A disposable flexible endoscope catheter and a preparation method thereof

Abstract

The present invention discloses a disposable flexible endoscope catheter and a preparation method thereof, comprising a hard tube end and a soft tube end, wherein the hard tube end comprises an inner hard tube, a woven mesh structure layer and an outer hard tube, and the outer surface of the inner hard tube is provided with a woven mesh structure layer. In the present invention, the hard tube part of the flexible endoscope catheter is prepared first, so that the woven wire mesh of the hard tube section extends to the required length of the entire flexible endoscope catheter, eliminating the process of sleeved snake bones and spot welding in the early stage of the traditional process, and the integral woven wire mesh greatly improves the structural strength of the flexible endoscope catheter, and the soft tube section adopts a double-layer structure, so that it is convenient to nest the snake bone structure inside the front end of the hose at one time, and the hard tube section is located between the inner tube layer and the wire mesh inside the wire mesh to form a step that can be used for nesting the snake bone joint and limiting fixation, avoiding the instability of the traditional process of segmented fixation and then bonding, and also improving the smoothness of the outer surface of the flexible endoscope catheter, ensuring the comfort of the patient during surgery.

Description

Technical Field

[0001] The invention relates to the technical field of medical care catheters, in particular to a disposable soft endoscope catheter and a preparation method thereof. Background Art

[0002] As the name implies, a soft endoscope is a flexible, bendable visual endoscope. In medicine, there are many types of endoscopes used in different systems, such as pharyngoscopes for the ear, nose and throat, bronchial fiberscopes for the respiratory system, choledochoscopes and colonoscopes for the digestive system, and there are also many types of endoscopes for the urinary system, such as ureteral soft endoscopes, nephroscopes, soft nephroscopes, and soft cystoscopes. These all belong to the soft endoscope series. From the perspective of structure and construction, they can be divided into two categories, one is a fiber soft endoscope, and the other is an electronic soft endoscope. The focus is on the soft endoscopes of the lower urinary system. The soft endoscopes of the urinary system include soft nephroscopes, which are mainly used for kidney stones, especially the removal and crushing of stones in the renal calyx, because the soft endoscope can be bent. There is also a ureteral soft endoscope, which is commonly used to treat upper urinary tract stones including stones above the ureter. The soft cystoscope is mainly used for urethral cystoscopy. Compared with the hardware of the urethral cystoscope, it is flexible, so the patient suffers less pain during the examination, and the more curved parts of the urethra and bladder can be seen.

[0003] Existing deficiencies:

[0004] Traditional disposable soft endoscopes are generally manufactured by combining soft and hard segments in order to achieve the sealing and electronic shielding functions of the entire insertion part while being able to bend. The front end of the soft endoscope needs to be implanted with a snake bone joint inside for bending. However, the traditional process is to first prepare the hard segment of the soft endoscope catheter, and then embed the snake bone inside, and dock the snake bone with the distal port of the hard tube. Then, a wire mesh is woven on the outside of the snake bone, and then the two ends of the wire mesh on the outside of the snake bone are spot welded to the meshes at both ends of the snake bone. Finally, a soft rubber tube is wrapped around the outside of the wire mesh of the soft section of the soft endoscope catheter, and the proximal end is wrapped around the distal end of the insertion tube 1CM away, and the distal end and the module are wrapped on the module, and glue is used for sealing. Although the traditional process solves the fixation of the snake bone end and the distinction between the soft and hard materials of the external catheter of the soft endoscope, and realizes the segmented connection and fixation of the snake bone and the lens, although the preparation process is simple in principle, the process is complicated, and there is an additional wire mesh spot welding process at the snake bone fixation, which has requirements on the welding quality and may damage the snake bone and the hard section end. When the hose is wrapped later, it is also easy to cause protruding joints at the connection between the soft and hard sections, steps in the catheter, uneven transition of the catheter, and poor aging resistance of the glue bonding, which affects the patient's use experience and product quality. Summary of the invention

[0005] The object of the present invention is to provide a disposable flexible endoscope catheter and a preparation method thereof, so as to solve the problems raised in the above-mentioned background technology.

