Real-time imaging pericardiocentesis device

Abstract

The present application provides a kind of real-time imaging pericardial puncture device, comprising: inner tube, outer tube, illumination light guide component and imaging component;Outer tube is set on the outside of inner tube, the distal end of inner tube has the puncture segment that protrudes relative to the distal end of outer tube, the end of puncture segment is formed with needle tip part;Inner tube, outer tube or both are jointly formed with: first installation slot for setting illumination light guide component at its nesting site;Second installation slot for setting imaging component;Illumination light guide component is used to conduct illumination light, so that it can illuminate target area;Imaging component is used to form the real image of target area;The distal end of illumination light guide component and imaging component is exposed to the distal end of inner tube, and towards the direction of needle tip part.This device is designed by the nested structure of inner tube and outer tube, combined with integrated illumination light guide component and imaging component, with real-time imaging function, can accurately guide puncture operation, with outstanding clinical application value and popularization prospect.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a real-time imaging pericardiocentesis device. Background Technology

[0002] The pericardium is a double-layered connective tissue membrane structure that surrounds the heart, consisting of a visceral layer and a parietal layer. The pericardial cavity, formed between these two layers, contains a small amount of serous fluid that serves a lubricating function. In cardiovascular clinical diagnosis and treatment, pericardiocentesis is a crucial procedure: on the one hand, for patients with pericardial effusion or cardiac tamponade, pericardiocentesis is necessary to establish a pathway to drain the fluid and relieve pressure; on the other hand, in procedures such as cardiac ablation, pericardial drug administration, and pericardial biopsy, the pericardium needs to be punctured and a pathway established to allow ablation catheters, drug delivery devices, or biopsy tools to enter the pericardial cavity and achieve the diagnostic and treatment goals.

[0003] In existing technologies, pericardiocentesis devices have evolved into various structural forms. For example, there is a non-invasive pericardiocentesis needle that includes an outer cannula, a solid needle core, and an end cap. After the needle core is inserted into the pericardium, it is withdrawn, while the outer cannula remains in place to complete fluid aspiration or instrument insertion. In addition, there is a split-type puncture needle, consisting of a puncture needle body and a drainage tube, and a graduated puncture needle, which allows for marking the insertion depth. Although existing devices have undergone partial structural optimization, there are still insurmountable technical defects that severely restrict the safety and effectiveness of clinical applications.

[0004] For example, current puncture needles lack real-time imaging capabilities. Operators can only rely on indirect localization via external ultrasound and tactile sensation to determine the needle tip position, making it impossible to directly observe the relative positional relationship between the needle tip and the pericardial wall, surrounding blood vessels (such as coronary artery branches), and myocardial tissue. When patients have pericardial adhesions, anatomical variations, or other conditions, needle placement deviations are highly likely, leading to puncture failure or requiring repeated adjustments to the needle angle, thus prolonging the procedure time.

[0005] Because the needle tip cannot be monitored in real time, the surgeon has difficulty controlling the depth of insertion precisely. If the needle is inserted too shallowly, it will not be able to penetrate the parietal pericardium to establish an effective pathway. If the needle is inserted too deeply, the needle tip may puncture the visceral pericardium and damage the myocardium, or accidentally puncture the large blood vessels around the pericardium, causing life-threatening complications such as cardiac tamponade and massive hemorrhage, significantly increasing the surgical risk.

[0006] The existing puncture needle's outer cannula and core only have puncture and access establishment functions, and cannot integrate auxiliary components such as illumination and imaging. If visualization is required, an external imaging device is needed, which not only increases the complexity of instrument use, but also makes it difficult to achieve accurate imaging of the needle tip area due to poor compatibility between the external device and the puncture needle, thus failing to meet the high precision requirements for access establishment in cardiac ablation surgery.

[0007] The high degree of reliance on experience in the procedure means that new operators need a long period of clinical practice to master the puncture skills. The long learning cycle is not conducive to the popularization and promotion of the technology, especially in primary healthcare institutions, where the incidence of puncture errors due to insufficient operator experience is even higher.

[0008] In summary, the development of a pericardiocentesis device with real-time imaging capabilities that can precisely guide the puncture procedure, in order to solve the problems of inaccurate positioning, high risk of complications, and high operational threshold of existing technologies, has become an urgent need in the field of clinical pericardiocentesis and cardiac ablation surgery. Summary of the Invention

[0009] In view of this, embodiments of the present invention provide a real-time imaging pericardiocentesis device to eliminate or improve one or more defects existing in the prior art.

[0010] A real-time imaging pericardiocentesis device includes: an inner tube, an outer tube, an illumination beam guiding component, and an imaging component; wherein, the outer tube is sleeved outside the inner tube, and the distal end of the inner tube has a puncture section extending relative to the distal end of the outer tube, the end of the puncture section forming a needle tip; the inner tube, the outer tube, or both, together form a first mounting groove at their nesting portion for mounting the illumination beam guiding component; the inner tube, the outer tube, or both, together form a second mounting groove at their nesting portion for mounting the imaging component; the illumination beam guiding component is used to conduct illumination light to illuminate a target area; the imaging component is used to form a real image of the target area; the distal ends of both the illumination beam guiding component and the imaging component are exposed at the distal end of the inner tube and face the needle tip.

[0011] In some embodiments of the present invention, the first mounting groove is formed on the inner wall of the outer tube and is parallel to the axial direction of the outer tube; the second mounting groove is formed on the inner wall of the outer tube and is parallel to the axial direction of the outer tube; the first mounting groove and the second mounting groove are spaced apart in the circumferential direction of the end face of the outer tube.

