• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to a balloon catheter for insertion into the blood vessel system of the human or animal body with a shaft (2) extending in the longitudinal direction, the balloon catheter having a distal section (A) in which a balloon (3) is arranged, which through The supply of a fluid via a lumen (9) running through the shaft (2) is expandable, the distal tip (8) of the balloon catheter (4) being coated with a hydrogel (7). The invention provides a balloon catheter which can also easily pass through constrictions in blood vessels.
    公开号:CH715955B1
    申请号:CH01418/19
    申请日:2019-11-08
    公开日:2020-09-15
    发明作者:Alexander Ruebben Dr
    申请人:Alexander Ruebben Dr；
    IPC主号:
    专利说明:

    The invention relates to a balloon catheter for introduction into the blood vessel system of the human or animal body with a longitudinally extending shaft, wherein the balloon catheter has a distal portion in which a balloon is arranged, which by supplying a fluid through a the shaft extending lumen is expandable.
    The use of balloon catheters is now standard in everyday clinical practice. Their use in the context of intravascular interventions mostly relates to the widening of narrowed vascular sites, either with the help of the balloon catheter itself or in combination with other medical products such as balloon expandable stents. In percutaneous transluminal angioplasty, a balloon catheter is brought to the site of the stenosis via a guide wire and a guide catheter and expanded by supplying a fluid under pressure (approx. 4 to 12 bar). Deposits in the area of the stenosis are pressed into the vessel wall. In addition, a stent (vascular endoprosthesis) can be placed to keep the blood vessel open permanently. In order to prevent the reoccurrence of a stenosis due to vasoconstricting overgrowth of the enlarged area, drug-coated balloon catheters can also be used, which release an active ingredient such as paclitaxel at the area of the vasoconstriction during expansion. After the treatment and the subsequent folding of the balloon, the balloon catheter is withdrawn from the vascular system and removed.
    As an access point for balloon catheters, but also other catheters, for example for setting a stent or for inserting other implants into the blood vessel system, the femoral artery in the groin is often chosen. The femoral artery runs relatively superficially at least partially and is therefore easily accessible to the attending physician. In addition, relatively large-lumen catheters with large external diameters can be introduced via the femoral artery (inguinal artery).
    Since the catheter has to be advanced over relatively long distances from the access point to the target position, which can for example be in the region of the heart or the brain, a low frictional resistance is advantageous. In the case of transurethral Foley catheters, it is known to coat them with a hydrogel immediately before use, which increases the gliding ability of the catheter when it is inserted into the urethra. At the same time, the urethra itself is usually provided with the hydrogel. However, these are not catheters which are introduced into the blood vessel system; in the case of such catheters, a pre-coating with a hydrogel is not usual.
    In some cases, the prior art, for example WO 2017/139357 A1, also found balloon catheters in which the balloon itself has a hydrogel coating in which an active ingredient that can be administered via the balloon is embedded. In this case, however, the hydrogel does not serve as a means to increase the lubricity of the balloon catheter, but rather as a matrix for the active substance to be delivered.
    Based on the prescribed state of the art, the task is thus to provide a balloon catheter which can be advanced to the target position particularly well over relatively large distances and through narrow blood vessels.
    According to the invention, this object is achieved by a balloon catheter for introduction into the blood vessel system of the human or animal body with a shaft extending in the longitudinal direction, the balloon catheter having a distal section in which a balloon is arranged, which by supplying a fluid is expandable via a lumen running through the shaft, the distal tip of the balloon catheter having a coating with a hydrogel.
    Unlike the balloon catheters described above, according to the invention, the hydrogel is applied to the distal tip of the balloon catheter and not, or at least not primarily, to the balloon itself. The application to the distal tip ensures that the balloon catheter can be easily advanced , even if there are constrictions in the blood vessel system. Rather, when passing such a narrow point, the hydrogel applied to the distal tip of the balloon catheter is pushed further in the proximal direction, so that the distal balloon catheter has particularly good sliding properties.
    The hydrogel can be applied in a form that it initially remains localized at the distal tip of the balloon catheter. If the hydrogel comes into contact with blood when the balloon catheter is inserted into the blood vessel system, it swells up due to the absorption of water and forms the gel that is very slippery, with partial peptization and thus a gel-sol transition taking place under certain circumstances.
