Detailed Description
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.
As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, the term "proximal" generally being the end near the operator and the term "distal" generally being the end near the lesion in the patient. As used in this specification, "one end" and "the other end" and "proximal end" and "distal end" generally refer to the corresponding two parts, which include not only the end points.
The core idea of the invention is to provide a flow-resisting catheter to solve the problems that the existing flow-resisting catheter cannot meet the requirements of the inner and outer diameters of the catheter, has an excessively small inner cavity, cannot adapt to instruments with larger sizes or treat thrombi with larger sizes and the like. The flow-blocking catheter includes: the flow-resisting device comprises an inner catheter, a flow-resisting element and an outer catheter, wherein the outer catheter is sleeved outside the inner catheter; at least one end of the flow-impeding element is connected to the outer circumference of the inner or outer catheter, the flow-impeding element having a contracted state and an expanded state; wherein a ratio of an inner diameter of the inner conduit to an outer diameter of the outer conduit is greater than or equal to 0.7. The configuration can increase the inner diameter of the flow-resisting catheter on the premise of controlling the outer diameter of the flow-resisting catheter, is suitable for larger thrombus or instruments, expands the application range of the flow-resisting catheter and improves the blood vessel treatment effect.
The following description refers to the accompanying drawings.
[ EXAMPLES one ]
Referring to fig. 1 to 10g, in which fig. 1 is a schematic view of a flow blocking catheter according to an embodiment of the present invention, fig. 2 is a schematic representation of a cross-section of an inner catheter provided in accordance with an embodiment of the present invention, fig. 3 is a schematic representation of an expanded flow-obstructing element provided in accordance with an embodiment of the present invention, fig. 4 is a schematic view of a control valve provided in accordance with an embodiment of the present invention, fig. 5 is a schematic view of a cross-section of a choke conduit provided in accordance with an embodiment of the present invention, fig. 6 is a schematic view of a flow-blocking duct provided with grooves according to an embodiment of the present invention, fig. 7 is a schematic view of a flow-blocking duct provided with a fixed film according to an embodiment of the present invention, FIG. 8 is a schematic view of the fixed connection of the two ends of the flow-resisting element to the inner conduit, fig. 9 is a schematic view of a weaving structure of a flow blocking element according to an embodiment of the present invention, and fig. 10a to 10g are schematic views of meshes of a support frame according to an embodiment of the present invention.
As shown in fig. 1 to 3, a flow blocking catheter according to a first embodiment of the present invention includes: aninner catheter 100, a flow-impedingelement 300, and anouter catheter 200; the flow-impedingelement 300 has self-expansion properties, and at least the proximal end (first end 310) of the flow-impedingelement 300 is attached (e.g., by gluing, welding, or using a fixed membrane) to the outer circumference of theinner catheter 100. Theouter catheter 200 is movably sleeved outside theinner catheter 100 to limit the expansion of theflow blocking element 300, wherein the ratio of the inner diameter of theinner catheter 100 to the outer diameter of theouter catheter 200 is greater than or equal to 0.7. In some embodiments, the flow-blockingelement 300 is configured such that, when theouter catheter 200 is moved in the proximal direction of theinner catheter 100, the flow-blockingelement 300 is released from its restriction, and the flow-blockingelement 300 expands (meaning expands radially) due to its self-expanding characteristic; theouter catheter 200 is moved toward the distal end of theinner catheter 100, so that the expansion of theflow blocking element 300 is restricted, and theflow blocking element 300 is contracted (i.e., restored by contraction in the radial direction). In other embodiments, the expansion and contraction of the flow-impedingelement 300 may also be controlled by movement of theinner catheter 100 relative to theouter catheter 200. In this embodiment, thefirst end 310 of the flow-obstructingelement 300 is disposed near the distal end of theinner catheter 100 to bring the flow-obstructing location closer to the location where the embolectomy device or other instrument is operated, reducing the effect on the proximal vascular blood flow, and in other embodiments, thefirst end 310 of the flow-obstructingelement 300 may be disposed in the middle of theinner catheter 100 or near the proximal end.
