Patent Application
20120088215
The present invention relates to simulated anatomical models and methods of making such models. More specifically, the present invention relates to simulated ear structures and related methods of manufacture.
Medical diagnostic and surgical techniques are learned by physically practicing such techniques. For example, a student may practice identifying and treating an ear disease on a living patient (e.g., a dog, pig, etc.) or a cadaver. Each of these has it disadvantages.
For example, while practicing diagnosing and treating ear diseases on living animals offers the advantage of actual conditions, there are high associated costs due to having to obtain, take care of, and dispose of the animals. Also, societal attitudes are increasingly less favorable towards the use of animals for such purposes.
Practicing diagnosing and treating ear diseases on cadavers is less realistic than with actual living animals due to a lack of flowing body fluids and living body temperatures, the differences between indications of an ear disease in living tissue versus dead tissue, and the physical characteristics of dead tissue. Also, there are high costs associated with obtaining, maintaining, and disposing of cadavers.
There is a need in the art for simulated otoscopic models useable for practicing diagnosis and treatment techniques for ear disease, wherein the simulated otoscopic models overcome the above-discussed disadvantages.
An otoscopic model is disclosed herein. In one embodiment, the otoscopic model includes an artificial ear, an artificial head and at least one tympanic membrane portion. The artificial ear includes a base portion and an ear portion extending from the base and having ear-like features including an auditory canal. The artificial head includes an opening adapted to receive the base portion. The at least one tympanic membrane portion includes an artificial tympanic membrane. The tympanic membrane portion is configured to be coupled with the artificial ear such that the artificial tympanic membrane is located relative to the auditory canal in a generally anatomically correct manner.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
Integrated otoscopic models 10 are disclosed herein. The otoscopic models 10 bring an increased level of realism in medical diagnostic and treatment education. Specifically, the otoscopic models 10 have realistic appearances and are realistic in response to manipulation and surgical interventions and diagnostic techniques. Such otoscopic models 10 can greatly enhance how diagnostic and surgical skills are taught with respect to ear diseases, bringing the medical trainee another step closer to mastering diagnostic and surgical techniques before ever touching a live patient. The otoscopic models 10 are advantageous because they offer a truly realistic diagnostic and treatment experience akin to working on a living animal.
In one embodiment, the integrated otoscopic models 10 include an artificial head 15 and an artificial ear 20 that is coupled to the head in a removable fashion. For example, as shown in
As can be understood from
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In one embodiment, as illustrated in
Depending on the embodiment, the tympanic membrane portion 35 may be received in recesses defined in both the head opening 30 and the artificial ear 20 (as shown in
In one embodiment, as illustrated in
As with the embodiment discussed with respect to
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Depending on the embodiment, the two-piece tympanic membrane portion 35 may be received in recesses defined in both the head opening 30 and the artificial ear 20 (as shown in
The artificial ear 20 and artificial tympanic membrane 45 and tympanic bulla 70 may be similar to their corresponding real structures in both appearance and physical characteristics. The artificial structures 20, 45, 70 may have accurate surface detail and realistic color and texture that closely mimics the surface of corresponding real structures. The shape of the artificial structures 20, 45, 70 may include the anatomical features common to the real corresponding structures, the anatomical features being correct with respect to shape, size and location.
In one embodiment, the artificial tympanic membrane 45 and/or tympanic bulla 70 are configured with respect to at least one of appearance or touch to mimic a specific real tympanic membrane medical condition. For example, the artificial tympanic membrane 45 and, in some embodiments, the adjacent regions of the tympanic membrane portion 35, have colors, tactile qualities (e.g., textures, resilience, etc.), shapes, etc. that mimic those of actual medical conditions of the tympanic membrane and adjacent regions. In one embodiment, the otoscopic model 10 may include multiple tympanic membrane portions 35 for use with a single artificial head 15 and one or more artificial ears 20. Each tympanic membrane portion 35 may represent a specific medical condition of an ear. If multiple artificial ears 20 are provided, each such ear 20 may also represent a specific medical condition by itself or in conjunction with a specific tympanic membrane portion 35.
Thus, in one embodiment, the otoscopic model 10 provides a diagnostic and treatment training experience that is very similar to a real diagnostic and treatment experience. Example diagnosis and treatment skills that can be practiced on such an otoscopic model 10 include myringotomies, otitis externa, deep ear canal cleaning, etc. The size and configuration of otoscopic model 10 may be tailored to represent the head and ear structure of a human or specific animal. Also, the artificial tympanic membrane 45 may be configured to have a normal, healthy shape or an abnormal or enlarged shape with punctures, discolorations, growths, abnormalities, injuries, etc. that can be diagnosed and the subject of a treatment technique. Different consistencies and textures for the material forming the artificial ear and its structures can be used so as to approximate a healthy, normal ear or an ear having a specific type of disease.
