Renal fistula fixation device and renal fistula kit

Abstract

Disclosed are a nephrostomy tube fixing device and a nephrostomy tube kit, wherein the urinary system postoperative indwelling tube fixing device comprises a fixing base plate and a fixing assembly, the fixing base plate is suitable for being fixed to the surface of a human body, and the fixing assembly is arranged on the fixing base plate to form a tube passing channel, the tube passing channel is suitable for passing through a nephrostomy tube, so as to fix the nephrostomy tube at a predetermined position of the body by embracing the nephrostomy tube through the fixing assembly.

Description

Technical Field

[0001] The present invention relates to the field of medical devices and supplies, and further relates to a nephrostomy tube fixing device and a nephrostomy tube kit. Background Art

[0002] Nephrostomy drainage surgery involves puncturing or incising the renal parenchyma to insert a catheter into the renal pelvis to drain urine, pus, blood, and facilitate the formation of a sinus tract. Nephrostomy drainage typically requires the use of a nephrostomy tube, which is placed in the nephrostomy tract for a predetermined period of time to assist drainage.

[0003] After the nephrostomy tube is placed, the patient needs to wear it for a period of time, that is, the nephrostomy tube needs to be kept in the body for a period of time. Since the patient will inevitably have some activities during use, such as turning over, in order to maintain a good diversion effect and prevent the nephrostomy tube from moving, the doctor usually sutures the nephrostomy opening or fixes it with tape, that is, temporarily fixes the nephrostomy tube to the skin.

[0004] Although the suturing process is performed under anesthesia and the patient does not feel pain immediately, it will inevitably cause wounds that need to be healed.

[0005] More importantly, this method of securing the fistula tube with sutures is not ideal. Because the tube is tubular and exposed outside the waist, it is difficult to secure it. The sutures can only be wrapped around the tube from the outside to secure it. This method is not only inconvenient to operate, but also provides unsatisfactory fixation.

[0006] The statements herein merely provide background information related to the present disclosure and do not necessarily constitute prior art. Summary of the Invention

[0007] One object of the present invention is to provide a nephrostomy tube fixing device and a nephrostomy tube kit, wherein the nephrostomy tube fixing device is suitable for fixing the nephrostomy tube body in an embracing manner so that the nephrostomy tube body and the body are relatively stably fixed without the need for additional suture fixation operations.

[0008] Another object of the present invention is to provide a nephrostomy tube fixing device and a nephrostomy tube kit, which do not require suturing operations and will not cause unnecessary wounds.

[0009] 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 the fixed position according to the required length of the nephrostomy tube body when it is used, is suitable for different types of people, and has a wide range of applications.

[0010] Another object of the present invention is to provide a nephrostomy tube fixing device and a nephrostomy tube kit, which gradually fix the nephrostomy tube body through the compression deformation of the airbag, thereby facilitating the adjustment of the tightness of the fixation.

[0011] Another object of the present invention is to provide a nephrostomy tube fixing device and a nephrostomy tube kit, wherein the airbag and the flexible nephrostomy tube body cooperate to increase the circumferential friction force for fixation, thereby preventing the nephrostomy tube body from undergoing excessive deformation.

[0012] Another object of the present invention is to provide a nephrostomy tube fixing device and a nephrostomy tube kit, wherein in one embodiment, the nephrostomy tube fixing device is suitable for fixing a nephrostomy tube with a traditional structure, without changing the structure of the traditional nephrostomy tube, thereby reducing unnecessary waste.

[0013] In order to achieve at least one of the above objectives, one aspect of the present invention provides a nephrostomy tube fixing device, comprising:

[0014] a fixed chassis adapted to be fixed to a surface of a human body; and

[0015] A fixing component is arranged on the fixing chassis to form a tube-penetrating channel, and the tube-penetrating channel is suitable for passing a fistula tube so as to be surrounded and fixed by the fixing component.

[0016] According to a nephrostomy tube fixing device described in one embodiment, the fixing assembly includes a fixing seat, an elastomer and an adjusting member, the elastomer is installed on the fixing seat, and the adjusting member is adjustably installed on the fixing seat to adjust the compression distance between the adjusting member and the elastomer.

[0017] According to a nephrostomy tube fixing device described in one embodiment, the elastomer has an inclined compression surface, the elastomer has a perforation suitable for the ostomy tube to pass through, the adjusting member includes an internal pressure column, the internal pressure column has a deformation channel, when the adjusting member is adjusted close to the elastomer, the internal pressure column compresses the compression surface of the elastomer, and the elastomer deforms and extends into the deformation channel of the internal pressure column to reduce the perforation.

[0018] According to a nephrostomy tube fixing device described in one embodiment, the end of the inner pressure column has an inclined mating compression surface, and the mating compression surface cooperates with the compression surface of the elastomer, so that when the inner pressure column moves downward, it applies an inwardly inclined pressure to the elastomer, thereby causing the elastomer to deform toward the center and shrink the perforation.

[0019] According to the nephrostomy tube fixing device described in one embodiment, the elastic body has two symmetrical compression surfaces, which are respectively located at the upper and lower ends of the elastic body.

[0020] According to a nephrostomy tube fixing device described in one embodiment, the adjusting member includes an outer operating tube, and an access loop is formed between the outer operating tube and the inner pressure column. When the adjusting member is installed on the fixing seat, the fixing seat extends into the access loop.

[0021] According to the nephrostomy tube fixing device of one embodiment, the inner pressure column is fixedly connected to the outer operating tube, so that the compression distance between the inner pressure column and the elastic body can be controlled by the outer operating tube.

[0022] According to the nephrostomy tube fixing device described in one embodiment, the fixing seat includes a fixing plate, which extends planarly from the circumferential side of the bottom end of the fixing seat and is fixed to the base layer.

[0023] According to the nephrostomy tube fixing device of one embodiment, the fixing seat is fixed to the fixing base.

[0024] According to a nephrostomy tube fixing device described in one embodiment, the fixing seat includes a fixing piece and a matching fixing piece, the fixing piece is detachably connected to the matching fixing piece, the matching fixing piece is fixed to the fixed chassis, the elastomer is installed on the fixing piece, and the adjusting piece is adjustably installed on the fixing piece to adjust the compression distance between the adjusting piece and the elastomer.

[0025] According to an embodiment of the nephrostomy tube fixing device, the elastic body is a balloon.

[0026] According to a nephrostomy tube fixing device described in one embodiment, the fixing chassis includes a base layer, an adhesive layer and a peelable layer, the adhesive layer is arranged on the base layer, and the peelable layer is laminated on a surface of the base layer in a peelable manner through the adhesive layer.

[0027] According to an embodiment of the nephrostomy tube fixing device, the peelable layer has a break line, and the break line separates the peelable layer into two parts.

[0028] According to an embodiment of the nephrostomy fixation device, the base layer includes an outer layer, an interlayer and an inner layer, and the interlayer is integrally clamped to the center portion of the outer layer and the inner layer.

[0029] According to one embodiment of the invention, the fixed chassis includes an upper end and a lower end, the upper end includes two first parts and a second part, the two first parts are symmetrically distributed on both sides of the second part, the second part is recessed inward from the first part, and the upper end and the lower end are symmetrical.

[0030] According to an embodiment of the nephrostomy tube fixing device, the fixing base is made of a flexible material.

[0031] According to the nephrostomy tube fixing device of one embodiment, the hardness of the center of the fixing base is greater than the hardness of the peripheral portion.

[0032] Another aspect of the present invention provides a nephrostomy tube kit comprising:

[0033] A nephrostomy tube fixing device; and

[0034] A nephrostomy tube is provided, wherein the nephrostomy tube is adapted to be fixed by the nephrostomy tube fixing device.

[0035] According to a nephrostomy tube kit described in one embodiment, the fistula tube body includes an airbag segment, an extension segment and an interface segment, and the airbag segment, the extension segment and the interface segment are connected in sequence to form the fistula tube body. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1A 1 is a front perspective schematic diagram of a nephrostomy tube fixing device according to a first embodiment of the present invention.

[0037] Figure 1B 2 is a schematic diagram of the back of a nephrostomy tube fixing device according to a first embodiment of the present invention.

[0038] Figure 1C FIG. 2 is a schematic diagram of a partial separation of the peelable layer 213 of the nephrostomy tube fixing device according to the first embodiment of the present invention.

[0039] Figure 2 1 is a schematic diagram of an exploded view of a nephrostomy tube fixing device according to a first embodiment of the present invention.

[0040] Figure 3A 1 is a schematic cross-sectional view of a nephrostomy tube fixing device in an open state according to a first embodiment of the present invention.

[0041] Figure 3B yes Figure 3A A partially enlarged schematic diagram of position A in the middle.

[0042] Figure 4A 1 is a schematic cross-sectional view of a fixed state of a nephrostomy tube fixing device according to a first embodiment of the present invention.

[0043] Figure 4B yes Figure 4A Enlarged schematic diagram of a local location.

[0044] Figure 5A FIG1 is a schematic diagram of a nephrostomy tube kit in a separated state according to a first embodiment of the present invention.

[0045] Figure 5B 1 is a schematic cross-sectional view of a fistula tube body according to a first embodiment of the present invention.

[0046] Figure 6 FIG1 is a partial cross-sectional schematic diagram of a nephrostomy tube kit in a sleeve connection state 1 according to a first embodiment of the present invention.

[0047] Figure 7 FIG2 is a partial cross-sectional schematic diagram of a semi-fixed state 2 of a nephrostomy tube kit according to a first embodiment of the present invention.

[0048] Figure 8 3 is a schematic cross-sectional view of a nephrostomy tube kit in a fully fixed state according to a first embodiment of the present invention.

[0049] Figure 9 1 is a schematic diagram of the use process of the nephrostomy tube kit according to the first embodiment of the present invention.

[0050] Figure 10 This is another embodiment of the elastic body of the nephrostomy tube fixing device according to the first embodiment of the present invention.

[0051] Figure 11 This is a modified embodiment of the fixed chassis of the nephrostomy tube fixing device according to the first embodiment of the present invention.

[0052] Figure 12 2 is a schematic cross-sectional view of a nephrostomy tube fixing device according to a second embodiment of the present invention.

[0053] Figure 13 2 is a schematic diagram of the separation of a nephrostomy tube fixing device according to a second embodiment of the present invention.

[0054] Figure 14 FIG1 is a cross-sectional view of a nephrostomy tube fixing device according to a third embodiment of the present invention.

[0055] Figure 15 FIG. 4 is a schematic diagram of a nephrostomy tube kit according to a fourth embodiment of the present invention.

[0056] Figure 16 Schematic diagram of a fixable nephrostomy tube device according to a preferred embodiment of the present invention.

[0057] Figure 17According to the above preferred embodiment of the present invention, the fixable nephrostomy tube device Figure 16 AA cross-sectional view of the position shown in FIG.

[0058] Figure 18 2 is a schematic cross-sectional view of the fixable nephrostomy tube device according to the preferred embodiment of the present invention.

[0059] Figure 19 Schematic diagram of the fixable nephrostomy tube device according to the above preferred embodiment of the present invention.

[0060] Figure 20A It is a three-dimensional schematic diagram of a nephrostomy tube in a naturally bent state according to a preferred embodiment of the present invention.

[0061] Figure 20B 3D schematic diagram of a nephrostomy tube in a straightened state according to the preferred embodiment of the present invention.

[0062] Figure 21A and Figure 21B 1 is a schematic diagram of the process of using a nephrostomy tube according to the preferred embodiment of the present invention in a patient's body.

