Mammary gland sheathing canal and mammary gland duct inspection device

By designing breast sheath tubes and breast duct examination devices, the OCT probe is introduced into the breast duct and injected into fluid, the problem that the existing technology cannot effectively check the inside of the breast duct is solved, and accurate examination and minimally invasive treatment of deep breast duct lesions are achieved. .

CN119279512APending Publication Date: 2025-01-10BEIJING CHINESE MEDICINE HOSPITAL AFFILIATED CAPITAL MEDICAL UNIV
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Patent Information

Application Number
CN202411549499.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-11-01
Publication Date
2025-01-10

AI Technical Summary

Technical Problem

The existing breast duct examination methods cannot effectively enter the breast duct, and optical coherence tomography technology is difficult to apply to breast duct examination. The reasons include extremely fine catheters, foreign body contraction and secretion interference, resulting in insufficient examination accuracy.

Method used

A mammary sheath and breast duct examination device was designed to introduce the OCT probe into the breast duct through the mammary sheath, and fluid is injected into the catheter to remove secretions, improving the accuracy of the examination.

Benefits of technology

Deep lesions inside the breast duct were realized, which improved the accuracy and diagnostic efficacy of the examination, and enhanced the possibility of minimally invasive treatment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a mammary gland sheathing canal and a mammary gland duct inspection device. The mammary gland sheathing canal comprises a holding column which comprises a first end and a second end which are opposite to each other; the pipe body is arranged at the first end of the holding column, and a guide hole is formed in the pipe body; the first connector is arranged at the second end of the holding column, and the first connector is communicated with the guide hole of the tube body and used for guiding an OCT probe into the guide hole; the second connector is arranged at the second end of the holding column, and the second connector communicates with the guide hole of the pipe body and is used for injecting fluid into the guide hole. The mammary gland sheathing canal can enter the mammary gland catheter, and the OCT probe can penetrate into the mammary gland sheathing canal to examine the interior of the mammary gland catheter.
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Description

Technical Field

[0001] The present application relates to the field of medical equipment, and in particular to a breast sheath and a breast duct inspection device. Background Art

[0002] Breast disease is one of the most common diseases among women. Breast examination methods include: breast X-ray examination, breast ultrasound examination, breast MRI examination, etc. However, none of the above examination methods can enter the breast duct. Ductoscopy can enter the breast duct and has the advantage of directly observing the lesions in the breast duct, but this method still has certain limitations. Its resolution is limited, and it can only observe the surface of the breast duct. The light source is not penetrating enough, and it cannot observe deep lesions.

[0003] The inspection device based on optical coherence tomography (OCT) technology can obtain images of deep tissue lesions, but OCT technology is difficult to apply to the internal examination of breast ducts for the following reasons:

[0004] 1. The mammary ducts are extremely thin and contract when encountering foreign objects, making it difficult for the OCT light source to enter directly for examination.

[0005] 2. There are secretions in normal breast ducts, which will interfere with the image acquisition after OCT enters the breast duct for examination. Summary of the invention

[0006] Based on the above problems, the present application provides a breast sheath and a breast duct inspection device, which applies OCT technology to breast duct inspection.

[0007] In a first aspect, the present application provides a breast sheath tube, comprising:

[0008] a gripping post including opposing first and second ends;

[0009] A tube body, arranged at the first end of the holding column, the tube body being provided with a guide hole;

[0010] A first interface, disposed at the second end of the holding column, the first interface being connected to the guide hole of the tube body and used to guide the OCT probe into the guide hole;

[0011] The second interface is arranged at the second end of the holding column, the second interface is connected to the guide hole of the tube body, and is used to inject fluid into the guide hole.

[0012] According to some embodiments of the present application, the breast sheath tube further includes a third interface, which is disposed at the second end of the holding column, the third interface is connected to the guide hole of the tube body, and the third interface can be connected to an invasive device.

