Myocardial biopsy sampling device, system and method based on CSP delivery sheath

Abstract

The invention relates to the technical field of myocardial biopsy, in particular to a myocardial biopsy sampling device, system and method based on a CSP delivery sheath, and the device comprises a pair of myocardial biopsy forceps and the CSP delivery sheath which is used for guiding the myocardial biopsy forceps to move to the inner wall of the myocardial and is in vertical contact with the inner wall of the myocardial; placing the CSP delivery sheath into the body of the patient by taking the axillary vein as a placing path until the extending end of the CSP delivery sheath is vertically positioned to a target biopsy area of the ventricular septum; the surface of the extending end of the CSP delivery sheath is provided with a buffering assembly used for buffering the pressure generated when the CSP delivery sheath makes contact with the myocardial inner wall. Through the directional guiding effect of the CSP delivery sheath, the myocardial biopsy forceps and the inner wall of the myocardial form accurate vertical contact, the success rate of deep myocardial sampling is increased, and damage to the myocardial is reduced by reducing the number of times that an instrument penetrates through the tricuspid valve.

Description

Technical Field

[0001] This invention relates to the field of myocardial biopsy technology, and specifically to a myocardial biopsy sampling device, system and method based on a CSP delivery sheath. Background Technology

[0002] The heart is the core organ of the human circulatory system. Through rhythmic contraction and relaxation, it continuously pumps blood, delivering oxygen and nutrients to all tissues, and is crucial for maintaining life. Influenced by various factors such as infection, genetics, metabolic abnormalities, and vascular lesions, the heart is prone to various diseases, commonly including cardiomyopathy, myocarditis, coronary heart disease, and valvular heart disease, as well as some rare invasive diseases or cardiac tumors. Many heart diseases lack specific clinical symptoms, and routine methods such as electrocardiograms, echocardiograms, and blood biochemistry tests are often insufficient to accurately determine the cause and pathological type. Therefore, for these complex cases, a small myocardial tissue sample obtained through myocardial biopsy is often necessary. Pathological analysis and immunohistochemistry are then used for specialized testing to ultimately diagnose the condition and provide the core basis for subsequent targeted treatment plans.

[0003] Percutaneous endocardial myocardial biopsy is currently the main method of myocardial biopsy. The surgeon uses specialized biopsy forceps, guided by X-ray fluoroscopy or other imaging techniques, to insert them into the heart via a blood vessel and obtain a small amount of myocardial tissue for pathological examination. Due to the special nature of the heart (containing myocardial tissue, valves, and other vital structures), myocardial biopsy forceps are usually not malleable and lack adjustable curvature (for adjusting the angle of the forceps). Avoiding angle adjustments could lead to serious complications such as myocardial tearing and valve damage. Therefore, the contact surface between the myocardial biopsy forceps and the myocardium is often at an acute angle, which can easily lead to superficial sampling, slippage, or difficulty in aligning with the septum, resulting in sampling difficulties, and may also lead to the risk of pericardial effusion being trapped by the free wall forceps. Therefore, this invention provides a myocardial biopsy sampling device, system, and method based on a CSP delivery sheath to solve the above problems. Summary of the Invention

[0004] To address the aforementioned issues, this invention provides a myocardial biopsy sampling device, system, and method based on a CSP delivery sheath. This device establishes a precise axillary vein-ventricular septum pathway during percutaneous myocardial biopsy using a CSP delivery sheath, enabling minimally invasive and precise sampling of endocardial myocardial tissue from target areas such as the ventricular septum. This solves problems such as large positioning deviations, high risk of operative injury, and low sampling efficiency in traditional biopsies, providing high-quality test samples for the pathological diagnosis of myocardial diseases while improving surgical safety and ease of operation.

[0005] To achieve the above objectives, the technical solution of the present invention is as follows: a myocardial biopsy sampling device based on a CSP delivery sheath, comprising a myocardial biopsy forceps and a CSP delivery sheath for guiding the myocardial biopsy forceps to move to the myocardial wall and make perpendicular contact with the myocardial wall; the CSP delivery sheath is inserted into the patient's body via the axillary vein until the insertion end of the CSP delivery sheath is vertically positioned to the target biopsy area of ​​the interventricular septum; the surface of the insertion end of the CSP delivery sheath is provided with a buffer component for buffering the pressure of the CSP delivery sheath contacting the myocardial wall.

[0006] The technical principle of the above scheme is as follows: This scheme uses the axillary vein as the insertion path, taking advantage of the smooth anatomical structure of this vessel and its distance from vital organs, thus reducing the risk of trauma during puncture and instrument delivery. The CSP delivery sheath serves as the core delivery and positioning carrier. Under real-time X-ray fluoroscopy guidance, precise navigation is achieved through the contrast markers on the insertion end of the CSP delivery sheath. After gradually reaching the target biopsy area of ​​the ventricular septum, the angle adjustment mechanism of the sheath itself ensures that the insertion end of the CSP delivery sheath forms a 90° perpendicular contact with the myocardial wall, providing a stable spatial reference for sampling. Furthermore, the buffer component at the insertion end of the CSP delivery sheath is made of medical-grade elastic material, which absorbs the impact force generated by cardiac pulsation and the instantaneous pressure during the operation through elastic deformation, reducing tissue damage caused by hard contact between the sheath and the myocardial wall. Meanwhile, the internal channel of the CSP delivery sheath provides a directional delivery path for the myocardial biopsy forceps. Combined with the vertical positioning posture of the sheath, it ensures that the gripping end of the myocardial biopsy forceps is precisely attached to the myocardial tissue along the preset direction, that is, vertically attached to the surface of the myocardial tissue. Finally, the mechanical gripping action of the myocardial biopsy forceps achieves targeted acquisition of myocardial tissue in the target area.

