WO2013128240A1 - Couvercle de protection pour un dispositif médical - Google Patents

Couvercle de protection pour un dispositif médical Download PDF

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Publication number
WO2013128240A1
WO2013128240A1 PCT/IB2012/050953 IB2012050953W WO2013128240A1 WO 2013128240 A1 WO2013128240 A1 WO 2013128240A1 IB 2012050953 W IB2012050953 W IB 2012050953W WO 2013128240 A1 WO2013128240 A1 WO 2013128240A1
Authority
WO
WIPO (PCT)
Prior art keywords
protective liner
extension
collar portion
spun
main collar
Prior art date
Application number
PCT/IB2012/050953
Other languages
English (en)
Inventor
Helen Zinreich Shafer
David Alan Zinreich
Douglas Crumb
Original Assignee
Izi Medical Products
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
Priority claimed from US13/408,582 external-priority patent/US20130220344A1/en
Priority claimed from US13/408,651 external-priority patent/US8661573B2/en
Priority claimed from US13/408,766 external-priority patent/US20130220343A1/en
Priority claimed from US13/408,699 external-priority patent/US20130220342A1/en
Application filed by Izi Medical Products filed Critical Izi Medical Products
Publication of WO2013128240A1 publication Critical patent/WO2013128240A1/fr

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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
    • A61B6/10—Application or adaptation of safety means
    • A61B6/107—Protection against radiation, e.g. shielding
    • 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
    • A61B6/54—Control of apparatus or devices for radiation diagnosis
    • A61B6/542—Control of apparatus or devices for radiation diagnosis involving control of exposure
    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
    • G21F3/00—Shielding characterised by its physical form, e.g. granules, or shape of the material
    • G21F3/02—Clothing

