WO1993015683A1 - Targeting guidance device for localization needle assemblies - Google Patents

Targeting guidance device for localization needle assemblies Download PDF

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Publication number
WO1993015683A1
WO1993015683A1 PCT/US1992/001037 US9201037W WO9315683A1 WO 1993015683 A1 WO1993015683 A1 WO 1993015683A1 US 9201037 W US9201037 W US 9201037W WO 9315683 A1 WO9315683 A1 WO 9315683A1
Authority
WO
WIPO (PCT)
Prior art keywords
localization needle
needle assembly
cannula
hairs
cross
Prior art date
Application number
PCT/US1992/001037
Other languages
French (fr)
Inventor
Daniel B. Kopans
Original Assignee
Medical Device Technologies, Inc.
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 Medical Device Technologies, Inc. filed Critical Medical Device Technologies, Inc.
Priority to PCT/US1992/001037 priority Critical patent/WO1993015683A1/en
Publication of WO1993015683A1 publication Critical patent/WO1993015683A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3908Soft tissue, e.g. breast tissue

Abstract

A targeting device (40) for use with a localization needle (32) in pinpointing lesions within body tissue which have been identified by an X-ray beam imaging procedure wherein an X-ray beam is directed onto the body tissue to facilitate identification and location of a lesion, the targeting device (40) including a mounting portion (44) adapted for mounting the targeting device on a cannula (31) near its proximal end (31a), and a display portion having a substantially flat surface portion (42) positioned such that the image of cross-hairs (26) being produced by the X-ray apparatus are projected onto the display portion (42) when the cannula axis is oriented and aligned with the axis (12) of the X-ray beam.

Description

TARGETING GUIDANCE DEVICE FOR LOCALIZATION NEEDLE ASSEMBLIES Background of the Invention

The present invention relates to localization procedures for pinpointing lesions or tumors within a human or veterinary body, and more particularly to a targeting guidance device for localization needle assemblies used in such procedures.

Accurate pre-operative localization of lesions is important to insure precise removal of the suspected area without also removing large quantities of normal tissue. Standard pre-operative procedures include X-ray imaging to identify and locate a lesion or area to be treated and then introducing a localization needle assembly based on the lesion location by the X-ray film. Commonly, the "cross¬ hairs," common in all forms of X-ray imaging, targeting and treatment, identify on the surface of the body, the lesion or area to be imaged or treated on the central axis of the X-ray beam. The developed X-ray films identify for the radiologist the location within the body of the diseased area situated among the healthy tissue of the patient's body.

The need for targeting guidance devices is critical in localization procedures and, particularly, breast localization procedures. The breast is a complex structure of glands, ducts, fibrous tissue and fat. Because of the complex structure of the breast, abnormal tissues may be difficult to identify and to locate during surgery. Because abnormal tissue produces distinctive features on an X-ray film for both palpable and non-palpable lesions, the location of the lesion is usually targeted using an X-Y axis grid plate having alphanumeric symbols.

Also, in the past, radiopaque spots have been used as skin surface locators of deep lying lesions. After the X-ray imaging has been carried out to identify the location of the lesion, a radiopaque spot is applied to the patient's skin surface at a point overlying the lesion located within the body. When the location of the lesion has bee targeted using X-ray imaging, the radiologist performs a localization procedure using any one of several commercially available localization needle assemblies, including a hollo cannula and a guide wire extending within the cannula. Using the X-ray machine "cross-hairs" or radiopaque spots as a guide, the radiologist inserts the localization needle assembly at the predetermined X-Y axis based on the lesion location on the film. The object is to insert the localization needle assembly through the identified lesion to pinpoint the location of the abnormality or lesion for the surgeon. When the localization needle assembly has been positioned in the tissue, an X-ray is taken to confirm the position of the localization needle assembly in the lesion. When the localization needle assembly is targeted correctly, the needle is anchored with the barbed guide wire and the hollow cannula is then removed. The guide wire acts as a guide for the surgeon who will then perform a surgical biopsy or removal of the lesion.

