Stent crimping device and method

Abstract

The application provides a stent compression device and method, and belongs to the technical field of stent compression in medical devices. The stent compression device comprises a compression structure, an open-ended compression space is formed in the compression structure, a support structure is arranged in the compression space and used for supporting a stent to be compressed, a gas conveying structure for conveying high-pressure clean gas to the compression space is arranged on the side wall of the compression space, and the gas conveying structure is used for applying radial extrusion force to the stent on the support structure from the inner side wall of the compression space to compress the stent, so as to solve the technical problem that the stent surface is damaged and contaminated due to the steel contact between the stent compression device and the stent in the prior art, and further health risks are brought to patients.

Description

Technical Field

[0001] This invention belongs to the field of stent compression technology in medical devices, specifically relating to a stent gripping device and method. Background Technology

[0002] The carotid arteries, located on either side of the trachea, are vital blood vessels carrying blood from the heart to the head. Carotid artery stenosis refers to the narrowing of the carotid artery lumen caused by factors such as atherosclerosis, tumors, chemotherapy damage, trauma, and congenital arterial atresia. Among these, atherosclerosis is the most common. Atherosclerosis is the deposition of lipids and complex carbohydrates on the arterial wall, forming a porridge-like substance. Local narrowing of the carotid artery leads to impaired blood flow, causing ischemia and hypoxia, resulting in softening and necrosis of brain tissue, and even ischemic stroke.

[0003] Currently, the main surgical treatments for carotid artery stenosis include endarterectomy and stent implantation. There is no significant difference in postoperative efficacy between the two procedures; however, endarterectomy is more prone to thrombosis during the procedure, increasing the risk of secondary stroke. Therefore, stent implantation demonstrates significant value in the clinical diagnosis and treatment of carotid artery stenosis. Among these, self-expanding stent implantation is widely used clinically. It involves placing a stent, laser-carved or braided from a shape-memory alloy, inside a delivery sheath. A guidewire within the sheath guides the delivery sheath to the lesion site, and the sheath is then withdrawn, causing the stent to expand and release. After release, the stent self-expands to open the blood vessel, providing support to the stenotic vessel and exhibiting strong resilience and flexibility.

[0004] Self-expanding stents are in a self-expanding state in their natural state. Their diameter is much larger than that of the radial or femoral artery (during surgery, the delivery sheath needs to be inserted into the body from these two sites to deliver the stent to the designated location). Therefore, a certain gripping device is needed to hold it in the delivery sheath before it can be delivered to the lesion site.

[0005] Existing stent clamping devices feature a rigid clamping structure that makes rigid contact with the stent to compress and deform it before delivery into the sheath. However, this rigid clamping structure inevitably causes microscopic scratches on the stent's outer surface during the clamping process. These scratches are difficult to observe with the naked eye, but once inserted into the patient's body, the stent's outer surface supports and contacts the inner wall of the blood vessel. At this point, the scratches may trigger an inflammatory response in the blood vessel and excessive proliferation of smooth muscle cells, leading to restenosis and postoperative recurrence. In addition, the stent inevitably becomes contaminated with dirt from the clamping structure's surface during clamping. Once the stent is clamped into the delivery sheath, it is in close contact with the sheath's inner wall, making it difficult to clean thoroughly. Therefore, there is a risk that contaminants from the stent surface may be carried into the body. Summary of the Invention

[0006] The purpose of this invention is to provide a stent gripping device to solve the technical problem that the stent gripping device causes damage and contamination to the stent surface due to rigid contact with the stent in the prior art, which brings further health risks to patients; the purpose of this invention is also to provide a method for the stent gripping device to grip the stent, so as to solve the above problems.

[0007] To achieve the above objectives, the bracket gripping device of the present invention adopts the following technical solution:

[0008] A stent clamping device is provided for compressing the radial dimension of a stent. The stent clamping device includes a clamping structure, a clamping space with openings at both ends formed inside the clamping structure, a support structure provided inside the clamping space for supporting the stent to be compressed, and a gas delivery structure provided on the side wall of the clamping space for delivering high-pressure clean gas to the clamping space. The gas delivery structure is used to apply radial extrusion force from the inner side wall of the clamping space to the stent on the support structure to compress the stent.

[0009] As a further optimized technical solution, the gripping structure includes a cylindrical component, the internal space of which constitutes the gripping space, and mounting holes are provided on the side wall of the cylindrical component. The gas delivery structure is fixedly connected to the cylindrical component through the mounting holes.

[0010] As a further optimized technical solution, the cross-section of the cylindrical component along the radial direction is a perfect circle, and the mounting holes are evenly distributed on the side wall of the cylindrical component.

[0011] As a further optimized technical solution, the support structure is located at the center of the cylindrical component and extends along the axial direction.

