WO2020170245A1 - Scanning breast examination device and procedure - Google Patents

Scanning breast examination device and procedure Download PDF

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Publication number
WO2020170245A1
WO2020170245A1 PCT/IL2020/050181 IL2020050181W WO2020170245A1 WO 2020170245 A1 WO2020170245 A1 WO 2020170245A1 IL 2020050181 W IL2020050181 W IL 2020050181W WO 2020170245 A1 WO2020170245 A1 WO 2020170245A1
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WO
WIPO (PCT)
Prior art keywords
female breast
article
receptacle
arrangement
sieve
Prior art date
Application number
PCT/IL2020/050181
Other languages
French (fr)
Inventor
Zeev Harel
Aharon Bar-David
Zeev Burshtein
Original Assignee
Convergent R.N.R Ltd.
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Filing date
Publication date
Application filed by Convergent R.N.R Ltd. filed Critical Convergent R.N.R Ltd.
Publication of WO2020170245A1 publication Critical patent/WO2020170245A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/50—Clinical applications
    • A61B6/502—Clinical applications involving diagnosis of breast, i.e. mammography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other 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
    • A61B10/0041—Detection of breast cancer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/02—Devices for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
    • A61B6/03—Computerised tomographs
    • A61B6/032—Transmission computed tomography [CT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/04—Positioning of patients; Tiltable beds or the like
    • A61B6/0407—Supports, e.g. tables or beds, for the body or parts of the body
    • A61B6/0421—Supports, e.g. tables or beds, for the body or parts of the body with immobilising means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/40—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment with arrangements for generating radiation specially adapted for radiation diagnosis
    • A61B6/4064—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment with arrangements for generating radiation specially adapted for radiation diagnosis specially adapted for producing a particular type of beam
    • A61B6/4085—Cone-beams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/10—Instruments, 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 for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
    • A61B90/17—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins for soft tissue, e.g. breast-holding devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other 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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/10—Instruments, 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 for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B2090/101—Instruments, 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 for stereotaxic surgery, e.g. frame-based stereotaxis for stereotaxic radiosurgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/06—Diaphragms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/42—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment with arrangements for detecting radiation specially adapted for radiation diagnosis
    • A61B6/4208—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment with arrangements for detecting radiation specially adapted for radiation diagnosis characterised by using a particular type of detector
    • A61B6/4233—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment with arrangements for detecting radiation specially adapted for radiation diagnosis characterised by using a particular type of detector using matrix detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/10—Instruments, 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 for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, 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 for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N2005/1092—Details
    • A61N2005/1097—Means for immobilizing the patient