[0006] To achieve the above object, the present invention provides the following technical solution: a disposable soft endoscope catheter, comprising a hard tube end and a soft tube end, wherein the hard tube end comprises an inner hard tube, a woven mesh structure layer and an outer hard tube, the outer surface of the inner hard tube is provided with a woven mesh structure layer, and the outer surface of the woven mesh structure layer is provided with an outer hard tube;

[0007] The hose end comprises an outer hose, which is arranged at one end of the outer hard tube. A snake-bone structure is arranged inside the outer hose, and the snake-bone structure is arranged on the inner side wall of the woven mesh structure layer.

[0008] As a further improvement of the present invention, the hardness of the inner hard tube is higher than that of the outer hard tube, the woven mesh structure layer extends to the end of the outer hose away from the outer hard tube, and a step structure is provided at the end of the inner hard tube close to the outer hose.

[0009] As a further improvement of the present invention, the serpentine structure includes a plurality of serpentines, one end of the serpentine structure is arranged on the end face of the inner hard tube step structure, the thickness of the serpentine structure is smaller than the tube wall thickness of the inner hard tube, and the upper and lower curvatures of the serpentine structure are both greater than 280°.

[0010] The present invention also provides a method for preparing a disposable flexible endoscope catheter. The production process of a disposable flexible endoscope catheter and the method for preparing the same in the present invention comprises the following steps: S1, preparation of an inner hard tube, S2, a braided mesh structure layer, S3, outer tube synthesis, and S4, a nested snake bone structure, wherein:

[0011] S1. Preparation of inner hard tube: firstly, the inner hard tube of the hard section of the soft endoscope catheter is formed in one step, and the two ends and the outer and inner sides of the inner hard tube are deburred;

[0012] S2, braided mesh structure layer: a braided mesh structure layer is arranged on the outer surface of the inner hard tube obtained in step S1, inner hard tube preparation, and the length of the braided mesh structure layer is greater than the length of the inner hard tube layer, so that a step is formed inside the hard section of the catheter;

[0013] S3, outer tube synthesis: preparing an outer tube combining an outer hard tube and an outer soft tube at one time, and bonding the outer tube as a whole to the outer surface of the braided mesh structure layer in step S2;

[0014] S4, nesting the snake-bone structure: in step S3, the outer tube synthesis, the snake-bone structure is embedded on the inner wall of the braided mesh structure layer inside the outer hose, and one end of the snake-bone structure is pressed against the step of the inner hard tube.

[0015] As a further improvement of the present invention, the inner layer hard tube prepared in step S1 of the present invention needs to be frosted on the outer surface and polished on the inner side of the inner layer hard tube before performing step S2, weaving the mesh structure layer.

[0016] As a further improvement of the present invention, in step S2 of the present invention, the length of the braided mesh structure layer is longer than the length of the inner hard tube, and the length of the braided mesh structure layer is the same as the length of the outer tube in step S3, outer tube synthesis.

[0017] As a further improvement of the present invention, in step S2 of the present invention, the woven mesh structure layer is any one of nylon steel wire fiber, pebax and fluoroplastic, and the woven mesh structure layer adopts a double-layer woven structure.

[0018] As a further improvement of the present invention, the preparation of the outer hard tube and the outer soft tube in step S3, outer tube synthesis, and the inner hard tube in step S1, inner hard tube preparation, are both prepared by extrusion molding devices.

[0019] As a further improvement of the present invention, in step S3 of the present invention, the outer tube in the outer tube synthesis can be prepared by directly bonding the outer hard tube and the outer soft tube or by using a soft-hard gradient form, and the length of the outer tube is the same as the length of the woven mesh structure layer.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] 1. The layered structure design of the flexible endoscope catheter in the present invention is that the hard tube section is divided into three layers, the inner tube layer has the highest hardness, the outer tube layer has the second highest hardness, and the woven wire mesh is embedded between the two layers. The front hose section only adopts a double-layer structure, and the inner tube layer is eliminated, so that the snake bone structure can be nested inside the front end of the hose at one time. The hard tube section is located between the inner tube layer and the wire mesh inside the wire mesh to form a step that can be used for nesting the snake bone joint and limiting and fixing, which can effectively increase the reliability and flexibility of the snake bone;

