Gas column pressure monitoring catheters

• US 6,673,022 B1
• Filed: 07/18/2000
• Issued: 01/06/2004
• Est. Priority Date: 08/20/1999
• Status: Expired due to Term

• Current Assignee: IRRAS USA, Inc. (Irras AB)
• Original Assignee: InnerSpace Medical, Inc.
• Inventors: Gerg, James, Bobo, Donald
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/618,495
• Time in Patent Office: 1,267 Days
• Field of Search: 600/485, 600/486, 600/487, 600/488, 600/561, 600/587, 737/00, 737/06, 737/48, 737/56, 604/96.01, 604/264
• US Class Current: 600/561
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/6864 Burr holes

Abstract

A catheter has a pressure sensitive bladder at a distal end and a pressure transducer at a proximal end with the proximal end attached to a mammalian body and the bladder inserted within the mammalian body. The bladder partially filled with a gas responds to pressure changes within the body and the pressure transducer senses the changes via gaseous communication with the bladder. In one embodiment, the bladder is inserted in a human brain with the transducer mounted on a bolt affixed to the skull. Initial dissection of the brain tissue is effected by over-inflation of the bladder by a manual piston pump or a blunt ended slender rod. The transducer may be mounted on a bolt inserted within a hole drilled in the skull. An antimicrobial agent may be dispersed from openings in a seal between the bolt and the skull, from a porous seal, or from a ribbed or threaded outer surface of the bolt. In one embodiment, the catheter is inserted through an inner opening in the bolt and a drain may also be inserted through the bolt. In another embodiment, the pressure transducer is attached to the neck or shoulder area of a patient and a flexible catheter connects the transducer to a bladder inserted in the brain of a patient. The flexible catheter runs under a patch of skin on the skull and into a hole drilled through the skull to prevent bacteria entering the brain. The transducer may be attached anywhere on the body adjacent to an opening into the body wherein the bladder is inserted in the opening and communicates with the transducer through a short flexible catheter.

Claims

1. A system for monitoring pressure within a mammalian body, the system comprising:

a catheter having a proximal end, a distal end, and an outer surface configured for insertion into the mammalian body with the distal end of the catheter positioned within the mammalian body;

a first lumen, filled with a gas, extending longitudinally through the length of the catheter, the lumen providing gaseous communication between the distal end and the proximal end 23 of the catheter;

a flaccid bladder, containing a gas, positioned at the distal end of the catheter, the bladder being in gaseous communication with the first lumen and being of a size configured for collapsing and expanding in response to changing pressure in the body so that a pressure change in the gas within the bladder reflects the pressure change within a body space in which the bladder is placed, the first lumen being thereby operable to transmit, in the gas from the distal end to the proximal end of the catheter, changes in pressure exerted against the bladder;

a pressure transducer mounted on the proximal end of the catheter, the pressure transducer being in gaseous communication with the first lumen; and

a second lumen, filled with the gas, positioned between the proximal end of the catheter and the pressure transducer and in gaseous communication there between;

wherein the total gas volume of the bladder represents no less than approximately 50% of the gas volume contained in the total system.

2. The system of claim 1 wherein the gas volume in the bladder represents approximately 75% of the gas volume contained in the total system so as to extend the operating life of the bladder.

3. The system of claim 1 further comprising an adapter capable of being affixed to the body, wherein the catheter and the pressure transducer are integrated with the adapter so as to minimize the gas volume in the second lumen connecting the catheter and pressure transducer.

4. The system of claim 3 wherein the adapter is a bolt capable of being affixed to the skull.

5. The system of claim 4 wherein the outer surface of the adapter comprises a set of at least two ribs each having a diameter slightly larger than the hole in the skull such that inserting the adapter in the hole will establish a compressive force sufficient to hold the adapter securely to the skull.