Definitions

  • the present invention relates generally to protective apparel employed as a barrier to prevent contamination of worn shielding attire. More particularly, it relates to a liner for averting transfer of bodily fluids from a patient and contamination of a radiation shield during radiological procedures.
  • Radiological technologists often utilize lead apparel for protection against X-rays needed during X-ray procedures. Dentists may also use lead apparel for the protection for their patients during dental X-ray examinations. It is estimated that upwards of 40 million mammography procedures are conducted annually in the United States; upwards of 100 million dental X-rays are estimated to be performed annually in the United States. Concerns exist for having to use a thyroid shield previously used by an undetermined number of people. Lead protective gear is expensive and therefore used over frequently by personnel and patients, which may cause it to become soiled and stained in the process. [0004] In general, radiation shields which cover portions of the body, such as the thyroid area, are known in the art. Examples of such radiation shields are described in U.S. Patent No.
  • These radiation shields are generally comprised of a body of radiation-attenuating material and an attachment member.
  • the attachment member of the radiation shield is configured to be worn around an appendage such as the neck so that the radiation-attenuating material protects a particular body portion.
  • Radiation shields are intended for use in non-sterile environments during radiological diagnostic procedures or oncological treatments.
  • the shields are worn, for example, by patients to selectively isolate, shroud and protect particular regions of the anatomy.
  • Many radiation shields are designed to be reusable.
  • the same radiation shield may be worn, perhaps, hundreds of times by different patients.
  • the radiation shield may become exposed, for example, to sweat and other fluids from a patient during radiological processes such as during mammograms and/or dental X-rays. It is, therefore, necessary to clean the radiation shield between patient uses.
  • the cleaning and disinfecting process may reduce the efficiency of the office practice due to the fact that the aforementioned cleaning process can take a considerable amount of time and effort to perform by office personnel.
  • the cleaning process would most likely need to be performed multiple times throughout the day to serve multiple patients.
  • the radiation shields often become soiled with bodily fluids or otherwise-unsightly disco lorations. These stained radiation shields, which often contain environmentally unfriendly materials, must, therefore, be disposed of. In addition, these events may pose a barrier against green efforts as the discarded radiation shields may eventually accumulate in landfills. Further, if the radiation shield is not properly cleaned, the patient or practitioner may unknowingly wear a soiled or otherwise unsanitary shield.
  • a protective liner comprising: a collar having a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction.
  • Disclosed embodiments may include a chest portion extending from the main collar portion.
  • the protective liner may also include an adjustable releasable fastener for joining the first extension to the second extension.
  • the adjustable releasable fastener may be disposed upon at least one of the first extension and second extension, wherein a material of the protective liner comprises a non-woven, fluid repellent material.
  • a protective liner comprising: a first material forming a collar having a main collar portion, a first extension emanating from the main collar portion in a first direction, and a second extension emanating from the main collar portion in a second direction opposite to the first direction.
  • Disclosed embodiments may include a chest portion extending from the main collar portion.
  • the protective line may also include an adjustable releasable fastener for joining the first extension to the second extension.
  • the adjustable releasable fastener may be disposed upon at least one of the first extension and second extension, wherein a material of the protective liner comprises a non-woven material.
  • a second material coating a surface of the first material may be provided, wherein the second material is fluid repellent.
  • a protective liner comprising: a collar having a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a first tie extension extending from the first extension and a second tie extension extending from the second extension.
  • Embodiments may provide a chest portion extending from the main collar portion, wherein a material of the protective liner comprises a non-woven, fluid repellent material.
  • a protective liner comprising: a first material forming a collar having a main collar portion, a first extension emanating from the main collar portion in a first direction and a second extension emanating from the main collar portion in a second direction opposite to the first direction.
  • the protective liner may provide a first tie extension extending from the first extension and a second tie extension extending from the second extension.
  • a chest portion may be provided extending from the main collar portion, wherein a material of the protective liner comprises a non-woven material.
  • Embodiments may provide a second material coating a surface of the first material, wherein the second material is fluid repellent.
  • a protective liner comprising: a collar comprising: a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a chest portion extending from the main collar portion, an adjustable releasable fastener for joining the first extension to the second extension, the adjustable releasable fastener disposed upon at least one of the first extension and second extension, wherein a material of the protective liner comprises a non- woven, fluid repellent material, wherein the adjustable releasable fastener comprises fastener portions formed from a surface of the first extension and a slot formed in the second extension for receiving the fastener portions.
  • a protective liner comprising: a collar comprising: a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a chest portion extending from the main collar portion, an adjustable releasable fastener for joining the first extension to the second extension, the adjustable releasable fastener disposed upon at least one of the first extension and second extension, wherein a material of the protective liner comprises a non- woven, fluid repellent material, and a radiation device attached to the material.
