Patent Application
20060247569
This invention relates generally to implantable fluid flow control devices and methods and, more particularly, to such devices and methods for controlling flow of cerebral spinal fluid.
Ventricles of the brain contain cerebrospinal fluid which cushions the brain against shock. Cerebral spinal fluid is constantly being secreted and absorbed by the body usually in equilibrium. Cerebral spinal fluid is produced in the ventricles of the brain, where under normal conditions, it is circulated in the subarachnoid space and reabsorbed into the bloodstream, predominantly via the arachnoids villi attached to the superior sagittal sinus. However, if blockages in circulation of cerebral spinal fluid, perhaps in the ventricles, cerebral spinal fluid can't be reabsorbed by the body at the proper rate.
This can create a condition known as hydrocephalus which is a condition marked by an excessive accumulation of fluid violating the cerebral ventricles, then the brain and causing a separation of the cranial bones. Hydrocephalus is a condition characterized by abnormal flow, absorption or formation of cerebrospinal fluid within the ventricles of the brain which subsequently increases the volume and pressure of the intracranial cavity. If left untreated, the increased intracranial pressure can lead to neurological damage and may result in death.
Over the past 40 years, a common treatment for hydrocephalus patients has been the cerebrospinal fluid shunt. The standard shunt consists of the ventricular catheter, a valve and a distal catheter. The excess cerebrospinal fluid is typically drained from the ventricles to a suitable cavity, most often the peritoneum or the atrium. A catheter is tunneled into the brain through a burr hole in the skull. The catheter is placed into ventricles to shunt cerebral spinal fluid to other areas of the body, principally the peritoneum, where it can be reabsorbed. The presence of the shunt relieves pressure from cerebral spinal fluid on the brain.
A flow or pressure regulating valve is usually placed along the catheter path. Differences in pressure due, at least in part, to differences in vertical position between the inlet (ventricles) and the outlet (peritoneum) can create too much drainage with such a flow or pressure regulating valve.
Current shunt valves are primarily pressure relief designs with a predetermined or adjustable opening pressure. Once open, flow rate is essentially unrestricted and over drainage can occur. Over drainage can lead to slit ventricles, slit ventricle syndrome, loss of brain compliance, shunt occlusion, sub-dural hematoma and many other complications.
Some shunt valves are also prone to becoming clogged. A clogged shunt valve could result in serious complications through a failure to provide proper drainage of cerebral spinal fluid from the ventricles of the brain.
Thus, there is needed a device and a method for reliably providing a controlled fluid flow for a cerebral spinal shunt, namely a cerebral spinal fluid control device and method which reliably provides shunting of cerebral spinal fluid without clogging and which provides a controlled flow rate preventing over drainage.
Another problem facing a medical professional when dealing with cerebral spinal fluid shunting devices and methods is determining whether or not the shunt is working, i.e., whether the shunt is still providing cerebral spinal fluid drainage and, possibly, at what flow rate. If the device is not working properly, the surgeon generally performs a shunt revision in which the shunting device is either revised or replaced. However, such a shunt revision is an invasive procedure that should be avoided if the procedure is not necessary.
One technique for determining if cerebral spinal fluid flow is present involves the injection of a contrast agent into the cerebral spinal fluid system following by several imaging sessions to monitor clearance of the contrast media, a procedure generally referred to as “shuntogram.” The procedure is generally time consuming, invasive and expensive. Further, if a patient is in critical condition, time may not be available to allow for the performance of a “shuntogram.”
A reliable device and method for cerebral spinal fluid shunting from the ventricles of the brain alleviates both the problem over drainage due to lack of fluid flow control as well as the problem of reliability. In an embodiment, a rotational element, preferably a pinwheel valve, avoids the use of tiny, restrictive or tortuous passages to control cerebral spinal fluid flow that can become clogged with debris. A braking mechanism can be associated with the rotational element to provide control of cerebral spinal fluid flow.
