A device for locating an intraductal lesion

Abstract

A kind of positioning device of intraductal lesion, the positioning device includes positioning catheter and breast ductoscope sheath cooperating with positioning catheter, breast ductoscope sheath includes mirror sheath body, hollow guide sleeve, first connector, second connector, third connector, one end of hollow guide sleeve is connected with the inside of mirror sheath body, first connector, second connector, third connector are communicated with the inside of hollow guide sleeve by mirror sheath body, positioning catheter includes intermediate pipeline and outer pipeline, outer pipeline is sleeved on the outside of intermediate pipeline, the outside of outer pipeline is equipped with the scale mark distributed along the axial direction, one end of intermediate pipeline is equipped with the liquid injection hole that can inject methylene blue.The utility model discloses by breast ductoscope sheath sends into the lesion position of breast duct with positioning catheter, and injects methylene blue, improves the accuracy of intraductal lesion position positioning and checking, reduces unnecessary resection the pain and tissue damage brought to patient.

Description

Technical Field

[0001] This utility model relates to the field of intraductal lesion localization technology, and in particular to a localization device for intraductal lesions. Background Technology

[0002] The mammary ductal system exhibits a typical tree-like branching structure. The openings on the nipple are numerous lactiferous pores, serving as channels for milk drainage. Anatomical studies show that this system originates at the base of the nipple (analogous to a tree trunk), extending into the mammary gland to form 12-20 primary main mammary ducts (equivalent to primary branches). Each primary main duct then differentiates into several secondary mammary ducts (secondary branches), which further branch into finer tertiary mammary ducts (tertiary branches). This hierarchical branching pattern continues, ultimately forming a complex network system with terminal ducts and alveoli, as shown in the accompanying diagram. Figure 1 As shown.

[0003] Nipple discharge is a common symptom of breast diseases and can be divided into physiological and pathological discharge. Currently, the main treatment for patients with bloody or pathological nipple discharge is surgical treatment using ductoscopy. Ductoscopy is a commonly used tool for observing lesions within the mammary ducts and for breast surgery. The localization of lesions within the mammary ducts is primarily achieved by the examiner inserting a fiber optic cable into the ductoscope. The cable is inserted through the milk duct opening at the nipple and used to examine which branch of the duct has a tumor or other lesion. The location of the lesion on the skin surface, its distance from the nipple, is then marked. When surgery is to be performed, methylene blue is injected into the diseased duct or the draining duct according to the guidance of the ductoscope. The lesion is then excised based on the extent of the methylene blue injection. However, existing methods for locating ductal lesions have the following shortcomings:

[0004] 1) After performing a ductoscopy, it is necessary to locate the previously marked lesion duct during the procedure. It is easy to find the lesion location inaccurately because some nipples may have crusts. Therefore, it is not possible to accurately locate the lesion during the procedure.

[0005] 2) The current method of injecting methylene blue involves injecting methylene blue into the opening of the mammary duct, which will stain the entire primary main mammary duct system with methylene blue. During surgical resection, the entire branch of the primary main mammary duct will be removed. However, sometimes, the patient may not have disease in the entire branch of the primary main mammary duct, but may have disease in the secondary or tertiary mammary duct. Removing the entire branch of the primary main mammary duct will also remove the mammary ducts that are not diseased, resulting in a relatively large wound area. Utility Model Content

[0006] In view of this, in order to solve the technical problems existing in the prior art, this utility model provides a positioning device that uses a ductoscope sheath to insert a positioning catheter into the primary, secondary, or tertiary mammary ducts to inject methylene blue into the lesion sites of the primary, secondary, or tertiary mammary ducts, thereby improving the accuracy of lesion location and examination within the mammary ducts, enhancing the diagnostic efficacy of lesions within the mammary ducts, facilitating subsequent specific resection of the lesion site, reducing unnecessary resection and the pain and tissue damage caused to the patient, and accelerating the patient's postoperative recovery and healing.

