Guiding sheath

Abstract

The present invention provides a guiding sheath tube, which includes a first sheath tube, being in a hollow tubular shape and made of a flexible material; a second sheath tube, being in a hollow tubular shape, connected to the first sheath tube and made of a rigid material; and a locking structure, partially or entirely disposed outside the second sheath tube for locking the position of the second sheath tube in the human bronchus. In the guiding sheath tube, the first sheath tube is made of a flexible material, which can enable the guiding sheath tube to easily reach the target tissue position, and the second sheath tube is made of a rigid material, which can play a supporting role, thereby preventing the tissue sample from falling off and improving the sampling efficiency of the tissue sample.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a guiding sheath tube. Background Art

[0002] For a mass (such as bronchial cancer) or an inflamed interstitial lung disease in the surrounding lung tissue, it is necessary to obtain a tissue sample from the surrounding lung tissue to diagnose the patient's disease through the tissue sample. However, in the existing sampling devices, both the probe and the sheath tube are made of soft materials, and the soft materials can easily control the probe to reach the treatment or sampling tissue site.

[0003] Chinese Patent Invention No. CN103284775A discloses an intracranial thrombus removal device, including a thrombus removal system, a delivery and detachment system, a handle system, and a guiding sheath tube. The guiding sheath tube is made of the polymeric material polytetrafluoroethylene. It can be seen therefrom that the whole guiding sheath tube is made of one material. If biopsy sampling is performed through this type of guiding sheath tube, since the sheath tube is soft, the tissue sample is likely to easily fall off during the pulling process, resulting in low sampling efficiency or even failure.

[0004] Therefore, it is necessary to provide a new type of guiding sheath tube and a method for using the guiding sheath tube to solve the above problems existing in the prior art. Summary of the Invention

[0005] The purpose of the present invention is to provide a guiding sheath tube to improve the sampling efficiency of tissue samples.

[0006] To achieve the above purpose, the guiding sheath tube of the present invention includes:

[0007] A first sheath tube, which is in a hollow tubular shape and made of a flexible material;

[0008] A second sheath tube, which is in a hollow tubular shape, connected to the distal end of the first sheath tube, and made of a rigid material;

[0009] A locking structure, which is partially or entirely arranged outside the second sheath tube and used to lock the position of the second sheath tube in the human bronchus.

[0010] The beneficial effect of the present invention is that: the first sheath tube is made of a flexible material, which can make the guiding sheath tube easily reach the target tissue position, and the second sheath tube is made of a rigid material, which can play a supporting role, thereby avoiding the tissue sample from falling off and improving the sampling efficiency of the tissue sample.

[0011] Preferably, the first sheath tube and the second sheath tube are adhesively bonded or fused to each other.

[0012] Preferably, the second sheath tube includes:

[0013] A metal tube, which is in a hollow tubular shape;

[0014] The joint part is in the shape of a hollow tube, the outer wall of which is in contact with the inner wall of the metal tube and is connected to the first sheath tube. The beneficial effect is that the connection between the first sheath tube and the second sheath tube is facilitated.

[0015] Further preferably, the second sheath tube is made of a hard polymer material, and a developing ring is provided on the outer side of the second sheath tube away from the end of the first sheath tube, and the distance from the end of the second sheath tube away from the first sheath tube is 2-5 mm. The beneficial effect is that it is convenient for auxiliary imaging equipment to determine the position of the metal tube in the human body.

[0016] Further preferably, the length of the second sheath is 5-10 mm. The beneficial effect is that it can not only play a supporting role, but also prevent the guide sheath from being too long and making it difficult for the guide sheath to reach the target tissue position.

[0017] Further preferably, the length of the joint portion in the metal tube is 2-7 mm, which has the beneficial effect of preventing the metal tube from falling off the joint portion.

[0018] Further preferably, one end of the second sheath tube is a breach structure, and the breach structure is expanded to form a trumpet structure. Its beneficial effect is to reduce the resistance of the tissue sample entering the second sheath tube, and avoid the tissue sample falling off due to excessive resistance.

