The epidural needle is equipped with a pressure sensor to enhance the success of neuraxial anesthesia through the epidural method

Abstract

Epidural anesthesia is commonly used for surgeries and pain control. However, identifying the epidural space can be challenging, resulting in failure rates of up to 32%. To address this issue, a new invention involving an epidural needle with electronic sensors and alarms has been developed. This portable device aims to improve accuracy in identifying the epidural space by utilizing auxiliary methods such as audio and optical systems. It features a high accuracy electronic barometer to measure pressure and ensure correct identification. The incorporation of a highly sensitive pressure sensor and other mechanisms like sound and optical alarms increase the reliability of the epidural method. Furthermore, the device allows for adjustment of pressure levels, sensitivity, and sterilization to maintain hygiene.

Description

The epidural needle is equipped with a pressure sensor to enhance the success of neuraxial anesthesia through the epidural method

[0001] Epidural anesthesia is a commonly used technique for surgeries and pain control, offering effective pain relief by injecting medication into the epidural space surrounding the spinal cord. However, accurately identifying the epidural space can be challenging, leading to failure rates as high as 32% in some cases. Recognizing the need for improved precision in this procedure, a groundbreaking invention has been introduced.

[0002] This device is designed to offer a new way epidurals can be administered by utilizing embedded electronic sensors that detect the precise location of the epidural space, ensuring accurate delivery of medication. To further enhance accuracy, the device is equipped with auxiliary methods such as sound and optical alarms, providing real-time feedback to the user during the insertion process.

[0003] Moreover, this groundbreaking device offers unparalleled customization options, allowing users to adjust pressure levels, sensitivity settings, and sterilization protocols to meet their specific needs. By focusing on high sensitivity to even the most minor pressure changes, this method is anticipated to provide consistently precise results and become an invaluable tool for anesthesiologists worldwide.

[0004] A61M 19 / 00 – A61M 5 / 32 – A61M 5 / 158

[0005] US4801293A United States

[0006] Apparatus and method for detecting probe penetration of human epidural space and injecting a therapeutic substance thereinto

[0007] A method for detecting probe penetration of human (i) target tissue having predetermined internal pressure and (ii) epidural space having essentially negative gauge pressure relative to atmosphere pressure and enlarging the epidural space in the neighborhood of said probe which includes inserting a hollow probe into the human body towards the internal target tissue and gradually increasing pressure in a closed volume defined by the probe interior and a conduit communicating therewith.

[0008] The above mentioned patent shares a purpose with our claimed one, however, the design and comprising elements are different. For instance, this one, unlike our claimed patent does not rely on highly sensitive barometer pressure sensor or include an alarm unit.

[0009] WO2015200712A1

[0010] Optical sensor for needle-tip tissue identification and diagnosis

[0011] This invention provides an apparatus and method for effective epidural anesthesia by providing realtime needle localization information. The idea of this invention is from the concept that different tissues have different optical properties such as absorption and reflection due to different compounds, so we can distinguish the types of tissues that the needle reaches with their distinct optical properties. This device and method can be very useful in epidural anesthesia and also reduce the risk of surgery.

[0012] The purpose and function of this mentioned patent resembles our design, as they both aim to increase accuracy in epidural administration for surgery. However, their comprising parts and placements are different in significant ways. Moreover, this one does not utilize a pressure sensor.

[0013] United States Patent Application 20090131832

[0014] Electronic Syringe with Safety System for Spinal Injection

[0015] A device for locating an epidural space. The device includes a connector for forming a hermetically sealed connection with a needle. An air vessel is formed by an air tank, a diaphragm, and a space in the needle when the needle is attached to the connector. The device includes a pressure sensor configured to detect the air pressure in the air vessel. An actuator is coupled to a switch and positioned adjacent to the diaphragm to compress the diaphragm when the switch is actuated by a user causing a reduction in volume in the air vessel. A circuit coupled to the pressure sensor and to an alarm detects a signal indicative of the air pressure sensed by the pressure sensor. The circuit compares the signal to a threshold and outputs a first state to the alarm when the pressure is above the threshold, and outputs a second state to the alarm when the pressure falls below the threshold.

[0016] This patent bears a strong resemblance to our claimed one as they have similar elements and mechanisms. However, the details of the process and achieving the results vary in the two inventions, for instance, this one calculates a threshold that helps with the epidural space determination, while ours relies on highly sensitive, customizable alarm units.

[0017] CN215018567

[0018] COMBINED SPINAL-EPIDURAL ANESTHESIA KIT

[0019] The utility model discloses a combined spinal-epidural anesthesia kit, and belongs to the technical field of medical equipment. An anesthesia puncture needle pushing piece is arranged at the needle tail of the epidural puncture needle, a pressure transmission catheter is movably arranged in the epidural puncture needle, a pressure sensor is fixedly communicated with the end portion of the outer side of the pressure transmission catheter, and a pressure measuring instrument is connected with the pressure sensor through a pressure transmission wire.

