Interventional angiography-based carotid plaque biopsy device

Abstract

This invention discloses a carotid artery plaque biopsy device based on interventional angiography, comprising a fusion catheter, the distal end of which is fixedly connected to one end of a biopsy probe. A freely rotatable transmission tube is located within the fusion catheter. A biopsy blade and a drug-loaded balloon coated with a drug layer are located on the side wall of the distal end of the transmission tube. The drug-loaded balloon is connected to a balloon-pressurized catheter. A biopsy window is formed on the outer wall of the biopsy probe. The biopsy blade and the drug-loaded balloon are located within the biopsy probe at positions corresponding to the biopsy window. The transmission tube is rotatably connected to a limiting structure that restricts the axial movement of the transmission tube. The limiting structure is fixed to the biopsy probe. A biopsy filter is covered and connected to the distal end of the biopsy probe. A contrast marker is provided on the outer side of the distal end of the biopsy probe. This invention's device removes carotid artery plaques based on vascular intervention, eliminating the need for open surgery and significantly reducing the risks of infection, bleeding, and carotid artery rupture. The carotid artery plaque is treated using a drug-loaded balloon.

Description

Technical Field

[0001] This invention relates to a carotid artery plaque biopsy device based on interventional angiography, belonging to the field of medical device technology. Background Technology

[0002] In the past, the investigation of the causes of carotid atherosclerotic plaque formation and the treatment of severe stenosis caused by severe carotid atherosclerotic plaque formation relied on surgical carotid endarterectomy. Carotid endarterectomy is a surgical procedure used to remove plaque from the patient's carotid artery. In practice, the carotid artery is surgically exposed, then the diseased carotid artery is incised, the narrowed area—the carotid plaque—is removed, and finally the carotid artery and the outer incision are sutured. The removed carotid plaque is mainly used for pathological examination and to relieve carotid stenosis.

[0003] Surgical carotid artery plaque removal for treatment or pathological biopsy purposes has the following main problems: surgery often results in a large surgical incision for the patient, requiring a long recovery period after surgery, and can also cause surgical complications such as bleeding, tissue adhesion, and infection; at the same time, carotid artery stripping is often used for patients with more severe carotid artery plaque formation. For patients with early-stage carotid artery plaque formation, there is a lack of means to clearly identify the nature and pathological characteristics of the plaque, thus making it impossible to provide targeted treatment for panvascular diseases in the early stages. Summary of the Invention

[0004] The technical problem to be solved by this invention is: how to determine the nature and pathological characteristics of carotid artery plaques in patients with early-stage carotid artery plaque formation.

[0005] To address the aforementioned technical problems, the present invention provides a carotid artery plaque biopsy device based on interventional angiography. The device comprises a fusion catheter, the distal end of which is fixedly connected to one end of a biopsy probe. A freely rotatable transmission tube is located within the fusion catheter. A biopsy blade and a drug-loaded balloon coated with a drug layer are located on the side wall of the distal end of the transmission tube. The drug-loaded balloon is connected to a balloon-pressurized catheter. A biopsy window is formed on the outer wall of the biopsy probe. The biopsy blade and the drug-loaded balloon are both located within the biopsy probe corresponding to the biopsy window. The transmission tube is rotatably connected to a limiting structure that restricts the axial movement of the transmission tube. The limiting structure is fixed to the biopsy probe. A biopsy filter is covered and connected to the distal end of the biopsy probe. A contrast marker is provided on the outer side of the distal end of the biopsy probe.

[0006] Preferably, the transmission tube has multiple water spray holes inside the biopsy probe, and all of the multiple water spray holes are connected to the distal end of the flushing conduit.

[0007] Preferably, the proximal end of the fusion catheter is fixedly connected to the delivery control handle, the transmission tube passes through the delivery control handle, the proximal end of the transmission tube is fixedly connected to the biopsy handle, the flushing catheter and the balloon pressurization catheter both pass through the biopsy handle on the transmission tube, and the delivery control handle is located at the distal end of the biopsy handle.

[0008] Preferably, the hollow cavity inside the transmission pipe serves as a flushing passage connecting the flushing conduit to the water spray hole, and the distal end of the transmission pipe is closed.

