• 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 method for reducing the outer diameter of the balloon (1) of a balloon catheter in the non-expanded state, at least one restriction element (3) being applied to at least part of the balloon (1) of the balloon catheter. The balloon prepared in this way is then passed through an opening which is designed in such a way that the outer diameter of the balloon is reduced, and a cover is applied. In this way, on the one hand, the outer diameter of the balloon (1) is reduced and, on the other hand, the flexibility is increased.
    公开号:CH716755B1
    申请号:CH00032/21
    申请日:2020-08-12
    公开日:2021-09-30
    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 method for reducing the outer diameter of the balloon of a balloon catheter in the deflated state.
    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.
    Since the present invention is concerned in particular with methods that relate to the balloon of a balloon catheter in the non-expanded state, the following is generally assumed to be a non-expanded, ie deflated, state of the balloon, unless otherwise expressly mentioned. In addition, the terms "diameter of the balloon catheter", "diameter of the balloon" and "outer diameter of the balloon catheter" and "outer diameter of the balloon" are used synonymously below and always refer to the balloon portion of the catheter in the deflated state, unless expressly stated otherwise . The terms “balloon catheter” and “catheter” in the sense of this application are also used synonymously for a catheter with a balloon, unless reference is made specifically to a catheter without a balloon.
    [0004] The essential parameters that must be taken into account when selecting a balloon catheter suitable for the respective intervention include the length of the balloon and its nominal outer diameter in the expanded state. These two parameters of the balloon are usually selected in relation to the nature of the vascular constriction. In addition to other factors, the internal diameter and morphology of the vessel concerned must also be taken into account when selecting a suitable balloon catheter. For example, the more tortuous a vessel, the more flexible the chosen balloon catheter must be. When it comes to flexibility, the outside diameter of the balloon in the non-expanded state also plays a role. Since the balloon usually forms the area of the balloon catheter with the largest outside diameter even in the non-expanded state, this is a further limiting factor when selecting a suitable catheter. Last but not least, the balloon catheter must not only be able to be easily advanced through the vascular system to the target location, the lesion, even in the non-expanded state, but it must also be able to be placed on the lesion.
    There are therefore various factors which influence the selection of a suitable balloon catheter, including the flexibility of the catheter and, in particular, the flexibility in the area of the balloon.
    In principle, such a balloon catheter is to be preferred for an intervention for vasodilation, which has the smallest possible outer diameter. A catheter should initially be as flexible as possible so that it can be pushed through tortuous and / or narrow vessels on the way to the target vessel. In addition to the materials used, an essential factor for the flexibility of a balloon catheter is the outer diameter in the area of the balloon. In simple terms, it can be said that the easier it is to navigate or advance a catheter through intertwined and / or narrow vessels, the smaller its outer diameter is in the area of the balloon.
    When making the selection, attention must also be paid to the already mentioned flexibility or flexibility, especially in the area of the folded balloon. The flexibility influences both the navigability of the catheter ("navigation") and the force required to advance the catheter ("pushability"). The more bendable, i.e. more flexible, a balloon catheter, the better and easier it can be pushed through tortuous vessels.
    As already mentioned, the balloon catheter must also be able to pass through the vascular constriction to be treated prior to expansion. More precisely, the balloon of the catheter must be able to be placed in the vascular constriction in order to then expand it when it expands. The stronger the constriction of the vessel, the more the vessel is closed at this point and consequently the smaller the area that is still open and therefore passable. Correspondingly, such a vascular constriction can be passed better or at all only with a balloon whose cross section is smaller than or equal to the passable area of the vascular constriction. Catheters with a smaller outer diameter are more likely to meet this requirement than those with a larger outer diameter.
    The aim is therefore to provide balloon catheters with the smallest possible outer diameter so that they can be used for the greatest possible number of interventions. Various techniques are known for reducing the outside diameter of a balloon in the non-expanded state.
    Typically, the deflated balloon of a finished 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 already results in a first significant reduction in the outer diameter.
    If one looks at a balloon folded in this way in cross section, then one can still see gaps between the individual wrinkled folds and between folds and the catheter shaft. Various methods are proposed in the prior art in order to further reduce these gaps as well. 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 usually funnel-like nozzle. The tube is thereby stretched and reduces its diameter, which consequently also reduces the diameter of the balloon located in the tube. Such a method is described in WO 2016/050303 A1.
    The reduction of the balloon diameter with known methods always leads to a stiffening of the balloon due to the multilayer and folded arrangement. This results in reduced flexibility in the area of the folded balloon, which can have a detrimental effect on the maneuverability and the advancement of the catheter, especially in very tortuous vessels. In some processes from the prior art, the balloon is also subjected to strong mechanical loads.