[0007] The present invention solves the above-mentioned technical problems through the following technical solution:

[0008] A device for locating lesions within the mammary duct, comprising a positioning catheter and a ductoscope sheath cooperating with the positioning catheter. The ductoscope sheath includes a sheath body, a hollow guide sleeve, a first connector for easy insertion of optical fibers, a second connector, and a third connector for easy insertion of the positioning catheter. The hollow guide sleeve is located at one end of the sheath body and is connected to the interior of the sheath body. The first, second, and third connectors are spaced apart at the other end of the sheath body and are connected to the sheath body. The first, second, and third connectors are connected to the interior of the hollow guide sleeve through the sheath body. The positioning catheter includes an intermediate tube and an outer tube. The outer tube is fitted over the intermediate tube and has axially distributed graduation marks on its exterior. One end of the intermediate tube has an injection port for injecting methylene blue.

[0009] As a further improvement to the above technical solution, a water bladder is formed at the head of the outer pipe, and a water inlet is provided at the tail of the outer pipe for connecting a syringe to inject water.

[0010] As a further improvement to the above technical solution, the other end of the intermediate pipe is provided with a liquid outlet hole, which is distributed opposite to the liquid injection hole, and a through channel is formed between the liquid outlet hole and the liquid injection hole so that the methylene blue can flow from the liquid injection hole to the liquid outlet hole.

[0011] As a further improvement to the above technical solution, a water injection channel is formed between the outer pipe and the intermediate pipe, and the water injection channel is connected to the water injection port.

[0012] As a further improvement to the above technical solution, the length of the hollow guide sleeve is 8-15cm, and the inner diameter of the hollow guide sleeve is 0.75-1.2mm.

[0013] As a further improvement to the above technical solution, the diameter of the intermediate pipe is 0.1-0.2 mm, and the diameter of the outer pipe is 0.3-0.4 mm.

[0014] As a further improvement to the above technical solution, the hollow guide sleeve is provided with a guide hole at its end, and the interior of the hollow guide sleeve communicates with the guide hole.

[0015] As a further improvement to the above technical solution, the first connector has an imaging channel inside, and the first connector is connected to the hollow guide sleeve through the imaging channel. The second connector has an instrument channel inside for surgical instruments to pass through, and the second connector is connected to the hollow guide sleeve through the instrument channel. The third connector has a working channel inside, and the third connector is connected to the hollow guide sleeve through the working channel.

[0016] As a further improvement to the above technical solution, one end of the optical fiber is connected to an optical fiber support, one end of the optical fiber support is threadedly connected to a threaded sleeve, the optical fiber passes through the threaded sleeve, and one end of the threaded sleeve is threadedly connected to the first connector at the other end of the mirror sheath body.

[0017] As a further improvement to the above technical solution, the main body of the mirror sheath is configured as a stepped shaft-shaped grip.

[0018] Compared with the prior art, the technical solution of this utility model has at least the following beneficial effects:

[0019] 1) The positioning device of this utility model includes a positioning catheter and a ductoscope sheath that cooperates with the positioning catheter. The ductoscope sheath includes a sheath body, a hollow guide sleeve, a first connector, a second connector, and a third connector. One end of the hollow guide sleeve is connected to the interior of the sheath body. The first connector, the second connector, and the third connector are distributed at intervals at the other end of the sheath body and are connected to the sheath body. The first connector, the second connector, and the third connector are connected to the interior of the hollow guide sleeve through the sheath body. The positioning catheter includes a middle tube and an outer tube. The outer tube is sleeved on the outside of the middle tube. The outer tube has axially distributed graduation marks on its outside. One end of the middle tube has an injection hole for injecting methylene blue. This invention uses a ductoscope sheath to insert a positioning catheter into the primary, secondary, or tertiary mammary ducts. This allows for the injection of methylene blue into lesions within the primary, secondary, or tertiary mammary ducts, improving the accuracy of lesion location and examination, enhancing the diagnostic efficacy of lesions within the mammary ducts, facilitating subsequent resection of the lesion-bearing duct, reducing unnecessary resections that cause pain and tissue damage to the patient, and accelerating postoperative recovery and healing.

