Device for coronary artery stent shaping

Abstract

The utility model provides a device for shaping a coronary stent, which is of a hollow tubular structure, a U-shaped or nearly U-shaped notch is arranged at one end of a tube, the inner diameter of the hollow tubular structure is equal to 1.05-1.25 times of the outer diameter of an unexpanded coronary stent, and the outer diameter of the hollow tubular structure is equal to 1.05-1.25 times of the outer diameter of the unexpanded coronary stent. The length of the hollow tubular structure is larger than that of the unexpanded coronary artery stent, the depth of the notch is larger than or equal to the height of a single-circle mesh of the stent, and the width of the notch is smaller than or equal to the outer diameter of the unexpanded stent and larger than or equal to the width of a single mesh. According to the stent shaping device, the risks of deformation and damage of the stent can be remarkably reduced, the risk of stent deloading is reduced, and the success rate of stent implantation operation is increased.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the technical field of medical devices, and particularly relates to a device for shaping a stent in a coronary stent implantation technique. BACKGROUND

[0002] With the increasing number of the elderly population, the number of patients with coronary heart disease is increasing year by year, which seriously endangers people's health. Percutaneous coronary stent implantation can effectively improve the prognosis of coronary heart disease, but stent implantation at the lesion site of the coronary artery opening and its branch vessel opening has always been a difficulty in interventional surgery. Due to the overlapping of blood vessels, X-ray imaging is not clear, the beating of the heart and the interference of respiratory motion, which makes it difficult to accurately implant the stent in the expected position. In 2005, Szabo proposed at the American Transcatheter Cardiovascular Therapeutics Annual Meeting: two guide wires are used, one of which passes through the stent balloon to implant the stent, and the other passes through the stent end mesh to anchor the stent, avoiding the stent from entering the distal end of the blood vessel opening, and the stent can be accurately positioned. This surgical method is named Szabo technology, i.e. stent tail end guide wire anchoring technology. Imaging studies have shown that Szabo technology is more accurate than traditional stent implantation in stent positioning, can completely cover the lesion and has fewer protruding stent beams.

[0003] Szabo technology needs to be pretreated before application in order to pass the anchoring guide wire through the stent mesh. The commonly used method is to first remove the protective cover of the balloon dilatation stent to just expose the first circle of mesh at the stent tail end, then dilate the balloon with a small pressure to make the first circle of mesh at the stent tail end rise, pass the anchoring guide wire through the stent mesh, and then use hands to pinch the raised mesh back to make it tightly adhere to the balloon. In this process, the stent may be deformed or even damaged, and the structure of the stent and the balloon originally adhered to each other may also change. If the stent and the balloon are not tightly adhered, the stent may be unloaded during implantation, which may cause a series of serious consequences and cause great harm to the patient. In addition, the guide wire is randomly selected to pass through the mesh to anchor the guide wire, which may cause the two guide wires to entangle during the stent pushing process, which may prevent the stent from advancing, resulting in the failure of such surgery.

[0004] The existing technology has not found an effective solution to the problems of Szabo technology. In the article entitled "Clinical Analysis of Szabo Technology for Treating Coronary Artery Opening Lesions via Radial Artery" published by Xu Rong et al., the matters needing attention for successful Szabo technology are summarized, which includes measures to prevent stent unloading, which is limited to standard operation, i.e. only the last circle of steel beams of the stent is lifted and the stent is directly fixed by hand.

[0005] In the clinic, even if the standard operation, the application of Szabo technology failure cases are many. For example, in the paper entitled "Szabo technology in the application of coronary artery opening lesions intervention" by Zhang Haitao et al. Retrospective analysis of 16 cases of coronary heart disease patients from October 2008 to October 2011 using Szabo technology intervention. Of all 16 patients, 15 cases successfully used Szabo technology to accurately position the release of the stent, the success rate of surgery was 94%, of which 1 case of stent unloading occurred during the stent pushing process along the double guide wire, after removing the unloaded stent, the stent was successfully released again using a single guide wire.

[0006] In the paper entitled "Clinical analysis of Szabo technology in the treatment of coronary artery opening lesions through radial artery" by Xu Rong et al., 18 cases of coronary artery opening lesions were selected from September 2012 to May 2014, all patients were treated with Szabo technology to place stents, 17 cases were successfully positioned and placed stents, the success rate of surgery was 94.4%, 1 case failed to position due to guide wire entanglement, the guide wire was adjusted and still pushed with resistance, and other methods of interventional therapy were used successfully.

