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CN-121421646-B - Real-time imaging pericardium puncture device

CN121421646BCN 121421646 BCN121421646 BCN 121421646BCN-121421646-B

Abstract

The invention provides a real-time imaging pericardium puncture device which comprises an inner tube, an outer tube, an illumination light guide assembly and an imaging assembly, wherein the outer tube is sleeved on the outer side of the inner tube, a puncture section extending out of the distal end of the outer tube is arranged at the distal end of the inner tube, a needle tip is formed at the end part of the puncture section, a first mounting groove is formed in the inner tube, the outer tube or the inner tube and the outer tube together at the nesting part of the inner tube and the outer tube, the illumination light guide assembly is used for arranging the imaging assembly, the illumination light guide assembly is used for conducting illumination light so that the illumination light can illuminate a target area, the imaging assembly is used for forming a real image of the target area, and the distal ends of the illumination light guide assembly and the imaging assembly are exposed at the distal end of the inner tube and face the direction of the needle tip. The device combines the integrated illumination light guide assembly and the imaging assembly through the nested structural design of the inner tube and the outer tube, has the real-time imaging function, can accurately guide puncture operation, and has outstanding clinical application value and popularization prospect.

Inventors

  • LONG DEYONG

Assignees

  • 心诺普医疗技术（北京）有限公司

Dates

Publication Date
20260508
Application Date
20251230

Claims (8)

  1. 1. The real-time imaging pericardium puncture device is characterized by comprising an inner tube (1), an outer tube (2), an illumination light guiding component (3) and an imaging component (4); The outer tube (2) is sleeved outside the inner tube (1), a puncture section (101) extending out of the distal end of the outer tube (2) is arranged at the distal end of the inner tube (1), and a needle point (102) is formed at the end part of the puncture section (101); the inner tube (1) is of a hollow tubular structure and is used for extracting pericardial effusion, injecting medicines or adapting to establish an extracardiac ablation operation passage; The inner tube (1), the outer tube (2) or both are formed with a first mounting groove (A) at the nesting part thereof for arranging the illumination light guiding component (3); The inner tube (1), the outer tube (2) or both are formed with a second mounting groove (B) at the nesting part thereof for arranging the imaging component (4); The illumination light guiding assembly (3) is used for guiding illumination light so as to illuminate a target area, the illumination light guiding assembly (3) comprises a plurality of guiding units (30), each guiding unit (30) is distributed on the distal end face (201) of the outer tube (2) at intervals along the circumferential direction, the guiding units (30) comprise a first optical fiber bundle (301), or the guiding units (30) comprise the first optical fiber bundle (301) and a light source end lens group (302) positioned at the distal end of the first optical fiber bundle (301), and the light source end lens group (302) is used for focusing illumination light into parallel light or focusing illumination light of all the guiding units (30) into a concentrated light beam; the distal ends of the illumination light guiding component (3) and the imaging component (4) are exposed to the distal end of the inner tube (1) and face the direction of the needle tip (102); The needle tip (102) is provided with two inclined planes intersecting with the axis of the tube body of the puncture section (101), the second mounting grooves (B) are respectively positioned at the highest point (102-1) and the lowest point (102-2) of the inclined planes, the imaging assembly (4) comprises two imaging units (40) respectively arranged in the two second mounting grooves (B), and the imaging assembly (4) is used for forming real images of a target area.
  2. 2. The real-time imaging pericardial puncture device according to claim 1, wherein the first mounting groove (a) is formed at an inner wall portion of the outer tube (2) and is parallel to an axial direction of the outer tube (2); The second mounting groove (B) is formed at the inner wall part 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 arranged at intervals.
  3. 3. The real-time imaging pericardium puncture device according to claim 1, characterized in that the illumination light guiding assembly (3) comprises a number of guiding units (30), the number of the first mounting grooves (a) is identical to the number of the guiding units (30), and each guiding unit (30) is respectively arranged in each first mounting groove (a).
  4. 4. The real-time imaging pericardial puncture device according to claim 1, wherein the first mounting groove (a) has a first main groove body and a first distal groove body, the first main groove body is used for the extension arrangement of the illumination light guiding assembly (3) in a tube body, the first distal groove body is positioned at the distal end of the outer tube (2) and used for exposing the distal end of the illumination light guiding assembly (3), so that the light source light conducted inside the illumination light guiding assembly (3) can illuminate a target part; the first main groove body is formed on the outer wall of the inner tube (1) entirely or jointly by the outer wall of the inner tube (1) and the inner wall of the outer tube (2), and the first far-end groove body penetrates from the inner wall of the outer tube (2) to the far-end face (201) of the first far-end groove body.
  5. 5. The real-time imaging pericardial puncture device according to claim 1, wherein the second mounting groove (B) has a second main groove body (B1) and a second distal groove body (B2), the second main groove body (B1) is used for the extension arrangement of the imaging assembly (4) in the tube body, the second distal groove body (B2) is located at the distal end of the outer tube (2) for exposing the distal end of the imaging assembly (4) so that the reflected light of the target site can enter the imaging assembly (4) and be imaged; The second main groove body (b 1) is formed on the outer wall of the inner tube (1) entirely or jointly by the outer wall of the inner tube (1) and the inner wall of the outer tube (2), and the second far-end groove body (b 2) penetrates from the inner wall of the outer tube (2) to the end face of the far end of the outer tube.
  6. 6. The real-time imaging pericardial puncture device according to claim 1, characterized in that the imaging assembly (4) comprises more than two imaging units (40); the imaging unit (40) comprises an imaging end lens group (401), wherein the imaging end lens group (401) is used for converging and imaging the reflected light of the target area, or The imaging unit (40) comprises an imaging end lens group (401) and a second optical fiber bundle (402), wherein the imaging end lens is positioned at the far end of the optical fiber, the second optical fiber bundle (402) is used for transmitting the light spot of the image formed by the imaging end lens group (401), or The imaging unit (40) comprises at least one imaging end lens group (401) and a miniature image sensor (403), wherein the imaging end lens group (401) is positioned at the far end of the miniature image sensor (403), and the miniature image sensor (403) is used for converting an image of the imaging end lens group (401) into corresponding electric signals.
  7. 7. Real-time imaging pericardial puncture device according to claim 1, characterized in that the distal end of the illumination light guide assembly (3) and/or the imaging assembly (4) is formed with a waterproof coating or the pericardial puncture device is provided with a transparent protective cover (21) at the distal end face (201) of the outer tube (2).
  8. 8. The real-time imaging pericardial puncture 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 5-10mm, and the outer edge of the far end of the outer tube (2) is provided with a smooth transition structure; The pericardial puncture device further comprises: The connecting seat (5) is arranged at the proximal ends of the inner tube (1) and the outer tube (2); The optical fiber connector (6) is connected with the optical fiber of the illumination light guiding component (3) so as to be connected with a light source, and the optical fiber connector (6) is also used for being connected with the optical fiber or the signal wire of the imaging component (4) so as to be connected with a display device; Luer fitting (7).

