time. Since the patient inevitably undergoes some movement during use, such as turning over, in order to maintain a good drainage effect and prevent the movement of the stoma, the doctor usually stitches the stoma or fixes the stoma to the body skin by means of an adhesive tape, i.e. temporarily fixes the stoma to the body skin.

Although the needle-sewing process is performed under anesthesia, the patient does not immediately feel pain, but inevitably has a wound requiring recovery.

On the other hand, and more importantly, this way of securing the stoma tube by means of a needle is not ideal. Because the tubular structure of the fistulation tube is exposed outside the waist of the body, the fistulation tube and the fistulation tube are difficult to fix, and the suture needle can only be wound around the fistulation tube from the outside for fixing, the operation is inconvenient in the mode, and the fixing effect is unsatisfactory.

The statements herein merely provide background information related to the present disclosure and may not necessarily constitute prior art.

Disclosure of Invention

It is an object of the present invention to provide a nephrostomy tube securing device and a nephrostomy tube kit, wherein the nephrostomy tube securing device is adapted to secure a fistulation tube body around such that the fistulation tube body and the body are relatively stably secured without requiring an additional needle securing operation.

It is another object of the present invention to provide a nephrostomy tube fixing device and a nephrostomy tube kit which do not require a needle operation and do not cause unnecessary wounds.

Another object of the present invention is to provide a nephrostomy tube fixing device and a nephrostomy tube kit, wherein the nephrostomy tube fixing device can determine a fixed position according to a required length of the main body of the nephrostomy tube when in use, and is suitable for different types of people with a wide application range.

Another object of the present invention is to provide a nephrostomy tube fixing device and a nephrostomy tube kit which gradually fix the fistulation tube main body by compressive deformation of a balloon, thereby facilitating adjustment of the degree of tightness of fixation.

Another object of the present invention is to provide a nephrostomy tube fixing device and a nephrostomy tube set in which the balloon and the flexible fistulation tube main body are fitted to increase the circumferential friction force for fixing, thereby preventing the fistulation tube main body from being excessively deformed.

It is another object of the present invention to provide a nephrostomy tube fixing device and a nephrostomy tube kit, wherein in one embodiment the nephrostomy tube fixing device is adapted to fix a conventional knot-structured fistula without changing the structure of the conventional fistula and reducing unnecessary waste.

To achieve at least one of the above objects, an aspect of the present invention provides a nephrostomy tube securing device comprising:

a fixed chassis adapted to be fixed to a surface of a human body; and

a fixation assembly disposed on the fixation chassis forming a tube-passing channel adapted to pass through a stoma for circumferential fixation of the stoma tube by the fixation assembly.

The nephrostomy tube fixing device according to one embodiment, wherein the fixing assembly includes a fixing base, an elastic body mounted to the fixing base, and an adjusting member adjustably mounted to the fixing base to adjust a compression distance of the adjusting member with the elastic body.

The nephrostomy tube securing device according to one embodiment, wherein the elastic body has an inclined compression surface, the elastic body has a through hole adapted to pass the fistulization tube therethrough, the adjustment member includes an inner compression post having a deformation passage, the inner compression post compresses the compression surface of the elastic body when the adjustment member is adjusted to be close to the elastic body, and the deformation of the elastic body extends into the deformation passage of the inner compression post to narrow the through hole.

The nephrostomy tube securing device according to one embodiment, wherein the inner pressing column end has a mating compression surface with an inclination, the mating compression surface is mated with the compression surface of the elastic body, so that when the inner pressing column moves downwards, an inward inclined pressure is applied to the elastic body, thereby causing the elastic body to deform toward the center to reduce the perforation.

According to one embodiment, the nephrostomy tube fixing device is characterized in that the elastic body is provided with two symmetrical compression surfaces which are respectively positioned at the upper end and the lower end of the elastic body.

The nephrostomy tube securing device according to one embodiment, wherein the adjustment member includes an outer operating tube forming an access loop between the outer operating tube and the inner compression post, the holder extending into the access loop when the adjustment member is mounted to the holder.

The nephrostomy tube securing device according to an embodiment, wherein the inner pressure applying column is fixedly connected to the outer operation tube to control a compression distance between the inner pressure applying column and the elastic body by the outer operation tube.

The nephrostomy tube fixing device according to an embodiment, wherein the fixing base includes a fixing piece extending planarly from a bottom end periphery side of the fixing base, the fixing piece being fixed to the base layer.

The nephrostomy tube fixation device according to one embodiment, wherein the fixation base is fixed to the fixation chassis.

The nephrostomy tube fixing device according to one embodiment, wherein the fixing base includes a fixing member detachably connected to a mating fixing member fixed to the fixing base, and a mating fixing member mounted to the fixing member, the elastic body being mounted to the fixing member, the adjusting member being adjustably mounted to the fixing member to adjust a compression distance of the adjusting member and the elastic body.

The nephrostomy tube securing device according to one embodiment, wherein the elastomer is a balloon.

The nephrostomy tube securing device according to an embodiment, wherein the securing base plate includes a base layer, an adhesive layer provided on the base layer, and a peelable layer laminated in a peelable manner on a surface of the base layer via the adhesive layer.

The nephrostomy tube securing device according to one embodiment, wherein the peelable layer has a break line that forms the peelable layer into two parts in a separable manner.

The nephrostomy fixation device according to an embodiment, wherein the base layer includes an outer layer, a sandwiching layer and an inner layer, the sandwiching layer being integrally sandwiched between the outer layer and a central portion of the inner layer.

The nephrostomy tube securing device according to one embodiment, wherein the securing base includes an upper end portion and a lower end portion, the upper end portion includes two first portions and a second portion, the two first portions are symmetrically distributed on both sides of the second portion, the second portion is recessed inward from the first portions, and the upper end portion and the lower end portion are symmetrical.

The nephrostomy tube fixation device according to one embodiment, wherein the fixation chassis is made of a flexible material.

The nephrostomy tube fixation device according to one embodiment, wherein the central stiffness of the fixation chassis is greater than the stiffness of the peripheral portion.

Another aspect of the present invention provides a nephrostomy tube kit comprising:

the nephrostomy tube fixing device is arranged on the base; and

a fistulation tube adapted to be secured by the nephrostomy tube securement device.

The nephrostomy tube kit of one embodiment wherein the fistulation tube body comprises a balloon section, an extension section and an interface section, the balloon section, the extension section and the interface section being connected in sequence to form the fistulation tube body.

Drawings

Fig. 1A is a front perspective view of a nephrostomy tube securing device according to a first embodiment of the present invention.

Fig. 1B is a schematic view of the back of a nephrostomy tube securing device according to a first embodiment of the present invention.

Fig. 1C is a partially separated schematic view of a peelable layer 213 of a nephrostomy tube securing device according to a first embodiment of the present invention.

Fig. 2 is an exploded view of a nephrostomy tube securing device according to a first embodiment of the present invention.

Fig. 3A is a schematic cross-sectional view of an open state of a nephrostomy tube securing device according to a first embodiment of the present invention.

Fig. 3B is a partially enlarged schematic view of a position a in fig. 3A.

Fig. 4A is a schematic cross-sectional view of a fixed state of the nephrostomy tube fixing device according to the first embodiment of the present invention.

Fig. 4B is an enlarged view of a portion of fig. 4A.

Fig. 5A is a schematic view of a first embodiment of a nephrostomy tube set in a separated state according to the present invention.

Figure 5B is a schematic cross-sectional view of a main body of an ostomy tube according to a first embodiment of the invention.

Fig. 6 is a partially schematic cross-sectional view of the sleeved state 1 of the nephrostomy tube set according to the first embodiment of the present invention.

Fig. 7 is a schematic partially cross-sectional view of a semi-fixed state 2 of a nephrostomy tube set according to a first embodiment of the invention.

Fig. 8 is a schematic partially sectional view of a fully secured state 3 of a nephrostomy tube set according to a first embodiment of the present invention.

Fig. 9 is a schematic view of a procedure for using the nephrostomy tube set according to the first embodiment of the present invention.

Fig. 10 is another embodiment of an elastomer of the nephrostomy tube securing device according to the first embodiment of the present invention.

Fig. 11 is a modified embodiment of a fixing chassis of the nephrostomy tube fixing device according to the first embodiment of the present invention.

Fig. 12 is a schematic cross-sectional view of a nephrostomy tube securing device according to a second embodiment of the present invention.

Fig. 13 is a schematic diagram of a separation of a nephrostomy tube securing device according to a second embodiment of the present invention.

Fig. 14 is a sectional view of a nephrostomy tube securing device according to a third embodiment of the present invention.

Fig. 15 is a schematic view of a nephrostomy tube set according to a fourth embodiment of the present invention.

Fig. 16 is a schematic view of a securable nephrostomy tube device in accordance with a preferred embodiment of the present invention.

Fig. 17 is a schematic cross-sectional view a-a of the securable nephrostomy tube device of the preferred embodiment in accordance with the invention at the location shown in fig. 16.

Fig. 18 is a schematic cross-sectional view of the securable nephrostomy tube device in accordance with the above-described preferred embodiment of the invention.

Fig. 19 is a schematic view of the securable nephrostomy tube device in accordance with the above-described preferred embodiment of the invention.

Fig. 20A is a perspective view of a nephrostomy tube in accordance with a preferred embodiment of the present invention in a naturally curved state.

Fig. 20B is a perspective view of the nephrostomy tube according to the above preferred embodiment of the present invention in a straightened state.

Fig. 21A and 21B are schematic views illustrating a procedure in which the nephrostomy tube according to the above-described preferred embodiment of the present invention is applied to the body of a patient.

Fig. 22 is a perspective view and a partially enlarged view of the fistulization tube according to the above preferred embodiment of the present invention in a natural bending state.

Figure 23A is a cross-sectional view of the ostomy tube a-a according to figure 22 in accordance with the above preferred embodiment of the invention.

Fig. 23B is a schematic cross-sectional view in the longitudinal section B-B of the ostomy tube according to fig. 22 according to the above preferred embodiment of the invention.

Fig. 24 is a perspective view of the fixing body of the fixing device according to the above preferred embodiment of the present invention.

Detailed Description

The following description is presented to disclose the invention so as to enable any person skilled in the art to practice the invention. The preferred embodiments in the following description are given by way of example only, and other obvious variations will occur to those skilled in the art. The basic principles of the invention, as defined in the following description, may be applied to other embodiments, variations, modifications, equivalents, and other technical solutions without departing from the spirit and scope of the invention.

It will be understood by those skilled in the art that in the present disclosure, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used in an orientation or positional relationship indicated in the drawings for ease of description and simplicity of description, and do not indicate or imply that the referenced devices or components must be in a particular orientation, constructed and operated in a particular orientation, and thus the above terms are not to be construed as limiting the present invention.

It is understood that the terms "a" and "an" should be interpreted as meaning that a number of one element or element is one in one embodiment, while a number of other elements is one in another embodiment, and the terms "a" and "an" should not be interpreted as limiting the number.