[0009] Preferably, the biopsy blade or drug-loaded balloon covers the biopsy window by rotating the transmission tube; the shape of the biopsy window matches the shape of the biopsy blade, and the size of the biopsy window is not larger than the size of the biopsy blade; after being pressurized, the drug-loaded balloon has a fan-shaped column structure, surrounds the transmission tube and is located inside the biopsy probe, and the side size of the drug-loaded balloon after inflation is not smaller than the size of the biopsy window.

[0010] Preferably, the limiting structure includes a limiting bracket, which is fixed on the inner wall of the biopsy probe near the distal end. The limiting bracket consists of an annular structure and at least two connecting rods evenly distributed and connected on the outer side of the annular structure. All connecting rods are fixedly connected to the inner wall of the biopsy probe. The distal end of the transmission tube passes through the limiting hole at the proximal end of the biopsy probe. The transmission tube is rotatably disposed within the limiting hole at the proximal end of the biopsy probe and within the annular hole of the annular structure of the limiting bracket.

[0011] Preferably, bearings are provided in the limiting hole at the proximal end of the biopsy probe and in the annular hole of the limiting bracket, and the limiting bracket and the biopsy probe are rotatably connected to the transmission tube through the bearings.

[0012] Preferably, the outer wall of the transmission tube is provided with grooves at the positions of the limiting hole and the annular hole, and the hole walls of the limiting hole and the annular hole are rotatably disposed in the grooves.

[0013] Preferably, the transmission tube has at least one vent hole at the position of the drug-loaded balloon, which is respectively connected to the drug-loaded balloon and the balloon pressurization conduit.

[0014] Preferably, it also includes an outer sheath, which is sleeved on the outside of the fusion catheter; an independent guidewire channel is opened in the inner wall of the biopsy probe.

[0015] Based on existing applications of endovascular angiography, the degree of stenosis and location of carotid artery plaques can be accurately determined. Using markers on the biopsy probe of this invention, the probe can be accurately positioned to the carotid artery plaque. By using a biopsy probe with a slightly larger vessel diameter, moving the probe allows the carotid artery plaque to enter the probe's interior for collection. Finally, a semi-cylindrical drug-eluting balloon is used to remove the carotid artery plaque, thus achieving treatment simultaneously.

[0016] This invention improves the success rate of carotid artery plaque biopsy and reduces the occurrence of complications by providing real-time assisted resection and biopsy of carotid artery plaques through minimally invasive intervention, thereby enabling early detection of the nature and pathological characteristics of carotid artery plaques and providing early and precise treatment for panvascular diseases.

[0017] The device of this invention performs carotid artery plaque removal via vascular intervention, eliminating the need for open surgery and significantly reducing the risks of infection, bleeding, and carotid artery rupture. Furthermore, the carotid artery plaque can be treated simultaneously with the biopsy using a drug-eluting balloon. Due to its low risk, it may be suitable for patients in the early stages of carotid artery plaque formation. Since atherosclerosis often occurs early in the carotid artery, early plaque biopsy to determine its nature can assist in the early and precise treatment of pan-atherosclerotic vascular diseases. Attached Figure Description

[0018] Figure 1 This is a schematic cross-sectional view of a carotid artery plaque biopsy device based on interventional angiography.

[0019] Figure 2 This is a schematic diagram of the biopsy probe on a carotid plaque biopsy device based on interventional angiography. Figure 3 A cross-sectional view (rear) of the biopsy probe on a carotid plaque biopsy device based on interventional angiography. Figure 4 A cross-sectional view (front) of the biopsy probe on a carotid plaque biopsy device based on interventional angiography. Detailed Implementation

