Oral ultrasound probe and method of use
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- ORAL DIAGNOSTIX LLC
- Filing Date
- 2024-02-14
- Publication Date
- 2026-06-26
Smart Images
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Abstract
Description
Technical Field
[0001] Cross - reference to Related Applications This application claims the priority of U.S. Provisional Patent Application No. 62 / 524,196, filed on June 23, 2017, the entire disclosure of which is incorporated herein by reference.
[0002] The present invention relates to an oral probe for ultrasonic imaging of the jaws, i.e., the temporomandibular joints.
Background Art
[0003] Temporomandibular disorder (TMD) is one of the major public health problems representing a group of potentially debilitating symptoms, affecting approximately 5 - 12% of the U.S. population. TMD is the second most common musculoskeletal disorder (after chronic low back pain), associated with pain and physical impairment, and in many cases, is a result of mechanical dysfunction of the temporomandibular joint (TMJ) where the disc is displaced. Painful TMD can affect an individual's daily activities, psychosocial function, and quality of life. In studies on disc displacement, it has been shown that the clinical approach for evaluating disc displacement can lead to a diagnosis only when the sensitivity is as low as 0.34 - 0.54 Vp - p. Therefore, imaging is required to improve clinical diagnosis, treatment decision - making in individual presentations, and confirmation of the diagnosis results of disc displacement.
[0004] Current TMJ imaging techniques include panoramic radiography, cone - beam CT (CBCT) (only for hard tissues), and magnetic resonance imaging (MRI). There are several barriers to the widespread use of these techniques and their effectiveness in TMD diagnosis. For example, panoramic radiography and CBCT involve the medical risk of exposure to ionizing radiation, both CBCT and MRI are costly, access to MRI located in hospitals and medical imaging laboratories is limited, there are concerns about claustrophobia related to patients and management requirements for reducing associated anxiety. Arthrography was also previously used for imaging but has been discontinued due to its invasiveness.
[0005] Previous attempts to develop ultrasound imaging of the TMJ were not optimal. This was because the imaging probes used were large and limited the imaging approach to only the axial and coronal planes of the biostructure, allowing images to be acquired only from the outside of the patient's face. Bone acts as a barrier, limiting the penetration of sound waves to the surface of the entire TMJ soft tissue biostructure. Even if the ultrasound energy had sufficient penetration capacity to image the entire axial and coronal biostructure of the TMJ, imaging only these two biostructure planes is insufficient to adequately depict disc displacement. In the study, the specificity achieved with the lateral imaging approach, as shown in Figure 1, was only 22.8% for disc displacement in the closed-mouth position and zero for disc displacement in the open-mouth position.
[0006] Figure 1 shows suboptimal ultrasound imaging performed externally with a large probe. External facial approaches are not clinically accepted for the following reasons: 1) sound penetration is severely limited by the prominent contours of the TMJ's condyles, tuberosities, and zygomatic arch bones; and 2) imaging is limited to depiction only in the axial (transverse) and coronal (longitudinal) planes. The external bones act as a barrier, limiting sound wave penetration to the surface of the TMJ's biostructure. Comprehensive literature and clinical experience from contrast-enhanced tomography, CT, and MRI of the TMJ have shown that sagittal plane imaging is preferable for effective and accurate depiction of TMJ disc displacement.
[0007] Therefore, a key feature of standard medical ultrasound imaging is the ability to accurately depict dynamic TMJ function, which is a necessary imaging modality. [Overview of the Initiative] [Problems that the invention aims to solve]
[0008] This invention was made to solve the problems of the prior art described above. [Means for solving the problem]
[0009] An oral ultrasound probe for imaging the temporomandibular joint, comprising: a handle portion having a longitudinal axis and configured to be connected to a power source; and an oral portion that is angled toward the head and positioned at a certain angle of action with respect to the longitudinal axis of the handle portion, and configured to emit and receive sound waves. The angle of action of the oral portion is preferably acute.
[0010] In one embodiment, the operating angle is less than 45 degrees and / or about 30 degrees. In a particular embodiment, the handle portion has a longitudinal length, the length of the oral portion is about one-third of the longitudinal length of the handle portion, the handle portion has a first width, the oral portion has a second width, the second width is greater than the first width, the handle portion and the oral portion are substantially the same thickness, this thickness is less than or equal to the first width, the handle portion and the oral portion define substantially flat sides and a thickness which is the distance between those sides, the distal end of the oral portion is rounded, the oral portion includes a transducer aperture configured to radiate and receive sound waves at its distal end, the handle portion is connected to a power source via a power cable, or the power source is at least one battery connected to the handle portion and / or the power source is coupled to or part of a control device.