  • a protective liner comprising: a first material forming a collar comprising a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a chest portion extending from the main collar portion, an adjustable releasable fastener for joining the first extension to the second extension, the adjustable releasable fastener disposed upon at least one of the first extension and second extension, wherein a material of the protective liner comprises a non-woven material, a second material coating a surface of the first material, wherein the second material is fluid repellent, and a radiation device attached to the first material.
  • a protective liner comprising: a collar comprising: a collar comprising a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a first tie extension extending from the first extension, a second tie extension extending from the second extension, a chest portion extending from the main collar portion, wherein a material of the protective liner comprises a non-woven, fluid repellent material, and a radiation device attached to the material.
  • a protective liner comprising: a first material forming a collar comprising: a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a first tie extension extending from the first extension, a second tie extension extending from the second extension, a chest portion extending from the main collar portion, wherein a material of the protective liner comprises a non-woven material, a second material coating a surface of the first material, wherein the second material is fluid repellent, and a radiation device attached to the first material.
  • a protective liner comprising: a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a chest portion extending from the main collar portion, and an adjustable releasable fastener for joining the first extension to the second extension, the adjustable releasable fastener disposed upon at least one of the first extension and second extension, wherein a material of the protective liner comprises a non-woven, fluid repellent material, wherein the material of the protective liner is configured to be folded upon itself for storage or packaging.
  • a protective liner comprising: a first material forming a collar comprising: a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a chest portion extending from the main collar portion, an adjustable releasable fastener for joining the first extension to the second extension, the adjustable releasable fastener disposed upon at least one of the first extension and second extension, wherein a material of the protective liner comprises a non-woven material, and a second material coating a surface of the first material, wherein the second material is fluid repellent, wherein the first material and the second material of the protective liner are configured to be folded upon itself for storage or packaging.
  • a protective liner comprising: a collar comprising: a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a first tie extension extending from the first extension, a second tie extension extending from the second extension, and a chest portion extending from the main collar portion, wherein a material of the protective liner comprises a non- woven, fluid repellent material, wherein the material of the protective liner is configured to be folded upon itself for storage or packaging.
  • a protective liner comprising: a first material forming: a collar comprising: a main collar portion, a first extension emanating from the main collar portion in a first direction, a second extension emanating from the main collar portion in a second direction opposite to the first direction, a chest portion extending from the main collar portion, an adjustable releasable fastener for joining the first extension to the second extension, the adjustable releasable fastener disposed upon at least one of the first extension and second extension, wherein a material of the protective liner comprises a non-woven material, and a second material coating a surface of the first material, wherein the second material is fluid repellent, wherein the first material and the second material of the protective liner are configured to be folded upon itself for storage or packaging.
  • FIG. 1 illustrates a protective liner in accordance with an embodiment of the invention
  • FIG. 2 illustrates a frontal view of the protective liner of FIG. 1 in accordance with an embodiment of the invention
  • FIG. 3 A illustrates a front view of the protective liner of FIG. 1 worn by a patient in accordance with an embodiment of the invention
  • FIG. 3B illustrates a rear view of the protective liner of FIG. 1 worn by a patient in accordance with an embodiment of the invention
  • FIG. 4A illustrates a front view of the protective liner of FIG. 1 employed underneath a radiation shield worn by a patient in accordance with an embodiment of the invention
  • FIG. 4B illustrates a rear view of the protective liner of FIG. 1 employed underneath a radiation shield worn by a patient in accordance with an embodiment of the invention
  • FIGS. 5A-5C illustrate views of a protective liner having a fastening means in accordance with a first embodiment of the invention
  • FIGS. 6A-6C illustrate views of a protective liner having a fastening means in accordance with a second embodiment of the invention
  • FIGS. 7A-7C illustrate views of a protective liner having a fastening means in accordance with a third embodiment of the invention
  • FIGS. 8A-8C illustrate views of a protective liner having a fastening means in accordance with a fourth embodiment of the invention.
  • FIGS. 9A-9C illustrate views of a protective liner having a fastening means in accordance with a fifth embodiment of the invention.
  • FIG. 10 illustrates a protective liner having a fastening means in accordance with a sixth embodiment of the invention
  • FIG. 11A illustrates a front view of a protective liner employing a retaining means to maintain a position of a radiation shield in accordance with an embodiment of the invention
  • FIG. 11B illustrates the protective liner of FIG. 11A employed underneath a radiation shield in accordance with an embodiment of the invention.
  • a "bib” is used to describe a garment worn hanging from the neck and extending to the chest area of a person.
  • Electromagnetic radiation (EM radiation or EMR) is meant to refer to a form of energy emitted and absorbed by charged particles, which exhibits wavelike behavior as it travels through space.
  • EMR has both electric and magnetic field components, which oscillate in phase perpendicular to each other and perpendicular to the direction of energy and wave propagation.
  • electromagnetic radiation propagates at a characteristic speed, the speed of light.
  • EMR carries energy - sometimes called radiant energy - and both momentum and angular momentum. These may be imparted to matter with which it interacts.
  • EMR is produced from other types of energy when created, and it is converted to other types of energy when it is destroyed.
  • the photon is the quantum of the electromagnetic interaction, and is the basic "unit" or constituent of all forms of EMR.