6. The system of claim 4 further comprising a piston lumen fixed in the bolt, tie piston lumen being in gaseous communication with the catheter, and a transducer housing configured for housing the pressure transducer, the housing provided with a hollow cylindrical segment that constitutes a female portion of an air pump, the cylindrical segment configured to be inserted in the bolt, the cylindrical segment being configured to receive a piston formed by the proximal end of the catheter or any adapting extension thereof and a sealing means between the piston and cylinder so that when the transducer housing engages the piston, the piston automatically pumps a desired amount of air into the bladder.

7. The system of claim 1, wherein the bladder is formed of material selected from the group of materials consisting of:

a) buna N

b) Nitrile

c) Neoprene

d) Butyl rubber.

8. A system for monitoring pressure within a mammalian body, the system comprising:

a catheter having a proximal end, a distal end, and an outer surface configured for insertion into the mammalian body with the distal end of the catheter positioned within the mammalian body;

a lumen, filled with a gas, extending longitudinally through the length of the catheter, the lumen providing gaseous communication between the distal end and the proximal end of the catheter;

a flaccid bladder, having an elongate shape and filled with a gas, positioned on the distal end of the catheter, the bladder being in gaseous communication with the lumen and being of a size configured for expanding in response to changing pressure in the body so that a pressure change in the gas within the bladder reflects the pressure change within a body space in which the bladder is placed, the lumen being thereby operable to transmit, in the gas from the distal end to the proximal end of the catheter, changes in pressure exerted against the bladder;

a stent anchored in the distal end of the catheter and positioned within the bladder so that the stent extends most of the length of the bladder so that the stent is configured for maintaining the elongate shape of the bladder as the bladder encounters resistive tissue; and

a device configured to limit the penetrating force between the stent and the distal end of the bladder such that the force generated by the stent on the bladder during the act of introducing the bladder into a brain does not exceed the ability of the bladder to resist being pierced.

9. The system of claim 8 wherein gas volume occupied by the stent is approximately 30% or less of the volume of the bladder.

10. The system of claim 8 wherein the stent comprises a single support member that is approximately 0.5 mm in diameter and having a tip of the stent enlarged to avoid penetration of the bladder.

11. The system of claim 8 wherein the stent comprises a U-shaped member having two legs and each of the two legs is approximately 0.25 mm in diameter.

12. A system for monitoring intracranial pressure in a brain inside a skull of a mammalian body, the system comprising:

a bolt having a device for affixing the bolt to the skull, an inner bore resident within the bolt configured for receiving a drainage catheter therein, the bore being of sufficient diameter to allow the drainage catheter to enter the brain at an appreciable angle to a centerline of the inner bore, and an outer bore within the bolt offset from the inner bore, the outer bore configured for receiving a sensing catheter therein;

a sensing catheter positioned within the outer bore such that the sensing catheter extends from the bolt into the brain for the purpose of sensing and responding to pressure within the brain;

a pressure transducer adapted to attach to the sensing catheter, the pressure transducer positioned adjacent to said bolt;

a drainage catheter positioned within the inner bore so that the sensing catheter and the drainage catheter are capable of operating within the bolt simultaneously; and

a device for engaging the drainage catheter in the inner bore to anchor the drainage catheter to the bolt and to provide a fluid seal there between.

13. The system of claim 12 wherein the angle is in the maximum range of about 15 degrees.

14. The system of claim 12 wherein the bolt is provided with a well through which the drainage catheter passes, the well having an external threaded portion and a top well face, and further comprising:

a compression cap configured to engage the external threaded portion to secure the drainage catheter to the bolt;

an anchor sleeve positionable within the well; and

wherein insertion of the anchor sleeve into the well and tightening of the compression cap secures the drainage catheter to the bolt and restricts the ability of bacteria to reach the well surfaces contacted by the anchor sleeve.

15. The system of claim 14 wherein a flange formed on the anchor sleeve is at the proximal end of the anchor sleeve so that the insertion of the anchor sleeve into the well and the tightening of the compression cap compresses the flange against the well face to prevent ingress of bacteria.

16. The system of claim 15 wherein the flange further comprises an element adapted to carry an antimicrobial agent configured to be secured between the flange surface and the well in a manner that insures that the antimicrobial agent is in contact with the well.

