Nipple dilator device for breast examination

Abstract

The application provides a nipple dilating device for breast examination, which comprises an outer sleeve assembly, an inner sleeve assembly and a spacer rod assembly, the outer sleeve assembly comprises an outer sleeve sleeve, the inner sleeve assembly comprises an inner sleeve sleeve, and the spacer rod assembly comprises a spacer rod which can be inserted into the inner sleeve sleeve, the inner sleeve sleeve can be inserted into the outer sleeve sleeve, and the inner sleeve sleeve and the spacer rod can be inserted into or pulled out of the outer sleeve sleeve in a combined state. Compared with the prior art, the nipple dilating device has close connections between components and is not easy to fall off. The device can establish a channel for a ductoscope to enter a milk duct, the milk duct is accurately positioned, instruments do not need to be replaced, and the problem that medical staffs are complicated in operation is effectively reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a nipple expansion device for breast examination. Background Art

[0002] Breast disease has become one of the most common diseases among women, and nipple discharge is one of the most common clinical symptoms of breast disease. Nipple discharge can have a variety of shapes, colors, and causes. Unilateral, single-hole, bloody, and pathological discharges are associated with a higher risk of cancer. Therefore, examinations after nipple discharge are essential.

[0003] The ultrafine fiber ductoscope can clearly observe the mammary duct wall and ductal secretions. If there is a space-occupying lesion, its color, size, shape, smoothness, etc. The ductoscope is easy to operate, minimally invasive, and intuitive, effectively improving the diagnosis rate of raised lesions in the milk duct.

[0004] The clinical procedure generally involves disinfection and local anesthesia, followed by dilation of the nipple duct using multiple tear duct probes, starting from thin and then coarse. A very thin ductoscope is then inserted through the discharge nipple, and the patient is guided toward the end of the duct while observing the condition inside the duct through a monitor. Therefore, during nipple dilation, medical staff must change probe specifications multiple times, making it easy to select the wrong duct during probe changes and cumbersome procedures. During use, the nipple dilator needs to be kept as upright as possible, so the weight of the instrument plays a significant role in actual operation. Summary of the Invention

[0005] Purpose of the invention: In order to solve the defects of the prior art, the present invention provides a nipple dilation device for breast examination, which can establish a channel for a ductoscope to enter the milk duct, accurately locate the milk duct, is lightweight, and the various components are tightly connected. There is no need to replace the instrument, which effectively reduces the cumbersome operation problem of medical staff.

[0006] Technical solution: The present invention provides a nipple expansion device for breast examination, including an outer sleeve assembly, an inner sleeve assembly and a liner rod assembly, the outer sleeve assembly includes an outer sleeve sleeve, the inner sleeve assembly includes an inner sleeve sleeve, the liner rod assembly includes a liner rod, the liner rod can be inserted into the inner sleeve sleeve, the inner sleeve sleeve can be inserted into the outer sleeve sleeve, and the inner sleeve sleeve and the liner rod can be inserted into the outer sleeve sleeve or pulled out from the outer sleeve sleeve in a combined state.

[0007] As a preferred solution, both the outer sleeve assembly and the inner sleeve assembly include a sleeve and a connecting portion, wherein the sleeve and the connecting portion in one assembly are eccentric, and the sleeve and the connecting portion in the other assembly are concentrically arranged.

[0008] As an embodiment, the outer sleeve assembly includes an outer sleeve sleeve and an inner sleeve connector connected together, the inner sleeve assembly includes an inner sleeve sleeve and an outer sleeve connector connected together, the liner rod assembly includes a liner rod and an operating head connected together, and the inner sleeve connector and the outer sleeve connector cooperate to connect or disassemble the outer sleeve assembly and the inner sleeve assembly; the liner rod assembly can be detachably connected to the inner sleeve assembly through the operating head.

[0009] As a specific implementation scheme, the outer sleeve assembly includes an outer sleeve and an expansion interface, one end of the expansion interface is open, and the other end is connected to one end of the outer sleeve; the inner sleeve assembly includes an inner sleeve and an expansion joint connected to one end of the inner sleeve; the liner rod assembly includes a liner rod and an operating head connected to one end of the liner rod; the liner rod can pass through the expansion joint and be inserted into the inner sleeve; the inner sleeve can pass through the expansion interface and be inserted into the outer sleeve; the expansion joint can be inserted into the expansion interface; the two can cooperate to connect or disassemble the outer sleeve assembly and the inner sleeve assembly, and the inner sleeve assembly can be detachably connected through the operating head and the liner rod assembly.