    The application of the hydrogel not only facilitates the advancement of the balloon catheter in the blood vessel, but also the insertion of the balloon catheter into an insertion aid or insertion sheath, which is usually placed in the area of the femoral artery. Such catheter insertion aids are mostly made of a plastic material and often have a membrane which must first be pierced by the balloon catheter to be advanced.
    [0011] The coating with the hydrogel is preferably limited to the distal tip of the balloon catheter. In particular, the balloon catheter should advantageously not or only partially be provided with the hydrogel. For example, although part of the balloon catheter could also be coated with the hydrogel beyond the immediate distal tip, this coating should, viewed from the distal end, extend at most to the middle of the balloon, preferably only over the distal third of the balloon. More preferably, the coating with the hydrogel only extends over the most distal quarter or the most distal fifth of the balloon, the longitudinal direction of the balloon catheter being considered in each case.
    The length of the area of the balloon catheter coated with the hydrogel can, for example, be max. 10 cm, preferably max. 5 cm, more preferably max. 3 cm, more preferably max. 2 cm, more preferably max. 1 cm, the distance from the distal end of the balloon catheter in the proximal direction being considered.
    Because only the distal tip of the balloon catheter is coated with the hydrogel, the total amount of applied hydrogel is kept low. On the other hand, the distally applied hydrogel coating fulfills its function, because the distal tip of the balloon catheter is primarily important for improving the pushability within a blood vessel. As soon as the distal tip with the immediately adjoining balloon section has overcome a narrow point, the other areas of the balloon catheter normally follow without any problems. In addition, it must be taken into account that the hydrogel applied to the distal tip has a consistency after activation by absorption of water that it is distributed to a certain extent in the proximal direction just by passing the constriction, so that the balloon catheter in the distal section overall has good sliding properties having.
    The amount of applied hydrogel should be chosen so that on the one hand it can fulfill its function of improving the pushability of the balloon catheter, but on the other hand is as small as possible. The hydrogel is an additive that should only be introduced into the blood vessel system in the smallest possible amount. Some substances that can be used as hydrogel, for example, are known to cause side effects or allergic reactions up to anaphylactic shock in large quantities.Just because the amount of coating applied should be kept relatively small, it is advantageous to only use the distal tip of the balloon catheter or to coat only small areas of the balloon catheter near the distal end. The total amount of hydrogel applied is preferably 5 mg, more preferably 3 mg, more preferably 1 mg. The hydrogel coating is usually free of active ingredients.
    The hydrogel coating per area is expediently 2.5 (µg / mm 2, more preferably 0.5 to 2.5 µg / mm 2, only the area of the balloon catheter coated with hydrogel being considered. In this way, a sufficient effect is achieved without running the risk of too large a quantity of the hydrogel being removed and absorbed by the blood.
    Common substances that can be used for hydrogels can be used for the hydrogel, in particular polysaccharides, modified polysaccharides, methacrylates, polypeptides, proteins or synthetic polymers. Modified polysaccharides are understood to mean, in particular, those polysaccharides which or their monomer units are functionalized in a special way. For example, individual monomer units can have amino or amide functions, carboxy functions or the like, or they can also be partially oxidized. Examples are polyaminosaccharides such as chitosan or hyaluronic acid with an N-acetylamino function and glucoronic acid units. The hydrogels may or may not be crosslinked.
    In particular, the hydrogel can contain: dextran, polyhydroxyethyl methacrylate, a polyacrylate, chitosan, oxidized cellulose, polyvinylpyrrolidone, polyethylene glycol, hyaluronic acid, agarose, starch, starch derivatives such as hydroxyethyl starch, a poloxamer, gelatin, fibrin, polyvinyl alcohol, polyacrylic glycol, propylene glycol Carboxymethyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, alginate, amylose, amylopectin, xanthan, xyloglucan, peptidoglycan, polyoxyethylene derivatives, a silicone and / or elastin. Polysaccharides are preferred.
    Under proximal is in the context of the invention in the direction of the exterior of the body, d. H. towards the attending physician, distal means the opposite direction, d. H. towards the target position. The longitudinal direction is the direction from proximal to distal or vice versa. Radial is understood to mean the plane perpendicular to the longitudinal axis of the balloon catheter.