[0063] Figure 22 1 is a three-dimensional schematic diagram of a fistula tube in a naturally bent state according to the preferred embodiment of the present invention and a partially enlarged diagram thereof.

[0064] Figure 23A The above preferred embodiment of the present invention is based on Figure 22 Schematic cross-sectional view of the fistula tube section AA.

[0065] Figure 23B The above preferred embodiment of the present invention is based on Figure 22 BB longitudinal section diagram of the fistula tube.

[0066] Figure 24 2 is a perspective schematic diagram of a fixing body of a fixing device according to the above preferred embodiment of the present invention. DETAILED DESCRIPTION

[0067] The following description is intended to disclose the present invention so that those skilled in the art can implement the present invention. The preferred embodiments described below are for illustrative purposes only, and those skilled in the art will readily appreciate other obvious variations. The basic principles of the present invention defined in the following description may be applied to other embodiments, variations, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the present invention.

[0068] Those skilled in the art should understand that, in the disclosure of the present invention, the terms "longitudinal", "transverse", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like to indicate orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation. Therefore, the above terms should not be understood as limiting the present invention.

[0069] It is to be understood that the term "one" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the elements may be multiple, and the term "one" should not be understood as a limitation on the quantity.

[0070] References to "one embodiment," "an embodiment," "example embodiment," "various embodiments," "some embodiments," etc., indicate that such embodiments describing the invention may include a particular feature, structure, or characteristic, but not every embodiment must include that feature, structure, or characteristic. Furthermore, some embodiments may have some, all, or none of the features described for other embodiments.

[0071] Figure 1A 1 is a front perspective schematic diagram of a nephrostomy tube fixing device according to a first embodiment of the present invention. Figure 1B 2 is a schematic diagram of the back of a nephrostomy tube fixing device according to a first embodiment of the present invention. Figure 1C FIG. 2 is a schematic diagram of a partial separation of the peelable layer 213 of the nephrostomy tube fixing device according to the first embodiment of the present invention. Figure 2 1 is a schematic diagram of an exploded view of a nephrostomy tube fixing device according to a first embodiment of the present invention. Figure 3A 1 is a schematic cross-sectional view of a nephrostomy tube fixing device in an open state according to a first embodiment of the present invention. Figure 3B yes Figure 3A A partially enlarged schematic diagram of position A in the middle. Figure 4A 1 is a schematic cross-sectional view of a fixed state of a nephrostomy tube fixing device according to a first embodiment of the present invention. Figure 4B yes Figure 4A Enlarged schematic diagram of a local location. Figure 5A FIG1 is a schematic diagram of a nephrostomy tube kit in a separated state according to a first embodiment of the present invention. Figure 5B 1 is a schematic cross-sectional view of a fistula tube body according to a first embodiment of the present invention. Figure 6 FIG1 is a partial cross-sectional schematic diagram of a nephrostomy tube kit in a sleeve connection state 1 according to a first embodiment of the present invention. Figure 7FIG2 is a partial cross-sectional schematic diagram of a semi-fixed state 2 of a nephrostomy tube kit according to a first embodiment of the present invention. Figure 8 3 is a schematic cross-sectional view of a nephrostomy tube kit in a fully fixed state according to a first embodiment of the present invention. Figure 9 1 is a schematic diagram of the use process of the nephrostomy tube kit according to the first embodiment of the present invention. Figure 10 This is another embodiment of the elastic body of the nephrostomy tube fixing device according to the first embodiment of the present invention. Figure 11 This is a modified embodiment of the fixed chassis of the nephrostomy tube fixing device according to the first embodiment of the present invention.

[0072] refer to Figures 1A-11 The present invention provides a fistula tube fixing kit, which includes a fistula tube main body 10 and a nephrostomy tube fixing device 20, and the nephrostomy tube fixing device 20 is suitable for fixing the fistula tube main body 10 to a predetermined part of the body. Preferably, the fistula tube main body 10 is suitable for being used in a nephrostomy channel, that is, the fistula tube main body 10 is a nephrostomy tube, that is, a channel is established between the patient's kidney and the side of the waist. For example, the nephrostomy tube fixing device 20 is suitable for fixing the fistula tube main body 10 to the side of the patient's waist. It is worth mentioning that different fistula positions form different conditions to be fixed, that is, there are differences in the fixing conditions of different positions of the patient. The present invention is suitable for fixing the nephrostomy tube to the side of the patient's waist, that is, it is suitable for the U-shaped fixing surface of the patient's waist.

[0073] The nephrostomy tube fixing device 20 has a tube passage 2001 , and the tube passage 2001 is used to pass through the nephrostomy tube body 10 .

[0074] Described nephrostomy tube fixing device 20 comprises a fixed chassis 21 and a fixed assembly 22, and described fixed assembly 22 is arranged on described fixed chassis 21.Described fixed chassis 21 and described fixed assembly 22 form the described pipe-piercing passage 2001 of part separately, and described fixed assembly 22 is suitable for fixing described nephrostomy tube main body 10.Described fixed chassis 21 is suitable for being fixed in patient's epidermal predetermined position.That is to say, by described fixed assembly 22, described nephrostomy tube main body 10 is fixed, and by described fixed chassis 21, the relative position of patient and described fixed assembly 22 is fixed, thus described nephrostomy tube main body 10 and patient's relative position are fixed indirectly.In other words, by this indirect fixing mode, replace the mode of traditional direct suture needle winding fixing nephrostomy tube, thereby reduce owing to fixing the unnecessary trauma that described nephrostomy tube main body 10 brings.

[0075] Furthermore, the fixing assembly 22 is adapted to surround and fix the fistula tube body 10. In other words, the fixing assembly 22 is adapted to fix the fistula tube body 10 from the outside of the circumference of the fistula tube body 10.

[0076] The fixing base 21 is flexible as a whole and can be bent and deformed, that is, the fixing base 21 can change with the shape of the patient's fixed position. Further, when in use, the fixing base 21 can form an arc shape suitable for the patient's waist.

[0077] The fixed base plate 21 has a central hole 201 , and the central hole 201 is suitable for the fistula tube body 10 to pass through.

[0078] The fixed chassis 21 includes a base layer 211, an adhesive layer 212, and a peelable layer 213. The adhesive layer 212 is provided on the base layer 211, and the peelable layer 213 is laminated on one surface of the base layer 211 in a peelable manner through the adhesive layer 212. In other words, the fixed chassis 21 is a roughly sheet body formed by the peelable layer 213 being laminated on one surface of the base layer 211 in a peelable manner with the help of the adhesive layer 212. The sheet body has a relatively small thickness, thereby improving the comfort and convenience of use for patients. The base layer 211, the adhesive layer 212, and the peelable layer 213 each form a portion of the center hole 201, or in other words, openings 101 are provided at corresponding positions.

[0079] For ease of explanation, in the embodiments of the present invention, the side close to the patient's skin is defined as the inner side, and the side opposite or facing away from the patient's skin is defined as the outer side, thereby explaining the relative position relationship.

[0080] In this embodiment of the present invention, the adhesive layer 212 is arranged on the inner side of the base layer 211, and accordingly, the peeling layer is laminated on the inner side of the base layer 211, so that when the fixing component 22 is used, the operator such as a doctor or a nurse peels off the peelable layer 213, so that the adhesive layer 212 adheres to the patient's skin surface.

[0081] It is worth mentioning that the adhesive layer 212 is a material suitable for multiple or repeated bonding and separation, that is, the adhesive layer 212 is not a setting agent or a disposable fixative. The fixing base 21 can be bonded to and detached from the patient's skin multiple or repeated times.

[0082] The fixed chassis 21 has an upper end 2101 and a lower end 2102 extending along the length of the fixed chassis 21, as well as a left end 2103 and a right end 2104 extending along the width 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. In other words, both ends of the upper end 2101 are connected to one end of the left end 2103 and the right end 2104, respectively, and both ends of the lower end 2102 are connected to the other ends of the left end 2103 and the right end 2104, respectively, thereby forming a closed edge.

[0083] In this embodiment of the present invention, the upper end portion 2101 and the end portion have the same shape, so that the fixing chassis 21 can be bonded with the same effect whether it is upright or inverted, or can be used in both upright and inverted positions.

[0084] The fixed chassis 21 has a bilaterally symmetrical shape about a central axis Y perpendicular to the longitudinal direction. In other words, the fixed chassis 21 has a bilaterally symmetrical shape relative to a central plane in the longitudinal direction of the fixed chassis 21. The fixed chassis 21 has a vertically symmetrical shape about a central axis X perpendicular to the width direction. In other words, the fixed chassis 21 has a vertically symmetrical shape relative to a central plane in the width direction of the fixed chassis 21.

[0085] The extension lengths of the upper end portion 2101 and the lower end portion 2102 are greater than the extension lengths of the left end portion 2103 and the right end portion 2104 , so as to facilitate extension, bonding and fixation to the patient's waist.

[0086] refer to Figure 1BThe upper end portion 2101 has a first portion 21011 and a second portion 21012, and the lower end portion 2102 has a first portion 21021 and a second portion 21022. The first portion 21011 of the upper end portion 2101 and the first portion 21011 of the lower end portion 2102 are vertically symmetrical about the X-axis, and the second portion 21012 of the upper end portion 2101 and the second portion 21022 of the lower end portion 2102 are vertically symmetrical about 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 about the X-axis. The second portion 21012 of the upper end portion 2101 is symmetrical about the Y-axis, and the second portion 21022 of the lower end portion 2102 is symmetrical about the Y-axis. The first portion 21011 of the upper end portion 2101 is located outside the central axis Y, and the central axis of the second portion 21012 of the upper end portion 2101 is aligned with the central axis Y of the fixed chassis 21. The first portion 21021 of the lower end portion 2102 is located outside the central axis Y, and the central axis of the second portion 21022 of the lower end portion 2102 is aligned with the central axis Y of the fixed chassis 21.

[0087] In this embodiment of the present invention, the first portion 21011 of the upper end portion 2101 forms a convex portion that curves outwardly along the X-axis of the fixed base, while the second portion 21012 of the upper end portion 2101 forms a concave portion that curves inwardly along the X-axis of the fixed chassis 21. Correspondingly, the first portion 21021 of the lower end portion 2102 forms a convex portion that curves outwardly along the X-axis of the fixed base, while the second portion 21022 of the lower end portion 2102 forms a concave portion that curves inwardly along the X-axis of the fixed chassis 21. Preferably, the first portion 21011 and the second portion 21012 of the upper end portion 2101 change into an arc shape. The first portion 21021 and the second portion 21022 of the lower end portion 2102 change into an arc shape.

[0088] Preferably, when in use, the second part 21012 of the upper end portion 2101 and the second part 21022 of the lower end portion 2102 are suitable for being bonded to the patient's waist and shoulders, and the first part 21011 of the upper end portion 2101 and the first part 21021 of the lower end portion 2102 are suitable for being bonded to the patient's waist near the abdomen. As a result, the fixing conditions provided by the fixed chassis 21 match the patient's fixed position, making the bonding stronger and more convenient. For example, the bonding area on the patient's waist and shoulders is smaller, which is convenient for the patient to turn around and reduce the feeling of pulling, while the bonding area on both sides is larger, which can provide a stronger bonding force, and the rotation requirement near the abdomen is smaller, and the larger bonding area will not affect the use experience.