In order for the localization needle assembly to pass through the lesion on the first pass, the localization needle assembly must be inserted and advanced into the patient's body at the location indicated by the "cross¬ hairs." However, oftentimes the radiologist will place the distal tip of the localization needle assembly at the intersection of the X-ray beam cross-hairs on the surface of the body with the localization needle assembly inclined at an incorrect angle relative to the axis of the X-ray beam. Consequently, when the localization needle assembly is advanced to the target area, the tip of the localization needle assembly misses the lesion. This results in a need to reposition the localization needle assembly to precisely target the patient's lesion. An X-ray must be taken to confirm the location of the localization needle assembly each time it is repositioned. Repositioning of the localization needle assembly is uncomfortable for the patient, time-consuming for the radiologist and increases the expense of the procedure because repositioning of the localization needle assembly requires additional X-rays to confirm the location and position of the localization needle assembly.

Summary of the Invention

It is an object of the present invention to provide a novel targeting guidance device for use with localization needle assemblies to provide precise needle localization of an abnormality or suspect lesion on the first insertion attempt.

Another object of present invention is to provide a targeting guidance device for use with localization needle assemblies which is simple in construction and easy to use.

A further object of the invention is to provide a novel method for positioning a localization needle assembly for pinpointing the precise location of an abnormality or lesion within a human body.

These and other objects are achieved by the present invention which provides a localization needle assembly for use in pinpointing lesions within body tissue. The lesions have been identified by an X-ray imaging procedure wherein an X-ray apparatus directs an X-ray beam onto the body tissue to facilitate identification and location of the lesion. The centering light of the X-ray apparatus is aligned with the X-ray beam. The X-ray apparatus projects the image of the lesion onto the surface of a film or detector. The cross-hairs are aligned with the coordinates of the lesion and the centering light projects these onto the surface of the body to align it with the axis of the X-ray beam. The localization needle assembly comprises a localization needle including an elongated hollow cannula having a proximal end and a distal end. A targeting means is comprised of an engaging portion and a display portion. In one embodiment of the present invention, the engaging portion is adapted for mounting or attaching the targeting means to the cannula at or near its proximal end. In another embodiment, the engaging means is integral with the cannula. The display portion of the targeting means is positioned such that the image of cross¬ hairs produced by the centering light of the X-ray apparatus is projected onto the display portion when the cannula axis is oriented and aligned with the axis of the X-ray beam. When the axis of the cannula is aligned with the axis of the centering light and, hence, the X-ray beam, the cannula is pushed into the body tissue until the distal tip of the cannula penetrates the suspected lesion. By placing the tip of the needle on the projection of the cross-hairs on the skin and then aligning the needle such that the cross-hairs are centered on the targeted device, the needle will be properly aligned with the axis of the X-ray beam.

The invention consists of certain novel features and structural details hereinafter fully described, illustrated in the accompanying drawings, and particularly pointed out in the appended claims, it being understood that various changes in the details may be made without departing from the spirit, or sacrificing any of the advantages of the present invention.

Description of the Drawings

For the purpose of facilitating and understanding the invention, there is illustrated in the accompanying drawings a preferred embodiment thereof, from an inspection of which, when considered in connection with the following description, the invention, its construction and operation, and many of its advantages will be readily understood and appreciated.

FIG. 1 is a simplified representation of an X-ray imaging apparatus illustrated in an application for detecting a lesion or tumor in body tissue;

FIG. 2 is an enlarged view illustrating an X-Y axis grid plate overlying a portion of a body being imaged by the X-ray apparatus of FIG. 1, and illustrating the positioning of a localization needle assembly at the junction of the cross-hairs produced by the X-ray apparatus;

FIG. 3 is a view similar to FIG. 1 but illustrating a localization needle assembly positioned off- target; FIG. 4 is an enlarged view illustrating the location of the distal tip of the localization needle assembly relative to a lesion for the condition illustrated in FIG. 3;

FIG. 5 is a view similar to FIG. 1 and illustrating a localization needle assembly extending along the axis of the X-ray beam and with its distal tip located in the lesion in accordance with the present invention;