[0020] 2) This invention features a water-filled bladder at the head of the outer tube and a water inlet at the tail of the outer tube for connecting a syringe to inject water. A water inlet channel is formed between the outer tube and the intermediate tube. Water is injected into the outer tube through the water inlet, causing the water-filled bladder at the head of the positioning catheter to inflate. This prevents the positioning catheter from dislodging from the lesion location in the mammary duct after the ductoscope sheath is removed, thus preventing displacement of the positioning catheter.

[0021] The above description is merely an overview of the technical solution of this utility model. In order to better understand the technical means of this utility model and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this utility model more obvious and understandable, the following detailed description is provided in conjunction with preferred embodiments and accompanying drawings. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the mammary duct system of this utility model;

[0023] Figure 2 This is a schematic diagram of the positioning catheter, ductoscope sheath, and optical fiber of this utility model;

[0024] Figure 3 This is a schematic diagram of the structure of the ductoscope sheath of this utility model;

[0025] Figure 4 This is an internal cross-sectional view of the ductoscope sheath of this utility model;

[0026] Figure 5 This is a schematic diagram of the positioning catheter water bladder of this utility model in the state of not being filled with water;

[0027] Figure 6 This is a schematic diagram showing the water meter of the positioning guide tube of this utility model bulging when filled with water;

[0028] Figure 7 This is a schematic diagram of the tube plug of this utility model;

[0029] Figure 8 This is a top view of the tube plug of this utility model.

[0030] In the figure: positioning catheter 1, intermediate tube 11, outer tube 12, water bag 13, water inlet 14, endoscope sheath 2, endoscope sheath body 21, first threaded connecting sleeve 211, hollow guide sleeve 22, second threaded connecting sleeve 221, guide hole 222, first connector 23, imaging tube 231, second connector 24, instrument channel 241, third connector 25, working channel 251, tube plug 26, extraction part 261, optical fiber 3, optical fiber support part 31, threaded sleeve 32. Detailed Implementation

[0031] The present invention will now be described in detail with reference to the accompanying drawings, which form part of this specification. The principles of the present invention will be illustrated through embodiments, and other aspects, features, and advantages of the present invention will become apparent from this detailed description. In the accompanying drawings, the same or similar parts in different figures are indicated by the same reference numerals.

