US 20090253981 A1
A marking tool for use in the context of radiological and other medical imaging is disclosed. The product is a marking tool for distributing an imaging material onto a patient's skin to mark that part of the patient's body for imaging. The imaging technician then knows the area of medical interest, such as an internal injury, and can image that area more accurately. The imaging material shows up on a resulting medical image such as an X-Ray, CT Scan, or MRI to direct a radiology professional to the most important area on the image for diagnostic purposes.
1. A marking tool for distributing an imaging material directly onto a patient's skin to indicate an examination area on the patient's skin and associated medical images, the marking tool comprising:
a hollow vessel having an opening at one end;
a closed chamber housing imaging material therein, wherein the closed chamber selectively releases the imaging material into the hollow vessel upon bending the hollow vessel and wherein the imaging material is released onto the patient through the opening in the hollow vessel.
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15. A marking tool for distributing an imaging material directly onto a patient's skin to indicate an examination area on the patient's medical images, comprising:
a substantially hollow vessel for holding the imaging material;
a tip at one end of said hollow vessel, said tip defining an opening to the interior of said hollow vessel for controlled distribution of said imaging material; and
an imaging material for distribution through said tip directly onto the patient's skin to mark the examination area.
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23. A marking tool for distributing an imaging material directly onto a patient's skin in a design that indicates an examination area on the patient's medical images, comprising:
a substantially hollow vessel defining an opening at a first end and a permeable bottom at a second end;
a skin stamp adjacent said permeable bottom;
an imaging material within said hollow vessel, wherein, said vessel releases said imaging material to flood said skin stamp through said permeable bottom.
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26. A marking tool for distributing an imaging material directly onto a patient's skin in a design that indicates an examination area on the patient's medical images, comprising:
a reservoir of imaging material in fluid communication with a patterned tape, wherein said patterned tape comprises raised ridges for absorbing said imaging material;
a stamping body for pressing said patterned tape onto the patient's skin to release said imaging material in a pattern on said patient's skin.
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30. A marking tool for distributing an imaging material directly onto a patient's skin in a design that indicates an examination area on the patient's medical images, comprising:
a marking head attached to said handle;
at least one applicator within said marking head for engaging a patient's skin, wherein said applicator is soaked with imaging material and distributes said imaging material onto the patient.
The invention relates to the field of radiology and includes tools for marking a patient's skin with an imaging material that is radiopaque or, depending upon the type of radiology, otherwise suitable to be visible on the image. The imaging material shows up as a visible indicator on both the patient's skin and the medical image associated with that area of the patient's body. The marking tool assists radiology professionals in achieving the highest quality medical image and in analyzing the image for proper diagnosis.
One of the biggest hurdles for a radiologist is the volume of images that must be analyzed every day for diagnostic purposes. Often, these images are collected from remote locations, such as individual physicians' offices or emergency centers. Medical professionals transmit the images to a central radiology unit where trained professionals “read” the image to determine the next course of action for treatment. Radiology professionals face the task of analyzing hundreds of images per day and providing a diagnosis for every patient in a timely manner. This pressure is compounded by the fact that the person reading the image may have no personal communication with the individual patient or with the person who actually performed the imaging. In some cases, the imaging specialist or attending physician sends a note with a brief explanation of the injury being imaged. Often, however, these notes are insufficient to give the radiologist reading the image a clear focus of the exact problem to look for on the multitude of images associated with a patient or group of patients.
As a result, the radiology professional's job is of an extremely broad scope, including the review of many different types of images and particular areas on those images. With better information regarding the actual area of medical interest on an image, the radiologist could focus the review to the most pertinent areas.
There is a need in the radiological arts, therefore, for a product that marks a patient's body to point out the most pertinent area on a corresponding radiological image.
Prior efforts to meet this need have included various attempts to add pointers to medical images. For instance, some imaging professionals place a foreign object on the patient during the scan to emphasize an area of interest to the person reading the image. Unfortunately, foreign objects also bring forth the possibility of obscuring a view of the medical problem on the image. Similarly, various directional arrows are sometimes placed on the image to direct the radiologist to a particular region on the scan. Unfortunately, these can be dislodged inadvertently, pointing to the entirely wrong area.