  • the quantum nature of light becomes more apparent at high frequencies (or high photon energy). Such photons behave more like particles than lower- frequency photons do.
  • EMR is considered to be produced when charged particles are accelerated by forces acting on them. Electrons are responsible for emission of most EMR because they have low mass, and therefore are easily accelerated by a variety of mechanisms. Rapidly moving electrons are most sharply accelerated when they encounter a region of force, so they are responsible for producing much of the highest frequency electromagnetic radiation observed in nature. Quantum processes can also produce EMR, such as when atomic nuclei undergo gamma decay, and processes such as neutral pion decay.
  • EMR is classified according to the frequency of its wave.
  • the electromagnetic spectrum in order of increasing frequency and decreasing wavelength, consists of radio waves, microwaves, infrared radiation, visible light, ultraviolet radiation, X-rays and gamma rays.
  • the eyes of various organisms sense a small and somewhat variable window of frequencies of EMR called the visible spectrum.
  • the effects of EMR upon biological systems depends both upon the radiation's power and frequency. For lower frequencies of EMR up to those of visible light (i.e., radio, microwave, infrared), the damage done to cells and also to many ordinary materials under such conditions is determined mainly by heating effects, and thus by the radiation power.
  • Micrommogram is meant to refer to the technique of using X-rays to examine the breast in the early detection of cancer.
  • Oncology is meant to refer to the branch of medical science dealing with tumors, including the origin, development, diagnosis, and treatment of malignant neoplasms.
  • a "radiation shield” is used to describe a lead shield that can be put over a patient to prevent radiation from spreading to parts other than the part of the body being tested during a radiological process.
  • Radiology is meant to refer to the science dealing with X-rays and the interpretation of medical X-ray photographs especially for medical uses. Radiology is a medical specialty that employs the use of imaging to both diagnose and treat disease visualized within the human body. Radiologists use an array of imaging technologies (such as X-ray radiography, ultrasound, computed tomography (CT), nuclear medicine, positron emission tomography (PET) and magnetic resonance imaging (MRI)) to diagnose or treat diseases.
  • imaging technologies such as X-ray radiography, ultrasound, computed tomography (CT), nuclear medicine, positron emission tomography (PET) and magnetic resonance imaging (MRI)
  • Radiological is of, relating to, or concerning radiology or the equipment used in radiology.
  • Radiograph is meant to refer to an image produced on a radio-sensitive surface, such as photographic film, by radiation other than visible light, as by X-rays passed through an object.
  • Non-woven fabric is meant to refer to fabric-like material made from long fibers, bonded together by chemical, mechanical, heat or solvent treatment.
  • Nonwoven fabrics are broadly defined as sheet or web structures bonded together by entangling fiber or filaments (and by perforating films) mechanically, thermally or chemically. They may comprise flat sheets that are made directly from separate fibers or from molten plastic or plastic film. They are not made by weaving or knitting and do not require converting the fibers to yarn. Typically, a certain percentage of recycled fabrics and oil-based materials are used in non-woven fabrics.
  • Non-woven fabrics are engineered fabrics that may be a limited life fabric, single-use fabric or a very durable fabric.
  • Non-woven fabrics provide specific functions such as absorbency, liquid repellence, resilience, stretch, softness, strength, flame retardancy, washability, cushioning, filtering, use as a bacterial barrier and sterility. These properties are often combined to create fabrics suited for specific jobs, while achieving a good balance between product use/life and cost.
  • Randomtion dosimeter is meant to refer to a device for measuring exposure to ionizing radiation such as X-rays, alpha rays, beta rays, and gamma rays.
  • Radiolucent is meant to refer to anything that permits the penetration and passage of X-rays or other forms of radiation.
  • SMS spun-melt-spun
  • thyroid is meant to refer to one of the largest endocrine glands.
  • the thyroid gland is found in the neck, below (inferior to) the thyroid cartilage (which forms the laryngeal prominence, or "Adam's apple”).
  • the isthmus (the bridge between the two lobes of the thyroid) is located inferior to the cricoid cartilage.
  • X-ray X-radiation (composed of X-rays) is meant to refer to a form of electromagnetic radiation.
  • X-rays have a wavelength in the range of 0.01 to 10 nanometers (nm), corresponding to frequencies in the range 30 petahertz to 30 exahertz (3* 10 16 Hz to 3* 10 19 Hz) and energies in the range 120 eV to 120 keV. They are shorter in wavelength than UV rays and longer than gamma rays.
  • X-rays from about 0.12 to 12 keV (10 to 0.10 nm wavelength) are classified as “soft" X-rays, and from about 12 to 120 keV (0.10 to 0.01 nm wavelength) as “hard” X- rays, due to their penetrating abilities.
  • Hard X-rays can penetrate solid objects, and their most common use is to take images of the inside of objects in diagnostic radiography and crystallography.
  • the term X-ray is metonymically used to refer to a radiographic image produced using this method, in addition to the method itself.
  • X-rays a form of electromagnetic radiation, similar to light but of shorter wavelength are capable of penetrating solids and of ionizing gases to produce a picture produced by exposing photographic film to X-rays.
  • X-rays may be used in medicine as a diagnostic aid as parts of the body, such as bones, absorb X-rays and so appear as opaque areas on the photographic film.
  • a protective liner 10 is illustrated as a disposable bib designed to keep a radiation shield ⁇ e.g. , a thyroid shield) clean from patient sweat and fluids during radiological procedures such as when receiving mammograms and dental X-rays.
  • a radiation shield e.g. , a thyroid shield
  • Protective liner 10 may be utilized, for example, by mammography technicians and dental hygenists/technicians to eliminate the need for cleaning and decontamination of thyroid shields between patient usage.
  • protective liner 10 serves as a barrier between the neck and chest area of a patient and the radiation shield.
  • a collar is provided generally at a top region of protective liner 10.
  • the collar is designed as a wide-strip collar portion that fits around the neck of a patient and may be secured at the back of the neck.
  • FIGS. 1 and 2 illustrate a main collar portion, which may be generally positioned at the front of the neck.
  • a right extension or arm 16 and left extension or arm 18 emanates from main collar portion 12.