Definitions

  • the present invention relates to breast examination and, more particularly, to a device for mammographic examination pneumatically immobilizing a patient’ s lacteal gland.
  • Mammography is a process of using low-energy X-rays (usually around 30 kVp) which enables examining a human breast for diagnosis and screening.
  • low-energy X-rays usually around 30 kVp
  • mammography is the early detection of breast cancer, typically through detection of characteristic masses or microcalcifications.
  • the gantry is rigidly mechanically suspended from the patient table.
  • the gantry is adapted to rotate about an approximately vertical rotational axis in continuous rotational movement for imaging the breast.
  • the gantry is also adapted to be moved in a vertical direction during said the rotational movement.
  • the aforesaid arrangement comprises a receptacle conformed with a shape of said female breast.
  • the receptacle is configured to be vacuumed such that said female breast is releasably securable within said receptacle;
  • Another object of the invention is to disclose a device for scanning a female breast comprising: (a) an arrangement for securing said female breast; (b) a gantry comprising an X-ray source generating an X-ray beam directed to said female breast secured within said arrangement, a detector configured for sensing said X-ray beam after passing through said female breast and computer means configured for generating tomographic images of said female breast; said gantry is rotatable around said female breast secured within said arrangement.
  • X-ray beam is selected from the group consisting of a fan beam, a conic beam and combination thereof.
  • a further object of the invention is to disclose the gantry comprising a wedge filter.
  • a further object of the invention is to disclose the gantry comprising a
  • a further object of the invention is to disclose the arrangement comprising a plurality of sealed passages between said first and second articles configured for accessing a biopsy needle to said female breast when secured by air exhausting from said cavity between said first and second articles.
  • a further object of the invention is to disclose the second article which is a sheath made of rubber covering the first article and allowing piercing thereof by said biopsy needle without breaking airtightness thereof.
  • a further object of the invention is to disclose a device for radiotherapeutic irradiation of a female breast.
  • the aforesaid device comprises: (a) an arrangement for securing said female breast; (b) an X-ray source generating a convergent X-ray beam directed to said female breast secured within said arrangement.
  • a further object of the invention is to disclose a method of securing a female breast during a medical procedure.
  • the aforesaid method comprises steps: (a) providing an arrangement for securing a female breast further comprising: a receptacle conformed with a shape of said female breast; said receptacle is configured to be vacuumed such that said female breast is releasably securable within said receptacle; said arrangement comprises first and second concave shell-like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewitbin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article; (b) placing said female breast within said receptacle; (c) air exhausting from said cavity; (d) attaching tissues of said female breast to said first sieve article.
  • a further object of the invention is to disclose a method of scanning a female breast; said method comprising steps: (a) providing a device for scanning said female breast further comprising: (i) an arrangement for securing said female breast; (ii) a gantry comprising an X-ray source generating an X-ray beam directed to said female breast secured within said arrangement, a detector configured for sensing said X-ray beam after passing through said female breast and computer means configured for generating tomographic images of said female breast; said gantry is rotatable around said female breast secured within said arrangement; said arrangement comprises a first and second concave shell -like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewithin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article; (b) placing said female breast within said receptacle
  • a further object of the invention is to disclose a method of radiotherapeutic irradiation of a female breast.
  • the aforesaid method comprises steps of: (a) providing a device for radiotherapeutic irradiation of said female breast: (i) an arrangement for securing said female breast; (ii) an X-ray source generating a convergent X-ray beam directed to said female breast secured within said arrangement; (iii) said arrangement comprises a first and second concave shell-like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewitbin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article; (b) placing said female breast within said receptacle; (c) air exhausting from said cavity; (d) vacuum attaching tissues of said female breast to said first sieve article; (
