Positioning sleeve
By designing a positioning cannula for intra-cumbered lesions, the problem of lack of special positioning devices in the prior art is solved, and the accurate marking and positioning of intra-cumbered lesions is achieved, which improves the accuracy of pathological diagnosis and the early stage of breast cancer. Discovery and treatment efficiency.
Patent Information
- Application Number
- CN202420930020.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-30
- Publication Date
- 2025-02-11
- Estimated Expiration
- 2034-04-30
AI Technical Summary
The prior art lacks medical devices specifically for preoperative and intraoperative positioning of intralabial lesions, resulting in poor marking and positioning functions and increasing the rate of pathological misdiagnosis.
A positioning sleeve is designed, including a mounting base, a first screw cover, a second screw cover and a rotatable handle, and the marking and positioning of the lesions in the milk duct through a positioning hose and a support core to ensure the stability and accuracy of the sleeve. sex.
Accurate marking and localization of lesions in the breast duct is achieved, the rate of pathological misdiagnosis is reduced, and the efficiency of early detection and treatment of breast cancer is improved.
Smart Images
Figure CN222444354U_ABST
Abstract
Description
Technical Field
[0001] The utility model belongs to the technical field of medical equipment, and in particular relates to a positioning sleeve. Background Art
[0002] Nipple discharge is a common clinical symptom with an incidence rate second only to breast lumps and breast pain. According to the cause of the disease, it can be divided into physiological nipple discharge and pathological nipple discharge. Pathological nipple discharge is caused by lesions in the milk ducts, and the incidence of breast cancer with it as the first symptom is 6-8%. Every year, about 3.0% to 13.7% of women seek medical treatment for nipple discharge, but in fact many women do not seek medical support for this symptom, so the reported incidence rate is still lower than the actual one. At the same time, studies have shown that compared with people without symptoms, patients with nipple discharge have a higher risk of cancer. Therefore, increasing the attention to nipple discharge, seeking medical treatment as soon as possible and discovering lesions in the milk ducts are conducive to the early detection and treatment of breast cancer.
[0003] Since some lesions in the milk ducts are so tiny that conventional mammography and ultrasound cannot detect them, with the continuous development of modern inspection equipment, the application of ductoscopes has greatly facilitated the diagnosis and treatment of nipple discharge. The use of ductoscopes can magnify the situation in the milk ducts by 80 times, helping doctors to directly see the diseased milk ducts, determine whether there are space-occupying lesions, and determine the approximate location of the lesions, which is convenient for subsequent positioning of the diseased milk ducts and surgical treatment.
[0004] During ductoscopy, the patient lies flat first, and then the doctor routinely disinfects the skin of the surgical field on the affected side and lays a drape to determine the opening of the discharge duct. In order to allow the anesthetic to enter the breast tissue smoothly, the nipple needs to be gently pinched before anesthesia, and a small-sized duct dilator (0.5mm and 0.6mm in diameter) is inserted into the discharge nipple to dilate it. 0.5% lidocaine is injected with a syringe for local anesthesia. After the anesthesia takes effect, a large-sized duct dilator (0.7mm and 0.8mm) is used again to continue to dilate the discharge duct. Finally, the duct is gradually expanded (from 0.5mm to 0.8mm in diameter), and a ductoscope is inserted from the opening of the expanded duct to observe the lumen and wall structure of the discharge duct and its branches one by one. When ductoscopy indicates the presence of space-occupying lesions in the duct, the doctor can observe the lesions through the ductoscope, and use specific dyes or duct positioning needles to mark the diseased ducts, and carry out surgical treatment.
