WO2023217274A1 - Visual puncture drainage apparatus - Google Patents

Abstract

The present application relates to a visual puncture drainage apparatus. The visual puncture drainage apparatus comprises a sheath tube and a sheath clip inner core, wherein the sheath tube comprises a hollow tubular opening structure and a rear functional base; the sheath clip inner core comprises a tubular inner core body, a puncture tip located at the far end, and an imaging objective lens; a sheath clip is detachably matched with the sheath clip inner core; when the sheath tube is matched with the sheath clip inner core, the sheath clip inner core is contained in the sheath tube and extends along an axial direction, and the tip at the far end thereof extends out of the sheath tube; the imaging objective lens is arranged inside the tip; and the visual puncture drainage device is configured to: under imaging assistance of a visual system, safely establish, by means of obtuse puncture of the tip, a channel of the outside of a human body with the inside of a body cavity, so as to collect images from a target body cavity in real time. According to the present application, a camera device is implanted into a puncture apparatus, such that the whole puncture process is visualized, execution is not carried out only according to the personal experience-based judgment of a doctor any more, and therefore a puncture operation is safer and more reliable; in addition, the occupied area of the device and the equipment cost are greatly reduced.

Description

Visual puncture and drainage device Technical field

The present application relates to the field of medical devices, and in particular to a visual puncture and drainage device.

Background technique

Chest closed drainage is a necessary surgical treatment method in postoperative wards, emergency rooms, first aid outside hospitals, and battlefield conditions. In an informal operating room, the puncture process is a blind operation under non-visual conditions, relying solely on the operating doctor's own experience. It is very easy to accidentally injure intercostal blood vessels, lung tissue, and important mediastinal organ structures, and may cause damage to the drainage tube. The placement position is deviated and the processing is unsuccessful. Therefore, a visual thoracic closed drainage auxiliary guidance device is very important. In addition, in addition to helping to complete closed chest drainage under visualization, the demand for various functions such as assisting local anesthesia and liquid biopsy of pleural tissue also needs to be met urgently.

Contents of the invention

The purpose of this application is to provide a visual thoracentesis guidance device to avoid iatrogenic damage caused by abnormal pleural cavity conditions (adhesion, abnormal spatial relationship), and to safely complete difficult positions such as the chest top and mediastinum surface. of deep drainage.

In one aspect of this application, a visual puncture and drainage device is disclosed, which includes: a sheath tube and a sheath card inner core, wherein the sheath tube includes a hollow tubular opening structure and a functional base at the rear; the sheath card inner core includes a tubular inner core The body, the puncture tip located at the distal end, and the imaging objective lens; the sheath card and the inner core of the sheath card are detachably matched;

When the sheath tube is matched with the inner core of the sheath card, the inner core of the sheath card is accommodated in the sheath tube and extends axially, and its distal end The tip extends out of the sheath; an imaging objective lens is provided inside the tip;

The visual puncture and drainage device is configured to safely establish channels outside the human body and within the body cavity through sudden puncture with the aid of the visual system, and collect images from the target body cavity in real time.

In a preferred example, the imaging objective lens is disposed inside the tip at a distance of 5 mm to 20 mm from the end.

In a preferred example, the sheath card inner core further includes an LED assembly, and the LED assembly includes an LED light source disposed at the proximal end of the sheath card inner core, and an optical fiber, wherein the optical fiber connects the LED light source to the tip.

In a preferred embodiment, an axially extending instrument channel is provided on the inner core of the sheath card, and the instrument channel is configured to advance diagnostic and treatment tools therein.

In a preferred embodiment, the diagnostic and treatment tool is selected from any one of the following: biopsy forceps, biopsy brush, and drug delivery device.

In a preferred embodiment, the instrument channel is provided on the peripheral wall surface of the inner core of the sheath card and is a downwardly depressed groove, or

The instrument channel is arranged inside the peripheral wall of the inner core of the sheath card and is a groove with a cavity in the peripheral wall.