[0019] Further preferably, the breach structure comprises breaches, and the number of the breaches is 2-16.

[0020] Further preferably, the maximum inner diameter of the bell mouth structure is 0.05 mm to 1.5 mm larger than the minimum inner diameter. The beneficial effect is that it prevents the maximum inner diameter of the bell mouth structure from being too large and causing harm to the human body.

[0021] Further preferably, the guide sheath tube further comprises an outer sleeve, the outer sleeve is sleeved on the outside of the second sheath tube, and a control structure is provided on the side of the outer sleeve away from the breach structure, the control structure is used to control the outer sleeve to slide on the outside of the second sheath tube to control the breach structure to expand or contract. The beneficial effect is that the breach structure is assisted to achieve the contraction and expansion of the breach structure.

[0022] Further preferably, the material of the breach structure is a memory alloy.

[0023] Preferably, the guide sheath further comprises an air supply pipeline, and the air supply pipeline is arranged on the inner side or the outer side of the first sheath and the second sheath.

[0024] Further preferably, the locking structure includes an airbag, and at least one inflation port is provided on the airbag, and the inflation port is communicated with the air delivery pipeline. The beneficial effect is that: the airbag can play a role in fixing and canceling the fixation, and when bleeding occurs in the bronchus, the airbag can compress the blood vessel to play a role in hemostasis.

[0025] Further preferably, when the airbag is not inflated, its length is 5-10 mm. The beneficial effect is that: it can play a role in fixing and avoid damaging the human bronchus due to excessive volume.

[0026] Preferably, continuous scale lines are provided on the outer sides of the first sheath tube and the second sheath tube along the length direction. The beneficial effect is that: it is convenient to determine the lengths of the first sheath tube and the second sheath tube extending into the human bronchus.

[0027] The present invention also provides a method for using a guiding sheath tube, including the following steps:

[0028] S1: Insert the guiding sheath tube into the working channel of the endoscope;

[0029] S2: Observe the human bronchus through the endoscope and extend the guiding sheath tube to the target position in the human bronchus;

[0030] S3: Lock the position of the guiding sheath tube relative to the human bronchus through the locking structure;

[0031] S4: Connect a sampling instrument into the guiding sheath tube for sampling. The beneficial effect is that: it avoids the tissue sample from falling off and improves the sampling efficiency of the tissue sample. Description of the Drawings

[0032] Figure 1 It is a schematic structural diagram of the guiding sheath tube of the present invention;

[0033] Figure 2 It is a schematic structural diagram of the guiding sheath tube in some other embodiments of the present invention;

[0034] Figure 3 It is a schematic structural diagram of the second sheath tube of the present invention;

[0035] Figure 4 It is a schematic diagram of the guiding sheath tube when the break structure is not expanded in some embodiments of the present invention;

[0036] Figure 5 It is a schematic diagram of the guiding sheath tube when the break structure is expanded in some embodiments of the present invention;

[0037] Figure 6 It is a schematic structural diagram of the non-inflated airbag on the second sheath tube of the present invention;

[0038] Figure 7 Schematic diagram of the inflated balloon on the second sheath tube of the present invention;

[0039] Figure 8 Flow chart of the usage method of the guiding sheath tube of the present invention. Detailed implementation manners

[0040] To make the objectives, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention. Unless otherwise defined, the technical terms or scientific terms used herein shall have the ordinary meanings understood by those of ordinary skill in the art in the field to which the present invention belongs. The words such as "including" used herein mean that the elements or objects appearing before the word cover the elements or objects listed after the word and their equivalents, without excluding other elements or objects.

[0041] In view of the problems existing in the prior art, embodiments of the present invention provide a guiding sheath tube. Referring to Figure 1 , the guiding sheath tube 10 includes:

[0042] A first sheath tube 11, which is in a hollow tubular shape and made of a flexible material;

[0043] A second sheath tube 12, which is in a hollow tubular shape, connected to the distal end of the first sheath tube 11 and made of a rigid material;

[0044] A locking structure 13, partially disposed outside the second sheath tube 12, for locking the position of the second sheath tube 12 in the human bronchus.