[0010] Preferably, the outer sleeve and the expansion interface are a pair of components, and the inner sleeve and the expansion joint are a pair of components. Among the two pairs of components, one pair is eccentric and the other pair is concentric.

[0011] As a more preferred solution, there is an eccentricity between the inner sleeve and the expansion joint, and the eccentricity distance is 0.05±0.01mm; the outer sleeve and the expansion joint are concentrically arranged.

[0012] Furthermore, the inner sleeve assembly further comprises an outer Luer threaded connector, one end of the expansion connector is connected to the inner sleeve cannula, and the other end is connected to the outer Luer threaded connector;

[0013] Furthermore, the liner rod assembly also includes an internal Luer threaded connector, which is arranged inside the operating head and located at one end of the liner rod.

[0014] As an embodiment, the outer diameter of the expansion joint is slightly smaller than the inner diameter of the expansion interface. "Slightly smaller" means that the dimensions should ensure that the expansion joint can rotate smoothly axially within the expansion interface without radial play that could cause radial displacement. Otherwise, the self-locking mechanism achieved by eccentricity would fail due to radial displacement between the expansion joint and the expansion interface.

[0015] As an embodiment, the surface of the operating head is provided with raised ribs.

[0016] Preferably, the specification of the outer sleeve is (1.0-2.5) mm×(0.8-2.3) mm; the specification of the inner sleeve is (0.7-2.2) mm×(0.2-1.7) mm; and the specification of the lining rod is 0.15 mm-1.65 mm.

[0017] As another embodiment, the outer sleeve assembly includes a first sleeve and a first silicone member, the inner sleeve assembly includes a second sleeve and a second silicone member, and the liner rod assembly includes a third sleeve and a third silicone member; the outer sleeve assembly, the inner sleeve assembly and the liner rod assembly have the same structure, and a center hole is set in the silicone member, the sleeve passes through the silicone member through the center hole, and is fixed by extrusion of the inner wall of the center hole; in addition, the second sleeve can be inserted into the center hole of the third silicone member and sleeved on the outer wall of the third sleeve, and the first sleeve can be inserted into the center hole of the second silicone member and sleeved on the outer wall of the second sleeve.

[0018] Preferably, the silicone piece is cylindrical in shape and has a hardness of 40-80A; the upper portion of the central hole of the silicone piece is funnel-shaped. The funnel-shaped silicone piece facilitates insertion of the sleeve, which is fixed by friction between the two and elasticity between the silicone piece.

[0019] As an improved solution, a plastic part is provided on the outside of the silicone part, and the plastic part is overmolded and fixed to the outside of the silicone part through a clamping structure; the plastic part is made of PP, PC or ABS.

[0020] Beneficial effects: Compared with the existing technology:

[0021] The nipple expansion device of the present invention provides an eccentric arrangement between the outer sleeve assembly and the inner sleeve assembly, which generates a self-locking effect through relative rotation between the inner and outer sleeves, thereby conveniently and quickly connecting the outer sleeve and the inner sleeve. The eccentric arrangement has the following advantages:

[0022] 1) Unlike traditional Luer connection structures, the eccentric setting only requires a central axis offset, without the need for further processing on the surface or inside of the component, thus effectively reducing the wall thickness of the component and reducing the weight of the product;

[0023] 2) Self-locking or disengagement can be achieved by simply rotating the parts, which is easy to use, convenient and practical;

[0024] 3) Only the center axis needs to be offset, and no further processing is required on the surface or inside of the component (reprocessing can easily damage the strength of the material). At the same time, stainless steel can be used, and the product has high strength;

[0025] 4) The traditional Luer connection structure requires the setting of threads, which is prone to wear after frequent use. The eccentric structure only needs to rotate to self-lock or disengage, which reduces wear and tear. Reusable materials such as stainless steel can be used, allowing the product to be repeatedly disinfected and used, with a long service life.

[0026] The present invention connects the inner sleeve assembly and the liner rod assembly, so the inner sleeve assembly and the liner rod assembly can be inserted or pulled out at the same time. The components of the nipple expansion device are tightly connected and are not easy to fall off.

