CA2202613C - Biopsy needle - Google Patents

Biopsy needle Download PDF

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Publication number
CA2202613C
CA2202613C CA002202613A CA2202613A CA2202613C CA 2202613 C CA2202613 C CA 2202613C CA 002202613 A CA002202613 A CA 002202613A CA 2202613 A CA2202613 A CA 2202613A CA 2202613 C CA2202613 C CA 2202613C
Authority
CA
Canada
Prior art keywords
tissue
notch
stylet
biopsy needle
penetrating
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002202613A
Other languages
French (fr)
Other versions
CA2202613A1 (en
Inventor
Michael S. H. Chu
Yem Chin
James Bates
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Corp
Original Assignee
Boston Scientific Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Corp filed Critical Boston Scientific Corp
Publication of CA2202613A1 publication Critical patent/CA2202613A1/en
Application granted granted Critical
Publication of CA2202613C publication Critical patent/CA2202613C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0208Biopsy devices with actuators, e.g. with triggered spring mechanisms

Abstract

A biopsy needle device includes an outer cannula (12) having a pointed, tiss ue- penetrating distal end and a side notched stylet (14) located within the cannula (12). The stylet (14) and cannula (12) are axiall y movable with respect to each other. The stylet (14) is constructed from a solid rod having a notch (8) near the distal end. The not ch (8) is bordered in portions along its length by a walled region to at least in part define a protected sample containment space. The stylet (14) includes a pointed, tissue-penetrating distal end. The notch (8) defines a full cylindrical region, and the walled region has a semicircular cross section.

Description

BIOPSY NEEDLE

This invention relates to biopsy needles.

Backaround of the Invention i s A biopsy needle instrument is frequently used to obtain a tissue specimen for microscopic examination to determined malignancy, while subjecting the patient to the least trauma. Typically, the instrument consists of a long, thin probe, termed a stylet, within a close-i0 fitting hollow needle, termed a cannula. A firing device first projects the stylet into the tissue, followed immediately by the cannula. The stylet has a notch into which tissue will prolapse when the stylet enters the tissue. As the cannula subsequently slides over the is stylet, it severs the prolapsed tissue from the surrounding mass and captures the prolapsed tissue as a specimen within the notch. The instrument then is typically withdrawn and the piece of tissue removed from the stylet.

zo ~ummarv of the Invention In an aspect, the invention features a biopsy needle device of the type including an outer cannula having a pointed, tissue penetrating distal end and a side-notched stylet located within the cannula. The 2s stylet and the cannula are axially movable with respect to each other. The stylet is constructed from a solid rod member having a notch near the distal end. The notch is bordered in portions along its length by a walled region to at least in part define a protected sample-3o containment space.

Embodiments may include one or more of the following features. The stylet includes a pointed, tissue penetrating distal end. The notch defines a full ' cylindrical region and the walled region has a semi-3s circular cross-section. The notch has a cross sectional area between about 90-97% of the diameter of the rod.
The wall thickness of the walled region is in the range of 0.008"-0.013". The cross section of the rod is in the range of 14 to 18 gauge. The length of the notch is about 10-20 mm. The length of the notch is about 17 mm.
A device of this invention may further include a spring-powered driving mechanism which acts to axially extend said stylet and said cannula without permitting substantial rotation of said stylet.
In another aspect, this invention provides the use of a device of this invention for taking a biopsy sample.
Also provided is the use of a tissue-penetrating biopsy needle device for taking a biopsy sample, wherein the device includes an outer cannula and a side-notch stylet located within said cannula, said stylet being axially extendable for penetration of a tissue mass, and said cannula being axially extendable over said stylet for severing a sample of tissue, wherein said stylet is substantially a solid rod member defining an outer perimeter and having a notch near a distal end, said notch having a notch length and including a wall defining a protected sample-containment space, said wall having a semi-circular cross-section, said distal end including a tissue-penetrating tip and an asymmetrically tapered portion.
Also provided is the use of a tissue-penetrating biopsy needle device for taking a biopsy sample, wherein the device includes an outer cannula and a side-notch stylet located within said cannula, said stylet being axially extendable for penetration of a tissue mass, and said cannula being axially extendable over said stylet for severing a sample of tissue, wherein said stylet is substantially a solid rod member defining an outer perimeter and having a notch near a distal end, said notch having a notch length and including a wall defining a protected sample-containment space, said wall having a semi-circular cross-section, said distal end including a tissue-penetrating tip and an asymmetrically tapered portion, said wall extending continuously from the perimeter of the rod member.

