Intracranial pressure monitor and drainage catheter assembly

• US 8,066,681 B1
• Filed: 10/01/1993
• Issued: 11/29/2011
• Est. Priority Date: 10/11/1989
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences (U.S.) Incorporated (Edwards Lifesciences Corporation)
• Inventors: Hall, John P., Beckman, Ronald B.
• Primary Examiner(s): REICHLE, KARIN M
• Assistant Examiner(s): REICHLE, KARIN M
• Application Number:
  US08/130,634
• Time in Patent Office: 6,633 Days
• Field of Search: 128/667, 128/691, 128/748, 128/710, 128672-675, 128/671, 604164-170, 604/264, 604/266, 604/268, 604/95, 604280-282, 604/170.02, 604/533, 604 8- 10, 600/561
• US Class Current: 604/264
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: G01L 9/0077 for measuring reflected light
• CPC Class Codes: G01L 9/0079 with Fabry-Perot arrangements

Abstract

A monitor-driven intracranial catheter assembly including dual lumen catheter for monitoring intracranial pressure via a pressure sensor located in one lumen while simultaneously draining cerebrospinal fluid through another lumen. A third lumen can also be provided with a side port for receiving a stylet. The stylet is used as a stiffening agent to aid in advancing the catheter into the patient'"'"'s brain. The pressure sensor is preferably a spectral modulation sensor that communicates with a photodetector apparatus by means of a single optical fiber, thus minimizing the diameter of the catheter. The photodetector is self-correcting for signal errors caused by temperature change, changes in intensity of the input light, and transmission losses within the optical apparatus. Moreover, the photodetector operates off the output voltage of the standard hospital monitor by “scaling” the signal from the monitor to provide a pressure measurement signal that emulates the output of a piezoresistive strain gauge sensor or Wheatstone bridge. Therefore, the entire catheter assembly is designed to be used with any of the common types of hospital monitors. The pressure monitoring catheter assembly can be used in any situation requiring very sensitive pressure measurements and can be zeroed and calibrated in situ.

Claims

1. An intracranial pressure monitoring catheter device which is insertable into the cranium of a mammal through a bore hole of the cranium comprising:

an elongate, tubular flexible catheter body having a proximal end, a distal end, and an outer sidewall;

a pressure transmitting component for receiving the pressure at the distal end of said catheter body and for transmitting an indication of said pressure through said catheter body to the proximal end thereof;

a connector on the proximal end of said catheter body for connecting said pressure transmitting component to an extracorporeal pressure monitoring device;

a stylet insertion aperture formed in the side wall of the catheter body near the distal end of the catheter body, a distal portion of the catheter body being thus defined between the stylet insertion aperture and the catheter body distal end; and

a stylet lumen extending between the stylet insertion aperture and the distal end of the catheter body, the stylet lumen being closed at the distal end of the catheter body;

said catheter device being thereby configured such that a rigid stylet may be inserted through said stylet insertion aperture and advanced in the distal direction through said stylet receiving lumen to the closed distal end thereof to impart stiffness to only the distal portion of the catheter body, the catheter device being adapted to be fed through a scalp tunnel formed between two scalp incisions, one of the scalp incisions being coincident with the bore hole in the cranium, the catheter body being sized so that it may extend through the scalp tunnel with the proximal and distal ends of the catheter body extending out of respective ones of said scalp incisions, the distal portion being sized so that it can be pulled up and away from the bore hole and the stylet inserted into the stylet insertion aperture to impart stiffness to the distal portion and thereby facilitate insertion through the bore hole;

wherein said stylet insertion aperture is formed in said sidewall at a location approximately four (4) inches from the distal end of said catheter body.

2. An intracranial pressure monitoring catheter device which is insertable into the cranium of a mammal through a bore hole of the cranium comprising:

an elongate, tubular flexible catheter body having a proximal end, a distal end, and an outer sidewall;

a pressure transmitting component for receiving the pressure at the distal end of said catheter body and for transmitting an indication of said pressure through said catheter body to the proximal end thereof;

a connector on the proximal end of said catheter body for connecting said pressure transmitting component to an extracorporeal pressure monitoring device;

a stylet insertion aperture formed in the side wall of the catheter body near the distal end of the catheter body, a distal portion of the catheter body being thus defined between the stylet insertion aperture and the catheter body distal end; and

a stylet lumen extending between the stylet insertion aperture and the distal end of the catheter body, the stylet lumen being closed at the distal end of the catheter body;

