CN111001079A

CN111001079A - Mammary duct positioning device

Info

Publication number: CN111001079A
Application number: CN201911336242.7A
Authority: CN
Inventors: 周茜; 吕明明; 张金波; 陆澄; 陆迅
Original assignee: Nanjing Maternity and Child Healthcare Hospital
Current assignee: Nanjing Maternity and Child Healthcare Hospital
Priority date: 2019-12-23
Filing date: 2019-12-23
Publication date: 2020-04-14
Anticipated expiration: 2039-12-23
Also published as: CN111001079B

Abstract

The invention discloses a mammary gland catheter positioning device, which comprises an outer sleeve, an annular balloon, a sleeve end part, a ceramic sleeve core and a guide wire arranged in a catheter, wherein the outer sleeve is sleeved with the annular balloon; the annular saccule is arranged at the front end of the outer sleeve and can be fully expanded, a porous piece for limiting the forward movement limit distance of the guide wire is fixed in the ceramic sleeve, and the porous piece can contain a slurry-coating ball of the Meilan reagent. The positioning device has the characteristics of simple and convenient operation and lower cost, assists an operator to display the traveling direction of the pathological change catheter and the distance between the pathological change catheter and a nipple before an operation, makes an operation scheme before the operation for the operator, and assists the operator to completely cut off a pathological change range in the operation.

Description

Mammary duct positioning device

Technical Field

The invention relates to a diagnosis device in the medical field, in particular to a breast duct positioning device.

Background

The breast cancer is one of the most common malignant tumors of Chinese women, and the incidence rate is on the rise in the last 10 years. The key to the treatment of breast cancer is early discovery, early diagnosis and early treatment of the disease. The early stage of the disease is treated timely, and the breast cancer healing and the quality of life are greatly improved.

Nipple discharge is one of the common abnormal manifestations of the breast, and is often associated with intraductal lesions of the breast, which are also closely related to the development of breast cancer. Nipple Discharge is divided into two categories, physiological Discharge and Pathological Discharge (PND). Pathological extravasation is often manifested as one or two-sided, intermittent or persistent extravasation (at least monthly) of one or more ducts, usually pathological nipple discharge, and especially haemorrhagic nipple, suggesting ductal lesions, of which 10% to 15% are the only manifestations of breast cancer, even a fraction of early breast cancer. The early diagnosis and the early operation of the patients have great significance for improving the treatment effect and the life quality.

The width of a normal mammary duct is generally within 1mm and is not easy to see. When nipple discharge occurs, the mammary duct is widened. The existing breast ductal examination device is a ductoscope, also known as an electronic breast fiberscope. The breast endoscope system includes: the system comprises a fiberscope, a camera system, a cold light source system and a display system computer control recording system. When in use, the device needs to comprise a light guiding and guiding part, a camera shooting and light source part, an image display part and an image management and output part. When the device is used, an endoscope with the diameter of about 0.75mm is inserted from a mammary duct orifice, a fiber endoscope is pushed inwards, a medical monitor is observed, and the wall of a mammary duct, secretion and internal space occupation are observed through the monitor. The ductoscopy system has the advantages that a plurality of devices are involved, the configuration cost is high, the ductoscopy inspection operation is complex, the endoscope used for inspection is easy to damage due to small diameter, the device has the biggest problem that the endoscope cannot be effectively fixed during use, and the endoscope is easy to slip when the internal pressure of a mammary duct is too high, so that the diagnosis is not facilitated; and the glutaraldehyde is required to be used for 30-40 minutes before use, so that the wide use of large area at each time is limited, the waiting time is long, and few hospitals which carry out the examination conventionally at present cannot meet the examination requirements of a plurality of patients.

Disclosure of Invention

The purpose of the invention is as follows: the invention aims to provide a catheter positioning device which can be punctured into a focus in a breast duct, and can realize positioning influence, measurement of the distance between the focus and a nipple and irrigation/diagnosis/treatment under any condition.

