WO2015101333A1 - 一种导引导管 - Google Patents
一种导引导管 Download PDFInfo
- Publication number
- WO2015101333A1 WO2015101333A1 PCT/CN2014/095936 CN2014095936W WO2015101333A1 WO 2015101333 A1 WO2015101333 A1 WO 2015101333A1 CN 2014095936 W CN2014095936 W CN 2014095936W WO 2015101333 A1 WO2015101333 A1 WO 2015101333A1
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- WIPO (PCT)
- Prior art keywords
- guiding catheter
- inner tube
- catheter
- tube
- shape
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
Definitions
- the present invention relates to the field of medical device technology, and in particular to a guiding catheter.
- the guiding catheter is a specially designed sheath that provides the direction of the channel. It is often used to deliver a variety of interventional devices to target, support and protect them. Modern technology is rapidly developing. In order to meet clinical needs, guiding catheters of various shapes and functions have been developed, such as guiding catheters with balloons.
- the balloon withdrawal time and the softness of the guiding catheter tip are also critical.
- the balloon collapses during the pumping process resulting in longer balloon withdrawal time, increasing the risk of thrombosis and distal vascular ischemia; Entering further blood vessels leads to failure of some stent or embolization procedures.
- the present invention provides a guiding catheter that can withstand not only a large negative pressure, but also a small balloon withdrawal time and a soft head end.
- the present invention provides the following technical solutions:
- a guiding catheter includes an outer tube, an inner tube, one or more liquid passing chambers, and a balloon communicating with the liquid passing chamber, wherein the one or more liquid passing chambers are distributed on the outer tube wall
- the cross section of the liquid passage chamber extends the farthest distance in the circumferential direction of the duct larger than the farthest distance in the radial direction of the duct.
- the wall of the liquid passage partially coincides or conforms to the outer wall of the inner tube.
- the shape of the cross section of the liquid passage cavity is a crescent shape, an elliptical shape, a bone shape, and a cashew shape. Or waist shape.
- the wall of the liquid passage is coated with a smooth film.
- the inner tube is composed of an outer layer, an intermediate layer and an inner layer, wherein the outer layer is made of polyurethane; the intermediate layer is made of wire wound and/or braided, and the wire is one of the following materials , or a combination of several: stainless steel, nickel titanium alloy, tungsten; the inner layer is a copolymer of one or more of polyfluorocarbon, polyethylene, polypropylene or polyamide.
- the material of the outer tube is one of the following materials, or a combination of several: polyamide, polyurethane, nylon, high density polyethylene, block polyetheramide elastomer; and the outer tube The hardness of the material is gradually reduced from the proximal end to the distal end.
- a distal end of the balloon and a distal end of the guiding catheter form a head end of the guiding catheter, the head end being an extension of an inner layer and an outer layer of the inner tube form.
- the length of the head end is from 3 mm to 100 mm.
- the guiding catheter is non-coaxial, and one or more liquid passing chambers form a non-coaxial cavity in the wall thickness of the outer tube wall, and the size and shape of the liquid passing chamber can be according to the balloon.
- the expansion time and the withdrawal time are required to design.
- the three-layer structure of the inner tube of such a catheter and the inner layer of braided and/or wound wire therein enable the inner tube of the catheter to participate in the support of the catheter, increasing the ability of the catheter to withstand negative pressure.
- the shape of the cross section of the liquid passage chamber can utilize the space in which the wall thickness of the outer tube is located as much as possible to provide a large flow rate and has less influence on the ability of the duct to withstand a negative pressure.
- FIG. 1 is a schematic view showing the outer shape of a guiding catheter according to an embodiment of the present invention
- FIG. 2 is a schematic view of a cross section of a guiding catheter in accordance with an embodiment of the present invention
- 3A to 3E are schematic views of several alternative versions of the A-A section of FIG. 2;
- FIGS. 4 and 5 are schematic structural views of an inner tube according to an embodiment of the present invention.
- Figure 6 is a schematic illustration of the tip end structure of a guiding catheter in accordance with an embodiment of the present invention.
- the guiding catheter in the embodiment of the present invention includes an expandable balloon 3, a delivery catheter body 2, a diffusion stress tube 4, and a connector 1.