[0005] Since there is no medical device specifically used to locate lesions in the milk ducts, after the lesions are detected using a ductoscope, the soft cannula (about 0.9 mm in diameter and about 2 cm in length) attached to the disposable intravenous indwelling needle used for intravenous infusion is often used to insert the diseased milk duct into the diseased milk duct, mark the diseased milk duct, and indicate the approximate depth of the lesion. During the operation, the needle cannula is removed, and an ophthalmic lacrimal sac probe is inserted into the diseased milk duct along the duct opening on the nipple to complete the positioning. During the operation, the subcutaneous tissue of the skin is incised, and the diseased milk duct with the ophthalmic lacrimal sac probe is carefully found and freed, and the diseased milk duct is freed along the probe. Before removing the diseased milk duct, the probe must be withdrawn to complete the step of cutting off the milk duct. After ligating and cutting the diseased milk duct behind the nipple, the diseased milk duct and part of the surrounding glandular tissue are removed together and sent for pathological diagnosis.
[0006] Disadvantages of existing technology:
[0007] 1. Clinically, there is no medical device specifically used for preoperative localization of intraductal lesions. The only way is to use the soft cannula attached to the disposable intravenous indwelling needle used for intravenous infusion to mark the milk duct and indicate the approximate depth of the lesion in the milk duct before surgery. However, the above-mentioned needle and cannula are relatively short, and the process of inserting the cannula for clinical ductoscopy is generally performed 12-24 hours before surgery. During this process, the patient cannot lie still for a long time. In addition, the breast is mainly composed of adipose tissue and connective tissue, which has high tissue elasticity and high mobility. The needle and cannula are easily displaced and fall off, which affects its function of marking the diseased milk duct and indicating the approximate depth of the lesion in the milk duct.
[0008] 2. Clinically, there is no medical device specifically used for intraoperative localization of lesions in the milk duct. The only way to mark the milk duct during surgery is to use a stainless steel ophthalmic lacrimal sac probe. Therefore, the probe must be withdrawn before the diseased milk duct is removed to complete the milk duct severance step. However, the inner diameter of the free milk duct is very small, less than 0.7 mm. After the probe is withdrawn and the milk duct is cut, the inner diameter will further shrink due to the elasticity of the milk duct itself. This makes it difficult to reinsert the probe along the broken end of the milk duct, so it is impossible to continue to accurately mark the lesions in the diseased milk duct, which increases the difficulty of subsequent pathological sampling and leads to an increase in the pathological missed diagnosis rate. Utility Model Content
[0009] In order to solve the above problems, the utility model provides a positioning sleeve for locating the lesion in the milk duct.
[0010] To achieve the above-mentioned purpose, the utility model adopts the following technical solution, including a mounting seat and a first screw cover, the mounting seat includes a front section, a middle section and a rear section, a passage penetrating the front section, the middle section and the rear section is arranged inside the mounting seat, and openings of the passage are arranged on the front section and the rear section of the mounting seat;
[0011] A positioning hose is connected to the front opening of the mounting seat;
[0012] The internal shape of the opening of the rear section of the mounting seat matches the shape of the standard syringe interface, the shape and size of the rear section of the mounting seat match the first screw cover, and the outer side of the rear section of the mounting seat is provided with an external thread, and the external thread matches the internal thread of the first screw cover; the first screw cover is connected by the external thread, and the first screw cover is provided with a support core for supporting the positioning hose toward the direction of the positioning hose, the position of the support core corresponds to the position of the positioning hose, and the outer diameter of the support core is smaller than the inner diameter of the positioning hose.
[0013] It also includes a second screw cover that plays a sealing role. The shape and size of the second screw cover match the rear section of the mounting seat, and the internal thread of the second screw cover matches the external thread on the outer side of the rear section of the mounting seat.
[0014] As a preferred solution of the utility model, it also includes a pair of identical handles, one end of which is provided with a connecting shaft, and both sides of the middle section of the mounting seat are provided with first mounting grooves arranged perpendicular to the direction of the positioning hose, and the mounting seat and the handles are connected by rotating in coordination with the connecting shaft and the first mounting groove.
[0015] As another preferred embodiment of the present invention, the handle cross-section is I-shaped, the notch size on one side of the I-shaped handle matches the size of the front section of the mounting seat, the notch size on the other side of the I-shaped handle matches the size of the rear section of the mounting seat, and the two I-shaped handles are symmetrically arranged on both sides of the middle section of the mounting seat.