[0045] Figure 2 Schematic diagram of the guiding sheath tube in some other embodiments of the present invention. Referring to Figure 2 , the guiding sheath tube 10 includes:

[0046] A first sheath tube 11, which is in a hollow tubular shape and made of a flexible material;

[0047] A second sheath tube 12, which is in a hollow tubular shape, connected to the first sheath tube 11 and made of a rigid material;

[0048] A locking structure 13, entirely disposed outside the second sheath tube 12, for locking the position of the second sheath tube 12 in the human bronchus.

[0049] The rigid material referred to in the present invention has a modulus of elasticity greater than or equal to 6.11 N / mm 2For the material, the flexible material referred to in the present invention has an elastic modulus less than 6.11 N / mm 2 of the material.

[0050] In some embodiments of the present invention, the materials of the first sheath tube and the second sheath tube are both medical plastics.

[0051] In some preferred embodiments of the present invention, referring to Figure 1 , scale lines are provided on the outer sides of the first sheath tube and the second sheath tube, which are distributed along the length direction and are continuous.

[0052] In some embodiments of the present invention, the first sheath tube and the second sheath tube are connected by bonding or fusing.

[0053] Figure 3 is a schematic structural diagram of the second sheath tube in some embodiments of the present invention. Referring to Figure 3 , the second sheath tube 12 includes:

[0054] A metal tube 121, which is in a hollow tubular shape;

[0055] A joint part 122, which is in a hollow tubular shape, the outer wall of which fits against the inner wall of the metal tube 122 and is connected to the first sheath tube (not marked in the figure).

[0056] In some preferred embodiments of the present invention, referring to Figure 1 , Figure 2 and Figure 3 , the second sheath tube 12 is made of a rigid polymer material, and a developing ring 123 is provided on the outer side of the end of the second sheath tube 12 away from the first sheath tube 11, and the distance from the port of the end of the second sheath tube 12 away from the first sheath tube 11 is 2 - 5 mm, which is convenient for assisting imaging equipment to determine the position of the second sheath tube 12 in the human body.

[0057] In some embodiments of the present invention, the length of the second sheath tube is 5 - 10 mm. Preferably, the length of the joint part located inside the metal tube is 2 - 7 mm.

[0058] In some preferred embodiments of the present invention, the length of the second sheath tube is 5 mm, and the length of the joint part located inside the metal tube is 2 mm.

[0059] In some preferred embodiments of the present invention, the length of the second sheath tube is 7 mm, and the length of the joint part located inside the metal tube is 4 mm.

[0060] In some preferred embodiments of the present invention, the length of the second sheath tube is 9 mm, and the length of the joint part located inside the metal tube is 6 mm.

[0061] In some preferred embodiments of the present invention, the length of the second sheath is 10 mm, and the length of the joint portion located within the metal tube is 7 mm.

[0062] Figure 4 Schematic diagram of the guiding sheath when the break structure is not expanded in some embodiments of the present invention. Refer to Figure 3 , one end of the second sheath 12 has a break structure 125, the break structure 125 includes a break 126, the number of the breaks 126 is 2 - 16, and the break is a slit. The guiding sheath further includes an outer sheath 124, the outer sheath 124 is sleeved on the outside of the second sheath 12, and the second sheath 12 can slide within the outer sheath 124.

[0063] In some specific embodiments of the present invention, the number of the breaks is one of 2, 5, 9, 12, and 16.

[0064] Figure 5 Schematic diagram of the guiding sheath after the break structure is expanded in some embodiments of the present invention. Refer to Figure 5 , the material of the break structure 125 is a shape memory alloy, specifically a nickel - titanium memory material. When the break structure extends out of the outer sheath 124, the break structure 125 expands to form a flared structure, and the minimum inner diameter of the flared structure is equal to the inner diameter of the middle section of the second sheath 12. Preferably, the maximum inner diameter of the flared structure is 0.05 - 1.5 mm larger than the minimum inner diameter. Among them, the maximum inner diameter of the flared structure is the inner diameter of the opening end, and the minimum inner diameter of the flared structure is the inner diameter of the end connected to the second sheath 12.

