# Patent

## Title
Catheter with adjustable guidewire exit position

## Abstract

Novel catheter systems including those having guidewire lumens that can convert from an Over-the-Wire mode to a Rapid Exchange mode are useful and effective when crafted such that this conversion happens without adjusting the position of the guidewire in a body lumen.

## Background
RELATED APPLICATIONS
This application claims the full Paris Convention priority to and benefit of U.S. Provisional Application Ser. No. 61/639,527, filed on Apr. 27, 2012, the contents of which are hereby incorporated by this reference, as if fully set forth herein in their entirety. Likewise, incorporated expressly by reference is U.S. Pat. No. 8,043,313, issued Oct. 25, 2011.


FIELD OF THE DISCLOSURES
The art defines a strong and unrequited need for novel catheter designs, including those having guidewire lumens that can convert from an Over-the-Wire mode to a Rapid Exchange mode.
BACKGROUND OF THE DISCLOSURES
Numerous procedures requires the use of different types of medical devices and the preferred approach is to have systems that can accommodate the need to rapidly convert from one apparatus type to another during procedures.
It is therefore desirable to provide a guidewire for such procedures, which works with a novel catheter system to allow for different functional aspects to be exercised through a common set-up.



BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 shows a schematized view of a novel catheter set according to the teachings of the present invention;
FIGS. 2A, 2B and 2C likewise each illustrate schematized views of a novel catheter set according to the teachings of the present invention;
FIGS. 3A, and 3B illustrate schematized views of a novel catheter set according to the teachings of the present invention;
FIGS. 4A, and 4B each illustrate schematized views of a novel catheter set according to the teachings of the present invention.