[0089] refer to Figure 11 In another embodiment of the present invention, the first portion 21011 of the upper end portion 2101 extends substantially linearly, and the second portion 21012 of the upper end portion 2101 gradually recesses inward from one end of the first portion 21011 to form a recess. The first portion 21021 of the lower end portion 2102 extends substantially linearly, and the second portion 21012 gradually recesses inward from one end of the first portion 21021 to form a recess. The first portion 21011 of the upper end portion 2101 is substantially parallel to the first portion 21021 of the lower end portion 2102.

[0090] In another embodiment of the present invention, the shape of the upper end portion 2101 and the shape of the lower end portion 2102 are not symmetrical about the X-axis, that is, the upper and lower shapes of the fixed chassis 21 are different.

[0091] refer to Figure 1C The base layer 211 of the fixed chassis 21 includes an operating portion 2110, which is located at the edge of the base layer 211 to provide an operating point for easy peeling. The operating portion 2110 is not provided with the adhesive layer, that is, the peeling portion cannot be bonded. The peelable layer 213 includes a peeling head 2130, which is located at the edge of the peelable layer 213. The position of the peeling head 2130 of the peelable layer 213 corresponds to the position of the operating portion 2110. In other words, the peeling head 2130 and the operating portion 2110 are not initially bonded, while the remaining position of the base layer 211 and the peelable layer 213 is releasably bonded via the adhesive layer 212. In other words, the peeling head 2130 and the operating portion 2110 are initially separated to provide a starting point for easy peeling of the peelable layer 213. On the other hand, the provision of the peeling layer and the peeling portion prevents the operator from directly contacting the adhesive layer 212 during operation, thereby preventing a decrease in adhesive strength. For example, during operation, the operator can pinch the operating portion 2110 with one hand while peeling the peelable layer 213 with the other hand.

[0092] The peelable layer 213 has a break line 231 that separates the peelable layer 213 into two parts so that they can be torn apart. The two parts formed by the break line 231 are located on either side of the fixing assembly 22. In other words, the provision of the break line 231 allows the peelable layer 213 to be detached from the fixing assembly 22 on either side without being blocked by the fixing assembly 22.

[0093] In another embodiment of the present invention, the peelable layer 213 is composed of two separate parts, that is, the peelable layer 213 can be directly separated without providing the discontinuity line 231. During operation, the two parts can be peeled off separately.

[0094] In this embodiment of the present invention, the base layer 211 includes an outer layer 2111, an interlayer 214, and an inner layer 2112. The interlayer 214 is integrally sandwiched between the outer layer 2111 and the inner layer 2112. For example, but not limited to, the outer layer 2111, the inner layer 2112, and the interlayer 214 are integrally formed by heat pressing. The adhesive layer 212 is disposed on the inner layer 2112.

[0095] Furthermore, the interlayer 214 is located in the center portion 2105 between the outer layer 2111 and the inner layer 2112. In other words, the center portion 2105 of the base layer 211 comprises three layers of material, while the edge portion 2106 comprises two layers of material. In other words, the center portion 2105 of the base layer 211 comprises the outer layer 2111, the interlayer 214, and the inner layer 2112. The edge portion 2106 of the base layer 211 comprises the outer layer 2111 and the inner layer 2112. In other words, the center portion 2105 of the fixing chassis 21, where the fixing assembly 22 is fixed, comprises three layers of material, thereby more stably securing the fixing assembly 22.

[0096] In one embodiment of the present invention, the hardness of the material of the interlayer 214 may be slightly greater than that 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 convex piece with a thickness gradually decreasing from the inside to the outside.

[0097] To reduce discomfort when the fixing base 21 adheres to the skin, the fixing base 21 preferably has a certain degree of flexibility and elasticity. The elastic fixing base 21 easily conforms to the patient's skin, preventing the nephrostomy tube fixing device 20 from detaching and providing a relatively stable fixation for the nephrostomy tube body 10.

[0098] In this embodiment of the present invention, due to the provision of the interlayer, the hardness of the center of the fixed chassis 21 is slightly greater than the hardness of the periphery of the fixed chassis 21. In addition, the thickness of the central portion 2105 of the fixed chassis 21 is slightly greater than the thickness of the peripheral portion.

[0099] It's worth noting that the rigid interior and soft exterior structure of the fixed chassis 21 balances operability and secure fixation. For example, because the central portion 2105 of the fixed chassis 21 is thicker and relatively rigid, and its surface has excellent shape-retaining properties (in other words, its surface is generally flat), an operator can quickly apply pressure to secure it to the soft surface of the human body without significant deformation. Furthermore, because the edges 2106 of the fixed chassis 21 are relatively soft, an operator can push outward from the center, allowing the more flexible edges 2106 of the fixed chassis 21 to adapt to the body's shape, thereby firmly connecting to the skin at these edges 2106.

[0100] refer to Figure 3A The fixing component 22 has a central channel 2201 , and the central channel 2201 of the fixing component 22 is connected to the central hole 201 of the fixing chassis 21 to form the pipe passage 2001 .

[0101] The fixing assembly 22 includes a fixing seat 221 , an elastic body 222 and an adjusting member 223 . The elastic body 222 is mounted on the fixing seat 221 . The adjusting member 223 is adjustably mounted on the fixing seat 221 to adjust the compression distance between the adjusting member 223 and the elastic body 222 .

[0102] The fixing base 221 is integrally fixed to the fixed chassis 21. Furthermore, the fixing base 221 is disposed on the base layer 211 of the fixed chassis. In this embodiment of the present invention, the fixing base 221 is integrally fixed to the center portion 2105 of the base layer 211 of the fixed chassis 21. In other words, the relative positions of the fixing base 221 and the base layer 211 of the fixed chassis 21 are fixed.

[0103] The fixing seat 221 has a first passage 22101 , and the first passage 22101 is suitable for the fistula tube body 10 to pass through.

[0104] The fixing seat 221 has a compression chamber 22103 . The compression chamber 22103 is connected to the pipe passage 2001 . The elastic body 222 is disposed in the compression chamber 22103 .

[0105] The elastic body 222 has a through-hole 22201 adapted to pass through the fistula tube body 10. The inner diameter of the through-hole 22201 is substantially the same as, or slightly larger than, the outer diameter of the fistula tube body 10. When the elastic body 222 is disposed within the compression chamber 22103, the through-hole 22201 communicates with the tube passage 2001, facilitating passage of the fistula tube body 10. Furthermore, the elastic body 222 surrounds the fistula tube body 10.

[0106] The adjusting member 223 has an inner channel 22302, and the inner channel 22302 connects the two ends of the adjusting member 223. In other words, the inner channel 22302 extends from one end of the adjusting member 223 to the other end.

[0107] The tube-penetrating channel 2001 , the compression chamber 22103 and the communicating hole are interconnected to form the central channel 2201 . The central channel 2201 is suitable for the fistula tube body 10 to pass through. The elastic body 222 surrounds the circumference of the fistula tube body 10 .

[0108] 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 arranged with respect to a horizontal center plane.

[0109] The elastomer 222 has two symmetrical compression surfaces 22211, 22221, which are respectively located at the upper and lower ends of the elastomer 222. The compression surfaces 22211, 22221 are formed by the surface of the middle part of the elastomer 222 shrinking inward to the port position. In other words, the surfaces of the compression surfaces 22211, 22221 are inclined. In one embodiment of the present invention, the elastomer 222 forms a gyroscope shape. Optionally, the inclination angle of the compression surfaces 22211, 22221 is 30°-60°, preferably 45°. It is worth mentioning that the inclination angle of the compression surfaces 22211, 22221 of the elastomer 222 affects the amount of compressed deformation. If the inclination angle of the elastomer 222 is too large or too small, it will affect or reduce the pipe-holding and fixing effect of the elastomer 222.

[0110] refer to Figure 2 , Figure 3AThe adjusting member 223 includes an outer operating tube 2231 and an inner pressure column 2232. An access channel 22301 is formed between the outer operating tube 2231 and the inner pressure column 2232. When the adjusting member 223 is connected to the fixing seat 221, the fixing seat 221 extends into the access channel 22301. Furthermore, in this embodiment of the present invention, the fixing seat 221 is threadedly connected to the access channel 22301. In other words, the inner wall of the outer operating tube 2231 and the outer surface of the fixing seat 221 are respectively provided with mating connecting threads. In this embodiment of the present invention, the outer operating tube 2231 and the inner pressure column 2232 extend in a generally tubular shape. In other embodiments of the present invention, the operating portion 2110 may also have other convenient shapes.

[0111] The inner pressure column 2232 forms the inner channel 22302 and communicates with the exterior at both ends. The inner pressure column 2232 is integrally connected to the end of the outer operating tube 2231. The inner pressure column 2232 is fixedly connected to the outer operating tube 2231 so that the compression distance between the inner pressure column 2232 and the elastic body 222 can be controlled by the outer operating tube 2231.

[0112] refer to Figure 3A , 4A, 4B, the end of the inner pressure column 2232 forms an inclined pressure surface 22321, and the pressure surface 22321 cooperates with the compression surface of the elastic body 222 to apply inward pressure to the inclined compression surface, so that the elastic body 222 is deformed inward or in the center direction, thereby reducing the through hole 22201.

[0113] The inner pressure column 2232 and the outer operating tube 2231 extend at substantially the same height, or the inner pressure column 2232 is slightly higher than the outer operating tube 2231. When the adjusting member 223 is connected to the fixing seat 221, the inner pressure column 2232 extends into the first channel 22101 of the fixing seat 221.

[0114] When the adjusting member 223 is connected to the fixed seat 221, the inner pressing column 2232 abuts against the elastic body 222, and as the adjusting member 223 approaches the fixed seat 221, the inner pressing column 2232 presses the elastic body 222, extruding the elastic body 222 to deform, so that the upper end portion 2101 of the elastic body 222 is extruded into the central passage 2201 of the adjusting member 223, and the lower end portion 2102 of the elastic body 222 is extruded into the second passage 22103, thus the elastic body 222 forms a deformation tube-holding passage that is contracted inward. That is, under the interaction of the adjusting member 223 and the fixed seat 221, the elastic body 222 deforms, and within the constraint range of the fixed seat 221, the elastic body 222 deforms along with the constraint space formed by the fixed seat 221 and the adjusting member 223.

[0115] In this embodiment of the present application, the adjusting member 223 is connected to the fixed seat 221 by screwing. For example, the adjusting member 223 is rotated clockwise, the adjusting member 223 approaches the fixed seat 221, the inner pressing column 2232 gradually extrudes the elastic body 222 to deform, and when the adjusting member 223 is rotated counterclockwise, the adjusting member 223 moves away from the fixed seat 221, and the elastic body 222 gradually recovers from the deformation.

[0116] In another embodiment of the present application, the adjusting member 223 is connected to the fixed seat 221 in a straight pushing manner, and a locking mechanism is arranged on the fixed seat 221, when the adjusting member 223 is compressed to a predetermined position, the locking mechanism locks the relative position of the adjusting member 223 and the elastic body 222, so that the elastic body 222 remains in a deformed state. That is, when the fistula tube body 10 passes through the fixed assembly 22, the adjusting member 223 is pushed to be locked, and the fistula tube body 10 is stably held by the elastic body 222.

