Needle biopsy device with exchangeable needle and integrated needle protection

• US 9,332,973 B2
• Filed: 11/16/2011
• Issued: 05/10/2016
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: McWeeney, John, Kelly, Micheal
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US13/297,766
• Publication Number:
  US 20120116248A1
• Time in Patent Office: 1,637 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 2090/3925 ultrasonic

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inner hub housing component configured to interchangeably receive a needle subassembly that can be inserting into and withdrawn from the proximal handle member.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.

Claims

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 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 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 needle further comprises a collet surrounding the distal end portion of the needle, the collet comprising a diameter larger than the diameter of the deformable O-ring of the needle protection hub, such that the collet traverses the deformable O-ring when the needle is inserted into or withdrawn from the lumen of the needle protection hub, thereby locking the needle protector subassembly onto the distal end portion of the needle during insertion and withdrawal of the needle subassembly from the delivery handle system.

17. The device of claim 16, wherein the collet is chamfered at a proximal end and a distal end of the collet to provide a smooth interface with the needle protector subassembly during needle exchange.

18. 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 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 proximal handle member further comprises an inner retention collar disposed at a distal end of the inner hub housing component, the inner retention collar configured to receive the needle protection hub coupled to the needle, at least a portion of the retention collar being recessed, and a deformable O-ring component disposed within the recessed portion for securing the needle protection hub within the retention collar upon insertion of the needle subassembly into the proximal handle member; and

wherein the O-ring of the retention collar has a diameter smaller than a diameter of the needle protection hub, such that the needle protection hub traverses the deformable retention collar O-ring when the needle subassembly is inserted into or withdrawn from the proximal handle member thereby locking the needle protector subassembly onto the proximal handle portion during insertion and withdrawal of the needle subassembly from delivery handle system.

19. 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 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 proximal handle member further comprises a locking mechanism for releasably locking the needle hub within the inner hub housing component of the proximal handle member; and

wherein the locking mechanism comprises a depressible latch component securely coupled to the proximal handle member, the latch comprising a deflectable hinge coupled to a barb component, the barb component coupled to the inner hub housing component, disposed within an interior portion of the proximal handle member.

20. The device of claim 19, wherein the needle hub of the needle subassembly further comprises an internal land ring for interacting with the deflectable hinge and barb component of the locking mechanism, whereby the internal land ring traverses the deflectable hinge of the latch component when the needle subassembly is inserted into the lumen of the proximal handle member, thereby causing the deflectable hinge to deflect against the barb component during insertion, the deflectable hinge returning to a home position once the internal land ring has cleared the deflectable hinge to prevent the needle hub from moving backwards, and whereby the needle subassembly is released from the inner hub housing component of the proximal handle member by depressing the latching component to cause the deflectable hinge to deflect against the barb component to allow the internal land ring to clear the deflectable hinge and barb.