    It is therefore the object of the invention to provide a method which enables the outside diameter of a non-expanded balloon of a balloon catheter to be reduced without having the disadvantages of known methods.
    This object is achieved by an invention with the features of claim 1. Advantageous embodiments are each subject matter of the dependent claims.
    For the purposes of the invention, the term “restriction element” is understood to mean both band-like or cord-like elongated objects, which are particularly suitable for helically wrapping an elongated balloon, as well as ring elements that are suitable for sliding onto an elongated balloon.
    [0016] For the sake of simplification, in the following, in the case of band-like or cord-like restriction elements, “bands” will be used in general, and in the case of annular restriction elements, “rings” will generally be used.
    A method according to the invention comprises at least the following steps: (A) providing a balloon catheter; (B) attaching at least one restriction element to at least a portion of the balloon of the balloon catheter; (C) passing the balloon prepared according to step (B) through an opening which is designed such that the outer diameter of the balloon is reduced when the prepared balloon is passed through; and (D) applying a wrap to the balloon.
    Preferably, the balloon of the balloon catheter is placed in folds before attaching the restriction element, but in principle the method can also be carried out with an unfolded balloon. A first reduction in diameter by folding is, however, sensible, since the diameter reduction by the method according to the invention then only has to be increased and the folding also allows an orderly inflation of the balloon.
    The attachment of the at least one restriction element on at least part of the balloon can be carried out according to the invention in different ways.
    When using bands as restriction elements, the attachment to the balloon is provided, for example, by a number of spiral or helical or helical wraps - which are to be summarized below as spiral wraps for the sake of simplicity.
    When using rings as restriction elements, attachment to the balloon is provided, for example, by sliding the rings onto the balloon. Usually several rings are applied to the balloon, typically 2 to 10, for example 3 to 6.
    A combination of rings and bands is conceivable.
    If a spiral wrapping is provided, wrapping with only one tape is preferred. The spiral wrapping is preferably carried out only in one direction in order to impress a corresponding spiral structure on the balloon. After passing through the opening, this spiral structure is retained even if the tape or tapes are removed again. As a rule, a single-layer, spiral-shaped wrapping of the balloon is sufficient, but a multilayered wrapping with several ribbons is also conceivable.
    The wrapping can be done in such a way that there is still a small gap between each turn of the tape, but the wrapping can also be provided without gaps. It is preferred to wrap the balloon in such a way that there is a gap, that is to say that the turns are spaced a certain distance apart. This is advantageously 0.5 to 7 mm, more preferably 1 to 5 mm. The band or bands should be wrapped around the balloon as tightly as possible, either in that the wrapping itself is already tight, ie. H. by exerting a tensile force acting in the longitudinal direction on the respective tape, or by pulling the respective tape tight after wrapping, which can be achieved in particular by tensile forces acting on the ends.
    When using tapes, flat tapes with a certain width of ≥ 2 mm are preferred. A width of 0.5 to 2 cm is particularly preferred. In this context, width is understood to mean the extension of the band parallel to the surface of the balloon and orthogonal to the longitudinal direction of the band. The length of the tape depends on the length and diameter of the balloon to be prepared and on the type of winding and is selected accordingly.
    If rings are provided as restriction elements, the attachment of several rings is preferred. The individual rings can be arranged completely disconnected from one another or they can be lined up in the form of a band, for example by means of corresponding entanglements or entanglements, also in the form of knots.
    The distances described for spiral wraps can also be used for the attachment of rings. The dimensions described for bands can also be transferred to rings.
    To simplify removal of the rings, predetermined breaking points can be provided on the rings. The rings can also comprise pull-off elements, in particular tab-like appendages, which enable the rings to be gripped easily. Such deduction elements can also be helpful when attaching the rings.
    A balloon which has been provided with restriction elements is to be referred to below as a “prepared balloon”.
    In an alternative embodiment, a sleeve can be placed around the prepared balloon in a further step (B1), ie a step after step (B) and before step (C), the length of which preferably corresponds to at least the length of the balloon. The inner diameter of the sleeve should preferably be selected so that the inner wall of the sleeve rests against the balloon with a friction fit. A sleeve is to be understood as a hose-shaped or tubular element.
    The sleeve protects the sensitive balloon from damage when it is pulled through the opening and also serves to stabilize the position of the restriction elements, ie to prevent the restriction elements from slipping or shifting during further handling. The additional provision of such a sleeve, preferably a tubular sleeve, is particularly advantageous in connection with the use of rings as restriction elements.
