CLIAMS:1. The SPINAL AND EPIDURAL ANAESTHESIA SIMULATOR developed is a near life model which shows movements of spinal curvatures with change in the body posture and is realistic or fidelity simulator and is developed as a teaching and training aid for undergraduates and post graduate students, junior teachers etc. as the SIMULATOR teaching and training in the days to come is becoming essential step for PG students of anaesthesia who are going to practice this technique as their speciality in their carrier as an anaesthesiologist and should result into safe practices and procedures to improve safety and better healthcare to general population. ,TagSPECI:
FORM 2

THE PATENT ACT 1970

(39 OF 1970)

&

THE PATENTS RULES, 2003

COMPLETE SPECIFICATION

(See SECTION 10, RULE 13)

1. TITLE OF THE INVENTION :

“SPINAL AND EPIDURAL ANAESTHESIA SIMULATOR”
2. APPLICANTS

NAME : KRISHNA INSTITUTE OF MEDICAL SCIENCES

NATIONALITY: DEEMED TO BE UNIVERSITY DECLARED U/S 3 OF UGC ACT, 1956 VIDE NOTIFICATION NO. F.9-15 / 2001 – U-3 OF THE MINISTRY OF HUMAN RESOURCES DEVELOPMENT, GOVT.OF INDIA

ADDRESS : KRISHNA INSTITUTE OF MEDICAL SCIENCES,
NEAR DHEBEWADI ROAD, MALKAPUR, KARAD 415110, MAHARASHTRA, INDIA

3. PREAMBLE TO THE DESCRIPTION

PROVISIONAL
N / A
COMPLETE

The following Specification particularly describes the nature of this invention and the manner in which it is to be performed :

4. TECHNICAL FIELD

Spinal and Epidural Anaesthesia is most commonly used Regional anaesthetic technique today in our country, which is a safe, effective and most economic mode of anaesthesia. It is essential that the student must learn detailed anatomy, understand the details, develop basic skills with hands on training and realise the difficulties on a dummy simulator before practicing on live human being & we devised and developed an innovative simulator to be used in the skill lab. In view of the above facts we planned and developed a spinal anaesthesia simulator which closely mimics a living patient with facilities of mobility of bony spinal column ensuring detailed anatomical relations which in medical terms called as fidelity simulator in a minimum of cost. It should prove a great asset in the development of Skill Lab.

Learning of gross anatomy of adult patient in sitting and lateral positions, with the entire bony landmark to feel. Detailed anatomical relations from skin to bones (Spine). Different structures that come in the way while inserting a needle. Changes in the curvatures of spine, in different body positions. Hands on experience of doing lumbar puncture with five different approaches. Understanding the difficulties and causation of complications of procedure. Useful for teaching under graduate, post graduate students, junior teachers etc.

5. BACKGROUND

The Health Care services is going through a significant change in recent years due to society getting easy access to health care information from various media. The developed countries have passed through this phase decades ago and therefore the students there are not allowed to learn the anaesthetic techniques - be it General or Regional anaesthesia – directly on the live patients without undergoing adequate and satisfactory training in the Skill Lab with a variety of simulators available for learning and developing necessary basic skills. Only then they are allowed to do the procedures in live patients under the supervision of experienced teaching staff, resulting in minimum of problems and improved standard of healthcare.

6. SUMMERY

Setting up of a Skill Lab is the need of the day and for this we decided to develop a simulator for spinal and epidural technique which is used for giving anaesthesia. In-house designed, matching a life size and realistic in nature with facility of spinal bones movement, the fidelity simulator was prepared at a very low cost. This simulator is used to teach students spinal and epidural anaesthesia technique with exact knowledge about technique to give them hands on training and achieve expertise before they use the same on actual live patients. This will surely save operation theatre man-hours, improved quality of patient care and confidence of the practitioner.

7. BRIEF DESCRIPTION OF DRAWING:
Fig I is the schematic representation of SPINAL AND EPIDURAL ANAESTHESIA SIMULATOR.
Fig II is the schematic representation of SPINAL AND EPIDURAL ANAESTHESIA SIMULATOR.
Fig III is the schematic representation of SPINAL AND EPIDURAL ANAESTHESIA SIMULATOR.
Fig IV is the schematic representation of SPINAL AND EPIDURAL ANAESTHESIA SIMULATOR.
Fig V is the schematic representation of SPINAL AND EPIDURAL ANAESTHESIA SIMULATOR.

8. DETAILED DESCRIPTION OF DRAWINGS :

Fig – I
The simulator simulates a human being in sitting position showing details of lower back (1) on backside and abdomen (2) on front side. The buttocks rest on the ground surface (3) firmly with stability, supporting waist (4) and the thighs in front of body (5)

Fig – II
It is designed and constructed basically from heavy wooden logs considering the dimensions in real situation (life size), giving accurate placement of normal bony prominences like iliac crest (6), Thigh bones (7), Greater Trochonter (8) and Ischeal Tuberosity (9) etc.

