Ultrasound probe catheter, ultrasound endoscope inspection assembly and biopsy sampling assembly

Abstract

The utility model provides an ultrasonic probe catheter, an ultrasonic endoscope examination assembly and a biopsy sampling assembly, the ultrasonic probe catheter comprises an outer sheath tube, an ultrasonic transducer and a flexible shaft, a penetrating channel is arranged in the outer sheath tube, the flexible shaft is connected with the ultrasonic transducer, and the ultrasonic transducer and the flexible shaft are installed in the penetrating channel; the outer sheath tube is provided with a far end and a near end, the ultrasonic transducer is located at the far end of the outer sheath tube, and the far end of the outer sheath tube is used for stretching into a human body so that the ultrasonic transducer can detect the human body; a plurality of marks are arranged on the outer surface of the near end of the outer sheath tube, and the marks are arranged at intervals in the axial direction of the outer sheath tube. According to the ultrasonic probe catheter, the operation time of examination can be greatly shortened, the accuracy of focus positioning is improved, the probability of occurrence of complications of patients is reduced, the operation efficiency of doctors is improved, and the positive diagnosis rate of biopsy sampling is improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to an ultrasound probe catheter, an ultrasound endoscopy examination component, and a biopsy sampling component. Background Technology

[0002] Currently, in the clinical application of peripheral lung lesions, transbronchial lung biopsy (TBLB) guided by endobronchial ultrasound-guided sheath (EBUS-GS) has become a safe and effective biopsy sampling technique. In this technique, an endoscopic ultrasound probe, in conjunction with the guiding sheath, is inserted into the forceps channel of the electronic bronchoscope's working channel. Simultaneously, the ultrasound probe performs radial scanning, allowing the physician to observe the target tissue within the airway through an image processor. After reaching the target sampling location, the ultrasound probe is withdrawn, leaving the guiding sheath in place within the lesion. Biopsy forceps are then inserted into the same location through the guiding sheath for repeated biopsies. This technique effectively improves the positive rate of biopsy sampling.

[0003] However, inserting biopsy forceps into the same location often relies on estimating the approximate distance to the lesion. This estimation method is not precise enough to confirm the distance to the lesion, often requiring secondary or multiple repositioning operations. This significantly increases the operation time, increases the probability of complications for patients, reduces the efficiency of doctors' surgeries, and carries the risk of a decrease in the positive diagnostic rate. Utility Model Content

[0004] This application provides an ultrasound probe catheter, an ultrasound endoscopy examination component, and a biopsy sampling component, which can solve the problem of insufficient accuracy in estimating the location of lesions during biopsy sampling.

[0005] To address the aforementioned technical problems, this application provides an ultrasonic probe catheter for use in endoscopes. The ultrasonic probe catheter includes an outer sheath, an ultrasonic transducer, and a flexible shaft. The outer sheath has a penetration channel, and the flexible shaft is connected to the ultrasonic transducer. The ultrasonic transducer and the flexible shaft are installed within the penetration channel. The outer sheath has a distal end and a proximal end. The ultrasonic transducer is located at the distal end of the outer sheath, which is used to extend into the human body so that the ultrasonic transducer can detect the human body. Multiple markings are provided on the outer surface of the proximal end of the outer sheath, and the markings are arranged at intervals along the axial direction of the outer sheath.

[0006] In one embodiment, the ultrasound probe catheter further includes a guide sheath configured as a transparent guide sheath, which is fitted around the periphery of the outer sheath and is slidable relative to the guide sheath. The guide sheath has a positioning portion located radially outward of a plurality of markings for positioning the depth to which the outer sheath is inserted into the human body.

[0007] In one embodiment, the positioning portion is at least one of a pattern, text, number, protrusion, and recess.

[0008] In one embodiment, multiple marks are first scale marks, the positioning part is a second scale mark, and the multiple marks and the positioning part have different graduation values, so that the multiple marks and the positioning part constitute a vernier caliper.

[0009] In one embodiment, the graduation value of the positioning part is 0.1 mm, 0.05 mm or 0.02 mm.