[0011] A method for imaging the temporomandibular joint using an oral probe having a handle portion and an oral portion, and being angled toward the head, comprising the steps of: holding the handle portion of the oral probe; inserting the oral portion into a recess in the patient's mouth between the cheek and the gums such that the transducer aperture of the oral portion of the oral probe is substantially facing the temporomandibular joint; and generating an image of the temporomandibular joint in at least the anatomical sagittal plane by emitting and receiving sound waves through the transducer aperture of the oral portion of the oral probe.
[0012] In one embodiment of the method, images of the temporomandibular joint in all anatomical planes, including the axial, coronal, and sagittal planes, are generated by the step of emitting and receiving sound waves. In another embodiment, the method further includes the steps of controlling the amplitude, frequency, and duration of sound waves emitted from the transducer aperture of the oral probe, and / or connecting the oral probe to a power source. In a particular embodiment of the method, the oral portion of the oral probe is positioned at a certain angle of action with respect to the longitudinal axis of the handle portion, the angle of action is acute, and the angle of action of the oral portion is approximately 30 degrees, the handle portion and the oral portion define substantially flat sides and a thickness which is the distance between those sides, the handle portion has a first width, the oral portion has a second width which is greater than the first width, and / or the distal end of the oral portion of the oral probe is rounded.
[0013] By referring to the following detailed description and considering it in conjunction with the attached drawings, the present invention and many of its associated advantages will be better understood, and their legitimate value will be more fully and easily recognized. The attached drawings are as follows. [Brief explanation of the drawing]
[0014] [Figure 1] This is a schematic diagram of a prior art method for imaging the temporomandibular joint. [Figure 2A] ~ [Figure 2C] These are perspective and elevation views of an oral probe according to one exemplary embodiment of the present invention. [Figure 3A] ~ [Figure 3C] This is a schematic diagram of an exemplary probe orientation and window for imaging the temporomandibular joint inside a patient's mouth according to the present invention. [Figure 4] This is an illustrative sonogram image of the temporomandibular joint generated according to the present invention and method. [Modes for carrying out the invention]
[0015] The present invention relates, in general terms, to an oral ultrasound probe 10 for imaging the oral cavity (e.g., temporomandibular joint) of a patient for the diagnosis and treatment of disc displacement disorders, and to a method of using the same. Preferably, the present invention provides oral sagittal high-resolution dynamic ultrasound as an effective imaging modality for depicting the structure and function of the temporomandibular joint (TMJ). The present invention can be an imaging tool capable of detecting TMJ disc displacement, evaluating the onset and progression of the disease, facilitating long-term diagnosis, and monitoring treatment outcomes. In particular, the present invention promotes imaging of TMJ disc displacement, complementing the patient's medical history and clinical examinations, providing dynamic TMJ imaging for improving the clinical research and imaging capabilities of practicing clinicians in the diagnosis and treatment of TMJ disorders, enabling multidimensional visualization of the joint, which is especially useful for routine screening of patients with joint dysfunction, and providing images that clearly show the structure of the disc, or the structure as part of the joint capsule or joint exudate, and is ergonomically designed to optimize patient comfort.
[0016] The intraoral ultrasound imaging achieved by the present invention can be used in clinical settings to screen for disc displacement in TMD patients. Other advantages of the present invention include providing a non-invasive procedure, eliminating the risk of ionizing radiation, enabling 3D and 4D imaging of joint function and mechanism, being easy to use and portable, being an interactive point-of-care clinical assistant, and being inexpensive.
[0017] Ultrasonography is a highly advanced medical technology that eliminates or minimizes many of the current shortcomings in TMJ diagnosis. One advantage of the present invention is that ultrasound imaging of TMD is expected to be more readily available and have a wide range of applications in augmented clinical diagnosis, screening for asymptomatic disease, and research.
[0018] The oral probe 10 of the present invention is designed to acquire an ultrasound image of the TMJ through an oral soft tissue window 200 that depicts the anatomical sagittal plane and has sufficient imaging depth to encompass the entire biostructure of the joint. Preferably, the probe 10 of the present invention will influence this field of study and provide oral sagittal imaging for use in point-of-care clinical diagnosis.