    A second lumen typically extends through the shaft at least partially in the longitudinal direction and serves to receive a guide wire. This lumen can extend to the distal end of the balloon catheter, i. H. the guide wire can exit from the balloon catheter at the distal end thereof. Accordingly, a guide wire can first be brought to the desired target position before the balloon catheter itself is advanced over the guide wire to the target position.
    In this context, two different systems are essentially known from the prior art, namely Over-The-Wire (OTW) and Rapid Exchange (Rx) balloon catheters. The balloon catheter according to the invention can be in the form of both an OTW and an Rx balloon catheter. While in an OTW catheter the lumen for the guide wire extends over the entire length of the catheter from proximal to distal, the Rx catheter has a separate feed opening for the guide wire (Rx port), where the guide wire is clearly distal to the proximal End of the catheter emerges from the catheter. Correspondingly, in the case of an OTW balloon catheter, the lumens for the fluid supply and the guide wire run concentrically or parallel to one another from the proximal end of the catheter to the balloon, whereas in an Rx catheter this is only the case between the Rx port and the balloon. The section between the Rx port and the proximal end, on the other hand, has only one lumen for the fluid supply. The lumens can be concentric in the areas where the catheter has two lumens, i.e. H. the narrower inner lumen for the guide wire runs through the further outer lumen for the fluid supply.
    Under balloon within the meaning of the invention, the element of a balloon catheter that can be expanded by supplying a fluid is understood, regardless of the shape of the expandable element or of what material it is made of. Balloon catheters are generally well known in the prior art and have an elongated shaft extending from proximal to distal and a balloon arranged in the distal section. It is a catheter whose dimensions are matched to the introduction into the respective blood vessel system. The exact dimensions can vary, depending on whether the blood vessel is, for example, a coronary artery, an intracranial blood vessel or a lower leg artery. In addition, the balloon catheter has means for supplying a fluid to the balloon in the form of a supply lumen which extends over the length of the balloon catheter. The lumens running through the shaft are normally each formed by a hose-shaped or tubular tube.
    The term tube is used in this context in the sense of a tube or a tube which extends at least partially through the balloon catheter in the longitudinal direction and has a lumen extending through the interior of the tube. The tube can have the shape of a hollow cylinder with a circular or elliptical cross-section, but this is not absolutely necessary. Almost any other shapes are also conceivable when viewed in cross section. A circular or elliptical cross-section, however, has the advantage that one tube can be easily guided through the other tube, the second tube usually being placed through the first tube.
    In the case of a compliant or semi-compliant balloon, the balloon can be at least partially made of an elastic material. As an elastic material, for. B. a polyurethane, a polyolefin copolymer, a polyethylene or a silicone can be used. Other materials that can be used are thermoplastic elastomers, in particular polyether block amides (PEBA). This is a thermoplastic elastomer that can be obtained by polycondensation of a carboxylic acid polyamide with a polyether with terminal OH groups. In particular, PEBA is sold under the name PEBAX <®> by the company Arkema. It is also possible to use polyamides such as nylon (polyhexamethylene adipamide) or polyamides such as those sold under the name Grilamid® by EMS-GRIVORY.
    The pressure with which the balloon is subjected to expansion in the blood vessel is typically between 4 and 12 bar, preferably 6 to 8 bar. The fluid used can be, for example, water mixed with contrast agent or a saline solution mixed with contrast agent. The dimensions of the balloon can differ greatly depending on the area of application, the diameter in the expanded state can for example be between approx. 1 and approx. 50 mm, the length between approx. 5 and approx. 300 mm. Possibly. however, the dimensions can also differ, for example when using the balloon / balloon catheter in veterinary medicine.
    The shaft of the balloon catheter can be made of conventional materials, different materials can also be used, for example to make the distal section softer than the proximal section. Common materials are polymers such as polyethylene, polyurethane, polyvinyl chloride, polyamides, polyimides, silicones, polyether amides, polytetrafluoroethylene, EPDM (ethylene-propylene-diene rubber), polyether block amides (PEBA) or polyamides, as they are known under the name Grilamid <®> from the Company EMS-GRIVORY. Possibly. In particular, proximal areas of the shaft can also be made of metal, for example stainless steel.
    The length of the shaft, including the area in which the balloon is arranged, but without hubs or similar connections arranged proximally on the shaft, is typically at least 160 cm, preferably at least 165 cm. A length between 160 and 180 cm is typical.