The technical scheme is as follows: in order to achieve the purpose, the breast catheter positioning device comprises an outer sleeve, an annular saccule, a sleeve end part, a ceramic sleeve core and a guide wire arranged in the catheter; a cavity channel is arranged in the wall of the outer sleeve, the annular balloon is arranged at the front end of the outer sleeve, and an inflated cavity communicated with the cavity channel is arranged inside the annular balloon; the sleeve end part is provided with a front opening and a rear opening and is arranged at the front end of the annular balloon; the outer surface of the ceramic sleeve core is simultaneously bonded with the front end of the outer sleeve, the annular balloon and the rear end of the sleeve end part; a porous piece for limiting the forward movement of the guide wire to the limit distance is fixed in the ceramic sleeve core.

When the positioning device is used, the guide wire is inserted into the outer sleeve, and due to the existence of the limiting porous piece, the guide wire cannot move forwards any more when inserted into the front end of the outer sleeve, so that the puncture safety is ensured, distance scales are arranged on the guide wire, and an operator can clearly know the puncture distance. After the puncture position is punctured to a designated position, for example, under the X-ray of a molybdenum target, after the position relation between the puncture position and a lesion is determined, the catheter needs to be fixed at the designated position, the current catheters have no good fixing means, and the invention is fixed by an inflatable annular balloon, wherein the inflatable fluid comprises air or fluid. The filling direction is forward through the cavity channel in the outer sleeve until the filling direction is injected into the filling cavity of the annular balloon.

Preferably, the outer sleeve is further provided with a branch pipe, one end of the branch pipe is opened, and the other end of the branch pipe is communicated with the outer sleeve cavity channel. The branch pipe is sequentially connected with a valve, a hose and an injector. Generally, a 5ml size syringe will suffice. The selected injector is also beneficial to restoring the expanded annular saccule to the original shape through suction when the mammary duct positioning device is taken out. The valve is used for preventing backflow of high-pressure filling liquid and is also beneficial to preventing physiological nipple discharge and backflow of blood in a milk duct.

In order to ensure the connection tightness of all parts, the front end of the outer sleeve, the annular balloon and the sleeve end part are connected adjacently in sequence and are jointly bonded and fixed on the outer surface of the ceramic sleeve core. Furthermore, a tightly-coated elastic membrane sleeve is arranged at the adjacent joint of the outer sleeve, the annular balloon and the sleeve end part, and the three parts are simultaneously connected from the inner side and the outer side. In order to further improve the connection tightness, the front end of the outer sleeve and the annular balloon, and a plurality of clamping groove structures can be arranged between the annular balloon and the sleeve end part to increase the adhesive area.

In view of the foregoing, it is described that the conventional breast catheter in the breast surgery has the characteristics of small diameter and difficult implantation, and it is very difficult to add other liquid injection pipelines after the pipeline for filling the balloon is provided. Therefore, the invention adopts the technical scheme that the slurry coating ball is added into the outer sleeve, the slurry coating ball is broken by utilizing the mutual extrusion between the front end of the guide wire and the conical surface, and the specific solution flows into the puncture front end or the focus area through the opening at the front end of the sleeve end part.

Specifically, the porous piece is provided with a concave surface, the concave direction of the concave surface is the same as the implantation direction of the positioning device, and the front end of the guide wire is provided with a protrusion matched with the concave surface. The concave surface of the porous piece is a conical surface, and the porous piece is provided with a plurality of narrow holes which are distributed in a central radiation manner. One or more slurry coating balls are contained in the concave surface of the porous piece, and the slurry coating balls are made of flexible film materials and contain specific solutions; the specific solution is normal saline, methylene blue or a combination of the two.

Preferably, the front end of the guide wire is a blunt round part, and all or part of the blunt round part is made of a radiographic material. The radiographic imaging material is currently known to those skilled in the art to be a metal-containing part, such as metallic titanium, developed under an X-ray molybdenum target. The whole guide wire is designed into a material which can be developed under an X-ray molybdenum target, the trend of the catheter can be seen clearly, and the surgical incision and the surgical excision range are designed according to the trend of the catheter.