- 2a -In another aspect, the invention features a method of taking a biopsy sample, including providing a biopsy needle of the type including an outer cannula having a pointed, tissue penetrating distal end, and a side-notch stylet located within the cannula. The stylet and the cannula are axially movable with respect to each other.
The stylet is constructed substantially of a solid rod member having a notch near the distal end. The notch is bordered along its length by a thin-walled region of the rod member to define a sample-containment space. The method includes aligning a distal end of the stylet with the pointed, tissue penetrating distal end of the cannula, introducing the biopsy needle into a tissue to be sampled, advancing the stylet distally so that tissue to be sampled prolapses into the notch, advancing the c;tusula distsll~r to ever the tissue and contain the tissue in the sample-containment space and removing the biopsy needle. The method may include taking a sample from a hard cancerous lesion.
The inventions have many advantages. For example, the biopsy needle stylet provides a large, substantially enclosed sample-containment space for receiving and protecting a large tissue sample that exhibits low crush artifact. Typically, the stylet notch is formed in a continuous solid rod and has a short axial length to maintain, generally, the strength of the stylet so that large samples can be taken from hard tissues, such as hard cancerous lesions or even bone (or if the needle should accidently strike bone), without buckling or other failure .
Still further advantages, features, and aspects follow. -brief Description of the Drawings Fig. 1 is a cross-sectional view of a type of s needle notch commonly used in conventional biopsy needles;

Fig. 2 is a top view of an embodiment of a biopsy needle device according to the invention;

Fig. 2a is a cross-sectional view-of the grooved io notch of the biopsy needle of Fig. 2 taken along line 2a-2a of Fig. 2; and Fig. 2b is a side view of the distal region of the biopsy needle of Fig. 2.

Description of the Preferred Embodiments 15 Referring to Fig. 1, commonly used biopsy needles have a stylet notch 8 that has an open shelf-like area.

For example, the notch may have a semi-cylindrical shape that is formed by sectioning a rod. The sample prolapses onto the shelf and is held there by the inner surfaces of zo a cannula that passes over the needle-to sever the tissue from the body.

Referring to Fig. 2, a biopsy needle device 10 according to the invention includes a handle 11, a hollow cannula 12, and a stylet 14. Stylet 14 includes a sharp 25 tip 20 at distal end 22. Proximal o~ the tip 20, the stylet includes a grooved notch 16, to be discussed in more detail immediately below, that enables large samples to be taken and protected while maintaining the strength of the needle so that it can penetrate hard lesions ~

3o and stylet 14 are without buckling. Cannula l2 axially movable with respect to each other. In use, biopsy needle 10, with stylet 14 within cannula 12, is inserted into the body to a tissue site to be sampled.

Stylet 14 is then advanced to expose grooved notch 16.

