The present invention relates to catheters. More specifically, the present invention relates to a coaxial guide coil catheter.
Current guide catheters have a propensity to back out of the coronary main branch or ostium when subsequent interventional coronary devices are passed through it and advanced more distally. This causes the operator to lose ability to advance coronary devices more distally.
Accordingly, there is a need for providing increased back-up support for guide catheters in interventional cardiology procedures.
The present application describes a coaxial guide coil catheter device to be placed inside of a standard cardiovascular guide catheter for facilitating extra support in the coronary artery when advancing interventional cardiology devices such as balloon catheters and stent delivery systems. The device is passed through the main lumen of a standard guide catheter so that the tip of the coaxial guide coil device is extended past the tip of the guide catheter and into the coronary artery. The proximal portion of the coaxial guide coil can remain within the guide catheter. The device can improve the ability of the guide catheter to remain seated in the coronary ostium during interventional procedures.
The device, in certain embodiments, is made of a distal tip, a first polymer jacketed flexible coil section, an optional second flexible coil section (optionally unjacketed) and a push rod. The push rod is made, for example, of high tensile stainless steel and is attached to the main flexible coil/lumen section using suitable attachment techniques such as welding, brazing or soldering. The first polymer jacketed flexible coil section is desirably made with a jacket material of Pebax® or urethane, and the flexible coil is desirably made of stainless steel.
The optional second flexible coil section is made, for example, of stainless steel, has a diameter slightly larger than the first coil section diameter (1.03-1.1 times larger, for example) and has a proximal luminal entry point for device passage adjacent to the push rod attachment point. The coil structure in both the first and second flexible sections are preferably made of multiple filar windings, for example 8-12 filar windings, or can also me made using a single wire wind. The filar windings are typically rectangular, or substantially rectangular in cross section.
The outer diameter of both flexible sections is made to fit closely, but passably, within standard guide catheters. The distal tip portion of the device can be made of a soft polymeric material and is attached to the first flexible section. The distal tip section provides a soft, leading edge when inserted into the coronary vasculature. The tip portion optionally contains a radiopaque material which allows a physician or technician to visualize the tip on fluoroscopy during the procedure.
Upon placement of a standard guide catheter into the coronary main branch, a physician or technician can advance the device (coaxial guide coil) through the main lumen of the guide catheter using the push rod until the tip of the coaxial guide coil tip is extended past the guide catheter tip and further into the coronary artery. This distance can range, for example, from 5 to 25 cm depending on the situation.
The proximal portion of the coaxial guide coil can remain within the guide catheter. The physician or technician can then deliver the interventional therapeutic device such as a stent or balloon device over a guide wire through the main lumen of the guide catheter and through the lumen of the coaxial guide coil until the working portion of the interventional device is past the coaxial guide coil tip. The physician or technician can then treat the coronary lesion using standard technique, but will have added back-up support on the guide catheter to provide extra ability to push and advance the device.
The outside diameter of the second flexible coil section can be 1.1 times or less larger than the outside diameter of the first flexible coil section. The first flexible coil section can have an outside diameter of 0.05 inches or more. The first flexible coil section can have an outside diameter of 0.090 inches or less. In an embodiment, the outside diameter of the first flexible coil section can be 0.064 inches. The first flexible coil section can have an inside diameter of 0.047 inches or more. The first flexible coil section can have an inside diameter of 0.084 inches or less. In an embodiment the inside diameter of the first flexible coil section 320 can be 0.057 inches.
This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense. The scope of the present invention is defined by the appended claims and their legal equivalents.
The invention may be more completely understood in connection with the following drawings, in which:
While the invention is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and will be described in detail. It should be understood, however, that the invention is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
The embodiments of the present invention described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices of the present invention.
All publications and patents mentioned herein are hereby incorporated by reference. The publications and patents disclosed herein are provided solely for their disclosure. Nothing herein is to be construed as an admission that the inventors are not entitled to antedate any publication and/or patent, including any publication and/or patent cited herein.
The present application describes a coaxial guide coil catheter device to be placed inside of a standard cardiovascular guide catheter for facilitating extra support in the coronary artery when advancing interventional cardiology devices such as balloon catheters and stent delivery systems. This device is passed through the main lumen of a standard guide catheter so that the tip of the coaxial guide coil device is extended past the tip of the guide catheter and into the coronary artery. The proximal portion of the coaxial guide coil can remain within the guide catheter. The device can improve the ability of the guide catheter to remain seated in the coronary ostium during interventional procedures.
The device, in certain embodiments, is made of a distal tip, a first polymer jacketed flexible coil section, an optional second flexible coil section (unjacketed) and a push rod. The push rod is made, for example, of high tensile stainless steel and is attached to the main flexible coil/lumen section using suitable attachment techniques such as welding, brazing or soldering. The first polymer jacketed flexible coil section is preferably made with a jacket material of Pebax® or urethane, and the flexible coil is typically made of stainless steel.
The optional second flexible coil section is also made, for example, of stainless steel, and can optionally have a diameter slightly larger than the first coil section diameter (1.03-1.1 times larger, for example) and has a proximal luminal entry point for device passage adjacent to the push rod attachment point. The coil structure in both the first and second flexible sections are desirably made of multiple filar windings for example 8-12 filar windings, or can also me made using a single wire wind.
