JPH0852142A - Biopsy needle assembly with sample holding means and method of using the same - Google Patents

Abstract

(57) [Abstract] [PROBLEMS] To enable smooth perforation, to suppress clogging of a flow path in a biopsy needle assembly due to the sample when aspirating the sample, and to appropriately hold the sample when the needle is pulled out of the body. A biopsy needle assembly to be obtained and a method of using the same. A biopsy needle assembly includes a needle (10) with a lumen (11) extending from its proximal end (26) to a tip (12) and a handle (16) with a bore (17) connected to the proximal end (26) of the needle (10). The proximal end 34 of the handle bore is provided with a conical portion 28 for receiving the aspirator valve 50,100. Valves 50 and 100 aid in the collection of tissue samples and are used when removing the biopsy needle assembly.
Hold the same sample in 11. Elastic plug 200 assists in holding the sample. The assembly further includes a stylet 14 sized for placement within the needle lumen 11 and for extending beyond the needle tip 12 for drilling.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates generally to medical devices. The present invention relates more particularly to an apparatus and method for taking a tissue sample in a patient. This device is commonly referred to as a biopsy needle. The device of the present invention is particularly effective in collecting bone marrow samples. However, the device can also be used to take tissue samples from muscle or organs.

[0002]

BACKGROUND OF THE INVENTION Devices for obtaining tissue samples in the body of a patient are generally known. For example, Jam Sidi (US Pat. No. 3,628,5
No. 24) discloses a biopsy needle assembly including a needle and a stylet. The biopsy needle according to this disclosure can be used to sample softer tissues such as liver, kidney, skin and muscle tissues. The biopsy needle may have a filed surface, or cutting edge. The filed surface is used to take biopsy samples of bone and bone marrow.

US Pat. No. 3, issued to Jam Sidi
The needle disclosed in 628,524 has an elongated and substantially cylindrical body having a lumen extending therethrough. In addition, the device has a stylet. The stylet is similar in shape and length to the needle and is also adapted for sliding into the needle.

When assembling the device to use it,
The stylet is inserted into the needle. The device includes a locking pin to hold the stylet in place. When fully inserted, the stylet tip and needle are arranged in a predetermined relationship to form a closed end surface, which is used to penetrate tissue or bone into the interior. .

Jamsidy further discloses that when the stylet is inserted and secured within the needle, the stylet exposes a tapered tip.
The tapered tip is arranged in a predetermined relationship with the tip cutting edge formed on the needle. The symmetrical closed end faces are then arranged substantially in a single plane. The needle is then inserted into the patient's body to the desired depth. Insertion of the device may require penetration into the bone. This penetration requires rotating the needle and stylet assembly about its longitudinal axis to effect perforation with a filed surface formed on the tip of the needle. .

When the tip of the needle reaches the tissue to be sampled, the stylet is withdrawn from the needle. The needle is then rotated again about its own axis extending in the lengthwise direction while pressing the needle forward. The movement of the needle causes a cutting action on the tissue, allowing the sample to be collected inside the needle. After the sample is collected, the needle is removed outside the patient's body.

Jam Sidi (US Pat. No. 3,598,1
08) discloses a biopsy device similar to the device described above. However, it further discloses that the stylet is first removed and the biopsy sample is collected in a separate sleeve member inserted inside the needle. The needle is left in place after the sample is taken. As a result, a heat transfer means such as a microcauter or a cryoprobe can be inserted inside the needle. These devices are used to reduce or prevent bleeding.

In US Pat. No. 4,163,446, Jamsidy discloses a pad for use with a bone marrow biopsy needle. The pad is attachable to the proximal end of the needle to provide an enlarged surface for pressure distribution across the user's palm. The device includes a generally disc-shaped palm engaging surface along the sleeve-covering needle for effecting a removable attachment to the biopsy needle.

Finally, Jam Sidi (US Pat.
30, 192) discloses a biopsy needle with a sheath, which is particularly suitable for taking biopsy samples from specific floating organs. The sheath disclosed by Jamshidi prevents accidental damage to free-floating organs that can cause unwanted blood flow or other complications.

In use of all these prior art devices, if a tissue sample is collected within the lumen of a biopsy needle, the needle must be withdrawn while the sample is retained within the lumen. However, nothing is disclosed that ensures retention of the sample within the needle lumen upon withdrawal of the needle. Thus, in use, problems arise when some of the tissue sample or fluid collected inside the needle is allowed to leak into the passageway formed by the incision. The problem is big 2
One of them is that the size of the analytical sample is reduced due to the loss of the sample. A second problem is that it is not desirable to leave the tissue sample in the patient's body at a location spaced from the source of the tissue sample.

