Myocardial biopsy equipment based on OCT real-time positioning

By integrating OCT technology into myocardial biopsy equipment, real-time myocardial imaging is solved, and the problem of not being able to judge the position and depth of the forceps in real time under X-ray guidance is improved, and the success rate and safety of the biopsy are improved.

CN222640517UActive Publication Date: 2025-03-21ZHONGSHAN HOSPITAL FUDAN UNIV
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Patent Information

Application Number
CN202420827620.1
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-04-19
Publication Date
2025-03-21
Estimated Expiration
2034-04-19

AI Technical Summary

Technical Problem

Myocardial biopsy operation guided by X-ray cannot provide real-time images of the heart structure, resulting in difficulty in direct and real-time judgment of the position, depth and repeated forceps, and serious complications such as empty forceps, false forceps or heart rupture are prone to occur.

Method used

Using real-time positioning technology based on OCT (optical coherence tomography), real-time scanning of the myocardium through optical fiber probes, combined with the operation of the controller and biopsy clamp handle, direct and real-time judgment of the clamp position and depth is achieved.

Benefits of technology

High resolution real-time images provided by OCT significantly improve the success rate of myocardial biopsy, reduce the occurrence of complications, and ensure the accuracy and safety of forceps.

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Abstract

The utility model provides myocardial biopsy equipment based on OCT (optical coherence tomography) real-time positioning. The myocardial biopsy equipment comprises a fusion catheter, a controller, a biopsy forceps handle, an optical fiber probe and biopsy forceps, the optical fiber probe and the biopsy forceps are arranged at the far end of the fusion catheter, the controller and the biopsy forceps handle are arranged at the near end of the fusion catheter, an optical fiber and a control line are arranged in the fusion catheter, the optical fiber is connected between the optical fiber probe and the controller, and the control line is connected with the controller. The controller is provided with a control button for controlling the optical fiber probe to be opened and closed, the control line is connected between the biopsy forceps handle and the biopsy forceps, the biopsy forceps handle is provided with an operation button for operating the biopsy forceps to be opened and closed, and the optical fiber probe is used for scanning the interior of the cardiac muscle in real time. After the cardiac muscle needing biopsy is determined, a biopsy forceps handle is operated, so that the biopsy forceps clamp the cardiac muscle tissue needing biopsy.
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Description

Technical Field

[0001] The utility model relates to the field of myocardial biopsy equipment, in particular to a myocardial biopsy equipment based on OCT real-time positioning. Background Art

[0002] The cause of cardiovascular diseases such as cardiomyopathy and heart failure, as well as the diagnosis of difficult cardiovascular diseases, rely on pathological diagnosis of the myocardium. Among them, the myocardial biopsy forceps is an instrument used to clamp tissue samples from the patient's heart. In actual operation, the biopsy forceps is sent into the heart through the veins, and under the guidance of X-ray fluoroscopy, the distal end of the biopsy forceps is placed against the septum of the atrium or ventricle, and the clamp is opened to clamp the myocardial tissue. The clamped myocardial tissue is mainly used for pathological examination.

[0003] The following problems exist in myocardial biopsy under X-ray guidance: X-rays cannot directly present real-time images of the heart structure, and the position of the septum must be indirectly determined based on the anatomical relationship with the spine before clamping the myocardial tissue. Therefore, the clamping position, clamping depth, and whether to repeat the clamping cannot be directly and real-time judged, which can easily lead to serious complications such as empty clamping, wrong clamping, and even heart rupture.

[0004] Based on this, there is an urgent need for a real-time image-assisted myocardial biopsy that can provide high resolution, thereby improving the success rate of myocardial biopsy and reducing the occurrence of complications. Utility Model Content

[0005] The purpose of the utility model is to provide a myocardial biopsy device based on OCT real-time positioning to address the deficiencies in the prior art, and to assist in myocardial biopsy through real-time myocardial images provided by optical coherence tomography (OCT).

[0006] In order to achieve the above purpose, the utility model provides the following technical solutions:

[0007] A myocardial biopsy device based on OCT real-time positioning, comprising a fusion catheter, a controller, a biopsy forceps handle, an optical fiber probe and a biopsy forceps;

[0008] The optical fiber probe and the biopsy forceps are arranged at the distal end of the fusion catheter, the controller and the biopsy forceps handle are arranged at the proximal end of the fusion catheter, an optical fiber and a control line are arranged inside the fusion catheter, the optical fiber is connected between the optical fiber probe and the controller, a control button for controlling the opening and closing of the optical fiber probe is arranged on the controller, the control line is connected between the biopsy forceps handle and the biopsy forceps, and an operation button for operating the opening and closing of the biopsy forceps is arranged on the biopsy forceps handle.

