阅读说明：本技术 一种药物球囊保护套管、包含其的药物球囊组件 (Medicine balloon protection sleeve and medicine balloon assembly comprising same ) 是由 刘振全 夏佩佩 邢若豪 于 2019-12-03 设计创作，主要内容包括：本发明提供了一种药物球囊保护套管、包含其的药物球囊组件,包括内层套管和外层套管,所述内层套管沿其轴向设置有两个对称的第一切口或者所述内层套管由缠绕于药物球囊外部的带状结构形成。本发明提供的药物球囊保护套管一方面可以保护球囊折翼不散落,也可以保护球囊以及球囊表面的药物不受损伤；另外一方面可以避免在安装或取下保护套管时,因摩擦而导致的药物损失。(The invention provides a medicine balloon protective sleeve and a medicine balloon assembly comprising the same. The drug balloon protective sleeve provided by the invention can protect balloon flaps from scattering on one hand, and can also protect the balloon and drugs on the surface of the balloon from being damaged; on the other hand, the loss of medicine due to friction when the protective sleeve is installed or removed can be avoided.)

1. The drug balloon protective sleeve is characterized by comprising an inner sleeve and an outer sleeve, wherein the inner sleeve is provided with two symmetrical first incisions along the axial direction of the inner sleeve or the inner sleeve is formed by a strip-shaped structure wound outside the drug balloon.

2. A drug balloon protective sleeve according to claim 1, wherein the difference between the length of the inner sleeve and the length of the first incision in the axial direction of the inner sleeve is 5-100 mm.

3. A drug balloon protective sleeve according to claim 1 or 2, wherein the outer sleeve is provided with a second cut along its axial direction or at a predetermined angle with respect to its axial direction;

preferably, the preset included angle is less than or equal to 75 degrees.

4. A drug balloon protective sleeve according to any one of claims 1-3, wherein the inner diameter of the outer sleeve is smaller than the outer diameter of the inner sleeve;

preferably, the inner diameter of the outer sleeve is 0.01-5mm smaller than the outer diameter of the inner sleeve.

5. A drug balloon protective sleeve according to any one of claims 1-4, wherein the length of the inner sleeve is longer than the length of the outer sleeve in the axial direction of the inner sleeve;

preferably, the length of the inner sleeve is 10-50mm longer than the length of the outer sleeve.

6. A drug balloon protective sleeve according to any one of claims 1-5, wherein the outer sleeve is of a circular or polygonal cylindrical structure, the central hole of the outer sleeve being a circular or polygonal hole;

preferably, the inner casing is a circular or polygonal columnar structure, and the central hole of the inner casing is a circular or polygonal hole;

preferably, the material of the outer sleeve and the material of the inner sleeve are respectively and independently selected from one or a combination of at least two of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyethylene, polyimide, polyformaldehyde, nylon, polyurethane or polyester.

7. A drug balloon assembly comprising a drug balloon and a drug balloon protective sleeve according to any one of claims 1-6 positioned outside the drug balloon.

8. The drag balloon assembly of claim 7, wherein the drag comprises any one or a combination of at least two of an anti-inflammatory drug, an anti-infective drug, a scar-inhibiting drug, an anti-adhesion anti-scarring drug, a macrolide antibiotic, or an aminoglycoside antibiotic selected from the group consisting of aspirin, salicylic acid, sodium salicylate, magnesium salicylate, diflunisal, salsalate, ibuprofen, indomethacin, flurbiprofen, phenoxyibuprofen, naproxen, piroxicam, phenylbutazone, fenbufen, carprofen, ketoprofen, diclofenac, ketorolac, tetrafluorofenamic acid, sulindac, tolmetin, celecoxib, streptomycin, gentamicin, kanamycin, sisomicin, tobramycin, amikacin, netilmicin, nebivy, isepamicin, puromycin, micronomicin, paromomycin, and the like, Neomycin, aspartame, glucocorticoids, triamcinolone acetonide, dexamethasone, betamethasone, cortisone, hydrocortisone, mometasone furoate, rimexolone, prednisone, prednisolone, methylprednisolone, triamcinolone, budesonide, beclomethasone dipropionate, fluticasone propionate, ciclesonide, fluocinolone acetonide, clorsulone, halometasone, diflorodiorosone, halomethasone, fluocinolone acetonide and derivatives thereof, erythromycin and derivatives thereof, azithromycin, midecamycin and derivatives thereof, spiramycin and derivatives thereof, acetylspiramycin, tacrolimus, sirolimus, everolimus, amphotericin B, pentamycin, fidaxomicin, telithromycin, mitomycin, rapamycin, mometasone furoate, mitomycin, dexamethasone, cyclosporin A, berberine hydrochloride, paclitaxel, docetaxel, vinorelbine, berbamine, doxycycline, Elemene or enalapril or the combination of at least two of them;

preferably, the balloon is folded into 3-8 wings.