    The balloon catheter according to the invention can also serve to place a stent (endoprosthesis) in the body lumen. Stents are tubular support structures that are implanted in a blood vessel to keep it permanently open. Such stents can be self-expanding or can be expanded with the aid of a balloon. For this purpose, the stent is crimped onto the balloon and inserted into the blood vessel with the aid of the balloon catheter. At the intended location, the balloon is then expanded by supplying a fluid, as a result of which the stent also expands and is anchored in the blood vessel. At the same time, when the balloon according to the invention is used, the active substance is released onto the wall of the blood vessel. Eventually the balloon is contracted again and removed from the blood vessel while the stent remains in the blood vessel.
    If required, the balloon catheter can have a balloon coated with an active substance, also called drug eluting balloons. The active ingredient is preferably selected from the group: tretinoin, orphan receptor agonists, elena derivatives, corticosteroids, steroid hormones, paclitaxel, rapamycin (sirolimus), tacrolimus, hydrophobic proteins, heparin and / or hormone-like or cell proliferation-changing substances. Paclitaxel, tacrolimus and sirolimus are particularly preferred.
    At the proximal end of the balloon catheter, adjoining the shaft, a so-called catheter hub is usually provided, d. H. a connector for the device for fluid supply and pressurization. The connection can e.g. B. be a conventional Luer or Luer lock connection. In particular, it makes sense to provide two Luer lock connections, typically female connections, one of which is used to connect the first lumen to a balloon dilator and a further one is used to introduce the guide wire into the balloon catheter. The connections can be made from a polycarbonate, for example. The guide wire running through the balloon catheter can be held at its proximal end by a torquer, which facilitates the handling of the guide wire, which is usually very thin.
    Typically, the deflated balloon of the balloon catheter is in a folded state. Depending on the size of the balloon, a different number of folds can be formed, which are then wound around the axis of the catheter in the same direction. This results in a significant reduction in the diameter. In order to further reduce the diameter, various methods are proposed in the prior art. As an example, the so-called cut-back process should be mentioned here, in which the folded balloon with the hose pulled over it is guided through a nozzle that is usually funnel-shaped. The tube is thereby stretched and its diameter is reduced, which consequently also reduces the diameter of the balloon located in the tube. Such a method is described in WO 2016/050303 A1.
    Radiopaque markings, which are used to visualize the catheter in the X-ray image, can be attached at various positions along the balloon catheter. In particular, these can be markings made of platinum or a platinum alloy.
    [0032] The invention is explained in more detail by way of example with reference to the accompanying figures. Show it:<tb> Fig. 1: <SEP> a balloon catheter according to the invention in a side view;<tb> Fig. 2 <SEP> the distal part of the shaft of the balloon catheter from FIG. 1 in a longitudinal section.
    In Fig. 1, the balloon catheter 1 according to the invention is shown in a side view, wherein in the representation selected here right means proximal and left means distal. The balloon catheter 1 has a shaft 2 extending in the longitudinal direction, the outer diameter of which in the proximal section 6, which is shown here only in shortened form, is greater than further distal. The section of the shaft 2 in which the balloon 3 is arranged is marked with the letter A. The balloon 3 is shown in the non-expanded, but not collapsed, state. A first lumen for the fluid supply and a second lumen for receiving the guide wire run through the shaft 2 (not shown here), the two lumens each being formed by a tube. Distal to balloon 3 can be seen the distal tip 8.
    Proximally adjoining the proximal section 6 of the shaft 2 are two catheter hubs in the form of Luer-Lock connections 4, 5, the connection 4 of the fluid supply into the first lumen by means of a balloon dilator and the connection 5 of the introduction of the guide wire serve in the second lumen.
    In Fig. 2 only the distal part of the shaft 2 is shown. A first lumen 9 is designed so that it can receive the second lumen 10, i. H. the second lumen 10 runs in the longitudinal direction through the first lumen 9. The first lumen 9 is connected at its distal end to the balloon 3, which can be expanded by supplying fluid through the first lumen 9. The second lumen 10, however, has an opening at the distal end and is used to receive the guide wire, not shown here.
    At the distal end of the shaft 2 is the distal tip 8. This is radial, d. H. Coated over the circumference with a hydrogel 8. The coating with the hydrogel 8 can extend slightly over the balloon 3, but this is not necessary; rather, it is advantageous if the hydrogel coating 8 remains essentially limited to the distal tip 8. When the balloon catheter 1 passes a constriction in the blood vessel, the hydrogel coating 8 is automatically partially distributed further in the longitudinal direction in the proximal direction and the balloon catheter 1 can be easily slid and pushed forward.