[0009] As a preferred embodiment, a bend is provided on the outer wall of the distal end of the fusion catheter, a drive cable is provided inside the fusion catheter, the drive cable is connected between the bend and the controller, and a control button for controlling the bending of the bend of the fusion catheter is provided on the controller.

[0010] As a preferred embodiment, it also includes:

[0011] A flushing catheter is connected to the proximal end of the fusion catheter.

[0012] As a preferred embodiment, the fusion catheter is divided into an optical fiber passage, a flushing passage and a clamp passage from the inside to the outside, the optical fiber probe and the optical fiber are arranged in the optical fiber passage, the flushing catheter is connected to the flushing passage, and the biopsy forceps and the control line are arranged in the clamp passage.

[0013] As a preferred embodiment, the biopsy forceps includes two clamps, the two clamps are surrounded on the outside of the optical fiber probe, and one of the clamps is connected to the control wire.

[0014] As a preferred embodiment, it also includes:

[0015] An operating console is connected to the controller.

[0016] As a preferred embodiment, the operating console includes a control unit, a light source, a fiber optic coupler, a data acquisition unit and a display unit;

[0017] The control unit, the light source and the optical fiber coupler are connected in sequence;

[0018] The optical fiber coupler, the data acquisition unit and the display unit are connected in sequence.

[0019] As a preferred embodiment, the operating table further includes a drive control board, and the drive control board is connected to the control unit.

[0020] As a preferred embodiment, the operating table further includes a photosensitive detector, and the photosensitive detector is connected between the optical fiber coupler and the data acquisition unit;

[0021] The control unit is connected to the optical fiber coupler, the photosensitive detector, the data acquisition unit and the display unit respectively.

[0022] Compared with the prior art, this technical solution has the following advantages:

[0023] The distal end of the fusion catheter is inserted into the patient's heart cavity, while the proximal end of the fusion catheter is located outside the patient's body cavity, so as to operate the controller and the biopsy forceps handle. The optical fiber probe can scan the inside of the myocardium, and the biopsy forceps clamp the myocardial tissue. It can be seen that by scanning the inside of the myocardium in real time through the optical fiber probe, after determining the myocardium that needs to be biopsied, the biopsy forceps handle is operated so that the biopsy forceps clamp the myocardial tissue that needs to be biopsied, and the clamping position, clamping depth, and whether to repeat the clamping can be directly and real-time judged, thereby avoiding serious complications such as empty clamping, wrong clamping, and even heart rupture, thereby improving the success rate of myocardial biopsy.

[0024] The present invention is further described below with reference to the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a schematic diagram of the structure of the myocardial biopsy device based on OCT real-time positioning according to the utility model;

[0026] Figure 2 It is a side view of the distal end of the fusion catheter of the utility model;

[0027] Figure 3 It is a front view of the distal end of the fusion catheter of the utility model;

[0028] Figure 4 It is a schematic diagram of the principle of the operating table of the utility model.

[0029] In the figure: 100 fusion catheter, 100a bend, 111 controller, 112 biopsy forceps handle, 113 flushing catheter, 121 fiber optic probe, 122 biopsy forceps, 1221 clamp, 1222 connecting rod, 131 optical fiber, 132 control line, 133 drive cable, 1001 optical fiber passage, 1002 flushing passage, 1003 clamp passage, 200 operating table. DETAILED DESCRIPTION

[0030] The following description is used to disclose the utility model so that those skilled in the art can implement the utility model. The preferred embodiments described below are only examples, and those skilled in the art can think of other obvious variations. The basic principles of the utility model defined in the following description can be applied to other embodiments, variations, improvements, equivalents, and other technical solutions that do not deviate from the spirit and scope of the utility model.

[0031] like Figure 1 and Figure 2 As shown, the myocardial biopsy device based on OCT real-time positioning includes a fusion catheter 100, a controller 111, a biopsy forceps handle 112, an optical fiber probe 121 and a biopsy forceps 122;

[0032] The optical fiber probe 121 and the biopsy forceps 122 are arranged at the distal end of the fusion catheter 100, the controller 111 and the biopsy forceps handle 112 are arranged at the proximal end of the fusion catheter 100, and the fusion catheter 100 is provided with an optical fiber 131 and a control line 132. The optical fiber 131 is connected between the optical fiber probe 121 and the controller 111, and the controller 111 is provided with a control button for controlling the opening and closing of the optical fiber probe 121. The control line 132 is connected between the biopsy forceps handle 112 and the biopsy forceps 122, and the biopsy forceps handle 112 is provided with an operation button for operating the opening and closing of the biopsy forceps 122.