[0020] To make the present invention more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0021] This invention provides a carotid artery plaque biopsy device based on interventional angiography for the pathological diagnosis of carotid artery plaques, such as... Figures 1-4As shown, it includes a fusion catheter 2, the distal end of which is welded to one end of a biopsy probe 4 (or integrally formed), and the proximal end of which is welded to a delivery control handle 21 (or integrally formed). The fusion catheter 2 contains a transmission tube 1 that passes through the delivery control handle 21. A biopsy blade 42 and a drug-loaded balloon 47 are mounted on the side wall of the distal end of the transmission tube 1. The biopsy blade 42 and the drug-loaded balloon 47 are symmetrical about the central axis of the transmission tube 1. The biopsy blade 42 is welded to one end of a blade connecting bracket 41 (or integrally formed). The other end of the support 41 is welded to (or integrally formed with) the transmission tube 1. The drug-loaded balloon 47 is connected to the balloon pressurization catheter 12. At least one vent is provided on the transmission tube 1 at the position of the drug-loaded balloon 47, which is connected to both the drug-loaded balloon 47 and the balloon pressurization catheter 12. A biopsy window 43 is provided on the outer wall of the biopsy probe 4. The biopsy blade 42 and the drug-loaded balloon 47 are located inside the biopsy probe 4 at the positions corresponding to the biopsy window 43. By rotating the transmission tube 1, the biopsy blade 42 or the drug-loaded balloon 47 covers the biopsy window 43. Multiple water spray holes 22 are provided on the transmission tube 1 at the position of the biopsy probe 4, and the water spray holes 22 are not located at the connection position between the biopsy blade 42 and the drug-loaded balloon 47. All the multiple water spray holes 22 are connected to the distal end of the flushing catheter 11. The proximal end of the transmission tube 1 is welded to (or integrally formed with) the biopsy handle 13. Both the flushing catheter 11 and the balloon pressurization catheter 12 pass through the biopsy handle 13 on the transmission tube 1. The delivery control handle 21 is located at the distal end of the biopsy handle 13. The drive tube 1 is rotatably confined within the biopsy probe 4, meaning that the drive tube 1 can rotate but cannot move axially. The two ends of the biopsy probe 4 are connected, and the distal end of the biopsy probe 4 is covered and connected (bonded or riveted) with a biopsy filter 44.

[0022] A limiting bracket 45 is fixed on the inner wall of the biopsy probe 4 near its distal end. The distal end of the transmission tube 1 passes through the limiting hole at the proximal end of the biopsy probe 4. The limiting bracket 45 consists of an annular structure and at least two connecting rods evenly distributed and connected to the outer side of the annular structure. All connecting rods are welded to (or integrally formed with) the inner wall of the biopsy probe 4. The transmission tube 1 is rotatably disposed within the limiting hole at the proximal end of the biopsy probe 4 and within the annular hole of the annular structure of the limiting bracket 45.

[0023] In one embodiment, bearings are provided in the limiting hole at the proximal end of the biopsy probe 4 and the annular hole of the limiting bracket 45. The limiting bracket 45 and the biopsy probe 4 are rotatably connected to the transmission tube 1 through the bearings.

[0024] In another embodiment, grooves are provided on the outer wall of the transmission tube 1 at the positions of the limiting hole and the annular hole, so that the walls of the limiting hole and the annular hole are locked in the grooves, thereby restricting the axial movement of the transmission tube 1.

[0025] The delivery control handle 21 is a gripping part used to control the fusion catheter 2, and in turn control the delivery and release of the biopsy probe 4 to the carotid artery plaque; the biopsy handle 13 is also a gripping part used to control the rotation of the biopsy blade 42 inside the biopsy probe 4.

[0026] In this embodiment, to save on catheters and processing steps, the hollow cavity inside the transmission tube 1 serves as the flushing passage connecting the flushing catheter 11 to the water spray hole 22, and the distal end of the transmission tube 1 is sealed. The distal end of the balloon pressurization catheter 12 is sealed to one end of the vent, and the other end of the vent is sealed inside the drug-loaded balloon 47. The periphery of the drug-loaded balloon 47 is sealed to the outer wall of the distal end of the transmission tube 1. The proximal end of the balloon pressurization catheter 12 passes through the biopsy handle 13, and the outer wall of the balloon pressurization catheter 12 is sealed to the biopsy handle 13.

[0027] The shape of the biopsy window 43 matches the shape of the biopsy blade 42, and the size of the biopsy window 43 is no larger than the size of the biopsy blade 42, so that the biopsy blade 42 can completely cover the biopsy window 43 and avoid loss of biopsy plaque samples when the retrieval device is used.

[0028] After being pressurized, the drug-loaded balloon 47 takes the form of a fan-shaped column structure, which surrounds the transmission tube 1 and is located inside the biopsy probe 4. The size of the side of the drug-loaded balloon 47 after inflation (i.e., the arc surface coaxial with the transmission tube 1) is not less than the size of the biopsy window 43, that is, the biopsy window 43 on the biopsy probe 4 can be completely covered by the drug-loaded balloon 47 after being pressurized.

