WO2023101627A1

WO2023101627A1 - An intrauterine imaging device

Info

Publication number: WO2023101627A1
Application number: PCT/TR2021/051640
Authority: WO
Inventors: Hidayet ŞAL; Ömer DEMİR; Hüccet KAHRAMANZADE
Original assignee: Karadeniz Teknik Universitesi Teknoloji Transferi Uygulama Ve Arastirma Merkezi
Current assignee: Karadeniz Teknik Universitesi Teknoloji Transferi Uygulama Ve Arastirma Merkezi
Priority date: 2021-12-01
Filing date: 2021-12-30
Publication date: 2023-06-08
Anticipated expiration: 2024-06-01
Also published as: TR2021018867A2; DE112021008022T5

Abstract

The invention relates to an intrauterine imaging device that displays images taken from the uterine cavity, by transferring the images taken from the uterine cavity to the screen taken by a wired camera, with a camera moving from the cervix and a light source rod (hysteroscopy), in order to provide a new approach to the camera imaging technique, one of the intrauterine imaging techniques. In order to fulfill this, the invention comprises energy storage and wireless communication apparatus, camera, light source and image reception screen, vaginal fluid inlet channel that allows the cavity to be filled with liquid to view the cavity in the uterus, intracervical fluid inlet channel, intracervical fluid inlet cannula, serum pressure control unit, fluid outlet channel, magnetic field control unit, (-) pole control probe, (+) pole control probe, (-) pole, (+) pole, capsule ejection element for removal after the procedure.

Description

AN INTRAUTERINE IMAGING DEVICE

Technical Field

The invention relates to an intrauterine imaging device developed to provide a new approach to camera imaging from intrauterine imaging techniques.

In particular, the invention relates to an intrauterine imaging device that displays images taken from the uterine cavity by transferring the images taken from the uterine cavity to the screen taken by a wired camera, with a camera advanced from the cervix and a light source rod (hysteroscopy) developed in order to provide a new approach to the camera imaging technique, one of the intrauterine imaging techniques.

State of the Art

Today, hysteroscopy procedure is used to evaluate the inside of the uterus with the help of a camera in the diagnosis and treatment of gynecological diseases.

In the present art, anesthesia application is needed especially in therapeutic hysteroscopy procedures. Although rare, this procedure has risks such as anesthesia-related complications, perforation of the uterus, injury to the cervix, excessive bleeding, and intrauterine infection. In addition, patients may experience a small amount of vaginal bleeding and cramp-like groin pain for a day or two after the procedure. Due to these disadvantages and risks, there is a need for intrauterine imaging procedures and devices that are easier to apply and do not require anesthesia and reduce post-procedure complaints.

An application US8870757B2 has been found in the literature. Here, a method, machine and endoscopy capsule developed to detect information about the three- dimensional structure of the inner surface of the body cavity are mentioned. Three- dimensional imaging with the camera is a common feature here. However, the imaging of the inside of the uterus and the imaging of the body cavities make a difference. The uterine cavity consists of two layers of endometrium that are attached to each other, and therefore, it is a cavity that cannot be viewed without filling the uterus with fluid. Therefore, in the method of the invention, there are apparatuses that allow liquid filling into the uterus specific to this method and machine, and these apparatuses are specific to the uterine selfie system. In addition, the use of more than one light source in the invention is another difference to this document. The device of the invention provides the visualization of the three-dimensional structure of the inner surface of the uterus of the patient by moving into the uterine cavity. The fact that the subject of the invention is the retraction rope is its most important advantage, which is different from the device presented in the document US8870757B2. In addition, the fact that the subject of the invention can be moved freely in the uterine cavity with remote control is an important advantage compared to this application. On the other hand, peristalsis (expulsion with contraction in the same direction) and gravity effect that move food in the gastrointestinal tract (mouth, esophagus, stomach, small intestine, large intestine) are the most important factors that facilitate the travel of the machine presented in this application. In the invention, there is no such advantage when used in the uterus. On the contrary, gravity is a disadvantage and the uterus does not show peristalsis. Therefore, the device of the invention is moved against gravity in the liquid. This is one of the features that makes the subject of the invention different. Finally, the machine in this application is too large in size to be inserted into the uterus.

