Medical follicle evaluation device with ergonomic grip

Abstract

A device adapted to monitor a subject's follicles and assess endometrial thickness, comprising: a) an elongated member having a tip that accommodates an ultrasound probe; and b) an ergonomic grip adapted to be held in the subject's hand, the grip having a recess, the lowest point of which is located on a virtual projection of the interior volume of the elongated member.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to the field of medical devices, and in particular to devices and systems for monitoring follicles and assessing endometrial thickness. [Background technology]

[0002] Background of the Invention In vitro fertilization (IVF) is a method of assisted fertilization in which eggs are combined with sperm outside the body ("in vitro"). IVF can be performed by harvesting the contents of a woman's fallopian tubes or uterus after natural ovulation or ovarian stimulation. Most IVF procedures involve stimulating the ovaries to develop follicles that produce mature eggs. Ovarian follicles play a vital role in every IVF cycle; therefore, monitoring follicular development is a critical part of the IVF process. Currently, IVF patients undergo several pelvic (vaginal) ultrasound scans performed by a specialist, either a nurse or a doctor, during their natural menstrual cycle or during ovarian stimulation to confirm the correct dosage of medication administered to stimulate ovulation and to determine when the eggs are ready for retrieval.

[0003] Furthermore, the thickness of the endometrium changes during the menstrual cycle, but other factors also drive the changes. Therefore, measuring the thickness of the tissue is very important in many cases. The endometrium is the lining of the uterus. It is one of the few organs in the human body that changes size every month throughout a person's fertile years. Each month, as part of the menstrual cycle, the body prepares the endometrium to receive an embryo. The thickness of the endometrium increases and decreases along the way. Two hormones, estrogen and progesterone, drive these endometrial growth cycles, which are shed by menstruation if pregnancy does not occur.

[0004] According to the Radiological Society of North America (RSNA), the endometrium is at its thinnest during menstruation, typically between 2 and 4 millimeters (mm). The first half of the proliferative phase begins approximately between days 6 and 14 of a woman's cycle, or between the end of her menstrual cycle (when bleeding stops) and before ovulation. During this phase, the endometrium begins to thicken and can reach a thickness of between 5 and 7 mm. As the cycle progresses and toward ovulation, the endometrium becomes thicker, reaching approximately 11 mm. Around day 14 of a woman's cycle, hormones trigger the release of an egg. The endometrium is at its thickest during this secretory phase, sometimes reaching a thickness of 16 mm. Endometrial thickness is important for conception. Healthcare professionals attribute the highest chance of a healthy, full-term pregnancy to an endometrium that is neither too thin nor too thick. This allows the embryo to successfully implant and receive the nutrients it needs. The endometrium thickens as pregnancy progresses. Therefore, monitoring and measuring its thickness is crucial for successful IVF and maintaining fertility.

[0005] Monitoring involves assessing the number and size of follicles in each ovary through ultrasound and specialized blood, saliva, or urine tests that measure concentrations of related hormones. When the follicles are prepared and reach the appropriate size, approximately 18-20 mm, a trigger injection of the hCG hormone is administered. This trigger stimulates the follicles to release mature eggs. The mature eggs are then collected by a specialist at a medical facility. Summary of the Invention

[0006] Because timing is critical in all IVF procedures, daily monitoring of follicles and endometrial thickness is necessary, placing a significant burden on the patient, as well as on medical personnel and equipment. It is therefore clear that eliminating the need for frequent visits to a medical center where follicular development is evaluated, thereby reducing burden and cost to the patient and the system, would be highly desirable.

[0007] To achieve the above objectives, a device has been developed that significantly reduces the need for specialized personnel to perform follicular monitoring and evaluation, as well as endometrial thickness, in medical facilities, and the device is suitable for use in evaluation purposes for IVF and Embryo Transfer (IVF-ET) and other infertility-related procedures, which may include, for example, monitoring natural ovulation, natural preservation procedures by determining when pregnancy is not at risk, and any other medical process requiring such monitoring.

[0008] The above-described medical follicle assessment device (hereinafter simply referred to as the "MFA device") is the subject of commonly assigned, co-pending Israeli patent applications Nos. 285798 (filed August 23, 2021), 293114 (filed May 12, 2022), and 295946 (filed August 25, 2022), the entire disclosures of which are incorporated herein by reference (hereinafter referred to as the "previous MFA device" for convenience). FIG. 1 illustrates an MFA device, generally designated by the numeral 100, according to one embodiment of the above-described patent applications. In this embodiment, a grip 111 includes a portion 112 that may optionally include an actuation switch for activating an ultrasound probe located at a tip 113. The handle or grip 111 is held in a patient's hand during operation of the ultrasound device, so that simple application or release of pressure optionally turns the probe on or off.

