Sheath tube for biopsy sampling under breast duct endoscope and breast biopsy device comprising sheath tube

Abstract

The sheathing canal comprises an outer sheathing canal body and an inner sheathing canal body, the outer sheathing canal body comprises an outer tube body and a first tube head, the outer tube body is of a hollow structure, one end of the outer tube body is provided with an opening and closing petal type clamping jaw, the other end of the outer tube body is connected with the first tube head, and the inner sheathing canal body is connected with the inner sheathing canal body. The inner-layer sheath tube comprises an inner-layer tube body of a hollow structure and a second tube head, one end of the inner-layer tube body is a free end, the other end of the inner-layer tube body is connected with the second tube head, the free end of the inner-layer tube body can be inserted into the outer-layer tube body from one end of the first tube head and can move back and forth, and the free end of the inner-layer tube body can eject open the opening and closing petals of the clamping jaws in the inward moving process; the opening and closing petals of the clamping jaw are in a closed state under the condition that no external force exists, and can recover to the original state under the condition that the external force is removed. The sheathing canal structure is installed in the breast biopsy device, automatic sampling can be achieved, damage to tissue is reduced, and sampling accuracy and sample quality are improved.

Description

Technical Field

[0001] The utility model belongs to the technical field of breast biopsy devices, and particularly relates to a sheath tube used for biopsy sampling under a breast ductoscope and a breast biopsy device comprising the sheath tube. Background Art

[0002] Breast biopsy is an important diagnostic tool used to detect abnormal cells or tumors in breast tissue. Existing biopsy methods use ultrasound guidance to sample diseased tissue, which can damage surrounding tissue during the sampling process or be imprecise when extracting samples, leading to insufficient or contaminated samples. Other endoscopic biopsy sheaths use welded traction wires. Due to the limited space inside the milk duct, the traction wires must be extremely thin, and the welds are extremely small. The strength of the welds is far lower than the force that can bend the sheath for sampling. Therefore, it is necessary to design a sheath that can automatically perform biopsy sampling under a ductoscope. Utility Model Content

[0003] Purpose of the utility model: In order to solve the defects of the prior art, the utility model provides a sheath for ductoscopy biopsy sampling and a breast biopsy device including the sheath.

[0004] Technical solution: To achieve the above purpose, the present invention adopts the following technical solution:

[0005] A sheath for endoscopic biopsy sampling of the breast duct, the sheath comprising an outer sheath and an inner sheath, the outer sheath comprising an outer tube body with a hollow structure and a first tube head, one end of the outer tube body being provided with an opening and closing flap-type clamping claw, and the other end being connected to the first tube head, the inner sheath comprising an inner tube body with a hollow structure and a second tube head, one end of the inner tube body being a free end, and the other end being connected to the second tube head, the free end of the inner tube body being able to be inserted into the interior of the outer tube body from one end of the first tube head and being able to move back and forth, and being able to push open the opening and closing flap of the clamping claw during the inward movement; the opening and closing flap of the clamping claw being in a closed state in the absence of external force, and being able to restore to its original state when the external force is removed.

[0006] As a specific implementation scheme, the outer tube body is made of a shape memory alloy, preferably a nickel-titanium alloy.

[0007] As a specific implementation scheme, the number of the jaw opening and closing petals is 3-6.

[0008] As a specific implementation scheme, one end of the first tube head is connected to the outer tube body, and the outer wall of the other end is provided with a pressing part, which is preferably selected from a nut.

[0009] As a specific embodiment, one end of the second tube head is connected to the inner tube body, which is called the front end, and the other end is provided with a connecting portion, which is called the rear end. The tube body of the second tube head is divided into two sections with different outer diameters. The outer diameter of the front tube body is smaller than the outer diameter of the rear end tube body. The front tube body can be inserted into the hollow structure of the first tube head, which facilitates the connection between the first and second tube heads and can avoid large eccentricity when the inner tube body is inserted into the outer tube body; the outer diameter of the rear end tube body of the second tube head is larger than the inner diameter of the hollow structure of the first tube head, which can avoid the second tube head from being inserted too long and difficult to remove. Preferably, the connecting portion is a Luer thread structure;

[0010] As a specific implementation scheme, one end of the second tube head connected to the inner tube body can be inserted into the hollow structure of the first tube head; preferably, a sealing ring is further provided on the inner wall of the first tube head.

[0011] As another embodiment, the front end tube body and the rear end tube body of the second tube head have the same or different outer diameters, and only the inner tube body can be inserted into the hollow structure and the outer tube body of the first tube head.

[0012] As a specific implementation scheme, the inner and outer diameters of the outer tube body are 0.75 mm and 0.85 mm; the inner and outer diameters of the inner tube body are 0.6 mm and 0.7 mm.

[0013] The utility model also provides a breast biopsy device, which comprises the above-mentioned sheath tube.

