WO2011101875A1 - Apparatus for detecting human and/or animal tissue tone - Google Patents
Apparatus for detecting human and/or animal tissue tone Download PDFInfo
- Publication number
- WO2011101875A1 WO2011101875A1 PCT/IT2010/000053 IT2010000053W WO2011101875A1 WO 2011101875 A1 WO2011101875 A1 WO 2011101875A1 IT 2010000053 W IT2010000053 W IT 2010000053W WO 2011101875 A1 WO2011101875 A1 WO 2011101875A1
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- WO
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- Prior art keywords
- arm
- patient
- box
- area
- stem
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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
- A61B5/0053—Detecting, measuring or recording by applying mechanical forces or stimuli by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B9/00—Instruments for examination by percussion; Pleximeters
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pathology (AREA)
- Gynecology & Obstetrics (AREA)
- Reproductive Health (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
An apparatus (1) for detecting human and/or animal tissue tone, in particular breast tissue tone, comprising a box-like body (2) provided with at least one grip portion (3) for an operator (4), at least one arm (6) which can move, with respect to the box-like body (2), comprising an abutment element, for abutting against the area (7) of the patient to be analyzed. The arm (6) is mounted on the box-like body (2) with the interposition of at least one actuator, for the automatic movement of the arm (6), and of at least one element such as a load cell for detecting the intensity of the force applied by the actuator at each variation of the position of the arm (6) associated with a compression of the area (7) of the patient to be analyzed.
Description
APPARATUS FOR DETECTING HUMAN AND/OR ANIMAL TISSUE TONE
Technical field
The present invention relates to an apparatus for detecting human and/or animal tissue tone.
Background art
It is possible to obtain important diagnostic information from tissue tone; in particular, it is possible to detect the consistency of tissues after a surgical procedure, in the case of neoformations, or during physical therapies and/or diets it allows the assigned personnel to check the specific condition of the patient.
According to a particular example of application, detecting mammary tone is fundamentally important, since this detection is useful for physicians in order to identify the presence of any pathological conditions and to identify correct postoperative course, particularly in the case of prosthesis implantation.
It may in fact be necessary to detect the presence of capsular contractures occurring as a consequence of surgical procedures: in particular, the apparatus according to the invention is adapted for the detection and measurement (intended to monitor variations over time and classify the extent of the capsular contracture) of the contraction of the periprosthetic capsule after an additive mastoplasty procedure.
The formation of a capsule around a mammary prosthesis is in itself an inevitable biological phenomenon as a consequence of the introduction in the human body of material that is foreign to it, albeit inert. It is the contracture of this structure that can make it clinically appreciable to various degrees, compromising, in the most severe cases, the result of the procedure. Over time, a concentric scar is formed^which reduces the deformability of the prosthesis and causes more or less conspicuous hardening of the capsule.
The increase in the consistency of the entire system causes the contracture. However, it is not correct to assume as a rule the constriction of every implant, since prostheses usually are able to cushion the formation of the periprosthetic fibrous capsule without generating pain or discomfort of any kind in the patient.
Severe capsular retractions compress the prostheses, cause their margins to stand out, making them visible and deformed, form falls and can dislodge them. Data related to the incidence of capsular contracture cited in the literature are highly variable and range from 0.5 to 15% after additive mastoplasty procedures. Although a series of intraoperative and extraoperative factors has been correlated with the onset of capsular contracture, unfortunately until now no study has been able to demonstrate the causes that originate this phenomenon.
The variability of the incidence of capsular contracture depends on various factors, such as the type of prosthesis used, the type of surface of the prosthetic enclosure, and the position in which the prosthesis is inserted.
Capsular contracture is assessed, on the basis of its extent, by palpating the portion of tissue involved, in accordance with Baker's classification.
It is evident that depending on the physician who performs the assessment, a same case can be classified according to a different degree of severity, expressed according to Baker's scale. This extreme subjectivity in assessment can lead to a problem for the patient, who must hope that she has contacted a physician that is sufficiently prepared and skilled, in order to obtain a diagnosis that is as objective as possible and establish a suitable therapy.
The therapy of capsular contracture can be pharmacological (use of antileukotriene drugs) or surgical (capsulotomy or capsulectomy with replacement of the prostheses and possible change of their plane of insertion). It is not simple to assess the results, especially from a distance,
for the reasons described above.