Still, however, with medical imaging taking on such high tech features as 3-D imaging and higher resolution scanning at various angles, efforts to incorporate directional arrows on an image do not meet the true needs of the radiologist.
Other efforts at marking a radiological image have been set forth in the patent literature and are summarized below.
U.S. Pat. No. 4,813,062 (Gilpatrick '062)
The Gilpatrick '062 patent describes a crayon-like marker composed of substances that are detectable by X-ray examination. Specifically, Gilpatrick discloses a crayon or marking pencil containing a radiopaque substance uniformly dispersed within a waxy medium (e.g., paraffin wax) that is used as a tool for applying a mark to an object for inspection.
The Gilpatrick '062 method for applying a radiopaque marker does not, however, disclose the use of such a device to indicate areas of interest on a medical patient. The stated use of the Gilpatrick device and method is to place a radiopaque mark on a substrate. Specifically, the radiopaque marker is intended for use in the context of textile inspection. Accordingly, Gilpatrick fails to disclose a method for using a radiopaque marker tool in a medical imaging process.
Because the Gilpatrick device is intended for use in textile examination, possible detrimental effects of human contact with certain radiopaque compositions may not have been considered by Gilpatrick. This lack of consideration is evidenced by the fact that the marker disclosed in the '062 patent focuses on compositions containing heavy metals (e.g., bismuth, lead), which in some forms can be toxic to humans.
U.S. Pat. No. 2,462,018 (Wood '018)
The Wood '018 patent also discloses a marker containing a material that is detectable by X-ray examination. Specifically, Wood discloses a crayon or pencil containing fine particles of radiopaque metal atoms in a carrier or vehicle material, such as a wax. Wood alternatively discloses the use of a brush or pen for applying a radiopaque substance in a liquid carrier. The marking device may then be used to apply an X-ray observable mark on the object to be inspected.
Like the Gilpatrick '062 patent, however, the Wood '018 patent discloses a number of heavy metals (e.g., lead, bismuth, uranium, thallium) as the appropriate radiopaque substances. In fact, Wood specifically focuses on lead and limits the list of appropriate materials to elements having an atomic weight of at least 184, which is even greater than the acceptable range noted by Gilpatrick. Thus, Wood likewise fails to disclose a radiopaque marker that is designed to be safe for use on medical patients.
Unlike Gilpatrick, however, the Wood '018 marker is disclosed for use in anatomical X-ray work. The disclosure of the use of the X-ray marker in a medical context is very limited, and appears that the use of the Wood X-ray marker is intended more for marking the plate or film for identification purposes than to mark the patient to pinpoint the site of injury.
U.S. Pat. No. 4,506,676 (Duska '676)
The Duska '676 patent describes a radiopaque identifier for identifying the location of concern on a medical patient so that the examining physician can communicate to an X-ray technician or diagnosing radiologist the area on a radiograph to be analyzed. Specifically, Duska discloses a tape provided with a series of radiopaque markings forming a dashed line along the center of the tape. The radiopaque material disclosed is barium sulfate, but Duska also notes that other pigments or powdered or finely divided material known to be opaque to X-radiation may also be appropriate. Accordingly, Duska discloses the use of safe radiopaque substances applied to a medical patient to identify the location of interest in medical imaging.
Duska does not, however, disclose any tool that applies the radiopaque substance directly to a patient's skin. The patent's disclosure is limited to a tape having radiopaque markings, so the examining physician is limited in the types of marks that can be made by the shape of the tape. Thus, although Duska discloses a radiopaque marking device and system that allows an examining physician to communicate the area of interest to later parties examining the resulting X-ray, the '676 patent fails to provide a better way to mark the skin in a visible manner so that the image is taken of the correct spot and the resulting picture is marked for diagnosing that spot.