    权利要求:
    Claims (14)
    [1]
    1. Balloon catheter for introduction into the blood vessel system of the human or animal body with a shaft (2) extending in the longitudinal direction, the balloon catheter (1) having a distal section (A) in which a balloon (3) is arranged which is expandable by supplying a fluid via a lumen (9) running through the shaft (2), characterized in thatthat the distal tip (8) of the balloon catheter (1) has a coating with a hydrogel (7).
    [2]
    2. Balloon catheter according to claim 1, characterized in that the coating with the hydrogel (7) is limited to the distal tip (8) of the balloon catheter (1).
    [3]
    3. Balloon catheter according to claim 1, characterized in that, viewed in the longitudinal direction, the area of the coating with the hydrogel (7) extends from the distal end of the balloon catheter (1) to a maximum of the center of the balloon (3).
    [4]
    4. Balloon catheter according to claim 3, characterized in that the area of the coating with the hydrogel (7), viewed in the longitudinal direction, comprises a maximum of the distal third of the balloon (3).
    [5]
    5. Balloon catheter according to one of claims 1 to 4, characterized in that the length of the area of the balloon catheter (1) coated with the hydrogel (7) is a maximum of 5 cm, preferably a maximum of 3 cm, more preferably a maximum of 2 cm.
    [6]
    6. balloon catheter according to one of claims 1 to 5, characterized in that the amount of hydrogel (7) per coated surface unit of the balloon catheter (1) ≤ 2.5 µg / mm 2, more preferably 0.5 to 2.5 µg / mm <2> is.
    [7]
    7. Balloon catheter according to one of claims 1 to 6, characterized in that the total amount of hydrogel (7) applied to the balloon catheter (1) is 5 mg, preferably 3 mg, more preferably 1 mg.
    [8]
    8. balloon catheter according to one of claims 1 to 7, characterized in that the hydrogel (7) is free of active ingredient.
    [9]
    9. balloon catheter according to one of claims 1 to 8, characterized in that the hydrogel (7) contains a polysaccharide, a modified polysaccharide, a methacrylate, a polypeptide, a protein and / or a synthetic polymer.
    [10]
    10. balloon catheter according to one of claims 1 to 9, characterized in that the hydrogel (7) is dextran, polyhydroxyethyl methacrylate, a polyacrylate, chitosan, oxidized cellulose, polyvinylpyrrolidone, polyethylene glycol, hyaluronic acid, agarose, starch, starch derivatives such as hydroxyethyl starch, a poloxamer, gelatin , Fibrin, polyvinyl alcohol, propylene glycol, polyacrylic acid, methyl cellulose, carboxymethyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, alginate, amylose, amylopectin, xanthan, xyloglucan, peptidoglycan, polyoxyethylene derivatives, a silicone and / or elastin.
    [11]
    11. Balloon catheter according to one of claims 1 to 10, characterized in that a second lumen (10) which is used to receive a guide wire extends at least partially through the shaft (2) in the longitudinal direction.
    [12]
    12. Balloon catheter according to one of claims 1 to 11, characterized in that the balloon (3) is coated with one or more active substances.
    [13]
    13. Balloon catheter according to claim 12, characterized in that the active ingredient used is selected from the group: tretinoin, orphan receptor agonists, elastin derivatives, corticosteroids, steroid hormones, paclitaxel, rapamycin, tacrolimus, hydrophobic proteins, heparin and / or hormone-like or cell proliferation-changing substances.
    [14]
    14. Balloon catheter according to one of claims 1 to 13, characterized in that one or more Luer lock connectors (4, 5) are connected to the proximal end of the shaft (6).
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    同族专利:
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    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    SG11201702533XA|2014-10-02|2017-05-30|Aachen Scient Internat Pte Ltd|Cutback method for intravascular dilation catheter|
    US20210196932A1|2016-02-08|2021-07-01|Orbusneich Medical, Inc.|Drug Eluting Balloon|
    US20170290561A1|2016-04-06|2017-10-12|Covidien Lp|Medical device imagable by ultrasound|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    DE102019129596.3A|DE102019129596A1|2019-11-04|2019-11-04|Balloon catheter|
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