In an exemplary embodiment, theinner catheter 100 and theouter catheter 200 are preferably circular tubes, theouter catheter 200 is sleeved outside theinner catheter 100, the difference between the inner diameter of theouter catheter 200 and the outer diameter of theinner catheter 100 can be 0.0001-0.1 inches, and theouter catheter 200 is preferably a single-layer tube made of one or more materials selected from the group consisting of polyether polyamide block copolymer (PEBA or Pebax), Polyamide (PA), and Polytetrafluoroethylene (PTFE). Theinner catheter 100 comprises at least one single polymer layer of a polymer material selected from one or more of Polytetrafluoroethylene (PTFE), High Density Polyethylene (HDPE), Pebax mixed with a coefficient of friction reducing additive, and polyolefin elastomer (POE). Theinner catheter 100 preferably comprises a three-layer structure, as shown in fig. 3, of afirst layer 101, asecond layer 102, and athird layer 103, respectively, from the inside out. Wherein, the material of thethird layer 103 may be one or more of nylon elastomer (such as Pebax), nylon and Polyurethane (PU); the material of thefirst layer 101 may be one or more of Polytetrafluoroethylene (PTFE), High Density Polyethylene (HDPE), Pebax mixed with a friction coefficient reducing additive, and polyolefin elastomer (POE); thesecond layer 102 is one or a combination of two or more of a braided structure, a coil and a cut hypotube (hypotube generally refers to a medical metal tube), and the material of thesecond layer 102 may be stainless steel, nickel-titanium alloy, cobalt-chromium alloy or polymer filament. To improve the mechanical transmission properties, the ovality resistance and the bending resistance of theinner catheter 100 and to reduce the force required for the recovery of the flow-impedingelement 300. It should be understood that the materials of the various layers of theinner catheter 100 are not limited to the above materials, and those skilled in the art can select other materials with similar properties according to the prior art. In an alternative embodiment, as shown in fig. 5, theinner catheter 100 comprises only two layers, from inside to outside, afirst layer 101 and asecond layer 102, wherein thefirst layer 101 is mainly a polymer layer and is made of one or more of Polytetrafluoroethylene (PTFE), High Density Polyethylene (HDPE), Pebax mixed with a friction-reducing additive, and polyolefin elastomer (POE), thesecond layer 102 is mainly a metal layer, such as one or more of a woven structure, a coil, and a cut hypotube, and thesecond layer 102 is made of stainless steel, nitinol, or cobalt-chromium alloy. Preferably, a layer ofadhesive 104 is disposed outside the polymer layer, and the adhesive 104 penetrates the metal layer (i.e., part of the adhesive 104 penetrates the meshes of the metal layer and is adhered to the outside of the metal layer), so that the metal layer and the polymer layer are firmly embedded to improve the conductive performance and the anti-elliptical capability. Of course, in other embodiments, theouter conduit 200 is not limited to a single-layer tube, and theouter conduit 200 may also include a two-layer structure, a three-layer structure, or a more-layer structure, and the specific structural configuration thereof may refer to theinner conduit 100.
Preferably, theinner catheter 100 includes afirst visualization ring 120, thefirst visualization ring 120 being located at the distal end of theinner catheter 100. Specifically, thefirst visualization ring 120 may be disposed at the distal end of thesecond layer 102 of theinner catheter 100. More preferably, theinner catheter 100 further comprises a second visualization ring (not shown) located at a position of theinner catheter 100 corresponding to the fixation point of the flow-obstructingelement 300 to theinner catheter 100. Further, when one end of theflow blocking element 300 is connected to the outer circumference of theinner guide tube 100 and the other end is a free end, theflow blocking element 300 further includes a third developing ring (not shown) at the free end of theflow blocking element 300, and the third developing ring is disposed to visually reflect the expanded state of the free end of theflow blocking element 300. Alternatively, the first developingring 120, the second developing ring and the third developing ring may be made of, but not limited to, platinum, iridium, tantalum, noble metal alloy, etc., or may be made of a polymer material containing a developer. The three visualization rings are provided to facilitate the operator to position theinner catheter 100 or to visually reflect the expanded state of theflow blocking element 300 during the operation. It should be understood that thefirst visualization ring 120 is located at the distal end of theinner catheter 100, and thefirst visualization ring 120 is not limited to being located at the distal end of theinner catheter 100, but may be located in an area near the distal end of theinner catheter 100. Further, the above examples merely exemplify the arrangement positions of the developing rings, and do not limit that the three developing rings are necessarily arranged at the same time, and any one or any two of the developing rings may be selectively arranged by those skilled in the art according to the actual situation.
