|Número de publicación||US20050021063 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||US 10/771,834|
|Fecha de publicación||27 Ene 2005|
|Fecha de presentación||2 Feb 2004|
|Fecha de prioridad||30 Mar 1999|
|También publicado como||US6911026, US20020019644, WO2001003589A1|
|Número de publicación||10771834, 771834, US 2005/0021063 A1, US 2005/021063 A1, US 20050021063 A1, US 20050021063A1, US 2005021063 A1, US 2005021063A1, US-A1-20050021063, US-A1-2005021063, US2005/0021063A1, US2005/021063A1, US20050021063 A1, US20050021063A1, US2005021063 A1, US2005021063A1|
|Inventores||Andrew Hall, Jonathan Sell|
|Cesionario original||Hall Andrew F., Sell Jonathan C.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (11), Citada por (34), Clasificaciones (28)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
This application is a continuation patent application of U.S. patent application Ser. No. 09/352,161, filed Jul. 12, 1999, which is a continuation-in-part of U.S. patent application Ser. No. 09/281,241, filed Mar. 30, 1999, the disclosures of which are incorporated by reference.
The present invention relates generally to the removal of occlusive material from body lumens, and more particularly both methods and devices for magnetically guided atherectomy of totally occluded arterial vasculature. Catheters which employ thermal as well as other energy sources are disclosed along with complementary equipment for carrying out the procedures.
Arteriolosclerosis is a progressive disease marked by deposits within the lumen of arterial vessels. Removal of these deposits restores blood flow and is a preferred treatment for this disease. In instances where the vessel cannot be salvaged, bypass grafts may be used to treat the disorder.
A wide range of recannalization techniques have been developed over time. The primary technique in clinical use today is balloon angioplasty. This is a “mechanical” treatment where a balloon at the treatment site is inflated to compress obstructive material against the vessel wall. In most treatment protocols the recannalization device is navigated to the treatment site through the patent's vasculature. The so-called “Seldinger” technique is used most often to gain access to and navigate through the blood vessels. In this technique the catheter enters the body in the groin area and is moved through the vasculature to the heart with the assistance of both guide wire and occasionally guide catheters or sheaths.
Although balloon angioplasty is probably the most common procedure, there are several drawbacks to this type of device. One problem is that the vascular occlusion must first be crossed with a guide wire to position the balloon. The balloon device follows the guide wire through the lesion and the wire biases the balloon against the walls of the vessel. If the vessel is totally occluded the wire cannot cross the lesion and therefore cannot be used to guide the balloon.
Other energy sources for recannalization have been proposed and studied as well. For example, U.S. Pat. No. 5,318,014 to Carter, teaches a device to treat occlusions with ultrasound. The Drasler U.S. Pat. No. 5,370,609 teaches the use of a high-energy rearward facing water jet to remove occlusive material. The art teaches the use of rotating mechanical burrs or blades for removing material. See for example Pannek, U.S. Pat. No. 5,224,945. Also the use of heat to reform and remodel a vessel is known from Eggers U.S. Pat. No. 4,998,933 among others.
The atherectomy devices according to the invention include a magnetic element that allows for the remote manipulation of the distal end of working tip of the catheter by a magnetic surgery system (MSS) or other magnetic field generator operated outside of the patient.
The application of external fields and gradients allows the physician to control the orientation and location of the distal tip of the catheter in the vessel at the treatment site. This permits the use of small and potentially single size catheters to treat either partial or total occlusions in the vasculature. In operation the device is moved to various treatment sites or locations in a vessel under the guidance of the MSS. The methods of the invention may be partially automated in the sense that the physician can image the current location of the device and program a desired location
with the MSS and designate a location or orientation of the device in a vessel. The MSS system can provide feedback to the physician to help the physician direct the device as “planned” with the MSS workstation. Robotic control of the device is also contemplated wherein the motion of the device in the vessel is entirely under software control. In this instance physician observation and transducer feedback manages the procedure.
Any of a variety of energy sources can be used to carry out the recannalization process of the invention, although thermal energy is preferred and is used as an illustrative but limiting energy source. The source of heat may include optical or radio frequency energy sources. However, the device is also useful with hydraulic energy, direct laser sources or ultrasonic energy sources. Physician supplied energy is contemplated as well in the sense that a doddering wire may manipulated by the physician and guided magnetically to treat the occlusion.
Devices which rely on heat or which generate heat in the body may include fluid cooling to manage the distribution of heat, several device with adjunctive fluid delivery are shown as illustrative of the invention.
Additional “delivery” structures are present in some embodiments of the device and may be used to accommodate various medical techniques and methods. For example lumens for “over the wire” and “rapid exchange” delivery of the catheters are shown. Also these lumens may be used with imaging and localization devices to carry out the methods of the invention. These lumens may also be used to introduce contrast agent into the treatment site.
Localization structures are disclosed for use in the procedure. Preoperative Magnetic Resonance Imaging (MRI), Computed Tomography (CT) or Ultrasound scans provide a “roadmap” for the procedure while X-ray, Doppler ultrasound, or other localization techniques are used to display the current real time position of the device in the lumen.
It is also contemplated that the “open” lumens of the device can be used with ultrasonic or laser based imaging systems to characterize the nature of the occlusion.
Throughout the various figures of the drawing like reference enumerates refer to identical structure. A typical and exemplary set of embodiments of the invention are shown in the drawing but various changes to the devices may be made without departing from the scope of the invention wherein:
The thermal catheter embodiment of
The lumen can also be used with an optical fiber to perform laser induced florescence spectroscopy or optical low coherence reflectometry. These procedures can be used to “look at” and evaluate the obstruction during treatment.
In general a fiducial marker on the catheter allows the preoperative scan and the real time scans to be appropriately merged. In operation the user can define a location on the MSS workstation 300 with a mouse or other pointing device which identifies the desired location of the therapy. Next the MSS workstation computes the forces and required fields and gradients required to navigate the catheter to the new location. This information controls the magnet system 308. An appropriate set of catheter actuators 306 may be provided to allow the MSS to move the catheter as well.
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|Clasificación de EE.UU.||606/159|
|Clasificación internacional||A61B18/28, A61B18/14, A61M25/01, A61B17/32, A61B18/00, A61B18/08, A61B19/00, A61B17/22|
|Clasificación cooperativa||A61M25/0127, A61B18/08, A61B2017/22094, A61B2017/22042, A61B18/28, A61B17/22012, A61B2019/5251, A61B17/22, A61B2017/00061, A61B18/1492, A61B2018/00011, A61B19/5244, A61B17/320758, A61M2025/0166, A61B2017/320004, A61B2019/2253|
|Clasificación europea||A61B19/52H12, A61B17/22, A61B17/3207R|