Catheter system and method for injection of a liquid embolic composition and a solidification agent

BACKGROUND THE INVENTION

territorially invention

The invention relates to a catheter system for combined injection of a liquid embolic composition and an embolic solidification agent, and particularly to a catheter system comprising a multiple lumen catheter for Injecting a liquid embolic composition through a first opening and an embolic Solidification agent through a second opening. The catheter system is for supplying the embolic composition in a controlled Way for embolizing blood vessels used.

State of technology

In many clinical situations it is desirable to Blood vessels selectively to close, and Although for a variety of purposes, such. as the control or prevention of bleeding, prevention of blood supply to tumors, and this Blocking the blood flow within an aneurysm. embolization was of blood vessels accomplished by employing certain polymer compositions and / or particles containing silicone balloons, metallic coils, PA particles, gelatin, sclerosis material and the like, to block the blood flow in the blood vessels selectively.

Intracranial aneurysms occur at 1-9% of the population and rupture at a rate of more than 50,000 per year in North America on. Intracranial aneurysms are abnormal blood filled dilations a blood vessel wall, the can break down what significant causing bleeding and damage to surrounding brain tissue or death can. Traditional intracranial aneurysms were surgically disconnected in order to reduce the risk of rupture by a metal clip around the neck of the aneurysm placed to further Blood inflow cut the aneurysm and prevent. Numerous An aneurysm can however are not treated surgically, either because the Location and shape of the aneurysm or because the condition of the patient no brain surgery allows.

When aneurysms not surgically can be treated, or when surgery too risky or invasive appears to Aneurysm with coils are treated endovaskular. coils are placed in the aneurysm by a catheter endovaskular stretching at the site of the aneurysm and one or more often Platinum or tungsten coils through the catheter into brings in the aneurysm. The inside placed in the aneurysm coils produce a thrombus the aneurism closes and other blood flow to the aneurysm prevented. The treatment of intracranial aneurysms with coils isolates the aneurysm from the arterial circulation and helps and before a rupture to protect a further growth of the aneurysm. The use of platinum coils However, for the treatment of intracranial aneurysms may not have a permanent solution represent, because the blood clot around the coils due tear the dynamic nature of the blood clotting function or dissolve can. When a formed around the coils in an aneurysm Clot breaks free, can fulfill its function of sealing the aneurysm no longer the coil. In addition, the Coils are moved and get into the blood stream of the patient, which cause blockages at other locations within the vascular system can.

A further with the use of Coils for closing an aneurysm related Disadvantage is that the coils are known to shrink over time, which cavities for a subsequent Growth of the aneurysm can. If subsequent surgical clamp procedure is provided, it also can be difficult the terminal over to place the coil mass.

Aneurysms with wide necks can surgical disconnection or not easily treated by coil , since the Aneurismenhals may have a shape which surgically not completely can be disconnected, and because the coils may tend to the Aneurism to be moved when the neck is particularly wide.

A minimally invasive procedure to Treating intracranial aneurysms, with the problems surgical avoids clamping and coil techniques, based on the endovascular Injection of a liquid embolic composition solidifies in aneurism to to close off the aneurysm. The liquid includes embolic composition generally a water-insoluble biocompatible polymer and a biocompatible solvent. When the liquid embolic composition is injected into the aneurysm, dissolves the biocompatible solvent into the blood, and the polymer solidifies, to increase blood flow through the Aneurysm to close.

Typically, liquid embolic Compositions of a water-insoluble, biocompatible, non-biodegradable polymer in a biocompatible solvent dissolved , and preferably these compositions include a radiopaque Material that allows the physician who Embolisationsprozedur by to consider fluoroscopy. Before the supply of the embolic composition for aneurism of the aneurysm and the feeder are preferably positioned such that the liquid emboli<?page 3?>cal composition fed by gravity into the aneurysm and will remain in the aneurysm (the Aneurismenhals upwards shows). When the embolic composition is delivered to the aneurysm, dissolves the solvent the polymer material, which results in that the polymeric material solidifies within the aneurysm.

Depending on the rate at which the liquid embolic injected material into the blood vessel is, and the existing amount of blood flow, the polymer during a can Period of time in liquid remain shape while the solvent dissolves in the bloodstream. In addition, the solvent may can not be completely resolved by a center of the polymer composition, resulting in a mass with a fixed outer shell and a liquid Inner leads. also , the solvent concentration at the injection point rise to a point where narrow Strip non-solidified polymer material of the polymer composition solve and can be carried off in the bloodstream, where it undesirable Vaskularstelle close can. Since the solvent generally has a greater density than comprising water or blood, gravity, the solvent can keep the aneurysm and prevent the solidification of the polymer.

It would therefore be desirable to provide a method for controlling the solidification of the polymeric material during the provide injection. Further, it would be desirable to provide a method for filling propose an aneurysm, which is not positioned so that gravity can be used to the embolic composition flow into the aneurysm and to remain as an anatomical patient position can not always be in a gravity dependent position.

As in patent application <patcit><text>US 5,830,178</text></patcit> disclosed comprising the embolization of blood vessel with a liquid embolic Composition generally includes a preparation step of rinsing a Delivery catheter through which the liquid embolic composition supplied to be, with the biocompatible solvent material to any aqueous to remove material from the catheter. The removal of any aqueous material from the catheter prevents the solidification of the embolic composition within the catheter during the feed. This prior step of rinsing with the solvent must take place at a low flow rate to avoid damage to the blood vessel, which is caused by high concentrations of the solvent, which can be toxic and may cause Vaskularspasmen. It would be however, desirable the previous flushing perform the delivery catheter to be able to without fear of causing tissue damage.