[0007] The above approach has the following beneficial effects:

[0008] 1. This protocol uses the axillary vein as the insertion route, which has significant advantages over the internal jugular vein and femoral vein: The internal jugular vein is close to the trachea, carotid sinus, and recurrent laryngeal nerve, and puncture can easily cause serious complications such as pneumothorax and nerve damage. Furthermore, its path is highly tortuous, resulting in high resistance to instrument delivery. The femoral vein is located deep within the body and surrounded by abundant muscle tissue, requiring prolonged immobilization post-operatively, which can easily lead to lower extremity venous thrombosis. Its proximity to the perineum also increases the risk of infection. In contrast, the axillary vein is superficial, has a smooth anatomical structure, and is far from vital organs and nerves. Puncture is less invasive, hemostasis is easier, and post-operative patient activity is unrestricted, significantly reducing the incidence of complications such as local hematoma, thrombosis, and infection. Additionally, its delivery route to the ventricular septum is more direct, reducing the risk of instrument kinking or displacement.

[0009] 2. In this approach, the CSP delivery sheath, serving as the guiding structure, differs from existing conventional techniques (primarily via direct transvascular pathways using biopsy forceps). Through contrast-enhanced marking at the insertion end and an angle adjustment mechanism, the CSP delivery sheath achieves stable 90° perpendicular contact with the myocardial wall, forming a reliable pre-defined path. The inner channel of the CSP delivery sheath then serves as the insertion channel for the myocardial biopsy forceps, providing rigid support and directional constraint. This ensures stable propulsion along the pre-defined safe path, effectively reducing interference from vascular anatomy and cardiac pulsation on the forceps' posture. Simultaneously, the inner channel of the CSP delivery sheath ensures precise 90° vertical contact between the forceps' gripping end and the myocardial tissue. This reduces accidental damage to non-target areas caused by path displacement and enhances tissue integrity through stable angle control. It also mitigates problems such as sample breakage, insufficient sample size, and sampling depth deviation caused by unstable forceps posture in traditional procedures, significantly improving the accuracy and reliability of myocardial tissue sampling.

[0010] Furthermore, the buffer assembly includes a rubber ring disposed around the surface of the CSP delivery sheath extending into the end, and the rubber ring has a plurality of buffer cavities disposed inside the rubber ring in a circular array along the circumference of the rubber ring.

[0011] Beneficial effects: The rubber ring, combined with the evenly distributed buffer cavity, can efficiently absorb the periodic impact force generated by the heartbeat and the instantaneous pressure of the operation during the procedure through multi-level elastic deformation, effectively reducing the hard contact between the CSP delivery sheath and the myocardial wall, and reducing the risk of complications such as myocardial tear and valve damage.

[0012] Furthermore, the CSP delivery sheath operating end is provided with an auxiliary positioning component for reflecting the angle between the CSP delivery sheath insertion end and the myocardial contact surface; the auxiliary positioning component is connected to the buffer cavity.

[0013] Beneficial effects: The design of the auxiliary positioning component communicating with the buffer cavity allows the volume change of the buffer cavity caused by myocardial contact pressure to be converted into a visual display signal of the auxiliary positioning component. Operators can intuitively determine whether the angle between the CSP delivery sheath insertion end and the myocardial contact surface is 90° through external observation, and at the same time estimate the contact pressure. Combined with X-ray fluoroscopy, this not only allows for further rapid calibration of the positioning angle and reduction of tissue damage caused by excessive pressure, but also further improves positioning accuracy and operational safety, achieving dual assistance of angle judgment and pressure monitoring, making the sampling operation more controllable and efficient.

[0014] Furthermore, the auxiliary positioning component includes a reaction ring disposed on the surface of the operating end of the CSP delivery sheath. The reaction ring is made of elastic material and has several reaction cavities disposed inside it. The reaction cavities are distributed in a circular array along the circumference of the reaction ring. The reaction cavities and the buffer cavities are connected in a one-to-one correspondence. The communication channels between the reaction cavities and the buffer cavities are all disposed inside the outer sheath of the CSP delivery sheath.

[0015] Beneficial effects: The reflective ring and buffer cavity are connected in a one-to-one correspondence and the channel is built-in, which can synchronously transmit the contact pressure changes of the CSP delivery sheath insertion end to the operating end. When the CSP delivery sheath insertion end forms a 90° angle with the myocardial contact surface, the buffer cavity is under uniform pressure, and the corresponding reflective cavity expands synchronously and uniformly, causing the elastic reflective ring to deform symmetrically. If the angle deviates, the local buffer cavity pressure is abnormal, and the deformation of the corresponding area of ​​the reflective ring is uneven. By observing the deformation state of the reflective ring, the operator can intuitively and accurately judge whether the angle is up to standard and the contact pressure distribution, achieving dual assistance of angle calibration and pressure monitoring. Combined with X-ray fluoroscopy, it forms a dual verification of angle positioning, reducing the error of relying solely on image judgment.