  • disclosed embodiments of the collar include main collar portion 12, right extension 16 and left extension 18.
  • The, collar is designed to cover the entire neck region and may run generally along or come into contact with the chin and lower jaw area of a patient when worn.
  • Chest portion 14 extends downwardly from and substantially perpendicular to collar portion 12 to cover the chest portion of a patient when worn.
  • right extension 16 and left extension 18 emanate and extend from opposite directions of main collar portion 12. As shown in FIGS. 1 and 2, right extension 16 and left extension 18 extend past a distance of the width of chest portion 14, thereby forming an overall "T" configuration of protective liner 10.
  • Protective liner 10 may be secured to a patient via a right extension 16 and a left extension 18.
  • the interior surface 27 of protective liner 10 faces the patient, when worn, to directly contact the body of the patient along the neck and chest region.
  • the exterior surface 29 of protective liner 10 faces outwardly from the patient, when worn, and is in direct contact with a radiation shield, as described below.
  • Right extension 16 and left extension 18 are wrapped around the neck and secured together in order to fit and secure protective liner 10 to a patient.
  • FIG. 3 A illustrates a rear view of protective liner 10 wherein right extension 16 and left extension 18 are fastened together behind the neck of a patient to secure protective liner 10 in position.
  • fastening means for securing protective line 10 are described below.
  • Protective liner 10 provides an overlapping of right extension 16 and left extension 18 such that no portion of the rear neck area is exposed after protective liner 10 is wrapped around the neck and secured.
  • Disclosed embodiments of protective liner 10 also may provide adjustability of right extension 16 and/or left extension 18 to accommodate a variety of sizes to fit an assortment of patient body types. Even more, embodiments of protective liner 10 may include dimensional sizes corresponding to cover a full range of patient sizes and thyroid shields. For example, the aforementioned multiple sizes may include child, small, medium large, extra-large.
  • protective liner 10 is configured to conform to the shape of the body of the patient and lying generally flat against the body of the patient such that relatively no bunching is permitted to, therby, allow exposure of a covered body portion and/or clothing material of the patient.
  • a radiation shield 22 is fitted and secured over protective liner 10 and around the neck of a patient.
  • radiation shield 22 is utilized as a thyroid shield employed to protect the thyroid region against exposure to radiation during a radiological process.
  • Radiation shield 22 may generally be designed to include a collar portion 21 which generally fits the patient at the thyroid region.
  • a portion 23 of radiation shield 22 may extend downwardly towards the chest region.
  • Extended arm portions 35, 37 of radiation shield 22 may wrap around the neck of a patient and connected together to secure radiation shield in position (e.g., see FIG. 4B).
  • radiation shield 22 is positioned over and on top of exterior surface 29 of protective liner 10.
  • protective liner 10 are designed to be larger and lie under radiation shield 22 wherein protective liner 10 is affixed by joining right extension 16 to left extension 18 behind the neck of a patient.
  • the dimensions of protective liner 10 are generally larger than the dimensions of radiation shield 22 in order to prevent radiation shield 22 from coming into direct contact with the patient and/or clothing worn by the patient. Accordingly, portions of radiation shield 22, for example, resting upon the chest and around the neck of the patient are shielded from direct contact with the patient by protective liner 10.
  • protective liner 10 acts as a barrier between the neck and chest of a patient and radiation shield 22. Once the radiological procedure is complete, radiation shield 22 is simply removed from the patient with no portion of radiation shield 22 coming into contact with the patient. Once radiation shield 22 is removed from the patient, protective liner 10 may be unsecured, removed and discarded, as discussed below.
  • protective liner 10 including, for example, main collar portion 12, chest portion 14, right extension 16 and left extension 18 may be formed as a unitary structure, such as from a pre-selected material as described herein.
  • Disclosed material utilized for protective liner 10 may include a soft, hypoallergenic, non-woven, latex-free, material. The material is pliable to achieve the shape of a body portion or region while remaining relative flat against a body contour thereof.
  • Select embodiments may include protective liner 10 as a fabric material that is fluid repellent to prevent sweat or other bodily fluid from penetrating the material.
  • the aforementioned fabric material may include non-woven fabric of an SMS (spun-melt-spun) plastic material, for example, having a prescribed tensile strength.
  • a coating may be applied to surfaces of the SMS material such as a polypropylene and polyethylene laminate to facilitate fluid repellency of the material.
  • Protective liner 10 may be supplied in a variety of colors including, for example, medical blue, green, white, purple or orange.
  • embodiments of the material of protective liner 10 may be printable, for example, to exhibit a logo or office design.
  • the material of protective liner 10 is also radio lucent, disposable and tear free.
  • a radiation device such as dosimeter 20 is provided, for example, on the exterior surface 29 of protective liner 10.
  • Any suitable connection means may be utilized to attach dosimeter 20, for example, to the exterior surface 29 of protective liner 10.
  • dosimeter 20 may be retrofitted within the material of protective liner 10.
  • Dosimeter 20 is generally disposed along a region of protective liner corresponding to a position over a prescribed body part being tested during a radiological process. In this case, dosimeter 20 is generally disposed at an area corresponding to a position over the thyroid region.
  • dosimeter 20 When radiation shield 22 is positioned over protective liner 10, dosimeter 20 will indicate (e.g., via change of color) whether any measured amounts of ionizing radiation have penetrated this area during a radiological procedure. Additional and/or alternative devices may be utilized as or in place of dosimeter 20 including, for example, Inlight® nanoDotTM utilized for diagnostic radiology, therapy, or any single point radiation assessment application.
  • FIGS. 5A-5C illustrate a first embodiment of protective liner 10 having a releasable fastener wherein one end of the collar has a fastening means with a weaker fastening strength than the other end of the collar.