[0012] As a further optimized technical solution, the guide wire inside the sheath forms a support structure.

[0013] As a further optimized technical solution, the number of mounting holes arranged circumferentially along the cylindrical component is not less than 10, in order to ensure that the compressed bracket is subjected to balanced circumferential force.

[0014] As a further optimized technical solution, the high-pressure clean gas is nitrogen.

[0015] As a further optimized technical solution, the gas delivery structure is a nitrogen booster pump, and the gas delivery pipe of the booster pump is fixedly connected to the cylindrical component through the mounting hole.

[0016] To achieve the above objectives, the method for gripping the bracket using the bracket gripping device in this invention adopts the following technical solution:

[0017] A method for gripping a support using a support gripping device, comprising the following steps:

[0018] Place the stent to be compressed on the guide wire, and then place the stent into the compression space through the guide wire;

[0019] High-pressure clean gas is introduced into the gripping space to compress the stent;

[0020] The compressed support is inserted into the sheath.

[0021] As a further optimized technical solution, after the high-pressure clean gas compresses the stent, the gas delivery structure switches the gas source to a liquid nitrogen source and sprays liquid nitrogen onto the compressed stent to cool it down and change its phase to maintain the compressed state.

[0022] The beneficial effects of the stent compression device provided by this invention are as follows: The stent to be compressed is placed into the compression space through a support structure, and high-pressure clean gas is delivered into the compression space through a gas delivery structure. The high-pressure clean gas blows onto the stent from around the compression structure to achieve radial compression of the stent, thereby compressing it. This method of using high-pressure clean gas to compress the stent achieves flexible contact with the stent during the compression process, without damaging the outer surface of the stent. This avoids postoperative recurrence caused by vascular inflammation and excessive proliferation of smooth muscle cells in the blood vessels due to stent damage. Furthermore, the high-pressure clean gas also plays a purging and cleaning role during the stent compression process, removing contaminants adhering to the stent before compression, ensuring the cleanliness of the stent before it is delivered into the sheath, reducing the risk of stent contamination, and solving the safety hazards caused by stent contamination.

[0023] The beneficial effects of the method for pressing the support using the support pressing device provided by the present invention are similar to those of the support pressing device, and will not be described in detail here. Attached Figure Description

[0024] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. Wherein:

[0025] Figure 1 This is a schematic diagram of the overall structure of a cylindrical component according to an embodiment of the present invention;

[0026] Figure 2 This is a side view of a cylindrical component according to an embodiment of the present invention;

[0027] Figure 3 for Figure 2A cross-sectional view along the AA direction;

[0028] Figure 4 This is a schematic diagram of the state of the stent gripping device before stent gripping according to an embodiment of the present invention;

[0029] Figure 5 This is a schematic diagram of the working state of the bracket gripping device gripping the bracket according to an embodiment of the present invention;

[0030] Figure 6 This is a schematic diagram of the compressed support of one embodiment of the present invention.

[0031] In the diagram: 1. Cylindrical component; 2. Grip space; 3. Mounting hole; 4. Sheath; 5. Guide wire; 6. Support. Detailed Implementation

[0032] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0033] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," 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 do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0034] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0035] This invention provides a stent clamping device. By uniformly connecting a gas delivery structure to the side wall of a cylindrical component 1, high-pressure clean gas is delivered into the cylindrical component 1. The high-pressure clean gas performs radial compression on the stent 6, solving the technical problem in existing clamping devices that damage and contaminate the stent 6 during the clamping process, thus posing further health risks to patients.

[0036] Specifically, such as Figure 1 , Figure 2 , Figure 3As shown, a stent gripping device is used to compress the radial dimension of a stent 6. The stent 6 is made of shape memory alloy. Shape memory alloy will deform under external force and can return to its original shape under certain temperature conditions after the external force is removed. Because it has a recovery function of more than one million times, it is called "shape memory alloy". In this embodiment, the shape memory alloy is made of titanium-nickel alloy. When in use, it needs to be compressed outside the body until the radial dimension is smaller than the blood vessel size before being inserted into the sheath. After surgery, the stent is placed inside the blood vessel and automatically expands to its original shape under the body temperature. This can expand and support the narrowed blood vessel, restore the smooth circulation of the blood vessel, and thus achieve the therapeutic purpose.