[0014] As a specific implementation scheme, it includes an outer sheath, an inner sheath, a handle tee, a length adjuster and a fiberscope, the free end of the inner tube body in the inner sheath is inserted into the outer tube body of the outer sheath from one end of the first tube head of the outer sheath, and can move back and forth, one end of the second tube head in the inner sheath is connected to one end of the handle tee, and the other end is inserted into the hollow structure of the first tube head, the inner sheath, the handle tee and the length adjuster are connected in sequence, and the fiberscope passes through the length adjuster, the handle tee, the inner sheath and the outer sheath in sequence.

[0015] The utility model device has the following characteristics:

[0016] 1) Sheath structure: The sheath is mainly made of memory alloy material, such as nickel-titanium material, and has a double-layer sheath structure. The inner sheath can push open the clamping claws at the end of the outer sheath to collect the diseased tissue. Since the opening and closing flaps of the clamping claws can return to their original state when the external force is removed, it is easy to control deformation and movement.

[0017] 2) Guiding system: The sheath structure is installed in the biopsy device and used under a ductoscope, so that the diseased tissue in the duct can be directly observed, and the sheath can be ensured to accurately reach the target sampling area.

[0018] 3) Sampling mechanism: Since the sheath is made of memory alloy, it has memory properties and can realize automatic sampling of the clamping claws without adjusting the bending wire.

[0019] Technical effect: Compared with the existing technology, when the sheath structure of the utility model is installed in the breast biopsy device, the clamping claws can automatically take samples, which can reduce damage to breast tissue, improve sampling accuracy and sample quality, simplify the doctor's operating procedures, and improve work efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a structural schematic diagram (perspective view) of the sheath tube of the utility model.

[0021] Figure 2 This is a diagram of the sheath tube of the utility model in use.

[0022] Figure 3 It is a structural schematic diagram of the breast biopsy device of the present utility model.

[0023] Among them, 1-outer sheath, 101-outer tube body, 1011-clamping claw, 102-first tube head, 1021-pressing part; 2-inner sheath, 201-inner tube body, 202-second tube head, 2021-connecting part; 3-handle tee, 4-length adjuster, 5-fiberscope, 6-lesioned tissue. DETAILED DESCRIPTION

[0024] The present invention will be further described below with reference to the accompanying drawings.

[0025] In the description of the present invention, it should be understood that if there are terms such as "upper", "lower", "left", "right", "top", "bottom", "inside", "outside", etc. indicating orientations or positional relationships, they are based on the orientations or positional relationships shown in the drawings. This is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the terms describing the positional relationship in the drawings are only used for illustrative purposes and cannot be understood as a limitation on this patent.

[0026] Example 1

[0027] A sheath for ductoscopy biopsy sampling, such as Figure 1 and Figure 2 As shown, the sheath tube includes an outer sheath tube 1 and an inner sheath tube 2 .

[0028] The outer sheath tube 1 includes a hollow outer tube body 101 and a first tube head 102. One end of the outer tube body 101 is provided with an open-closed petal-type clamping jaw 1011, and the other end is connected to the first tube head 102 (which can be connected by bonding). One end of the first tube head 102 is connected to the outer tube body 101, and the outer wall of the other end is provided with a clamping portion 1021, which is preferably selected from a nut. The number of open and close petals of the clamping jaw 1011 is 3-6. The open and close petals of the clamping jaw 1011 are closed in the absence of external force and can return to their original state when the external force is removed.

[0029] The inner sheath tube 2 includes an inner tube body 201 with a hollow structure and a second tube head 202. One end of the inner tube body 201 is a free end, and the other end is connected to the second tube head 202 (which can be connected by bonding). One end of the second tube head 202 is connected to the inner tube body 201, which is called the front end, and the other end is provided with a connecting portion 2021, which is called the rear end. The tube body of the second tube head 202 is divided into two sections with different outer diameters. The outer diameter of the front tube body is smaller than the outer diameter of the rear end tube body. The front tube body can be inserted into the hollow structure of the first tube head 102, which facilitates the connection between the first tube head 102 and the second tube head 202 and can avoid large eccentricity when the inner tube body 201 is inserted into the outer tube body 101; the outer diameter of the rear end tube body of the second tube head 202 is larger than the inner diameter of the hollow structure of the first tube head 102, which can avoid the second tube head 202 from being inserted too long and difficult to remove. Preferably, the connecting portion 2021 is a Luer thread structure.

[0030] Based on the above structure, the free end of the inner tube body 201 can be inserted into the interior of the outer tube body 101 from one end of the first tube head 102 and can move back and forth, and can push open the opening and closing petals of the clamping claw 1011 during the inward movement; the front end tube body of the second tube head 202 can be inserted into the hollow structure of the first tube head 102, and the inner wall of the first tube head 102 is also provided with a sealing ring, which is arranged at a position corresponding to the clamping part 1021. The clamping part 1021 can deform the sealing ring by squeezing it, thereby sealing the first tube head 102 and the inner tube body 201 (the inner tube body 201 can pass through the front end tube body of the second tube head 202).