- the delivery catheter body 2 includes an outer tube 21, The inner tube 22, the liquid passage chamber 5 and the guiding chamber 6, wherein the inner surface of the liquid passage chamber 5 is made of a low friction coefficient material, and the guiding chamber 6 is constituted by the inner cavity of the inner tube 22;
- the outer tube 21 of the body 2 is sleeved on the outer circumference of the inner tube 22.
- the length of the outer tube 21 of the delivery catheter body 2 is smaller than the length of the inner tube 22, that is, at the distal end of the delivery catheter body 2 (near the expandable At one end of the balloon 3, the outer circumference of a portion of the inner tube 22 is not covered by the outer tube 21, but is covered by the expandable balloon 3.
- the proximal end of the expandable balloon 3 is sealingly connected to the distal end of the outer tube 21, and the distal end of the expandable balloon 3 is sealingly connected to the distal end of the inner tube 22; the proximal end portion of the delivery catheter body 2 extends into the connection
- the distal end of the device 1 is such that the connector main hole 12 at the proximal end of the connector 1 communicates with the guiding cavity 6 of the delivery catheter body 2, and the diffusion stress tube 4 is disposed at the junction of the connector 1 and the outer tube 21, and diffuses
- the proximal end of the stress tube 4 is connected to the distal end of the connector 1 by, for example, glue 9.
- a developing point 7 is embedded in the wall of the inner tube 22 at the portion of the balloon 3, and the developing point 7 is used for accurate positioning of the catheter during the operation.
- the guiding catheter in this embodiment is non-coaxial, and the liquid passing chamber 5 is located in the wall thickness of the outer tube 21, so it is non-coaxial with the inner tube 22 and the outer tube 21.
- the cavity, the liquid passage 5 communicates with the balloon 3 for transporting and recovering the balloon expansion medium.
- the size and shape of the liquid passage 5 can be designed according to the required expansion time and the withdrawal time of the balloon.
- This non-coaxial fluid passage 5 enables the inner tube 22 of the catheter to participate in the support of the catheter, increasing the ability of the catheter to withstand negative pressure.
- a portion of the wall of the liquid passage 5 may be the outer wall of the inner tube.
- the wall of the liquid-passing chamber 5 can also be covered with a smooth membrane, which can reduce the friction coefficient of the wall of the liquid-passing chamber 5, and avoid the catheter retraction caused by the excessive expansion of the balloon-expanding medium in the liquid-passing chamber. Difficulties help reduce the time to balloon withdrawal and reduce the risk of thromboembolic complications and distal ischemia.
- the liquid passage chamber can be designed in various shapes. In order to make the expansion time and the withdrawal time of the balloon as short as possible, it is necessary to have the flow volume as large as possible, but the entire tube needs to have a thin outer diameter. To this end, in the present embodiment, the distance of the liquid passage chamber extending in the circumferential direction of the conduit is greater than the distance of the liquid passage chamber extending radially along the conduit, that is, the distance between the cross section of the liquid passage chamber and the farthest point in the circumferential direction of the conduit is greater than The distance between the farthest points in the radial direction is as shown in the liquid passing chambers 51 to 55 in FIGS. 3A to 3E.
- FIG. 3A a cross section of the liquid passage cavity in the shape of a crescent is shown (FIG. 3A, The liquid passing chambers 51, 54, 55 in 3D, 3E and the cross section of the liquid passage similar to the bone shape (such as the liquid passing chamber 53 in Fig. 3C).
- the cross section of the liquid passage chamber may also be elliptical, as shown by the liquid passage chamber 52 in Fig. 3B.
- the fluid passage can also be shaped like a waist; the shape can also be longer, ie similar to the shape of a cashew.
- All of the above shapes are able to utilize the space in which the wall thickness of the outer tube 21 is located as much as possible to provide a large flow rate and have less influence on the ability of the catheter to withstand a negative pressure.
- the wall of the liquid passage chamber 5 may be directly constituted by the material of the outer tube 21; or a part thereof is the outer wall of the inner tube 22, at which time the wall of the liquid passage chamber 5 coincides with the wall portion of the inner tube 22.
- the liquid passage chamber may also have a special wall which can be attached or separated from the outer wall of the inner tube, that is, the material of the wall of the liquid passage chamber is different from the outer tube and the inner tube, and polytetrafluoroethylene (PTFE) may be used.
- PTFE polytetrafluoroethylene
- FEP Fluorinated ethylene propylene
- the liquid passage chamber 5 communicates with the side hole 11 of the connector 1, and the balloon expansion medium is injected into the liquid passage chamber 5 through the side hole 11 of the connector.