FIG. 6 is a view similar to FIG. 4 illustrating the distal tip of the localization needle assembly precisely located in the lesion in accordance with the present invention;

FIG. 7 is an elevational view of a targeting guidance device provided in accordance with the present invention;

FIG. 8 is a sectional view of a second embodiment of a targeting guidance device provided in accordance with the present invention;

FIG. 9 is a top plan view of the targeting guidance device shown in FIG. 7;

FIG. 10 is a bottom view of the targeting guidance device shown in FIG. 7;

FIG. 11 is an exploded elevational view of a localization needle assembly including a localization needle and one embodiment of a targeting guidance device provided by the present invention;

FIG. 12 is an assembled view of a localization needle assembly shown in FIG. 11;

FIG. 13 is a perspective view of a localization needle assembly including a targeting guidance device provided in accordance with the present invention and illustrating the cross-hairs of an X-ray apparatus depicted on the top surface of the targeting guidance device, thereby facilitating orientation of the axis of the localization needle assembly along the axis of the X-ray beam;

FIG. 14 is a sectional view of a further embodiment of a localization needle assembly including the targeting guidance device of FIG. 8; FIG. 15 is a sectional view of another embodiment of a localization needle assembly including the targeting guidance device of FIG. 8; and

FIG. 16 is a sectional view of another embodiment of a localization needle assembly including a targeting surface formed integrally with the cannula.

Description of a Preferred Embodiment

Referring to FIGS. 1 and 2, there is illustrated a simplified representation of an X-ray apparatus, indicated generally by reference numeral 10, for use in X-ray imaging and targeting of cancerous, nonpalpable lesions within a human or animal body or in any other medical procedure which requires the pinpointing of a lesion, foreign body or normal structure within body tissue or organ of a body. In the exemplary illustration, the X-ray apparatus 10 is assumed to direct an X-ray beam along an axis 12 toward a body mass 16 to pinpoint a lesion 18 by projecting an image of the lesion onto a film or a detector, as is known in the art. The body mass 16 is compressed between a pair of compression plates 20 and 22, as is known in the art. The X-ray apparatus includes a centering light which directs a beam of light along the same axis 12 during localization procedures. The centering light of the X-ray apparatus 10 produces a "cross¬ hair" image 26 which is projected onto the upper surface 17 of the body mass 16, as is known in the art, for indicating the location of the lesion within the body. A grid 24 is provided which includes alphanumeric symbols for enabling the radiologist to pinpoint a location and identify the pinpoint location by indicating X and Y coordinates relative to the axis of the X-ray beam and indicate the location of the lesion within the body. Although the exemplary embodiment refers to the use of X-ray imaging and use of the centering light beam of an X-ray apparatus in the lesion locating, identifying and localization procedures, it is apparent that laser beams, or other optical arrangements, can be used in such procedures.

The use of "cross-hairs" 26 is common in all forms of X-ray imaging, targeting and treatment. Their purpose is to line up the lesion or area 18 to be imaged o treated with the central axis 12 along which the X-ray bea was directed during the X-ray imaging procedure. This produces the best image or delivers maximum treatment to a specific diseased area while allowing healthy tissue to be properly shielded to protect the patient.

The need for targeting guidance devices is especially important in breast localization procedures. The breast is a complex structure of glands, ducts, fibrous tissue and fat. Because of this, abnormal tissues may be difficult to find during surgery. During the mammogram procedure, the patient's breast is compressed between a pair of compression plates 20 and 22 and an X-ray is taken by a radiologist. The resultant mammogram film is read and analyzed to detect the presence of abnormal tissue. Abnormal tissue produces distinctive features on a mammogram film for both palpable and non-palpable lesions. The location is usually targeted using an X-Y axis grid plate 24 with alphanumeric symbols. The lesion is also noted on the patient's breast questionnaire to aid in the location of the lesion in the breast, as is known in the art.

When the presence of a lesion has been detected and its location pinpointed, the radiologist performs the localization procedure using any one of several commercially available breast localization needle assemblies, including repositionable and non-repositionable localization needle assemblies. Examples of breast localization needle assemblies are disclosed in U.S. Patent 4,986,279 and U.S. patent application Serial No. 644,027, now co-pending.