[0012] In some embodiments of the present invention, the needle tip has an inclined surface that intersects the axis of the tube body of the puncture section; two second mounting grooves are provided, respectively located at the highest and lowest points of the inclined surface; the imaging assembly includes two imaging units, respectively disposed in the two second mounting grooves.

[0013] In some embodiments of the present invention, the lighting beam guiding assembly includes a plurality of guiding units, the number of the first mounting slots is the same as the number of the guiding units, and each of the guiding units is respectively disposed in each of the first mounting slots.

[0014] In some embodiments of the present invention, the first mounting groove has a first main groove and a first distal groove. The first main groove is used for the extension arrangement of the lighting light guiding component within the tube. The first distal groove is located at the distal end of the outer tube and is used to expose the distal end of the lighting light guiding component, so that the light source transmitted inside the lighting light guiding component can illuminate the target area. The first main groove is entirely formed on the outer wall of the inner tube, or is formed by the outer wall of the inner tube and the inner wall of the outer tube together. The first distal groove extends from the inner wall of the outer tube to its distal end face.

[0015] In some embodiments of the present invention, the second mounting groove has a second main groove and a second distal groove. The second main groove is used for the extended arrangement of the imaging component within the tube. The second distal groove is located at the distal end of the outer tube and is used to expose the distal end of the imaging component, allowing reflected light from the target area to enter the imaging component and form an image. The second main groove is entirely formed on the outer wall of the inner tube, or is formed by the outer wall of the inner tube and the inner wall of the outer tube together. The second distal groove extends from the inner wall of the outer tube to its distal end face.

[0016] In some embodiments of the present invention, the lighting beam guiding assembly includes a plurality of guiding units, and each of the guiding units is spaced apart along the circumferential direction on the distal end face of the outer tube;

[0017] The guiding unit includes a first fiber bundle; or...

[0018] The guiding unit includes a first optical fiber bundle and a light source end lens group located at the distal end of the first optical fiber bundle. The light source end lens group is used to focus the illumination light into parallel light or to focus the illumination light from all the guiding units into a concentrated beam.

[0019] In some embodiments of the present invention, the imaging component includes two or more imaging units;

[0020] The imaging unit includes an imaging end lens group; the imaging end lens group is used to converge the reflected light from the target area to form an image; or...

[0021] The imaging unit includes an imaging end lens group and a second fiber bundle. The imaging end lens is located at the distal end of the fiber, and the second fiber bundle is used to transmit the light spot of the image formed by the imaging end lens group; or...

[0022] The imaging unit includes at least one imaging end lens group and a miniature image sensor, wherein the imaging end lens group is located at the distal end of the miniature image sensor; the miniature image sensor is used to convert the image of the imaging end lens group into a corresponding electrical signal.

[0023] In some embodiments of the present invention, the distal end of the illumination beam guiding component and / or the imaging component is formed with a waterproof coating, or the pericardiocentesis device is provided with a transparent protective cover on the distal end face of the outer tube.

[0024] In some embodiments of the present invention, the angle of the needle tip is 10° to 40°; the length of the puncture section is 5-10 mm; the outer edge of the distal end of the outer tube is provided with a smooth transition structure; the pericardiocentesis device further includes: a connecting seat disposed at the proximal end of the inner tube and the outer tube; an optical fiber connector for connecting to the optical fiber of the illumination light guiding assembly to connect to a light source; the optical fiber connector is also used for connecting to the optical fiber or signal line of the imaging assembly to connect to a display device; and a Luer connector.

[0025] This invention provides a real-time imaging pericardiocentesis device. The device, through a nested structure of inner and outer tubes, combined with an integrated illumination guide component and imaging component, has real-time imaging capabilities and can accurately guide the puncture operation, demonstrating outstanding clinical application value and promising prospects for widespread application.

[0026] Additional advantages, objects, and features of the invention will be set forth in part in the description which follows, and will also become apparent in part to those skilled in the art upon studying the description, or may be learned by practice of the invention. The objects and other advantages of the invention can be realized and obtained by means of the structures specifically pointed out in the description and drawings.

[0027] Those skilled in the art will understand that the objectives and advantages achievable with the present invention are not limited to those specifically described above, and that the above and other objectives achievable with the present invention will become clearer from the following detailed description. Attached Figure Description

[0028] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, are not intended to limit the scope of the invention. The components in the drawings are not drawn to scale but are merely illustrative of the principles of the invention. For ease of illustration and description of certain parts of the invention, corresponding portions in the drawings may be enlarged, i.e., may appear larger relative to other components in an exemplary device actually manufactured according to the invention.

[0029] Figure 1 This is a structural diagram of a real-time imaging pericardiocentesis device according to an embodiment of the present invention.

[0030] Figure 2 This is a schematic cross-sectional view of the distal end of a real-time imaging pericardiocentesis device according to an embodiment of the present invention.

[0031] Figure 3This is a three-dimensional structural diagram of the distal end of a real-time imaging pericardiocentesis device according to an embodiment of the present invention.

[0032] Figure 4 This is a three-dimensional structural diagram of the distal end of a real-time imaging pericardiocentesis device according to another embodiment of the present invention.

[0033] Figure 5 This is a schematic cross-sectional view of the distal end of the real-time imaging pericardiocentesis device in another embodiment of the present invention.

[0034] Figure 6 This is a three-dimensional structural diagram of the distal end of the real-time imaging pericardiocentesis device in another embodiment of the present invention.

[0035] Figure 7 This is a schematic diagram of the distal end face structure of a real-time imaging pericardiocentesis device according to an embodiment of the present invention.

