Method of draining cerebrospinal fluid

Abstract

A method of draining cerebrospinal fluid from a human brain. The method includes providing a drainage catheter having a proximal end and a distal end. The drainage catheter has a plurality of openings formed therein. The plurality of openings includes a first opening, a second opening, and a most proximal opening. The second opening is disposed closer to the distal end than the first opening. A cross-sectional area of the first opening is less than a cross-sectional area of the second opening. The distal end of the drainage catheter is inserted into a human brain. Cerebrospinal fluid is drained from the human brain. The cerebrospinal fluid passes into the drainage catheter through the plurality of openings and out of the drainage catheter through the proximal end. A rate at which the cerebrospinal fluid passes through the drainage catheter is controlled to maintain intracranial pressure within a selected range.

Claims

1. A method of draining cerebrospinal fluid from a human brain, the method comprising: providing a drainage catheter having a proximal end and a distal end, wherein the drainage catheter has a plurality of openings formed therein, wherein the plurality of openings includes a first opening, a second opening, and a most proximal opening, wherein the second opening is disposed closer to the distal end than the first opening and wherein a cross-sectional area of the first opening is less than a cross-sectional area of the second opening; inserting the distal end of the drainage catheter into a human brain; diverting excess cerebrospinal fluid from the human brain, wherein the cerebrospinal fluid passes into the drainage catheter through the plurality of openings and out of the drainage catheter through the proximal end; and distributing the draining of the cerebrospinal fluid between the plurality of openings, wherein the distributed flow of cerebrospinal fluid delays or prevents occlusion of the catheter caused by choroid plexus tissue being drawn into the plurality of openings.

2. The method of claim 1, and further comprising accumulating over time a greater amount of debris deposits in the second opening as compared to the most proximal opening.

3. The method of claim 1, further comprising connecting the proximal end of the catheter to a component to divert the cerebrospinal fluid received by the plurality of openings from the human brain.

4. The method of claim 1, wherein a ratio of total hole area to an internal area of the drainage catheter is 0.0699*exp[0.216*(X8)] where X is a longitudinal position along the drainage catheter.

5. The method of claim 1, wherein the plurality of openings are formed at a plurality of inflow positions with at least one opening being formed at each of the inflow positions, wherein each inflow position has a total hole area, wherein the inflow positions include a first inflow position and a second inflow position, the second inflow position being disposed closer to the distal end than the first inflow position, and wherein the total hole area at the first inflow position is less than the total hole area at the second inflow position.

6. The method of claim 5, wherein the total hole area at the plurality of inflow positions increases with distance of the inflow positions from the proximal end.

7. The method of claim 5, wherein the total hole area at the first inflow position is approximately 0.1 square millimeters and the total hole area at the second inflow position is approximately 0.2 square millimeters.

8. The method of claim 1, wherein the drainage catheter has an inner passageway with a uniform inner diameter, wherein the uniform inner diameter is between approximately 1.0 millimeter and approximately 3.0 millimeters.

9. The method of claim 8, wherein the uniform inner diameter is approximately 1.2 millimeters.

10. The method of claim 1, wherein the second opening has a diameter of approximately 0.5 millimeters.

11. The method of claim 1, wherein draining fluid includes allowing substantially equal fluid flow into each of the plurality of openings.

12. The method of claim 1, wherein the cross-sectional areas of the plurality of openings increase with distance from the proximal end.

13. The method of claim 1, wherein inserting the drainage catheter into the human brain comprises inserting the drainage catheter into a ventricle of the human brain.

14. The method of claim 1, wherein the human brain is part of a patient with hydrocephalus.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.

(2) FIG. 1 illustrates an embodiment of the present invention having two inlet holes at eight inflow positions.

(3) FIG. 2 is a cross-sectional view of FIG. 1.

(4) FIG. 3 illustrates a portion of another embodiment of the present invention having one inlet hole at three inflow positions.

(5) FIG. 4 illustrates a portion of a further embodiment of the present invention having three inlet holes at two inflow positions.

(6) FIG. 5 graphically illustrates the fluid inflow distribution of a catheter having two inlet holes at eight inflow positions wherein all inlet holes have the same cross-sectional area.

(7) FIG. 6 graphically illustrates the fluid inflow distribution of one embodiment of the present invention having two inlet holes at eight inflow positions wherein the progressive decrease in the cross-sectional areas of the inlet holes was calculated using the curve illustrated in FIG. 7.

(8) FIG. 7 illustrates the curve that can be used to design one embodiment of the present invention whereby the fluid inflow distribution is essentially uniform at all inflow positions.

