# US 11,027,101 B2 · Catheter assembly including ECG sensor and magnetic assemblies > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,101 B2 - Document ID: US11027101B2 - Status: Granted - Kind: B2 - Application number: 15/900,623 - Filed: 2018-02-20 - Published: 2018-06-21 - Granted: 2021-06-08 - Earliest claimed: 2008-08-22 - Assignees: C. R. Bard, Inc. - Applicants: C. R. Bard, Inc. - Inventors: Ryan R. Lemon; Matthew W. Bown - Web page: https://patentgrep.com/patent/US11027101B2 ## CPC - A61M 25/09: Guide wires - A61B 5/283: Invasive - A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod} - A61B 2017/00044: {Sensing electrocardiography, i.e. ECG} - A61B 2017/00331: {with preformed bends} - A61B 2034/2051: {Electromagnetic tracking systems} - A61M 25/0054: {with regions for increasing flexibility} - A61M 2025/09116: {Design of handles or shafts or gripping surfaces thereof for manipulating guide wires} - A61M 2025/09141: {made of shape memory alloys which take a particular shape at a certain temperature} - A61M 2025/09175: {having specific characteristics at the distal tip} - A61M 2025/09183: {having tools at the distal tip} - A61M 2205/3507: with implanted devices, e.g. external control - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A stylet for use in guiding a distal tip of a catheter to a predetermined location within the body of a patient. In one embodiment the stylet is configured for use within a lumen of the catheter and comprises a core wire, an ECG sensor, and a magnetic assembly. The ECG sensor senses an ECG signal of a patient when the stylet is disposed within the lumen of the catheter and the catheter is disposed within the body of the patient. The magnetic assembly includes at least one element capable of producing a magnetic or electromagnetic field for detection by a sensor external to the patient. In another embodiment, the stylet includes a pre-shaped distal segment that is deflected with respect to a more proximal portion of the stylet, which in turn causes a distal segment of the catheter to be deflected when the stylet is received within the lumen. ## Claims ### Claim 1 A catheter assembly, comprising: a stylet including: a core wire having a straight proximal segment aligned with a longitudinal axis of the core wire, and a pre-shaped distal segment having a bent configuration deflected from the longitudinal axis; and a sleeve positioned over the pre-shaped distal segment, the sleeve adhered to the core wire near a distal end of the straight proximal segment; and a catheter having a distal portion, the pre-shaped distal segment of the core wire designed to bend the distal portion of the catheter into the bent configuration upon insertion of the stylet into the catheter. ### Claim 2 (depends on 1) The catheter assembly according to claim 1, wherein the stylet includes a memory shape material, and wherein the pre-shaped distal segment of the stylet defines an arc shape. ### Claim 3 (depends on 2) The catheter assembly according to claim 2, wherein the stylet includes nitinol, and wherein the stylet further includes a handle to axially rotate the stylet. ### Claim 4 (depends on 1) The catheter assembly according to claim 1, wherein the straight proximal segment of the core wire has a first diameter, and wherein the pre-shaped distal segment of the core wire includes a second diameter less than the first diameter. ### Claim 5 (depends on 4) The catheter assembly according to claim 4, wherein the core wire transitions from the first diameter to the second diameter along a tapered region. ### Claim 6 (depends on 5) The catheter assembly according to claim 5, wherein the sleeve is adhered to the core wire at a proximal end of the tapered region. ### Claim 7 (depends on 6) The catheter assembly according to claim 6, wherein the stylet comprises an air gap along the second diameter between an outer surface of the pre-shaped distal segment of the core wire and an inner surface of the sleeve. ### Claim 8 (depends on 7) The catheter assembly according to claim 7, further comprising a magnetic element disposed in the air gap, the magnetic element having a magnetic field strength sufficient to be detectable following insertion of the catheter assembly into a patient. ### Claim 9 (depends on 8) The catheter assembly according to claim 8, wherein the magnetic element is a plurality of permanent magnets. ### Claim 10 (depends on 8) The catheter assembly according to claim 8, wherein the magnetic element is one or more electromagnets. ### Claim 11 (depends on 1) The catheter assembly according to claim 1, wherein the sleeve includes a reinforcement element to maintain the pre-shaped distal segment in the bent configuration. ### Claim 12 (depends on 11) The catheter assembly according to claim 11, wherein the reinforcement element is selected from the group consisting of a coil, a braided mesh, a substrate, and combinations thereof. ### Claim 13 (depends on 11) The catheter assembly according to claim 11, wherein the reinforcement element is a stainless steel coil and the sleeve is composed of polyimide. ### Claim 14 (depends on 1) The catheter assembly according to claim 1, wherein the stylet further comprises a hydrophilic coating. ### Claim 15 (depends on 1) The catheter assembly according to claim 1, wherein the stylet further comprises a handle oriented in a direction corresponding to a direction of the bent configuration.