WO2019038775A1

WO2019038775A1 - Womb simulator for training purposes

Info

Publication number: WO2019038775A1
Application number: PCT/IN2017/000141
Authority: WO
Inventors: S. Suresh
Original assignee: Suresh S
Priority date: 2017-08-21
Filing date: 2017-12-08
Publication date: 2019-02-28

Abstract

The present invention relates to a womb simulator for training pre-natal surgical/handling methods and for simulating invasive fetal surgical procedures. The present invention can be used for active training of such individuals, thereby training them to perform such procedures easily on the individual. The present invention is also intended to imitate the human womb of mid-pregnancy stage.

Description

TITILE

"WOMB SIMULATOR FOR TRAINING PURPOSES" TECHNICAL FIELD

This invention relates to surgical training tools and in particular to simulated womb structures and models for teaching, training and practicing invasive fetal surgical procedures.

BACKGROUND OF THE INVENTION

The present invention relates to a womb simulator for training pre-natal surgical /handling methods and for simulating invasive fetal surgical procedures.

Training of Doctors is very costly, as it can be hardly carried out with pregnant women themselves. Especially, when complex emergency situations occur, it is not possible or justifiable for ethical reasons to include inexperience individuals for surgical procedures. In some cases the situations are very complex; lot of care and diligence has to be exercised while performing such procedures, therefore it is not advisable to practice or perform such delicate procedures directly on the individuals, in this case pregnant women.

The present invention can be used for active training of such individuals, thereby training them to perform such procedures easily on the individual. The present invention is intended to imitate the human womb of mid-pregnancy stage. This helps to perform the actual procedures accurately and with high precision.

Thus, Doctors can utilise such models and exercise definite basic manipulations in order to get a preclinical orientation of the complex 3-dimenstional relationship of the fetus, baby, uterus etc. These invasive procedures may require dedicated training for physicians and surgeons to master the indirect hand-eye coordination required by the imaging system. Computerised medical procedure training simulators may enable the trainees to develop and improve the practice, in a virtual reality environment before actually practicing in the operation room. Various conditions may be selected. Natural variations as encountered over the years by practicing Doctors can also be simulated for training purposes.

PRIOR ART

In WO2003001482 the inventor describes an invention related to an active and interactive birth simulator for replicating human pregnancy and the birth process. Said birth simulator comprises the following: a womb body (1); a model child (2); which is located in the womb body ( 1), the natural form, size and position being retained and the model child (2) being connected to a controllable drive (5) by means of a coupling device (7), in order to move the model child (2) in the womb body or to push said child through the birth canal out of the womb body ( 1); and a programmable control device for controlling the drive (5) .

In US20090035741 the invention relates to a birth simulator having an interactive optical display for displaying prenatal handling methods and for simulating selected situations during birth. The birth simulator has the following features: A womb torso (1), which is joined to a base (3), a child model (2), which is placed inside the womb torso (1); a force /moment sensor arrangement (6), which connects the child model (2) to the base (3) in a fixed manner, whereby said force/moment sensor arrangement (6) is configured for detecting forces and moments, which an examining individual (5) exerts via hands or medical instruments onto the child model (2) , and for providing the result of this detection in the form of measurement signals; a display screen and a programmable evaluation device, which has a computer and which is connected to the force /moment sensor arrangement (6) and to the display screen in a manner that enables the transmission of signals, whereby a simulation program implemented inside the computer is configured so that the measurement signals are transformed into image signals of the type that depict, in real time, the natural movement behavior of a child in the womb as adequate reaction movements of the action of the exerted forces and moments.

In US 8696362 B2 the inventor describe a method of teaching patient care is provided. The method includes providing a medical simulator including a model of at least a portion of a human body. The simulator is configured to execute a simulated medical scenario. The method also includes defining a plurality of palette items, each of the plurality of palette items associated with a physiological state of the simulator, and defining at least one scenario, the at least one scenario including a series of linked palette items. The method also includes selecting a scenario for execution by the simulator, communicating the selected scenario to the simulator, and utilizing the simulator to execute the selected scenario.

In US2015004583A1 , the inventor claims an invention relates to a system for moving an anatomical model of a fetus inside a mannequin having a birth canal. The system comprises a descent mechanism and a rotation mechanism. The descent mechanism is integrated in the mannequin and can move an anatomical model of a fetus longitudinally towards the birth canal of the mannequin. The rotation mechanism is mounted to the descent mechanism and can rotate the anatomical model of the

SUBSTITUTE SHEET RULE 26 fetus. The model of the fetus is inserted in the rotation mechanism. Also provided is a childbirth simulator comprising a mannequin with a birth canal, and the aforementioned system integrated in the mannequin for moving an anatomical model of a fetus inside the mannequin.