The outer diameter of both flexible sections is made to fit closely, but passably, within standard guide catheters. The distal tip portion of the device can be made of a soft polymeric material and is attached to the first flexible section. The distal tip section provides a soft, leading edge when inserted into the coronary vasculature. The tip portion preferably contains a radiopaque material which allows the physician to visualize the tip on fluoroscopy during the procedure.
Upon placement of a standard guide catheter into the coronary main branch, the physician can advance the device (coaxial guide coil) through the main lumen of the guide catheter using the push rod until the tip of the coaxial guide coil tip is extended past the guide catheter tip and further into the coronary artery. This distance can range, for example, from 5 to 25 cm depending on the situation.
The proximal portion of the coaxial guide coil can remain within the guide catheter. The physician can then deliver the interventional therapeutic device such as a stent/balloon device over a guide wire through the main lumen of the guide catheter and through the lumen of the coaxial guide coil until the working portion of the interventional device is past the coaxial guide coil tip. The physician can then treat the coronary lesion using standard technique, but will have added back-up support on the guide catheter to provide extra ability to push and advance the device.
In reference now to the figures,
The inner coil 108 can comprise metal. The inner coil 108 can be flexible. and can define a first center lumen, such as to allow a therapeutic device to pass through the coaxial guide coil. The inner coil 108 is helically wound in typical embodiments. The inner coil 108 can be a single wire wind, but is more typically a multiple filar winding. In an embodiment, the inner coil 108 comprises 8 or more filar windings. In another embodiment, the inner coil 108 comprises 12 or less filar windings. The ends of the inner coil 108 are welded in some implementations so as to prevent the inner coil from unraveling. In an embodiment, the ends of the inner coil 108 are welded prior to cutting the inner coil to the desired length.
The collar 106 can define a second center lumen. The second center lumen can be consistent with the first center lumen, such that they share a common center axis or a substantially similar diameter. The second center lumen and the first center lumen can be configured to allow a therapeutic device to pass through the coaxial guide coil catheter 100, such as from a position external from a patient's body to a position within the patient's body. In an example, the therapeutic device can be a balloon or a stent. The collar 106 can be, for example, formed of a gold-plated coil.
The push rod 114 can assist a user, such as a surgeon, in inserting, positioning and removal of the coaxial guide coil catheter 100. The push rod 114 can comprise, for example, high tensile stainless steel. The push rod 114 can be semi-rigid, such as to transfer enough force from a user to the rest of the coaxial guide coil catheter 100, such as when position the coaxial guide coil catheter 100.
The coaxial guide coil catheter 100 can comprise radiopaque material 116 at one or more locations, such as the distal tip 112. The radiopaque material 116 can comprise gold. The radiopaque material 116 can be located at known locations along the coaxial guide coil catheter 100, such that a surgeon can use the locations of the radiopaque material to know the positioning of the coaxial guide coil catheter 100, such as with an x-ray.
In an example embodiment the coaxial guide coil catheter 100 can have a length of 30 inches or more. The coaxial guide coil catheter 100 can have a length of 80 inches or less. In an embodiment, the coaxial guide coil catheter 100 can have a length of 55 inches. The push rod 114 can have a length of 33 inches or more. The push rod 114 can have a length of 60 inches or less. In an embodiment, the push rod 114 has a length of 43 inches.
The outside diameter of the outer jacket 110 can be smaller than the outside diameter of the second flexible coil section 322. In an embodiment, the outside diameter of the outer jacket 110 can be substantially the same size as the outside diameter of the second flexible coil section 322. In an embodiment, the outside diameter of the first flexible coil section 320 can be smaller than the outside diameter of the second flexible coil section 322, such as to allow for the outer jacket 110 to cover the first flexible coil section 320, and the outer jacket 110 can have substantially the same outside diameter as the second flexible coil section 322. The outside diameter of the second flexible coil section 322 can be 1.03 times or more larger than the outside diameter of the first flexible coil section 320. The outside diameter of the second flexible coil section 322 can be 1.1 times or less larger than the outside diameter of the first flexible coil section 320. The first flexible coil section 320 can have an outside diameter of 0.05 inches or more. The first flexible coil section 320 can have an outside diameter of 0.090 inches or less. In an embodiment, the outside diameter of the first flexible coil section 320 can be 0.064 inches. The first flexible coil section 320 can have an inside diameter of 0.047 inches or more. The first flexible coil section 320 can have an inside diameter of 0.084 inches or less. In an embodiment the inside diameter of the first flexible coil section 320 can be 0.057 inches.
The outer jacket 110 can comprise a polymer. The outer jacket 110 can comprise, for example, one or more of the following: Pebax® and urethane. The outside diameter of the outer jacket 110 can be 0.092 inches or less. The outside diameter of the outer jacket 110 can be 0.055 inches or more. In an embodiment the outside diameter for the outer jacket 110 can be 0.084 inches.
It should be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a composition containing “a compound” includes a mixture of two or more compounds. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration to. The phrase “configured” can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, and the like.
All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference.
The invention has been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention.
This application is being filed as a PCT International Patent application on Jun. 10, 2013 in the name of NorMedix LLC, a U.S. national corporation, applicant for the designation of all countries and Gregg Stuart Sutton, a U.S. Citizen, Jeffrey M. Welch, a U.S. Citizen, and Karl V. Ganske, a U.S. Citizen, are inventors only for the designated states, and claims priority to U.S. Provisional Patent Application No. 61/657,381, filed Jun. 8, 2012, the contents of which are herein incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US13/45045 | 6/10/2013 | WO | 00 |
Number | Date | Country | |
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61657381 | Jun 2012 | US |