[0036] Figure 8 This is a schematic diagram of the distal end of the lighting light guiding component in one embodiment of the present invention.

[0037] Figure 9 This is a schematic diagram of the distal end of the lighting light guiding component in another embodiment of the present invention.

[0038] Figure 10 This is a schematic diagram of the distal end of the imaging component in one embodiment of the present invention.

[0039] Figure 11 This is a schematic diagram of the distal end of the imaging component in another embodiment of the present invention.

[0040] Figure 12 This is a schematic diagram of the distal end of the inner tube in another embodiment of the present invention.

[0041] Figure label:

[0042] 1. Inner tube; 101. Puncture segment; 102. Needle tip; 102-1. Highest point; 102-2. Lowest point;

[0043] 2. Outer tube; 201. Distal end face; 202. Rounded corner; 21. Transparent protective cover;

[0044] 3. Illumination beam guiding assembly; 30. Guiding unit; 301. First fiber bundle; 302. Light source end lens group;

[0045] 4. Imaging assembly; 40. Imaging unit; 401. Imaging end lens group; 402. Second fiber bundle; 403. Miniature image sensor;

[0046] A. First mounting slot;

[0047] B, second mounting slot; b1, second main slot; b2, second distal slot;

[0048] 5. Connector; 6. Fiber optic connector; 7. Luer connector. Detailed Implementation

[0049] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the embodiments and accompanying drawings. Here, the illustrative embodiments and descriptions of this invention are used to explain the invention, but are not intended to limit the invention.

[0050] It should also be noted that, in order to avoid obscuring the invention with unnecessary details, only the structures and / or processing steps closely related to the solution according to the invention are shown in the accompanying drawings, while other details that are not closely related to the invention are omitted.

[0051] It should be emphasized that the term "including / comprises" as used herein refers to the presence of a feature, element, step, or component, but does not exclude the presence or addition of one or more other features, elements, steps, or components.

[0052] It should also be noted that, unless otherwise specified, the term "connection" in this article can refer not only to a direct connection, but also to an indirect connection involving an intermediary.

[0053] In the following description, embodiments of the invention will be illustrated with reference to the accompanying drawings. In the drawings, the same reference numerals represent the same or similar parts, or the same or similar steps.

[0054] To address or alleviate the problems of inaccurate positioning, high risk of complications, and high operational threshold of existing technologies, this invention provides a real-time imaging pericardiocentesis device. This device, through a nested structure design of inner and outer tubes, combined with an integrated illumination and imaging component, has real-time imaging capabilities, can accurately guide the puncture operation, and has outstanding clinical application value and promising prospects for promotion.

[0055] It should be noted that, in this invention, unless otherwise stated, the terms "proximal" and "distal" are based on the relative position of the operator when operating the puncture device: "proximal" refers to the end closer to the operator (operating end) used for holding, controlling, or connecting external devices (such as light source, imaging host, handle); "distal" refers to the end further away from the operator (patient's internal end), inserted into the patient's body and in direct contact with the target tissue (such as pericardium, pericardial cavity), performing core functions such as puncture, illumination, and imaging.

[0056] like Figures 1-12 As shown, the real-time imaging pericardiocentesis device in this embodiment of the invention includes: an inner tube 1, an outer tube 2, an illumination light guiding component 3, and an imaging component 4, etc.

[0057] Among them, such as Figure 2 and Figure 5 As shown, the outer tube 2 is sleeved outside the inner tube 1. The distal end of the inner tube 1 has a puncture section 101 extending relative to the distal end of the outer tube 2, and the end of the puncture section 101 forms a needle tip 102. The inner tube 1 is hollow, and its interior can be used for basic needs such as pericardial effusion aspiration or drug injection, or to establish a surgical access for extracardiac ablation. The needle tip 102 at the end of the puncture section 101 ensures the puncture penetration power of the device, which can effectively puncture the pericardial wall layer. The distal end of the illumination and imaging component 4 is simultaneously exposed at the distal end of the inner tube 1 and faces the needle tip, ensuring that the imaging field of view is not obstructed during the puncture.

[0058] The inner tube 1, outer tube 2, or both at their nested portion together form a first mounting groove A for mounting the illumination light guiding component 3; the inner tube 1, outer tube 2, or both at their nested portion together form a second mounting groove B for mounting the imaging component 4; the nested structure of the inner tube 1 and outer tube 2, and the dedicated design of the first mounting groove A and second mounting groove B, can stably accommodate the illumination light guiding component 3 and the imaging component 4 without increasing the outer diameter of the puncture device, ensuring the minimally invasive nature of the device and avoiding additional tissue damage caused by excessively large instrument diameter; at the same time, the components are integrated inside the puncture device, eliminating the need for external devices, simplifying the operation process, and improving the convenience of clinical use.

[0059] The illumination guide component 3 is used to conduct illumination light so that it can illuminate the target area; the imaging component 4 is used to form a real image of the target area; the distal ends of both the illumination guide component 3 and the imaging component 4 are exposed at the distal end of the inner tube 1 and face the needle tip 102. In this scheme, by integrating the illumination guide component 3 and the imaging component 4, with the distal ends of the components facing the needle tip 102, the target area in front of the needle tip can be directly illuminated and a clear real image can be formed. The operator can observe the anatomical structures around the needle tip (such as the pericardial cavity boundary, the location of adjacent tissues, etc.) in real time, completely eliminating the dependence on external imaging equipment and the blind puncture operation mode, and fundamentally solving the problems of incorrect needle insertion position and incomplete puncture.