[0065] Refer to Figure 3 and Figure 5 , on the side of the outer sheath 124 away from the break structure, there is a control structure 127. The control structure 127 is used to control the sliding of the outer sheath 124 on the outside of the second sheath 12 to control the expansion or contraction of the break structure 125. Among them, the control structure 127 includes a first pushing part 1271, a second pushing part 1272, and a spring 1273. The first pushing part 1271 and the second pushing part 1272 are connected by the spring 1273. The first pushing part 1271 is fixed on the outside of the outer sheath 124, and the second pushing part 1272 is fixedly connected to the first sheath 11 through a connecting rod 1274. Preferably, the first pushing part 1271 and the second pushing part 1272 are annular.

[0066] In some preferred embodiments of the present invention, the maximum inner diameter of the flared structure is 0.05 mm larger than the minimum inner diameter.

[0067] In some preferred embodiments of the present invention, the maximum inner diameter of the flared structure is 0.25 mm larger than the minimum inner diameter.

[0068] In some preferred embodiments of the present invention, the maximum inner diameter of the flared structure is 0.5 mm larger than the minimum inner diameter.

[0069] In some preferred embodiments of the present invention, the maximum inner diameter of the flared structure is 0.75 mm larger than the minimum inner diameter.

[0070] In some preferred embodiments of the present invention, the maximum inner diameter of the flared structure is 1 mm larger than the minimum inner diameter.

[0071] In some preferred embodiments of the present invention, the maximum inner diameter of the flared structure is 1.25 mm larger than the minimum inner diameter.

[0072] In some preferred embodiments of the present invention, the maximum inner diameter of the flared structure is 1.5 mm larger than the minimum inner diameter.

[0073] In some preferred embodiments of the present invention, the maximum inner diameter of the flared structure is 3 - 4 mm, the maximum inner diameter of the first sheath tube and the second sheath tube is 2.3 mm, and the maximum outer diameter of the first sheath tube and the second sheath tube is 2.95 mm.

[0074] In some embodiments of the present invention, the first sheath tube includes a handheld end, and an operating rod is provided on the handheld end. The operating rod is used to stretch the break structure so that the break structure faces the outside of the second sheath tube, thereby enlarging the opening size at one end of the second sheath tube to facilitate the entry of tissue samples into the second sheath tube.

[0075] Figure 6 It is a schematic structural diagram of an uninflated airbag on the second sheath tube in some embodiments of the present invention. Refer to Figure 6 , the locking structure (not labeled in the figure) includes an airbag 131. At least one inflation port 132 is provided on the airbag 131. The inflation port (not labeled in the figure) is connected to the gas transmission pipeline (not labeled in the figure). Among them, the gas transmission pipeline is arranged inside or outside the first sheath tube (not labeled in the figure) and the second sheath tube 12. Specifically, when the airbag 131 is not inflated, its length is 5 - 10 mm and it adheres to the outer wall of the second sheath tube 12. The airbag 131 can play a role in fixing and canceling fixation, and when bleeding occurs in the bronchus, the airbag 131 can compress blood vessels to play a role in hemostasis.

[0076] In some preferred embodiments of the present invention, when the gas transmission pipeline is arranged inside the first sheath and the second sheath, the inflation port is arranged on the fitting wall of the airbag and the second sheath and penetrates through the second sheath. More preferably, a protective layer is arranged on the outer side of the gas transmission pipeline, the protective layer covers the outer side of the gas transmission pipeline, and is seamlessly connected with the inner walls of the first sheath and the second sheath.