[0022] 2. The present invention adopts a one-step forming process for preparing the flexible endoscope catheter, and prepares the hard tube part of the flexible endoscope catheter first, so that the woven steel wire mesh of the hard tube section extends to the required length of the entire flexible endoscope catheter, eliminating the process of sleeve snake bones and spot welding in the early stage of the traditional process. The integral woven steel wire mesh greatly improves the structural strength of the flexible endoscope catheter;

[0023] 3. The outer tube in the present invention can be directly bonded and fixed by an outer hard tube and an outer soft tube, or prepared in a soft-hard gradient form, avoiding the instability of the traditional process of segmented fixation and then bonding, and also improving the smoothness of the outer surface of the soft endoscope catheter, ensuring the patient's comfort during surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic diagram of the overall structure of a disposable flexible endoscope catheter of the present invention;

[0025] Figure 2 The present invention is a preparation flow chart of a method for preparing a disposable flexible endoscope catheter.

[0026] In the figure: 1. hard tube end; 101. inner hard tube; 102. woven mesh structure layer; 103. outer hard tube; 2. soft tube end; 21. outer soft tube; 3. snake-bone structure. DETAILED DESCRIPTION

[0027] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0028] Example 1

[0029] See also Figure 1-2 The present invention provides the following technical solution: a disposable soft endoscope catheter, comprising a hard tube end 1 and a soft tube end 2, the hard tube end 1 comprising an inner hard tube 101, a woven mesh structure layer 102 and an outer hard tube 103, the outer surface of the inner hard tube 101 is provided with a woven mesh structure layer 102, and the outer surface of the woven mesh structure layer 102 is covered with an outer hard tube 103;

[0030] The hose end 2 includes an outer hose 21 , which is disposed at one end of the outer hard tube 103 . A snake-bone structure 3 is distributed inside the outer hose 21 , and the snake-bone structure 3 is embedded on the inner wall of the woven mesh structure layer 102 .

[0031] Preferably, the hardness of the inner hard tube 101 is higher than that of the outer hard tube 103 , the woven mesh structure layer 102 extends to the end of the outer hose 21 away from the outer hard tube 103 , and a step structure is formed at the end of the inner hard tube 101 close to the outer hose 21 .

[0032] Preferably, the serpentine structure 3 includes a plurality of serpentines, one end of the serpentine structure 3 is against the end face of the step structure of the inner hard tube 101, the thickness of the serpentine structure 3 is smaller than the tube wall thickness of the inner hard tube 101, and the upper and lower curvatures of the serpentine structure 3 are both greater than 280°.

[0033] The present invention also provides a method for preparing a disposable flexible endoscope catheter. The production process of a disposable flexible endoscope catheter and the method for preparing the same in the present invention comprises the following steps: S1, preparation of an inner hard tube, S2, a braided mesh structure layer, S3, outer tube synthesis, and S4, a nested snake bone structure, wherein:

[0034] S1. Preparation of inner hard tube: firstly, the inner hard tube 101 of the hard section of the flexible endoscope catheter is formed in one step, and the two ends and the outer and inner sides of the inner hard tube 101 are deburred;

[0035] S2, braided mesh structure layer: a braided mesh structure layer 102 is arranged on the outer surface of the inner hard tube 101 obtained in step S1, inner hard tube preparation, and the length of the braided mesh structure layer 102 is greater than the length of the inner hard tube 101, so that a step is formed inside the hard section of the catheter;

[0036] S3, outer tube synthesis: prepare an outer tube combining the outer hard tube 103 and the outer soft tube 21 at one time, and bond the outer tube to the outer surface of the braided mesh structure layer 102 in the braided mesh structure layer in step S2 by wrapping and bonding the outer tube as a whole;

[0037] S4, nested snake-bone structure: in step S3, outer tube synthesis, the snake-bone structure 3 is embedded on the inner wall of the woven mesh structure layer 102 inside the outer hose, and one end of the snake-bone structure 3 is pressed against the step of the inner hard tube 101.

