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

• US 9,649,048 B2
• Filed: 04/17/2009
• Issued: 05/16/2017
• 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: Stats, Jason R., Burnside, Eddie K., Cox, Jeremy B., Misener, Anthony K., Breiter, Catherine C.
• Primary Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US12/426,175
• Publication Number:
  US 20090234328A1
• Time in Patent Office: 2,951 Days
• Field of Search: 600373, 600374
• 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 means for establishing a conductive pathway between a sterile field of the patient and a non-sterile field to enable passage of ECG signals from the catheter to the tip location sensor are also disclosed.

Claims

1. A medical device placement system, comprising:

a medical device assembly including a medical device for placement within a body of a patient and a sensing component, the medical device assembly at least partially disposed in a sterile field, a first connector operably connected to the sensing component including a first contact;

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

means for establishing a conductive pathway between the sterile field and the non-sterile field after the sterile field has been established by creating a perforation in a drape separating the sterile field and the non-sterile field with either the first connector or second connector so as to operably connect the sensing component to the data-receiving component without compromising the sterile field.

2. The placement system as defined in claim 1, wherein the means for establishing the conductive pathway includes:

the second connector including a second contact that operably connects with the first contact when the first and second connectors connect with one another.

3. The placement system as defined in claim 2, wherein the first and second contacts physically connect to one another through the drape to provide the conductive pathway between the sterile field and the non-sterile field.

4. The placement system as defined in claim 3, wherein the first connector is a tether connector that is operably connected to the sensing component via a tether, and wherein the second connector is directly or remotely attached to the data-receiving component.

5. The placement system as defined in claim 4, wherein the first contact includes a blade for creating a perforation in the drape when the first and second connectors connect with one another.

6. The placement system as defined in claim 4, wherein the tether connector is selectively connectable to an intermediate module, the intermediate module including the second connector and being operably connected to the data-receiving component.

7. The placement system as defined in claim 6, wherein the tether connector includes a sterile shield disposed proximate the first contact to protect sterility of a hand of a clinician when operably connecting the tether connector to the intermediate module.

8. The placement system as defined in claim 6, wherein the intermediate module is disposed within a sterile sheath so that the intermediate module is disposed within the sterile field, the tether connector able to operably connect with the intermediate module through the sterile sheath.

9. The placement system as defined in claim 8, wherein the intermediate module includes an ultrasound probe of the medical device placement system.

10. The placement system as defined in claim 4, wherein the first contact includes a pin contact for piercing the drape so as to operably connect with the second contact.

11. The placement system as defined in claim 10, wherein engagement of the pin contact with the second contact prevents relative movement between the tether connector and the second connector.

12. The placement system as defined in claim 4, wherein the tether connector includes a male end that is received into a receptacle included on the data-receiving component.

13. The placement system as defined in claim 4, wherein the tether connector is threadably engageable with the second connector.

14. The placement system as defined in claim 4, wherein the tether connector includes at least one slide arm on which the first contact is included, the at least one slide arm being selectively movable so as to operably connect the first contact with the second contact of the data-receiving component.

15. The placement system as defined in claim 4, wherein the second connector is remotely disposed from the data-receiving component and wherein the first connector and the second connector operably connect to one another via a fenestration defined in the drape, the fenestration disposed proximate an insertion site for the medical device on the body of the patient.

16. The placement system as defined in claim 1, wherein the means for establishing the conductive pathway breaches or circumvents a sterile barrier that at least partially separates the sterile field from the non-sterile field.

17. The placement system as defined in claim 16, wherein the sterile barrier includes the drape and wherein the means for establishing the conductive pathway breaches or circumvents the drape in such a way as to prevent contamination of sterile field.

18. The placement system as defined in claim 17, wherein the means for establishing the conductive pathway provides a perforation in the drape while also preventing access to the perforation.

19. The placement system as defined in claim 1, wherein the means for establishing the conductive pathway includes an integrated connector included in a sterile drape that at least partially separates the sterile field from the non-sterile field.

20. The placement system as defined in claim 19, wherein the integrated connector includes a snap connector for operably connecting with a first connector associated with the sensing component and a second connector associated with the data-receiving component.

21. The placement system as defined in claim 1, wherein the medical device includes a catheter, wherein the sensing component is an ECG sensing component for detecting ECG signal data relating to a heart of the patient after insertion of the catheter into a vasculature of the patient, and wherein the data-receiving component is a chest sensor that receives the ECG signal data from the ECG sensing component via the conductive pathway.