In US2015020574, the inventor discloses an invention to provide a surgical training device for training laparoscopic first entry surgical techniques. The training device includes a simulated abdominal wall that is penetrable with an optical trocar. A receptacle containing a tissue simulation is located inside the receptacle. The tissue simulation is observable via scope placed inside the optical trocar. Upon penetration of the one or more of the simulated abdominal wall and receptacle, the tissue simulation appears to translate distally relative to the simulated abdominal wall. The distal translation is effected by a variety of ways including

SUBSTITUTE SHEET RULE 26 the release of negative pressure inside the receptacle upon penetration and the expansion of an elastic wall of the receptacle with the introduction of fluid under pressure into the receptacle.

In CN 201662927 U the inventor discloses an analog womb for abortion mainly comprises three analog wombs in different positions, a fixing band, a fastener, a base and an analog gestation sac, and is characterized in that the analog wombs respectively adopt a horizontal womb, a 6-7 week forwardly inclined womb and a 6-7 week backwardly inclined womb. The analog womb allows the insertion of a dilating device and a curette, thereby realizing not only simulation of uterine curettage and gestation sac curettage but also practice of the placement of an intrauterine device.

In US20170065352 the inventor presents the methods, systems, devices, and computer-readable media for image management in image-guided medical procedures. Some embodiments herein allow a physician to use multiple instruments for a surgery and simultaneously provide image-guidance data for those instruments. Various embodiments disclosed herein provide information to physicians about procedures they are performing, the devices (such as ablation needles, ultrasound transducers or probes, scalpels, cauterizers, etc.) they are using during the procedure, the relative emplacements or poses of these devices, prediction information for devices, and other information. Some embodiments provide useful information about 3D data sets and allow the operator to control the presentation of regions of interest. Additionally, some embodiments provide for quick calibration of surgical instruments or attachments for surgical instruments.

In US201701 10032 - Embodiments of flexible ultrasound simulation devices, methods, and systems described herein may facilitate various medical procedure training by rendering realistic ultrasound images in accordance with the end user interaction with an anatomy model, an ultrasound probe replica and a medical tool. An ultrasound probe replica may be adapted with a low friction tip, such as a roller ball. A data processing unit may compute and display an accurate Virtual Reality /Augmented Reality (VR/AR) model and an ultrasound image in accordance with the position and orientation tracking of the VR/AR ultrasound simulator elements. The VR/AR ultrasound simulator may be adapted to realistically render the VR/AR model and the ultrasound image as a function of the user interaction with the VR/AR simulator elements.

Based on the foregoing, it is believed that a need exists for a novel device to imitate a human womb of mid-pregnancy uterus and tummy to simulate complex situations to train Doctors. Hence

SUBSTITUTE SHEET RULE 26 the present invention has been invented and further described in greater detail herein.

TECHNICAL PROBLEM TO BE SOLVED

Performing surgery on fetuses whilst still in the womb is a risky business. Fetal surgery is a broad range of surgical techniques that are used to treat birth defects in fetuses that are still in the pregnant uteri. Although pioneering work in this field began in the 1980's, it remains very challenging with only a few highly trained teams around the world treating a handful of conditions. Around 2 in 100 babies are born with severe birth defects. There are three main types of fetal surgery,

1. Open fetal surgery, which involves completely opening the uterus to operate on the fetus.

2. Minimally invasive fetoscopic surgery, which uses small incisions and is guided by fetoscopy and sonography; and 3. Percutaneous fetal therapy, which involves placing a catheter under continuous ultra sound guidance.

The above mentioned invasive procedures or fetal interventions are very complex; lot of care and diligence has to be exercised while performing such procedures, therefore it is not advisable to practice or perform such delicate procedures directly on the individuals, in this case pregnant women.

The present invention aims to actively train the Doctors/ Surgeons enabling them to perform such procedures easily on the pregnant women. The present invention is intended to imitate the human womb of mid-pregnancy stage. This helps to perform the procedures accurately and with high precision.

SUMMARY OF THE INVENTION

The following summary is provided to facilitate an understanding of some of the innovative features unique to the disclosed embodiment and is not intended to be a full description. A full appreciation of the various aspects of the embodiments disclosed herein can be gained by taking the entire specification, claims, drawings, and abstract as a whole.