- the outer tube 22 is formed by three tubes of different hardness, and is divided into a proximal body having a relatively high hardness from the proximal end to the distal end, an intermediate transition portion having a medium hardness, and a distal body portion having a relatively low hardness. The proximal body portion, the intermediate transition portion and the distal body portion are sequentially connected to form the outer tube 22.
- the outer tube 22 may be a combination of one or more of polyamide, polyurethane, nylon, high density polyethylene, or block polyetheramide elastomer (PEBAX) having a hardness ranging from 78D to 20D.
- the inner tube 22 in the guiding catheter of the embodiment of the present invention includes an inner layer 223, an outer layer 221 and an intermediate layer 222 (spring coil reinforcement), and the guiding cavity 6 is an inner tube.
- the inner layer 223 of 22 is constructed, and a development point 7 may be added to the inner tube 22, see Fig. 6.
- the inner layer 223 of the inner tube is smaller or substantially the same as the outer layer 221 of the inner tube; wherein the inner layer 223 can be made of one of PTFE, FEP and high density polyethylene, or a combination of the two.
- the surface smoothness of the guiding cavity 6 can be improved, so that the guide wire, the thrombectomy device and the like can reach the lesion site more smoothly.
- the inner diameter of the inner tube 22 is preferably from 1.2 mm to 2.1 mm.
- the outer layer 221 may be composed of one or more of nylon, silicone rubber, polyurethane, polyamide series or block polyetheramide elastomer (PEBAX), and has a hardness of 25D-55D.
- the intermediate layer 222 is formed by winding two wires in different directions, and the density of the wires can be set according to the required strength of the product, and each wire is wound into a coil.
- the intermediate layer 222 may include a first wire 2222 wound around the outer surface of the inner layer 223 in a first direction at a higher wire winding density, and is different from the lower wire density.
- the second direction of the first direction wraps around the second wire 2221 outside the first wire 2222.
- the material of the first and second wires 2222, 2221 may be a metal material such as stainless steel 304v, nickel titanium alloy or tungsten, and the diameter is between 0.1 mm and 0.3 mm, and a round wire or a flat wire may be used.
- the distal end of the balloon 3 and the distal end of the inner tube 22 may be sealed by an adhesive to form a connection region, which may serve as a head end or at a distance from the head end, as shown in Figure 6, the catheter head end 8 is The portion between the distal end 81 of the balloon and the distal end of the inner tube 22 (and also the distal end of the entire catheter) 82, in order to make the head end 8 of the catheter as soft as possible so as to be able to enter a further blood vessel, the head end 8
- the inner tube 22 extension portion includes only the inner layer 223 and the outer layer 221 without providing the intermediate layer 222.
- the length of the head end 8 is: 3 mm - 100 mm.
- the entire surface of the guiding catheter of the embodiment of the present invention or at least the portion of the balloon 3 and the head end 8 is formed by a coating such as coating, spraying or the like to form a coating composed of a hydrophilic material, which contributes to lowering surface friction.
- the catheter as a whole enters the blood vessel more smoothly, improving the operational performance of the catheter.
- the hydrophilic coating material may be polyvinylpyrrolidone (PVP), sodium hyaluronate, polyurethane or the like.
- three developing points 7 are used, which are respectively disposed between the head end 8 and the balloon 3, and the material is silver.
- the material of the outer tube 21 is PEBAX, and the hardness from the proximal end to the distal end is gradually reduced to 78D, 55D, and 35D, respectively.
- the inner tube 22 is made of three layers of material, the outer layer 221 is made of polyurethane, the intermediate layer 222 is made of stainless steel, the width of the wire is 0.2 mm, and the inner layer 223 is PTFE.
- the inner tube 22 has an inner diameter of 3 mm.
- the cross section of the liquid passage chamber 5 is in the shape of a crescent as shown in Fig. 3A or 3E.
- the head end 8 of the catheter is designed to have a length of 3 mm. After the whole connection of the catheter is completed, the surface of the catheter is coated with a hydrophilic coating, and the hydrophilic material is selected from: sodium hyaluronate.
- two developing points 7 are used, which are respectively disposed between the head end 8 and the balloon 3, and the material is made of platinum-rhodium alloy.
- the material of the outer tube 21 is PEBAX, and the hardness from the proximal end to the distal end is gradually reduced to 72D, 63D, and 40D, respectively.