[0032] like Figures 2-8As shown, Embodiment 1 of this utility model provides a positioning device for intraductal lesions. The positioning device includes a positioning catheter 1 and a ductoscope sheath 2 that cooperates with the positioning catheter 1. The ductoscope sheath 2 includes a sheath body 21, a hollow guide sleeve 22, a first connector 23 for easy insertion of an optical fiber 3, a second connector 24, and a third connector 25 for easy insertion of the positioning catheter 1. The hollow guide sleeve 22 is located at one end of the sheath body 21, and one end of the hollow guide sleeve 22 is connected to the interior of the sheath body 21. The first connector 23 and the second connector... 24. The third connector 25 is spaced apart from each other at the other end of the endoscope sheath body 21 and communicates with the endoscope sheath body 21. The first connector 23, the second connector 24, and the third connector 25 are connected to the interior of the hollow guide sleeve 22 through the endoscope sheath body 21. The positioning catheter 1 includes an intermediate tube 11 and an outer tube 12. The outer tube 12 is sleeved on the outside of the intermediate tube 11. The outer tube 12 has axially distributed scale markings on its exterior. In this embodiment, the scale markings have readable numbers, and the 0 mark of the readable numbers is located at the head of the outer tube 12. The depth of the positioning catheter 1 inserted into the lesion in the mammary duct can be read directly from the readable numbers on the surface of the positioning catheter 1, thereby determining the distance between the lesion in the mammary duct and the nipple, so as to determine the surgical range and facilitate the surgical operation. One end of the intermediate tube 11 is provided with an injection port for injecting methylene blue. Specifically, the hollow guide sleeve 22 can be 8–15 cm long, with an inner diameter of 0.75–1.2 mm, a diameter of 0.1–0.2 mm for the intermediate tube 11, and a diameter of 0.3–0.4 mm for the outer tube 12. The positioning catheter 1 of this invention can be inserted into the third connector 25 of the ductoscope sheath 2. The hollow guide sleeve 22 of the ductoscope sheath 2 guides the positioning catheter 1 into the nipple orifice and into the milk duct of the nipple. The ductoscope sheath 2 can guide the positioning catheter 1 to any branch of the milk duct within the nipple, i.e., a primary, secondary, tertiary, quaternary, or quinary milk duct, etc., to the specific lesion location of the milk duct. Then, the ductoscope sheath 2 is withdrawn, leaving the positioning catheter 1 in the milk duct. The positioning catheter 1 is marked with graduations. The exposed scale markings allow for reading the insertion depth of the positioning catheter 1, facilitating the determination of the specific distance between the lesion and the nipple. Methylene blue is injected through the injection port of the middle tube 11 of the positioning catheter 1 to mark the location of lesions within the mammary ducts. Since the positioning catheter 1 can be inserted into any branch of the mammary duct within the nipple, it is possible to specifically mark the location of a particular branch of the mammary duct with methylene blue, thereby improving the accuracy of lesion examination within the mammary ducts, enhancing the diagnostic efficacy of lesions within the mammary ducts, reducing unnecessary excisions that cause pain and tissue damage to the patient, shortening the postoperative recovery time, and accelerating the patient's postoperative healing.

[0033] This invention features a water-filled bladder 13 at the head of the outer conduit 12 and a water inlet 14 at the tail of the outer conduit 12 for connecting a syringe to inject water. Specifically, a water inlet channel is formed between the outer conduit 12 and the intermediate conduit 11, and this channel is connected to the water inlet 14. The water inlet 14 on the outer conduit 12 can be designed as a tapered hole, narrower inside and wider outside. The water inlet 14 of the outer conduit 12 is made of an elastic membrane material. When the blunt tip of the syringe is inserted into the water inlet 14, it expands the water inlet 14 to inject liquid. When the blunt tip of the syringe is withdrawn, the water inlet 14 elastically retracts and closes. Water is injected into the outer conduit 12 through the water inlet 14, causing the water-filled bladder 13 at the head of the positioning catheter 1 to inflate, preventing the positioning catheter 1 from dislodging from the lesion location in the mammary duct after the ductoscope sheath 2 is removed, and preventing displacement of the positioning catheter 1.

[0034] This invention features an outlet hole at the other end of the intermediate tube 11, which is opposite to the injection hole. A through channel is formed between the outlet hole and the injection hole to allow methylene blue to flow from the injection hole to the outlet hole. A tube plug 26 is also provided at the outlet hole, which can movably block the outlet hole. An extraction part 261 is fixed at the top of the tube plug 26. By providing the extraction part 261, it is convenient to use forceps or similar tools to grasp the tube plug 26 so that the tube plug 26 can block the outlet hole of the intermediate tube 11, or the tube plug 26 can be removed from the outlet hole of the intermediate tube 11. The intermediate tube 11 is mainly used to inject methylene blue into the lesion site in the mammary duct for staining and localization. The water balloon 13 at the head of the outer tube 12 plays a radial fixing role to prevent the positioning catheter 1 from shifting during the operation.

[0035] This invention features a guide hole 222 at the end of a hollow guide sleeve 22, with the interior of the hollow guide sleeve 22 communicating with the guide hole 222. The optical fiber 3 or the positioning catheter 1 can be delivered into the nipple through the guide hole 222 of the hollow guide sleeve 22.

