Patent Application
20200258426
The present invention relates to the field of uterine models with pathology that provide a simulated environment of the human uterus which is capable of uterine distention and collapse.
Hysteroscopes, tissue removal devices and fluid management systems used to remove polyps and myomas in the uterus, need to be evaluated for visualization, cutting ability, and fluid balance to properly assess their capabilities and performance. Unfortunately, obtaining cadaveric human or animal pathologies are difficult because pathologies can only be identified by subjecting them to medical radiological instruments, a random and expensive ordeal. As such, usually synthetic models are used to simulate a uterus.
Several uterine models exist. However, none represent the dynamics of uterine distention and collapse. The human uterus is generally a flat, fan shaped organ capable of expanding. It is further compressed by other neighboring organs. Removal of uterine pathologies such as polyps and fibroids often require the physician to visualize the pathology, provide clearance for instruments such as tissue removal devices, and enable continuous fluid flow inside the uterus to move cut pathologies and clear the environment from blood. Therefore, uterine distention is critical to the proper function of the instrumentations. Proper distention requires a fine balance between the geometry and material properties of the uterus as well as the fluid mechanics passing inside the uterus.
In parallel, several synthetic pathologies are currently available, but none represent the modulus of elasticity found in polyps and myomas that were clinically tested.
Hence, what is needed in the art is a uterine model with pathology that more accurately creates an environment that is similar to a human uterus and synthetic pathologies that better represent those found in the clinical setting by, for example, allowing the pathology to sway with respect to the fluid flow inside the uterine model. Such uterine and pathology models can be used for validation testing of hysteroscopes, tissue removal devices and fluid management systems as well as user and sales representative training.
The present invention is directed to meeting the aforementioned needs by providing a device and method for providing a uterine model with pathology that more accurately creates an environment similar to human anatomy.
One aspect of the invention provides a uterine model that includes a proximal portion with a rigid portion defining a cavity shaped to mimic a human uterus and including a terminal end defining an opening, the terminal end mimicking a human cervix; at least one elastic portion connected to the rigid portion and partially defining the cavity; and a distal portion configured to mate with the proximal portion and to hold a synthetic pathology model between the distal portion and the proximal portion in a sealed manner such that fluid injected into the cavity does not leak out of the cavity around the pathology. When liquid is injected into said cavity through said opening, said elastic portions expand due to fluid pressure, at least partially separating said elastic portions from said pathology.
In one aspect, the uterine model further comprises a base removably supporting the proximal portion and the distal portion.
In another aspect the distal portion and the proximal portion are configured to mate using threaded features.
In still another aspect, the at one elastic portion comprises two elastic portions.
In still another aspect, the at least one elastic portion comprises silicone rubber.
In yet another aspect, a longitudinal axis of the pathology and a longitudinal axis of the proximal portion are aligned.
In still another aspect, a longitudinal axis of the pathology and a longitudinal axis of the proximal portion are perpendicular.
In one aspect the pathology may be a somewhat spherical shape representing a myoma.
In yet another aspect, the pathology comprises one or more elongate features representing polyps.
In still another aspect of the invention, a uterine model is provided including a first structure defining a cavity representing a uterus, the cavity at least partly defined by elastic portions that give the cavity a deflated configuration and an inflated configuration; a second structure removably placeable within the cavity and including a component representing a pathology; wherein when the second structure is placed within the first structure, liquid may be introduced into the cavity to inflate the cavity from the deflated configuration to the inflated configuration.
The uterine model may include a hole at a terminal end of the first structure and sized to receive an instrument useable for inflation of the cavity and having an imagining capability.
In the deflated configuration, a view of the pathology through the instrument may be at least partially obstructed by the first structure.
In one aspect, when the uterine model is in the inflated configuration, a view of said pathology through the instrument is less obstructed by the first structure than in the deflated configuration.
The second structure may include a pathology removably connected to a housing. The housing may be threadably connectable to the first structure.
The first structure may have a rigid portion and at least one elastic portion.
Another aspect of the invention provides a method of simulating a uterine medical procedure that includes: providing a synthetic model of a uterine cavity; introducing an instrument into the uterine cavity; using the instrument to inject a liquid into the cavity until the cavity expands from a deflated configuration to an inflated configuration. A procedure may then be performed within the cavity with an instrument. Further, a synthetic pathology model may be provided within the cavity, and a procedure may be performed on the synthetic pathology.