[0027] Another solution of the present invention is to provide a soft channel through a silicone piece, so that the length of the channel entering the body can be flexibly adjusted.

[0028] Therefore, the device can establish a channel for the ductoscope to enter the milk duct, accurately locate the milk duct, and does not require the replacement of instruments, effectively reducing the tedious operation problems of medical staff. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 Schematic diagram of the structure of the nipple expansion device according to embodiment 1 of the present invention (combined diagram), wherein:

[0030] 1- outer sleeve assembly, 3- liner rod assembly.

[0031] Figure 2 Schematic diagram (exploded view) of the nipple expansion device according to embodiment 1 of the present invention, wherein:

[0032] 1-outer jacket assembly, 1-1 outer jacket sleeve, 1-2 expansion interface;

[0033] 2-inner sleeve assembly, 2-1 inner sleeve cannula, 2-2 expansion joint, 2-3 outer Luer thread joint;

[0034] 3-liner rod assembly, 3-1 liner rod, 3-2 operating head, 3-3 internal Luer thread connector;

[0035] Figure 3 Schematic diagram of the eccentric structure of the present invention;

[0036] Figure 4 Schematic diagram of the structure of the nipple expansion device according to embodiment 2 of the present invention, wherein:

[0037] 1- jacket assembly, 101 first sleeve, 102 first silicone member;

[0038] 2-inner sleeve assembly, 201 second sleeve, 202 second silicone member;

[0039] 3- liner rod assembly, 301 third sleeve, 302 third silicone component;

[0040] 40 plastic parts, 50 snap-on structures. DETAILED DESCRIPTION

[0041] The present invention will be further described below with reference to the accompanying drawings.

[0042] 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 relationships in the drawings are only used for illustrative purposes and cannot be understood as limitations on this patent.

[0043] Example 1

[0044] A nipple dilation device for breast examination, such as Figure 1 and Figure 2 As shown, it includes an outer sleeve assembly 1, an inner sleeve assembly 2 and a liner rod assembly 3.

[0045] The outer sleeve assembly 1 includes an outer sleeve 1-1 and an expansion interface 1-2. One end of the expansion interface 1-2 is open, and the other end is connected to one end of the outer sleeve 1-1.

[0046] The inner sleeve assembly 2 includes an inner sleeve tube 2-1 and an expansion joint 2-2 connected to one end of the inner sleeve tube 2-1, and an outer Luer threaded joint 2-3. One end of the expansion joint 2-2 is connected to the inner sleeve tube 2-1, and the other end is connected to the outer Luer threaded joint 2-3.

[0047] The liner rod assembly 3 includes a liner rod 3-1 and an operating head 3-2 connected to one end of the liner rod 3-1, and an inner Luer threaded joint 3-3. The inner Luer threaded joint 3-3 is arranged inside the operating head 3-2 and located at one end of the liner rod 3-1.

[0048] The outer Luer threaded connector 2-3 and the inner Luer threaded connector 3-3 match and can detachably connect the inner sleeve assembly 2 and the liner rod assembly 3. The outer sleeve 1-1, the inner sleeve 2-1, and the liner rod 3-1 are all made of stainless steel, and the expansion interface 1-2, the expansion joint 2-2, and the operating head 3-2 can all be made of stainless steel or plastic.

[0049] The liner rod 3-1 can pass through the expansion joint 2-2 (and pass through the outer Luer threaded joint 2-3) and be inserted into the inner sleeve 2-1. The inner sleeve 2-1 can pass through the expansion interface 1-2 and be inserted into the outer sleeve 1-1. The outer sleeve 1-1 and the expansion interface 1-2 are concentrically arranged. There is an eccentricity between the inner sleeve 2-1 and the expansion joint 2-2. Preferably, the eccentricity distance is 0.05±0.01mm. The above eccentricity means that the central axes of the two are not collinear, but parallel to each other, and the distance between the two central axes is 0.05±0.01mm (such as Figure 3As shown, m = 0.05 ± 0.01 mm). When the inner sleeve assembly 2 is inserted into the outer sleeve assembly 3, the cooperation between the expansion interface 1-2 and the expansion joint 2-2 plays a guiding role in axial relative movement and an inhibiting role in radial relative movement, so that when the inner sleeve assembly 2 is rotated, the inner sleeve sleeve 2-1 will make a circular motion around a circle with a radius of 0.05 mm, and at this time, the inner sleeve sleeve 2-1 will be in close contact with the outer sleeve sleeve 1-1, thereby preventing the two from being separated.