  • Fig. 1 is a schematic cross sectional view of an arrangement for securing a female breast during a medical procedure
  • Fig. 2 is a detailed cross sectional view of a passage for breast biopsy
  • Figs 3 and 4 illustrate a biopsy procedure
  • Fig. 5 illustrates a procedure of radiotherapeutic irradiation by a converging X-ray beam
  • Fig. 6 shows a setup providing a narrow fan beam enabling a computer tomography examination performed around the breast
  • Fig. 7 shows a setup providing a cone beam enabling a computer tomography
  • Fig. 8 shows an exemplary embodiment a computer tomography device provided with a wedge filter, monochromator and a flat panel detector.
  • Fig. 1 presenting device 10 for holding a female breast (12) during a scanning examination.
  • the aforesaid device comprises first and second concave shell-like articles nested one into another. According to an exemplary
  • the first and second articles are embodied as outer cone 13 and inner sieve cone (11) nested therewithin.
  • Inner sieve cone (11) contacts with female breast (12).
  • Numeral (9) refers to a port connectable to a vacuum pump providing temperate negative pressure within a cavity (14) defined by outer cone (13) and inner cone (11). Vacuum created in cavity 14 enables immobilizing female breast (12) within device (10) by attaching the aforesaid breast to inner sieve cone (11) thereby securing it in place.
  • Device (10) comprises a plurality of passages (70) between said first and second articles configured for accessing a biopsy needle to said female breast when secured by air exhausting from said cavity between said first and second articles.
  • Passages (70) are provided with rubber plugs (73) configured for piercing a biopsy needle therethough in order to access a tissue of female breast (12).
  • Tube (71) is open to the skin (77) at its distal terminal (76).
  • Proximal terminal of tube 70 is provided with a rubber plug (73) configured for piercing needle (75) therethrough to access breast tissue (77).
  • the tube’s exit (76) is surrounded with a rubber washer (72) to be pressed against tissue (77) to seal the space around distal terminal (76), where the needle goes through.
  • the diameter of the tube (71) is elected in order to allow varying an angle of inserting biopsy needle into tissue 77.
  • the size of rubber plug (73) is larger from the needle thickness so that it can be inserted in an angle like the needle (75).
  • passages 70 are distributed over the device such that all locations within breast 12 are accessible for biopsy.
  • Figs 3 and 4 illustrating a biopsy procedure within female breast (12) immobili ed within device (10).
  • needle 75 is inserted into tumor 45 via passage 70 and rubber plug 73.
  • rigid sieve element 81 the sieve (81) is covered outside with a rubber sheath (82) to enclose the space for vacuum.
  • the breast is placed inside the sieve (81) the rubber cover seals the vacuum allowing a needle to pierce the rubber and enter the breast through the sieve for biopsy.
  • Fig. 5 presenting radiotherapy treatment of tumor 45.
  • Convergent beam (46) is focused on tumor (45).
  • An exemplary embodiment of device 100 comprises X-ray source (21) generating fan- shaped narrow beam (24) to be captured by a banana-shaped (linear) detector (31).
  • Fig. 7 presenting an alternative embodiment of device 100a for local computer tomography of female breast 12.
  • X-ray source (21) provides cone beam (25) detectable by a detector matrix (32).
  • FIG. 8 presenting alternative embodiment 100b usable for imaging a female breast.
  • Device 100b for local computer tomography of female breast 12 comprises monochromator (62) and filter (64).
  • the aforesaid filter is configured difference in intensity to be detected by matrix (67) because of variation of X-ray absorption within breast.
  • Incoming beam (61) from X-ray source 21 is incident on monochromator (62) and reflected (63) in the direction of filter (64). Then, via filter (65) the X-ray beam (65) goes through the breast and comes out (66) to the detector matrix (67).
  • Decrease in spectral bandwidth of selected X-ray used in imaging provides higher contrast of obtained images. Images obtained in X-rays of different narrowly selected energies when inspected together can also improve visibility of malignant structure in the breast.
  • the purpose of the present invention is in reliable and safe securement of a patient’s breast within a device for local computer tomography.
  • the double cone arrangement enhances accuracy during guided biopsy and radiotherapy treatment. Therefore, imaging, biopsy and treatment are performable in a single session.

