Patent Application
20070282302
The field of the invention is catheters, particularly for positioning and advancing stents and other medical devices in blood vessels and other lumens of the body.
Blood vessels can suffer from various diseases, in particular arteriosclerosis, in which obstructions form in a lumen of a blood vessel, narrowing or clogging it. Emboli can also cause clogging of blood vessels. A common treatment method for narrowing is inserting a catheter with a balloon at its end to a clogged portion of the blood vessel, inflating the balloon and possibly leaving a stent at the clogged location, to keep the blood vessel open.
Precise positioning of the stent in the blood vessel is important. For example, stents are often placed over plaque in arteries. Placing the stent at a wrong position, for example not directly over the plaque, can increase the chance of complications such as stent thrombosis and restenosis. Precise positioning also allows a stent with the right length to just cover the plaque. It is also important, in the case of plaque located near a bifurcation in an artery, not to position the stent so that it will block the ostium of the artery in the bifurcation. However, it is often difficult for physicians to precisely control the position of a catheter, even when imaging techniques make it possible to tell exactly where the stent is, relative to the plaque. This difficulty is due to the friction between the catheter and the blood vessel. A certain force is needed to get the catheter to start moving, but once it starts moving, the catheter might jump a finite distance. Typically, the friction is dominated by the body of the catheter, which can be a meter or more in length, and not by the balloon and the stent, which tend to have relatively little friction with the blood vessel wall when the balloon is not inflated.
In some implementations, a guide wire is brought to the narrowed location, and then the catheter is pushed over the guide wire. If the catheter is soft, helping it to negotiate curves, it may be difficult to convey the pushing force along the catheter from outside the body to the tip. If the catheter is stiffer, it may be less able to negotiate sharp curves. In either case, excessive pushing may damage the blood vessels.
One solution suggested in the art is providing a catheter with varying levels of stiffness along its length—stiff at its proximal end and soft at its distal end.
Catheters with a balloon at the distal end typically have a separate lumen for an inflation tube, made of flexible plastic or metal for example, to inflate the balloon. The inflation tube is typically part of and inside a sheath which is stiff enough to push through the blood vessel.
An aspect of some embodiments of the invention concerns a catheter with a balloon, for example for expanding a stent. In an embodiment, the catheter comprises a relatively stiff inflation tube inside an outer sheath, and the inflation tube can move relative to the outer sheath. The catheter as a whole is used for coarse positioning of the balloon in a blood vessel or other lumen, as in conventional catheters. For example, the catheter is pushed and sometimes twisted by hand, while its progress is followed by using medical imaging device such as a fluoroscope. For fine adjustment in the position of the balloon, the inflation tube is used to push or pull the balloon, while keeping the outer sheath in place relative to the blood vessel wall. Because there is less friction between the inflation tube and the outer sheath than there is between the outer sheath and the blood vessel, there is better control on the positioning of the balloon and the stent and there is little or no jumping when using the inflation tube to move the balloon, and the balloon may be positioned accurately. The inflation tube is stiff enough to push or pull the balloon by itself. In addition, the stiffness of the inflation tube helps make the catheter as a whole stiff enough for the initial coarse positioning of the balloon. Once the balloon is accurately positioned, it is used to expand a stent, or to perform another task.
An aspect of some embodiments of the invention concerns a catheter with a balloon and an inflation tube, in which the inflation tube comprises two tubes: a relatively stiff inner inflation tube surrounded by a relatively flexible outer inflation tube. The inner inflation tube can be manipulated relative to the outer inflation tube from outside the body. Normally, both the inner and outer inflation tubes extend to the distal end of the catheter. When it is desired for the catheter to have a more flexible end, for example in order to negotiate sharp turns without damaging the blood vessel, the inner inflation tube is drawn back from the distal end of the catheter. This leaves an end portion of the outer inflation tube empty, and makes the end portion of the catheter more flexible than it would be with the inner inflation tube inside. When it is desired for the catheter to have a stiffer end, for example in order to push past a narrow region in a blood vessel, then the inner inflation tube is pushed to the distal end of the catheter. The relatively stiff inner inflation tube then stiffens the end portion of the catheter.
