• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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  • 优先权
    • 专利摘要:
    REINFORCED BALLOON CATHETER One embodiment of the present invention describes a balloon-type catheter employing a reinforced, coaxial, dual-lumen design. In certain embodiments, at least one of the lumens is formed from a multilayer tubular element in which one of the layers functions, in part, to provide radial reinforcement for the tubular element.
    公开号:BR112013021755B1
    申请号:R112013021755-3
    申请日:2012-02-24
    公开日:2021-08-31
    发明作者:Joseph Gulachenski；Cathy Lei；Nelson Peralta；Tadele Haile
    申请人:Microvention, Inc；
    IPC主号:
    专利说明:

    Related Orders
    [001] This application claims priority from provisional U.S. Application No. 61/446,879, filed February 25, 2011, entitled Reinforced Balloon Catheter, which is incorporated herein by reference in its entirety. Field of Invention
    [002] The present invention relates to balloon catheters and, more particularly, to balloon catheters having a plurality of reinforced coaxial guiding lumens. Fundamentals of the Invention
    [003] Balloon catheters are increasingly being used to conduct neurological procedures in patients. However, the design parameters for balloon catheters intended for use in neurological procedures are significantly different from the design parameters for balloon catheters used in non-neurological procedures such as cardiac procedures. For example, the width of the circulatory system within the neuroanatomy is significantly smaller and more tortuous than the circulatory system elsewhere in the body. In order to access the smallest and most tortuous regions of the neuroanatomy, it is necessary to minimize the external diameter of the balloon catheter while simultaneously maintaining the propulsion and tracking capacity of the catheter.
    [004] In order to minimize the external diameter, balloon catheters intended for neurological procedures employ an unreinforced single-lumen over-the-wire design. Accordingly, these balloon catheters tend to have several problems. First, the unreinforced lumen is susceptible to ovalization and/or bending, which, in turn, impairs the advancement of the catheter through the guidewire, in addition to deflating the balloon. Second, the single lumen is in communication with the arterial blood flow. As the guidewire and balloon catheter are manipulated through the circulatory system, blood is drawn into the single lumen of the balloon catheter. Blood can thus enter the balloon during inflation and cause (1) poor balloon imaging, eg, poor fluoroscopic imaging; (2) poor balloon passage through the circulatory system due to premature balloon inflation; and (3) poor balloon deflation due to blood clotting at the filling port and balloon deflation. An additional disadvantage of single-lumen balloon catheters is that interference fit of the guidewire and balloon inflation seal can result in the removal of the hydrophilic coating from the guidewire.
    [005] In order to minimize the outside diameter, current balloon catheters intended for neurological procedures are also typically designed to work with only a narrow calibration guidewire that is supplied by a manufacturer along with the balloon catheter. Current balloon catheters employ guide wires having diameters in the range of 0.25 mm to 0.3 mm. These relatively narrow guidewires are soft and therefore very difficult to maneuver through the small tortuous neuroanatomy.
    [006] What is needed in the field is a balloon catheter that is operative for use with larger gauge guide wires; that resists ovalization and bending of the fill and guide wire lumens; and that deploys with improved propulsion and tracking capabilities. Objectives and Summary of the Invention
    [007] It is an object of the present invention to provide a balloon catheter that is operated for use with large gauge guidewires; that resists ovalization and bending of filler and guidewire lumens and that deploys with improved propulsion and tracking capability.
    [008] One embodiment of the present invention achieves these goals by providing a balloon catheter that employs a reinforced, coaxial, double-lumen design. In certain embodiments, the lumen is formed from a multilayer tubular element in which one of the layers functions, in part, to provide radial reinforcement for the tubular element.
    [009] In another embodiment of the present invention, the distal part of an outer lumen is locked or secured to a part of an inner lumen. A proximal portion of a balloon is attached to a distal portion of the outer lumen and a distal portion of the balloon is attached to a distal portion of the inner lumen. In another embodiment a fluid flow passage is provided between the external lumen and an internal volume of the balloon, and a unique passage for gas or air is formed from the internal volume of the balloon longitudinally through a distal portion of the balloon catheter. .