    As materials for the sleeve come in particular materials in question, which generate a low friction, so that the material of the underlying expandable element is not damaged. Polytetrafluoroethylene (PTFE, Teflon) is particularly suitable. However, it is also possible to use other materials, in particular plastic materials, which have low friction.
    The opening through which the prepared balloon is to be passed is such that the outer diameter of the balloon and, if necessary, of the sleeve are reduced when the prepared balloon is passed through, d. H. the inside diameter of the opening is preferably chosen so that it is smaller than the outside diameter of the prepared balloon, but on the other hand not so much smaller that it would be almost impossible to pass the prepared balloon through. The same applies to a prepared balloon provided with a sleeve.
    As a rule, the diameter of the opening should be selected so that the prepared balloon can only be passed through with a certain amount of force, which then leads to the desired reduction in diameter.
    As a rule, the opening has a circular cross-section. In general, an opening in the sense of the invention is to be understood as any type of recess through which the prepared balloon can be guided. For example, it can be a continuous opening within an object or a plate, but it can also be a ring. An opening with a certain depth such as a nozzle is also understood as an opening in the context of the invention.
    The opening is advantageously conical, with a larger first inner diameter at the first end, at which the prepared balloon is introduced into the opening, and with a smaller second inner diameter at the second end, through which the prepared balloon leaves the opening again.
    The first inner diameter is to be selected so that it enables easy insertion of the prepared balloon, possibly with a sleeve. The second inner knife should be selected so that pulling through the prepared balloon, possibly with the sleeve, actually leads to a reduction in diameter. In other words, the first inside diameter of the opening is equal to or larger than the outside diameter of the prepared balloon and the second inside diameter of the opening is smaller than the outside diameter of the prepared balloon. Normally, after the prepared balloon has been passed through the opening and before the covering is applied, the restriction elements and, if necessary, the sleeve are removed from the balloon (step C1). The spiral or ring-shaped corrugated structure is impressed on the balloon or the folds on the balloon by the restriction elements and the narrow opening, i. H. it is retained even if the restriction elements and, if applicable, the sleeve are removed. The embossing of the structure described at the same time increases the flexibility of the balloon, which is advantageous when it is pushed through narrow blood vessels.
    It is also conceivable, however, to leave the restriction elements and, if necessary, the sleeve on the balloon and to cover the envelope. In this case, not only the covering but also the restriction elements and, if necessary, the sleeve must be removed before the balloon catheter is used.
    The covering pulled over the balloon serves as a protector of the balloon and protects it from damage, etc. during storage. In addition, in the case of balloons coated with active ingredient, the envelope ensures that it remains on the balloon and does not come off prematurely. The sheath is typically a tubular cover.
    If necessary, step (C) for reducing the balloon diameter can be repeated until the desired diameter reduction is achieved. An opening with a reduced diameter can be used in each case, i. H. when step (C) is repeated, the inner diameter of the opening is reduced in each case.
    Instead of or in addition to repeating step (C), it is also possible to repeat steps (B), (C) and (C1) in each case, d. H. not only the passage through an opening or the passage through a sequence of openings is repeated, but also the attachment and removal of the restriction elements. In this way, when it is re-attached, a tighter winding can be made, for example, or rings with a smaller internal diameter can be used in order to further reduce the external diameter of the balloon.
    It is also possible in this context to repeat step (B1), that is to say the application of a sleeve to the prepared balloon, it being understood that the previous sleeve is usually to be removed before a new sleeve is applied.
    The balloon catheter according to the invention typically has lumens, preferably at least two lumens, one lumen being used for fluid supply and pressurization and being connected to the interior of the balloon, while the other lumen is used to receive a guide wire which is first advanced to the target location in the blood vessel to then bring the balloon catheter over the guide wire to the target site. 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 the case of 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 typically run parallel to one another in the areas in which the catheter has two lumens, with an inner lumen also being able to run through the further outer lumen.
    While performing step (C), i. H. the reduction of the balloon diameter by passing the prepared balloon through an opening, the guide wire preferably extends through the lumen of the balloon catheter provided for this purpose. This prevents the lumen for the guide wire from being compressed and narrowed. For later use as a balloon catheter, it is important that the guide wire can be moved distally or proximally in the longitudinal direction with respect to the balloon catheter through the corresponding lumen, which is why a narrowing of the lumen is disadvantageous. This applies regardless of whether it is an OTW or an Rx catheter, because as part of step (C), a force acting radially inward is primarily exerted in the balloon area of the balloon catheter, as this has a considerably larger cross-section than Has areas of the catheter without a balloon. Both the OTW and the Rx catheters have a guide wire lumen in the area of the balloon, the narrowing of which should be avoided.