The prior arts are insufficiently suited for carrying out training of invasive surgical procedures of fetus in a womb, close to reality. The object of the present invention is to provide a device for simulating womb of mid-pregnancy stage to train fetal surgery, which enables procedures and surgery to be learned or trained more effectively than corresponding means according to prior art are capable to do.

SUBSTITUTE SHEET RULE 26 This object is attained by a womb simulator [of mid- pregnancy stage] along with an interactive optical display, which could be an ultra-sound machine or a computer screen, wherein the womb simulator comprises the following features;

1. A cylindrical chamber;

2. According to another feature of the present invention, the cylindrical chamber's floor is a flat circular plate affixed to the chamber with a waterproof sealing on which appropriate tissue required depending upon the type of intervention shall be placed;

3. The inner wall of the chamber is affixed with 4 short rectangular perforated acrylic stubs with a button-hole near the inner tip. The stubs are affixed at different heights inside the chamber and at different points of the internal circumference for fixing tissues; 4. The sidewalls of the chamber have two circular openings for the purpose of inserting of the catheter/needle;

5. A circular layer of non-sticky synthetic clay is placed over the floor of the chamber for the protection of the chamber floor;

6. The inner wall of the chamber has an internal rim, below the upper most level of the chamber, to support accessory replaceable roofs as described in items 7 and 8.

7. A plastic tray with a circular central hole with elastic rope net is placed on the internal rim described above;

8. A plastic tray with a double acrylic sheet is placed on the internal rim as an alternative to the replaceable roof described in item 7;

9. A clylindrical replaceable acrylic inner chamber with silicone rubber roof. The inner chamber is used to simulate the internal organs inside the fetus.

10. The lid is made of single layer silicone rubber attached to steel rim. An inlet pipe is attached to the lid;

1 1. An outlet pipe with control valve is attached flush to the floor to drain the chamber;

12. Externally, the chamber is enveloped with a vinyl cover with two openings for the side windows.

It is, therefore, one aspect of the disclosed embodiments to provide for a device for simulating womb of mid-pregnancy stage to train fetal surgery.

It is another object of the present embodiment is to provide a portable and pre-assembled unit. It is yet another object of the present embodiment is to provide a versatile model which is suitable for training a variety of fetal interventions including but not limited to :

a. Amniocentesis,

b. Cordocentesis,

c. Intrauterine transfusion,

d. Fetal Shunt placement,

e. Bipolar Cord Occlusion,

f. Fetoscopic Laser Photocoagulation for both anterior and posterior placenta.

It is another object of the present embodiment suitable for small scale as well as large scale production;

It is yet another object of the present embodiment to provide a device which is sturdy and simple to use. It is another aspect of the present embodiment to provide a model closely approximate to that of a second trimester pregnant abdomen of an averagely built lady.

It is another object of the present embodiment is to be efficient, a one-time investment and to remain as economical as possible.

It is another object of the present embodiment which is simple design for multiple times usage.

It is another object of the present embodiment to closely simulate real-life experience when using the device for training.

It is yet another object of the present embodiment to provide a device which is acceptable as a learning and teaching medium by both trainers and trainees in an actual training scenario.

The aforementioned aspects and other objectives and advantages can now be achieved as described herein. BRIEF DESCRIPTION OF THE DRAWING

Below, embodiments of this invention will be described in detail in connection with the acoompanying drawing.

Fig. 1. Shows schematically this invention [Cylindrical chamber] with the components thereof.

Fig. 2. Shows the main lid of the Cylindrical chamber .

Fig. 3. Shows a replaceable roof; placental support tray with rope net and clamps.

Fig. 4. Shows a replaceable double acrylic sheet roof ; Silicone sheet held between the upper acrylic ring and lower acrylic ring , which is also replaceable.

Fig. 5. Shows a cross section view of replaceable double acrylic sheet roof ; The upper acrylic ring has two blocks on either side of the upper acrylic ring that are used as handle. The lower acrylic

SUBSTITUTE SHEET RULE 26 ring is placed below the Silicone sheet which is fastened to upper acrylic ring using screws .

Fig. 6. Shows a clylindrical replaceable acrylic inner chamber with silicone rubber roof. The inner chamber is replaceable with replaceable roof or double acrylic sheet roof .

Fig. 7. Shows the vinyl cover with opening for the sidewalls of the cylindrical chamber.