[0117] It is worth mentioning that in this embodiment of the present invention, the deformation of the elastic body 222 can be gradually adjusted and changed by the threaded connection between the adjusting member 223 and the fixing seat 221, thereby adjusting the size of the deformation tube-holding channel 22202. On the one hand, it can adjust the degree of tightness of the holding of the same fistula tube body 10 and the degree of contraction of the fistula tube body 10. On the other hand, it can adapt to fistula tube bodies 10 of different thicknesses. In other words, it can achieve a roughly consistent degree of tightness and fixation for fistula tube bodies 10 of different thicknesses, or form different degrees of contraction for each fistula tube body 10. In other words, compared with the above-mentioned direct push locking method, the gradual adjustment method of the threaded connection has a wider range of adaptability. In other embodiments of the present invention, other propulsion connection methods can also be provided, and the present invention is not limited in this respect.

[0118] The fixing base 221 includes a fixing member 2213 that extends planarly from the circumference of the bottom end of the fixing base 221. The fixing member 2213 is integrally fixed to the base layer 211. In other words, the fixing member 2213 forms a larger connection area between the fixing base 221 and the base layer 211, thereby stably fixing the fixing base 221.

[0119] Furthermore, the fixing seat 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.

[0120] For example, when manufacturing the nephrostomy tube fixing device 20, the fixing assembly 22 is first manufactured, such as the independent fixing base 221, the elastic body 222, and the adjusting member 223. Then, when manufacturing the fixing base 21, the fixing base 221 is integrally formed within the fixing base 21. The elastic body 222 and the adjusting member 223 are then installed. Of course, the elastic body 222 and the adjusting member 223 can also be installed on the fixing base 221 first, and then the fixing base 21 is integrally formed on the fixing base 221.

[0121] The fixing seat 221 includes a first component 2211 and a second component 2212. The first component 2211 forms a first channel 22101 and the compression chamber 22103, and the second component 2212 forms a second channel 22103. The first channel 22101 is connected, and the compression chamber 22103 and the second channel 22103 are connected to each other in sequence.

[0122] The second component 2212 is integrally connected to the fixing member 2213. Further, the second component 2212 and the fixing member 2213 are fixed by the base layer 211 of the fixing base 21. In this embodiment of the present application, the second component 2212 is a tubular structure, and the tubular wall is fixed by the base layer 211 at the bottom end.

[0123] The first component 2211 is taperingly connected to the upper end of the second component 2212 to form the compression cavity 22103. The inner diameter of the first component 2211 is larger than that of the second component 2212. The inner compression column 2232 forms a channel substantially consistent with the second component 2212, which matches the diameter of the fistula tube body 10, thereby facilitating the guidance of the delivery of the fistula tube body 10.

[0124] The adjusting member 223 is connected to the first component 2211 of the fixing seat 221. Further, the first component 2211 of the fixing seat 221 is connected to the outer operation tube 2231 of the adjusting member 223. In this embodiment of the present application, the outer side of the first component 2211 forms a threaded surface matched with the adjusting member 223. In other embodiments of the present application, other matching locking modes can be used between the outer operation tube 2231 and the first component 2211 of the fixing seat 221. That is, after the compression of the elastic body 222 is completed, the relative positions of the adjusting member 223 and the fixing seat 221 are locked, that is, the force acting on the fistula tube body 10 is locked.

[0125] FIG. 5 is a schematic diagram of the fistula tube kit 100 in a separated state according to the first embodiment of the present application.

[0126] Referring to FIG. 5, the fistula tube body 10 and the nephrostomy tube fixing device 20 form a fistula tube kit 100, that is, the nephrostomy tube fixing device 20 and the fistula tube body 10 are matched with each other. In other words, the nephrostomy tube fixing device 20 and the fistula tube body 10 are matched in terms of the model.

[0127] The fistula tube body 10 has a fluid channel 102, which communicates the two ends of the fistula tube body 10 to deliver liquid along the fistula tube body 10, such as from the inside of the human kidney to the outside.

[0128] The fistula tube body 10 includes a balloon segment 11, an extension segment 12, and a connector segment 13, which are sequentially connected to form the fistula tube body 10. Further, the balloon segment 11, the extension segment 12, and the connector segment 13 are sequentially connected from inside to outside.

[0129] Furthermore, the airbag segment 11 , the extension segment 12 and the interface segment 13 are integrally connected.

[0130] The airbag section 11 includes a head end 111 and an airbag 112. The head end 111 has at least one opening 101. The opening 101 is connected to the fluid channel 102, so that the internal liquid can enter the fluid channel 102 through the opening 101. The airbag 112 is used for inflation and fixation. That is, during use, the operator inflates the airbag 112, causing the airbag 112 to expand and be confined within the human renal pelvis. In other words, the airbag 112 is blocked at the patient's nephrostomy opening, preventing the fistula tube body 10 from detaching. The opening 101 is located near the end of the fistula tube body 10. And with the compression effect of the airbag 112, the airbag 112 can prevent bleeding from the patient's fistula opening, that is, it has a compression and hemostasis effect.

[0131] The balloon 112 of the fistula tube body 10 has an inflated state and a non-inflated state. In the inflated state, the balloon 112 expands to a larger volume suitable for position control. In the non-inflated state, the surface of the balloon 112 and the surface of the fistula tube body 10 are substantially aligned. In other words, the balloon section 11 of the fistula tube body 10 is a generally elongated tubular shape suitable for adjustable movement.

[0132] The fistula tube body 10 has an inflation channel 103 , which is connected to the airbag 112 to facilitate inflation or deflation of the airbag 112 . In this embodiment of the present invention, the inflation channel 103 is provided in the extension section 12 .

[0133] The interface section 13 includes a drainage interface 131 and an inflation interface 132. The drainage interface 131 is used to connect to external receiving or drainage components. In this embodiment of the present invention, the drainage interface 131 extends generally uniformly along the extension section 12, while the inflation interface 132 extends in a bifurcated manner from the extension section 12. In other words, the inflation interface 132 and the drainage interface 131 form two branches that extend in a bifurcated manner.

[0134] The inflation port 132 is used to connect an inflation device. The inflation port 132 is connected to the inflation channel. In other words, when the airbag 112 needs to be inflated, the inflation device is connected to the inflation port 132, thereby inflating the inflation channel, thereby placing the airbag 112 in the inflated state.

[0135] The inflation interface 132 includes a valve, which is used to control the opening or closing of the inflation interface 132. In other words, the valve controls the inflation and deflation of the airbag. Preferably, the valve is a one-way valve. In other words, when the inflation device is connected to the valve, the gas injected into the inflation device automatically opens the valve. When the inflation device is released, the valve automatically prevents the internal gas from flowing outward. When deflation is required, that is, to restore the airbag 112 to the uninflated state, the operator operates the valve, such as by pressing or pulling it out, so that the gas in the airbag 112 can flow to the outside, thereby deflation.

[0136] The fistula tube body 10 includes a positioning line 14, which is used to locate the position of the fistula tube body 10 when it enters the body. The positioning line 14 is integrally provided along the extension section 12 of the fistula tube body 10. For example, but not limited to, when the fistula tube body 10 enters the human body's fistula passage, the positioning line 14 can be visualized under X-ray or B-ultrasound examination, that is, the positioning line 14 can be observed on an imaging device.

[0137] In other embodiments of the present invention, the positioning line 14 may also be extended to the airbag segment 11 or the interface segment 13 , and the present invention is not limited in this respect.

[0138] Figure 6 FIG1 is a partial cross-sectional view of a fistula tube kit 100 in a sleeve connection state 1 according to a first embodiment of the present invention.

[0139] refer to Figure 6 When the fistula tube kit 100 is in use, the end of the fistula tube body 10 passes through the tube insertion channel 2001 of the nephrostomy tube fixing device 20 while the balloon is in an uninflated state. More specifically, the end of the balloon segment 11 of the fistula tube body 10 enters through the outer port of the fixing assembly 22, advances along the fixing assembly 22, and exits through the central hole 201 of the fixing base 21, thereby completing the tube insertion process of the fistula tube body 10 and the fixing assembly 22. Specifically, the fistula tube body 10 and the fixing assembly 22 are in a sleeved state 1. In this sleeved state 1, the elastic body 222 loosely surrounds the extension section 12 of the fistula tube body 10 and is in an undeformed state, or in other words, has not undergone significant deformation to secure the fistula tube body 10.

[0140] It should be noted that, in this state, the fistula tube body 10 and the fixing assembly 22 can move relative to each other, that is, on the one hand, the operator, such as a doctor or a nurse, can adjust the length of the fistula tube body 10 entering the patient's body, and on the other hand, the operator can adjust the relative position of the fistula tube fixing device 20 and the fistula tube body 10, so that the fixed position of the fistula tube body 10 can be adjusted.

[0141] Figure 7 FIG2 is a partial cross-sectional view of a fistula tube kit 100 in a semi-fixed state 2 according to a first embodiment of the present invention. Figure 8 3 is a partial cross-sectional view of the fistula tube kit 100 in a fully fixed state according to the first embodiment of the present invention.

[0142] refer to Figure 7 When the extension section 12 of the fistula tube body 10 passes through the fistula tube fixing device 20, adjusting (e.g., rotating) the adjusting member 223 causes the inner pressure column 2232 of the adjusting member 223 to approach the elastic body 222. The pressure-applying surface 22321 of the inner pressure column 2232 applies oblique inward pressure to the elastic body, causing the elastic body 222 to deform toward both ends and compress the fistula tube body 10, forming a semi-fixed state 2. In this semi-fixed state 2, the fluid channel 102 of the fistula tube body 10 communicates with the inside and outside. In other words, fluid within the human kidney can be transported to the outside through the fluid channel 102. The flow rate of the fluid channel 102 or the size of the connection opening can be adjusted by adjusting the adjusting member 223.

[0143] refer to Figure 7 and Figure 9During use, after the operation is completed, the length of the fistula tube body 10 entering the patient's body is determined, that is, the position where the fistula tube body 10 is suitable for being fixed is determined. Then, gas is filled into the airbag through the inflation device, so that the airbag is in the inflated state, that is, the position of the fistula tube body 10 and the patient's body is preliminarily limited. It is worth mentioning that the airbag can relatively limit the movement of the fistula tube body 10 toward the outside of the body, but the airbag has no obvious effect on the swing of the fistula tube body 10 toward the inside or outside the fistula opening; then, the operator peels off the peelable layer 213 of the fixed chassis 21, and adheres the base layer 211 to the patient's skin; further operates the adjusting member 223, such as rotating the adjusting member 223, so that the adjusting member 223 moves toward the direction of the fixing seat 221, so that the elastic body 222 is gradually compressed and deformed, and then the fistula tube body 10 is constrained by the circumferential side, that is, the relative position of the fistula tube body 10 and the fixing component 22 is preliminarily determined. At this point, the nephrostomy tube fixing device 20 is in the semi-fixed state 2, that is, the adjusting member 223 has not reached the maximum adjustment position. The interior of the fistula tube body 10 is still partially connected to the outside, or in other words, mostly connected. In other words, in this state, the deformation of the fistula tube body 10 is small, and the relative position of the fistula tube body 10 and the fixing assembly 22 is mainly fixed by the friction between the fistula tube body 10 and the elastic member of the fixing assembly 22, and the frictional effect is relatively small.

[0144] Of course, in another operation mode, fixation can be performed first and then inflation. That is, after the operation is completed, the length of the fistula tube body 10 inserted into the patient's body is determined, that is, the position of the fistula tube body 10 suitable for fixation is determined. The operator peels off the peelable layer 213 of the fixed chassis 21 and adheres the base layer 211 to the patient's skin. The operator then operates the adjusting member 223, such as rotating the adjusting member 223, so that the adjusting member 223 moves toward the fixing seat 221, causing the elastic body 222 to be gradually compressed and deformed, thereby constraining the fistula tube body 10 from the circumference. In other words, the relative position of the fistula tube body 10 and the fixing assembly 22 is preliminarily determined. After adjusting the adjusting member 223, gas is injected into the airbag through the inflation device, so that the airbag is in the inflated state.