Fig – III
Shows the construction of the main Central Wooden Board with the nut (11) and bolt (12) fixed in the centre of the board (10).

Fig - IV
A strong central wooden board (13) mounted in the main wooden frame (14) is prepared by mounting all vertebral bodies (16 and 17) on to this board with the help of a pair of Titanium elastic nails (15). Bent metal rods represent bony ridge of ileac crest (18) and the lower part of sacral bone is covered with a leather pouch (19)
Fig – V
The fully developed simulator with exposed back cover (20) shows the whole body development by Leather sheet (21), the wooden block at the top with anatomic diagrams (22) and vertebrae covered with thick and tough rubber pads (23) For hands on training, the backside is covered with the leather sheet (20) fixing it in place by Velcro ribbon (24) The central vertebral canal (26) accommodates the PVC tube (25) representing the dural tube.

1. A life size simulator resembling an adult patient in the sitting position (1) is constructed using a strong and heavy wooden frame, steel bars, foam and leather covering.

2. The simulator can be put in either sitting position or in lateral position with adequate stability (both these positions being used for giving spinal anaesthesia).

3. The design of wooden frame and bars is made in such a way that all the bony prominence of the pelvis bone and backbone are matched exactly to a living person’s dimensions and can be felt by hand easily (2).

4. The mid vertical portion of the simulator on backside is designed to mount the Lumbar and Sacral vertebrae (natural) with help of Titanium elastic nail (TEN) with elastic discs interposed between each two vertebral bodies, on to a strong wooden board which can be removed or fixed into the main body frame very firmly (3).

5. The wooden board used for mounting vertebral column has a midline hole opposite lumbar 3 – 4 vertebrae, to which a hexagonal threaded screw is fitted firmly on back side. A long length nut with a suitable wheel is threaded through the screw to point at the curved vertebral column (back bone) which is protected from screw movement by interposition of a thick block rubber pad.

6. When the screw wheel is moved by clockwise rotation from anteriorly, its shaft pushes the spinal curvature backwards; on unscrewing (anticlockwise) the spinal curvature regains its natural curvature due to the TEN threaded through the vertebrae.

7. In the canal which naturally accommodates spinal cord with its coverings a blind ended PVC tube of 0.8 mm diameter is inserted for simulation. It is filled with a coloured fluid when needed to simulate cerebrospinal fluid in life situation.

8. The top portion of vertebral canal is covered to the skin level to accommodate two wooden blocks which depict coloured drawings of the anatomical structures in real life situation in horizontal as well as mid vertical plain (4).

9. Top part of the vertebral column also shows the different important structures (ligaments) which in natural situations support the vertebral curvatures and protect the underlying spinal cord.

10. The lower half of the lumbar vertebrae are padded by a tough block rubber piece to give the similar resistance to needle prick in life situation. The lumbar puncture is done in this region of the spine in anaesthesia practice.

11. The sacral bone is covered by a special leather pouch to give it a natural look and feel of the underlying bone which in practical situation is necessary while giving caudal epidural anaesthesia.

12. The open upper half of the backbone facilitates the trainer or supervisor in viewing the course of the needle tip when a learner is trying the lumbar puncture and pointing out the common problems or difficulties the learner faces along with demonstrating the mistakes he has committed during the procedure.

13. The wrong placement of needle can give rise to different post anaesthesia complications which can be precisely demonstrated and taught to the learner thereby to avoid the same.

9. I claim

1. The SPINAL AND EPIDURAL ANAESTHESIA SIMULATOR developed is a near life model which shows movements of spinal curvatures with change in the body posture and is realistic or fidelity simulator and is developed as a teaching and training aid for undergraduates and post graduate students, junior teachers etc. as the SIMULATOR teaching and training in the days to come is becoming essential step for PG students of anaesthesia who are going to practice this technique as their speciality in their carrier as an anaesthesiologist and should result into safe practices and procedures to improve safety and better healthcare to general population.

Dated this 5th June, 2013.

DR.M.V.GHORPADE
(REGISTRAR)
FOR KRISHNA INSTITUTE OF MEDICAL SCIENCES

To
The Controller of Patents,
The patent office,
At Mumbai – 400 037

10. ABSTRACT OF THE INVENT

Increasing awareness in the society about the healthcare has resulted in heightened expectations of improved surgical outcome, patient safety and care. The junior doctors, who are going to practice spinal and epidural anaesthesia on patients, therefore must go through an initial step of training in skill lab which can make him a well learned adequately trained in skills and a wise health provider than one without it. To achieve this goal, we intend to develop an innovative, life size simulator to be used with full advantage in the skill lab.

DR.M.V.GHORPADE
(REGISTRAR)
FOR KRISHNA INSTITUTE OF MEDICAL SCIENCES