In the literature, the application JP2004121733 has also been found. Here, intrauterine embedding type fetal monitoring device is mentioned. However, obstetric imaging is not performed in our subject of the invention. The machine mentioned in this document is moved by feet. On the other hand, our subject of the invention differs in that it can move freely in the uterine cavity and with magnetic probes and magnets. In addition, the most important difference between a uterus with a baby and a uterus that is not pregnant is that the inside of the uterus is enlarged. The subject of the invention differs from this document in this sense as well; because with the subject of the invention, it is aimed to view an unexpanded small and adjacent uterine cavity. Therefore, in the subject of our invention, apparatuses that can be given liquid have been developed to expand the cavity. Another difference is that the device mentioned in this document cannot monitor the fetus, record images and illuminate with light. In addition, the microcapsule here can only be used in the active phase of labor. This is one of the most important disadvantages of the said machine according to the subject of the invention. Shortly, the machine mentioned in this document cannot take images, cannot illuminate, and cannot be used to show the cavity in the non-pregnant uterus, since it cannot give liquid inside. Finally, in order for the baby to come out of the womb, the baby must be born and the microcassette must be expelled with the birth. For all these reasons, it is considered that the subject of the invention includes novelty in the presence of this document.

In the literature, the application CN109621169A has also been found. Here, an apparatus developed for obstetric (birth) observation and treatment is mentioned. This apparatus is attached to the uterus with suction cup-shaped feet. It can only enter the uterine cavity after birth, and it is not possible to place it in the uterus when there is no pregnancy. The machine here is remotely controlled via a wireless network. This machine contains an electric liquid spray apparatus for obstetric observation and stopping bleeding in treatment. Shortly, the machine here is an obstetric observation and treatment tool used to treat postpartum hemorrhage; it is not possible to perform uterine imaging in terms of Gynecological Diseases. On the other hand, the imaging machine of the invention has been developed for the diagnosis and observation of gynecological diseases. It is quite different from the machine mentioned in this document. The subject of the invention can enter the non-pregnant uterine cavity since it also includes system apparatuses that will deliver fluid to the uterine cavity. As another difference, the subject of the invention is remotely controlled by magnetism and magnet. In addition, the subject of the invention has the ability to move freely in the liquid. For all these reasons, it is thought that the subject of the invention developed for gynecological procedures has novelty in the presence of this document.

In the literature, the application EP2667763A2 with the title "Systems and methods for the protection of the narrow body lumen" was also found. The machine herein has a hydraulic drive mechanism that propels an imaging segment or a therapeutic segment through a narrow body lumen. A wire retrieval mechanism removes the imaging segment or the therapeutic segment from the narrow stem lumen. This machine is mostly used for imaging very narrow spaces such as the fallopian tube and works with a mechanism that is activated by using guide wires working with the principle of hydrostatic pressure. This machine cannot move freely and cannot view the internal entrance of the cervix, which is the entrance part. This machine allows treatment with the guidewire channel and increases the outer diameter of the catheter. This allows the user to control the amount and angle of light needed to capture a clearer image. As such, there is no remote-control system. In particular, it helps to visualize the clogged part in vessels such as the coronary artery and to apply the necessary treatment to open the clot. They do not have suitable apparatus to pass the vagina and cervix. The most important disadvantage is that the fallopian tube cannot move freely in order to control it from within the uterus. It is seen that this device does not have much superiority over the hysteroscopy machine in imaging the inside of the uterus, as being controlled manually from the outside and having a camera system that moves with a guide at the tip of the apparatus. On the other hand, the subject of the invention can be remotely controlled by magnetism and can move freely. The subject of the invention is different from this machine, which is used in the imaging of the fallopian tube, in terms of its purpose of use and its design.

In conclusion, it was deemed necessary to make an improvement in the relevant technical field due to the disadvantages described above and the inadequacy of the existing solutions on the subject.

