Biopsy devices and related methods

• US 7,850,620 B2
• Filed: 09/11/2007
• Issued: 12/14/2010
• Est. Priority Date: 05/31/2002
• Status: Expired due to Term

• Current Assignee: Teleflex Life Sciences II LLC
• Original Assignee: Vidacare Corp. (Teleflex Incorporated)
• Inventors: Miller, Larry J., Titkemeyer, Robert W., Bolleter, David S., Kilcoin, Christopher Brian, Craig, Bradford Hughes
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C
• Application Number:
  US11/853,685
• Publication Number:
  US 20080045860A1
• Time in Patent Office: 1,190 Days
• Field of Search: 600/568, 600564-567
• US Class Current: 600/568
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• 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 2010/0258 Marrow samples
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 46/23 with means to retain or hold surgical implements
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays

Abstract

Apparatus and methods provided to remove biopsy specimens from bone and/or associated bone marrow. A powered driver may rotate a biopsy needle at an optimum speed to obtain the biopsy specimen. A thread or a groove may be disposed on interior portions of the biopsy needle. The thread or groove may engage a biopsy specimen and enhance removal of a bone marrow core from cancellous bone. Manufacturing procedures are provided for bonding a single helical thread with interior portions of the biopsy needle. The apparatus may also include a biopsy sample ejector and/or ejector funnel. A biopsy needle set may include a cannula and a trocar with respective tips having optimum configurations, dimensions and/or orientations relative to each other to optimize penetration of a bone and/or bone marrow with minimum patient trauma and enhanced reliability of obtaining a biopsy specimen.

Claims

1. A method of obtaining a bone marrow specimen from a bone marrow cavity disposed within a bone comprising:

engaging one end of a drive shaft extending from a powered driver with one end of a coupler assembly by inserting the drive shaft into an opening formed in the one end of coupler assembly to releasably engage the drive shaft with an omega-shaped latch without rotation of the coupler assembly and drive shaft;

releasably engaging one end of a biopsy needle set to an opposite end of the coupler assembly by inserting the one end of the biopsy needle set into an opening formed in the opposite end of the coupler assembly;

rotating the powered driver and coupler assembly in one direction at a relatively constant speed while inserting another end of the biopsy needle through the bone and into adjacent bone marrow; and

obtaining a bone marrow specimen using the biopsy needle set.

2. The method of claim 1 further comprising rotating the biopsy needle at approximately two hundred and fifty to three hundred (250-300) revolutions per minute.

3. The method of claim 1, wherein releasably engaging one end of a biopsy needle set further comprises inserting the one end of the biopsy needle set into an opening formed in the opposite end of the coupler assembly to releasably engage the biopsy needle with an omega-shaped latch without rotation of the coupler assembly and biopsy needle.

4. Apparatus operable to obtain a biopsy sample of a bone and/or associated bone marrow comprising;

a powered driver having a drive shaft with a portion of the drive shaft extending from one end of the powered driver;

a biopsy needle set having a first end operable to penetrate the bone and associated bone marrow;

a coupler assembly having a first end operable to be releasably engaged with a second end of the biopsy needle set;

the coupler assembly having a second end operable to be releasably engaged with the portion of the drive shaft extending from the one end of the powered driver using an omega-shaped latch without rotation of the coupler assembly and drive shaft;

the biopsy needle set including a cannula having a first end and a second end with a longitudinal bore extending through the cannula from the first end to the second end;

the biopsy needle set including a trocar having a first end and a second end;

the trocar slidably disposed within the longitudinal bore of the cannula with the first end of the trocar disposed proximate the first end of the cannula;

an opening formed in the first end of the cannula;

a plurality of cutting surfaces disposed on the first end of the cannula proximate the opening;

the cutting surfaces operable to penetrate bone and associated bone marrow;

a containment bag having a closable opening sized to allow placing the powered driver within the containment bag;

the second end of the coupler assembly disposed within the containment bag;

the first end of the coupler assembly disposed exterior to the containment bag; and

wherein the first end of the coupler assembly is operable to be releasably engaged with the second end of the biopsy needle set using an omega-shaped latch without rotation of the coupler assembly and biopsy needle.

5. The apparatus of claim 4 further comprising a single thread disposed on interior portions of the longitudinal bore of the cannula proximate the opening in the first end of the cannula.

6. The apparatus of claim 5 wherein the single thread further comprises:

a generally helical coil having a wedge shaped cross section defined in part by a base portion wider than other portions of the helical coil; and

the base portion of the wedge shaped cross section bonded with adjacent interior portions of the longitudinal bore of the cannula.

7. The apparatus of claim 6 further comprising:

one side of the cross section extending generally perpendicular from the base portion; and

the base portion of the helical coil welded to the adjacent interior portions of the longitudinal bore of the cannula.

8. The apparatus of claim 4 further comprising a fluid barrier formed between adjacent portions of the containment bag and exterior portions of the coupler assembly.

9. The apparatus of claim 4 further comprising:

a powered driver having a gear assembly;

an associated hollow biopsy needle with at least one internal thread having a pitch; and

the gear assembly having a speed reduction ratio synchronized with rotational speed of the motor and the pitch of the at least one internal thread for optimum performance of the biopsy needle in obtaining a bone marrow sample.

10. The apparatus of claim 4 wherein the powered driver further comprises:

a gear assembly disposed between and rotatably engaged with the motor and the drive shaft; and

the gear assembly having a speed reduction ratio selected to optimize insertion of a biopsy needle into a target area.

11. The apparatus of claim 10 further comprising the gear assembly operable to rotate the drive shaft, coupler assembly and biopsy needle attached thereto at optimum revolutions per minutes (RPM) to capture a bone marrow biopsy specimen.