[0145] Figure 8 3 is a partial cross-sectional view of the fistula tube kit 100 in a fully fixed state according to the first embodiment of the present invention.

[0146] Further, refer to Figure 8 When the adjusting member 223 is rotated to the bottom, the internal pressure-applying column 2232 of the adjusting member 223 compresses the elastic body 222 to maximum pressure. The pressure-applying surface 22321 of the internal pressure-applying column 2232 applies oblique inward pressure to the elastic body, causing the elastic body 222 to deform to its maximum value at both ends. This compresses and contracts the fistula tube body 10, forming a fully fixed state 3. In this fully fixed state 3, the fluid passage 102 of the fistula tube body 10 is substantially sealed. This means that the fluid in the kidney cannot be transported to the outside of the body, or only a small amount can be transported through the fluid passage 102.

[0147] refer to Figure 8 and Figure 9 During use, after the operation is completed, the length of the fistula tube body 10 that has entered the patient's body is determined, that is, the position where the fistula tube body 10 is suitable for being fixed is determined. Then, gas is inflated into the airbag through the inflation device, so that the airbag is in the inflated state, that is, the position of the fistula tube body 10 and the patient's body is preliminarily limited. Then, the operator operates the adjustment member 223, such as rotating the adjustment member 223, so that the adjustment member 223 moves toward the fixing seat 221, and adjusts the adjustment member 223 to the maximum adjustment position, so that the elastic body 222 is gradually compressed and deformed, and the deformation amount reaches the maximum state, thereby constraining the fistula tube body 10 from the circumferential side, that is, the relative position of the fistula tube body 10 and the fixing assembly 22 is fixed to the greatest extent. In this state, the adjusting member 223 reaches its maximum adjustment position, the elastic body 222 is deformed to its maximum value, and the deformation of the fistula tube body 10 is also maximized, and the fluid passage 102 of the fistula tube body 10 is partially reduced to a significant extent. In other words, the fixing assembly 22 controls whether the fistula tube body 10 is opened or closed.

[0148] It is worth mentioning that this usage state is suitable for patients with less drainage needs and no large amount of liquid flowing out from the body.

[0149] In another embodiment of the present invention, the fully fixed state 3 may also be a state in which the fluid channel 102 of the fistula tube body 10 is basically connected, that is, even if the adjustment member 223 is adjusted to the maximum adjustment position, the fistula tube body 10 still has a good diversion effect.

[0150] The degree to which the fixing assembly 22 controls the deformation of the fistula tube body 10 is not a limitation of the present invention.

[0151] Figure 10 FIG. 2 is another embodiment of the elastic body 222 of the fistula tube fixing device 20 according to the first embodiment of the present invention.

[0152] The difference from the first embodiment is that Figure 10 In this embodiment of the present invention, the elastic body 222 is an airbag. That is, the elastic body 222 has an inner cavity 22203, and the inner cavity 22203 seals at least part of the gas to support the elastic body 222 to form a predetermined shape.

[0153] The outer surface of the elastic body 222 forms the inclined upper end portion 2221 and the inclined lower end portion 2222 .

[0154] Figure 11 This is a modified embodiment of the fixing base plate 21 of the fistula tube fixing device 20 according to the first embodiment of the present invention.

[0155] This embodiment of the present invention is different from the first embodiment described above in that the first portion 21011 of the upper end portion 2101 of the fixed chassis 21 extends in a substantially straight line, and the first portion 21021 of the lower end portion 2102 extends in a substantially straight line, and the first portion 21011 of the upper end portion 2101 of the fixed chassis 21 and the first portion 21021 of the lower end portion 2102 are parallel to each other.

[0156] Furthermore, the upper end 2101 of the fixed chassis 21 has two first portions 21011, one located on either side of a recess formed by the second portion 21012. Symmetrically, the lower end 2102 of the fixed chassis 21 has two first portions 21021, one located on either side of a recess formed by the second portion 21022.

[0157] Figure 12 FIG1 is a schematic cross-sectional view of a fistula tube assembly according to a second embodiment of the present invention. Figure 13 1 is an exploded schematic diagram of a fistula tube assembly according to a second embodiment of the present invention.

[0158] The nephrostomy tube fixing device 20 of the second embodiment differs from the fistula tube fixing device 20 of the first embodiment in that the fixing seat 221 of the fixing assembly 22 includes a fixing member 2213 and a matching fixing member 2214. The matching fixing member 2214 is fixed to the fixing base 21, and the fixing member 2213 is detachably connected to the matching fixing member 2214. The elastic body 222 is mounted on the portion of the fixing seat 221 where the fixing member 2213 is located, and the adjusting member 223 is adjustably mounted on the portion of the fixing seat 221 where the fixing member 2213 is located to adjust the compression distance between the adjusting member 223 and the elastic body 222.

[0159] In this embodiment of the present invention, the fixing member 2213 is detachably connected to the matching fixing member 2214 in a threaded connection manner. In other words, the connecting parts of the fixing member 2213 and the matching fixing member 2214 are each provided with matching threads.

[0160] In other embodiments of the present invention, the fixing member 2213 is detachably connected to the matching fixing member 2214 in other ways, such as a snap-fit ​​method.

[0161] Figure 14 FIG1 is a cross-sectional view of a nephrostomy tube fixing device according to a third embodiment of the present invention.

[0162] 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 seat 221 is integrally connected to the fixing base 21 .

[0163] Furthermore, the fixing seat 221 is integrally extended upward from the surface of the base layer 211 of the fixing chassis 21 to form the fixing seat 221 .

[0164] The fixing seat 221 includes a first component 2211 and a second component 2212. The first component 2211 forms a first channel 22101 and the compression chamber 22103, and the second component 2212 forms a second channel 22103. The first channel 22101 is connected, and the compression chamber 22103 and the second channel 22103 are connected to each other in sequence.

[0165] The second component 2212 is integrally connected to the fixed base 21. Further, the second component 2212 is integrally connected to the base layer 211 of the fixed base 21. In this embodiment of the present application, the second component 2212 is a tubular structure, and the tubular wall is integrally connected to the base layer 211. The bottom end of the first component 2211 is taperedly connected to the upper end of the second component 2212 to form the compression cavity 22103. The inner diameter of the first component 2211 is greater than the inner diameter of the second component 2212.

[0166] The inner compression column 2232 forms a passage substantially consistent with the second component 2212, and the passage cooperates with the diameter of the fistula tube body 10, thereby facilitating the guidance of the delivery of the fistula tube body 10.

[0167] Figure 15 A schematic view of a renal fistula kit 100 according to a fourth embodiment of the present application is shown.

[0168] The renal fistula kit 100 of the fourth embodiment differs from the renal fistula kit 100 of the first embodiment in that the fistula tube body 10 does not include the airbag. That is, in this embodiment of the present application, the extension segment 12 of the fistula tube body 10 integrally extends to the outer end portion, and the opening 101 is formed at the outer end portion. The fistula tube body 10 without the airbag is easy to be detached from the body, and is suitable for short-term or temporary use.

[0169] Reference is made to the accompanying drawings that show Figures 16 to 19 A fixable renal fistula device according to a preferred embodiment of the present application is shown.

[0170] The fixable renal fistula device includes a fixing unit 810 and at least one renal fistula 820. It is understood that the number of the renal fistula 820 can be two, three, four or more. The fixing of a plurality of the renal fistula 820 can be adapted by the same fixing unit 810.

[0171] The renal fistula 820 of the fixable renal fistula device can be inserted into a renal fistula passage of a subject through a fistula opening adapted to communicate with the renal fistula passage and located on the surface of the subject. It is understood that the subject can be a human, an animal, etc., and a human is taken as an example for illustration.

[0172] The nephrostomy tube 820 inserted into the nephrostomy channel can be fixedly mounted on the user with the aid of the fixing unit 810. The nephrostomy tube 820 has a starting end and an opposite end. During the insertion process, the starting end of the nephrostomy tube 820 is adapted to be inserted into a preset position in the body of the user along the nephrostomy channel. The preset position is different depending on the individual differences of the user. The end of the nephrostomy tube 820 is located on the 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 user so that the nephrostomy tube 820 is fixed at least in one position.

[0173] In detail, part of the nephrostomy tube 820 extends into the body, and part 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 user, thereby preventing the nephrostomy tube 820 from falling out of the body or the nephrostomy tube 820 from being inserted into a deeper position.

[0174] The fixing unit 810 has a restrained state and an open state. In the restrained state, the nephrostomy tube 820 is restrained by the fixing unit 810 and cannot move relative to the fixing unit 810. In the open state, the nephrostomy tube 820 can move relative to the fixing unit 810, thereby changing the position from the starting end of the nephrostomy tube 820 to the position where the nephrostomy tube 820 is fixed to the fixing unit 810, thereby changing the insertion depth of the nephrostomy tube 820 to meet the different needs of the user. The fixing unit 810 is operable to switch between the restrained state and the open state.

[0175] Furthermore, the fixing unit 810 can not only fix the nephrostomy tube 820 to prevent the nephrostomy tube 820 from moving forward or backward to prevent the nephrostomy tube 820 from failing to play the expected drainage role, but also prevent the nephrostomy tube 820 from moving left and right in the nephrostomy channel to reduce the pulling of the nephrostomy tube 820 on the body tissue of the user during the movement, thereby avoiding the fistula opening from being pulled further or causing damage to the nephrostomy channel.

[0176] It is worth mentioning that when the nephrostomy tube 820 exposed to the outside is accidentally caught or pulled by an object, the fixing unit 810 can disperse the force acting on the nephrostomy tube 820 to the body surface of the user, thereby reducing damage to the body around the nephrostomy tube 820.

[0177] 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 suitable for being fixed to the body surface of the user. The fixing support 811 is connected to the fixing patch 812 to be fixed by the fixing patch 812.

[0178] Since the nephrostomy tube 820 is fixedly mounted on the fixed support portion 811, the fixed support portion 811 is fixedly mounted on the fixed patch 812, and the fixed patch 812 is fixed to the body surface of the user, when the nephrostomy tube 820 is pulled by external force, the fixed support portion 811 bears most of the force from the nephrostomy tube 820, and the fixed patch 812 further bears most of the force from the fixed support portion 811, thereby dispersing the pulling force to the body surface portion of the user to which the fixed patch 812 is attached.

[0179] In this way, the probability of the nephrostomy tube 820 being pulled and causing damage to the ostomy opening is greatly reduced. On the one hand, the nephrostomy tube 820 can be safely fixed in the fixing unit 810. On the other hand, the activity restrictions of the user during activities are also lifted to a certain extent, and the restrictions on the amplitude and range of activities are reduced.

[0180] In addition, the fixing patch 812 is arranged around the fixing support portion 811, and when the nephrostomy tube 820 fixing unit 810 is installed on the user, the nephrostomy tube 820 fixing unit 810 can close the fistula opening to prevent the fluid overflowing through the fistula opening from continuing to overflow outward, thereby reducing the chance of emitting odor.