Preferably, theflow blocking element 300 includes a support frame having at least one end connected to the outer circumference of theinner catheter 100 and having a self-expanding property, and a flow blocking film, and optionally, theflow blocking element 300 further includes a flow blocking film attached to the support frame. In one example, the scaffold is a tubular body that is capable of being transitioned between a retracted state and an expanded state under the constraints of theouter catheter 200, it being understood that the scaffold is not limited to being switchable only between the retracted state and the expanded state, and in some cases, may be in an intermediate state between the retracted state and the expanded state (i.e., a semi-expanded state or a partially expanded state). The material of the support frame can be nickel-titanium alloy, 304 stainless steel, platinum-tungsten alloy, platinum-iridium alloy, cobalt-chromium alloy or developed metal, and the structure of the support frame can be obtained by winding, cutting or weaving. In this embodiment, the supporting frame comprises a plurality of mesh holes 340, and as shown in fig. 10a to 10g, the mesh holes 340 may be diamond-shaped (fig. 10a), square-shaped (fig. 10b), rectangular-shaped (fig. 10c), parallelogram-shaped (fig. 10d), polygonal-shaped (not shown), circular-shaped (fig. 10e), oval-shaped (fig. 10f), irregular-shaped (fig. 10g), and the like, and preferably diamond-shaped (fig. 10 a). The flow-blocking film can be attached to the inner surface or the outer surface of the support frame, and is preferably a polymer film, and the material of the flow-blocking film can be Polyurethane (PU), Polyethylene (PE), Expanded Polytetrafluoroethylene (EPTFE) or the like. It is to be understood that the material of the supporting frame and the flow-resisting film is not limited to the above materials, and those skilled in the art can select other materials with similar performance according to the prior art. As shown in fig. 9, in some embodiments, the supporting frame may have a mesh structure, and is woven by 1 to 64 wires, wherein the wires are selected from at least one of common wires, developing wires and composite wires, and the common wires may be selected from one or more of nickel-titanium alloy, cobalt-nickel alloy, stainless steel, polymer, and the like; the developing wire can be made of developing metals such as platinum, iridium, gold, tungsten and the like or alloys thereof, or can be made of polymer wires added with developers; the composite wire is made by compounding a developing core wire and a common wire and has a double-layer structure, wherein the developing core wire at the inner layer is made of one or more developing metals such as platinum, iridium, gold or tungsten or alloys thereof, and the common wire at the outer layer is made of one or more materials such as nickel-titanium alloy, cobalt-nickel alloy, stainless steel, high polymer and the like. The developingwire 330 improves the developing performance of theflow blocking element 300 and improves the trackability of theflow blocking element 300 in use. In other embodiments, the scaffold may also be an open-loop structure or a helical structure, or the scaffold may be composed of several of a lattice structure, an open-loop structure and a helical structure.
Referring to fig. 1 and 3, theouter catheter 200 may control the expansion of the flow-blockingelement 300 when moving along the axial direction of the inner catheter 100 (the expansion of the flow-blockingelement 300 may be understood to be the same as the expansion of the scaffold). Specifically, in the initial default state of the flow-blocking catheter, the outer catheterdistal end 210 overlies the flow-blockingelement 300, limiting expansion of the flow-blockingelement 300, such that the flow-blockingelement 300 is in a retracted state and is crimped between theinner catheter 100 and theouter catheter 200, facilitating transport of the flow-blocking catheter in the blood vessel. When theouter catheter 200 is moved proximally relative to the inner catheter 100 (i.e., theouter catheter 200 is withdrawn), the flow-blockingelement 300 is exposed from theouter catheter 200, and the flow-blockingelement 300 self-expands to adhere to the blood vessel wall, so that the blood flow is blocked due to the adhesion of a flow-blocking film on the scaffold of the flow-blockingelement 300. It is to be understood that the expanded configuration of the obstructingelement 300 is now adapted to the vessel wall and is not necessarily in a fully expanded state (i.e. possibly in a semi-expanded state). In other cases, of course, when theouter catheter 200 is withdrawn, thedistal end 210 of the outer catheter may not leave the flow-blockingelement 300, such that a portion of the flow-blockingelement 300 is no longer constrained by theouter catheter 200, and therefore, the portion of the flow-blockingelement 300 may naturally expand and conform to the blood vessel wall, thereby blocking blood flow, i.e., theouter catheter 200 may release a portion of the flow-blockingelement 300, rather than having to release all of the flow-blocking element 300 (i.e., the flow-blockingelement 300 may be in a partially expanded state). The flow-impedingelement 300 preferably has a certain compliance that can adapt to the morphology of the vessel wall in the expanded state (including the fully expanded state, the semi-expanded state, or the partially expanded state). So configured, some relatively weak vessel walls may be accommodated, which may reduce the pressure on the vessel wall caused by the expansion of theresistive element 300. Thus, the obstructingelement 300 may reduce the irritation to the cerebral vessel wall and reduce the occurrence of various complications such as vasospasm during the surgical procedure.
Further, after the blood flow is blocked, suction or thrombus retraction can be directly performed through the lumen of the inner catheter 100 (the lumen of theinner catheter 100 of the flow blocking catheter can also be passed through a suction catheter or a support catheter, suction of thrombus can be performed through the suction catheter, or thrombus removal can be performed through a thrombus removal stent in the support catheter). As shown in fig. 2, since the thickness of theflow blocking element 300 is smaller when in the retracted state, the ratio of the inner cavity of theinner catheter 100 in the cross section of the whole flow blocking catheter is much larger than that of the existing balloon flow blocking catheter, so that the flow blocking catheter with the same outer diameter can be adapted to medical devices such as a suction catheter, a support catheter or a stent with a larger lumen, and is suitable for treating larger thrombus, and simultaneously, the outer diameter of the whole flow blocking catheter is limited to smoothly enter a tortuous distal end blood vessel and form a smaller wound for a patient.