    [010] In other certain modalities, the air removal channels or accessories are employed between an outer surface of the inner lumen and an inner surface of the balloon in order to facilitate the purging of gas from the filling passage of the balloon catheter. Brief Description of Drawings
    [011] These and other aspects, characteristics and advantages of which the modalities of the invention are capable will be apparent and elucidated from the following description of the modalities of the present invention, reference being made to the attached drawings, in the which: Figure 1 is an elevation view of a balloon catheter according to an embodiment of the present invention; Figure 2 is a partial elevation view of a balloon catheter in accordance with an embodiment of the present invention; Figure 3 is a cross-sectional view taken along line A-A of Figure 1 of a balloon catheter in accordance with an embodiment of the present invention; Figure 4A is a partial elevation view of an external assembly of a balloon catheter in accordance with an embodiment of the present invention; Figure 4B is a cross-sectional view taken along line C-C of Figure 4A of an outer assembly of a balloon catheter in accordance with an embodiment of the present invention; Figure 5A is a partial elevation view of an inner assembly of a balloon catheter in accordance with an embodiment of the present invention; Figure 5B is a cross-sectional view taken along line D-D of Figure 5A of a balloon catheter inner assembly in accordance with an embodiment of the present invention; Figure 5C is a cross-sectional view taken along line E-E of Figure 5A of an inner assembly of a balloon catheter in accordance with an embodiment of the present invention; Figure 6 is an exploded view of the region 13 indicated in Figure 1 of a balloon catheter according to an embodiment of the present invention; Figure 7 is a cross-sectional view taken along line B-B of Figure 2 of a balloon catheter inner assembly in accordance with an embodiment of the present invention; Figure 8 is a cross-sectional view taken along line D-D of Figure 5A of an inner assembly of a balloon catheter in accordance with an embodiment of the present invention; Figure 9 is a cross-sectional view taken along line B-B of Figure 2 of a balloon catheter inner assembly in accordance with an embodiment of the present invention. Description of Modalities
    [012] Specific embodiments of the invention will now be described with reference to the attached drawings. This invention can, however, be embodied in many different forms and should not be considered limited by the modalities presented here; rather, these modalities are provided so that this description is thorough and complete, and fully conveys the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the attached drawings should not be limiting of the invention. In the drawings, like numbers refer to like elements.
    [013] The balloon catheter of the present invention solves many of the disadvantages of current balloon catheters intended for use in neurological procedures. Broadly speaking, the balloon catheter of the present invention employs a reinforced, coaxial, dual-lumen design. The innermost lumen operates to serve, among other functions, as a guidewire lumen for over-the-wire procedures. The outer lumen operates to serve as a fill lumen for one or more balloons positioned along the length of the balloon catheter. Each lumen is formed by a multi-layer tubular element in which one of the layers, for example an intermediate layer in a three-layer modality, functions in part to provide radial reinforcement for the tubular element. Accordingly, the balloon catheter of the present invention operates with large gauge guidewires; resists ovalization and bending of fill and guide wire lumens; and unfolds with improved propulsion and tracking capabilities over current balloon catheters intended for use in neurological procedures.
    [014] With reference to Figures 1 to 3 and 6, a balloon catheter 10 according to an embodiment of the present invention comprises a hub 12, a balloon 18, and an outer assembly 14 having a lumen 20 through which an assembly inner 16 is coaxially positioned. As best illustrated in Figure 6, an exploded view of the region 13 indicated in Figure 1, a proximal portion 36 of the outer assembly 14 is associated with a fill lumen 32 of the hub 12. A proximal portion 38 of the inner assembly 16 extends from It forms proximally from the lumen 20 of the outer assembly 14 and is associated with the guidewire port 34 of the hub 12. At an opposite end of the catheter, a proximal portion 24 of the balloon 18 is associated with a distal portion 26 of the outer assembly 14 , and a distal portion 28 of balloon 18 is associated with a distal portion 30 of inner assembly 16. Alternatively, opposite ends of balloon 18 span between distal portion 26 of outer assembly 14 and distal portion 30 of internal assembly 16 .
