# Patent

## Title
Needle and guidewire holder

## Abstract

Device and method for puncturing blood vessels while using fluoroscopy. The disclosed device enables improved needle orientation control and avoids direct exposure of the clinician's hand to X-ray during the puncturing procedure.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
The present application is a continuation of prior U.S. application Ser. No. 13/390,143, filed Feb 13, 2012, entitled “NEEDLE AND GUIDEWIRE HOLDER,” which is the United States national phase of International Application No. PCT/US11/64301 filed Dec 12, 2011 entitled “NEEDLE AND GUIDEWIRE HOLDER,” which claims the benefit of and priority to, under 35 U.S.C. §119(e) and/or 120, U.S. Provisional Application Ser. No. 61/516,906 filed Apr 11, 2011 entitled “DEVICE AND METHOD FOR BTK BLOOD VESSEL TREATMENT,” and U.S. Provisional Application Ser. No. 61/571,856 filed Jul 7, 2011 entitled “NEEDLE-HOLDER FOR BLOOD VESSELS PUNCTURE,” and U.S. Provisional Application Ser. No. 61/575,160 filed Aug 17, 2011 entitled “DEVICE AND METHOD FOR GUIDEWIRES CAPTURING,” and U.S. Provisional Application Ser. No. 61/573,935 filed Sep 15, 2011 entitled “NEEDLE-HOLDER WITH INTEGRATED GUIDEWIRE HOLDER FOR BLOOD VESSELS PUNCTURE,” and U.S. Provisional Application Ser. No. 61/626,183 filed Sep 22, 2011 entitled “HYPO-TUBE BASED SUPPORT CATHETER,” each of which is hereby incorporated herein by reference in its entirety for all that it teaches and for all purposes.


FIELD OF THE INVENTION
The present invention generally relates to a device and a method for needle puncturing of small blood vessels for small vessel angioplasty, such as below the knee (BTK) blood vessels and other small blood vessels (e.g., coronary, pediatric), which are partially or totally occluded.
BACKGROUND OF THE INVENTION
A chronic total occlusion (CTO) is an arterial vessel blockage that prevents blood flow beyond the obstruction. CTO's typically occur in coronary, peripheral, pediatric, and other small arteries. In the coronary and peripheral arteries, they result from the same underlying cause—atherosclerosis.
Endovascular therapies for arteries below the knee have emerged as a promising revascularization technique for patients with critical limb ischemia (CLI). However, when employing standard angioplasty techniques, angioplasty of BTK arteries fails to achieve revascularization in up to 20% of cases. The main cause for failure is the inability to penetrate the plaque's proximal cap with the guidewire.
A new technique of approaching the plaque from below—known as the retrograde approach—is often used to pass the guidewire through the plaque from the other direction. This approach has high success rates, but is technically challenging to perform and has its own complications, especially the danger of vessel perforation.
In order to use the retrograde technique, the clinician must puncture the small target artery with a needle—usually smaller than a 21 gauge needle. The clinician relies on several angiographic images to aim the needle into the artery, and verifies proper needle tip location by observing blood flow exiting from the needle's proximal end.
Puncturing small arteries is not easy; it requires proper manipulation of the C-arm and a gentle needle stick to avoid arterial perforation. Once a guidewire is inserted (through a small sheath or directly (sheath-less) through the skin) within the needle into the artery, the needle can be removed.
Currently, relative short standard needles are used to puncture small blood vessels. Long needles that might potentially extend the user hand from the puncturing site are not used for two reasons:
1) Long thin needles are too flexible, which prevents accurate and controlled positioning of the needle tip in the direction of the blood vessel; and
2) Blood is expected to come out from the proximal end of the needle. This is fine for a short needle, but for a long needle the blood may not reach the proximal end due to low blood pressure in the treated vessel and high flow resistance of the long narrow needle lumen.
Another important disadvantage of the prior art, is that during this needle insertion the clinician's hand is exposed to direct X-ray radiation which may have deleterious long-term health effects.
SUMMARY OF THE INVENTION
The present invention is directed to a device and a method for needle puncturing of blood vessels for vessel angioplasty. The invention seeks to provide a special needle holder that facilitates needle insertion, and increases the needle puncturing procedure accuracy, while preventing hand exposure to radiation.
In accordance with an embodiment of the invention, a standard needle is affixed onto a special extended needle holder, e.g., by using a female to male standard luer connection. The needle holder reduces the clinician's hand exposure to x-rays during the needle insertion and provides better control of the needle trajectory and puncture. The device includes a vent for both blood passage to confirm needle tip location in the target artery and for guidewire passage. A standard guidewire may be inserted through the needle into the artery. Afterwards, the needle and needle holder are removed.
Optionally, a guidewire holding mechanism is provided that reduces procedure time and minimizes blood spillage, by holding the distal portion of the guidewire inside the needle holder.



BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
FIG. 1 is a simplified cross-sectional illustration of a needle holder, in accordance with an embodiment of the present invention.
FIG. 2 is a simplified cross-sectional illustration of a needle holder with a guidewire holder, in accordance with an embodiment of the present invention.