[0019] The ultrasound probe (or transducer) 10 generates sound waves that bounce off body tissue to form echoes, and further receives these echoes and sends them to a control device or computer 12, which uses the echoes to generate an image or sonogram. The probe 10 is configured to be connected to a power supply 14, which may be separate from the control device 12 or may be part of the control device 12. The control device 12 also performs calculations and is capable of displaying and / or printing the processed image. In one embodiment, the probe 10 is connected to the power supply 14 via a power cable C. Alternatively, the power supply 14 may be one or more batteries connected to or housed in the probe 10. The control device 12 may further include pulse control to change the amplitude, frequency, and duration of the sound waves emitted from the probe 10.
[0020] The probe 10 is designed to be acoustically, mechanically, and electrically optimized. For example, the probe 10 may have a wide bandwidth (at least over 70% bandwidth) with a center frequency of 8-10 MHz, 32 elements, a pitch of approximately 0.3 mm, and a height of approximately 3.5 mm. In the acoustic design of the probe 10, the piezoelectric composite material may be integrated with matching layer and backing components optimized for high resolution in a shallow depth range (e.g., 40-45 mm). The electrical design of the probe 10 may consist of dedicated circuits that enable a minimal probe size structure. The probe cable exit 122 may be reduced to a minimum circumference.
[0021] As shown in FIGS. 2A to 2C, the oral probe 10 generally includes a handle portion 102 configured to facilitate gripping and operation of the probe 10, and an oral portion 104 configured to be inserted into a patient's oral cavity for ultrasonic imaging of the temporomandibular joint. The probe 10 preferably has an ergonomic configuration that allows the patient to feel at ease even when the probe 10 is inserted into the patient's oral cavity. The probe 10 may be particularly optimized ergonomically to fit snugly between the cheek and the gum in the soft tissue recess of the posterior upper jaw region in the oral cavity. The ergonomic configuration of the probe 10 may include substantially flat sides 106 and 108, and opposing, generally rounded edges 110 and 112 extending between the sides 106 and 108. In a preferred embodiment, the thickness T at the edges 110 and 112 of the probe 10 is relatively thin, so that the probe 10 has a substantially flat shape (especially when compared with the rounded shape of conventional probes), which is similar to a spatula.
[0022] The ergonomic configuration of the probe 10 is further preferably compact and not bulky or rectangular with squared edges like some conventional probes. The distal end 118 of the oral portion 104 may be rounded for further patient comfort. The length of the oral portion 104 is preferably shorter than the length of the handle portion 102. For example, the oral portion 104 may be about one-third the length of the handle portion 102. In one embodiment, when the overall length of the probe 10 is about 5.66 inches or about 14 cm, the length of the oral portion 104 is about 1.88 inches or about 4.5 cm and the length of the handle portion 102 is about 3.77 inches or about 9.5 cm. The width W1 of the oral portion 104 is preferably greater than the width W2 of the handle portion 102. The width W1 of the oral portion 104 may be, for example, about 0.45 inches or about 1.1 cm. The thickness T of the probe 10 is preferably the same in both the handle portion 102 and the oral portion 104 and preferably not more than the width W2 of the handle portion 102. The thickness T may be, for example, about 0.35 inches or about 0.9 cm. The ergonomic and compact design of the probe 10 further enables it not to restrict the movement of the patient's jaw during imaging of the patient's jaw, thereby obtaining a more accurate image of the movement of the TMJ and further enhancing patient comfort.
[0023] The oral portion 104 is disposed at an angle of action α with respect to the longitudinal axis 114 of the handle portion 102 and is shaped like a reversed U facing the head, which is for optimizing the imaging of the temporomandibular joint and patient comfort when the oral portion 104 is inserted into the patient's mouth. The angle of action α is preferably less than 90 degrees, more preferably less than 45 degrees, and most preferably about 30 degrees. The oral portion 104 is configured to emit and receive sound waves via the transducer aperture 120. In a preferred embodiment, as best shown in FIGS. 2A and 2C, the transducer aperture 120 is disposed at or near the distal end 118 of the oral portion 104.
