CN113856005A - Drug-coated balloon catheter assembly for promoting tissue repair and fiber connection and use method thereof - Google Patents
Drug-coated balloon catheter assembly for promoting tissue repair and fiber connection and use method thereof Download PDFInfo
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- CN113856005A CN113856005A CN202111129640.9A CN202111129640A CN113856005A CN 113856005 A CN113856005 A CN 113856005A CN 202111129640 A CN202111129640 A CN 202111129640A CN 113856005 A CN113856005 A CN 113856005A
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- balloon catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
- A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
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Abstract
The invention relates to a drug-coated balloon catheter assembly for promoting tissue repair and fiber connection and a using method thereof. Compared with the prior art, when the drug coating balloon reaches a target lesion part and is expanded to be in contact with the inner wall of a blood vessel, the drug can be quickly transferred from the surface of the balloon to the tissue of the blood vessel wall, and the repairing effect is quickly played.
Description
Technical Field
The invention belongs to the technical field of interventional medical instruments, and relates to a drug-coated balloon catheter assembly for promoting tissue repair and fiber connection and a using method thereof.
Background
Drug-coated balloons are an important instrument in the field of interventional procedures and are widely used for the treatment of stenosis and occlusion of blood vessels, including coronary arteries and peripheral vessels.
The drug coating balloon has the action mechanism that active drugs are coated on the surface of the balloon, the balloon is conveyed to a blood vessel pathological change part through a percutaneous intervention technology, external equipment is used for expanding the balloon, the drugs on the surface of the balloon are in contact with the inner wall of a blood vessel, and the drugs are quickly released and transferred to the inner wall of a local blood vessel. The stent has the advantages that the stent can uniformly release the coated medicine on the inner wall of a diseased blood vessel in the expansion process, is beneficial to endothelial tissues to absorb the medicine, can avoid adverse reaction of systemic application of the medicine, and simultaneously avoids the long-term existence of an implant compared with the stent. It is particularly advantageous in the treatment of vascular stenosis and in-stent restenosis. The drug-coated balloon can effectively inhibit the smooth muscle excessive proliferation after operation, has no exogenous stimulation to peripheral blood vessels after the implantation of an exogenous stent, reduces inflammatory reaction, and reduces the incidence rate of restenosis and the risk of thrombosis.
The existing drug coating balloon has the following defects: after balloon dilatation, vascular endothelium injury and elastic fiber fracture of an artery segment are expanded, so that thrombosis and intimal hyperplasia are caused; the balloon has short expansion time and lacks long-term supporting force in the use process, so that the tube wall is elastically retracted and remodeled.
For example, chinese patent 202011411416.4 discloses a drug balloon, which comprises a balloon body, an outer tube, a hypotube and a catheter seat that are connected in sequence, wherein dimples are distributed on the outer side of the balloon body, a tip tube is provided at one end of the balloon body far from the outer tube, and a drug coating is coated on the outer side of the balloon body, which is a release layer and a drug dispersion layer in sequence from inside to outside. However, the drug balloon still can avoid injury to the vascular endothelium of the arterial segment after expansion.
Disclosure of Invention
The invention aims to provide a drug-coated balloon catheter assembly for promoting tissue repair and fiber connection and a using method thereof, and solves the problems of injury and fracture of collagen fibers on the inner wall of a blood vessel and elastic retraction of the blood vessel after balloon dilatation in the prior art.
The purpose of the invention can be realized by the following technical scheme:
one of the technical schemes of the invention provides a drug-coated balloon catheter assembly for promoting tissue repair and fiber connection, which comprises a balloon body, a balloon catheter and an optical fiber guide wire, wherein the balloon body is connected with the balloon catheter, a catheter cavity for the optical fiber guide wire to pass through is further arranged in the balloon catheter, a drug coating is coated on the outer side of the balloon body, and the drug coating comprises an angioplasty drug coating and an active drug coating.
In the balloon catheter assembly of the present invention, the drug loading of the angioplasty drug (including but not limited to 4-amino-1, 8-naphthalimide, N-5-azido-2-nitrobenzoyloxysuccinimide, N- (. beta. -maleimidopropoxy) succinimidyl ester, etc.) used is generally 0.5 to 80. mu.g/mm2The drug loading rate of the active drug (including, but not limited to, paclitaxel, rapamycin, zotarolimus, tacrolimus and/or CD34 antibody and the like) on the surface of the balloon is generally 0.5-20 mu g/mm2Finally, the total content of the drug on the surface of the balloon is 1-100 mu g/mm2In the meantime.
Furthermore, the coating layer of the blood vessel forming drug is composed of the blood vessel forming drug or the blood vessel forming drug and a carrier, wherein the blood vessel forming drug can be activated under the illumination of the absorption wavelength of 400-500nm and is connected with the broken collagen fiber through a covalent bond.