DETAILED DESCRIPTION OF THE INVENTION

Fig.1 shows the schematic cylindrical chamber 1 approximating the size of a womb of mid- pregnancy stage. The cylindrical chamber 1 is made up of transparent acrylic. The inner wall of the cylindrical chamber 1 has an internal support rim 2 made up of thick acrylic to support the replaceable roofs shown in fig. 3 and fig.4. The inner wall of the cylindrical chamber 1 is affixed with four perforated stubs 3 with a button hole near the tip for fixing tissues. The perforated stubs 3 are made up of thick acrylic. These perforated stubs 3 are affixed at different heights inside the cylindrical chamber 1 at different points of the internal circumference. The side walls of the cylindrical chamber 1 has two circular openings 4. These circular openings 4 are covered with thick food-grade double layered frosty silicone rubber. The circular openings 4 are framed with a stainless steel ring 5. The stainless steel ring 5 are lined with leak proof dual layer silicone rubber. The floor 7 of the cylindrical chamber 1 is a flat circular plate affixed with the cylindrical chamber 1 with a water proof sealing. The flat circular plate is made up of thick transparent acrylic. Placed over the floor 7 of the Cylindrical chamber 1 is a circular clay layer 6 of non-sticky synthetic clay for protection of the floor 7. The cylindrical chamber 1 has a inlet pipeline 9 to fill the chamber with fluid medium . The cylindrical chamber 1 has an outlet pipe 10 with control valve attached to flush to the floor 7 to drain the chamber 1.

Fig. 2 shows the lid 1 1 of the cylindrical chamber 1 which is made of food-grade frosty silicone rubber. The lid has a stainless steel outer ring 12. Next to the outer ring 12 is the insert gap 13 used to insert cylindrical chamber 1. Next to the insert gap 13 is the inner ring 14 made of stainless steel. Next to the inner ring 14 is the rubber fixing ring 15 made of stainless steel.

Fig . 3 shows a replaceable roof 16; placental support tray with rope net 17 and clamps 18.

Fig. 4. Shows a replaceable double acrylic sheet roof 19; Silicone sheet 20 held between the upper acrylic ring 21 and lower acrylic ring 23, which is also replaceable.

Fig. 5. Shows a cross section view of replaceable double acrylic sheet roof 19; The upper acrylic ring 21 has two blocks 22 on either side of the upper acrylic ring 21 that are used as handle. The lower acrylic ring 23 is placed below the Silicone sheet 20 which is fastened to upper acrylic ring 21 using screws 24.

Fig. 6. Shows a clylindrical replaceable acrylic inner chamber 25 with silicone rubber roof 26. The inner chamber 25 is replaceable with replaceable roof 16 or double acrylic sheet roof 19.

Fig. 7. Shows the vinyl cover 27 with opening for the sidewalls of the cylindrical chamber 1.

Claims

CLAIMS I /We Claim

1 . A womb simulator of mid-pregnancy tummy comprising;

A cylindrical chamber with internal support rim to support the replaceable roofs;

The inner wall of the cylindrical chamber is affixed with four perforated stubs with a button hole near the tip for fixing tissues;

The side walls of the cylindrical chamber has two circular openings;

The circular openings are framed with a ring;

The rings are lined with leak proof dual layer silicone rubber; The floor of the cylindrical chamber is a flat circular plate affixed with the cylindrical chamber with a water proof sealing. Placed over the floor of the Cylindrical chamber is a circular clay layer for protection of the floor ;

An inlet pipeline is placed at the side of the cylindrical chamber just below the internal support rim and outlet pipeline is connected to the floor; The Cylindrical chamber is closed with a lid. The lid has a outer ring;

Next to the outer ring is the insert gap used to insert cylindrical chamber;

Next to the insert gap is the inner ring;

Next to the inner ring is the rubber fixing ring.

The Cylindrical chamber is enveloped with vinly cover having two side openings for the side windows.

2. A womb simulator claimed in claim 1 has a replaceable roof; a replaceable roof is a placental support tray with rope net and clamps.

3. A womb simulator claimed in claim 1 has another replaceable roof comprising a silicone sheet held within a acrylic ring; that can be replaced with the replaceable roof claimed In claim 2. The silicone sheet is also replaceable.

4. A womb simulator claimed in claim 1 has another clylindrical replaceable acrylic inner chamber with silicone rubber roof. The inner chamber is replaceable with replaceable roof or double acrylic sheet roof.