  • exemplary embodiments of the invention may includes a loop element 26 and hook element 28 of a hook and loop fastener, i.e., a VELCRO® fastener.
  • hook element 28 is attached to the interior surface 27 of right extension 16 and loop element 26 is attached to the exterior surface 29 of left extension 18 by any suitable attachment means.
  • FIGS. 6A-6C illustrate a second embodiment of protective liner 10 having a releasable fastener such as an adhesive element 30.
  • adhesive element 30 may comprise double-sided tape.
  • One side of adhesive element 30 may be attached to the interior surface 27 of right extension 16.
  • the exposed side of adhesive element 30 may be utilized to join exterior surface 29 of left extension 18.
  • adhesive element 30 comprises double-sided tape
  • the exposed side of the double-sided tape may be covered with a removable cover until protective liner 10 is ready for use.
  • the removable cover is removed from the exposed side of the double-sided tape.
  • the exposed side of the double-sided tape i.e., adhesive element 30
  • adhesive element 30 may be affixed to exterior surface 29 of left extension 18 in order to secure protective liner 10 around the neck. It is expected that right extension 16 may overlap left extension 18 during fastening so that no portion of the neck area is exposed. Portions of adhesive element 30 are sufficiently provided in order to adjust right extension 16 and left extension 18 with respect to one another to allow the collar to accommodate a variety of bodily dimensions of the patient.
  • interior surface 27 of the collar rests substantially flat against the neck area of the patient. Additionally, interior surface 27 of chest portion 14 lies relatively flat against the chest of the patient.
  • FIGS. 7A-7C illustrate a third embodiment of protective liner 10 having a releasable fastener such as a slip-through-and-catch design.
  • the slip-through-and-catch design includes etched fastener portions 32 configured into the design of right extension 16. Outside edges 19 of right extension 16 taper towards the middle 44 to form reduced portions 41. Reduced portions 41 may taper back to increased portions 39 at outside edges 19. A series of reduced and increased portions may be formed from the surface of right extension 16 to create etched fastener portions 32. Therefore, a design of the etched fastener portions 32 forms reduced portions 41 between increased portions 39.
  • the material of protective liner 10 may be stamped out to form etched fastener portions 32.
  • spaces 43 are formed between increased portions 39. Any suitable number of increased portions 39 and reduced portions 41 may be formed on right extension 16 to provide adjustability of the collar around the neck of a patient, as described below.
  • the described embodiment provides a slot 34 to receive one or more increased portions 39 of etched fastener portions 32 therethrough to secure protective liner 10 around the neck of the patient. Slot 34 may fall into alignment with one of spaces 43 between increased portion 39, thereby fixing the collar in place around the neck of a patient.
  • the increased portions 39 surrounding space 43 act as stops and will prevent right extension 16 from becoming unfastened from slot 34. Any appropriate space may be selected to fit the collar securely around the neck of a patient. It is expected that right extension 16 may overlap left extension 18 during fastening so that no portion of the neck area is exposed.
  • Multiple spaces 43 are sufficiently provided in order to adjust right extension 16 and left extension 18 with respect to one another to allow the collar to accommodate a variety of bodily dimensions of the patient.
  • the length "z" of etched portions 32 along right extension 16 may be established between a range of sizes. For example, in one select embodiment, the length "z" is 5.50 inches.
  • FIGS. 8A-8C illustrate a fourth embodiment of protective liner 10 having a releasable fastener such as a button and snap design.
  • a button 36 is attached to the interior surface 27 of right extension 16 by any suitable attachment means.
  • a plurality of snaps 38 are attached to the exterior surface 29 of left extension 18 by any suitable attachment means.
  • button 36 may engage and couple with any one of snaps 38 to secure protective liner 10 around the neck of a patient. Coupling may occur by snap-fit arrangement. It is expected that right extension 16 may overlap left extension 18 during fastening so that no portion of the neck area is exposed.
  • FIGS. 9A-9C illustrate a fifth embodiment of protective liner 10 having a releasable fastener such as clip fastener and tab design.
  • a clip fastener 40 is attached to the interior surface 27 of right extension 16 by any suitable attachment means.
  • a plurality of tabs 42 are attached to the exterior surface 29 of left extension 18 by any suitable attachment means.
  • clip fastener 40 may engage and couple with any one of tabs 42 to secure protective liner 10 around the neck of a patient. Coupling may occur by clip fastener 40 latching onto one of tabs 42. It is expected that right extension 16 may overlap left extension 18 during fastening so that no portion of the neck area is exposed. Multiple tabs 42 are provided along the length of left extension 18 in order to provide selective adjustment of right extension 16 with respect to left extension 18, thereby allowing the collar to accommodate a variety of bodily dimensions of the patient.
  • interior surface 27 of the collar rests substantially flat against the neck area of the patient. Additionally, interior surface 27 of chest portion 14 lies relatively flat against the chest of the patient.
  • tabs 42 may be replaced with slots, wherein clip fastener 40 latches onto or hooks into the slot to fasten right extension 16 to left extension 18 at a prescribed position to secure protective liner 10 around the neck of a patient.
  • FIG. 10 illustrates a sixth embodiment of protective liner 10 having a releasable fastener such as tie design.
  • extended pieces of material extend from the collar of protected liner 10.
  • the extended pieces of material may form a right tie extension 31 and a left tie extension 33 as continuing pieces of material extending from right extension 16 and left extension 18, respectively.
  • components of protective liner 10 including, for example, main collar portion 12, chest portion 14, right extension 16, left extension 18, right tie extension 31 and left tie extension 33 may be formed as a unitary structure, such as from the pre-selected material, as described herein.
  • Each of the right tie extension 31 and the left tie extension 33 may comprise a width "w" established between a range of sizes.
  • An overall or total length of the top of the collar including right tie extension 31 and left tie extension 33 may comprise a length "p" established between a range of sizes.