References to "one embodiment," "an embodiment," "example embodiment," "various embodiments," "some embodiments," etc., indicate that the embodiment described herein may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the feature, structure, or characteristic. In addition, some embodiments may have some, all, or none of the described features of other embodiments.

Fig. 1A is a front perspective view of a nephrostomy tube securing device according to a first embodiment of the present invention. Fig. 1B is a schematic view of the back of a nephrostomy tube securing device according to a first embodiment of the present invention. Fig. 1C is a partially separated schematic view of a peelable layer 213 of a nephrostomy tube securing device according to a first embodiment of the present invention. Fig. 2 is an exploded view of a nephrostomy tube securing device according to a first embodiment of the present invention. Fig. 3A is a schematic cross-sectional view of a nephrostomy tube fixation device according to a first embodiment of the present invention in an open state. Fig. 3B is a partially enlarged schematic view of a position a in fig. 3A. Fig. 4A is a schematic cross-sectional view of a fixed state of the nephrostomy tube fixing device according to the first embodiment of the present invention. Fig. 4B is an enlarged partial view of fig. 4A. Fig. 5A is a schematic view of a first embodiment of a nephrostomy tube set in a separated state according to the present invention. Figure 5B is a schematic cross-sectional view of a main body of an ostomy tube according to a first embodiment of the invention. Fig. 6 is a partially schematic cross-sectional view of the sleeved state 1 of the nephrostomy tube set according to the first embodiment of the present invention. Fig. 7 is a partially schematic cross-sectional view of a semi-secure state 2 of a nephrostomy cuff member in accordance with a first embodiment of the present invention. Fig. 8 is a schematic partially cross-sectional view of a fully secured state 3 of a nephrostomy tube kit according to a first embodiment of the invention. Fig. 9 is a schematic view of a procedure for using the nephrostomy tube set according to the first embodiment of the present invention. Fig. 10 is another embodiment of an elastomer of the nephrostomy tube securing device according to the first embodiment of the present invention. Fig. 11 is a modified embodiment of a fixing chassis of the nephrostomy tube fixing device according to the first embodiment of the present invention.

Referring to fig. 1A to 11, the present invention provides a fistula fixing kit comprising a fistula main body 10 and a nephrostomy tube fixing device 20, the nephrostomy tube fixing device 20 being adapted to fix the fistula main body 10 to a predetermined site of the body. Preferably, the stoma tube body 10 is adapted to be used in a nephrostomy passage, i.e. the stoma tube body 10 is a nephrostomy tube, i.e. a passage is established between the kidney and the lumbar side of the patient. For example, the nephrostomy tube fixing device 20 is adapted to fix the fistulation tube main body 10 to the side of the waist of the patient. It is worth mentioning that the conditions to be fixed formed by different fistulization positions are different, namely, the fixing conditions of different positions of the patient are different, and the fixing device is suitable for fixing the nephrostomy tube on the waist side of the patient, namely, the fixing surface of the waist side of the patient in a U-shaped manner.

The nephrostomy tube fixing device 20 has a tube passing passage 2001 for passing through the fistulation tube main body 10.

The nephrostomy tube fixing device 20 includes a fixing base plate 21 and a fixing member 22, and the fixing member 22 is provided on the fixing base plate 21. The fixation chassis 21 and the fixation assembly 22 each form part of the tube passing channel 2001, the fixation assembly 22 being adapted to fix the nephrostomy tube body 10. The fixing chassis 21 is adapted to be fixed to a predetermined position of the patient's epidermis. That is, the fistulization tube main body 10 is fixed by the fixing member 22, and the relative position of the patient and the fixing member 22 is fixed by the fixing chassis 21, thereby indirectly fixing the relative position of the fistulization tube main body 10 and the patient. In other words, the indirect fixing method replaces the traditional direct suture needle winding method for fixing the fistulation tube, thereby reducing unnecessary trauma caused by fixing the fistulation tube main body 10.

Further, the fixation assembly 22 is adapted to secure the fistula tract body 10 therearound. That is, the securing assembly 22 is adapted to secure the fistula catheter body 10 externally from the peripheral side of the fistula catheter body 10.

The fixing chassis 21 is flexible as a whole and can be bent and deformed, that is, the fixing chassis 21 can change with the shape of the patient fixing position. Further, the fixing chassis 21 can form an arc shape suitable for the waist side of the patient when in use.

The fixation chassis 21 has a central hole 201, the central hole 201 being adapted for the passage of the fistula tract body 10.

The fixing chassis 21 includes a base layer 211, an adhesive layer 212, and a peelable layer 213, the adhesive layer 212 being provided on the base layer 211, and the peelable layer 213 being laminated in a peelable manner on one side of the base layer 211 via the adhesive layer 212. That is, the fixing base 21 is a substantially sheet body in which the peelable layer 213 is laminated on one surface of the base layer 211 via the adhesive layer 212 so as to be peelable. The lamellar body has less thickness to travelling comfort and convenience when improving the patient and using. The base layer 211, the adhesive layer 212, and the peelable layer 213 each form part of the central aperture 201 or are provided with openings 101 at corresponding locations.

For convenience of description, in the embodiment of the present invention, the side close to the skin of the patient is defined as the inner side and the side opposite or opposite to the inner side is defined as the outer side with reference to the usage state of the patient, so as to describe the relative position relationship.

In this embodiment of the present invention, the adhesive layer 212 is disposed on the inner side of the base layer 211, and accordingly, the release layer is laminated on the inner side of the base layer 211, whereby when the fixing member 22 is used, an operator such as a doctor or a nurse peels off the releasable layer 213, so that the adhesive layer 212 is adhered to the skin surface of the patient.

It is worth mentioning that the adhesive layer 212 is a material suitable for multiple or repeated adhesion and separation, that is, the adhesive layer 212 is not a fixative or a disposable fixative. The fixing chassis 21 can be bonded and detached from the patient's epidermis a plurality of times or repeatedly.

The fixed chassis 21 has an upper end 2101 and a lower end 2102 extending in the longitudinal direction of the fixed chassis 21, and has a left end 2103 and a right end 2104 extending in the width direction of the fixed chassis 21. The upper end 2101 and the lower end 2102 form a set, and the left end 2103 and the right end 2104 form a set. Both ends of the upper end 2101 and both ends of the lower end 2102 are connected to both ends of the left end 2103 and the right end 2104, respectively. That is, both ends of the upper end portion 2101 are respectively connected to one ends of the left end portion 2103 and the right end portion 2104, and both ends of the lower end portion 2102 are respectively connected to the other ends of the left end portion 2103 and the right end portion 2104, thereby forming a closed edge.

In this embodiment of the present invention, the upper end 2101 and the end are shaped to match so that the fixed chassis 21 is glued right or left or both right and left.

The fixed chassis 21 is formed in a left-right symmetrical shape with respect to a central axis Y perpendicular to the longitudinal direction. That is, the fixed base 21 has a shape symmetrical to the left and right with respect to the center plane in the longitudinal direction of the fixed base 21. The fixed chassis 21 is formed in a vertically symmetrical shape with respect to a central axis X perpendicular to the width direction. That is, the fixed base 21 has a vertically symmetrical shape with respect to a center plane of the fixed base 21 in the width direction.

The upper end 2101 and the lower end 2102 have a longer extension than the left end 2103 and the right end 2104 so as to be adhesively secured to the waist of the patient.

Referring to fig. 1B, the upper end 2101 has a first portion 21011 and a second portion 21012, the lower end 2102 has a first portion 21021 and a second portion 21022, the first portion 21011 of the upper end 2101 and the first portion 21011 of the lower end 2102 are vertically symmetrical with respect to the X-axis, and the second portion 21012 of the upper end 2101 and the second portion 21022 of the lower end 2102 are vertically symmetrical with respect to the X-axis. The second portion 21012 of the upper end portion 2101 and the second portion 21022 of the lower end portion 2102 are vertically symmetrical with respect to the X-axis. The second portion 21012 of the upper end 2101 is symmetrical about the Y-axis and the second end 21022 of the lower end 2102 is symmetrical about the Y-axis. The first part 21011 of the upper end 2101 is positioned outside the central axis Y, and the central axis of the second part 21012 of the upper end 2101 coincides with the central axis Y of the fixed chassis 21. The first portion 21021 of the lower end 2102 is located outside the central axis Y, and the central axis of the second portion 21022 of the lower end 2102 coincides with the central axis Y of the fixed chassis 21.

In this embodiment of the present invention, the first portion 21011 of the upper end 2101 forms a convex portion that is curved outward in the X-axis direction of the fixed base, and the second portion 21012 of the upper end 2101 forms a concave portion that is curved inward in the X-axis direction of the fixed base 21. Accordingly, the first portion 21021 of the lower end 2102 forms a convex portion which is curved outward in the X-axis direction of the fixed base, and the second portion 21022 of the lower end 2102 forms a concave portion which is curved inward in the X-axis direction of the fixed base 21. Preferably, the first portion 21011 and the second portion 21012 of the upper end 2101 are arcuately varied. The first portion 21021 and the second portion of the lower end 2102 are in an arcuate change 21022.

Preferably, in use, the second part 21012 of the upper end 2101 and the second part 21022 of the lower end 2102 are adapted to be adhered to the waist and the shoulders of the patient, and the first part 21011 of the upper end 2101 and the first part 21021 of the lower end 2102 are adapted to be adhered to the waist and the abdomen of the patient, so that the fixing condition provided by the fixing chassis 21 is matched with the fixing position of the patient, the adhesion is firmer and more convenient, for example, the adhering area on the waist and the shoulders of the patient is smaller, the turning movement of the patient is facilitated, the pulling feeling is reduced, the adhering areas on the two sides are larger, firmer adhering force can be provided, the rotating requirement on the position close to the abdomen is smaller, and the larger adhering area does not influence the use feeling.

Referring to fig. 11, in another embodiment of the present invention, a first portion 21011 of the upper end 2101 extends substantially linearly, and a second portion 21012 of the upper end 2101 is gradually recessed inward from one end of the first portion 21011 to form a recess. The first portion 21021 of the lower end 2102 extends substantially linearly, and the second portion 21012 is gradually recessed inward from one end of the first portion 21021 to form a recess. The first portion 21011 of the upper end 2101 is substantially parallel to the first portion 21021 of the lower end 2102.

In another embodiment of the present invention, the shape of the upper end 2101 and the shape of the lower end 2102 are not symmetrical about the X-axis, that is, the upper and lower shapes of the fixed chassis 21 are different.

Referring to fig. 1C, the base layer 211 of the fixing chassis 21 includes an operation portion 2110, and the operation portion 2110 is disposed at an edge position of the base layer 211 to provide an operation point for facilitating peeling. The operation portion 2110 is not provided with the adhesive layer, that is, the peeling portion cannot be adhered. The peelable layer 213 includes a peeling head 2130, the peeling head 2130 is disposed at an edge of the peelable layer 213, and the peeling head 2130 of the peelable layer 213 is located corresponding to the operating portion 2110, that is, the peeling head 2130 and the operating portion 2110 are not bonded in an initial state, while the base layer 211 and the peelable layer 213 are releasably bonded at the remaining positions by the adhesive layer 212. In other words, the peeling head 2130 and the operation portion 2110 provide an operation start position for facilitating the operation of peeling the peelable layer 213 in such a manner as to initiate separation. On the other hand, the peeling layer and the peeling portion are provided so that an operator does not directly contact the pressure-sensitive adhesive layer 212 during operation, thereby preventing a decrease in adhesive force. For example, the operator may pinch the operation portion 2110 with one hand and peel the peelable layer 213 with the other hand during operation.

