|Publication number||USRE39668 E1|
|Application number||US 08/843,711|
|Publication date||May 29, 2007|
|Filing date||Apr 16, 1997|
|Priority date||May 27, 1994|
|Also published as||CA2191574A1, EP0760695A1, US5498240, WO1995032755A1|
|Publication number||08843711, 843711, US RE39668 E1, US RE39668E1, US-E1-RE39668, USRE39668 E1, USRE39668E1|
|Inventors||Celso S. J. Bagaoisan, John P. Shanahan, Ketan P. Muni, Elizabeth N. Hammack, Robert M. Abrams, James C. Peacock, III, William S. Tremulis|
|Original Assignee||Bagaoisan Celso S J, Shanahan John P, Muni Ketan P, Hammack Elizabeth N, Abrams Robert M, Peacock Iii James C, Tremulis William S|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (21), Non-Patent Citations (1), Referenced by (7), Classifications (18), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention generally relates to the field of intravascular catheters which are advanceable over a guidewire into a desired region of a patient's vasculature, and particularly to an intravascular catheter which is advanceable into a patient's coronary arteries for therapeutic or diagnostic procedures therein.
In percutaneous transluminal coronary angioplasty (PCTA) procedures, a guiding catheter having a preshaped distal tip is percutaneously introduced by a Seldinger techniques into the cardiovascular system of a patient and advanced within the system until the preshaped distal tip of the guiding catheter is disposed within the ascending aorta adjacent the ostium of the desired coronary artery. The guiding catheter is relatively stiff and when it is twisted or torqued from its proximal end, which extends outside the patient, the distal tip of the guiding catheter may be guided into the desired coronary ostium. With the distal end of the guiding catheter well seated within the ostium of the desired coronary artery, a balloon dilatation catheter is introduced into and advanced through the guiding catheter and out the distal tip thereof into the patient's coronary artery until the balloon on the distal extremity of the dilatation catheter is properly positioned across the lesion to be dilated. Once properly positioned, the balloon is inflated one or more times to a predetermined size with radiopague liquid at relatively high pressures (e.g., generally 4-12 atmospheres) to dilate the stenotic region of the diseased artery. When the dilatations have been completed, the balloon is finally deflated so that the dilatation catheter can be removed from the dilated stenosis to allow the resumption of increased blood flow through the dilated artery.
One frequently used type of angioplasty catheter is an over-the-wire type catheter which has an inner lumen extending within the catheter shaft which is configured to slidably receive a guidewire which facilitates advancement of the catheter over the guidewire to the desired location within the patient's coronary arteries. The guidewire receiving inner lumen may extend the entire length of the catheter as in conventional over-the-wire catheters or only in the distal portion of the catheter between a distal guidewire port and a proximal guidewire port which is spaced a short distance proximally from the distal guidewire port and a substantial distance from the proximal end of the catheter as in rapid exchange type catheters.
It is not uncommon during an angioplasty procedure to exchange the dilatation catheter once the dilatation catheter has been advanced within the patient's arterial system. For example, if the physician determines that the inflated size of the balloon or the length of the balloon is inappropriate for the stenosis to be dilated, the dilatation catheter will be withdrawn and another, more appropriately sized dilatation catheter will be advanced into the coronary artery over the guidewire which remains in-place to dilate the stenosis. However, if the catheter is a conventional over-the-wire catheter, before the catheter is withdrawn either the guidewire in place must be replaced with an exchange wire, which is similar to the in-place guidewire except about twice as long, e.g. about 300 cm, as the normal guidewire or an extension wire about the same length as the in-place guidewire must be secured to the proximal end of the in-place guidewire to facilitate the withdrawal of the catheter from the patient's vasculature without loss of the distal position of the guidewire. The reason that it is important to maintain the position of the distal tip of the guidewire across the stenosis, is that, if the guidewire is withdrawn, it may take the attending physician a substantial amount of time, e.g. from about 15 minutes up to about two hours or more, to advance a replacement guidewire into the patient's coronary artery and across the stenosis to be dilated and to then advance the dilatation catheter until the dilatation balloon thereof crosses the stenotic region. The original unsuitable catheter is usually discarded.
In some instances, after a dilatation is complete, it is necessary or at least desireable to implant a stent in the dilated stenotic region to provide long term patency thereto. In these cases the dilatation catheter which has performed the dilatation is removed and another balloon catheter having an unexpanded stent mounted about the balloon is advanced over the in-place guidewire to the stenotic region where the balloon is inflated to expand and thus implant the stent in the stenotic region. In this case the original angioplasty catheter is also discarded.
What has been needed and heretofore unavailable is a system for easily changing a shaft section of an intravascular catheter without the need to discard the entire catheter. The present invention satisfies these and other needs.