3s Tissue prolapses into grooved notch 16 and cannula 12 is advanced shearing the tissue to sewer a sample. The samgle is held protected inside the grooved notch. Biopsy needle device 20 is then removed frpm the body. The cannula is retracted, the sample is removed from the notch, and the sample is analyzed for malignaxxcy, e.g. by DNA ox other testing. A mechanism for driving the biopsy needle is taught in caimnonly-owned U.S. Patent Nos.
4,958,625 and 5.195,533. A spring powered driving mechanism is disclosed is U.S. 4.958.625 issued September 25, 1990.
Refatring as well to Fig. 2a, needle stylet I4 is io a solid xad except for grooved notch sample-oontairunent area 16 located in d~.stal region ~.8. The grooved notch defines a f~z~.i cylindrically shaped volume having a arose-sectional area on~.y sl,ight~.y less than the cross sectional area of stylet 14. The loner portions of the i5 region are bordered by a walled, semi-circular sectipn Z4 which can prateat large portions of the Sample from engaging the canx~ula as it slides over the styist at high velocity. The length of the notch is kept relatively shQxt to prevent buckling and allow for high torque 2l? t=ansm~~on- Even with a short notch, a relativ$ly large sample cart collected because the lower portion of the notch, bordered by the semi-circular portion of the stylet provide a large area tar receiving sample.
The grooved notch can be formed by electric 25 discharge m2tchinirig or grinding a solid, rod pf 304 stainless steel. In an emhodiraent, the grooved notch is located about o.2lo"=0.ZS0" from the d3.stal end ~~ of stylet 14. The wall thickness o~ semicircular section ~4 is about o_008 "-4.013" for ail 1~-18 gauge stylet, or 3o approximately 3-'7% of the diameter of stylet 14. The length of grooved notch 16 is about 10-20 mm, for example about 17 mra.
8y compariefln to a stylet of the same gauge with a semi-~lindrieal notch of the seine length, the grooved notch typ~.cally has a cross-sectional area approximately 35 -- 40% larger, can take a large sample that provides approximately 35 - 40% more DNA per sample, and can take a sample with a tissue weight that is 23.4% greater for a 14 gauge needle,-27% greater for a 15 gauge needle, and s 30.8% greater for a 18 gauge needle. Tissue samples are tightly packed within the grooved notch and after removal from the biopsy needle have been found to be 10.2%longer for a 14 gauge needle and 5.7% longer for a 15 gauge needle, as compared to a semi-cylindrical notch biopsy 1o needle. The increased notch volume permits a larger tissue sample to prolapse into the notch resulting in a larger specimen sampled from a wider, deeper area of the tissue. The ability to take a larger sample reduces the number of biopsies required and a single large biopsy 15 sample providing a sufficient number of cells for histopathological evaluation taken in one biopsy is better than several smaller samples. The grooved notch biopsy design is particularly advantageous when taking samples where damage to small samples could prevent 2o accurate analysis, e.g., in samples from hard cancerous lesions. The samples exhibit reduced crush artifact.

The biopsy needle devices according to the invention can be used for sampling in many parts of the body. It can be used on all soft tissue, e.g., lung, 25 kidney, liver and breast with that advantages of obtaining and protecting large samples. The grooved notch biopsy needle stylet design can be also used for penetrating very hard lesions or even_bone because the columnar strength can be maintained without sacrificing 30 sample size.

In alternative embodiments, the cross sectional geometry ofthewalled section of grooved notch sample-containment area may vary. More than one grooved notch sample-containment area can be formed in axial sequence 35 on t the stylet for multiple biopsy sampling. The grooved - 6 =
notch can used in other systems for taking multiple samples, such as described in of-commonly owned U.S.
Patent-No. 5,195,533, The grooved notch can also be used to take deep tissue biopsy samples by placing the groove s notch within a long flexible catheter body, as described in WO 94/26172.
Still further embodiments are within the following claims.

Claims (25)