[0050] The outer diameter of the expansion joint 2-2 is slightly smaller than the inner diameter of the expansion interface 1-2, and the expansion joint 2-2 can be inserted into the expansion interface 1-2, and due to the eccentric arrangement, self-locking can be generated by rotation. The surface of the operating head 3-2 is also provided with raised ribs, which facilitates the rotation of the operating head 3-2.

[0051] As some specific embodiments, the following components have the following specifications:

[0052]

[0053] Note: Unit: mm

[0054] In clinical application, first, the liner rod 3-1 is inserted into the inner sleeve sleeve 2-1 (the liner rod 3-1 is inserted from one end of the outer luer thread joint 2-3, sequentially passes through the outer luer thread joint 2-3, the expansion joint 2-2 and the inner sleeve sleeve 2-1), and is fastened together by tightening the outer luer thread joint 2-3 and the inner luer thread joint 3-3, and then the outer sleeve sleeve 1-1 and the expansion interface 1-2 are sleeved on the inner sleeve sleeve 2-1 and the expansion joint 2-2 (the inner sleeve sleeve 2-1 is inserted from one end of the opening of the expansion interface 1-2), and then one hand rotates the operating head 3-2 to drive the inner sleeve assembly 2 to rotate, and the other hand holds the expansion interface 1-2, so that the expansion interface 1-2 and the expansion joint 2-2 are self-locked, and the components of the nipple expansion device are tightly connected and not easy to fall off.

[0055] After connection, the operating head 3-2 at the rear of the nipple expansion device is held by hand, and the nipple expansion device is inserted into the human body cavity through the nipple tube.

[0056] After the nipple expansion device is inserted, one hand holds the expansion interface 1-2 of the outer sleeve assembly 1, and the other hand holds the operating head 3-2, and the inner sleeve assembly 2 and the liner rod assembly 3 are pulled out from the outer sleeve assembly 1, and the outer sleeve assembly 1 of the nipple expander is left on the human body, thereby establishing a channel for entering the breast cavity.

[0057] Example 2

[0058] A nipple expansion device for breast examination, such as Figure 4As shown, it includes an outer sleeve assembly 1, an inner sleeve assembly 2 and a liner rod assembly 3.

[0059] The outer sleeve assembly 1 includes a first sleeve 101 and a first silicone part 102, the inner sleeve assembly 2 includes a second sleeve 201 and a second silicone part 202, and the liner rod assembly 3 includes a third sleeve 301 and a third silicone part 302; the outer sleeve assembly 1, the inner sleeve assembly 2 and the liner rod assembly 3 have the same structure, and the silicone part is provided with a center hole, the sleeve passes through the silicone part through the center hole, and is fixed by extrusion of the inner wall of the center hole; in addition, the second sleeve 201 can be inserted into the center hole of the third silicone part 302 and sleeved on the outer wall of the third sleeve 301, and the first sleeve 101 can be inserted into the center hole of the second silicone part 202 and sleeved on the outer wall of the second sleeve 201.

[0060] The silicone piece is cylindrical in shape and has a hardness of 40-80A. The upper portion of the center hole of the silicone piece is funnel-shaped. The funnel-shaped upper portion of the center hole of the silicone piece facilitates the insertion of the sleeve, which is fixed by friction between the two and the elasticity of the silicone piece.

[0061] A plastic part 40 is also located outside the silicone component. This plastic part 40 is overmolded and secured to the silicone component via a clip-on structure 50. Plastic part 40 is made of PP, PC, or ABS. Made of a high-hardness polymer, plastic part 40 protects the silicone component within while also providing a stress point for smaller-diameter sleeves. The clip-on structure 50 effectively secures the silicone component, preventing axial movement.

[0062] During clinical use, each sleeve is first inserted into each silicone member. Then, the second sleeve 201 is inserted through the funnel-shaped center hole of the third silicone member 302. The second sleeve 201 is then sheathed over the third sleeve 301 to securely connect the inner sleeve assembly 2 and the backing rod assembly 3. Finally, the first sleeve 101 is inserted through the funnel-shaped center hole of the second silicone member 202. The first sleeve 101 is then sheathed over the second sleeve 201 to securely connect the outer sleeve assembly 1, the inner sleeve assembly 2, and the backing rod assembly 3.