The peelable layer 213 has a break line 231, and the break line 231 forms the peelable layer 213 into two parts in a tearable manner. The two portions formed by the break line 231 are respectively located at both sides of the fixing member 22, that is, the break line 231 is disposed such that the peelable layer 213 can be separated from the peelable layer 213 from both sides of the fixing member 22, respectively, without being blocked by the fixing member 22.

In another embodiment of the present invention, the peelable layer 213 is two parts separated from each other, that is, is directly separated without providing the break line 231. In operation, the two parts may be peeled apart.

In this embodiment of the invention, the base layer 211 includes an outer layer 2111, an interlayer 214, and an inner layer 2112, the interlayer 214 being integrally sandwiched between the outer layer 2111 and the inner layer 2112. By way of example and not limitation, the outer layer 2111, the inner layer 2112 and the interlayer 214 are integrally formed by means of heat pressing. The adhesive layer 212 is disposed on the inner layer 2112.

Further, the interlayer 214 is located in the center portion 2105 of the outer layer 2111 and the inner layer 2112, that is, the center portion 2105 of the base layer 211 comprises three layers of material, while the edge portion 2106 comprises two layers of material. Stated differently, the central portion 2105 of the base layer 211 includes the outer layer 2111, the interlayer 214, and the inner layer 2112. The edge portion 2106 of the base layer 211 includes the outer layer 2111 and the inner layer 2112. In other words, the center portion 2105 of the fixing chassis 21 fixing the fixing member 22 has three layers of materials, thereby more stably fixing the fixing member 22.

In one embodiment of the present invention, the material hardness of the interlayer 214 may be slightly greater than the material hardness of the outer layer 2111 and the inner layer 2112, so as to better determine the directionality of the fixing seat 221. Preferably, the interlayer 214 may be a tab with a gradually decreasing thickness from the inside to the outside.

In order to reduce the discomfort when the fixing base 21 is adhered to the skin, it is preferable that the fixing base 21 has flexibility and elasticity. And the fixing chassis 21 with elasticity is easy to follow the skin of the body of the patient, so that the nephrostomy tube fixing device 20 is not easy to be separated, and relatively stable fixing action can be provided for the fistulation tube main body 10.

In this embodiment of the present invention, the hardness of the center of the fixed base plate 21 is slightly greater than that of the periphery of the fixed base plate 21 due to the provision of the interlayer. And the thickness of the central portion 2105 of the fixed chassis 21 is slightly larger than that of the peripheral portion.

It is worth mentioning that the operability and the fixing firmness of the fixing chassis 21 are balanced by the structure arrangement of the fixing chassis 21, which is hard inside and soft outside. For example, since the center portion 2105 of the fixing chassis 21 is thick and relatively hard, that is, has a surface with good shape-retaining property, that is, its surface is substantially flat and extended, the operator can press it to fix it on the soft skin surface of the human body quickly without large deformation, and since the edge portion 2106 of the fixing chassis 21 is relatively soft, the operator can push it away from the center, so that the edge portion 2106 of the fixing chassis 21, which is more soft, changes its body shape, and is firmly attached to the skin surface of the body at the edge portion 2106.

Referring to fig. 3A, the fixing member 22 has a central passage 2201, and the central passage 2201 of the fixing member 22 communicates with the central hole 201 of the fixing base plate 21 to form the pipe passing passage 2001.

The fixing assembly 22 includes a fixing seat 221, an elastic body 222 and an adjusting member 223, wherein the elastic body 222 is mounted on the fixing seat 221, and the adjusting member 223 is adjustably mounted on the fixing seat 221 to adjust a compression distance between the adjusting member 223 and the elastic body 222.

The fixing base 221 is integrally fixed to the fixing chassis 21. Further, the fixing base 221 is disposed on the base layer 211 of the fixed base chassis. In this embodiment of the present invention, the fixing base 221 is integrally fixed to a central portion 2105 of the base layer 211 of the fixing base plate 21. That is, the relative positions of the fixing base 221 and the base layer 211 of the fixing chassis 21 are fixed.

The fixing seat 221 has a first passage 22101, and the first passage 22101 is suitable for the fistula main body 10 to pass through.

The fixing seat 221 has a compression cavity 22103, the compression cavity 22103 is communicated with the tube penetrating channel 2001, and the elastic body 222 is arranged in the compression cavity 22103.

The elastic body 222 has a perforation 22201, and the perforation 22201 is adapted to pass through the fistula main body 10. The inner diameter of the perforation 22201 is substantially the same as the outer diameter of the ostomy main body 10 or slightly larger than the outer diameter of the ostomy main body 10. When the elastic body 222 is disposed in the compression cavity 22103, the perforation 22201 communicates with the tube passing passage 2001 so that the fistula main body 10 passes through, and the elastic body 222 surrounds the circumference side of the fistula main body 10.

The adjusting member 223 has an inner channel 22302, and the inner channel 22302 communicates with both ends of the adjusting member 223. That is, the inner channel 22302 extends from one end of the adjustment member 223 to the other end.

The tube passing channel 2001, the compression cavity 22103 and the communication hole are communicated with each other to form the central channel 2201, the central channel 2201 is suitable for the fistulization tube main body 10 to pass through, and the elastic body 222 surrounds the periphery of the fistulization tube main body 10.

The elastic body 222 includes an upper end portion 2221 and a lower end portion 2222, and the upper end portion 2221 and the lower end portion 2222 are symmetrically disposed with respect to a horizontal center plane.

The elastic body 222 has two

symmetrical compression surfaces

22211, 22221, which are respectively located at the upper and lower ends of the elastic body 222. The compression surfaces 22211, 22221 are formed by the surfaces of the central portion of the resilient body 222 converging inwardly to a ported position. That is, the compression surfaces 22211, 22221 are inclined in surface. In one implementation of the present invention, the elastomer 222 forms a top-of-the-loop shape. Optionally, the compression surfaces 22211, 22221 are inclined at an angle of 30 ° to 60 °, preferably 45 °. It should be noted that the inclination angle of the compression surfaces 22211, 22221 of the elastic body 222 affects the amount of deformation in compression, and an excessively large or excessively small inclination angle of the elastic body 222 affects or reduces the tube holding fixing effect of the elastic body 222.

Referring to fig. 2 and 3A, the adjusting member 223 includes an outer operating tube 2231 and an inner pressing column 2232, an access loop 22301 is formed between the outer operating tube 2231 and the inner pressing column 2232, and when the adjusting member 223 is connected to the fixing seat 221, the fixing seat 221 extends into the access loop 22301. Further, in this embodiment of the present invention, the permanent seat 221 is threaded into the access loop 22301. That is, the inner wall of the outer operating tube 2231 and the outer surface of the fixing base 221 are respectively provided with connecting threads that are engaged with each other. In this embodiment of the present invention, the outer operating tube 2231 and the inner pressing post 2232 extend substantially in a tubular shape. In other embodiments of the present invention, the operation portion 2110 may be in other shapes for convenient operation.

The inner pressing post 2232 forms the inner channel 22302 and communicates both ends of the outside. The inner pressing post 2232 and the outer operating tube 2231 are integrally connected at their ends. The inner pressing post 2232 is fixedly connected to the outer operating tube 2231, so that a compression distance between the inner pressing post 2232 and the elastic body 222 is controlled by the outer operating tube 2231.

Referring to fig. 3A, 4A and 4B, the end of the inner pressing post 2232 forms an inclined pressing surface 22321, and the pressing surface 22321 cooperates with the compression surface of the elastic body 222 to apply an inward pressure to the inclined compression surface, so that the elastic body 222 is deformed in an inward or central direction, thereby reducing the through hole 22201.

The inner pressing columns 2232 and the outer operating tube 2231 extend substantially uniformly in height, or the inner pressing columns 2232 have a height slightly higher than that of the outer operating tube 2231. When the adjustment member 223 is coupled to the fixing seat 221, the inner pressing post 2232 extends into the first passage 22101 of the fixing seat 221.

When the adjusting member 223 is connected to the fixing seat 221, the inner pressing column 2232 abuts against the elastic body 222, and as the adjusting member 223 approaches the fixing seat 221, the inner pressing column 2232 presses the elastic body 222 to press and deform the elastic body 222, so that the upper end 2101 of the elastic body 222 is pressed and deformed to enter the central channel 2201 of the adjusting member 223, and the lower end 2102 of the elastic body 222 is pressed and deformed to enter the second channel 22103, thereby the elastic body 222 forms a deformed pipe embracing channel which contracts inwards. That is, under the interaction of the adjusting member 223 and the fixing seat 221, the elastic body 222 deforms, and within the constraint range of the fixing seat 221, the elastic body 222 deforms along with the constraint space formed by the fixing seat 221 and the adjusting member 223.

In this embodiment of the present invention, the adjusting member 223 is coupled to the fixing base 221 by a mating screw. For example, when the adjusting member 223 is rotated clockwise, the adjusting member 223 approaches the fixing seat 221, the inner pressing column 2232 gradually presses the elastic body 222 to deform, and when the adjusting member 223 is rotated counterclockwise, the adjusting member 223 moves away from the fixing seat 221, and the elastic body 222 gradually recovers the deformation.

In another embodiment of the present invention, the adjusting member 223 is connected to the fixing seat 221 in a straight pushing manner, and a locking mechanism is provided on the fixing seat 221, and when the adjusting member 223 is compressed to a predetermined position, the locking mechanism locks the relative positions of the adjusting member 223 and the elastic body 222, so that the elastic body 222 is maintained in a deformed state. That is, when the fistula main body 10 passes through the fixing member 22 and the adjustment member 223 is pushed and locked, the fistula main body 10 is stably held by the elastic body 222.

It should be noted that in this embodiment of the present invention, the size of the deformation amount of the elastic body 222 can be gradually adjusted and changed by the threaded connection between the adjusting member 223 and the fixing base 221, so that the size of the deformation embracing tube passage 22202 can be adjusted, on one hand, the holding tightness of the same fistulization tube main body 10 and the contraction degree of the fistulization tube main body 10 can be adjusted, and on the other hand, the size of the deformation embracing tube passage can be adjusted to adapt to different sizes of fistulization tube main bodies 10, that is, the fistulization tube main bodies 10 with different sizes can be fixed to be substantially consistent tightness, or can be respectively contracted to different degrees. That is, the application range is wider than the gradual adjustment mode of the threaded connection in the direct-push locking mode. In other embodiments of the invention, other push-on connections may be provided, and the invention is not limited in this respect.