[0010] In one embodiment, the markings are at least one of patterns, text, numbers, embossing, and recessing; or, the markings include multiple marking rings and multiple number markings, with a number marking disposed between two adjacent marking rings.

[0011] In one embodiment, multiple markings are arranged at predetermined intervals along the axial direction of the outer sheath.

[0012] In one embodiment, the marking is formed by ink pad printing, laser marking, or UV inkjet printing.

[0013] To address the aforementioned technical problems, this application provides an ultrasonic endoscopy examination assembly, which includes an endoscope and an ultrasonic probe catheter provided in any of the above embodiments. The endoscope has a working channel, and the ultrasonic probe catheter passes through the working channel.

[0014] To address the aforementioned technical problems, this application provides a biopsy sampling assembly, which includes a sampling tool and an ultrasound endoscopy examination assembly as provided in any of the above embodiments.

[0015] This application provides an ultrasonic probe catheter, an ultrasonic endoscopy examination assembly, and a biopsy sampling assembly. The ultrasonic probe catheter is used in an endoscope and includes an outer sheath, an ultrasonic transducer, and a flexible shaft. The outer sheath has a penetration channel, and the flexible shaft is connected to the ultrasonic transducer. The ultrasonic transducer and the flexible shaft are installed in the penetration channel. The outer sheath has a distal end and a proximal end. The ultrasonic transducer is located at the distal end of the outer sheath. The distal end of the outer sheath is used to extend into the human body so that the ultrasonic transducer can detect the human body. Multiple marks are provided on the outer surface of the proximal end of the outer sheath, and the marks are arranged at intervals along the axial direction of the outer sheath. This application features multiple spaced markers on the proximal surface of the outer sheath. When the ultrasound transducer at the distal end of the outer sheath detects a target, the physician can determine the insertion depth of the distal end of the outer sheath relative to the reference point based on the relative positions of the markers and reference points (e.g., reference points on an endoscope). This allows for the determination of the distance of the lesion relative to the reference point. Consequently, when inserting the biopsy forceps after withdrawing the outer sheath, the tip of the biopsy forceps can reach the same distance relative to the reference point for biopsy sampling. Because the outer sheath is marked, the physician can accurately determine the location of the lesion based on the markers. This significantly reduces the operation time of the examination, improves the accuracy of lesion location, reduces the probability of complications for patients, increases the efficiency of the physician's surgery, and improves the positive diagnostic rate of biopsy sampling. Attached Figure Description

[0016] Figure 1 A schematic diagram of the proximal end of an ultrasonic endoscope examination component provided in an embodiment of this application;

[0017] Figure 2 for Figure 1 A partial schematic diagram.

[0018] Reference numerals: Endoscope 10, Working channel 11, Ultrasonic probe catheter 20, Outer sheath 21, Mark 22, Marking ring 221, Numerical mark 222, Guiding sheath 23, Positioning part 231. Detailed Implementation

[0019] The present application will now be described in further detail with reference to the accompanying drawings and specific embodiments. Similar elements in different embodiments are referred to by related similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0020] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments, and the operational steps involved in each embodiment can also be rearranged or adjusted in a manner that is obvious to those skilled in the art. Therefore, the specification and drawings are only for clearly describing a particular embodiment and do not imply that they represent the necessary components and / or order.

[0021] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0022] The terms "parallel" and "perpendicular," etc., are specific to the current technological level, not absolute mathematical definitions. Slight deviations are permissible; approximations of parallelism or perpendicularity are acceptable. For example, "A and B are parallel" means that A and B are parallel or approximately parallel, with the angle between A and B ranging from 0° to 10°. Similarly, "A and B are perpendicular" means that A and B are perpendicular or approximately perpendicular, with the angle between A and B ranging from 80° to 100°. The directional terms used in the embodiments of this application, such as "upper," "inner," "outer," and "side," are merely for reference to the accompanying drawings. Therefore, the directional terms used are for better and clearer explanation and understanding of the embodiments of this application, and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.