[0181] Furthermore, the fixing unit 810 has a holding channel 81110. The nephrostomy tube 820 is adapted to be inserted into and held in the holding channel 81110 of the fixing unit 810. The size of the holding channel 81110 is adjustable. When the nephrostomy tube 820 needs to be removed from the fixing unit 810, the holding channel 81110 can be adjusted to be larger. When the nephrostomy tube 820 needs to be removed from the fixing unit 810, the holding channel 81110 can be adjusted to be smaller.

[0182] It is worth mentioning that, in the present embodiment, described nephrostomy tube 820 is implemented as a hose, can be made of materials such as rubber or silica gel, to reduce the discomfort of described user. It will be appreciated by those skilled in the art that the manufacturing material of described nephrostomy tube 820 can be selected according to demand, is only illustrated here, and does not limit the present invention. Of course, it is understandable that described nephrostomy tube 820 can also be implemented as a pipe of harder material, is selected according to actual demand.

[0183] After the nephrostomy tube 820 is inserted into the holding channel 81110 of the fixing unit 810, the holding channel 81110 is adjusted to be smaller, and the fixing unit 810 squeezes the nephrostomy tube 820 to deform, thereby holding the nephrostomy tube 820 tightly. The nephrostomy tube 820 has a drainage channel 8200, a drainage inlet 8201, and a drainage outlet 8202. The drainage inlet 8201 and the drainage outlet 8202 are respectively connected to the drainage channel 8200 at both ends of the drainage channel 8200. The nephrostomy tube 820 is provided with a marking line so that the nephrostomy tube 820 can be positioned under the detection equipment after being inserted into the body, so as to facilitate the operator to control the insertion position and depth.

[0184] In this embodiment, the nephrostomy tube 820 is fixed to the fixing unit 810 by squeezing the nephrostomy tube 820 while maintaining the drainage channel 8200 of the nephrostomy tube 820 in a conductive state. In other words, the nephrostomy tube 820 made of a soft material can maintain its normal drainage function after being fixed.

[0185] The fixed support portion 811 of the fixing unit 810 includes a force-applying component 8111 and a deformable member 8112, wherein the force-applying component 8111 is arranged on opposite sides of the deformable member 8112 to relatively squeeze the deformable member 8112 to deform, thereby changing the size of at least part of the retaining channel 81110 formed by the deformable member 8112, and further fixing the nephrostomy tube 820 passing through at least part of the retaining channel 81110 formed by the deformable member 8112.

[0186] The nephrostomy tube 820 passes through the deformable member 8112 in the axial direction of the deformable member 8112, and the force-applying component 8111 is configured to apply an extrusion force to the deformable member 8112 in the axial direction of the deformable member 8112 so that the deformable member 8112 is deformed in the circumferential direction, thereby changing the size of the retaining channel 81110.

[0187] In more detail, the force-applying assembly 8111 includes a fixed support seat 81111, a movable member 81112, and has the retaining channel 81110 and a gap 811110. The retaining channel 81110 is provided through the retaining channel 81110. The gap 811110 is connected to the retaining channel 81110 and radially expands the radial space of the retaining channel 81110. The retaining channel 81110 is located in the retaining channel 81110. The fixed support seat 81111 is adapted to be connected to the fixed patch 812 to be fixed thereto. The movable member 81112 is adapted to be movably connected to the fixed support seat 81111. The gap 811110 is formed between the movable member 81112 and the fixed support seat 81111. When the movable member 81112 is moved toward the fixed support seat 81111, the gap 811110 is reduced.

[0188] The deformable member 8112 is accommodated in the gap 811110 , and when the movable member 81112 is moved toward the fixed support seat 81111 , the deformable member 8112 can be squeezed by the relatively moving movable member 81112 and the fixed support seat 81111 to be deformed in a radial direction.

[0189] In this embodiment, the retaining channel 81110 formed in the deformable member 8112 is partially formed in a middle position of the deformable member 8112, which is defined as the inner side of the deformable member 8112. Correspondingly, the outer side of the deformable member 8112 is arranged on the force-applying component 8111, and when the deformable member 8112 is squeezed by the fixed support seat 81111 and the movable member 81112 of the force-applying component 8111, the force-applying component 8111 limits the deformable member 8112 from deforming outward, thereby ensuring that the deformable member 8112 will definitely deform inward after being squeezed to a certain extent, so as to change the size of the retaining channel 81110.

[0190] In other words, the deformable member 8112 is configured to be positionally mounted on the force-applying assembly 8111 and is positionally limited on the outside to allow inward deformation.

[0191] It is worth noting that, during the process of the deformable member 8112 being squeezed and deformed, the drainage channel 8200 of the nephrostomy tube 820 can be reduced to a certain extent, and the degree of reduction is controllable. In fact, the drainage channel 8200 can be sealed by the fixing unit 810. In other words, when the operator wishes to stop the nephrostomy tube 820 from draining, the fixing unit 810 can be used to seal the drainage channel 8200 of the nephrostomy tube 820.

[0192] Furthermore, in this embodiment, the deformable member 8112 is a solid elastic member. Since the raised top surface 81121 and the raised bottom surface 81122 are squeezed, the deformable member 8112 is flattened as a whole and due to the limitation of the force-applying component 8111 on the outside, the deformable member 8112 is squeezed inward to restrain the nephrostomy tube 820.

[0193] In the present embodiment, the nephrostomy tube 820 has at least one drainage groove 8203, and the number of the drainage groove 8203 can be one, two, three, four or more. The drainage inlet 8201 is arranged close to the starting end of the nephrostomy tube 820, relative to the end. Each drainage groove 8203 is connected to the drainage inlet 8201, and the drainage groove 8203 is set to the drainage inlet 8201 position and extends toward the starting end. The drainage groove 8203 is opened and arranged on the surface of the nephrostomy tube 820.

[0194] In this embodiment, six drainage grooves 8203 are used as an example. The nephrostomy tube 820 includes a front section 821 and a rear section 822. The front section 821 includes a support column 8211 and at least two partition walls 8212. The drainage grooves 8203 are formed between two adjacent partition walls 8212, and the partition walls 8212 extend outward from the circumference of the support column 8211. The rear section 822 extends from the front section 821. The drainage inlet 8201 is located at the junction of the front section 821 and the rear section 822.

[0195] The nephrostomy tube 820 has a guide channel 8210 that can be extended from the starting end to the end. The guide channel 8210 is suitable for being installed with a guide member 830 such as a guide wire to guide the flexible nephrostomy tube 820 to the desired position. At least part of the guide channel 8210 of the nephrostomy tube 820 is formed on the front section 821 of the tube, and at least part of it is formed on the rear section 822 of the tube. The drainage channel 8200 of the nephrostomy tube 820 is formed on the rear section 822 of the tube, and the drainage groove 8203 is connected to the drainage channel 8200 via the drainage inlet 8201. At the rear section 822 of the tube, the drainage channel 8200 forms at least part of the guide channel 8210. In other words, at least part of the drainage channel 8200 and the guide channel 8210 are shared.

[0196] In this embodiment, there are six drainage grooves 8203 and six drainage inlets 8201, with each drainage groove 8203 corresponding to one drainage inlet 8201. There are six partition walls 8212 to separate and form six drainage grooves 8203. At least a portion of the guide channel 8210 is formed on the support column 8211 of the front tube section 821.

[0197] Compared to conventional nephrostomy tubes 820, the nephrostomy tube 820 provided in this embodiment provides multiple drainage inlets 8201 for fluid to enter the tube, thereby reducing the chance of one drainage inlet 8201 becoming blocked, leading to failure of the entire nephrostomy tube 820. Furthermore, if the fluid may contain large aggregates, such as blood clots, which adhere to the surface of the front section 821 of the tube and, under the suction force at the location of the drainage inlet 8201, move along the drainage groove 8203 toward the drainage inlet 8201, the blood clots may be separated into smaller pieces by the partition walls 8212, thereby reducing the chance of blood clots blocking the drainage inlet 8201.

[0198] It is understood that the multiple drainage inlets 8201 can be arranged in the same plane, or in a non-planar arrangement. The upper and lower ends of the multiple drainage grooves 8203 can be arranged flush, or the upper and lower ends of the multiple drainage grooves 8203 can be arranged at different heights to reduce the chance of the drainage grooves 8203 being blocked.

[0199] Furthermore, the drainage groove 8203 of the nephrostomy tube 820 is arranged near the starting end of the nephrostomy tube 820, and at least a portion of the nephrostomy tube is configured to bend outward from the starting end. For example, in this embodiment, the starting end of the nephrostomy tube 820 forms a structure similar to a pig's tail. During the insertion of the nephrostomy tube 820, the curved section of the nephrostomy tube is guided into a straight line along a guide. After the guide is removed, the previously curved section automatically curls back into a curved shape, i.e., returns to its original shape. In this way, the nephrostomy tube 820 itself can have a certain degree of fixation, preventing it from easily falling out of the user's body. In addition, the curved arrangement of the nephrostomy tube 820 reduces irritation to the user's body, which helps the user wear the nephrostomy tube 820 for a longer period of time. Of course, it is understood that the nephrostomy tube 820 can also be implemented as a straight tube.

[0200] Furthermore, the drainage grooves 8203 can be designed to have different lengths so that different drainage inlets 8201 are located at different positions. In this embodiment, the longest drainage groove 8203 is arranged outside the curved portion of the nephrostomy tube 820. This not only maximizes the drainage function of the drainage groove 8203, but also reduces the chance of blockage at this location by allowing the drainage groove 8203 to bend along with the nephrostomy tube 820.

[0201] Reference to the accompanying drawings Figure 20A and Figure 24 A nephrostomy tube according to a preferred embodiment of the present invention will be disclosed in detail in the following description, wherein the nephrostomy tube comprises a tube body 91 and a fixing device 92 detachably mounted on the nephrostomy tube. When the tube body 91 passes through an external channel 9400 of a patient 94 and penetrates into the body of the patient 94, the fixing device 92 is used to fix the tube body 91 to a waist 941 of the patient 94 to prevent the tube body 91 from moving in and out and causing wear and pain to the wound of the patient 94.

[0202] The tube body 91 has a guide port 91001 and an external port 91002, wherein the guide port 91001 and the external port 91002 of the tube body 91 are arranged opposite each other, and the fixing device 92 is inserted from the guide port 91001 of the tube body 91 into the tube body 91, so that the fixing device 92 is retained by the guide port 91001 and the external port 91002 of the tube body 91. The tube body 91 of the nephrostomy tube is provided with a positioning line, so that the operator can observe the position and insertion depth of the tube body 91 of the nephrostomy tube using a detection device after the tube body 91 of the nephrostomy tube is inserted into the patient's body.

[0203] The fixing device 92 includes a fixing body 921 and an adaptor valve 922, wherein the fixing body 921 and the adaptor valve 922 are integrally mounted. When the tube body 91 is in a straightened state, the fixing device 92 can be inserted from the guide port 91001 of the tube body 91 into the middle portion of the tube body 91, so that the fixing device 92 is restrained by the external port 91002 of the tube body 91, allowing the tube body 91 to be inserted into a waist 941 of the patient 94 and into a kidney 942. The fixing body 92, inserted into the tube body 91, can adaptably fit the waist 941 of the patient 94, securing the tube body 91 in position at the waist 941 of the patient 94, thereby preventing the tube body 91 from moving in and out through the external channel 9400 of the patient 94 and causing discomfort to the patient 94.

[0204] The end of the tube 91 that extends into the body can switch between a naturally curled state and a straightened state. In the absence of external force, the end of the tube 91 that extends into the patient's 94 body is in the naturally curled state. When a linear guide member 93 extends from the external port 91002 and is subsequently led out through the guide port 91001, the tube 91 is guided from the naturally curled state to the straightened state.