[0016] Furthermore, the CSP delivery sheath operating end surface is provided with an observation cover for covering the reaction ring. The observation cover is made of transparent material and the observation surface of the observation cover adopts a convex arc-shaped curved surface structure.

[0017] Beneficial effects: The transparent material fully presents the deformation state of the reaction ring, and the convex arc magnification function clearly highlights subtle deformation differences, making it easy for operators to quickly capture signals of angular deviation or uneven pressure; at the same time, it can effectively prevent dust and pollution, protecting the reaction ring from external interference.

[0018] Furthermore, the outer sheath surface of the CSP delivery sheath is provided with several auxiliary anchoring components for stabilizing the CSP delivery sheath when the CSP delivery sheath guides the insertion of the myocardial biopsy forceps; and the auxiliary anchoring components are driven by the volume change of the reflection ring.

[0019] Beneficial effects: When the ring changes, the anchoring component takes effect simultaneously, stabilizing the position of the CSP delivery sheath in the blood vessel, reducing the angular deviation caused by sheath displacement during sampling, and further improving sampling stability and accuracy.

[0020] Furthermore, each auxiliary anchoring component includes an anchoring ring disposed on the surface of the outer sheath of the CSP delivery sheath. The anchoring rings are all made of elastic material and have a hollow internal structure. The gap between the observation hood and the reaction ring is set as a compression chamber. The anchoring rings are all connected to the compression chamber, and the communication channels between the anchoring rings and the compression chambers are all disposed inside the outer sheath of the CSP delivery sheath. The communication channels between the anchoring rings and the compression chambers are all provided with one-way valves that allow only the gas in the compression chamber to flow to the anchoring rings. The operating end surface of the CSP delivery sheath is provided with a press-type vent valve for releasing the gas in the anchoring rings. The operating end surface of the CSP delivery sheath is provided with a balance channel that communicates with the compression chamber. The balance channel is provided with a one-way valve that allows only external gas to enter the compression chamber.

[0021] Beneficial Effects: Through the linkage mechanism of the compression chamber, the reaction ring, and the anchoring ring, the anchoring ring can be driven to work by the volume change of the reaction ring. When the CSP delivery sheath extends at a precise 90° angle to the myocardial contact surface, the reaction ring deforms uniformly to compress the chamber. Gas is injected into the anchoring ring through the built-in channel and one-way valve, causing the elastic anchoring ring to inflate and tightly adhere to the inner wall of the blood vessel, forming a stable anchor. This effectively reduces sheath displacement caused by cardiac pulsation and instrument pushing during the sampling operation, ensuring the stability of the 90° vertical positioning. The one-way valve design can firmly lock the gas in the anchoring ring, ensuring continuous stability of the anchoring state; the press-type degassing valve makes postoperative retrieval more convenient. A light press releases the gas, causing the anchoring ring to contract, avoiding damage to the inner wall of the blood vessel during retrieval, further improving the stability, accuracy, and clinical applicability of the surgical operation, and reducing the operational risks of minimally invasive biopsy.

[0022] Furthermore, a myocardial biopsy sampling system based on a CSP delivery sheath includes a sampling unit, an insertion unit, and a guiding unit;

[0023] The sampling unit is used to extract endocardial myocardial tissue using myocardial biopsy forceps, providing test samples for subsequent myocardial pathology testing.

[0024] The insertion unit is used to insert the CSP delivery sheath along the axillary vein until the insertion end of the CSP delivery sheath reaches the predetermined biopsy area of ​​the interventricular septum, and the angle between the sheath head of the CSP delivery sheath and the myocardial contact surface is 90° under X-ray fluoroscopy.

[0025] The guiding unit is used to push the myocardial biopsy forceps to the myocardial contact surface of the predetermined biopsy area in the interventricular septum through the luminal channel of the CSP delivery sheath, and then complete the sampling under dynamic monitoring of X-ray fluoroscopy.

[0026] Beneficial Effects: This solution achieves precision, safety, and efficiency in myocardial biopsy through the modular and collaborative design of the sampling unit, insertion unit, and guiding unit. The insertion unit leverages the anatomical advantages of the axillary vein pathway, combined with the precise 90° angle positioning of the CSP delivery sheath, avoiding the high complication risks associated with the internal jugular vein and femoral vein pathways while providing a stable spatial reference for sampling. The guiding unit, through the directional constraint of the sheath's internal lumen, ensures the myocardial biopsy forceps are smoothly pushed along the preset path, reducing postural deviations caused by vascular curvature and cardiac pulsation, and providing dual protection with dynamic monitoring via X-ray fluoroscopy.

[0027] Meanwhile, based on pre-positioning and guidance, the sampling unit precisely grasps myocardial tissue from the target area, ensuring sample integrity and targeting, and providing reliable evidence for pathological testing. The three components work together, and through the buffering and anchoring design of the CSP delivery sheath, further reduce the risk of tissue damage, shorten operation time, and improve patient tolerance, providing systematic and standardized technical support for the accurate diagnosis of myocardial diseases.

[0028] Furthermore, in the sampling unit, after the myocardial biopsy forceps are pushed to the target position, the CSP delivery sheath is retracted 1-2 cm, and then the myocardial biopsy forceps are opened to grab the test sample. After the grabbing is completed, the myocardial biopsy forceps clamp is closed, and the myocardial biopsy forceps clamp is withdrawn by rotating clockwise.

