Invented by Timothy Schweikert, Skender Daerti, Rose Rowan, Eric M. Harris, Michael Joyce, Angiodynamics Va LLC
The Angiodynamics Va LLC invention works as followsWireless technology is used to transmit information from sensors to a computing system or mobile device. The information can be displayed by a software application running on a mobile device or computer system. This allows the user to control the display, without having to touch any non-sterile items.
Background for Medical Device Placement System and Method for Its Use
Many different types of medical devices have been inserted in the body. In order to make these devices work properly, it is often necessary to determine their exact location within the body. In order for medications to be delivered properly, the infusion catheters need to be placed at a specific location near the heart. It is important to place the infusion catheters at a precise location to ensure that medication is delivered to an area of high blood flow. It allows for the proper mixing and dilution of the medication before it is distributed throughout the body. Other medical devices, such as catheters, must also be placed at the correct location to perform their intended function. Enteral feeding tubes, for example, must be placed within the stomach to ensure that the patient receives the nutrition they need from the tube. The incorrect positioning of some of these medical devices inside the body can have catastrophic results. The precise location of these medical devices must be quickly and easily determined in order to continue the appropriate medical treatment.
Currently, a variety of systems are used to locate a device in the body. The location of a catheter in the Superior Vena Cava near the heart can be done using a variety of methods and technologies. Magnets, ultrasounds, x-rays and fluoroscopy are some of the methods used. Each of these methods has drawbacks which make them less than ideal. Magnets can be easily interfered by electrical devices or other external sources.
Electrocardiography technology, in conjunction with location-based technologies, is one of the most common methods used to determine the exact location of a device within the SVC. The ECG is a graph that shows electrical currents in the heart. The graph contains significant peaks which occur at specific times within the heart. The P-wave can be used to locate a medical device close to the heart. The P-wave occurs when the electrical vector for a heart contraction moves from the sinoatrial to the atrioventricular, from the left to right atrium. The P-wave is atrial depolarization which leads to atrial contraction.
The first operation that this system will perform is to locate the catheter tip using triangulation technology. This technology uses a paddle with three coils and an additional sensor coil on the tip. The guide wire is attached to the catheter. Software can activate two or more coils in the paddle to create different magnetic fields which are detected by the sensor coil on the end of catheter. The location of the tip of the catheter can be determined by using software algorithms that perform triangulation analysis based on energized coils. The user can then see the location of the catheter tip on a screen. The technology can then be switched on to determine the exact location once the tip is close to the heart.
The ECG is produced by placing electrodes on the chest of the patient, across the heart. This allows the electrical currents in the heart to be measured and graphically displayed. The ECG graph contains several peaks which can give the medical practitioner important information. The user concentrates on the P wave for location purposes. The P-wave peak height increases as the catheter tip approaches the lower third SVC. This is because the tip gets closer to the Sinoatrial node (SA), and receives a stronger signal. When the P-wave is at its maximum height, the catheter tip is located in the lower third SVC. The tip must be inserted beyond the optimal position or peak. The P-wave will be reflected, and the graph will show a negative peak because the tip is past the SA node. The user can now pull back the tip until the wave is no longer reflected. This indicates that the tip is past the optimal point.
The need to control technology is a problem with the current method for determining the location of devices inside the body. Computers are required to connect the electrodes for the ECG and the paddle for triangulation. The stylet (a portion of the cathter that is controlled by this system and located) must be connected to the PC. On the cable that connects the stylet and the computer is a remote control. This allows the user control over the information shown on the screen, as well as the technology being used. It is important that the person inserting a catheter does not use the remote, because their hands need to remain sterile. “Since the remote is not sterile and the hands of the user will only be in contact with the sterile area, the current method to maintain a sterile atmosphere involves wrapping the remote in autoclaved wrap.
This system should be easy to prepare and have a well-known interface. This system should be simple to set up and have an easy-to-use interface.
The present device provides a system and method for locating a medical device in a person’s body. This eliminates or reduces the requirement that the user contact any element not within the sterile area. The system is simple to prepare, and has a well-known interface.
These, together with other aspects, and advantages, which will be apparent subsequently, are found in the details of the construction and operation, as described and claimed more fully below, referring to the accompanying drawings, where like numbers refer to similar parts throughout.
The drawings are part of the written description. The description may use relative terms like?lower? ?upper,? ?horizontal,? ?vertical,?, ?above,? ?below,? ?up,? ?down,? ?top? As well as derivatives thereof (e.g.,?horizontally? As well as their derivatives (e.g.?horizontally? ?downwardly,? ?upwardly,? etc.) The orientation described in the text or shown on the drawing should be understood to be the orientation. These relative terms serve as a convenient way to describe the apparatus and are not intended to require it be built or operated in any particular orientation. Terms referring to attachments, couplings and similar terms, such as “connected” Terms such as?connected? Refers to a relationship in which structures are attached or secured to each other either directly or through intermediary structures. This can be done by either movable or fixed attachments, or both, unless otherwise specified.
The accompanying drawings show examples of how the system and method can be used to locate a medical device in a body.