Preferably, the ceramic sleeve core is in clearance fit with the guide wire, and the inner diameter of the rear end of the ceramic sleeve core is gradually increased until the inner diameter is the same as the outer diameter. This design has guaranteed that the seal wire implantation in-process can be squeezed the package thick liquid ball in the concave surface just and has broken, and the change of ceramic cover core internal diameter makes the liquid that is extruded can only flow forward from the space of porous piece, gets into patient's mammary gland pipe. And the design is also beneficial to further refining the advancing limit distance of the guide wire implantation.

Furthermore, the outer sleeve cavity channel and the end face of the front end of the outer sleeve are at least provided with one connecting port, and each connecting port corresponds to one connecting pipe and is communicated to the filling cavity of the annular balloon. The invention can also be provided with a plurality of parallel cavities in the closed outer sleeve, which are communicated with each other to increase the flow of injection and improve the filling efficiency of the annular saccule, so that each cavity corresponds to a connecting pipe and is communicated to the filling cavity of the annular saccule.

Furthermore, the outer sleeve and the sleeve end part can be made of transparent TPU material, and the surface of the outer sleeve is provided with scale marks to help an operator to quantify the distance between a focus and a nipple.

Furthermore, the elastic membrane sleeve is made of any one of polytetrafluoroethylene, rubber and silica gel.

For the technical scheme, the outer diameter of the outer sleeve of the breast catheter positioning device is preferably not more than 1mm, and the length is generally required to be more than or equal to 80mm, because the redundant part can be left outside the body for fixation; the length of the guide wire is slightly longer than that of the outer sleeve so as to facilitate the operation, and preferably, the guide wire is provided with scales so as to facilitate the operator to read the length of the guide wire entering the outer sleeve. The maximum diameter of the expanded annular balloon is 1-2 ml, so that the necessary filling capacity of the injected liquid is ensured, and the catheter can be effectively prevented from slipping.

Has the advantages that: the breast catheter positioning device belongs to a noninvasive diagnosis instrument, has the characteristics of simple and convenient operation and lower cost, and causes little pain to patients in the diagnosis process; the device can completely display the traveling direction of the pathological change catheter and the distance between the pathological change catheter and the nipple before the operation, so as to provide help for an operator to make an operation scheme before the operation and completely excise the pathological change range in the operation and reduce the operation wound of a patient; the device designs the annular saccule which is suitable for the breast catheter to be inflated and positioned originally, provides a flexible and accurate target positioning diagnosis method by the way that the front end of the guide wire and the porous piece extrude the pulp coating ball, is matched with the existing hospital equipment for use, can help an operator to accurately position a focus, and determines the incision and cutting range of the mastectomy.

Drawings

FIG. 1 is a schematic longitudinal section of the present invention;

FIG. 2 is a schematic view of the annular balloon of the present invention in an inflated condition;

FIG. 3 is a schematic view of a guidewire tip structure according to the present invention;

fig. 4 is a schematic structural view of the porous member.

Detailed Description

The present invention is further illustrated by the following specific examples.

Example 1

As shown in fig. 1 to 3, a breast catheter positioning device comprises an outer sleeve end part 1, an outer sleeve 6, an annular balloon 3, a ceramic sleeve core 11 and a guide wire 12 arranged in a catheter.

The outer sleeve 6 is made of TPU material, 80mm and 1mm in outer diameter, a narrow cavity channel 5 is arranged in the outer sleeve 6, a branch pipe 7 is arranged on the outer sleeve 6, one end of the branch pipe 7 is opened, and the other end of the branch pipe is communicated with the cavity channel 5 of the outer sleeve 6. The branched pipe 7 is connected with a valve, a hose and a 5ml injector in sequence.

The annular sacculus 3 is located the outer tube 6 front end, and the inside of annular sacculus 3 is sufficient cavity 4 with the chamber way 5 intercommunication, and 6 chamber ways of

outer tube

5 and 6 front end terminal surfaces set up a connector at least, and every connector corresponds a connecting pipe, communicates to the sufficient cavity 4 of annular sacculus 3.