[0038] Preferably, the inner layer hard tube 101 prepared in step S1, the inner layer hard tube in the present invention needs to be frosted on the outer surface before performing step S2, the woven mesh structure layer, to ensure that the surface of the inner layer hard tube 101 provides sufficient friction so that the woven mesh structure layer 102 can be better fixed on the outer surface of the inner layer hard tube 101, and the inner side surface of the inner layer hard tube 101 is polished at the same time.

[0039] Preferably, in step S2 of the present invention, the length of the braided mesh structure layer 102 is longer than the length of the inner hard tube 101, and the length of the braided mesh structure layer 102 is the same as the length of the outer tube in step S3, outer tube synthesis.

[0040] Preferably, in step S2 of the present invention, the woven mesh structure layer 102 is made of any one of nylon steel wire fiber, pebax and fluoroplastic, and the woven mesh structure layer 102 adopts a double-layer woven structure.

[0041] Preferably, in the present invention, the preparation of the outer layer hard tube 103 and the outer layer soft tube 21 in step S3, outer tube synthesis, and the inner layer hard tube 101 in step S1, inner layer hard tube preparation, are both prepared by an extrusion molding device.

[0042] Preferably, in step S3 of the present invention, the outer tube in the outer tube synthesis can be directly bonded and fixed by the outer hard tube 103 and the outer soft tube 21, and the length of the outer tube is the same as the length of the braided mesh structure layer.

[0043] Experimental test: 100 disposable flexible endoscope catheters processed by this process were selected and named A, and 100 disposable flexible endoscope catheters processed by traditional process were selected and named B. The diameter difference at the connection of the outer tube and the connection strength test were performed, and the following results were obtained:

[0044]

[0045] Table 1

[0046] Example 2

[0047] See also Figure 1-2 The present invention provides the following technical solution: a disposable soft endoscope catheter, comprising a hard tube end 1 and a soft tube end 2, the hard tube end 1 comprising an inner hard tube 101, a woven mesh structure layer 102 and an outer hard tube 103, the outer surface of the inner hard tube 101 is provided with a woven mesh structure layer 102, and the outer surface of the woven mesh structure layer 102 is covered with an outer hard tube 103;

[0048] The hose end 2 includes an outer hose 21 , which is disposed at one end of the outer hard tube 103 . A snake-bone structure 3 is distributed inside the outer hose 21 , and the snake-bone structure 3 is embedded on the inner wall of the woven mesh structure layer 102 .

[0049] Preferably, the hardness of the inner hard tube 101 is higher than that of the outer hard tube 103 , the woven mesh structure layer 102 extends to the end of the outer hose 21 away from the outer hard tube 103 , and a step structure is formed at the end of the inner hard tube 101 close to the outer hose 21 .

[0050] Preferably, the serpentine structure 3 includes a plurality of serpentines, one end of the serpentine structure 3 is against the end face of the step structure of the inner hard tube 101, the thickness of the serpentine structure 3 is smaller than the tube wall thickness of the inner hard tube 101, and the upper and lower curvatures of the serpentine structure 3 are both greater than 280°.

[0051] The present invention also provides a method for preparing a disposable flexible endoscope catheter. The production process of a disposable flexible endoscope catheter and the method for preparing the same in the present invention comprises the following steps: S1, preparation of an inner hard tube, S2, a braided mesh structure layer, S3, outer tube synthesis, and S4, a nested snake bone structure, wherein:

[0052] S1. Preparation of inner hard tube: firstly, the inner hard tube 101 of the hard section of the flexible endoscope catheter is formed in one step, and the two ends and the outer and inner sides of the inner hard tube 101 are deburred;

[0053] S2, braided mesh structure layer: a braided mesh structure layer 102 is arranged on the outer surface of the inner hard tube 101 obtained in step S1, inner hard tube preparation, and the length of the braided mesh structure layer 102 is greater than the length of the inner hard tube 101, so that a step is formed inside the hard section of the catheter;

