The present application relates to the field of medical instruments and, in particular, to a flow blocking catheter.
Strokes, mainly caused by blood clots in cerebral blood vessels, are a common medical condition that seriously threatens human health, which is also the third leading cause of death worldwide and the leading cause of long-term disability in adults. In the current clinical practice, treatments of directly sucking the thrombus with an aspiration catheter or removing the thrombus with the assistance of a stent are used to eliminate the thrombus to achieve recanalization of the blood vessel. After the aspiration catheter reaches the thrombus location along the blood vessel, a negative pressure is applied at its proximal end to suck the clot into the aspiration catheter or onto the opening of aspiration catheter, followed by slow retraction of the clot into a guide catheter. As a result, the blood vessel recovers back to its normal hemodynamic condition. The thrombectomy stent is required to cross over the clot, trap the clot within meshes of the stent and then retract back into the support catheter, so as to recanalize the blood vessel. After the stent is retracted back into the support catheter, the support catheter together with the stent and blood clot trapped in the stent, is in turn withdrawn into the guide catheter. However, during the thrombus removal process, the fragment clots often fall off and are rushed to the distal blood vessel due to the impact of proximal blood flow, or during the operation of the aspiration catheter or the delivery of thrombectomy stent into the interventional instrument (the guide or support catheter) after the successful capture of clots, the clots break up to create clot fragments that are rushed to the distal blood vessel by the blood flow to cause secondary blocking, which results in the failure of operation and may even threaten the patient's life in severe cases. For example, the possibility of percutaneous coronary intervention (PCI) caused myocardial necrosis reaches as high as 16%-39%, and most of these cases have been found to be attributable to escape of clots into distal blood vessels during the intervention operation. In order to solve the problems caused by clot fragmentation, the balloon guide catheter has been adopted commonly in prior art to facilitate the thrombus removal operation by temporarily occluding the blood flow.
Typically, during the operation, after a thrombus removal device is delivered to a target site with the assistance of a balloon guide catheter (i.e., an aspiration or support catheter passes through a lumen of the balloon guide catheter to reach the target site), the balloon is expanded against the blood vessel wall by injecting a radiopaque fluid in the balloon so as to temporarily occlude blood flow in the vessel. Moreover, after the blood clot has been taken into a lumen of the aspiration or support catheter, the balloon is contracted, followed by withdrawal of the balloon guide catheter. In this way, the blood clot is taken out of the patient's body to achieve the effect of blood flow reconstruction.
However, in existing balloon guide catheters, the balloon is typically provided on the outside of an outer tube. As the balloon has a certain thickness itself and given that an outer diameter of the catheter must be designed to be not too large to ensure its smooth passage in blood vessels, the catheter has to assume a very small inner diameter, making it impossible to be fitted with a wide-lumen aspiration or support catheter. This therefore makes it unable to treat large-size thrombi. Moreover, for balloon guide catheter, since it is necessary to fill the balloon with the radiopaque or other liquid to make the balloon bulge and attach to the blood vessel wall for blocking the blood flow, it may take some time to achieve a complete blood flow blocking effect. It may also be the case for the withdrawal of the balloon guide catheter by drawing out the radiopaque fluid. This not only prolongs the surgical time, but may also lead to ischemia or even necrosis of the tissue due to an excessively long blood flow blocking time. This may also results in a risk of blood vessel damage from over-expansion or bursting of the balloon. More importantly, during surgery, if it is found that the balloon is dilated at an improper location, the radiopaque fluid has to be completely discharged before the balloon can be relocated and re-expanded. This not only takes much more time but also increases risk of bursting of the balloon to cause secondary damage to the blood vessel due to the repeated dilation. Further, the pressure exerted by the dilated balloon tends to stimulate the wall of the cerebral blood vessel and thus cause various complications during the surgical procedure. All these shortcomings limit the benefits of using balloons in thrombus removal procedures, increase complexity of such procedures and expose the patients to high risk.
It is an object of the present application to provide a flow blocking catheter to overcome the problems of slow flow blocking, low safety and reliability, poor reproducibility and small catheter lumen of existing guide catheters that are brought by the use of balloon for blood flow blocking.
