WO2001019248A1

WO2001019248A1 - Device and method for establishing stability in an implant or unit

Info

Publication number: WO2001019248A1
Application number: PCT/SE2000/001762
Authority: WO
Inventors: Neil Meredith; Anders Petersson
Original assignee: Integration Diagnostics Ltd
Priority date: 1999-09-16
Filing date: 2000-09-12
Publication date: 2001-03-22
Also published as: SE9903304D0; SE9903304L; WO2001019248A8; EP1280450A1; JP2003524475A; US20020177790A1

Abstract

For the determination of stability of an implant in bone (K), a vibration effectuating unit (1) is used, which gives a frequency signal A corresponding to the stability. A receiving unit receives this signal and converts it to digital information signal (i2), which relates to the stability. A processing unit (4), receives the digital signal and processes it together with information relating to distortion factors from the current situation, such as implant dimension, surface, material, anatomical site etc. The processing unit gives as output a presentation information (i4), which disregards said factors and therefore representing only the stability. Alternatively, the processed information is stored for comparison with later information, to make it possible to follow the healing process, or otherwise monitor the function of the implant.

Description

Device and method for establishing stability in an implant or unit.

The invention relates to a device and method for the measurement of implant stability as a function of, amongst other things, the resonance frequency of the implant, of the implant with an attached structure and/or of a transducer in contact with the implant or a structure that is attached to the implant The invention also relates to establish the stability of an anchorage of a first unit It also relates to the preamble of claims 1, 2, 3, 9 and 12 Bone anchored threaded any cylindrical metallic, endosseous implants are now widely used in Medicine and Dentistry Such implants are inserted into a pre-dπlled hole in the facial skeleton and used to provide a means of anchorage for a dental or facial prosthesis which may be a single replacement tooth, a bridge, a denture or even a false eye or ear Implants may be placed as a one or two stage procedure In a one stage procedure the implant is placed and exposed immediately in, for instance, the patient's mouth A prosthesis may then be con- structed and the implant loaded immediately This method is less popular because immediate loading carries with it an increased risk of failure as the implant may not be sufficiently stable to distribute the stresses from the prosthesis effectively In a two stage procedure, the implant is placed in two parts and the implant fixture is buried beneath the soft tissue and left to heal for three to six months before connection of a metal collar or transmucosal abutment This transmucosal abutment then allows connection of the prostheses It is generally accepted that the success of a two stage procedure is higher because of the delayed loading

The key to successful implant placement is achievement of good implant stability Implant stability is the resistance of an implant to movement and reflects its ability to distribute stresses The stability of an implant at placement is a function of a number of parameters These relate to the implant itself, its length, diameter, and surface characteristics They also relate to the type of surgical procedure, the size of hole that is drilled and the amount of tissue removed Equally important is the quality of the bone, which may vary from a dense cortical plate in the anterior part of the man- dible to an open trabecular network in the posterior part of the maxilla Following implant placement stability changes as a healing and remodelling process takes place within the bone It is likely that there is a degree of stress relaxation following the placement of the implant followed by an inflammatory response with wound healing Following this there will be remodelling until an equilibrium stage is reached A suc- cessful, osseointegrated implant shows no decrease in the height of bone surrounding it nor a decrease in stiffness The current most commonly used method for assessing implant performance is the use of radiographs, however these are two dimensional in nature and difficult to reproduce It has been demonstrated that implant stability and bone height can be related to the first (and higher) resonance frequencies of a trans- ducer attached to the implant It has also been demonstrated that the resonance frequency could be measured on the implant itself

A measurement of implant stability is a useful parameter for both the diagnosis of problem implants and the monitoring of implants throughout their lifetime It is generally referred to in WO92/18053, US 5,518,008, US 5,392,779 and US 4 499,906 Through the prior art it is known to use the resonance frequency as a parameter, but this causes problems when the resonance is used for determing the stability and is affected by another factors than the stability

The basic parameter for the measurement of implant stability is resonance frequency (F_r) F_r is specific for an implant situation and, as described above, is depend- ent on a number of different parameters, for instance the geometry and the material of the implant This means that measurements on different implants can give different resonance frequencies although they have the same stability In practice, this makes it difficult to evaluate the real stability in the actual case