[0077] In some preferred embodiments of the present invention, when the gas transmission pipeline is arranged outside the first sheath and the second sheath, the inflation port is arranged on the side of the airbag facing the first sheath. More preferably, a protective layer is arranged on the outer side of the gas transmission pipeline, the protective layer covers the outer side of the gas transmission pipeline, and is seamlessly connected with the outer walls of the first sheath and the second sheath.

[0078] Figure 7 It is a schematic structural diagram of an inflated airbag on the second sheath in some embodiments of the present invention. Refer to Figure 7 , when the airbag 131 is inflated, it expands to form an oval or a circle outside the second sheath 12, and the outer wall of the airbag 131 presses against the human bronchial wall, thus playing a role in fixing the second sheath 12.

[0079] Figure 8 It is a flowchart of the usage method of the guiding sheath in some embodiments of the present invention. Refer to Figure 8 , the usage method of the guiding sheath includes the following steps:

[0080] S1: Insert the guiding sheath into the working channel of the endoscope;

[0081] S2: Observe the human bronchus through the endoscope and extend the guiding sheath to the target position of the human bronchus;

[0082] S3: Lock the position of the guiding sheath relative to the human bronchus through the locking structure;

[0083] S4: Connect a sampling instrument into the guiding sheath for sampling.

[0084] Although the embodiments of the present invention have been described in detail above, it is obvious to those skilled in the art that various modifications and changes can be made to these embodiments. However, it should be understood that such modifications and changes all fall within the scope and spirit of the present invention as described in the claims. Moreover, the present invention described herein can have other embodiments and can be implemented or realized in various ways.

Claims

1. A guiding sheath tube, characterized in that, Comprising: A first sheath tube, which is a hollow tube made of a flexible material; A second sheath tube, which is a hollow tube, connected to the distal end of the first sheath tube and made of a rigid material. The first sheath tube and the second sheath tube are adhesively bonded or fused to each other; A locking structure, which is partially or entirely disposed outside the second sheath tube and is used to lock the position of the second sheath tube in the human bronchus; The second sheath tube includes: A metal tube, which is a hollow tube; A joint portion, which is a hollow tube. The outer wall of the joint portion fits against the inner wall of the metal tube and is connected to the first sheath tube; One end of the second sheath tube has a break structure, and after the break structure is expanded, it forms a flared structure; An outer sheath tube, which is sleeved outside the second sheath tube. A control structure is provided on a side of the outer sheath tube away from the break structure. The control structure is used to control the outer sheath tube to slide outside the second sheath tube so as to control the expansion or contraction of the break structure.

2. The guiding sheath according to claim 1, characterized in that, The second sheath tube is made of a hard polymer material, and a developing ring is provided on the outer side of the end of the second sheath tube away from the first sheath tube, and the distance from the port of the end of the second sheath tube away from the first sheath tube is 2 - 5 mm.

3. The guiding sheath according to claim 1, characterized in that, The length of the second sheath tube is 5 - 10 mm.

4. The guiding sheath according to claim 1, wherein The length of the joint portion located inside the metal tube is 2 - 7 mm.

5. The guiding sheath according to claim 1, wherein, The break structure includes breaks, and the number of breaks is 2 - 16.

6. The guiding sheath according to claim 1, characterized in that, The maximum inner diameter of the flared structure is 0.05 mm - 1.5 mm larger than the minimum inner diameter.

7. The guiding sheath according to claim 1, characterized in that, The material of the break structure is a shape memory alloy.

8. The guiding sheath according to claim 1, characterized in that, It further includes a gas transmission pipeline, and the gas transmission pipeline is disposed inside or outside the first sheath tube and the second sheath tube.

9. The guiding sheath according to claim 8, characterized in that, The locking structure includes an airbag, and at least one inflation port is provided on the airbag. The inflation port is communicated with the gas transmission pipeline.

10. The guiding sheath according to claim 9, characterized in that, The length of the airbag when not inflated is 5 - 10 mm.

11. The guiding sheath according to claim 1, characterized in that, Continuous scale lines are provided on the outer sides of the first sheath tube and the second sheath tube along the length direction.

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