In a preferred example, the depth of field range of the imaging objective lens is 3-100 mm.

In a preferred example, the outer diameter of the sheath ranges from 8mm to 16mm; the inner diameter ranges from 5mm to 10mm.

In a preferred example, the outer diameter of the inner core of the sheath card ranges from 5 mm to 10 mm.

On the other hand, this application also discloses a thoracentesis and drainage method, which includes the following steps:

Make a 0.5-1cm incision on the patient's skin surface;

Used as claimed in a preferred example, the tip is inserted from the patient's skin incision, and enters the target chest area through sudden separation;

During the process of suddenly passing through the chest wall tissue and the chest cavity, use the external display device to observe whether the puncture device reaches the ideal chest cavity position and whether the process is smooth;

Unlock the sheath tube and the inner core of the sheath card at the distal end, and pull out the inner core of the sheath card;

Insert the drainage tube into the target chest area through the sheath to an appropriate length, remove the sheath, and fix the chest drainage tube to complete drainage.

This application has at least the following beneficial effects:

1. Implanting camera equipment in the puncture device allows the entire puncture process to be visualized, and is no longer performed solely based on the doctor's personal experience and judgment, making the puncture operation safer and more reliable;

2. The original large-scale camera and imaging equipment in the operating room is omitted, the equipment footprint is greatly reduced, and the equipment cost is greatly reduced;

3. There is also an internal channel for auxiliary tools for biopsy and anesthesia administration, providing a multi-functional integrated puncture device for puncture drainage, specimen acquisition, and administration.

The description of this application records a large number of technical features, which are distributed in various technical solutions. If we want to list all possible combinations of technical features (ie, technical solutions) of this application, the description will be too lengthy. In order to avoid this problem, the technical features disclosed in the above-mentioned summary of the present invention, the technical features disclosed in the various embodiments and examples below, and the technical features disclosed in the drawings can be freely combined with each other to form Various new technical solutions (these technical solutions should be deemed to have been recorded in this specification), unless this combination of technical features is technically unfeasible. For example, feature A+B+C is disclosed in one example, and feature A+B+D+E is disclosed in another example. However, features C and D are equivalent technical means that play the same role. Technically, as long as you choose It can be used as soon as it is used, and it is impossible to use it at the same time. Feature E can technically be combined with feature C. Then, the solution A+B+C+D should not be regarded as documented because it is technically unfeasible, while A+B+ C+E's plan should be deemed to have been documented.

Description of the drawings

Figure 1 is a combined state diagram of the visual puncture and drainage device according to the first embodiment of the present application;

Figure 2A is a schematic diagram of the inner core of the sheath card according to the first embodiment;

Figure 2B is a top view of the inner core of the sheath card according to the first embodiment;

Figure 3 is a schematic diagram of a sheath according to a first embodiment;

Figure 4 is a combined state diagram of the visual puncture and drainage device according to the second embodiment of the present application;

Figure 5A is a schematic diagram of the inner core of the sheath card according to the second embodiment;

Figure 5B is a top view of the inner core of the sheath card according to the second embodiment;

Figure 6 is a schematic diagram of a sheath according to a second embodiment;

Figure 7 is a schematic diagram of the assembly process of the visual puncture and drainage device according to the present application;

Figure 8 is a schematic diagram of the use of the instrument channel according to the preferred embodiment of the present application.

Explanation of reference signs:

10-sheath card inner core; 11-rod; 111-instrument channel; 12-tip; 120-imaging objective lens; 13-power cord; 14-syringe adapter

20-Sheath; 21-Gas input interface

Detailed ways

In the following description, many technical details are provided to enable readers to better understand this application. However, those of ordinary skill in the art can understand that the technical solution claimed in this application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

the term

As used herein, "visual puncture and drainage device", "puncture and drainage device", "puncture and drainage device" "Device", "drainage device" and "device" can be used interchangeably, and all refer to the visual puncture drainage device of the present application.