The document US-A-5443454 discloses an embolectomy catheter having an opening for introducing a liquid substance covers and at the distal end thereof a spinning means for extruding the liquid having substance in the form of a filamentous embolic material.

Summary the invention

According to one aspect of the invention, includes a catheter system for controlled delivery of polymer compositions a multiple lumen catheter with a first opening and a second opening for supplying fluid. A first fluid supply port leads fluid the first opening to, and a liquid supply is for supplying a liquid embolic composition through the first opening connected to the first fluid supply port. A second fluid supply port leading fluid to the second opening, and a solidifying agent supply is to supply a solidifying agent through second opening connected to the second fluid supply port to the solidification the through the first opening supplied liquid embolic to strengthen the composition.

According to a further aspect of the Invention comprises a catheter for controlled delivery of embolic Compositions formed of a DMSO compatible material first tube, a device connected to the first tube and second tube an actuating element to move the first tube in the longitudinal direction relative to the second Pipe. A first fluid supply port is connected to an opening of the first tube connected to the supply of a liquid embolic composition, the one dissolved in DMSO biocompatible, water-insoluble Polymer composition. A second fluid supply port is connected to an opening of the second tube for supplying a solidifying agent, the dissolving of the DMSO and solidification of the polymer composition favored.

According to a further aspect of the Invention comprises a method for embolizing a Vaskularstelle, such as. for example, an aneurysm with a liquid embolic composition the steps of the endovascular insertion of a multiple lumen catheter at a Vaskularstelle, of injecting a liquid embolic Composition by a first opening of the multiple lumen catheter at the Vaskularstelle, and controlling solidification of the liquid embolic Composition within the Vaskularstelle by injecting a Solidification agent through a second opening of the multiple lumen catheter at the Vaskularstelle.

According to a further aspect of the present invention comprises a method for reducing toxic Effects of an intravascular supplied non-aqueous solvent positioning a multiple lumen catheter in a Vaskularstelle a mammal, injecting a one &lt;?page 4?&gt;non-aqueous solvent containing composition through a first opening of the multiple lumen catheter at the Vaskularstelle, and injecting an aqueous solution by at least one second opening of the multiple lumen catheter at the Vaskularstelle to dilute the non-aqueous solvent and toxic effects of the non-aqueous solvent reduce to surrounding tissue.

According to a further aspect of the present invention comprises a system for controlled delivery in vivo of a liquid embolic composition is a liquid embolic composition and a multiple lumen catheter for Supply of liquid embolic composition through a first opening and supply a solidifying agent through a second opening.

Short description tHE dRAWINGS

The invention is detailed with reference to the accompanying Drawings will be described in which like elements have the same have reference numerals, and in which:

<figref idrefs="S32">1</figref> a Side view of the catheter system according to the invention is;

<figref idrefs="S32">2</figref> a Exploded side view of the catheter system of <figref idrefs="S32">1</figref> is;

<figref idrefs="S33">3</figref> a enlarged cross-sectional view of the Multiple lumen catheter taken along line 3-3 in <figref idrefs="S32">1</figref> is;

<figref idrefs="S33">4</figref> a enlarged cross-sectional view of the Multiple lumen catheter taken along line 4-4 in <figref idrefs="S32">1</figref> is;

<figref idrefs="S33">5</figref> a enlarged cross-sectional view of the Multiple lumen catheter taken along line 5-5 in <figref idrefs="S32">1</figref> is;

<figref idrefs="S33">6</figref> a enlarged side cross-sectional view an aneurysm is, the method of the invention by means of is treated;

<figref idrefs="S34">7</figref> a enlarged side cross-sectional view an aneurysm is that of the delivery of an embolic mass the catheter shows;

<figref idrefs="S34">8th</figref> a enlarged perspective view a distal end of a catheter according to a first alternative embodiment of the invention;

<figref idrefs="S34">9</figref> a enlarged perspective view a distal end of a catheter according to a second alternative embodiment of the invention;

<figref idrefs="S34">10</figref> a enlarged cross-sectional view of the distal end of a catheter according to a third alternative embodiment of the invention; and

<figref idrefs="S34">11</figref> a enlarged cross-sectional view of a distal end of a catheter according to a fourth alternative embodiment of the invention.

Detailed Description of the Preferred Embodiments

The catheter system in <figref idrefs="S32">1</figref> includes a catheter with at least two openings for supplying a liquid embolic composition through a first opening and supply a solidifying agent through a second opening. The liquid embolic Composition and the solidifying agent are the two openings supplied by a catheter connecting element of the adjustment relative longitudinal positions the two openings allowed. The catheter system is used to Vaskularstellen by controlled solidification of embolic composition embolize within such bodies.

The catheter system <figref>10</figref> includes an inner tube <figref>12</figref>, An outer tube <figref>14</figref>, and a also referred to as Y-connection element or Y-fitting Proximalendenanschlussele ment <figref>16</figref> to the Connect of fluid supplies to the inner and the outer tube. The outer tube<figref>14</figref> is coaxially around the inner tube <figref>12</figref> positioned around what a ring opening between the inner and the outer tube and a ring outlet of the outer tube forms. The inner tube<figref>12</figref> by means of an actuating element <figref>18</figref> within the outer tube <figref>14</figref> movable and may at its location relative to the outer tube by a locking mechanism <figref>20</figref> blocked will.

The method in which the present Invention can be used comprises the insertion of the multiple lumen catheter the catheter system <figref>10</figref> endovaskular in a Vaskularstelle, such. as an aneurysm, and injecting a liquid embolic Composition through a first opening, while a solidifying agent through a second opening is injected to the solidification of the liquid embolic composition control. The controlled solidification of the liquid embolic composition allows accurate and faster filling of Vaskularstelle even when the aneurysm is located such that gravity not to remain liquid embolic composition results in such places.

