Disclosure of Invention
The invention aims to provide a guiding sheath tube which improves the sampling efficiency of a tissue sample.
To achieve the above object, the guide sheath of the present invention includes:
a first sheath tube which is hollow and tubular and is made of flexible materials;
A second sheath tube which is hollow and tubular, is connected with the distal end of the first sheath tube, and is made of rigid material;
and the locking structure is partially or completely arranged outside the second sheath tube and used for locking the position of the second sheath tube in the bronchus of the human body.
The invention has the beneficial effects that the first sheath tube is made of flexible materials, so that the guiding sheath tube can easily reach the target tissue position, and the second sheath tube is made of rigid materials, so that the supporting effect can be realized, the falling-off of a tissue sample is avoided, and the sampling efficiency of the tissue sample is improved.
Preferably, the first sheath and the second sheath are bonded or fused to each other.
Preferably, the secondary sheath comprises:
A metal tube which is hollow and tubular;
the joint part is hollow and tubular, and the outer wall is attached to the inner wall of the metal tube and is connected with the first sheath tube. The connecting device has the beneficial effects that the connection of the first sheath tube and the second sheath tube is convenient to realize.
Further preferably, the second sheath is made of a hard polymer material, a developing ring is arranged on the outer side of one end, far away from the first sheath, of the second sheath, and the distance from the end port, far away from the first sheath, of the second sheath is 2-5mm. The metal tube positioning device has the beneficial effects that the positioning device is convenient for assisting the image equipment to determine the position of the metal tube in the human body.
Further preferably, the length of the secondary sheath is 5-10mm. The guiding sheath has the beneficial effects of not only playing a supporting role, but also avoiding the situation that the guiding sheath is not easy to reach the target tissue position due to overlong length.
It is further preferred that the length of the joint located within the metal tube is 2-7mm. The metal pipe has the beneficial effect of preventing the metal pipe from falling off from the joint part.
Further preferably, one end of the second sheath tube is in a break structure, and the break structure forms a horn mouth structure after being spread. The secondary sheath tube has the beneficial effects that the resistance of the tissue sample entering the secondary sheath tube is reduced, and the falling-off of the tissue sample caused by overlarge resistance is avoided.
Further preferably, the break structure comprises breaks, and the number of the breaks is 2-16.
Further preferably, the maximum inner diameter of the bell mouth structure is 0.05mm to 1.5mm larger than the minimum inner diameter. The horn mouth structure has the beneficial effects that the damage to human bodies caused by the overlarge maximum inner diameter of the horn mouth structure is avoided.
Still preferably, the guiding sheath further comprises an outer sleeve, the outer sleeve is sleeved on the outer side of the second sheath, a control structure is arranged on one side, away from the break structure, of the outer sleeve, and the control structure is used for controlling the outer sleeve to slide on the outer side of the second sheath so as to control the break structure to open or contract. The beneficial effects are that the opening structure is assisted, and the contraction and the expansion of the opening structure are realized.
Further preferably, the material of the break structure is a memory alloy.
Preferably, the guiding sheath further comprises a gas pipeline, and the gas pipeline is arranged on the inner side or the outer side of the first sheath and the second sheath.
Further preferably, the locking structure comprises an air bag, at least one air charging port is arranged on the air bag, and the air charging port is communicated with the air transmission pipeline. The hemostatic balloon has the advantages that the balloon can play a role in fixing and canceling the fixing, and can press blood vessels to play a role in hemostasis when bleeding occurs in bronchus.
Further preferably, the length of the balloon is 5-10mm when not inflated. The fixing device has the beneficial effects of being capable of playing a role in fixing and avoiding damage to bronchus of a human body caused by overlarge volume.
Preferably, the outer sides of the first sheath tube and the second sheath tube are provided with graduation marks which are distributed and continuous along the length direction. The method has the beneficial effects that the length of the first sheath tube and the second sheath tube stretching into the bronchus of a human body can be conveniently determined.
The invention also provides a use method of the guiding sheath, which comprises the following steps:
s1, inserting the guiding sheath tube into a working channel of an endoscope;
s2, observing the bronchus of the human body through the endoscope, and extending the guiding sheath tube into a target position of the bronchus of the human body;
s3, locking the position of the guiding sheath tube relative to the bronchus of the human body through the locking structure;
And S4, a sampling instrument is connected into the guiding sheath tube for sampling. The tissue sampling device has the beneficial effects that the tissue sample is prevented from falling off, and the sampling efficiency of the tissue sample is improved.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the present invention more apparent, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention. Unless otherwise defined, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. As used herein, the word "comprising" and the like means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof without precluding other elements or items.
