WO2006119243A2 - Outil diagnostique non invasif diagnostic detectant l'integrite structurelle d'un implant rempli de fluide - Google Patents

Outil diagnostique non invasif diagnostic detectant l'integrite structurelle d'un implant rempli de fluide Download PDF

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Publication number
WO2006119243A2
WO2006119243A2 PCT/US2006/016728 US2006016728W WO2006119243A2 WO 2006119243 A2 WO2006119243 A2 WO 2006119243A2 US 2006016728 W US2006016728 W US 2006016728W WO 2006119243 A2 WO2006119243 A2 WO 2006119243A2
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WO
WIPO (PCT)
Prior art keywords
implant
baseline
property
response
defective
Prior art date
Application number
PCT/US2006/016728
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English (en)
Other versions
WO2006119243A3 (fr
Inventor
Michael Liebschner
Original Assignee
William Marsh Rice University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by William Marsh Rice University filed Critical William Marsh Rice University
Publication of WO2006119243A2 publication Critical patent/WO2006119243A2/fr
Publication of WO2006119243A3 publication Critical patent/WO2006119243A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4312—Breast evaluation or disorder diagnosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
    • A61B5/0051—Detecting, measuring or recording by applying mechanical forces or stimuli by applying vibrations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4851—Prosthesis assessment or monitoring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B9/00—Instruments for examination by percussion; Pleximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches

Definitions

  • a ruptured implant may cause other undesirable conditions. Some patients may notice decreased breast size, or a change in the shape or firmness of the breast. Patients may also notice hard knots, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. A rupture may require a second operation and replacement of the leaking implant, thereby exposing the patient to possible complications from such operations.
  • Imaging systems represent the current state-of-the-art technology in SGBI in vivo evaluation. Such imaging systems include mammography, ultrasonography, X-rays, CT scans, and magnetic resonance imaging (MRI). However, these imaging systems are lacking because they do not have sufficient sensitivity to accurately detect implant rupture.
  • MRI the most accurate imaging system for the evaluation of SGBI rupture, has a reasonably high sensitivity to extracapsular rupture (a rupture that has breached the scar capsule around the implant), but has an unacceptably low sensitivity to intracapsular rupture (scar capsule is still intact) due to the difficulty in imaging such a rupture.
  • Ultrasonography provides some accuracy and is more available than MRI, but is highly operator dependent and has a steep learning curve. Mammography is inexpensive compared to the other imagining techniques mentioned above, and its findings may be specific if free silicone is present in the breast, but mammography has very low sensitivity.
  • the limitations of the imaging techniques described above often mean that undesired surgical exploration is required to confirm the presence of implant rupture. And, as noted above, neither the rate of rupture nor its incidence can be reliably predicted. Therefore, there exists a need for more reliable in vivo diagnostic tools and testing to detect implant leakage at an early stage.
  • Embodiments of the present invention are directed toward methods and apparatus for detecting the structural integrity of a fluid-filled implant, and, more specifically, a silicone gel-filled breast implant while it is implanted in the patient.
  • a mechanical action or vibration is applied to the implant in vivo in a safe and noninvasive manner, and a response is measured and analyzed.
  • the measured response may be compared to a predetermined baseline, and the comparison used to indicate the structural integrity of the implant. The severity and location of any rupture may also be indicated.
  • the measured dynamic response which is a direct mechanical measurement, may be used to more accurately determine the structural integrity of the implant than conventional imaging techniques.
  • Figure 1 is a block diagram of one embodiment of an implant testing device
  • Figure 2 is an enlarged perspective view of an alternative embodiment of a portion of the implant testing device of Figure 1.
  • the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to".
  • the terms “couple,” “couples,” and “coupled” used to describe any connections are each intended to mean and refer to either an indirect or a direct electrical or mechanical connection.
  • that interconnection may be through a conductor directly interconnecting the two devices, or through an indirect connection via other devices, conductors and connections.
  • the dynamic response of an object to a dynamic stimulus is more directly related to the structural integrity of the object than the responses gathered from conventional imaging techniques.
  • the dynamic stimulus preferably a mechanical action
  • the dynamic stimulus is created by a testing unit 100, illustrated in the block diagram of Fig. 1.
  • Testing unit 100 includes an electrical component 102 and a mechanical component 140.
  • Electrical component 102 may be a computer-based interface that provides power for testing unit 100, communicates with mechanical component 140, and performs data analysis on the dynamic response.
  • Mechanical component 140 may be a portable testing interface responsible for both applying a dynamic mechanical stimulus to the implant and measuring the response of the object to the stimulus. Together, the mechanical and electrical components form a closed system that is capable of noninvasively testing the integrity of SGBI's.
  • the present invention is not limited to use with silicone implants and persons of ordinary skill in the art will appreciate that the presently described embodiments may be used with breast implants other than those specifically described herein. Furthermore, the present invention is not limited to a testing unit having separate mechanical and electrical components, and persons of ordinary skill in the art will appreciate that the present invention includes testing unit configurations other than those specifically described herein, such as a self-contained testing module or handheld diagnostic tool.
  • electrical component 102 includes a dynamic signal generator 104, a data acquisition system 106 having a computer interface 108, and a dynamic frequency generator 110.
  • Dynamic frequency generator 110 excites mechanical component 140 with constant amplitude pulses of a continuously variable driving frequency.
  • Data acquisition system 106 further includes a processor 112 and memory 114.
  • Memory 114 includes dedicated memory slots 116, 118, 120 and 122, which may include, among other things, computer programs or algorithms, implant property data and baseline value data.
  • the processor 112 may be any logic performing circuitry that can interface with an input signal, memory 114, and data output device 108.
  • Memory 114 may be any type of storage media suitable for storing data 116, 118, 120 and 122, described more fully below. Persons of ordinary skill in the art are aware of several types of processors 112 and memory 114 that are suitable for the embodiments described herein.
  • mechanical component 140 includes a vibrometer 142 and a mechanostatic core 144 for vibrational dampening.
  • Vibrometer 142 includes a transducer 152, preferably a dual electromagnetic and piezo-electric driven transducer, an accelerometer 146 and a tip or contact member 150 for contacting an implant 200.
  • the tip 150 may have a dynamic load cell 148 mounted in it.
  • contact member 150 may be fitted with a terminal-testing tip or plate 154 to ensure a solid, stable mechanical interface between mechanical component 140 and the testing site.
  • Persons of ordinary skill in the art are aware of several types of vibrometers 142, accelerometers 146 and contact members 150 that are suitable for the embodiments described herein.
  • the present invention is not limited to the specific mechanical and electrical devices described herein and persons of ordinary skill in the art will appreciate that the present invention includes mechanical and electrical devices and components other than those specifically described herein and capable of creating and analyzing the dynamic stimulus required for in vivo evaluation of implants.
  • vibrometer 142 may be rigidly mounted to the applicator of a six degree-of-freedom robotic arm with an aluminum base plate adapter.
  • the weight and size of the robotic arm ensures that the resonance frequency of the testing unit is in the upper end of the dynamic spectrum.
  • the spatial control of the robotic arm also allows for accurate positioning of the testing tip or contact member with respect to the implant, and repeatable contact; pressure. between the testing tip and implant.
  • vibrometer 142 may be applied to the implant via other configurations. Dynamic testing of implant 200 begins when contact member 150 is brought into contact with, or engaged with, implant 200 (or, the skin surrounding implant 200, in the case of in vivo evaluation). Next, a contact pressure is applied to the implant.