    [015] As illustrated in figures 4A and 4B, the outer assembly 14 is a tubular structure having a multilayer wall; an inner layer 40, an intermediate layer 42 and an outer layer 44. The inner layer 40 of the outer assembly 14 is formed of a longitudinally continuous or segmented tubular member. In embodiments in which the inner layer 40 of the outer assembly 14 is formed of longitudinally segmented tubular elements, the individual segments can be manufactured from the same material or different materials and can be fixed to each other by soldering, fusing, adhesion, casting or other methods of polymerization or non-polymerization. Inner layer 40 of outer assembly 14 is fabricated from one or more different polymeric materials, or alternatively, inner layer 40 of outer assembly 14 is formed of a single etched polytetrafluoroethylene, PTFE tube. While a variety of materials are contemplated for use in the fabrication of inner layer 40 of outer assembly 14, it is of particular importance that the material from which inner layer 40 is formed has a higher melting temperature than that the temperature employed to melt or otherwise secure the outer layer 44 to the inner layer 40 and to the intermediate layer 42 of the outer assembly 14.
    [016] In one embodiment of the present invention, the intermediate layer 42 of the outer assembly 14 comprises a wire 46 spirally wound around the outer surface 48 of the inner layer 40 of the outer assembly 14. The wire 46 can be wound in a single layer from one end of inner layer 40 to the other end to form a spiral-like structure or, alternatively, may be repeatedly rolled from one end of inner layer 40 to the other end to form a multiple spiral shape. layers as illustrated in Figure 4A. In embodiments employing the intermediate layer 42 having a multilayer spiral shape, the different windings may be formed from one or multiple independent strands 46. The strand 46 may have a circular, rectangular, triangular or flat type cross-sectional shape. tape, or combinations thereof. Wire 46 is fabricated from a variety of polymeric and/or metallic materials, for example stainless steel. Wire 72 has a diameter that is variable or consistent along the length of wire 72. For example, wire 72 may have a diameter of approximately 0.03 mm. It is also contemplated that the intermediate layer 42 may be formed from a weave, braid and/or weft of one or more yarns 46.
    [017] The slope of the winding of wire 46 can be consistent or varied along the length of the inner layer 40. For example, a first proximal segment of the winding may have an inclination of approximately 0.08 mm, a second more distal segment may have an inclination of approximately 0.09 mm, a third most distal segment may have an inclination of approximately 0.1 mm, a fourth most distal segment may have an inclination of approximately 0.11 mm, a fifth more distal segment may have a slope of approximately 0.13 mm, and a more distal sixth segment may have a slope of approximately 0.03 mm. In embodiments employing the intermediate layer 42 having a multilayer spiral the outermost winding may, for example, have a slope of approximately 2.54 cm.
    [018] In an embodiment of the present invention, the outer layer 44 of the outer assembly 14 comprises a longitudinally continuous or segmented tubular element. The outer layer 44 of the outer assembly 14 is formed from longitudinally segmented, heat-shrunk tubular elements. The individual segments can be fabricated from the same material or different materials and can be bonded together by soldering, melting, bonding, casting, or curing or non-curing methods, or combinations thereof.
    [019] In one embodiment, the outer layer 44 of the outer assembly 14 is manufactured from multiple different polymeric tubular segments. For example, a proximal segment 50 of outer layer 44 of outer assembly 14 may be formed of a tubular polyamide such as Girlamid L25. The proximal segment 50 has a length 51 of, for example, approximately 110 cm. A second more distal segment 52 may be formed from a tubular polyether block amide such as Pebax 72D. The second most distal segment 52 has a length 53 of, for example, approximately 10 cm. A third most distal segment 54 may be formed from a tubular polyether block amide such as Pebax 63D. The third most distal segment 54 has a length 55 of, for example, approximately 5 cm. A fourth most distal segment 56 may be formed from a tubular polyether block amide such as Pebax 55D. The fourth most distal segment 56 has a length 57 of, for example, approximately 20 cm. A fifth most distal segment 58 can be formed from a tubular polyether block amide such as Pebax 45D. The fifth most distal segment 58 has a length 59 of, for example, approximately 10 mm. A sixth most distal segment 60 can be formed of a polyolefin such as Plexar. A sixth most distal segment 60 has a length 61 of, for example, approximately 2 mm. A most distal segment 62 may be formed from a polyolefin such as Engage 8003. The most distal segment 62 has a length 63 of, for example, approximately 13 cm.
