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EP-4740894-A2 - SYSTEM AND METHOD FOR DETECTING MEDICAL DEVICE LOCATION AND ORIENTATION IN RELATION TO PATIENT ANATOMY

EP4740894A2EP 4740894 A2EP4740894 A2EP 4740894A2EP-4740894-A2

Abstract

A medical device position guidance system is provided. The system includes at least one reference transmitter and a receiver system configured to receive signals from the at least one reference transmitter. The reference transmitter is configured to maintain a static position on a subject. The system further includes a memory device and a processor configured to (i) receive signals relating to the location and orientation of each sensor of the receiver system relative to the at least one reference transmitter; and (ii) using the received signals, create an anatomical coordinate system. The memory device further includes information defining a pre-defined anthropometric relationship between the anatomical coordinate system of the subject's external anatomy and the internal anatomical shape and size of the subject. A method for medical device position guidance is also provided.

Inventors

  • BJURBO, KARL THOMAS
  • ROBERTS, ANTHONY D.
  • PURNELL, SHAWN G.
  • BLUVSHTEIN, Vlad

Assignees

  • Avent, Inc.

Dates

Publication Date
20260513
Application Date
20210819

Claims (13)

  1. A medical device position guidance system (100) comprising: at least one reference transmitter (110), wherein the at least one reference transmitter is configured to maintain a fixed position relative to a subject (10); a receiver system (300) configured to receive signals from the at least one reference transmitter (110); a processor (120), wherein the at least one reference transmitter and the receiver system are operatively coupled to the processor; and a memory device (122) storing instructions which when executed by the processor, cause the processor to: (i) receive signals relating to a location and orientation of the receiver system relative to the at least one reference transmitter; and (ii) using the received signals, create an anatomical coordinate system (101); wherein the memory device further includes information defining a pre-defined anthropometric relationship between the anatomical coordinate system of the subject's external anatomy and the internal anatomical shape and size of the subject.
  2. The medical device position guidance system of claim 1, wherein the reference transmitter (110) comprises a registration transmitter (400), wherein the registration transmitter is configured to be placed on an anatomical landmark (60) of the subject, wherein the receiver system is configured to receive signals from the at least one registration transmitter; wherein the memory device stores instructions which when executed by the processor, cause the processor to: (i) receive signals relating to the location and orientation of the at least one registration transmitter relative to the receiver system; (ii) using the received signals relating to the location and orientation of the at least one transmitter relative to the receiver system, plot the location and orientation of the registration transmitter on the anatomical coordinate system; and (iii) register the anatomical landmark on the anatomical coordinate system such that the anatomical coordinate systems forms a representation of the subject's external anatomy.
  3. The medical device position guidance system of claim 1, further comprising an inserted transmitter (220) configured to be inserted into the subject, wherein the receiver system is configured to receive signals from the inserted transmitter; wherein the memory device stores instructions which when executed by the processor, cause the processor to: (i) receive signals relating to the location and orientation of the inserted transmitter relative to the receiver system; and (ii) using the received signals relating to the location and orientation of the inserted transmitter relative to the receiver system, plot the location and orientation of the inserted transmitter on the anatomical coordinate system.
  4. The medical device position guidance system of claim 3, wherein the inserted transmitter is mounted to a catheter (200) or mounted on a stylet configured to be inserted within a catheter.
  5. The medical device position guidance system of claim 3, wherein the inserted transmitter comprises at least one coil (226) configured to generate electromagnetic signals.
  6. The medical device position guidance system of claim 5, wherein the at least one coil (226) is a single-axis coil or a multi-axis coil.
  7. The medical device position guidance system of claim 1, further comprising a display device (129) operatively coupled to the processor; wherein the memory device stores instructions which when executed by the processor, cause the processor to cause the display device to display the anatomical coordinate system (101).
  8. The medical device position guidance system of claim 1, wherein each reference transmitter (110) comprises a set of three coils (113, 114, 115) oriented orthogonally to one another, wherein each of the coils is configured to transmit electromagnetic signals.
  9. The medical device position guidance system of claim 1, wherein the receiver system (300) includes a sensor (310, 312) comprising a tri-axial coil configured to receive electromagnetic signals.
  10. The medical device position guidance system of claim 1, wherein the receiver system (300) is configured to be able to move relative to the at least one reference transmitter (110).
  11. The medical device position guidance system of claim 10, wherein the receiver system (300) comprises at least two sensors (310, 312) configured to receive signals from the at least one reference transmitter (110).
  12. The medical device position guidance system of claim 11 wherein each sensor (310, 312) of the receiver system comprises an independent housing (500) such that each sensor of the receiver system is in a dynamic spatial relationship relative to each other.
  13. The medical device position guidance system of claim 11, wherein the at least two sensors (310, 312) are enclosed in a unitary receiver housing (600).