Before further detailed discussion the present invention, the following terms are defined:

The term "embolic composition" refers to a A fluid composition that is injected into a blood vessel and solidifies, completely around the Vaskularstelle or partially close.

The term "embolizing" or "embolization" refers to a process in which a Fluid composition is injected into a blood vessel, for example, in the case of aneurysm fills the Aneurismensack or blocked and / or the formation of a clot favors, so that the blood flow in the Aneursma and the pressure in the aneurysm after&lt;?page 5?&gt;leaves, and in the case of arterialvenösen Malformations (AVMs) and fistulas arterialvenösen (AVFs) a graft or a clot forms in order to control the flow of blood / redirecting to enable a correct tissue perfusion.

Embolization may be used, to bleeding due to lesions to prevent / control (eg, organ bleeding, gastrointestinal bleeding, Vaskularblutung and bleeding in connection with an aneurysm). also can embolization used to remove abnormal tissue (Eg, tumors, etc.), by interrupting its blood supply.

The term "biocompatible polymer" refers to polymers, the non-toxic in the amounts used, and chemically inert are substantially non-immunogenic when used internally in the patient are, and which is substantially insoluble in blood and other aqueous solutions are, however, in the fluid composition to the extent are soluble, as it is necessary to form a solid mass in vivo.

The term "contrast agent" refers to water-insoluble and water-based contrast agents, by X-ray, fluoroscopy, CT scans MRI or the like are visible.

The term "biocompatible solvent" refers to solvents capable are, the selected dissolve biocompatible polymer and in aqueous Compositions (eg., Blood) are miscible or soluble. Suitable biocompatible solvents include ethanol, dimethyl sulfoxide (DMSO), ethyl lactate, acetone, and like, and aqueous Mixtures thereof. With not more than about 30% water If with this used level, the amount of water is sufficiently small that the dissolved Polymer precipitates upon contact with the blood. Preferably, the biocompatible solvent anhydrous, and more preferably, the biocompatible solvent Anhydrous dimethyl sulfoxide (DMSO).

The term "solidification agent" refers to a liquid composition, when they close the liquid embolic composition, increases the rate at which the liquid embolic Composition solidifies. Examples of such solidification agent include sterile water, sterile saline, 5% dextrose in water (D5W), Ringer's lactate solution, Contrast agents and the like.

The term "catheter" includes both catheters and microcatheter. The catheter and microcatheter are used in the very curvy Blood vessels of the body determined, for example, intracranial blood vessels. With my very curvy we the typical tortuosity that one in vascular way of a remote access site, such. as the femoral artery to target sites deep encounters within the coronary, Renal- and Cerebralvaskulatur. Specific embodiments can be constructed for access to target sites that pathologically curvy Blood vessels include, and with pathological tortuosity, we believe that the vascular Way from a remote access point, such. As the femoral artery, contains the target sites curves of more than 90 °, when one of a blood vessel in a another blood vessel turns (Paths under the propagation vessel Angles greater than a right angle branching), and where the total path length within the target tissue is at least about 5 cm, and which is further characterized by the fact that it passes through a Wire 0.018 inches or less accessible, but to fine and / or curved to access with a wire considerably larger diameter.

The <figref idrefs="S32">1</figref> and <figref idrefs="S32">2</figref> show catheter system of the invention <figref>10</figref>. through which the liquid embolic Composition and the solidification agent in a Vaskularstelle are injected to a controlled solidification of the liquid embolic to achieve composition within the blood vessel. Like in the Exploded view of <figref idrefs="S32">2</figref> shown is running a proximal end of inner tube <figref>12</figref> by a rigid pipe <figref>22</figref>Which stabilizes the proximal end of the inner tube. The proximal ends of the rigid tube <figref>22</figref> and the inner tube <figref>12</figref> are to the actuator <figref>18</figref> connected. The actuator <figref>18</figref> is on a first luer hub <figref>24</figref> positioned and includes a substantially flat rectangular manipulator by the doctor is taken to the inner tube <figref>12</figref> longitudinal within the outer tube <figref>14</figref> to move. The rigid tube<figref>22</figref> is within the connecting element <figref>16</figref> positioned wherein a stopper <figref>26</figref> the rigid tube between corresponding first and second stops <figref>28</figref>. <figref>30</figref> within the joining element <figref>16</figref> is arranged. The first and second stop <figref>28</figref>. <figref>30</figref> the joining element <figref>16</figref> to grab the stop <figref>26</figref> the rigid tube <figref>22</figref> in to the Longitudinal movement of the inner tube <figref>12</figref> relative to the outer tube <figref>14</figref> limit.

According to an alternative embodiment, proximal movement of the actuating element <figref>18</figref> and of the inner tube <figref>12</figref> by engagement of the stopper <figref>26</figref> at the second stop <figref>30</figref> limited. The distal movement of the inner tube<figref>12</figref> relative to the outer tube <figref>14</figref> becomes by the engagement of the actuating element <figref>18</figref> With the locking mechanism <figref>20</figref> limited.

The first luer hub <figref>24</figref> is proximal to the actuator <figref>18</figref> positioned and comprises connection means for connecting a (non-shown) Syringe, the liquid with the filled embolic composition is. Although the liquid embolic Composition is generally the catheter through a syringe in an amount would be fed, the can be controlled continuously by the doctor, they can also by other means, such as. for example, a high pressure injector or a pump can be injected.