[0013] According to some embodiments of the present application, the length of the tube body is 5 to 15 cm, and the inner diameter of the tube body is 0.2 to 2 mm.

[0014] According to some embodiments of the present application, the outer wall of the tube body is provided with a scale.

[0015] In a second aspect, the present application provides a breast duct inspection device, comprising:

[0016] Mammary sheath as described above;

[0017] An OCT probe, capable of passing through the first interface of the breast sheath tube and entering the guide hole of the tube body;

[0018] An OCT imaging device, connected to the OCT probe, and used to display images acquired by the OCT probe;

[0019] A delivery device is connected to the second interface of the breast sheath tube and is used to inject fluid / gas into the second interface.

[0020] According to some embodiments of the present application, the OCT probe includes:

[0021] Bourdon tube;

[0022] A support tube connected to one end of the spring tube, wherein a light-transmitting hole is provided on a side wall of the support tube;

[0023] A first optical fiber passes through the spring tube and enters the support tube;

[0024] A microlens, disposed between the first optical fiber and the light-transmitting hole;

[0025] A micro-reflector, used for reflecting the light emitted from the micro-lens to the light-transmitting hole, and / or reflecting the light entering the light-transmitting hole to the micro-lens;

[0026] A rotary connector, connecting the spring tube and the first optical fiber respectively;

[0027] A first driver, used for driving the rotary connector to rotate;

[0028] The second optical fiber is respectively connected to the rotary connector and the OCT imaging device.

[0029] According to some embodiments of the present application, the OCT probe further includes: a translation mechanism, wherein the translation mechanism is used to drive the rotary connector to translate.

[0030] According to some embodiments of the present application, the translation mechanism includes:

[0031] Pedestal;

[0032] A bracket, slidably disposed on the base, the rotary connector and the first driver are both disposed on the bracket, and the bracket is provided with a threaded hole;

[0033] A second driver is disposed on the base;

[0034] A lead screw is connected to the output end of the second driver, and the lead screw is adapted to the threaded hole of the bracket.

[0035] According to some embodiments of the present application, the support tube includes a thick-walled portion and a thin-walled portion that are connected to each other, and the microlens and the microreflector are both arranged in the thin-walled portion.

[0036] According to some embodiments of the present application, the breast duct inspection device further includes an invasive device, which can pass through the third interface of the breast sheath tube and enter the guide hole of the tube body.

[0037] The mammary sheath of the present application can enter the mammary duct, and the OCT probe can penetrate the mammary sheath to inspect the inside of the mammary duct. When performing OCT inspection on the mammary duct, fluid can be injected into the mammary duct through the mammary sheath to clear the secretions in the mammary duct and improve the accuracy of the inspection. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to more clearly illustrate the technical solution of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without exceeding the scope of protection required by the present application.

[0039] Figure 1 is a schematic diagram of a breast sheath tube according to an embodiment of the present application;

[0040] Figure 2 is a cross-sectional view of a breast sheath tube according to an embodiment of the present application;

[0041] Figure 3 is a schematic diagram of a split breast sheath tube according to an embodiment of the present application;

[0042] Figure 4 is a schematic diagram of the first interface, the second interface and the third interface of the embodiment of the present application;

[0043] Figure 5 is a schematic diagram of connecting the first interface and the second interface of an embodiment of the present application to an external device;

[0044] Figure 6 is a schematic diagram of a mammary duct inspection device according to an embodiment of the present application;

[0045] Figure 7 is a schematic diagram of an OCT probe according to an embodiment of the present application;

[0046] Figure 8 is a schematic diagram of another OCT probe according to an embodiment of the present application;

[0047] Fig. 9 It is a schematic diagram of the support tube of the embodiment of the present application. DETAILED DESCRIPTION

[0048] The following is a clear and complete description of the technical solution of the present application in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present application.