Further, when it is desired to change the flow-blocking position to reposition or remove the flow-blocking catheter, theouter catheter 200 may be operated to move distally relative to the inner catheter 100 (i.e., to advance the outer catheter 200) until the distal end of theouter catheter 200 abuts against the flow-blockingelement 300, as shown in fig. 3. And continues to push theouter catheter 200 distally until the flow-obstructingelement 300 is constrained to the collapsed state. On the basis of fig. 3, when theouter catheter 200 is withdrawn proximally, the state of the flow-blockingelement 300 is reversible, i.e. the flow-blockingelement 300 may expand again by itself. The repeatable contractibility of the flow-impedingelement 300 facilitates the re-delivery positioning of the flow-impeding conduit. Therefore, the flow blocking catheter provided by the embodiment can conveniently realize repeated operation and accurate positioning, and can also conveniently withdraw the blood vessel after thrombus removal.
As shown in fig. 4, the flow blocking conduit further comprises acontrol valve 400, thecontrol valve 400 being configured to drive theouter conduit 200 to move relative to theinner conduit 100. In one embodiment, thecontrol valve 400 includes acontrol valve body 410 and acontrol slider 420, wherein thecontrol valve body 410 is provided with a slidinggroove 430 along an axial direction, and thecontrol slider 420 is matched with the slidinggroove 430 and can slide along the direction of the slidinggroove 430. Further, one end of thecontrol valve body 410 has acatheter insertion opening 440, and the proximal end of theinner catheter 100 is inserted into thecontrol valve 400 through thecatheter insertion opening 440 and fixedly connected to thecontrol valve body 410, while the proximal end of theouter catheter 200 is connected to thecontrol slider 420, for example, by gluing or snapping. With such a configuration, the sliding of theslider 420 is controlled to control the movement (e.g., withdrawing or pushing) of theouter catheter 200 relative to theinner catheter 100, and thecontrol valve 400 controls the expansion or retraction state of theflow blocking element 300, so as to simplify the operation, save the operation time, and conveniently realize the repetitive operation. Optionally, the proximal end of theouter catheter 200 includes a diffusion stressedtube 220, and the diffusion stressedtube 220 may be flared towards the proximal end, i.e. the distal end of the diffusion stressedtube 220 has the same diameter as theouter catheter 200, while the proximal end of the diffusion stressedtube 220 has a larger diameter than theouter catheter 200. With this configuration, the diameter of the portion of theouter guide pipe 200 for connection with thecontrol slider 420 is increased, and the flareddiffusive stress pipe 220 disperses the driving force of thecontrol slider 420 to theouter guide pipe 200, thereby improving the reliability of control of theouter guide pipe 200 by thecontrol slider 420. In other embodiments, the outer conduit may be connected to thecontrol valve body 410, theinner conduit 100 may be connected to thecontrol slider 420, or other direct or indirect connection methods may be used, and the present invention is not particularly limited.
Referring to fig. 6, in a preferred embodiment, theinner catheter 100 is provided with agroove 110 at the periphery, and thegroove 110 matches with the shape of theflow blocking element 300 to accommodate theflow blocking element 300. Alternatively, therecess 110 is an annular recess around theinner catheter 100, and the obstructingelement 300 may be embedded in therecess 110 when the obstructingelement 300 is in the fully retracted state. Preferably, the length of therecess 110 is greater than or equal to the length of the obstructingelement 300 in the retracted state, so that the obstructingelement 300 can be completely accommodated in therecess 110. The provision of thegrooves 110 allows the gap between theouter catheter 200 and theinner catheter 100 to be smaller, thereby further reducing the proportion of catheter in the cross-section of the entire flow-obstructing catheter and increasing the proportion of lumen of theinner catheter 100. The provision of thegrooves 110 may maintain a uniform outer diameter throughout the catheter, preventing the flow-impedingelement 300 from being damaged when the catheter passes through a tortuous blood vessel during transport in the blood vessel. Furthermore, the radial distances of the fixed points of the flow-obstructingelement 300 and theinner catheter 100 relative to the axial direction of theinner catheter 100 are substantially equal, which facilitates the concentricity of the flow-obstructingelement 300 without eccentricity when expanding, increases the adherence uniformity of the flow-obstructingelement 300, and thus reduces the risk of leakage.