[0036] In this embodiment of the present invention, an imaging channel 231 is formed inside the first connector 23, and the first connector 23 is connected to the hollow guide sleeve 22 through the imaging channel 231. An instrument channel 241 is formed inside the second connector 24 so that surgical instruments can pass through, and the second connector 24 is connected to the hollow guide sleeve 22 through the instrument channel 241. A working channel 251 is formed inside the third connector 25, and the third connector 25 is connected to the hollow guide sleeve 22 through the working channel 251.

[0037] In a specific implementation of this utility model, the first connector 23, the second connector 24, and the third connector 25 of the ductoscope sheath 2 can also be threadedly connected with a first cap, a second cap, and a third cap. The first cap, the second cap, and the third cap are detachably installed with the first connector 23, the second connector 24, and the third connector 25, respectively. Before the operation, when the first connector 23, the second connector 24, and the third connector 25 have not been inserted with the optical fiber 3, surgical instruments, or the positioning catheter 1, the first cap, the second cap, and the third cap can be used to cover the first connector 23, the second connector 24, and the third connector 25 to prevent foreign objects from entering the internal channels of the first connector 23, the second connector 24, and the third connector 25.

[0038] This invention features an optical fiber support 31 connected to one end of an optical fiber 3. A threaded sleeve 32 is threadedly connected to one end of the optical fiber support 31. The optical fiber 3 passes through the threaded sleeve 32, and one end of the threaded sleeve 32 is threadedly connected to a first connector 23 at the other end of the mirror sheath body 21. Specifically, the optical fiber 3 is a Raman spectroscopy guide fiber. Through the optical fiber support 31, the optical fiber 3 can be inserted into a hollow rigid sleeve via the first connector 23 to detect lesions within the nipple.

[0039] In this embodiment, the sheath body 21 is configured as a stepped shaft-shaped grip. A first threaded connecting sleeve 211 is fixed to one end of the sheath body 21. The side wall of the first threaded connecting sleeve 211 is provided with external threads. The front end of the hollow guide sleeve 22 is provided with a second threaded connecting sleeve 221 that mates with the first threaded connecting sleeve 211. The second threaded connecting sleeve 221 is provided with internal threads. The sheath body 21 is threadedly connected to the second threaded connecting sleeve 221 at the front end of the hollow guide sleeve 22 through the first threaded connecting sleeve 211, thereby realizing a detachable connection between the hollow guide sleeve 22 and the sheath body 21.

[0040] In other embodiments, the hollow guide sleeve 22 and the mirror sheath body 21 can also be fixed into an integral structure.

[0041] The working process of the positioning device of this utility model for locating the lesion in the mammary duct:

[0042] First, the positioning catheter 1 is inserted into the third connector 25 of the ductoscope sheath 2. The positioning catheter 1 can be guided through the hollow guide tube 22 of the ductoscope sheath 2 to be inserted into the nipple orifice of the patient and delivered to the lesion site in the duct. A length of the tail of the positioning catheter 1 is reserved outside the nipple, which can be 4-8 cm.

[0043] Then, remove the ductoscope sheath 2, leaving the positioning catheter 1 in the duct, and inject water through the water inlet 14 to inflate the water bladder 13 at the head of the positioning catheter 1, thus preventing the positioning catheter 1 from shifting.

[0044] Next, the depth of insertion of the positioning catheter 1 can be read by the scale markings exposed on the positioning catheter 1, thereby obtaining the specific distance between the lesion location and the nipple;

[0045] Finally, methylene blue is injected through the injection port of the intermediate tube 11 of the positioning catheter 1 to mark the location of the lesion in the mammary duct.