Optionally, both of these aspects may be present in an embodiment of the invention, in which there are three concentric tubes, an outer sheath, a relatively flexible outer inflation tube and a relatively stiff inner inflation tube, which may be moved relative to each other. Optionally, either or both of these features may be combined with the hydraulic mechanism for advancing the catheter described in PCT/IL03/00995. In that case, there are as many as four concentric tubes: an outer sheath, an inner sheath which comprises the hydraulic mechanism, an outer inflation tube inside the inner sheath, and an inner inflation tube. The outer inflation tube, or the inflation tube if there is only one tube, need not move relative to the inner sheath. The physician then has at his disposal three different means to position the balloon: 1) moving the outer sheath, i.e. the whole catheter, as in conventional catheters; 2) using the hydraulic mechanism to move the inner sheath, together with the inflation tube and the balloon; and 3) using the inflation tube to move the inner sheath and the balloon. Once the balloon is in the desired position, it is inflated, for example in order to expand a stent which surrounds the balloon, and once the stent is in place, or another therapeutic or diagnostic task has been accomplished, the balloon is deflated and the catheter is withdrawn.
There is thus provided, according to an exemplary embodiment of the invention, a catheter adapted for performing a task at a location inside a lumen, the catheter comprising:
and
In an embodiment of the invention, the inflation tube comprises:
Optionally, the inner inflation tube element has a lumen which carries the fluid which causes the inflating of the balloon.
In an embodiment of the invention, the catheter includes a propulsion compartment located proximal to the balloon, the propulsion compartment comprising an outer tube and an inner tube, said tubes being concentric, wherein one of said outer tube and inner tube can slidingly move in relation to the other of said outer tube and inner tube in response to a pressure exerted thereon by a fluid introduced into one or both of said outer tube and inner tube.
Optionally, one of said outer tube and inner tube is the outer sheath, and the balloon inflation tube runs through and is attached to the other of said outer tube and inner tube.
Optionally, the outer tube is the outer sheath.
Alternatively, the inner tube is the outer sheath.
Optionally, the task comprises dilating the lumen.
Optionally, the lumen is inside the body.
Optionally, the lumen is a blood vessel.
Optionally, the task comprises placing a stent.
Optionally, the balloon inflation tube comprises stainless steel.
Alternatively, the balloon inflation tube comprises NiTi.
Optionally, the balloon comprises plastic.
Alternatively or additionally, the balloon comprises a polymer.
In an embodiment of the invention, the catheter is adapted for using a guide wire.
Optionally, the catheter is adapted for using an “over the wire” guide wire.
Alternatively or additionally, the catheter is adapted for using a “rapid exchange” guide wire.
There is further provided, in accordance with an exemplary embodiment of the invention, a method of positioning a balloon of a balloon catheter in a lumen, the method comprising:
Optionally, moving the inflation tube relative to the outer sheath comprises moving the inflation tube while keeping the outer sheath stationary with respect to the lumen.
Optionally, positioning the balloon approximately comprises moving the entire catheter through the lumen.
Alternatively or additionally, positioning the balloon approximately comprises using hydraulic force.
Optionally, fine adjusting also comprises using hydraulic force to move the balloon, while keeping the outer sheath of the catheter stationary with respect to the lumen.
There is further provided, in accordance with an exemplary embodiment of the invention, a method of manipulating a balloon catheter through a lumen comprising both sharply curved portions and partially obstructed straight portions, the method comprising:
Optionally, the stiffening element is located inside a balloon inflation tube of said catheter.
Alternatively, the stiffening element comprises a balloon and a balloon inflation tube of said catheter, and arranging the stiffening element to be withdrawn some distance back comprises withdrawing the balloon into an outer sheath of said catheter.
