| WO1997022015A1 | 1997-06-19 | |||
| WO2003013654A1 | 2003-02-20 | |||
| WO1997022015A1 | 1997-06-19 |
| US5350351A | 1994-09-27 | |||
| US6128522A | 2000-10-03 | |||
| US5393296A | 1995-02-28 | |||
| US5350351A | 1994-09-27 |
C L A I M S
1 ) Method to induce the osteogenesis in a bone region of a patient, characterized by the fact of including the steps of producing at least one beam (3,4) of ultrasounds; focusing such ultrasounds beam (3,4); directing the ultrasounds beam (3,4) to a bone region (1) of a patient letting the focus of the beam (3,4) itself coinciding with a calculated point of the bone region (1 ); the power by which the ultrasounds beam (3,4) hits the the said bone region (1 ) and the lasting of such action on the bone region (1 ) are to be chosen to give origin, in the bone zone itself (1), to a haematoma and/or a local inflammation and/or to a series of micro-fractures, next to which an osteogenetic mechanism will be activated.
2) Method according to claim 1 , characterized by the fact of producing two ultrasounds focused beams (3,4) converging to the said calculated point of the bone region (1 ).
3) Method according to claim 1 or 2, wherein the bone region (1 ) is subjected to a radioscopy, the result of such radioscopy is displayed by a video terminal (11 ) connected to a computerized unit (8), supplied with references, so that the computerized unit itself (8) is able to know the coordinates of every point which is visualized by the radioscopy itself, and so that the position of the focus of the said at least one beam (3,4) of ultrasounds is clearly identified and displayed in the same video (11 ), second after second.
4) Method according to claim 1 or 2, wherein the bone region (1) is explored by an equipment for magnetic resonance imaging, the result of such exploration is displayed by a video (11 ) connected to a computerized unit (8), supplied with references, in such a way that the same computerized unit (8) knows the coordinates of every displayed point , and the position of the focus of the said at least one ultrasounds beam (3,4) is clearly identified and visualized in the same video (11 ), second after second. 5) Method according to claim 3 or 4, wherein an operator can modify the position of the focus of the said at least one ultrasounds beam (3,4) to match it with the said calculated point of the said bone region (1 ).
6) Method according to claim 5, wherein the operator can modify the direction of the spreading of the said at least one ultrasounds beam (3,4) by working on a joystick connected to a computerized unit (8).
7) Equipment to induce osteogenesis to a bone region of a patient, characterized by the fact of comprising emitter means (5,6) to generate at least one focused beam of ultrasounds (3,4) and to direct such an ultrasounds beam (3,4) to the said bone region (1 ) letting the focus of the beam itself (3,4) matching a calculated point of the bone region itself (1 ); the power of the said ultrasounds beam (3,4) to hit the said bone region (1 ) and the lasting of such action on the bone region (1 ) being chosen to give origin, in the bone region itself (1), to a haemathoma and/or a local inflammation and/or to a series of micro-fractures, next to which an osteogenetic mechanism will be activated.
8) Equipment according to claim 7, characterized by the fact of comprising power means (7) to modify the direction of the spreading of the said at least one focused beam of ultrasounds (3,4).
9) Equipment according to claim 7 or 8, characterized by the fact that the said focused beams of ultrasounds (3,4) converging towards the said calculated point of the bone region (1 ) are in the number of two.
10) Equipment according to any of the claims from 7 to 9, characterized by the fact of including a computerized unit (8) to which a video (11 ) is connected, and by the fact that, in use, the said bone region (1 ) is subjected to radioscopy, that the result of such radioscopy is displayed by the said video (11 ) supplied with references, so that the computerized unit itself (8) identifies the coordinates of every point displayed through the radioscopy itself, and that the position of the focus of the said at least one beam (3,4) of ultrasounds is clearly identified and displayed on the said video (11), second after second. 11 ) Equipment according to any of the claims from 7 to 9, characterized by the fact of including a computerized unit (8) to which a video (11 ) is connected, and by the fact that, in use, the said bone region (1 ) is explored by ad equipment for the magnetic resonance imaging, that the result of such an exploration is displayed by the said video (11 ) supplied with references, so that the computerized unit (8) itself knows the coordinates of every displayed point, and that on the said video (11 ) is clearly identified and displayed, second after second, the position of the focus of the said at least one beam (3,4) of ultrasounds.
12) Equipment according to the claim 10 or 11 , characterized by the fact of including controlling means to modify, in use, the position of the focus of the said at least one ultrasounds beam (3,4) to place it over the said calculated point of the bone region
(1 )-
13) Equipment according to the claim 12, characterized by the fact that the said controlling means include a joystick connected with the said computerized unit (8) and moved by an operator.
14) Method to induce the osteogenesis in a bone region of a patient, according to any of the claims from 1 to 6, characterized by the fact that the said bone region (1) is the neck of the femur (Ward Triangle).
15) Equipment to induce the osteogenesis in a bone region of a patient, according to any of the claims from 7 to 13, characterized by the fact that the said bone region (1 ) is the neck of the femur (Ward Triangle). |
D E S C R I P T I O N
FIELD OF THE INVENTION
The invention concerns a method and an equipment to induce osteogenesis in a bone region of a patient.
The fracture problem in osteoporotic subjects, with particular reference to the femur, is of huge significance in the social, health and human fields.
In the last thirty years an exponential growth of clinical cases and a consequential raising of social costs has been registered due to the ageing process of the world population and to the changing of the life-style.
The phenomenon, once especially concerning the Western and the North American countries (because of the common economic welfare), is now spreading through the
Oriental countries, too.
Moreover, the femural fractures, once regarding in the vast majority the female sex, are nowadays widely affecting the male population.