[0023] It should be noted that the terms "front end", "distal end", and "head end" used in this application refer to the end that is closer to the inside of the human body during surgery, while the terms "rear end", "proximal end", and "tail end" used in this application refer to the end that is further away from the inside of the human body during surgery, which is usually the end held or operated by the doctor.

[0024] like Figure 1 As shown, this application provides a biopsy sampling assembly, which includes a sampling tool (not shown) and an endoscopic ultrasound examination component. This biopsy sampling assembly is primarily used in transbronchial lung biopsy. However, the biopsy sampling assembly of this application is not limited to this procedure and can also be used in other types of surgeries requiring biopsy sampling. The sampling tool may include, for example, biopsy forceps, a cell brush, a biopsy needle, etc.

[0025] This application provides an ultrasonic endoscopy examination assembly, which includes an endoscope 10 and an ultrasonic probe catheter 20. The endoscope 10 is provided with a working channel 11, and the ultrasonic probe catheter 20 can be inserted into the working channel 11. After the ultrasonic probe catheter 20 is withdrawn from the working channel 11, the working channel 11 can also be used for sampling tools to be inserted.

[0026] This application provides an ultrasonic probe catheter 20, which is used in an endoscope 10. The ultrasonic probe catheter 20 includes an outer sheath 21, an ultrasonic transducer (not shown), and a flexible shaft (not shown). The outer sheath 21 has a penetration channel (not shown), and the flexible shaft is connected to the ultrasonic transducer. The ultrasonic transducer and the flexible shaft are installed within the penetration channel. The outer sheath 21 has a distal end and a proximal end. The ultrasonic transducer is located at the distal end of the outer sheath 21, which is used to extend into the human body so that the ultrasonic transducer can detect the human body. The outer sheath 21 is typically made of multiple polymer materials fused together and has a wire-wound structure. The ultrasonic transducer mainly refers to a small, single-element ultrasonic probe, which has a piezoelectric effect and is connected to a coaxial cable. Under certain pulse excitation conditions, it can emit and receive ultrasonic signals to achieve the conversion of electrical energy into acoustic energy, and can be used to detect the location of lesions. A flexible shaft is a structure made of wound metal wires that enables torque transmission, and it is not limited to single-layer or multi-layer structures.

[0027] A plurality of marks 22 are provided on the outer surface of the proximal end of the outer sheath 21, and the marks 22 are arranged at intervals along the axial direction of the outer sheath 21. In one embodiment, the marks 22 may be at least one of the following: patterns, text, numbers, raised areas, and recesses, for example, such as... Figure 1As shown, the multiple markings 22 include multiple marking rings 221 and multiple numerical markings 222. The multiple marking rings 221 are arranged at intervals along the axial direction of the outer sheath 21, and the central axis of each marking ring 221 coincides with the central axis of the outer sheath 21. A numerical marking 222 is provided between two adjacent marking rings 221, and the multiple numerical markings 222 are also arranged at intervals along the axial direction of the outer sheath 21. Thus, different numerical markings 222 can indicate the distance between the corresponding marking ring 221 and the ultrasonic transducer. In other embodiments, the markings 22 can also be made in the style of a marking ruler. In some embodiments, the markings 22 may not include numerical markings 222. For example, multiple markings 22 can be arranged at equal intervals along the axial direction of the outer sheath 21 at a predetermined distance. For example, adjacent marking rings 221 can be arranged at equal intervals sequentially. The predetermined distance can be, for example, 1mm-3mm, such as 1mm, 2mm, 3mm, etc. The doctor only needs to know the distance between the marker ring 221 at the outermost end of the axial direction and the ultrasonic transducer, as well as the preset distance between adjacent marker rings 221, to calculate the distances between the other marker rings 221 and the ultrasonic transducer. However, this method does not include the intuitive marking of the numerical marker 222. In one embodiment, the marker 22 is formed using ink pad printing, laser marking, or UV inkjet printing to prevent wear of the marker 22 after multiple surgeries.