- the inner tube 22 is made of three layers of material, the outer layer material 221 is polyurethane, the intermediate layer 222 is made of stainless steel, the wire width is 0.15 mm, and the inner layer 223 is FEP. Inside The inner diameter of the tube 22 is 2 mm, and the liquid passage chamber 54 has a double channel crescent shape as shown in Fig. 3D.
- the catheter head end 8 is designed to have a length of 10 mm. After the entire connection of the catheter is completed, the surface of the catheter is coated with a hydrophilic coating, and the hydrophilic material is selected from polyvinylpyrrolidone (PVP).
- PVP polyvinylpyrrolidone
- two developing points 7 are used, which are respectively disposed between the head end 8 and the balloon 3, and the material is made of platinum-rhodium alloy.
- the material of the outer tube 21 is PEBAX, and the hardness from the proximal end to the distal end is gradually reduced to 72D, 55D, and 25D, respectively.
- the inner tube 22 is made of three layers of material, the outer layer 221 is made of PEBAX, the intermediate layer 222 is made of nickel-titanium alloy, the wire width is 0.15 mm, the inner layer 223 is fluororesin (EFEP), and the inner tube 22 has an inner diameter of 1 mm.
- the liquid-passing chamber adopts a three-channel bone shape, for example, the shape of the liquid-passing chamber 53 shown in FIG. 3C can be set according to the arrangement of the three liquid-passing chambers in FIG. 3E.
- the catheter head end 8 is designed to have a length of 15 mm. After the entire connection of the catheter is completed, the surface of the catheter is coated with a hydrophilic coating, and the hydrophilic material is selected from polyurethane.
- the guiding catheter is non-coaxial, and one or more liquid passing chambers form a non-coaxial cavity in the wall thickness of the outer tube wall, and the size and shape of the liquid passing chamber can be according to the balloon
- the required expansion time and withdrawal time are designed.
