Cutting balloon catheter
A system for removing matter from a partially or totally occluded stent includes a cutter that is urged radially outward toward the inner surface of the stent. Preferably, the cutter has a hardness that is less than or equal to the hardness of the material used to make the stent. Aspiration may be provided to remove portions of the occluding material from the vessel.
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Notice: More than one reissue application has been filed for the reissue of U.S. Pat. No. 6,500,186. The reissue applications are application Ser. No. 11/027,583 (the present application) and Ser. No. 13/368,116, each of which are divisional reissues of U.S. Pat. No. 6,500,186.
FIELD OF THE INVENTIONThe present invention relates to medical devices in general, and in particular, to rotational atherectomy devices.
BACKGROUND OF THE INVENTIONOne of the most common types of vascular diseases afflicting Americans today involves the narrowing of blood vessels by plaque or other materials. Left untreated, such narrowed vessels can contribute to high blood pressure, strokes, or cardiac arrest.
One of the most common techniques for treating a fully or partially blocked vessel is to bypass the blockage with a healthy vessel obtained from elsewhere in the body. A less traumatic approach involves the insertion of a balloon angioplasty device into the vessel and expanding the balloon to compress the occlusion against the vessel wall. Another minimally invasive technique is an atherectomy procedure, where a high-speed cutting device such as the Rotoblator™, produced by SCIMED Life Systems, Inc., the U.S. assignee of the present invention, is inserted into the vessel and advances against the occlusion in order to grind it into small particles that are passed by the body.
In many instances, a physician will place a stent in the area of the treated occlusion. In the case of balloon angioplasty, stents operate to prevent the compressed occlusion from springing back to its former size. For vessels that have undergone an atherectomy procedure, the stent helps maintain an open passage or lumen through the vessel.
Regardless of the procedure used, a fair percentage of stents become re-occluded within a relatively short period of time. However, the material that occludes the stent is somewhat different from the occluding material that blocked the vessel in the first instance. Therefore, techniques used to treat an original occlusion are not believed to be as effective when treating a re-occluded stent. Therefore, there is a need for a device and method of effectively treating re-occluded stents in a manner that does minimal or no damage to the stent itself.
SUMMARY OF THE INVENTIONThe present invention is a system and method for removing occluding material from a stent that is positioned within a vessel. In one embodiment of the invention, a rotational cutter is made of a material having a hardness less than or equal to the hardness of the material used to make the stent. The cutter has a number of recessed blades such that the outer surface of the cutter is relatively smooth and cutting is limited to tissue that enters channels in which the blades are placed. The cutter is preferably routed on a guide wire that is shaped such that the cutter is pressed radially outward against the inner surface of the stent. To aid in the removal of ablated material that is cut from the stent, an aspiration system including a catheter coupled to a source of negative pressure operates to aspirate ablated particles.
In another embodiment of the invention, a cutting mechanism includes a catheter with a self-expanding stent on the distal end thereof. One or more knives are secured to the stent such that the knives are pushed radially outward by the stent. Once the expanding stent is positioned in an occluded stent, the one or more knives are extended and rotated to remove occluding material. Ablated material from the occluded stent is preferably aspirated from the vessel.
In another embodiment of the invention, a cutting mechanism includes a helically-wound cutter that surrounds an inflatable balloon. The balloon is inflated to urge the cutter radially outward against the inner wall of the stent. Ablated particles removed from the stent are preferably aspirated from the vessel.
The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
To remove the occluding material 12 from the stent, the present invention includes a cutter 20 that is rotated by a drive shaft 22. The drive shaft 22 is advanced and rotated by an advancer/rotational drive 23 at the maximal end of the drive shaft 22. The cutter 20 and the drive shaft 22 are routed within a catheter 30 that is coupled to a source of negative pressure to provide a corresponding negative pressure or slight vacuum within the vessel 16 at the location of the stent. The catheter 30 may have a mechanism for sealing the catheter within the vessel such as a self-expanding stent 32 that is covered with an elastomeric coating such that when the stent 32 expands, the vessel is sealed. Alternatively, inflatable balloons at the end of the catheter 30 or other mechanisms may be used to seal the vessel in order to provide proper aspiration of the ablated particles.
To ensure that the cutter 20 clears a passage with a fairly large diameter, the cutter 20 is preferably routed over a guide wire 40 that is helical or otherwise shaped to force the cutter 20 toward the inner surface of the stent 14 when the cutter is advanced over the guide wire.