BACKGROUND OF THE INVENTION
The prevention attempts in the medical field (antiosteoporotics and recalcification substances) have not succeded in bettering the statistical data of the femural fractures.
Trying to reduce the problem range, a "support" system has been suggested, to strengthen the bone zone most subjected to spontaneus femural fracture; the system consisted in the preventive introduction of a metal "nail", after the bone densitometry estimation of the consequent femural fracture.
The named method has not been followed, for it is extremely invasive and it involves medical and legal risks.
SUMMARY OF THE INVENTION
The aim of the present invention is to supply a method and an equipment to induce osteogenesis in a bone region of a patient, with particular reference to the neck of the femur, this zone being the mostly often affected by the spontaneous fracture due to osteoporosis (Ward Triangle).
The present invention relates to a method which induces osteogenesis in a bone region of a patient as described in the claim 1 or in each of the following claims directly or indirectly depending on the claim 1.
The present invention also relates to an equipment to induce osteogenesis in a bone region of a patient as described in the claim 6 or in each of the following claims directly or indirectly depending on the claim 6.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will now be described with reference to the enclosed drawing, which explains and schematizes a non-limitative realization-example.
DETAILED DESCRIPTION OF THE DRAWINGS
Number 1 in the figure indicates a bone portion of a patient to be subjected to treatment, the example depicts the upper portion of a femur (neck of the femur). Number 2 indicates an equipment for the emission of at least two focalized beams 3 and 4 of ultrasounds, which are emitted and focalized, in a way itself known, by respective emitter-elements 5 and 6 which are reciprocally connected in a not-shown way.
The emitter elements 5 and 6 are able to move in any direction due to the operation of a power-element 7, the type itself known, which is activated with a mode itself known and later on clarified, by an operator working on a computerized unit 8. Obviously, as an alternative to the movement of the emitter-elements 5 and 6, the power-elements 7 could vary the position of any mechanical or optical means able to modify the positions of the focuses of the focalized ultrasounds beams 3 and 4. Having acquired and demonstrated by recent studies that the regenerative process of the bone consists in two types of osteogenesis, the first one being static and the second one dinamic, the use of the equipment 2 is estimated in accordance with the present invention to induce local micro-injuries in a bone region of a patient, particularly referred to the neck of the femur 1 in the zone statistically most affected by spontaneous femural fractures due to osteoporosis (Ward triangle), considering that it has been demonstrated that the regenerating process of the bone do substantially reply the event-sequence of the normal bone histogenesis. The osteogenetic process follows two schemes: a static osteogenesis and a dinamic osteogenesis.
Around and in the bone injury, after the haemathoma phase and the inflammatory process, the presence of a connective tissue rich of blood vessels can be noticed. Afterwards, in the area among the vessels, stable osteoblast cords are to be noticed, which do not move but change into osteocytes in the same place where they differentiate and originate a bone trabecula: static osteogenesis.
In the meantime, the typical floating osteoblasts form strata on the surface of the trabecula shaped by static osteogenesis and they thicken them: dinamic osteogenesis.
It is to be assessed that in both the osteogenesis types are involved different signals and factors both in normal and in pathological conditions.
The static osteogenesis depends on inductive factors, the dinamic osteogenesis mostly depends on mechanical stimuli.
Using the equipment 2 to "hit" some internal portions of the neck of the femur 1 (e.g. portion 9) with focused ultrasounds beams 3 and 4, converging towards the internal portions themselves next to their focuses, it is possible to provoke a calculated series of "micro-fractures" in the neck of the femur zone 1 , next to which the osteogenetic mechanism of both the explained types will be activated.
The focused ultrasounds beams 3 and 4, when reaching and superposing the precise points chosen by the operator, produce a resonance effect together with a heat effect which induce haemathoma and local inflammation.
This process is to be preferably checked by the computerized unit 8, which very precisely regulates the power of the focused beams 3 and 4 avoiding the creation of less-resistance zones, that could lead to spontaneous fractures of the neck of the femur.
When exposing the osteoporotic femur to successive sessions of ultrasounds "firing", the affected zone will regain its strong ultrastructure of bearing bone.
The bone region 1 is preferably displayed by radioscopy, so that the operator who activates the equipment 2 can clearly visualize the bone portions that are subjected to the effect of the ultrasounds focused beams 3 and 4.
Alternatively, the bone region 1 could be displayed, as a further example, using an equipment for magnetic resonance imaging.
Preferably, the display of the radioscopic system or of the magnetic resonance imaging equipment is in a way itself known fed into the computerized unit 8, supplied with references, so that the computerized unit 8 itself will "know" the coordinates of every displayed point and is able to show the result of the radioscopy or of the magnetic resonance imaging by a video terminal 11 ; it will be similarly advantageous that the position of the coinciding focus of the ultrasounds focused beams 3 and 4 is clearly identified and visualized in the same video terminal 11 , second after second.
The coordinates of the points and the zones to be hitten by the beams 3 and 4 being known, and the coordinates of the point 10 where the focused beams 3 and 4 intersect being known too, for they are dimensional features of the equipment 2, and having a display of the points and the zones in the video terminal 11 , it will be easy for the operator who is working on a control element such as a joystick (not illustrated) connected to the computerized unit 8 to fix the movement of the emitter elements 5 and 6 through the power element 7 in order to let the point 10 matching the points of the neck of the femur 1 , where the beams 3 and 4 must operate. In such a way it will be possible to give origin to the above-mentioned calculated series of micro-fractures in the neck of the femur 1 , producing ultrasounds beams 3 and 4 having properly determined power, next to the micro-fractures the above-stated osteogenetic mechanism will be activated.
When wished, the equipment 2 could provide for the use of only one of the beam 3, 4, or of any numberof ultrasounds focused beams, more than two, converging to a point.
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