[0031] Alternatively, as another embodiment, the front and rear ends of the second tube head 202 have the same or different outer diameters, and only the inner tube body 201 is inserted into the hollow structure of the first tube head 102 and the outer tube body 101. The sealing ring on the inner wall of the first tube head 102 contacts the inner tube body 201, and the pressing part 1021 can deform the sealing ring by squeezing it. When the inner tube body 201 slides back and forth in the outer tube body 101, sealing is achieved by relying on the cooperation between the inner tube body 201 and the sealing ring.

[0032] In order to achieve the above functions, the outer tube body 101 is made of a shape memory alloy, preferably a nickel-titanium alloy.

[0033] The inner and outer diameters of the outer tube 101 are 0.75 mm and 0.85 mm; the inner and outer diameters of the inner tube 201 are 0.6 mm and 0.7 mm.

[0034] Example 2

[0035] A breast biopsy device, comprising the sheath described in Example 1, such as Figure 3 As shown, the breast biopsy device includes an outer sheath 1, an inner sheath 2, a handle tee 3, a length adjuster 4 and a fiberscope 5. The free end of the inner tube body 201 in the inner sheath 2 is inserted into the outer tube body 101 of the outer sheath 1 from one end of the first tube head 102 of the outer sheath 1, and can move back and forth. One end of the second tube head 202 in the inner sheath 2 is connected to one end of the handle tee 3, and the other end is inserted into the hollow structure of the first tube head 102. The inner sheath 2, the handle tee 3 and the length adjuster 4 are connected in sequence. The fiberscope 5 passes through the length adjuster 4, the handle tee 3, the inner sheath 2 and the outer sheath 1 in sequence, and finally passes through the clamping claw 1011 of the outer sheath 1.

[0036] The specific design principle and working mode of the above-mentioned device of the utility model are as follows:

[0037] (1) Material selection

[0038] Nickel-titanium alloy is a shape-memory alloy that automatically returns to its original shape after plastic deformation at a specific temperature. It exhibits excellent plasticity, wear resistance, corrosion resistance, high damping, and superelasticity, making it a functional material that can meet the needs of various medical applications. Therefore, in the present invention, both the outer sheath 1 and the inner sheath 2 are made of nickel-titanium alloy, and the jaws 1011, in particular, are able to return to their original state upon removal of external force, automatically grasping diseased tissue.

[0039] (2) Product size

[0040] This sheath tube utilizes a dual-layer design: The outer sheath tube 1, with its outer tube body 101 laser-cut and shaped to a closed position, is formed by a process called laser cutting and shaping. The inner sheath tube 2, with its inner tube body 201, is a nickel-titanium tube. The outer tube body 1 has an inner and outer diameter of 0.75 x 0.85 mm, while the inner tube body 2 has an inner and outer diameter of 0.6 x 0.7 mm.

[0041] (3) Assembly method

[0042] 1) Insert the fiberscope main mirror 5 from the tail end of the length adjuster 4 and fix the length adjuster 4 on the main mirror support outer tube;

[0043] 2) Insert the assembled fiberscope main lens 5 through the middle channel of the handle tee 3, and connect the Luer thread at the front end of the length adjuster 4 to the Luer thread at the end of the middle channel of the handle tee 3;

[0044] 3) Insert the inner sheath 2 from the front end of the fiberscope main mirror 5, and connect the Luer thread at the rear end of the inner sheath 2 (the Luer thread on the connecting part 2021) and the Luer thread at the front end of the handle tee 3;

[0045] 4) After inserting the assembled fiberscope component from the tail of the outer sheath 1, tighten the nut (compression part 1021) at the tail of the outer sheath to compress the internal sealing ring, fix the outer sheath 1 and the fiberscope component relatively, and ensure that the outer sheath 1 can slide on the inner sheath 2 while ensuring a certain sealing performance.

