Myocardial patch with microneedles for heart bypass

Abstract

The utility model discloses a cardiac muscle patch with a microneedle for cardiac bypass, which comprises a patch main body used for being adhered and wrapped on the surface of a vein bridge blood vessel in a cardiac bypass operation; the plurality of microneedles are uniformly distributed on the adhesive surface of the patch main body, and drug particles are attached to the surfaces of the microneedles; and the reinforced connection structures are uniformly distributed on the surface of the patch main body, are connected to the interiors of the microneedles, and are used for reinforcing the connection between the microneedles and the patch main body. According to the myocardial patch with the micro-needle for heart bypass, the surface of the patch is combined with the hydrogel micro-needle to form an integrated structure, so that loaded drugs, such as antiplatelet tirofiban sustained-release particles, are loaded to the needle body of the micro-needle, and continuous and stable release of the tirofiban sustained-release particles can be ensured; the myocardial patch is directionally conveyed to a vein bridge area, so that simple and convenient application of the myocardial patch in a vein bridge is facilitated.

Description

Technical Field

[0001] The utility model relates to the technical field of surgical medical instruments, in particular to a myocardial patch with microneedles for heart bypass. Background Art

[0002] The number of patients with left main trunk disease and three-vessel disease is gradually increasing, and they need to take coronary artery bypass grafting (CABG) for treatment. Therefore, CABG is one of the effective treatments for myocardial ischemia caused by coronary heart disease. Because this surgical method is like building a bridge, it is figuratively called "coronary artery bypass grafting." Commonly used arteries are the internal mammary artery, radial artery, and right gastroepiploic artery, and commonly used veins are the great saphenous vein under the skin of the inner side of the calf.

[0003] However, after coronary artery bypass grafting, the vascular graft will be diseased and may be blocked, especially the venous graft. In cases where the great saphenous vein is used, 20% of the cases will have stenosis within one year at the anastomosis between the great saphenous vein and the ascending aorta, but only 25% of the cases will be obstructed within 5 years. Therefore, for venous grafts, restenosis is an important problem to be faced. However, the first few days after surgery are the critical period. Because the patient is intubated, he cannot eat, and he cannot take antiplatelet drugs such as aspirin and Plavix orally. He can only rely on intravenous administration of anticoagulants, such as heparin or low molecular weight heparin. However, after cardiac surgery, the surgical wound is severely oozing. Systemic administration of anticoagulants may invisibly aggravate the bleeding of the wound. Therefore, local administration can minimize the effect on coagulation function. If local administration can be adopted, slow-release antiplatelet drugs can be used for 48-72 hours until the endotracheal tube is removed after surgery. Oral antiplatelets can be used clinically to play a bridging role and reduce thrombosis and blockage of venous grafts after bypass surgery.

[0004] At present, antiplatelet drugs are available in oral and intravenous dosage forms. Common oral drugs include aspirin and Plavix, and intravenous drugs include tirofiban. Although oral antiplatelet drugs are commonly used, their shortcomings of in vivo absorption limit their clinical application. Tirofiban is an intravenous drug that can be used in vivo and works through intravenous absorption. Tirofiban is a highly effective, reversible, non-peptide platelet surface glycoprotein (GP) Ⅱb / Ⅲa receptor antagonist that takes effect in 5 minutes and lasts for 3 to 8 hours. The steady-state distribution volume ranges from 22 to 42L. Within the concentration range of 0.01 to 25μg / ml, the plasma protein binding rate is 65%, which is independent of the drug concentration. These pharmacokinetic characteristics make it more advantageous for in vivo use. How to release drugs in vivo to ensure that, for example, antiplatelet drugs can effectively work at the target tissue during cardiac surgery is a problem that needs to be solved during surgery. Utility Model Content

[0005] In view of the deficiencies of the prior art, the utility model provides a myocardial patch with microneedles for cardiac bypass, which solves the above-mentioned problems.

[0006] To achieve the above objectives, the utility model is implemented through the following technical solutions: a myocardial patch with microneedles for cardiac bypass, comprising:

[0007] The patch body is used to be attached and wrapped around the surface of the venous graft during heart bypass surgery;

[0008] A plurality of microneedles are arranged and evenly distributed on the adhesive surface of the patch body, and drug particles are attached to the surface of the microneedles;

[0009] The strengthening connection structure is evenly distributed on the surface of the patch body and connected to the inside of the microneedle, and is used to strengthen the connection between the microneedle and the patch body.

[0010] Preferably, the edge of the patch body is divided into multiple petals by a plurality of slits evenly arranged in an annular direction.

[0011] Preferably, the patch body is a film made of polycaprolactone-based polyurethane by electrospinning.

[0012] Preferably, the microneedle is made of silk fibroin and bionic MNs, has a diameter of 10 nm-500 nm, and has nanoscale micropores or pits on its surface.

[0013] Preferably, the drug particles are antiplatelet tirofiban sustained-release particles.

[0014] Preferably, the reinforced connection structure is a fiber filament extending from the surface of the patch body, and the microneedles wrap the fiber filament and are connected to the surface of the patch body.

[0015] Beneficial Effects

[0016] The utility model provides a myocardial patch with microneedles for cardiac bypass. Compared with the prior art, it has the following beneficial effects:

[0017] 1. By combining the hydrogel microneedles on the patch surface into an integrated structure, the loaded drugs, such as the antiplatelet tirofiban sustained-release microparticles, are loaded onto the needle body of the microneedles. While ensuring the continuous and stable release of the tirofiban sustained-release microparticles, they can be directed to the vein bridge area, which is helpful for the simple application of the myocardial patch in the vein bridge.