    [020] The outer assembly 14 can be manufactured by winding the wire 46 around the inner layer 40, thus forming the intermediate layer 44. The tubular segment or segments of the outer layer 44 are then slid over the intermediate layer 42. A tube A heat shrinkage of, for example, fluorinated ethylene propylene, FEP, is then slipped over outer layer 44. FEP is heated so as to distribute heat to outer layer 44, and outer layer 44 then softens to encapsulate yarn 46 The FEP tube is then removed from the outer layer 44.
    [021] In an embodiment of the present invention, the outer diameter of the outer layer 44 of the outer assembly 14 is in the range of 0.76 mm to 1.02 mm. The lumen 20 of the outer assembly 14 can have a diameter between 0.51 mm and 0.74 mm. In one embodiment, the lumen 20 of the outer assembly 14 may have a diameter of approximately 0.72 mm.
    [022] As illustrated in Figures 5A and 5B, the inner assembly 16 is a tubular structure having a multilayer wall formed of an inner layer 64, intermediate layer 66, and outer layer 68. The inner layer 64 of the inner assembly 16 is formed of longitudinally continuous or segmented tubular elements. In embodiments in which the inner layer 64 of the inner assembly 16 is formed from longitudinally segmented tubular elements, the individual segments may be manufactured from the same material or different materials and may be fixed to one another by welding, fusion , adhesion, casting or other polymerization or non-polymerization methods, or combinations thereof. Inner layer 64 of inner assembly 16 is fabricated from one or more different polymeric materials, or alternatively, inner layer 64 of outer assembly 14 is formed from a non-segmented etched polytetrafluoroethylene tube, single, PTFE. While a variety of materials are contemplated for use in manufacturing the inner layer 64 of the inner assembly 16, it is important to employ a material that has a higher melting temperature than the temperature employed to melt or otherwise fix the outer layer. suit 68 to inner layer 64 and intermediate layer 66 of inner assembly 16. It is also desirable to employ a material which has a relatively low coefficient of friction.
    [023] In one embodiment of the present invention, the intermediate layer 66 of the inner assembly 16 comprises a wire 70 spirally wound around the outer surface 72 of the inner layer 64 of the inner assembly 16. The wire 72 can be wound in a single layer from one end of inner layer 64 to the other or, alternatively, may be repeatedly wound from one end of inner layer 46 of outer assembly 14. In embodiments employing intermediate layer 66 having a multilayer spiral shape , the different spirals may be formed from single strands or multiple independent strands 72. The strand 72 may have a circular, rectangular, triangular, flat or ribbon-shaped cross-sectional shape, or a combination thereof. Wire 72 can be fabricated from a variety of metallic and/or polymeric materials, for example, stainless steel. Wire 72 may have a diameter that varies or is consistent along the length of wire 72. For example, wire 72 may have a diameter of approximately 0.03 mm. It is also contemplated that the intermediate layer 42 may be formed from a weft or weft of one or more yarns 46.
    [024] The slope of the wire winding 72 can be consistent or varied along the length of the inner layer 64 of the inner assembly 16. For example, a first proximal segment of the wire winding 72 can have a slope of approximately 0.08 mm , a second more distal segment may have a slope of approximately 0.08 mm and a third more distal segment may have a slope of approximately 0.03 mm.
    [025] As illustrated in Figures 2 and 5A, in one embodiment of the present invention, one or more marker strips 82A, 82B and 82C are placed, for example, over wire 70 forming the intermediate layer 66 of the assembly internal 16. Marker strips 82A, 82B and 82C comprise a radiopaque material such as gold, aluminum or silver, and are used to determine the location of balloon catheter 10 within a patient. In certain embodiments of the present invention, the marker strip 82A may be located at a distance L3 near a distal end 86 of the inner assembly 16. For example, the distance L3 may be 5 mm.
    [026] The marker strips 82B and 82C may be positioned more proximally to the marker strip 82A so as to indicate or mark the proximal part 24 and the distal part 28 of the balloon 18. It will be understood that the exact placement of the balloons marker strips 82B and 82C with respect to distal end 86 of inner assembly 16 will depend on the dimensions of balloon 18 employed in balloon catheter 10.