In another embodiment, a remotely detectable element, such as a magnetic element, can be affixed to the rotational element, e.g., pinwheel, in the fluid flow control device, and sensing movement, e.g., rotation, of the element non-invasively. Qualitatively, movement or rotation of the element can immediately and easily determine whether or not the fluid flow control device operational, i.e., shunting cerebral spinal fluid, or whether the fluid flow control device has become clogged or otherwise malfunctioned.
Further, a quantitative measurement of the amount of flow of cerebral spinal fluid can easily be obtained by measuring the rotational speed of the rotational element, e.g., pinwheel, and performing a simple arithmetic calculation. A quantitative measurement can be important because the current flow rate can be compared with a baseline of flow rate established at or near the time of implantation, or another prior time, to possibly predict impending shunt failure. The potential ability to predict shunt failure could allow safer, non-emergency revisions and result in less neurological deficit and/or injury to patients.
In an embodiment, the present invention provides an implantable cerebral spinal fluid flow device. A body has an inlet for the cerebral spinal fluid, an outlet for the cerebral spinal fluid and a first interior cavity fluidly coupled with the inlet and the outlet. A first rotational element is mounted in the first interior cavity in a pathway between the inlet and the outlet. The first rotational element provides resistance to flow of the cerebral spinal fluid from the inlet to the outlet.
In a preferred embodiment, the first rotational element comprises a pinwheel mounted in the first interior cavity.
In a preferred embodiment, the pinwheel is braked to provide the resistance to flow of the cerebral spinal fluid.
In a preferred embodiment, the device further has a pre-loaded spring mounted against the pinwheel to provide braking.
In a preferred embodiment, the pre-loaded spring is mounted radially with respect to the pinwheel to provide a resistance to rotation of the pinwheel.
In a preferred embodiment, the pre-loading of the pre-loaded spring is adjustable to provide a variable pressure against the pinwheel.
In a preferred embodiment, a second rotational element, rotationally coupled with the first rotational element, is mounted in a second interior cavity and a viscous fluid is contained in the second interior cavity providing rotational resistance to the second rotational element.
In a preferred embodiment, the second rotational element is mounted co-axially with the first rotational element.
In a preferred embodiment, the second rotational element is a pinwheel.
In a preferred embodiment, the pinwheel has a plurality of blades and the each of the plurality of blades contains at least one hole.
In a preferred embodiment, the at least one hole is selected in size to provide a selected resistance to rotation.
In a preferred embodiment, the viscous fluid has a shear that increases with a rotational speed of the second rotational element.
In a preferred embodiment, the viscous fluid comprises a fluid whose viscosity increases as the shear increases.
In a preferred embodiment, the viscous fluid comprises silicone fluid.
In a preferred embodiment, a remotely detectable element is mounted with respect to the first rotational element.
In a preferred embodiment, the remotely detectable element provides information regarding flow of the cerebrospinal fluid.
In a preferred embodiment, the remotely detectable element provides information regarding a flow rate of the cerebrospinal fluid.
In a preferred embodiment, the remotely detectable element provides information regarding a rotational speed of the first rotational element.
In another embodiment, the present invention provides a method of controlling a flow of cerebral spinal fluid. A cerebral spinal fluid flow device is implanted. The cerebral spinal fluid flow device has an inlet for the cerebral spinal fluid, an outlet for the cerebral spinal fluid and a first interior cavity fluidly coupled with the inlet and the outlet, and a first rotational element mounted in the first interior cavity in a pathway between the inlet and the outlet. Resistance to rotation of the first rotational element to flow of the cerebral spinal fluid from the inlet to the outlet is provided.
In a preferred embodiment, the pinwheel is braked to provide the resistance to rotation.
In a preferred embodiment, resistance to rotation is provided radially with respect to the pinwheel.
In a preferred embodiment, the resistance to rotation is adjustable.