Referring to fig. 3, in a preferred embodiment, one end of the flow-resistingelement 300 is connected to the outer circumference of theinner catheter 100, for example, by gluing or welding, and the other end of the flow-resistingelement 300 is a free end. Optionally, the first end 310 (e.g., proximal end) of the flow-blockingelement 300 is attached to the outer surface of theinner catheter 100, and the second end 320 (e.g., distal end) is free, such that when the flow-blockingelement 300 is in the expanded state, thesecond end 320 is spaced from the distal end of theinner catheter 100 by a distance of 0-500mm, it being understood that thesecond end 320 does not extend beyond the distal end of theinner catheter 100, i.e., the flow-blockingelement 300 is positioned closer to the operator than the distal end of theinner catheter 100.
As shown in fig. 7, the catheter may further include a fixingfilm 500, and the fixingfilm 500 may be attached to the outer portion of the proximal end of theflow blocking element 300, at least partially covering theflow blocking element 300 and partially covering theinner catheter 100. The fixing means of the fixingfilm 500 to theflow blocking element 300 and theinner catheter 100 may be gluing, heat shrinking, or the like, and the fixing capability between theflow blocking element 300 and theinner catheter 100 may be enhanced by the fixingfilm 500. Optionally, thefixation membrane 500 has an axial length between 1mm and 10 mm. It should be noted that, in some embodiments, the flow-resistingelement 300 may be first fixed (e.g., bonded or welded) to theinner catheter 100, and then the fixingfilm 500 may be used as a second reinforcing fixing, further reinforcing the reliability of the fixing; in other embodiments, the flow-obstructingelement 300 and theinner catheter 100 may be fixed by the fixingfilm 500 only by a size fit or an interference fit, but the invention is not limited thereto.
Referring to fig. 8, in another preferred embodiment, both ends of the flow-obstructingelement 300 are respectively connected to the outer circumference of theinner catheter 100, for example, by gluing, welding or using a fixing film. Optionally, the both ends of chokedflow element 300 are separated by a certain distance and are arranged, so the configuration, when chokedflow element 300 is in the expansion state, chokedflow element 300 is a shuttle type, which can better fit the blood vessel wall to reach the effect of blocking blood flow, in addition, under the impact of blood flow, chokedflow element 300's form is more stable, can further reduce the risk of leakage. Of course, in other embodiments, the two ends of theflow blocking element 300 may be disposed adjacent to each other or overlapped with each other, and the corresponding expanded state of theflow blocking element 300 may be an Ω shape, which may also achieve better effect, so the present invention does not limit the distance between the two ends of theflow blocking element 300.
[ example two ]
Referring to fig. 11 to 14, fig. 11 is a schematic diagram of a flow-blocking element in a contracted state according to a second embodiment of the present invention, fig. 12 is a schematic diagram of a flow-blocking element in an expanded state according to a second embodiment of the present invention, fig. 13 is a schematic diagram of a flow-blocking duct provided with an enlarged portion according to a second embodiment of the present invention, and fig. 14 is a schematic diagram of a flow-blocking duct provided with an equal-diameter section according to a second embodiment of the present invention.
The flow-obstructing conduit provided by the second embodiment of the present invention is basically the same as the flow-obstructing conduit provided by the first embodiment, and the description of the same parts is omitted, and only different points will be described below.
In the second embodiment, the disposition of theflow blocking element 300 is different from that of the first embodiment. Specifically, referring to fig. 11 and 12, in this embodiment, the proximal end (the first end 310) of the flow-resistingelement 300 is connected to the outer circumference of the inner catheter 100 (e.g., by gluing, welding or using a fixing film), and the other end (the second end 320) is connected to the distal end (thedistal end 210 of the outer catheter 200) (e.g., by gluing, welding or using a fixing film); the flow-obstructingelement 300 is configured such that, when theouter catheter 200 is moved in the distal direction of theinner catheter 100, the flow-obstructingelement 300 expands (meaning bulges radially); when theouter catheter 200 is moved away from the distal direction of the inner catheter 100 (i.e., toward the proximal direction of the inner catheter 100), the flow-impedingelement 300 contracts (i.e., radially contracts and recovers). In other embodiments, the expansion and contraction of the flow-impedingelement 300 may also be controlled by movement of theinner catheter 100 relative to theouter catheter 200. In this embodiment, thefirst end 310 of the flow-obstructingelement 300 is disposed near the distal end of theinner catheter 100 to bring the flow-obstructing location closer to the location of the embolectomy or other instrument operation, reducing the effect on the proximal vascular blood flow, and in other embodiments, thefirst end 310 of the flow-obstructingelement 300 may be disposed in the middle or near the proximal end of theinner catheter 100.