    [027] For example, in an embodiment employing a 10 mm long balloon 18, a proximal end 84 of the marker strip 82C is at a distance L1 from the distal end 86 of the inner assembly 16. For example, the distance L1 can be of approximately 19.5 mm. Opposite ends of marker strips 82B and 82C are at a distance L2 from each other. For example, the L2 distance can be 10 mm. In an embodiment employing a 20 mm long balloon 18, the distance L1 is, for example, approximately 29.5 mm, and the distance L2 is, for example, 20 mm. In another embodiment, marker band 82C may be located directly under filler plug 88.
    [028] In an embodiment of the present invention, the outer layer 68 of the inner assembly 16 comprises a longitudinally continuous or segmented tubular element. Preferably, the outer layer 68 of the inner assembly 16 is formed from a series of longitudinally segmented, heat-shrinkable tubular elements. The individual segments are fabricated from the same material or different materials and can be bonded together by soldering, fusing, bonding, casting, or other curing or non-curing methods. Preferably, outer layer 68 of inner assembly 16 is fabricated from multiple different polymeric tubular segments. For example, a proximal segment 74 of outer layer 68 of inner assembly 16 may be formed of a tubular polyether block amide such as Pebax 63D. The proximal segment 74 has a length 75 of, for example, approximately 150 cm. A second more distal segment 76 can be formed from a tubular polyester block amide such as Pebax 45D. The second most distal segment 76 has a length 77 of, for example, approximately 10 cm. A third most distal segment 78 may be formed of a polyolefin such as Plexar 3080. The third most distal segment 78 has a length 79 of, for example, approximately 2 mm. A more distal segment 80 may be formed of a polyolefin such as Engage 8003 and has a length 81 of, for example, approximately 5 cm.
    [029] The inner assembly 16 can be manufactured by winding the wire 70 around the inner layer 64, thus forming the intermediate layer 66. Next, the marker strips 82A, 82B and 82C are placed on or within the intermediate layer 66, and the tube segment or segments of the outer layer 68 are then slid over the marker strips 82A, 82B and 82C in the intermediate layer 66. A heat shrink tube of, for example, fluorinated ethylene propylene, FEP, is then slipped over outer layer 68. FEP is heated to distribute heat to outer layer 68, thereby softening outer layer 68 so as to encapsulate yarn 70 forming intermediate layer 66. The FEP tube is then removed of the outer layer 68.
    [030] In one embodiment of the present invention, the wire 70 forming the intermediate layer 66 of the inner assembly 16 may terminate near the distal end 86 of the outer assembly 16. A tubular element 100 may be employed for all or part of the length between the distal end 86 is the point at which wire 70 terminates. The tubular element 100 may, for example, be formed of a cross-linked polyolefin tube having a length of approximately 5 mm.
    [031] In an embodiment of the present invention, the outer diameter of the outer layer 68 of the inner assembly 16 is in the range of 0.38 mm to 0.64 mm, and more preferably in the range of 0.51 mm to 0. 57 mm.
    [032] As illustrated in Figures 2, 5A and 5C, in one embodiment of the present invention, the inner assembly 16 may additionally comprise a filling plug 88. The filling plug 88 is formed of a tubular segment of material having a wall of uniform or asymmetrical thickness. In some embodiments, the fill plug may have a durometer ranging from 18A to 55D. The filling plug 88 may, for example, be formed of polyether block amide such as Pebax 55D. The fill plug can, for example, be approximately 5 mm long and a distal end 90 of the fill plug 88 can, for example, be positioned approximately 4 mm from the proximal end 84 of the marker strip 82C. An outer dimension or diameter of the fill plug 88 is large enough that the fill plug 88 does not completely pass into the lumen 20 of the outer assembly without significant force. Filler plug 88 may be formed in inner assembly 16 as described above in connection with forming outer layer 68 of inner assembly 16.
    [033] As illustrated in Figure 5C, the fill plug 88 may comprise one or more passages or channels 92 formed longitudinally along the length of the fill plug. Channel 92 can be formed by placing a mandrel along the outer surface of filler plug 88 prior to sliding the heat shrink tube of, for example, FEP over filler plug 88. When FEP is heated so as to distributing heat to the fill plug 88, the mandrel melts within the fill tube, thereby channel 92 within the fill plug 88. The FEP tube is then removed from the fill plug 88.