[0029] Beneficial effects: Retracting the CSP delivery sheath by 1-2 cm provides sufficient space for the myocardial biopsy forceps to open, preventing the sheath tube of the CSP delivery sheath from obstructing the forceps movement, and reducing the compression of the CSP delivery sheath tube on the surrounding myocardial tissue; after closing the forceps, rotating clockwise to withdraw can effectively prevent sample drop, and the rotation action reduces scratching damage to blood vessels and myocardial walls.

[0030] Furthermore, a myocardial biopsy sampling method based on a CSP delivery sheath includes the following steps:

[0031] Step 1, Placement and Positioning: The axillary vein puncture area is disinfected and locally anesthetized. The axillary vein is percutaneously punctured to establish access. The CSP delivery sheath is pushed along the guidewire through the placement unit. Under real-time X-ray fluoroscopy guidance, the insertion end of the CSP delivery sheath is gradually brought to the predetermined biopsy area of ​​the ventricular septum. The angle of the sheath is adjusted through the operating end of the CSP delivery sheath until the imaging marker at the insertion end of the CSP delivery sheath forms a 90° angle with the myocardial contact surface, thus completing the establishment of the myocardial biopsy forceps delivery channel.

[0032] Step 2, guided positioning: Push the myocardial biopsy forceps along the inner channel of the CSP delivery sheath. Under dynamic monitoring of X-ray fluoroscopy, adjust the pushing depth of the myocardial biopsy forceps in real time until the gripping end of the myocardial biopsy forceps fits against the myocardial contact surface of the predetermined biopsy area of ​​the interventricular septum, and maintain a 90° angle between the gripping end and the contact surface.

[0033] Step 3, Sampling and Retrieval: After the myocardial biopsy forceps complete the gripping action, rotate clockwise to retract the myocardial biopsy forceps into the CSP delivery sheath, then remove the myocardial biopsy forceps and collect and preserve the sample in a timely manner. Subsequently, remove the CSP delivery sheath, apply pressure to the puncture site to stop bleeding, and send the sample for pathological testing.

[0034] Beneficial effects: This protocol uses the axillary vein as the insertion route, avoiding the internal jugular vein's proximity to vital organs and the postoperative immobilization limitations of the femoral vein. It results in minimal puncture trauma, convenient hemostasis, and reduced risks of complications such as hematoma, thrombosis, and infection. Step one utilizes dual guidance of X-ray fluoroscopy and contrast-enhanced marking, combined with the adjustment of the CSP delivery sheath angle to achieve a 90° angle positioning, establishing a stable delivery channel for the myocardial biopsy forceps. Step two relies on the directional constraint of the CSP delivery sheath lumen, coupled with dynamic fluoroscopic monitoring, to ensure precise contact between the gripping tip of the myocardial biopsy forceps and the target area, reducing positioning deviations caused by vascular curvature and cardiac pulsation. Step three, the clockwise rotation and retraction operation, effectively prevents sample dislodgement and reduces scratching damage to the blood vessels and myocardial walls, ensuring sample integrity and tissue safety.

[0035] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0036] Figure 1 This is an overall schematic diagram of an embodiment of the myocardial biopsy sampling device based on the CSP delivery sheath of the present invention;

[0037] Figure 2 This is an embodiment of the myocardial biopsy sampling device based on the CSP delivery sheath of the present invention. Figure 1 Enlarged view of section A in the middle;

[0038] Figure 3 This is an embodiment of the myocardial biopsy sampling device based on the CSP delivery sheath of the present invention. Figure 1 Enlarged view of section B;

[0039] Figure 4 This is an embodiment of the myocardial biopsy sampling device based on the CSP delivery sheath of the present invention. Figure 1 Enlarged view of section C;

[0040] Figure 5 This is an isometric image of the reflection ring of an embodiment of the myocardial biopsy sampling device based on the CSP delivery sheath of the present invention;

[0041] Figure 6 This is a cross-sectional view of the reflection ring of an embodiment of the myocardial biopsy sampling device based on the CSP delivery sheath of the present invention;

[0042] Figure 7 This is a flowchart illustrating an embodiment of the myocardial biopsy sampling system based on a CSP delivery sheath according to the present invention;

[0043] Figure 8 This is a schematic diagram of an embodiment of the myocardial biopsy sampling method based on the CSP delivery sheath of the present invention.

[0044] The reference numerals in the accompanying drawings include: 1. Myocardial biopsy forceps; 2. CSP delivery sheath; 201. Sheath tube; 202. Operating end; 3. Rubber ring; 4. Observation cover; 5. Anchoring ring; 6. Reflection ring; 601. Reflection cavity; 7. Deflator. Detailed Implementation

[0045] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0046] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0047] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0048] The following detailed description illustrates the specific implementation method:

[0049] Example 1:

[0050] like Figure 1As shown, a myocardial biopsy sampling device based on a CSP delivery sheath includes a myocardial biopsy forceps 1 and a CSP delivery sheath 2 for guiding the forceps 1 to move to the myocardial wall and make perpendicular contact with it. From right to left, the CSP delivery sheath 2 consists of an operating end 202 (integrating a rotary knob and a bending wire, which can be rotated to control the bending of the distal end of the CSP delivery sheath 2) and a sheath tube 201. The left end of the sheath tube 201 is the insertion end (the end face in contact with the myocardial tissue). The sheath tube 201 employs a multi-layered composite structure (inner layer, reinforcing layer, and outer layer). The inner layer is preferably polytetrafluoroethylene (PTFE); the reinforcing layer is preferably woven from nickel-titanium alloy wire in a spiral or grid structure, providing flexural strength and torque transmission capability; the outer layer is preferably polyether block amide, and contrast markers are embedded in the outer layer to clearly display the position of the sheath tube 201 under X-ray.