The fixing base 221 includes a fixing piece 2213, and the fixing piece 2213 extends from the bottom peripheral side of the fixing base 221 in a plane. The fixing member 2213 is integrally fixed to the base layer 211. That is, a large connection area between the fixing base 221 and the base layer 211 is formed by the fixing member 2213, thereby stably fixing the fixing base 221.

Further, the fixing base 221 is fixed inside the interlayer 214 of the base layer 211. That is, both sides of the fixing member 2213 of the fixing seat 221 are fixed by the interlayer 214, the outer layer 2111 and the inner layer 2112, respectively.

For example, when manufacturing the nephrostomy tube fixing device 20, the fixing member 22 is manufactured as separate bodies such as the fixing base 221, the elastic body 222 and the adjustment member 223, and then the fixing base 221 is integrally formed in the fixing base 21 when manufacturing the fixing base 21. And then the elastic body 222 and the adjustment member 223 are installed. Of course, the elastic body 222 and the adjusting member 223 may be mounted on the fixing seat 221 first, and then the fixing chassis 21 is integrally formed on the fixing seat 221.

The fixing seat 221 includes a first part 2211 and a second part 2212, the first part 2211 forms a first passage 22101 and the compression cavity 22103, the second part 2212 forms a second passage 22103, the first passage 22101 is communicated, and the compression cavity 22103 and the second passage 22103 are communicated in sequence.

The second part 2212 is integrally connected to the fixing member 2213. Further, the second part 2212 and the fixing piece 2213 are fixed by the base layer 211 of the fixing chassis 21. In this embodiment of the present invention, the second component 2212 is a tubular structure, and the bottom circumference of the tube wall is fixed by the base layer 211.

The bottom end of the first part 2211 is conically connected to the upper end of the second part 2212 to form the compression chamber 22103. The first part 2211 has an inner diameter larger than that of the second part 2212. The inner compression post 2232 forms a channel that substantially conforms to the second component 2212 that matches the diameter of the ostomy tube body 10, thereby facilitating guided delivery of the ostomy tube body 10.

The adjusting member 223 is connected to the first component 2211 of the fixing base 221. Further, the first part 2211 of the fixing base 221 is fittingly connected with the outer operation tube 2231 of the adjusting member 223. In this embodiment of the present invention, the outer side surface of the first member 2211 forms a screw surface engaged with the adjusting member 223. In other embodiments of the present invention, there may be other ways of locking the outer operating tube 2231 and the first part 2211 of the fixing seat 221. That is, after the compression of the elastic body 222 is completed, the relative positions of the adjustment member 223 and the fixing base 221, i.e., the force to which the fistula tract main body 10 is subjected, are locked.

Fig. 5 is a schematic view of a first embodiment of a ostomy kit 100 in a separated state according to the invention.

Referring to fig. 5, the fistulization tube main body 10 and the nephrostomy tube fixing device 20 constitute a fistulization tube kit 100, that is, the nephrostomy tube fixing device 20 and the fistulization tube main body 10 are fitted to each other. In other words, the models of the nephrostomy tube securing device 20 and the fistulation tube body 10 are matched.

The ostomy body 10 has a fluid passage 102, and the fluid passage 102 communicates with both ends of the ostomy body 10 to deliver liquid along the ostomy body 10, for example, from the inside of the kidney of the human body to the outside.

The main body 10 of the fistulization tube comprises a balloon section 11, an extension section 12 and a connector section 13, wherein the balloon section 11, the extension section 12 and the connector section 13 are sequentially connected to form the main body 10 of the fistulization tube. Further, the balloon section 11, the extension section 12 and the interface section 13 are connected in sequence from the inside to the outside.

Further, the balloon section 11, the extension section 12 and the interface section 13 are integrally connected.

The airbag section 11 includes a head end 111 and an airbag 112, the head end 111 has at least one opening 101, and the opening 101 communicates with the fluid channel 102, so that the liquid inside enters the fluid channel 102 through the opening 101. The balloon 112 is used for inflation fixation, that is, in use, an operator inflates the balloon 112 to make the balloon 112 expand to be limited in the renal pelvis of the human body, that is, the balloon 112 is blocked at the position of the renal pelvis fistulization opening of the patient so that the fistulization tube body 10 is not separated. The opening 101 is located near the proximal end of the ostomy tube body 10. And the balloon 112 can prevent the reduction of the bleeding of the stoma of the patient by the compression action of the balloon 112, i.e. has the function of compression hemostasis.

The balloon 112 of the fistula tract body 10 has an inflated state in which the balloon 112 has an expanded volume adapted to be restrained, and a non-inflated state. In the non-inflated state, the surface of the balloon 112 and the surface of the fistula tract body 10 are at substantially the same height, i.e. the balloon section 11 of the fistula tract body 10 is substantially elongate and tubular and is adapted to be adjusted for movement.

The main body 10 has an inflation channel 103, and the inflation channel 103 communicates with the balloon 112 so as to inflate or deflate the balloon 112. In this embodiment of the invention, the inflation channel 103 is provided to the extension 12.

The interface section 13 comprises a drainage interface 131 and an inflation interface 132, the drainage interface 131 being used to connect external receiving or drainage components. In this embodiment of the invention, the drainage port 131 extends substantially uniformly along the extension 12, and the inflation port 132 extends divergently from the extension 12. That is, the inflation port 132 and the drainage port 131 form two branches, bifurcating in extension.

The inflation port 132 is used to connect an inflator. The inflation interface 132 communicates with the inflation channel. That is, when it is desired to inflate the airbag 112, the inflator is connected to the inflation interface 132, thereby inflating the inflation channel and thereby placing the airbag 112 in the inflated state.

The inflation interface 132 includes an air valve, and the air valve is used to control the opening or closing of the inflation interface 132, that is, the air valve controls the inflation and deflation state of the airbag. Preferably, the gas valve is a one-way valve, that is, when the inflator is connected to the gas valve, the gas valve is automatically opened by the gas filled in the inflator, and when the inflator is released, the gas valve automatically prevents the gas inside from flowing outwards. When deflation is required, that is, when the air bag 112 is caused to return to the uninflated state, the operator operates the air valve, such as a pressing operation, or a pulling operation, so that the gas inside the air bag 112 can flow to the outside, thereby deflating.

The ostomy main body 10 comprises a positioning line 14, the positioning line 14 being used for positioning the ostomy main body 10 into position in the body. The positioning wire 14 is integrally provided along the extension 12 of the fistula tract body 10. By way of example and not limitation, after the fistula tract main body 10 enters the body's fistula tract, the location wire 14 can be developed under X-ray or B-ultrasound examination, i.e., the location wire 14 can be viewed from an image display device.

In other embodiments of the present invention, the positioning line 14 may also be extended from the balloon segment 11 or the interface segment 13, and the present invention is not limited in this respect.

Fig. 6 is a partially cut-away schematic view of a sleeved state 1 of a ostomy kit 100 according to a first embodiment of the invention.

Referring to fig. 6, when the ostomy kit 100 is required to be used, the end of the ostomy tube body 10 is passed through the tube passing passage 2001 of the nephrostomy tube fixation device 20 when the balloon is in an uninflated state. More specifically, the end of the balloon section 11 of the fistula catheter main body 10 enters from the outer port of the fixing member 22 and advances along the fixing member 22 to pass out from the central hole 201 of the fixing chassis 21, thereby completing the tube passing process in which the fistula catheter main body 10 and the fixing member 22 are fitted, i.e., the fistula catheter main body 10 and the fixing member 22 are in the sleeved state 1. In the sleeved state 1, the elastic body 222 surrounds the extension section 12 of the fistula main body 10 more loosely, and the elastic body 222 is in an undeformed state or does not generate a large deformation for fixing the fistula main body 10.

It should be noted that in this state, the fistula main body 10 and the fixing member 22 are relatively movable, that is, on the one hand, an operator, such as a doctor or a nurse, can adjust the length of the fistula main body 10 into the patient, and on the other hand, the operator can adjust the relative positions of the fistula fixing device 20 and the fistula main body 10 so that the fixing position of the fistula main body 10 can be adjusted.

Figure 7 is a schematic partially cross-sectional view of a semi-fixed state 2 of a ostomy kit 100 according to a first embodiment of the invention. Fig. 8 is a schematic partially cross-sectional view of a fully secured state 3 of a ostomy kit 100 according to a first embodiment of the invention.

Referring to fig. 7, when the extension section 12 of the fistula main body 10 is passed through the fistula fixing device 20 and the adjustment member 223 is adjusted, for example, rotated, the inner pressing column 2232 of the adjustment member 223 is brought close to the elastic body 222, and a pressure obliquely inward is applied to the elastic body by the pressing surface 22321 of the inner pressing column 2232, the elastic body 222 is deformed toward both ends and the fistula main body 10 is compressed and contracted, forming a half-fixed state 2. In the semi-secure state 2, the fluid passageway 102 of the ostomy tube body 10 is in communication with the inside and the outside. That is, the liquid in the kidney of the human body can be transferred to the outside through the fluid passage 102. The delivery flow rate of the fluid channel 102 or the size of the communication opening can be adjusted by adjusting the adjusting element 223.

Referring to figures 7 and 9, in use, after the procedure is completed, the length of the ostomy tube body 10 into the patient is determined, i.e. the position where the ostomy tube body 10 is suitable to be secured. Then, the air bag is inflated by the inflating device, so that the air bag is in the inflated state, namely, the position of the fistulization tube main body 10 and the body of the patient is limited preliminarily, and it is worth mentioning that the air bag can relatively limit the movement of the fistulization tube main body 10 to the outside of the body, but the air bag has no obvious effect on the swinging of the fistulization tube main body 10 to the inside or the outside of the stoma; then, the operator operates to peel off the peelable layer 213 of the fixing chassis 21 and adhesively fix the base layer 211 to the skin of the patient; further manipulation of the adjustment member 223, such as rotation of the adjustment member 223, causes the adjustment member 223 to move in the direction of the fixing base 221, such that the elastic body 222 is gradually deformed by pressure, thereby circumferentially constraining the fistula tract body 10, i.e., such that the relative positions of the fistula tract body 10 and the fixing member 22 are preliminarily determined. At this time, the nephrostomy tube securing device 20 is in the semi-fixation state 2, that is, the adjustment member 223 does not reach the maximum adjustment position. The interior of the fistula tract body 10 is still partly in communication with the interior and the exterior, or largely in communication. In other words, in this state, the amount of deformation of the fistula main body 10 is small, the relative positions of the fistula main body 10 and the fixing member 22 are fixed mainly by the frictional force between the fistula main body 10 and the elastic member of the fixing member 22, and the frictional force acts relatively small.

Of course, in another mode of operation, the air can be inflated after being fixed. That is, after the operation is completed, the length of the fistula tract body 10 that enters the patient is determined, i.e., determining a position where the ostomy tube body 10 is suitably fixed, an operator operates to peel off the peelable layer 213 of the fixing chassis 21, and adhesively securing the substrate 211 to the patient's skin, further manipulation of the adjustment member 223 by the operator, such as rotation of the adjustment member 223, so that the adjusting member 223 moves towards the fixing seat 221, so that the elastic body 222 is gradually pressed and deformed, thereby circumferentially constraining the fistula catheter body 10, that is, such that the relative positions of the fistula catheter body 10 and the fixation assembly 22 are initially determined, after the adjustment of the adjustment member 223, the airbag is inflated by the inflator so that the airbag is in the inflated state.