[0020] The above mentioned patent involves an anesthetic kit that aims to minimize movement and discomfort during spinal epidural. While this is an important part of our design as well, the two patents do not share any qualities or features in function and structure. For instance, this one utilizes a clamp to fix the syringe during injection and ours relies on alarms. Moreover, our design has a wider scope and also helps determine the epidural space.

[0021] JP2013009919

[0022] EPIDURAL NEEDLE PUNCTURE SYSTEM

[0023] The epidural needle includes: a needle body having a through-hole formed therein; a needle base at which the needle body is fixed; and a holding body removably retained at the needle base. The removal of the holding body from the needle base can be decided according to a pressure value detected by a pressure sensor for detecting the puncture pressure of the needle body.

[0024] This mentioned patent includes a puncture system that features a pressure sensor similar partly to our design. However, the scope of our claimed method is wider as it also helps with the accurate placement of the epidural injection.

[0025] KR1020170059656

[0026] EPIDURAL SPACE COGNITION DEVICE AND PUNCTURE NEEDLE FOR RECOGNIZING EPIDURAL SPACE

[0027] The present invention relates to an epidural cortex cognition system that supports epidural anesthesia. The epidural cortex cognition system that supports epidural anesthesia visually recognizes the moment when an injection needle enters an epidural space, according to a change in an image inputted through an optical fiber at the time of entry into an epidural space in epidural anesthesia.

[0028] While this mentioned patent and our claimed one have common ground in overall function and the use of a pressure sensor, other comprising elements and design vary. For instance, ours also features sound alerts and utilizes an electronic module.

[0029] WO2020003313

[0030] EPIDURAL DELIVERY DEVICE

[0031] A device for safe epidural drug delivery configured to be used with standard epidural stylet and needle. The correct placement of an epidural needle and stylet within the epidural space is provided with the device comprising at least one position sensor for determining the relative position of both an epidural needle and stylet and relative to one another.

[0032] This invention has a similar purpose to our claimed patent in aiding a more convenient epidural delivery. However, the comprising elements are different, for instance, while they both feature sensors, ours also includes a barometer and an alarm unit that alerts the operator with sound and light.

[0033] The present invention involves an epidural needle and method that utilizes electronic sensors and alarms for accurate neuraxial anesthesia results. It features sensitive electronic components, a rechargeable battery, and auxiliary methods like audio and optical systems to reduce failure rates. The device incorporates a high accuracy electronic barometer to measure pressure and identify negative pressure for precise identification of the epidural space. The pressure sensor enhances reliability and includes sound and optical alarms to increase accuracy. The device allows adjustment of pressure levels and sensitivity and can be sterilized for hygiene. The method focuses on high sensitivity to minor pressure changes for convenient and accurate results, making it a valuable tool for anesthesiologists.

[0034] Epidural anesthesia is one of the main methods of anesthesia for abdominal and lower limb surgeries. This method can also be used as a supplement to general anesthesia, especially for thoracic and upper abdominal surgeries. Epidural anesthesia is commonly used for post-operative pain control as well as labor pain control. This method is also used to treat chronic pain using steroid injection and local anesthetic.

[0035] The main challenge in using epidural anesthesia is identifying the epidural space. In fact, most anesthesiologists have experienced anesthesia failure and epidural analgesia. It has been shown in the studies that the probability of failure varies from thirty-two percent (32%) in thoracic epidural to twenty-seven percent (27%) in lumbar epidural.

[0036] The epidural space is located between the durometer and the wall of the vertebral canal, the irregular column of fat, lymphatics and blood vessels. This space is limited above by the foramen magnum, below by the sacrococcygeal ligament, around by the vertebral pike, and behind by the ligamentum flavum and the vertebral lamina. Epidural space is not a closed space and communicates with adjacent vertebral spaces through the intervertebral hole. The depth of the epidural space in the midline at the level of the second lumbar vertebra (L2) is maximum 6mm and in the middle thoracic region is 4mm to 5mm. Where the spinal cord becomes larger, especially in T9-T12 and C3-T2, the epidural space is minimal and approximately 3mm remains between the flavum and dura ligaments. The epidural space has a negative pressure compared to the surrounding tissues, and for this reason, help is needed to identify this space.

[0037] Injection in the wrong space can have unwanted side effects for the patient. including insufficient anesthesia and forcing to change the anesthesia method in the middle of surgery, which can multiply the complications of anesthesia, while in some patients, epidural anesthesia will be the only way for the patient's surgery.

[0038] Therefore, due to the smallness of the epidural space, moving the epidural needle forward while both hands are placed in the space is a difficult task and may cause a severe dural tear. Another problem may occur during drug injection. Due to the fact that the volume of drug injection is large (15 to 20 cc), the pressure applied to the syringe piston during injection may cause the needle to move. If the needle is pushed forward, it will cause laceration and damage of the dura mater.