[0033] The optical fiber probe 121 and the biopsy forceps 122 are arranged at the distal end of the fusion catheter 100, and the controller 111 and the biopsy forceps handle 112 are arranged at the proximal end of the fusion catheter 100. The optical fiber probe 121 is controlled to open and close by the controller 111, and the biopsy forceps 122 are controlled to open and close by the biopsy forceps handle 112. The distal end of the fusion catheter 100 is inserted into the patient's heart cavity, and the proximal end of the fusion catheter 100 is located outside the patient's body cavity to operate the controller 111 and the biopsy forceps handle 112. The optical fiber probe 121 can scan the inside of the myocardium, and the biopsy forceps 122 can clamp the myocardial tissue. It can be seen that the optical fiber probe 121 is used to scan the inside of the myocardium in real time. After the myocardium that needs biopsy is determined, the biopsy forceps handle 112 is operated to enable the biopsy forceps 122 to clamp the myocardial tissue that needs biopsy. The clamping position, clamping depth, and whether to repeat the clamping can be directly and real-time judged, thereby avoiding serious complications such as empty clamping, wrong clamping, and even heart rupture, thereby improving the success rate of myocardial biopsy.

[0034] The optical fiber probe 121 can emit broadband near-infrared rays to scan the inside of the myocardium, with a central wavelength of about 1300um and a bandwidth of 40-50nm.

[0035] like Figure 2 and Figure 3 As shown, the fusion catheter 100 is divided into an optical fiber passage 1001 and a clamp passage 1003 from the inside to the outside, the optical fiber probe 121 and the optical fiber 131 are arranged in the optical fiber passage 1001, and the biopsy forceps 122 and the control line 132 are arranged in the clamp passage 1003. It can be seen that the optical fiber probe 121 and the biopsy forceps 122 are respectively arranged in different passages to prevent the optical fiber 131 and the control line 132 from being entangled or even unable to operate in the same passage.

[0036] The biopsy forceps 122 includes two clamps 1221, which are arc-shaped, surround the outer side of the optical fiber probe 121, and are arranged at intervals, one of the clamps 1221 is connected to the control line 132, and the biopsy forceps handle 112 pulls and releases the control line 132 to change the angle between the clamp 1221 and the other clamp 1221, thereby completing the opening and closing of the biopsy forceps handle 112. When the biopsy forceps handle 112 is closed, myocardial tissue can be clamped.

[0037] Further, refer to Figure 2 The biopsy forceps 122 further includes a connecting rod 1222, and the two clamps 1221 are divided into an upper clamp and a lower clamp, and the lower clamp is connected to the control line 132, wherein the upper clamp is fixedly connected to the connecting rod 1222, and the lower clamp is rotatably connected to the connecting rod 1222. When the control line 132 is operated and pulled by the biopsy forceps handle 112, the lower clamp and the upper clamp are closed or opened. Figure 2 The connecting rod 1222 passes through the wall between the optical fiber passage 1001 and the clamp passage 1003 and is fixed inside the fusion catheter 100 .

[0038] like Figures 1 to 3 As shown, the myocardial biopsy device based on OCT real-time positioning also includes:

[0039] The flushing catheter 113 is connected to the proximal end of the fusion catheter 100 .

[0040] The flushing catheter 113 is respectively connected between the contrast agent and the proximal end of the fusion catheter 100, so that the contrast agent can enter the fusion catheter 100 and be ejected from the distal end of the fusion catheter 100 to flush the blood on the myocardial surface and improve the clarity of the optical fiber probe 121 scanning the myocardium.

[0041] Furthermore, the fusion catheter 100 also has a flushing passage 1002, which is located between the optical fiber passage 1001 and the clamp passage 1003, and the flushing catheter 113 is connected to the flushing passage 1002. In this way, the contrast agent introduced from the flushing catheter 113 can be ejected from the distal end of the fusion catheter 100 along the flushing passage 1002.

[0042] The optical fiber passage 1001, the flushing passage 1002 and the clamp passage 1003 are radially arranged and spaced from the inside to the outside. It can be seen that the contrast agent in the flushing passage 1002 will not flow radially into the optical fiber passage 1001 and the clamp passage 1003, avoiding interference and affecting the operation.