said catheter device being thereby configured such that a rigid stylet may be inserted through said stylet insertion aperture and advanced in the distal direction through said stylet receiving lumen to the closed distal end thereof to impart stiffness to only the distal portion of the catheter body, the catheter device being adapted to be fed through a scalp tunnel formed between two scalp incisions, one of the scalp incisions being coincident with the bore hole in the cranium, the catheter body being sized so that it may extend through the scalp tunnel with the proximal and distal ends of the catheter body extending out of respective ones of said scalp incisions, the distal portion being sized so that it can be pulled uP and away from the bore hole and the stylet inserted into the stylet insertion aperture to impart stiffness to the distal portion and thereby facilitate insertion through the bore hole;

wherein said stylet insertion aperture is formed in said sidewall at a location approximately 15 cm from the distal end of said catheter body.

3. An intracranial pressure monitoring catheter device which is insertable into the cranium of a mammal through a bore hole of the cranium comprising:

an elongate, tubular flexible catheter body having a proximal end, a distal end, and an outer sidewall;

a pressure transmitting component for receiving the pressure at the distal end of said catheter body and for transmitting an indication of said pressure through said catheter body to the proximal end thereof;

a connector on the proximal end of said catheter body for connecting said pressure transmitting component to an extracorporeal pressure monitoring device;

a stylet insertion aperture formed in the side wall of the catheter body near the distal end of the catheter body, a distal portion of the catheter body being thus defined between the stylet insertion aperture and the catheter body distal end; and

a stylet lumen extending between the stylet insertion aperture and the distal end of the catheter body, the stylet lumen being closed at the distal end of the catheter body;

said catheter device being thereby configured such that a rigid stylet may be inserted through said stylet insertion aperture and advanced in the distal direction through said stylet receiving lumen to the closed distal end thereof to impart stiffness to only the distal portion of the catheter body, the catheter device being adapted to be fed through a scalp tunnel formed between two scalp incisions, one of the scalp incisions being coincident with the bore hole in the cranium, the catheter body being sized so that it may extend through the scalp tunnel with the proximal and distal ends of the catheter body extending out of respective ones of said scalp incisions, the distal portion being sized so that it can be pulled uP and away from the bore hole and the stylet inserted into the stylet insertion aperture to impart stiffness to the distal portion and thereby facilitate insertion through the bore hole;

wherein said connector for connecting said pressure transmitting component to said extracorporeal pressure monitoring device comprises a connector body which is larger in cross-sectional dimension than said catheter body.

4. A pressure monitoring catheter system comprising the combination of:

a) an intracranial pressure monitoring catheter device which is insertable into the cranium of a mammal through a bore hole of the cranium comprising;

an elongate, tubular flexible catheter body having a proximal end, a distal end, and an outer sidewall;

a pressure transmitting component for receiving the pressure at the distal end of said catheter body and for transmitting an indication of said pressure through said catheter body to the proximal end thereof;

a connector on the proximal end of said catheter body for connecting said pressure transmitting component to an extracorporeal pressure monitoring device;

a stylet insertion aperture formed in the side wall of the catheter body near the distal end of the catheter body, a distal portion of the catheter body being thus defined between the stylet insertion aperture and the catheter body distal end; and

a stylet lumen extending between the stylet insertion aperture and the distal end of the catheter body, the stylet lumen being closed at the distal end of the catheter body;

said catheter device being thereby configured such that a rigid stylet may be inserted through said stylet insertion aperture and advanced in the distal direction through said stylet receiving lumen to the closed distal end thereof to impart stiffness to only the distal portion of the catheter body, the catheter device being adapted to be fed through a scalp tunnel formed between two scalp incisions, one of the scalp incisions being coincident with the bore hole in the cranium, the catheter body being sized so that it may extend through the scalp tunnel with the proximal and distal ends of the catheter body extending out of respective ones of said scalp incisions, the distal portion being sized so that it can be pulled up and away from the bore hole and the stylet inserted into the stylet insertion aperture to impart stiffness to the distal portion and thereby facilitate insertion through the bore hole; and

b) an elongate rigid stylet having a proximal end and a distal end, said stylet being shorter than said catheter body and insertable into said stylet lumen for the purpose of imparting stiffness only to said distal portion of said catheter body.