With continued reference to fig. 11 and 12, theouter catheter 200 may control the expansion of the flow-blockingelement 300 as it moves along the axial direction of the inner catheter 100 (the expansion of the flow-blockingelement 300 may be understood to be the same as the expansion of the scaffold). Specifically, as shown in fig. 11, for convenience of description, the fixing point of thefirst end 310 of the obstructingmember 300 to theinner catheter 100 is referred to as a first fixing point, the fixing point of thesecond end 320 of the obstructingmember 300 to theouter catheter 200 is referred to as a second fixing point, and in the initial default state of the obstructing catheter, the distance between the first fixing point and the second fixing point along the axial direction of theinner catheter 100 is the largest, and at this time, the obstructingmember 300 is in the fully retracted state, and the largest outer diameter of the obstructing member corresponds to the outer diameter of theouter catheter 200. On the basis of fig. 11, theouter catheter 200 is pushed distally such that the axial distance between the first fixing point and the second fixing point is reduced, and the flow-obstructingelement 300 expands radially outwards, as shown in fig. 12, which illustrates the flow-obstructingelement 300 in a fully expanded state. When the flow-obstructingelement 300 expands outward to fit the inner diameter of the vessel wall, the flow-obstructingelement 300 is attached to the vessel wall, and the blood flow is blocked because a flow-obstructing membrane is attached to the support frame of the flow-obstructingelement 300. It is to be understood that the expansion of the obstructingelement 300 is now adapted to the vessel wall and not necessarily in a fully expanded state (i.e. possibly in a semi-expanded state or in a partially expanded state), the obstructingelement 300 preferably has a compliance which is adapted to the shape of the vessel wall in the expanded state (including the fully expanded state, the semi-expanded state or the partially expanded state). So configured, some relatively weak vessel walls may be accommodated, which may reduce the pressure on the vessel wall caused by the expansion of theresistive element 300. Therefore, theflow blocking element 300 can reduce the stimulation to the cerebral vessel wall, reduce the occurrence of various complications such as vasospasm and the like in the operation process, and simultaneously thoroughly avoid the risk of secondary damage to the vessel caused by the rupture of the balloon or the balloon bonding section.
Further, when it is desired to change the flow blocking position to reposition or remove the flow blocking catheter, theouter catheter 200 is operable to move proximally relative to the inner catheter 100 (i.e., to withdraw the outer catheter 200) to a maximum distance between the first fixation point and the second fixation point along the axial direction of theinner catheter 100. On the basis of fig. 12, when theouter catheter 200 is withdrawn proximally, the state of the flow-blockingelement 300 is reversible, i.e. the flow-blockingelement 300 can be retracted until the state shown in fig. 11 is reached. The repeatable contractibility of the flow-impedingelement 300 facilitates the re-delivery positioning of the flow-impeding conduit. Therefore, the flow blocking catheter provided by the embodiment can conveniently realize repeated operation and accurate positioning, and can also conveniently withdraw the blood vessel after thrombus removal.
Referring to fig. 13, in a preferred embodiment, the outer circumference of the distal end of theinner catheter 100 includes anenlarged portion 110, the outer circumference of theenlarged portion 110 is larger than the outer circumference of the other portion of theinner catheter 100, one end (a first end 310) of the obstructingmember 300 is connected to theenlarged portion 110, and the other end (a second end 320) is connected to thedistal end 210 of the outer catheter. Preferably, theenlarged portion 110 matches the outer circumference of theouter catheter 200, theenlarged portion 110 is located distally of the distal end of theouter catheter 200, and in an exemplary embodiment, the main body portion of theinner catheter 100 has an outer diameter of between 0.070-0.113 inches and a length of between 70-100 mm; and theenlarged portion 110 has an outer diameter of between 0.079 and 0.122 inches and a length of between 1 and 50 mm. Preferably, the inner diameter of theouter catheter 200 is slightly larger than the outer diameter of the main body portion of theinner catheter 100, theouter catheter 200 is mainly sleeved outside the main body portion of theinner catheter 100, and the outer diameter of theouter catheter 200 may be the same as the outer diameter of theenlarged portion 110. Preferably, the axial distance between thedistal end 210 of the outer catheter and theenlarged portion 110 is between 5-50mm, and the first fixing point between thefirst end 310 of the flow-obstructingelement 300 and theenlarged portion 110 is close to the connection point of theenlarged portion 110 and the main body portion of theinner catheter 100; a second fixation point between thesecond end 320 of the flow-impedingelement 300 and theouter catheter 200 is near the outer catheterdistal end 210. Theenlarged portion 110 of theinner catheter 100 may be configured to maintain a consistent outer diameter of the entire catheter, preventing the obstructingmember 300 from being damaged when the catheter passes through a tortuous blood vessel during transport of the catheter in the blood vessel. Furthermore, the radial distances of the first and second fixation points with respect to the axial direction of theinner catheter 100 are substantially equal, which facilitates the retention of concentricity of theflow blocking element 300 without eccentricity when expanding, increases the uniformity of adherence of theflow blocking element 300, and thus reduces the risk of leakage.