[0060] Furthermore, the field of view of the illumination and imaging component 4 is completely consistent with the direction of needle tip advancement, achieving "what you see is what you pierce." The surgeon can precisely adjust the needle insertion depth and angle based on real-time images, effectively avoiding damage to vital organs such as the heart and blood vessels from excessive needle tip insertion, significantly reducing the puncture failure rate and complication rate, and improving surgical safety. The real-time visualization visual field intuitively reflects the puncture environment, reducing reliance on the surgeon's clinical experience. Novice doctors can quickly master the key points of operation, shorten the learning cycle, and facilitate the clinical promotion and application of the technology. The device structure is compatible with various clinical operations such as pericardial effusion aspiration, establishment of extracardiac ablation pathways, pericardial drug administration, and biopsy, without the need to change equipment for different scenarios, improving clinical operation efficiency. At the same time, the nested design of the inner tube 1 and the outer tube 2 supports the placement of the outer tube 2, simplifying the surgical procedure.

[0061] This invention achieves a stable fit between the lighting and imaging components 4 and the nested structure of the inner tube 1 and outer tube 2 by rationally setting the first mounting slot A and the second mounting slot B, while ensuring the minimally invasive nature and operational reliability of the device. Based on the nested fit relationship between the inner tube 1 and the outer tube 2, the first mounting slot A and the second mounting slot B can adopt various setting forms, such as the mounting slots being formed on the inner wall of the outer tube 2, the mounting slots being formed on the outer wall of the inner tube 1, or the mounting slots being formed jointly by the outer wall of the inner tube 1 and the inner wall of the outer tube 2, etc.

[0062] As at least one possible implementation, the first mounting groove A is formed on the inner wall of the outer tube 2 and is parallel to the axial direction of the outer tube 2; the second mounting groove B is formed on the inner wall of the outer tube 2 and is parallel to the axial direction of the outer tube 2; the first mounting groove A and the second mounting groove B are spaced apart in the circumferential direction of the end face of the outer tube 2. Specifically, the outer tube 2 is a hollow tubular structure, and multiple grooves parallel to the axis of the outer tube 2 are formed on its inner wall by mechanical processing, which serve as the first mounting groove A and the second mounting groove B, respectively. The spaced arrangement ensures that the distal ends of the illumination light guiding component 3 and the imaging component 4 (the part exposed at the distal end of the inner tube 1) do not obstruct each other and can jointly cover the target area in front of the needle tip 102. Optionally, the cross-sectional shape of the first mounting groove A and the second mounting groove B is semi-circular (e.g., Figure 3 (as shown in the embodiment) or U-shaped (such as) Figure 4 (As shown in the embodiment), the width and depth of the groove are adapted to the outer diameter of the corresponding component, ensuring that the component is flush with the inner wall of the outer tube 2 after being embedded, without affecting the nesting fit between the inner tube 1 and the outer tube 2. After the inner tube 1 is fitted into the outer tube 2, the outer wall of the inner tube 1 can fit tightly against the inner wall of the outer tube 2 (including the surface after the mounting groove is embedded in the component), avoiding radial wobbling of the inner tube 1 relative to the outer tube 2 during the puncture process.

[0063] As another possible implementation, both the first mounting groove A and the second mounting groove B are integrally formed on the outer wall of the inner tube 1, extending along the axial direction of the inner tube 1 from the proximal end to the root of the distal puncture section 101, thus achieving full-length accommodation of the component from the proximal end to the distal end. Specifically, multiple grooves parallel to the axis of the inner tube 1 are precisely machined on the outer wall of the hollow main body section of the inner tube 1, serving as the first mounting groove A and the second mounting groove B, respectively. Optionally, the cross-sectional shape of the mounting groove is semi-circular, rectangular, or V-shaped, the size of the groove is adapted to the outer diameter of the component, and the depth of the groove does not exceed 1 / 2 of the wall thickness of the inner tube 1, ensuring that the structural strength of the inner tube 1 is not affected, that is, the inner tube 1 can withstand the thrust required to penetrate the pericardial wall during puncture, and the tube wall will not rupture due to the setting of the mounting groove.

[0064] As another possible implementation, the first mounting groove A has a first main groove and a first distal groove. The first main groove is used for the extension arrangement of the lighting light guiding component 3 within the tube body. The first distal groove is located at the distal end of the outer tube 2 and is used to expose the distal end of the lighting light guiding component 3 so that the light source transmitted inside the lighting light guiding component 3 can illuminate the target area. The first main groove is entirely formed on the outer wall of the inner tube 1, or is formed by the outer wall of the inner tube 1 and the inner wall of the outer tube 2. The first distal groove extends from the inner wall of the outer tube 2 to its distal end face 201.

[0065] Similarly, such as Figure 5 and Figure 6 As shown, the second mounting groove B has a second main groove b1 and a second distal groove b2. The second main groove b1 is used for the extended arrangement of the imaging component 4 inside the tube. The second distal groove b2 is located at the distal end of the outer tube 2 and is used to expose the distal end of the imaging component 4 so that the reflected light from the target part can enter the imaging component 4 and form an image. The second main groove b1 is entirely formed on the outer wall of the inner tube 1, or is formed by the outer wall of the inner tube 1 and the inner wall of the outer tube 2. The second distal groove b2 extends from the inner wall of the outer tube 2 to its distal end face. Figure 5 and Figure 6 In the embodiment shown, the second distal groove b2 is disposed inside the outer tube 2. One end of the second distal groove b2 is connected to the inner wall of the outer tube 2, and the other end is connected to the distal end face 201. Of course, the second distal groove b2 can also be disposed on the inner wall of the outer tube 2.

