Rotating fine needle for core tissue sampling

• US 7,722,549 B2
• Filed: 11/29/2005
• Issued: 05/25/2010
• Est. Priority Date: 11/29/2004
• Status: Active Grant

• Current Assignee: Granit Medical Innovations LLC
• Original Assignee: Granit Medical Innovations LLC
• Inventors: Nakao, Naomi L.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US11/289,657
• Publication Number:
  US 20060116605A1
• Time in Patent Office: 1,638 Days
• Field of Search: 600566-567, 604/22
• US Class Current: 600/564
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603

Abstract

A medical instrument usable with an ultrasound-endoscope for performing a needle biopsy on a patient'"'"'s internal body tissues usable at a surgical site not visible to the unaided eye or viewed endoscopically, comprises an elongate tubular member with a hollow needle element connected at its distal end, a sheath member housing said tubular member and needle element, an actuator subassembly with a shifter member operatively connected to elongate tubular member'"'"'s proximal end, and a distal camming subassembly, said subassembly enabling a rotating motion of said needle member while handle actuator is moved in the forward direction. Upon inserting an ultrasound-endoscope into a patient and locating a mass, the fine needle with sharply pointed spoon shaped distal end is inserted into the mass aided by endoscopic and ultrasonographic guidance. Once in the mass, a camming action is initiated, causing rotation of the fine needle within the mass, resulting in a scooped out core biopsy. This instrument enables the performance of a fine needle aspiration requiring only one or two needle introductions, with a resultant core biopsy substantial enough for diagnostic purposes.

Claims

1. A medical instrument comprising:

an elongate tubular sheath member having a diameter sufficiently small so that said sheath member is disposable in a channel of a flexed flexible endoscope, said sheath member having an opening at a distal tip, said opening extending in a plane at least partially transverse to a longitudinal axis of said sheath member;

an elongate shaft member longitudinally passing through at least a substantial portion of said elongate tubular sheath member;

an actuator handle subassembly with a manually actuated shifter member operatively connected to a proximal end of said elongate shaft member at least for longitudinally moving said shaft member;

a camming subassembly operatively connected to said shaft member and to said shifter member at least for causing said elongate shaft member to rotate during an axial motion of said shaft member, wherein said camming subassembly comprises at least one key element and at least one corresponding cutout or guide element; and

an operative element disposed at a distal end of said shaft member, said shifter member being operatively connected to said proximal end of said elongate shaft member,

wherein an axial force applied to said shifter member shifting said shifter member in an axial direction causes said shaft member and said operative element to advance in an axial direction, while concurrently effecting an at least 360°

degree rotation of said operative element.

2. The medical instrument set forth in claim 1 wherein said operative element takes the form of a hollow needle member.

3. The medical instrument set forth in claim 2 wherein said hollow needle member is made at least partially of a shape memory material.

4. The medical instrument set forth in claim 1, wherein said shaft member is made, at least in part, of a shape memory metal material.

9. The medical instrument set forth in claim 1 wherein one of said key element and said cutout or guide element is affixed directly or indirectly to one of (a) said elongate shaft member and (b) a member of said actuator handle subassembly.

10. The medical instrument set forth in claim 9 wherein a manually induced axial motion of said shifter member of said actuator handle subassembly engages said key element member with said cutout or guide element, thereby causing said shaft member to simultaneously advance and execute at least a 360°

rotation.

11. The medical instrument set forth in claim 9 wherein said key element is taken from the group consisting of a stub and a flange or rib having a helical shape.

12. The medical instrument set forth in claim 1 wherein said shaft member is made at least partially of braided stainless steel.

5. A medical instrument assembly comprising:

a flexible elongate shaft member with a hollow needle element disposed at a distal end thereof, wherein at least said shaft member is configured to possess shape memory;

a flexible elongate outer tubular sheath member slidably housing at least partially said elongate shaft member and said needle element, said tubular sheath member having a diameter sufficiently small so that said tubular sheath member is disposable in a biopsy channel of a flexed flexible endoscope, said sheath member having an opening at a distal tip, said opening extending in a plane at least partially transverse to a longitudinal axis of said sheath member; and

an actuator subassembly with an operator actuated shifter member operatively connected to a proximal end of said shaft member; and

a rotation-generating mechanism disposed in said actuator subassembly and operatively connected to said shaft member and to said shifter member, wherein said rotation-generating mechanism comprises at least one key element and at least one corresponding cutout or guide element,

wherein an axial force applied to said shifter member causing said shifter member to move in an axial direction causes said shaft member and said needle element to advance in the axial direction, concurrently bringing about an at least 360°

degree rotation of said needle element.

6. A medical instrument assembly comprising:

a substantially rigid shaft member;

an operative needle element provided on a distal end of said shaft member, said needle element having an opening at a distal tip, said opening extending in a plane at least partially transverse to a longitudinal axis of said needle member;

an actuator handle subassembly with an operator actuated shifter member operatively connected to a proximal end of said shaft member; and

a camming subassembly disposed in said actuator handle subassembly, said camming subassembly being operatively connected to said shaft member and to said shifter member, wherein said camming subassembly comprises at least one key element and at least one corresponding cutout or guide element,

wherein an axial force applied to said shifter member causing said shifter member to shift in an axial direction causes said shaft member to advance in the axial direction, concurrently bringing about an at least 360°

degree rotation of said shaft member.

7. The instrument assembly set forth in claim 6 wherein:

said shaft member is a tubular member configured with a longitudinally extending lumen; and

said operative needle element is a hollow needle tip provided at one end of said shaft member, said needle tip extending in a direction away from said one end of said shaft member.

8. The instrument assembly set forth in claim 6 wherein said camming subassembly includes a spiral-shaped element.