[0063] After connection, hold the plastic part 40 and insert the front end insertion part of the nipple expansion device into the human body cavity through the nipple duct.

[0064] After the front end of the nipple expansion device is inserted, hold the plastic part 40 of the outer sleeve component 1 with one hand, and grasp the plastic part 40 of the inner sleeve component 2 with the other hand, pull out the inner sleeve component 2 and the lining rod component 3 from the outer sleeve component 1, and leave the outer sleeve component 1 of the nipple expander on the human body to establish a channel that can enter the breast cavity.

[0065] While embodiments of the application have been shown and described, it is to be understood that the embodiments described are merely exemplary of the principles and application of the present application. Numerous modifications and adaptions can be effected without departing from the spirit and scope of the present application, which is not limited to the exact construction and arrangement described. It is intended, therefore, to cover all modifications and adaptions that fall within the scope of the claims and their equivalents.

Claims

1. A nipple expansion device for breast examination, characterized in that: The invention comprises an outer sleeve component (1), an inner sleeve component (2) and a liner rod component (3), wherein the outer sleeve component (1) comprises an outer sleeve tube (1-1) and an expansion interface (1-2), wherein the expansion interface (1-2) is open at one end and connected to one end of the outer sleeve tube (1-1) at the other end, the inner sleeve component (2) comprises an inner sleeve tube (2-1) and an expansion joint (2-2) connected to one end of the inner sleeve tube (2-1), and the liner rod component (3) comprises a liner rod (3-1) and an operating head (3-2) connected to one end of the liner rod (3-1), wherein the liner rod (3-1) can pass through the expansion joint (2-2). -2) is inserted into the inner sleeve (2-1), and the inner sleeve (2-1) can pass through the expansion interface (1-2) and be inserted into the outer sleeve (1-1); the expansion joint (2-2) can be inserted into the expansion interface (1-2), and the two can cooperate to connect or disassemble the outer sleeve component (1) and the inner sleeve component (2), and the inner sleeve component (2) can be detachably connected through the operating head (3-2) and the liner rod component (3); the inner sleeve (2-1) and the liner rod can be inserted into the outer sleeve (1-1) or pulled out from the outer sleeve (1-1) in a combined state; There is eccentricity between the inner sleeve (2-1) and the expansion joint (2-2), and the outer sleeve (1-1) and the expansion interface (1-2) are concentrically arranged; the outer diameter of the expansion joint (2-2) is smaller than the inner diameter of the expansion interface (1-2), and the aforementioned smaller means that the size should be able to ensure that the expansion joint (2-2) can rotate smoothly in the axial direction within the expansion interface (1-2) and there should be no radial gap that causes radial displacement; The nipple expansion device is provided with an eccentricity between the outer sleeve component (1) and the inner sleeve component (2), so that self-locking or disengagement is generated by relative rotation between the inner and outer sleeves. The above-mentioned eccentricity means that the central axes of the outer sleeve component (1) and the inner sleeve component (2) are not collinear, but parallel to each other.

2. The nipple expansion device for breast examination according to claim 1, characterized in that: The eccentric distance is 0.05±0.01 mm.

3. The nipple expansion device for breast examination according to any one of claims 1 to 2, characterized in that: The inner sleeve assembly (2) further comprises an outer Luer threaded connector (2-3), one end of the expansion connector (2-2) being connected to the inner sleeve tube (2-1) and the other end being connected to the outer Luer threaded connector (2-3).

4. The nipple expansion device for breast examination according to any one of claims 1 to 2, characterized in that: The liner rod assembly (3) further comprises an inner Luer threaded joint (3-3), which is arranged inside the operating head (3-2) and located at one end of the liner rod (3-1).

5. The nipple expansion device for breast examination according to any one of claims 1 to 2, characterized in that: The surface of the operating head (3-2) is provided with raised ribs.

6. The nipple expansion device for breast examination according to any one of claims 1 to 2, characterized in that: The specification of the outer sleeve (1-1) is (1.0-2.5) mm×(0.8-2.3) mm; the specification of the inner sleeve (2-1) is (0.7-2.2) mm×(0.2-1.7) mm; and the specification of the lining rod (3-1) is 0.15 mm-1.65 mm.

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