- the three-layer structure of the inner tube of such a catheter and the inner layer of braided and/or wound wire therein enable the inner tube of the catheter to participate in the support of the catheter, increasing the ability of the catheter to withstand negative pressure.
- the shape of the cross section of the liquid passage chamber can utilize the space in which the wall thickness of the outer tube is located as much as possible to provide a large flow rate and has less influence on the ability of the duct to withstand a negative pressure.
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Abstract
一种导引导管,包括外管(21)、内管(22)、一个或多个通液腔(5)以及与所述通液腔(5)连通的可扩张球囊(3)。通液腔(5)分布在外管壁厚的圆周上,且其截面在导管周向上延伸的最远距离大于在导管径向上延伸的最远距离。该导引导管能够承受较大的负压并且具有较小的球囊回抽时间。
Description
本发明涉及医疗器械技术领域,特别地涉及一种导引导管。
导引导管是一种专门设计的鞘管,可以提供通道方向。它常用于输送各种介入器械到达靶定目标,为其提供支持和保护。现代技术飞速发展,为了满足临床需求,各种形状、各种功能的导引导管被开发,如带球囊的导引导管等。
对于球囊导引导管来说,除了需要能够承受一定的负压以免发生导管塌陷,球囊回抽时间和导引导管头端的柔软性也至关重要。目前市面上的产品,由于球囊在回抽的过程中,导管发生塌陷,导致球囊回抽时间较长,增加了血栓形成和远端血管缺血的风险;由于导管头端较硬,无法进入更远的血管,导致一些支架或栓塞手术的失败。
发明内容
有鉴于此,本发明提供一种导引导管,不仅能够承受较大的负压,且具有较小的球囊回抽时间和柔软的头端。
为实现上述目的,本发明提供如下技术方案:
一种导引导管,包括外管、内管、一个或多个通液腔以及与所述通液腔连通的球囊,所述一个或多个通液腔分布在所述外管壁厚的圆周上,所述通液腔的截面在所述导管的周向上延伸的最远距离大于其在所述导管的径向上延伸的最远距离。
可选地,所述通液腔的壁部分地与所述内管的外壁重合或贴合。
可选地,所述通液腔截面的形状为月牙形、椭圆形、骨头形、腰果形
或腰子形。
可选地,所述通液腔的壁上贴覆有光滑的膜。
可选地,所述内管由外层、中间层和内层构成,其中外层的材料为聚氨酯;中间层由金属丝缠绕和/或编织制成,所述金属丝为以下材料中的一种,或几种的组合:不锈钢、镍钛合金、钨;内层为聚碳氟化合物、聚乙烯、聚丙烯或聚酰胺中的一种或多种的共聚物。
可选地,所述外管的材料为以下材料中的一种,或几种的组合:聚酰胺、聚氨酯、尼龙、高密度聚乙烯、嵌段聚醚酰胺弹性体;且所述外管的材料的硬度从近端到远端逐级变小。
可选地,所述球囊的远端与所述导引导管的远端之间构成所述导引导管的头端,所述头端由所述内管的内层和外层的延伸段形成。
可选地,所述头端的长度为3mm-100mm。
根据本发明的技术方案,导引导管是非同轴式,一个或多个通液腔在外管壁的壁厚中形成非同轴的腔体,通液腔的大小和形状可以根据球囊的所需膨胀时间和回抽时间来设计。这种导管的内管所具有的三层结构以及其中的编织和/或缠绕有金属丝的内层使得导管的内管能够参与导管的支撑,提高了导管承受负压的能力。通液腔的截面的形状能够尽可能地利用外管的壁厚所在的空间,以提供较大的流量,并且对导管承受负压的能力的影响较小。
附图用于更好地理解本发明,不构成对本发明的不当限定。其中:
图1是根据本发明实施例的导引导管的外形的示意图;
图2是根据本发明实施例的导引导管的剖面的示意图;
图3A至图3E是图2的A-A截面的几种可选型式的示意图;
图4和图5是根据本发明实施例的内管的结构示意图;
图6是根据本发明实施例的导引导管的头端结构的示意图。
图中:1-连接器,2-输送导管体,3-可扩展球囊,4-扩散应力管,5-通液腔,6-导引腔,21-外管,22-内管,11-连接器侧口,12-连接器主孔,221-内管的外层,222内管的中间层,223-内管的内层,2221-第二金属丝,2222-第一金属丝,7-显影点,8-头端,9-胶水。