[0028] In use, the endoscope 10 is first inserted into the body through the body's natural passage. Then, the ultrasound transducer and flexible shaft inside the outer sheath 21 are passed through the working channel 11 of the endoscope 10 and inserted into the body. When the ultrasound transducer detects the location of the sampling target, the reference surface (e.g., the proximal end face of the endoscope 10) or reference point will be opposite to a mark 22 on the proximal end of the outer sheath 21. Therefore, the distance H represented by the mark 22 opposite to the reference point is the distance H between the sampling target and the reference point. Thus, the doctor can determine the specific location of the sampling target. The outer sheath 21 of the ultrasound probe catheter 20 is then withdrawn from the working channel 11. A mark can be made on the examination tool at a distance H from the tip of the examination tool. The examination tool is then inserted into the working channel 11 so that the mark on the examination tool is aligned with the reference surface. At this point, the tip of the examination tool has reached the location of the sampling target, and a biopsy can be performed. Because the outer sheath 21 is marked with markers 22, doctors can accurately determine the location of the lesion based on these markers. This significantly reduces examination time, improves the accuracy of lesion location, lowers the probability of complications, increases surgical efficiency, and raises the positive diagnostic rate of biopsy samples. Especially when markers 22 include numerical markers 222, doctors can quickly read the value of the corresponding numerical markers 222 externally, greatly improving surgical efficiency.

[0029] In one embodiment, the proximal end of the examination tool may also have a marking, which may be at least one of a pattern, text, number, raised surface, and recess. Preferably, the marking includes a number, so that the doctor does not need to measure and mark the examination tool each time, but can directly insert the examination tool into the working channel 11, and determine whether the examination tool is inserted in place by the relative position of the number on the marking and the reference surface.

[0030] In one embodiment, such as Figure 1 As shown, the ultrasound probe catheter 20 also includes a guide sheath 23, which is a catheter composed of a polymer material, a radiopaque metal ring, and other components. The guide sheath 23 is configured to be transparent, for example, it can be made of a fully transparent or semi-transparent material. The guide sheath 23 is fitted around the outer periphery of the outer sheath 21, and the outer sheath 21 can slide relative to the guide sheath 23. The proximal end of the guide sheath 23 has a positioning part 231, which is located radially outward of a plurality of marks 22 after the outer sheath 21 is inserted into the guide sheath 23, for positioning the depth of the outer sheath 21 inserted into the human body.

[0031] In use, the endoscope 10 is first inserted into the body through the body's natural passage. Then, the outer sheath 21, which is fitted with a guide sheath 23, and the ultrasound transducer and flexible shaft inside the outer sheath 21 are passed through the working channel 11 of the endoscope 10 and inserted into the body. When the ultrasound transducer detects the location of the sampling target, the positioning part 231 of the guide sheath 23 will be aligned with a mark 22 on the proximal end of the outer sheath 21. Therefore, the distance L indicated by the mark 22 opposite to the positioning part 231 is the distance L between the sampling target and the positioning part 231. Thus, the doctor can determine the specific location of the sampling target. The endoscope 10 and the guide sheath 23 are then kept in their current positions, and the outer sheath 21 is withdrawn from the guide sheath 23. A mark is made on the examination tool at a distance L from the tip of the examination tool. The examination tool is then inserted into the working channel 11 so that the mark on the examination tool is aligned with the positioning part 231. At this point, the tip of the examination tool has reached the location of the sampling target, and a biopsy can be performed. Preferably, the inner diameter of the guide sheath 23 is slightly larger than the outer diameter of the outer sheath 21. This makes it easier for doctors to read the reading on the mark 22 on the outer sheath 21 opposite to the positioning part 231. By setting the guide sheath 23, the positioning part 231 on the guide sheath 23 can be closer to the mark 22 on the outer sheath 21, minimizing the deviation of the reading and improving the accuracy of locating the lesion.

[0032] In other embodiments, the physician may also perform the examination without using the guiding sheath 23, using only the endoscope 10, the outer sheath 21, the ultrasound transducer, and the flexible shaft. The insertion depth of the outer sheath 21 can be determined by the change in the relative position of the mark 22 on the outer sheath 21 relative to the endoscope 10.