[0037] The support clamping device specifically includes a clamping structure, within which a clamping space 2 with openings at both ends is formed. A gas delivery structure (not shown in the figure) is provided on the sidewall of the clamping space 2 to deliver high-pressure clean gas into the clamping space 2. The gas delivery structure is used to apply radial compressive force to the support 6 from the inner sidewall of the clamping space 2 to compress the support 6. The clamping structure can be any component with a clamping space 2. The cross-section of the clamping space 2 can be square, triangular, elliptical, etc., but the length extension direction of the clamping space 2 is uniform and constant. The purpose is to allow the gas delivery structure to deliver high-pressure clean gas from the inner sidewall of the clamping space 2 into the clamping space 2, specifically delivering... The high-pressure clean gas method involves arranging multiple through holes connected to the outside on the side wall of the gripping space 2. A sealed chamber is connected to the outside of the gripping structure, located outside the through holes and connected to them. The gas delivery pipe of the gas delivery structure is directly connected to the chamber, thus the gas delivery structure delivers high-pressure clean gas into the chamber, and then delivers it into the gripping space 2 through the through holes on the side wall of the gripping space 2. There is a force-balanced position in the length extension direction of the gripping space 2 (this can be achieved by adjusting the size of each through hole to adjust the pressure of the gas ejected into the gripping space 2 from various directions). This position facilitates balanced compression of the support 6 to uniformly compress the support 6 and prevent uneven circumferential deformation of the support 6. It should be noted that the "circumferential" direction mentioned above refers to the direction within the gripping space 2 excluding the two ends, which is the radial direction relative to the support 6. The reason for using clean gas is twofold: firstly, to avoid contaminating the support 6, and secondly, to prevent contaminant particles from impacting the support 6 under high pressure and damaging its outer surface.

[0038] A support structure is provided within the compression space 2 to support the bracket 6 that needs to be compressed. Preferably, the support structure is located at a force-balanced position within the compression space 2, thereby facilitating the gas delivery structure to apply radial extrusion force to the bracket 6 on the support structure from the inner wall of the compression space 2. In this embodiment, the support structure can be a support rod that extends and is fixedly installed along the force-balanced position. A linear reciprocating drive mechanism is connected to the right end of the sheath 4. When the bracket needs to be compressed, the bracket 6 is fitted onto the support rod. Then, the gas delivery structure is activated, and the high-pressure clean gas blown out by the gas delivery structure compresses the bracket 6. After compression is completed, the linear reciprocating drive mechanism is activated. The linear reciprocating drive mechanism first pushes the sheath 4 to the left, thereby loading the compressed bracket 6 into the sheath 4, and then pulls the sheath 4 to the right to reset. The linear reciprocating drive mechanism can be a common electric actuator; in other embodiments, it can also be a reciprocating screw structure.

[0039] In an optional embodiment, the gripping structure includes a cylindrical component 1, and the internal space of the cylindrical component 1 forms a gripping space 2. Mounting holes 3 are provided on the side wall of the cylindrical component 1. The gas delivery structure is fixedly connected to the cylindrical component 1 through the mounting holes 3. In this embodiment, the gas delivery structure is provided with multiple gas delivery pipes, each of which is fixedly connected to a mounting hole 3. The cylindrical component 1 has a simple structure and is easy to manufacture. By providing mounting holes 3 on the side wall of the cylindrical component 1, it is convenient to install the gas delivery pipes of the gas delivery structure. Preferably, when the radial cross-section of the cylindrical component 1 is a perfect circle, it is easier to control the balance of the gas pressure output by the gas delivery structure. For example, if the gas pressure output in each mounting hole 3 is the same, the position of force balance is at the axial position of the cylindrical component 1. Therefore, when the radial cross-section of the cylindrical component 1 is a perfect circle, the support structure is preferably located at the center of the cylindrical component 1 and extends along the axial direction, thereby ensuring that the support 6 is subjected to uniform force and deformation when squeezed. At this time, the mounting holes 3 are evenly distributed on the side wall of the cylindrical component 1, which also facilitates the processing of the mounting holes 3. In this embodiment, when processing the mounting holes on the side wall of the cylindrical component 1, they can be processed row by row along the axial direction of the cylindrical component 1. In order to ensure that the support 6 is subjected to balanced force in the circumference, the number of mounting holes 3 arranged in each row along the circumference of the cylindrical component 1 is not less than 10. Under the premise of ensuring that the gas conveying pipe installed on the mounting holes 3 does not interfere during installation, the more mounting holes 3 there are, the more evenly the support 6 in the pressure space 2 is subjected to force. Of course, in actual production, various factors such as processing difficulty and processing cost need to be considered. Therefore, the most suitable number needs to be determined according to the specific situation.