In view of the problems of the prior art, an embodiment of the present invention provides an introducer sheath, referring to fig. 1, the introducer sheath 10 includes:
the primary sheath 11 is hollow and tubular and is made of flexible materials;
a second sheath 12 having a hollow tubular shape, connected to the distal end of the first sheath 11, and made of a rigid material;
And a locking structure 13, which is partially arranged outside the second sheath 12 and is used for locking the position of the second sheath 12 in the bronchus of the human body.
Fig. 2 is a schematic view of the structure of a guiding sheath according to still another embodiment of the present invention. Referring to fig. 2, the guide sheath 10 includes:
the primary sheath 11 is hollow and tubular and is made of flexible materials;
a second sheath 12 having a hollow tubular shape, connected to the first sheath 11, and made of a rigid material;
and locking structures 13 which are all arranged outside the second sheath 12 and are used for locking the position of the second sheath 12 in the bronchus of the human body.
The rigid material is a material with the elastic modulus being more than or equal to 6.11N/mm2, and the flexible material is a material with the elastic modulus being less than 6.11N/mm2.
In some embodiments of the invention, the material of the first sheath and the second sheath are both medical grade plastics.
In some preferred embodiments of the present invention, referring to fig. 1, the outer sides of the first sheath tube and the second sheath tube are provided with graduation marks which are distributed along the length direction and are continuous.
In some embodiments of the invention, the first sheath and the second sheath are connected by means of adhesion or fusion.
Fig. 3 is a schematic structural view of a secondary sheath according to some embodiments of the present invention. Referring to fig. 3, the secondary sheath 12 includes:
a metal pipe 121 having a hollow tubular shape;
The joint 122 is hollow and tubular, and the outer wall is attached to the inner wall of the metal tube 122 and connected to the primary sheath (not shown).
In some preferred embodiments of the present invention, referring to fig. 1, 2 and 3, the second sheath 12 is made of a hard polymer material, a developing ring 123 is disposed on the outer side of the end of the second sheath 12 away from the first sheath 11, and the distance between the second sheath 12 and the end of the second sheath 12 away from the first sheath 11 is 2-5mm, so as to facilitate the auxiliary imaging device to determine the position of the second sheath 12 in the human body.
In some embodiments of the invention, the length of the secondary sheath is 5-10mm. Preferably, the length of the joint located in the metal tube is 2-7mm.
In some preferred embodiments of the invention, the length of the secondary sheath is 5mm and the length of the junction within the metal tube is 2mm.
In some preferred embodiments of the invention, the length of the secondary sheath is 7mm and the length of the junction within the metal tube is 4mm.
In some preferred embodiments of the invention, the length of the secondary sheath is 9mm and the length of the junction within the metal tube is 6mm.
In some preferred embodiments of the invention, the length of the secondary sheath is 10mm and the length of the junction within the metal tube is 7mm.
Fig. 4 is a schematic view of an introducer sheath with a breach structure not being deployed in some embodiments of the invention. Referring to fig. 3, one end of the secondary sheath 12 is provided with a breach structure 125, and the breach structure 125 includes a number of breaches 126, that is, slits, from 2 to 16 breaches 126. The guiding sheath further comprises an outer sleeve 124, the outer sleeve 124 is connected to the outer side of the second sheath 12, and the second sheath 12 can slide in the outer sleeve 124.
In some embodiments of the invention, the number of breaks is one of 2, 5, 9, 12 and 16.
Fig. 5 is a schematic view of the introducer sheath after the breach structure has been deployed in some embodiments of the invention. Referring to fig. 5, the material of the breach structure 125 is a memory alloy, specifically a nickel-titanium memory material, when the breach structure extends out of the outer sleeve 124, the breach structure 125 is opened to form a bell mouth structure, and the minimum inner diameter of the bell mouth structure is equal to the inner diameter of the middle section of the second sheath 12. Preferably, the maximum inner diameter of the bell mouth structure, i.e. the inner diameter of the open end, is 0.05-1.5mm larger than the minimum inner diameter of the bell mouth structure, i.e. the inner diameter of the end connected to the secondary sheath 12.