[0049] like Figure 1 As shown, an embodiment of the present application provides a breast sheath tube 10, which includes a holding column 11, a tube body 12, a first interface 13 and a second interface 14. The breast sheath tube 10 can penetrate into the breast duct to provide guidance for the OCT probe so as to apply OCT (optical coherence tomography) technology to the inspection inside the breast duct. Optionally, the breast sheath tube 10 is made of metal.

[0050] like Figure 2 As shown, the gripping column 11 includes a first end 11a and a second end 11b opposite to each other. Optionally, the gripping column 11 is in the shape of a stepped shaft, including a large diameter portion 111 and a small diameter portion 112 connected to each other, the first end 11a is located at the small diameter portion 112, and the second end 11b is located at the large diameter portion 111. An opening 113 is provided on the end surface of the first end 11a, and the opening 113 extends along the axis of the gripping column 11, and one end of the opening 113 is open. The diameters of the large diameter portion 111 and the small diameter portion 112 are set according to requirements, for example, the diameter of the large diameter portion 111 is 30 mm, and the diameter of the small diameter portion 112 is 20 mm.

[0051] The tube body 12 is disposed at the first end 11a of the holding column 11. Optionally, the axis of the tube body 12 is colinear with the axis of the holding column 11. The tube body 12 is provided with a guide hole 121, which is a through hole and extends along the axis of the tube body 12. The guide hole 121 is connected to the opening 113.

[0052] like Figure 3As shown, optionally, the tube body 12 is detachably connected to the gripping column 11. The first end 11a of the gripping column 11 is provided with a boss 114, the side wall of the boss 114 is provided with an external thread, and the end of the tube body 12 is provided with an internal thread that matches the external thread of the boss 114, so as to realize the detachable connection between the tube body 12 and the gripping column 11. As needed, the tube body 12 and the gripping column 11 can also be integrally formed.

[0053] like Figure 4 and Figure 5 As shown, the first interface 13 is provided at the second end 11b of the holding column 11, and the first interface 13 is connected to the guide hole 121 of the tube body 12, and the first interface 13 can guide the OCT probe 20 into the guide hole 121. The aperture of the guide hole 121 is larger than the outer diameter of the OCT probe. For example, the first interface 13 is provided with a first through hole 131, and the first through hole 131 is connected to the opening 113. The OCT probe 20 passes through the first through hole 131 and the opening 113 and enters the guide hole 121. The end of the OCT probe extends out of the bottom end of the guide hole 121. The tube body 12 is inserted into the mammary duct, and the OCT probe can inspect the inside of the mammary duct.

[0054] The second interface 14 is provided at the second end 11b of the holding column 11, and the second interface 14 is connected to the guide hole 121 of the tube body 12, and is used to inject fluid into the guide hole 121. Optionally, the fluid is a liquid or a gas, for example, the fluid is a cleaning fluid. The second interface 14 is provided with a second through hole 141, and the second through hole 141 is connected to the opening 113. The fluid injected by the second interface 14 enters the mammary duct through the second through hole 141, the opening 113 and the guide hole 121 to clean the inside of the mammary duct, which is beneficial for the OCT probe 20 to obtain a clear inspection image. When the OCT probe is located in the guide hole 121, the fluid flows in the gap between the OCT probe and the guide hole 121.

[0055] Optionally, the delivery device is connected to the second interface 14 via a connecting tube 41 , and the delivery device can deliver fluid to the second interface 14 . The connecting tube 41 is a flexible tube.

[0056] The breast sheath tube 10 of this embodiment provides a channel for the OCT probe to enter the mammary duct, so that the OCT technology is applied to the inspection of the inside of the mammary duct. When in use, the OCT probe 20 is sent into the tube body 12 through the first interface 13, the connecting tube 41 is connected to the second interface 14, the tube body 12 enters the mammary duct along the diseased nipple, and the end of the OCT probe 20 extends out of the tube body 12 to inspect the mammary duct. When the mammary duct needs to be flushed, the delivery device is started to inject the cleaning fluid into the mammary duct.

