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Angled hole ventricular catheter with non-circular bore    

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United States Patent5180387   
Link to this pagehttp://www.wikipatents.com/5180387.html
Inventor(s)Ghajar; Jamshid B. G. (New York, NY); Hariri; Robert J. (New York, NY); Ghadjar; Fathali G. (New York, NY)
AbstractA catheter for placement into the ventricular system of the brain or any other member or cavity of the body of a subject comprising a flexible elongated body having a non-circular bore, a wall thickness sufficient to contain and transport fluid therein, a forward end and tip for insertion into the ventricular system of the brain of a subject, and a plurality of spaced apertures located in the forward end of the body spaced from the tip. The apertures are configured and positioned to minimize abrasion of brain tissue upon insertion of the catheter and to prevent tissue from growing into the catheter apertures, thereby providing improved flow of fluid into or from said ventricular system. The non-circular bore, preferably triangular, provides increased structural integrity and increased effective flow through the catheter compared to those having a circular bore. Also methods of using such catheters are disclosed herein.
   














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Drawing from US Patent 5180387
Angled hole ventricular catheter with non-circular bore - US Patent 5180387 Drawing
Angled hole ventricular catheter with non-circular bore
Inventor     Ghajar; Jamshid B. G. (New York, NY); Hariri; Robert J. (New York, NY); Ghadjar; Fathali G. (New York, NY)
Owner/Assignee     Neurodynamics, Inc. (New York, NY)
Patent assignment
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Company News
Publication Date     January 19, 1993
Application Number     07/266,451
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     November 2, 1988
US Classification     604/266 604/523
Int'l Classification     A61M 031/00
Examiner     Rosenbaum; C. Fred
Assistant Examiner    
Attorney/Law Firm     Pennie & Edmonds
Address
Parent Case     CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of application Ser. No. 098,097 filed Sep. 17, 1987 now U.S. Pat. No. 4,784,638.
Priority Data    
USPTO Field of Search     604/280 604/282 604/264 604/266
Patent Tags     angled hole ventricular catheter non-circular bore
   
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What is claimed is:

1. A catheter for placement into a host comprising

a flexible elongated body having a wall thickness sufficient to contain and transport fluid therein and having a forward end and tip for insertion into the host;

a plurality of spaced apertures located in said forward end of said body spaced from said tip and positioned so as to minimize abrasion of tissue upon insertion of said catheter into said host; and

said body having an internal bore having a non-circular cross section to increase the structural integrity and effective flow area of the catheter compared to those having a circular cross sectional bore;

wherein each of said apertures extends through the wall thickness at an angle such that a portion of said wall thickness is visible when viewing said aperture perpendicular to the axis of said body.

2. The catheter of claim 1 wherein each of said apertures extends through said wall thickness at an angle of about 35.degree. with respect to the longitudinal axis of said body.

3. The catheter of claim 1 wherein said apertures are aligned in rows which are spaced about 120.degree. apart around the circumference of said body.

4. The catheter of claim 1 wherein the cross sectional area of the bore is a polygon, and wherein said apertures are positioned along the midpoint of each side of said polygon.

5. The catheter of claim 4 wherein an inner bore surface of said catheter is substantially smooth and free of any projections extending into said bore.

6. The catheter of claim 1 wherein said forward end of said body is integrally formed of a radioopaque material at least in the area surrounding said apertures to facilitate monitoring of the placement of said catheter within said host.

7. The catheter of claim 6 wherein said body further comprises means to indicate the depth of penetration of said catheter forward end.

8. The catheter of claim 7 wherein said means comprises markings of a radioopaque material to facilitate monitoring of the placement of said catheter.

9. A catheter for placement into the ventricular system of the brain of a subject comprising:

a flexible elongated body having a wall thickness sufficient to contain and transport fluid therein and having a forward end and tip for insertion into the ventricular system of the brain of a subject; and

a plurality of spaced apertures located in said forward end of said body spaced from said tip, each of said apertures extending through the wall thickness at an angle such that a portion of the wall thickness is visible when viewing said aperture perpendicular to the axis of said body so as to minimize abrasion of brain tissue upon insertion of said catheter and to hinder the growth of brain tissue into said catheter apertures thereby providing improved flow of fluid into or from said ventricular system;

said body having internal bore of a polygonal cross-section to increase the structural integrity and effective flow area of the catheter compared to those having a circular cross-sectional bore.

10. The catheter of claim 9 wherein the cross-section of the bore is triangular, and wherein said apertures are positioned along the midpoint of each side of the triangle.

11. A method of accessing fluid within a host which comprises: providing a cateter comprising a flexible elongated body having a wall thickness sufficient to contain and transport fluid therein and having a forward end and tip for insertion into said host, and a plurality of spaced apertures located in said forward end of said body spaced from said tip, each of said apertures extending through the wall thickness at an angle such that a portion of said wall thickness is visible when viewing said aperture perpendicular to the axis of said body; inserting said catheter into said host while minimizing abrasion of tissue therein; and increasing the flow of fluid to or from said host by minimizing or preventing tissue growth into said catheter apertures through the position and configuration of said apertures in said catheter.

12. The method of claim 11 which further comprises selecting a catheter having a bore configured of a non-circular cross-section to increase the effective flow of fluid through the catheter and to increase the structural integrity of the catheter compared to those having a circular bore and further wherein the non-circular cross section is such that it prevents a flow restriction where said catheter is bent.

