Patent Application
20070299403
The headings (such as “Brief Summary”) used are intended only for general organization of topics within the disclosure of the invention and are not intended to limit the disclosure of the invention or any aspect of it. In particular, subject matter disclosed in the “Related Art” includes aspects of technology within the scope of the invention and thus may not constitute solely background art. Subject matter disclosed in the “Brief Summary” is not an exhaustive or complete disclosure of the entire scope of the invention or any particular embodiment.
As used herein, the words “preferred,” “preferentially,” and “preferably” refer to embodiments of the invention that afford certain benefits, under certain circumstances. However, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful and is not intended to exclude other embodiments from the scope of the invention and no disclaimer of other embodiments should be inferred from the discussion of a preferred embodiment or a figure showing a preferred embodiment.
In one aspect, the introducer can be used like a cannula to straighten devices as they are being inserted into the body. Such an introducer is generally an elongated, rigid, hollow tube having a proximal (gripping) end, a distal end, and a lumen or passageway extending therebetween. The distal end includes a curved or angled region or region having a defined curvature. In other examples, the introducer can include a shape-memory element or a memory of directionality at the distal end so that it can be partially deformed during use.
A preferred uniform curvature region is used at the angled exit of the tube introducer at the distal end. In one example, the degree of curvature at the distal end is approximated by an osculating circle, meaning a circle that has a common curvature at the point of contact with the distal end. The osculating circle contacts the distal end at the most curved point. The diameter of the osculating circle, D1, is between about two to about three times the diameter of the external diameter, D2, of the lumen or distal end of the introducer. Alternatively, D1 can be greater than or less than D2. More highly curved regions of the distal end can also be selected, as well as regions that have more than one degree of curvature over its length. Alternatively, the curvature at the distal exit end can be defined by an angle of bending. Such angle can be measured by the angle formed at the intersection of a line parallel to the straight proximal region and a line tangent to the curved distal region. The angle can be any suitable angle, and is preferably about 10 to about 70 degrees, and even more preferably about 30 to 65 degrees, or about 40 to 60 degrees.
The introducer can be composed of any biocompatible material or material used in a medical device. Preferably, the material is a polymer that is at least partially transparent, however, stainless steel and other materials can be selected for use. The material selected for the introducer can also be heat-stable, so that the introducer can be sterilized using a suitable sterilization process such as heat sterilization, gamma sterilization, ethylene oxide sterilization or any other suitable sterilization or cleaning process.
Preferably, the introducer has an outer circular cross-sectional shape for smooth insertion into and through tissue. Other shapes can be used such as an oblong, square, rectangular or any other suitable shape. Similarly, the interior shape can be circular in cross-section, oblong, square, rectangular, or any other suitable shape. The inner surface of the lumen or passageway can be custom designed to fit and guide a specific instrument, such as the band-like ablation device as shown in U.S. Pat. No. 7,052,493, which is expressly incorporated herein by reference in its entirety. Such a custom design can also orient the ablating elements in a desired position relative to the tissue it is intended to treat and/or relative to the angle or curvature at the distal end and the anatomical features relevant for the procedure.
The proximal end of the introducer, which typically is not inserted into the body or through tissue, will remain outside of the patient. The shape or contour region at the proximal end can vary. For example, the proximal end can be an ergonomic knob-like shape for the physician to hold onto during a surgical procedure. The proximal end can also include valves and/or ports for liquid and/or other devices entering the introducer, or for irrigation and/or suction. The proximal end can include an indicator, such as on its surface, for indicating the direction of the curve in the distal end. Thus, an indicator can be used as a signal that allows the user to know the direction of the curve at the distal end and the degree to which the introducer can be rotated during a particular procedure to result in a predictable redirection of its distal end. In other embodiments, an indicator can be present on the distal end exit region, such as an electronic device, light, or imaging material that can be viewed on a computer screen.
The distal end of the introducer is closest to the site of use in the patient and will have a curved or directional aspect to at least the exit region. The distal end can be the same shape and cross-sectional diameter as the remainder of the introducer, or alternatively, it can be wider or narrower than other regions of the introducer. Additionally, the distal end can be tapered.
The thickness of the introducer can be uniform and can also be different along the length. For example, the introducer at the proximal end is preferably thicker than at the distal end.
Referring briefly to the drawings,
An instrument or device can be inserted through the passageway of the introducer as shown in
In a preferred aspect and use of the introducer, the introducer is used in an ablation treatment for atrial fibrillation. The introducer is positioned so that an instrument or device is able to curve around the bend at the distal end and therefore be positioned to move around the pulmonary vein in a right thoracic approach to the heart. As shown in
Similarly, the ablating device or series of ablating elements can be inserted through the introducer passageway so that it is directed around the pulmonary vein and atrial region in order to cinch or hold the ablating elements at a desired point. The use of the introducer again prevents unintended damage to tissue and facilitates the insertion procedure. The sizing device and the ablating device can be used one after the other by insertion and removal, or the sizing device can be moved out the distal end of the introducer and then followed by the ablating device which is linked, temporarily or otherwise, to the end of the sizing device as it moves through the introducer and then out of the insertion site.
Methods of treatment can be performed by inserting an introducer into a patient, introducing an instrument or device through a passageway of the introducer while maintaining the bend or angle of the distal end of the introducer, utilizing the instrument or device to perform at least one step of a surgical procedure, such as measuring the circumferential size of a left atrial region and/or ablating left atrial tissue, removing the instrument or device from the surgical site and from the introducer, and removing the introducer from the body.
There are many procedures where it may be desirable to use an introducer to be able to change the directionality of the distal end. Thus, a curved distal end of the introducer is advantageous in reaching tissues and structures that are unreachable from a straight insertion and/or present difficulties in bending around tissues through a straight insertion.
Although various embodiments of this invention have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention.
All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.
This application claims full priority benefit of U.S. Provisional application 60/815,882, filed Jun. 23, 2006, the entire contents of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60815882 | Jun 2006 | US |