Summary of the Invention

Present invention relates to an intrauterine imaging device that meets the aforementioned needs and eliminates all the disadvantages and provides advantages thereof.

The primary object of the invention is to develop an intrauterine imaging device that can display the uterine cavity in three dimensions, unlike hysteroscopy.

An object of the invention is to develop an intrauterine imaging device that allows to view the inner hole of the cervix (cervical internal os), which can more clearly display the niche (pocketing) in the uterus, which is called isthmocele. Another object of the invention is to develop an intrauterine imaging device that can move in the uterus with the control of the probes and transmit the image without a cable.

A similar object of the invention is to develop an intrauterine imaging device that makes it easier for the surgeon to use the medical device and provides intrauterine imaging with smaller instruments and setups that require less setup instead of many surgical equipment required for hysteroscopy.

In order to fulfill above-mentioned objects, the subject of the invention, contains energy storage and wireless communication apparatus, camera, light source and imaging screen, vaginal fluid inlet channel that allows the cavity to be filled with liquid to view the cavity in the uterus, intracervical fluid inlet channel, intracervical fluid inlet cannula, serum pressure control unit, fluid outlet channel, magnetic field control unit, (-) pole control probe, (+) pole control probe, (-) pole, (+) pole, capsule ejection element in order to be able to move freely in the uterus.

Structural and characteristic features of the invention and all the advantages it provides will be understood more precisely with the Figures hereinbelow and the detailed explanation with references to these Figures; the evaluation should be made by taking these Figures and detailed explanation into consideration for this reason.

Figures for Understanding of the Invention

Figure 1. Figurative representation of hysteroscopy

Figure 2. Uterine selfie imaging apparatus

Figure 3. Elements used to place the uterine selfie imaging capsule into the uterine cavity

Figure 4. Uterine selfie imaging steps

Figure 5. Detailed view of the uterine selfie imaging apparatus

The drawings are not necessarily drawn to scale and details which are not necessary for the understanding of the present invention may be omitted. In addition, elements that are substantially identical or have substantially identical functions are denoted by the same reference signs. Description of the References

1 Imaging screen

2 Data transfer mechanism of the cable

3 Magnetic field control unit

4 Serum pressure control unit

5 Vaginal fluid inlet channel

6 Intracervical fluid inlet channel

7 Intracervical fluid inlet cannula

8 (-) pole control probe

9 (+) pole control probe

10 Capsule

11 Control element

12 Capsule ejector

13 Camera

14 Light source

15 Energy storage

16 Wireless communication

17 Main (outer) body

18 (-) pole

19 (+) pole

20 Liquid fluid inlet

21 Inlet part of the liquid mine

22 Liquid outlet channel

23 Imaging element

24 Vagina

25 Intrauterine 26 Hysteroscopy

Detailed Description of The Invention

In this detailed description, the intrauterine imaging device, which is the subject of the invention, is described only for a better understanding of the subject and without any limiting effect.

The invention has been developed to provide a new approach to camera imaging from intrauterine imaging techniques. Here, the uterine cavity is evaluated with a camera and a light source (hysteroscopy), which is advanced into the uterus from the cervix. On the other hand, hysteroscopy performs imaging by transferring images taken via a wired camera to the screen. This system is presented in detail in Figure 1 .

The subject of the invention is designed for easier and clearer visualization of the inside and the whole of the uterus. This device is a medical device assembly with an imaging camera placed in the capsule and a light source that illuminates the darkness in the cavity. The capsule herein is preferably round and has dimensions of 7x20 mm. In the capsule placed inside the body cavity, besides the camera and light source, an energy source and bluetooth communication elements are located for wireless data transfer with a computer. In addition, (+) and (-) poles are placed at the two ends of the capsule so that it can be moved with probes outside the body. The view regarding this is presented in Figure 2. The imaging capsule must be produced from transparent, biocompatible polyethylene. In addition, the main body consists of two parts. Thus, when necessary, necessary arrangements can be made to the interior of the capsule.