[0007] The success rate of surgery is 94%, which seems very high in terms of numerical value, but in the medical field related to human life and health, it still needs to be further improved. Practical new type content

[0008] In order to solve the problems in Szabo technology, the utility model provides a device for shaping coronary stent, which can solve the problems of stent deformation and guide wire entanglement.

[0009] The inventor provides the following technical solutions:

[0010] A device for shaping coronary stent, which is a hollow tubular structure, a U-shaped or near U-shaped notch is formed at one end of the tube, the inner diameter of the hollow tubular structure is 1.05-1.25 times the outer diameter of the unexpanded coronary stent, the length of the hollow tubular structure is greater than the length of the unexpanded coronary stent, the depth of the notch is greater than the height of a single stent beam, and the width of the notch is less than or equal to the outer diameter of the unexpanded stent and greater than or equal to the width of a single stent mesh.

[0011] The above-mentioned device for shaping coronary stent, the coronary stent is a balloon expandable stent.

[0012] The inner diameter of the above-mentioned device for shaping coronary stent is preferably 1.1-1.2 times the outer diameter of the unexpanded coronary stent. The determination of the inner diameter size is optimal when the unexpanded stent can smoothly enter the shaping device and the stent can rotate, but the stent does not expand except for the mesh expansion at the notch during pretreatment.

[0013] The length of the hollow tubular structure is preferably 1.25 times the length of the unexpanded coronary stent. This ensures that the entire stent is wrapped in the shaping device, facilitates the stent pre-treatment operation, and reduces production costs.

[0014] The depth of the notch is preferably equal to the height of a single stent beam, and the width of the notch is preferably equal to the width of a single stent mesh. This ensures that only one mesh is expanded during stent pre-treatment, minimizing the impact on the stent structure.

[0015] The proximal U-shaped notch can be semi-circular, superior arc, inferior arc, etc. The specific shape of the notch can be adjusted according to the shape of the mesh on the stent to ensure that the mesh to be expanded is exposed and can be lifted from the notch. The curved edge of the notch can prevent damage to the stent caused by sharp corners.

[0016] One or more tear strips can be provided on the stent shaping device, and the shaping device can be torn along the tear strips after the stent pre-treatment is completed. The end of the tear strip can also be provided with a component that facilitates hand pulling.

[0017] The stent shaping device can also be directly manufactured as a stent protective sleeve during stent production. This saves the cost of separately manufacturing a stent protective sleeve and eliminates the need to remove the original stent protective sleeve and then insert the stent shaping device during the stent pre-treatment process.

[0018] The stent shaping device is suitable for use in the pre-treatment process of coronary stents during a Szabo procedure for coronary stent implantation. It is suitable for various types of heart stents.

[0019] The stent shaping device requires a material that is not easily deformed to ensure that it does not deform when the balloon is pressurized during the stent pre-treatment process, thereby ensuring that the stent outside the notch is not expanded.

[0020] The stent shaping device can adjust the relative position of the shaping device and the mesh of the stent as needed during use. When the notch position is rotated above the stent rod, the anchor guide wire can be placed above the stent rod after being inserted into the mesh, and the main guide wire can be placed below the stent rod. The two guide wires are effectively isolated, which prevents the main guide wire and the anchor guide wire from entangling during the operation, thereby improving the success rate of the operation.

[0021] When the Szabo technique is used for pre-treatment of a coronary stent, after the stent mesh is expanded and the anchor guide wire is inserted into the mesh, the raised mesh needs to be pressed back to the surface of the balloon. At present, it is directly pressed back by hand, and the operator visually judges the effect of the stent reattaching to the balloon by experience. The inventors consider that this process is greatly affected by human factors, which is one of the reasons for stent unloading. Therefore, a fastening device is selected to replace the human hand to press the expanded stent mesh. The fastening device is composed of a clamping sleeve and a rotating sleeve. The clamping sleeve is a hollow cylinder, and at least one slot is arranged in the axial direction, and a thread is arranged on the outer surface. The rotating sleeve is also a hollow cylinder, and a thread is arranged inside. The clamping sleeve and the rotating sleeve are used together like a screw rod and a nut. When in use, the clamping sleeve is first sleeved on the stent, and then the rotating sleeve is rotated. Since the clamping sleeve is provided with a slot, as the rotating sleeve is rotated, the inner diameter of the clamping sleeve gradually decreases, and at the same time, the raised stent mesh is pressed back to the surface of the balloon. This way is controllable, safer and more reliable than the traditional hand pressing method, the effect of stent reattachment is better, and the risk of stent unloading can be further reduced.