The catheter connector element <figref>16</figref> includes a Y-Arm <figref>32</figref> with a second luer hub <figref>34</figref>, The connection means to connect a Verfesti&lt;?page 6?&gt;transmission medium supply provides. The Y-arm<figref>32</figref> extends from one side of the main body the joining element <figref>16</figref> for delivery of the solidification agent in the interior of the connection element. From inside the connecting element<figref>16</figref> reaches the solidification agent into the annular opening between the outer tube <figref>14</figref> and the inner tube <figref>12</figref>, The outer tube<figref>14</figref> is by means a distal end cover <figref>46</figref> of the connecting element to the connecting element <figref>16</figref> connected. The outer tube<figref>14</figref> can be connected by a pipe fitting by the proximal end of the tube between the connecting element <figref>16</figref> and the end cap <figref>46</figref> clamps by a screw. The outer tube <figref>14</figref> can to the connection element by an adhesive bond, by insert and the like is to be closed. The solidifying agent may the outer tube <figref>14</figref> by the Y-Arm <figref>32</figref> out fed a variety of sources are, for example, a gravity-driven saline bag, a pump, a power injector, or a syringe.

An anti-kink feature of the present Invention is provided by bending of the inner tube <figref>12</figref> to avoid when it distally within the outer tube <figref>14</figref> shifted becomes. The anti-kink feature comprises a rigid outer tube<figref>48</figref>which inside the stopper <figref>28</figref> is pressed. The stop<figref>28</figref> in turn is within the main body the joining element <figref>16</figref> pressed. The rigid inner tube<figref>22</figref> is within the slightly larger rigid outer tube <figref>48</figref> displaced, around the inner tube <figref>12</figref> without buckling inside the outer tube <figref>14</figref> to to lead. If the rigid inner tube <figref>22</figref> has been moved proximally, until the stop <figref>26</figref> the rigid tube on the stop <figref>30</figref> attacks, remains one end of the rigid inner tube inside the rigid outer tube <figref>48</figref>, Without the rigid pipes <figref>22</figref>. <figref>48</figref> It would not be possible, the inner tube <figref>12</figref> in the outer tube <figref>14</figref> to push, because the flexible inner tube inside the connecting element <figref>16</figref> unfold would.

The rigid outer tube <figref>48</figref> extends from stop <figref>28</figref> to the distal end cover <figref>46</figref>, The rigid outer tube <figref>48</figref> ends However, against a proximal end of the outer tube <figref>14</figref>, what to a gap leads. Accordingly flows the through the luer hub <figref>34</figref> injected fluid to the rigid outer tube <figref>48</figref>. through the gap between the rigid outer tube and the outer tube <figref>14</figref>. and into the outer tube into it.

The locking mechanism <figref>20</figref> to the Block the relative longitudinal positions of the inner tube <figref>12</figref> and the outer tube <figref>14</figref> is by best in the exploded view of the <figref idrefs="S32">2</figref> shown. The locking mechanism <figref>20</figref> includes an external thread-end <figref>36</figref> of connecting element <figref>16</figref>, A rotatable lid <figref>38</figref> With an internal thread, and an elastic sealing member <figref>40</figref>, If the connecting element <figref>16</figref> with the inside of the outer tube <figref>14</figref> positioned inner tube <figref>12</figref> is assembled, the, sealing member <figref>40</figref> around the rigid tube <figref>22</figref> positioned around the interior of the Kathetenohr <figref>12</figref> connected. The sealing member<figref>40</figref> Has a mold having an annular rejuvenated surface at each end and a through bore for receiving the rigid tube <figref>22</figref> includes. The opposite annular tapered surfaces of the sealing member <figref>40</figref> engage corresponding tapered surfaces <figref>42</figref>. <figref>44</figref> within the joining element <figref>16</figref> or within a distal End of the rotatable lid <figref>38</figref> at. In a preferred embodiment the present invention is the sealing element <figref>40</figref> on Seal type, called a Tuohy Borst seal.

The rigid tube <figref>22</figref> is within the joining element <figref>16</figref> placed so that the inner tube <figref>12</figref> within of the outer tube <figref>14</figref> is displaceable, and the rigid tube <figref>22</figref> is within the connecting element and the rigid tube <figref>48</figref> displaced. Since the rotatable cover <figref>38</figref> onto the threaded end <figref>36</figref> the joining element <figref>16</figref> is attached, is the sealing element <figref>40</figref> between the tapered inner surface <figref>42</figref> of connecting element <figref>16</figref> and the tapered inner surface <figref>44</figref> of Lid compressed. If the sealing element<figref>40</figref> longitudinal is compressed, it expands radially inwardly and radially Outside out to the position of the rigid tube <figref>22</figref> within the connecting element <figref>16</figref> lock and a fluid seal between the inner surfaces of the connecting element and the outer surface of the rigid tube to effect. In this way fixed the lock mechanism <figref>20</figref> the ends of the inner and outer tube <figref>12</figref>. <figref>14</figref> relative to each other.

The inner and the outer tube <figref>12</figref>. <figref>14</figref> for use in the present invention are particularly designed to provide a to have sufficient strength, so that they without one or a guidewire used at a site within a blood vessel for embolization may be, and so that they at the distal end having sufficient flexibility, in order to avoid tissue damage. These goals in strength on to reach the proximal end and flexibility at the distal end, , the inner and the outer tube <figref>12</figref>. <figref>14</figref> each assembled from two Segments to be formed with different flexibility. The connections between the distal and the proximal segment of the hold and reindeer of the outer tube are longitudinal added to three different cross-sections of which in the <figref idrefs="S33">3</figref> to <figref idrefs="S33">5</figref> catheter shown results. Although The invention will be described so that they together by compounds used connected catheter segments, the catheter segments with different cross-sections and flexibilities coextruded story in order to avoid the necessity of compounds. alternative can the inner and the outer tube <figref>12</figref>. <figref>14</figref> along their lengths continuously variable flexibilities exhibit.