    The guide wire preferably already runs through the guide wire lumen of the balloon during step (B) and possibly (B1). In this way it is ensured that a narrowing of the guide wire lumen is avoided even when the restriction elements are put on tightly and pulled tight.
    The material of the restriction elements should be chosen so that it does not adhere to any part of the catheter. This requirement of a non-adhesive restriction element is met in particular by materials containing polytetrafluoroethylene (PTFE).
    If a multilayer attachment is provided, it is usually sufficient if the restriction elements lying directly on the balloon have non-adhesive properties, that is to say, for example, consist of PTFE-containing materials.
    The invention is of particular importance for balloons loaded with active ingredient, also called drug eluting balloons (DEB). These usually have a larger cross-section than unloaded balloons, e.g. B. because between the folds in which the balloon is placed in the contracted state, an active ingredient such as paclitaxel is. In the case of very long balloons in particular, this makes it difficult to advance them through the blood vessel system. The active ingredients are preferably selected from the group: tretinoin, orphan receptor agonists, elaine derivatives, corticosteroids, steroid hormones, paclitaxel, rapamycin, tacrolimus, hydrophobic proteins and / or substances that change cell proliferation.
    In addition to the method according to the invention, the invention also relates to a balloon catheter which is obtained by the method according to the invention.
    Balloon catheters are generally well known in the prior art and have an elongated catheter shaft extending from proximal to distal and a balloon arranged in the distal area. It is a catheter which, with regard to its dimensions, is matched to the introduction into a body lumen, in particular a (blood) vascular 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. This can be a delivery lumen that extends the length of the balloon catheter.
    Furthermore, the balloon catheter according to the invention can serve not only to remove stenoses and the local introduction of active substance, but also to place a stent (endoprosthesis) in the body lumen. Stents are tubular support structures that are implanted in a body lumen, for example a blood vessel, in order to keep this 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 body lumen with the aid of the balloon catheter. The balloon is then expanded at the intended location by supplying a fluid, as a result of which the stent also expands and is anchored in the body lumen. Finally, the balloon is contracted again and removed from the body lumen while the stent remains in the body lumen.
    A so-called catheter hub is usually provided at the proximal end of the balloon catheter, i. H. a connector for the fluid supply and pressurization device. The connection can e.g. B. be a conventional Luer or Luer lock connection. Under proximal is in the direction of the exterior of the body, i. H. towards the attending physician, distal means the opposite direction, d. H. in the direction of the blood vessel to be treated. The balloon catheter is usually introduced into the human body in the groin area via the femoral artery.
    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, markings made of platinum or a platinum alloy can be involved.
    The method according to the invention has the advantage over the prior art that the mechanical loads on the balloon, which are the cause of possible damage to the balloon, are reduced to a minimum. This is mainly due to the attachment of the restriction elements according to the invention directly to the balloon by wrapping or sliding it on. In contrast to other methods, significantly lower tensile forces occur here than with known methods from the prior art.
    All statements made about the manufacturing process apply in a corresponding manner to the balloon and the balloon catheter and vice versa.
    The invention is explained in more detail by way of example with the aid of the figures. It should be pointed out that the figures show preferred embodiment variants of the invention, but the invention is not restricted thereto.
    1 shows a balloon of a balloon catheter with band-shaped restriction elements; FIG. 2 shows the balloon according to FIG. 1 after the band-shaped restriction elements have been pulled tight; FIG. 3 shows the balloon according to FIG. 2 after being passed through an opening; 4 shows a balloon of a balloon catheter with annular restriction elements; 5 shows the balloon according to FIG. 4 after the annular restriction elements have been tightened, and FIG. 6 shows the balloon according to FIG. 5 after it has been passed through an opening.
    FIG. 1 shows part of a balloon catheter, namely the catheter shaft 2 with the balloon 1 arranged at the distal end. A band 3, preferably made of PTFE, is placed around the balloon 1 as a restriction element, so that a multiplicity of turns 4 results.
    FIG. 2 shows the balloon 1 from FIG. 1, but after the band-shaped restriction element 3 placed around the balloon 1 and the windings 4 have been pulled tight. This already brings about a significant reduction in the outer diameter of the balloon 1, which, however, is not yet sufficient.
    FIG. 3 shows the result after passing through the balloon 1 with a band-shaped restriction element 3 laid in turns 4 through an opening not shown here. The outer diameter of the balloon 1 has been reduced considerably. The band-shaped restriction element 3 can then be removed and the balloon 1 provided with a cover as a protector.