Similar tone detections can be necessary, moreover, in the medical, physiotherapy and sports field to identify the state of tissues, in order to assess increases or decreases in tone linked to inflammatory or degenerative processes or as a consequence of treatments (training, massages and others) aimed at toning such tissues.
Disclosure of the invention
The aim of the present invention is to solve the problems described above, by providing an apparatus for detecting human and/or animal tissue tone that is capable of making the detection objective.
Within this aim, an object of the invention is to propose an apparatus for detecting human and/or animal tissue tone that is particularly suitable for identifying capsular contractures that occur after additive mastoplasty procedures, adapted to classify the detected value according to Baker's scale or another equivalent scale in a standardized and automatic manner.
Another object of the invention is to propose an apparatus for detecting human and/or animal tissue tone that is adapted to detect a specific value or a train of information that corresponds to the successive values progressively detected by the apparatus during a measurement cycle, values which can optionally be represented as a curve on a graphic plotting plane.
Another object of the invention is to propose an apparatus for detecting human and/or animal tissue tone that is simple to use.
Another object of the invention is to propose an apparatus for detecting human and/or animal tissue tone that is adapted to be interfaced with a personal computer or other data processing system for in-depth study of the detection.
A further object of the present invention is to provide an apparatus for detecting human and/or animal tissue tone that has low costs, is relatively simple to provide in practice and safe in application.
This aim and these objects, as well as others that will become better
apparent hereinafter, are achieved by an apparatus for detecting human and/ or animal tissue' tone, characterized in that it comprises a box-like body provided with at least one grip portion for an operator, at least one arm which can move, with respect to said box-like body, toward a respective abutment element, when the area of the patient to be analyzed is interposed between them, said arm being mounted on said box-like body with the interposition of at least one actuator, for the automatic movement of said arm, and of at least one element such as a load cell for detecting the intensity of the force applied by said actuator at each variation of the position of said arm associated with a compression of the area of the patient to be analyzed.
Brief description of the drawings
Further characteristics and advantages of the invention will become better apparent from the following detailed description of a preferred but not exclusive embodiment of the apparatus for detecting human and/or animal tissue tone according to the invention, illustrated by way of non-limiting example in the accompanying drawings, wherein:
Figure 1 is a schematic perspective view of an apparatus for detecting human and/or animal tissue tone according to the invention during a detection;
Figure 2 is a front view of the apparatus for detecting human and/or animal tissue tone according to the invention;
Figure 3 is a side view of the apparatus for detecting human and/or animal tissue tone according to the invention;
Figure 4 is a top view of the apparatus for detecting human and/or animal tissue tone according to the invention;
Figure 5 is a schematic perspective view of the apparatus for detecting human and/or animal tissue tone according to the invention during a detection in association with a respective processing unit;
Figure 6 is a front view of the apparatus for detecting human and/or
animal tissue tone according to the invention, provided with a base plate designed to detect the contact area;
Figure 7 is an enlarged-scale front view of the base plate of the apparatus of Figure 6;
Figure 8 is a schematic view of the type of detection performed by means of a stem provided with a base plate with the apparatus of Figure 1 ;
Figure 9 is a schematic view of the type of detection performed by means of a stem provided with a base plate with the apparatus of Figure 6. Ways of carrying out the invention
With reference to the figures, the reference numeral 1 generally designates an apparatus for detecting human and/or animal tissue tone.
The apparatus 1 comprises a box-like body 2 which is provided with at least one grip portion 3 for an operator 4 (in particular for the hand 5): specifically, there must be a proper handle, by means of which the operator 4 can grip firmly the apparatus 1 in order to be able to handle it and arrange it according to the detection requirements of the patient.
The apparatus 1 further comprises at least one arm 6, which can move with respect to the box-like body 2 toward a respective abutment element when the area 7 of the patient to be analyzed is interposed between them.
In particular, the possibility is not excluded to provide an apparatus 1 in which there is a fixed plate, which protrudes from the box-like body 2 and faces the arm 6, and toward which the arm 6 is directed when it is moved.
In this case, the arm 6 would move toward a fixed surface, "squeezing" the area 7 interposed between the end of the arm and such surface.