17. The system of claim 14 wherein the anchor sleeve is engaged with either the drainage catheter or the compression cap in a manner that insures that the anchor sleeve will be withdrawn from the well as the catheter is withdrawn from the brain.

18. An applicator for applying an antimicrobial agent to a cut surface of a drill hole, the applicator comprising:

an element for fixing a bolt to the skull, the element configured to fit within the drill hole in a manner that at least a portion of the element engages the cut surface of the drill hole, the element having an outer surface having at least one irregularity of the surface; and

a coating of an antimicrobial agent placed within the at least one irregularity of the surface of the element such that the introduction of the element into the drill hole and its continuing residence in the hole will result in the transferring of a portion of the agent to the cut surface of the drill hole.

19. The applicator of claim 18 wherein the outer surface of the element consists of a series of circular ribs encircling the element;

and

wherein the irregularity of the surface comprises each of the ribs being separated from an adjacent rib by a space between the ribs.

20. The applicator of claim 18 wherein the outer surface of the element consists of a helical thread encircling the element.

21. An applicator for applying an antimicrobial agent to a surface of a skull between the skull and a skull bolt inserted in the skull, the applicator comprising an element containing an antimicrobial agent, the element configured to be secured between the skull bolt and the skull in a manner that insures that the antimicrobial agent is in contact with the skull.

22. The applicator of claim 21 wherein the element is a gasket formed of a porous material impregnated with an antimicrobial agent.

23. A method for measuring intracranial pressure in a mammalian body comprising:

providing an air column catheter including a flaccid bladder externally secured to a distal end of air column catheter;

coupling the air column catheter with a pressure transducer into an adapter configured to be affixed to the mammalian body;

affixing the adapter to the mammalian body, with the catheter inserted within the skull of the mammalian body; and

sensing the intracranial pressure in the mammalian body utilizing the catheter and the pressure transducer.

24. The method of claim 23 further comprising inserting a drainage catheter into the mammalian body;

and draining a portion of the mammalian body with the drainage catheter.

25. A system for monitoring pressure within a mammalian body, the system comprising:

a pressure sensing arrangement designed to be inserted into the mammalian skull for sensing pressure therein including a flaccid bladder externally secured to a distal end of the arrangement;

a mounting assembly designed to be mounted directly to the mammalian body in close proximity to the insertion point of the pressure sensing arrangement; and

a pressure transducer configured for translating a pressure signal received from the pressure sensing arrangement into an electrical signal, said pressure transducer mounted on the mounting assembly and operatively connected with the pressure sensing arrangement.

26. A method of monitoring pressure within a mammalian body, comprising the steps of:

inserting a pressure sensing arrangement into the mammalian skull for sensing pressure therein including a flaccid bladder externally secured to a distal end of the arrangement;

connecting a mounting assembly directly to the mammalian body in close proximity to the insertion site of the pressure sensing arrangement;

mounting a pressure transducer in close proximity to the mounting assembly and operatively connecting the transducer with the pressure sensing arrangement;

translating a pressure signal received from the pressure sensing arrangement into an electrical signal; and

monitoring pressure within the mammalian body utilizing the pressure sensing arrangement and the pressure transducer.

27. The method according to claim 26 wherein the flaccid bladder is air-filled.

28. The method according to claim 26 wherein the transducer is operatively connected to the pressure sensing assembly through a single passageway within the mammalian body between the transducer and the pressure sensing assembly and further comprising the step of inserting a drainage tube at least in part through the single passageway and draining liquid from the mammalian body using the drainage tube.

29. The method according to claim 26 wherein the transducer is operatively connected to the pressure sensing assembly through a single passageway within the mammalian body between the transducer and pressure sensing assembly, wherein the mounting assembly includes an elongated, tubular fastening member having longitudinally spaced annular ribs extending around the outer surface of the member, and further comprising the step of inserting the fastening member into the passageway in a friction fitting manner.