[0054] S3, outer tube synthesis: prepare an outer tube combining the outer hard tube 103 and the outer soft tube 21 at one time, and bond the outer tube to the outer surface of the braided mesh structure layer 102 in the braided mesh structure layer in step S2 by wrapping and bonding the outer tube as a whole;

[0055] S4, nested snake-bone structure: in step S3, outer tube synthesis, the snake-bone structure 3 is embedded on the inner wall of the woven mesh structure layer 102 inside the outer hose, and one end of the snake-bone structure 3 is pressed against the step of the inner hard tube 101.

[0056] Preferably, the inner layer hard tube 101 prepared in step S1, the inner layer hard tube in the present invention needs to be frosted on the outer surface before performing step S2, the woven mesh structure layer, to ensure that the surface of the inner layer hard tube 101 provides sufficient friction so that the woven mesh structure layer 102 can be better fixed on the outer surface of the inner layer hard tube 101, and the inner side surface of the inner layer hard tube 101 is polished at the same time.

[0057] Preferably, in step S2 of the present invention, the length of the braided mesh structure layer 102 is longer than the length of the inner hard tube 101, and the length of the braided mesh structure layer 102 is the same as the length of the outer tube in step S3, outer tube synthesis.

[0058] Preferably, in step S2 of the present invention, the woven mesh structure layer 102 is made of any one of nylon steel wire fiber, pebax and fluoroplastic, and the woven mesh structure layer 102 adopts a double-layer woven structure.

[0059] Preferably, in the present invention, the preparation of the outer layer hard tube 103 and the outer layer soft tube 21 in step S3, outer tube synthesis, and the inner layer hard tube 101 in step S1, inner layer hard tube preparation, are both prepared by an extrusion molding device.

[0060] Preferably, in step S3 of the present invention, the outer tube in the outer tube synthesis can be prepared by the outer hard tube 103 and the outer soft tube 21 in a soft-hard gradient form, and the length of the outer tube is the same as the length of the braided mesh structure layer.

[0061] Experimental test: 100 disposable flexible endoscope catheters processed by this process were selected and named A, and 100 disposable flexible endoscope catheters processed by traditional process were selected and named B. The diameter difference at the connection of the outer tube and the connection strength test were performed, and the following results were obtained:

[0062]

[0063] Table 2

[0064] In the present invention, in combination with Table 1 and Table 2, the outer tube can be directly bonded and fixed by the outer hard tube and the outer soft tube, or prepared in a soft-hard gradient form. The soft endoscope catheter has a layered structure design, and the hard tube section is divided into a three-layer structure. The inner hard tube 101 has the highest hardness, and the outer hard tube 103 has the second highest hardness. The woven mesh structure layer 102 is embedded between the inner hard tube 101 and the outer hard tube 103, and the soft tube end 2 adopts a double-layer structure, eliminating the inner tube layer, so as to facilitate the one-time nesting of the snake bone structure 3 inside the front end of the soft tube, and the hard tube end 1 is located between the inner hard tube 101 and the woven mesh structure layer 102 inside the woven mesh structure layer 102 to form a step that can be used for nesting the snake bone structure 3 and limiting fixation. The reliability and flexibility of the snake bone can be effectively increased. Through the one-time molding preparation process of the soft endoscope catheter, the inner hard tube 101 of the soft endoscope catheter is prepared in advance, so that the woven mesh structure layer 102 of the hard tube end 1 extends to the required length of the entire soft endoscope catheter, eliminating the process of sleeve snake bones and spot welding in the early stage of the traditional process. The integral woven wire mesh greatly improves the structural strength of the soft endoscope catheter. The outer tube can be directly bonded and fixed by the outer hard tube 103 and the outer soft tube 21 or prepared in a soft-hard gradient form, avoiding the instability of the traditional process of segmented fixation and then bonding, and also improving the smoothness of the outer surface of the soft endoscope catheter, ensuring the comfort of the patient during surgery.