[0046] Compared with the prior art, the technical solution disclosed in the above embodiments has the following beneficial effects:

[0047] In the above embodiments, the positioning device of this utility model has scale markings on the positioning catheter 1. The depth of insertion of the positioning catheter 1 can be read through the scale markings exposed on the positioning catheter 1, which makes it easy to know the specific distance between the lesion location and the nipple. Methylene blue is injected through the injection hole of the middle tube 11 of the positioning catheter 1 to mark the location of the lesion in the mammary duct. Since the positioning catheter 1 can be inserted into any branch of the mammary duct in the nipple, it can be specifically marked with methylene blue at the location of a certain branch of the mammary duct, which improves the accuracy of lesion location. It solves the technical problems of inaccurate location of lesions in the mammary duct, large lesion resection area, and increased wound area in the patient in the prior art. It effectively improves the accuracy of diagnosis of lesion location in the mammary duct, reduces the range of methylene blue staining, and thus reduces the wound area that needs to be removed in the patient's body.

[0048] The above description is the preferred embodiment of this utility model. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of this utility model, and these improvements and modifications are also considered to be within the protection scope of this utility model.

Claims

1. A device for locating lesions within the mammary ducts, characterized in that: The positioning device includes a positioning catheter and a ductoscope sheath that cooperates with the positioning catheter. The ductoscope sheath includes a sheath body, a hollow guide sleeve, a first connector, a second connector, and a third connector for easy insertion of optical fibers. The hollow guide sleeve is located at one end of the sheath body and is connected to the interior of the sheath body. The first, second, and third connectors are spaced apart at the other end of the sheath body and are connected to the sheath body. The first, second, and third connectors are connected to the interior of the hollow guide sleeve through the sheath body. The positioning catheter includes an intermediate tube and an outer tube. The outer tube is fitted over the intermediate tube and has axially distributed graduation marks on its exterior. One end of the intermediate tube has an injection port for injecting methylene blue.

2. The device for locating intraductal lesions according to claim 1, characterized in that: The head of the outer pipe has a water bladder, and the tail of the outer pipe has a water inlet for connecting a syringe to inject water.

3. The device for locating intraductal lesions according to claim 2, characterized in that: The other end of the intermediate pipe is provided with a liquid outlet hole, which is distributed opposite to the liquid injection hole. A through channel is formed between the liquid outlet hole and the liquid injection hole so that the methylene blue can flow from the liquid injection hole to the liquid outlet hole.

4. The device for locating intraductal lesions according to claim 1, characterized in that: A water injection channel is formed between the outer pipe and the middle pipe, and the water injection channel is connected to the water injection port.

5. The device for locating intraductal lesions according to claim 1, characterized in that: The hollow guide sleeve has a length of 8 to 15 cm and an inner diameter of 0.75 to 1.2 mm.

6. The device for locating intraductal lesions according to claim 1, characterized in that: The diameter of the intermediate pipe is 0.1 to 0.2 mm, and the diameter of the outer pipe is 0.3 to 0.4 mm.

7. The device for locating intraductal lesions according to claim 5, characterized in that: The hollow guide sleeve has a guide hole at its end, and the interior of the hollow guide sleeve communicates with the guide hole.

8. The device for locating intraductal lesions according to claim 1, characterized in that: The first connector has an imaging channel inside, and the first connector is connected to the hollow guide sleeve through the imaging channel. The second connector has an instrument channel inside, so that surgical instruments can pass through. The second connector is connected to the hollow guide sleeve through the instrument channel. The third connector has a working channel inside, and the third connector is connected to the hollow guide sleeve through the working channel.

9. The device for locating intraductal lesions according to claim 8, characterized in that: One end of the optical fiber is connected to an optical fiber support, and one end of the optical fiber support is threadedly connected to a threaded sleeve. The optical fiber passes through the threaded sleeve, and one end of the threaded sleeve is threadedly connected to the first connector at the other end of the mirror sheath body.

10. The device for locating intraductal lesions according to claim 1, characterized in that: The main body of the mirror sheath is configured as a stepped shaft-shaped grip.

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