[0051] The CSP delivery sheath 2 is inserted into the patient via the axillary vein until its insertion end is vertically positioned at the target biopsy area of ​​the ventricular septum. Combined with... Figure 2 As shown, the CSP delivery sheath 2 has a rubber ring 3 on the surface of its extended end. The rubber ring 3 has several buffer cavities inside, and the buffer cavities are distributed in a circular array around the circumference of the rubber ring 3.

[0052] The specific implementation process is as follows: First, the axillary vein puncture area is disinfected, local anesthetized, and a percutaneous puncture is performed to establish a pathway. A guidewire is inserted along the pathway and positioned near the ventricular septum. Then, the CSP delivery sheath 2 is slowly advanced along the guidewire. During advancement, the embedded contrast markers are observed using X-ray fluoroscopy, and the position of the sheath 201 is tracked in real time. When the inserted end of the CSP delivery sheath 2 approaches the target area of ​​the ventricular septum, the rotation knob of the operating end 202 is rotated, and the left end of the sheath 201 is bent by pulling the bending wire (e.g., ...). Figure 1 As shown in the figure, precisely adjust the angle until the imaging marker shows that the insertion end of the CSP delivery sheath 2 is perpendicular to the myocardial contact surface at 90°. At this time, the rubber ring 3 contacts the myocardial tissue, and the buffer cavity of the internal circumferential array undergoes uniform elastic deformation due to the heartbeat and contact pressure, thereby absorbing the impact force during the initial positioning between the rubber ring 3 and the myocardial inner wall, reducing hard injury.

[0053] After confirming stable positioning, the myocardial biopsy forceps 1 are pushed through the inner channel of the CSP delivery sheath 2. Relying on the low-friction properties of the inner polytetrafluoroethylene layer, they move smoothly forward. The spiral (or grid) structure of the reinforcing layer ensures that the sheath 201 is free from bending and that torque transmission is stable, until the gripping end of the myocardial biopsy forceps 1 is in contact with the target myocardial tissue. By limiting the angle of the CSP delivery sheath 2, the gripping end of the myocardial biopsy forceps 1 is made perpendicular to the contacting myocardial tissue. Then, the CSP delivery sheath 2 is withdrawn 1-2 cm, and the myocardial biopsy forceps 1 is opened again to complete the gripping. After closing the forceps, they are rotated clockwise to withdraw back into the sheath 201. Finally, the myocardial biopsy forceps 1 and the CSP delivery sheath 2 are removed in sequence to complete the sampling operation.

[0054] Example 2:

[0055] The difference from Example 1 is that although the angle between the CSP delivery sheath 2 and the myocardial wall can be observed via X-ray (to determine if it is perpendicular), there may still be a certain tilt angle between the insertion end of the sheath 201 and the myocardial wall. Firstly, individual patient vascular anatomy varies, and the path from the axillary vein to the interventricular septum may have slight bends, resulting in uneven force during sheath 201 insertion, thus preventing the insertion end of the CSP delivery sheath 2 from fully adhering perpendicularly to the myocardial surface. Secondly, relying solely on two-dimensional X-ray images to determine three-dimensional spatial angles is prone to visual errors. This can lead to sampling angle deviation, sample breakage, or tissue damage. Therefore, this solution also adds an auxiliary positioning component to the surface of the operating end 202 of the CSP delivery sheath 2 to accurately calibrate the positioning posture.

[0056] Specifically, such as Figure 1 , Figure 4 , Figure 5 and Figure 6 As shown, the auxiliary positioning component includes a reaction ring 6 disposed on the surface of the operating end 202 of the CSP delivery sheath 2. The reaction ring 6 is made of an elastic material, and a plurality of reaction cavities 601 are disposed inside the reaction ring 6. The reaction cavities 601 are distributed in a circular array around the circumference of the reaction ring 6. The reaction cavities 601 are connected to the buffer cavities one by one, and the communication channels between the reaction cavities 601 and the buffer cavities are all disposed inside the outer sheath of the CSP delivery sheath 2. An observation cover 4 is disposed on the surface of the operating end 202 of the CSP delivery sheath 2 to cover the reaction ring 6. The observation cover 4 is made of a transparent material, and the observation surface of the observation cover 4 adopts a convex arc-shaped curved surface structure.

[0057] The specific implementation process is as follows: During the push-in process, the contrast markers on the outer layer of the sheath 201 are observed through X-ray fluoroscopy. The position of the sheath 201 is initially tracked and its direction is adjusted until the insertion end of the sheath 201 approaches the target biopsy area of ​​the ventricular septum. At this time, the operator continues to confirm the overall angle of the sheath 201 through X-ray fluoroscopy, and observes the reflection ring 6 through the observation cover 4. Since the reflection cavity 601 and the buffer cavity are connected one-to-one, if there is a slight tilt between the insertion end and the myocardial inner wall, the local buffer cavity will be under uneven pressure, and the corresponding reflection cavity 601 will show asymmetrical deformation. The convex arc surface of the observation cover 4 can magnify this slight difference, making it easy to quickly identify the deviation.