[0057] In some embodiments, the breast sheath tube 10 further includes a third interface 15, which is disposed at the second end 11b of the holding column 11, and the third interface 15 is connected to the guide hole 121 of the tube body 12. For example, the third interface 15 is provided with a third through hole 151, and the third through hole 151 is connected to the opening 113 to connect the third through hole 151 to the guide hole 121. The third interface 15 is used to connect an invasive device, for example, to connect a puncture device or a surgical sampling device such as an ablation / net basket.

[0058] The lesion position in the mammary duct is detected by the OCT probe, and the lesion position is located by the mammary sheath 10 . The invasive device is connected to the third interface 15 , and the invasive device passes through the tube body 12 to perform an invasive operation on the lesion position.

[0059] Optionally, when performing an invasive operation, it is determined as needed whether to remove the OCT probe from the breast sheath 10. For example, if there is enough space for the invasive operation, it is not necessary to remove the OCT probe from the breast sheath 10.

[0060] like Figure 3 As shown, in some embodiments, the length L of the tube body 12 is 5 to 15 cm, and the inner diameter D of the tube body 12 is 0.2 to 2 mm. The tube body 12 can be prepared into various models to meet the needs of different patients.

[0061] In some embodiments, a scale (not shown) is disposed on the outer wall of the tube body 12. The scale is used to remind the operator of the depth of the tube body 12 entering the mammary duct.

[0062] like Figure 6 As shown, an embodiment of the present application provides a breast duct inspection device 100, which includes the breast sheath 10, the OCT probe 20, the OCT imaging device 30 and the conveying device 40 as described above.

[0063] The OCT probe 20 can pass through the first interface 13 of the breast sheath tube 10 and enter the guide hole 121 of the tube body 12. For example, the OCT probe 20 is detachably connected to the first interface 13, and the inspection end 20a of the OCT probe 20 passes through the first through hole 131, the opening 11 and the guide hole 121, and extends out of the guide hole 121.

[0064] The OCT imaging device 30 is connected to the OCT probe 20 and is used to display the image acquired by the OCT probe 20. The OCT imaging device 30 can use an existing OCT imaging device, and the OCT imaging device 30 can convert the optical signal collected by the OCT probe 20 into a digital signal to display an OCT real-time image, which is convenient for accurate diagnosis of breast diseases. Optionally, the OCT imaging device 30 also has the function of storing and analyzing the inspection image.

[0065] The delivery device 40 is connected to the second interface 14 of the breast sheath tube 10, for example, the delivery device 40 is connected to the second interface 14 through a connecting tube 41. The delivery device 40 can inject fluid into the second interface 14, and the breast sheath tube 10 guides the fluid into the breast duct to clean the breast duct so as to obtain a clearer inspection image. Optionally, the delivery device 40 is a delivery pump.

[0066] When using the mammary duct inspection device 100 of this embodiment, the OCT probe 20 and the delivery device 40 are respectively connected to the mammary sheath 10, and the OCT probe 20 is connected to the OCT imaging device 30. The tube body 12 enters the mammary duct through the diseased nipple, the OCT probe 20 obtains a three-dimensional structural image inside the mammary duct, and the OCT imaging device 30 displays the acquired image in real time.

[0067] like Figure 7 As shown, in some embodiments, the OCT probe 20 includes: a spring tube 21, a support tube 22, a first optical fiber 23, a microlens 24, a micromirror 25, a rotary connector 26, a first driver 27 and a second optical fiber 28. Figure 7 The arrow in the middle is the direction of light propagation.