U.S. Pat. No. 5,193,106 (DeSena '106)
The DeSena '106 patent describes a device for marking landmarks on the skin as a means of identifying areas of interest under x-radiography. The device involves a radiopaque material affixed to an adhesive tape. The radiopaque material may be formed into a variety of shapes, such as a circle, triangle, or square to provide a marker that encircles the point of interest. The markers are pre-cut and affixed to a roll of tape and distributed from a dispenser, so the markers can be easily dispensed.
DeSena does not disclose a pencil, pen, marker, or any other tool that applies the radiopaque substance, though. Further, the DeSena markers are limited in size and shape to the preformed stickers. In fact, DeSena notes that the markers disclosed are different from prior markers in that they are specifically designed to identify small areas. Accordingly, the examining physician is limited in the markings that can be made and may be especially limited if a relatively large area is the area to be analyzed. Thus, although DeSena discloses another form of radiopaque marker, the '106 patent likewise fails to disclose each and every element of the current invention
This review of the pertinent art shows that none of the published material or known products on the market fully address the radiologists' problems of image placement during the patient scanning process or image marking to focus the radiologists' review. The invention herein is, therefore, an important advancement over all prior work in the related fields.
The invention is a tool and an associated method of distributing a radiopaque material directly onto the skin of a patient in a medical environment to highlight an area of medical interest on a radiological image. The radiopaque material is visible on the patient's skin to assist medical personnel in taking an image of the most useful area for diagnosis. Accordingly, the radiological image shows an area of a patient's body with an opaque marker highlighting the most useful part of the image for diagnosis. The radiopaque material shows up on the image but does not block the view of an underlying internal condition that the patient is experiencing.
In other embodiments, the invention is a tool for distributing the radiopaque material onto the patient's skin. The distribution tools described herein are compact, portable, and useful for more than one application to different patients while maintaining sterility and appropriate hygienic standards. Without limiting the scope of the invention in any way, the tools disclosed herein include technology for swabbing the radiopaque material onto the patient with a disposable applicator, stamping the radiopaque material onto the patient's skin, and drawing on the patient's skin with radiopaque media via an applicator.
The invention is a device and method for marking a patient's body with a suitable substance to identify a location of medical interest, such as the site of a patient's injury. The marking substance, or imaging material, is selected to show up on medical images associated with that patient so that a radiologist or clinician evaluating the images can easily determine the exact site of medical interest. The imaging material further marks the patient's skin to assist the person preparing the image in the first place.
The invention is intended to be used in any setting where medical images are used for diagnosis. Accordingly, the term “medical image” is used in its broadest sense and includes, but is not limited to X-rays, CT scans, fluoroscopy, and MRI technology.
The invention includes the use of specialized substances, referred to herein as “imaging materials” that show up on a medical image to mark the area of medical interest without obscuring the view of important features. The imaging material may be contained in a dispenser capable of placing a small, quick-drying mark on the patient. In a preferred embodiment, the imaging material is visible on the patient's skin to assist the person preparing the patient for imaging in identifying the optimal location. The imaging material has a sufficient concentration to be visible to medical imaging devices (e.g., appears on x-ray films, CT scans, and MRIs), and yet it is not so dense that it obscures the image.
The imaging material is selected based on the type of medical imaging used. For example, compositions containing barium or iodine are suitable for radiographic imaging (i.e., x-ray); dilute iodine-based substances may be appropriate for use with computed tomography (CT); oil based substances, such as Vitamin E or flax seed oil mixtures, and gadolinium compositions are used for magnetic resonance imaging (MRI). In general terms, the imaging material incorporates a substance for highlighting an examination area on both a patient's skin and an associated radiological image. The radiological images include, without limitation, CT scans, MRI, X-ray, and fluoroscopy technology. The invention incorporates the use of any material that is safe for application directly onto a patient's skin and that will show up as a marker on an associated radiological image. Regardless of the application, the imaging material used in this context is safe for skin contact.