Still further, the angiogenic drugs include, but are not limited to, 4-amino-1, 8-naphthalimide, N-5-azido-2-nitrobenzoyloxysuccinimide, N- (. beta. -maleimidopropoxy) succinimide ester, N- [ e-maleimidoacetoxy ] succinimide ester, N- [ gamma-maleimidobutyryloxy ] succinimide, succinimidyl-6- (3- [ 2-pyridyldithio ] -propionamido) acetate, m-maleimidobenzoyl-N-hydroxysuccinimide ester, 3- [ 2-pyridyldithio ] propionohydrazide, N-succinimidobromoacetate, N-succinimidoiodoacetate, N-succinimido-N-acetyloxy-succinimidyl ester, N-maleimido-N-hydroxysuccinimide ester, N-maleimido-N-acetyloxy-succinimidyl ester, N- [ 2-pyridyldithio ] -propionyloxy-N-succinimidyl-acetate, N-succinimidyl-iodoacetate, N-maleimido-N-acetyloxy-succinimidyl ester, N-maleimido-acetyloxy-succinimidyl ester, N-maleimido-6-succinimidyl ester, N-2-maleimido-acylimino-N-acylimino-acyloxy-N-acylimino-acylic-ester, N-acylimino-acylic acid, and, N-sulfosuccinimidyl iodoacetate, succinimidyl-4- [ N-maleimidomethyl ] cyclohexane-1-carboxylate, N-succinimidyl 4- [ 4-maleimidophenyl ] butyrate, succinimide-6- [ beta-maleimidopropionamido ] acetate, N-succinimidyl 3- [ 2-pyridyldithio ] -propionate, sulfosuccinimidyl 6- (3 ' - [ 2-pyridyldithio ] -propionamido) hexanoate, m-maleimidobenzoyl-N-hydroxysulfosuccinimidyl ester, N-sulfosuccinimidyl-6- [4 ' -azido-2 ' -nitrophenylamino ] hexanoate, N-sulfosuccinimide-4- [4 ' -maleimidomethyl ] hexanoate, N-maleimidomethyl ] propionate, N-6- [4 ' -maleimidomethyl ] propionate, N-2 ' -maleimidomethyl ] propionate, N-succinimidyl 6- [2 ' -maleimidomethyl ] propionate, N-imidomethyl ] propionate, N-6- [2 ' -maleimidomethyl ] propionate, N-maleimido-6- [2 ' -pyridimidomethyl ] propionate, N-propionamido ] propionate, and mixtures thereof, Or one or more of sulfosuccinimidyl-4- [ N-maleimidomethyl ] cyclohexane-1-carboxylic acid and structural analogues thereof.
Further, the active drug coating is composed of an active drug or the active drug and a carrier, wherein the active drug is a drug for promoting endothelial cell repair and regeneration and/or a drug for inhibiting tissue regeneration.
Furthermore, the active drug is one or more of paclitaxel, rapamycin, zotarolimus, tacrolimus, everolimus, temsirolimus, azolsirolimus, bisolimus, docetaxel, albumin-bound paclitaxel or dexamethasone, or derivatives of the above drugs, monoclonal antibodies, polyclonal antibodies, animal antibodies or human antibodies with the function of recognizing and adsorbing endothelial progenitor cells, or antibody fragments with the function of recognizing and adsorbing endothelial progenitor cells.
In the above drug coating layer, optionally, the carrier may be one or more of succinyl chitosan, polyhydric alcohol, soybean lecithin, egg yolk lecithin, phosphatidylethanolamine, phosphatidylserine, phosphatidylglycerol, diphosphatidylglycerol, phosphatidylinositol, sphingomyelin, organic acid salt, laurocapram, urea, polyester substances, polyvinylpyrrolidone and derivatives thereof.
Further, the drug coating coated on the outer side of the balloon body is any one of the following structures:
the blood vessel forming medicine coating and the active medicine coating are respectively provided with one layer, and the blood vessel forming medicine coating is positioned on the inner side of the active medicine coating;
or the blood vessel forming medicine coating and the active medicine coating are both provided with one layer, and the blood vessel forming medicine coating is positioned on the outer side of the active medicine coating;
or the blood vessel forming medicine coating is provided with two layers, the active medicine coating is provided with one layer, and the blood vessel forming medicine coating is respectively positioned on the inner side and the outer side of the active medicine coating.
Further, different medicine coatings on the outer side of the balloon body are in contact connection.
Furthermore, the center of the optical fiber guide wire is an optical fiber connected with a light source, and a hydrophilic coating is wrapped outside the optical fiber.
The second technical scheme of the invention provides a use method of a drug-coated balloon catheter assembly for promoting tissue repair and fiber connection, which comprises the following steps:
(1) delivering the balloon body to the vascular lesion part along the PTCA guide wire;
(2) expanding the balloon body until the drug coating coated on the outer surface of the balloon body contacts the vessel wall;
(3) releasing the balloon body, removing the original PTCA guide wire, and feeding the optical fiber guide wire to the position of the balloon body through a catheter cavity in the balloon catheter;
(4) opening an external light source connected with the optical fiber guide wire after the balloon body is expanded again, so that light is transmitted to the position of the balloon body along the optical fiber guide wire, and irradiating the blood vessel forming medicine coating to solidify the blood vessel forming medicine coating;
(5) and turning off the external light source, releasing the balloon body, and withdrawing the drug-coated balloon catheter assembly out of the body.