Accordingly, there is a need for devices or biopsy needles for taking tissue samples and methods of use that prevent loss of tissue or fluid samples during needle withdrawal. These devices and methods need to include a device that prevents accidental loss of some of the sample during removal of the biopsy needle assembly. Further, these features require a simple design to prevent a significant increase in the overall cost of the biopsy needle assembly and procedure.

The present invention has been made in view of the above-mentioned circumstances, and an object thereof is to enable smooth perforation and to suppress the blockage of the flow path in the biopsy needle assembly due to the sample when the sample is sucked. The present invention provides a biopsy needle assembly that can appropriately hold a sample when the needle is pulled out of the body, and a method of using the biopsy needle assembly.

[0013]

SUMMARY OF THE INVENTION The present invention is directed to a device for taking a tissue or fluid sample from the body of a patient, which device will be referred to hereinafter as a biopsy needle assembly. The present invention can be packaged as a kit including all parts necessary for collecting a tissue sample. The present invention includes methods of using the devices of the present invention used to collect biopsy fluid samples or biopsy tissue samples. The biopsy needle assembly is designed to include features that prevent the loss of a portion of the tissue or fluid sample when the sample is withdrawn into the needle lumen and the biopsy needle is then removed from the incision track. ing. That is, the biopsy needle assembly includes at its proximal end a tapered section forming a generally conical surface, which section is in communication with the needle lumen. The aspirator valve is sealingly insertable within a tapered section to provide suction, which suction and assists in the collection and retention of at least one of the tissue and fluid samples.

The biopsy needle assembly of the present invention may include a tapered elastic plug or a plug made of a polymeric material for insertion into a tapered section at the proximal end of the biopsy needle assembly. It fits. In this embodiment, the sample can be aspirated into the needle lumen by using an aspirator valve. The aspirator valve can then be removed and the aspirator valve replaced with a tapered plug. The tapered plug holds the sample properly as the needle is withdrawn from the tissue.

In another preferred embodiment, means are provided for preventing occlusion at the proximal end of the needle lumen or into the aspirator valve. The means for preventing needle occlusion may include a transition region located near the tip of the aspirator valve. The transition region is divided into at least two lumens, the radial center of which is not coincident with the radial center of the needle lumen. Placing a surface in the flow channel that can redirect the flow and even prevent the migration of tissue into the aspirator valve region, with which the needle lumen terminates at the proximal end of the aspirator valve. This reduces possible tissue obstruction from the lumen to the aspirator valve.

The biopsy needle assembly of the present invention includes a needle having a distal end, a proximal end and a lumen, the lumen extending from the distal end to the proximal end. The needle is preferably substantially cylindrical and is preferably made of metal.

Further, the biopsy needle assembly of the present invention includes a handle having a distal end, a proximal end and a bore, the bore extending from the distal end to the proximal end. The proximal end of the needle lumen is in communication with and secured to the distal end of the handle bore. The proximal end of the handle bore has a tapered section. The tapered section forms a substantially conical surface with a gradual increase in diameter from a point located distal to the proximal end of the handle to the proximal end of the handle.
The conical surface is used to hermetically house an aspirator valve or plug, as described in more detail below.

Further, the biopsy needle assembly has a stylet, the stylet having a distal end, a proximal end and a lumen.
The lumen extends from the distal end to the proximal end. The stylet is an elongated cylindrical body having a substantially cylindrical shape. The tip of the stylet has a cutting edge formed on the tip.
The cutting edge may be a beveled surface formed by machining. The cutting edge is concave and may be beveled with respect to the lumen of the stylet. The stylet is sized for removable placement within the bore of the handle and the lumen of the needle. The tip of the stylet extends beyond the tip of the needle in the fully inserted position (hereinafter, referred to as the mounting completion position), thereby exposing the cutting edge.

Further, the biopsy needle assembly includes means for preventing rotation of the stylet relative to the needle when the stylet is in the fully loaded position. The biopsy needle assembly also has means for removably fixing the stylet at the attachment completion position.