  • Dynamic frequency generator 110 excites mechanical component 140, and specifically vibrometer 142, with constant amplitude pulses of a continuously variable driving frequency. The electrical signal is then converted to a mechanical vibration, resulting in a dynamic stimulus or mechanical action. The mechanical action is applied within a frequency range, preferably between 20 and 1,000 Hz. A reaction or response force is generated, which excites the implant under test. Accelerometer 146 of mechanical component 140 measures the response force, or acceleration, at the point of contact between contact member 150 and implant 200. Both the input signal (dynamic force) and the output signal (acceleration) are measured at the point of contact between contact member 150 and implant 200 using an impedance head.
  • the present invention is not limited to the specific methods of applying forces or measuring signals described herein and persons of ordinary skill in the art will appreciate that the present invention includes methods and measurements other than those specifically described herein.
  • the contact pressure and mechanical vibrations may be applied in different manners.
  • the force and frequency ranges may be varied.
  • the measured response to the input signal may be in terms of displacement or velocity rather than acceleration.
  • the response signals are relayed by mechanical component 140 to data acquisition system 106 of electrical component 102, where the signals are recorded in memory 114 as a recorded implant property 116.
  • additional implant properties may be calculated, such as resonance frequencies (first and second), amplitude at resonance, half-power bandwidth, energy at half-power bandwidth and vibration coherence for a fixed bandwidth.
  • more implant properties may be obtained, as will be explained below.
  • a custom computer program or algorithm 118 may be used to perform a real-time data analysis on recorded implant property 116. First, algorithm 118 converts implant property 116 from the time domain into the frequency domain using Fourier Transformation. Frequency response functions may be applied to implant property 116 to account for fluctuations within the recorded signals. Implant property 116 may then be converted to a set of dynamic response, or transfer functions, including transfer function parameters such as accelerance, impedance, compliance and stiffness. These transfer function parameters are also implant properties shown as implant property 120 in Figure 1.
  • implant properties 116, 120 may be compared to known values of undamaged implants of similar shape, size and type. Recorded signals such as acceleration, displacement, velocity or resonance frequency may be predetermined for any undamaged implant and later compared with implant property 116 of in vivo implant 200. Transfer function parameters such as accelerance, impedance, stiffness, mobility and compliance may also be predetermined for any undamaged implant and later compared with implant property 120. These predetermined values may also be called baseline values, and they are represented in Figure 1 as baseline 122. When the structural integrity of implant 200 is acceptable, baseline 122 is identical or substantially similar to the implant property it is being compared to. More detail regarding comparison of baseline 122 and implant properties 116, 120 is provided below.
  • baseline 122 may be created at the manufacturing facility where implant 200 is manufactured.
  • baseline 122 may be created from empirical data developed from in vivo evaluation of implant 200. For example, during the first few months after implantation or at other times when implant 200 is known to have sound structural integrity, implant properties 116, 120 may be used to create a baseline 122.
  • the present invention is not limited to the baseline creation methods described herein and persons of ordinary skill in the art will appreciate that the present invention includes baseline creation methods other than those specifically described herein.
  • baseline 122 is not necessarily fixed. Although it is within the scope of the present invention described herein that baseline 122 remains the same once created, it is also within the scope of the present invention that baseline 122 be adjustable based on implant properties 116, 120 observed over time.
  • baseline 122 may be adjusted based on trends observed through research in implant properties 116, 120. For example, it is conceivable that the implant manufacturer or another entity would discover certain indicators that appear before implant 200 ruptures or its structural integrity is otherwise compromised. It is therefore within the scope of the present invention that baseline 122 is updatable so that it may include these indicators. Persons of ordinary skill in the art are aware of other situations where it will be advantageous to update baseline 122. The present invention is not limited to the baseline update methods described herein and persons of ordinary skill in the art will appreciate that the present invention includes baseline update methods other than those specifically described herein.
  • implant property 116 and/or implant property 120 is displayed on interface 108 along with baseline 122. If a difference in the values is shown, implant 200 is defective. Alternatively, interface 108 may simply indicate whether implant 200 is damaged or undamaged.
  • baseline 122 may include a range of values which have been predetermined to reflect an undamaged implant. If implant property 116, 120 falls outside of this range, interface 108 may indicate that implant 200 is defective. Similarly, a percentage change in value between implant property 116, 120 and baseline 122 may be calculated and used to indicate the structural integrity of implant 200. For example, it may be determined that a 5% change in value between implant property 116, 120 and baseline 122 is acceptable (due to background noise), while a 30% change is not.
  • the comparison between implant property 116, 120 and baseline 122 may be used to indicate the severity of the damage to implant 200.
  • a 700 micron puncture in implant 200 is detectable by the present invention, but may only be slightly outside the baseline range or may only indicate a 10% change in value from baseline 122. However, a lmm or 5mm long rupture is more severe, and will be indicated by an implant property value that is further outside the baseline range or a 30% change in value over baseline 122, for example.
  • the location of the implant rupture may also be indicated in a manner similar to the one just described with respect to rupture severity.
  • An increased difference between implant property 116, 120 and baseline 122 generally indicates a rupture located close to the point of contact for contact member 150.
  • the sensitivity of the present invention is such that rupture location will typically not have a major effect on the observed differences between implant property 116, 120 and baseline 122.
  • the location of a 700 micron rupture in implant 200 will not effect the detectability of the rupture, but may provide a slight difference in implant property 116, 120 such that comparison with baseline 122 will provide information as to the location of the rupture.
  • information regarding location of the rupture or defect may be gained.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Transplantation (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Prostheses (AREA)