9. A drug balloon assembly according to claim 7 or 8, wherein the inner diameter of the inner sleeve of the drug balloon protective sleeve is smaller than the outer diameter of the balloon after being crimped;

preferably, the inner diameter of the inner sleeve is 0.01-5mm smaller than the outer diameter of the rolled balloon.

10. The drug balloon assembly of any of claims 7-9, wherein an outer sleeve of the drug balloon protective sleeve has a length greater than a length of the drug balloon;

preferably, the drug balloon is positioned in a lumen formed by the first incision arranged on the inner layer sleeve, and the inner layer sleeve exceeds the proximal end of the drug balloon by 10-40mm in the axial direction of the inner layer sleeve;

preferably, the inner sheath includes a portion not provided with a first incision, the portion not provided with a first incision being located at a distal end of the drug balloon;

preferably, the outer sleeve is sleeved on the inner sleeve and covers the drug balloon.

Technical Field

The invention belongs to the technical field of medical instruments, and relates to a drug balloon protective sleeve and a drug balloon assembly comprising the same.

Background

The medicine balloon is a new means for intracavity treatment in recent years, and is a technology for coating medicine on the surface of the balloon, expanding the balloon by pressurizing when the balloon reaches pathological changes, contacting with an inner membrane of a cavity and applying pressure to quickly release and transfer the medicine to the inner membrane wall of the cavity, so that the treatment effect is achieved by short-term exposure of the medicine.

The prior medicine saccule is sleeved with a protective sleeve to protect the saccule and prevent the saccule and a medicine coating on the surface of the saccule from being damaged in the transportation process, the prior general production method is to fold the saccule into 3/4/5/6/7 or 8 wings, then to roll and hold the wings tightly, and to sleeve a tubular protective sleeve with a certain inner diameter on the surface of the saccule. Because the balloon is folded and rolled, if the wing pieces are not restrained, the wing pieces can be scattered after the balloon is placed for a period of time, and the corresponding outer diameter can be increased. The disadvantage of this method is that the loss of drug due to friction with the protective sheath during installation and removal of the protective sheath is uncontrolled and affects the final drug content on the balloon surface and thus the therapeutic effect.

CN209361621U discloses a drug balloon, which comprises a balloon body and a coating, wherein the coating comprises a drug layer and a protective layer; the medicine layer covers on the balloon body, and the protective layer covers outside the medicine layer and is used for protecting the medicine on the medicine layer from being washed away by blood. Although the medicine balloon provided by the patent is provided with the protective layer, the loss of the medicine can be avoided, and the protective layer can take away part of the medicine in the process of falling off due to impact, so that the loss of the dosage is caused. CN206325106U discloses a medicine balloon catheter, which comprises a needle seat, a catheter part, a balloon and a catheter tip sequentially connected from a proximal end to a distal end, and further comprises a protective sleeve arranged outside the balloon, the protective sleeve covers the balloon, and a plurality of axial incisions are arranged on the circumferential side of the protective sleeve. The medicine balloon of this patent has better penetrability, but has certain hole between its protective sheath and the balloon, and leads to unable sufficient binding power to balloon production, and the balloon flap can scatter.

Therefore, there is a need to develop a protective sleeve for a drug balloon, which can prevent the balloon and the drug coating on the surface of the balloon from being damaged, and can prevent the protective sleeve from wearing the drug balloon.

Disclosure of Invention

The invention aims to provide a medicine balloon protective sleeve and a medicine balloon assembly comprising the same. The drug balloon protective sleeve provided by the invention can protect balloon flaps from scattering on one hand, and can also protect the balloon and drugs on the surface of the balloon from being damaged; on the other hand, the loss of medicine due to friction when the protective sleeve is installed or removed can be avoided.