The handle of the biopsy needle of the present invention may have a cross member arranged in a direction substantially orthogonal to the length of the bore of the handle. A cross member can be disposed intermediate the distal and proximal ends of the handle to provide a structure for gripping the assembly for insertion into the patient's body and for rotating the assembly.

Further, the stylet may include a knob. The knob has a distal end and a proximal end, the distal end being fixed relative to the proximal end of the stylet. Means may be incorporated into the knob to prevent rotation of the stylet with respect to the needle. As a result, the locating projections can extend from the knob toward the tip near the surface of the stylet. The locating slot may be located within the bore of the handle to accommodate the locating boss when the stylet is in the fully loaded position. This prevents rotation of the stylet relative to the needle during insertion into the patient's body.

The means for releasably fixing the stylet in the completely mounted position may include any conventional means.
This means may include a threaded connection or may include a combination of a male luer fitting and a female luer fitting. For example, the male luer fitting may be positioned concentric with the handle bore and may extend distally from the proximal end of the handle. A female luer fitting may further be provided, the female luer fitting being concentric with the stylet and extending distally from the midpoint of the knob. The female luer fitting cooperates with the male luer fitting to removably secure the stylet in the fully installed position.

The kit according to the invention for taking a tissue sample may comprise an aspirator valve. The aspirator valve has a conical taper tip that approximates the conical surface of the handle bore and tapers in diameter. In use, the aspirator valve provides suction during tissue or fluid sample collection, and also within the conical portion of the bore to help retain the sample within the needle lumen during needle removal. It is placed with a tight seal. Alternatively or additionally, a kit according to the invention for taking a tissue sample may have an elastic plug with a conical taper approximating the conical surface of the handle bore. After taking the sample inside the needle, a plug can be inserted into the bore of the handle to help hold the sample.

A method of obtaining a tissue sample in the body using the apparatus, assembly or kit described above may include providing the biopsy needle assembly described above. The stylet is then positioned within the lumen of the needle in the fully loaded position.
Then, the biopsy needle assembly is inserted into a desired position in the patient's body with the stylet placed in the complete mounting position. The cutting edge is used to help reach the desired insertion depth. The stylet is then removed.

An aspirator valve having an internal volume is compressed to a compressed state to expel a portion of the internal volume.
The aspirator valve is then hermetically disposed within the conical portion of the handle bore. The pressure applied to compress the valve is released to provide a suction force that draws tissue and fluid into the lumen of the needle. The device is removed with the aspirator valve in a sealed arrangement. This holds the sample in the lumen of the needle. Alternatively, the aspirator valve may be removed and the aspirator valve replaced with an elastic plug prior to removal of the device. Thereby, the sample is held when the needle is pulled out.

[0026]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described in detail below. However, the embodiments disclosed below merely exemplify the present invention that can be implemented in various forms. Therefore, the specific detailed description disclosed herein is not intended to limit the invention, but rather as the basis for the claims, and as a basis for disclosing one technique in the art for implementing the invention in various ways. Should be understood.

FIG. 1 is a side view of biopsy needle assembly 9 and stylet 14 fully inserted within biopsy needle assembly 9. 2 to 4 are partially enlarged views of the biopsy needle assembly 9 of FIG. 1, each showing detailed features of the present invention. FIG. 2 is a partially enlarged longitudinal sectional view of the proximal end of the biopsy needle assembly 9 with the stylet 14 fully inserted. 3 shows needle 1
The stylet 14 is shown separated from zero. FIG. 4 shows the needle 10 with the stylet 14 removed.

The biopsy needle assembly 9 according to the present invention has a needle 10. The needle 10 has a distal end 12, a proximal end 26 and a lumen 11.
And the lumen 11 extends from the distal end 12 to the proximal end 26. Needle 10 is an elongated, generally cylindrical member having a generally cylindrical lumen extending therethrough. The needle 10 is preferably made of metal. The tip 12 of the needle 10 is preferably tapered with respect to the longitudinal axis of the needle 10 to cooperate with the cutting edge of the stylet 14 in use as described in detail below.

The biopsy needle assembly 9 has a handle 16 having a distal end 32, a proximal end 34 and a bore 17, the bore 17
Extends from the distal end 32 to the proximal end 34. The proximal end 26 of the lumen 11 of the needle 10 is in communication with and fixed to the distal end 32 of the bore 17 of the handle 16. Any of the conventional means can be used to secure the needle 10 to the handle 16. Examples of this means include the use of adhesive or threaded connections.
Further, this means is shown in FIG.
It may include molding a handle 16 around the circumference of 9. Any of the conventional molding techniques such as injection molding can be used.