[0066] The combined installation groove in this embodiment does not require deep grooves to be machined on a single tube wall, which can preserve the structural strength of the inner tube 1 and the outer tube 2 to the greatest extent, adapt to puncture devices with smaller outer diameters, and further improve minimally invasiveness; at the same time, the combined structure makes the inner tube 1 and the outer tube 2 mutually limit each other, which can not only prevent component displacement, but also enhance the stability of the nesting of the inner and outer tubes 2, reduce radial shaking during puncture, and improve the accuracy of operation.

[0067] As another possible implementation, one type of mounting groove can be formed on the inner wall of the outer tube 2, and the other type on the outer wall of the inner tube 1. For example, this embodiment uses a hybrid arrangement, where, based on the different performance requirements of the lighting light guiding component 3 and the imaging component 4, the first mounting groove A is set on the inner wall of the outer tube 2, and the second mounting groove B is set on the outer wall of the inner tube 1, achieving an optimized design for functional adaptation. This embodiment selects the mounting positions according to the different requirements of the lighting component (which requires a stable light path) and the imaging component 4 (which requires a fixed field of view), achieving optimized design on demand; at the same time, the hybrid structure can flexibly adjust the size and position of the two mounting grooves to adapt to components of different specifications, improving the compatibility of the device, and is especially suitable for scenarios where the outer diameters of the lighting and imaging components 4 differ significantly.

[0068] Optionally, the inner wall of the mounting groove in each embodiment may be provided with anti-slip texture or adhesive layer. After the component is embedded, it can be tightly connected to the mounting groove by adhesive fixation or interference fit, further avoiding axial or radial displacement of the component during puncture. The far end of the mounting groove may be provided with a chamfer structure to prevent the far end of the component from being scratched by sharp edges during assembly or puncture, thus protecting the functional integrity of the component.

[0069] In some embodiments, the needle tip 102 has an inclined surface that intersects the axis of the tube body of the puncture section 101; further, the angle between the inclined surface of the needle tip 102 and the axis of the tube body of the puncture section 101 can be flexibly set according to the puncture requirements, for example, the angle of the needle tip 102 is 10° to 40°, and this angle design can take into account both the puncture sharpness of the needle tip 102 and the imaging field of view coverage.

[0070] In some embodiments, such as Figure 7As shown, there are two second mounting slots B, located at the highest point 102-1 and the lowest point 102-2 of the inclined plane, respectively. The imaging component 4 includes two imaging units 40, each correspondingly positioned within one of the two second mounting slots B. This design ensures that the distal ends of the two imaging units 40 can acquire images of the target area in front of the needle tip 102 from different perspectives. The two imaging units 40 work synchronously, allowing for image stitching to create a wider field of view, or achieving depth perception of the target area through stereoscopic imaging principles. This helps the operator more accurately determine the relative position of the needle tip to the pericardial wall and surrounding tissues, further improving puncture safety and positioning accuracy.

[0071] In some embodiments, the illumination beam guiding assembly 3 includes a plurality of guiding units 30, the number of the first mounting slots being the same as the number of guiding units 30, and each guiding unit 30 being disposed in a corresponding manner within each of the first mounting slots. This design, through the dispersed arrangement of multiple guiding units 30, achieves multi-directional and uniform illumination of the target area in front of the needle tip 102, avoiding shadow areas generated by illumination from a single guiding unit 30, and improving imaging clarity. Simultaneously, the outer diameter of a single guiding unit 30 can be designed to be smaller; the combination of multiple small-sized guiding units 30 ensures both overall illumination intensity and reduces the processing difficulty of a single first mounting slot, adapting to the structural requirements of ultra-fine puncture devices, and balancing illumination performance and minimal invasiveness. Figure 7 As shown, the illumination beam guiding component 3 includes eight guiding units 30, and the imaging component 4 includes two imaging units 40. The two imaging units 40 are located on the same straight line, and the eight guiding units 30 are symmetrically arranged about the straight line containing the two imaging units 40. A total of 10 first mounting slots A and second mounting slots B are provided, evenly distributed along the circumference of the nested part of the inner tube 1 and the outer tube 2, ensuring the synergistic compatibility of illumination and imaging. This symmetrical and evenly distributed layout enables the illumination beam to form a symmetrical and uniform illumination field in the target area, effectively eliminating blind spots in the imaging field of view. At the same time, the collinear arrangement of the two imaging units 40 can optimize the accuracy of image stitching or stereoscopic imaging, further improving positioning accuracy.

[0072] Optionally, based on actual imaging requirements, the imaging unit 40 may also be configured with three, four or more units; the number of corresponding second mounting slots B may be adjusted accordingly, and the number of guide units 30 and the number of first mounting slots A may be optimized according to the layout and lighting requirements of the imaging unit 40, as long as each mounting slot is reasonably distributed along the circumferential direction and does not interfere with each other.

[0073] In some embodiments, the illumination light guiding assembly 3 includes a plurality of guiding units 30, which are spaced apart along the circumferential direction on the distal end face 201 of the outer tube 2. The important function of the guiding units 30 is to introduce external light sources into the surgical area, and the guiding units 30 can be implemented in various ways.

[0074] As one possible approach, such as Figure 8 As shown, the guiding unit 30 includes only a first optical fiber bundle 301, which carries the illumination light and extends to the distal end face 201 of the outer tube 2. The guiding unit 30, containing only the first optical fiber bundle 301, has a simple and compact structure, occupies little space, and can be adapted to the installation requirements of small-sized outer tubes 2, thus helping to improve the minimally invasive nature of the puncture device. Simultaneously, the optical fiber bundle has efficient light transmission capabilities, reducing energy loss during transmission and ensuring illumination intensity.