The imaging material may be selected from a variety of colors appropriate for the patient's skin tone, the radiologists' goals in providing certain information on the skin, and the availability of particular pigments for the desired application. In the most preferred embodiment, the imaging material should be of a color, consistency, and density that allows the material to dry onto the skin quickly without running or smearing. The imaging material should further be of the appropriate density to show up on a medical image as a marker without completely obscuring the view of the underlying area of medical interest within the patient's body. The imaging materials described herein include versions that are appropriately diluted for use in any particular situation.
The substance may be applied as a liquid or paste dispensed from a device that is convenient to use in a medical setting. The device, or marking tool, may take any form that produces a quick-drying mark that may be quickly and easily placed on the patient without causing any discomfort. In a preferred embodiment of this invention, the marking tool applies the imaging material directly to the patient's skin prior to completing the imaging.
The marking tool (10) may be in the form set forth in the attached figures and the following claims. In a first embodiment, the marking tool (10) includes a substantially hollow vessel (15) for holding the imaging material (13). The marking tools of this invention include a tip (17) at one end of the hollow vessel (15) to define an opening to the interior of the vessel (15) for controlled distribution of the imaging material (13). By using the marking tool (10), a radiology professional can apply an imaging material (13) for distribution through the tip (17) directly onto the patient's skin to mark the examination area.
As shown in
In a most preferred embodiment of the device of
One useful feature of the marking tool (10) is that it is adapted for use with imaging materials (13) that dry or otherwise stay on the skin so that an imaging technician can use the mark to ensure more accurate scanning. Furthermore, the imaging material (13) shows up on the image (usually an X-ray, CT scan, or MRI) for diagnosis by another medical professional. The image on the scan pinpoints areas of medical inquiry to allow a radiologist to focus the review on the most critical areas within an image.
In a different embodiment of
Using a separate chamber (25, 50) in any embodiment of this invention may be generally preferred for better control over distribution or for allowing a marking tool (10, 35) to be re-used by simply incorporating a new chamber (25, 50) full of imaging material (13) when the prior chamber runs dry.
As shown in
Using a removable, disposable tip (42) on the marking tool (35) of
Various embodiments of the removable, replaceable tip (42) are also available for use in this embodiment. In the examples of
In a different embodiment of
If the chamber (50) incorporated into the device of
The vessels that house and distribute the imaging material of this invention are in no way limited by the figures and discussions above. The vessel can take the shape of any container capable of distributing the imaging material (13), including but not limited to vessels that squirt or spray the imaging material directly onto the patient. For vessels that spray the imaging material, the invention encompasses all peripheral devices such as straws or nozzles that direct the spray in a desired manner. The vessel, then, includes embodiments such as aerosol containers or pump action bottles configured for the application at hand.
The sealing cap (61, 67) on each wick (60, 66) in
The nesting feature of the marking tools (55, 65) shown in
In the dispenser (80), the retention lip (89) engages the body (68) of the marking tool (65) that is in line for dispensing next. The body (68), therefore, includes the grip (67) with ridges (102) that pass through the retention lip (89). The body (68) of the marking tool (65), however, engages the retention lip (89) and rests against the lip (89). In this embodiment, the body (68) of the marking tool (65) includes a protrusion (104) that is sufficiently wide for the retention lip (89) to hold the body (68) back. As shown in
In use, then, the dispenser of
The embodiment of
The embodiments depicted in
The next embodiment of the marking tool according to this invention is shown in
In the embodiment of
In using the marking tool (200) of
The marking tool of
The patterns are in no way limited to any one design. Useful designs include, but are not limited to, grids as shown in
In one embodiment, the marking tool of
In operation, the marking tool (300) is useful for pressing the stamping body (318) onto the patient's skin with the patterned tape (302) between the stamping body and the skin. In this way, the ridges (303) on the patterned tape (302) release the imaging material (13) absorbed therein and form a pattern of imaging material (13) onto the patient. Again, the pattern of imaging material is visible to the technologist setting up and operating the imaging machinery. The imaging material (13) pattern also shows up on the associated medical image without obscuring the underlying medical condition.