[0068] One end of the spring tube 21 connected to the support tube 22, optionally, the support tube 22 is a metal hard tube, which is not easy to deform. The side wall of the support tube 22 is provided with a light-transmitting hole 221. The first optical fiber 23 passes through the spring tube 21 and enters the support tube 22. Optionally, the end of the first optical fiber 23 is fixed to the support tube 22 by adhesive glue, and the support tube 22 and the spring tube 21 are fixed by adhesive glue. The microlens 24 is arranged between the first optical fiber 23 and the light-transmitting hole 221, and the microlens 24 can prevent external substances from entering the first optical fiber 23 and avoid contamination of the first optical fiber 23. The light emitted by the first optical fiber 23 can pass through the microlens 24. The micro-reflector 25 is arranged on the side of the light-transmitting hole 221 away from the microlens 24, and the micro-reflector 25 can reflect the light emitted by the microlens 24 to the light-transmitting hole 221, and the light is irradiated to the inner wall of the mammary duct 200 through the light-transmitting hole 221.

[0069] The mammary duct 200 reflects the light emitted from the light transmission hole 221 to form an inspection light. The inspection light passes through the light transmission hole 221 and enters the micro-reflector 25 , and is reflected by the micro-reflector 25 to the micro-lens 24 . The inspection light transmitted by the micro-lens 24 enters the first optical fiber 23 .

[0070] One side of the rotary connector 26 is respectively connected to the spring tube 21 and the first optical fiber 23. The rotary connector 26 uses an existing optical fiber rotary connector. The spring tube 21 has a torque transmission function. The rotary connector 26 can drive the spring tube 21 and the first optical fiber 23 to rotate, and the spring tube 21 drives the support tube 22 to rotate accordingly, so as to collect more comprehensive internal images of the mammary duct 200.

[0071] The first driver 27 is used to drive the rotary connector 26 to rotate. Optionally, the first driver 27 is a motor. The first driver 27 is connected to the rotary connector 26 via a flexible belt 271 .

[0072] The second optical fiber 28 is respectively connected to the other side of the rotary connector 26 and the OCT imaging device 30. The inspection light is sequentially transmitted through the first optical fiber 23, the rotary connector 26 and the second optical fiber 28 to the OCT imaging device 30, and the OCT imaging device 30 converts the optical signal into a digital signal to display the OCT real-time image.

[0073] like Figure 8 As shown, in some embodiments, the OCT probe 20 further includes a translation mechanism 29. The translation mechanism 29 connects the rotary connector 26 and the first driver 27, and the translation mechanism 29 can drive the rotary connector 26 to translate, thereby driving the inspection end 20a of the OCT probe 20 to translate, so as to better obtain a three-dimensional structural image inside the breast duct.

[0074] In some embodiments, the translation mechanism 29 includes: a base 291 , a bracket 292 , a second driver 293 and a screw rod 294 .

[0075] The bracket 292 is slidably disposed on the base 291. For example, a guide rail 295 is disposed on the base 291, and the bracket 292 is slidably disposed on the guide rail 295. The rotary connector 26 and the first driver 27 are both disposed on the bracket 292, and the bracket 292 can drive the rotary connector 26 and the first driver 27 to translate. The bracket 292 is provided with a threaded hole.

[0076] The second driver 293 is disposed on the base 291, and optionally, the second driver 293 is a motor. The screw rod 294 is connected to the output end of the second driver 293, and the screw rod 294 is adapted to the threaded hole of the bracket 292. The rotation of the screw rod 294 can drive the bracket 292 to translate along the guide rail 295. Optionally, the first driver 27 and the second driver 293 are both controlled by an existing control method.

[0077] like Fig. 9 As shown, the support tube 22 includes a thick-walled portion 222 and a thin-walled portion 223 connected to each other, and the end of the thin-walled portion 223 is connected to one end of the thick-walled portion 222. The microlens 24 and the microreflector 25 are both arranged in the thin-walled portion 223. The wall thickness of the thin-walled portion 223 is less than the wall thickness of the thick-walled portion 222, and the aperture of the thin-walled portion 223 is larger than the aperture of the thick-walled portion 222, which facilitates the installation of the microlens 24 and the microreflector 25.