[0205] The tube body 91 further includes a guide portion 911, an extension portion 912, and an external portion 913. The tube body 91 further has a conducting channel 9101, a guide port 91001, and an external port 91002, each of which connects the conducting channel 9101 to the outside world. The guide portion 911, the extension portion 912, and the external portion 913 extend integrally. The conducting channel 9100 is interconnected with the guide port 91001 and the external port 91002, each of which connects the conducting channel 9100 to the outside world. The guide port 91001 is formed in the guide portion 911 and connects to the outside world. The external port 91002 is formed in the external portion 913 and connects to the outside world.

[0206] The guide portion 911 has a guide channel 91100, wherein the extension portion 912 has an extension channel 91200, wherein the external portion 913 has an external channel 91300, wherein the guide channel 91100, the extension channel 91200 and the external channel 91300 are sequentially connected to form a guide channel 9101, wherein the guide port 91001 is formed at the port of the guide portion 911, wherein the external port 91002 is formed at the port of the external portion 913, so that the straight guide member 93 is inserted from the external port 91002, and passes through the external channel 91300, the extension channel 91200 and the guide channel 91100 in sequence and is led out from the guide port 91001, so that the tube body 91 is transformed from a naturally curled state to a straightened state.

[0207] Reference to the accompanying drawings Figure 21A and Figure 21BThe tube body 91 is secured within the patient's body by being fixed at at least two ends. The guide portion 911 of the nephrostomy tube is secured so as to be secured outside the patient's body, and the extension portion 912 of the nephrostomy tube is secured so as to be positioned within an organ in the patient's body after inflation. The tube body 91 switches between a naturally curled state 9100 and a straightened state 9200. In the naturally curled state 9100, the portion of the tube body 91 that can be inserted into the patient's body 94 is naturally curved. In the straightened state 9200, the guide portion 911 is guided to extend in a substantially straight line. In other words, when the tube body 91 is in the straightened state 9200, it is guided into the straightened state 9200 to be suitable for insertion into the kidney 942 of the patient 94. When the tube body 91 is in the naturally curled state 9100, the portion of the fistula tube that inserts into the patient 94's body naturally bends, better retaining it within the kidney 942 of the patient 94, thereby effectively locking the tube body 91 in place. Furthermore, the inner end of the guide portion 911 retained within the patient's body is curled to prevent contact with internal organs and causing adverse irritation.

[0208] Preferably, the tube body 91 switches between an uninflated state 9300 and an inflated state 9400. When the tube body 91 is in the uninflated state 9300, the tube body 91 can move freely in the external channel 9401 of the patient 94; when the tube body 91 is in the inflated state 9400, the tube body 91 is inflated to be stuck in the kidney 942 of the patient 94, thereby limiting the position of the tube body 91.

[0209] The tube body 91 further includes an expandable portion 914 and an air inlet portion 915. The tube body 91 has an inflation channel 9102 and an air inlet port 91003 communicating with the inflation channel 9102. The inflation channel 9102 is defined by the expandable portion 914 and the air inlet portion 915. The air inlet port 91003 is formed at the end of the air inlet portion 915. By inflating air into the inflation channel 9102, the expandable portion 914 is inflated, thereby achieving an expansion effect on the expandable portion 914.

[0210] The expandable portion 914 includes an expandable layer 9141 and a connecting layer 9142, and has an expandable cavity 91401 and a connecting channel 91402. The expandable layer 9141 and the connecting layer 9142 are respectively formed radially outward of the extension portion 912, with the expandable layer 9141 defining the expandable cavity 91401 and the connecting layer 9142 defining the connecting channel 91402.

[0211] The air inlet portion 915 has an air inlet channel 91500. The connecting channel 91402 connects the expandable chamber 91401 and the air inlet channel 91500. The expandable layer 9141 is elastic, and the expandable chamber 91401 can be inflated. The expandable layer 9141 is retained on the outside of the extension portion 912 near the guide portion 911 to define the expandable chamber 91401. The connecting channel 91402 is formed outside the extension portion 912 so that the connecting channel 91402 and the extension channel 91200 are separated. The connecting channel 91402 and the expandable chamber 91401 extend radially outward from the extension portion 912, and the expandable portion 914 is formed on the outside of the extension portion 912.

[0212] The channel 91402 connects the expandable cavity 91401 and the air inlet channel 91500. In other words, the extension portion 912 serves as a connection between the guide port 91001 and the external port 91002, and also connects the expandable cavity 91401 and the air inlet channel 91500.

[0213] The expandable portion 914 is disposed between the guide portion 91 and the extension portion 912. The air inlet portion 915 is connected to the extension portion 912 to connect to the expandable portion 914, thereby allowing the air inlet portion 915 to communicate with the expandable portion 914 and the external space. When the air inlet portion 915 is inflated, gas sequentially passes through the air inlet channel 91500 of the air inlet portion 915, the inflation channel 9102 defined by the extension portion 912, and the expandable chamber 91401 of the expandable portion 914. Furthermore, the extension channel 91200 of the extension portion 912 and the connecting channel 91402 are spaced apart.

[0214] Reference to the accompanying drawings Figure 21A and Figure 21B After the air inlet 915 is inflated, the expandable portion 914 connected to the air inlet 915 is inflated and expanded, so that the expandable portion 914 is formed in the extension portion 912 and protrudes from the surface of the extension portion 912. After the guide portion 911 of the tube body 91 is inserted into the kidney 942 of the waist 941 of the patient 94 through the preset external channel 9400, the expandable portion 914 expands, so that the expandable portion 914 is retained in the kidney 942 after expansion, and the expandable portion 914 is blocked inside the kidney 942 so that it cannot be withdrawn through the external channel 9400, thereby ensuring that the tube body 91 is stably maintained inside the body of the patient 94.

[0215] Furthermore, the tube body 91 includes an air inlet valve 916, which is disposed on the air inlet portion 915 and is arranged around the air inlet portion 915 in an openable and closable manner, thereby controlling the flow of gas in the air inlet portion 915. Furthermore, the fixing device 92 is arranged around the extension portion 912. The fixing device 92 preferably does not affect the inflation and deflation of the inflation channel 9102. The fixing device 92 can also work together with the air inlet valve 916 to control the inflation and deflation of the inflation channel 9102.

[0216] The fixing device 92 can be movably moved on the extension portion 912 to adaptively adjust the distance between the waist 941 and the kidney 942 of different patients 94, thereby enabling the nephrostomy tube to adaptively fit the waist 941 of different patients 94. Furthermore, the fixing body 921 of the fixing device 92 is adaptively fitted to the waist 941 of different patients 94.

[0217] Reference to the accompanying drawings Figure 24 The fixing body 921 of the fixing device 92 includes a reinforcing layer 9211, a fitting layer 9212, and a protective layer 9213, and has a fixing body channel 9210 and a first fixing body opening 9201 and a second fixing body opening 9202 that connect the fixing body channel 9210 to the external space. The fitting layer 9212 is supported by the reinforcing layer 9211 and the protective layer 9213. The side of the fitting layer 9212 that is attached to the protective layer 9213 is adhesive, so that the fitting layer 9212 is used to contact the skin of the patient 94. The fixing body channel 9210 is defined by the reinforcing layer 9211, the fitting layer 9212, and the protective layer 9213. That is, the reinforcing layer 9211 , the bonding layer 9212 , and the protective layer 9213 all have openings at the center, so that when the reinforcing layer 9211 , the bonding layer 9212 , and the protective layer 9213 are bonded together, they define the fixed main body channel 9210 .

[0218] The reinforcing layer 9211 is used to reinforce and fix the tube body 91 , wherein the adapting valve 922 is installed on the reinforcing layer 921 , and thus the adapting valve 922 is stably connected to the reinforcing layer 921 .

[0219] Preferably, the reinforcing layer 9211 is adhered to one side of the bonding layer 9212 by hot melting or gluing, wherein the bonding layer 9212 is not sticky on the side adhered to the reinforcing layer 9211 .

[0220] The protective layer 9213 is a sticky layer covering the laminating layer 9212 to prevent external dust and the like from contaminating the laminating layer 9212. It is worth mentioning that the protective layer 9213 is adhered to the laminating layer 9212 by virtue of its own adhesiveness, and the protective layer 9213 can be repeatedly torn off from the laminating layer 9212 and then attached to the laminating layer 9212.

[0221] The reinforcing layer 9211 has a relatively small area and only needs to securely support a small area near the peripheral channel 9400 of the patient 94. The conforming layer 9212 has a larger area to better conform to the skin of the patient 94. Furthermore, the reinforcing layer 9211 has a certain strength to ensure greater stability when the adapting valve 922 is connected to the reinforcing layer 9211, thereby improving the connection strength between the fixing body 9211 and the adapting valve 922.

[0222] It is worth mentioning that the conforming layer 9212 is shaped to fit the patient's 94 waist 941. Therefore, the conforming layer 9212 is longer in the x-direction and shorter in the y-direction, allowing it to flexibly wrap around the patient's 94 waist 941. To adapt to the curve of the waist 941, the conforming layer 9212 is shortest in the y-direction near the center and gradually becomes longer in the y-direction as it moves away from the center. In other words, the conforming layer 9212 has a dumbbell-like cross-section, with wider sides and a narrower center. The width of the fixing body 921 in the middle is smaller than the width of its ends. The shape of the fixing body 921 matches the curvature of the patient's waist, facilitating its secure attachment to the patient's body.

[0223] The guide portion 911 comprises a first tube 9111 and a guide vane 9112. Laterally, the guide vane 9112 radially extends outward from the outer wall of the first tube 9111 to a predetermined height, forming the drainage groove 91101. Vertically, the guide vane extends longitudinally along the exterior of the first tube 9111 for a predetermined length. In other words, the guide vane 9112 divides the space outside the first tube 9111, forming the drainage groove 91101. The first tube 9111 forms the first inner channel 91102. The rear end of the guide vane is connected to the expandable portion 914.

[0224] The guide portion 911 includes a plurality of guide vanes 9112 symmetrically distributed on the exterior of the first tube 9111, thereby forming a plurality of diversion grooves 91101. Each of the plurality of diversion grooves 91101 independently connects to the extension channel 91200. According to this embodiment of the present invention, the guide portion 911 includes 96 guide vanes, each of which forms 96 diversion grooves 91101. From the inner portion of the bend outward, they are a first diversion groove 911011, a second diversion groove 911012, a third diversion groove 911013, a fourth diversion groove 911014, a fifth diversion groove 911015, and a sixth diversion groove 911016. Each of the 96 diversion grooves 91101 independently connects to the second inner channel 91201.

[0225] It is worth noting that in one embodiment of the present invention, during manufacturing, the first tube body 9111 and the plurality of guide vanes 9112 can be integrally formed at one time. That is, the first tube body 9111 and the plurality of guide vanes are connected in one piece, without a distinct interface or requiring separate molding steps. In another embodiment, during manufacturing, the first tube body 9111 can be formed first, and then the plurality of guide vanes 9112 can be formed on the exterior of the first tube body 9111. This is preferably an integral molding method. It should be noted that in this embodiment of the present invention, the guide portion 911 is described as having 96 guide vanes and 96 drainage grooves formed by isolation. However, in other embodiments of the present invention, the guide portion 911 can also be formed with a desired number and arrangement of guide vanes, such as 92, 93, 94, 95, or more guide vanes, arranged in a longitudinally extending asymmetric arrangement. The present invention is not limited in this respect.

