Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3403—Needle locating or guiding means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
  • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0113—Mechanical advancing means, e.g. catheter dispensers

Definitions

• This invention relates to a method and apparatus including a guide assembly, catheter, and obdurator contained in the catheter, for reproducibly and accurately inserting the catheter and obdurator through the cranial surface and into the ventricular system of the human brain.
• the four ventricles of the human brain are inter- connected cavities that produce and circulate cerebral- spinal fluid (CSF) .
• CSF cerebral- spinal fluid
• Procedures involving ventriculos- to y i.e., placement of a catheter into the ventricular system of the brain, form a major part of the neuro- surgeon's clinical practice.
• General areas of application of ventricular catheter placement include intracranial pressure monitoring (ICP) , draining or shunting of CSF and the instillation of pharmacologi ⁇ cal therapeutic agents.
• ICP intracranial pressure monitoring
• Intracranial pressure monitoring a monitoring of ventricular pressure
• Intracranial pressure monitoring a monitoring of ventricular pressure
• the ventricles are usually compressed after head trauma and thus technically difficult to cannulate for ICP monitoring.
• subarachnoid pressure monitoring which is not as true a measure of cerebral pressure as intraventricular pressure monitoring, is generally used.
• CSF drainage is essential for patients with con ⁇ genital or acquired hydrocephalus.
• CSF drainage which can only be performed with an intraventricular catheter, is a life-preserving procedure, because it can immediately reduce intracranial pressure.
• the ventricular catheter used to drain cerebral-spinal fluid, is connected to a peripheral subcutaneous drainage system, i.e., to the peritoneal cavity or systemic circulation via the heart.
• a peripheral subcutaneous drainage system i.e., to the peritoneal cavity or systemic circulation via the heart.
• the ventricles are enlarged and are an easier target for cannulation.
• recent reports in neurosurgical literature indicate that suboptimal placement in dilated ventricles can subsequently produce catheter obstruction when the ventricles are decompressed and become smaller, thus emphasizing the need for accurate placement.
• Catheter placement in cerebral ventricles is widely performed on patients with carcinomatous and fungal meningitis for the administration of well-known anti- neoplastic and antifungal chemotherapeutic agents, respectively.
• the ventricles in these patients are small or normal sized and difficult to cannulate.
• the most frequently chosen site for ventricular cath- eterization is coronal.
• a catheter is inserted in the anterior horn of the lateral ventricle through an orifice or burr hole drilled just anterior to the coronal suture in the midpupillary line of the cranium, i.e., in the frontal bone over the ventricle. This is known in the field as Kocher's point.
• the burr hole only slightly larger than the diameter of the selected catheter to insure a snug fit and provide a seal against CSF leakage, is placed approximately 1 cm. anterior to the coronal suture, approximately 10 to 12 cm. above the nasion, and approximately 2 to 3 cm. from the midline over the nondominant hemisphere.
• the dura and underlying pia-arachnoid are opened and coagulated, for example, with a fine- tipped blade after cauterizing the dural surface.
• a pre-measured catheter having a stylet is then intro ⁇ quizd and directed freehand through the burr hole, approximately in the coronal plane, and angled towards the medial canthus of the ipsilateral eye, using external landmarks such as the inner canthus of the eye in the frontal plane and a point just in f-ront of the external auditory meatus in the lateral plane as guides to place ⁇ ment.
• CSF should flow freely from the catheter tip at a depth of approximately 4 to 5 cm. from the interior cranial surface.
• Intraoperative fluoroscopy and air ventriculography have been used to- confirm freehand catheter placement. While these procedures can be helpful in placing the catheter if the ventricles are small, they also add to the complexity of the overall procedure.
• An object of the present invention is to provide a method and apparatus for inserting a catheter through the cranial surface into the anterior horn of the lateral ventricle of the human brain which eliminates the problems, inaccuracies and risks associated with prior art freehand catheter placement.
• Another object of the invention is to provide a method and apparatus for inserting a catheter through the cranial surface into the anterior horn of the lateral ventricle of the human brain which optimizes accurate and reproducible placement of the catheter.
• Another object of the present invention is to provide a method and apparatus for accurately and reproducibly inserting a catheter through the cranial surface into the anterior horn of the lateral ventricle of the human brain which prevents insertion of the catheter into cerebral matter or subarachnoid space.
• the anatomical basis for the present invention lies in the fact that the lateral ventricles of the human brain form an arc parallel to the arc of the cranium, i.e., the contour of the lateral ventricles parallels the arc of the surface of the skull.
