Ventricular catheter with reduced size connector and method of use

• US 6,453,185 B1
• Filed: 03/17/2000
• Issued: 09/17/2002
• Est. Priority Date: 03/17/2000
• Status: Expired due to Fees

• Current Assignee: Integra Lifesciences Corporation (Integra LifeSciences Holdings Corporation)
• Original Assignee: Integra Lifesciences Corporation (Integra LifeSciences Holdings Corporation)
• Inventors: OʼKeefe, Jonathan B.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/528,478
• Time in Patent Office: 914 Days
• Field of Search: 606/129, 606/130, 600/544, 600/378, 600/383, 600/561, 128/898
• US Class Current: 600/378
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A sensing and drainage catheter for use in a cranial site includes a reduced diameter connector so that traditional tunneling techniques may be used with the connector-equipped proximal end of the catheter, rather than the sensor-equipped distal end of the catheter. The catheter includes a drainage lumen and a signal conducting lumen. The signal conducting lumen including a distal sensor for sensing the properties of cerebral spinal fluid and means for transmitting data signals representing those properties in either optical or electrical form to a reduced diameter connector attached to the proximal end of the lumen. A method comprises first accurately locating the distal end of the ventricular catheter in the brain ventricle prior to the catheter being tunneled under the scalp. The connector end of the catheter is then tunneled or threaded through a subdermal tunnel, and is then coupled to a counterpart connector for communication of the sensor signals to a monitor, and the drainage lumen is coupled to a bag for receiving excess CSF.

Claims

1. A method for accessing a site within the cranium of a patient, the method comprising the steps of:

forming an access hole through the skull;

introducing a catheter into the access hole, the catheter having a distal end and a proximal end with a sensor disposed at its distal end and a reduced diameter connector located at its proximal end, the reduced diameter connector adapted to conduct signals provided by the sensor;

positioning the distal end of the catheter at the cranial site; and

thereafter

forming a subdermal tunnel with an entrance at a location adjacent the access hole and an exit at a location remote from the access hole; and

threading the proximal end of the catheter including the connector into the entrance of the subdermal tunnel and out the exit of the subdermal tunnel.

2. The method of claim 1 further comprising the steps of:

connecting the connector to a tunneling instrument prior to threading the catheter into the entrance, and wherein the step of forming the subdermal tunnel comprises the step of forming the tunnel with the tunneling instrument; and

disconnecting the connector from the tunneling instrument after the connector has been pulled out the exit.

3. The method of claim 1 further comprising the step of covering a drainage port formed in the catheter prior to the step of threading the catheter into the entrance.

4. The method of claim 3 further comprising the step of positioning a slotted sleeve over the drainage port to cover the port.

5. The method of claim 4 further comprising the step of sliding the slotted sleeve to cover and uncover the drainage port.

6. The method of claim 2 further comprising the steps of:

mounting a protective tunneling sleeve over the connector;

connecting the tunneling sleeve to the tunneling instrument;

threading the connector and the tunneling sleeve with the tunneling instrument;

disconnecting the tunneling sleeve from the tunneling instrument after the connector has been pulled through the tunnel by the tunneling instrument.

7. The method of claim 6 further comprising the step of covering a drainage port formed in the catheter with the protective tunneling sleeve prior to the step of threading the catheter into the entrance.

8. The method of claim 2 further comprising the step of:

mounting a protective tunneling sleeve over the connector, the tunneling sleeve having a diameter greater than the connector and greater than the tunneling instrument;

connecting the tunneling sleeve to the tunneling instrument; and

threading the catheter through the tunnel and increasing the size of the tunnel by pulling the tunneling sleeve and connector through the tunnel with the tunneling instrument.

9. The method of claim 1 further comprising the step of mounting a protective tunneling sleeve over the connector prior to the step of threading the catheter through the tunnel.

10. The method of claim 9 further comprising the steps of forming the final configuration of the subdermal tunnel with the tunneling sleeve.

11. The method of claim 1 further comprising the step of connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site.

12. The method of claim 11 wherein the step of connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site comprises connecting the drainage lumen prior to the step of threading the catheter through the tunnel.

13. The method of claim 11 wherein the step of connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site comprises connecting the drainage lumen after the step of threading the catheter through the tunnel.

14. The method of claim 1 further comprising the step of connecting the connector to a monitor to display signals from the sensor after the step of threading the connector out the exit of the tunnel.

15. The method of claim 1 wherein the step of forming a subdermal tunnel comprises the step of forming a subdermal tunnel with a diameter no greater than 12 French.

16. The method of claim 1 wherein the step of forming a subdermal tunnel comprises the step of forming a subdermal tunnel with a diameter within the range of 6 to 9 French.

17. The method of claim 1 further comprising the step of conducting optical signals through the catheter from the sensor to the connector.

18. The method of claim 17 further comprising the step of connecting the optical signals at the catheter connector with an optical conductor in a complementary connector when the catheter connector and the complementary connector are joined together.

19. The method of claim 1 further comprising the step of conducting electrical signals through the catheter from the sensor to the connector.

20. The method of claim 19 further comprising the step of connecting the electrical signals at the catheter connector with an electrical conductor in a complementary connector when the catheter connector and the complementary connector are joined together.