[0078] In some embodiments, the breast duct inspection device 100 further includes an invasive device (not shown in the figure), which can pass through the third interface 15 of the breast sheath tube 10 and enter the guide hole 121 of the tube body 12. When the third interface 15 is not in use, the third through hole 151 of the third interface 15 is sealed with a sealing plug to reduce the possibility of contamination of the third interface 15.

[0079] Optionally, the invasive device includes at least one of a puncture device, an ablation device, a laser generating device, and a surgical device. The breast duct inspection device 100 of this embodiment applies OCT technology to the inspection of the inside of the breast duct, and can locate the lesion through the breast sheath, and based on this positioning, perform corresponding positioning, sampling or treatment, thereby enhancing the diagnostic efficiency of lesions in the breast duct, improving the accuracy of the internal inspection of the breast duct, and being more minimally invasive in treatment.

[0080] The embodiments of the present application are described in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only used to help understand the technical solution and core ideas of the present application. Therefore, changes or deformations made by those skilled in the art based on the ideas of the present application, the specific implementation methods and the scope of application of the present application, all belong to the scope of protection of the present application. In summary, the contents of this specification should not be construed as limiting the present application.

Claims

1. A breast sheath, characterized in that: include: a gripping post including opposing first and second ends; A tube body, arranged at the first end of the holding column, the tube body being provided with a guide hole; A first interface, disposed at the second end of the holding column, the first interface being connected to the guide hole of the tube body and used to guide the OCT probe into the guide hole; The second interface is arranged at the second end of the holding column, the second interface is connected to the guide hole of the tube body, and is used to inject fluid into the guide hole.

2. The breast sheath according to claim 1, characterized in that: It also includes a third interface, which is arranged at the second end of the holding column, the third interface is connected to the guide hole of the tube body, and the third interface can be connected to an invasive device.

3. The breast sheath according to claim 1, characterized in that: The length of the tube body is 5 to 15 cm, and the inner diameter of the tube body is 0.2 to 2 mm.

4. The breast sheath according to claim 1, characterized in that: The outer wall of the tube body is provided with a scale.

5. A mammary duct inspection device, characterized in that: include: The breast sheath according to any one of claims 1 to 4; An OCT probe, capable of passing through the first interface of the breast sheath tube and entering the guide hole of the tube body; An OCT imaging device, connected to the OCT probe, and used to display images acquired by the OCT probe; A delivery device is connected to the second interface of the breast sheath tube and is used to inject fluid into the second interface.

6. The mammary duct inspection device according to claim 5, characterized in that: The OCT probe comprises: Bourdon tube; A support tube connected to one end of the spring tube, wherein a light-transmitting hole is provided on a side wall of the support tube; A first optical fiber passes through the spring tube and enters the support tube; A microlens, disposed between the first optical fiber and the light-transmitting hole; A micro-reflector, used for reflecting the light emitted from the micro-lens to the light-transmitting hole, and / or reflecting the light entering the light-transmitting hole to the micro-lens; A rotary connector, connecting the spring tube and the first optical fiber respectively; A first driver, used for driving the rotary connector to rotate; The second optical fiber is respectively connected to the rotary connector and the OCT imaging device.

7. The mammary duct inspection device according to claim 6, characterized in that: The OCT probe further comprises: The translation mechanism is used to drive the rotary connector to translate.

8. The mammary duct inspection device according to claim 7, characterized in that: The translation mechanism comprises: Pedestal; A bracket, slidably disposed on the base, the rotary connector and the first driver are both disposed on the bracket, and the bracket is provided with a threaded hole; A second driver is disposed on the base; A lead screw is connected to the output end of the second driver, and the lead screw is adapted to the threaded hole of the bracket.

9. The mammary duct inspection device according to claim 6, characterized in that: The support tube comprises a thick-walled portion and a thin-walled portion connected to each other, and the microlens and the microreflector are both arranged in the thin-walled portion.

10. The breast duct inspection device according to claim 5, characterized in that: An invasive device is also included, and the invasive device can pass through the third interface of the breast sheath tube and enter the guide hole of the tube body.