The present invention is directed to an intraluminal catheter with an exchangeable shaft section.
The intraluminal catheter of the invention has an elongated shaft having a proximal shaft section with at least one inner lumen extending therein and a distal shaft section with an inner lumen extending therein which is in communication with the inner lumen of the proximal shaft section. Means are provided to releasably secure the proximal end of the distal shaft section to the distal end of the proximal shaft portion, The proximal end of the distal shaft section is provided with releasable connecting means which is configured to be connected to connecting means on the distal end of the proximal shaft section which allows the distal section to be readily exchanged for another distal section. The preferred releasable connecting means are matching threads, male threads on the exterior of one shaft section member and female threads on the interior of another shaft section member which are configured to receive shaft section member with the male threads.
In one aspect of the invention, the intraluminal catheter is a dilatation catheter for performing angioplasty procedures with a dilatation balloon on the distal shaft section thereof. This allows the original distal shaft section to be exchanged for another distal shaft section when, for example, the dilatation balloon is of inappropriate size, either in length or in inflated diameter, for a particular stenotic region of the patient's artery.
The distal shaft section 42 of the above dilatation catheter may also be replaced when it is necessary or desireable to instal a stent in a dilated stenotic region of the patient's artery to ensure that the region remains patent after the dilatation. In this case, the original distal shaft section is removed after the dilatation has been performed and a replacement distal shaft section having an inflatable balloon or other expandable means thereon with a stent mounted about the inflatable balloon or other expandable means. The catheter with the replacement distal shaft section is advanced within the arterial system of the patient until the inflatable balloon or other expandable means is disposed within the stenosis so expansion thereof expands the stent to secure the stent within the arterial passageway. The expanded balloon may then be deflated and the catheter removed from the patient with the expanded stent maintaining within the arterial passageway to maintain its patency.
In a presently preferred embodiment, the exchangeable catheter shaft section has an inner and an outer tubular member with the threaded connections on an end of either the outer tubular member or the inner tubular member or both which engage the matching treads on the mating ends of the tubular members of the shaft section which is not to be replaced when the threaded connections are made.
The above described advantages of the invention as well as others will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying exemplary drawings.
With reference to
A dilatation balloon 22 is provided on the replaceable distal section 13 which has an interior in fluid communication with the annular inner lumen 23 defined between the inner and outer tubular members 18 and 17 and the annular lumen 24 defined between the outer and inner tubular members 14 and 15 of the proximal section 12.
A multiarm adaptor 25 is provided on the proximal end of the proximal section 12 to facilitate delivery of inflation fluid to the interior of dilatation balloon 22 through side arm 26 and annular lumens 23 and 24. The inner tubular members 15 and 18 define a guidewire receiving lumen 27 which extends from the adapter 25 through the length of the catheter to a distal guidewire port 28 in the distal end of the distal placeable section 13 and is configured to slidably receive a guidewire 30.
Due to strength requirements for the threaded connection between the outer tubular members 14 and 17, it is usually preferable to form the threaded portions 31 and 32 of these members of a high strength material (e.g. stainless steel, NiTi alloys and the like). In this instance, the separate threaded connecting elements 31 and 32 would be formed independently of the other portions of the outer tubular members 14 and 17 and then secured to these members by a suitable adhesive or other means such as a fusion or solvent bond, depending upon the nature of the material from which the separate connecting elements 31 and 32 are formed. Other materials which are suitable for forming the connecting elements 31 and 32 include high strength polymers such as polycarbonate polymers and the like.
The dilatation catheter 10 depicted in
The distal shaft section 42 of the catheter 40 may be replaced as in the previously described embodiment, the only major difference being that there is no need for an extension wire to facilitate withdrawal of the original catheter 40 and the introduction of the replacement catheter with a different distal section.
The catheter construction and the materials of the various portions thereof may be conventional. Moreover, while the invention is described herein in terms of certain preferred embodiments, a variety of modification can be made. For example, threaded connections are described between the proximal and distal shaft sections to facilitate separation of the distal shaft section from the proximal shaft section. However, other types of connections are contemplated with the present invention, the threaded connection being a presently preferred embodiment. Other connections include projections and corresponding detentes. Additionally, while replacement of the distal shaft section is primarily described herein, those skilled in the art will recognize that the proximal shaft section may be the replaceable shaft section. Other modifications and improvements may be made to the invention without departing from the scope thereof.
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|U.S. Classification||604/96.01, 604/523, 604/533|
|International Classification||A61F2/958, A61M29/00, A61M25/01, A61M39/00, A61M29/02, A61M25/00|
|Cooperative Classification||A61M2025/0183, A61M25/104, A61M2025/1079, A61M25/10, A61M25/0905, A61M25/00, A61M25/1025|
|European Classification||A61M25/10P, A61M25/10|