The angioplasty drug reaches a lesion part through a percutaneous intervention technology, after contacting with lesion tissues, the angioplasty drug is activated through optical fiber illumination in a guide wire and is stably connected with local collagen fibers through covalent bonds, the collagen fiber part which is damaged and broken by external force is quickly recovered to be normally arranged, the collagen fiber part is not easily washed away and lost after reperfusion, the stability is good, the elastic retraction of the lesion part can be prevented, and a supporting force is provided. The vessel is maintained in an expanded state without the implant.
The active drug coating of the invention can inhibit smooth muscle cell proliferation, prevent restenosis, and reduce restenosis in the stent; the endothelial progenitor cells in the blood flow are captured, the endothelial healing is promoted, the thrombus in the stent is reduced, and the endothelial repair function is promoted.
When the drug coating balloon reaches a target lesion part and is expanded to be in contact with the inner wall of a blood vessel, the drug can be quickly transferred to the tissue of the blood vessel wall from the surface of the balloon, and the repairing effect is quickly played.
Drawings
Fig. 1 is a cross-sectional schematic view of a balloon body of the present invention;
FIG. 2 is a schematic longitudinal sectional view of a drug coating applied to the surface of a balloon body;
FIG. 3 is a schematic structural view of a drug-coated balloon catheter assembly;
FIG. 4 is a schematic structural view of a fiber optic guidewire;
FIGS. 5 and 6 are the cytotoxicity evaluation of Human Umbilical Vein Endothelial Cells (HUVEC) in culture with different coating drugs;
FIGS. 7 and 8 evaluation of cytotoxic and antiproliferative effects of Human Aortic Smooth Muscle Cells (HASMCs) in different coated drug cultures;
the notation in the figure is:
1-balloon body, 2-balloon cavity, 3-inner layer angioplasty drug coating, 4-middle layer active drug coating, 5-outer layer angioplasty drug coating, 6-balloon catheter, 7-catheter cavity, 8-optical fiber guide wire, 9-hydrophilic coating.
Detailed Description
The invention is described in detail below with reference to the figures and specific embodiments. The present embodiment is implemented on the premise of the technical solution of the present invention, and a detailed implementation manner and a specific operation process are given, but the scope of the present invention is not limited to the following embodiments.
In the following embodiments or examples, unless otherwise specified, raw materials, functional components, or processing techniques are all conventional commercially available raw materials in the art, or conventional components or processing techniques in the art used for achieving the corresponding functions in the art.
A detailed description of the drug-coated balloon catheter assembly of the present invention will begin with.
In order to solve the problems of injury and fracture of collagen fibers on the inner wall of a blood vessel and elastic retraction of the blood vessel after balloon dilatation operation caused by existing balloon dilatation, the invention provides a drug-coated balloon catheter assembly for promoting tissue repair and fiber connection, the structure of which is shown in fig. 1 and 3, the drug-coated balloon catheter assembly comprises a balloon body 1, a balloon catheter 6 and an optical fiber guide wire 8, the balloon body 1 is connected with the balloon catheter 6, a catheter cavity 7 for the optical fiber guide wire 8 to pass through is further arranged in the balloon catheter 6, a drug coating is coated on the outer side of the balloon body 1, and the drug coating comprises an angioplasty drug coating and an active drug coating.
Specifically, when the angioplasty drug reaches a lesion part through a percutaneous intervention technology, after contacting with a lesion tissue, the angioplasty drug is activated through optical fiber illumination in a guide wire and is stably connected with local collagen fibers through covalent bonds, the collagen fiber part which is damaged and broken by external force is quickly restored to normal arrangement, and the angiogenesis drug is not easily washed away and lost after reperfusion, has good stability, can prevent the lesion part from elastic retraction, provides a supporting force, and maintains a blood vessel in an expansion state without an implant. Meanwhile, the active drug coating can inhibit smooth muscle cell proliferation, prevent restenosis and reduce restenosis in the stent; the endothelial progenitor cells in the blood flow are captured, the endothelial healing is promoted, the thrombus in the stent is reduced, and the endothelial repair function is promoted.
In some embodiments, the coating of the angioplasty drug is composed of the angioplasty drug, or the angioplasty drug and a carrier, wherein the angioplasty drug can be activated under the illumination of the absorption wavelength of 400-500nm and the broken collagen fibers are connected by covalent bonds.