It is one objective of the invention to solve this problem and make it possible to determine the true stability in spite of differences between different implants

When the measurement of implant stability is made indirectly, by measuring the resonance frequency with a transmucosal abutment or other structure mounted on the implant, the geometry of the abutment and/or structure will affect the resulting resonance frequency This will make it difficult to directly compare measurements of F_r for objects in different situations It is a general objective of the invention to solve this problem

The resonance frequency can have a substantial variation, which means that an instrument that can cover a wide frequency range is necessary In normal situations, the clinically interesting range is smaller than what is actually possible, leading to dif- Acuities in achieving good resolution in that range It is an objective of the invention to solve this problem

For a stability value to be useful to a clinician, the presented value has to be comparable between implants of different types, different lengths and also between situations with different clinical/surgical conditions (for instance the drill hole diame- ter, the bone quality and the anatomical area)

It is an objective of the invention to solve this problem

It is of interest to compare stability measurements made at different occasions during the treatment process It is an objective of the invention to solve this problem That mainly can be considered as characteristic for a device according to the invention is, amongst other things, that it contains receiving organs which receives the respective frequency signal and transforms it to a digital information signal which is related to and/or is representing the stability and/or, under the above specific circumstances, distinctive features in the implant situation Further characteristics are the it works together with organs that contains information which shows or is working with information which represents those distinctive features and that it also contains a calculation unit (for example a microcomputer), or is working together with such a unit which with a software program processes one or more information sιgnal(-s) with the above information According to the invention, the processing with a preferably mainly known program, results in a presentation information, which could be trans- ferred to a presentation unit which could be separate or included in the calculation unit and arranged to present the stability independent of the implant type, geometry et cetera It is also referred to the characteristic parts of claims 1 , 2 and 3

The invention proposes l a the use of internal memory circuits and/or an external memory unit and/or memory circuits in the transducer The memory circuits con- tains in use information about the present implant system, I e the distinctive features of the implant of the patient to be assessed The memory contents is used in an arithmetic unit (for example a microcomputer), which can be built in the instrument or be external The arithmetic unit uses the information in the memory circuits to compensate the measurement value for differences in the geometry and other factors between different implant systems

In one embodiment where, for example, the implant is used with an abutment, information about the dimensions of the specific abutment and/or other specific information are used in the same way to compensate the measurement value for influences from these In another embodiment, the system of the invention uses knowledge about which is the clinically interesting frequency range, to map F_r to a scale with good resolution in that range The scale could run from, for instance 0 to 100 These previous versions have the form of a system or device, which translates Fr to a compensated value, given the abutment, dimensions (if an abutment is used) and information about the implant system used, as input It could also be used to compensate for other clinical parameters, such as the diameter of the drilled hole, the quality of the bone, the anatomical area et cetera, which can be added by the clinician or otherwise communicated to the arithmetic unit

In a further aspect of the present invention there is provides a device as claimed in claim 9 of the claims hereinafter The device the mentioned receiving organs contains or co-operates with one or more storage units, internal and/or external, which stores the digital information signal, and/or its presentation, for each respective measurement, such that the sιgnal(-s) and/or presentatιon(-s) is/are reusable in order to be run together or compared with other corresponding information signals and/or pres- entations that are received at consecutive interactions, separated in time, between the ιmplant(-s) and one or more vibration effectuating unit It is also referred to the characteristic part of claim 9 According to a yet further aspect of the present invention there is provided a method as claimed in claim 12 of the claims hereinafter

In one version, stability values are stored in the instrument or in external memory circuits, to make it possible to compare measurements made at different occasions, and simplify for the clinician and/or let the arithmetic unit make calculations based upon these comparisons

All suggested solutions are achieved by using hardware to determine the resonance frequency in a specific frequency range, and then using an arithmetic unit together with stored information for determining the stability value

A working set-up and method according to the invention may look and work according to the attached drawing, which partly and principally shows a longitudinally sectioned view of an implant in bone, and an instrument, in a block diagram, for measuring implant stability An embodiment of the present invention will now be more particularly described by way of example with references to the accompanying drawing, which principally discloses components and signals included and attained in the actual apparatus