    [034] The fill plug 88 functions, in part, to longitudinally lock the inner assembly 16 to the outer assembly 14 so as to prevent changes in the length of the distal extension of the distal portion 30 of the inner assembly 16 with respect to a distal end 98 of outer assembly 14 due to inflation and orientation of balloon 18 during a procedure. The passageway or channel 92 formed in the plug 88 allows fluid communication between the lumen 20 of the outer assembly and an inner volume of the balloon 18.
    [035] As illustrated in figures 3, 5B, 5C and 7, the inner assembly 16 comprises an inner lumen 22. The lumens function as a guidewire lumen for over-the-wire procedures. Lumen 22 of inner assembly 16 may have a diameter of at least approximately 0.42 mm. Accordingly, the balloon catheter 10 of the present invention can be used with guide wires having a larger diameter than guide wires supplied with current balloon catheters intended for use in neurological procedures. For example, the present balloon catheter 10 can be used with a guidewire having a diameter of 0.36 mm. This feature allows a physician to more easily access a neuroanatomical target, such as an aneurysm, as the relatively larger guidewire provides more support for the balloon catheter 10 through which to track.
    [036] Additionally, the guidewire can be removed from the lumen 22 after placement of the balloon catheter into a patient and the lumen 22 can serve as a functional lumen for the passage of additional medical devices or substances to the target site. inside the patient.
    [037] It will be understood that it is generally beneficial for outer assembly 14 and inner assembly 16 to be more flexible in their distal parts than in their proximal parts. Additionally, it is contemplated that the distal portions of outer assembly 14 and/or inner assembly 16 may be pre-shaped or operable to be formatted by a physician prior to commencing a procedure using, for example, vapor shaping techniques.
    [038] As illustrated in Figures 1 and 6, the proximal part 36 of the outer assembly 14 ends distally from the proximal part 38 of the inner assembly 15. Accordingly, the lumen 20 of the outer assembly is in communication with the filling port 32 Figures 1 and 6 also illustrate that the proximal portion 38 of the inner assembly 16 extends proximally beyond the proximal portion 36 of the outer assembly 14 and is associated with the guidewire port 34 of the hub 12. Accordingly, the lumen 22 of the inner assembly and guidewire port 34 of hub 12 together form a substantially continuous lumen through which a guidewire or other medical device can pass. Outer assembly 14 and inner assembly 16 can be secured to hub 12 by various methods, including soldering, melting, tacking, casting, or other polymerizing or non-polymerizing method, or combinations thereof. It is noted that this configuration of hub 12 and association of hub 12 with outer assembly 14 and inner assembly 16 advantageously provides isolation of lumen 22 of inner assembly 16 from lumen 20 of outer assembly 14. Isolation of these lumens and their functionality serves , in part, to address many of the disadvantages described above with regard to current single-lumen balloon catheters intended for neurological procedures.
    [039] As illustrated in Figures 1 and 2, the proximal part 24 of the balloon 18 is associated with the distal part 26 of the outer set 14, and the distal part 28 of the balloon 18 is associated with the distal part 30 of the inner set 16. Balloon 18 can be attached to distal portion 26 of outer assembly 14 and distal portion 30 of inner assembly 16 by various methods including soldering, fusing, bonding, casting, or other polymerizing or non-polymerizing methods and combinations thereof. In certain embodiments, the distal portion of balloon 18 covers and extends to the distal end 86 of inner assembly 16. Balloon 18 may, for example, be formed of Polyblend 45A or other polymeric elastomeric material. Balloon 18 may have an outside diameter of up to approximately 15 mm and a length in the range of 5 to 50 mm, and preferably a length in the range of 10 to 20 mm.
    [040] As illustrated in Figure 7, in an embodiment of the present invention, one or more air vent ports 94 are employed at the interface of the distal part 30 of the inner assembly 16 and the distal part 28 of the balloon 18. The vent ports of air 94 are formed by placing one or more mandrels having diameters in the range of 0.01 mm to 0.76 mm on the outer surface of outer layer 68 of inner assembly 16. An inner surface 96 of balloon 18 is then secured over the mandrels to the outer layer 68 of the inner assembly 16. After the balloon 18 is secured to the distal portion 30 of the inner assembly 16 the mandrels are removed. Accordingly, flow paths large enough for the passage of gas and small enough to seal against the passage of liquids are formed.