Referring to FIGS. 2 and 12, in the exemplary embodiment, the localization needle assembly 30 includes a tubular outer cannula 31 having a proximal end 31a and a distal end 31b and a needle structure 32, shown in phantom in FIG. 12, which is adapted for sliding movement within the outer cannula 31. The cannula 31 has a hub 33 at its proximal end 31a which defines the proximal end 30a of the localization needle assembly. The needle structure 32 defines a retractable side barb (not shown) which, when deployed, projects outward through an aperture 34 in the outer cannula 31, near its distal end 31b, for anchoring the localization needle assembly 30 to body tissue. Distal end 31b defines the distal end 30b of the localization needle assembly. The barb is retracted within the outer cannula 31 during introduction of the needle guide assembly into the patient's body during localization procedures, and is deployed by withdrawing the wire structure by pulling on its proximal end for immobilizing the localization needle assembly 30 during mammography. The needle structure may have markings thereon, as is known in the art, to provide an indication to the user as to the location of the tip and barb relative to the tip and aperture of the cannula, as is known in the art. The markings enable the surgeon to know when the barb is retracted and when it is deployed.

Referring to FIGS. 2, 3 and 4, using the cross¬ hairs 26 being projected onto the surface 17 of body 16 by the centering light of the X-ray machine as a guide and the grid 24, the radiologist inserts the localization needle assembly 30 into the body at the predetermined X-Y axis based on the lesion location on the mammogram film. The object is to insert the localization needle assembly through the lesion. When the localization needle assembly 30 has been advanced to the target area, the guide wire 32 (FIG. 12) is retracted to deploy the barb and anchor the needle assembly to the lesion. Then, an X-ray is taken to determine if the distal end 30a of the localization needle assembly 30 is at or within the lesion. Once targeted correctly, the cannula 31 of localization needle assembly 30 is removed. The guide wire 32 acts as a guide for the surgeon during a surgical biopsy for removing the lesion.

Frequently, the distal end 30b of the localization needle assembly 30 is placed at the intersection of the cross-hairs projected onto the body with the needle extending at a slight angle relative to the axis 12 along which the X-ray beam was directed during the mammography procedure. This results in the localization needle assembly 30 missing the target or lesion 18. Consequently, the localization needle assembly must b repositioned in order to precisely target the patient' lesion. This not only is uncomfortable for the patient, bu also time-consuming for the medical facility and adds extra expense to the biopsy procedure because repositioning of th localization needle assembly requires additional X-ra analysis and assistance.

Referring to FIGS. 5 and 6, the localization needle assembly 30 is shown aligned along the axis 12 on which the centering light beam is being projected, and thus the exact same axis 12 on which the X-ray beam was directed, prior to advancing the localization needle assembly 30 into the body 16 to the target area or lesion 18. In order for the distal end 30b of the localization needle assembly 30 to pass through the lesion 18 on the first pass, the axis of the cannula 31 of the localization needle assembly must lie along the exact same axis 12 along which the centering light beam is directed during the localization procedure, and thus the axis along which the X-ray beam was directed during the mammography procedure. In accordance with the present invention, the localization needle assembly 30 includes a targeting guidance device 40 which is mounted on the cannula at or near its proximal end. The targeting guidance device 40 enables the radiologist to align the axis of the localization needle assembly 30 with the axis 12 of the X-ray beam using the centering light to insure precise needle localization of suspect lesions on the first insertion attempt.

Referring now to FIG. 7, the targeting means or guidance device 40 includes a flat, disc-like top portion 41 having an upper surface 42 and a lower surface 43. An extension 44 is formed integrally with the lower surface 43 and depends therefrom. The extension 44 is bevelled, decreasing in diameter outwardly in a direction away from the lower surface 43. The bevelled extension 44 is adapted to fit snugly in all commercially available localization needle assemblies. Referring to FIG. 8, in accordance with anothe embodiment, a targeting means or guidance device 46 include a cylindrical extension 44' which depends from the lowe surface 43 of the flat, disc-like top portion 41. Th targeting guidance device 46 is particularly suited for us with localization needle assemblies such as the localizatio needle assembly assemblies 50 and 60 illustrated in FIGS. 14 and 15, respectively, which include hubs having a generall cylindrical bore or well 54 and 64, respectively, at thei proximal end. The outer diameter of the extension portio 44 ' is slightly less than the inner diameter of the bore o the cannula hub with which it is used.