In a preferred embodiment, the resistance to rotation is provided by the body having a second interior cavity, a second rotational element mounted in the second interior cavity; and a viscous fluid contained in the second interior cavity providing rotational resistance to the second rotational element, wherein the second rotational element and the first rotational element are rotationally coupled.
In a preferred embodiment, an element mounted with respect to the first rotational element is remotely detected.
In a preferred embodiment, information regarding the flow of cerebral spinal fluid is remotely detected.
In a preferred embodiment, information regarding a flow rate of the cerebral spinal fluid is remotely detected.
In a preferred embodiment, information regarding a rotational speed of the first rotational element is detected.
In a preferred embodiment, the remotely detectable element is a magnetic element.
In a preferred embodiment, the remotely detectable element comprises a magnetic element.
Consistent and reliable drainage of cerebral spinal fluid from one area of the body to another, e.g., from a ventricle or ventricles of the brain to another region of the body such as the peritoneum pr sagittal sinus, can be desirable. A consistent and reliable drainage method and system can minimize the expense as well as trauma and inconvenience to the patient associated with cerebral spinal fluid revision surgery and can also lesson risk to the patient due to an inoperative cerebral spinal fluid drainage system.
Flow control device 14 may be located anywhere along the path of cerebral spinal fluid flow. For example, flow control device 14 may be located at or near the inlet for cerebral spinal fluid, e.g., at or near the ventricles, or may be located at or near the outlet for the cerebral spinal fluid, e.g., at or near the peritoneum. Alternatively, flow control device 14 may be located as illustrated in
Ventricular catheter 16, having a lumen, is connects flow control device 14 to inlet location 18 in the ventricle of patient 12. It is to be recognized and understood that other locations, other than inlet location 18, can be used. Distal catheter 20 connects flow control device 14 with an outlet for cerebral spinal fluid, not shown, which preferably is in the peritoneum. It is to be recognized and understood that other outlet locations can be used. Examples of other possible outlet locations include the atrium and the sagittal sinus.
Although not required, flow control device 14 can help alleviate cerebral spinal fluid flow differential due to different positioning of the body. For example, when the body is supine, the difference in elevation between the inlet of ventricular catheter 16 and the outlet of distal catheter 20 may be relatively small. Thus, the pressure differential due to elevation between the inlet and outlet may also be relatively small. This may result in a relatively small flow rate of cerebral spinal fluid through shunt system 10.
However, when the body is erect, for example, the difference in elevation between the inlet of ventricular catheter 16 and the outlet of distal catheter 20 may be relatively large. Thus, the pressure differential due to elevation between the inlet and outlet may also be relatively large. This may result in a relatively large flow rate of cerebral spinal fluid through shunt system 10.
The presence of a flow control device 14 in shunt system 10 can help to stabilize the rate of flow of cerebral spinal fluid through shunt system 10 by limiting the higher flow rates associated with, for example, an erect position of the body.
Body 26 of flow control device 14A holds a rotational element, namely pinwheel 28, mounted on axis 30. Pinwheel 28 is rotatable around axis 30. Cerebral spinal fluid enters flow control device 14A through inlet port 22 and is directed around one side of pinwheel 28 (the right hand in
Rotational element or pinwheel 28 has a resistance to rotation. That is, rotational element or pinwheel 28 is resistant to the flow of cerebral spinal fluid through flow control device 14A because pinwheel 28 is resistant to rotation.
Such resistance to rotation may be provided by a number of different mechanical or magnetic techniques.
In one alternative embodiment, body 26 of flow control device 14A also contains a viscous fluid, e.g., silicone fluid, 34 which provides drag to the free rotation of pinwheel 28.
Blades 32 of pinwheel 28 may contain holes 46, for example, if viscous fluid were employed as a damping agent, to allow some, but not all, of cerebral spinal fluid to pass through flow control device 14A without or with relatively little resistance.