In some instances, it may be desirable to deliver a saline solution or other liquid through the drive shaft 22 and/or the cutter 20 to provide additional liquid volume in the vessel so that the vessel 16 doesn't collapse during aspiration. Saline and blood aspirated from the vessel are received in a collecting jar 42 and returned by a pump 44 to the patient via an intravenous drip or other mechanism.
In order to prevent damage to the stent, the cutter 20 as shown in
To further hold the catheter 70 in position within the stent, a guide wire 80 has one or more hooks 82 (that may or may not be barbed) at its distal end that can be implanted into the occluding matter 64. The guide wire 80 serves an anchor against which the catheter 70 can be pulled in order to advance the one or more cutting knives 76, 77 within the occluded stent 60. Once the one or more cutting knives 76, 77 are rotated 360° in the stent 60, the guide wire 80 can be further advanced into the occluding material 64 and the process repeated.
Alternatively, as shown in
Alternatively, as shown in
While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention. It is therefore intended that the scope of the invention be determined from the following claims and equivalents thereto.
Claims
1. A system for removing deposits from a partially or totally occluded stent balloon catheter, comprising:
- a catheter shaft configured to be routed over a guidewire;
- an expandable cutter disposed over a guide wire coupled to the catheter shaft, the cutter including a coiled member having a proximal end directly affixed to a distal end of the catheter shaft and a distal end directly affixed to a distal bearing through which the guidewire is routed; and
- a balloon disposed within the coiled member that expands to urge the cutter radially outward, the balloon being a separate component from the expandable cutter, a proximal end of the balloon directly affixed to the distal end of the catheter shaft proximate the proximal end of the coiled member and a distal end of the balloon directly affixed to the distal bearing proximate the distal end of the coiled member, wherein the balloon is inflated when the cutter is within the occluded stent to urge the cutter toward an inner wall of the occluded stent, the expandable cutter being rotatable in the occluded stent to remove occluding matter with a fluid delivered through the catheter shaft.
2. The system balloon catheter of claim 1, wherein the coiled member is a diamond coated helical wire.
3. The system balloon catheter of claim 1, wherein the coiled member is a flat spring having a sharpened outer edge.
4. The system balloon catheter of claim 1, wherein the coiled member is a semi-cylindrical wire having a sharpened edge.
5. A method for removing restenotic tissue from within a stent, comprising:
- advancing a cutter into the stent, the cutter being secured to a drive shaft and including an expandable coil having a cutting surface, wherein the cutting surface is positioned on the coil such that the cutting surface does not contact the stent when removing restenotic tissue from within the stent;
- rotating the cutter; and
- aspirating ablated particles of the restenotic tissue.
6. The balloon catheter of claim 1, wherein the cutter is rotatable to remove occluding matter during use.
7. A medical device, comprising:
- a catheter shaft having a proximal and a distal end, the catheter shaft being configured to be routed over a guidewire;
- an inflatable balloon having a proximal end directly affixed to the distal end of the catheter shaft and a distal end directly affixed to a distal member through which the guidewire is routed; and
- a helical cutter disposed over a portion of the inflatable balloon such that the balloon is disposed within the helical cutter, the helical cutter being a separate component from the inflatable balloon, a proximal end of the helical cutter being directly affixed to the distal end of the catheter shaft proximate the proximal end of the inflatable balloon and a distal end of the helical cutter being directly affixed to the distal member proximate the distal end of the inflatable balloon;
- wherein the inflatable balloon is inflated with a fluid delivered through the catheter shaft to move the helical cutter radially outward.
8. The medical device of claim 7, wherein the helical cutter includes an abrasive.
9. The medical device of claim 8, wherein the abrasive is a diamond coating.
10. The medical device of claim 7, wherein the helical cutter is a flat spring.
11. The medical device of claim 7, wherein the helical cutter is a wire.
12. The medical device of claim 7, wherein the helical cutter is rotatable to remove occluding matter during use.
13. The medical device of claim 7, wherein the distal member is a distal bearing.
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Type: Grant
Filed: Dec 30, 2004
Date of Patent: Oct 24, 2017
Assignee: Boston Scientific Scimed, Inc. (Maple Grove, MN)
Inventors: Daniel M. Lafontaine (Plymouth, MN), Kurt M. Laundroche (Snohomish, WA)
Primary Examiner: David Shay
Application Number: 11/027,583
International Classification: A61B 17/22 (20060101); A61B 17/3207 (20060101); A61F 2/82 (20130101);