13. The method of claim 12 which further comprises providing the catheter with a bore said which is configured of a cross section having the form of an equilateral triangle and wherein said apertures are aligned in rows spaced about the circumference of said body at 120.degree. intervals to coincide with the midpoint of each leg of said triangle.

14. The method of claim 11 which further comprises utilizing a stylet to assist in the insertion of said catheter in a manner such that the catheter is stretched so as to flatten said apertures to further reduce abrasion of tissue upon insertion therein.

15. The method of claim 11 wherein said catheter body further comprises means for indicating the depth of penetration of said catheter forward end and wherein said method further comprises inserting said catheter to a predetermined depth.

16. The method of claim 11 wherein said indicating means comprises radioopaque markings and wherein said method further comprises monitoring the placement of said catheter.

17. The method of claim 11 wherein cerebral spinal fluid in a ventrical within a human cranium is accessed by drilling an orifice in the cranium just anterior to a coronal suture in a midpupillary line of the cranium prior to inserting said catheter into said ventricle.
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TECHNICAL FIELD

The present invention relates to a catheter having specifically angled apertures and a non-circular bore which facilitate access to or drainage of fluid within or from a host.

BACKGROUND OF THE INVENTION

The four ventricles of the human brain are interconnected cavities that produce and circulate cerebral spinal fluid (CSF). Procedures involving ventriculostomy, i.e., placement of a catheter into the ventricular system of the brain, form a major part of a neurosurgeon'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 pharmacological therapeutic agents.

CSF drainage is essential for patients with congenital 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 CSF, is connected to a peripheral subcutaneous drainage system, i.e., to the peritoneal cavity or systemic circulation via the heart or in the case of ICP to an external drainage collection system. Standard procedures for ventricular catherization are disclosed in the textbook literature. See, for example, Neurosurgery, edited by Robert H. Wilkins and Setti S. Rengachary, Section A, Chapter 13, Techniques of Ventricular Puncture (McGraw Hill 1984).

The most frequently chosen site for ventricular catheterization is coronal. In most cases, 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. After the burr hole is made, the dura and underlying pia-arachnoid are opened and coagulated, for example, with a fine-tipped blade after cauterizing the dural surface.

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. Thus, a catheter guided perpendicular to the cranial surface at the point of entry into the cranium will enter the ventricular system. Specifically, any line penetrating a burr hole in the surface of the skull at a 90.degree. angle also bisects the lateral ventricle.

A more recently developed procedure to ensure correct catheter placement is disclosed in U.S. Pat. No. 4,613,324. The apparatus 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 obturator 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, while the corresponding method comprises providing 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 obturator through the orifice towards a lateral ventricle, wherein the catheter containing the obturator 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.

A wide variety of catheters are known in the prior art for the purpose of penetrating the ventricular cavity. Such catheters are typically in the form of a hollow tube with a circular bore which is provided with a plurality of apertures at the ventricular or inflow end to permit the passage of CSF from the brain into the catheter and thence to the bloodstream or peritoneal cavity of the patient or to an external drainage system. However, malfunctions frequently occur with such a catheter due to the blockage of the apertures in the inflow end of the catheter. Such blockage is usually caused by the growth of choroid plexus or ependymal tissue within the ventricle into the apertures in the inflow end of the catheter. This tissue may block the apertures in the inflow end of the catheter in a relatively short period of time after the catheter has been inserted into the ventricle thereby rendering the cathether inoperative in relieving excess pressure due to the build-up of CSF within the ventricle. Furthermore, prior art catheter apertures are cut perpendicular to the length of the catheter, thus causing abrasion of brain tissue when the catheter is inserted.

The likelihood of ventricular catheter malfunction by aperture plugging with brain tissue can be lessened by angling the aperture holes in the wall of the catheter such that there is "no see through" flow from the outside to the inside of the lumen. Also, by positioning the rows of apertures 120.degree. apart there is essentially no chance for direct ingrowth of ventricular tissue therethrough. In addition, the apertures are angled away from the direction of the insertion of the catheter into the brain thus lessening the chance of brain abrasion. Further, by slightly stretching the catheter by means of the stylet (which is integral to the catheter and used for placement of it into the brain) the holes will close so that no opening will be visible during the placement thereof, with the holes re-opening after the tension on the catheter is relieved by removal of the stylet.

A catheter may also malfunction by kinking due to insufficient structural rigidity. Kinking may cause blockages or ineffective flow paths within the catheter, thereby rendering it inoperative in relieving excess pressure due to the build-up of CSF within the ventricle. In addition, kinking may cause the catheter to wander off course and make the insertion more difficult for the neurosurgeon and more harmful to the patient. The likelihood of the catheter kinking can be lessened by using a non-circular bore which will increase structural rigidity and strength.

As such, it would be desirable to provide a catheter which overcomes the problems of previously devised ventricular catheters which are emplaceable within a ventricle of a human brain to control the flow of excess fluids to or from the brain. The present invention provides a simple solution which resolves the problems of prior art catheters in a novel and unexpected manner.

SUMMARY OF THE INVENTION

The present invention relates to a catheter for placement into a host for accessing fluid therein, preferably for insertion into the ventricular system of the brain of a subject to access CSF. This catheter comprises a flexible elongated body with a non-circular bore having a wall thickness sufficie