More specifically, the angiogenic drug includes, but is not limited to, 4-amino-1, 8-naphthalimide, N-5-azido-2-nitrobenzoyloxysuccinimide, N- (. beta. -maleimidopropoxy) succinimide ester, N- [ e-maleimidoacetoxy ] succinimide ester, N- [ gamma-maleimidobutyryloxy ] succinimide, succinimidyl-6- (3- [ 2-pyridyldithio ] -propionamido) acetate, m-maleimidobenzoyl-N-hydroxysuccinimide ester, 3- [ 2-pyridyldithio ] propionohydrazide, N-succinimidobromoacetate, N-succinimidoiodoacetate, N-succinimido-N-acetyloxy-succinimidyl ester, N-maleimido-N-hydroxysuccinimide ester, N-maleimido-N-acetyloxy-succinimidyl ester, N- [ 2-pyridyldithio ] -propionyloxy ] succinimide ester, N-succinimidobromoacetate, N-succinimido-iodoacetate, N-maleimido-N-acetyloxy-succinimidyl ester, N-maleimido-acetyloxy-succinimidyl ester, N-maleimido-succinimidyl ester, N-2-maleimido-acetyloxy-succinimidyl ester, N-maleimido-acylimido-N-acylimido-acylimino, N-acylimido-acylic ester, N-acylimido-acylic acid, N-acylimido-acylic acid, N-acylic acid, and (or a-acylic acid, N-sulfosuccinimidyl iodoacetate, succinimidyl-4- [ N-maleimidomethyl ] cyclohexane-1-carboxylate, N-succinimidyl 4- [ 4-maleimidophenyl ] butyrate, succinimide-6- [ beta-maleimidopropionamido ] acetate, N-succinimidyl 3- [ 2-pyridyldithio ] -propionate, sulfosuccinimidyl 6- (3 ' - [ 2-pyridyldithio ] -propionamido) hexanoate, m-maleimidobenzoyl-N-hydroxysulfosuccinimidyl ester, N-sulfosuccinimidyl-6- [4 ' -azido-2 ' -nitrophenylamino ] hexanoate, N-sulfosuccinimide-4- [4 ' -maleimidomethyl ] hexanoate, N-maleimidomethyl ] propionate, N-6- [4 ' -maleimidomethyl ] propionate, N-2 ' -maleimidomethyl ] propionate, N-succinimidyl 6- [2 ' -maleimidomethyl ] propionate, N-imidomethyl ] propionate, N-6- [2 ' -maleimidomethyl ] propionate, N-maleimido-6- [2 ' -pyridimidomethyl ] propionate, N-propionamido ] propionate, and mixtures thereof, Or one or more of sulfosuccinimidyl-4- [ N-maleimidomethyl ] cyclohexane-1-carboxylic acid and structural analogues thereof. The medicines are all conventional commercial products in the field.
In some embodiments, the active drug coating is composed of an active drug, or an active drug and a carrier, wherein the active drug is an endothelial cell repair and regeneration promoting drug and/or a tissue regeneration inhibiting drug.
Furthermore, the active drug is one or more of paclitaxel, rapamycin, zotarolimus, tacrolimus, everolimus, temsirolimus, azolsirolimus, bisolimus, docetaxel, albumin-bound paclitaxel or dexamethasone, or derivatives of the above drugs, monoclonal antibodies, polyclonal antibodies, animal antibodies or human antibodies with the function of recognizing and adsorbing endothelial progenitor cells, or antibody fragments with the function of recognizing and adsorbing endothelial progenitor cells. Optionally, the endothelial progenitor cells are endothelial progenitor cells of CD133 positive antigen, CD34 positive antigen, CD117 positive antigen or VEGF positive antigen.
In some embodiments, in the above drug coating layer, the carrier may be one or more of succinyl chitosan, polyhydric alcohol, soybean lecithin, egg yolk lecithin, phosphatidylethanolamine, phosphatidylserine, phosphatidylglycerol, diphosphatidylglycerol, phosphatidylinositol, sphingomyelin, salts of organic acids, laurocapram, urea, polyesters, polyvinylpyrrolidone and derivatives thereof.
In some embodiments, the drug coating applied on the outside of the balloon body 1 is any one of the following structures:
the blood vessel forming medicine coating and the active medicine coating are respectively provided with one layer, and the blood vessel forming medicine coating is positioned on the inner side of the active medicine coating;
or the blood vessel forming medicine coating and the active medicine coating are both provided with one layer, and the blood vessel forming medicine coating is positioned on the outer side of the active medicine coating;
or the angioplasty drug coating is provided with two layers, the active drug coating is provided with one layer, and the angioplasty drug coating is respectively positioned at the inner side and the outer side of the active drug coating, please refer to fig. 2, where the inner side refers to the side close to the balloon body 1, and the outer side refers to the side far away from the balloon body 1.
In some embodiments, the contact connection between different drug coatings outside the balloon body 1.
In some embodiments, the drug coating may be applied to the surface of the balloon body 1 using a coating method including, but not limited to, ultrasonic spraying, repeated dropping, and the like.
In some embodiments, the balloon body 1 may be an existing balloon structure having a balloon cavity 2, including but not limited to, for expansion only, or having special functions such as freezing, ultrasound, cutting, etc.