An instructor may desire to test a student with respect to diagnosing and/or treating a variety of ear medical conditions. The instructor selects a tympanic membrane portion 35 corresponding to a known ear medical condition and inserts the portion 35 and artificial ear 20 into the head opening 30. The student then conducts and ear examination using an otoscope and/or video otoscope on the otoscopic model 10 and the instructor can assess the student with respect to examination technique due to the model's realism and assess whether or not the student is capable of correctly identifying the medical condition of the ear. If a treatment is warranted, the student can then perform a realistic treatment on the artificial ear due to the realism of the ear. Once the student has correctly assessed the medical condition and/or treated the medical condition, the tympanic membrane portion 35 the student has been assessing/treating can be changed out by the instructor to another tympanic membrane portion 35 exhibiting traits common to another ear medical condition and the assessment process can begin anew for the student.
An understanding of how the artificial tympanic membranes 45 of different tympanic membrane portions 35 may differ in appearance although used with the same artificial ear 20 and head 15 can be obtained from
As indicated in
In one embodiment, the ear portion 40 of the artificial ear 20 is substantially formed of platinum cured room temperature vulcanization silicone rubber (“PCRTVS”). The ear portion 40 of the artificial ear 20 may be formed of one type of PCRTVS, and the artificial tympanic membrane 45 may be formed of another type of PCRTVS. In one embodiment, the artificial head 10 is substantially formed of polyurethane.
A discussion regarding a method of manufacturing the model 10 is now provided. In one embodiment, molds of the head and ear are provided. In one embodiment, the molds are sculpted or machined to resemble negative of a head and ear the model 10 is to replicate. In another embodiment, the molds are a result of initial molds taken of a head and ear of a living or deceased creature or a sculpted liver body. For example, short-lived molds are created from an original that may be deceased, alive, or sculpted. Clay positives are cast utilizing the short-lived molds, the clay positives representing the head and ear. The clay positives are corrected as needed, in accordance to the objective of the final product. As an example, it may be desirable to have more anatomically correct molds if the objective is the training of surgical approaches or techniques that require recognition of specific landmarks.
Polyurethane molds are then formed about the clay positives. In doing so, borders are created around the clay positives with a moldable oil based soft clay. The molds are then pulverized with a release agent and allowed to dry. A first layer of polyurethane Shore A 30 is then poured or painted over the clay positives, followed by a minimum of three and a maximum of five layers of the same material, which are reinforced with polyester fibers. A period of 15-20 minutes is allowed to elapse between layers of polyurethane. Once all layers of polyurethane are laid up, the polyurethane molds are left to completely cure for a period of 24 hours prior to being used in the molding of the artificial head 15 and ear 20 of the model 10. Some of the mold embodiments require a hard shell in order to prevent permanent deformation or simply to facilitate handling of the mold. In one embodiment, the outer shell is created using a fast set liquid plastic. In other embodiments, the outer shell is created using other materials, such as, for example, plaster and fiberglass. Some molds will be multi-part and, as a result, will have an outer shell so as to facilitate the creation of a tight seal between the edges of the mold.
Each mold has a first portion and a second portion, each of said portions having a void defined therein that corresponds to a negative of a surface of one side of the item to be molded via the mold (e.g., the head or ear). The mold portions mate together such that the voids in each portion form a complete void that has a shape and volume corresponding to the real head or ear to be modeled.
Once the molds are provided, the manufacture of the artificial head and ear can begin. For example, the material used to form the artificial head is poured, sprayed, injected or otherwise deposited into the void of the head mold. In one embodiment, the material deposited in the artificial head mold is polyurethane, such as, for example, Reoflex 30 from Smooth-on® 2000 Saint John Street, Easton Pa. 18042.
Similarly, the material used to form the artificial ear is poured, sprayed, injected or otherwise deposited into the void of the corresponding mold. In one embodiment, the material deposited in the artificial ear mold is PCRTVS. In one embodiment, the PCRTVS for the artificial ear is PCRTVS durometer Shore A10 or PCRTVS durometer Shore OO50. Thus, in one embodiment, the artificial ear 20 of the model 10 has a cured durometer of approximately Shore A10 or approximately Shore OO50.
In one embodiment, the PCRTVS durometer Shore OO50 is Ecoflex OO50®, and the PCRTVS durometer Shore A10 is Dragon Skin 10®, all of which are manufactured by Smooth-on of Easton, Pa. As can be understood by those skilled in the art, the Shore durometer numbers provided above represent the Shore durometer of the respective cured material.