To solve the above problem, present application provides a flow blocking catheter comprising:
an inner tube;
an outer tube movably sleeved on the exterior of the inner tube; and
a flow blocking member having one end attached to an outer circumference of the inner tube and the other end attached to a distal end of the outer tube, wherein the flow blocking member is configured to expand as the outer tube moves toward a distal end of the inner tube and to collapse as the outer tube moves away from the distal end of the inner tube.
Optionally, in the flow blocking catheter, the flow blocking member comprises a support frame having opposing ends thereof attached to the inner tube and the outer tube respectively, wherein the support frame is configured to expand when axially compressed and collapse when axially pulled.
Optionally, in the flow blocking catheter, the flow blocking member further comprises a flow blocking membrane attached to the support frame.
Optionally, in the flow blocking catheter, the distal end of the inner tube comprises an expanded section that has an outer circumferential size greater than that of rest portion of the inner tube, wherein the flow blocking member is connected to the expanded section at one end and to the distal end of the outer tube at the other end.
Optionally, in the flow blocking catheter, the outer circumference of the expanded section is sized to fit with an outer circumferential size of the outer tube.
Optionally, in the flow blocking catheter, the flow blocking member further comprises an isodiametric section that has an equal outer circumferential size along an axial direction of the flow blocking member in an expanded configuration.
Optionally, the flow blocking catheter further comprises a control valve configured to drive relative movements between the inner and outer tubes.
Optionally, in the flow blocking catheter, the control valve comprises a control valve body and a control slider configured to be axially slidable, wherein: the control valve body is coupled to a proximal end of the inner tube with the control slider being coupled to a proximal end of the outer tube; or the control valve body is coupled to the proximal end of the outer tube with the control slider being coupled to a proximal end of the inner tube.
Optionally, in the flow blocking catheter, both or either of the inner tube and the outer tube is a single-layered tube made of macromolecular material.
Optionally, in the flow blocking catheter, both or either of the inner tube and the outer tube has a structure comprising at least two layers, in which both or either of a first layer and a second layer from inside to outside is made of macromolecular.
Optionally, in the flow blocking catheter, both or either of the inner tube and the outer tube has a structure comprising at least two layers, in which a second layer from inside to outside comprises one or more selected from the group consisting of braided structure, coil, and cut hypotube.
Optionally, in the flow blocking catheter, each of the inner and outer tubes has a triple-layered structure.
Optionally, in the flow blocking catheter, the inner tube comprises a first radiopaque ring disposed at a distal end of the inner tube.
Optionally, in the flow blocking catheter, the inner tube further comprises a second radiopaque ring disposed at a location of the inner tube where the flow blocking member is attached to the inner tube.
Optionally, in the flow blocking catheter, the outer tube further comprises a third radiopaque ring disposed at a location of the outer tube where the flow blocking member is attached to the outer tube.
Optionally, in the flow blocking catheter, the flow blocking member comprises at least one selected from the group consisting of mesh structure, open-loop structure and spiral structure, and the flow blocking member is fabricated by braiding, winding or cutting.
Optionally, in the flow blocking catheter, the mesh structure is braided from 1-64 filaments. The filament is at least one selected from the group consisting of regular filament, radiopaque filament and composite filament. The regular filaments is made of at least one selected from the group consisting of nickel-titanium alloy, cobalt-chromium alloy, stainless steel and macromolecular material. The radiopaque filaments is made of at least one selected from the group consisting of radiopaque metal, alloy of radiopaque metals and macromolecular material containing a radiopaque agent. The composite filament is formed by a radiopaque core filament combined with a regular filament.
In summary, the flow blocking catheter of the present application comprises an inner tube, an outer tube movably sleeved on the exterior of the inner tube; and a flow blocking member having one end attached to an outer circumference of the inner tube and the other end attached to a distal end of the outer tube. The flow blocking member is configured to expand as the outer tube moves toward a distal end of the inner tube and to collapse as the outer tube moves away from the distal end of the inner tube.
