Systems and methods for breaching a sterile field for intravascular placement of a catheter

• US 10,849,695 B2
• Filed: 05/02/2017
• Issued: 12/01/2020
• Est. Priority Date: 11/26/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Cox, Jeremy B., Misener, Anthony K., Breiter, Catherine C., Burnside, Eddie K., Stats, Jason R.
• Primary Examiner(s): D Abreu, Michael J
• Application Number:
  US15/585,051
• Publication Number:
  US 20170231700A1
• Time in Patent Office: 1,309 Days
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/372 Details of monitor hardware
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

An integrated catheter placement system for accurately placing a catheter within a patient'"'"'s vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient'"'"'s chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient'"'"'s heart. Various methods for establishing a conductive pathway between a sterile field of the patient and a non-sterile field are also disclosed.

Claims

1. A medical method, comprising:

positioning a medical device at least partially in a sterile field, the medical device including a first connector operably connected to a sensing component, the first connector including a first contact;

placing a data-receiving component at least partially in a non-sterile field, a second connector including a second contact operably connected to the data-receiving component; and

establishing a conductive pathway from the first contact to the second contact between the sterile field and the non-sterile field without compromising the sterile field.

2. The method according to claim 1, wherein the establishing step comprises connecting the first connector to the second connector through a physical barrier separating the sterile field and the non-sterile field.

3. The method according to claim 2, wherein the physical barrier is a drape, and wherein the establishing step comprises breaching the drape with one of the first connector or the second connector.

4. The method according to claim 3, wherein the establishing step comprises physically contacting the second contact with the first contact.

5. The method according to claim 4, wherein the first contact includes a blade or a pin, the establishing step comprising piercing the drape with the blade or the pin.

6. The method according to claim 3, wherein the first connector includes a male end and the second connector includes a receptacle, the establishing step comprising inserting the male end into the receptacle such that relative movement between the first connector and the second connector is prevented.

7. The method according to claim 6, wherein the first connector male end and the second connector receptacle include threading, the establishing step comprising engaging the male end and the receptacle via the threading.

8. The method according to claim 2, wherein the first connector is selectively connectable to an intermediate module including the second connector, the establishing step comprising operably connecting the intermediate module to the data-receiving component.

9. The method according to claim 2, wherein the physical barrier is a drape including an integrated connector, the establishing step comprising connecting the integrated connector to both the first connector and the second connector.

10. The method according to claim 1, wherein the medical device includes a catheter, and wherein the sensing component is designed to detect ECG signal data, further comprising:

inserting the catheter into a vasculature of a patient; and

sending ECG signal data from the sensing component to the data-receiving component via the conductive pathway.

11. The method according to claim 10, wherein the sensing component is coupled to a stylet designed for removable insertion into the catheter, the stylet including the first connector, the establishing step comprising connecting the first connector to the second connector through a physical barrier separating the sterile field and the non-sterile field.

12. The method according to claim 1, wherein the establishing step comprises wirelessly connecting the first connector to the second connector.

13. The method according to claim 1, wherein the data-receiving component is a tip location sensor (TLS), and wherein the placing step comprises placing the TLS sensor on a patient'"'"'s chest.