Abstract

An arrangement for securing a female breast during a medical procedure comprises a receptacle conformed to a shape of the female breast. The receptacle is configured to be vacuumed such that the female breast is releasably securable within the receptacle. The arrangement comprises a first and second concave shell-like articles; the first article is sieve and forms the receptacle. The first article is nested into the second article such that an internal cavity is formed therebetween. The female breast when placed into the receptacle is securable therewithin by exhausting air from the internal cavity and pneumatically attaching tissues of the female breast to the first sieve article.

Description

SCANNING BREAST EXAMINATION DEVICE AND PROCEDURE
FIELD OF THE INVENTION
The present invention relates to breast examination and, more particularly, to a device for mammographic examination pneumatically immobilizing a patient’ s lacteal gland.
BACKGROUND OF THE INVENTION
Mammography is a process of using low-energy X-rays (usually around 30 kVp) which enables examining a human breast for diagnosis and screening. The goal of
mammography is the early detection of breast cancer, typically through detection of characteristic masses or microcalcifications.
US 7864918 discloses an X-ray machine for imaging a breast of a female patient comprises a gantry with an X-ray tube and an X-ray detector, and a horizontally disposed patient table with a cut-out portion for accommodating a breast of the patient. The gantry is rigidly mechanically suspended from the patient table. The gantry is adapted to rotate about an approximately vertical rotational axis in continuous rotational movement for imaging the breast. The gantry is also adapted to be moved in a vertical direction during said the rotational movement.
SUMMARY OF THE INVENTION
It is hence one object of the invention to disclose an arrangement for securing a female breast during a medical procedure. The aforesaid arrangement comprises a receptacle conformed with a shape of said female breast. The receptacle is configured to be vacuumed such that said female breast is releasably securable within said receptacle;
It is a core purpose of the invention to provide the arrangement comprising a first and second concave shell-like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewithin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article.
Another object of the invention is to disclosea device for scanning a female breast comprising: (a) an arrangement for securing said female breast; (b) a gantry comprising an X-ray source generating an X-ray beam directed to said female breast secured within said arrangement, a detector configured for sensing said X-ray beam after passing through said female breast and computer means configured for generating tomographic images of said female breast; said gantry is rotatable around said female breast secured within said arrangement.
The device according claim 2, X-ray beam is selected from the group consisting of a fan beam, a conic beam and combination thereof.
A further object of the invention is to disclose the gantry comprising a wedge filter.
A further object of the invention is to disclose the gantry comprising a
monochromator.
A further object of the invention is to disclose the arrangement comprising a plurality of sealed passages between said first and second articles configured for accessing a biopsy needle to said female breast when secured by air exhausting from said cavity between said first and second articles.
A further object of the invention is to disclose the second article which is a sheath made of rubber covering the first article and allowing piercing thereof by said biopsy needle without breaking airtightness thereof.
A further object of the invention is to disclose a device for radiotherapeutic irradiation of a female breast. The aforesaid device comprises: (a) an arrangement for securing said female breast; (b) an X-ray source generating a convergent X-ray beam directed to said female breast secured within said arrangement.
A further object of the invention is to disclose a method of securing a female breast during a medical procedure. The aforesaid method comprises steps: (a) providing an arrangement for securing a female breast further comprising: a receptacle conformed with a shape of said female breast; said receptacle is configured to be vacuumed such that said female breast is releasably securable within said receptacle; said arrangement comprises first and second concave shell-like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewitbin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article; (b) placing said female breast within said receptacle; (c) air exhausting from said cavity; (d) attaching tissues of said female breast to said first sieve article.
A further object of the invention is to disclose a method of scanning a female breast; said method comprising steps: (a) providing a device for scanning said female breast further comprising: (i) an arrangement for securing said female breast; (ii) a gantry comprising an X-ray source generating an X-ray beam directed to said female breast secured within said arrangement, a detector configured for sensing said X-ray beam after passing through said female breast and computer means configured for generating tomographic images of said female breast; said gantry is rotatable around said female breast secured within said arrangement; said arrangement comprises a first and second concave shell -like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewithin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article; (b) placing said female breast within said receptacle; (c) air exhausting from said cavity; (d) vacuum attaching tissues of said female breast to said first sieve article; (e) rotating said gantry around said female breast; (f) generating said tomographic images of said female breast.