In some embodiments, the center of the optical fiber guide wire 8 is an optical fiber connected to an external light source, and the optical fiber is wrapped with a hydrophilic coating 9, as shown in fig. 4.
The method of using the drug-coated balloon catheter assembly is described in detail below.
The invention also synchronously discloses a using method of the drug-coated balloon catheter assembly, which comprises the following steps:
(1) delivering the balloon body 1 to a vascular lesion part along a PTCA guide wire;
(2) expanding the balloon body 1 (including filling fluid through a catheter) until the drug coating coated on the outer surface of the balloon body 1 contacts the blood vessel wall;
(3) releasing the balloon body 1, removing the original PTCA guide wire, and feeding an optical fiber guide wire 8 to the position of the balloon body 1 through a catheter cavity 7 in the balloon catheter 6;
(4) opening an external light source connected with the optical fiber guide wire 8 after the balloon body 1 is expanded again, so that light is transmitted to the position of the balloon body 1 along the optical fiber guide wire 8, and irradiating the blood vessel forming medicine coating to be solidified;
(5) the external light source is turned off, the balloon body 1 is released, and the drug-coated balloon catheter assembly is withdrawn from the body.
The above embodiments are described in more detail below with reference to specific examples and the accompanying drawings.
The drug-coated balloon catheter assembly for promoting tissue repair and fiber connection used in the following embodiments is structurally shown in fig. 1 and fig. 3, and comprises a balloon body 1 with a balloon cavity 2, a balloon catheter 6 and an optical fiber guide wire 8, wherein the balloon body 1 is connected with the balloon catheter 6, a catheter cavity 7 for the optical fiber guide wire 8 to pass through is further arranged in the balloon catheter 6, a drug coating is coated on the outer side of the balloon body 1, the drug coating comprises an angioplasty drug coating and an active drug coating, and the drug coating coated on the outer side of the balloon body 1 is any one of the following structures: the blood vessel forming medicine coating and the active medicine coating are respectively provided with one layer, and the blood vessel forming medicine coating is positioned on the inner side of the active medicine coating; or the blood vessel forming medicine coating and the active medicine coating are both provided with one layer, and the blood vessel forming medicine coating is positioned on the outer side of the active medicine coating; or the blood vessel forming medicine coating is provided with two layers, the active medicine coating is provided with one layer, and the blood vessel forming medicine coating is respectively positioned at the inner side and the outer side of the active medicine coating, namely the whole medicine coating comprises an inner blood vessel forming medicine coating 3, a middle active medicine coating 4 and an outer blood vessel forming medicine coating 5, please refer to fig. 2, wherein the inner side refers to one side close to the balloon body 1, and the outer side refers to one side far away from the balloon body 1. The different medicine coatings on the outer side of the balloon body 1 are in contact connection. The center of the optical fiber guide wire 8 is an optical fiber connected with an external light source, and the outside of the optical fiber is wrapped with a hydrophilic coating 9, please refer to fig. 4 again.
Example 1
S1: 4-amino-1, 8-naphthalimide with the concentration of 8mM is used as an angioplastic drug, succinyl chitosan is used as a carrier of the coating of the angioplastic drug, specifically, 2g of chitosan is dissolved in 40ml of 8% (wt) acetic acid, 160ml of ethanol is used for dissolving, and 1.4g of succinic anhydride dissolved in 50ml of acetone is added to obtain the succinyl chitosan carrier. Crosslinking the succinyl chitosan carrier with 4-amino-1, 8-naphthalimide using carbodiimide (refer to U.S. Pat. No.9,822,189b2) to obtain 4-amino-1, 8-naphthalimide angioplastic drug coating solution;
s2: taking paclitaxel as an active drug, mixing paclitaxel and PEG1000 according to a mass ratio of 4:1 to serve as solutes, and dissolving 1g of the solutes in 50ml of ethanol to obtain a paclitaxel active drug coating solution;
s3: carrying out medicine spraying operation in a hundred-grade clean environment after folding a freezing balloon catheter containing a cooling device in a ten-thousand-grade clean environment;
s4: the coating solution of the angioplasty drug is sprayed on the preset area of the angioplasty drug coating on the surface of the freezing balloon catheter (namely the preset area of the outer surface of the balloon body), and the coating amount of the embodiment is controlled to be 30 mug/mm2Drying to obtain an angioplastic drug layer;
s5: the paclitaxel active drug coating solution was sprayed to a predetermined region of the active drug coating on the surface of the balloon catheter (the coating amount in this example was 10 μ g/mm)2) Drying to obtain an active drug coating, wherein the active drug coating is positioned on the surface of the dried active drug coating;
s6: dried, ethylene oxide sterilized and packaged to give drug coated balloons as provided in this example.