The proximal end 34 of the bore 17 of the handle 16 includes a tapered section 28. The tapered section 28 forms a generally conical inner surface of increasing diameter from a point spaced from the proximal end 34 of the handle 16 to the proximal end 34 of the handle 16. This conical inner surface is designed to hermetically house the aspirator valve 50 shown in FIG. Tip 15
And a stylet 14 having a proximal end 42 are included in the biopsy needle assembly 9 of the present invention. The tip 15 has a cutting edge formed on the tip 15. The tip 15 may be machined with a taper to the longitudinal axis of the stylet 14 to form a distally extending cutting edge.
The stylet 14 includes the bore 17 of the handle 16 and the needle 10.
It is formed in such a size that it can be removably inserted into the inner cavity 11. As shown in FIG. 1, when the stylet 14 is located at the mounting completion position, the tip 15 of the stylet 14 extends beyond the tip 12 of the needle 10. This exposes the cutting edge. As mentioned above, the cutting edge and the tip of the needle are shaped to provide a continuous closed surface. This provides a suitable cutting surface and facilitates insertion of the biopsy needle assembly insert 9 into the patient's body.

The biopsy needle assembly 9 is rotatable when inserted into the patient's body to facilitate the cutting action, particularly for cutting through bone. It is possible to provide means for preventing rotation of the stylet 14 relative to the needle 10 during cutting. Further, a means may be provided to secure the stylet 14 in the fully mounted position.

For ease of operation, the handle 16 may include a cross member 18 which extends midway between the distal end 32 and the proximal end 34 of the handle 16 to the length of the bore 17 of the handle 16. They are arranged so as to be substantially orthogonal to each other. The cross member 18 assists in orienting the biopsy needle assembly 9 and provides a means for gripping and rotating the device during use.

The biopsy needle assembly 9 may include a knob 20. Knob 20 has a proximal end 40 and a distal end 38. Knob 20
May be secured to the proximal end 42 of the stylet 14. Means for removably fixing the stylet 14 to the mounting completion position and means for preventing rotation of the stylet 14 with respect to the needle 10 at the mounting completion position can be incorporated in the knob 20.

In the preferred embodiment, the means for preventing rotation of the stylet 14 relative to the needle 10 when the stylet 14 is in the fully loaded position may include a locating protrusion 44. The positioning protrusion 44 extends from the tip 38 of the knob 20 toward the tip direction in the vicinity of the cylindrical surface of the stylet 14. Positioning slot 36 is positionable within bore 17 of handle 16 to accommodate positioning projection 44 when stylet 14 is positioned in the fully mounted position. This causes the locating protrusion 44 and the slot 36 to cooperate with each other to prevent rotation of the stylet 14 with respect to the needle 10.

As previously mentioned, any conventional means such as threaded connections or caps can be used to secure the stylet to the needle in the completed position. In a preferred embodiment, the means for securing the stylet 14 in the fully installed position may include male luer fittings and corresponding female luer fittings that cooperate with each other to secure the stylet.

The male luer fitting 30 can be mounted concentrically with the bore 17 of the handle 16 and can extend from the proximal end 34 of the handle 16 in the distal direction. The female luer fitting 46 is concentrically attachable to the stylet 14.
Further, the female luer fitting 46 is used when the stylet 1 is used.
Luer fittings 30, 46 may extend distally from the midpoint of the knob 20 with which the lure fittings 30, 46 cooperate to releasably secure 4 to the fully mounted position.

In a preferred embodiment, the biopsy needle assembly 9 can be incorporated into a kit, as described above, which kit can include the necessary components for performing the desired tissue sampling. As mentioned above, the kit may include a biopsy needle assembly. The kit includes an aspirator valve 50 shown in FIG. 5, a non-plugging aspirator bulb 100 shown in FIG. 7, and FIG.
At least one of the elastic plugs for holding a sample shown in FIG.

The aspirator valve 50 has a tip 56 which has a conical taper 52 which approximates the conical surface of the bore 17 and which gradually decreases in diameter. The aspirator valve 50 shown in FIG. 6 provides a suction force at the time of collecting a tissue sample, and also supplies the tissue sample with the needle 10.
Is hermetically disposed within the conical portion of bore 17 for retention within lumen 11. While the design of the aspirator valve 50 can be modified, the aspirator valve 50 needs to have an internal volume 54. The internal volume 54 can be emptied when the aspirator valve 50 is compressed. Further, the aspirator valve 50 has a duct 60 communicating with the internal volume 54 and the tip 56 of the aspirator valve 50.