The sleeve end part 1 is opened at the front and the back and is arranged at the front end of the annular balloon 3; the outer surface of the ceramic sleeve core 11 is simultaneously bonded with the front end of the outer sleeve 6, the annular balloon 3 and the rear end of the sleeve end part 1; a porous piece 8 for limiting the forward movement limit distance of the guide wire 12 is fixed in the ceramic sleeve core 11. The front end of the outer sleeve 6, the annular balloon 3 and the sleeve end part 1 are connected adjacently in sequence and are jointly bonded and fixed on the outer surface of the ceramic sleeve core 11. The adjacent joint of the outer sleeve 6, the annular balloon 3 and the sleeve end part 1 is provided with a tightly coated polytetrafluoroethylene elastic membrane sleeve 2 which connects the three parts from the inner side and the outer side.

The porous member 8 is provided with a concave surface, the concave direction of the concave surface is the same as the implantation direction of the positioning device, one or more pulp coating balls are contained in the concave surface, the pulp coating balls are made of flexible film materials and contain specific solutions such as physiological saline, methylene blue and the like, and the film materials can be made of polyvinyl alcohol. The forward end of the guide wire 12 can be pressed against the concave surface, so that the solution can be extruded out and then flows into the focal region from the opening at the forward end of the sleeve end part 1 along with the porous member.

The guide wire 12 has a length of 90mm, and has a blunt rounded portion 9 at the tip, and the blunt rounded portion 9 is partially made of metallic titanium 14 developed under an X-ray molybdenum target as shown in FIG. 3. The whole guide wire 12 is designed into a material which can be developed under an X-ray molybdenum target, the trend of the catheter can be seen clearly, and the surgical incision and the surgical excision range are designed according to the trend of the catheter.

The outer sleeve 6 and the guide wire 12 can be designed with scale marks 13 to help the operator to quantify the distance of the focus from the nipple.

Utilize the device to combine the patient that modern imaging diagnosis nipple hemorrhage needs the operation, the visual hypoechoic pathological change in the suggestion mammary duct of earlier through the imaging inspection, the mammary duct positioner who utilizes this embodiment before the operation carries out the location before the operation, and concrete operation is: firstly, the outer sleeve 6 containing the guide wire 12 is stretched into a galactorrhea tube and slowly enters the tube, meanwhile, the distance from the top end of the B-ultrasonic detection catheter to a low-echo lesion in the galactorrhea tube is used, the direction of a B-ultrasonic probe is changed after the B-ultrasonic probe reaches the lesion, the position of the catheter is verified longitudinally, and after the B-ultrasonic probe is accurate, the guide wire 12 is extruded forwards to puncture a serous coating ball containing methylene blue, and a positioning mark is left; then the guide wire 12 is drawn out, only the soft outer sleeve 6 is left in the breast duct, then the annular saccule 3 on the outer sleeve 6 is injected with liquid through the injector, the filled annular saccule 3' is fixed in the breast duct as shown in figure 2, the duct is prevented from slipping, the rest part of the outer sleeve 6 can be pasted on the body surface of the patient through adhesive plaster, and the operation is further carried out when the follow-up operation is carried out.

Example 2

This embodiment is substantially the same as embodiment 1, and is improved in that the fitting of the porous member to the inner wall of the ceramic core is further optimized.

Referring to fig. 1 and 4, the front end of the guide wire 12 is provided with a protrusion matching with the concave surface. The concave surface of the porous member 8 is a conical surface 15, and the porous member 8 is provided with a plurality of narrow holes 16 which are distributed in a central radiation manner. One or more pulp coating balls are contained in the concave surface of the porous piece 8, and the pulp coating balls are made of flexible film materials and contain specific solutions such as physiological saline, methylene blue and the like. The radiation narrow hole design can prevent blockage and facilitate the outflow of solution.