Example 2
S1: 4-amino-1, 8-naphthalimide with the concentration of 8mM is used as an angioplastic drug, and succinyl chitosan is used as a coating carrier of the angioplastic drug. 2g of chitosan was dissolved in 40ml of 8% (wt) acetic acid, and dissolved using 160ml of ethanol, and 1.4g of succinic anhydride dissolved in 50ml of acetone was added to obtain a succinyl chitosan carrier. Crosslinking the succinyl chitosan carrier with 4-amino-1, 8-naphthalimide using carbodiimide (refer to U.S. Pat. No.9,822,189b2) to obtain 4-amino-1, 8-naphthalimide angioplastic drug coating solution;
s2: preparing a coating solution (refer to CN102648988A) of the CD34 antibody active drug by taking the CD34 antibody as the active drug, wherein the total dosage of the antibody is about 100 mu g;
s3: after the balloon catheter is cut into the flap in a ten-thousand-grade clean environment, carrying out medicine spraying operation in a hundred-grade clean environment;
s4: the CD34 antibody active drug coating solution is sprayed on the predetermined area of the active drug coating on the surface of the balloon catheter (namely the predetermined area of the outer surface of the balloon body, the coating amount of the embodiment is controlled to be 10 mug/mm2) Drying to obtain a CD34 antibody active drug coating;
s5: the vasoactive drug coating solution was sprayed to the predetermined region of the angioplasty drug coating on the surface of the balloon catheter (the coating amount in this example was 10. mu.g/mm)2) Drying to obtain an angioplastic drug coating, wherein the angioplastic drug coating is positioned on the surface of the dried active drug coating;
s6: dried, ethylene oxide sterilized and packaged to give drug coated balloons as provided in this example.
Example 3
S1: using the drug coated balloon of example 1 above over a PTCA guidewire into a coronary target lesion of the heart;
s2: starting a balloon freezing system, and completing balloon expansion, drug adherence and target lesion freezing treatment at a lesion, wherein the surface temperature of the freezing balloon is generally controlled to be-5 ℃ to-20 ℃, and the freezing time is controlled to be 30s to 120s as required;
s3: after the saccule is reheated, releasing the saccule, removing the original PTCA guide wire, and feeding the optical fiber guide wire to the far end of the saccule (namely, in the saccule body) along the catheter cavity;
s4: opening a blue light source of 400-500nm after the saccule is expanded again, so that light is transmitted to the saccule part at the head end along the pipeline, and irradiating the blood vessel forming medicine coating to enable the blood vessel forming medicine coating to be solidified quickly;
s5: the light source is turned off, the balloon is released and the product system is withdrawn from the body along the guide catheter.
Example 4
S1: using the drug coated balloon of example 2 above over a PTCA guidewire into a coronary target lesion of the heart;
s2: introducing a fluid filling balloon into the catheter to make the balloon contact with the wall of the blood vessel after being inflated, wherein the introduced fluid is normal saline;
s3: starting an ultrasonic control generator to send out ultrasonic waves, so that the ultrasonic waves act on a target lesion part; the working frequency of the ultrasonic control generator is within a range of 15K-3 MHz, the working voltage is 300-600V, and the ultrasonic wave has good safety to human bodies during working;
s4: after the shock wave is finished, releasing the balloon, removing the original PTCA guide wire, and feeding the product guide wire containing the optical fiber to the far end of the balloon;
the subsequent operation was the same as in example 3.
Example 5:
in vitro testing
Materials (I) and (II)
The in vitro test was conducted to examine the cytotoxicity and antiproliferative ability of the drug coated in the above examples 1-2 and comparative examples.
Secondly, a detection method comprises the following steps:
human Umbilical Vein Endothelial Cells (HUVEC) and Human Aortic Smooth Muscle Cells (HASMC) cultured to logarithmic growth phase were divided into a control group, a comparative example drug-coated drug-dried group, and a composite drug-dried group. After drug treatment and 24 hours of culture, CCK-8 was used for cell proliferation assay to determine drug cytotoxicity and antiproliferative effects.
Cell culture conditions: complete medium special for HUVEC and HASMC, 5% CO at 37 DEG C2Culturing
Adding chemicals for treatment: the control group was not added, the control drug-coated drug dry run group was cultured in a dedicated complete medium plus Paclitaxel (Paclitaxel) 1. mu.M, and the composite drug dry run group was cultured in a dedicated complete medium plus Paclitaxel 1. mu.M plus 4-amino-1, 8-naphthalimide angioplasty drug (20. mu.M) coating solution (4-ANI).
And (3) CCK-8 detection: after 24h of cell-dosing culture, 10. mu.l of CCK8 solution was added to each cell culture well and absorbance at 450nm was measured with a microplate reader as a baseline reading. The plates were incubated in the incubator for 0.5 hours and absorbance at 450nm was again measured with the microplate reader as the final reading. The difference between the two is the relative cell proliferation.
Third, experimental results
As can be seen from FIGS. 5 to 6, compared with the drug intervention group of the drug coating of the comparative example, the intervention of the composite drug coating has no obvious influence on the cytotoxicity of endothelial cells and has good safety; as can be seen from fig. 7 to 8, compared with the drug intervention group of the coating of the comparative example drug, the inhibition effect of the antiproliferative drug on smooth muscle cells is not weakened after the compound angioplastic drug is used, and the anti-proliferative effect is good.