A preferred design of the anti-occlusion aspirator valve 100 is shown in FIGS. 7 and 8.
The blockage prevention type aspirator valve 100 is a handle 1.
It is inserted in the proximal end 34 of 6 and is sealingly engaged with the conical surface of the bore 17. In this embodiment, the aspirator valve 100 has a duct 60 tissue.
It is designed to enter and prevent the tissue from blocking the duct 60. The duct 60 is an aspirator
It communicates with the internal volume 54 of the valve 100 and the tip 103 of the aspirator valve 100. As shown in FIG. 6, the duct 60 has a flow path that is linearly aligned with the lumen 11 of the needle, and is further occluded by tissue when the sample is aspirated using the aspirator valve 50. It has been confirmed that it can cause.

The anti-occlusion aspirator valve 100 has a transition region or section 105 near its tip 103. The transition region 105 provides communication between the proximal end 26 of the needle 10 and the interior volume 54 of the aspirator valve 100. The transition region 105 preferably has two ducts 60. The ducts 60 each have a flow path, and the tip 1 of the aspirator valve 100 is
When 03 is hermetically inserted into the conical taper 17 of the handle 16, the flow path of the duct 60 is the needle 1
It is not linearly aligned with the 0 lumen 11.

As shown in FIGS. 7 and 8, the duct 60 has first and second channels 107.
And the second channel 107 extends parallel to the conical taper of the bore 17. At the midpoint of the transition region 105, the channel 107 is offset from parallel to the conical taper of the bore 17. Furthermore,
Channel 107 is in communication with central bore 110. The central bore 110 is in communication with the internal volume 54 of the aspirator valve 100. With this design, the lumen 11 of the needle 10 and the aspirator valve 10
The flow paths between the zero interior volumes 54 are offset within the transition region 105, further preventing blockage.
A small piece of tissue may occlude the duct 60 with a flow path that is linear with respect to the lumen 11 of the needle 10.
The surface 110 located at the tip of 05 is placed directly in the channel to assist in holding small pieces of the same tissue.

FIG. 9 shows another embodiment of the biopsy needle assembly 9 of the present invention. In this embodiment, the elastic plug 200 is included in the kit. Elastic plug 200
Has a conical tip section 202, which can be hermetically received within the conical tapered section 17 of the handle 16. The elastic plug 200 can be used in the preferred method of the present invention. At this time, after collecting the tissue sample or the fluid sample in the lumen 11, the aspirator valve 54 or 100 is removed to assist in holding the sample in the lumen, and the aspirator valve 54 or 100 is removed.
Is replaced with the elastic plug 200. In a method that does not use an aspirator valve, the elastic plug 200 can be used to help hold the sample as the needle is withdrawn from the tissue.

The method of using the biopsy needle assembly or kit described above may initially include providing the same.
The biopsy needle assembly 9 is inserted into a desired position in the patient's body in a state where the stylet 14 is placed in the mounting completion position. At this time, the cutting edge at the tip of the stylet 14 is used to facilitate reaching the desired insertion depth. The stylet 14 is then removed. Then the needle 10
May be inserted deeper to force tissue into lumen 11.

In using an aspirator valve 50 or 100 having an internal volume 54, the aspirator valve
Valve 50 or 100 is compressed to drain a portion of interior volume 54. The aspirator valve 50 or 100 is then sealingly placed within the conical portion 28 of the bore of the handle 17. The aspirator valve 50 or 100 is then released from the compressed state to provide a suction force that facilitates the suction of the sample into the lumen 11 of the needle 10. After the sample is collected, biopsy needle assembly 9 can be withdrawn from the incision site. At this time, the aspirator valve 50 or 100 is maintained in a hermetically sealed position so as to assist in holding the sample in the lumen 11 of the needle 10.

Alternatively, the aspirator valve 50 or 100 may be removed and the aspirator valve 50 or 100 replaced with the elastic plug 200 prior to withdrawing the biopsy needle assembly 9. Then the needle is the elastic plug 2
With 00, it is extracted from the incision site. At this time, needle 1
The sealed arrangement of the elastic plug 200 is maintained to assist in retaining the sample within the 0 lumen 11.