    [041] Air purge ports 94 function to facilitate removal of air from lumen 20 and balloon 18 prior to starting a medical procedure. With current coaxial balloon catheters, it is very difficult to remove all the air from the fill/deflate lumen before starting a medical procedure. Clinicians must typically remove air from a balloon catheter for several minutes of aspiration or suction through the fill/deflate lumen. Air that is not removed will show in images taken during the procedure and may obscure details that the meter must otherwise need to observe in order to perform the procedure.
    [042] In contrast, the air purge ports 94 of the present invention allow a user to more efficiently remove air from lumen 20, the fill/empty lumen. In practice, before starting the procedure, a physician must position the distal end of the balloon catheter 10 higher than the proximal end and then inject a balloon-filling medium, such as contrast medium or saline, through the fill port 32 and associated lumen 20. As the fill medium fills lumen 20, air is forced out of the air bleed ports 94 until there is no more air inside lumen 20 or balloon 18. The clinician may repeat the process as necessary to ensure all air is removed from lumen 20 of outer assembly 14 and balloon 18.
    [043] In another embodiment of the present invention, as illustrated in Figures 8 and 9, the above described functionality of the filling ports 32 is improved by employing one or more air removal channels 102. The air removal channel 102 is formed in outer layer 68 of inner assembly 16. At a minimum, air removal channel 102 initiates longitudinal approach from distal end 90 of filler plug 88 and continues uninterruptedly to a proximal end of air purge port 94. The length of the air removal channel 102 may extend to or overlap the distal end 90 of the fill plug 88 and/or the proximal end of the air purge port 94. The air removal channel 102 may be radially aligned or radially offset with channel 92 of fill plug 88 and/or vent port 94 with respect to a geometric axis through lumen 22 of inner assembly 16.
    [044] The air removal channel 102 is formed by placing one or more mandrels having diameters in the range of 0.03 mm to 0.76 mm between the outer layer 68 of the inner assembly 16 and the heat shrink tube and then heating the shrink tube by heat as described above. In certain embodiments, the air removal channel 102 is radially aligned with the air bleed port 94 and/or with the channel 92 formed in the filler plug 88. For example, Figure 9 illustrates an embodiment in which the Air removal channel 102 is radially aligned with air purge port 94. Air removal channel 102 and air purge port 94 each form a part of a unified channel. In embodiments in which the air removal channel 102 is radially aligned with the air bleed port 94 and/or with the channel 92 formed in the filler plug 88, the air removal channel 102 may extend longitudinally the length of the vent port 94 and/or may extend longitudinally inward or proximally beyond channel 92 formed in filler plug 88.
    [045] The air removal channel 102 helps ensure that a fluid and air flow path is kept unobstructed between the outer surface of the inner assembly 16 and the inner surface 96 of the balloon 18. Whereas the balloon 18 it can be snugly fitted over the inner assembly 16 when the balloon is not inflated, without an air removal channel 102, it may not always be possible to purge air from the lumen 20 of the outer assembly 14 without deflating the balloon 18. Thus, the air removal channel 102 provides an unobstructed recess or channel in the outer surface of the inner assembly 16 that permits the passage of air and fluid between the deflated balloon and the outer surface of the inner assembly 16. Thus, air can be purged from balloon catheter 10 without inflating balloon 18.
    [046] It is also contemplated that the air removal channel 102 may take the form of one or more channels or spiral grooves, spiral protrusions, and/or longitudinal protrusions on the outer surface of the inner assembly 16. The removal channel air 102 may also take the form of one or more small tubular elements joined to the outer surface of inner assembly 16.
    [047] It is noted that while the present invention has been described with respect to neurological procedures, it is contemplated that certain features of the present balloon catheter also address needs in non-neurological fields.