[0022] The stent shaping device provided by the utility model is suitable for pre-treatment of a stent in a stent tail end guide wire anchoring technology. The U-shaped or near U-shaped notch is arranged, so that the area of the stent expansion is limited to the notch position when the anchor guide wire is inserted. Compared with the traditional stent expansion method, the area of the stent structure damaged is obviously reduced, the risk of stent deformation and damage can be obviously reduced, the risk of stent unloading is reduced, and the success rate of the operation is improved. In the traditional stent expansion operation, the pressure applied to the balloon is usually 3-4 atm. When the stent shaping device provided by the utility model is used for stent expansion, the pressure applied to the balloon is only 2 atm. The pressure that the stent needs to bear is obviously reduced, the influence on the mesh structure is also obviously reduced, the risk of stent unloading and the success rate of the operation are improved. When the stent is pre-treated, the operator can also make the two guide wires in the stent implantation operation farthest away from each other by adjusting the position of the notch on the shaping device, so as to avoid the entanglement of the two guide wires, thereby further improving the success rate of the stent implantation operation. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 The utility model discloses a structure diagram for the device for coronary stent shaping.

[0024] Figure 2 The utility model discloses a partial structure diagram of the coronary stent.

[0025] Figure 3 The utility model discloses a schematic diagram of the relative position between the notch of the coronary stent shaping device and the stent mesh in the specific embodiment, wherein 1 is the stent mesh, and 2 is the notch of the shaping device. DETAILED DESCRIPTION

[0026] The present invention will be further described in detail below with reference to specific embodiments.

[0027] like Figure 1 As shown, this utility model is a hollow tubular structure with a notch at one end. The notch can be U-shaped or nearly U-shaped.

[0028] Taking the Firebird series cardiac stent, model 3.0×18, produced by Shanghai MicroPort CardioFlow Medical Technology (Group) Co., Ltd. as an example, the unexpanded stent has a diameter of 1.1 mm and a length of 18 mm. The inner diameter of the stent shaping device is 1.2 mm and the length is 22.5 mm. The width of the U-shaped notch on the shaping device is 0.5 mm and the depth is 1 mm.

[0029] In use, first remove the original protective cover of the support, then place the support shaping device of this invention onto the unexpanded support. Rotate the support shaping device so that the U-shaped notch is above the support rod, and at the same time adjust the main guide wire so that it is below the support rod. Then fine-tune the support shaping device so that the U-shaped notch is aligned with a single mesh on the last ring of the support, making it completely exposed. Apply 2 atm of pressure to the balloon, and the balloon will inflate. The mesh at the notch will lift up. Release the pressure on the balloon, pass the anchoring guide wire through the lifted mesh, remove the support shaping device, and press the lifted mesh back onto the balloon surface.

[0030] In addition to the above-mentioned usage, the shaping device of this utility model can also be directly made into a support protective sleeve during the support production process, saving the operation of replacing the original protective sleeve when using it, and the subsequent operation is the same as above.

Claims

1. A device for coronary stent reshaping, characterized by, The device is a hollow tubular structure, a U-shaped or near U-shaped notch is formed at one end of the tube, the inner diameter of the hollow tubular structure is 1.05-1.25 times of the outer diameter of the unexpanded coronary stent, the length of the hollow tubular structure is greater than the length of the unexpanded coronary stent, the depth of the notch is greater than the height of the single stent steel beam, the width of the notch is less than the outer diameter of the unexpanded stent and greater than the width of the single stent mesh.

2. The device for coronary stent reshaping of claim 1, wherein, The coronary stent is a balloon-expandable stent.

3. The device for coronary stent reshaping of claim 1, wherein, The inner diameter of the hollow tubular structure is 1.1-1.2 times of the outer diameter of the unexpanded coronary stent.

4. The device for coronary stent reshaping of claim 1, wherein, The length of the hollow tubular structure is 1.25 times of the length of the unexpanded coronary stent.

5. The device for coronary stent reshaping of claim 1, wherein, The depth of the notch is equal to the height of the single stent steel beam.

6. The device for coronary stent reshaping of claim 1, wherein, The width of the notch is equal to the width of the single stent mesh.

7. The device for coronary stent reshaping of claim 1, wherein, The near U-shaped notch includes a semicircular shape, a superior arc shape and an inferior arc shape.

8. The device for coronary stent reshaping of claim 1, wherein, One or more tearable strips are further arranged on the device.

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