In any case, the arm 6 is mounted on the box-like body 2 with the interposition of at least one actuator (designed to move the arm 6 with respect to the box-like body 2) and of at least one element such as a load cell for detecting the intensity of the force applied by the actuator upon each
variation of the position of the arm 6 associated with a compression of the area 7 of the patient to be analyzed.
In practice, every movement of the arm 6 imparted by the actuator causes a controlled compression of the area 7; the extent, in terms of displacement of the end of the arm 6 and of applied force, of this compression will be known by gathering all the information needed to catalogue the area 7 as a function of the consistency of the tissues.
In particular it must be noted that the apparatus 1 comprises a control and management unit which is connected to the at least one actuator, to the element such as a load cell and to a position sensor associated with the arm 6: the unit is capable of processing the data received from these components to assign a specific value to the consistency of the tissues of the area 7 of the patient to be analyzed.
By way of non-limiting example of the applications of the present invention, with particular reference to the verification of the presence of capsular contractures as a consequence of additive mastoplasty procedures, the values attributed by the apparatus can be defined according to Baker's scale.
In order to facilitate immediate identification of the values attributed as a consequence of the detection, the apparatus 1 comprises at least one display element 8, such as a screen, a luminous display and the like.
It is evident that if a display element 8 is available, it is important to be able to view (and optionally store, for subsequent assessments) the value detected at each specific pressure applied by the arm 6 (or other equivalent portion actuated by a respective actuator).
The values that are progressively stored may optionally be used subsequently to trace curves that represent the behavior of the investigated tissues, allowing the assigned personnel a more complete and in-depth analysis.
It is in any case fundamental to note that the apparatus 1 according to
the invention detects a specific value (or a series of specific values) and therefore reduces the approximation caused by known types of classification, such as Baker's classification and the like, which only have ranges (brackets) within which large tissue tone values are included.
The example shown in the accompanying figures shows, an apparatus
1 provided with an actual display 8 (by means of which the values progressively detected are displayed): actually, in a simplified version, it would also be sufficient to have a set of light sources, each corresponding to a value according to Baker's scale, in order to obtain a result that can be interpreted excellently for the operator (this solution is a possible simplified version of a display element). Of course, this constructive solution offers less information to physicians, limiting itself to a simple classification of mammary tone, instead of making a specific measurement of such value.
The apparatus 1, according to an embodiment of unquestionable interest in practice and in application, which also corresponds to the embodiment shown in the figures, also comprises a second arm 9 which faces and is symmetrical to the first arm 6 with respect to the box-like body 2.
In this case, the movement of the arms 6 and 9 occurs according to a direction of mutual approach/spacing.
In order to improve detection, by ensuring that the apparatus 1 examines as many data as possible, data referred to detections performed even in different directions, the apparatus 1 can also comprise at least one extendable stem 10, which is arranged substantially at the plane of symmetry of the box-like body 2, in front of the box-like body 2.
According to this particular application, a movement assembly is designed to actuate the extension , of the stem 10 toward the area 7 of the patient to be analyzed, while a device such as a load cell is associated with the stem 10 in order to detect the intensity of the force applied by the movement assembly, at each position variation of the stem 10, such
variation being associated with a compression of the area 7 of the patient to be analyzed.
Of course, in order to give assurance to the patient that the detection is not painful and/or unpleasant in any way, a rounded base plate 1 1 is arranged at the tips of each arm 6 and 9 and of the stem 10
Each base plate 1 1 abuts against the area 7 of the patient to be treated during the detection phase.
It is specified that the base plates 1 1 can comprise specific surface sensors 1 1a (such as optical presence sensors or sensors of another kind or true screens of the type known normally as "touch screen") to detect the surface area that comes into contact with them.
The advancement of the base plate 1 1 on the area 7 can in fact cause a penetration of the base plate 11 in the area 7 (in this case, the penetration depth and the force needed to determine it will be the data of interest for the detection): in this case, the base plate 1 1 must have a reduced surface.
The convenience is further noted of providing base plates 1 1 with a large surface, which is affected in this case by surface sensors and which, once pressed against the area 7 of the patient, detects the extent of the tissue that adheres (as a consequence of the compression) to the surface of the base plate 11 as a function of the pressure applied thereby.