[0029] In this embodiment, the biopsy probe 4 is a hollow cylindrical structure, and the biopsy blade 42 is an arc-shaped or fan-shaped columnar structure, surrounding one side (half side) of the inside of the biopsy probe 4. One long side of the biopsy blade 42 is the sharp side, and the other long side is the blunt side.

[0030] The drug-loaded balloon 47 occupies one-half to one-third of the circumference of the biopsy probe 4; the biopsy blade 42 occupies one-half to one-third of the circumference of the biopsy probe 4. The diameter of the biopsy probe 4 is generally 1.2 to 1.3 times that of the carotid artery. Since the carotid artery varies in size among patients, the average or maximum value is used. Before surgery, a device with a suitable diameter for the biopsy probe 4 is selected based on the patient's carotid artery diameter.

[0031] An independent guidewire channel 48 is provided inside the outer wall of the biopsy probe 4, through which the ultra-rigid guidewire 5 can pass. A contrast marker 46 is also provided on the outer side of the distal end of the biopsy probe 4. An outer sheath 3 is fitted on the outer side of the fusion catheter 2.

[0032] Except for the biopsy window 43, the outer side of the biopsy probe 4 is covered with a membrane. The biopsy window 43 is a rectangular cutout, and above the biopsy window 43 is an angiography marker (i.e., contrast marker 46). The outer wall of the drug-loaded balloon 47 is coated with a drug layer (e.g., paclitaxel). When the drug-loaded balloon 47 is pressurized, it can make full contact with the carotid plaque resection site, thereby releasing the drug and accelerating the healing of the surgical site.

[0033] The usage process of this invention is as follows: After puncturing the femoral artery, the operator first inserts a short guidewire through the needle core, then withdraws the puncture needle. An arterial sheath is then inserted along the short guidewire to establish a stable channel from outside the body to the femoral artery. The short guidewire is then withdrawn, and a three-way stopcock and pressurized heparinized saline solution (to prevent thrombosis) are connected to the end of the arterial sheath. An angiography catheter is then selected and, in conjunction with a super-slippery guidewire (using a "loach" super-slippery guidewire), is inserted through the arterial sheath. After confirming the location, shape, and size of the carotid plaque using carotid angiography, the angiography catheter and super-slippery guidewire are withdrawn, and a super-stiff guidewire 5 is inserted into the carotid artery. The delivery system is first flushed with saline to ensure complete venting. The fusion catheter 2 is then inserted into the carotid artery along the super-stiff guidewire 5. The entire insertion process is performed under X-ray fluoroscopy monitoring to ensure that the super-stiff guidewire 5 remains in place and that the system does not enter any branch vessels. Insertion is paused when the contrast marker 46 at the distal end of the fusion catheter 2 reaches the predetermined proximal carotid plaque side. A small amount of contrast agent is injected again through the irrigation catheter 11 for confirmatory angiography, and the position of the biopsy probe 4 is fine-tuned. Then, the outer sheath 3 is withdrawn, the biopsy probe 4 is released, and it is rotated to ensure that the marker (i.e., contrast marker 46) above the biopsy window 43 is above the plaque. Finally, contrast agent is injected again along the irrigation catheter 11 to ensure the plaque is within the biopsy window 43. Next, the biopsy handle 13 is turned clockwise 3-5 times. After this, the biopsy blade 42 is rotated to the opposite side of the biopsy window 43. The balloon is inflated through the balloon inflator catheter 12 to fully inflate the drug-loaded balloon 47, allowing for sufficient drug release to the plaque resection wound and promoting wound healing. After balloon inflatation, the biopsy blade 42 is rotated to one side of the biopsy window 43 to ensure it completely covers the window. Finally, the fusion catheter 2 and the ultra-stiff guidewire 5 are withdrawn, and contrast agent is injected again through the arterial sheath for final carotid angiography to assess the surgical outcome.