[0058] Subsequently, the rotary knob of the rotating operating end 202 is used to bend the distal end of the sheath 201 (i.e., the insertion end of the CSP delivery sheath 2) by pulling the bending wire, while simultaneously observing the deformation of the reflective ring 6 in real time: until the reflective ring 6 is in a symmetrical state of uniform circumferential expansion, combined with X-ray fluoroscopy showing that the contrast marker and the myocardial contact surface are at 90°, completing double verification and ensuring accurate positioning. After confirming stable positioning, the myocardial biopsy forceps 1 are smoothly pushed into the target area through the inner channel of the sheath 201. After completing the clamping operation, the myocardial biopsy forceps 1 and the CSP delivery sheath 2 are withdrawn according to the standard procedure.

[0059] The entire process utilizes a dual approach of "image guidance + mechanical deformation feedback" to effectively reduce positioning errors caused by visual errors in two-dimensional images and individual anatomical differences, thereby improving the accuracy of angular positioning, reducing the risk of sampling damage, and ensuring sample integrity.

[0060] Example 3:

[0061] The difference from Embodiment 2 is that during the pushing, opening, clamping, and retraction of the myocardial biopsy forceps 1 by the CSP delivery sheath 2, the movement of the instrument will exert a lateral force on the sheath 201. In addition, the axillary vein wall has natural elasticity, which can easily cause slight displacement of the sheath 201 located in the axillary vein, thereby disrupting the calibrated 90° vertical positioning angle and affecting the sampling accuracy. Therefore, this embodiment further provides several auxiliary anchoring components on the outer sheath surface of the CSP delivery sheath 2 to stabilize the CSP delivery sheath 2 when the myocardial biopsy forceps 1 is inserted by the CSP delivery sheath 2, further reducing the displacement of the sheath 201 during the operation.

[0062] Specifically, such as Figure 1 , Figure 3 and Figure 5As shown, each auxiliary anchoring component includes an anchoring ring 5 disposed on the outer surface of the CSP delivery sheath 2. The anchoring rings 5 ​​are all made of elastic material and have a hollow internal structure. The gap between the observation cover 4 and the reaction ring 6 is set as a compression chamber. The anchoring rings 5 ​​are all connected to the compression chamber, and the communication channels between the anchoring rings 5 ​​and the compression chamber are all disposed inside the outer layer of the CSP delivery sheath 2. The communication channels between the anchoring rings 5 ​​and the compression chamber are all provided with one-way valves that allow only the gas in the compression chamber to flow to the anchoring rings 5. The operating end 202 of the CSP delivery sheath 2 is provided with a balance channel that communicates with the compression chamber. The balance channel is provided with a one-way valve that allows only external gas to enter the compression chamber. The operating end 202 of the CSP delivery sheath 2 is provided with a press-type vent valve 7 for releasing the gas in the anchoring rings 5. The press-type vent valve 7 is preferably from The Lee Company 558 series. The anchoring ring 5 is initially in a contracted state with an outer diameter that is the same as the outer diameter of the CSP delivery sheath 2. When the anchoring ring 5 expands, its diameter is larger than the outer diameter of the CSP delivery sheath 2. In addition, the CSP delivery sheath 2 will retract after positioning (the rubber ring 3 will no longer be compressed), providing operating space for the myocardial biopsy forceps 1. Therefore, the anchoring ring 5 only expands during the initial positioning operation.

[0063] The specific implementation process is as follows: First, complete the axillary vein puncture and guidewire insertion according to the procedure in Example 1, and push the CSP delivery sheath 2 along the guidewire to the vicinity of the target area of ​​the interventricular septum. Then, through dual judgment using X-ray fluoroscopy and the reflective ring 6, rotate the knob of the operating end 202 to adjust the angle of the sheath 201 until the reflective ring 6 shows a uniform and symmetrical deformation in the circumference, confirming that the inserted end is precisely positioned at a 90° perpendicular angle to the myocardial wall.

[0064] At this time, the deformation (expansion) of the reflective ring 6 will compress the compression chamber between the observation cover 4 and the reflective ring 6. The gas in the chamber is pushed through the built-in connecting channel and guided by the one-way valve (which only allows gas to flow to the anchoring ring 5), and continuously injected into the elastic anchoring ring 5 in its initial contracted state. At the same time, the one-way valve of the balance channel (which only allows external gas to enter) replenishes the gas in the compression chamber in time, ensuring that the anchoring ring 5 is fully expanded and that the reflective ring 6 and the rubber ring 3 are stable. The diameter of the anchoring ring 5 increases to be larger than the outer diameter of the sheath 201, and it fits tightly against the inner wall of the axillary vein (using the elasticity of the blood vessel, it expands appropriately to form an anchoring point), stabilizing the position of the sheath 201.

