Self-coiling stylet needle device

Patent metadata

Field	Value
Publication number	US-9855403-B2
Application number	US-201314055232-A
Country	US
Kind code	B2
Filing date	Oct 16, 2013
Priority date	Oct 19, 2012
Publication date	Jan 2, 2018
Grant date	Jan 2, 2018

Abstract

A medical device includes an elongate single-wire memory-metal body with a complete length that includes a proximal stylet length, an intermediate self-coiling stylet length, and a distal stylet length that is generally straight and non-self-coiling. The moment of force of the self-coiling stylet length is less than the moment of force of the medical endoscopy needle that is resistant to the stylet's self-coiling force. The device may further include being incorporated into an endoscopy needle system where the single-wire stylet body is disposed through a lumen of a medical endoscopy needle.

First claim

We claim:

1. A medical tube passage system with stylet, the system comprising:
a medical endoscopy needle including at least one longitudinal needle lumen extending through a length thereof; and
an elongate single-wire stylet body, removably disposed at least partially within the at least one longitudinal needle lumen, with a complete stylet body length equal to or less than a complete needle length measured from a proximal stylet terminus portion to a distal stylet end that aligns with a distal end of the needle when the proximal stylet terminus portion contacts a proximal end terminus of the needle, where the complete stylet body length includes
a non-self-coiling proximal stylet length,
an intermediate self-coiling shape-memory material stylet length that disposes the stylet to coil itself upon removal from the lumen, and

a generally straight non-self-coiling distal-most stylet length;
where the intermediate self-coiling stylet length effectively limits a default droop length of, and decreases a tangling risk of, the stylet body that is outside of the needle lumen; and

where a diameter of the proximal stylet terminus portion is larger than a diameter of the needle and thereby prevents a proximal end of the elongate single-wire stylet body from traveling into the needle lumen, and where the proximal stylet terminus portion contacts the proximal terminus of the needle when the distal stylet end aligns with the distal end of the needle, and where the proximal stylet terminus portion is structurally configured as a proximal stylet handle with at least one portion that is both generally perpendicular and transverse to a longitudinal axis of the stylet, the longitudinal axis extending along a length of the stylet body disposed immediately adjacent the proximal stylet terminus portion.

2. The system of claim 1 , where the shape-memory material comprises a polymer selected from PEEK, polyurethane, polyethylene, PTFE, nylon, a metal material selected from nickel-titanium, nickel-titanium-cobalt, nickel-titanium-chromium, nickel-titanium-niobium, nickel-titanium-hafnium, nickel-titanium-palladium, nickel-titanium-platinum, nickel-titanium-iron, nickel-titanium plus rare earth elements, iron-manganese-silicon, iron-platinum, iron-nickel, iron-nickel-cobalt, iron-nickel-cobalt-aluminum-tin-tantalum, stainless steel, spring steel, and any combination of said polymer(s) and/or metal material(s).

3. The system of claim 1 , where the intermediate self-coiling stylet length forms one or more coils having an outer diameter of about 7 cm to about 30 cm.

4. The system of claim 1 , where the generally straight non-self-coiling distal most stylet length is at least 4%, and no more than about 10% of the complete stylet body length.

5. The system of claim 1 , where the intermediate self-coiling stylet length comprises about 80% to about 95% of the complete length.

6. The system of claim 1 , comprising the complete stylet body length of about 180 cm, the generally straight non-self-coiling distal-most stylet length of about 2 cm to about 20 cm, and the non-self-coiling proximal stylet length of about 5 cm to about 14 cm.

7. The system of claim 1 , where the distal stylet end is configured as a sharp, beveled tip.

8. The system of claim 1 , where the proximal stylet terminus portion is structured as a loop.

9. The system of claim 1 , where the intermediate self-coiling stylet length, when unconstrained, forms a plurality of coils as a spiral wherein each coil has substantially the same outer diameter.

10. The system of claim 1 , where the intermediate self-coiling stylet length, when unconstrained, forms a plurality of coils as a spiral wherein each coil has a smaller outer diameter than a more proximal adjacent coil, and the coil outer diameters decrease likelihood of tangling or binding of the unconstrained stylet length.

11. The system of claim 1 , where at least one coil of the intermediate self-coiling stylet length, when unconstrained, forms at least one coil shaped as a generally circular, generally elliptical, generally oval, or generally obround shape.

12. The system of claim 11 , where a coil immediately adjacent to the at least one coil is disposed at a slight pitch relative thereto, includes a different coil diameter in at least one dimension, or any combination thereof.

13. The system of claim 1 , where the default droop length of the stylet body that is outside of the needle lumen is such that a complete droop length of the stylet body is less than or equal to approximately 80% of the complete stylet body length.

14. A medical tube passage system with stylet, the system comprising:
a medical endoscopy needle including at least one longitudinal needle lumen extending through a length thereof; and
an elongate single-wire stylet body, removably disposed at least partially within the at least one longitudinal needle lumen, with a complete stylet body length equal to or less than a complete needle length measured from a proximal stylet terminus portion to a distal stylet end that aligns with a distal end of the needle when the proximal stylet terminus portion contacts a proximal end terminus of the needle, where the complete stylet body length includes
a non-self-coiling proximal stylet length,
an intermediate self-coiling shape-memory material stylet length that disposes the stylet to coil itself upon removal from the lumen, and

a generally straight non-self-coiling distal-most stylet length;
where the intermediate self-coiling stylet length effectively limits a default droop length of, and decreases a tangling risk of, the stylet body that is outside of the needle lumen, and where the inherent moment of force of the intermediate self-coiling stylet length is less than a moment of force inherent to the medical endoscopy needle that is resistant to a self-coiling force of the stylet body and where the intermediate self-coiling stylet length, when unconstrained, forms a plurality of coils as a spiral wherein each coil has a smaller outer diameter than a more proximal adjacent coil, and the coil outer diameters decrease likelihood of tangling or binding of the unconstrained stylet length; and

where a diameter of the proximal stylet terminus portion is larger than a diameter of the needle and thereby prevents a proximal end of the elongate single-wire stylet body from traveling into the needle lumen, and where the proximal stylet terminus portion contacts the proximal terminus of the needle when the distal stylet end aligns with the distal end of the needle, and where the proximal stylet terminus portion is structurally configured as a proximal stylet handle with at least one portion that is both generally perpendicular and transverse to a longitudinal axis of the stylet, the longitudinal axis extending along a length of the stylet body disposed immediately adjacent the proximal stylet terminus portion.

15. A medical tube passage system with stylet, the system comprising:
a medical endoscopy needle including at least one longitudinal needle lumen extending through a length thereof; and
an elongate single-wire stylet body, removably disposed at least partially within the at least one longitudinal needle lumen, with a complete stylet body length equal to or less than a complete needle length measured from a proximal stylet terminus portion to a distal stylet end that aligns with a distal end of the needle when the proximal stylet terminus portion contacts a proximal end terminus of the needle, where the complete stylet body length includes
a non-self-coiling proximal stylet length,
an intermediate self-coiling shape

Assignees

• Cook Medical Technologies Llc

Inventors

• Irwin Nathaniel A
• Clancy Michael S
• Mcgrath Darach
• Toomey Ciarán
• Leahy Ronan
• Keady Fionan

Classifications

• A61B10/0233

  Pointed or sharp biopsy instruments · CPC title

• A61B10/04

  Endoscopic instruments, e.g. catheter-type instruments · CPC title

• A61B17/3478

  Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067) · CPC title

• A61M25/0102 Primary

  Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod · CPC title

• A61B2010/045

  Needles (pointed biopsy devices with vacuum aspiration A61B10/0283) · CPC title