Referring to fig. 14, in a preferred embodiment, theflow blocking element 300 includes aconstant diameter section 350, and when theflow blocking element 300 is expanded, theconstant diameter section 350 has the same outer circumferential dimension in the axial direction (i.e., is cylindrical). Optionally, theconstant diameter section 350 of theflow blocking element 300 is shaped into a constant diameter tubular state in an expansion state during thermoforming, and thus, when theflow blocking element 300 expands due to axial pressure, theconstant diameter section 350 expands synchronously along the axial direction, and the shape can better fit the blood vessel wall and has a better blood flow blocking effect. It should be appreciated that in some embodiments, when theflow blocking element 300 expands, theconstant diameter section 350 is not limited to synchronous expansion, but both ends expand one after another, and the outer surface of theconstant diameter section 350 is a slope (i.e., the overall shape is conical), and theconstant diameter section 350 does not reach the same shape (i.e., cylindrical) of the outer circumference dimension along the axial direction until theflow blocking element 300 is in the fully expanded state or the state of being adapted to the inner diameter of the blood vessel wall, which is not limited by the present invention.
[ EXAMPLE III ]
The flow-obstructing duct provided by the third embodiment of the present invention is basically the same as the flow-obstructing duct provided by the first embodiment, and the description of the same parts is omitted, and only different points will be described below.
In the flow-blocking duct provided in the third embodiment, the specific dimensions and the components of theinner duct 100, theouter duct 200, and the flow-blockingelement 300 are different from those of the flow-blocking duct provided in the first embodiment. Optionally, the ratio of the inner diameter of theinner catheter 100 to the outer diameter of theouter catheter 200 is greater than or equal to 0.76; preferably, the ratio of the inner diameter of theinner catheter 100 to the outer diameter of theouter catheter 200 is greater than or equal to 0.81; more preferably, the ratio of the inner diameter of theinner catheter 100 to the outer diameter of theouter catheter 200 is greater than or equal to 0.85. Further, the inner diameter of theinner catheter 100 ranges between 0.059-0.118 inches and the outer diameter of theouter catheter 200 ranges between 0.078-0.137 inches. This is specifically illustrated below by preferred examples.
In a first preferred example of the third embodiment, theinner catheter 100 comprises a three-layer structure, namely, afirst layer 101, asecond layer 102 and athird layer 103 from the inside to the outside. Thefirst layer 101 was 0.001 inch thick, thesecond layer 102 was a braided structure, the wire diameter of the braided wire was 0.002 inch, and thethird layer 103 was 0.003 inch thick. Theouter catheter 200 comprises a single layer structure having a thickness of 0.003 inches; theflow resisting element 300 is positioned between theinner catheter 100 and theouter catheter 200, theflow resisting element 300 comprises a support frame and a coating, the support frame is in a structure of a cutting pipe, the thickness of the pipe is 0.004 inch, the coating is positioned outside the support frame, and the thickness of the coating is 0.0025 inch; the outer diameter of the entire flow blocking conduit (i.e., the outer diameter of the outer conduit 200) was 0.117 inches, the inner diameter of theinner conduit 100 was 0.082 inches, and the ratio of the inner diameter to the outer diameter of the entire flow blocking conduit was 0.7.
In a second preferred example of the third embodiment, theinner catheter 100 comprises a three-layer structure, which is afirst layer 101, asecond layer 102 and athird layer 103 from the inside to the outside. Thefirst layer 101 was 0.001 inch thick, thesecond layer 102 was braided, the wire diameter of the braiding wire was 0.0015 inch, and thethird layer 103 was 0.002 inch thick. Theouter catheter 200 comprises a single layer structure having a thickness of 0.002 inches; theflow resisting element 300 is positioned between theinner catheter 100 and theouter catheter 200, theflow resisting element 300 comprises a support frame and a coating, the support frame is in a structure of a cutting pipe, the thickness of the pipe is 0.003 inch, the coating is positioned outside the support frame, and the thickness of the coating is 0.002 inch; the outer diameter of the entire flow-blocking conduit (i.e., the outer diameter of the outer conduit 200) was 0.112 inches, the inner diameter of theinner conduit 100 was 0.085 inches, and the ratio of the inner diameter to the outer diameter of the entire flow-blocking conduit was 0.76.
In a third preferred example of the third embodiment, theinner catheter 100 comprises a three-layer structure, namely, afirst layer 101, asecond layer 102 and athird layer 103 from inside to outside. Thefirst layer 101 was 0.001 inch thick, thesecond layer 102 was a braided structure, the wire diameter of the braided wire was 0.001 inch, and thethird layer 103 was 0.002 inch thick. Theouter catheter 200 comprises a single layer structure having a thickness of 0.002 inches; theflow resisting element 300 is positioned between theinner catheter 100 and theouter catheter 200, theflow resisting element 300 comprises a support frame and a coating, the support frame is of a woven structure, the wire diameter of a wire for weaving is 0.0014 inch, the coating is attached to the grids of the support frame in a leaching mode, and the thickness of the coating is 0.002 inch; the outer diameter of the entire flow-blocking conduit (i.e., the outer diameter of outer conduit 200) was 0.1076 inches, the inner diameter ofinner conduit 100 was 0.087 inches, and the ratio of the inner diameter to the outer diameter of the entire flow-blocking conduit was 0.81.