[0226] According to an embodiment of the present invention, the position of the enclosed area 9113 of the drainage groove 91101 and the curvature of the guide portion 911 cooperate with each other. In other words, the opening and connection arrangement of the drainage groove 91101 with the outside is different depending on the curvature position of the guide portion 911. The length of the longitudinally extending opening 91001 of the drainage groove 91101 is adjusted by controlling the longitudinal extension length of the enclosed area 9113. That is, the partially enclosed drainage grooves with different opening 91001 lengths are formed at different length positions. On the other hand, the number or position of the drainage grooves 91101 that need to be enclosed is controlled by the size of the enclosed area 9113 or the number of enclosed areas 9113 formed by design. In other words, the size, corresponding position, and number of the external open areas of the drainage groove 91101 are adjusted by the arrangement of the enclosed area 9113 and the coordination of the drainage groove 91101. For example, but not limited to, taking the arc line of the outer bend of the guide portion 911 as a reference position, and taking the arrangement of the drainage grooves 91101 after the drainage end is horizontally expanded as an example, in one embodiment, the length of the closed area 9113 can gradually decrease from the center position to both sides, that is, a symmetrical stepped distribution. Accordingly, the length of the multiple drainage grooves 91101 gradually increases from the center to the length of the outer openings 91001 on both sides, corresponding to the symmetrical inverted stepped arrangement of the closed area 9113. In another embodiment of the present invention, the length of the closed area 9113 can gradually decrease from a predetermined position, that is, forming a unidirectional stepped arrangement. Accordingly, the length of the multiple drainage grooves 91101 gradually increases from the predetermined position. In another embodiment of the present invention, the multiple drainage grooves 91101 are spaced apart, such as one drainage groove 91101 is partially closed, and the adjacent drainage groove 91101 is fully open, that is, no closed area 9113 is provided. In other words, the closed areas 9113 are arranged at intervals on the openings 91001 of the plurality of drainage grooves 91101 .

[0227] According to this embodiment of the present invention, the length of the opening 91001 of the partially enclosed drainage groove gradually increases from the inner bend of the guide portion 911 to the outer side. In other words, the longitudinal extension length of the semi-enclosed area located inside the guide portion 911 is the longest, that is, the length of the opening 91001 of the drainage groove 91101 is the smallest. The longitudinal extension length of the adjacent semi-enclosed area decreases by a predetermined length, and the length of the opening 91001 of the drainage groove 91101 increases by a predetermined length, and so on, until the enclosed area 9113 is no longer provided, that is, the opening 91001 of the drainage groove 91101 is completely connected to the outside.

[0228] For example, in this embodiment of the present invention, reference is made to Figures 22 to 23BThe guide portion 911 includes 96 guide vanes and forms 96 guide grooves 91101, which are respectively 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. The 96 guide grooves are respectively a first guide groove 911011, a second guide groove 911012, a third guide groove 911013, a fourth guide groove 911014, a fifth guide groove 911015 and a sixth guide groove 911016, and include 95 closed Area 9113 is respectively a first closed area 91131, a second closed area 91132, a third closed area 91133, a fourth closed area 91134, and a fifth closed area 91135. The first closed area 91131 is arranged in the first drainage groove 911011, the second closed area 91132 is arranged in the second drainage groove 911012, the third closed area 91133 is arranged in the third drainage groove 911013, the fourth closed area 91134 is arranged in the fifth drainage groove 911015, and the fifth closed area 91135 is arranged in the sixth drainage groove 911016, and the first drainage groove 911011 is located at the inner bend of the guide part, and the fourth drainage groove 911014 is located at the outer bend of the guide part 911. Furthermore, the length of the first enclosed area 91131 is greater than the length of the second enclosed area 91132, the length of the second enclosed area 91132 is greater than the length of the third enclosed area 91133, the length of the second enclosed area 91132 is the same as the length of the fifth enclosed area 91135, and the length of the third enclosed area 91133 is the same as the length of the fourth enclosed area 91134. In other words, the first enclosed area 91131, the second enclosed area 91132, and the third enclosed area 91133 form a step-wise change in length, and the first enclosed area 91131, the fifth enclosed area 91135, and the fourth enclosed area 91134 form a step-wise change in length.

[0229] It is worth mentioning that in an embodiment of the present invention, the closed area 9113 is set in at least a partial area of ​​the drainage groove 91101 located at the inner bend, that is, the partially closed drainage groove 91101 is formed, and the closed area of ​​the closed area 9113 of the drainage groove 91101 located at the outer bend is reduced, that is, the opening 91001 is enlarged, or the fully-open drainage groove is formed, so that the curve turning of the guide part 911 is matched with the opening size of the drainage groove 91101.

[0230] Further, according to an embodiment of the present invention, referring to Figure 22 and Figure 23AThe guide portion 911 includes at least one protective leaf 9114, which is arranged at the outer end of the guide leaf 9112 to prevent the end of the guide leaf 9112 from directly contacting the outside. For example, it prevents the planar end of the guide leaf 9112 from directly contacting the human tracheal endothelium and causing adverse stimulation reactions.

[0231] Preferably, the protective blade 9114 is provided in an arc shape at the outer end of the guide blade 9112. In other embodiments of the present invention, the protective blade 9114 may also be in other shapes.

[0232] According to this embodiment of the present invention, the plurality of guard vanes 9114 are respectively disposed at the outer ends of the guide vanes. In other words, the number of guard vanes 9114 matches the number of guide vanes. A gap 91140 is formed between two adjacent guard vanes 9114, and the gap 91140 connects the drainage groove 91101 to the outside.

[0233] Multiple guard vanes 9114 are arranged at intervals to form a generally annular outer surface. In other words, the overall structure forms a relatively flat, curved surface, rather than a striped, spaced surface formed directly on the end face of the guide vane. In other words, the guard vanes 9114 mitigate the irritation of the guide vanes. The guard vanes 9114 arcuately cover the exterior of the guide vanes, with gaps 91140 formed between adjacent guard vanes 9114. This allows liquid to flow through, forming a circumferential protective guide wall.

[0234] In one embodiment of the present invention, the protective vanes 9114 extend on both sides of the guide vanes, that is, forming a roughly T-shaped structure.

[0235] In another embodiment of the present invention, the protective blade 9114 extends unidirectionally on one side of the guide vane, that is, the protective blade 9114 and the guide vane form an L-shaped structure, and the present invention is not limited in this regard.

[0236] Those skilled in the art will appreciate that the embodiments of the present invention described above and shown in the accompanying drawings are intended to be illustrative only and are not intended to limit the present invention. The objectives of the present invention have been fully and effectively achieved. The functional and structural principles of the present invention have been demonstrated and illustrated in the embodiments. Any variations or modifications may be made to the embodiments of the present invention without departing from the principles described.

Claims

1. A nephrostomy tube fixing device, characterized in that: include: a fixed chassis, the fixed chassis being adapted to be fixed to a surface of a human body; and A fixing assembly, wherein the fixing assembly is arranged on the fixed chassis to form a tube-penetrating channel, and the tube-penetrating channel is suitable for passing a nephrostomy tube so as to be fixed by the fixing assembly around the nephrostomy tube, wherein the fixing assembly comprises a fixing seat, an elastic body and an adjusting member, the fixing seat has a compression chamber, the compression chamber is connected to the tube-penetrating channel, the elastic body is installed in the compression chamber, and the adjusting member is adjustably installed on the fixing seat, wherein the elastic body comprises an upper end and a lower end, the upper end and the lower end are symmetrically arranged about a horizontal center plane, the elastic body has two symmetrical compression surfaces, respectively located at the upper end and the lower end, the two compression surfaces are respectively contracted inwardly from the middle of the elastic body to the two port positions to form a gyro shape, the elastic body has a through hole, the through hole is suitable for being passed through by the nephrostomy tube, the adjusting member comprises an outer operating tube and an inner pressure column, an access loop is formed between the outer operating tube and the inner pressure column, when the When the adjusting member is connected to the fixing seat, the fixing seat extends into the access loop, and the inner wall of the outer operating tube and the outer surface of the fixing seat are respectively provided with mutually matching connecting threads, and the end of the inner pressure column has an inclined pressure surface, which matches the compression surface of the elastic body, and the height of the inner pressure column is greater than the height of the outer operating tube. When the adjusting member is connected to the fixing seat, the inner pressure column abuts against the compression surface of the elastic body located above, and the compression surface of the elastic body located below is supported on the inner support surface of the fixing seat, so that when the inner pressure column moves downward, an inwardly inclined pressure is applied to the elastomer, so that the two compression surfaces of the elastomer are respectively subjected to symmetrical pressure, deforming toward the center to narrow the perforation and allowing the elastomer to be extended in the longitudinal direction, so as to adjust the compression distance between the adjusting member and the elastomer, and adjust the compression distance to adjust the degree of fixation of the same nephrostomy tube and adapt to nephrostomy tubes of different sizes.

2. The nephrostomy tube fixing device according to claim 1, wherein the perforation of the elastomer is suitable for the nephrostomy tube to pass through, and the internal pressure column has a deformation channel. When the adjusting member is adjusted close to the elastomer, the internal pressure column compresses the compression surface of the elastomer, and the elastomer is deformed and extends into the deformation channel of the internal pressure column, thereby reducing the perforation.

3. The nephrostomy tube fixing device according to claim 2, wherein the elastic body has two symmetrical compression surfaces, respectively located at the upper and lower ends of the elastic body.

4. The nephrostomy tube fixing device according to claim 3, wherein the inner pressure column is fixedly connected to the outer operating tube so that the compression distance between the inner pressure column and the elastic body can be controlled by the outer operating tube.

5. The nephrostomy tube fixing device according to any one of claims 1 to 4, wherein the fixing seat comprises a fixing plate, the fixing plate extends planarly from the circumferential side of the bottom end of the fixing seat, and the fixing plate is fixed to the fixing chassis.

6. The nephrostomy tube fixing device according to claim 1, wherein the fixing seat is fixed to the fixing chassis, wherein the fixing seat includes a fixing piece and a matching fixing piece, the fixing piece is detachably connected to the matching fixing piece, the matching fixing piece is fixed to the fixing chassis, the elastomer is mounted on the fixing piece, the adjusting piece is adjustably mounted on the fixing piece to adjust the compression distance between the adjusting piece and the elastomer, wherein the elastomer is an air bag, wherein the fixing chassis includes a base layer, an adhesive layer and a peelable layer, the adhesive layer is arranged on the base layer, and the peelable layer is laminated in a peelable manner through the adhesive layer. On a surface of the base layer, the peelable layer has a discontinuity line, and the discontinuity line separates the peelable layer into two parts, wherein the base layer includes an outer layer, an interlayer and an inner layer, and the interlayer is integrally clamped in the center part of the outer layer and the inner layer, wherein the fixed chassis includes an upper end and a lower end, the upper end includes two first parts and a second part, the two first parts are symmetrically distributed on both sides of the second part, the second part is recessed inward from the first part, and the upper end and the lower end are symmetrical, wherein the fixed chassis is made of a flexible material, and the hardness of the center of the fixed chassis is greater than the hardness of the peripheral part.

7. A nephrostomy tube kit, characterized in that include: A nephrostomy tube fixing device according to any one of claims 1 to 6; and A nephrostomy tube is provided, wherein the nephrostomy tube is adapted to be fixed by the nephrostomy tube fixing device.

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