As used herein, in the description of the device, component, or component of the present application, the "proximal end" refers to the end of the device, component, or component that is close to the operator during use; the "distal end" refers to the "distal end" "Proximal end" refers to the opposite end, that is, the end of the device, component, or part that is away from the operator during the removal process.

The following outlines some of the innovations in the implementation of this application:

As shown in Figure 1, this application provides a visual puncture and drainage device, which includes a sheath card inner core 10 and a sheath tube 20. As shown in Figure 3, the sheath tube 20 includes an outer tube that is the inner core 10 of the sheath card. It has a hollow, equal-width tubular opening structure, and the opening is an oblique section. The outer diameter of the sheath ranges from 8mm to 16mm, more preferably from 9mm to 14mm; the inner diameter ranges from 5mm to 10mm. In one embodiment, the sheath has an outer diameter of 9 mm and an inner diameter of 5 mm. In another embodiment, the sheath has an outer diameter of 14 mm and an inner diameter of 10 mm.

As shown in Figures 2A and 2B, the inner core of the sheath card is in the shape of a pen tube and has a rod 11 of uniform thickness. The outer diameter of the rod section ranges from 5mm to 15mm, preferably from 8mm to 12mm, and more preferably from 10mm. In the two embodiments of the present application, the outer diameters of the inner core of the sheath card are 5 mm and 10 mm respectively. The distal end of the shaft includes a tapered tip. The tip is set in a tapered shape to facilitate puncture. The inner core of the sheath card is made of medical grade PC, and the length (ie, the distance from the tip end to the proximal handle) is preferably 100 mm. The inner core of the sheath card can be installed in the sheath tube, and the two are detachably matched through the bayonet at the proximal end. When the two are fixedly matched, the inner core of the sheath card is accommodated in the sheath tube and extends axially, and the tip of its distal end extends out of the sheath tube.

The inner core of the sheath card is provided with an imaging objective lens (or camera). The imaging objective lens is set at the tip of the inner core of the sheath card. In a preferred embodiment, the imaging objective lens is disposed at the transition point between the tip and the stem, preferably 5 mm to 20 mm from the tip end. The imaging objective lens is preferably a lens based on a CMOS sensor. The camera lens has a diameter of 3.8 mm and a depth of field range of 3-100 mm. In a preferred embodiment, the depth of field range is 40 mm. The camera angle range is from 90° to 270°. In one embodiment, the angle is 100°. The resolution of the imaging objective lens is not less than 800X800 pixels. In an alternative embodiment, the imaging objective also Magnified viewing structure including optical zoom. The imaging objective is connected to the proximal end via a power cord with a diameter of 0.6 mm.

The inner core of the sheath card also includes LED components. LED components include LED light sources and optical fibers. The LED light source is arranged inside the proximal end of the inner core of the sheath card; the optical fiber is arranged on the inner wall of the inner core of the sheath card; the optical fiber connects the LED light source to the tip. In an optional embodiment, the LED assembly further includes a beam splitter, which is disposed at the proximal end together with the LED light source. From the beam splitter, at least 2 different optical fibers are led out and extend in the inner core of the sheath card, and at the tip is provided with at least 2 different openings are used to accommodate the aforementioned optical fibers.

In a preferred embodiment, the inner core of the sheath card is provided with an axially extending instrument channel. The instrument channel is a long and narrow groove-shaped channel, which is arranged on the peripheral wall surface of the inner core of the sheath card, or can also be arranged inside the peripheral wall surface (that is, a cavity is dug in the peripheral wall). The instrument channel may be circular or rectangular in cross-section. When the channel is a groove with a circular cross-section, the cross-sectional diameter of the groove may range from 3 mm to 5 mm, and in a preferred embodiment, the diameter is 3.8 mm. When the channel is a trough with a rectangular cross-section, the cross-sectional length x width of the trough may be 3.8mm×3.8mm. The channel is used to advance diagnostic and treatment tools therethrough, including but not limited to biopsy forceps, biopsy brushes, drug delivery devices, etc. Instrument channels and the above-mentioned diagnostic and processing tools can be used for local anesthetic injection, irrigation, and thoracic drainage fluid sample acquisition.