1. A biopsy needle device including an outer cannula having a pointed, tissue penetrating distal end and a side-notched stylet located within said cannula, said stylet and said cannula being axially movable with respect to each other, wherein said stylet is constructed from a solid rod member having a notch near the distal end, said notch being bordered in portions along its length by a walled region to at least in part define a protected sample-containment space.
2. The biopsy needle device of claim 1, wherein said stylet comprises a pointed, tissue penetrating distal end.
3. The biopsy needle device of claim 1 or 2, wherein the notch defines a full cylindrical region and said walled region has a semi-circular cross-section.
4. The biopsy needle of claim 3, wherein said rod has a diameter and said notch has a cross sectional area between about 90-97% of the diameter of the rod.
5. The biopsy needle device of claim 3 or 4, wherein said walled region has a wall thickness of 0.008"-0.013".
6. The biopsy needle device of claim 5, wherein the rod has a 14 to 18 gauge cross section.
7. The biopsy needle device of claim 6, wherein said notch has a length of about 10-20 mm.
8. The biopsy needle device of claim 7, wherein the length of said notch is about 17 mm.
9. A tissue-penetrating biopsy needle device including an outer cannula and a side-notch stylet located within said cannula, said stylet being axially extendable to penetrate a tissue mass, and said cannula being axially extendable over said stylet to sever a sample of said tissue, wherein said stylet is substantially a solid rod member defining an outer perimeter and having a notch near a distal end, said notch having a notch length and including a wall defining a protected sample-containment space, said wall extending along the notch length from the perimeter of the rod member, said wall having a semi-circular cross-section, said distal end further including a tissue-penetrating tip and an asymmetrically tapered portion.
10. The tissue-penetrating biopsy needle device of claim 9, wherein said stylet comprises a pointed, tissue-penetrating distal end.
11. The tissue-penetrating biopsy needle device of claim 9 or 10, wherein said wall includes a wall portion having a thickness in the range of 0.008" - 0.013".
12. The tissue-penetrating biopsy needle device of any one of claims 9 to 11, wherein said notch has a cross-section defining an area that is about 90-97% of an area defined by a cross-section of said rod member.
13. The tissue-penetrating biopsy needle device of any one of claims 9 to 12, wherein said rod is in the range of 14 to 18 gauge.
14. The tissue-penetrating biopsy needle device of any one of claims 9 to 13, wherein the length of said notch is about 10-20 mm.
15. The tissue-penetrating biopsy needle device of any one of claims 9 to 23, wherein the length of said notch is about 17 mm.
16. The tissue-penetrating biopsy needle device of any one of claims 9 to 15, wherein said solid rod member defines a longitudinal axis and said tissue-penetrating tip is positioned off-centre of the longitudinal axis,
17. The tissue-penetrating biopsy needle device of any one of claims 9 to 15, wherein said tissue-penetrating tip is axially aligned with said rod perimeter.
18. The tissue-penetrating biopsy needle device of any one of claims 9 to 17, wherein said taper portion extends continuously to said tissue-penetrating tip.
19. The tissue-penetrating biopsy needle device of any one of claims 9 to 18, wherein said wall defines a lateral opening to said containment space, said lateral opening is at least as wide as the maximum width of said sample containment space.
20. The biopsy needle device of any one of claims 2 to 19, further including a spring-powered driving mechanism which acts to axially extend said stylet and said cannula.
21. Use of the biopsy needle device of any one of claims 1 to 20 for taking a biopsy sample.
22. Use of a tissue-penetrating biopsy needle device for taking a biopsy sample, wherein the device includes an outer cannula and a side-notch stylet located within said cannula, said stylet being axially extendable for penetration of a tissue mass, and said cannula being axially extendable over said stylet for severing a sample of tissue, wherein said stylet is substantially a solid rod member defining an outer perimeter and having a notch near a distal end, said notch having a notch length and including a wall defining a protected sample-containment space, said wall having a semi-circular cross-section, said distal end including a tissue-penetrating tip and an asymmetrically tapered portion.
23. Use of a tissue-penetrating biopsy needle device for taking a biopsy sample, wherein the device includes an outer cannula and a side-notch stylet located within said cannula, said stylet being axially extendable for penetration of a tissue mass, and said cannula being axially extendable over said stylet for severing a sample of tissue, wherein said stylet is substantially a solid rod member defining an outer perimeter and having a notch near a distal end, said notch having a notch length and including a wall defining a protected sample-containment space, said wall having a semi-circular cross-section, said distal end including a tissue-penetrating tip and an asymmetrically tapered portion, said wall extending continuously from the perimeter of the rod member.
24. The use of any one of claims 21 to 23, wherein the sample is taken from a hard cancerous lesion.
25. The use of any one of claims 21 to 23, wherein the sample is taken from bone.
CA002202613A 1994-10-31 1995-10-26 Biopsy needle Expired - Fee Related CA2202613C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33200094A 1994-10-31 1994-10-31
US08/332,000 1994-10-31
PCT/US1995/013863 WO1996013214A1 (en) 1994-10-31 1995-10-26 Biopsy needle

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CA2202613A1 CA2202613A1 (en) 1996-05-09
CA2202613C true CA2202613C (en) 2006-06-06

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US (1) US5989196A (en)
EP (1) EP0841874B1 (en)
JP (1) JP3678752B2 (en)
CA (1) CA2202613C (en)
DE (1) DE69532654T2 (en)
WO (1) WO1996013214A1 (en)

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DE69532654D1 (en) 2004-04-08
DE69532654T2 (en) 2005-05-25
WO1996013214A1 (en) 1996-05-09
CA2202613A1 (en) 1996-05-09
EP0841874B1 (en) 2004-03-03
JPH10507952A (en) 1998-08-04
JP3678752B2 (en) 2005-08-03
EP0841874A1 (en) 1998-05-20
EP0841874A4 (en) 1998-05-20
US5989196A (en) 1999-11-23

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