Cutting Edge of Stylet 14 and Needle 10
Another embodiment of the tip of is shown in Figures 10 (a) -12. These alternative embodiments provide a more effective cutting tool, more strength and reduced tissue replacement.
ue replacement).

As shown in FIG. 10 (b), an inclined surface 62 with an angle lambda with respect to the axis extending in the longitudinal direction of the needle 10.
Completely surrounds the tip 12 of the needle 10.
The beveled surface 62 provides a wedge-shaped insertion edge that is penetrated into the body with minimal force and minimal tissue replacement.
The use of the beveled surface 62 to provide a smaller edge provides a more robust edge than that formed by the conventional practice of needle tip polishing. Polishing the tip of the needle makes the tip of the needle thin and weak. This will tend to bend or break the tip of the needle.
The use of bevels provides a more robust edge.

FIG. 10A shows the slope 62. However, the tip surface of the needle 10 is inclined with an angle phi. This further reduces the force required for penetration, so that when the needle is pressed into the body, not all cross sections of the needle are inserted into the body at the same time.

The tip of the stylet 14 may be inclined with respect to the longitudinal axis of the stylet 14.
FIG. 12 shows said tilt with angle theta with respect to the longitudinal axis of the stylet 14. A preferred shape of the tip surface 13 of the stylet 14 is a spoon shape. That is, the tip surface 13 of the stylet 14 is concave with respect to two mutually orthogonal axes of the tip surface. The first of the mutually orthogonal axes forms an acute angle with the axis extending in the longitudinal direction of the stylet, and the second axis
The axis of is orthogonal to the first axis.

The spoon shape of the tip surface 13 is shown in FIG. The edge of the tip surface 13 is sharply formed to improve the cutting action. This spoon shape has the effect of gripping the hard, smooth surface of the outside of the bone. This prevents slippage during the cutting process and provides a better drilling effect into the bone cortex. These functions are enhanced by the sharp edges on the tip surface.

The new features and advantages covered by this specification are disclosed in the above description. However, this disclosure is, in many respects, merely exemplary. Changes may be made in details, particularly in matters of shape, size, arrangement of parts, etc. without exceeding the scope of the invention. Of course, the scope of the invention is limited by the description set out in the claims of the invention.

[0052]

As described in detail above, according to the present invention,
It is possible to perform smooth perforation, and it is possible to suppress the blockage of the flow path in the biopsy needle assembly due to the sample at the time of aspirating the sample, and it is possible to appropriately hold the sample when the needle is pulled out of the body.

[Brief description of drawings]

FIG. 1 is a side view of a biopsy needle assembly with a fully inserted stylet.

FIG. 2 is a partially enlarged vertical sectional view of a proximal end portion of the biopsy needle assembly shown in FIG.

FIG. 3 is a partially enlarged vertical sectional view of a base end portion of a stylet to which a knob assembly is attached.

FIG. 4 is a partially enlarged vertical sectional view of a needle and a handle with a stylet removed.

FIG. 5 is a partially enlarged vertical sectional view of an aspirator valve.

FIG. 6 is a partially enlarged vertical sectional view of an aspirator valve inserted in a handle.

FIG. 7 is a partially enlarged vertical sectional view of a transition region of an aspirator valve.

8 is a cross-sectional view taken along line 8-8 of FIG.

FIG. 9 is a partially enlarged vertical sectional view of the elastic plug inserted into the handle.

FIG. 10A is a vertical cross-sectional view of a needle. (B) is a partially enlarged vertical sectional view of the tip of the needle.

FIG. 11 is a side view of the stylet.

FIG. 12 is a partially enlarged side view of the tip portion of the stylet.

[Explanation of symbols]

10 ... Needle, 11 ... Needle lumen, 12 ... Needle tip, 13 ... Concave surface, 14 ... Stylet, 15 ... Stylet tip,
16 ... Handle, 17 ... Bore of handle, 20 ... Means for closing lumen at proximal end of needle, 26 ... Proximal end of needle, 28
... a tapered section that is a conical part, 30,
46 ... Means for fixing stylet, 32 ... Tip of handle, 34 ... Base end of handle, 36, 44 ... Means for preventing rotation of stylet, 42 ... Base end of stylet,
50, 100 ... Aspirator valve, 54 ... Internal volume, 200 ... Elastic plug.