以下结合附图对本发明的示范性实施例做出说明,其中包括本发明实施例的各种细节以助于理解,应当将它们认为仅仅是示范性的。因此,本领域普通技术人员应当认识到,可以对这里描述的实施例做出各种改变和修改,而不会背离本发明的范围和精神。同样,为了清楚和简明,以下的描述中省略了对公知功能和结构的描述。
如图1、图2所示,本发明实施例中的导引导管包括可扩张球囊3、输送导管体2、扩散应力管4和连接器1,所述输送导管体2包括外管21、内管22、通液腔5和导引腔6,其中,通液腔5的内表面是由低摩擦系数材料制成,导引腔6是由内管22的内腔构成;所述输送导管体2的外管21套设在内管22外周,如图2所示,输送导管体2的外管21的长度小于内管22的长度,即在输送导管体2的远端(靠近可扩张球囊3的一端),有部分内管22的外周没有被外管21覆盖,而是被所述可扩张球囊3覆盖。具体的,可扩张球囊3的近端与外管21的远端密封相连,可扩张球囊3的远端与内管22的远端密封相连;输送导管体2的近端部分伸入连接器1的远端,使得连接器1近端的连接器主孔12与输送导管体2的导引腔6相连通,扩散应力管4设于连接器1与外管21的交界处,且扩散应力管4的近端与连接器1的远端通过例如胶水9相连。如图6所示,位于球囊3部位的内管22的管壁上嵌设有显影点7,显影点7用于手术过程中导管的准确定位。
参考图2、图3A至图3E,本实施例中的导引导管是非同轴式,通液腔5位于外管21的壁厚内,因此与内管22和外管21为非同轴的腔体,通液腔5与球囊3连通,用于输送和回收球囊扩张介质,通液腔5的大小和形状可以根据球囊的所需膨胀时间和回抽时间来设计。这种非同轴式的通液腔5使得导管的内管22能够参与导管的支撑,提高了导管承受负压的能力。通液腔5的壁的一部分可以是内管的外壁。通液腔5的壁上也可贴覆有光滑的膜,这样可降低通液腔5的壁的摩擦系数,避免球囊扩张介质过多地粘附在通液腔中而导致的导管回撤困难,有助于减少球囊回抽的时间,降低血栓栓塞性并发症和远端缺血的风险。
通液腔可以设计成各种形状,为了使球囊的膨胀时间和回抽时间尽可能地短,需使通液腔有尽可能大的流量,但导管整体需要有较细的外径。为此在本实施例中,通液腔沿导管周向延伸的距离大于通液腔沿导管径向延伸的距离,即通液腔的截面在导管圆周向上最远两点之间的距离大于其径向上最远两点之间的距离,如图3A至图3E中的通液腔51至55所示,作为示例,图中示出了呈月牙形的通液腔截面(如图3A、3D、3E中的通液腔51、54、55)以及类似于骨头形的通液腔截面(如图3C中的通液腔53)。通液腔的截面也可以是椭圆形,如图3B中的通液腔52所示。通液腔还可以是类似于腰子的形状;形状也可以更长,即类似于腰果的形状。上述的这些形状都能够尽可能地利用外管21的壁厚所在的空间,以提供较大的流量,并且对导管承受负压的能力的影响较小。另外通液腔也可以是多个,如图3D中所示的两个,图3E中所示的三个,甚至更多。
通液腔5的壁可以直接由外管21的材料构成;或者其中一部分是内管22的外壁,此时通液腔5的壁与内管22的壁部分重合。通液腔也可以具有专门的壁,可以与内管的外壁贴合或分离,即通液腔的壁的材料不同于外管以及内管,可采用聚四氟乙烯(PTFE),也可以是氟化乙丙烯(FEP)。
通液腔5与连接器1的侧孔11相通,球囊扩张介质通过连接器的侧孔11注入通液腔5中。外管22是由三段不同硬度的管材形成,从近端到远端分为相对硬度较高的近端体部、具有中等硬度的中间过渡段和相对硬度较低的远端体部,所述近端体部、中间过渡段和远端体部依次连接构成所述外管22。外管22可以采用如下材料:聚酰胺、聚氨酯、尼龙、高密度聚乙烯、或者嵌段聚醚酰胺弹性体(PEBAX)中的一种或多种组合而成,硬度范围为78D-20D。
如图4和图5所示,本发明实施例的导引导管中的内管22包括内层223、外层221和中间层222(弹簧圈加强),所述导引腔6即由内管22的内层223构成,另外还可以在内管22上添加显影点7,见图6。内管的内层223比内管的外层221的厚度小或者大致相同;其中,内层223的构成材料可为:PTFE、FEP和高密度聚乙烯中的一种,或者两种组合而成,可提高导引腔6的表面光滑性,从而使导丝、取栓器等更加顺畅的到达病灶部位。内管22的内径优选值为1.2mm-2.1mm。其中,外层221的构成材料可为:尼龙、硅橡胶、聚氨酯、聚酰胺系列或者嵌段聚醚酰胺弹性体(PEBAX)中的一种或多种组合而成,硬度为25D-55D。其中,中间层222是由两根金属丝沿不同方向绕丝而成的,可根据产品所需的强度,来设置绕丝的密度,每一根金属丝绕制成一个弹簧圈。具体的,如图5所示,中间层222可包括以较高的绕丝密度沿第一方向绕在内层223外表面的第一金属丝2222,以及以较低的绕丝密度沿不同于第一方向的第二方向绕在第一金属丝2222外侧的第二金属丝2221。所述第一、第二金属丝2222、2221的材料可以是不锈钢304v、镍钛合金或钨等金属材料,直径为0.1mm-0.3mm之间,并且可以采用圆丝或扁丝。通过在内管22的内层223和外层221之间设置所述中间层222,可有效增强内管22的支撑强度,提高导管承受负压的能力。