[0016] As a third preferred scheme of the utility model, a positioning chuck is arranged on the connecting shaft of the handle, and a plurality of hemispherical positioning grooves are evenly arranged on the positioning chuck; two positioning chucks are arranged on the same side, and a limiting seat is arranged on the side of the middle section of the mounting seat close to the two positioning chucks, and a second mounting through groove penetrating the limiting seat is arranged on the limiting seat, a spring is arranged in the second mounting through groove, and positioning beads are connected on both sides of the spring, the size of the positioning beads matches the positioning groove, and the position of the positioning beads corresponds to the position of the positioning groove.
[0017] Beneficial effects of the utility model:
[0018] The utility model designs a novel intraductal lesion positioning sleeve, which is used for marking the diseased milk duct containing the lesion during surgery; it includes and optimizes all the functions of two positioning instruments used for clinical intraductal lesion positioning - "a soft sleeve attached to a disposable intravenous indwelling needle used for intravenous infusion" and "an ophthalmic lacrimal sac probe".
[0019] The positioning hose is 7cm long with scales and is made of polyvinyl chloride (PVC). Compared with the currently used 2cm needle cannula, it is longer and can be used to mark lesions deeper in the milk duct. Before and during surgery, the physician can use the scales on the positioning hose to determine whether the cannula has been displaced after being inserted into the diseased milk duct, which facilitates the physician to reposition the positioning cannula and continue to perform the function of marking lesions. After the positioning hose is separated from the milk duct during surgery, the presence of continuous scales can help the physician ensure that all positioning cannulas are removed to avoid residues in the patient's body. The polyvinyl chloride (PVC) hose material allows it to be separated from the milk duct during surgery, avoiding the problem that the traditional positioning needle is difficult to insert into the broken end of the milk duct a second time, and cannot accurately mark the lesions in the milk duct, which increases the difficulty of subsequent pathological sampling and leads to an increased chance of missed pathology.
[0020] The mounting base has an "I"-shaped rotatable handle with a middle section of 2 cm in length, a bilateral connection length of 9 cm, a width of 1.5 cm, and a thickness of 1.5 cm. The rotatable handle is made of polyethylene (PE) and can protect the front section of the cannula from contamination by rotating it to a suitable angle, serve as an intraoperative handle, and better fit the patient's breast skin surface. The anti-slip surface (the surface is frosted to increase friction) can improve the effectiveness of fixation with medical tape and effectively prevent the positioning cannula from shifting or falling off. The design of the rotatable handle closing backwards to a holding state also makes it easier for the physician to hold and adjust the positioning cannula, making it easier for it to be inserted into the diseased duct to mark the diseased duct and indicate the approximate depth of the lesion in the duct.
[0021] The rear section of the mounting base has a standard syringe socket, which is matched with two replaceable screw caps with different functions; the first screw cap has a 9.5 cm long support core made of stainless steel, cylindrical, with a blunt end that is not exposed to the positioning hose to avoid puncturing tissues; it can support the positioning cannula, and before surgery, it can assist the physician in inserting the positioning cannula into the patient's diseased milk duct, avoiding the situation where the traditional syringe cannula is soft and difficult to insert into the top opening of the milk duct; during surgery, it can assist the physician in finding and freeing the diseased milk duct, making it easier to operate; the second screw cap plays a sealing role after being tightened; according to actual clinical needs, before surgery, the physician can connect a syringe to the standard syringe socket on the rear section to inject liquids such as anesthetics, dyes, saline or contrast agents into the diseased milk duct, and after completion, tighten the second screw cap to play a sealing role. BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Figure 1 This is a schematic diagram of the overall structure of the handle of the utility model in a gripping state.
[0023] Figure 2 This is the front view of the handle of the utility model in the gripping state.
[0024] Figure 3It is a schematic diagram of the overall structure of the first screw cover and the second screw cover of the utility model.
[0025] Figure 4 This is a front view of the first screw cover and the second screw cover of the utility model.
[0026] Figure 5 This is a schematic diagram of the overall structure of the handle of the utility model in a fixed state.
[0027] Figure 6 This is the front view of the handle of the utility model in a fixed state.