[0075] As another possible approach, such as Figure 9 As shown, the guiding unit 30 includes a first optical fiber bundle 301 and a light source end lens group 302 located at the distal end of the first optical fiber bundle 301. The light source end lens group 302 is coaxially arranged with the first optical fiber bundle 301 and is used to focus the illumination light into parallel light or to focus the illumination light from all the guiding units 30 into a concentrated beam. The addition of the light source end lens group 302 enables selectable adjustment of the illumination light. For example, when focused into parallel light, the propagation distance of the light can be increased, the illumination coverage can be expanded, and the illumination needs of deeper puncture sites can be met; when focused into a concentrated beam, the light energy can be concentrated on the target puncture point, enhancing the local illumination brightness, making it easier for the operator to clearly observe fine tissue structures (such as tissue gaps, blood vessel edges, etc.), and improving the puncture positioning accuracy; the two functions can be selected according to the needs of the clinical scenario, improving the adaptability and practicality of the component.

[0076] In some embodiments, the imaging component 4 includes two or more imaging units 40. The arrangement of multiple imaging units 40 enables multi-view image acquisition, providing a foundation for subsequent image stitching, stereoscopic imaging, and other functions. The important function of the imaging unit 40 is to project the image of the target area to the outside world. The guiding unit 30 can be implemented in various ways.

[0077] As one possible implementation, the imaging unit 40 includes an imaging end lens group 401; the imaging end lens group 401 is used to converge the reflected light from the target area to form an image; the core function of the imaging end lens group 401 is to collect the reflected light from the target area and converge the reflected light to form a clear image. This method has a simple and compact structure, occupies little space, is suitable for minimally invasive device designs, and can meet basic imaging needs.

[0078] As another possible approach, such as Figure 10 As shown, the imaging unit 40 includes an imaging end lens group 401 and a second fiber bundle 402. The imaging end lens is located at the distal end of the fiber, and the second fiber bundle 402 is used to transmit the light spot of the image formed by the imaging end lens group 401, stably transmitting the image light spot formed by the imaging end lens group 401 to the subsequent processing module. This method transmits images through the second fiber bundle 402, eliminating the need for complex electronic components at the distal end, improving the stability and safety of the component in the internal environment, and adapting to long-distance image transmission scenarios.

[0079] The second fiber bundle 402 can be a transmission fiber bundle composed of a large number of extremely fine optical glass fibers arranged in a regular pattern. The objective lens group at the head end forms a clear real image of the observed scene, which falls on the input end face of the transmission fiber bundle; each individual fiber in the transmission bundle only receives and transmits light that illuminates the point on its end face. In this way, the entire image is divided into tens of thousands of independent light spots (pixels), and each fiber utilizes the principle of total internal reflection. The fiber consists of a high-refractive-index core and a low-refractive-index cladding. The light entering the fiber undergoes continuous total internal reflection at the core-cladding interface, thus transmitting losslessly along a curved path from inside the several-meter-long endoscope catheter to the other end. At the output end face of the transmission fiber bundle, the arrangement of these fibers is completely consistent with that at the input end face; each light spot is sent out from the corresponding fiber and arranged in its original relative position at the output end face.

[0080] As another possible approach, such as Figure 11 As shown, the imaging unit 40 includes at least one imaging lens group 401 and a miniature image sensor 403. The imaging lens group 401 is located at the distal end of the miniature image sensor 403. The miniature image sensor 403 receives the image and converts the image from the imaging lens group 401 into a corresponding electrical signal, realizing photoelectric conversion and digital output of the image. This method integrates the miniature image sensor 403 to achieve direct photoelectric conversion of the image, reducing signal loss during image transmission, improving imaging accuracy and real-time performance, and adapting to high-precision puncture positioning requirements.

[0081] The miniature image sensor 403 can be a CCD or CMOS chip. Each photosensitive unit (pixel) on the sensor converts the intensity of the received light signal into a corresponding electrical signal. The generated electrical signal (analog or digital) is transmitted to the back-end video processing host through a tiny internal cable. The video processing host performs complex processing on the electrical signal (such as color correction, noise reduction, image enhancement, etc.), reconstructs it into a standard video signal, and finally outputs it to the display screen for display.

[0082] In some embodiments, the distal ends of the illumination light guiding component 3 and / or the imaging component 4 are formed with a waterproof coating. In other embodiments, such as Figure 12 As shown, the pericardiocentesis device has a transparent protective cover 21 on the distal end face 201 of the outer tube 2, which can encapsulate and protect the distal lighting and imaging components. The waterproof coating or transparent protective cover 21 can effectively prevent bodily fluids (such as blood and tissue fluid) from invading the lighting and imaging components 4, avoiding functional failure of the components due to moisture, short circuit or contamination, and improving the stability and reliability of the components in the complex environment of the body.

[0083] Optionally, the transparent protective cover 21 is made of a high-transmittance material, and the waterproof coating is made of a material with excellent light transmittance. Neither of these materials will significantly obstruct or attenuate the transmission of illumination light or the collection of reflected light from the target area, ensuring that the illumination intensity and imaging clarity are not affected. Both the coating and protective cover materials used in the protective structure have good biocompatibility and will not cause allergic or inflammatory reactions in the body's tissues, ensuring the safety of the puncture procedure. At the same time, the protective structure reduces direct friction between the components and the body's tissues, minimizing damage to surrounding tissues. By isolating the components from corrosive bodily fluids and mechanical wear, the waterproof coating and transparent protective cover 21 effectively extend the service life of the illumination light guiding component 3 and the imaging component 4, reducing the maintenance cost and replacement frequency of the device.