In some embodiments, the cap of the removable housing is taller to cover all stock of the fibroid/polyp after assembly. In some embodiments, the cap is flush with the uterine model after locking down.
According to some embodiments, the cap of the removable housing has an improved threaded form to tightly seal the mating components. In some embodiments, the cap is a two-piece assembly.
In some embodiments, the uterine model provides two configurations; a side pathology location (as current design) or a Fundal pathology location.
In some embodiments, the uterine model withstands a pressure of 150 mmHg.
In some embodiments, the uterine model may withstand under varying pressure conditions up to 150 mmHg after 1 hour of use.
In some embodiments, the hole for the cervix may be undersized to keep a 5.8 mm hysteroscope from leaking fluid therefrom.
These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which
Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.
The uterine model with pathology presented here will be able to test the ability of hysteroscope and fluid management systems to distend and maintain intrauterine pressure during a diagnostic portion of the surgery. For instance, when the uterus is in its collapsed, non-distended state, the hysteroscope will not be able to see the pathology in full view. Once the fluid media is pushed by the fluid management system into the hysteroscope, the uterine model will expand its elastic portion to represent distention. The model will also be able to test the ability of the tissue removal device and fluid management system to remove and irrigate pathologies and the fluid media during the therapeutic portion of the surgery. It is always important to maintain a certain distention during the therapeutic procedure, and the uterine model presented here will test if the instruments will be able to do perform such.
The uterine model with pathology was invented to create a simulated environment the same as a human uterus. It can be used for validation testing of hysteroscopes, tissue removal devices (TRDs) and fluid management system as well as user and sales representative training.
The proximal rigid portion 12 further tapers to a mushroom shaped terminal end 18 which mimics the cervix of a human body. The rigid portion 14 further includes a main structure and two frames 20 to capture the elastic silicone rubber portion 16. The simulated uterine model further comprises a support base 50 to hold the entire assembly of rigid portion and removable housing in firm positions during simulated removal of uterine pathologies such as polyps and fibroids and enabling continuous fluid flow inside the simulated uterus to move cut pathologies. The flared distal end of the removable housing of the uterine model pathology 60 is firmly attached with the support base with a locking clip 52 that prevents the distal portion 30 from being lifted out of the base 50.
The uterine model in its initial state represents the uterus in a collapsed, non-distended state (
The elastic portion 16 of the uterine model has a material property that matches the human uterus. The material that is used to make the uterine model must have an elastic tensile/compressive modulus ˜34 kPa. This represents the average of the parallel and perpendicular uterine tissues measured by Kiss et al. The material used in this invention, provided by Remedy, is 38 kPa (5 mm thick sheet) which is close to the required thickness of the uterine tissues measured by Kiss et al.
As can be seen in
In some embodiments, the present invention features a uterine model having a pathology located at the fundal wall. In some embodiments, synthetic materials that match the static and dynamic elastic modulus of human polyps and myomas are employed.
According to some embodiments, as shown in
Having described the various embodiments of the invention, a method of using the device is now described. In one example involving a diagnostic hysteroscopy, a hysteroscope is introduced into opening 22 of the terminal end 18. Saline or a similar liquid is introduced through the hysteroscope into the uterine cavity while pressure data is being recorded by the pressure sensor 70. As the cavity fills, the elastic portion 16 will expand and separate from the pathology, allowing a view of the pathology 60 through the hysteroscope. Once the diagnostic hysteroscopy is complete, the hysteroscope may be used to vacuum the saline out of the cavity.
If an operative hysteroscopy is to be performed, a hysteroscope or TRD is placed through the opening 22 of the terminal end 18. Saline or similar liquid is introduced and removed constantly such that irrigation and tissue removal is established. The TRD is used to remove pieces of the pathology 60, whether in the form of a myoma or polyps. The hysteroscope may be used to view the progress or may be equipped with tissue removal capabilities.
Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.
This application claims priority to U.S. Provisional Application Ser. No. 62/803,358 filed Feb. 8, 2019 entitled Uterine Model With Pathology, which is hereby incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62803358 | Feb 2019 | US |