[0028] Figure 7 This is a partial enlarged view of the position limit seat when the handle of the utility model is in a fixed state.
[0029] Figure 8 This is a partial enlarged view of the limit seat when the handle of the utility model is in the gripping state.
[0030] Fig. 9 This is a schematic diagram of the structure of the mounting seat of the utility model.
[0031] Fig.10 This is a partial enlarged view of the upper limit seat of the mounting seat of the utility model without the spring and positioning beads.
[0032] Fig.11 This is a partial enlarged view of the spring and positioning beads loaded at the upper limit seat of the mounting seat of the utility model.
[0033] Fig.12 This is a schematic diagram of the overall structure of the handle of the utility model.
[0034] Fig.13 This is a three-view diagram of the handle of the utility model.
[0035] Fig.14 This is a schematic diagram of the overall structure of the handle of the utility model when it is in a closed state.
[0036] In the accompanying drawings, 1 is a mounting seat, 2 is a first screw cover, 3 is a positioning hose, 4 is a supporting core, 5 is a second screw cover, 6 is a handle, 7 is a connecting shaft, 8 is a first mounting slot, 9 is a positioning chuck, 10 is a positioning groove, 11 is a limit seat, 12 is a second mounting slot, 13 is a spring, and 14 is a positioning bead. DETAILED DESCRIPTION
[0037] The utility model adopts the following specific scheme, including a mounting seat 1 and a first screw cover 2, wherein the mounting seat 1 includes a front section, a middle section and a rear section, a passage penetrating the front section, the middle section and the rear section is arranged inside the mounting seat 1, and openings of the passage are arranged on the front section and the rear section of the mounting seat 1;
[0038] The front opening of the mounting seat 1 is connected with a positioning hose 3, which is made of polyvinyl chloride (PVC). The diameter of the positioning hose 3 is set to 0.5mm, 0.6mm, 0.7mm and 0.8mm, etc. The total length of the positioning hose 3 is 7cm, and a scale line is set on the positioning hose 3;
[0039] The rear section of the mounting seat 1 is about 1 cm long and has an outer diameter of about 1 cm. The inner shape of the opening of the rear section of the mounting seat 1 matches the shape of the interface of a standard syringe, and a standard syringe can be used here to inject liquid medicine, and the liquid medicine is delivered to the patient's milk duct lesion through the channel and the positioning hose. The shape and size of the rear section of the mounting seat 1 match the first screw cover 2. The outer side of the rear section of the mounting seat 1 is provided with an external thread, and the external thread matches the internal thread of the first screw cover 2; the first screw cover 2 is connected through the external thread, and the first screw cover 2 is provided with a support core 4 for supporting the positioning hose 3 in the direction of the positioning hose 3, and the position of the support core 4 corresponds to the position of the positioning hose 3, and the outer diameter of the support core 4 is smaller than the inner diameter of the positioning hose 3;
[0040] It also includes a second screw cover 5 that plays a sealing role. After the drug solution is injected, the second screw cover 5 can be screwed on the rear section of the mounting seat 1 to play a sealing role. The shape and size of the second screw cover 5 match the rear section of the mounting seat 1, and the internal thread of the second screw cover 5 matches the external thread on the outer side of the rear section of the mounting seat 1.
[0041] The rear section of the mounting base 1 is equipped with two first screw caps 2, which have a 9.5 cm long steel core made of stainless steel and cylindrical, with a blunt end that is not exposed to the positioning sleeve to avoid puncturing tissue. It can support the positioning sleeve, making it easier to insert the positioning sleeve into the milk duct. Before surgery, it can assist the doctor to insert the positioning sleeve into the patient's diseased milk duct; during surgery, it can assist the doctor to free the diseased milk duct for easier operation.
[0042] The second screw cap 5 has a sealing effect after being tightened; according to actual clinical needs, before the operation, the doctor can connect an external syringe through the standard syringe socket of the rear section to inject anesthetics, dyes, saline or contrast agents into the diseased milk duct, and after completion, the second screw cap 5 is tightened to seal the duct.
