Patent Application
20240188916
The present disclosure relates to the field of dental radiography and more specifically to a dental x-ray digital image receptor holder and corresponding intraoral plastic barrier.
The various aspects and embodiments of the invention described herein relate to the acquisition of dental x-rays. These images are obtained by means of x-radiation passing through the tissues of a patient's mouth onto an image receptor. Diagnostic quality intraoral radiographic images allow the dentist to diagnose carious lesions, apical infections, periodontal disease, some forms of oral cancer and many other conditions. In addition to their diagnostic value, radiographs are legal documents often presented as evidence in malpractice cases. It is crucial that dental auxiliaries obtain radiographs that meet the criteria for diagnostic quality. Therefore, the image receptor must be placed in the oral cavity with a degree of precision and held there stably. This can be challenging. Poor quality radiographs result in unnecessary exposure to ionizing radiation, missed diagnosis, and legal liability.
Dental professionals recognize the need for devices which hold the image receptor (such as film[[,]] or digital sensor or phosphor plates) where it is placed in the mouth. U.S. Pat. No. 4,866,750A discloses a device for positioning dental x-ray image receptor within the mouth for producing x-ray images. The methods and devices used to position the image receptor adjacent to the teeth have evolved as technology has progressed over the years. Devices that held traditional film packets produced reliable results for decades. However, since the invention of the wired digital image receptor to produce digital x-ray images, those holding devices no longer sufficed. U.S. Pat. No. 6,652,141 is an example of a digital image receptor which is incorporated here for background purposes.
It has become more difficult to position the digital image receptor to obtain diagnostic quality x-rays with the digital image receptor comfortably and with stability. There are many reasons for this. The mouth is a very sensitive area, where approximately 19% of the body's sensory receptors are located. It is relatively small and has many structures (tongue, teeth, tori, frenum), that take space. The wired digital image receptor is hard, inflexible and bulkier than film making it more uncomfortable in the mouth. When patients are uncomfortable, they are less cooperative making the task of obtaining diagnostic quality radiographs much more difficult and time consuming.
In addition, the wired digital image receptor is considered a semi-critical device because it is used in the mouth and contacts the patients' saliva. It is always assumed that saliva may contain microscopic amounts of blood therefore may be capable of transmitting pathogens such as Hepatitis C and HPV (Human Papilloma Virus). Semi critical items must be sterilized. There are two ways to effectively sterilize semi critical instruments. They may be immersed in liquid glutaraldehyde for ten hours or run through a 20-to-30-minute cycle of steam under pressure in the autoclave. Neither of these methods is possible for the wired digital image receptor because it is highly sensitive electronic device and would not function if it were to go through either sterilization process. Therefore, a thin plastic barrier is relied upon to isolate and separate a patient's germs from the digital image receptor and subsequent patients. There are significant drawbacks to relying on thin plastic to perform this important function; The plastic barrier is slippery and becomes even more so when covered in saliva. As a result, the operator may position the digital image receptor in the patient's mouth with care, but the plastic barrier may cause the digital image receptor to slip out of the holder and the precise position the operator has placed it. The two sides of the plastic barrier are joined by a seam which forms a raised ridge. This seam can feel sharp and uncomfortable to the patient's thin oral mucosa. The plastic is often loose, and the extra material can irritate and activate the patient's gag reflex. Of higher importance the plastic barrier is also fragile. The plastic barrier may become scored or torn during the procedure, becoming antithetical to its purpose. Small holes in the plastic allow saliva to enter the barrier creating a risk of cross contamination between patients. Even if the operator wipes the digital image receptor down with disinfectant, that is not effective to kill tenacious and virulent pathogens which may harbor on the digital image receptor (example given: the reservoir formed by the junction of the digital image receptor and the data cable). When the digital image receptor is thus contaminated and used on a subsequent patient, and that plastic barrier gets a hole, saliva enters and exits the plastic and the previous patient's germs may be introduced to the current patient's system. There is a very real risk that disease may be transmitted in this manner. “U.S. Pat. No. 7,004,627 B2 discloses a barrier and cushioning apparatus for use with sensors as a means to avoid contamination of the sensor while providing improved comfort through the use of a cushion that may incorporate an integrated adhesive portion for securing to a positioning device such as a sensor holder”.
Furthermore, traditional film packets are white, but the color of most digital image receptor is black or dark blue. The color matters because the inside of the mouth is dark. Without clear contrast, it is difficult to see a black or dark blue image receptor in the mouth especially when placing the digital image receptor sense in the visually obscured maxillary molar region.
A wide variety of dental x ray digital image receptor holders exist, and attempt to solve the issues of discomfort, and lack of stability.