SUMMARY OF THE DISCLOSURES
According to embodiments, the present disclosure provides a novel catheter design, comprising, in combination; at least a guidewire lumen that can convert from an Over-the-Wire mode to a Rapid Exchange mode, without adjusting the position of the guidewire in a body lumen.
According to embodiments there is provided a method for pushing a guidewire out of a guidewire lumen, comprising, in combination; providing a catheter system having a plurality of lumens, at least a proximate and a distal exit point with a slit disposed therebetween and an ejector wire; pulling the guidewire in a direction transverse to the catheter's longitudinal axis to initiate pulling it pulling oput of the slit; inserting the ejector wire into a proximal exit port; advancing the ejector wires down the guidewire lumen; causing the guidewire to pop out of the slit until the ejector wire and the guidewire reach the distal exit point; and withdrawing the ejector wire, leaving the catheter with the guidewire in the distal exit point.
There has thus been outlined, rather broadly, certain embodiments of the guidewire device which will form the subject matter of the claims appended hereto.
In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present disclosure. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTIONS
The present inventor has discovered that novel catheter designs, including those having guidewire lumens that can convert from an Over-the-Wire mode to a Rapid Exchange mode are useful and effective when crafted such that this conversion happens without adjusting the position of the guidewire in a body lumen.
Referring now to the Figures, FIG. 1 illustrates that the catheter is comprised of elongate tubular member (1) having distal and proximal ends. Hub or other connecting device (2) is present on the proximal end of the device. Therapeutic element (3), such as a balloon, stent, or other structure, is present on the distal end of the device. Elongate tubular member (1) includes at least a guidewire lumen, and may contain other lumens such as balloon inflation lumens, aspiration lumens, pull/push wire lumens, or any other elongate structures required to operate therapeutic element (3) or other desired functions of the device.
As would be known to artisans, catheter (1) also contains two guidewire exit points (4) along the device. Distal guidewire exit point (4a) is located near the distal end of the device, while proximal guidewire exit point (4b) is located near the proximal end of the device. Slit (5) is made between the two guidewire exit points (4). This Figure shows guidewire (6) existing within the guidewire lumen from the devices distal tip to the proximal guidewire exit point (4b).
FIG. 2 illustrates the mechanism of transitioning a guidewire from its proximal exit point (4b) to its distal exit point (4a). In specific, FIG. 2A shows guidewire (6) is in proximal guidewire exit point (4b). This is a similar condition to a device having an Over-The-Wire construction as the guidewire exits near the proximal end of the catheter.
FIG. 2B shows guidewire (6) being pushed out of guidewire lumen using ejector wire (7). To use the ejector wire, the user first pulls the guidewire (6) in a transverse direction to the catheter long direction to initiate it pulling out of the slit (5). The ejector wire (7) is then inserted into the proximal exit port (4b) and advanced down the guidewire lumen. As the ejector wire progresses, it causes the guidewire to pop out of the slit until the guidewire (6) and ejector wire (7} reach the distal exit point (4a). The ejector wire (7) may then be withdrawn, leaving the catheter with the guidewire in the distal exit point (4a).
FIG. 2C illustrates the ejector wire removed and the guidewire in the distal exit point, the device is in a similar condition as a device having a Rapid-Exchange construction.
Turning now also to FIG. 3, this depiction shows a cross-sectional view of the previously illustrated catheter (1), illustrating how guidewire (6) is pushed from slit (5) in the guidewire lumen when using ejector wire (7).
Likewise, FIG. 3A illustrates how guidewire (6) exists in a guidewire lumen, and is retained by the walls of the guidewire lumen. The slit (5 remains substantially closed to retain the guidewire (6).
FIG. 3B illustrates ejector wire (7) being advanced, causing guidewire (6) to be pushed out of slit (5). Note that in this embodiment, the ejector wire and the guidewire lumen have similar and noncircular cross-sectional profiles. This ensures that the ejector wire (7) and guidewire (6) do not flip positions, resulting in the ejector wire passing out of the slit in the guidewire lumen.
FIG. 4 shows a cross-sectional view of the catheter, illustrating yet another important embodiment, where the guidewire is ejected due to the inflation of a bladder contained within the catheter. Turning now specifically to the other figures.
FIG. 4A illustrates the catheter shaft construction wherein therapeutic lumen (8) operates a balloon or other therapeutic element on the distal end of the catheter, wire ejection lumen (9) that is in fluid communication with a port on the proximal end of the catheter. A distensible wall (10) is shared between the wire ejection lumen (9) and the guidewire lumen (11). Those of skill in the art well understand how this embodiment is exchangeable for the prior discussed catheter system, thus further distinguishement has been omitted in the interest of clarity.
FIG. 4B shows that to eject a guidewire, a pressurized fluid is provided into the wire ejection lumen (9) causing the distensible wall (10) to expand outward into the guidewire lumen, which in turn pushes the guidewire (6) out through the slit (5).
While the method and apparatus have been described in terms of what are presently considered to be the most practical and preferred embodiments, it is to be understood that the disclosure need not be limited to the disclosed embodiments. It is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, the scope of which should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. The present disclosure includes any and all embodiments of the following claims.
It should also be understood that a variety of changes may be made without departing from the essence of the invention. Such changes are also implicitly included in the description. They still fall within the scope of this invention. It should be understood that this disclosure is intended to yield a patent covering numerous aspects of the invention both independently and as an overall system and in both method and apparatus modes.
Further, each of the various elements of the invention and claims may also be achieved in a variety of manners. This disclosure should be understood to encompass each such variation, be it a variation of an embodiment of any apparatus embodiment, a method or process embodiment, or even merely a variation of any element of these.
Particularly, it should be understood that as the disclosure relates to elements of the invention, the words for each element may be expressed by equivalent apparatus terms or method terms—even if only the function or result is the same.
Such equivalent, broader, or even more generic terms should be considered to be encompassed in the description of each element or action. Such terms can be substituted where desired to make explicit the implicitly broad coverage to which this invention is entitled.
It should be understood that all actions may be expressed as a means for taking that action or as an element which causes that action.
Similarly, each physical element disclosed should be understood to encompass a disclosure of the action which that physical element facilitates.
Any patents, publications, or other references mentioned in this application for patent are hereby incorporated by reference.
Finally, all references listed in the Information Disclosure Statement or other information statement filed with the application are hereby appended and hereby incorporated by reference; however, as to each of the above, to the extent that such information or statements incorporated by reference might be considered inconsistent with the patenting of this/these invention(s), such statements are expressly not to be considered as made by the applicant.
In this regard it should be understood that for practical reasons and so as to avoid adding potentially hundreds of claims, the applicant has presented claims with initial dependencies only.
Support should be understood to exist to the degree required under new matter laws—including but not limited to United States Patent Law 35 USC §132 or other such laws—to permit the addition of any of the various dependencies or other elements presented under one independent claim or concept as dependencies or elements under any other independent claim or concept.
To the extent that insubstantial substitutes are made, to the extent that the applicant did not in fact draft any claim so as to literally encompass any particular embodiment, and to the extent otherwise applicable, the applicant should not be understood to have in any way intended to or actually relinquished such coverage as the applicant simply may not have been able to anticipate all eventualities; one skilled in the art, should not be reasonably expected to have drafted a claim that would have literally encompassed such alternative embodiments.
Further, the use of the transitional phrase “comprising” is used to maintain the “open-end” claims herein, according to traditional claim interpretation. Thus, unless the context requires otherwise, it should be understood that the term “compromise” or variations such as “comprises” or “comprising”, are intended to imply the inclusion of a stated element or step or group of elements or steps but not the exclusion of any other element or step or group of elements or steps.
Such terms should be interpreted in their most expansive forms so as to afford the applicant the broadest coverage legally permissible.
The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, because numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to falling within the scope of the invention.