21. The method of claim 1 wherein the step of positioning the distal end of the catheter at the cranial site comprises the step of inserting a stylet into the catheter to stiffen the catheter as it is positioned.

22. The method of claim 1 wherein the step of introducing a catheter having a reduced diameter connector located at its proximal end comprises introducing a catheter having a connector adapted to fit within a complementary connector, wherein the complementary connector is larger than the catheter connector and the tunnel and is connected to the catheter connector after the step of threading the catheter connector out the exit of the tunnel.

23. The method of claim 22 further comprising the steps of:

connecting the catheter connector to the complementary connector outside the tunnel; and

connecting the complementary connector to a monitor to display signals from the sensor.

24. The method of claim 23 further comprising the step of connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site.

25. The method of claim 22 wherein the step of introducing a catheter having a connector adapted to fit within a complementary connector comprises the step of introducing the catheter with a male connector adapted to fit within a female complementary connector, wherein the female connector is larger than the catheter connector and the tunnel and is connected to the male catheter connector after the step of threading the male catheter connector out the exit of the tunnel.

26. The method of claim 25 further comprising the steps of:

connecting the male catheter connector to the female complementary connector outside the tunnel; and

connecting the female complementary connector to a monitor to display signals from the sensor.

27. The method of claim 23 further comprising the step of connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site.

28. A method for accessing a site within the cranium of a patient, the method comprising the steps of:

forming an access hole through the skull;

introducing a catheter into the access hole, the catheter having a distal end and a proximal end with a sensor disposed at its distal end and a reduced diameter catheter connector located at its proximal end, the reduced diameter catheter connector adapted to conduct signals provided by the sensor;

positioning the sensor of the catheter at the cranial site;

forming a subdermal tunnel with an entrance at a location adjacent the access hole and an exit at a location remote from the access hole;

threading the catheter connector into the entrance of the subdermal tunnel and out the exit of the subdermal tunnel.

29. The method of claim 28 further comprising the steps of:

connecting the connector to a tunneling instrument prior to threading the catheter connector into the entrance, and wherein the step of forming the subdermal tunnel comprises the step of forming the tunnel with the tunneling instrument.

30. The method of claim 28 further comprising the step of mounting a protective tunneling sleeve over the catheter connector prior to the step of threading the catheter through the tunnel.

31. The method of claim 28 further comprising the steps of:

mounting a protective tunneling sleeve over the catheter connector;

connecting the tunneling sleeve to a tunneling instrument;

threading the catheter connector and the tunneling sleeve with the tunneling instrument;

disconnecting the tunneling sleeve from the tunneling instrument after the connector has been pulled through the tunnel by the tunneling instrument.

32. The method of claim 28 further comprising the step of covering a drainage port formed in the catheter prior to the step of threading the catheter into the entrance.

33. The method of claim 32 further comprising the step of positioning a slotted sleeve over the drainage port to cover the port.

34. The method of claim 28 further comprising the step of connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site.

35. The method of claim 34 wherein the step of connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site comprises connecting the drainage lumen prior to the step of threading the catheter through the tunnel.

36. The method of claim 34 wherein the step of connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site comprises connecting the drainage lumen after the step of threading the catheter through the tunnel.

37. The method of claim 28 further comprising the step of connecting the catheter connector to a monitor to display signals from the sensor after the step of threading the connector out the exit of the tunnel.

38. The method of claim 28 further comprising the step of conducting optical signals through the catheter from the sensor to the catheter connector.

39. The method of claim 38 further comprising the step of connecting the optical signals at the catheter connector with an optical conductor in a complementary connector when the catheter connector and the complementary connector are joined together.

40. The method of claim 28 further comprising the step of conducting electrical signals through the catheter from the sensor to the connector.

41. The method of claim 40 further comprising the step of connecting the electrical signals at the catheter connector with an electrical conductor in a complementary connector when the catheter connector and the complementary connector are joined together.

42. The method of claim 28 wherein the step of positioning the distal end of the catheter at the cranial site comprises the step of inserting a stylet into the catheter to stiffen the catheter as it is positioned.

43. The method of claim 40 further comprising the steps of:

positioning a working sheath in the subdermal tunnel prior to threading the catheter through the tunnel; and

threading the catheter through the sheath; and

threading the catheter connector into the working sheath at the entrance of the subdermal tunnel and out the working sheath at the exit of the subdermal tunnel.

44. A method for accessing a site within the cranium of a patient, the method comprising the steps of:

forming an access hole through the skull;

introducing a catheter into the access hole, the catheter having a distal end and a proximal end with a sensor disposed at its distal end and a reduced diameter catheter connector located at its proximal end, the reduced diameter catheter connector adapted to conduct signals provided by the sensor;

inserting a stylet into the catheter to stiffen the catheter;

positioning the sensor of the catheter at the cranial site;

connecting the connector to a tunneling instrument;

forming a subdermal tunnel with a tunneling instrument with an entrance at a location adjacent the access hole and an exit at a location remote from the access hole;

threading the catheter connector into the entrance of the subdermal tunnel and out the exit of the subdermal tunnel;

connecting a drainage lumen of the catheter to a fluid reservoir to drain fluid from the cranial site.