(9) FIG. 8 provides in tabular form the measurements illustrated by the curve in FIG. 7.

(10) FIG. 9 is an illustration of a cerebrospinal fluid removal system according to an embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(11) An embodiment of the invention is directed to a method of removing cerebrospinal fluid using a catheter that is implanted in one of the ventricles of a human brain. The method thereby enables intracranial pressure to be maintained within a desired range of between about 15 and 25 mm Hg.

(12) Drainage catheters can be improved by designs that force the fluid to be drained into a greater number of inlet holes. The present invention accomplishes this by progressively decreasing the cross-sectional areas of the inlet holes as the proximal end of the catheter is approached.

(13) FIGS. 1-4 show a catheter 1 as an elongated tube in accordance with an embodiment of the invention. The catheter 1 has a proximal end 2 and a distal end 3. The distal end 3 is adapted for implantation into a body cavity of an animal and the proximal end 2 is adapted for connection to means to divert fluid from that particular body cavity.

(14) The catheter 1 has an annular wall 4 that defines a central passageway 5. Along the longitudinal axis of the wall 4 two or more inflow positions 6, 7, 8 can be identified. At each inflow position 6, 7, 8 there are one or more inlet holes 9, 10, 11, 12, 13. The inlet holes 9, 11, 13 at each inflow position 6, 7, 8 progressively decrease in cross-sectional area as the inflow positions 6, 7, 8 approach the proximal end 2 of the catheter 1.

(15) The catheter 1 so designed may be used to divert fluid from any body cavity where the fluid flow dynamics can be described in the art as laminar flow and, more specifically, by mathematically expressing the flow as a Reynolds number between 20 and 800. It is not a limitation of this invention that the inflow positions 6, 7, 8 be equidistant.

(16) The space located at the distal end 14 of the catheter 1 functions to maintain the structural integrity of the catheter and may have any length that provides that integrity in order to accomplish the purpose for which the particular catheter is used. It is understood that the overall dimensions of the present invention can vary.

(17) FIG. 3 illustrates one embodiment of the invention. One inlet hole is located at each of three inflow positions along the longitudinal axis of the catheter 1. Each inlet hole 9, 11, 13 has a smaller cross-sectional area 16, 17, 18 than the one preceding it.

(18) FIG. 4 illustrates another embodiment of the invention. Three round inlet holes are located at each inflow position 6 and 7. The cross-sectional area of each inlet hole at inflow position 7 is less than the cross-sectional area of each inlet hole at inflow position 6.

(19) In an exemplary embodiment, the catheter 1 can be used to divert CSF from the ventricles of a human brain. In this embodiment, the catheter 1 has a length that ranges from about 10 centimeters to about 50 centimeters. The inner diameter 15 of the catheter ranges from about 1.0 millimeters to about 3.0 millimeters.

(20) The progressive decrease in the inlet holes 9, 11, 13 cross-sectional areas 16, 17, 18 need not be uniform. However, a method is herein described that results in near equal fluid inflow into the inlet holes 9, 10, 11, 12, 13 at each inflow position 6, 7, 8.

(21) The primary variable that controls fluid inflow into a proximal catheter is the distribution of the total hole areas along its longitudinal axis. Total hole area is defined as the sum of all the inlet hole areas at a given inflow position 9, 10. Inlet hole area is defined as, and is used interchangeably with, the cross-sectional area of one inlet hole.

(22) The phrase distribution of the total hole areas is understood to mean the pattern of change in the total hole areas along the longitudinal axis of the catheter 1. Through the tools of computational fluid dynamics and experiment, the distribution of the total hole areas was calculated and optimized to approximate equal inflow into each inflow position for a number of catheter operating conditions, typical implant positions, and body locations.

(23) This optimization was accomplished by numerically solving the conservation equations involving mass, energy, and momentum that govern the flow fields to and within the subject catheters. Total hole areas were adjusted for each computational trial until approximately equal inflows were obtained at each inflow position for every catheter analyzed in the study.

(24) FIG. 7 displays a total hole area distribution curve that provides the means for producing approximately equal inflows in proximal catheters having four to sixteen inflow positions. This distribution curve was generated by compiling all the calculations from the CFD analysis and is, therefore, a generalized curve that can be applied to the manufacture of proximal catheters irrespective of any particular proximal catheter's dimensions.

(25) The curve was plotted as the ratio between the total hole area at each inflow position and the internal diameter 15 of a proximal catheter having an internal diameter 15 of 1.2 millimeters. The curve can be expressed mathematically by the equation F(X)=0.0699*exp[0.216*(X8)] where F(X) is the y-coordinate of the graph at FIG. 7, X is the x-coordinate of the graph at FIG. 7, and exp is the exponent e (approximately 2.71828).