In order to further improve the connection tightness, the front end of the outer sleeve 6 and the annular balloon 3, and a clamping groove structure is arranged between the annular balloon 3 and the sleeve end part 1 to increase the adhesive area. The ceramic sleeve core 11 is in clearance fit with the guide wire 12, and the inner diameter of the rear end of the ceramic sleeve core 11 is gradually increased until the inner diameter is the same as the outer diameter. The design can further refine the advancing limit distance of the guide wire 12 implantation, and ensure that the pulp coating ball is just pressed into the concave surface to be extruded and broken in the process of implanting the guide wire 12, and the change of the inner diameter of the ceramic sleeve core 11 enables the extruded liquid to only flow forwards from the gap of the porous piece 8 and enter the mammary duct of a patient.

The above description is only of the preferred embodiments of the present invention, and it should be noted that: it will be apparent to those skilled in the art that various modifications and adaptations can be made without departing from the principles of the invention and these are intended to be within the scope of the invention.

Claims

1. A breast duct positioning device is characterized in that: comprises an outer sleeve, an annular saccule, a sleeve end part, a ceramic sleeve core and a guide wire arranged in a catheter;

a cavity channel is arranged in the wall of the outer sleeve, the annular balloon is arranged at the front end of the outer sleeve, and an inflated cavity communicated with the cavity channel is arranged inside the annular balloon; the sleeve end part is provided with a front opening and a rear opening and is arranged at the front end of the annular balloon; the outer surface of the ceramic sleeve core is simultaneously bonded with the front end of the outer sleeve, the annular balloon and the rear end of the sleeve end part;

a porous piece for limiting the forward movement of the guide wire to the limit distance is fixed in the ceramic sleeve core.

2. The breast duct positioning device of claim 1, wherein: the front end of the outer sleeve, the annular balloon and the sleeve end part are connected adjacently in sequence and are jointly bonded and fixed on the outer surface of the ceramic sleeve core.

3. A breast duct positioning device according to claim 2, wherein: and a tightly-coated elastic membrane sleeve is arranged at the adjacent joint of the outer sleeve, the annular balloon and the sleeve end part.

4. The breast duct positioning device of claim 1, wherein: the porous piece is provided with a concave surface, the concave direction of the concave surface is the same as the implantation direction of the positioning device, and the front end of the guide wire is provided with a bulge matched with the concave surface.

5. The breast duct positioning device of claim 4, wherein: the concave surface of the porous piece is a conical surface, and the porous piece is provided with a plurality of narrow holes which are distributed in a central radiation manner.

6. The breast duct positioning device of claim 5, wherein: the guide wire front end is blunt circle portion, blunt circle portion is whole or partly by ray development material to make.

7. The breast duct positioning device of claim 1, wherein: the ceramic sleeve core is in clearance fit with the guide wire, and the inner diameter of the rear end of the ceramic sleeve core is gradually increased until the inner diameter is the same as the outer diameter.

8. The breast duct positioning device of claim 1, wherein: the outer sleeve cavity channel and the end face of the front end of the outer sleeve are at least provided with one connecting port, and each connecting port corresponds to one connecting pipe and is communicated to the filling cavity of the annular balloon.

9. The breast duct positioning device of claim 1, wherein: the outer sleeve is provided with a branch pipe, one end of the branch pipe is opened, and the other end of the branch pipe is communicated with the outer sleeve cavity channel.

10. The breast duct positioning device of claim 9, wherein: the branch pipe is sequentially connected with a valve, a hose and an injector.

11. The breast duct positioning device of claim 1, wherein: the outer sleeve and the sleeve end part are made of transparent TPU materials, and the surface of the outer sleeve is provided with scale marks.

12. The breast duct positioning device of claim 1, wherein: the elastic membrane sleeve is made of any one of polytetrafluoroethylene, rubber and silica gel.

13. The breast duct positioning device according to any one of claims 1 to 12, wherein: one or more pulp coating balls are contained in the porous piece, and the pulp coating balls are made of flexible film materials and contain specific solutions; the specific solution is normal saline, methylene blue or a combination of the two.