Fig. 8 is a schematic partially cross-sectional view of a fully secured state 3 of a ostomy kit 100 according to a first embodiment of the invention.

Further, referring to fig. 8, when the adjusting member 223 is adjusted to the bottom end by rotating, the inner pressing column 2232 of the adjusting member 223 compresses the elastic body 222 to the maximum pressure, and applies an obliquely inward pressure to the elastic body via the pressing surface 22321 of the inner pressing column 2232, so that the elastic body 222 has the maximum deformation toward both ends, and the fistula catheter main body 10 is compressed and contracted to form a fully fixed state 3. In the fully secured state 3, the fluid passage 102 of the ostomy tube body 10 is substantially closed. That is, the liquid in the kidney of the human body cannot be or is less transported to the outside through the fluid passage 102.

Referring to figures 8 and 9, in use, after the procedure is completed, the length of the ostomy tube body 10 into the patient is determined, i.e. the position where the ostomy tube body 10 is suitable to be secured. Then, the air bag is inflated by the inflating device, so that the air bag is in the inflated state, namely, the position of the fistulization main body 10 and the body of the patient is limited preliminarily. Then, the operator operates the adjustment member 223, for example, rotates the adjustment member 223, so that the adjustment member 223 moves toward the fixing base 221, and adjusts the adjustment member 223 to the maximum adjustment position, so that the elastic body 222 is gradually deformed by pressure, and the amount of deformation reaches the maximum state, thereby circumferentially constraining the fistula main body 10, that is, so that the relative positions of the fistula main body 10 and the fixing member 22 are fixed to the maximum extent. In this state, the regulating member 223 reaches the maximum regulating position, the amount of deformation of the elastic body 222 reaches the maximum state, the amount of deformation of the fistula main body 10 reaches the maximum state, and a part of the fluid passage 102 of the fistula main body 10 is greatly reduced. That is, the fistula tract body 10 is controlled to be opened or closed by the fixing member 22.

It is worth mentioning that this condition of use is suitable for situations where the patient needs less drainage and no more fluid is flowing inside.

In another embodiment of the invention, the fully secured state 3 may also be a state in which the fluid passage 102 of the ostomy main body 10 is substantially open, i.e. the ostomy main body 10 has a better flow guiding effect even if the adjustment member 223 is adjusted to a maximum adjustment position.

The extent to which the fixation assembly 22 controls the amount of deformation of the ostomy tube body 10 is not a limitation of the invention.

Fig. 10 is another embodiment of an elastomeric body 222 of the ostomy fixation device 20 according to the first embodiment of the invention.

In contrast to the first embodiment described above, and with reference to fig. 10, in this embodiment of the invention, the resilient body 222 is a bladder. That is, the elastic body 222 has an inner cavity 22203, and the inner cavity 22203 is at least partially sealed with gas to support the elastic body 222 to form a predetermined shape.

The outer surfaces of the elastic bodies 222 form the upper end portion 2221 and the lower end portion 2222, which are inclined, respectively.

Fig. 11 is a modified embodiment of the mounting chassis 21 of the ostomy fixation device 20 according to the first embodiment of the invention.

In this embodiment of the present invention, the difference from the above-described first embodiment is that the first portion 21011 of the upper end portion 2101 of the fixed chassis 21 extends substantially straight, the first portion 21021 of the lower end portion 2102 extends substantially straight, and the first portion 21011 of the upper end portion 2101 and the first portion 21021 of the lower end portion 2102 of the fixed chassis 21 are parallel to each other.

Further, the upper end portion 2101 of the fixed chassis 21 has two first portions 21011 on both sides of a recess formed by one second portion 21012. Symmetrically, the lower end 2102 of the fixed chassis 21 has two first portions 21021, one on each side of the recess formed by one second portion 21022.

Figure 12 is a schematic cross-sectional view of a ostomy assembly according to a second embodiment of the invention. Figure 13 is an exploded schematic view of a ostomy assembly according to a second embodiment of the invention.

The second embodiment of the renostomy fixing device 20 differs from the first embodiment of the ostomy fixing device 20 in that the fixing base 221 of the fixing assembly 22 comprises a fixing member 2213 and a mating fixing member 2214, the mating fixing member 2214 is fixed to the fixing base plate 21, and the fixing member 2213 is detachably connected to the mating fixing member 2214. The elastic body 222 is mounted on the fixing part 2213 of the fixing base 221, and the adjusting part 223 is adjustably mounted on the fixing part 2213 of the fixing base 221 to adjust the compression distance between the adjusting part 223 and the elastic body 222.

In this embodiment of the present invention, the fixing member 2213 is detachably connected to the mating fixing member 2214 in a screw-coupling manner. That is, the attachment portions of the fixture 2213 and the mating fixture 2214 are each provided with mating threads.

In other embodiments of the present invention, the securing member 2213 can be detachably connected to the mating securing member 2214 in other manners, such as by snapping.

The nephrostomy tube fixing device 20 of the third embodiment is different from the nephrostomy tube fixing device 20 of the first embodiment in that the fixing base 221 is integrally connected to the fixing chassis 21.

Further, the fixing seat 221 integrally extends upward from the surface of the base layer 211 of the fixing chassis 21 to form the fixing seat 221.

The holder 221 includes a first part 2211 and a second part 2212, the first part 2211 forms a first passage 22101 and the compression cavity 22103, the second part 2212 forms a second passage 22103, the first passage 22101 is communicated, and the compression cavity 22103 and the second passage 22103 are communicated with each other in sequence.

The second member 2212 is integrally connected to the fixed chassis 21. Further, the second part 2212 is integrally connected to the base layer 211 of the fixed chassis 21. In this embodiment of the present invention, the second component 2212 is a tubular structure with walls integrally connected to the base layer 211. The bottom end of the first part 2211 is conically connected to the upper end of the second part 2212 to form the compression chamber 22103. The first part 2211 has an inner diameter larger than that of the second part 2212.

The inner compression post 2232 forms a channel that substantially conforms to the second component 2212 that matches the diameter of the ostomy tube body 10, thereby facilitating guided delivery of the ostomy tube body 10.

Fig. 15 is a schematic view of a nephrostomy tube kit 100 according to a fourth embodiment of the present invention.

The nephrostomy tube kit 100 of the fourth embodiment differs from the nephrostomy tube kit 100 of the first embodiment in that the fistula main body 10 does not include the balloon. That is, in this embodiment of the invention, the extension 12 of the ostomy main body 10 integrally extends to an outer end and forms the aperture 101 at the outer end. The fistula tract body 10 without the balloon is readily detached from the body and is suitable for short-term or temporary use.

Referring to fig. 16-19, a securable nephrostomy tube device in accordance with a preferred embodiment of the present invention is shown.

The fixable nephrostomy tube device comprises a fixing unit 810 and at least one nephrostomy tube 820, it being understood that the number of nephrostomy tubes 820 may be two, three, four or more. The same fixing unit 810 can be adapted to fix a plurality of nephrostomy tubes 820.

The nephrostomy tube 820 of the fixable nephrostomy tube device can be inserted into a nephrostomy passage of a subject through a stoma adapted to communicate with the nephrostomy passage and which is located at a body surface of the subject. It is understood that the subject may be a human, an animal, etc., and the description herein is made by way of example of a human.

The nephrostomy tube 820 inserted into the nephrostomy passage can be fixedly mounted to the subject of use by means of the fixing unit 810. The nephrostomy tube 820 has an initial end and an opposite terminal end, and the initial end of the nephrostomy tube 820 is adapted to be inserted into a predetermined position in the body of the subject along the nephrostomy passage first during insertion. The preset positions are different according to individual differences of the using objects. The distal end of the nephrostomy tube 820 is located outside. On the side close to the end of the nephrostomy tube 820, the nephrostomy tube 820 can be fixed to the fixing unit 810 and the fixing unit 810 can be fixed to the body surface of the subject, so that the nephrostomy tube 820 is fixed at least in one position.

In detail, a portion of the nephrostomy tube 820 is extended into the body, a portion is exposed outside the body and fixed to the fixing unit 810, and the fixing unit 810 can be fixed to the body surface of the subject, thereby preventing the nephrostomy tube 820 from coming out of the body by the fixing unit 810 or preventing the nephrostomy tube 820 from being inserted to a deeper position.

The fixing unit 810 has a tied state in which the nephrostomy tube 820 is tied by the fixing unit 810 so as not to be movable with respect to the fixing unit 810, and an open state in which the nephrostomy tube 820 is movable with respect to the fixing unit 810, so that the position of the starting end of the nephrostomy tube 820 to the fixing unit 810 can be changed to change the depth of insertion of the nephrostomy tube 820 to fit to the user of different needs. The securing unit 810 is operable to be shifted between the restrained state and the open state.

Further, the fixing unit 810 can fix the nephrostomy tube 820 not only to prevent the nephrostomy tube 820 from moving forward or backward to prevent the nephrostomy tube 820 from failing to perform an intended drainage function, but also prevent the nephrostomy tube 820 from moving left and right within the nephrostomy passage to reduce the pulling of the nephrostomy tube 820 on the body tissue of the subject during the movement, thereby preventing the stoma from being pulled larger or causing damage to the nephrostomy passage.

It is worth mentioning that when the external exposed nephrostomy tube 820 is accidentally caught or pulled by an object, the fixing unit 810 can disperse the force applied to the nephrostomy tube 820 to the body surface of the subject, thereby reducing the damage to the body around the nephrostomy tube 820.

Specifically, the fixing unit 810 includes a fixing support 811 and a fixing patch 812, wherein the fixing support 811 is used to fix the nephrostomy tube 820, and the fixing patch 812 is adapted to be fixed to the body surface of the subject. The fixing support 811 is connected to the fixing patch 812 to be fixed by the fixing patch 812.

Since the nephrostomy tube 820 is fixedly attached to the fixing support 811, the fixing support 811 is fixedly attached to the fixing patch 812, and the fixing patch 812 is fixed to the body surface of the subject, when the nephrostomy tube 820 is pulled by an external force, the fixing support 811 receives most of the force from the nephrostomy tube 820, and the fixing patch 812 further receives most of the force from the fixing support 811, thereby distributing the pulling force to the body surface portion of the subject to which the fixing patch 812 is attached.

In this way, the possibility that the nephrostomy tube 820 is torn to cause injury to the stoma is greatly reduced, and on the one hand, the nephrostomy tube 820 can be safely fixed on the fixing unit 810, and on the other hand, the movement restriction of the subject during movement is also relieved to a certain extent, and the limitation of the movement range and the movement range is reduced.

In addition, the fixing patch 812 is disposed around the fixing support 811, and after the fixing unit 810 of the nephrostomy tube 820 is installed in the subject, the fixing unit 810 of the nephrostomy tube 820 can close the stoma to prevent the fluid overflowing through the stoma from continuously overflowing outward, thereby reducing the possibility of emitting odor.