A further object of the invention is to disclose a method of radiotherapeutic irradiation of a female breast. The aforesaid method comprises steps of: (a) providing a device for radiotherapeutic irradiation of said female breast: (i) an arrangement for securing said female breast; (ii) an X-ray source generating a convergent X-ray beam directed to said female breast secured within said arrangement; (iii) said arrangement comprises a first and second concave shell-like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewitbin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article; (b) placing said female breast within said receptacle; (c) air exhausting from said cavity; (d) vacuum attaching tissues of said female breast to said first sieve article; (e) irradiating said female breast by said convergent beam.
BRIEF DESCRIPTION OF THE DRAWINGS
In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments is adapted to now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which
Fig. 1 is a schematic cross sectional view of an arrangement for securing a female breast during a medical procedure;
Fig. 2 is a detailed cross sectional view of a passage for breast biopsy;
Figs 3 and 4 illustrate a biopsy procedure;
Fig. 5 illustrates a procedure of radiotherapeutic irradiation by a converging X-ray beam;
Fig. 6 shows a setup providing a narrow fan beam enabling a computer tomography examination performed around the breast;
Fig. 7 shows a setup providing a cone beam enabling a computer tomography
examination performed around the breast; and
Fig. 8 shows an exemplary embodiment a computer tomography device provided with a wedge filter, monochromator and a flat panel detector.
DETAILED DESCRIPTION OF THE INVENTION
The following description is provided, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, are adapted to remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a scanning device for examining a feminine breast and a method of performing the same.
Reference is now made to Fig. 1 presenting device 10 for holding a female breast (12) during a scanning examination. The aforesaid device comprises first and second concave shell-like articles nested one into another. According to an exemplary
embodiment of the present invention, the first and second articles are embodied as outer cone 13 and inner sieve cone (11) nested therewithin. Inner sieve cone (11) contacts with female breast (12). Numeral (9) refers to a port connectable to a vacuum pump providing temperate negative pressure within a cavity (14) defined by outer cone (13) and inner cone (11). Vacuum created in cavity 14 enables immobilizing female breast (12) within device (10) by attaching the aforesaid breast to inner sieve cone (11) thereby securing it in place.
Device (10) comprises a plurality of passages (70) between said first and second articles configured for accessing a biopsy needle to said female breast when secured by air exhausting from said cavity between said first and second articles. Passages (70) are provided with rubber plugs (73) configured for piercing a biopsy needle therethough in order to access a tissue of female breast (12).
Reference is now made to Fig. 2 presenting passages (70) in detail usable for access to the breast tissue. Tube (71) is open to the skin (77) at its distal terminal (76). Proximal terminal of tube 70 is provided with a rubber plug (73) configured for piercing needle (75) therethrough to access breast tissue (77). The tube’s exit (76) is surrounded with a rubber washer (72) to be pressed against tissue (77) to seal the space around distal terminal (76), where the needle goes through. The diameter of the tube (71) is elected in order to allow varying an angle of inserting biopsy needle into tissue 77. In other words, the size of rubber plug (73) is larger from the needle thickness so that it can be inserted in an angle like the needle (75). According to the present invention, passages 70 are distributed over the device such that all locations within breast 12 are accessible for biopsy.
Reference is now made to Figs 3 and 4 illustrating a biopsy procedure within female breast (12) immobili ed within device (10). In Fig. 3, needle 75 is inserted into tumor 45 via passage 70 and rubber plug 73. As an alternative, in Fig. 4, rigid sieve element 81 , the sieve (81) is covered outside with a rubber sheath (82) to enclose the space for vacuum. The breast is placed inside the sieve (81) the rubber cover seals the vacuum allowing a needle to pierce the rubber and enter the breast through the sieve for biopsy.
Reference is now made Fig. 5 presenting radiotherapy treatment of tumor 45. Convergent beam (46) is focused on tumor (45).
Reference is now made to Fig. 6 presenting device 100 for local computer
tomography of female breast 12. An exemplary embodiment of device 100 comprises X-ray source (21) generating fan- shaped narrow beam (24) to be captured by a banana-shaped (linear) detector (31).
Reference is now made to Fig. 7 presenting an alternative embodiment of device 100a for local computer tomography of female breast 12. X-ray source (21) provides cone beam (25) detectable by a detector matrix (32).
Reference is now made to Fig. 8 presenting alternative embodiment 100b usable for imaging a female breast. Device 100b for local computer tomography of female breast 12 comprises monochromator (62) and filter (64). The aforesaid filter is configured difference in intensity to be detected by matrix (67) because of variation of X-ray absorption within breast. Incoming beam (61) from X-ray source 21 is incident on monochromator (62) and reflected (63) in the direction of filter (64). Then, via filter (65) the X-ray beam (65) goes through the breast and comes out (66) to the detector matrix (67).
Decrease in spectral bandwidth of selected X-ray used in imaging provides higher contrast of obtained images. Images obtained in X-rays of different narrowly selected energies when inspected together can also improve visibility of malignant structure in the breast. The purpose of the present invention is in reliable and safe securement of a patient’s breast within a device for local computer tomography. The double cone arrangement enhances accuracy during guided biopsy and radiotherapy treatment. Therefore, imaging, biopsy and treatment are performable in a single session.