The drawing shows a bone K The implant I has been applied in the bone according to known procedures, and can be selected from a range of diameters D and lengths L A vibration- or force effectuating and vibration detecting unit (I) is brought in contact with the implant (or an attached structure) The umt is connected or possible to connect to an instrument In, through a connection I ed The instrument includes a vibration effectuating unit (2), an A/D-converter (3), an arithmetic unit (microcom- puter) (4), one or more memories (5, 6), a presentation umt (7), a memory for storing measurement data (8), and a comparing unit (9)

A frequency signal ι_o is sent from the unit, and a frequency signal ι_l5 is achieved from the unit ( 1 ) when it is activated against the implant (or attached structure) The unit (3) converts the signal iι to a digital information signal ι₂ The unit (4) which can work with a known program, processes the signal ι₂ combimng it with the signal ι₃ which is representative for distortion factors such as differences in diameter and length (D and L), and more The result is a presentation signal ι₄ which relates only to the stability and not to any of the distortion factors

The program executes the equation ISQ=F x (F_r-Fj) / (F_h-Fι) x 100, where ISQ= implants stability F= a compensating function which can be linear or non-linear and dependent of the implant geometry, the geometry of the abutment or any other attached structure, clinical conditions et cetera

Fι= low limit of the clinically relevant frequency range F_r= the resonance frequency

F_h= high limit of the clinically relevant frequency range

Fi preferably has values around 5000 Hz (4500-5500 Hz), and F_h preferably has values around 10000 Hz (9000-1 1000 Hz)

In a case in which one would use measurements separated in time or measure the stability at two or more occasions, the memory (8) and the comparator (9) is used Storage of measurements and/or reusable values is indicated with lj, and the comparing function with ι₆ The program in the unit (4) is illustrated as the memory function (6) Also, activating buttons or a keyboard is indicated (10) Control information ι₇ can be typed in or received with the key- board In the example, the functional components 2-10 are realised in the instrument In One or more of the components can be external components to which the instrument is attachable at or between the measurement occasions The instrument can interact with other equipment (for example computer equipment, communication wires, computer network et cetera) which is sym- bo sed with (1 1) and its connections with Ledi, at which signal ι₈ is present

In an embodiment sensors are used Each model of sensor is then applied on several calibrating block having a known stability and in which a function is decided by means of a resonance frequency as a function of the stability (defined as ISQ, scaled with 0-100) The factors of this function are pro- grammed in a memory applied in the connecting member of the sensor, together with an individual calibrating factor for each sensor (this one is decided on one or more calibrating blocks after the manufacture of the sensor) If the sensor is to be adapted on distance level, the procedure is the same, apart from the fact that the resonance frequency is measured for several different lengths of dis- tances on respective calibrating block. Factors, which compensate for the distance length, are also memorised in the memory of the connection member.

In another embodiment only the resonance frequency is shown and after that the sensor is used on a calibrating block with known stability is calibrated. The absolute stability then can be calculated

In a general embodiment the new apparatus and method can be used for checking the stability of a unit (first unit) which is enclosed in a substrate, foundation, material etc. in a corresponding way as above with implant and bore. The first unit may be mounted and/or is preformed with some elasticity, spring effects, etc The preambles, characteristic part of the independent claims and the sub-claims can be mutually

The invention is not limited to the above example, and can undergo modifications within the following claims and the intention of the invention.

Claims

1 A device to enable determination of the stability of the anchorage of a unit, here called first unit, which is anchored in a substrate (material), and wherein the respective first unit can be affected by a vibration effectuating unit, which interacts with the first unit and generates a frequency signal (il) depending on the stability and distinctive feature(-s) (characteristics), for example dimension, placement, etc., of the first unit, characterised in that the device operates with a digital information signal (i2), which represents said stability and distinctive feature(-s) and is generated in a receiving unit, which receives the frequency signal (il) and transforms it to said digital information signal (i2), in that information(-s) representing said distinctive feature(-s) is or are, respectively, contained in or can be supplied to one or more information storing means (memories), and in that one or more information signals (i4) are adapted to represent substantially only the stability, which information signal(-s) emanate(-s) from treatment in an arithmetic unit, preferably in a microcomputer, or the digital information signal (i2) and the information(-s) representing the distinctive feature(-s).