The number and/or size of holes 46 may be adjusted in order to modify the amount of or proportion of cerebral spinal fluid that is subject to relatively little resistance.
In another alternative embodiment, spring 36 is mounted along the circumference of pinwheel 28 and mechanically impinges against outside rim 38 of pinwheel 28 providing mechanical resistance to the free rotation of pinwheel 28. Spring 36, shown in greater detail in
Body 26 of flow control device 14B has two interior cavities. First interior cavity 48 holds a first rotational element, namely pinwheel 28, mounted on axis 30. Pinwheel 28 is rotatable around axis 30. Cerebral spinal fluid enters first interior cavity 48 of flow control device 14B through inlet port 22 and is directed around one side of pinwheel 28 (the right hand in
Second interior cavity 50 holds a second rotational element, namely pinwheel 52, mounted co-axially with respect to pinwheel 28. Second interior cavity 50 contains a viscous fluid 56, e.g., silicone fluid. Blades 58, fixed to axle 30, rotate through viscous fluid 56 providing a resistance to rotation of pinwheel 52. Since pinwheel 52 and pinwheel 28 are co-axial, a resistance to rotation provided to pinwheel 52 will provide a resistance to rotation to pinwheel 28 which, in turn, will provide a resistance to rotation of cerebral spinal fluid passing through flow control device 14B.
While one particular mechanism has been illustrated for providing resistance to rotation of one rotational element, e.g., pinwheel 28, by providing resistance to rotation to a second rotational element, e.g., pinwheel 52, it should be recognized and understood that other mechanical and magnetic relationships between the two rotational elements are possible and are contemplated. For example, it is not necessary that the two rotational elements be co-axial, only that resistance to rotation of one element provides some resistance to rotation of the other element.
Blades 56 of pinwheel 52 may contain holes 58 to allow some, but not all, of viscous fluid to pass through blades 56 without or with relatively little resistance. The number and/or size of holes 58 may be adjusted in order to modify the amount of or proportion of viscous fluid that is subject to relatively little resistance. This adjustment will modify the amount of resistance of pinwheel 52 to rotation.
Magnet 60 may be mounted anywhere on either pinwheel 28 or pinwheel 52. As either pinwheel 28 rotates, magnet 60 will also rotate. Note that even if magnet 60 is mounted exactly co-axially with respect to either pinwheel 28 or pinwheel 52, that magnet 60 will still rotate. The rotation of magnet 60 may transcutaneously sensed by well know and standard magnetic measuring equipment. The rotation of magnet 60 is directly proportional to the speed of rotation of pinwheel 28. The speed of rotation of pinwheel 28 is directly proportional to the rate of flow of cerebral spinal fluid through flow control device 14B. Thus, the presence of magnet 60 allows the non-invasive determination of whether or not cerebral spinal fluid is flowing through flow control device 14B, whether magnet 60 is rotating at all, and will also allow a determination of the amount of flow of cerebral spinal fluid through flow control device 14B, using the speed of rotation of magnet 60 using well know mathematical techniques.
While magnet 60 has been described with respect to flow control device 14B, it is to be recognized and understood that magnet 60 could also be utilized equally well with respect to flow control device 14A by mounting magnet 60 with respect to pinwheel 28.
It may be preferable to provide anti-thrombogenic and/or clot busting properties to either flow control device 14A or 14B. Such anti-thrombogenic and/or clot busting properties are described in co-pending U.S. patent application filed on even date herewith in the names of Ari Moskowitz and William J. Bertrand and entitled “Anti-Thrombogenic Venous Shunt System and Method”, carrying attorney docket number 151P21060US01, the contents of which are hereby incorporated by reference.
Thus, embodiments of the implantable cerebral spinal fluid flow device and method of controlling flow of cerebral spinal fluid are disclosed. One skilled in the art will appreciate that the present invention can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation, and the present invention is limited only by the claims that follow.