Abstract

L'invention porte dans une exécution sur des méthodes et un appareil de détection de l'intégrité structurelle d'un implant rempli de fluide et plus spécifiquement d'un implant mammaire rempli de fluide en cours d'implantation. A cet effet on applique une action ou vibration mécanique à l'implant in vivo d'une manière sûre et non invasive, et on mesure et analyse la réponse. Ladite réponse peut être comparée à une ligne de base prédéterminée, la comparaison indiquant l'intégrité structurelle de l'implant, et en particulier l'importance et l'emplacement de toute rupture. Cette réponse mécanique mesurée qui est une mesure mécanique directe permet de mieux déterminer l'intégrité structurelle de l'implant que les méthodes d'imagerie usuelles.
PCT/US2006/016728 2005-04-29 2006-05-01 Outil diagnostique non invasif diagnostic detectant l'integrite structurelle d'un implant rempli de fluide WO2006119243A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US67605905P 2005-04-29 2005-04-29
US60/676,059 2005-04-29

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WO2006119243A2 true WO2006119243A2 (fr) 2006-11-09
WO2006119243A3 WO2006119243A3 (fr) 2009-04-16

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007128133A1 (fr) * 2006-05-09 2007-11-15 David James Haddon marqueur enferme dans un poil destine a detecter la fuite d'une prothese
WO2011101875A1 (fr) * 2010-02-18 2011-08-25 Metis S.R.L. Appareil pour la détection de la tonicité d'un tissu humain et/ou animal
US11647990B2 (en) * 2018-12-05 2023-05-16 Verathon Inc. Implant assessment using ultrasound and optical imaging

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5024239A (en) * 1988-12-21 1991-06-18 Rosenstein Alexander D Method and apparatus for determining osseous implant fixation integrity
US5161521A (en) * 1989-11-06 1992-11-10 Nikon Corporation Oscillation degree measuring apparatus
US5518008A (en) * 1994-08-25 1996-05-21 Spectral Sciences Research Corporation Structural analyzer, in particular for medical implants
US6312466B1 (en) * 1995-05-22 2001-11-06 Board Of Regents, University Of Texas System Prosthesis containing a solution of polyethylene glycol
US20020143268A1 (en) * 2001-04-03 2002-10-03 Neil Meredith Bone implant testing

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5024239A (en) * 1988-12-21 1991-06-18 Rosenstein Alexander D Method and apparatus for determining osseous implant fixation integrity
US5161521A (en) * 1989-11-06 1992-11-10 Nikon Corporation Oscillation degree measuring apparatus
US5518008A (en) * 1994-08-25 1996-05-21 Spectral Sciences Research Corporation Structural analyzer, in particular for medical implants
US6312466B1 (en) * 1995-05-22 2001-11-06 Board Of Regents, University Of Texas System Prosthesis containing a solution of polyethylene glycol
US20020143268A1 (en) * 2001-04-03 2002-10-03 Neil Meredith Bone implant testing

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007128133A1 (fr) * 2006-05-09 2007-11-15 David James Haddon marqueur enferme dans un poil destine a detecter la fuite d'une prothese
WO2011101875A1 (fr) * 2010-02-18 2011-08-25 Metis S.R.L. Appareil pour la détection de la tonicité d'un tissu humain et/ou animal
US11647990B2 (en) * 2018-12-05 2023-05-16 Verathon Inc. Implant assessment using ultrasound and optical imaging

Also Published As

Publication number Publication date
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