Further, the fixation unit 810 has a retention channel 81110, the nephrostomy tube 820 is adapted to be inserted into the retention channel 81110 of the fixation unit 810 and can be retained to the retention channel 81110, the retention channel 81110 being sized to be adjustable. The holding channel 81110 may be adjusted to be larger when the nephrostomy tube 820 needs to be detached from the fixing unit 810, and the holding channel 81110 may be adjusted to be smaller when the nephrostomy tube 820 needs to be detached from the fixing unit 810.

It should be noted that, in the present embodiment, the kidney fistulation tube 820 is implemented as a hose, and may be made of rubber or silica gel, so as to reduce the discomfort of the user. It will be understood by those skilled in the art that the materials from which the nephrostomy tube 820 is made may be selected as desired and are intended to be illustrative only and not limiting of the invention. It will of course be appreciated that the nephrostomy tube 820 may also be implemented as a tube of a relatively rigid material, selected according to the actual requirements.

After the nephrostomy tube 820 is inserted into the retention channel 81110 of the fixation unit 810, the retention channel 81110 is adjusted to be contracted, and the fixation unit 810 presses the nephrostomy tube 820 to be deformed, thereby clasping the nephrostomy tube 820. The nephrostomy tube 820 has a drainage channel 8200, a drainage inlet 8201 and a drainage outlet 8202, wherein the drainage inlet 8201 and the drainage outlet 8202 are respectively communicated with the drainage channel 8200 at two ends of the drainage channel 8200. The nephrostomy tube 820 is provided with a marker line so that the nephrostomy tube 820 can be positioned under a detection device after being inserted into the inside of the body to facilitate the operator to control the position and depth of insertion.

In this embodiment, the kidney fistula 820 is fixed to the fixing unit 810 by pressing the kidney fistula 820 and the drainage channel 8200 of the kidney fistula 820 can be maintained in a conduction state. In other words, the nephrostomy tube 820 made of flexible material can maintain normal flow guiding function after being fixed.

The fixation support 811 of the fixation unit 810 includes a force application component 8111 and a deformable member 8112, wherein the force application component 8111 is disposed on opposite sides of the deformable member 8112 to press the deformable member 8112 against each other to deform, thereby changing the size of at least a portion of the retention passage 81110 formed by the deformable member 8112, and thereby fixing the nephrostomy tube 820 through at least a portion of the retention passage 81110 formed by the deformable member 8112.

The nephrostomy tube 820 passes through the deformable member 8112 from an axial direction of the deformable member 8112, and the force application assembly 8111 is configured to apply a squeezing force to the deformable member 8112 in the axial direction of the deformable member 8112 to deform the deformable member 8112 in a circumferential direction to change the size of the retention channel 81110.

In more detail, the force application assembly 8111 includes a fixed support seat 81111, a movable member 81112 and has the holding passage 81110 and a gap 811110, the holding passage 81110 is disposed through, the gap 811110 is communicated with the holding passage 81110 and expands a space in a radial direction of the holding passage 81110 in a radial direction, and the holding passage 81110 is located in the holding passage 81110. The fixed support 81111 is adapted to be coupled to the fixed patch 812 to be secured to the fixed patch 812, the movable member 81112 is adapted to be movably coupled to the fixed support 81111, and the gap 811110 is formed between the movable member 81112 and the fixed support 81111. As movable member 81112 is moved toward fixed bearing 81111, gap 811110 is reduced.

The deformable member 8112 is accommodated in the gap 811110, and when the movable member 81112 is moved to move toward the fixed support 81111, the deformable member 8112 can be pressed by the movable member 81112 and the fixed support 81111 which move relatively to each other to be deformed in a radial direction.

In this embodiment, the retaining channel 81110 formed in the deformable element 8112 is partially formed in an intermediate position of the deformable element 8112, which is defined as an inner side of the deformable element 8112, and correspondingly, an outer side of the deformable element 8112 is disposed in the force application component 8111, and when the deformable element 8112 is pressed by the fixed supporting seat 81111 and the movable element 81112 of the force application component 8111, the force application component 8111 limits the deformation of the deformable element 8112 toward the outer side, thereby ensuring that the deformable element 8112 is deformed toward the inner side after being pressed to a certain degree, so as to change the size of the retaining channel 81110.

In other words, the deformable member 8112 is configured to be captively mounted to the force application assembly 8111 and is captured on the outside to allow inward deformation.

It is noted that the drainage channel 8200 of the nephrostomy tube 820 can be reduced to a certain extent during the process of pressing the deformable member 8112 to deform, and the reduction can be controlled, and even the drainage channel 8200 can be closed by the fixing unit 810. In other words, when the operator wishes the kidney stoma tube 820 to stop draining, the drainage channel 8200 of the kidney stoma tube 820 can also be closed by means of the fixing unit 810.

Further, in this embodiment, the deformable member 8112 is a solid, resilient member, and as the raised top surface 81121 and the raised bottom surface 81122 are compressed, the deformable member 8112 is entirely collapsed and as it is restrained by the outer force application component 8111, the deformable member 8112 is squeezed inwardly to restrain the nephrostomy tube 820.

In this embodiment, the nephrostomy tube 820 has at least one drainage slot 8203, and the number of the drainage slots 8203 can be one, two, three, four or more. The drainage inlet 8201 is disposed proximate to the starting end of the nephrostomy tube 820, relative to the terminal end. Each of the drainage grooves 8203 is communicated with the drainage inlet 8201, and the drainage groove 8203 is formed by extending the drainage inlet 8201 towards the starting end. The drainage slots 8203 are openly disposed on the surface of the nephrostomy tube 820.

In this embodiment, six drainage grooves 8203 are exemplified. The nephrostomy tube 820 includes a tube front section 821 and a tube rear section 822, the tube front section 821 includes a support column 8211 and at least two partition walls 8212, the flow guide grooves 8203 are formed between two adjacent partition walls 8212, and the partition walls 8212 extend outward from the peripheral side of the support column 8211. The rear pipe section 822 extends from the front pipe section 821. The drainage inlet 8201 is provided at a junction of the tube front section 821 and the tube rear section 822.

The nephrostomy tube 820 has a guide channel 8210, which guide channel 8210 can be penetratingly extended from the starting end to the ending end. The guide channel 8210 is adapted to be fitted with a guide 830 such as a guide wire to guide the flexible nephrostomy tube 820 to a desired position. At least a portion of the guide channel 8210 of the nephrostomy tube 820 is formed in the anterior tube segment 821 and at least a portion is formed in the posterior tube segment 822. The drainage channel 8200 of the nephrostomy tube 820 is formed at the tube posterior section 822 and the drainage groove 8203 communicates with the drainage channel 8200 through the drainage inlet 8201. At the location of the tube rear section 822, the drainage channel 8200 forms at least part of the guide channel 8210. In other words, at least a portion of the drainage channel 8200 and the guide channel 8210 are common.

In this embodiment, the number of the drainage grooves 8203 is six, the number of the drainage inlets 8201 is six, and one drainage inlet 8201 corresponds to each drainage groove 8203. The number of the partition walls 8212 is six to partition six of the flow-guiding grooves 8203. At least part of the guide channel 8210 is formed in the support column 8211 of the tube front section 821.

Compared with the traditional nephrostomy tube 820, the nephrostomy tube 820 provided in the embodiment provides a plurality of drainage inlets 8201 for fluid to enter into the nephrostomy tube 820, so that the probability that one drainage inlet 8201 is blocked to cause the whole nephrostomy tube 820 to fail is reduced. In addition, large agglomerates, such as blood clots, may be entrained in the fluid and may be separated into smaller pieces by the separation wall 8212 during the process of the blood clots attaching to the surface of the forward tube section 821 and moving along the drainage channel 8203 toward the drainage inlet 8201 under the suction force at the location of the drainage inlet 8201, thereby reducing the chance of blood clots blocking the drainage inlet 8201.

It is understood that a plurality of the flow induction inlets 8201 may be arranged on the same plane, and that a plurality of the flow induction inlets 8201 may be arranged in a non-planar manner. The upper and lower ends of the plurality of flow-guiding grooves 8203 can be arranged to be flush, or the upper and lower ends of the plurality of flow-guiding grooves 8203 can be arranged to be staggered in height, so as to reduce the probability that the flow-guiding grooves 8203 is blocked.

Further, the drainage groove 8203 of the nephrostomy tube 820 is disposed near the starting end of the nephrostomy tube 820, and at least a part of the nephrostomy tube is formed to be curved and extended outward centering on the starting end, for example, in the present embodiment, a structure similar to a pigtail is formed at the position of the starting end of the nephrostomy tube 820. In such a manner that the bending section of the nephrostomy tube is guided straight along the guide during the introduction of the nephrostomy tube 820 until the guide is removed and the previously bent position is automatically curled into a curved shape, i.e., restored to its original shape, the nephrostomy tube 820 itself can have a certain fixing function so as not to be easily removed from the body contents of the subject of use. In addition, due to the curved arrangement of the nephrostomy tube 820, irritation to the subject is reduced inside the body to facilitate longer wearing of the nephrostomy tube 820 by the subject. It is of course understood that the nephrostomy tube 820 may be implemented as a straight tube.

Further, the drainage channels 8203 can be designed with different lengths so that different drainage inlets 8201 can be located at different positions. In this embodiment, the longest drainage groove 8203 is disposed outside the curved portion of the nephrostomy tube 820, on the one hand to allow the drainage groove 8203 to function as much as possible for drainage, and on the other hand to allow the drainage groove 8203 itself to curve with the curvature of the nephrostomy tube 820, thereby reducing the chance of blockage at this location.

Referring to fig. 20A and 24 of the drawings, a nephrostomy tube in accordance with a preferred embodiment of the present invention will be disclosed in detail in the following description, wherein the nephrostomy tube includes a tube 91 and the fixing means 92 detachably mounted to the nephrostomy tube, and the fixing means 92 is adapted to fix the tube 91 to a waist 941 of a patient 94 after the tube 91 is introduced into the patient 94 through a peripheral passage 9400 of the patient 94, so as to prevent the tube 91 from moving inward and outward to cause abrasion and pain of a wound of the patient 94.

The tube 91 has a leading port 91001 and an external port 91002, wherein the leading port 91001 and the external port 91002 of the tube 91 are oppositely disposed, wherein the fixing device 92 is sleeved on the tube 91 from the leading port 91001 of the tube 91, so that the fixing device 92 is retained on the leading port 91001 and the external port 91002 of the tube 91. The tubular body 91 of the nephrostomy tube is provided with a positioning wire so that an operator can observe the position and the depth of penetration of the tubular body 91 of the nephrostomy tube by means of a detection device after the tubular body 91 of the nephrostomy tube has been inserted into the patient's body.