In FIGS. 7-12, the targeting guidance devices 40 and 46 each has a throughbore 47 extending along the cente axis of the device from its upper surface 42 to its lowe surface 43, and located to be coaxial with the axis of th cannula 31 when the device is mounted on the cannula. Th throughbore 47 enables the guide wire 22 to be advance through the cannula 31 while the targeting guidance devic 40 or 46 is mounted thereon. The upper surface 42 has countersunk portion 48 around the throughbore 47 t facilitate insertion of the distal end of the guide wir into the hollow cannula 31.

As shown in FIG. 14, the localization needl assembly 50 includes a cannula 51 and a hub 53 mounted o the proximal end 51a of the cannula 51. The hub 53 has a inner bore 54 which tapers inwardly from a flared mout portion 53a near its outer edge to a diameter correspondin approximately to the inner diameter of the cannula 51 at th proximal end 51a of cannula 51. The targeting guidanc device 46 is mounted on the hub 53 with its extension 44' extending within the flared mouth portion 53a of the hub 53 and with its lower surface 43 engaging the upper surface 53 of the flared mouth portion of the hub 53. The axis of th throughbore 47 is aligned with the axis of the cannula 51. A localization needle assembly having this configuration i commercially available from Medical Device Technologies, Inc. of Gainesville, Florida 32608 Referring to FIG. 15, the localization needl assembly 60 includes a cannula 61 and a hub 63. The cannul 61 extends through the hub 63 with its proximal end 61 projecting outwardly from the flared mouth portion 63a of the hub 63. The hub 63 has a central bore 64 which has a generally cylindrical cross section over its extent. The extension 44' of the targeting guidance device 46 extends within the bore 64 of the hub 63 and the proximal end 61a of the cannula 61 extends within the throughbore 47, terminating at the innermost edge of the countersunk portion 48 of the throughbore 47 so that the countersunk portion defines a guide surface for directing the guide wire into the cannula 61. A localization needle assembly having this configuration is commercially available from Cook Inc. of Bloomington, Indiana 47401.

In FIG. 16, there is shown a further embodiment for a localization needle assembly 70 which includes a cannula 71 and a hub 73 mounted on the proximal end 71a of the cannula 71. In this embodiment, the targeting and guidance means 75 is formed integrally with the hub and comprises a substantially planar surface 77 having a peripheral portion 78 which is of a diameter greater than the diameter of the hubs 53 and 63 shown in FIGS. 14 and 15 to define a display surface for receiving the image of the cross-hairs produced by the centering light of the X-ray apparatus.

Referring to FIGS. 2, 5 and 13, during a localization procedure, the shadow of the cross-hairs 26 produced by the centering light of the X-ray apparatus 10 are depicted on the upper surface 42 of the targeting guidance device 40, providing a direct lineup of the assembly with the X-ray beam axis. This enables precise needle localization of suspect lesions on the first insertion attempt. Consequently, use of the targeting guidance device in localization procedures employing X-ray imaging reduces or eliminates the need to reposition the localization needle assembly. After a lesion within body tissue has been identified and located by an X-ray imaging procedure, the centering light of the X-ray apparatus 10 is used to project an image of cross-hairs 26 onto the surface 17 of the body 16 to align the lesion 18 with the axis 12 of the X-ray beam. Then, the localization needle assembly 30 with the targeting guidance device 40 mounted on the proximal end 30a thereof is used to pinpoint the lesion for the surgeon.

