# US 11,298,202 B2 · Biopsy devices and related methods

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- Number: US 11,298,202 B2
- Document ID: US11298202B2
- Status: Granted
- Kind: B2
- Application number: 15/615,596
- Filed: 2017-06-06
- Published: 2017-11-30
- Granted: 2022-04-12
- Earliest claimed: 2002-05-31
- Assignees: Teleflex Life Sciences Limited
- Applicants: Teleflex Life Sciences Limited
- Inventors: Larry J. Miller; David S. Bolleter; Robert W. Titkemeyer; Christopher Brian Kilcoin; Bradford Hughes Craig
- Web page: https://patentgrep.com/patent/US11298202B2

## CPC

- A61B 46/10: specially adapted for instruments{, e.g. microscopes}
- A61B 10/025: {for taking bone, bone marrow or cartilage samples}
- A61B 10/0283: {with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe (A61B10/025, A61B10/0266 take precedence)}
- A61B 17/162: {Chucks or tool parts which are to be held in a chuck}
- A61B 17/1637: {Hollow drills or saws producing a curved cut, e.g. cylindrical (A61B10/025, A61B17/1695 take precedence)}
- A61B 46/00: Surgical drapes
- 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)
- A61B 50/33: Trays
- A61B 17/32002: {with continuously rotating, oscillating or reciprocating cutting instruments}
- A61B 17/32053: {Punch like cutting instruments, e.g. using a cylindrical or oval knife (A61B17/326 takes precedence; trepans A61B17/1695)}
- A61B 46/23: with means to retain or hold surgical implements
- A61B 90/40: Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
- A61B 2010/0258: {Marrow samples}
- A61B 2017/00362: {Packages or dispensers for MIS instruments (A61B2017/0479 takes precedence)}
- A61B 2017/0046: {with a releasable handle; with handle and operating part separable}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00685: {Archimedes screw}
- A61B 2017/00734: {battery operated}
- A61B 2017/320064: {with tissue or sample retaining means}
- A61B 2050/3008: {having multiple compartments}
- A61B 2090/062: {penetration depth}
- Y10T 29/49826: Assembling or joining
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 1

An intraosseous biopsy needle set operable to be rotatably inserted into a bone and associated bone marrow, the intraosseous biopsy needle set comprising:
an outer cannula having a first end, a second end, and a longitudinal bore, the longitudinal bore extending from the first end of the outer cannula to the second end of the outer cannula;
an inner penetrator operable to be slidably received within the longitudinal bore of the outer cannula, the inner penetrator having a first end configured to at least partially extend from the first end of the outer cannula;
a helical thread disposed on an interior portion of the outer cannula proximate to the first end of the outer cannula, the helical thread configured to assist with capturing a specimen of bone or bone marrow;
the first end of the outer cannula having a plurality of cutting surfaces adjacent to an opening in the first end of the outer cannula;
the first end of the inner penetrator having a plurality of tapered cutting surfaces, the plurality of tapered cutting surfaces forming a cutting tip on the first end of the inner penetrator;
the plurality of tapered cutting surfaces of the inner penetrator comprising a first tapered cutting surface and a second tapered cutting surface, the first tapered cutting surface extending a first length from the cutting tip on the first end of the inner penetrator, and the second tapered cutting surface extending a second length from the cutting tip on the first end of the inner penetrator;
where a portion of the first tapered cutting surface is disposed within the longitudinal bore of the outer cannula and the second tapered cutting surface is disposed outside the longitudinal bore of the outer cannula such that a proximal end of the second tapered cutting surface is disposed adjacent to a respective cutting surface of the plurality of cutting surfaces of the outer cannula when the inner penetrator is fully received within the longitudinal bore of the outer cannula; and
where the plurality of cutting surfaces of the outer cannula and the plurality of tapered cutting surfaces of the inner penetrator are configured to cooperate with each other to penetrate the bone and associated bone marrow.

### Claim 2 (depends on 1)

The intraosseous biopsy needle set according to claim 1, where the plurality of tapered cutting surfaces of the inner penetrator are proximate to the first end of the outer cannula when the inner penetrator is inserted into the outer cannula.

### Claim 3 (depends on 1)

The intraosseous biopsy needle set according to claim 1, where the plurality of cutting surfaces of the outer cannula form a plurality of crowns.

### Claim 4 (depends on 1)

The intraosseous biopsy needle set according to claim 1, wherein the helical thread comprises a wedge shaped cross-section defined in part by a base portion.

### Claim 5 (depends on 4)

The intraosseous biopsy needle set according to claim 4, wherein the base portion of the wedge shaped cross-section of the helical thread is bonded with the interior portion of the outer cannula.

### Claim 6 (depends on 4)

The intraosseous biopsy needle set according to claim 4, wherein the base portion of the wedge shaped cross-section of the helical thread is welded to an adjacent interior portion of the longitudinal bore of the outer cannula.