  • interior surface 27 of chest portion 14 lies relatively flat against the chest of the patient.
  • tabs 42 may be replaced with slots, wherein clip fastener 40 latches onto or hooks into the slot to fasten right extension 16 to left extension 18 at a prescribed position to secure protective liner 10 around the neck of a patient.
  • the dimensions of protective liner 10 are generally larger than the dimensions of radiation shield 22 in order to prevent radiation shield 22 from coming into direct contact with the patient and/or clothing worn by the patient.
  • an overall or total length "1" of the collar i.e., main collar portion 12, right extension 16 and left extension 18
  • the diameter formed by wrapping the length "1" of main collar portion 12, right extension 16, and left extension 18 around the neck of a patient may be adjusted by moving and positioning right extension 16 with respect to left extension 18.
  • the described releasable fasteners unite right extension 16 with left extension 18 in an overlapped fashion thereby establishing an adjusted length and diameter of the collar when wrapped around the neck of a patient.
  • the adjusted length and diameter will meet the circumference dimensions of the neck of a patient during use. In doing so, the collar may be fit snugly around the neck of the patient and lie substantially flat against the body of the patient such that gathering or bunching of protective liner 10 material is significantly reduced or avoided.
  • each arm 16 or 18 measured from an edge of chest portion 14 to the end of arm 16 or 18 may be established between a range of sizes.
  • a thickness “d" the collar may be established between a range of sizes.
  • a design of chest portion 14 may include a straight portion, having a width "a,” extending from main collar portion 12 and terminating at a curved end portion.
  • the overall width "a” may be established between a range of sizes.
  • the length “c” of the straight portion of chest portion 14 may be established between a range of sizes.
  • the radius "R” of the curved end portion may be established between a range of sizes.
  • protective liner 10 includes an overall length "1" equaling approximately 24.00 inches, wherein the thickness "d" of the collar is approximately 3.00 inches.
  • the length of arms 16, 18 is approximately 8.00 inches.
  • the length "c” of the straight portion of chest portion 14 is approximately 5.00 inches, wherein the width "a” of the straight portion is approximately 8.00 inches.
  • a radius “R” of the curved portion is approximately 5.00 inches.
  • FIG. 11A illustrates an embodiment of protective liner 12 employing a retaining means to maintain a position of radiation shield 22.
  • Select embodiments may provide securing areas 50 disposed directly on exterior surface 29 for gripping and maintaining radiation shield 22 to thereby hold radiation shield 22 in position over top of protective liner 10. While two securing areas 50 are illustrated in FIG. 11 A, it is readily appreciated that more or less securing areas 50 may be provided. The dimensions of securing areas 50 may also vary in sufficiency for holding radiation shield 22 in place over top of protective liner 10.
  • An embodiment of securing areas 50 may include covering the entire exterior surface 29, such as, with a slip-resistant material; alternatively, only select portions of exterior surface may be covered.
  • Embodiments of securing areas 50 may include an adhesive and/or a tactile finish comprising a coefficient of friction sufficient for supporting and retaining radiation shield 22 in place over top of protective liner 10.
  • the adhesive area may be covered until such time for usage whereupon the cover is removed to expose the adhesive for securing radiation shield 22 thereto.
  • Such an adhesive is appropriately applied such that it is releasable by reasonable amount of force to remove radiation shield 22 therefrom.
  • Additional embodiments may employ other finishes or retaining means including, for example, double-sided tape. [0076] Turning to FIG. 1 IB, radiation shield 22 is fitted over protective liner 10 and retained in position via securing areas 50.
  • any variety of fastening means may be employed to retain protective liner 10 around the neck of the patient.
  • Securing areas 50 facilitate retention of radiation shield 22 in position over protective liner 10 so that it does not easily move with respect to protective liner 10.
  • radiation shield 22 When secured in the aforementioned manner, radiation shield 22 easily conforms to the shape of protective liner 10. Further, protective liner 10 protects the user from coming into contact with and possible contamination of radiation shield 22.
  • protective liner 10 may be packaged as individual liners, for example, aligned in a stacked configuration within a packaging container.
  • the total number of protective liners 10 with the packaging container may be preselected prior to packaging.
  • protective liner 10 may be stamped from a roll of material from which it is comprised (e.g. , SMS fluid-repellent material) and perforated such that individual protective liners 10 may be separated from other protective liners 10 within the same roll.
  • the stamping process may facilitate large production scale output of protective liners 10 to efficiently meet prescribed production demands. Suitable manufacturing equipment may be secured and employed to perform stamping and production operations, as necessary.
  • Select packaging options for protective liner 10 may include shrink wrapping and /or polybagging.
  • the material of protective liner 10 is generally foldable upon itself in any direction to facilitate storage and packaging for use. This includes any fluid repellent coating materials that may be applied to protective liner 10. There are no shelf life restrictions or claims imposed upon protective liner 10.
  • embodiments of the present invention provide a protective liner 10 that eliminates the need for cleaning and disinfecting radiation shields between patient use.
  • protective liner 10 adequately protect the radiation shield 22 from being soiled.
  • Protective liner 10 is applied and attached easily and comfortably to the patient. It remains attached through the radiological procedure and is easily removed from the patient after the procedure.
  • Protective liner 10 is disposable and is sized to cover a full range of patient sizes and radiation shields.
  • Embodiments of protective liner 10 are tear free and packaged to protect it from moisture and contamination.
  • the material of protective liner 10 is printable, yet radiolucent. The material is also comfortable and does not make the patient feel claustrophobic.
  • Disclosed embodiments of protective liner 10 offer no shelf life expiration.
  • Material embodiments of protective liner 10 may include a soft, hypoallergenic, non-woven, latex-free, material.