球囊3的远端与内管22的远端可通过粘合剂密封连接,形成连接区域,此可作为头端,或者离头端有一段距离,如图6所示,导管头端8是球囊的远端81与内管22的远端(同时也是整个导管的远端)82之间的部分,为了使导管的头端8尽可能柔软,以便能够进入更远的血管,头端8处的内管22延伸部分仅包括内层223和外层221,而不设置中间层222。头端8的长度为:3mm-100mm。
此外,本发明实施例的导引导管的整体表面或者至少球囊3和头端8部分通过例如涂覆、喷射等方法形成由亲水性材料构成的涂层,有助于降低表面摩擦,使导管整体进入血管通行时更加顺畅,提高导管的操作性能。上述亲水涂层材料可以是:聚乙烯吡咯烷酮(PVP)、透明质酸钠、聚氨酯等。以下举几个本发明的具体实施例。
实施例1
本实施例中采用3个显影点7,分别设置在头端8和球囊3中间,材料采用银。外管21材料为PEBAX,从近端到远端的硬度逐级变小,分别为78D,55D,35D。内管22采用三层编制材料,外层221材料为聚氨酯,中间层222由不锈钢绕丝而成,丝宽0.2mm,内层223为PTFE。内管22内径为3mm。通液腔5的截面采用如图3A或3E所示的月牙形。导管的头端8设计长度为3mm。导管整体连接完成后,导管表面涂敷亲水涂层,亲水材料选用:透明质酸钠。
实施例2
本实施例中采用2个显影点7,分别设置在头端8和球囊3中间,材料采用铂铱合金。外管21材料为PEBAX,从近端到远端的硬度逐级变小,分别为72D,63D,40D。内管22采用三层编制材料,外层材料221为聚氨酯,中间层222由不锈钢绕丝而成,丝宽0.15mm,内层223为FEP。内
管22内径为2mm,通液腔54采用图3D所示的双通道月牙形。导管头端8设计长度为10mm。导管整体连接完成后,导管表面涂敷亲水涂层,亲水材料选用聚乙烯吡咯烷酮(PVP)。
实施例3
本实施例中采用两个显影点7,分别设置在头端8和球囊3中间,材料采用铂铱合金。外管21材料为PEBAX,从近端到远端的硬度逐级变小,分别为72D,55D,25D。内管22采用三层编制材料,外层221材料为PEBAX,中间层222由镍钛合金绕丝而成,丝宽0.15mm,内层223为氟树脂(EFEP),内管22内径为1mm。通液腔采用三通道骨头形,例如可采用图3C所示的通液腔53形状按照图3E中的三个通液腔的排布方式进行设置。导管头端8设计长度为15mm。导管整体连接完成后,导管表面涂敷亲水涂层,亲水材料选用聚氨酯。
根据本发明实施例的技术方案,导引导管是非同轴式,一个或多个通液腔在外管壁的壁厚中形成非同轴的腔体,通液腔的大小和形状可以根据球囊的所需膨胀时间和回抽时间来设计。这种导管的内管所具有的三层结构以及其中的编织和/或缠绕有金属丝的内层使得导管的内管能够参与导管的支撑,提高了导管承受负压的能力。通液腔的截面的形状能够尽可能地利用外管的壁厚所在的空间,以提供较大的流量,并且对导管承受负压的能力的影响较小。
上述具体实施方式,并不构成对本发明保护范围的限制。本领域技术人员应该明白的是,取决于设计要求和其他因素,可以发生各种各样的修改、组合、子组合和替代。任何在本发明的精神和原则之内所作的修改、等同替换和改进等,均应包含在本发明保护范围之内。
Claims (8)
- 一种导引导管,包括外管、内管、一个或多个通液腔以及与所述通液腔连通的球囊,其特征在于,所述一个或多个通液腔分布在所述外管壁厚的圆周上,所述通液腔的截面在所述导管的周向上延伸的最远距离大于其在所述导管的径向上延伸的最远距离。
- 根据权利要求1所述的导引导管,其特征在于,所述通液腔的壁部分地与所述内管的外壁重合或贴合。
- 根据权利要求1所述的导引导管,其特征在于,所述通液腔截面的形状为月牙形、椭圆形、骨头形、腰果形或腰子形。
- 根据权利要求1所述的导引导管,其特征在于,所述通液腔的壁上贴覆有光滑的膜。
- 根据权利要求1至4中任一项所述的导引导管,其特征在于,所述内管由外层、中间层和内层构成,其中外层的材料为聚氨酯;中间层由金属丝缠绕和/或编织制成,所述金属丝为以下材料中的一种,或几种的组合:不锈钢、镍钛合金、钨;内层为聚碳氟化合物、聚乙烯、聚丙烯或聚酰胺中的一种或多种的共聚物。
- 根据权利要求1至4中任一项所述的导引导管,其特征在于,所述外管的材料为以下材料中的一种,或几种的组合:聚酰胺、聚氨酯、尼龙、高密度聚乙烯、嵌段聚醚酰胺弹性体;且所述外管的材料的硬度从近端到远端逐级变小。
- 根据权利要求5所述的导引导管,其特征在于,所述球囊的远端与所述导引导管的远端之间构成所述导引导管的头端,所述头端由所述内管的内层和外层的延伸段形成。
- 根据权利要求7所述的导引导管,其特征在于,所述头端的长度为3mm-100mm。
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