SYSTEMS AND METHODS FOR BREACHING A STERILE FIELD FOR INTRAVASCULAR PLACEMENT OF A CATHETER

• US 20090234328A1
• Filed: 04/17/2009
• Published: 09/17/2009
• 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., Stats, Jason R., Breiter, Catherine C., Misener, Anthony K., Burnside, Eddie K., Hamatake, Bret, Orome, Amir
• Granted Patent: US 9,649,048 B2
• Time in Patent Office: Days
• US Class Current: 604/523
• 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 data-receiving component at least partially disposed in a non-sterile field; and

means for establishing a conductive pathway between the sterile field and the non-sterile field so as to operably connect the sensing component to the data-receiving component.

2. 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 a patient after insertion of the catheter into the 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.

3. 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.

4. The placement system as defined in claim 3, wherein the sterile barrier includes a 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.

5. The placement system as defined in claim 4, wherein the means establishing the conductive pathway provides a perforation in the drape while also preventing access to the perforation.

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

a first connector operably connected to the sensing component, the first connector including a first contact; and

a second connector operably connected to the data-receiving component, the second connector including a second contact that operably connects with the first contact when the first and second connectors connect with one another.

7. The placement system as defined in claim 6, wherein the first and second contacts physically connect to one another through a sterile drape to provide the conductive pathway between the sterile field and the non-sterile field.

8. The placement system as defined in claim 7, 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.

9. The placement system as defined in claim 8, wherein the first contact includes a blade for creating a perforation in the drape when the first and second connectors connect with one another.

10. The placement system as defined in claim 8, 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 8, 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 8, wherein the tether connector is threadably engageable with the second connector.

14. The placement system as defined in claim 8, wherein the tether connector includes at least one slide arm on which the first contact is included, the slide arm being selectively movable so as to operably connect the first contact with a second contact of the data-receiving component.

15. The placement system as defined in claim 8, 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.

16. The placement system as defined in claim 15, 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.

17. The placement system as defined in claim 15, 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.

18. The placement system as defined in claim 17, wherein the intermediate module includes an ultrasound probe of the medical device placement system.

19. The placement system as defined in claim 8, 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.

20. 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.

21. The placement system as defined in claim 20, 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.

22. The placement system as defined in claim 1, wherein the means for establishing the conductive pathway includes a wireless link between the sensing component and the data-receiving component.

23. A method for operably connecting an ECG sensing component included with a medical device at least partially disposed in a sterile field of a patient with a data-receiving component at least partially disposed in a non-sterile field, the method comprising:

providing the medical device and the ECG sensing component, the ECG sensing component configured to detect ECG signals of the patient after the medical device is at least partially inserted into a body of the patient, the ECG sensing component operably connected to a first communication node disposed in the sterile field; and

operably connecting a second communication node of the data-receiving component to the first communication node without compromising the sterile field.

24. The method for operably connecting as defined in claim 23, wherein operably connecting the first and second communication nodes enables ECG signals to be passed from the ECG sensing component of the medical device to the data-receiving component, and wherein the second communication node is at least partially disposed in the non-sterile field.

25. The method for operably connecting as defined in claim 23, wherein the sterile and the non-sterile fields are separated by a sterile drape, and wherein operably connecting the second communication node with the first communication node further includes:

physically connecting the first communication node with the second communication node via a perforation in the drape, a physical connection of the first and second communication nodes covering the breach so as to not compromise the sterile field.

26. The method for operably connecting as defined in claim 25, wherein physically connecting the first communication node with the second communication node produces the perforation in the drape.

27. The method for operably connecting as defined in claim 23, wherein operably connecting the second communication node further includes:

operably connecting the second communication node of the data-receiving component to the first communication node in manner using a force that is substantially lateral with respect to the body of the patient.

28. The method for operably connecting as defined in claim 23, wherein operably connecting the second communication node further comprises:

wirelessly connecting the second communication node of the data-receiving component to the first communication node.

29. A catheter system for providing a conductive pathway between a sterile field of a patient and a non-sterile field, the system comprising:

a stylet positionable in a lumen of a catheter, the stylet including an ECG sensing component that detects ECG signals of the patient, the stylet further including a first connector operably connected to the ECG sensing component and disposed within the sterile field; and

a data-receiving component including a second connector, the second connector at least partially disposed in the non-sterile field and operably connectable to the first connector through a sterile drape without compromising the sterile field such that the ECG signals can be received by the data-receiving component.

30. The catheter system as defined in claim 29, wherein the data-receiving component is a chest sensor of a catheter placement system, and wherein the second connector is removably attachable to the chest sensor.

31. The catheter system as defined in claim 30, wherein the first connector includes a body defining a channel and a pin contact extending into the channel, the pin contact being operably connected to the ECG sensing component via a tether, wherein the first connector slidably receives in the channel thereof an upper portion of the second connector such that the pin contact pierces the drape to define a perforation and operably connects with a contact of the second connector, and wherein the perforation is confined within the channel of the first connector.

32. The catheter system as defined in claim 31, wherein the chest sensor includes a channel that slidably receives a lower portion of the second connector such that at least one contact of the chest sensor is placed in operable communication with at least one contact of the second connector.

33. The catheter system as defined in claim 32, wherein the at least one contact of the second connector includes an indented retention feature that physically engages with the at least one contact of the chest sensor to prevent inadvertent separation of the second connector from the chest sensor.

34. The catheter system as defined in claim 33, wherein the second connector further includes at least one engagement tab that is received by at least one detent defined on the body of the first connector so as to prevent inadvertent separation of the first connector from the second connector.

35. A method for creating a connection through a sterile barrier, the method comprising:

positioning a sensor on a patient;

placing the sterile barrier over the sensor; and

establishing a connection through the sterile barrier between the sensor and a distal end of a catheter.

36. The method for creating a connection as defined in claim 35, further comprising:

positioning a catheter into the patient using the connection.

37. A method for positioning a catheter within a vasculature of a patient, the method comprising:

positioning a sensor on the patient;

placing a sterile barrier over the sensor;

establishing a connection through the sterile barrier between the sensor and a distal end of the catheter; and

inserting the catheter into the vasculature of the patient using the connection to position the catheter within the vasculature of the patient.

38. The method for positioning as defined in claim 37, wherein inserting the catheter further includes:

inserting the catheter into the vasculature of the patient using ECG signals from a heart of the patient, the ECG signals being provided via the connection.