## Claims

1. A catheter system, comprising:
a catheter comprising a guidewire lumen configured to convert from an Over-the-Wire mode to a Rapid Exchange mode, and a slit at least partially along the guidewire lumen;
a guidewire configured to be inserted within the guidewire lumen of the catheter; and
an ejector wire configured to push the guidewire out of the slit at least partially along the guidewire lumen without adjusting a lateral position of the guidewire in a body lumen,
wherein the ejector wire and the guidewire lumen have similar noncircular cross-sectional profiles.

2. The catheter system of claim 1, wherein the catheter further comprises a therapy device at a distal end of the catheter.

3. The catheter system of claim 2, wherein the therapy device is a balloon or a stent.

4. The catheter system of claim 1, wherein the catheter further comprises a balloon inflation lumen, an aspiration lumen, or a pull/push wire lumen.

5. The catheter system of claim 1, wherein the catheter further comprises at least two guidewire exit points along the guidewire lumen, wherein one of the at least two guidewire exit points is proximal of the other of the at least two guidewire exit points.

6. The catheter system of claim 5, wherein the one of the at least two guidewire exit points is a distal guidewire exit point at a distal end of the guidewire lumen, and the other of the at least two guidewire exit points is a proximal guidewire exit point at a proximal end of the guidewire lumen.

7. The catheter system of claim 6, wherein the slit is between the proximal guidewire exit point and the distal guidewire exit point.

8. The catheter system of claim 1, wherein the ejector wire has an axial length that is greater than an axial length of the slit at least partially along the guidewire lumen.

9. The catheter system of claim 1, wherein the ejector wire and the guidewire lumen have semicircle cross-sectional profiles.

10. The catheter system of claim 9, wherein the guidewire has a circular cross-sectional profile.

11. A method for pushing a guidewire out of a guidewire lumen, the method comprising:
receiving a catheter system comprising:
a catheter comprising a guidewire lumen, the guidewire lumen defining a proximal guidewire exit point and a distal guidewire exit point, and a slit between the proximal guidewire exit point and the distal guidewire exit point of the guidewire lumen,
a guidewire configured to be inserted within the guidewire lumen of the catheter, and
an ejector wire configured to push the guidewire out of the slit along the guidewire lumen, wherein the ejector wire and the guidewire lumen have similar noncircular cross-sectional profiles;

causing at least some of the guidewire to be received within the guidewire lumen of the catheter;
inserting the ejector wire into the proximal guidewire exit point to cause the guidewire to release through the slit of the guidewire lumen without adjusting a lateral position of the guidewire in a body lumen; and
withdrawing the ejector wire from the guidewire lumen.

12. The method of claim 11, wherein the catheter of the catheter system further comprises a therapeutic lumen comprising a balloon on its distal end.

13. The method of claim 11, wherein inserting the ejector wire into the proximal guidewire exit point comprises advancing the ejector wire until the ejector wire reaches the distal guidewire exit point of the guidewire lumen.

14. The method of claim 11, wherein the ejector wire of the catheter system and the guidewire lumen of the catheter have semicircle cross-sectional profiles.

15. A catheter system, comprising:
a catheter comprising a guidewire lumen, the at least one guidewire lumen defining a proximal guidewire exit point and a distal guidewire exit point, and a slit along an entirety of the guidewire lumen between the proximal guidewire exit point and the distal guidewire exit point;
a guidewire configured to be inserted within the guidewire lumen of the catheter; and
an ejector wire configured to push the guidewire out of the slit without adjusting a lateral position of the guidewire in a body lumen,
wherein the ejector wire and the guidewire lumen have similar noncircular cross-sectional profiles.

16. The catheter of claim 15, wherein the catheter further comprises a therapeutic lumen adjacent the guidewire lumen.

17. The catheter system of claim 15, wherein the ejector wire has an axial length that is greater than an axial length of the slit along the entirety of the guidewire lumen between the proximal guidewire exit point and the distal guidewire exit point.

18. The catheter system of claim 15, wherein the ejector wire and the guidewire lumen have semicircle cross-sectional profiles.

19. The catheter system of claim 18, wherein the guidewire has a circular cross-sectional profile.