The radiologist positions the distal end 30b of the localization needle assembly 30 at the junction of the cross-hairs 26 being projected onto the surface of the body 16. Then, the proximal end 30a of the localization needle assembly is positioned so that the image of the cross-hairs 26 is projected onto the display portion of the targeting device 40 with the junction of the cross-hairs located at the center of the display portion 42 of the targeting device. Consequently, the axis of the localization needle assembly is oriented and aligned with the axis 12 of the X-ray beam axis so that when the localization needle assembly is advanced into the body, it will engage the lesion 18.

As shown in FIG. 13, the image of the cross¬ hairs 26 produced by the centering light of the X-ray apparatus 10 is projected onto the upper surface of the targeting guidance device 40 or 46 centered on the top surface 42 of the targeting guidance device. This provides a reference which enables the localization needle assembly axis to be aligned with X-ray beam axis to insure correct needle localization on the first insertion pass. The use of the targeting guidance device 40 or 46 enhances the correct placement of localization needle assemblies and subsequent anchoring of guide wires. This improves the accuracy of the localization procedure.

It is within the scope of the present invention that the target means include an upper display surface that is substantially perpendicular with respect to the cannula axis. This insures that the cross-hairs produced by the centering light of the X-ray apparatus are produced on a plane that is visible and readily observable by the radiologist using the apparatus. The display surface may be circular or any other geometric shape which will provide indication of the cross-hair alignment and registration from the centering light. Also, it is sufficient that the target means include a display portion and an attachment or engaging portion which will permit attachment or mounting to the proximal end of the cannula with which it is used. Moreover, the display portion of the target means may be formed integrally with the cannula. Also, the attachment or engaging portion can mount the target portion on the cannula in the hub portion thereof or can connect or attach the target portion to the cannula in other manners such as by connection to the cylindrical outer surface of the hub, by magnetic attachment when the hub is of metal, or by other securing means such as adhesive for example. Thus, the target means or guidance device provided by the present invention can be used with virtually all commercially available localization needle assemblies. In addition, the target means or guidance device can be used with localization needles having other types of guide wires than the side-barb equipped guide wire disclosed herein. For example, the localization needle may include a guide wire having a barb formed at its tip or a spring-hook lesion localizer, commonly referred to as a Kopans localizer needle, or a localizer needle having a spring hook which takes a "set," commonly referred to as a Homer MEMOLOCK type needle. The localization needles may be respositionable or non-repositionable.