&lt;?page 7?&gt;

As in <figref idrefs="S33">3</figref> shown, is a proximal segment <figref>12a</figref> of the inner tube <figref>12</figref> out a material having a preferred durometer of approximately 40 Shore D formed to 90 Shore D, preferably about 60 Shore D to 80 Shore D, and having a diameter D1. A proximal segment<figref>14a</figref> of the outer tube <figref>14</figref> is of a material having a preferred durometer of approximately 40 Shore D to 90 Shore D, preferably about 60 Shore D to 80 Shore D, formed, and a diameter D2.

The proximal segment <figref>14a</figref> of outer tube <figref>14</figref> With the diameter D2 is a in <figref idrefs="S33">4</figref> shown distal segment <figref>14b</figref> the outer tube having a smaller Diameter D3 melted. The distal segment<figref>14b</figref> of outer tube <figref>14</figref> Has a durometer that is less than that of the proximal segment <figref>14a</figref> is. Preferably, the durometer of the distal segment <figref>14b</figref> about 40 Shore A to 45 Shore D, more preferably approximately 80 Shore A to 100 Shore A. The transition between segments <figref>14a</figref>. <figref>14b</figref> of the outer tube <figref>14</figref> done between the section line 3-3 and the section line 4-4 in <figref idrefs="S32">1</figref>, The transition between the distal and the proximal segment <figref>14a</figref>. <figref>14b</figref> of the outer tube <figref>14</figref> is along the length of the catheter so localized, as is required to ensure an to allow the course of the catheter along a tortuous path, preferably the transition from the distal end of the catheter between 15 and 20 cm.

The proximal segment <figref>12a</figref> of inner tube <figref>12</figref> is a in <figref idrefs="S33">5</figref> shown distal segment <figref>12b</figref> of the inner tube melted executed. The proximal and the di stale segment <figref>12a</figref>. <figref>12b</figref> of The inner tube preferably have the same diameter D1, are but formed of different materials with different flexibilities. The distal segment <figref>12b</figref> of the inner tube <figref>12</figref> Has preferably a durometer of about 40 Shore A to 45 Shore D, more preferably about 80 Shore A to 100 Shore A.

An example of a present in the Invention used multiple lumen catheter has a usable length of about 150 cm, a proximal portion of the outer tube of about 1.2 mm (3.6 French) is, and a distal portion of the outer tube which is about 0.87 mm (2.6 French) is. The wall thicknesses the inner and outer tube vary from about 0.003 inch (0.008 cm) to about 0.005 inch (0.013 cm), wherein the proximal portion of the outer tube the largest wall thickness. The proximal areas of the inner and outer tubes are made of high density polyethylene formed with a durometer of about 70 Shore D. The more flexible the distal portions of the inner and outer tubes are made of about 40% polyethylene low density and about 60% Engage of Dow (polyolefin) having a durometer of approximately 35 Shore D formed. This catheter configuration is only one example been described.

Catheter having a size between about 0.5 and 1.67 mm (1.5 and 5.0 French) can contribute to the treatment of aneurysms be used, and other sizes may also for others Types are used by vascular treatments bodies. The catheters can also braided or coil reinforced be and formed from a wide variety of materials. braided or reinforced in other ways Catheters provide kink resistance, crush resistance and controllability.

The inner tube <figref>12</figref> movable from an extended position in which the inner tube is approximately 30 mm above the distal end of the outer tube <figref>14</figref> survives, to a retracted Position in which the distal end of the inner tube on a level with or within the distal end of the outer tube <figref>14</figref> is. A Movement of the actuator <figref>18</figref> in the direction of arrow A in <figref idrefs="S32">1</figref> causes a corresponding movement of the distal end of the inner tube <figref>12</figref> in the direction of arrow B. Preferably, the inner and learn the outer tube <figref>12</figref>. <figref>14</figref> a minimal extension or compression so that the stroke of the actuating element <figref>18</figref> in the Substantially equal to the stroke of the distal end of the inner tube <figref>12</figref> is The catheter tip is preferably used by the doctor in a desired form for the particular location and configuration of the placed to be treated vasculature. The catheter tip is shaped by an acute shaping mandrel into opening of the inner tube <figref>12</figref> uses. Further, a sleeve in the opening between the outer tube <figref>14</figref> and the inner tube <figref>12</figref> while molding be used to support the outer tube. The Catheter tip with the mandrel and the sleeve is then by the doctor in a desired curvature shaped and subsequently heated steam, in order to maintain the curvature when the Dom and the sleeve withdrawn are.

The method comprises injecting a solidifying agent to control the solidification of the embolic Composition within a blood vessel. The solidifying agent allows rapid controlled solidification of the embolic composition and provides the physician with better control of Embolisationsprozedur.

An example of a liquid embolic Composition for embolizing aneurysms comprises a biocompatible, water-insoluble Polymer, a contrast agent and a biocompatible solvent, such as. for example, dimethylsulfoxide (DMSO). Examples of such are Embolisationszusammensetzungen described in U.S. Patent No. 5,667,767 of 16 September 1997, US Pat. No. 5,580,568 from 03 December 1996 and allowed US patent application Serial Number 08 / 688.050, which is incorporated in each completely Reference may be made.