Comparative example 1:
s1: taking paclitaxel as an active drug, mixing paclitaxel and PEG1000 according to a mass ratio of 4:1 to serve as solutes, and dissolving 1g of the solutes in 50ml of ethanol to obtain a paclitaxel active drug coating solution;
s2: carrying out drug spraying operation in a hundred-grade clean environment after folding a freezing balloon catheter containing a cooling device in a ten-thousand-grade clean environment, and drying to obtain a paclitaxel active drug coating;
s3: drying, ethylene oxide sterilization and packaging to obtain the freezing balloon catheter provided in the comparative example (the coating amount is 10 mug/mm) with the surface only coated with the paclitaxel active drug2)。
S4: using the freezing saccule only coated with the paclitaxel active drug to enter the target lesion part of the coronary artery of the heart along the PTCA guide wire;
s5: starting a balloon freezing system to complete balloon expansion, drug adherence and target lesion freezing treatment; wherein the surface temperature of the freezing saccule is-5 ℃ to-20 ℃, and the freezing time is 30s to 120 s;
s6: after the saccule is rewarming, the saccule is released and the product system is withdrawn from the body along the guide catheter.
Comparative example 2:
s1: preparing a coating solution (refer to CN102648988A) of the CD34 antibody active drug by taking the CD34 antibody as the active drug, wherein the total dosage of the antibody is about 100 mu g;
s2: after the balloon catheter is cut into the flap in a ten-thousand-grade clean environment, carrying out medicine spraying operation in a hundred-grade clean environment;
s3: the CD34 antibody active drug coating solution is sprayed on the surface of the balloon catheter (the coating amount is 10 mu g/mm)2) Drying to obtain a CD34 antibody active drug coating;
s4: dried, ethylene oxide sterilized and packaged to give drug coated balloons coated with only CD34 antibody active drug as provided in this comparative example.
S5: the drug-coated balloon enters a target lesion part of a coronary artery of a heart along a PTCA guide wire, and fluid filling balloon is introduced into a guide tube to be attached to the wall of the blood vessel after being expanded, wherein the introduced fluid is usually physiological saline;
s6: starting an ultrasonic control generator to send out ultrasonic waves, so that the ultrasonic waves act on a target lesion part; the working frequency of the ultrasonic control generator is within a range of 15K-3 MHz, the working voltage is 300-600V, and the ultrasonic wave has good safety to human bodies during working;
s7: after the shock wave is finished, the saccule is released and the product system is withdrawn from the body along the guide catheter.
In comparative examples 1 and 2 described above, most of them were the same as in examples 1 and 2 except that the drug-coated balloon was used in which the coating of the angioplasty drug coating was omitted, that is, with reference to examples 1 and 2, only the active drug coating was applied to the surface of the balloon body. The data of example 5 show that the present invention does not add additional steps to the clinical application process, but compared to the comparative example, it provides immediate support and lumen area access to the treated vessel, facilitating the long-term repair of the vessel and inhibiting remodeling.
The embodiments described above are described to facilitate an understanding and use of the invention by those skilled in the art. It will be readily apparent to those skilled in the art that various modifications to these embodiments may be made, and the generic principles described herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present invention is not limited to the above embodiments, and those skilled in the art should make improvements and modifications within the scope of the present invention based on the disclosure of the present invention.
Claims (10)
1. A drug-coated balloon catheter assembly for promoting tissue repair and fiber connection is characterized by comprising a balloon body, a balloon catheter and an optical fiber guide wire, wherein the balloon body is connected with the balloon catheter, a catheter cavity for the optical fiber guide wire to penetrate through is further arranged in the balloon catheter, a drug coating is coated on the outer side of the balloon body, and the drug coating comprises an angioplasty drug coating and an active drug coating.
2. The drug-coated balloon catheter assembly for promoting tissue repair and fiber attachment of claim 1, wherein the angioplasty drug coating is composed of an angioplasty drug or an angioplasty drug and a carrier, wherein the angioplasty drug can be activated under the illumination of light with absorption wavelength of 400 nm and 500nm and can be attached to the broken collagen fibers by covalent bonds.