The proximal end of the inner core of the sheath card provides I/O interfaces, including but not limited to USB interfaces and Type-C interfaces, at least for the connection between this device and external display devices. In an optional implementation, the puncture device supports HDMI external output, which can synchronously output images to an external display in real time.

There is a processor inside the puncture device. The processor includes an image processing module. The operations performed on the image acquired by the imaging objective lens include but are not limited to: center enhancement, denoising, and color rendering processing to improve image quality and recognition. In a preferred embodiment, the inner core of the sheath card and its image processing module assist in operating the function of automatic white balance adjustment: the image processing module of the puncture device is preset with a variety of white balance reference data based on different color temperatures. When the processor After reading the white balance data of the image from the CMOS sensor, it automatically matches a set of white balance reference data applicable in that color temperature and controls the image The intensity of the R, G, and B signal output in the processing module is finally displayed on the display device to display an image that meets the doctor's diagnostic requirements. The function of automatic white balance adjustment can also be realized by manual adjustment, allowing different users to adjust the white balance display of the display screen by themselves, thereby achieving the best picture effect.

In a preferred embodiment, the device also includes wipe channels with capillary effect, which are used to automatically remove and filter substances remaining in the inner core of the sheath card during the drainage process.

In order to better understand the technical solution of the present application, a specific example will be used for description below. The details listed in this example are mainly for ease of understanding and are not intended to limit the scope of protection of the present application.

The puncture and drainage device of this embodiment is shown in Figures 4 to 6 and includes a sheath card inner core 10 and a sheath tube 20. As shown in Figure 6, the sheath 20 has an outer diameter of 14mm and an inner diameter of 10mm. The sheath also includes a gas input interface 21 . The inner core of the sheath card is shown in Figure 5A to Figure 5B. It is in the shape of a pen tube, has an outer diameter of 10mm, and is made of medical-grade PC.

The inner core of the sheath card is provided with an imaging objective lens. The camera lens has a diameter of 3.8mm and a depth of field of 40mm. The camera angle is 100°.

The inner core of the sheath card is provided with an axially extending instrument channel. The instrument channel is set inside the surface of the peripheral wall (that is, a cavity is dug in the peripheral wall). The cross-section is circular, and the cross-sectional diameter of the groove is 3.8 mm. The purpose of this channel is to advance the biopsy forceps through it for obtaining pleural drainage fluid specimens.

Use the puncture device of the present application to perform clinical puncture and drainage on patients with pleural effusion. Assemble the sheath tube 20 and the sheath card inner core 10 as shown in Figure 7 . An incision is made on the surface of the patient's skin at the site of drainage. Use this device with the sheath and the inner core of the sheath card in a mated state to perform puncture: the operator holds the sheath with the index finger and rotates the tip into the subcutaneous fat-muscle-pleural fat-pleural cavity of the human body in sequence. During the puncture process, due to the placement of the built-in imaging objective lens, the operator can observe the puncture position and depth on the external display device. After the puncture is completed and a connected channel is established between the device and the lesion, the operator Pass the proximal bayonet button to disengage the inner core of the sheath card from the sheath tube, pull out the inner core of the sheath card, insert the drainage tube to the appropriate position, remove the sheath tube, and fix the drainage tube on the skin.

As shown in Figure 8, insert the biopsy forceps into the instrument channel of the inner core of the self-sheath card to obtain the lesion biopsy sample.

It should be noted that in the application documents of this patent, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply these There is no such actual relationship or sequence between entities or operations. Furthermore, the terms "comprises," "comprises," or any other variations thereof are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that includes a list of elements includes not only those elements, but also those not expressly listed other elements, or elements inherent to the process, method, article or equipment. Without further limitation, an element defined by the statement "comprises a" does not exclude the presence of additional identical elements in a process, method, article, or device that includes the stated element. In the application documents of this patent, if it is mentioned that an act is performed based on a certain element, it means that the act is performed based on at least that element, which includes two situations: performing the act based on that element only, and performing the act based on both that element and Other elements perform this behavior. Expressions such as multiple, multiple times, multiple, etc. include 2, 2 times, 2 kinds, and 2 or more, 2 or more times, or 2 or more kinds.