<figref idrefs="S33">6</figref> shows the use of the method and the device according to the invention for closing a aneurysm <figref>70</figref> with a relatively wide neck <figref>72</figref>. which egg on a lay-in&lt;?page 8?&gt;nem blood vessel <figref>74</figref> has formed. The aneurysm <figref>70</figref> is treated by the multi-lumen catheter out <figref idrefs="S32">1</figref> endo Vascular introduced until a distal end of the catheter within or near the aneurysm or the neck <figref>72</figref> of the aneurysm is positioned.

The position of the catheter tip is dependent of the shape, size and the Flow pattern of Aneurism vary. A in the inner tube<figref>12</figref> positioned (Not shown) guidewire may well or may not be used to the catheter through the to lead blood vessels. Other A method for tracking the catheter to the aneurysm include steerable Systems in which the catheter tip is directed flow directed, Systems, or coat-related systems, in which the catheter through fed a coat becomes. The insertion of the catheter is generally carried out in a known manner under fluoroscopic visualization.

As in <figref idrefs="S33">6</figref> shown, , the distal ends of the inner and outer tube <figref>12</figref>. <figref>14</figref> each a radiopaque marker <figref>50</figref> or. <figref>52</figref> on to the Doctor looking at the relative positions of the distal ends of the two catheter tubes and the position of relative to the Kathetenohre aneurysm <figref>70</figref> to allow. The radiopaque marker<figref>50</figref>. <figref>52</figref> can to the inner or the outer diameters the pipes <figref>12</figref>. <figref>14</figref> be formed. When steering the Catheter through a typical curved path, the inner tube 12 from the end of the outer tube <figref>14</figref> extended be to enhance the flexibility and improve the steering of the catheter distal end.

Prior to feeding the liquid embolic Composition for aneurysm <figref>70</figref> , the opening <figref>62</figref> of inner tube <figref>12</figref> preferably flushed with a barrier fluid to remove any aqueous Material such. As blood, saline or contrast medium from remove the inner tube, which to a solidification of the embolic could lead composition within the catheter and block the catheter. Of the Catheter need not be completely be coated with the barrier fluid as long as the barrier fluid column a sufficient length has to make contact between the liquid embolic composition and any aqueous to prevent material in the catheter. The barrier fluid may be the biocompatible solvent his or another fluid that is a lock between aqueous Fluids and the liquid embolic composition causes.

When organic solvents such as, for example, DMSO, Ethanol and other used in high concentrations as barrier fluids be able they Fabrics be toxic and cause Vaskularspasmen. To the high solvent concentrations for tissue are toxic to avoid a dilution liquid through the annular opening <figref>60</figref> in between the inner and outer tube <figref>12</figref>. <figref>14</figref> during the Injection of the barrier fluid injected. The diluting liquid, the same liquid as be the solidifying agent such. as saline, or may be a different liquid be.

The injection of a diluent minimizes the effect of the toxicity an organic solvent and increased considerably the flow rate of the solvent for injection, which can be used safely. Preferably, the diluent is the opening <figref>60</figref> of outer tube <figref>14</figref> injected, before or as soon as the solvent the inner opening <figref>62</figref> to begins to leave before the embolic composition injected has been. The diluent leads to, that the solvent in vascular treatment area with much greater rate diffuses, and therefore, the concentration of the tissue strongly in contact stationary solvent reduced. As the diluent can be used a contrast medium to assist in the visualization of flow characteristics of the aneurysm and the determination of the optimal Catheter placement to help within the aneurysm.

According to the in <figref idrefs="S33">6</figref> explained Method of aneurysm <figref>70</figref> by injection of the liquid embolic Composition in the aneurysm <figref>70</figref> through the opening <figref>62</figref> of inner tube <figref>12</figref> means of a syringe or other treated feed mechanism, of the Luer connector <figref>24</figref> connected. The solidifying agent, for example, saline, is through the opening <figref>60</figref> of the outer tube <figref>14</figref> simultaneously and immediately thereafter the injection of liquid embolic composition injected. The solidifying agent may are injected continuously or in pulses. The solidifying agent washed the Aneurismabereich free from saturated with solvent Blood and replaces it with fresh strength agents. The washing effect of the solidification agent is used to remove blood and other viscous remove fluids in aneurism, which are otherwise difficult to remove are. also offers strengtheners a diffusion bed of solidification agent and increased the diffusion gradient, which the diffusion of the solvent improved from the embolic composition when the composition a coherent Mass solidified.

Without the use of the fixing means takes the Lösungsmittelkonzentrationsgradient between the injected liquid embolic composition and the surrounding blood from when the solvent propagates from the embolic composition, which slows the rate, with the solvent diffuses from the embolic composition. The solidifying agent is used to the Lösungsmittelkonzentrationsgradienten to increase, representing an increase of solvent diffusion rate causes.

According to an alternative embodiment of the Invention, the liquid embolic composition and the solidification agent alternately injected instead of simultaneously. The injection of the liquid embolic Composition alone will form a nearly spherical shape. In the&lt;?page 9?&gt;jection the liquid embolic composition may then be interrupted while the Solidification agent is injected to the spherical mass the liquid embolic composition to solidify. The timing of injection the liquid embolic composition and the solidification agent can vary in order to achieve different results.

The inner tube <figref>12</figref> is within of the outer tube <figref>14</figref> displaced, so that the tip of the inner pipe to different lengths on the distal end of the outer tube can be extended out to the solidification of the embolic composition dependent the size, shape to continue to monitor and flow properties of the aneurysm. injection a fluid through the annulus between the inner and the outer tube <figref>12</figref>. <figref>14</figref> can also be used to control the movement of the inner tube within of the outer tube to support, by a moving fluid column is formed, which reduces the friction between the pipes. The Using fluid as a friction-reducing mechanism particularly useful be when the catheter through a typically curved path has been controlled, such as that which through the blood vessels of the brain is formed.