[0084] Optionally, the transparent protective cover 21 can be connected to the far end of the outer tube 2 via a threaded structure, which not only enables detachable fixing, facilitating the disassembly, maintenance, and component replacement of the device, but also enhances the connection sealing through the tightening action of the threads, further preventing the intrusion of bodily fluids.

[0085] Optionally, the transparent protective cover 21 or other end cap structure can be formed with a tapered hole structure, and the distal end of the outer tube 2 can be formed with a tapered shaft section structure. The two can work together to achieve the clamping and fixing of the two components and enhance the sealing connection. With the help of the threaded connection and the self-centering characteristics of the tapered structure, the two can be quickly and accurately positioned and assembled, improving assembly efficiency. At the same time, the tight fit of the tapered surfaces during the clamping process can form an effective sealing surface, significantly enhancing the sealing performance and avoiding the protection failure caused by the sealing gap. Meanwhile, the spiral locking function can generate a certain deformation clamping force in the outer tube 2. This clamping force can act on the internal illumination beam guiding component 3 and imaging component 4, which helps to improve the installation and positioning accuracy of these two types of components, prevents the components from shifting during the puncture operation, and ensures the stability of the illumination beam path and imaging beam path.

[0086] In some embodiments, the length of the puncture segment 101 is 5-10 mm; this length range ensures that the needle tip 102 has sufficient puncture travel to penetrate the pericardial wall layer, while the puncture segment 101 is not too long, thus reducing the flexibility of operation and balancing puncture reliability and ease of operation, adapting to the path requirements of routine clinical pericardiocentesis.

[0087] In some embodiments, the outer edge of the distal end of the outer tube 2 is provided with a smooth transition structure; such as Figures 2-6 As shown, the smooth transition structure can be a rounded corner 202 structure. The rounded corner 202 structure can eliminate the sharp edges of the distal outer edge of the outer tube 2, avoid sharp edges scratching internal tissues, blood vessels or pericardium during puncture, significantly reduce the trauma risk of puncture operation and improve surgical safety.

[0088] In some embodiments, such as Figure 1 As shown, the pericardiocentesis device also includes: a connector 5, an optical fiber connector 6, and a Luer connector 7, etc.

[0089] The connecting seat 5 is located at the proximal end of the inner tube 1 and the outer tube 2, which can realize a stable connection between the proximal ends of the inner tube 1 and the outer tube 2, ensure the stability of the relative position of the inner and outer tubes 2, avoid relative displacement of the tubes during the puncture operation, and improve the overall structural reliability of the device.

[0090] The fiber optic connector 6 is connected to the optical fiber of the illumination light guiding component 3 to connect to the light source; the fiber optic connector 6 is also used to connect to the optical fiber or signal line of the imaging component 4 to connect to the display device; the fiber optic connector 6 realizes a convenient and stable connection between the illumination light guiding component 3 and the light source, and between the imaging component 4 and the display device, ensuring efficient transmission of illumination light and real-time, low-loss transmission of imaging signals, providing a guarantee for clear illumination and accurate imaging.

[0091] The Luer connector 7 and other auxiliary connecting components are compatible with commonly used medical consumables or equipment in clinical practice, improving the device's versatility and clinical adaptability. At the same time, the integrated design of each connecting component makes the proximal layout of the device neat, which facilitates the operator's operation and equipment docking, thereby improving the efficiency of surgical operations.

[0092] The real-time imaging pericardiocentesis device according to the embodiments of the present invention has at least the following technical effects:

[0093] (1) The present invention adopts an integrated design of fiber optic light source and imaging. Compared with the solution that relies on miniature cameras in the prior art, the fiber optic structure is more compact and occupies less space, which can greatly reduce the overall size of the device and make the puncture approach more minimally invasive. It can not only reduce the pain of patients during puncture, but also reduce the probability of tissue damage and help patients recover quickly after surgery.

[0094] (2) The present invention adopts an integrated surround fiber optic illumination component, which precisely solves the problems of blurred imaging and unclear details caused by the lack of a dedicated light source in the chest cavity in the prior art. It can realize clear real-time visualization of the puncture area, allowing the operator to intuitively observe the tissue morphology, accurately avoid key structures such as blood vessels and nerves, flexibly select the optimal puncture position, and greatly improve the safety and accuracy of puncture.

[0095] (3) The present invention adopts an integrated structure design, which eliminates the need to replace instruments such as endoscope sheath, puncture device, and guide wire multiple times as in the prior art. This greatly simplifies the clinical operation process, reduces the difficulty of operation for the surgeon, and is especially easy for novice doctors to master quickly, effectively shortening the learning curve. It also significantly reduces the operation time and reduces the risk of patient infection caused by frequent instrument replacement.

[0096] (4) The present invention is equipped with optimized structures such as sealing protection and smooth transition at the distal end of the outer tube, which can further ensure the stable operation of the device in the complex environment inside the body, avoid sharp edges scratching tissue, and comprehensively improve the safety and reliability of the surgery.

[0097] In this invention, features described and / or illustrated for one embodiment may be used in the same or similar manner in one or more other embodiments, and / or combined with or in place of features of other embodiments.