Abstract

L'invention concerne une chemise de protection comprenant un collier ayant une partie collier principale, une première extension s'étendant à partir de la partie collier principale dans une première direction, une seconde extension s'étendant à partir de la partie collier principale dans une seconde direction opposée à la première direction. Des modes de réalisation décrits peuvent comprendre une partie boîte s'étendant à partir de la partie collier principale. La chemise de protection peut également comprendre un organe de fixation détachable ajustable pour réunir la première extension à la seconde extension. L'organe de fixation détachable ajustable peut être disposé sur au moins l'une de la première extension et de la seconde extension, un matériau de la chemise de protection comprenant un matériau imperméable au fluide, non tissé.
PCT/IB2012/050953 2012-02-29 2012-03-01 Couvercle de protection pour un dispositif médical WO2013128240A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US13/408,582 US20130220344A1 (en) 2012-02-29 2012-02-29 Protective cover for medical device
US13/408,766 2012-02-29
US13/408,651 2012-02-29
US13/408,582 2012-02-29
US13/408,651 US8661573B2 (en) 2012-02-29 2012-02-29 Protective cover for medical device having adhesive mechanism
US13/408,766 US20130220343A1 (en) 2012-02-29 2012-02-29 Protective cover for medical device having etched fasteners
US13/408,699 US20130220342A1 (en) 2012-02-29 2012-02-29 Protective cover for medical device having a radiation detector
US13/408,699 2012-02-29

Publications (1)

Publication Number Publication Date
WO2013128240A1 true WO2013128240A1 (fr) 2013-09-06

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Application Number Title Priority Date Filing Date
PCT/IB2012/050953 WO2013128240A1 (fr) 2012-02-29 2012-03-01 Couvercle de protection pour un dispositif médical

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WO (1) WO2013128240A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020251468A1 (fr) 2019-06-14 2020-12-17 Ten Medical Design Ab Dispositif de protection contre les rayonnements

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4220867A (en) * 1978-07-18 1980-09-02 Bloch Winston N Jr Neck x-ray protective shield
WO1989000831A1 (fr) * 1987-08-03 1989-02-09 Tekton, Inc. Ecran absorbant le rayonnement
JPH07216606A (ja) * 1994-02-08 1995-08-15 Reiko Shimazaki 保温アンダーケープ
US5523581A (en) * 1994-09-23 1996-06-04 Wit, Inc. Slipcover for radiation shields
US20050211930A1 (en) * 1998-12-07 2005-09-29 Meridian Research And Development Radiation detectable and protective articles
US20090126088A1 (en) * 2007-08-14 2009-05-21 Yadav Sudhansu S Protective garment for use with radiation monitoring devices

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4220867A (en) * 1978-07-18 1980-09-02 Bloch Winston N Jr Neck x-ray protective shield
WO1989000831A1 (fr) * 1987-08-03 1989-02-09 Tekton, Inc. Ecran absorbant le rayonnement
JPH07216606A (ja) * 1994-02-08 1995-08-15 Reiko Shimazaki 保温アンダーケープ
US5523581A (en) * 1994-09-23 1996-06-04 Wit, Inc. Slipcover for radiation shields
US20050211930A1 (en) * 1998-12-07 2005-09-29 Meridian Research And Development Radiation detectable and protective articles
US20090126088A1 (en) * 2007-08-14 2009-05-21 Yadav Sudhansu S Protective garment for use with radiation monitoring devices

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020251468A1 (fr) 2019-06-14 2020-12-17 Ten Medical Design Ab Dispositif de protection contre les rayonnements
EP3982835A4 (fr) * 2019-06-14 2023-07-26 Ten Medical Design AB Dispositif de protection contre les rayonnements

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