30. A method of monitoring pressure within a mammalian body, comprising the steps of:

inserting a pressure sensing arrangement into the mammalian body for sensing pressure therein;

connecting a mounting assembly directly to the mammalian body in close proximity to the insertion site of the pressure sensing arrangement;

operatively connecting a transducer with the pressure sensing assembly through a single passageway within the mammalian body between the transducer and pressure sensing assembly;

introducing an antimicrobial agent into the passageway;

translating a pressure signal received from the pressure sensing arrangement into an electrical signal; and

monitoring pressure within the mammalian body utilizing the pressure sensing arrangement and the transducer.

31. A fixture enabling access of at least two medical instruments to an intercranial target site comprising:

at least one lumen sized to receive a pressure monitoring device;

at least one lumen sized to receive a drainage catheter;

a shank section through which said lumens extend; and

a bacteria barrier disposed on said shank, said barrier configured to be coupled to a pressure sensing transducer and configured to contact skull tissue in a region near said intercranial target site.

32. A method of monitoring intercranial pressure, comprising:

creating an access opening in the skull of a subject;

providing a mounting assembly having an anchor sleeve with an inner lumen disposed within an inner bore of the mounting assembly;

attaching the mounting assembly to the skull of the subject proximal to the access opening;

identifying a conduit having a bladder secured to a distal end of said conduit;

placing said conduit through the inner lumen of the anchor sleeve such that said distal end of said conduit is located at a target intercranial site;

positioning a terminal end of said conduit at a location near said access opening;

attaching said terminal end of said conduit to a pressure transducer such that said pressure transducer is in fluid communication with said bladder; and

determining the pressure at said target intercranial site by monitoring the pressure in said bladder.

33. An assembly for monitoring intercranial pressure of a mammal comprising:

a mounting fixture sized for fixation on a subject mammal;

a hollow conduit extending from said mounting fixture a sufficient distance to place said hollow conduit at a desired pressure monitoring site and having a length less than or equal to about 45 cm;

a pressure transducer placed in fluid communication with said hollow conduit, said pressure transducer located in close proximity to said mounting fixture; and

a thin-walled, substantially non air-permeable bladder externally secured to a distal end of said hollow conduit, said bladder being in fluid communication through said hollow conduit with said pressure transducer.

34. A system for monitoring intercranial pressure of a mammal comprising:

a mounting fixture sized for placement on a subject, said mounting fixture having a passageway extending substantially along the length of said mounting fixture;

a conduit sized for communication with said passageway of said mounting fixture and having a distal end, a proximal end and a length less than or equal to about 45 cm;

an inflatable bladder mounted toward said distal end of said conduit;

said conduit sized such that said distal end extends to a target pressure monitoring site and said proximal end terminates at a location near said mounting fixture; and

a pressure transducer sized for fluid connection to said conduit, said pressure transducer positioned adjacent to said mounting fixture and in communication with said conduit.

35. A system for monitoring pressure within a mammalian body, comprising:

a catheter having a proximal end, a distal end, a length less than or equal to about 45 cm and an outer surface configured for insertion into the mammalian body with the distal end of the catheter positioned within the mammalian body;

a lumen, filled with a gas, extending longitudinally through the length of the catheter, the lumen providing gaseous communication between the distal end and the proximal end of the catheter;

a flaccid bladder, containing a gas, positioned at the distal end of the catheter, the bladder being in gaseous communication with the lumen and being of a size configured for collapsing and expanding in response to changing pressure in the body so that a pressure change in the gas within the bladder reflects the pressure change within a body space in which the bladder is placed, the lumen being thereby operable to transmit, in the gas from the distal end to the proximal end of the catheter, changes in pressure exerted against the bladder; and

a pressure transducer mounted adjacent to the proximal end of the catheter, the pressure transducer being in gaseous communication with the lumen.

36. The system of claim 35 wherein the gas volume in the bladder represents approximately 75% of the gas volume in the system.

37. The system of claim 35 further comprising an adapter capable of being affixed to the body, wherein the catheter and the pressure transducer are integrated with the adapter so as to minimize the gas volume in the lumen connecting the catheter and pressure transducer.