Claims (5)

[Claims] 1. A method for collecting a tissue sample from the body of a patient, comprising the steps of: (a) providing a biopsy needle assembly, wherein the biopsy needle assembly comprises (I) a tip (12) and a proximal end ( 26) and lumen (1
1) with a needle (10), the lumen (11) extending from the distal end (12) to the proximal end (26);
(II) a handle (16) having a distal end (32), a proximal end (34) and a bore (17), the bore (17) extending from the distal end (32) to the proximal end (34), ), The proximal end (26) of the lumen (11) communicates with and is fixed to the distal end (32) of the bore (17) of the handle (16), and the proximal end of the bore (17) of the handle (16). (34) has a tapered section (28), said tapered section (28) being the base of the handle (16) for hermetically housing the aspirator valve (50, 100). Forming a substantially conical surface whose diameter gradually increases from a point located on the tip side of the end (34) to the base end (34) of the handle (16), and (III) an inclined tip A stylet (14) with (15), Tip (15) comprises a concave surface (13) which is located approximately in the middle of the tip, wherein the concave surface (1
3) is concave with respect to two mutually orthogonal axes, and one of the two mutually orthogonal axes forms an acute angle with respect to an axis extending in the longitudinal direction of the stylet (14), and the concave surface ( 13) has sharp edges and the stylet (14) has a bore (17) in the handle (16) and a needle (1).
0) has a dimension such that it can be removably inserted into the lumen (11) of the needle (10), and the tip (15) of the stylet (14) holds the tip (12) of the needle (10) when the needle (10) is placed in the completed position. Extending over, thereby exposing the cutting edge;
(IV) A means (36, 44) for preventing the stylet (14) from rotating with respect to the needle (10) when the stylet (14) is placed at the mounting completion position, and a (V) stylet (14). And (b) positioning the stylet (14) at the mounting completion position, and (c) reaching a desired insertion depth. Stylet (1
4) inserting the biopsy needle assembly to a desired position in the patient's body using the cutting edge of the tip (15), (d) extracting the stylet (14), and (e) internal volume ( 54) providing an aspirator valve (50, 100), the aspirator valve (50, 100) having a conical shape that approximates the conical surface of the bore (17) and has a gradually decreasing diameter. Having a tapered tip, (f) compressing the aspirator valve (50, 100) to a compressed state to expel a portion of the internal volume (54), (g) the handle (16) Conical portion of bore (17) (2
8) aspirator valve (50, 100) is hermetically positioned within the aspirator valve (50) from the compressed state to provide a suction force to aspirate the sample into the lumen (11) of the needle (10). 50, 100) opening, and (h) maintaining the aspirator valve (50, 100) in a sealed arrangement to hold the sample in the lumen (11) of the needle (10). , Withdrawing the needle (10). 2. An aspirator valve (50,100)
After releasing the aspirator valve from the compressed state, the aspirator valve (50, 100) is removed, and then the elastic plug (20
0) to the conical portion (2) of the bore (17) of the handle (16)
8. The method of obtaining a tissue sample of claim 1, further comprising the step of hermetically positioning within 8). 3. A biopsy needle assembly, comprising: (a) an elongated needle element (1) forming a lumen (11).
0), the lumen (11) extends from the proximal end (26) to the distal end (12) of the needle element (10), (b) an elongated stylet element (14), and the stylet. The element (14) has its own proximal end (4
2) extending from the tip to the tip (15) and removably disposed within the lumen (11) of the needle (10), the tip (15) of the stylet element (14) has an inclined concave surface (13).
And (c) is attached to the stylet element (14) housed within the lumen (11) and during insertion of the biopsy needle assembly into the patient's body. Means (2) for closing the lumen (11) at the proximal end (26) of the needle element (10)
0) and (d) the proximal end of the needle element (10) when the stylet element (14) is withdrawn from the lumen (11) after inserting the biopsy needle assembly into the patient. (26)
Means (50, for applying suction force to the lumen (11) in
100) and a biopsy needle assembly having. 4. A means (50, 10) for applying the suction force.
0) comprises an aspirator valve (50,100) having a tapered nipple insertable into the lumen (11) at the proximal end (26) of the needle element (10). The biopsy needle assembly described in. 5. The aspirator valve (50, 10)
0) seals the lumen (11) at the proximal end (26) of the needle element (10) when the tapered nipple is inserted into the lumen (11). The biopsy needle assembly described in.