[0065] The myocardial biopsy forceps 1 are then pushed through the lumen of the sheath 201. Whether the forceps 1 is opening, gripping, or retracting, the lateral forces and torque generated are resisted by the anchoring ring 5 through friction against the vessel wall. Simultaneously, the anti-bending properties of the CSP delivery sheath 2 further reduce the possibility of displacement of the sheath 201 disrupting the calibrated vertical angle. After sampling, the press-type vent valve 7 on the operating end 202 is gently pressed, rapidly releasing the gas within the anchoring ring 5. The anchoring ring 5 retracts back to its initial diameter (consistent with the outer diameter of the sheath 201), at which point the CSP delivery sheath 2 can be smoothly removed, avoiding damage to the vessel wall during retrieval.

[0066] Example 4:

[0067] like Figure 6 As shown, a myocardial biopsy sampling system based on a CSP delivery sheath, based on the schemes in Examples 1, 2 and 3, includes a sampling unit, an insertion unit and a guiding unit;

[0068] The sampling unit is used to clamp endocardial myocardial tissue with myocardial biopsy forceps 1 to provide test samples for subsequent myocardial pathology testing. Secondly, after the myocardial biopsy forceps 1 is pushed to the target position, the CSP delivery sheath 2 is retracted 1-2cm, and then the myocardial biopsy forceps 1 is opened to clamp the test sample. After the clamping is completed, the myocardial biopsy forceps 1 is closed and rotated clockwise to withdraw the myocardial biopsy forceps 1.

[0069] The insertion unit is used to insert the CSP delivery sheath 2 along the axillary vein until the insertion end of the CSP delivery sheath 2 reaches the predetermined biopsy area of ​​the interventricular septum, and the angle between the head of the sheath 201 of the CSP delivery sheath 2 and the myocardial contact surface is 90° under X-ray fluoroscopy.

[0070] The guiding unit is used to push the myocardial biopsy forceps 1 to the myocardial contact surface of the predetermined biopsy area in the interventricular septum through the inner channel of the CSP delivery sheath 2, and then complete the sampling under dynamic monitoring of X-ray fluoroscopy.

[0071] Example 5:

[0072] like Figure 7 As shown, a myocardial biopsy sampling method based on a CSP delivery sheath, based on the schemes in Examples 1, 2, and 3, includes the following steps:

[0073] Step 1, Placement and Positioning: The axillary vein puncture area of ​​the patient is disinfected and locally anesthetized. The axillary vein is percutaneously punctured to establish access. The CSP delivery sheath 2 is pushed along the guidewire through the placement unit. Under real-time X-ray fluoroscopy guidance, the insertion end of the CSP delivery sheath 2 is gradually brought to the predetermined biopsy area of ​​the ventricular septum. The angle of the sheath 201 is adjusted through the operating end 202 of the CSP delivery sheath 2 until the imaging mark at the insertion end of the sheath 201 forms a 90° angle with the myocardial contact surface, thus completing the establishment of the myocardial biopsy forceps 1 delivery channel.

[0074] Step 2, guided positioning: push the myocardial biopsy forceps 1 along the inner channel of the CSP delivery sheath 2, and adjust the pushing depth of the myocardial biopsy forceps 1 in real time under dynamic monitoring of X-ray fluoroscopy until the gripping end of the myocardial biopsy forceps 1 is in contact with the myocardial contact surface of the predetermined biopsy area of ​​the interventricular septum, and maintain a 90° angle between the gripping end and the contact surface.

[0075] Step 3, Sampling and Retrieval: After the myocardial biopsy forceps 1 completes the gripping action, rotate clockwise to retract the myocardial biopsy forceps 1 into the CSP delivery sheath 2, then remove the myocardial biopsy forceps 1, collect and preserve the sample in time, then remove the CSP delivery sheath 2, apply pressure to the puncture site to stop bleeding, and send the sample for pathological testing.

[0076] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A myocardial biopsy sampling device based on a CSP delivery sheath, comprising a myocardial biopsy forceps (1), characterized in that, It also includes a CSP delivery sheath (2) for guiding the myocardial biopsy forceps (1) to move to the myocardial wall and make perpendicular contact with the myocardial wall. The CSP delivery sheath (2) is divided into an operating end (202) and a sheath tube (201). The CSP delivery sheath (2) is inserted into the patient's body through the axillary vein until the insertion end of the CSP delivery sheath (2) is vertically positioned to the target biopsy area of ​​the interventricular septum. The surface of the insertion end of the CSP delivery sheath (2) is provided with a buffer component for buffering the pressure of the CSP delivery sheath (2) contacting the myocardial wall.

2. The myocardial biopsy sampling device based on a CSP delivery sheath according to claim 1, characterized in that, The buffer assembly includes a rubber ring (3) that is disposed around the surface of the CSP delivery sheath (2) extending into the end. The rubber ring (3) has several buffer cavities inside, and the buffer cavities are distributed in a circular array around the rubber ring (3).

3. The myocardial biopsy sampling device based on a CSP delivery sheath according to claim 2, characterized in that, The CSP delivery sheath (2) operating end (202) is provided with an auxiliary positioning component for reflecting the angle between the CSP delivery sheath (2) insertion end and the myocardial contact surface; the auxiliary positioning component is connected to the buffer cavity.