    [048] Although the invention has been described in terms of particular embodiments and applications, those skilled in the art, in view of the teachings, may generate additional embodiments and modifications without departing from the spirit or exceeding the scope of the claimed invention . Accordingly, it is to be understood that the drawings and descriptions herein are given by way of example to facilitate understanding of the invention and are not to be considered as limiting the scope of the invention.
    权利要求:
    Claims (15)
    [0001]
    1. Balloon catheter, comprising: a reinforced outer tubular assembly (14); a reinforced inner tubular assembly (16) coaxially inserted into a lumen (20) of the outer assembly (14); and a balloon (18) having a proximal end (24) attached to a distal portion (26) of the outer tube assembly (14) and a distal portion (28) attached to a distal portion (30) of the inner tube assembly (16) , and wherein the reinforced inner tube assembly (16) comprises a tube filling plug (88) longitudinally locking the inner tube assembly (16) to the outer tube assembly (14) so as to prevent changes in the length of the distal extension of the distal portion. (30) of the inner tube assembly (16) with respect to a distal end (98) of the outer tube assembly (14), and the tube filling plug (88) comprises one or more passages (92) for fluid communication between the lumen (20) of the outer assembly (14) and an inner volume of the balloon (18); CHARACTERIZED by: a channel having a length formed entirely and directly on the outer surface of the inner tube assembly (16); the length extending longitudinally towards a distal portion of the balloon catheter and at least partially under the distal portion (28) of the balloon (18).
    [0002]
    2. Balloon catheter, according to claim 1, CHARACTERIZED by the fact that the reinforced outer tubular assembly (14) comprises an inner (40), intermediate (42) and outer (44) layer.
    [0003]
    3. Balloon catheter, according to claim 2, CHARACTERIZED by the fact that the intermediate layer (42) of the reinforced outer tubular assembly (14) comprises a coil.
    [0004]
    4. Balloon catheter, according to claim 3, CHARACTERIZED by the fact that the coil is encapsulated.
    [0005]
    5. Balloon catheter, according to claim 3, CHARACTERIZED by the fact that an inclination of the coil varies along a length of the coil.
    [0006]
    6. Balloon catheter, according to claim 2, CHARACTERIZED in that the outer layer (44) of the reinforced outer tubular assembly (14) comprises a plurality of different longitudinal sections (52, 54, 56, 58, 60, 62 ).
    [0007]
    7. Balloon catheter, according to claim 1, CHARACTERIZED by the fact that the reinforced inner tubular assembly (16) comprises an inner, intermediate and outer layer.
    [0008]
    8. Balloon catheter, according to claim 7, CHARACTERIZED by the fact that the intermediate layer (66) of the reinforced inner tubular assembly (16) comprises a coil.
    [0009]
    9. Balloon catheter, according to claim 8, CHARACTERIZED by the fact that the coil is encapsulated.
    [0010]
    10. Balloon catheter, according to claim 8, CHARACTERIZED by the fact that the inclination of the coil varies along a length of the coil.
    [0011]
    11. Balloon catheter, according to claim 7, CHARACTERIZED by the fact that the outer layer (68) of the reinforced inner tubular assembly (16) comprises a plurality of different longitudinal sections (74, 76, 78, 80).
    [0012]
    12. Balloon catheter, according to claim 1, CHARACTERIZED by the fact that a lumen of the reinforced inner tubular assembly (16) has a diameter of approximately 0.42 mm.
    [0013]
    13. Balloon catheter, according to claim 1, CHARACTERIZED by the fact that the filling plug (88) is formed in the reinforced inner tubular catheter assembly (16).
    [0014]
    14. Balloon catheter, according to claim 13, CHARACTERIZED in that the filling plug (88) comprises the passage (92) formed longitudinally along the length of the tubular filling plug (88) that allows fluid communication between the lumen (20) of the outer assembly (14) and an inner volume of the balloon (18).
    [0015]
    15. Balloon catheter, according to claim 1, CHARACTERIZED by the fact that it comprises one or more air bleed ports (94) in a distal part of the balloon catheter.
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-15| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2021-03-16| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2021-07-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-08-31| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/02/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161446879P| true| 2011-02-25|2011-02-25|
    US61/446,879|2011-02-25|
    PCT/US2012/026638|WO2012116337A1|2011-02-25|2012-02-24|Reinforced balloon catheter|
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