2 A device to determine the stability of an implant in the human body, preferably in the facial skeleton, characterised in that the device in use combines a frequency signal or resonance frequency with one or more factors affecting the frequency signal and the resonance frequency, respectively, in a way that the output (i4) of the device substantially depends only on the stability

3 A device to enable determination of the stability of an implant in the human body, preferably in the facial skeleton, and wherein the respective implant can be affected by a vibration effectuating unit, which interacts with the implant and generates a frequency signal (il) depending on the stability and distinctive feature(-s) (characteristics), for example dimension, placement, etc., of the implant, characterised in that it operates with a digital information signal (i2), which represents said stability and distinctive feature(-s) and is generated in a receiving unit, which receives the frequency signal (il) and transforms it to said digital information signal (i2), in that information(-s) representing said distinctive feature(-s) is or are, respectively, con- tained in or can be supplied to one or more information storing members (memories), and in that one or more information signals (i4) are adapted to represent substantially only the stability, which information signal(-s) emanate(-s) from treatment in an arithmetic unit, preferably in a microcomputer, of the digital information signal (i2) and the information(-s) representing the distinctive feature(-s). 4 A device according to claim 3, characterised in that it has an integrated member unit, or is possible to attach to an external unit, for example said microcomputer or another computer, by which respective resulting presentation- or storage result may be stored in order for it to be comparable with previous presentation- or storage result(-s) 5 A device according to claim 3 or 4, characterised in, that the calculation of the stability is possible to make with the equation ISQ=F x (F_r-Fι) / (F_h-Fι) x 100, where ISQ is the implant stability, F is a compensating function which can be linear or nonlinear and dependent on the implant geometry, the geometry of any abutment or other structure attached to the implant and/or clinical conditions et cetera, Fi is the lower limit of the clinically relevant frequency range, F_r is the resonance frequency and F_h is the upper limit of the clinically relevant frequency range

6 A device according to claim 3, 4 or 5, characterised in that Fi has a value of approximately 5000 Hz.

7 A device according to claim 3, 4, 5 or 6, characterised in that F_h has a value of approximately 10000 Hz

8 A device according to claim 3, 4, 5, 6 or 7, characterised in that F is a nonlinear function

9 A device to enable determination of the stability of an implant in the human body, preferably in the facial skeleton, where an implant vibration effectuating unit is adapted to interact with the implant and generate a frequency signal (il) dependent on the stability the device having, characterised in, that it operates with a digital information signal, which represents or is related to the stability of the implant, which digital information signal (i2) can be generated in receiving means which transform the frequency signal to said digital information signal, and that it includes or is connected to one or more storage units (memories), which stores respective implants digital infor- mation signal(-s) or presentation(-s), and in that respective implants stored digital information signal(-s) is/are reusable to be processed together with, or compared to another digital information signal or presentation which is present at consecutive interactions, separated in time, between the implant and the vibration effectuating unit

10 A device according to claim 9, characterised in, that first and second storage units (memories), stores information- or presentation signal(-s) from two or more occasions, that comparing organs are arranged to compare information signals which has been sent to first and second storage units, and send information depending of the comparison, which represents the actual stability during a period of time of approximately one month and forward, to a presentation means

1 1 A device according to claim 9 or 10, characterised in, that it gives an information corresponding to the actual stability for each implant respectively, independent of its length in the bone, dimensions, type, etc. 12 A method to measure the stability of the anchorage of a unit, here called first unit, which is anchored in a substrate (material), where one or more vibration effectuating units is applied to the anchored unit or an attached structure and where one or more stability dependent frequency signals is achieved from the vibration effecting unit(-s), characterised in: a) that the frequency signal(-s) is/are converted to one or more information signal(-s) representing the stability, b) that the information signal(-s) is/are processed in a processor means to eliminate distortion factors dependent of the structure of the first unit, implement situation etc. to provide an information output signal that is dependent mainly only on the stability, and c) that the last mentioned information output signal is transferred to direct use in said measure and/or is stored in one or more memory means to be reused for comparison between two or more set of presentation information, separated in time.

13 A method according to claim 12, characterised in that it detects the stability of an implant in the human body, preferably in the facial skeleton.