Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2000-03-16
2002-08-13
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S461000
Reexamination Certificate
active
06432058
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a device for fastening in a bone, preferably the cranial bone. Alternatively, the device may also be used in connection with tubular bones. The device is intended for use by momentary or continual supervision and examination of physical conditions in the inner cavities of the bone or behind the bone. Pathological conditions may be examined, as for example cerebral haemorrhage, oedema. squeezing off. extension of the ventricular system. dislocation of anatomical structures. tumours, accumulations of blood and liquid.
The invention is developed for and will especially be explained in connection with examination of accumulation in the cranial cavity and especially the content of this which is located behind the cranial bone. But it also gives advantages by use in tubular bones in order to examine developments in the bone marrow in the inner of the bone.
The invention furthermore relates to a kit comprising such a device, and which is intended for use by continual supervision and examination of physical conditions in the inner cavity of the bone or behind the bone. preferably in the cranial cavity.
Furthermore. the invention relates to the use of the device by continual supervision and examination of physical conditions in the cranial cavity.
Devices which have been used for examining physical conditions in the cranial cavity are known. However, the known devices are disadvantageous as they give a signal which occurs with a delay in relation to the physical condition which it is desired to supervise. Furthermore, it is a signal which indicates a stationary condition in the cranial cavity.
The known devices may also be disadvantageous by requiring greater surgical interventions necessitating sterile conditions and full anaesthesia. They are thus not suited for use in a hospital department where patients lie for observation.
The known devices and systems will be designed as explained in the following.
There is known a device whereby the pressure in the cranial cavity is supervised. This device may be placed without using full anaesthesia. The device may be removed without having to move the patient to a surgical department.
If a person is desired to be observed in order to detect physical conditions in the cranial cavity, for example, as a consequence of blows to the head, or as a supervision of a condition occurring after a surgical intervention, or for supervising a condition of sickness. it has been known to insert a screw through the cranial bone. This screw is hollow and has a point which passes through the membrane of the brain so that an open connection is established between the inner of the membrane of the brain and a manometer which is connected with the outer end of the screw situated outside the cranial bone.
On the manometer it is possible to register surpressure in the cranial cavity which is an indication of different subsequent damages which may occur in the cranial cavity. In practice, it has shown that these devices do not imply a great risk of infection. The intervention itself and the locating of the device, thus takes place without using full anaesthesia. However, the known system has a limitation as only an appearing increase in the pressure is occurring. It is not possible to determine a cause, which, for example, may be accumulations of blood or liquid in the cranial cavity.
Furthermore, the system will be tied to another drawback, because one will get an indication via the increase of pressure after an accumulation of blood or liquid has been built up through a certain time. Thus, a delay occurs before signal is received, and the signal is only an expression of a subsequent reaction.
Previously, there have been tests with measuring flow of blood to and from the cranial cavity. Through changes in the pressure in the blood supply vessels, it is possible to get an indication of a pressure built-up in the cranial cavity. This method is also disadvantageous by a delayed indication of a condition which is under development. This system is thus connected with the same drawbacks as mentioned above as one just get an indication of the symptom, and this indication comes with a delay.
For many years, a Doppler-ultrasound directly through the cranium has been used for measuring the rate of flow of blood. Because of the characteristic of the cranial bone, the ultrasound will have difficulty in penetrating and the measurements can therefore only be made in the temple region where the cranial bone is thinnest and allows penetration of ultrasound. With this access, it is not possible to achieve creation of an image of a technically usable quality.
Also, scanners are known, so-called CT-scanners and MR-scanners. Such scanners are, however, very costly in use. Furthermore, these are not devices which are practical in use in connection with beds in hospital departments where patients are admitted for observation.
As an expression of the need that has existed. it may be mentioned that in USA in 1992, 20 inhabitants out of 100,000 died because of so-called cranial traumas. The total number of severe cranial traumas is estimated to be about 5 times as large. The need for a supervision may thus be estimated to be several hundred thousand a year in the Western world. In spite of this need, there has until now not been proposed devices or methods for continual supervision with a cerebral image forming technique which is competitive in relation to the known scannings.
Previously, there has been proposed an equipment using ultrasound scanning of physical conditions in the cranial cavity. This equipment and the use thereof are described in International patent application WO 87/03190. This equipment is intended for mounting over a hole in the cranial bone formed for this purpose and is placed in a way so that it fits tightly to the cranial bone. However, this equipment and the described method are unfavourable as they require craniotomi, i.e. removal of a larger piece of bone. The equipment has to be used under full anaesthesia and under sterile conditions and is intended for use in connection with neurosurgical interventions in the cranial cavity. Use of the described equipment will thus be very demanding on resources, because of requirements of sterile conditions and requirements of full anaesthesia. This is the case with locating as well as the subsequent supervision situation.
The equipment is furthermore unfavourable as a risk of contamination occurs. In the system, there is used a transducer which in principle participates in the closing of the formed hole in the cranial bone. As the equipment comprises elements making possible access of different instruments to the cranial cavity, we are speaking about a complete system which cannot be said to be closed, and thereby a system which may be considered to be used under unsterile conditions.
The equipment furthermore requires complicated fastening in the opening formed in the cranial bone by means of a clamping technique. Even though the described equipment makes possible the creation of an image of physical conditions in the cranial cavity, it will not be suitable for use for continual supervision and examination of the cranial cavity on persons situated in unsterile hospital departments.
A holder that may be fastened in a bone, for example the cranium, is known from U.S. Pat. No. 4,681,103. This holder may be used for an ultrasound transducer. This holder is, however, open towards the inner of the cranium and may thus not be used outside a sterile area in a hospital. This holder and the equipment belonging to it in the form of an ultrasound transducer and a needle on the described apparatus, may thus not be used for supervision, but only to perform localisation of a spot by means of an ultrasound transducer in connection with a surgical intervention. After determining the positioning, a guide is adjusted in the holder. Subsequently, this guide is used as support for the needle. There is no precise indication of how to ensure a correct screwing of the holder into the bone
Jain Ruby
Ladas & Parry
Lateef Marvin M.
LandOfFree
Device for fastening in the cranial bone and a kit... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Device for fastening in the cranial bone and a kit..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Device for fastening in the cranial bone and a kit... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2945740