To use the marking tool (300) of
After rolling the patterned tape (302) to the appropriate marked positions, the patterned tape (302) from the dispensing roller (310) passes in compressed engagement with the sponge (328) soaked with imaging material (13). The degree of compression between the patterned tape (302) and the sponge (328) is sufficient to soak completely the ridges (303) that form the pattern on the tape (302). For a clear image on the patient's skin, the degree of compression between the patterned tape (302) and the sponge (328) should minimize the amount of imaging material dispersed on portions of the patterned tape (302) other than the design ridges (303). The amount of compression is controlled by a spring (327) connected to the body of the marking tool (300) and pushing against the sponge (328). The spring (327), therefore, biases the sponge to remain in contact with the patterned tape (302). By winding the take-up roller (311), the dispensing roller (310) moves in conjunction to pull the patterned tape (302) across the saturated sponge to allow the absorbent ridges (303) to become fully engorged with imaging material (13). Once the patterned tape (302) has been placed in proper position, the user presses the stamping body (318) against the patient's skin. The stamping body (318) exerts sufficient compressive force on the patterned tape (302) so that the ridges (303) expel the imaging material (13) onto the patient's skin in a desirable imaging pattern.
The embodiment of
The patterned tape (302, 350) of both
Both embodiments shown in
The marking head (420) includes multiple wicks (415) that are soaked in imaging material (13). To ensure that the marking head wicks (415) remain saturated during periods of storage, the marking head (420) includes imaging material reservoirs (422) in fluid communication with each wick (415) to constantly supply imaging material to the wicks.
To ensure that the handle (410) is reusable, the marking heads may be stored and sold in the cartridge format of
The invention herein is sufficiently broad to account for various other means of applying the imaging material to skin stamp. Of course, a traditional ink pad could be used in conjunction with the marking tool by pressing the marking tool with a skin stamp thereon against a pad soaked with imaging material. In this embodiment, an entire stack of skin stamps could be affixed to the bottom of the marking tool, one attached to the other with a releasable adhesive. As the bottom stamp is used, that skin stamp is peeled away and the next skin stamp is made available. To ensure complete sterility, the invention may include a release layer, or peel away strip of paper, between each skin stamp.
In a marking tool according to this invention, the skin stamp comprises a uniform design of raised ridges for placing a planned pattern of imaging material directly onto a patient's skin. When that pattern is retained on the skin by drying or otherwise, the radiologist will have a mapping diagram visible on the skin to plan medical intervention with needles or other tools. When a medical imaging test is performed on the patient, the imaging material design also shows up on the image to inform the radiologist even further in treating the patient. This is especially useful in tracking imaging material position on the skin with the imaging material that shows up on the medical image. For example, if the imaging material is placed on the skin in a series of visible hash marks, those same marks will show up on the image to help the radiologist pinpoint better locations of medical interest by counting the marks.
The invention herein is adaptable to multiple tools that implement this new method of indicating an examination area on a patient's medical images by distributing imaging material directly onto the patient's skin. The descriptions of the embodiments noted above are in no way limiting of the devices that could be used to form radiological markings directly onto a patient's skin. Many different adaptations of this invention are available to ensure that a patient is marked with imaging material forming patterns on the skin that are visible on the patient and visible on the medical images associated with that patient's medical condition. The invention is further intended for all medical purposes, including but not limited to treatment of the human population as well as veterinarian applications.
Those having skill in the art will recognize that the invention may be embodied in many different types of hollow vessels with distribution tools for imaging material. For example, the invention described herein may be adjusted for use in a sterile environment such as an operating room or a clean-room portion of a laboratory. Accordingly, the invention is not limited to the particular structures illustrated herein.
In the drawings and specification there has been set forth a preferred embodiment of the invention, and although specific terms have been employed, they are used in a generic and descriptive sense only and not for purposes of limitation, the scope of the invention being further defined in the claims.