This specification includes combinations of various embodiments described herein. Individual references to "one embodiment" or a particular embodiment, etc., are not necessarily all referring to the same embodiment; however, unless indicated to be mutually exclusive or it would be clear to one skilled in the art that such embodiments are mutually exclusive, these embodiments are not Not mutually exclusive. It should be noted that the word "or" is used in this specification in a non-exclusive sense unless the context clearly indicates or requires otherwise.

All documents mentioned in this application are considered to be included in the disclosure of this application in their entirety so as to serve as a basis for modifications when necessary. In addition, it should be understood that after reading the above disclosure of this application, those skilled in the art can make various changes or modifications to this application, and these equivalent forms also fall within the scope of protection claimed by this application.

Claims (10)

A visual puncture and drainage device, characterized in that it includes: a sheath tube and a sheath card inner core, wherein the sheath tube includes a hollow tubular opening structure and a functional base at the rear; the sheath card inner core includes a tubular inner core body located at the distal The puncture tip and imaging objective lens at the end; the sheath card and the inner core of the sheath card are detachably matched; When the sheath tube is matched with the inner core of the sheath card, the inner core of the sheath card is accommodated in the sheath tube and extends axially, and its distal tip extends out of the sheath tube; an imaging objective lens is provided inside the tip; The visual puncture and drainage device is configured to safely establish channels outside the human body and within the body cavity through sudden puncture with the aid of the visual system, and collect images from the target body cavity in real time. The visual puncture and drainage device according to claim 1, wherein the imaging objective lens is arranged inside the tip and at a distance of 5mm-20mm from the end. The visual puncture and drainage device according to claim 1, wherein the inner core of the sheath card further includes an LED assembly, and the LED assembly includes an LED light source disposed at the proximal end of the inner core of the sheath card, and an optical fiber, wherein the light guide Fibers connect the LED light source to the tip. The visual puncture and drainage device of claim 1, wherein an axially extending instrument channel is provided on the inner core of the sheath card, and the instrument channel is configured to advance diagnostic and treatment tools therein. The visual puncture and drainage device according to claim 4, wherein the diagnosis and treatment tools are selected from any one of the following: biopsy forceps, biopsy brushes, and drug delivery devices. The visual puncture and drainage device according to claim 4, wherein the instrument channel is provided on the peripheral wall surface of the inner core of the sheath card and is a downwardly depressed groove, or The instrument channel is arranged inside the peripheral wall of the inner core of the sheath card and is a groove with a cavity in the peripheral wall. The visual puncture and drainage device according to claim 1, wherein the depth of field range of the imaging objective lens is 3-100 mm. The visual puncture and drainage device according to claim 1, wherein the outer diameter of the sheath ranges from 8 mm to 16 mm; and the inner diameter ranges from 5 mm to 10 mm. The visual puncture and drainage device according to claim 1, wherein the outer diameter of the inner core of the sheath card ranges from 5 mm to 10 mm. A thoracentesis and drainage method, characterized by including the following steps: Make a 0.5-1cm incision on the patient's skin surface; Use the visual puncture and drainage device as described in any one of claims 1 to 8, insert the tip from the patient's skin incision, and enter the target chest area through sudden separation; During the process of suddenly passing through the chest wall tissue and the chest cavity, use the external display device to observe whether the puncture device reaches the ideal chest cavity position and whether the process is smooth; Unlock the sheath tube and the inner core of the sheath card at the distal end, and pull out the inner core of the sheath card; Insert the drainage tube into the target chest area through the sheath to an appropriate length, remove the sheath, and fix the chest drainage tube to complete drainage.