U.S. Pat. No. 7,309,158, B2 a device attempting to address this problem. The plastic material and design are insufficient to fix that problem, instead it has introduced additional corners and bulk. However, there are problems with the existing sensor holders. The rigid structure of the sensor combined with the cable which connects the sensor to the computer dictates the manner that the sensor must be inserted into the sensor holding device. The requirement for holding the sensor in specific positions to obtain precise images are factors which limit how a sensor may be secured. The cable must be directed out of the patient's mouth. In most instances the side along which the cable exits the mouth becomes known as the anterior edge. No sensor holding device has succeeded in cushioning those corners because the rigid sensor must be inserted and removed from that side to obtain the periapical and bitewing images in the four quadrants of a patient's mouth. The anterior edge and adjacent corners often contact the thin sublingual oral mucosa, causing most patients significant discomfort. Edge ease U.S. Pat. No. 5,784,433A is a product that has long been used to cushion the edge of dental x-ray film. It has a smooth texture that is comfortable in the mouth. However, when moving the sensor to different quadrants within the mouth, the Styrofoam must be repositioned while taking a full mouth series of x-rays. Edge ease is fastened with adhesive which has a tendency to rip the plastic barrier when the operator pulls it off to reposition it. In addition, the Styrofoam material does not conform to the shape of the sensor resulting in added bulk further irritating the patients' tissues. Styrofoam cushioning sheaths (U.S. Pat. No. 9,643,355 B2) have extended corners and add bulk to the mouth triggering a patient's gag reflex. Padded foam bite tabs or Styrofoam bite tabs do nothing to alleviate patient discomfort. The biting surfaces of the teeth do not need a cushion the mucosa does. These do not prevent the anterior corners of the sensor from offending the patients' tissues. The comfort wand encircles the perimeter of the x-ray sensor but does not effectively retain the sensor. The sensor slips out of the wand easily due to the inelasticity of the material. In addition, its only application is as a wand. It is not designed for use taking bitewings or periapical images using the paralleling technique. Neither the sensor cushion, JP2007001194U or the sensor protector KR200303670Y1 have appendages or bite tabs for holding the sensor in position. No sensor holding device seeks to protect the integrity of the plastic barrier. Rather when inserting the sensor into the device some of these devices cause tears and holes.
Previous sensor holding devices designed for positioning the sensor for bitewings and periapical x rays are insufficient to: cushion the hard bulky sensor, improve the visibility for the operator, and are not custom encased by a material that is soft and smooth with all the corners rounded, none is of elastomeric material that stretches to contain the sensor and plastic barrier yet compresses the barrier to be as compact and imperceptible as possible, and none provides protection to improve the integrity of the barrier with durable material such as silicone. Accordingly, there is a need in the art for an improved holding device for holding an image receptor for dental x-rays.
It is therefore the objective of this invention to provide a digital image receptor holding system to address:
Comfort: This invention is made of soft, smooth, radiolucent, and elastomeric material which encases the digital image receptor on the surfaces that touch the patient's sensitive oral mucosal tissues. The material may be made of silicone, rubber, or other similar materials. The elastomeric nature of the material of this invention is unique in that it allows for the coverage and cushioning of every corner. The device encases the recording surface, all four sides, twelve edges and eight corners of the digital image receptor. The material extends partially around the side where the data cord is connected to the digital image receptor. Excess plastic from loose fitting barriers is compressed within the Sensorskinz holding device which reduces the perception of added bulk felt in the mouth.
Safety: This invention envelopes and improves the infection prevention integrity of the plastic barrier protecting it from rips and tears. The device touches human saliva and other potentially infectious material, therefore it must either tolerate the temperature and pressure of the autoclave or be sterilized in cold sterile. Alternatively, it may be disposable.
Stability and functionality: This invention contains the digital image receptor securely. It is made to fit the smallest digital image receptor and stretches to fit even the largest size of wired digital image receptors. The slippery surface of the plastic is covered which allows the digital image receptor to be held reliably where it is placed in the mouth. Bite tabs are required to take bite wing and periapical x-rays using the paralleling technique. Bite tabs made from a variety of rigid materials such as polyethylene may be integrated into the device, fabricated as one unit with the silicone image receptor skin perimeter in a plurality of positions and orientations to procure the required images. Alternatively, slots can be made in the fabric of the Sensorskinz holding device relative to the position of the Bite tabs of other sensor holding devices know in the industry. The Sensorskinz holding device can be slipped over the existing sensor holder through the slot in this manner the existing holding device has improved stability, retention and patient comfort.
Visibility: In addition, the color of the device appears white, but is not limited to white. Slight shades of radiolucent pigment may be used to quickly differentiate between the types of holders.
The features of the present invention can be more readily understood with the drawings herein and accompanying description.
To obtain diagnostic quality dental x-rays, dental personnel must place the digital image receptor (
When taking a full mouth series of x-rays with the wired digital image receptor sense 20 (
When taking a full mouth series of x-rays using the bisecting technique, the operator begins by placing a plastic barrier (25) over the digital image receptor (20) and the data cable (22). The digital image receptor and plastic barrier are placed inside the SnapJack with the rigid edge corresponding to edge of the digital image receptor. The SnapJack is then placed inside the jaws of the Snap-a-ray U.S. Pat. No. 8,641,275B2.
Previous holding devices did nothing to contain the corners and sharp seam of the plastic barrier. When placing the digital image receptor in the maxillary molar region it is common to trigger the gag reflex with the corner of the plastic barrier. The Sensorskinz holding device envelope the irritating plastic and compress the plastic barrier keeping the bulk of the device as compact as possible. Patients often complain that the hard bulking digital image receptor hurts their palate. The Sensorskinz holding device cushions the hard edges (
When placing the digital image receptor to obtain the mandibular premolar region previous holding devices allowed the hard anterior edges of the digital image receptor to irritate the thin sublingual mucosa. The Sensorskinz holding device unique opening combined with the elastomeric material allows for covering the anterior edges by inserting the digital image receptor into the Sensorskinz holding device via an opening (
Previously when taking a periapical x-ray with the Snap-a-ray it was common for the digital image receptor to slip out of the snap a ray due to the slippery plastic barrier. In addition, 0.5 cm of recording surface was lost due to the way it was previously held in the snap a-ray. The Snapjack (drawing not included) provides a stable nonslip edge which allows the snap a ray to secure the digital image receptor. The SnapJack “jacks up” the digital image receptor by providing a 0.5 cm rigid edge that elevates the digital image receptor from the jaws of the snap a ray recovering the lost recording surface.
This application claims priority from U.S. Provisional Patent Application No. 63/431,599, filed on Dec. 9, 2022, the contents of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63431599 | Dec 2022 | US |