When the embolization of aneurysm is finished or stopped for another reason, the outer tube is used <figref>14</figref> as a lip to detach the embolic mass from the catheter by to the inner tube <figref>12</figref> withdraws into the external tube. The separation of a coherent solid mass of embolic composition E from the end of the catheter is in <figref idrefs="S34">7</figref> shown. Without the by the movable inner tube <figref>12</figref> provided detachment mechanism it may for the doctor be difficult, the embolic mass from the catheter to E separate; without the surrounding tissue inflicting trauma. The detachment can by more of the following steps are effected one or: 1) withdrawal of the inner tube <figref>12</figref> in the outer tube <figref>14</figref>; 2) advancing of the outer tube over the Inner tube; or 3) injecting solidification agent to detach the embolic mass from the outer tube.

To visualize the flow in treated area, including the river out into the aneurysm and out of him, the thinner and / or the solidifying agent combined with a contrast agent and prior to the injection of the liquid embolic composition are injected alone. Further, a washout can be visualized by injection of contrast agent by the inner opening, while Solidification agent through the annular opening between the inner and outer tube <figref>12</figref>. <figref>14</figref> injected becomes.

Although the present invention has been described that it employs a Koaxialkatheter with coaxial opening the present invention also other types of multiple lumen catheters use, such. as those described in <figref idrefs="S34">8th</figref> to <figref idrefs="S34">11</figref> shown. Other multiple lumen catheter configurations can than those shown also be used, including catheters having multiple openings for feeding the liquid embolic composition and catheters with several openings for feeding the solidifying agent. Further, two independent catheters for the separate supply of liquid embolic composition and the solidification agent used are to the controlled solidification of the liquid composition according to the present process to achieve.

one in <figref idrefs="S34">8th</figref> shown Multiple lumen catheter <figref>80</figref> Has a first opening <figref>82</figref> and a second opening <figref>84</figref>. which are positioned side by side. In this juxtaposition-embodiment, the liquid embolic composition through the first opening <figref>82</figref> injected, while the solidification agent through the second opening <figref>84</figref> is injected.

As in <figref idrefs="S34">9</figref> shown, can the outlets of the two openings <figref>82a</figref>. <figref>84a</figref> in longitudinal direction be offset so that the through the second opening <figref>84a</figref> injected Solidifying agent outlet of the first opening <figref>82a</figref> washed, the the embolic composition supplies. In addition, the coexistence embodiments of the <figref idrefs="S34">8th</figref> and <figref idrefs="S34">9</figref> Means for adjusting the longitudinal position one of the openings relative to the other opening include.

<figref idrefs="S34">10</figref> shows another alternative embodiment a multiple lumen catheter <figref>90</figref> with a inner tube <figref>92</figref> and an inner tube coaxially surrounding outer tube <figref>94</figref>, The outer tube <figref>94</figref> includes a distal tapered Area <figref>96</figref> and a plurality of openings <figref>98</figref> or side holes. The liquid embolic Composition is formed by the inner tube <figref>92</figref> supplied while the Solidification agent through the outer tube <figref>94</figref> is supplied, and both from the end of the outer tube as well as from the openings <figref>98</figref> exits. The tapered Area <figref>96</figref> of the outer tube <figref>94</figref> leads to Injection of the solidification agent at an increased speed along of the inner tube <figref>92</figref> and washed the liquid embolic Composition when it is injected from the inner tube. The size and number the openings <figref>98</figref> and the degree of taper can be varied to accommodate different flow rates through the end of the outer tube <figref>94</figref> and through the openings provide.

<figref idrefs="S34">11</figref> shows a further alternative embodiment a multiple lumen catheter <figref>100</figref>. in an outer coaxial tube <figref>104</figref> at a distal end of the catheter to an internal coaxial <figref>102</figref> melted is. One or more openings<figref>106</figref> or side holes are in a side wall of the outer tube <figref>104</figref> to Supply of the fixing means provided. The openings<figref>106</figref> can especially designed be to the solidifying agent in a desired pattern by supplying Varying the number, size and location the openings supply.

&lt;?page 10?&gt;

Although the present invention described in detail for use in the treatment of aneurysms is, it can also be in a variety of other applications be used where the controlled solidification of a liquid embolic desired composition becomes. For example, the present invention can be used a to seal the blood vessel to the to block blood flow to a tumor, in order to detach the tumor tissue. The present invention can be used to treat a hemorrhage in Blood Vessels close a blood vessel to control. Further the present invention can be used to control the solidification a biocompatible polymer to control, which for reversible Sterilization is used, or to swelling of tissues to Treatment of urinary incontinence.

The injection of the strength agent to control the solidification of the embolic composition according to the present Invention is particularly useful in situations where high flow rates the liquid carry away embolic composition of the embolization can, before it is solidified into a mass, such as an AVF, and in situations where the position of the embolic with the composition to be filled Formation does not allow that the liquid embolic composition remains due to gravity in the formation. The invention may further particularly useful in situations be where the fluid flow is very low and the solvent is not carried away, if it is from the embolic composition spreads.

The catheter for use in the present invention, particularly the inner tube <figref>12</figref>and and the connecting element <figref>16</figref> and the actuator <figref>18</figref>. are made of solvent-compatible materials educated. According to a preferred embodiment, of the invention in which the solvent DMSO, the catheter elements which are in contact with the solvent can reach, DMSO-compatible. Examples of DMSO compatible materials and some of the preferred include durometer of these materials for use in a catheter Polyolefins such. As polyethylene (<figref>80A</figref>-<figref>80D</figref>), Polyester-polyether block copolymers (<figref>30D</figref>-<figref>80D</figref>) Alcryn (chlorinated polyolefin) (<figref>60A</figref>-<figref>80A</figref>), Pebax (polyamide polyether block copolymer) (<figref>25D</figref>-<figref>70D</figref>); Fluoropolymers such as PTFE (such as Teflon.), ETFE, and SEBS (styrene-ethylene-butadiene-styrene). silicones; interleaved silicone networks; and nylon materials (6/6, 6/10 and 6/12); and polyimides.