In order to achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, the invention provides a drug balloon protection sleeve, which comprises an inner sleeve and an outer sleeve, wherein the inner sleeve is provided with two symmetrical first cuts along the axial direction of the inner sleeve or the inner sleeve is formed by a belt-shaped structure wound outside a drug balloon.

In the invention, the outer layer sleeve is bound to the inner layer sleeve, the inner layer sleeve is bound to the drug balloon, the outer diameter of the drug balloon after being folded can be reduced, and the inner layer sleeve naturally falls off and does not generate friction to the drug balloon when the outer layer sleeve is removed by arranging the symmetrical first cut or arranging the winding belt-shaped structure, so that the drug loss caused by friction during installation or disassembly is avoided.

In the present invention, the difference between the length of the inner sleeve and the length of the second incision in the axial direction of the inner sleeve is 5-100mm, such as 10mm, 20mm, 40mm, 50mm, 60mm, 80mm, 90mm, etc.

For convenience of use, the first incision is provided not to completely bifurcate the inner sleeve, but to leave an uncut portion of 5-100mm at one end, as shown in fig. 1.

Preferably, the outer sleeve is provided with a first notch along the axial direction or forming a preset included angle with the axial direction.

Preferably, the preset included angle is less than or equal to 75 degrees, such as 70 degrees, 60 degrees, 50 degrees, 40 degrees, 30 degrees, 20 degrees, 10 degrees and the like.

A notch is arranged along the axial direction of the sleeve, and the outer sleeve is completely spread to form a rectangle; if the angle is a certain angle with the axial direction, the completely spread parallelogram is formed.

Preferably, the inner diameter of the outer sleeve is smaller than the outer diameter of the inner sleeve.

In order to bind the outer sleeve to the inner sleeve, the inner diameter of the outer sleeve is slightly smaller than the outer diameter of the inner sleeve.

Preferably, the inner diameter of the outer sleeve is 0.01-5mm smaller than the outer diameter of the inner sleeve, e.g. 0.05mm, 0.1mm, 0.5mm, 1.0mm, 2mm, 3mm, 4mm, etc.

Preferably, the length of the inner sleeve is longer than the length of the outer sleeve in the axial direction of the inner sleeve.

Preferably, the length of the inner sleeve is 10-50mm longer than the length of the outer sleeve, e.g. 15mm, 20mm, 30mm, 40mm, etc.

Through setting up that the length of inlayer sleeve pipe is longer than outer sheathed tube, then when getting rid of protective case, can fix the inlayer sleeve pipe and get rid of outer sleeve pipe to produce the friction with the medicine sacculus in order to prevent that the medicine is impaired because of the friction.

Preferably, the outer casing is a circular or polygonal columnar structure, and the central hole of the outer casing is a circular or polygonal hole.

Preferably, the inner casing is a circular or polygonal columnar structure, and the central hole of the inner casing is a circular or polygonal hole.

Preferably, the material of the outer sleeve and the inner sleeve is independently selected from one or a combination of at least two of Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), polyethylene, polyimide, Polyoxymethylene (POM), nylon, polyurethane or polyester.

In a second aspect, the present invention provides a drug balloon assembly comprising a drug balloon and a drug balloon protective sleeve of the first aspect positioned outside the drug balloon.

Preferably, the drug comprises any one or a combination of at least two of an anti-inflammatory drug, an anti-infective drug, a scar-inhibiting drug, an anti-adhesion and anti-scarring drug, a macrolide antibiotic or an aminoglycoside antibiotic selected from the group consisting of aspirin, salicylic acid, sodium salicylate, magnesium salicylate, diflunisal, salsalate, ibuprofen, indomethacin, flurbiprofen, phenoxyibuprofen, naproxen, piroxicam, phenylbutazone, fenprofen, fenbufen, carprofen, ketoprofen, diclofenac, ketorolac, tetrafluorofenamic acid, sulindac, tolmetin, celecoxib, streptomycin, gentamycin, kanamycin, sisomicin, tobramycin, amikacin, netilmicin, linopirox, ispamixin, liromycin, micronomicin, paromomycin, neomycin, aspartame, glucocorticoids, triamcinolone acetonide, and the like, Dexamethasone, betamethasone, cortisone, hydrocortisone, mometasone furoate, rimexolone, prednisone, prednisolone, methylprednisolone, triamcinolone, budesonide, beclomethasone dipropionate, fluticasone propionate, ciclesonide, fluocinolone, clobetasone, halometasone, difloron diacetate, halomethasone, fluocinolone acetonide and its derivatives, erythromycin and its derivatives, azithromycin, any one or combination of at least two of midecamycin and derivatives thereof, spiramycin and derivatives thereof, acetyl spiramycin, tacrolimus, sirolimus, everolimus, amphotericin B, pentamycin, fidaxomicin, telithromycin, mitomycin, rapamycin, mometasone furoate, mitomycin, dexamethasone, cyclosporine A, berberine hydrochloride, paclitaxel, docetaxel, vinorelbine, elemene or enalapril.