Referring to fig. 3 and 5, a control structure 127 is disposed on a side of the outer sleeve 124 away from the breach structure, and the control structure 127 is used for controlling the outer sleeve 124 to slide outside the second sheath 12, so as to control the breach structure 125 to open or contract. The control structure 127 includes a first pushing portion 1271, a second pushing portion 1272, and a spring 1273, wherein the first pushing portion 1271 and the second pushing portion 1272 are connected by the spring 1273, the first pushing portion 1271 is fixed on the outer side of the outer sleeve 124, and the second pushing portion 1272 is fixedly connected with the first sheath 11 by a connecting rod 1274. Preferably, the first pushing part 1271 and the second pushing part 1272 are ring-shaped.
In some preferred embodiments of the invention, the maximum inner diameter of the flare structure is 0.05mm greater than the minimum inner diameter.
In some preferred embodiments of the invention, the maximum inner diameter of the flare structure is 0.25mm greater than the minimum inner diameter.
In some preferred embodiments of the invention, the maximum inner diameter of the flare structure is 0.5mm greater than the minimum inner diameter.
In some preferred embodiments of the invention, the maximum internal diameter of the flare structure is 0.75mm greater than the minimum internal diameter.
In some preferred embodiments of the invention, the maximum inner diameter of the flare structure is 1mm greater than the minimum inner diameter.
In some preferred embodiments of the invention, the maximum inner diameter of the flare structure is 1.25mm greater than the minimum inner diameter.
In some preferred embodiments of the invention, the maximum inner diameter of the flare structure is 1.5mm greater than the minimum inner diameter.
In some preferred embodiments of the present invention, the maximum inner diameter of the bell mouth structure is 3-4mm, the maximum inner diameters of the first and second sheaths are 2.3mm, and the maximum outer diameters of the first and second sheaths are 2.95mm.
In some embodiments of the present invention, the first sheath includes a holding end, and an operation rod is disposed on the holding end, and is used for stretching the breach structure, so that the breach structure faces to the outer side of the second sheath, and the opening size at one end of the second sheath is oversized, so that a tissue sample can conveniently enter the second sheath.
FIG. 6 is a schematic illustration of an uninflated balloon on a secondary sheath in some embodiments of the invention. Referring to fig. 6, the locking structure (not shown) includes an air bag 131, at least one air charging port 132 is provided on the air bag 131, and the air charging port (not shown) is connected to the air pipe (not shown), where the air pipe is disposed inside or outside the first sheath tube (not shown) and the second sheath tube 12. Specifically, the length of the balloon 131 is 5-10mm when not inflated, and is attached to the outer wall of the secondary sheath 12. The balloon 131 can play a role in fixation and cancellation, and the balloon 131 can press a blood vessel to play a role in hemostasis when bleeding occurs in a bronchus.
In some preferred embodiments of the present invention, when the gas delivery pipe is disposed inside the first sheath pipe and the second sheath pipe, the gas charging port is disposed on an adhesion wall between the balloon and the second sheath pipe, and penetrates the second sheath pipe. More preferably, a protective layer is arranged on the outer side of the gas pipeline, and the protective layer covers the outer side of the gas pipeline and is in seamless connection with the inner walls of the first sheath pipe and the second sheath pipe.
In some preferred embodiments of the present invention, when the gas delivery conduit is disposed outside of the first sheath tube and the second sheath tube, the inflation port is disposed on a side of the balloon facing the first sheath tube. More preferably, a protective layer is arranged on the outer side of the gas transmission pipeline, and the protective layer covers the outer side of the gas transmission pipeline and is in seamless connection with the outer walls of the first sheath pipe and the second sheath pipe.
FIG. 7 is a schematic illustration of an inflated balloon on a secondary sheath in some embodiments of the invention. Referring to fig. 7, the balloon 131 is inflated to form an oval or circular shape at the outer side of the secondary sheath 12, and the outer wall of the balloon 131 presses against the wall of the human body bronchus to fix the secondary sheath 12.
Fig. 8 is a flow chart of a method of using an introducer sheath in some embodiments of the invention. Referring to fig. 8, the method of using the guiding sheath includes the steps of:
s1, inserting the guiding sheath tube into a working channel of an endoscope;
s2, observing the bronchus of the human body through the endoscope, and extending the guiding sheath tube into a target position of the bronchus of the human body;
s3, locking the position of the guiding sheath tube relative to the bronchus of the human body through the locking structure;
And S4, a sampling instrument is connected into the guiding sheath tube for sampling.
While embodiments of the present invention have been described in detail hereinabove, it will be apparent to those skilled in the art that various modifications and variations can be made to these embodiments. It is to be understood that such modifications and variations are within the scope and spirit of the present invention as set forth in the following claims. Moreover, the invention described herein is capable of other embodiments and of being practiced or of being carried out in various ways.