The inner and outer tubes (<figref>12</figref>. <figref>14</figref>) are preferably coated with lubricious coatings, namely both at their inner and outer diameters. Especially supports a lubricating coating on the outer diameter of the outer tube <figref>14</figref> the Introduce of the catheter, whereas Lubricating coatings on the inner diameter of the outer tube and the outer diameter of the inner tube <figref>12</figref> the longitudinal movement of the inner tube inside the outer tube improve. A lubricating coating on the inner diameter of the inner tube<figref>12</figref> becomes a guidewire movement improve within the catheter. The lubricating coating on the inner diameter of the inner tube <figref>12</figref> should be compatible with the biocompatible solvent be.

The inner and outer rigid tube <figref>22</figref>. <figref>48</figref> within the joining element <figref>16</figref> of the present invention may also comprise a key slot, extending substantially along its Length stretches, to the relative rotation of the inner and outer tube <figref>12</figref>. <figref>14</figref> at to prevent its proximal end. For example, the rigid inner tube <figref>22</figref> an outer longitudinal groove comprise an inner longitudinal rib the rigid outer tube <figref>48</figref> receives.

Suitable biocompatible polymers for use in the liquid include embolic composition of the present invention For example, non-biodegradable Po mers such. as cellulose acetates (including Cellulose diacetate), ethylene vinyl alcohol copolymers, hydrogels (eg. Acrylic, acetate), polyacrylonitrile, polyvinyl acetate, cellulose acetate butyrate, Nitrocellulose, copolymers of urethane / carbonate, copolymers of Styrene / maleic acid, and Mixtures thereof. Other suitable biocompatible polymers For example, biodegradable polymers such. B. straight Polymers such. B. Polyakide, polyglycolides, polycaprolactones, Polyanhydrides, polyamides, polyurethanes, polyesteramides, polyorthoesters, Polydioxanone, polyacetals, polyketals, polycarbonates, Polyorthokarbonate, Polyhydroxybutorate, Polyhydroxyvalerates, polyalkylene oxalates, polyalkylene succinates, poly (maleic acids), poly (amino acids), Polyhydroxyzellulose, Chitin, chitosan, and copolymers, terpolymers and combinations therefrom.

Preferably causes the biocompatible polymer when used in vivo no adverse combustion reactions.

The particular biocompatible polymer used is relative to the viscosity the resulting polymer solution, solvability of the biocompatible polymer in the biocompatible solvent, and the like selected. Such factors are known in the art.

Preferred biocompatible polymers include Zellulosediacetate and Ehtylenvinylalkohol copolymer. Cellulose diacetate polymers are either commercially available, or can be prepared by methods known in the art. In a preferred embodiment, is the teilchengemittelte molecular weight, determined by gel permeation chromatography, the cellulose diacetate composition from about 25,000 to about 100,000, more preferably of about 50,000 to 75,000, and more preferably from unge&lt;?page 11?&gt;mately 58000-64000. The weight-average Molecular weight of the cellulose diacetate composition, as determined by gel permeation chromatography, is preferably about 50,000 to 200,000, and more preferably about 100,000 to about 180,000. As the skilled artisan will appreciate, then, if all other factors are equal, cellulose diacetate polymers having a lower molecular weight the composition has a lower viscosity than polymers impart higher molecular weight. Accordingly, an adjustment of the viscosity of the composition by mere adjustment of the molecular weight of the polymer composition be easily achieved.

Ethylene vinyl alcohol copolymers comprise residues both of ethylene and of vinyl alcohol monomers. little one Amounts (eg., Less than 5 mole percent) of additional monomers can in its polymer structure contain or be grafted, provided that such additional monomers does not adversely affect the composition Embolisationseigenschaften. Such zusätzichen Monomers include purely exemplary maleic anhydride, styrene, propylene, Acrylic acid, Vinyl acetate and the like.

Ethylene vinyl alcohol copolymers are either commercially available or can be prepared by methods known in the art. Preferably is the ethylene-vinyl alcohol copolymer composition is selected such that a solution of 6 wt .-% of the ethylene vinyl alcohol copolymer, 25 wt .-% of tantalum contrast agent in DMSO has a viscosity has less than or equal to 60 cps at 20 ° C. As the skilled person is, then, if all other factors being equal, copolymers having a lower molecular weight of the composition less viscosity confer as copolymers with higher Molecular weight. Accordingly, an adjustment of the viscosity of the composition, as described for the catheter supply is required by mere adjustment of the easily obtained molecular weight of the copolymer composition will.

What is also clear, affects the relationship of ethylene to vinyl alcohol in the copolymer the total hydrophobicity / hydrophilicity of the composition, in turn, the relative water solubility / insolubility of the composition as well as the rate of precipitation of the copolymer in an aqueous solution (Eg., Blood) affected. In a particularly preferred embodiment comprising copolymers used herein a mole percentage of ethylene of about 25 to about 60 and a mole percent of vinyl alcohol of approximately 40 to about 75. These compositions provide the required Ausfällungsraten intended for use useful in embolizing blood vessels are.

While the invention in detail with reference to a preferred embodiment the same has been described, it will be clear to the expert, that numerous changes and modifications can be made within the scope of the claims.