[0040] In an alternative embodiment, such as Figure 4 , Figure 5 , Figure 6As shown, the guide wire 5 inside the sheath 4 forms a support structure. Therefore, no additional support structure is needed, further simplifying the device's structure. In use, the bracket 6 is placed on the guide wire 5, which then guides the bracket 6 into the gripping space 2. The guide wire 5 is adjusted to the axial position of the cylindrical component 1, and the bracket 6 is fully placed into the gripping space 2. Then, the gas delivery structure is activated to discharge high-pressure clean gas into the gripping space 2. Initially, the bracket 6 will experience uneven force, resulting in displacement until it is coaxial with the guide wire. Afterward, the bracket 6 is compressed until its radial dimension meets the requirements. Then, the sheath 4 is moved to the left to insert the compressed bracket 6 into the sheath. In other embodiments, the bracket 6 can be gradually compressed until fully deformed. That is, the gas delivery structure on the two rightmost rows of mounting holes 3 is first opened, and the rightmost end of the bracket 6 is first compressed and deformed. Then, the gas portion of the bracket 6 is gradually compressed and deformed until the bracket 6 is completely deformed.

[0041] In an optional embodiment, the high-pressure cleaning gas is nitrogen, which is a colorless, odorless, and non-toxic inert gas with stable chemical properties, making it more conducive to cleaning the stent 6.

[0042] In an optional embodiment, the gas delivery structure is a nitrogen booster pump, and the gas delivery pipe of the booster pump is fixedly connected to the cylindrical component 1 through the mounting hole 3.

[0043] In an optional embodiment, the present invention also provides a method for a support gripping device to grip a support, wherein the gripping device is used in any of the above embodiments for gripping, and the method for the gripping device to grip the support 6 includes the following steps:

[0044] S1: Place the bracket 6 to be compressed on the guide wire 5, and place the bracket 6 in the clamping space 2 through the guide wire 5. Then adjust the position until the guide wire 5 is placed at the axial position of the clamping space.

[0045] S2: High-pressure clean gas is introduced into the compression space to compress the stent 6. After the high-pressure clean gas compresses the stent 6, the gas delivery structure switches the gas source to liquid nitrogen source and sprays liquid nitrogen onto the compressed stent 6 to cool the stent 6 and change its phase to maintain its compressed state, thereby preventing the stent 6 from rebounding after compression and affecting normal surgical operations.

[0046] S3: The cooled and shaped bracket 6 is inserted into the sheath tube 4, thereby completing the operation of compressing the bracket 6 and inserting it into the sheath tube 4.

[0047] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention shall be protected within the scope of the pending claims of the present invention.

Claims

1. A support clamping device for compressing the radial dimension of a support (6), characterized in that, The support clamping device includes a clamping structure, and a clamping space (2) with openings at both ends is formed inside the clamping structure. A support structure is provided in the clamping space (2) to support the support (6) that needs to be compressed. A gas delivery structure is provided on the side wall of the clamping space (2) to deliver high-pressure clean gas to the clamping space (2). The gas delivery structure is used to apply radial extrusion force from the inner side wall of the clamping space (2) to the support (6) on the support structure to compress the support (6). The gripping structure includes a cylindrical component (1), the internal space of the cylindrical component (1) constitutes the gripping space (2), and mounting holes (3) are provided on the side wall of the cylindrical component (1). The gas delivery structure is fixedly connected to the cylindrical component (1) through the mounting holes (3). The cross-section of the cylindrical component (1) along the radial direction is a perfect circle, and the mounting holes (3) are evenly distributed on the side wall of the cylindrical component (1); The support clamping device also includes a sheath (4) for inserting the compressed support (6).

2. The bracket gripping device according to claim 1, characterized in that, The support structure is located at the center of the cylindrical component (1) and extends along the axial direction.

3. The bracket gripping device according to any one of claims 1-2, characterized in that, The guide wire (5) inside the sheath (4) forms a support structure.

4. The bracket gripping device according to any one of claims 1-2, characterized in that, The number of mounting holes (3) arranged along the circumference of the cylindrical component (1) is not less than 10, which is used to ensure that the compressed bracket (6) is subjected to balanced circumferential force.

5. The bracket gripping device according to any one of claims 1-2, characterized in that, The high-pressure clean gas is nitrogen.

6. The bracket gripping device according to claim 5, characterized in that, The gas delivery structure is a nitrogen booster pump, and the gas delivery pipe of the booster pump is fixedly connected to the cylindrical component (1) through the mounting hole (3).

7. A method for gripping a bracket using a bracket gripping device, wherein the gripping device according to any one of claims 1-6 is used for gripping, characterized in that, The method of pressing the gripper on the support (6) includes the following steps: Place the support (6) to be compressed on the guide wire (5), and place the support (6) into the gripping space (2) through the guide wire (5); High-pressure clean gas is introduced into the pressure-gripping space (2) to compress the support (6); The compressed support (6) is inserted into the sheath (4).

8. The method for gripping a bracket using the bracket gripping device according to claim 7, characterized in that, After the high-pressure clean gas compresses the support (6), the gas delivery structure switches the gas source to liquid nitrogen source and sprays liquid nitrogen onto the compressed support (6) to cool the support (6) and change its phase to maintain its compressed state.

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