DETAILED DESCRIPTION OF EMBODIMENTS
Reference is now made to FIG. 1, which illustrates a needle holder 10, constructed and operative in accordance with an embodiment of the present invention.
Needle holder 10 is an elongate stiff member 13 that includes a needle connector 14, such as but not limited to, a male luer connector, at a distal end 15 thereof. Connector 14 connects to a needle 11, such as by means of connecting with a female luer connector affixed to the proximal end of the needle 11. Needle holder 10 may be supplied without the needle 11 and the user connects the holder to the needle. Alternatively, needle holder 10 may be supplied with needle 11 already assembled therewith. Without limitation, needle holder 10 preferably has a length of at least 12 cm, most preferably in the range of 20-25 cm; holder 10 is preferably longer than the needle 11. The elongate stiff member 13 may be a hollow tube with a lumen 16, which may be made, without limitation, from a stiff, clear polymeric material, e.g., polycarbonate. Lumen 16 is big enough for easy blood flow therethrough, preferably, but not necessarily, having a diameter of equal to or more than 1.0 mm
The long and stiff holder 10 reduces the clinician's hand exposure to x-rays during insertion of needle 11, and provides better control of the needle orientation, trajectory, and puncture.
Needle holder 10 includes a vent 12 at a proximal end thereof for blood flow to verify that the needle tip is properly located inside the blood vessel. Vent 12 preferably, but not necessarily, has a standard female luer shape.
Reference is now made to FIG. 2, which illustrates a needle holder 10 and guidewire holder 17, constructed and operative in accordance with an embodiment of the present invention.
Guidewire holder 17 may be used to hold the distal portion of a guidewire 25 inside the needle holder lumen before and during blood vessel puncturing. The option to hold the guidewire distal section inside the needle holder lumen may be useful for the operator, because it eliminates the need to look for the guidewire at the operation table, while holding the needle and needle holder steady. It reduces the amount of blood coming out of the needle, and spillage near the patient, by shortening the time needed to insert the guidewire through the needle.
Guidewire holder 17 includes a guidewire locking element 18, which may be made of a flexible material, such as but not limited to, silicone. A sliding knob 19 is arranged to slide over guidewire locking element 18, which forces element 18 through a small hole 41 in elongate stiff member 13 into lumen 16, thereby pressing the distal end of guidewire 25 against the inner wall of lumen 16 and holding guidewire 25 in place. To release guidewire 25, the user slides sliding knob 19 to release guidewire locking element 18 from lumen 16.
A vent hole 20 may be added to elongate stiff member 13 distal to guidewire holder 17 to allow free blood flow outwards from the needle, even if lumen 16 is blocked by guidewire holder closing element 18.
Guidewire locking element 18 and/or other locking elements can be alternatively assembled to vent 12.
In accordance with an embodiment of the present invention, the procedure steps are:
a. Fix needle 11 into connector 14.
b. Optionally insert and lock the distal portion of guidewire 25 inside needle holder lumen 16.
c. Using x-ray angiography, insert and adjust the needle and needle tip until entering the blood vessel.
d. Confirm needle tip is inside the blood vessel by looking at blood coming up into lumen 16 of elongate stiff member 13.
e. Insert guidewire 25 through vent 12 (e.g., female luer) and lumen 16 (if not inserted and locked before), through connector 14 and needle 11, and into the blood vessel.
f. Extract needle holder 10 together with needle 11 from the patient, and remove proximally from guidewire 25.
g. Continue the angioplasty procedure.

## Claims

1. A method comprising:
connecting a needle to a needle holder, the needle holder comprising:
an elongate stiff member having a proximal end, a distal end, and a longitudinal axis;
a connector coupled to the distal end of the elongate stiff member;
a guidewire holder coupled to the elongate stiff member proximally of the distal end, the guidewire holder comprising:
(a) a flexible locking element located proximally of the distal end of the elongate stiff member;
(b) a sliding knob arranged to slide over the locking element in a direction parallel to the longitudinal axis and force the flexible locking element in a radial direction;

a lumen traversing the connector, the elongate stiff member, and the guidewire holder, wherein the lumen comprises an inner wall and an opening disposed proximally of the locking element;

inserting the needle into a blood vessel;
inserting a guidewire into the blood vessel through the lumen and the needle;
sliding the sliding knob over the flexible locking element to cause the flexible locking element to directly contact and press the guidewire against the inner wall and hold the guidewire in place.

2. The method according to claim 1, wherein inserting the needle into the blood vessel comprises using x-ray angiography.

3. The method according to claim 1, further comprising confirming that the needle is positioned in the blood vessel by viewing blood in the elongate stiff member.

4. The method according to claim 1, further comprising removing the needle holder together with the needle from the blood vessel.

5. The method according to claim 4, further comprising removing the needle holder and the needle proximally from the guidewire.

6. The method according to claim 5, further comprising conducting an angioplasty procedure after removing the needle holder and the needle proximally from the guidewire.

7. The method according to claim 1, further comprising conducting an angioplasty procedure after sliding the sliding knob over the flexible locking element.

8. The method according to claim 1, wherein the connector comprises a male luer connector.

9. The method according to claim 1, wherein the opening comprises a female luer connector.

10. The method according to claim 1, wherein the needle holder has a length of at least 12 cm.

11. The method according to claim 1, wherein the needle holder has a length of 20 cm to 25 cm.

12. The method according to claim 1, further comprising a second opening in fluid communication with the lumen.

13. The method according to claim 12, wherein the second opening is located distal to the flexible locking element and proximal of the distal end of the elongate stiff member.

14. The method according to claim 1, wherein the elongate stiff member is constructed of a clear polymeric material.

15. The method according to claim 1, wherein the flexible locking element is located within a hole within the elongate stiff member.