[0024] Ultrasound imaging according to the present invention can be performed using pulsed echo technology, in which sound waves / energy are sent and received, for example, through an oral portion 104 and an aperture 120. The oral probe 10 converts electrical energy into short pulses of high-frequency sound energy, which are sent into the patient's tissue. The probe 10 then acts as a receiver, detecting echoes of the sound energy reflected from the tissue. Real-time images of the moving patient's tissue can be generated and displayed by a control device 12 that depicts the movement of the TMJ condyles, discs, and muscles. According to the present invention, images of any anatomical plane (virtual plane), namely the axial plane (or horizontal plane), coronal plane (or vertical plane), and sagittal plane (or median plane), can be generated. The anatomical axial plane divides the body into the cranial and caudal (head and foot) parts, the anatomical coronal plane divides the body into the dorsal and abdominal (posterior and anterior) parts, and the anatomical sagittal plane divides the body into the left and right parts. The oral probe 10 is designed to obtain images of the TMJ in the sagittal plane as well as the axial and coronal planes, thereby achieving the most effective and accurate depiction of the TMJ, including the disc, condyles, and fossa (and their movements) of the TMJ.
[0025] Optimal visualization of the temporomandibular joint (TMJ) can be achieved through the oral window 200 (between the cheek and gums), where sound can be transmitted effectively due to the absence of bone. Figures 3A-3C are schematic diagrams of preferred orientations of the oral probe 10 of the present invention, showing how the probe 10 should be positioned in the window 200 between the cheek and gums above the maxillary arch to obtain sagittal ultrasound images of the condyles and discs of the temporomandibular joint, free from bone obstruction.
[0026] A method for imaging the temporomandibular joint according to the present invention, using an oral probe 10, mainly includes the steps of: connecting the oral probe 10 to a power source, holding and manipulating the handle portion 102 of the oral probe 10; and inserting the oral portion 104 of the oral probe 104 into a window 200 between the cheek and gums in the patient's mouth, such that the transducer aperture 120 of the oral probe 104 substantially faces the temporomandibular joint. After the probe 10 is properly inserted and positioned in the patient's mouth, it is activated to emit and receive sound waves through the transducer aperture 120, thereby generating (by software and control device 12) an image of the temporomandibular joint, at least in the anatomical sagittal plane, preferably in all anatomical planes, i.e., the axial, coronal, and sagittal planes. The amplitude, frequency, and duration of the sound waves emitted from the transducer aperture 120 of the oral probe 10 may be controlled and adjusted by the control device 12.
[0027] In open-label preliminary observations, the present invention yielded the first TMJ images acquired by sagittal oral sonography. In all joints of the subjects, the condyles and their inferior surfaces were visible, as shown in Figure 4. The condyle (C) is a rounded prominence at the end of the bone for articulation with another bone, oriented vertically and hypoechoic, while the inferior surface of the condyle is arched, echogenic, and has a cap-like appearance (the small arrowhead in Figure 4). The condyle is also identifiable by its translational and rotational movements due to jaw opening and closing.
[0028] Although the present invention has been described by selecting specific embodiments, various changes and modifications may be made to those embodiments, as will be understood by those skilled in the art, as long as they do not deviate from the scope of the invention as defined in the appended claims. [Note 1] An oral ultrasound probe for imaging the temporomandibular joint, A handle portion having a longitudinal axis, the handle portion being configured to be connected to a power source, The oral portion is shaped like a "V" towards the head and is positioned at a certain angle of action with respect to the longitudinal axis of the handle portion, and is configured to emit and receive sound waves. Includes, The angle of action of the oral portion is acute. Oral ultrasound probe. [Note 2] The oral ultrasound probe described in Appendix 1, wherein the operating angle is less than 45 degrees. [Note 3] The aforementioned operating angle is approximately 30 degrees, as described in Appendix 1, for the oral ultrasound probe. [Note 4] The oral ultrasound probe according to Appendix 1, wherein the handle portion has a certain longitudinal length, and the length of the oral portion is about one-third of the longitudinal length of the handle portion. [Note 5] The oral ultrasound probe according to Appendix 1, wherein the handle portion has a first width, and the oral portion has a second width, the second width being greater than the first width. [Note 6] The oral ultrasound probe as described in Appendix 5, wherein the handle portion and the oral portion have approximately the same thickness, and the thickness is less than or equal to the first width. [Note 7] The oral ultrasound probe according to Appendix 6, wherein the handle portion and the oral portion define a substantially flat side surface and the thickness which is the distance between the side surfaces. [Note 8] The oral ultrasound probe described in Appendix 7, wherein the distal end of the oral portion is rounded. [Note 9] The oral ultrasound probe according to