    FIG. 4 shows part of a balloon catheter, namely the catheter shaft 2 with the balloon 1 arranged at the distal end. A plurality of ring-shaped restriction elements 3, preferably made of PTFE, are placed around the balloon 1.
    FIG. 5 shows the balloon 1 from FIG. 4, but after the annular restriction elements 3 placed around the balloon 1 have contracted and correspondingly widened slightly. This already brings about a significant reduction in the outer diameter of the balloon 1, which, however, is not yet sufficient.
    FIG. 6 shows the result after the balloon 1 with the annular restriction elements 3 has been passed through an opening not shown here. The outer diameter of the balloon 1 has been reduced considerably. The ring-shaped restriction elements 3 can then be removed and the balloon 1 provided with a cover as a protector.
    权利要求:
    Claims (15)
    [1]
    1. A method for reducing the outer diameter of the balloon (1) of a balloon catheter in the non-expanded state, comprising the following steps:A) providing a balloon catheter;B) attaching at least one restriction element (3) to at least part of the balloon (1) of the balloon catheter;C) passing the balloon (1) prepared according to step B through an opening which is designed such that the outer diameter of the balloon (1) is reduced when the prepared balloon (1) is passed through; andD) applying a cover to the balloon (1).
    [2]
    2. The method according to claim 1, characterized in that the balloon (1) is placed in folds according to step B before the restriction elements (3) are attached.
    [3]
    3. The method according to claim 1 or 2, characterized in that the restriction elements (3) are removed from the balloon (1) in an additional step C1, namely after step C and before step D.
    [4]
    4. The method according to any one of claims 1 to 3, characterized in that step C is repeated until the desired outer diameter of the balloon (1) is reached, an opening with a reduced diameter being used in each case.
    [5]
    5. The method according to claim 3, characterized in that steps B to C1 are repeated until the desired outer diameter of the balloon (1) is reached, an opening with a reduced diameter being used in each case.
    [6]
    6. The method according to claim 1 or 2, characterized in that a sleeve is pushed over the prepared balloon in a step B1, the length of which corresponds at least to the length of the balloon (1), step B1 after step B but before step C is carried out .
    [7]
    7. The method according to any one of claims 1 to 6, characterized in that bands and / or rings are provided as restriction elements (3).
    [8]
    8. The method according to any one of claims 1 to 7, characterized in that the balloon catheter has a lumen for a guide wire which extends at least through the balloon (1), wherein during step C, preferably during steps B and C and possibly B1 the guide wire passes through the lumen.
    [9]
    9. The method according to any one of claims 1 to 8, characterized in that the restriction elements (3) are wholly or partially made of polytetrafluoroethylene.
    [10]
    10. The method according to any one of claims 1 to 9, characterized in that the restriction elements (3) have a width ≥ 2 mm, preferably from 0.5 to 2 cm.
    [11]
    11. The method according to any one of claims 7 to 10, characterized in that the distance between the individual turns of the respective band or the individual rings (3) is 0.5 to 7 mm, preferably 1 to 5 mm.
    [12]
    12. The method according to any one of claims 7 to 11, characterized in that the attachment of the bands is carried out in a spiral.
    [13]
    13. The method according to any one of claims 1 to 12, characterized in that the opening is conical with a larger first inner diameter at the first end, at which the prepared balloon (1) is inserted into the opening, and with a smaller second inner diameter at second end through which the prepared balloon (1) leaves the opening again.
    [14]
    14. Balloon catheter, obtained by a method according to any one of claims 1 to 13.
    [15]
    15. Balloon catheter according to claim 14, characterized in that the balloon (1) of the balloon catheter has an active substance coating.
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    同族专利:
    公开号 | 公开日
    DE102020111805A1|2021-03-11|
    WO2021047848A1|2021-03-18|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    JP3756088B2|2001-08-29|2006-03-15|朝日インテック株式会社|Catheter balloon and method of manufacturing the same|
    JP4412467B2|2004-01-30|2010-02-10|日本ゼオン株式会社|Balloon winding method of balloon catheter|
    US9730726B2|2011-10-07|2017-08-15|W. L. Gore & Associates, Inc.|Balloon assemblies having controllably variable topographies|
    SG11201702533XA|2014-10-02|2017-05-30|Aachen Scient Internat Pte Ltd|Cutback method for intravascular dilation catheter|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    DE102019124056|2019-09-09|
    DE102020111805.8A|DE102020111805A1|2019-09-09|2020-04-30|Diameter reduction|
    PCT/EP2020/072571|WO2021047848A1|2019-09-09|2020-08-12|Reduction in diameter|
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