According to a particular embodiment that has excellent simplicity of use, the apparatus 1 comprises a centering assembly, which can be coupled to the front face 12 of the box-like body 2, in a condition of noninterference with the movements of the arms 6 and 9 and of the stem 10.
The assembly has a substantially conical shape for the centering of the apparatus 1 , and therefore of the arms 6 and 9 of the stem 10, on a breast: this area 7 in fact requires investigation aimed at verifying the presence of capsular contractions, particularly after an additive mastoplasty procedure (capsular contracture can in fact occur around the implanted prosthesis).
With the aim of simplifying its use and of making the detected data easily usable even by other operators, the apparatus 1 can comprise at least one connector, such as a USB port, an RS232 port and the like, for connection to an external component such as a personal computer (PC), a data communications network, an electro-medical apparatus and the like.
Likewise, the apparatus 1 can also (or as an alternative) comprise at least one transceiver, such as a Bluetooth® antenna, an antenna for connection to wireless networks and the like, for connection to an external component such as a personal computer PC, of a data communications network, of an electro-medical apparatus.
According to a particularly efficient embodiment, the apparatus 1 can comprise a memory component for storing all the signals that reach the control and management unit during detection: this memory component can be fixed within the apparatus 1 or can be constituted by a card, a drive or the like, of the removable type.
It is noted, therefore, that the apparatus 1 for detecting human and/or animal tissue tone is capable of rendering the detection objective.
The fact is also equally advantageous that the apparatus 1 for detecting human and/or animal tissue tone is adapted to detect a specific value or a train of information corresponding to the subsequent values that are progressively detected by the apparatus during a measurement cycle, such values being represented optionally as a curve on a plane in a graphical representation.
Advantageously, the apparatus 1 according to the invention is capable of rendering the detection objective, classifying it according to Baker's scale or another equivalent scale, in a standardized and automatic manner.
Conveniently, the apparatus 1 , if used to detect capsular contractures occurring as a consequence of surgical procedures, has a particularly simple method of use.
Positively, the apparatus 1 is adapted to be interfaced with a personal
computer (PC) or other data processing system for in-depth study of the detection.
The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims; all the details may further be replaced with other technically equivalent elements.
In the exemplary embodiments shown, individual characteristics, given in relation to specific examples, may actually be interchanged with other different characteristics that exist in other exemplary embodiments.
Moreover, it is noted that anything found to be already known during the patenting process is understood not to be claimed and to be the subject of a disclaimer.
In practice, the materials used, as well as the dimensions, may be any according to requirements and to the state of the art.
Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.
Claims
1. An apparatus for detecting human and/or animal tissue tone, characterized in that it comprises a box-like body (2) provided with at least one grip portion (3) for an operator (4), at least one arm (6) which can move, with respect to said box-like body (2), toward a respective abutment element, when the area (7) of the patient to be analyzed is interposed between them, said arm (6) being mounted on said box-like body (2) with the interposition of at least one actuator, for the automatic movement of said arm (6), and of at least one element such as a load cell for detecting the intensity of the force applied by said actuator at each variation of the position of said arm (6) associated with a compression of the area (7) of the patient to be analyzed.
2. The apparatus according to claim 1, characterized in that it comprises a control and management unit which is connected to said at least one actuator, to said element such as a load cell and to a position sensor associated with said arm (6), said unit processing the data received from said components in order to assign a specific value to the consistency of the tissues of the area (7) of the patient to be analyzed.
3. The apparatus according to claim 2, characterized in that it comprises at least one display element (8), such as a screen, a luminous display and the like, to indicate to the operator (4) the specific value determined as a consequence of the detection.
4. The apparatus according to claim 1, characterized in that it comprises a second arm (9), which faces the first arm (6) and is symmetrical thereto with respect to said box-like body (2), the movement of said arms (6, 9) occurring in a direction of mutual approach/spacing.
5. The apparatus according to claim 1, characterized in that it comprises at least one extendable stem (10), which is arranged substantially at the plane of symmetry of said box-like body (2), in front of said box-like body (2), a movement assembly being designed to actuate the extension of said stem (10) toward the area (7) of the patient to be analyzed and a device such as a load cell being associated with said stem (10) in order to detect the intensity of the force applied by said movement assembly, at each variation of the position of said stem (10), said variation being associated with a compression of the area (7) of the patient to be analyzed.