[0009] The MFA device is adapted to identify the nature of ovarian follicles and the thickness of the endometrium. The MFA device is connected to a smart device, such as a smartphone, via a wireless or wired connection, allowing a lay operator to generate ultrasound images, for example, at the convenience of their own home, without the need for the direct presence of a professional ultrasound operator. The MFA device can be connected to a portable communication device, such as a smartphone, tablet, or other suitable device, via a wireless or wired connection. Wireless connections include, for example, Bluetooth, Wi-Fi, WIFI 5 / 6 / 7 / 8, UWB (ultra-wideband), etc. In one embodiment of the present invention, the identification of ovarian follicles and the determination of endometrial thickness are performed automatically using image processing and related processes. Alternatively, these determinations are performed remotely by a professional who examines the images generated by the MFA device. The images are transferred via a wired or wireless connection to a smart device connected to the MFA device of the present invention and then transmitted to a professional for evaluation.

[0010] By instructing the patient to move the MFA device with simple hand movements, the MFA device enables the capture of valid clinical data. The instructions can be provided in any suitable manner, for example, by audio or video instructions that can be played or displayed on the user's smart device. Thus, without requiring any technical background, the patient can scan an image and automatically send it to a doctor or other technician.

[0011] As will be appreciated by those skilled in the art, the MFA devices of the present invention have a defined grip that also defines the position of the ultrasound probe. For example, when gripping the handle 111 of the MFA device of FIG. 1, rotation of the probe is restricted by the movement of the user's hand, and thus the direction in which the probe scans is essentially defined, as opposed to prior art MFA devices in which the elongated member is free to rotate, such that by simply looking at the acquired image, it is not possible to know whether the scan was along a vertical line, a horizontal line, or a mid-line.

[0012] " monitoring " as used herein may refer to visual inspection and parameter measurement.For example, monitoring the development of ovarian follicle often includes measuring their size, as when IVF treatment is involved, but in some cases, it may be enough to qualitatively confirm that ovarian follicle is developing, and in some cases, for example, when natural ovulation is required to be confirmed, it may be desirable or necessary to measure the size of ovarian follicle when monitoring natural ovulation.The same applies to endometrium monitoring.

[0013] Therefore, providing a means for users to safely and easily operate MFA devices for monitoring is also an important factor for successful monitoring. Allowing users to self-control the insertion depth of the MFA device so that it is not too deep, which may adversely affect the quality of the recorded image, but not too deep, which may be unsafe, can provide an improved user experience.

[0014] Additionally, allowing the user to select the angle at which the MFA device is held in the user's hand relative to the entry axis of the MFA device can also contribute to the user experience and monitoring quality.

[0015] Previous MFA devices have represented significant advances in the IVF field, providing solutions to the problems described above, improving the quality of treatment and making the challenging process more accessible to patients. However, in pursuit of further improving treatment outcomes and patient compliance, the inventors have surprisingly found that an ergonomically designed grip significantly improves patient response and the quality of the ultrasound scans they perform. This result is surprising, as the grip shown at 111 in FIG. 1 is widely recognized as the optimal grip shape for a variety of devices and operations.

[0016] It is therefore an object of the present application to provide a follicle and endometrial thickness monitoring device that is an improvement over previous MFA devices.

[0017] It is a further object of the present invention to provide a follicle and endometrial thickness monitoring device that is comfortable and easy to operate even for unskilled patients.

[0018] It is yet another object of the present invention to provide an improved MFA device that may be useful and easy to use for monitoring during various stages of the menstrual cycle, as well as an adjunct to other infertility treatments. Other objects and advantages of the present invention will become a parent as the description proceeds.

[0019] Summary of the Invention The present invention: a) an elongated member having a tip that houses an ultrasound probe; b) an ergonomic grip adapted to be held in the subject's hand; wherein the grip has a recess, the lowest point of which is located on a virtual projection of an interior volume of the elongate member.

[0020] In embodiments of the present invention, the device includes a depth-limiting element, which may be made from one piece, such as a rubber ring, or other suitable material. In some embodiments, the depth-limiting element includes two part rings hinged together and a suitable clamp to connect them. The depth-limiting element may also include an elastomeric friction-generating layer.