### Claim 7 (depends on 1)

The intraosseous biopsy needle set according to claim 1, wherein the helical thread comprises a helical coil formed in part from a metal alloy.

### Claim 8 (depends on 1)

The intraosseous biopsy needle set according to claim 1, further comprising a plurality of markings disposed on exterior portions of the outer cannula, the plurality of markings configured to indicate a depth of penetration of the intraosseous biopsy needle set into the bone and associated bone marrow.

### Claim 9 (depends on 1)

The intraosseous biopsy needle set according to claim 1, where the outer cannula is configured to communicate with a vacuum source for aspirating bone marrow through the opening in the first end of the outer cannula and the longitudinal bore of the outer cannula.

### Claim 10 (depends on 1)

The intraosseous biopsy needle set according to claim 1, wherein an outside diameter of the inner penetrator is reduced to accommodate a height of the helical thread.

### Claim 11

A method of forming an intraosseous biopsy needle operable to obtain a sample of bone marrow from a selected target area, the method comprising:
providing the biopsy needle with an elongated hollow bore extending longitudinally from a first end to a second end thereof, the first end having an opening in communication with the hollow bore;
providing a mandrel having a first end and an insulator, the first end operable to be inserted into the first end of the biopsy needle, and the insulator disposed adjacent to the first end;
placing a helical coil on an exterior portion of the mandrel adjacent to the first end of the mandrel;
inserting the helical coil and the first end of the mandrel into the opening at the first end of the biopsy needle until the insulator contacts the first end of the biopsy needle, such that the helical coil and the first end of the mandrel are positioned at a location within the elongated hollow bore of the biopsy needle; and
transferring the helical coil from the mandrel to an inside diameter of the biopsy needle adjacent to the first end thereof, such that the helical coil is disposed at the first end of the biopsy needle proximate the opening and away from the second end of the biopsy needle.

### Claim 12 (depends on 11)

The method of claim 11, further comprising:
forming the mandrel from material operable to function as an electrode; and
applying electrical power to the mandrel to weld the helical coil with interior portions of the longitudinal bone.

### Claim 13 (depends on 11)

The method of claim 11, further comprising:
forming a helical groove in exterior portions of the mandrel adjacent to the first end of the mandrel; and
installing the helical coil within the helical groove.

### Claim 14 (depends on 11)

The method of claim 11, further comprising:
an enlarged outside diameter portion on the mandrel spaced a distance from the first end of the mandrel, where the
distance from the first end of the mandrel to the enlarged outside diameter portion corresponds with a desired location for installing the helical coil within the biopsy needle; and
contacting the first end of the hollow biopsy needle with the enlarged outside diameter portion of the mandrel.

### Claim 15 (depends on 11)

The method of claim 11, further comprising forming a plurality of sharp cutting surfaces immediately adjacent to exterior portions of the first end of the biopsy needle.

### Claim 16

An intraosseous access device operable to be rotatably inserted into a bone and associated bone marrow, the intraosseous access device comprising:
an outer penetrator including a first end having a cutting surface, a second end, and a longitudinal bore extending from the first end of the outer penetrator to the second end of the outer penetrator;
an inner penetrator operable to be slidably received within the longitudinal bore of the outer penetrator, the inner penetrator including a first end having a first tapered cutting surface and a second tapered cutting surface, the first and second tapered cutting surfaces forming a tip on the first end of the inner penetrator;
the first tapered cutting surface extending a first length from the cutting tip on the first end of the inner penetrator, and the second tapered cutting surface extending a second length from the cutting tip on the first end of the inner penetrator;
where a portion of the first tapered cutting surface of the inner penetrator is located proximally to the cutting surface of the outer penetrator when the inner penetrator is fully received in the outer penetrator, where the second tapered cutting surface of the inner penetrator is located distally to the cutting surface of the outer penetrator when the inner penetrator is fully received in the outer penetrator, and where a proximal end of the second tapered cutting surface is disposed adjacent to the cutting surface of the outer penetrator when the inner penetrator is fully received in the outer penetrator; and
where the cutting surface of the outer penetrator and the first and second tapered cutting surfaces of the inner penetrator are configured to cooperate with each other to penetrate the bone and associated bone marrow.

### Claim 17 (depends on 16)

The intraosseous access device according to claim 16, wherein the first length of the first tapered cutting surface of the inner penetrator is greater than the second length of the second tapered cutting surface of the inner penetrator.

### Claim 18 (depends on 17)

The intraosseous access device according to claim 17, where the cutting surface of the outer penetrator includes a plurality of crowns.

### Claim 19 (depends on 16)

The intraosseous access device according to claim 16, wherein the outer penetrator includes an interior portion comprising a thread configured to assist with capturing a specimen of bone or bone marrow.

### Claim 20 (depends on 16)

The intraosseous access device according to claim 16, wherein the outer penetrator includes a plurality of markings configured to indicate a depth of penetration of the intraosseous access device into the bone and associated bone marrow.