[0043] As a preferred embodiment of the present invention, it also includes a pair of identical handles 6, which are about 9.5 cm long, 1.5 cm wide and 1.5 cm thick. A connecting shaft 7 is provided at one end of the handle 6, and first mounting grooves 8 are provided on both sides of the middle section of the mounting seat 1 and are arranged perpendicular to the direction of the positioning hose 3. The mounting seat 1 and the handle 6 are connected by rotating the connecting shaft 7 and the first mounting groove 8, and the handle 6 can be rotated 180°.
[0044] As another preferred embodiment of the present invention, the cross-section of the handle 6 is I-shaped, the notch size on one side of the I-shaped handle 6 matches the size of the front section of the mounting seat 1, the notch size on the other side of the I-shaped handle 6 matches the size of the rear section of the mounting seat 1, and the two I-shaped handles 6 are symmetrically arranged on both sides of the middle section of the mounting seat 1.
[0045] The handle 6 has three forms, namely a holding state, a closed state and a fixed state; the holding state is that the two handles 6 are closed at one side of the rear section of the mounting seat 1, which is convenient for the doctor to hold and adjust the positioning sleeve, and to insert it into the diseased milk duct to play the function of marking the diseased milk duct and indicating the approximate depth of the lesion in the milk duct; the closed state is that the two handles 6 are closed at one side of the front section of the mounting seat 1, which has the effect of protecting the positioning hose 3; the fixed state is a form between the holding state and the closed state, and the two handles 6 are at a certain angle at the front section of the mounting seat 1 based on the size of the patient's breast, and a fixing device such as medical tape can be set on the side of the handle 6 that fits the patient's breast.
[0046] As the third preferred scheme of the utility model, a positioning chuck 9 is arranged on the connecting shaft 7 of the handle 6, and a plurality of hemispherical positioning grooves 10 are evenly arranged on the positioning chuck 9; two positioning chucks 9 are arranged on the same side, and a limiting seat 11 is arranged on the side of the middle section of the mounting seat 1 close to the two positioning chucks 9, and a second mounting through groove 12 penetrating the limiting seat 11 is arranged on the limiting seat 11, and a spring 13 is arranged in the second mounting through groove 12, and positioning beads 14 are connected to both sides of the spring 13, and the size of the positioning beads 14 matches the positioning groove 10, and the position of the positioning beads 14 corresponds to the position of the positioning groove 10.
[0047] When the handle 6 is rotated, the positioning bead 14 and the spring 13 are squeezed and contracted into the second installation slot 12 until the positioning bead 14 can be stuck into the next positioning groove 10 to achieve the different angle adjustment and fixing effects of the handle.
[0048] The method of using the utility model is as follows: first, the handle 6 connected to the middle section of the mounting seat 1 is rotated from the closed state to the backward closed holding state. After the diseased milk duct is confirmed by the ductoscope, the first screw cap 2 with the support core 4 is screwed to the rear section of the mounting seat 1. The support core 4 passes through the channel and the positioning hose 3 to support the positioning hose 3. The positioning sleeve is inserted into the milk duct along the top opening of the milk duct. The insertion depth of the positioning hose 3 is confirmed according to the approximate position of the lesion in the milk duct seen by the ductoscope and the corresponding scale is recorded, so as to realize the function of marking the diseased milk duct and indicating the approximate depth of the lesion in the milk duct by the positioning sleeve; while waiting for the operation, the first screw cap 2 on the rear section of the mounting seat 1 is replaced by the second screw cap 5 to prevent the patient's nipple discharge from flowing out along the positioning sleeve. At the same time, the handle 6 is rotated from the backward closed holding state to a fixed state fitting the breast angle, and fixed to the skin surface by medical tape, and then combined with the engraved marks on the positioning hose 3, the positioning sleeve is fixed to the skin surface. degree, assisting the physician to judge in real time whether the positioning sleeve is displaced, so as to return it to its original position in time; taking off the second screw cap 5 at the rear section of the mounting seat 1, connecting an external syringe through the standard syringe socket at the rear section of the mounting seat 1, and injecting anesthetics, dyes, saline or contrast agents and other liquids into the milk duct according to the actual situation; replacing another first screw cap 2 during the operation, continuing to play a supporting role, assisting the physician to find and free the diseased milk duct; after the freeing is completed, removing the first screw cap 2, replacing the second screw cap 5, cutting off the diseased milk duct together with the positioning hose 3, removing the diseased milk duct and part of the surrounding glandular tissue together, and then checking the continuous scale on the positioning hose 3 to ensure that there is no residual positioning sleeve in the patient's body; after the operation, the breast excised tissue with the positioning hose 3 inside is sent to the pathology department, and the pathologist can obtain samples of the lesions in the milk duct according to the instructions of the positioning hose 3, thereby improving the accuracy of pathological sampling and the accuracy of diagnosis.