[0021] The present invention: i) a device according to the present invention; ii) a smart device adapted to display information to the user regarding the operation of the device; a communication element adapted for communication and data transfer between the device and the smart device; The present invention also encompasses a system for monitoring ovarian follicles and assessing endometrial thickness in a subject, comprising: [Brief explanation of the drawings]

[0022] BRIEF DESCRIPTION OF THE DRAWINGS In the drawing: [Figure 1] Figure 1 shows an illustrative example of a previous MFA device; [Figure 2A] FIG. 2A is a perspective view of a wireless MFA device according to an embodiment of the present invention; [Figure 2B] FIG. 2B is a perspective view of a wireless MFA device according to an embodiment of the present invention; [Figure 3] FIG. 3 is a cross-sectional view of the MFA device of FIG. [Figure 4] FIG. 4 is a cross-sectional view of a wired MFA device according to another embodiment of the present invention; [Figure 5] FIG. 5 illustrates a depth limiting ring according to an embodiment of the present invention; [Figure 6] FIG. 6 shows a schematic diagram of a wired system according to the present invention; and [Figure 7] FIG. 7 illustrates the importance of the present invention to the home user. DETAILED DESCRIPTION OF THE INVENTION

[0023] Detailed Description of the Invention The MFA device is adapted to identify ovarian follicle characteristics and endometrial thickness and includes all elements and components described above in connection with and in the descriptions of IL285798, IL293114, and IL295946. Figures 2 (A and B) show two different views of an MFA device 200 according to one embodiment of the present invention, with an ultrasound probe housed in a tip 201 located at the distal end of the MFA device and its elongated member 202, which is inserted into the vagina for ultrasound scanning. Similar to the MFA device of Figure 1, a handle or grip 203 is the part held by the user during scanning. The grip 203 can hold various components of the system, such as communication elements, image processing, and power supplies, but these do not affect the mechanical elements of the present invention and will not be described in detail herein for brevity. Similarly, the elongated member 202 can include wired or wireless components for transmitting data generated by the ultrasound probe to a handle or external device. In some embodiments, particularly wireless devices, a pressure switch 204 is provided to power on the MFA device and enable ultrasound scanning. In some other embodiments, when the MFA device is wired to a smart device such as a smartphone, the MFA device does not require an internal battery; instead, the MFA device is controlled by an app running on the smart device and is powered by the smart device's battery. A depth limiting element 205 is also shown in FIG. 2 , which is novel and can be used alone or in combination with scale 206, as described further below. Additionally, in some embodiments, a pressure sensor is located at the distal tip of the device. The pressure reading allows the user to determine if the device has been introduced deeper than desired and, in some embodiments, can alert the user if undesirable pressure is being applied by the tip of the device. For example, this may occur if the user used a depth limiting element but the original depth was set incorrectly or if the element was inadvertently moved.Of course, as will be clear to those skilled in the art, instead of a pressure sensor any other suitable method can be employed, such as optical measurement, ultrasonic distance measurement and any other proximity sensor.

[0024] Unlike the grip of a prior art MFA device such as that illustrated in FIG. 1 , in the MFA device of FIG. 2 (A and B), the grip 203 is not tubular in nature, but rather is ergonomically formed to have a recess, the lowest point (or saddle) 207 of which is located on a virtual projection of the interior volume of the elongated member 202. As will be explained further below, this is a highly counterintuitive and surprising structure for a handle of an intracavity ultrasound device, and therefore prior art devices employ handles of the type shown in FIG. 1 . This is further explained with reference to FIG. 3 . The virtual projection of the interior volume of the elongated member 202 is indicated by the numeral 300 and, as explained above, is bounded by the saddle 207. As can be seen in the cross-sectional view of FIG. 3 , the grip 203 can also house the electronic components necessary to operate the ultrasound probe or to communicate with external devices via a wireless or wired connection. The electronic components can vary according to the specific needs of different MFA devices and are well within the purview of one skilled in the art, so the electronic parts will not be discussed in detail for the sake of brevity, and some such elements are shown for illustrative purposes only.

[0025] The embodiment shown in Figures 2 and 3 is a wireless MFA device. A wired MFA device embodiment is shown in Figure 4, where a segment of wire 400 can be seen exiting grip 203 via wire guide 401. Wire 400 can be used to communicate with an external device such as a PC, tablet, or cell phone, to power the MFA device from a remote power source, or for other purposes.

[0026] As can be clearly seen in the embodiment of Figure 2B, the grip 203 is in some embodiments made of two parts: a mean body part 208 and a lid 209 that can be removed to access the electronic components contained within the grip. These two parts can be held together by mechanical pressure, as is common in the art of plastic materials, not to be discussed further, or by any other known fastening element.