[0033] In one embodiment, the positioning part 231 is at least one of the patterns, text, numbers, protrusions and recesses provided on the guide sheath 23.

[0034] In one embodiment, such as Figure 2 As shown, multiple marks 22 are first scale marks, and the positioning part 231 is a second scale mark. The scale division values ​​of the multiple marks 22 and the positioning part 231 are different, so that the multiple marks 22 and the positioning part 231 constitute a vernier caliper. The scale marks are typically composed of equally spaced graphics and numbers, such as the style of scale marks on a ruler, or as described in this application. Figure 1 As shown, the markings consist of equally spaced marking rings 221 and numerical markings 222 between the marking rings 221. Markings 222 similar to the above style can be considered as scale markings. The graduation value of the positioning part 231 can be 0.1 mm, 0.05 mm, or 0.02 mm. The accuracy of the first scale marking is lower than that of the positioning part 231. Therefore, the outer sheath 21 can be compared to the main scale on a vernier caliper, and the guide sheath 23 can be compared to the vernier scale. A highly accurate value for the insertion depth of the outer sheath 21 can be obtained by reading the alignment line of the first and second scale markings. By making the outer sheath 21 and guide sheath 23 into vernier calipers, the accuracy of lesion location during surgery can be further improved.

[0035] The above examples illustrate this application only to aid in understanding the invention and are not intended to limit the scope of the application. Those skilled in the art to which this application pertains can make various simple deductions, modifications, or substitutions based on the concept of this application.

Claims

1. An ultrasonic probe catheter applied to an endoscope, characterized by, The ultrasonic probe catheter comprises an outer sheath, an ultrasonic transducer and a soft shaft, the outer sheath is provided with a penetrating channel, the soft shaft is connected with the ultrasonic transducer, and the ultrasonic transducer and the soft shaft are installed in the penetrating channel; the outer sheath has a distal end and a proximal end, the ultrasonic transducer is located at the distal end of the outer sheath, the distal end of the outer sheath is used to extend into a human body so that the ultrasonic transducer can detect the human body, and a plurality of marks are arranged on the outer surface of the proximal end of the outer sheath.

2. The ultrasonic probe catheter of claim 1, wherein, The ultrasonic probe catheter further comprises a guide sheath, the guide sheath is configured as a transparent guide sheath, the guide sheath is sleeved on the outer periphery of the outer sheath, the outer sheath can slide relative to the guide sheath, the guide sheath has a positioning part, and the positioning part is located on the radial outside of the plurality of marks to position the depth of the outer sheath extending into the human body.

3. The ultrasonic probe catheter of claim 2, wherein, The positioning part is at least one of a pattern, a character, a number, a protrusion and a recess.

4. The ultrasonic probe catheter of claim 2, wherein, The plurality of marks are first scale marks, the positioning part is a second scale mark, and the scale values of the plurality of marks and the positioning part are different, so that the plurality of marks and the positioning part constitute a vernier caliper.

5. The ultrasonic probe catheter of claim 4, wherein, The scale value of the positioning part is 0.1 mm, 0.05 mm or 0.02 mm.

6. The ultrasonic probe catheter according to any one of claims 1 to 5, characterized in that The marks are at least one of a pattern, a character, a number, a protrusion and a recess, or the plurality of marks comprise a plurality of mark rings and a plurality of number marks, and one number mark is arranged between two adjacent mark rings.

7. The ultrasonic probe catheter of claim 6, wherein, The plurality of marks are arranged at equal intervals along the axial direction of the outer sheath according to a preset distance.

8. The ultrasonic probe catheter according to any one of claims 1-5, characterized in that, The marks are formed by means of ink pad printing, laser marking or UV inkjet printing.

9. An ultrasonic endoscopy assembly, characterized by The ultrasonic endoscopy assembly comprises an endoscope and the ultrasonic probe catheter according to any one of claims 1-8, the endoscope is provided with a working channel, and the ultrasonic probe catheter penetrates the working channel.

10. A biopsy sampling assembly comprising: The ultrasonic endoscopy assembly comprises a sampling tool and the ultrasonic endoscopy assembly according to claim 9.

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