[0049] It can be understood that the above specific description of the utility model is only used to illustrate the utility model and is not limited to the technical solution described in the embodiments of the utility model. Ordinary technicians in the field should understand that the utility model can still be modified or replaced by equivalents to achieve the same technical effect; as long as the use requirements are met, they are within the protection scope of the utility model.
Claims
1. A positioning sleeve, characterized in that: The mounting seat (1) comprises a mounting seat (1) and a first screw cover (2), wherein the mounting seat (1) comprises a front section, a middle section and a rear section, a passage penetrating the front section, the middle section and the rear section is arranged inside the mounting seat (1), and openings of the passage are arranged on the front section and the rear section of the mounting seat (1); A positioning hose (3) is connected to the front opening of the mounting seat (1); The internal shape of the opening of the rear section of the mounting seat (1) matches the shape of the interface of a standard syringe, the shape and size of the rear section of the mounting seat (1) match the first screw cover (2), and the outer side of the rear section of the mounting seat (1) is provided with an external thread, and the external thread matches the internal thread of the first screw cover (2); the first screw cover (2) is connected via the external thread, and the first screw cover (2) is provided with a support core (4) for supporting the positioning hose (3) in the direction of the positioning hose (3), the position of the support core (4) corresponds to the position of the positioning hose (3), and the outer diameter of the support core (4) is smaller than the inner diameter of the positioning hose (3); It also includes a second screw cover (5) that performs a sealing function. The shape and size of the second screw cover (5) match the rear section of the mounting seat (1). The internal thread of the second screw cover (5) matches the external thread on the outer side of the rear section of the mounting seat (1).
2. A positioning sleeve as claimed in claim 1, characterized in that: It also includes a pair of identical handles (6), one end of each handle (6) being provided with a connecting shaft (7), and both sides of the middle section of the mounting seat (1) being provided with first mounting slots (8) arranged perpendicular to the direction of the positioning hose (3), and the mounting seat (1) and the handles (6) are connected by rotationally cooperating with the connecting shaft (7) and the first mounting slots (8).
3. A positioning sleeve as claimed in claim 2, characterized in that: The handle (6) has an I-shaped cross section, the notch size on one side of the I-shaped handle (6) matches the size of the front section of the mounting seat (1), the notch size on the other side of the I-shaped handle (6) matches the size of the rear section of the mounting seat (1), and the two I-shaped handles (6) are symmetrically arranged on both sides of the middle section of the mounting seat (1).
4. A positioning sleeve as claimed in claim 2, characterized in that: A positioning chuck (9) is arranged on the connecting rotating shaft (7) of the handle (6), and a plurality of hemispherical positioning grooves (10) are evenly arranged on the positioning chuck (9); the two positioning chucks (9) are arranged on the same side, and a limiting seat (11) is arranged on the side of the middle section of the mounting seat (1) close to the two positioning chucks (9), and a second mounting through groove (12) penetrating the limiting seat (11) is arranged on the limiting seat (11), and a spring (13) is arranged in the second mounting through groove (12), and positioning beads (14) are connected to both sides of the spring (13), and the size of the positioning beads (14) matches the positioning groove (10), and the position of the positioning beads (14) corresponds to the position of the positioning groove (10).