Description

RELATED APPLICATION The present application claims priority to U.S. Application Serial No. 17/007,576 filed on August 31, 2020, which is incorporated herein in its entirety by reference thereto. FIELD OF THE INVENTION The subject matter of the present invention relates generally to an electromagnetic system and method for detecting the location and orientation of a medical device in relation to a patient's anatomy. BACKGROUND Physicians and other health care providers frequently use catheters to treat patients. The known catheters include a tube which is inserted into the human body. Certain catheters are inserted through the patient's nose or mouth for treating the gastrointestinal tract. These catheters, sometimes known as enteral catheters, typically include feeding tubes. The feeding tube lies in the stomach or intestines, and a feeding bag delivers liquid nutrient, liquid medicine or a combination of the two to the patient. Other types of catheters are inserted into the patient's veins or arteries for treating the cardiovascular system. These intravascular catheters include, among others, central venous catheters, peripheral venous catheters and the peripherally inserted central catheters. These catheters include a relatively small tube that passes through the patient's veins or arteries. Depending on the application, the health care provider can use an intravascular catheter to remove blood vessel blockages, place inserts into blood vessels and provide patients with injections of medications, drugs, fluids, nutrients, or blood products over a period of time, sometimes several weeks or more. When using these known enteral and intravascular catheters, it is important to place the end of the catheter at the proper location within the human body. Erroneous placement of the catheter tip may injure or harm the patient. For example, if the health care provider erroneously places an enteral catheter into the patient's lungs, liquid may be introduced into the lungs with harmful results. If the health care provider erroneously places an intravascular catheter into the wrong blood vessel of the cardiovascular system, the patient may experience infection, injury or a harmful blockage. With feeding tubes in particular, it is also prudent to check that the exit aperture of the feeding tube (typically located at the distal end/tip of the tube) remains in its desired location over the period of treatment, e.g., feeding. Protocols that address this requirement in enteral feeding tubes include frequent monitoring for the appropriate pH of fluids extracted from the feeding tube when not carrying nutritional liquids and careful patient monitoring to ensure nutritional uptake is as expected. In some cases, health care providers use X-ray machines to gather information about the location of catheters within the body. There are several disadvantages with using X-ray machines. For example, these machines are relatively large and heavy, consume a relatively large amount of energy and expose the patient to a relatively high degree of X-ray radiation. Also, these machines are typically not readily accessible for use because, due to their size, they are usually installed in a special X-ray room. This room can be far away from the patient's room. Therefore, health care providers can find it inconvenient to use these machines for performing catheter insertion procedures. Furthermore, it can be inconvenient to transport these machines to a patient's home for home care catheter procedures. Moreover, even X-rays are not necessarily conclusive as to the location of the catheter tip, as the natural and continuous movement of the internal organs can make it difficult for the physician interpreting the X-ray to be sure of the actual location of the distal end of the catheter. Another existing catheter locating means involves using an electromagnetic coil positioned inside the catheter and an electromagnetic coil locating receiver outside of the patient's body. The electromagnetic coil is generally incorporated into a stylet or guide wire which is inserted within the catheter. The coil locating receiver can be used to determine the distance the coil is from the receiver and its depth in the patient's body and can communicate with a display to show a reference image of a non-subject body and an image of the coil located on the display with the reference image. However, these systems also have several disadvantages. For example, the coil locating receiver is a large device that must rest in a precise location outside the patient's body and does not permit for adjustments due to each individual patient's anatomical size or shape. However, a patient undergoing a feeding tube placement will be agitated and sudden movements are expected, which can move the coil locating receiver, thus increasing the likelihood of positional errors or complications in locating the catheter. Additionally, these existing systems can only display the coil location