With this configuration, expansion of the flow blocking member is able to be controlled simply by pushing/retracting the outer or inner tube, which allows to achieve a fast shifting between different configurations, relocatability during a surgical procedure, and simple and time-saving operation. In addition, the flow blocking member is able to occlude blood flow with a controllably expansion, thereby lowering stimulation to the wall of the blood vessel while avoiding the problem of easy bursting arising from the use of a balloon. Moreover, the flow blocking member has a small thickness when in a collapsed configuration, allowing an increased inner diameter of the catheter at a given outer diameter of the flow blocking catheter and thus making it applicable to the treatment of large blood clots or passage of large instruments.
Those of ordinary skill in the art would appreciate that the appended figures are presented merely to enable a better understanding of the present application rather than limit the scope thereof in any sense. In the figures,
In the figures,
100, inner tube; 101, first layer; 102, second layer; 103, third layer; 104, adhesive; 110, expanded section; 120, first radiopaque ring;
200, outer tube; 210, distal end of the outer tube; 220, stress dispersion tube;
300, flow blocking member; 310, first end; 320, second end; 330, radiopaque filament; 340, mesh opening; 350, isodiametric section;
400, control valve; 410, control valve body; 420, control slider; 430, sliding slot; 440, catheter insertion opening; 500, securing film.
To make objects, advantages and features of the present application more apparent, present application is described in detail by the particular embodiments made in conjunction with the accompanying drawings. Note that the figures are provided in a very simplified form not necessarily drawn to exact scale, with the only intention to facilitate convenience and clarity in explaining the present application. In addition, structures shown in the figures are usually part of actual structures. In particular, as the figures tend to have distinct emphases, they are often drawn to different scales.
As used in present specification, the meaning of “a,” “an,” and “the” include singular and plural references, unless the context clearly dictates otherwise. As used in present specification and appended claims, the term “or” generally includes the meaning of “and/or”, unless the context clearly dictates otherwise. Additionally, the terms “proximal” and “distal” are generally used to refer to an end close to an operator and an end close to a lesion site in a patient, respectively. Further, the terms “one end” and “the other end”, or “proximal end” and “distal end”, are generally used to refer to two opposing portions including not only the endpoints.
The core idea of the present application is to provide a flow blocking catheter to overcome the problems of slow flow blocking, low safety and reliability, poor reproducibility and small catheter lumen of existing guide catheters that are brought by the use of balloon for blood flow blocking. The flow blocking catheter comprises an inner tube, an outer tube movably sleeved on the exterior of the inner tube; and a flow blocking member having one end attached to an outer circumference of the inner tube and the other end attached to a distal end of the outer tube. The flow blocking member is configured to expand as the outer tube moves toward a distal end of the inner tube and to collapse as the outer tube moves away from the distal end of the inner tube. With this configuration, expansion of the flow blocking member is able to be controlled simply by pushing/retracting the outer or inner tube, which allows to achieve a fast shifting between different configurations, a few influence on tissue blood supply, relocatability during a surgical procedure, and simple and time-saving operation. In addition, the flow blocking member is able to occlude blood flow with a controllably expansion, thereby lowering stimulation to the wall of the blood vessel while avoiding the problem of easy bursting arising from the use of a balloon. Moreover, the flow blocking member has a small thickness when in a collapsed configuration, allowing an increased inner diameter of the catheter at a given outer diameter of the flow blocking catheter and thus making it applicable to the treatment of large blood clots or instruments.