Claims

Cla ims
1. A localization needle assembly for use in pinpointing lesions within body tissue which have been identified by an X-ray imaging procedure wherein an X-ray apparatus directs an X-ray beam along an axis onto the body tissue to facilitate identification and location of a lesion, the X-ray apparatus projecting an image of cross¬ hairs onto the surface of the body to align the lesion with said axis, said localization needle assembly comprising: a localization needle including an elongated hollow cannula having a proximal end and a distal end; and targeting means on said cannula near at least its proximal end, said targeting means including a display portion positioned such that the image of cross-hairs produced by the X-ray apparatus is projected onto said display portion when said cannula axis is oriented and aligned with said axis along which the X-ray beam was directed in identifying and locating the lesion.
2. A localization needle assembly according to claim 1 wherein said display portion has a substantially flat upper surface for receiving the image of cross-hairs produced by the X-ray apparatus.
3. A localization needle assembly according to claim 2 wherein said targeting means further comprises an engaging portion adapted for mounting said targeting means on said cannula, said engaging portion including an extension portion adapted to engage the proximal end of said cannula.
4. A localization needle assembly according to claim 3 wherein said cannula includes a hub at its proximal end, said hub having a cylindrical well, said extension portion being received by said well.
5. A localization needle assembly according to claim 3 wherein said extension portion is generally cylindrical in shape.
6. A localization needle assembly according to claim 3 wherein said extension portion is bevelled and decreases in diameter in a direction away from said display surface of said display portion to permit attachment to said proximal end of said cannula.
7. A localization needle assembly according to claim 2 wherein said targeting means has an aperture therethrough which is aligned with the axis of the hollow cannula, said localization needle further including a guide wire adapted to extend coaxially with said hollow cannula, said guide wire extending through said aperture in said targeting means and through said hollow cannula.
8. A localization needle assembly according to claim 7 wherein a portion of said upper surface adjacent to said aperture is countersunk for guiding said guide wire into said cannula.
9. A localization needle assembly for use in pinpointing lesions within body tissue which have been identified by an X-ray imaging procedure wherein an X-ray apparatus directs an X-ray beam along an axis onto the body tissue to facilitate identification and location of a lesion, the X-ray apparatus projecting an image of cross¬ hairs onto the surface of the body to align the lesion with said axis, said localization needle assembly comprising: a localization needle including an elongated hollow cannula having a proximal end and a distal end; and targeting means comprised of an engaging portion and a display portion, with said engaging portion being adapted for mounting said targeting means to said cannula near at least its- proximal end, with said display portion of said targeting means positioned such that the image of cross-hairs produced by the X-ray apparatus is projected onto said display portion when said cannula axis is oriented and aligned with said axis along which the X-ray beam was directed in identifying and locating the lesion.
10. A localization needle assembly according to claim 2 wherein said display portion has a substantially flat upper surface for receiving the image of cross-hairs produced by the X-ray apparatus.
11. A localization needle assembly according to claim 3 wherein said engaging portion includes an extension portion adapted to engage the proximal end of said cannula.
12. A localization needle assembly according to claim 4 wherein said cannula includes a hub at its proximal end, said hub having a cylindrical well, said extension portion being received by said well.
13. A localization needle assembly for use in pinpointing lesions within body tissue which have been identified by an X-ray imaging procedure wherein an X-ray apparatus directs an X-ray beam along an axis onto the body tissue to facilitate identification and location of a lesion, the X-ray apparatus projecting an image of cross¬ hairs onto the surface of the body to align the lesion with said axis, said localization needle assembly comprising: a localization needle including an elongated hollow cannula having a proximal end and a distal end; and targeting means comprised of an engaging portion and a display portion, with said engaging portion being adapted for mounting said targeting means to said cannula near at least its proximal end, whereby when the distal end of said cannula is positioned to engage the outer surface of the body at the junction of the cross-hairs being projected onto the surface of the body, and the proximal end of said cannula is then positioned so that the image of the cross¬ hairs is projected onto said display portion with the junction of the cross-hairs being located at the center of said display portion of said targeting means, the axis of said cannula is oriented and aligned with said axis along which the X-ray beam was directed in identifying and locating the lesion.
14. A localization needle assembly according to claim 13, wherein said display portion includes a portion having a substantially flat upper surface and wherein said engaging portion includes an extension portion adapted to engage the proximal end of said cannula.
15. A targeting means for use with a localization needle assembly for pinpointing lesions within body tissue which have been identified by an X-ray imaging procedure wherein an X-ray apparatus directs an X-ray beam along an axis onto the body tissue to facilitate identification and location of a lesion, the X-ray apparatus projecting an image of cross-hairs onto the surface of the body to align the lesion with said, the localization needle including an elongated hollow cannula having a proximal end and a distal end; said targeting means comprising: a member including a display portion having a substantially flat upper surface for receiving the image of cross-hairs produced by the X-ray apparatus, and an engaging portion for mounting said member to the cannula near its proximal end.
16. A targeting means according to claim 15 wherein said engaging portion comprises an extension portion adapted to engage the proximal end of the localization needle.
17. A targeting means according to claim 16 wherein said extension portion is generally cylindrical.
18. A targeting means according to claim 16 wherein said extension portion is bevelled and decreases in diameter in a direction away from said upper surface of said display portion to permit attachment to said proximal end of said cannula.
19. A targeting means according to claim 15 wherein said member has an aperture therethrough which is aligned with the axis of the localization needle when said member is mounted to said cannula.
20. A method of positioning a localization needle assembly for pinpointing lesions within body tissue which have been identified by an X-ray imaging procedure wherein an X-ray beam is directed along an axis onto body tissue to facilitate identification and location of a lesion, the X-ray apparatus projecting an image of cross¬ hairs onto the surface of the body to align the lesion with said axis, said method comprising the steps of: projecting the image of the cross-hairs produced by the X-ray apparatus onto the surface of the body with the junction of the cross-hairs aligned with the axis along which the X-ray beam was directed during identification and location of the lesion, positioning the distal end of the localization needle assembly on the surface of the body at the junction of the cross-hairs which are being projected onto the surface of the body, maintaining the distal end of the localization needle assembly at the junction of the cross-hairs being projected onto the surface of the body, orienting the localization needle assembly to cause the image of the cross-hairs being produced by the X-ray apparatus to be projected onto a display surface of a targeting means on the localization needle means near its proximal end, positioning the proximal end of the localization needle assembly to align the junction of the cross-hairs projected onto said display surface with the center line of the localization needle assembly, and advancing the localization needle assembly into the body while maintaining the center line of the localization needle assembly aligned with the cross-hairs projected onto said display surface.
PCT/US1992/001037 1992-02-07 1992-02-07 Targeting guidance device for localization needle assemblies WO1993015683A1 (en)