• a catheter guided perpendicular to the cranium surface at the point of entry into the cranium will enter the ventricular system.
• any line penetrating a burr hole in the surface of the skull at a 90° angle also bisects the . lateral ventricle.
• the apparatus of the present invention comprises a guide assembly which, when positioned over an orifice drilled in the cranium above the anterior horn of the lateral ventricle, guides a catheter and obdurator through the orifice and into the lateral ventricle at an angle normal to an imaginary plane formed by a tangent to the cranium at the orifice.
• the method of the present invention comprises provid- ing an orifice in the cranium just anterior to a coronal suture in a midpupillary line of the cranium and inserting a ventricular catheter containing an obdurator through the orifice towards a lateral ventricle, wherein the catheter containing the obdurator is guided through .the orifice, by means of a novel guide assembly, at an angle normal to an imaginary plane formed by a tangent to the cranium at the orifice.
• Fig. 1 is a front view of a human skull with a catheter inserted in an anterior horn of a lateral ventricle in accordance with the invention
• Fig. 2 is a side view of the invention shown in Fig. 1;
• Fig. 3 is a front elevational view of the guide assembly of the present invention.
• Fig. 4 is a top plan view of the guide assembly shown in Fig. 3;
• Fig. 5 is a section taken along line 5-5 of Fig. 1, on an enlarged scale;
• Fig. 6 is a section taken along line 6-6 of Fig. 5, on an enlarged scale.
• Fig. 1 is a front view and Fig. 2 is a side view of the apparatus of the present invention for accurately and reproducibly locating a catheter containing an obdurator in an anterior horn of a lateral ventricle of the human brain.
• an orifice 2 is drilled on the right or left side of a patient's skull 1 in the midpupillary line by conventional techniques.
• the orifice 2 is located above the anterior horn of lateral ventricle 3, approximately 10 cm. posterior to the nasion 4 and approximately 3 cm. lateral to midline 5 of the skull 1.
• the dura and underlying pia-arachnoid are cut and coagulated, as is well known in the art.
• a catheter 6 containing a rigid obdurator 7 is then accurately guided through the orifice 2 and dural opening into ventricle 3 by guide assembly 8, which is placed and rests on the skull 1 over the orifice 2.
• guide assembly 8 which is placed and rests on the skull 1 over the orifice 2.
• Any well known catheter and obdurator such as the commerci ⁇ ally-available Cod an Accu-flo ventricular catheter and obdurator, made by Codman and Shurtleff, Inc., may be used in the present invention.
• the guide assembly 8 is rigid and non-deformable.
• the purpose and function of guide assembly 8 necessitates that it be made of a rigid, non-deformable material, such as a rigid plastic or stainless steel.
• guide assembly 8- includes a platform 14. Extending from platform 14 in diverging manner are three legs 9, which terminate in free ends 10. Free ends 10 of legs 9 define a triangle lying in a defined plane. Guide assembly 8 further includes guide means for guiding the catheter 6 in.a direction perpendi ⁇ cular to the plane defined by the triangle and through the geometric center of the triangle. As shown in Figs. 3 and 4, the guide means comprises a tubular member 12 which extends through platform 14 in a direction perpendicular to the plane of the triangle defined by the free ends 10 of legs 9 at the geometric center of this triangle.
• Tubular member 12 is hollow, defining a central lumen, to allow passage therethrough of the catheter 6 and obdurator 7.
• the diameter of the central lumen is not critical, but must be sufficient to allow passage of the catheter therethrough.
• legs 9 of guide assembly 8 are of equal
• the invention can be practiced with a guide assembly having more than three legs, as long as the above-described directional criteria are maintained.
• the preferred embodiment of the guide assembly 8 includes a platform 14 for connecting legs 9 to tubular member 12, the platform is not an essential element of guide assembly 8.
• legs 9 may be connected directly to tube 12, as long as tubular member 12 guides the catheter 6 in a direction perpendicular to the plane of the triangle formed by the free ends 10 of legs 9 and through the geometric center of said triangle.
• tubular member 12 is illustrated as cylindrical, any shape which allows smooth passage of catheter 6 and obdurator 7 therethrough can be employed.
• a guide assembly 8 as shown in Figs. 3 and 4 was made of stainless steel.
• the guide assembly measured 4.5 cm. in height.
• the distance between free ends 10 of legs 9 measured' 2.5 cm.
• the central lumen of ' tubular member 12 had an internal diameter of 2.6 mm.
• tubular member 12 is normal to the plane of the triangle defined by free ends 10 of legs 9.