In the following description, reference is made to
Please refer to
As shown in
In one exemplary embodiment, both the inner 100 and outer 200 tubes are preferred to be circular tubes and the outer tube 200 is sleeved on the inner tube 100. The difference between an outer diameter of the inner tube 100 and an inner diameter of the outer tube 200 may range from 0.0001 inch to 0.1 inch. The outer tube 200 is preferred to be a single-layered tubular member formed of, for example, one or more of a polyether-polyamide block copolymer (PEBA or Pebax), polyamide (PA) and polytetrafluoroethylene (PTFE). The inner tube 100 includes at least a single macromolecular layer made of a macromolecular material that may be one or more selected from the group consisting of PTFE, high-density polyethylene (HDPE), Pebax mixed with a friction coefficient reducing additive, and polyolefin elastomer (POE). Preferably, the inner tube 100 includes a triple-layered structure, as shown in
Preferably, the inner tube 100 includes a first radiopaque ring 120 disposed at the distal end of the inner tube 100. In particular, the first radiopaque ring 120 may be disposed at a distal end of the second layer 102 of the inner tube 100. More preferably, the inner tube 100 further includes a second radiopaque ring (not shown) disposed at a location of the inner tube 100 where the flow blocking member 300 is attached to the inner tube 100. Further, the flow blocking member 300 further includes a third radiopaque ring (not shown) disposed at a location of the outer tube 200 where the flow blocking member 300 is attached to the outer tube 200. Optionally, examples of materials of the first 120, second and third radiopaque rings may include, but are not limited to, platinum, iridium, tantalum, noble metal alloys and macromolecular materials containing radiopaque agents. Arranging the three radiopaque rings helps the operator locate the inner tube 100 during a surgical procedure. It is to be understood that the first radiopaque ring 120 is located at the distal end of the inner tube 100, but it is not intended to limit that the first radiopaque ring 120 can only be located at the distal end face of the inner tube 100, which can be located in an area close to the distal end of the inner tube 100. While the above embodiment exemplifies the positions of the three radiopaque rings, it is not intended to limit that the three radiopaque rings must be provided at the same time, and those skilled in the art may select to provide any one or two of them according to the actual circumstances.
Preferably, the flow blocking member 300 includes a support frame, and a flow blocking membrane attached to the support frame. The opposing ends of the support frame are attached to the inner tube 100 and outer tube 200 respectively. The support frame is configured to expand (i.e., bulge radially) when axially compressed and to collapse (i.e., retract and recover radially) when axially pulled. In one example, the support frame is a tubular member that is able to switch between a collapsed configuration and an expanded configuration. It is to be understood that the support frame is not limited to switch only between the collapsed configuration and the expanded configuration. In some cases, it may also assume an intermediate configuration between the collapsed and expanded configurations (i.e., a semi-expanded or partially-expanded configuration). The support frame may be formed of, for example, nickel-titanium alloy, Type 304 stainless steel, platinum-tungsten alloy, platinum-iridium alloy, cobalt-chromium alloy, radiopaque metal or the like. The support frame may be fabricated by winding, cutting or braiding. In this embodiment, the support frame includes a plurality of mesh openings 340, as shown in
Referring to
Further, when blood flow blocking has been attained, a blood clot can be directly sucked, or captured and pulled back via the lumen of the inner tube 100 (a aspiration catheter may be deployed in the lumen of the inner tube 100 of the flow blocking catheter to suck the clot, or a support catheter may be deployed in the lumen, in which a thrombectomy stent is provided for removing the clot). As shown in
Further, when it is necessary to change positions of the blood flow blocking by relocating or withdrawing the flow blocking catheter, the outer tube 200 may be caused to move proximally relative to the inner tube 100 (i.e., retracting the outer tube 200) until the distance between the first and second attachment points along the axial of the inner tube 100 becomes maximum. The configuration of the flow blocking member 300 shown in
As shown in
Referring to
Referring to
In summary, the flow blocking catheter of the present application comprises an inner tube, an outer tube and a flow blocking member. The flow blocking member has one end attached to an outer circumference of the inner tube and the other end attached to a distal end of the outer tube. The flow blocking member is configured to expand as the outer tube moves toward a distal end of the inner tube and to collapse as the outer tube moves away from the distal end of the inner tube. With this configuration, expansion of the flow blocking member is able to be controlled simply by pushing/retracting the outer or inner tube, which allows to achieve a fast shifting between different configurations, relocatability during a surgical procedure, and a simple and time-saving operation. In addition, the flow blocking member is able to occlude blood flow with a controllably expansion, thereby lowering stimulation to the wall of the blood vessel while avoiding the problem of easy bursting arising from the use of a balloon. Moreover, the flow blocking member has a small thickness when in a collapsed configuration, allowing an increased inner diameter of the catheter at a given outer diameter of the flow blocking catheter and thus making it applicable to the treatment of large blood clots or passage of instruments.
The description presented above is merely a few preferred embodiments of the present application and does not limit the protection scope of present application in any sense. Any change and modification made by those of ordinary skill in the art based on the above teachings fall within the protection scope of the appended claims.