The fixing device 92 includes a fixing body 921 and an adaptive valve 922, wherein the fixing body 921 and the adaptive valve 922 are installed in one body. When the tube 91 is in a straightened state, the fixing device 92 can be sleeved in the middle of the tube 91 from the guiding port 91001 of the tube 91, so that the fixing device 92 is limited by the external port 91002 of the tube 91, so that the tube 91 is extended into a waist 941 of the patient 94 and extends into the inside of a kidney 942, so that the fixing body 92 sleeved on the tube 91 can be fittingly attached to the waist 941 of the patient 94, and the tube 91 is fixed in a manner of being positioned at the waist 941 of the patient 94, thereby preventing the tube 91 from moving inside and outside the external channel 9400 of the patient 94 to cause discomfort of the body of the patient 94.

The end of the tube 91 that protrudes into the body can be switched between a naturally coiled state and a straightened state. The end of the tube 91 that extends into the body of the patient 94 is in the natural state of crimping without external force. When a linear guide 93 is inserted from the external port 91002 and is sequentially led out through the guide port 91001, the tube 91 is guided to be converted from the natural curling state to the straightening state.

The tube 91 further comprises a guiding portion 911, an extending portion 912 and an external portion 913, and the tube 91 further has a communicating passage 9101 and a guiding port 91001 and an external port 91002 respectively communicating the communicating passage 9101 and the external space, wherein the guiding portion 911, the extending portion 912 and the external portion 913 are integrally extended. The conduction channel 9100 is communicated with the guide port 91001 and the external port 91002 in a penetrating manner, wherein the guide port 91001 and the external port 91002 are respectively communicated with the conduction channel 9100 in an external space. The guide port 91001 is formed at the guide portion 911, and the guide port 91001 conducts an external space. Wherein the external port 91002 is formed at the external portion 913, and the external port 91002 conducts an external space.

The guiding portion 911 has a guiding channel 91100, wherein the extending portion 912 has an extending channel 91200, wherein the outer portion 913 has an outer channel 91300, wherein the guiding channel 91100, the extending channel 91200 and the outer channel 91300 are sequentially conducted to form a guiding channel 9101, wherein the guiding port 91001 is formed at a port of the guiding portion 911, wherein the outer port 91002 is formed at a port of the outer portion 913, such that the guiding member 93 in a straight line is inserted from the outer port 91002 and is led out from the guiding port 91001 after sequentially passing through the outer channel 91300, the extending channel 91200 and the guiding channel 91100, such that the tube 91 is transformed from a natural curling state to a straightened state.

Referring to fig. 21A and 21B of the drawings, the tube 91 is fixed to the patient's body by at least two ends, the guide portion 911 of the nephrostomy tube is fixed to the outside of the patient's body, and the extension portion 912 of the nephrostomy tube is fixed to the inside of the organ of the patient's body after being inflated. The tube body 91 is switched between a naturally curled state 9100 in which a portion of the tube body 91 that can be inserted into the body of the patient 94 is naturally bent, and a straightened state 9200 in which the guide portion 911 is guided to extend substantially linearly. In other words, when the tube 91 is in the straightened state 9200, the tube 91 is guided into the straightened state 9200 to be suitable for accessing the kidney 942 of the patient 94; when the tube 91 is in the natural curl 9100, the part of the fistula that protrudes into the body of the patient 94 is bent by itself, and is better held in the kidney 942 of the patient 94, and the tube 91 is further restrained in a locked position, and the inner end portion of the guide portion 911 held in the body of the patient is rolled up, so that the tube does not touch the organ in the body of the patient, which may cause bad stimulation. .

Preferably, said tube 91 is switchable between an uninflated state 9300 and an inflated state 9400, said tube 91 being freely movable with said peripheral channel 9401 of said patient 94 when said tube 91 is in said uninflated state 9300; when the tube 91 is in the inflated state 9400, the tube 91 is inflated to be locked in the kidney 942 of the patient 94, thereby limiting the tube 91 in a locked position.

The tube 91 further includes an expandable portion 914 and an air inlet portion 915 and the tube 91 has an inflation channel 9102 and an air inlet port 91003 in communication with the inflation channel 9102. The charge passage 9102 is defined by the inflatable portion 914 and the intake portion 915. The intake port 91003 is formed at an end portion of the intake portion 915 to enlarge the expandable portion 914 by inflating the inflation passage 9102, thereby achieving the expansion effect of the expandable portion 914.

The expandable portion 914 includes an expandable layer 9141 and a connecting layer 9142, and the expandable portion 914 has an expandable chamber 91401 and a connecting channel 91402. The expandable layer 9141 and the connection layer 9142 are each formed radially outward of the extension 912, and the expandable layer 9141 defines the expandable lumen 91401 and the connection layer 9142 defines the connection channel 91402.

The intake portion 915 has an intake passage 91500. The connection passage 91402 communicates the expandable chamber 91401 and the intake passage 91500. The expandable layer 9141 has elasticity and the expandable chamber 91401 can be inflated. The expandable layer 9141 is held outside the extension 912 near the guide portion 911 to define the expandable cavity 91401, and the connection passage 91402 is formed outside the extension 912 such that the connection passage 91402 and the extension passage 91200 are held spaced apart. The connection channel 91402 and the expandable chamber 91401 are extended radially outward of the extension 912 and the expandable portion 914 is formed outward of the extension 912.

Lane 91402 communicates between the inflatable chamber 91401 and the intake channel 91500. That is, the extension 912 serves to communicate between the inlet port 91001 and the outer port 91002, as well as between the expandable chamber 91401 and the inlet channel 91500.

The expandable portion 914 is disposed between the guide portion 91 and the extension portion 912, and the air intake portion 915 is communicated with the extension portion 912 to be connected to the expandable portion 914, so that the air intake portion 915 is communicated with the expandable portion 914 and an external space. By inflating the intake portion 915, gas passes through the intake passage 91500 of the intake portion 915, the inflation passage 9102 defined by the extension portion 912, to the inflatable chamber 91401 of the inflatable portion 914 in this order. Further, the extension passage 91200 and the connection passage 91402 of the extension 912 are maintained spaced apart.

Referring to fig. 21A and 21B of the drawings, after the air inlet 915 is inflated, the expandable portion 914 conducted to the air inlet 915 is inflated and expanded, so that the expandable portion 914 is formed on the extension 912 and protrudes from the surface of the extension 912. When the guiding portion 911 of the tube 91 is inserted into the kidney 942 at the waist 941 of the patient 94 through the preset peripheral channel 9400, the expandable portion 914 is expanded so that the expandable portion 914 is reserved in the kidney 942 after being expanded, wherein the expandable portion 914 is blocked inside the kidney 942 so that the expandable portion 914 cannot be extracted through the peripheral channel 9400, thereby stably keeping the tube 91 inside the body of the patient 94.

Further, the tube 91 includes an air inlet valve 916, wherein the air inlet valve 916 is disposed on the air inlet 915, and the air inlet valve 916 is openably and closably disposed on the air inlet 915, so that the air inlet valve 916 controls the air flow of the air inlet 915. Further, the fixation device 92 is looped around the extension 912. The securing device 92 preferably does not interfere with inflation or deflation of the inflation channel 9102. The fixture 92 may also control the inflation and deflation of the inflation passage 9102 in conjunction with the intake valve 916.

The securing device 92 is movable within the extension 912 to adapt to the distance between the waist 941 and the kidney 942 of different patients 94, so that the gastrostomy tube can be adapted to fit different waist 941 of patients 94. Further, the fixing body 921 of the fixing device 92 is adapted to fit to the waist 941 of the different patient 94.

Referring to fig. 24 of the drawings, the fixing body 921 of the fixing device 92 includes a reinforcing layer 9211, an adhesive layer 9212 and a protection layer 9213 and has a fixing body passage 9210 and a first fixing body opening 9201 and a second fixing body opening 9202 which communicate the fixing body passage 9210 with an external space, wherein the adhesive layer 9212 is held by the reinforcing layer 9211 and the protection layer 9213, and a side of the adhesive layer 9212 adhered to the protection layer 9213 has an adhesive property, so that the adhesive layer 9212 is used for contacting the skin of the patient 94. The fixed body passage 9210 is defined by the reinforcement layer 9211, the conforming layer 9212, and the protective layer 9213. That is, the reinforcement layer 9211, the conforming layer 9212, and the protective layer 9213 all have centrally located openings such that the fixation body passage 9210 is defined when the reinforcement layer 9211, the conforming layer 9212, and the protective layer 9213 are conformed together.

The reinforcing layer 9211 is used to reinforce and fix the pipe body 91, wherein the adaptive valve 922 is installed on the reinforcing layer 921, and the adaptive valve 922 is stably connected to the reinforcing layer 921.

Preferably, the reinforcement layer 9211 is heat fused or adhesively bonded to one side of the conforming layer 9212, wherein the side of the conforming layer 9212 that is bonded to the reinforcement layer 9211 is not adhesive.

The protective layer 9213 covers an adhesive layer of the adhesive layer 9212 to prevent an external gray layer and the like from contaminating the adhesive layer 9212. It is worth mentioning that the protection layer 9213 is attached through the self-adhesive property of the attachment layer 9212, wherein the protection layer 9213 can be repeatedly attached to the attachment layer 9212 after being torn off from the attachment layer 9212.

The reinforcement layer 9211 has a smaller area, and only needs to be fixed and supported to a small area near the peripheral channel 9400 of the patient 94, and the attachment layer 9212 has a larger area to better attach to the skin of the patient 94. Further, the reinforcing layer 9211 has a strength such that the adapting valve 922 is more stable when being coupled to the reinforcing layer 9211, increasing the coupling strength of the fixing body 9211 and the adapting valve 922.

It is worth mentioning that the form of the attachment layer 9212 is configured to fit the waist 941 of the patient 94, so that the attachment layer 9212 is longer in the x direction and shorter in the y direction, so that the attachment layer 9212 can flexibly surround the waist 941 of the patient 94. To fit the curve of the waist 941, the attached layer 9212 is shortest in the y direction near the center and gradually becomes longer in the y direction away from the center. That is, the adhesive layer 9212 has a cross-sectional shape of a dumbbell, and has two wide sides and a narrow middle. The middle width of the fixing body 921 is smaller than the width of the two ends of the fixing body 921, and the shape of the fixing body 921 is matched with the curvature of the waist of the patient, so that the fixing body 921 can be firmly adhered to the body of the patient.

The guide portion 911 includes a first tube 9111 and a guide vane 9112, and in the transverse direction, the guide vane 9112 radially extends outward from the outer wall of the first tube 9111 by a predetermined height to form the flow guide slot 91101, and in the longitudinal direction, the guide vane longitudinally extends along the outside of the first tube 9111 by a predetermined length. That is, the vanes 9112 separate the space outside the first tube 9111 into the flow directing slots 91101. The first tube 9111 defines the first inner channel 91102. The guide vane aft end outer side is connected to the expandable portion 914.

The guide portion 911 includes a plurality of guide vanes 9112 symmetrically distributed outside the first tube 9111, thereby defining a plurality of flow guide slots 91101. Each of the plurality of drainage slots 91101 independently communicates with the extension channel 91200. According to this embodiment of the present invention, the guiding portion 911 includes 96 guide vanes, 96 drainage grooves 91101 are formed at intervals, and a first drainage groove 911011, a second drainage groove 911012, a third drainage groove 911013, a fourth drainage groove 911014, a fifth drainage groove 911015 and a sixth drainage groove 911016 are formed from the bent inner portion to the outside. 96 of the drainage slots 91101 each independently communicate with the second inner channel 91201.