Claims

Claims:
1. An arrangement for securing a female breast during a medical procedure; said arrangement comprising a receptacle conformed with a shape of said female breast; said receptacle is configured to be vacuumed such that said female breast is releasably securable within said receptacle;
wherein said arrangement comprises a first and second concave shell -like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewithin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article.
2. The arrangement according claim 1, comprising a plurality of sealed passages between said first and second articles configured for accessing a biopsy needle to said female breast when secured by air exhausting from said cavity between said first and second articles.
3. The arrangement according claim 1, wherein said second article is a rubber sheath covering the first article and allowing piercing thereof by said biopsy needle without breaking airtightness thereof.
4. A device for scanning a female breast comprising:
a. an arrangement for securing said female breast; b. a gantry comprising an X-ray source generating an X-ray beam directed to said female breast secured within said arrangement; a detector configured for sensing said X-ray beam after passing through said female breast and computer means configured for generating tomographic images of said female breast; said gantry is rotatable around said female breast secured within said arrangement;
wherein said arrangement comprises a first and second concave shell - like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewithin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article.
5. The device according claim 4, X-ray beam is selected from the group
consisting of a fan beam, a conic beam and combination thereof.
6. The device according claim 4, wherein said gantry comprises a wedge filter.
7. The device according claim 4, wherein said gantry comprises a
monochromator.
8. The device according claim 4, wherein said arrangement comprises a plurality of sealed passages between said first and second articles configured for accessing a biopsy needle to said female breast when secured by air exhausting from said cavity between said first and second articles.
9. The device according claim 4, wherein said second article is a rubber sheath covering the first article and allowing piercing thereof by said biopsy needle without breaking airtightness thereof.
10. A device for radiotherapeutic irradiation of a female breast; said device
comprising:
a. an arrangement for securing said female breast;
b. an X-ray source generating a convergent X-ray beam directed to said female breast secured within said arrangement;
wherein said arrangement comprises a first and second concave shell like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewithin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article.
11. The device according claim 10, wherein said arrangement comprises a plurality of sealed passages between said first and second articles configured for accessing a biopsy needle to said female breast when secured by air exhausting from said cavity between said first and second articles.
12. The device according claim 10, wherein said second article is a sheath made of rubber covering the first article allowing piercing thereof by said biopsy needle without breaking airtightness thereof.
13. A method of securing a female breast during a medical procedure; said method comprising steps:
a. providing an arrangement for securing a female breast further
comprising: a receptacle conformed with a shape of said female breast; said receptacle is configured to be vacuumed such that said female breast is releasably securable within said receptacle; said arrangement comprises a first and second concave shell-like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewitbin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article;
b. placing said female breast within said receptacle;
c. air exhausting from said cavity; d. attaching tissues of said female breast to said first sieve article.
14. A method of scanning a female breast; said method comprising steps: a. providing a device for scanning said female breast further comprising: i. an arrangement for securing said female breast; ii. a gantry comprising an X-ray source generating an X-ray beam directed to said female breast secured within said arrangement, a detector configured for sensing said X-ray beam after passing through said female breast and computer means configured for generating tomographic images of said female breast; said gantry is rotatable around said female breast secured within said arrangement;
said arrangement comprises a first and second concave shell - like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewithin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article; b. placing said female breast within said receptacle;
c. air exhausting from said cavity;
d. vacuum attaching tissues of said female breast to said first sieve
article; e. rotating said gantry around said female breast;
f. generating said tomographic images of said female breast.
15. A method of radiotherapeutic irradiation of a female breast; said method
comprising steps of:
a. providing a device for radiotherapeutic irradiation of said female
breast:
i. an arrangement for securing said female breast; ii. an X-ray source generating a convergent X-ray beam directed to said female breast secured within said arrangement;
iii. said arrangement comprises a first and second concave shell - like articles; said first article is sieve and forms said receptacle; said first article is nested into said second article such that an internal cavity is formed therebetween; said female breast when placed into said receptacle is securable therewithin by exhausting air from said internal cavity and pneumatically attaching tissues of said female breast to said first sieve article; b. placing said female breast within said receptacle;
c. air exhausting from said cavity; d. vacuum attaching tissues of said female breast to said first sieve
article;
e. irradiating said female breast by said convergent beam
PCT/IL2020/050181 2019-02-18 2020-02-18 Scanning breast examination device and procedure WO2020170245A1 (en)

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US62/806,917 2019-02-18

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6146377A (en) * 1998-09-22 2000-11-14 Rubicor Medical, Inc. Breast stabilization devices and methods
US20040215101A1 (en) * 2003-04-23 2004-10-28 Robert Rioux Method and assembly for breast immobilization
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