Needle biopsy device with exchangeable needle and integrated needle protection

Patent metadata

Field	Value
Publication number	US-9332973-B2
Application number	US-201113297766-A
Country	US
Kind code	B2
Filing date	Nov 16, 2011
Priority date	Oct 1, 2008
Publication date	May 10, 2016
Grant date	May 10, 2016

Abstract

The invention provides a device for needle biopsy having a novel delivery handle system for interchangeably delivering needles of various sizes to a biopsy site. The delivery handle system is adjustable in length and includes a proximal handle member slideably disposed over a middle handle member, and the middle handle member is slideably disposed over a distal handle member. The proximal handle member includes an inner hub housing component configured to interchangeably receive a needle subassembly that can be inserting into and withdrawn from the proximal handle member. The needle subassembly includes a needle of a plurality of different sizes, a needle luer, a needle hub coupled to a proximal end portion of the needle, and a needle protector subassembly. The needle protector subassembly includes a needle protection hub configured to receive the distal end of a needle.

First claim

What is claimed is:

1. A device for needle biopsy comprising:
a delivery handle system having an adjustable length, a longitudinal axis defining a lumen extending therethrough, and comprising a proximal handle member, a middle handle member and a distal handle member, the proximal handle member being slideably disposed over at least a portion of the middle handle member, the middle handle member being slideably disposed over at least a portion of the distal handle member, the proximal handle member comprising an inner hub housing component comprising an internally cylindrical shape configured to interchangeably receive a needle subassembly configured for inserting into and withdrawing from the proximal handle member;
the needle subassembly comprising a needle having a proximal end portion and a distal end portion, a needle luer coupled to the proximal end portion of the needle, and a needle hub coupled to the proximal end portion of the needle, the needle hub configured for coupling with the inner hub housing component of the proximal handle member; and
the needle subassembly further comprising a needle protector subassembly configured for coupling to the distal end portion of the needle, the needle protector subassembly comprising a needle protection hub having a lumen extending therethrough configured for receiving the distal end portion of the needle, a deformable O-ring axially disposed within the lumen of the needle protection hub, and a tubular sheath defining a lumen and extending from a distal end of the needle protection hub, the lumen of the tubular sheath in communication with the lumen of the needle protection hub for receiving the needle when inserted into the needle protection hub;
wherein the lumen extending through the delivery handle system comprises:
an inner hypotube component at least partially disposed within the proximal handle member;
an outer hypotube component disposed at least partially within the middle handle member, the inner hypotube component being coupled to the outer hypotube component and configured to longitudinally slide within the outer hypotube component when the proximal handle member is distally advanced or proximally retracted over the middle handle member; and
a tubular catheter sheath coupled to a distal end of the outer hypotube component,
the inner hypotube component, outer hypotube component and catheter sheath being in constant communication with each other;

the device further comprising an inner handle member disposed within an inner portion of the middle handle member, the inner handle member coupled to a proximal portion of the catheter sheath and a distal portion of the outer hypotube, such that the catheter sheath is distally extended into the distal handle member when the middle handle member is distally advanced over the distal handle member.

2. The device of claim 1 , further comprising:
a first locking mechanism configured to prevent the proximal handle member from longitudinally sliding over the middle handle member; and
a second locking mechanism configured to prevent the middle handle member from longitudinally sliding over the distal handle member.

3. The device of claim 2 , wherein the first locking mechanism comprises a first ring slidably disposed around at least a portion of the middle handle member, and a screw threaded within the first ring for locking the first ring in a fixed position along the middle handle member, and the second locking mechanism comprises a threaded insert disposed along a distal portion of the middle handle member, the threaded insert coupled to a screw for tightening the threaded insert to lock middle handle member in a fixed position along the distal handle member.

4. The device of claim 1 , wherein the needle subassembly comprises an aspiration needle ranging from 15 AWG to 28 in size.

5. The device of claim 1 , wherein the inner hub housing component comprises a plurality of depressions spaced around an internal circumference of the hub housing component and the needle hub comprises a plurality of protrusions, the plurality of depressions configured to receive the plurality of protrusions to prevent the needle hub from rotating relative to the hub housing component.

6. The device of claim 1 , wherein the inner hub housing component comprises a smooth internal circumference and the needle hub comprises a smooth outer surface to allow the needle hub rotate relative to the hub housing component.

7. The device of claim 1 , wherein the needle comprises a distal tip having four distinct angular bevel grinds.

8. The device of claim 7 , wherein the four angular bevel grinds comprise a primary angle relative to the needle shaft, a secondary angle relative to the needle shaft, and a back-cut angle relative to the secondary angle for providing a smooth needle passage during needle insertion and withdrawal during a biopsy procedure, and enhanced echogenicity or acoustic reflection of the distal tip of the needle.

9. The device of claim 1 , wherein the tubular sheath extends distally from the needle protector subassembly and comprises an internally tapering distal end.

10. The device of claim 1 , wherein the catheter sheath comprises an outer diameter ranging from 0.05 inches to 0.140 inches, and an inner diameter ranging from 0.05 inches to 0.120 inches.

11. The device of claim 1 , wherein the catheter sheath comprises a tapered distal tip comprising outer and inner diameters, wherein the outer and inner diameters of the tapered distal tip are smaller than the outer and inner diameters of the catheter sheath, respectively.

12. The device of claim 11 , wherein the inner diameter of the distal tip ranges from 0.020 inches to 0.060 inches.

13. The device of claim 1 , wherein the catheter sheath comprises a helically braided reinforcement structure.

14. The device of claim 1 , further comprising a luer holder coupled to a distal end of the distal handle member and configured for coupling the distal handle member to a working channel port of an endoscope.

15. The device of claim 14 , wherein the luer holder comprises a luer lock for locking the distal handle member in a fixed position relative to the working channel of the endoscope to prevent the delivery handle system from rotating about the working channel.

16. A device for needle biopsy comprising:
a delivery handle system having an adjustable length, a longitudinal axis defining a lumen extending therethrough, and comprising a proximal handle member, a middle handle member and a distal handle member, the proximal handle member being slideably disposed over at least a portion of the middle handle member, the middle handle member being slideably disposed over at least a portion of the distal handle member, the proximal handle member comprising an inner hub housing component comprising an internally cylindrical shape configured to interchangeably receive a needle subassembly configured for inserting into and withdrawing from the proximal handle member;
the needle subassembly comprising a needle having a proximal end portion and a distal end portion, a needle luer coupled to the proximal end portion of the needle, and a needle hub coupled to the proximal end portion of the needle, the needle hub configured for coupling with the inner hub housing component of the proximal handle member; and
the needle subassembly further comprising a needle protector subassembly configured for coupling to the distal end portion of the needle, the needle protector subassembly comprising a needle protection hub having a lumen extending therethrough configured for receiving the distal end por

Assignees

• Mcweeney John
• Kelly Micheal
• Covidien Lp

Inventors

• Mcweeney John
• Kelly Micheal

Classifications

• A61B10/04 Primary

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

• A61B10/0283

  with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe (A61B10/025, A61B10/0266 take precedence) · CPC title

• A61B2017/00477

  Coupling (A61B2017/0046 takes precedence) · CPC title

• A61B2010/045

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

• A61B2019/4805

  Human Necessities · mapped topic