The base 25 of the ear 20 and the hole 30 of the head 15 are configured (e.g., via the molding process) so as to result in a complementary interference fit between the base 25 and hole 30 when the base is received in the hole. For example, as can be understood from
In one embodiment, the mold for the artificial tympanic portion 35 is sculpted or machined so as to have one of the configurations discussed above with respect to
The material used to form the artificial tympanic portion 35 and, more specifically, its artificial tympanic membrane 45 is poured, sprayed, injected or otherwise deposited into the void of the corresponding mold. In one embodiment, the material deposited in the artificial tympanic portion mold is PCRTVS. In one embodiment, the PCRTVS for the artificial tympanic portion is PCRTVS durometer Shore A10 or PCRTVS durometer Shore OO10. Thus, in one embodiment, the artificial tympanic portion 35 of the model 10 has a cured durometer of approximately Shore A10 or approximately Shore OO50.
In one embodiment, the PCRTVS durometer Shore A10 is Dragon Skin A10®, and the PCRTVS durometer Shore OO50 is Ecoflex OO50®, all of which are manufactured by Smooth-on of Easton, Pa. As can be understood by those skilled in the art, the Shore durometer numbers provided above represent the Shore durometer of the respective cured material.
In one embodiment, the artificial tympanic membrane 45 will have a relatively thin transverse cross sectional thickness, much like a real tympanic membrane found in the ear of a human or animal. For example, in one embodiment, the artificial tympanic membrane 45, which is made from PCRTVS, has a transverse cross sectional thickness of between approximately 0.25 mm and approximately 0.5 mm.
In one embodiment, the ear canal 57 and/or tympanic bulla 70 are formed of a first type of PCRTVS, and the rest of the artificial ear 20 and/or artificial tympanic portion 35 in which said structures are defined are formed of another type of PCRTVS. For example, in one embodiment, the ear canal 57 and/or tympanic bulla 70 are formed of PCRTVS durometer Shore OO50, and the artificial ear 20 and or artificial tympanic portion 35 are formed of PCRTVS durometer Shore A 10. In one embodiment, the ear canal 57 and/or tympanic bulla 70 are first molded and allowed to cure. These cured portions 57 and/or 70 are then supported in the cavity of the mold used to form the rest of the artificial ear 20 and/or artificial tympanic portion 35, and the ear 20 and portion 35 are then molded about the molded and cured canal 57 and bulla 70.
For each of the above-described molded portions, specifically, the head 15, ear 20 and tympanic portion 35, the materials from which the molded portions are created can be provided with mixed-in color or tint, mixed in fibers or textures, and surface color, tint or texture to mimic as closely as possible the touch and appearance of the artificial head 15, artificial ear 20 and artificial tympanic membrane 45 and other ear structures.
For each of the above-described molded portions, specifically, the head 15, ear 20 and tympanic portion 35, once the material used to form these components of the model 10 has cured within their respective molds, each mold is opened by separating its two portions from each other. The molded components of the model are then removed from its respective mold and the components can be combined together to form the model.
The model 10 disclosed herein is a life like representation of the head 20 and ear structure 25 of a real living animal (e.g., a dog). The disclosure provided herein is applicable to all animals and humans having an ear structure. The ear structure includes a realistic auditory canal with a tympanic membrane and bulla. The ear structures are built with different types of PCRTV having distinct textures, consistencies and colors resembling with close approximation the same textures, consistencies and colors encountered in organic specimens. The model is designed to create a situation or scenario that will allow a trainee to experience a close to real life auditory canal evaluation and to take appropriate action in order to remedy the pathology encountered. The ear, pina, auditory canal and head can be made in several different sizes, different shapes, colors and textures to mimic the anatomical geography and physical characteristics of the ones found in other animal species.
The model can be used for training purposes in evaluating a trainee's ear diagnosis and treatment skills. For example, the model can be used to evaluate and train the trainee's ear handling abilities, conventional and video otoscopic evaluation of vertical and horizontal canals including the tympanum, gross examination and recognition of anatomic landmarks, especially at the entrance to the vertical canal, identification of pathologies associated with the ear canal, tympanic membrane and tympanic bulla, removal of foreign bodies, collection of samples for culture and cytology, etc. The model can also be used for training of middle ear cleaning, deep ear canal cleaning with the utilization of alligator forceps, ear curettes, or ear brushes, flushing and suctioning under use of conventional surgical otoscopes and video otoscopes.
Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
The present application incorporates in its entirety and claims the benefit under 35U.S.C. §119(e) of U.S. Provisional Application 61/391,768, which was filed Oct. 11, 2010 and entitled “Integrated Model for Otoscopic Procedures.”
| Number | Date | Country | |
|---|---|---|---|
| 61391768 | Oct 2010 | US |