6. The apparatus according to one or more of the preceding claims, characterized in that a rounded base plate (1 1) is arranged at the ends of each one of said arms (6, 9) and of each one of said stems (10), each one of said base plates (1 1) abutting against the area (7) of the patient to be treated during the detection step.
7. The apparatus according to one or more of the preceding claims, characterized in that it comprises a centering assembly which can be coupled to the front face (12) of said box-like body (2), in a configuration of noninterference with the movements of the arms (6, 9) and of the stem (10), said assembly having a substantially conical shape for centering said apparatus (1), and therefore the arms (6, 9) and the stem (10), on a breast, in particular following an additive mastoplasty procedure.
8. The apparatus according to one or more of the preceding claims, characterized in that it comprises at least one connector, such as a USB port, an RS232 port and the like, for connection to an external component such as a personal computer (PC), a data communications network, an electromedical apparatus and the like.
9. The apparatus according to one or more of the preceding claims, characterized in that it comprises at least one transceiver, of the type of a Bluetooth® antenna, an antenna for connection to wireless networks and the like, for connection to an external component such as a personal computer (PC), a data communications network, an electro-medical apparatus and the like.
10. The apparatus according to one or more of the preceding claims, characterized in that it comprises a memory component for storing all the signals that reach the control and management unit during said detection.
11. The apparatus according to one or more of the preceding claims, characterized in that said rounded base plate (1 1) comprises at least one surface sensor .(1 la) for detecting the extent of the contact surface between the base plate (1 1) and the area (7) of the patient.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IT2010/000053 WO2011101875A1 (en) | 2010-02-18 | 2010-02-18 | Apparatus for detecting human and/or animal tissue tone |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IT2010/000053 WO2011101875A1 (en) | 2010-02-18 | 2010-02-18 | Apparatus for detecting human and/or animal tissue tone |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2011101875A1 true WO2011101875A1 (en) | 2011-08-25 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IT2010/000053 WO2011101875A1 (en) | 2010-02-18 | 2010-02-18 | Apparatus for detecting human and/or animal tissue tone |
Country Status (1)
| Country | Link |
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| WO (1) | WO2011101875A1 (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5038795A (en) * | 1987-08-05 | 1991-08-13 | Roush Elsie S | Muscle tonometer apparatus and method |
| WO2005023093A2 (en) * | 2003-09-05 | 2005-03-17 | William Marsh Rice University | Noninvasive tissue assessment |
| US20050277852A1 (en) * | 2004-05-24 | 2005-12-15 | Shih Wan Y | All electric piezoelectric finger sensor (PEFS) for soft material stiffness measurement |
| WO2006119243A2 (en) * | 2005-04-29 | 2006-11-09 | William Marsh Rice University | Tool to detect structural integrity of implant |
| EP1880668A1 (en) * | 2006-07-21 | 2008-01-23 | Paolo Mezzana | Tonometer for determining the tension and consistency of body tissues |
| WO2009146881A2 (en) * | 2008-06-02 | 2009-12-10 | Rohde & Schwarz Gmbh & Co. Kg | Breast cancer detection device having a fixing cone |
-
2010
- 2010-02-18 WO PCT/IT2010/000053 patent/WO2011101875A1/en active Application Filing
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5038795A (en) * | 1987-08-05 | 1991-08-13 | Roush Elsie S | Muscle tonometer apparatus and method |
| WO2005023093A2 (en) * | 2003-09-05 | 2005-03-17 | William Marsh Rice University | Noninvasive tissue assessment |
| US20050277852A1 (en) * | 2004-05-24 | 2005-12-15 | Shih Wan Y | All electric piezoelectric finger sensor (PEFS) for soft material stiffness measurement |
| WO2006119243A2 (en) * | 2005-04-29 | 2006-11-09 | William Marsh Rice University | Tool to detect structural integrity of implant |
| EP1880668A1 (en) * | 2006-07-21 | 2008-01-23 | Paolo Mezzana | Tonometer for determining the tension and consistency of body tissues |
| WO2009146881A2 (en) * | 2008-06-02 | 2009-12-10 | Rohde & Schwarz Gmbh & Co. Kg | Breast cancer detection device having a fixing cone |
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