[0039] The most important complication of dura mater perforation is the resulting headaches. If the needle is pulled back, it will cause the needle to exit the epidural space, in which case the anesthesia will not be successful. Another complication of wrong injection is the formation of abscess and hematoma, which can have irreparable consequences for the patient.Solution of Problem

[0040] The present invention involves an epidural needle and method of epidural space identification which utilizes electronic sensors and alarms to provide accurate results in neuraxial anesthesia. The design features highly sensitive electronic parts and a chargeable battery. This portable device is light, portable and energy conscious.

[0041] The purpose of this invention is to identify the epidural space using auxiliary methods such as audio and optical systems, so that it can reduce the failure rate of this method. In order to achieve optimal results, this device uses a high accuracy electronic barometer. This apparatus works by measuring pressure and identifying negative pressure by increasing the certainty of correctly identifying the epidural space.

[0042] The innovative aspect of this design is the incorporation of the pressure sensor which makes the epidural method more reliable. It also features other mechanisms that such as sound alarms, optical alarms, the ability to select the type of alarm to increase the accuracy of epidural space identification.

[0043] Another feature that adds to the reliability of this epidural method is the ability to adjust the pressure level and sensitivity in pressure measurement. The device also provides the the possibility to be sterilized and placed in medical equipment disinfectants to avoid any hygienic complications.

[0044] The process of the claimed method includes the following: the pressure is measured by the air pressure sensor and after that the signal obtained from the sensor is differentially amplified by the operational amplifier OP-AMP to determine the space. Using a differential amplifier increases accuracy and sensitivity and reduces the impact of noise on system performance. The output signal of the amplifier unit is connected to the sound and light alarm (LED) to announce the space to the operator.

[0045] Selecting the type of warning (audio or optical) and its intensity is determined by the operator. It is noteworthy that the option to choose the type of alarm increases the accuracy of the operation due to the simultaneous engagement of the user's senses of sight and hearing. Due to the flexibility in performance and this alarm system, this design can be implemented in different environments such as crowded hospital spaces. The design has a simple structure which comprises a needle, a catheter, a pressure sensor, an alarm unit, LEDs and an off / on switch as captures in. The needle is connected to the sensor by a catheter.

[0046] The implementation of the claimed method brings a primary focus on high sensitivity in minor changes in pressure and as a result makes the procedure convenient and accurate. As a result, the identification of the epidural space is obtained with the least amount of error, and the claimed method is expected to be well received and widely used by anesthesiologists.Advantage Effects of the Invention

[0047] • Accurate diagnosis of the epidural space

[0048] • Reducing the probability of failure and minimizing complications of an epidural

[0049] • Reducing the risk of dural tears

[0050] • Speeding up the epidural anesthesia process

[0051] • Increasing the use of epidural anesthesia instead of general anesthesia

[0052] • No need for a separate power supply due to low energy consumption

[0053] • Ensuring the correct placement of the catheter and not moving it during surgery and drug injection

[0054] • Audible and optical alarms when the needle is correctly placed in the epidural space

[0055] Shows a general view of the device and the comprising elements.

[0056] Shows a general view of the device components and the connection between its parts which are:

[0057] 1. Needle

[0058] 2. Catheter

[0059] 3. Diaphragm

[0060] 4. Catheter

[0061] 5. Pressure sensor

[0062] 6. Alarm Unit

[0063] 7. LEDs

[0064] 8. Sound alarm

[0065] 9. The switchExamples

[0066] The invention involves an epidural administration method and device which utilizes a pressure sensor for high accuracy delivery. It can be of interest to anestheticians in various operations, for instance those specializing in maternity wards and labor. As determined by the doctors, or other present healthcare providers, the injection is prepared, the epidural space is determined using the sensors and alarms embedded in the device, and the delivery is done with minimized risks and high accuracy.

[0067] This invention will be very widely used in epidural administration in operating rooms for various surgeries that need spinal anesthesia. It can also be beneficial in medical residency programs in teaching innovative methods, therefore, universities, hospitals and medical facilities of all kinds can utilize this device and method. More specifically, It can be a new and convenient way to administer epidurals during labor which would lower health risks and minimize unwanted c-section procedures.

Claims

An epidural needle and administration method is designed which utilizes an electronic barometer sensor to optimize accuracy of epidural space determination in neuraxial anesthesia. The design includes a needle, a catheter, a pressure sensor, an alarm unit, LEDs and an off / on switch.According to claim 1, the pressure is measured by the air pressure sensor and after that the signal obtained from the sensor is differentially amplified by the operational amplifier OP-AMP to determine the space.According to claim 2, using a differential amplifier increases accuracy and sensitivity and reduces the impact of noise on system performance.According to claim 3, the output signal of the amplifier unit is connected to the sound and light alarm (LED) to announce the space to the operator.According to claim 4, selecting the type of warning (audio or optical) and its intensity is determined by the operator.According to claim 5, the option to choose the type of alarm increases the accuracy of the operation due to the simultaneous engagement of the user's senses of sight and hearing.According to claim 6, due to the flexibility in performance and the alarm system, this design can be implemented in different environments such as crowded hospital spaces.According to claim 1, the needle is connected to the sensor by a catheter.

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