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EP1003435A1 (en) * 1997-01-22 2000-05-31 Minrad Inc. Energy guided apparatus and method
WO2004100793A1 (en) * 2003-05-15 2004-11-25 Etelä-Savon Sairaanhoitopiirin Kuntayhtymä Arrangement and method in gamma-radiography
WO2007023050A1 (en) * 2005-08-22 2007-03-01 Siemens Aktiengesellschaft Laser device for a mammography apparatus
JP2007528239A (en) * 1995-08-31 2007-10-11 バイオレーズ テクノロジー インコーポレイテッド Tissue removal device and method
EP3003181A4 (en) * 2013-06-03 2017-01-11 Faculty Physicians and Surgeons of Loma Linda University School of Medicine Methods and apparatuses for fluoro- less or near fluoro-less percutaneous surgery access
EP3352834A4 (en) * 2015-09-22 2019-05-08 Faculty Physicians and Surgeons of Loma Linda University School of Medicine Kit and method for reduced radiation procedures

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US4826487A (en) * 1987-05-04 1989-05-02 Victory Engineering Company Alignment button for stereotaxic plug and method of using the same
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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007528239A (en) * 1995-08-31 2007-10-11 バイオレーズ テクノロジー インコーポレイテッド Tissue removal device and method
CH690707A5 (en) * 1996-06-10 2000-12-29 Leica Mikroskopie Sys Ag Markers for position detection with electrical or electronic light-transmitting elements
WO1997047240A1 (en) * 1996-06-10 1997-12-18 Leica Ag Position-determination system using a marker, and a marker for use in such a system
EP1003435A1 (en) * 1997-01-22 2000-05-31 Minrad Inc. Energy guided apparatus and method
EP1003435A4 (en) * 1997-01-22 2000-05-31 Minrad Inc Energy guided apparatus and method
WO2004100793A1 (en) * 2003-05-15 2004-11-25 Etelä-Savon Sairaanhoitopiirin Kuntayhtymä Arrangement and method in gamma-radiography
WO2007023050A1 (en) * 2005-08-22 2007-03-01 Siemens Aktiengesellschaft Laser device for a mammography apparatus
US8611491B2 (en) 2005-08-22 2013-12-17 Siemens Aktiengesellschaft Compression plate for a mammography unit and a mammography unit
EP3003181A4 (en) * 2013-06-03 2017-01-11 Faculty Physicians and Surgeons of Loma Linda University School of Medicine Methods and apparatuses for fluoro- less or near fluoro-less percutaneous surgery access
EP3398543A1 (en) * 2013-06-03 2018-11-07 Faculty Physicians and Surgeons of Loma Linda University School of Medicine Apparatuses for fluoro-less or near fluoro-less percutaneous surgery access
EP3352834A4 (en) * 2015-09-22 2019-05-08 Faculty Physicians and Surgeons of Loma Linda University School of Medicine Kit and method for reduced radiation procedures
US10405943B2 (en) 2015-09-22 2019-09-10 Faculty Physicians And Surgeons Of Loma Linda University School Of Medicine Kit and method for reduced radiation procedures

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