FIG. The prior art medical device placing system is shown in Figure 1. It can be used to locate a catheter tip near the heart. Current technology to locate a tip 102 in a patient 105 uses several pieces of equipment that all provide a direct link between the computer and the patient through cords 107 and 109. A stylet 101 is used to control the insertion of peripherally inserted central cathter (PICC)100. A catheter tip can include a sensor coil for sensing magnetic fields created by two or more coils housed in a paddle. The paddle 104 and electrocardiogram electrodes (ECG) 103 can both be used to contact the patient’s surface 105. They can also connect via a corded connector 107 into a computer. The cord 109, which connects the stylet 101 with the computer 106, has a remote control. The remote control 108, which is not sterile, requires special handling before each user. Each user must maintain sterility while touching the remote in order to control an electronic display 110. The display 110 must be controlled to record the screen images and switch to the ECG system if necessary. Current practice requires that the user place a bag with a cord 101 plugged into it through the bag 150, which has been autoclave-sterilized. The user must carefully follow this process to avoid contamination of their hands.
The present medical device placing system uses Bluetooth technology to establish a wireless link between sensor devices and computers. Wireless technology eliminates the need for cords to connect the computer and patient. The patient is completely separated from the computer that displays information from the location-determination system with the invention. The computer system, which can only display this information, can be replaced by a mobile computing device such as a smart phone or tablet. Software that controls and displays the system may be integrated in a software program. This allows the user to operate the system without touching a surface.
FIG. According to one embodiment, FIG. 2 shows a medical device positioning system and its position on the body as it is used to determine a catheter’s location near the heart. PICC 100 can be inserted through an insertion site 221, which is an incision, into a peripheral area, such as the arm or leg, to position a catheter near the center. The stylet 101 can be used to guide the PICC 100 through veins in the body and into the heart. It is important to determine the exact location of the PICC, and its tip 102 in order to ensure that the procedure performed on the patient will be beneficial.
The patient can be prepared for the procedure by ensuring the insertion site is sterile. ECG electrodes can be placed on the chest 105 of the patient in areas that provide a reliable ECG signal. The paddle 104 is then placed on or above the middle of the chest 105. The electrodes can be attached to the paddle 104. When not in use, the electrodes can be stored within the paddle. The coils 227, which are located within the paddles 104, can be used to extend the electrodes 103 from the paddles 104. The coils 227 are retractable back into the paddle after use.
The data used in this document can include at least two types, electrocardiograph data (ECG data) and catheter tip position data. The data includes the original analog signals that are detected by the components (e.g. electrodes, coils of sensor, stylet). The digital representations are also available for the analog signals.
A bridge 229 can connect the stylet 104 to the paddle 104, at a connection junction 230, in order to allow the stylet to send the ECG detected by the heart to paddle. In an alternative embodiment, stylets 101 can communicate ECG data from the catheter tip to the paddle via Bluetooth or another wireless transmitter. The bridge wire 229 would then not be required. The paddle 104 may house a processor that converts and interprets the ECG signals generated by the electrodes and stylet 101, as well as the location data from the paddle. The location data, ECG data, and other data can be encrypted and transmitted via Bluetooth or another wireless transmission method to the mobile device 228, if desired. The location data and ECG information entering the paddle can also be sent via Bluetooth or other wireless communication methods to the mobile device 228, if desired. If each element of the system has a Bluetooth or wireless transmitter, the data generated by each element can directly be sent from the stylet 101, electrodes 103 and paddle 104.
FIG. According to one embodiment, FIG. 3 shows a paddle and its components in the retracted position. The ECG electrodes can be seen in this view. The paddle may have three ECG housings 950 and at least three ECG housings 103. When contracted, the ECG cords can be coiled underneath the ECG electrodes. The paddle 104 may also include a Bluetooth or wireless transmitter 300. The paddle 104 may also include a battery 301. This can be a lithium-ion rechargeable battery or another suitable energy storage device. The paddle 104 can also include a jack configured to receive a PICC lead cable 229 The PICC lead cable can also be attached at the bottom of paddle 104.
FIG. According to one embodiment, FIG. 4 shows a paddle and its components extended. The ECG electrodes can be seen in this view being extended from the paddle. The paddle may have three ECG housings 950 and at least three ECG 103 electrodes. When the ECG electrodes are extended, the ECG cords can be seen.
FIG. According to one embodiment, FIG. 5 shows a view in reverse of a paddle. In one embodiment, the paddle can include multiple feet 905 on the backside to allow it to rest comfortably on the chest of a patient (not shown). The feet 905 can be made from a non-slip rubber material to ensure that the paddle 104 rests securely on the chest of the patient. The feet 905 are positioned so that they do not interfere with the extendable components on the paddle 104.
FIG. A paddle 104 is shown in FIG. 6 according to a different embodiment. In an alternative embodiment, the paddle can contain at minimum two tracking coils (500) that can be used to detect a catheter tip as it moves in the correct position. The coils 500 are made from a ferrous metal, or composite material that generates an electrical current when the stylet wire passes through their detectable region. The three analog signals that represent the location of the catheter tip can be generated by measuring the current values in the tracking coils when the stylet wire is close. After being converted into digital format, the location data can then be triangulated by either the processor on the paddle or processor on the mobile device to show the user the approximate location of the catheter. The tracking coils can be placed so that they don’t interfere with the extendable components on the paddle 104. The paddle 104 may also contain at least three extendable ECG housings 905, as well as a wireless transmitter and a PICC cable port.Click here to view the patent on Google Patents.