Exemplary, non-limiting embodiments of the invention will be described below, with reference to the following drawings, which are not generally drawn to scale. The same elements are marked with the same or similar reference numbers in different drawings.
An inflation tube manipulator 108, outside the body, allows the inflation tube, together with the balloon, to be moved back and forth axially with respect to the outer sheath. Optionally, inflation tube manipulator 108 also includes, or is connected to, an indeflator, i.e. an element for pumping a fluid such as saline solution into the balloon, to inflate it. If manipulator 108 includes a reservoir and plunger for pumping fluid into balloon 106, it would preferably be bigger, relative to balloon 106, than shown in
The balloon catheter may be used, for example, to place a stent in an artery, as shown in
In
Optionally, balloon catheter 100 performs any other therapeutic or diagnostic task, including any of those listed above, once balloon 106 is in position, instead of or in addition to placing the stent. Similar balloon catheters, of appropriate dimensions, are optionally used in lumens other than blood vessels.
Inflation tube 102 is optionally made of stainless steel, nickel-titanium (Nitinol), or other biocompatible materials with the right mechanical properties, including plastics or polymers. The inflation tube is preferably stiff enough so that it can be used to push the balloon for fine positioning, but flexible enough so that it can bend with the catheter in going around sharp curves in blood vessels. Also, outer sheath 104, in combination with inflation tube 102, is stiff enough to enable the catheter to be manipulated through the blood vessel for coarse positioning, but flexible enough to allow the catheter to follow turns in the blood vessel.
The portion of outer sheath 104 proximal to seal 304 is filled with saline solution or another relatively incompressible fluid, and there is an indeflator 306, or a similar hydraulic displacement element such as a plunger or a flexible bulb, located outside the body at the proximal end of outer sheath 104. When indeflator 306 is compressed, pressure builds up in the fluid, which exerts an unbalanced longitudinal force on surface 308. This force causes inner sheath 302 to move, together with balloon 106 which is attached to inner sheath 302. This forward motion of inner sheath 302 increases the volume of fluid again, relieving the build up in pressure. Realistically, indeflator 306 would preferably be larger in volume, relative to the volume of inner sheath 302, than shown in
Indeflator 306, like manipulator 108, is optionally used only for fine positioning of balloon 106, after coarse positioning the balloon by manipulating the entire catheter through the blood vessel. In this case, inner sheath 302 is optionally rather short, only as long as the greatest distance needed for fine positioning. Also in this case, there is optionally no inner sheath 302 at all, and seal 304 is attached directly to inflation tube 102. But using an inner sheath, with surface 308 greater in area than seal 304, has the potential advantage that most of the force is applied to surface 308, which is close to the location of the balloon, rather than to seal 304, which is removed some distance from the balloon.
Alternatively, indeflator 306 is used not just for fine positioning, but for the initial coarse positioning of the balloon as well, instead of or in addition to manipulating outer sheath 104, as in a conventional catheter, for initial positioning. In this case, inner sheath 302 is optionally almost as long as outer sheath 104, and seal 304 is optionally located near the proximal end of outer sheath 104 initially. Particularly in this case, surface 308 is preferably much greater in area than seal 304, so that the hydraulic force is exerted mostly on surface 308, near the balloon, and not on seal 304, which may be very far from the balloon.
Optionally, whether or not indeflator 306 is used for initial coarse positioning of the balloon, inner sheath 302 makes a sufficiently close fit to the inside of outer sheath 104 that there is no need for seal 304 at all, and almost all of the hydraulic force is applied to surface 308, near the balloon. Alternatively, there is a seal attached to the distal end of outer sheath 104 which prevents fluid from leaking out, instead of or in addition to seal 304.
Depending on the shape and texture of the inner wall of the blood vessel adjacent to the balloon, either indeflator 306 or manipulator 108 may be more effective for fine positioning of the balloon, or manipulating the catheter as a whole may even be more effective. Alternatively, a combination of two of these methods of moving the balloon, or all three, may be more effective than any one of them. A potential advantage of catheter 300 is that the physician has a choice of these three options when positioning the balloon.