3. The drug-coated balloon catheter assembly for promoting tissue repair and fiber attachment of claim 2, wherein said angioplasty drug is 4-amino-1, 8-naphthalimide, N-5-azido-2-nitrobenzoyloxy succinimide, N- (. beta. -maleimidopropoxy) succinimide ester, N- [ e-maleimidoacetoxy ] succinimide ester, N- [ gamma-maleimidobutyryloxy ] succinimide, succinimido-6- (3- [ 2-pyridyldithio ] -propionamido) acetate, m-maleimidobenzoyl-N-hydroxysuccinimide ester, 3- [ 2-pyridyldithio ] propionohydrazide, N-maleimido-propylhydrazide, N-Succinimidyl bromoacetate, N-Succinimidyl iodoacetate, Succinimidyl-4- [ N-maleimidomethyl ] cyclohexane-1-carboxylate, N-Succinimidyl 4- [ 4-maleimidophenyl ] butyrate, Succinimidyl-6- [ beta-maleimidopropionamido ] acetate, N-Succinimidyl 3- [ 2-pyridyldithio ] -propionate, Succinimidyl 6- (3 ' - [ 2-pyridyldithio ] -propionamido) hexanoate, M-maleimidobenzoyl-N-hydroxysulfosuccinimidyl ester, N-Succinimidyl-6- [4 ' -azido-2 ' - One or more of nitrophenylamino caproate, or sulfosuccinimidyl-4- [ N-maleimidomethyl ] cyclohexane-1-carboxylic acid and structural analogs thereof.
4. The drug-coated balloon catheter assembly for promoting tissue repair and fiber attachment of claim 1, wherein the active drug coating is composed of an active drug or an active drug and a carrier, wherein the active drug is an endothelial cell repair and regeneration promoting drug and/or a tissue regeneration inhibiting drug.
5. The drug-coated balloon catheter assembly for promoting tissue repair and fiber attachment according to claim 4, wherein the active drug is one or more of paclitaxel, rapamycin, zotarolimus, tacrolimus, everolimus, temsirolimus, zotarolimus, bisolimus, docetaxel, albumin-bound paclitaxel or dexamethasone, or derivatives thereof, monoclonal antibodies, polyclonal antibodies, animal antibodies or human antibodies having the function of recognizing and adsorbing endothelial progenitor cells, or antibody fragments having the function of recognizing and adsorbing endothelial progenitor cells.
6. The drug-coated balloon catheter assembly for promoting tissue repair and fiber attachment according to claim 2 or 4, wherein the carrier is one or more of succinyl chitosan, polyhydric alcohol, soybean lecithin, egg yolk lecithin, phosphatidylethanolamine, phosphatidylserine, phosphatidylglycerol, diphosphatidylglycerol, phosphatidylinositol, sphingomyelin, organic acid salts, laurocapram, urea, polyester substances, polyvinylpyrrolidone and derivatives thereof.
7. A drug-coated balloon catheter assembly for promoting tissue repair and fiber attachment as claimed in claim 1, wherein the drug coating applied to the outside of the balloon body is any one of the following structures:
the blood vessel forming medicine coating and the active medicine coating are respectively provided with one layer, and the blood vessel forming medicine coating is positioned on the inner side of the active medicine coating;
or the blood vessel forming medicine coating and the active medicine coating are both provided with one layer, and the blood vessel forming medicine coating is positioned on the outer side of the active medicine coating;
or the blood vessel forming medicine coating is provided with two layers, the active medicine coating is provided with one layer, and the blood vessel forming medicine coating is respectively positioned on the inner side and the outer side of the active medicine coating.
8. A drug-coated balloon catheter assembly for facilitating tissue repair and fiber attachment as claimed in claim 1 wherein the contact connection between different drug coatings on the outside of the balloon body.
9. The drug-coated balloon catheter assembly for promoting tissue repair and fiber attachment of claim 1, wherein the center of the optical fiber guide wire is an optical fiber connected to a light source, and the optical fiber is coated with a hydrophilic coating.
10. A method of using a drug-coated balloon catheter assembly to facilitate tissue repair and fiber attachment according to claim 1, comprising the steps of:
(1) delivering the balloon body to the vascular lesion part along the PTCA guide wire;
(2) expanding the balloon body until the drug coating coated on the outer surface of the balloon body contacts the vessel wall;
(3) releasing the balloon body, removing the original PTCA guide wire, and feeding the optical fiber guide wire to the position of the balloon body through a catheter cavity in the balloon catheter;
(4) opening an external light source connected with the optical fiber guide wire after the balloon body is expanded again, so that light is transmitted to the position of the balloon body along the optical fiber guide wire, and irradiating the blood vessel forming medicine coating to solidify the blood vessel forming medicine coating;
(5) and turning off the external light source, releasing the balloon body, and withdrawing the drug-coated balloon catheter assembly out of the body.
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| CN114931695A (en) * | 2022-05-11 | 2022-08-23 | 上海玮沐医疗科技有限公司 | Shock wave balloon catheter device with photocuring coating |
| CN115920139A (en) * | 2022-11-25 | 2023-04-07 | 杭州矩正医疗科技有限公司 | Photodynamic balloon catheter system |
| WO2024045982A1 (en) * | 2022-09-02 | 2024-03-07 | 杭州矩正医疗科技有限公司 | Drug carrier balloon catheter and method for preparing same, balloon catheter system, and method for intravascular in-situ stent generation |
| CN118161730A (en) * | 2024-05-13 | 2024-06-11 | 鼎科医疗技术（苏州）有限公司 | Medicine balloon catheter and preparation method of coating thereof |
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