[0027] Additionally, in some embodiments, the lid 209 can be manufactured to exhibit a soft, somewhat resilient surface to provide more comfort to the grip holder.

[0028] 5 shows depth-limiting ring 500, seen in operation in FIG. 2B. In this particular embodiment, the ring has two portions 501 and 502 (but could also be made from one piece, e.g., a ring made from rubber or other material), connected by a hinge 503 (not shown) and by a clasp 504 that secures portions 501 and 502 together on elongated member 202, thus applying pressure to prevent movement of ring 205. In some embodiments, an elastomer layer can be added to the inner surface of the ring to increase friction and stabilize ring 205. The presence of the ring and its large diameter limits the insertion depth of the probe.

[0029] Additionally, in this particular embodiment, notches 505 are provided to allow easy reading of scale 206 in FIG. 2 and to facilitate the user in placing ring 205 in the same position each time.

[0030] FIG. 6 illustrates the operation of an MFA device of the present invention in conjunction with a smart device. In this figure, a wired MFA device is seen. However, if a wireless MFA device is used, the connecting wires are simply omitted, and the following description applies mutatis mutandis. MFA device 600 is as described with reference to the previous figure. It is inserted and operated within the vagina until the ultrasound probe contained in tip 601 is positioned at the desired location. Images generated by the ultrasound probe are transmitted to smart device 602, which is held in cradle 603 in this embodiment, or wirelessly in wireless embodiments. In addition to the electronics necessary to communicate with MFA device 600, the cradle can also include electronic elements that enable communication with smart device 602, both to display images acquired by the ultrasound probe and to perform any other functions that may be appropriate, such as conveying instructions to the user, allowing a remote health professional to communicate with the user and guide the user in the operation of the MFA device, act as a relay to a remote station, etc. If the connection is wireless, depending on the embodiment of the invention and the smart device employed, the cradle can be omitted and the MFA device 600 can communicate wirelessly directly with the smart device 602.

[0031] Referring now to FIG. 7, a key advantage of the present invention during operation (FIG. 7B) is illustrated compared to the prior art (FIG. 7A). When using the device of the present invention, the location where the user applies pressure to direct the tip 701 of the MFA device toward the desired location 700 is on axis 702, located at the center of symmetry of elongated member 703. This allows the user to naturally make a cognitive connection with the location of tip 701 and, thus, easily direct it toward the correct location 700. In contrast, as shown in FIG. 7A, when using prior art grip 704, there is a disconnect between the user's hand and the tip 701′ of the MFA device. Because the imaginary dotted line 702′ does not pass directly through the user's hand and elongated member 703′ simultaneously, the movement of the user's hand does not result in a linear movement of tip 701′. This makes it difficult for the user to correctly position tip 701′ relative to location 700′. The grip of the present invention provides easier and more comfortable operation for the user during a procedure that is itself uncomfortable and inconvenient. Users report that procedures take significantly less time and have fewer irrelevant or erroneous readings than when operating with prior art devices.

[0032] All of the above descriptions of embodiments of the present invention are provided for illustrative purposes and are not intended to limit the invention in any way. Many changes can be made to the various elements of the present invention; for example, the ergonomic grip can be provided with different shapes and various materials can be used, all without departing from the scope of the present invention.

Claims

1. a) an elongated member having a distal end that houses an ultrasonic probe; b) an ergonomic grip adapted to be held in the subject's hand; 1. A device adapted to monitor ovarian follicles and assess endometrial thickness in a subject, comprising: a grip having a recess, the lowest point of which is located on a virtual projection of an interior volume of the elongate member.

2. The device of claim 1 including a depth-limiting element.

3. 3. The device of claim 2, comprising two partial rings hinged together and a clamp suitable for connecting them.

4. The device of claim 1 , wherein the depth-limiting element comprises an elastomeric friction-generating layer.

5. i) A) an elongated member having a tip that houses an ultrasound probe; B) an ergonomic grip adapted to be held in the subject's hand; a device adapted to monitor ovarian follicles and assess endometrial thickness of a subject, the device comprising: a grip having a recess, the lowest point of which is located on a virtual projection of an interior volume of the elongate member; ii) a smart device adapted to display information to a user regarding the operation of the device; iii) a communication element adapted to communicate and transfer data between the device and the smart device; A system for monitoring ovarian follicles and assessing endometrial thickness in a subject, comprising:

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