Optionally, indeflator 306 can only exert a force which moves balloon 106 in a distal direction. Alternatively, indeflator 306 is reversible, and can be used both to pull and to push on surface 308 and seal 304, moving balloon 106 in either a distal or a proximal direction. In the latter case, indeflator 306 can be used to adjust the position of the balloon by pulling it back if it is inadvertently pushed too far. In the former case, only manipulator 108, or the catheter as a whole, can be used to pull the balloon back.
In
Controlling the flexibility of the tip of a catheter is potentially useful for manipulating the catheter through a blood vessel, as shown in
Optionally, inner inflation tube 404 is not a complete tube, but has, for example, a C-shaped cross-section, at least in the part of its length that is inside outer inflation tube 402. Optionally, no part of inner inflation tube 404 is a complete tube, and the fluid for inflating balloon 106 is pumped not into inner inflation tube 404, but directly into outer inflation tube 402. In this case, “inner inflation tube” would be a misnomer, and it would be more accurate to call inner inflation tube 404 a “stiffening element” for outer inflation tube 402. However, it is potentially advantageous to make inner inflation tube 404 a complete tube, since that will increase its stiffness and its resistance to buckling, for a given material and inner and outer diameter. For similar reasons, it is potentially advantageous to have inner inflation tube 404 fill up almost all of the cross-sectional area of the lumen of outer inflation tube 402. In that case, there will not be much room for fluid to flow through outer inflation tube 402, so it may be advantageous to inflate balloon 106 through inner inflation tube 404, as described.
It should be appreciated that catheter 100 or catheter 300 is also optionally used in a manner similar to catheter 400, to adjust the stiffness of the catheter tip. In the case of catheter 100 or catheter 300, the tip is optionally made more flexible by using inflation tube 102 to pull balloon 106 back some distance inside outer sheath 104, leaving the distal end of outer sheath 104 empty and relatively flexible. When inflation tube 102 is used to push balloon 106 back up to the distal end of outer sheath 104, then the tip of the catheter (i.e. the distal end of outer sheath 104) becomes stiffer. Depending on the relative stiffness of outer sheath 104, balloon 106 and inflation tube 102, pushing balloon 106 some distance beyond the distal end of outer sheath 104, as shown in
Like catheter 400, catheter 600 has an inner inflation tube 404, which can be withdrawn back any distance from the tip of the catheter, in order to reduce the stiffness of some portion of the catheter near the tip. The adjustability of the flexibility of catheter 600 is potentially useful both when manipulating the catheter as a whole, and when moving the balloon separately, using either manipulator 108 or indeflator 306, as well as when using any combination of these methods. Thus, catheter 600 potentially provides more options for precise positioning of balloons in difficult situations than catheters 100, 300,310 or 400.
The invention has been described in the context of the best mode for carrying it out. It should be understood that not all features shown in the drawings or described in the associated text may be present in an actual device, in accordance with some embodiments of the invention. Furthermore, variations on the method and apparatus shown are included within the scope of the invention, which is limited only by the claims. Also, features of one embodiment may be provided in conjunction with features of a different embodiment of the invention. As used herein, the terms “have”, “include” and “comprise” or their conjugates mean “including but not limited to.” As used herein, the term “outermost sheath” does not imply that there cannot be still another sheath surrounding it, for example a guide catheter, but only means that the “outermost sheath” is outside the “outer sheath.”
This application claims priority from and is a continuation-in-part of PCT application PCT/IL03/00995 filed on Nov. 25, 2003, which designates the United States, and is also a continuation-in-part of U.S. application Ser. No. 10/303,064, filed on Nov. 25, 2002, the disclosures of which are incorporated herein by reference. This application also incorporates by reference a patent application titled “Catheter Drive,” agent's file reference 378/04070, filed on May 27, 2004, the same day as the current application, at the United States Patent and Trademark Office.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IL04/00456 | 5/27/2004 | WO | 7/11/2007 |