It should be noted that in one embodiment of the present invention, the first tube body 9111 and the plurality of vanes 9112 may be integrally formed at a time during the molding process, that is, the first tube body 9111 and the plurality of vanes are integrally connected at a time without an obvious interface or need of step-by-step molding, and in another embodiment, the first tube body 9111 may be formed first and then the plurality of vanes 9112 may be formed outside the first tube body 9111 during the molding process. Preferably in one piece. It should be noted that, in this implementation of the present invention, the guide portion 911 is described as forming 96 guide vanes and forming 96 isolated drainage slots, but in other embodiments of the present invention, the guide portion 911 may also form guide vanes in number and arrangement manner, for example, the number of the guide vanes is 92, 93, 94, 95 or more, and the arrangement manner is a longitudinally extending asymmetric arrangement, and the present invention is not limited in this respect.

According to an embodiment of the present invention, the position of the closed region 9113 of the drainage groove 91101 and the curvature of the guide portion 911 are matched with each other. In other words, the open communication of the drainage grooves 91101 with the outside is differently arranged according to the bent position of the guide portion 911. The longitudinally extending opening 91001 of the drainage channel 91101 is sized in length by controlling the longitudinal extension of the enclosed region 9113. That is, the partially closed drainage channels of different opening 91001 lengths are formed at different length locations. On the other hand, the number or positions of the conduction slots 91101 that need to be closed is controlled by the size of the area of the closed region 9113 or the number of closed regions 9113 that is formed. In other words, the size, corresponding location, number of outer open areas of the drainage slots 91101 are adjusted by the disposition of the enclosed region 9113 in cooperation with the drainage slots 91101. For example, but not limited to, taking the arc line of the outer curve of the guiding portion 911 as a reference position for splitting, and the arrangement of the drainage grooves 91101 after the drainage end is transversely unfolded as an example, in one embodiment, the length of the closed region 9113 may gradually decrease from the center position to two sides, that is, the closed region 9113 has a symmetrical step distribution, and accordingly, the lengths of the drainage grooves 91101 gradually increase from the center to the outer openings 91001 at two sides, and are symmetrically arranged in an inverted step corresponding to the closed region 9113. In another embodiment of the present invention, the length of the closed region 9113 may be gradually decreased from a predetermined position, i.e., in a unidirectional stepwise arrangement, and accordingly, the length of the plurality of drainage grooves 91101 is gradually increased from a predetermined position. In another embodiment of the present invention, the plurality of drainage slots 91101 are spaced at intervals such that if one of the drainage slots 91101 is partially closed, the other adjacent drainage slot 91101 is fully open, i.e., the closed region 9113 is not provided. In other words, the closed regions 9113 are provided at intervals at the positions of the openings 91001 of the plurality of drainage grooves 91101.

According to this embodiment of the present invention, the partially closed drainage groove opening 91001 is gradually increased in length outward from the inward curvature of the guide portion 911. In other words, the semi-closed longitudinal extension at the interior of the guide portion 911 is the longest, i.e., the opening 91001 of the conduction slit 91101 is the smallest in length, the longitudinal extension of the adjacent semi-closed region is reduced by a predetermined length, and the opening 91001 of the conduction slit 91101 is increased by a predetermined length, in turn, until the closed region 9113 is not provided, i.e., the opening 91001 of the conduction slit 91101 is entirely open to the exterior.

For example, in this embodiment of the present invention, referring to fig. 22 to 23B, the guide portion 911 includes 96 guide vanes and forms 96 drainage grooves 91101, which are a first guide vane, a second guide vane, a third guide vane, a fourth guide vane, a fifth guide vane, and a sixth guide vane, 96 drainage grooves are a first drainage groove 911011, a second drainage groove 911012, a third drainage groove 911013, a fourth drainage groove 911014, a fifth drainage groove 911015, and a sixth drainage groove 911016, respectively, and includes 95 closed regions 9113, which are a first closed region 91131, a second closed region 91132, a third closed region 91133, a fourth closed region 91134, and a fifth closed region 91135, respectively, the first closed region 91131 is disposed in the first drainage groove 911011, the second closed region 91132 is disposed in the second drainage groove 911012, and the third closed region 91133 is disposed in the third drainage groove 911013, The fourth closed region 91134 is disposed at the fifth sealing region 911015, the fifth closed region 91135 is disposed at the sixth drainage groove 911016, and the first drainage groove 911011 is located at an inner curve of the guide portion, and the fourth drainage groove 911014 is located at an outer curve of the guide portion 911. Further, the length of the first closed region 91131 is greater than the length of the second closed region 91132, the length of the second closed region 91132 is greater than the length of the third closed region 91133, the length of the second closed region 91132 is the same as the length of the fifth closed region 91135, and the length of the third closed region 91133 is the same as the length of the fourth closed region 91134. That is, the first, second, and

third closing regions

91131, 91132, and 91133 form a stepped variation having a gradually decreasing length, and the first, fifth, and

fourth closing regions

91131, 91135, and 91134 form a stepped variation having a gradually decreasing length.

It is worth mentioning that in the embodiment of the present invention, at least a partial region of the flow guiding groove 91101 located at the inner curve is provided with the closed region 9113, i.e., the partial closed flow guiding groove 91101 is formed, and the flow guiding groove 91101 located at the outer curve, and the closed region of the closed region 9113 is reduced, i.e., the opening 91001 is increased, or the fully opened flow guiding groove is formed, so that the curve of the guiding portion 911 is turned to match the opening size of the flow guiding groove 91101.

Further, according to an embodiment of the present invention, referring to fig. 22 and 23A, the guiding portion 911 includes at least one protection leaf 9114 disposed at an outer end of the guide vane 9112 to prevent an end portion of the guide vane 9112 from directly contacting an outside, for example, a flat end portion of the guide vane 9112 from directly contacting a human body endotracheal membrane to cause an adverse stimulation reaction.

Preferably, the protection leaves 9114 are arcuately disposed at outer ends of the guide vanes 9112. In other embodiments of the invention, the guard leaves 9114 may be other shapes.

According to this embodiment of the present invention, a plurality of the guard blades 9114 are provided at the outer ends of the guide vanes, respectively, that is, the number of the guard blades 9114 is matched to the number of the guide vanes. A gap 91140 is formed between two adjacent protection leaves 9114, and the gap 91140 connects the drainage groove 91101 and the outside.

A plurality of the guard vanes 9114 are spaced apart to form a generally annular outer surface, i.e., a relatively flat arcuate surface is integrally formed rather than a striated spaced apart surface formed directly by the end surfaces of the guide vanes. In other words, the irritation of the guide vane is moderated by the protective leaf 9114. The protective leaves 9114 are arc-shaped and cover the outer part of the guide vane, and gaps 91140 are formed between the adjacent protective leaves 9114, so that a protective guide wall which tends to the circumference is formed under the condition that liquid can pass through.

In one embodiment of the invention, the guard vanes 9114 extend on both sides of the guide vane, i.e., form a generally T-shaped structure.

In another embodiment of the present invention, the guard leaves 9114 extend unidirectionally on one side of the guide vane, i.e., the guard leaves 9114 and the guide vane form an L-shaped structure, the present invention is not limited in this respect.

It will be appreciated by persons skilled in the art that the embodiments of the invention described above and shown in the drawings are given by way of example only and are not limiting of the invention. The objects of the invention have been fully and effectively accomplished. The functional and structural principles of the present invention have been shown and described in the embodiments, and any variations or modifications of the embodiments of the present invention may be made without departing from the principles.

Claims

1. Nephrostomy tube fixing device, its characterized in that includes:

a fixed chassis adapted to be fixed to a surface of a human body; and

a fixing component, the fixing component is arranged on the fixing chassis to form a tube penetrating channel, and the tube penetrating channel is suitable for penetrating through a nephrostomy tube so as to facilitate the nephrostomy tube to be encircled and fixed by the fixing component.

2. The nephrostomy tube securing device according to claim 1, wherein the securing assembly includes a fixing base, an elastic body mounted to the fixing base, and an adjusting member adjustably mounted to the fixing base to adjust a compression distance of the adjusting member with the elastic body.

3. The nephrostomy tube securing device of claim 2 wherein said elastic body has an inclined compression surface, said elastic body has a perforation adapted for said nephrostomy tube to pass through, said adjustment member includes an inner compression post having a deformation passage, said inner compression post compresses said compression surface of said elastic body when said adjustment member is adjusted to be adjacent to said elastic body, said elastic body deformation extends into said deformation passage of said inner compression post to reduce said perforation.

4. The nephrostomy tube securing device of claim 3 wherein the inner pressure applying column end has a mating compression face that mates with the compression face of the elastic body at an incline such that when the inner pressure applying column moves downward, an inwardly inclined pressure is applied to the elastic body causing the elastic body to deform centrally to reduce the perforation.

5. The nephrostomy tube securing device according to claim 3, wherein said elastic body has two symmetrical compression surfaces, one at each of the upper and lower ends of said elastic body.

6. The renostomy fixation device of claim 3, wherein said adjustment member comprises an outer handling tube forming an access loop between said outer handling tube and said inner compression post, said fixation seat extending into said access loop when said adjustment member is mounted to said fixation seat.

7. The renostomy fixation device of claim 5, wherein said inner pressure applying column is fixedly connected to said outer operating tube to control a compression distance between said inner pressure applying column and said elastic body by said outer operating tube.

8. The nephrostomy tube fixing device according to claim 2, wherein the fixing base includes a fixing piece extending planarly from a bottom end periphery side of the fixing base, the fixing piece being fixed to the base layer.

9. The nephrostomy tube securing device according to claim 2, wherein the fixing base is fixed to the fixing chassis, wherein the fixing base comprises a fixing member detachably connected to a mating fixing member and a mating fixing member fixed to the fixing chassis, the elastic body is mounted to the fixing member, the adjusting member is adjustably mounted to the fixing member to adjust a compression distance of the adjusting member from the elastic body, wherein the elastic body is a balloon, wherein the fixing chassis comprises a base layer, an adhesive layer provided to the base layer, and a peelable layer laminated to a surface of the base layer in a peelable manner via the adhesive layer, wherein the peelable layer has a break line that forms the peelable layer into two parts in a separable manner, the base layer comprises an outer layer, an interlayer and an inner layer, the interlayer is integrally clamped at the central parts of the outer layer and the inner layer, the fixed chassis comprises an upper end part and a lower end part, the upper end part comprises two first parts and a second part, the two first parts are symmetrically distributed at two sides of the second part, the second part is inwards recessed from the first parts, the upper end part and the lower end part are symmetrical, the fixed chassis is made of flexible materials, and the central hardness of the fixed chassis is greater than that of the peripheral parts.

10. A nephrostomy tube kit, comprising:

a nephrostomy tube securement device according to any of claims 1-9; and

a nephrostomy tube adapted to be secured by the nephrostomy tube securing device.