Claims

1. A carotid artery plaque biopsy device based on interventional angiography, characterized in that, The device includes a fusion catheter (2), the distal end of which is fixedly connected to one end of a biopsy probe (4). The fusion catheter (2) is equipped with a freely rotating transmission tube (1). The side wall of the distal end of the transmission tube (1) is equipped with a biopsy blade (42) and a drug-loaded balloon (47) coated with a drug layer on its outer wall. The drug-loaded balloon (47) is connected to a balloon pressurization catheter (12). A biopsy window (43) is opened on the outer wall of the biopsy probe (4). The biopsy blade (42) and the drug-loaded balloon (47) are both located in the biopsy probe (4) at the position corresponding to the biopsy window (43). The transmission tube (1) is rotatably connected to a limiting structure that restricts the axial movement of the transmission tube (1). The limiting structure is fixed on the biopsy probe (4). The distal end of the biopsy probe (4) is covered and connected with a biopsy filter (44). A contrast marker (46) is provided on the outer side of the distal end of the biopsy probe (4).

2. The carotid artery plaque biopsy device based on interventional angiography as described in claim 1, characterized in that, The transmission tube (1) has multiple water spray holes (22) located inside the biopsy probe (4), and the multiple water spray holes (22) are all connected to the far end of the flushing conduit (11).

3. The carotid artery plaque biopsy device based on interventional angiography as described in claim 2, characterized in that, The proximal end of the fusion catheter (2) is fixedly connected to the delivery control handle (21), the transmission tube (1) passes through the delivery control handle (21), the proximal end of the transmission tube (1) is fixedly connected to the biopsy handle (13), the flushing catheter (11) and the balloon pressurization catheter (12) both pass through the biopsy handle (13) on the transmission tube (1), and the delivery control handle (21) is located at the distal end of the biopsy handle (13).

4. The carotid artery plaque biopsy device based on interventional angiography as described in claim 2, characterized in that, The hollow cavity inside the transmission pipe (1) is the flushing passage connecting the flushing conduit (11) to the water spray hole (22), and the distal end of the transmission pipe (1) is closed.

5. The carotid artery plaque biopsy device based on interventional angiography as described in claim 1, characterized in that, The biopsy blade (42) or drug-loaded balloon (47) covers the biopsy window (43) by rotating the transmission tube (1); the shape of the biopsy window (43) matches the shape of the biopsy blade (42), and the size of the biopsy window (43) is not greater than the size of the biopsy blade (42); the drug-loaded balloon (47) is pressurized into a fan-shaped column structure, surrounding the transmission tube (1) and located inside the biopsy probe (4), and the side size of the drug-loaded balloon (47) after inflation is not less than the size of the biopsy window (43).

6. The carotid artery plaque biopsy device based on interventional angiography as described in claim 1, characterized in that, The limiting structure includes a limiting bracket (45), which is fixed on the inner wall of the biopsy probe (4) near the distal end. The limiting bracket (45) consists of an annular structure and at least two connecting rods evenly distributed on the outer side of the annular structure. All connecting rods are fixedly connected to the inner wall of the biopsy probe (4). The distal end of the transmission tube (1) passes through the limiting hole at the proximal end of the biopsy probe (4). The transmission tube (1) is rotatably disposed in the limiting hole at the proximal end of the biopsy probe (4) and in the annular hole of the annular structure of the limiting bracket (45).

7. The carotid artery plaque biopsy device based on interventional angiography as described in claim 6, characterized in that, Bearings are provided in the limiting hole at the proximal end of the biopsy probe (4) and the annular hole of the limiting bracket (45). The limiting bracket (45) and the biopsy probe (4) are rotatably connected to the transmission tube (1) through the bearings.

8. The carotid artery plaque biopsy device based on interventional angiography as described in claim 6, characterized in that, The transmission tube (1) has grooves on its outer wall at the positions of the limiting hole and the annular hole, respectively, and the hole walls of the limiting hole and the annular hole are rotatably located in the grooves.

9. The carotid artery plaque biopsy device based on interventional angiography as described in claim 1, characterized in that, The transmission tube (1) has at least one vent hole at the position of the drug-loaded balloon (47) that is connected to the drug-loaded balloon (47) and the balloon pressurization conduit (12).

10. The carotid artery plaque biopsy device based on interventional angiography as described in claim 1, characterized in that, It also includes an outer sheath (3), which is fitted on the outside of the fusion catheter (2); an independent guidewire channel (48) is opened in the outer wall of the biopsy probe (4).

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