5. An intracranial pressure monitoring catheter system wherein a catheter is passable through a subcutaneous scalp tunnel which extends between a first scalp incision and a second scalp incision, and wherein said catheter is subsequently insertable into the cranium through a bore hole formed in the cranium beneath said second scalp incision, said system comprising:

a. a pressure monitoring catheter device comprising;

an elongate tubular flexible catheter body having a proximal end, a distal end and an outer surface;

a pressure transmitting component for receiving the pressure at the distal end of said catheter body and for transmitting an indication of the pressure at the distal end of said catheter body to the proximal end of said catheter body;

a connector on the proximal end of said catheter body for connecting said pressure transmitting component to an extracorporeal pressure monitoring device;

a stylet insertion aperture formed in the side wall of the catheter body near the distal end of the catheter body, a distal portion of the catheter body being thus defined between the stylet insertion aperture and the catheter body distal end; and

a stylet lumen extending between the stylet insertion aperture and the distal end of the catheter body, the stylet lumen being closed at the distal end of the catheter body; and

b. a stylet which is shorter than said catheter body, said stylet being insertable into, and removable from, said stylet lumen to impart stiffness to only said distal portion of said catheter body;

c. said intracranial pressure monitoring catheter system being thereby constructed and configured for insertion into the cranium by;

i) initially inserting the distal end of said catheter body into said subcutaneous scalp tunnel through said first scalp incision;

ii) advancing a portion of said catheter body through said subcutaneous scalp tunnel and out of said second scalp incision such that said stylet insertion aperture and said distal portion of the catheter body are exteriorized out of said second scalp incision;

iii) inserting said stylet through said stylet insertion aperture and into said stylet lumen;

iv) introducing the distal end of said catheter body through said bore hole and advancing said distal portion of said catheter body into said cranium such that said stylet insertion aperture remains outside of said cranium;

v) removing said stylet from said catheter body; and

,

vi) effecting closure of said second scalp incision over said catheter body.

6. The pressure monitoring catheter system of claim 5 wherein:

said stylet insertion aperture is located approximately four (4) inches from the distal end of said catheter body.

7. The pressure monitoring catheter system of claim 5 wherein:

said stylet insertion aperture is located approximately 15 cm from the distal end of said catheter body.

8. The pressure monitoring catheter system of claim 5 wherein said pressure transmitting component comprises an optical pressure sensing system.

9. The pressure monitoring catheter system of claim 8 wherein said optical pressure sensing system comprises:

a light-reflective diaphragm positioned at the distal end of said catheter body, said diaphragm being constructed and positioned so as to move in accordance with changes in pressure at the distal end of said catheter;

a distally directed light transmitting member extending longitudinally through said catheter body, said distally directed light transmitting member having a proximal end and a distal end, the proximal end of said distally directed light transmitting member being connectable to a light source such that light from said light source will be transmitted in the distal direction, through said distally directed light transmitting member, to said light-reflective diaphragm positioned at the distal end of said catheter;

a proximally directed light transmitting member extending longitudinally through said catheter, said proximally directed light transmitting member having a proximal end and a distal end, said proximally directed light transmitting member being configured and positioned to transmit reflected light from said light-reflecting diaphragm, in the proximal direction, to the proximal end of said catheter; and

the proximal end of said proximally directed light transmitting member being connectable by way of said connector to a monitoring device operative to generate indicia of pressure relative to changes in said reflected light received from said proximally directed light transmitting member.

10. The pressure monitoring catheter system of claim 6 further comprising at least one drainage lumen for draining intracranial cerebrospinal fluid, said at least one fluid drainage lumen being formed separate and apart form said stylet lumen, said at least one fluid drainage lumen comprising:

a hollow passageway extending longitudinally through said catheter body;

at least one distal drainage aperture to permit cerebrospinal fluid to enter said at least one fluid drainage lumen; and

a proximal outlet aperture to permit cerebrospinal fluid to exit said at least one distal drainage lumen.

11. The pressure monitoring catheter system of claim 10 wherein said at least one distal drainage aperture comprises:

a plurality of apertures aligned in a longitudinal row near the distal end of said catheter body and forming openings into said drainage lumen.

12. The pressure monitoring catheter system of claim 10 wherein said at least one distal drainage aperture comprises:

a plurality of longitudinal rows of apertures formed near the distal end of said catheter body and opening into said at least one fluid drainage lumen.

13. The pressure monitoring catheter system of claim 5 wherein said connector for connecting said pressure transmitting component to said pressure monitoring device comprises a connector body which is larger in cross-sectional dimension than said catheter body.

14. The pressure monitoring catheter system of claim 5 wherein said connector for connecting said pressure transmitting component to said pressure monitoring device comprises a fiber optic connector.