Appendix 1, wherein the oral portion includes a transducer aperture configured to emit and receive the sound waves at its distal end. [Note 10] The oral ultrasound probe according to Appendix 1, wherein the handle portion is connected to the power source via a power cable, or the power source is at least one battery connected to the handle portion. [Note 11] The oral ultrasound probe described in Appendix 10, wherein the power supply is coupled to or is part of the control device. [Note 12] A method for imaging the temporomandibular joint using an oral probe having a handle portion and an oral portion, and being angled toward the head, The steps include: holding the handle portion of the oral probe, The steps include inserting the oral portion of the oral probe into a recess in the patient's mouth between the cheek and gums such that the transducer aperture of the oral portion of the oral probe is substantially facing the temporomandibular joint, The steps include generating an image of the temporomandibular joint in at least the anatomical sagittal plane by emitting and receiving sound waves through the transducer aperture of the oral portion of the oral probe, A method that includes this. [Note 13] The method according to Appendix 12, wherein the step of emitting and receiving sound waves generates images of the temporomandibular joint in all anatomical planes, including the axial, coronal, and sagittal planes. [Note 14] The method according to Appendix 12, further comprising the step of controlling the amplitude, frequency, and duration of the sound waves emitted from the transducer aperture of the oral probe. [Note 15] The method described in Appendix 12, further comprising the step of connecting the oral probe to a power source. [Note 16] The method according to Appendix 12, wherein the oral portion of the oral probe is positioned at a certain angle of action with respect to the longitudinal axis of the handle portion, and the angle of action is acute. [Note 17] The method according to Appendix 16, wherein the angle of action of the oral portion is approximately 30 degrees. [Note 18] The method described in Appendix 12, wherein the handle portion and the oral portion define substantially flat sides and a thickness which is the distance between the sides. [Note 19] The method according to Appendix 18, wherein the handle portion has a first width, and the oral portion has a second width, the second width being greater than the first width. [Note 20] The method according to Appendix 12, wherein the distal end of the oral portion of the oral probe is rounded.
Claims
1. An oral ultrasound probe for imaging the temporomandibular joint, A handle portion having a longitudinal axis, the handle portion being configured to be connected to a power source, The mouth portion is shaped like a "V" towards the head and is positioned at an angle of action with respect to the longitudinal axis of the handle portion, and is configured to emit and receive sound waves. The aforementioned operating angle is approximately 45 degrees or approximately 30 degrees. The oral portion includes a transducer aperture at its distal end that is configured to emit and receive the sound waves. Oral ultrasound probe.
2. The oral ultrasound probe according to claim 1, wherein the handle portion has a certain longitudinal length, and the length of the oral portion is about one-third of the longitudinal length of the handle portion.
3. The oral ultrasound probe according to claim 1, wherein the handle portion has a first width, and the oral portion has a second width, the second width being greater than the first width.
4. The oral ultrasound probe according to claim 1, wherein the handle portion and the oral portion define substantially flat sides.
5. The oral ultrasound probe according to claim 1, wherein the distal end of the oral portion is rounded.
6. The oral ultrasound probe according to claim 1, wherein the handle portion is connected to the power supply via a power cable, or the power supply is at least one battery connected to the handle portion.
7. The oral ultrasound probe according to claim 1, wherein the power supply is coupled to or is part of the control device.
8. An oral ultrasound probe for imaging the temporomandibular joint, A handle portion having a longitudinal axis, the handle portion being connected to or configured to receive power, The mouth portion is shaped like a "V" towards the head and is positioned at an angle of action with respect to the longitudinal axis of the handle portion, and is configured to emit and receive sound waves. The probe has an ergonomic configuration, The aforementioned operating angle is approximately 45 degrees or approximately 30 degrees. The distal end of the oral portion is rounded and includes a transducer opening configured to emit and receive sound waves. Oral ultrasound probe.
9. The oral ultrasound probe according to claim 8, wherein the ergonomic configuration comprises a handle portion defining a substantially flat side and an oral portion.
10. The oral ultrasound probe according to claim 8, wherein the ergonomic configuration comprises the handle portion and the oral portion having substantially the same thickness.
11. The oral ultrasound probe according to claim 8, wherein the ergonomic configuration comprises a handle portion having a certain longitudinal length and an oral portion having a length of about one-third of the longitudinal length of the handle portion.
12. The oral ultrasound probe according to claim 8, wherein the handle portion is connected to the power source via a power cable, or the power source is at least one battery connected to the handle portion.