[0098] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, various modifications and variations of the embodiments of the present invention are possible. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A real-time imaging pericardiocentesis device, characterized in that, include: Inner tube (1), outer tube (2), illumination beam guiding assembly (3) and imaging assembly (4); The outer tube (2) is sleeved on the outside of the inner tube (1), and the distal end of the inner tube (1) has a puncture section (101) that extends relative to the distal end of the outer tube (2), and the end of the puncture section (101) is formed with a needle tip (102). The inner tube (1) is a hollow tubular structure used for pericardial effusion aspiration, drug injection, or to establish an extracardiac ablation surgical pathway. The inner tube (1), the outer tube (2), or both of them together form a first mounting groove (A) at their nesting parts, for setting the lighting light guiding component (3); The inner tube (1), the outer tube (2), or both of them together form a second mounting groove (B) at their nesting parts for setting the imaging component (4). The illumination beam guiding component (3) is used to conduct illumination light so that it can illuminate the target area; the illumination beam guiding component (3) includes a plurality of guiding units (30), and each guiding unit (30) is distributed at intervals along the circumferential direction on the distal end face (201) of the outer tube (2); the guiding unit (30) includes a first fiber bundle (301); or, the guiding unit (30) includes a first fiber bundle (301) and a light source end lens group (302) located at the distal end of the first fiber bundle (301), the light source end lens group (302) is used to focus the illumination light into parallel light or to focus the illumination light of all the guiding units (30) into a concentrated beam; The distal ends of the illumination beam guiding component (3) and the imaging component (4) are both exposed to the distal end of the inner tube (1) and are directed toward the needle tip (102); The needle tip (102) has an inclined surface that intersects the axis of the tube body of the puncture section (101); two second mounting slots (B) are provided, located at the highest point (102-1) and the lowest point (102-2) of the inclined surface, respectively; the imaging component (4) includes two imaging units (40), which are respectively disposed in the two second mounting slots (B); the imaging component (4) is used to form a real image of the target area.

2. The real-time imaging pericardiocentesis device according to claim 1, characterized in that, The first mounting groove (A) is formed on the inner wall of the outer tube (2) and is parallel to the axial direction of the outer tube (2); The second mounting groove (B) is formed on the inner wall of the outer tube (2) and is parallel to the axial direction of the outer tube (2); In the circumferential direction of the end face of the outer tube (2), the first mounting groove (A) and the second mounting groove (B) are spaced apart.

3. The real-time imaging pericardiocentesis device according to claim 1, characterized in that, The lighting beam guiding assembly (3) includes a plurality of guiding units (30), the number of the first mounting slots (A) is the same as the number of the guiding units (30), and each of the guiding units (30) is respectively disposed in each of the first mounting slots (A).

4. The real-time imaging pericardiocentesis device according to claim 1, characterized in that, The first mounting slot (A) has a first main slot and a first distal slot. The first main slot is used for the extension arrangement of the lighting light guiding component (3) inside the tube. The first distal slot is located at the distal end of the outer tube (2) and is used to expose the distal end of the lighting light guiding component (3) so that the light source transmitted inside the lighting light guiding component (3) can illuminate the target part. The first main groove is formed entirely on the outer wall of the inner tube (1), or is formed by the outer wall of the inner tube (1) and the inner wall of the outer tube (2). The first distal groove extends from the inner wall of the outer tube (2) to its distal end face (201).

5. The real-time imaging pericardiocentesis device according to claim 1, characterized in that, The second mounting slot (B) has a second main slot (b1) and a second distal slot (b2). The second main slot (b1) is used for the extended arrangement of the imaging component (4) inside the tube. The second distal slot (b2) is located at the distal end of the outer tube (2) and is used to expose the distal end of the imaging component (4) so ​​that the reflected light from the target part can enter the imaging component (4) and form an image. The second main groove (b1) is formed entirely on the outer wall of the inner tube (1), or is formed by the outer wall of the inner tube (1) and the inner wall of the outer tube (2). The second distal groove (b2) extends from the inner wall of the outer tube (2) to its distal end face.

6. The real-time imaging pericardiocentesis device according to claim 1, characterized in that, The imaging component (4) includes two or more imaging units (40). The imaging unit (40) includes an imaging end lens group (401); the imaging end lens group (401) is used to converge the reflected light from the target area to form an image; or, The imaging unit (40) includes an imaging end lens group (401) and a second fiber bundle (402). The imaging end lens is located at the far end of the fiber, and the second fiber bundle (402) is used to transmit the light spot of the image formed by the imaging end lens group (401). or, The imaging unit (40) includes at least one imaging end lens group (401) and a miniature image sensor (403). The imaging end lens group (401) is located at the far end of the miniature image sensor (403). The miniature image sensor (403) is used to convert the image of the imaging end lens group (401) into a corresponding electrical signal.

7. The real-time imaging pericardiocentesis device according to claim 1, characterized in that, The distal end of the illumination light guiding component (3) and / or the imaging component (4) is formed with a waterproof coating, or the pericardial puncture device is provided with a transparent protective cover (21) on the distal end face (201) of the outer tube (2).

8. The real-time imaging pericardiocentesis device according to claim 1, characterized in that, The angle of the needle tip (102) is 10° to 40°; the length of the puncture section (101) is 5-10 mm; and the outer edge of the distal end of the outer tube (2) is provided with a smooth transition structure. The pericardiocentesis device also includes: A connecting seat (5) is disposed at the proximal end of the inner tube (1) and the outer tube (2); The fiber optic connector (6) is connected to the optical fiber of the illumination light guiding assembly (3) to connect to the light source; the fiber optic connector (6) is also used to connect to the optical fiber or signal line of the imaging assembly (4) to connect to the display device. Luer joint (7).

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