Preferably, the balloon is folded into 3-8 wings, such as 4 wings, 5 wings, 6 wings, 7 wings, and the like.

The preparation method of the drug balloon is a preparation method commonly used in the prior art, and the preparation method comprises the following steps: folding and rolling the balloon catheter; adding an active drug, an excipient, an adhesive and the like into a solvent, dissolving the drug to obtain an active drug solution, wherein the concentration of the active drug solution in the drug solution is 15mg/mL, spraying the drug solution on the surface of the balloon by adopting a spraying mode, and drying at 35 ℃ for 5min to obtain the rolled drug balloon. The excipient and the binder used in the invention are all conventional auxiliary agents used in the field, for example, the excipient is commonly used with iopromide, and the binder is commonly used with polyvinyl alcohol.

In the invention, the inner diameter of the inner sleeve of the drug balloon protective sleeve is smaller than the outer diameter of the rolled balloon.

Preferably, the inner diameter of the inner sleeve is 0.01-5mm smaller than the outer diameter of the crimped balloon, such as 0.05mm, 0.1mm, 0.5mm, 1.0mm, 2mm, 3mm, 4mm, etc.

Preferably, the length of the outer sleeve of the drug balloon protective sleeve is greater than the length of the drug balloon.

Preferably, the drug balloon is located in the lumen formed by the first incision provided by the inner sleeve, and the inner sleeve is 10-40mm, such as 15mm, 20mm, 30mm, 35mm, etc., beyond the proximal end of the drug balloon in the axial direction of the inner sleeve.

Preferably, the inner sheath includes a portion not provided with a first incision, the portion not provided with a first incision being located at a distal end of the drug balloon.

The far end is the end far away from an operator when the handheld medicine balloon component is operated.

Preferably, the outer sleeve is sleeved on the inner sleeve and covers the drug balloon.

In the actual preparation process, the inner layer sleeve is covered on the surface of the drug balloon, and the non-incision part is positioned at the far end (the end far away from an operator in the actual operation) of the balloon and does not contact the balloon; the lumen formed by the incision covers the entire length of the balloon, ensuring that the entire balloon is within the length of the incision while the incised portion extends 10-40mm beyond the proximal end of the balloon.

The inner sleeve beyond the proximal end of the balloon was then manually fixed and the outer sleeve was sleeved from the uncut inner sleeve portion so that the outer sleeve covered the entire length of the balloon while not covering the inner sleeve portion beyond the proximal end of the balloon, resulting in a drug balloon assembly.

When the protective sleeve is used, the part, which is not covered, of the inner sleeve exceeding the proximal end of the balloon is fixed by hands, the outer sleeve is removed towards the distal direction, after the outer sleeve is removed, the inner sleeve naturally separates due to the loss of constraint and breaks away from the surface of the balloon, and the protective sleeve is removed.

Compared with the prior art, the invention has the following beneficial effects:

in the invention, the outer layer sleeve is bound with the inner layer sleeve, the inner layer sleeve is bound with the drug balloon, the folded outer diameter of the drug balloon can be reduced, and the inner layer sleeve naturally falls off without friction to the drug balloon by arranging the symmetrical first cut or arranging the wound strip-shaped structure when the outer layer sleeve is removed, so that the drug loss caused by friction during installation or disassembly is avoided, wherein the drug loss is extremely small and is less than 0.1%.

Drawings

FIG. 1 is a schematic view of the construction of an inner sleeve leaving a portion of the inner sleeve partially uncovered by a first incision.

Fig. 2 is a schematic structural diagram of the drug balloon assembly provided in example 1.

Detailed Description

The technical solution of the present invention is further explained by the following embodiments. It should be understood by those skilled in the art that the examples are only for the understanding of the present invention and should not be construed as the specific limitations of the present invention.