In a fourth preferred example of the third embodiment, theinner catheter 100 includes a three-layer structure, i.e., afirst layer 101, asecond layer 102, and athird layer 103 from the inside to the outside. Thefirst layer 101 has a thickness of 0.0005 inches, thesecond layer 102 has a helical configuration, the wire diameter of the wire forming the helix is 0.001 inches, and thethird layer 103 has a thickness of 0.002 inches. Theouter catheter 200 comprises a single layer structure having a thickness of 0.002 inches; theflow resisting element 300 is positioned between theinner catheter 100 and theouter catheter 200, theflow resisting element 300 comprises a support frame and a coating, the support frame is of a woven structure, the wire diameter of a wire for weaving is 0.001 inch, the coating is attached to the grids of the support frame in a leaching mode, and the thickness of the coating is 0.002 inch; the outer diameter of the entire flow-blocking conduit (i.e., the outer diameter of the outer conduit 200) was 0.105 inches, the inner diameter of theinner conduit 100 was 0.089 inches, and the ratio of the inner diameter to the outer diameter of the entire flow-blocking conduit was 0.85.
The flow-obstructing catheters in the four preferred examples can achieve a good use effect, the ratio of the inner diameter to the outer diameter of each flow-obstructing catheter is larger than 0.7, and the inner diameter can be greatly improved under the condition that the outer diameter of each flow-obstructing catheter is limited, so that the flow-obstructing catheter is suitable for large thrombus or instruments.
[ EXAMPLE IV ]
The flow blocking catheter provided by the fourth embodiment of the invention is a balloon catheter, which comprises: aninner catheter 100, a flow-impedingelement 300, and anouter catheter 200. Referring to fig. 15, in the balloon catheter, theinner catheter 100 may be a three-layer structure including a first layer, a second layer and a third layer from the inside to the outside, the first layer having a thickness of 0.0005 inch, the second layer having a spiral structure, the wire diameter of the wire constituting the spiral being 0.001 inch, and the third layer having a thickness of 0.002 inch. Theouter catheter 200 is a single layer structure with a wall thickness of 0.0025 inches. In this embodiment, the flow-resistingelement 300 is aballoon 350, theballoon 350 is pressed on the outside of theouter catheter 200, that is, the proximal end and the distal end of theballoon 350 are connected to the outer surface of theouter catheter 200, a cavity is formed between theballoon 350 and theouter catheter 200, and the cavity is in fluid communication with the lumen between theinner catheter 100 and theouter catheter 200. Specifically, afluid passage 230 is disposed between theinner catheter 100 and theouter catheter 200 for allowing fluid or gas to flow from the proximal end to the distal end of the flow blocking catheter, and a plurality offluid passages 231 are disposed in a portion of theouter catheter 200 surrounded by theballoon 350 for allowing fluid or gas to enter theballoon 350 from thefluid passage 230 to expand theballoon 350. In this embodiment, theballoon 350 is made of a polymer material and is prepared by blow molding or extrusion, and both ends of theballoon 350 are fixedly connected to the outer surface of theouter catheter 200 by bonding, hot pressing or welding (e.g., high frequency welding), and theballoon 350 can be in a contracted state by folding or other processes, so as to be conveniently transported in a blood vessel. Optionally, the wall thickness of theballoon 350 is 0.004 inches, the overall outer diameter of the flow-blocking catheter is 0.108 inches, the inner diameter of theinner catheter 100 is 0.087 inches, and the ratio of the inner diameter to the outer diameter of the overall flow-blocking catheter is 0.81. The balloon catheter achieves inflation of the flow-blockingelement 300 by injecting fluid into theaccess lumen 230 and retraction of the flow-blockingelement 300 by withdrawing the fluid. In this embodiment, the fluid is a contrast fluid, which is convenient for a physician to clearly observe the position and state of theballoon 350 during the operation of the balloon catheter.
It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, similar parts between the embodiments may be referred to each other, and different parts between the embodiments may also be used in combination with each other, which is not limited by the present invention.
In conclusion, the flow-obstructing catheter provided by the invention has a larger inner-to-outer diameter ratio, so that the inner diameter of the flow-obstructing catheter can be increased on the premise of controlling the outer diameter of the flow-obstructing catheter, and the flow-obstructing catheter is suitable for larger thrombus or instruments.
The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.