[0043] like Figure 2 As shown, a bend 100a is provided on the outer wall of the distal end of the fused catheter 100, a drive cable 133 is provided inside the fused catheter 100, the drive cable 133 is connected between the bend 100a and the controller 111, and a control button for controlling the bending of the bend 100a of the fused catheter 100 is provided on the controller 111.

[0044] The distal end of the fusion catheter 100 can be controlled to bend to increase the functionality, and the optical fiber probe 121 can bend along with the bending of the distal end of the fusion catheter 100 .

[0045] like Figure 1 and Figure 4 As shown, the myocardial biopsy device based on OCT real-time positioning also includes:

[0046] An operating console 200 , wherein the operating console 200 is connected to the controller 111 .

[0047] The operating console 200 is used for data analysis and myocardial image display.

[0048] refer to Figure 4 , the operating table 200 includes a control unit, a light source, a fiber coupler, a data acquisition unit and a display unit;

[0049] The control unit, the light source and the optical fiber coupler are connected in sequence;

[0050] The optical fiber coupler, the data acquisition unit and the display unit are connected in sequence.

[0051] The control unit can control the opening and closing of the light source, the fiber coupler, the data acquisition unit and the display unit. The control unit controls the light source to emit incident light to the fiber coupler. When the controller 111 is executed to start the fiber optic probe 121, the fiber optic coupler serves as a connector between the light source and the optical fiber 131, so that the fiber optic probe 121 emits a measuring beam to the myocardium. At the same time, the fiber optic coupler receives the reflected measuring beam and sends the reflected measuring beam to the data acquisition unit. Finally, the display unit displays the image scanned by the fiber optic probe 121, so that medical staff can clamp the myocardial tissue according to the image displayed by the display unit.

[0052] The light source and the fiber coupler display through light interference, integrate the signal arm and the reference arm to form an optical signal of the tissue, and after the optical signal is analyzed and processed by the data acquisition unit, it is displayed in the form of a tomographic image of the tissue through the display unit.

[0053] like Figure 4 As shown, the operating console 200 further includes a drive control board, and the drive control board is connected to the control unit.

[0054] Medical staff can open and close the operating table 200 according to the drive control panel.

[0055] like Figure 4 As shown, the operating table 200 further includes a photosensitive detector, which is connected between the optical fiber coupler and the data acquisition unit;

[0056] The control unit is connected to the optical fiber coupler, the photosensitive detector, the data acquisition unit and the display unit respectively.

[0057] The photosensitive detector converts the optical signal into an electrical signal by using the photoelectric effect, and converts the light beam output by the optical fiber coupler into an electrical signal that can be collected by the data acquisition unit. The control unit can analyze and process the electrical signal that can be collected by the data acquisition unit, so that the display unit can display a clear image scanned by the optical fiber probe 121.

[0058] Continue to refer Figure 4 The operating table 200 also includes a reference mirror, which is connected to the optical fiber coupler. The optical fiber coupler sends a reference beam to the reference mirror and receives the reference beam sent by the reference mirror. The control system can analyze the reference beam and the measuring beam to obtain a biological tissue tomographic image, that is, the image scanned by the optical fiber probe 121.

[0059] The operating table 200 includes a housing, the control unit, light source, fiber coupler, and data acquisition unit can be integrated inside the housing, and the display unit is arranged on the surface of the housing for medical staff to watch. Rollers can be arranged at the bottom of the housing for easy movement.

[0060] As can be seen from the above, optical coherence tomography OCT uses near-infrared light interference imaging, that is, the optical fiber probe 121 emits near-infrared rays to scan the inside of the myocardium, and uses an interferometer to receive and record the reflected light of biological tissue components at different depths, and then processes it through a computer system to obtain a biological tissue tomographic image. The resolution of OCT can reach 10um, and the tissue penetration depth can reach 2mm, so that the fine structure inside the tissue can be clearly observed. OCT can not only detect abnormal myocardial tissue in real time and improve the positive detection rate of biopsy, but also determine the thickness and structure of the myocardium to be biopsied, and prevent the occurrence of complications such as cardiac perforation or mis-clamping of normal heart structures such as valves.

[0061] OCT, also known as "optical biopsy", can help the surgeon observe the structure of the heart and myocardium in real time due to its penetration depth and resolution, and guide the surgeon to truly target and clamp the myocardial tissue that requires pathological biopsy during myocardial biopsy. At the same time, through clear and real-time images, the surgeon can avoid clamping too thin myocardium, prevent heart perforation, and avoid accidentally clamping valves, blood vessels, conduction bundles and other tissue structures.