Description

Real-time imaging pericardium puncture device Technical Field The invention relates to the technical field of medical equipment, in particular to a real-time imaging pericardium puncture device. Background The pericardium is a double connective tissue membrane structure for wrapping the heart, and is divided into a dirty layer and a wall layer, and a small amount of slurry is contained in a pericardial cavity formed between the two layers to play a role in lubrication. In cardiovascular clinical diagnosis and treatment, pericardial puncture is a key operation, namely, on one hand, aiming at pericardial effusion and pericardial tamponade patients, the effusion is required to be extracted through a pericardial puncture establishment passage to relieve compression, and on the other hand, in the operations of extracardiac ablation operation, pericardial administration, pericardial biopsy and the like, the pericardium is required to be punctured and the passage is reserved, so that an ablation catheter, an administration instrument or a biopsy tool enters a pericardial cavity, and the diagnosis and treatment aim is fulfilled. In the prior art, various structural forms of pericardial puncture equipment have been developed, such as a conventional noninvasive pericardial puncture needle, which comprises an outer sleeve, a solid needle core and an end sealing cap, wherein the needle core is withdrawn after penetrating into the pericardium, the outer sleeve is reserved to complete effusion extraction or instrument placement, and a split puncture needle which consists of a puncture needle body and a drainage tube and is provided with a graduated puncture needle, wherein the needle penetration depth can be marked through graduations. Despite the structural optimization of the existing equipment, technical defects which are difficult to overcome still exist, and the safety and effectiveness of clinical application are severely restricted. For example, the existing puncture needle has no real-time imaging function, and an operator can only judge the position of the needle tip by means of indirect positioning of in-vitro ultrasound and needle insertion hand feeling, so that the relative position relation between the needle tip and pericardial wall, peripheral blood vessels (such as coronary artery branches) and myocardial tissues cannot be intuitively observed. When the patient has the conditions of pericardial adhesion, anatomical variation and the like, the deviation of the needle insertion position is very easy to occur, so that puncture failure is caused, or the needle insertion angle needs to be adjusted repeatedly, so that the operation time is prolonged. Because the advanced state of the needle tip cannot be monitored in real time, the operator cannot accurately control the needle insertion depth, if the needle insertion is too shallow, an effective passage cannot be established by penetrating the pericardium of a wall layer, and if the needle insertion is too deep, the needle tip is easy to puncture the pericardium of a dirty layer to damage cardiac muscle or wrongly penetrate a large blood vessel around the pericardium, so that serious complications such as pericardium filling and massive hemorrhage endanger life are caused, and the operation risk is obviously increased. The outer sleeve and the needle core of the existing puncture needle only have the functions of puncture and passageway establishment, cannot integrate auxiliary components such as illumination and imaging, and if visual operation needs to be realized, external imaging equipment needs to be additionally matched, so that the use complexity of the instrument is increased, the suitability of the external equipment and the puncture needle is poor, accurate imaging of a needle point area is difficult to realize, and the high-precision requirement of the extra-cardiac ablation operation on passageway establishment cannot be met. The high experience dependence of the operation leads a new operator to master the puncture skill through long-term clinical practice, has long learning period, is unfavorable for popularization and popularization of the technology, and particularly has higher puncture error occurrence rate caused by insufficient experience of the operator in basic medical institutions. In summary, a pericardial puncture device with a real-time imaging function and capable of accurately guiding puncture operation is developed to solve the problems of inaccurate positioning, high complication risk and high operation threshold in the prior art, and the pericardial puncture device has become an urgent requirement in the fields of clinical pericardial puncture and extracardiac ablation operations. Disclosure of Invention In view of this, embodiments of the present invention provide a real-time imaging pericardial puncture device that obviates or mitigates one or more of the disadvantages of the prior art. A real-time imaging pericardium puncture de