[0046] (4) Operation steps: First, assemble the biopsy sheath device according to the assembly method, first adjust the position of the length adjuster 4 on the main mirror support outer tube, and expose the fiber mirror objective lens about 1mm long from the front end of the inner sheath tube 2; then adjust the front and rear position of the outer sheath tube 1 on the inner sheath tube 2, so that the front end of the inner sheath tube 2 is located inside the outer sheath tube 1, and the opening and closing flap of the clamping claw 1011 at the front end of the outer sheath tube 1 is in a closed state; then insert the adjusted device into the breast cavity for 10 to 20 mm, and then fix the outer sheath tube 1 relative to the human body, and move the remaining components of the device together along the outer sheath tube 2. The inner channel of the sheath tube 1 is pushed forward, and the free end of the inner tube body 201 in the inner sheath tube 2 is used to open the clamping claw 1011 at the front end of the outer sheath tube 1 to expose the objective lens of the fiberscope; when the diseased tissue is found during the intraoperative examination, the length adjuster 4 is adjusted to retract the main mirror 5 of the fiberscope into the inner sheath tube 2, aim at the diseased tissue and wrap the clamping claw 1011 of the outer sheath tube 1 around the diseased tissue 6, and then the inner sheath tube 2 is retracted into the outer sheath tube 1 together. At this time, the clamping claw 1011 of the outer sheath tube 1 will close under the action of prestress after losing the support of the inner sheath tube 2, and the diseased tissue 6 will be clamped off after closing (such as Figure 2 ).

[0047] Although the embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and variations may be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A sheath for ductoscopy biopsy sampling, characterized in that: The sheath tube comprises an outer sheath tube (1) and an inner sheath tube (2), wherein the outer sheath tube (1) comprises an outer tube body (101) with a hollow structure and a first tube head (102), one end of the outer tube body (101) is provided with an opening and closing flap-type clamping claw (1011), and the other end is connected to the first tube head (102), and the inner sheath tube (2) comprises an inner tube body (201) with a hollow structure and a second tube head (202), one end of the inner tube body (201) is a free end, and the other end is connected to the second tube head (202), the free end of the inner tube body (201) can be inserted into the interior of the outer tube body (101) from one end of the first tube head (102) and can move back and forth, and can push open the opening and closing flap of the clamping claw (1011) during the inward movement; the opening and closing flap of the clamping claw (1011) is in a closed state when there is no external force, and can return to its original state when the external force is removed.

2. The sheath for ductoscopy biopsy sampling according to claim 1, characterized in that: The outer tube (101) is made of shape memory alloy.

3. The sheath for ductoscopy biopsy sampling according to claim 2, characterized in that: The outer tube (101) is made of nickel-titanium alloy.

4. The sheath for ductoscopy biopsy sampling according to claim 1, characterized in that: The number of opening and closing petals of the clamping jaw (1011) is 3-6.

5. The sheath for ductoscopy biopsy sampling according to claim 1, characterized in that: One end of the first tube head (102) is connected to the outer tube body (101), and the outer wall of the other end is provided with a pressing portion (1021).

6. The sheath for ductoscopy biopsy sampling according to claim 5, characterized in that: The pressing portion (1021) is selected from a nut.

7. The sheath for ductoscopy biopsy sampling according to claim 1, characterized in that: One end of the second tube head (202) is connected to the inner tube body (201), which is called the front end, and the other end is provided with a connecting portion (2021), which is called the rear end. The tube body of the second tube head (202) is divided into two sections of tube bodies with different outer diameters. The outer diameter of the front tube body is smaller than the outer diameter of the rear tube body. The front tube body can be inserted into the hollow structure of the first tube head (102), which facilitates the connection between the first tube head (102) and the second tube head (202) and can avoid a large degree of eccentricity when the inner tube body (201) is inserted into the outer tube body (101); the outer diameter of the rear end tube body of the second tube head (202) is larger than the inner diameter of the hollow structure of the first tube head (102), which can avoid the second tube head (202) from being inserted too long and difficult to remove. Preferably, the connecting portion (2021) is a Luer thread structure.

8. The sheath for ductoscopy biopsy sampling according to claim 1, characterized in that: One end of the second tube head (202) connected to the inner tube body (201) can be inserted into the hollow structure of the first tube head (102); preferably, a sealing ring is further provided on the inner wall of the first tube head (102).

9. The sheath for ductoscopy biopsy sampling according to claim 1, characterized in that: The inner and outer diameters of the outer tube body (101) are 0.75 mm and 0.85 mm; the inner and outer diameters of the inner tube body (201) are 0.6 mm and 0.7 mm.

10. A breast biopsy device, characterized in that: The breast biopsy device comprises the sheath according to any one of claims 1 to 7.

11. The breast biopsy device according to claim 10, characterized in that: The invention comprises an outer sheath tube (1), an inner sheath tube (2), a handle tee (3), a length adjuster (4) and a fiberscope (5); the free end of the inner tube body (201) in the inner sheath tube (2) is inserted into the outer tube body (101) of the outer sheath tube (1) from one end of the first tube head (102) of the outer sheath tube (1) and can move back and forth; one end of the second tube head (202) in the inner sheath tube (2) is connected to one end of the handle tee (3), and the other end is inserted into the hollow structure of the first tube head (102); the inner sheath tube (2), the handle tee (3) and the length adjuster (4) are connected in sequence; the fiberscope (5) passes through the length adjuster (4), the handle tee (3), the inner sheath tube (2) and the outer sheath tube (1) in sequence.

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