• a 2.6 mm. central lumen internal diameter accommodates the commercially available Codman Accu-flo ventricular catheter and obdurator previously mentioned, which has an outer diameter of 2.5 cm.
• the invention is not limited in this regard and catheters of different diameters can be used, with corresponding changes in the diameter of the central lumen of tubular member 12. Since most catheters range from about 2 mm. to about 4 mm. in outer diameter, a preferred range of internal diameter for the central lumen of tubular member 12 is about 1 mm. to about 5 mm. It is also within the scope of the invention to provide one or more inserts, telescopically receivable within tubular member 12, to accommodate smaller diameter catheters.
• the height of guide assembly 8 and the distance between free ends 10 of legs 9 can be varied, as long as the following principles are observed.
• the base of the guide assembly must preferably form an equilateral triangle defined by the free ends 10 of legs 9.
• a line through the central lumen of tubular member 12 must be normal to the plane of the triangle defined by the free ends 10 of legs 9 and must pass through the geometric center thereof.
• the distance between free ends 10 of legs 9 ranges from about 1 cm. to about 6 cm.
• the lower limit is established based on the smallest burr hole or orifice necessary for passing a catheter therethrough.
• the upper limit is established based on the change in skull curvature which occurs when one crosses the midline 5 of the skull 1. Specifically, since the orifice or burr hole 2 is drilled generally from about 2 cm. to about
• the upper limit of about 6 cm. is preferred so that a leg 9 does not rest on skull 1 at a point beyond the midline 5 where the skull curvature has changed. This would place the guide assembly 8 at such an angle that tubular member 12 would not be directed normal to the imaginary plane defined by a tangent to the orifice 2 at the point of entry.
• a preferred height range for guide assembly 8 is about 2 cm. to about 10 cm.
• the lower limit is established based on a minimum central lumen length necessary for guidance accuracy.
• the upper limit is established on the basis of the usual length of a catheter (15 cm.) minus the standard intracranial distance to the ventricle (5 cm. ) .
• the guide assembly 8 of the present invention has been illustrated with three legs 9, this is not a critical limitation.
• the guide assembly 8 of the present invention may be made with four legs.
• the free ends of the four legs define the corners of a square or rectangle
• the axis of tubular member 12 passes through the geometric center of the square or rectangle
• said axis is normal to the plane of the square or rectangle.
• the efficacy of the present invention was evaluated in seventeen patients who required ventriculostomy.
• Nine of the patients had normal or smaller ventricles (less than 3 mm. width of the anterior horn) .
• the age range was 12 to 78.
• Nine'patients were diagnosed for carcinomatous meningitis and seven for hydrocephalus.
• One patient had a caudate tumor lateral to the anterior horn and cannula- tion of the ventricle was used as a fluoroscopic reference point for tumor biopsy.
• cerebral-spinal fluid was obtained in all patients on the first pass of the catheter at an approximate intracranial distance of about 5 cm. Confirmation of catheter placement in the ipsilateral anterior horn of the lateral ventricle was made by intraoperative fluoroscopy or postoperative CT scan.
• the method and apparatus of the present invention insures optimal ventricular catheter placement. It can be used in any situation requiring placement of a catheter in the ventricular system, e.g., intracranial pressure monitoring, drainage or shunting of cerebral- spinal fluid and the installation of pharmacologic therapeutic agents. Moreover, the present invention is so anatomically consistent that it can be employed as a reference point for biopsy of brain lesions.
• the present invention eliminates the anxiety ordinar ⁇ ily experienced by neurosurgeons when passing a catheter. Patient care is improved by eliminating complications and associated morbidity. A reduction in cost of the patient is achieved by eliminating the need for intraoperative radiographic monitoring and by decreasing operating room time.

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• Health & Medical Sciences (AREA)
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• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Biophysics (AREA)
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• External Artificial Organs (AREA)
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• 1985
  • 1985-06-17 US US06/745,673 patent/US4613324A/en not_active Expired - Lifetime
  • 1985-08-02 CA CA000488098A patent/CA1263580A/en not_active Expired
• 1986
  • 1986-05-28 AU AU59685/86A patent/AU572400B2/en not_active Expired
  • 1986-05-28 WO PCT/US1986/001167 patent/WO1986007542A1/en not_active Ceased
  • 1986-05-28 EP EP86903921A patent/EP0229105B1/en not_active Expired - Lifetime
  • 1986-05-28 JP JP61503271A patent/JPS63500220A/ja active Granted

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