[0062] The biopsy route can be selected according to the biopsy site. For example, the biopsy of the left ventricle and left atrium can reach the left heart system through radial artery puncture or femoral artery puncture; the biopsy of the right atrium and right ventricle can reach the right heart system through the femoral vein. After operating the fusion catheter 100 to reach the vicinity of the myocardium to be biopsied, the contrast agent is injected into the flushing catheter 113 to flush the myocardial surface. After the optical fiber probe 121 is attached to the observed myocardium, the optical fiber probe 121 is controlled by the controller 111 to emit near-infrared light. The myocardial tissue structure can be observed in real time and in a positioned manner through the display unit of the operating table 200. After the myocardium to be biopsied is determined, the biopsy forceps handle 112 connected to the biopsy forceps 122 is operated to clamp the myocardial tissue.

[0063] The embodiments described above are only used to illustrate the technical ideas and features of the utility model, and their purpose is to enable technicians in this field to understand the content of the utility model and implement it accordingly. The patent application scope of the utility model cannot be limited only by this embodiment, that is, any equivalent changes or modifications made according to the spirit disclosed by the utility model still fall within the patent scope of the utility model.

Claims

1. A myocardial biopsy device based on real-time OCT positioning, characterized in that: It comprises a fusion catheter (100), a controller (111), a biopsy forceps handle (112), an optical fiber probe (121) and a biopsy forceps (122); The optical fiber probe (121) and the biopsy forceps (122) are arranged at the distal end of the fusion catheter (100), the controller (111) and the biopsy forceps handle (112) are arranged at the proximal end of the fusion catheter (100), an optical fiber (131) and a control line (132) are arranged inside the fusion catheter (100), the optical fiber (131) is connected between the optical fiber probe (121) and the controller (111), the controller (111) is provided with a control button for controlling the opening and closing of the optical fiber probe (121), the control line (132) is connected between the biopsy forceps handle (112) and the biopsy forceps (122), and the biopsy forceps handle (112) is provided with an operation button for operating the opening and closing of the biopsy forceps (122).

2. The myocardial biopsy device based on real-time OCT positioning according to claim 1, characterized in that: A bend (100a) is provided on the outer wall of the distal end of the fused catheter (100), a drive cable (133) is provided inside the fused catheter (100), the drive cable (133) is connected between the bend (100a) and the controller (111), and a control button for controlling the bending of the bend (100a) of the fused catheter (100) is provided on the controller (111).

3. The myocardial biopsy device based on real-time OCT positioning according to claim 1, characterized in that: Also includes: A flushing catheter (113), wherein the flushing catheter (113) is connected to the proximal end of the fusion catheter (100).

4. The myocardial biopsy device based on real-time OCT positioning as claimed in claim 3, characterized in that: The fusion catheter (100) is divided into an optical fiber passage (1001), a flushing passage (1002) and a clamp passage (1003) from the inside to the outside. The optical fiber probe (121) and the optical fiber (131) are arranged in the optical fiber passage (1001), the flushing catheter (113) and the flushing passage (1002) are connected, and the biopsy forceps (122) and the control line (132) are arranged in the clamp passage (1003).

5. The myocardial biopsy device based on real-time OCT positioning according to claim 1, characterized in that: The biopsy forceps (122) includes two clamps (1221), and the two clamps (1221) are surrounded on the outside of the optical fiber probe (121), and one of the clamps (1221) is connected to the control line (132).

6. The myocardial biopsy device based on real-time OCT positioning according to claim 1, characterized in that: Also includes: An operating console (200), wherein the operating console (200) is connected to the controller (111).

7. The myocardial biopsy device based on real-time OCT positioning according to claim 6, characterized in that: The operating table (200) comprises a control unit, a light source, a fiber optic coupler, a data acquisition unit and a display unit; The control unit, the light source and the optical fiber coupler are connected in sequence; The optical fiber coupler, the data acquisition unit and the display unit are connected in sequence.

8. The myocardial biopsy device based on real-time OCT positioning as claimed in claim 7, characterized in that: The operating table (200) also includes a drive control board, and the drive control board is connected to the control unit.

9. The myocardial biopsy device based on real-time OCT positioning according to claim 7, characterized in that: The operating table (200) further comprises a photosensitive detector, wherein the photosensitive detector is connected between the optical fiber coupler and the data acquisition unit; The control unit is connected to the optical fiber coupler, the photosensitive detector, the data acquisition unit and the display unit respectively.