[0018] 2. The microneedle myocardial patch uses an electrospinning process to integrate a new polycaprolactone-based polyurethane PCL scaffold with a surface-covered bionic MNs into its center, and loads the antiplatelet tirofiban sustained-release microparticles into it, which can optimize the medical functions of ordinary myocardial patches.

[0019] 3. Compared with ordinary myocardial patches, this product has the characteristic that the viscosity of the hydrogel microneedle patch increases by about 10 times as the temperature rises (20℃ to 37℃), so that it can be attached to the outer membrane of the venous graft, creating a bionic microenvironment in the venous graft area, which can be conducive to the sustained release of tirofiban and more effectively prevent the formation of venous graft thrombosis and blockage of the graft blood vessels within 3 days after bypass surgery.

[0020] 4. By setting fiber filaments to connect the patch body and the microneedles, the connection strength between the two can be strengthened, which can prevent the microneedles from falling off easily. The edge of the patch body is divided into multiple petals, so that even if there is local warping on the edge, it will not cause most of the falling off, and only one petal will be warped, which also improves the anti-falling performance of the patch body itself. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the overall structure of the utility model;

[0022] Figure 2 It is an exploded view of the utility model;

[0023] Figure 3 Schematic diagram of the microneedle of the present invention.

[0024] In the figure: 1-patch body, 2-microneedles, 3-reinforced connection structure, 4-drug particles, 5-cutting seam. DETAILED DESCRIPTION

[0025] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0026] The utility model provides the following technical solutions:

[0027] Figure 1-3 A myocardial patch with microneedles for cardiac bypass is shown, comprising:

[0028] The patch body 1 is used to be pasted and wrapped on the surface of the venous bridge during heart bypass surgery. The patch body 1 is a film made of polycaprolactone-based polyurethane by electrospinning, which has a high water content and excellent plasticity, can promote the exchange of oxygen and soluble factors, and also has stable mechanical strength such as elasticity and viscoelasticity. As the temperature rises (20°C to 37°C), the viscosity of the hydrogel microneedle patch increases by about 10 times, which can ensure that the myocardial patch promotes the attachment, arrangement, growth and elongation of myocardial cells, and supports the dynamic and continuous expansion and contraction of the heart; and this composite biomaterial patch has memory, and can be frozen in an in vitro refrigerator, and then the shape memory function of the patch is induced in vivo by body temperature, so that it becomes rubbery in the body and wraps the surface of the venous bridge; the edge of the patch body 1 is divided into multiple petals by a plurality of slits 5 evenly arranged in an annular direction.

[0029] The microneedles 2 are provided with a plurality of microneedles and are evenly distributed on the adhesive surface of the patch body 1. The microneedles 2 are made of silk fibroin and biomimetic MNs, with a diameter of 10nm-500nm. The surface of the microneedles 2 is provided with nanoscale micropores or pits. The surface of the microneedles 2 is attached with drug particles 4. The drug particles 4 are antiplatelet tirofiban sustained-release particles. The sustained-release particles are solid colloidal particles with a particle size of 10nm to 500nm. The diameter can ensure that tirofiban is slowly and stably released to the venous bridge site. Compared with the myocardial patch of ordinary biomaterials, it can more effectively prevent the formation of venous bridge thrombosis and blockage of the bridge blood vessel within 3 days after bypass surgery. The sustained release at the location of the target tissue exerts an antiplatelet effect for up to 48-72 hours until the endotracheal tube is removed after surgery. Oral antiplatelets can prevent blood vessel blockage and play a bridging role.

[0030] The strengthening connection structure 3 is evenly distributed on the surface of the patch body 1 and connected to the inside of the microneedle 2, and is used to strengthen the connection between the microneedle 2 and the patch body 1. The strengthening connection structure 3 is a fiber filament extending from the surface of the patch body 1, and the microneedle 2 wraps the fiber filament and is connected to the surface of the patch body 1.

[0031] Meanwhile, the contents not described in detail in this specification belong to the prior art known to those skilled in the art.

[0032] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0033] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A myocardial patch with microneedles for cardiac bypass, characterized in that: include: The patch body (1) is used to be adhered and wrapped on the surface of the venous graft during heart bypass surgery; A plurality of microneedles (2) are arranged and evenly distributed on the adhesive surface of the patch body (1), and drug particles (4) are attached to the surface of the microneedles (2); The strengthening connection structure (3) is evenly distributed on the surface of the patch body (1) and connected to the inside of the microneedle (2), and is used to strengthen the connection between the microneedle (2) and the patch body (1).

2. The myocardial patch with microneedles for cardiac bypass according to claim 1, characterized in that: The edge of the patch body (1) is divided into multiple petals by a plurality of slits (5) evenly arranged in a circumferential direction.

3. The myocardial patch with microneedles for cardiac bypass according to claim 1, characterized in that: The patch body (1) is a film made of polycaprolactone-based polyurethane by electrostatic spinning.

4. The myocardial patch with microneedles for cardiac bypass according to claim 1, characterized in that: The diameter of the microneedle (2) is 10nm-500nm, and the surface of the microneedle (2) is provided with nanoscale micropores or pits.

5. The myocardial patch with microneedles for cardiac bypass according to claim 1, characterized in that: The drug particles (4) are antiplatelet tirofiban sustained-release particles.

6. The myocardial patch with microneedles for cardiac bypass according to claim 1, characterized in that: The reinforcing connection structure (3) is a fiber filament extending from the surface of the patch body (1), and the microneedles (2) wrap the fiber filament and are connected to the surface of the patch body (1).

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