LARGE SAMPLE LOW ASPECT RATIO BIOPSY NEEDLE

• US 20130023789A1
• Filed: 08/14/2012
• Published: 01/24/2013
• Est. Priority Date: 10/24/2006
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Anderson, Tyson D., Almazan, Daniel O., Talpade, Dnyanesh A.
• Granted Patent: US 10,149,664 B2
• Time in Patent Office: Days
• US Class Current: 600/566
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• 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

Abstract

A high aspect ratio biopsy needle achieves reliable performance with large solid sample size by means of a variety of features and combinations thereof, including support to prevent bending, reinforcement of the needle, and cutting edges arranged to resist deformation.

Claims

1. A biopsy device, comprising:

a cylindrical hollow stylet having a distal end with a sample recess configured to receive biopsy samples, and a proximal portion;

a mounting member configured to support the proximal portion of the stylet at multiple points such that bending of the proximal portion is resisted by the mounting member supporting the proximal portion at at least three spaced support points;

a longitudinal reinforcement affixed to the cylindrical hollow stylet and configured to extend between the at least three spaced support points, such that the reinforcement also resists bending.

79. The biopsy device of claim 1, wherein the longitudinal reinforcement is an insert positioned in the proximal portion of the cylindrical hollow stylet, the longitudinal reinforcement having a portion internal to the cylindrical hollow stylet that has a non-circular cross-sectional shape.

80. The biopsy device of claim 1, comprising an elongate cutting sheath coaxial with the cylindrical hollow stylet, and interposed between at least one of the at least three spaced support points of the mounting member and the cylindrical hollow stylet.

81. The biopsy device of claim 1, wherein the sample recess is a longitudinal opening in a side wall of the cylindrical hollow stylet, the longitudinal opening having longitudinally oriented cutting edges on lateral sides of the longitudinal opening.

82. The biopsy device of claim 81, wherein the longitudinally oriented cutting edges define an apex angle of about 40°

.

83. The biopsy device of claim 1, comprising a cutting sheath coaxial with the cylindrical hollow stylet, the cutting sheath having second longitudinally oriented cutting edges.

84. The biopsy device of claim 83, where at least one of the second longitudinally oriented cutting edges is a longitudinally oriented curved cutting edge.

2-78. -78. (canceled)

85. A biopsy device, comprising:

a hollow stylet having a side wall and a distal end portion with a sample recess extending through the side wall to define a sample chamber, and a proximal end portion proximal to the sample recess, the distal end portion and the proximal end portion being disposed on a longitudinal axis;

a mounting structure configured to define at least three longitudinally spaced support points; and

a longitudinal reinforcement located at the proximal portion of the stylet and configured to reinforce the hollow stylet at the at least three longitudinally spaced support points of the mounting structure.

86. The biopsy device of claim 85, wherein one of the at least three longitudinally spaced support points is included in an axially-elongated support element located at a distal end of the mounting structure.

87. The biopsy device of claim 85, wherein the hollow stylet has a first cross-sectional shape, and the longitudinal reinforcement is a longitudinal insert having a portion positioned internal to the hollow stylet that has a second cross-sectional shape different from the first cross-sectional shape of the hollow stylet.

88. The biopsy device of claim 85, wherein the longitudinal reinforcement is a longitudinal insert affixed within the stylet at a position proximal the sample recess.

89. The biopsy device of claim 85, wherein the longitudinal reinforcement is a longitudinal insert affixed to the hollow stylet between the sample recess and a proximal end of the hollow stylet.

90. The biopsy device of claim 85, wherein a ratio of the diameter of the hollow stylet to the wall thickness of the hollow stylet is between about 10 to 15:

1.

91. The biopsy device of claim 85, wherein the stylet has a working length that extends distally from the mounting structure.

92. The biopsy device of claim 85, wherein the sample recess is a longitudinal recess having cutting edges that extend parallel to the longitudinal axis on lateral sides of the longitudinal recess.

93. The biopsy device of claim 92, wherein the cutting edges having a depth, perpendicular to the longitudinal axis, of between 2.5 and 4 times a thickness of the side wall.

94. The biopsy device of claim 92, wherein the cutting edges define an apex angle of about 40°

.

95. The biopsy device of claim 92, wherein the distance between the cutting edges is less than an outer diameter of the stylet.

96. The biopsy device of claim 85, further comprising a vacuum pump coupled in fluid communication with the hollow stylet.

97. A biopsy device having a mounting structure, comprising:

a cylindrical hollow tube having a side wall with a uniform wall thickness, an inner diameter, an outer diameter, and a longitudinal axis, the cylindrical hollow tube having a distal end portion, and a mounting portion by which the cylindrical hollow tube is supported, the distal portion and mounting portion being disposed on the longitudinal axis, the mounting portion being configured to engage the mounting structure at at least three separated support points;

a longitudinal sample recess that extends radially through the side wall to form a sample chamber in the cylindrical hollow tube, the longitudinal sample recess being located in the distal end portion;

a pair of cutting edges extending parallel to the axis on respective lateral sides of the longitudinal sample recess, the pair of cutting edges having a depth, perpendicular to the axis, of between 2.5 and 4 times a wall thickness of the side wall; and

a longitudinal insert positioned at the mounting portion of the cylindrical hollow tube, wherein the longitudinal insert is affixed within the cylindrical hollow tube.