In order to easily insert the capsule of the invention into the uterine cavity and not to expose the patient to surgical conditions, device usage elements specific to the subject of the invention have been designed. These elements are presented in Figure 3. The elements used at this step must be produced from disposable biocompatible plastic materials.

The biomedical medical device, which is the subject of the invention, designed as uterine selfie, is expected to perform the function of hysteroscopy in a simpler, more useful and less invasive manner. Although the hysteroscope can be performed in the outpatient clinic under office conditions, it has several disadvantages that trouble the surgeon, such as local anesthetizing the cervix before the procedure or performing the procedure under general anesthesia, and moving the hysteroscopy rod from side to side during imaging. However, with the machine developed in the subject of the invention, it is planned to eliminate these disadvantages and to perform these functions by means of probes outside the body. In short, the subject of the invention is applied more simply than the hysteroscopy in the present art. In addition, since local or general anesthesia will not be applied for the invention, it is a less invasive application.

The necessary application steps to take an image with the device subject to the invention are presented in Figure 4. In the first step, the control element is placed at the entrance of the vagina and after the serum inlet valve is opened from the vaginal fluid inlet channel, the inside of the vagina is filled with serum. In the second step, the image-taking process is started and the capsule placed at the end of the cannula is advanced through the vagina with the cannula, passed through the cervix and reached into the uterus. At this step, serum flow takes place from the interacervical fluid inlet channel through the cannula. The capsule is released through the cannula on which it is fixed and left in the uterine cavity. Serum flow continues until the uterine cavity is filled at the desired level. Then the flow of serum is stopped and the cannula is taken out. By means of the designed probes, the capsule is moved in the uterine cavity with the effect of the magnetic field, and the tissues can be observed in the desired proximity by moving it in the desired direction. At the same time, images are viewed from the computer with the wireless communication element in the capsule. After the imaging process is completed, the capsule is taken out with the help of the element fixed by the capsule to the body.

The imaging device developed with the subject of the invention, unlike the hysteroscopy in the present art, it is possible to display the cavity in the uterus in three dimensions. In addition, the subject of the invention performs a function that has not been done before in the literature by providing imaging for the inner hole of the cervix (cervical internal os). Accordingly, it is possible to visualize the situation of having a niche (pocketing) in the uterus, which is called isthmocele, more clearly. In addition, as mentioned above, the device of the invention is able to move in the uterus by controlling the probes. The ability to transfer the image without a cable also facilitates the use of the device. Thus, instead of many surgical equipment required for hysteroscopy, it is possible to perform intrauterine imaging with smaller instruments and setups that require less setup. Finally, disposable instruments and materials also reduce the infection rate of patients.

Claims

CLAIMS An intrauterine imaging device with at least a camera, at least a light source, and imaging screen, characterized by comprising: a. the vaginal fluid inlet channel, which allows the cavity in the uterus to be filled with fluid for viewing, intracervical fluid inlet channel, intracervical fluid inlet cannula, serum pressure control unit, fluid outlet channel, b. magnetic field control unit for moving freely in the uterus, (-) pole control probe, (+) pole control probe, (-) pole, (+) pole, c. energy storage and wireless communication apparatus, d. capsule ejection element for removal after the procedure. The intrauterine imaging device according to the claim 1 , characterized in that the intrauterine imaging device is in capsule form. A method for applying the intrauterine imaging device according to any of the preceding claims, characterized by comprising the steps of: placing the liquid fluid inlet part of the control element into the vagina inlet, providing the fluid flow into the vagina from the liquid fluid inlet port, transferring the images taken by the wireless communication element to the imaging screen, insertion of the capsule into the uterine cavity with the interacervical fluid inlet cannula, filling the uterine cavity with fluid through the intracervical fluid inlet cannula, removing the interocervical fluid inlet cannula, taking a 360-degree image and transferring to the live imaging screen by moving the capsule in the uterine cavity with (+) and (-) pole control probes, taking the capsule out of the body by means of the ejection element.