[0065] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0066] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A disposable flexible endoscope catheter, comprising a hard tube end (1) and a soft tube end (2), characterized in that: The hard tube end (1) comprises an inner hard tube (101), a woven mesh structure layer (102) and an outer hard tube (103); the outer surface of the inner hard tube (101) is provided with the woven mesh structure layer (102), and the outer surface of the woven mesh structure layer (102) is provided with the outer hard tube (103); The hose end (2) comprises an outer hose (21), the outer hose (21) being arranged at one end of the outer hard tube (103), a snake-bone structure (3) being arranged inside the outer hose (21), and the snake-bone structure (3) being arranged on the inner side wall of the woven mesh structure layer (102); The woven mesh structure layer (102) extends to an end of the outer layer hose (21) away from the outer layer hard tube (103), and an end of the inner layer hard tube (101) close to the outer layer hose (21) is provided with a step structure; One end of the snake-bone structure (3) is arranged on the end surface of the step structure of the inner layer hard tube (101); The woven mesh structure layer (102) is any one of nylon steel wire fiber, pebax and fluoroplastic, and the woven mesh structure layer (102) adopts a double-layer woven structure.

2. A disposable flexible endoscope catheter according to claim 1, characterized in that: The hardness of the inner layer hard tube (101) is higher than the hardness of the outer layer hard tube (103).

3. A disposable flexible endoscope catheter according to claim 2, characterized in that: The snake bone structure (3) comprises a plurality of snake bones, the thickness of the snake bone structure (3) is smaller than the wall thickness of the inner layer hard tube (101), and the upper curvature and the lower curvature of the snake bone structure (3) are both greater than 280°.

4. The method for preparing a disposable flexible endoscope catheter according to claim 1, characterized in that: The following steps are involved: S1, preparation of inner hard tube, S2, woven mesh structure layer, S3, outer tube synthesis and S4, nested snake bone structure, wherein: S1. Preparation of the inner hard tube: firstly, the inner hard tube (101) of the hard section of the flexible endoscope catheter is formed in one step, and the two ends and the outer and inner sides of the inner hard tube (101) are deburred; S2, braided mesh structure layer: a braided mesh structure layer (102) is arranged on the outer surface of the inner hard tube (101) obtained in step S1, inner hard tube preparation, and the length of the braided mesh structure layer (102) is greater than the length of the inner hard tube (101), so that a step is formed inside the hard section of the catheter; S3, outer tube synthesis: an outer tube composed of an outer hard tube (103) and an outer soft tube (21) is prepared at one time, and the outer tube is integrally wrapped and bonded to the outer surface of the braided mesh structure layer (102) in the braided mesh structure layer in step S2; S4, nesting the snake-bone structure: in step S3, the outer tube synthesis, the snake-bone structure (3) is embedded on the inner wall of the woven mesh structure layer (102) inside the outer layer hose (21), and one end of the snake-bone structure (3) is pressed against the step of the inner layer hard tube (101); In step S2, the length of the braided mesh structure layer (102) is longer than the length of the inner hard tube (101), and the length of the braided mesh structure layer (102) is the same as the length in step S3, the outer tube synthesis.

5. The method for preparing a disposable flexible endoscope catheter according to claim 4, characterized in that: The inner layer hard tube (101) prepared in step S1, inner layer hard tube, needs to be frosted on the outer surface and polished on the inner side of the inner layer hard tube (101) before step S2, weaving the mesh structure layer.

6. The method for preparing a disposable flexible endoscope catheter according to claim 4, characterized in that: The preparation of the outer layer hard tube (103) and the outer layer soft tube (21) in step S3, outer tube synthesis, and the preparation of the inner layer hard tube (101) in step S1, inner layer hard tube preparation are both prepared by an extrusion molding device.

7. The method for preparing a disposable flexible endoscope catheter according to claim 4, characterized in that: In step S3, the outer tube synthesis, the outer tube can be prepared by directly bonding the outer hard tube (103) and the outer soft tube (21) together or by using a soft-hard gradient form, and the length of the outer tube is the same as the length of the braided mesh structure layer.

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