4. The myocardial biopsy sampling device based on a CSP delivery sheath according to claim 3, characterized in that, The auxiliary positioning component includes a reaction ring (6) disposed on the surface of the operating end (202) of the CSP delivery sheath (2). The reaction ring (6) is made of elastic material and has a number of reaction cavities (601) disposed inside the reaction ring (6). The reaction cavities (601) are distributed in a circular array along the circumference of the reaction ring (6). The reaction cavities (601) are connected to the buffer cavities one by one. The communication channels between the reaction cavities (601) and the buffer cavities are all disposed inside the outer sheath of the CSP delivery sheath (2).

5. The myocardial biopsy sampling device based on a CSP delivery sheath according to claim 4, characterized in that, The CSP delivery sheath (2) has an observation cover (4) on its operating end (202) surface for covering the reaction ring (6). The observation cover (4) is made of transparent material and the observation surface of the observation cover (4) has a convex arc-shaped curved surface structure.

6. The myocardial biopsy sampling device based on a CSP delivery sheath according to claim 5, characterized in that, The outer sheath surface of the CSP delivery sheath (2) is provided with several auxiliary anchoring components for stabilizing the CSP delivery sheath (2) when the CSP delivery sheath (2) guides the insertion of the myocardial biopsy forceps (1); and the auxiliary anchoring components are driven by the volume change of the reflective ring (6).

7. The myocardial biopsy sampling device based on a CSP delivery sheath according to claim 6, characterized in that, All auxiliary anchoring components include anchoring rings (5) set on the surface of the tube sheath of the CSP delivery sheath (2). The anchoring rings (5) are all made of elastic material and have a hollow structure inside. The gap between the observation cover (4) and the reaction ring (6) is set as a squeezing chamber. The anchoring rings (5) are all connected to the squeezing chamber. The communication channel between the anchoring rings (5) and the squeezing chamber is set inside the tube sheath of the CSP delivery sheath (2). The communication channel between the anchoring rings (5) and the squeezing chamber is set with a one-way valve that only allows gas in the squeezing chamber to flow to the anchoring rings (5). The surface of the operating end (202) of the CSP delivery sheath (2) is set with a press-type vent valve (7) for releasing gas in the anchoring rings (5). The surface of the operating end (202) of the CSP delivery sheath (2) is set with a balance channel that communicates with the squeezing chamber. The balance channel is set with a one-way valve that only allows external gas to enter the squeezing chamber.

8. A myocardial biopsy sampling system based on a CSP delivery sheath, comprising the myocardial biopsy sampling device based on a CSP delivery sheath (2) according to any one of claims 1-7, characterized in that, Includes a sampling unit, an insertion unit, and a guiding unit; The sampling unit is used to clamp endocardial myocardial tissue with myocardial biopsy forceps (1) to provide test samples for subsequent myocardial pathological examination; The insertion unit is used to insert the CSP delivery sheath (2) along the axillary vein until the insertion end of the CSP delivery sheath (2) reaches the predetermined biopsy area of ​​the interventricular septum, and the angle between the head of the sheath (201) of the CSP delivery sheath (2) and the myocardial contact surface under X-ray fluoroscopy is 90°. The guiding unit is used to push the myocardial biopsy forceps (1) to the myocardial contact surface of the predetermined biopsy area of ​​the interventricular septum through the inner channel of the CSP delivery sheath (2), and then complete the sampling under dynamic monitoring of X-ray fluoroscopy.

9. The myocardial biopsy sampling system based on a CSP delivery sheath according to claim 8, characterized in that, In the sampling unit, after the myocardial biopsy forceps (1) are pushed to the target position, the CSP delivery sheath (2) is retracted 1-2 cm, and then the myocardial biopsy forceps (1) are opened to grab the test sample. After the grabbing is completed, the myocardial biopsy forceps (1) are closed and the myocardial biopsy forceps (1) are removed by rotating clockwise.

10. A myocardial biopsy sampling method based on a CSP delivery sheath, comprising the myocardial biopsy sampling device based on a CSP delivery sheath (2) according to any one of claims 1-7, characterized in that, Includes the following steps: Step 1, placement and positioning: Disinfect and anesthetize the axillary vein puncture area of ​​the patient, and establish a pathway by percutaneous puncture of the axillary vein; push the CSP delivery sheath (2) along the guidewire through the placement unit, and under real-time guidance of X-ray fluoroscopy, gradually bring the insertion end of the CSP delivery sheath (2) to the predetermined biopsy area of ​​the ventricular septum. Adjust the angle of the sheath (201) through the operating end (202) of the CSP delivery sheath (2) until the imaging mark of the insertion end of the CSP delivery sheath (2) forms a 90° angle with the myocardial contact surface, thus completing the establishment of the myocardial biopsy forceps (1) delivery channel; Step 2, guided positioning: push the myocardial biopsy forceps (1) along the inner channel of the CSP delivery sheath (2), and adjust the pushing depth of the myocardial biopsy forceps (1) in real time under dynamic monitoring of X-ray fluoroscopy until the gripping end of the myocardial biopsy forceps (1) fits against the myocardial contact surface of the predetermined biopsy area of ​​the interventricular septum, and maintain a 90° angle between the gripping end and the contact surface. Step 3, sample collection and retrieval: After the myocardial biopsy forceps (1) complete the clamping action, rotate clockwise to withdraw the myocardial biopsy forceps (1) into the CSP delivery sheath (2), then remove the myocardial biopsy forceps (1), collect and preserve the sample in time, then remove the CSP delivery sheath (2), apply pressure to the puncture site to stop bleeding, and send the sample for pathological testing.

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