38. The system of claim 37 wherein the adapter is a bolt capable of being affixed to a skull of the mammalian body.

39. The system of claim 38 wherein the adapter comprises an elongated, tubular fastening element with an outer surface wherein the outer surface consists of a set of ribs consisting of at least two ribs each having a diameter slightly larger than a hole in the skull such that inserting the bolt in the hole will establish a compressive force sufficient to hold the bolt securely to the skull.

40. The system of claim 38 further comprising a piston lumen fixed in the bolt the piston lumen being in gaseous communication with thecatheter, and a transducer housing configured for housing the pressure transducer, the housing provided with a hollow cylindrical segment that constitutes a female portion of an air pump, the cylindrical segment having a distal end adapted to be inserted in the bolt and a proximal end adjacent to the pressure transducer, the cylindrical segment being configured to receive a piston formed by the proximal end of the catheter or any adapting extension thereof and a sealing means between the piston and cylinder so that when the transducer housing engages the piston, the piston automatically pumps a desired amount of air into the bladder.

41. The system of claim 35, wherein the bladder is formed of material selected from the group of materials consisting of:

a) buna N

b) Nitrile

c) Neoprene

d) Butyl rubber.

42. The system of claim 35 wherein said pressure transducer is configured to be attached to the body of a patient proximate to said proximal end of said catheter.

43. An applicator for applying an antimicrobial agent to a surface of a skull between the skull and a skull bolt inserted in the skull, the applicator comprising a gasket formed of a porous material impregnated with an antimicrobial agent, the gasket configured to be secured between the skull bolt and the skull in a manner that insures that the antimicrobial agent is in contact with the skull.

44. A method of monitoring pressure within a mammalian body, comprising:

inserting a pressure sensing arrangement into the mammalian body for sensing pressure therein;

connecting a mounting assembly directly to the mammalian body in close proximity to the insertion site of the pressure sensing arrangement;

mounting a pressure transducer in close proximity to the mounting assembly and

operatively connecting the transducer with the pressure sensing arrangement through a single passageway within the mammalian body between the transducer and the pressure sensing arrangement;

inserting a drainage tube at least in part through the single passageway and draining liquid from the mammalian body using the drainage tube;

translating a pressure signal received from the pressure sensing arrangement into an electrical signal; and

monitoring pressure within the mammalian body utilizing the pressure sensing arrangement and the pressure transducer.

45. A method of monitoring pressure within a mammalian body, comprising:

inserting a pressure sensing arrangement into the mammalian body for sensing pressure therein;

connecting a mounting assembly including an elongated tubular fastening member having longitudinally spaced annular ribs extending around the outer surface of the member directly to the mammalian body in close proximity to the insertion site of the pressure sensing arrangement;

mounting a pressure transducer in close proximity to the mounting assembly and operatively connecting the transducer with the pressure sensing arrangement through a single passageway within the mammalian body between the transducer and the pressure sensing arrangement;

inserting the fastening member into the single passageway in a friction fitting manner;

translating a pressure signal received from the pressure sensing arrangement into an electrical signal; and

monitoring pressure within the mammalian body utilizing the pressure sensing arrangement and the pressure transducer.

46. A system for monitoring pressure within a mammalian body, comprising:

a catheter having a proximal end, a distal end, and an outer surface configured for insertion into the mammalian body with the distal end of the catheter positioned within the mammalian body;

a lumen, filled with a gas, extending longitudinally through the length of the catheter, the lumen providing gaseous communication between the distal end and the proximal end of the catheter;

a flaccid bladder, containing a gas, positioned at the distal end of the catheter, the bladder being in gaseous communication with the lumen and being of a size configured for collapsing and expanding in response to changing pressure in the body so that a pressure change in the gas within the bladder reflects the pressure change within a body space in which the bladder is placed, the lumen being thereby operable to transmit, in the gas from the distal end to the proximal end of the catheter, changes in pressure exerted against the bladder and the bladder having approximately 75% of the gas volume of the system; and

a pressure transducer mounted adjacent to the proximal end of the catheter, the pressure transducer being in gaseous communication with the lumen.