(26) The sixteenth inflow position of the curve is located at the most distal end of the catheter, i.e., the end furthest from the draining end of the catheter. The curve has been normalized for a sixteen inflow position catheter. FIG. 8 provides in tabular form the measurements illustrated by the curve in FIG. 7.

(27) To design a proximal catheter by utilizing the curve, a catheter designer must first define the catheter's inner diameter 15. The inner diameter 15 of many proximal catheters is 1.2 millimeters. After selecting an inner diameter, a catheter designer intent on making a twelve inflow position catheter, for example, would merely apply the value at curve inflow position sixteen to calculate the total hole area for his or her twelfth inflow position.

(28) The designer would then apply the value at curve inflow position fifteen to calculate the total hole area at his or her eleventh inflow position. In like manner, the designer can calculate the remaining total hole areas. The designer would then select the number of inlet holes 9, 10, 11, 12, 13 desired at each inflow position 6, 7, 8 and divide each calculated total hole area by that number.

(29) Because the curve defines the total hole area at the various inflow positions, any number of inlet holes at any one inflow position may be selected. The result of this calculation for each inflow position will be the inlet hole area 16, 17, 18 for each inlet hole at each inflow position. For example, a catheter as represented by FIG. 8 has an internal diameter of 1.2 mm.

(30) The catheter includes sixteen holes divided into eight pairs, one for each of the eight inflow positions: 9-16. In this example, hole diameters for each hole of the pair at that inflow positions ordered from the most distal inflow position, inflow position 16, to the most proximate inflow position, inflow position 9, are as follows: 0.5323 mm, 0.4778 mm, 0.4289 mm, 0.3850 mm. 0.3456 mm, 0.3102 mm, 0.2784 mm and 0.2499 mm.

(31) The present invention is intended to include all variations in the distribution of total hole areas along the longitudinal axis so long as the inlet holes 9, 11, 13 at each inflow position 6, 7, 8 progressively decrease in cross-sectional area as the inflow positions 6, 7, 8 approach the proximal end 2 of the catheter 1. The means in the exemplary embodiment for making this progressively decreasing distribution of total hole areas is but one embodiment of the present invention.

(32) By dividing the CSF flow more evenly among all of the flow holes through the progressively larger hole sizes, the magnitude of the flow at any one point is greatly reduced. Through such a process, there is less force available to drag the choroid plexus tissue into the holes to thereby delay or prevent occlusion of the catheter.

(33) The invention is not limited by any particular shape or shapes of the inlet holes 9, 10, 11, 12, 13. It is also intended that all changes in the total hole areas resulting from altered entrance conditions of the inlet holes, such as an angled entrance or slits in the wall 4 of the catheter 1 adjacent to and in communion with the inlet hole, are within the scope of this invention.

(34) In addition the catheter 1 discussed above, the invention is also directed to a system as illustrated in FIG. 9 for removing CSF from around a human brain. The CSF removal system may also include a pressure monitoring device 30. In certain embodiments, the pressure monitoring device 30 is a pressure transducer.

(35) The pressure transducer may be operably connected to the catheter 1. Such a configuration enables the intracranial pressure to be monitored while the excess CSF is being removed from inside of the cranium. Alternatively or additionally, the pressure transducer may be separately attached to the person's head.

(36) The CSF removal system may also include a valve 32 that is operably attached to the catheter. The valve 32 may be used to control the rate at which the cerebrospinal fluid is removed from the cranium to thereby maintain the intracranial pressure within a desired range.

(37) It is also possible for the pressure monitoring device 30 and the valve 32 to linked or otherwise connected such that the position of the valve 32 may be changed in response to the intracranial pressure that is monitored by the pressure monitoring device 30.

(38) It is also possible for the CSF removal system to include a collection vessel that is operably attached to the catheter. The collection vessel receives CSF that is removed from the cranium. Alternatively, the CSF removed from inside of the cranium may be directed to another location within the person's body where it is possible for the CSF to be absorbed into the tissue.

(39) The drawings are understood to be illustrative of the concepts disclosed herein to facilitate an understanding of the invention. Further, the drawings are not to scale, and the scope of the invention is not to be limited to the particular embodiments shown and described herein.

(40) In the preceding detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as top, bottom, front, back, leading, trailing, etc., is used with reference to the orientation of the FIGURE(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The preceding detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

(41) It is contemplated that features disclosed in this application, as well as those described in the above applications incorporated by reference, can be mixed and matched to suit particular circumstances. Various other modifications and changes will be apparent to those of ordinary skill.