CA1109252A - Breast cancer detection training system - Google Patents
Breast cancer detection training systemInfo
- Publication number
- CA1109252A CA1109252A CA312,932A CA312932A CA1109252A CA 1109252 A CA1109252 A CA 1109252A CA 312932 A CA312932 A CA 312932A CA 1109252 A CA1109252 A CA 1109252A
- Authority
- CA
- Canada
- Prior art keywords
- model
- breast
- tumor
- simulated
- trainee
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired
Links
- 238000001514 detection method Methods 0.000 title abstract description 31
- 208000026310 Breast neoplasm Diseases 0.000 title abstract description 26
- 206010006187 Breast cancer Diseases 0.000 title abstract description 19
- 238000012549 training Methods 0.000 title abstract description 12
- 206010028980 Neoplasm Diseases 0.000 claims abstract description 84
- 210000000481 breast Anatomy 0.000 claims abstract description 56
- 239000012528 membrane Substances 0.000 claims description 32
- 210000001519 tissue Anatomy 0.000 claims description 18
- 230000000762 glandular Effects 0.000 claims description 13
- 229920000642 polymer Polymers 0.000 claims description 13
- 210000000577 adipose tissue Anatomy 0.000 claims description 6
- 239000004020 conductor Substances 0.000 claims description 6
- 208000036366 Sensation of pressure Diseases 0.000 claims description 3
- 230000001788 irregular Effects 0.000 claims description 3
- 239000011347 resin Substances 0.000 claims description 2
- 229920005989 resin Polymers 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 27
- 210000004379 membrane Anatomy 0.000 description 30
- 239000000499 gel Substances 0.000 description 25
- 239000000463 material Substances 0.000 description 17
- 238000002559 palpation Methods 0.000 description 13
- 239000011159 matrix material Substances 0.000 description 10
- 229920001296 polysiloxane Polymers 0.000 description 8
- 239000000126 substance Substances 0.000 description 7
- 239000003795 chemical substances by application Substances 0.000 description 6
- 201000011510 cancer Diseases 0.000 description 5
- 239000000306 component Substances 0.000 description 5
- 229920001940 conductive polymer Polymers 0.000 description 5
- 230000006870 function Effects 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 3
- 210000002808 connective tissue Anatomy 0.000 description 3
- 230000000875 corresponding effect Effects 0.000 description 3
- 230000034994 death Effects 0.000 description 3
- 231100000517 death Toxicity 0.000 description 3
- 230000000994 depressogenic effect Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 210000002216 heart Anatomy 0.000 description 3
- 239000012212 insulator Substances 0.000 description 3
- 210000000867 larynx Anatomy 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 229920002379 silicone rubber Polymers 0.000 description 3
- 230000000007 visual effect Effects 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000006073 displacement reaction Methods 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 238000009607 mammography Methods 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 229920000136 polysorbate Polymers 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 239000004945 silicone rubber Substances 0.000 description 2
- 210000000779 thoracic wall Anatomy 0.000 description 2
- BSFODEXXVBBYOC-UHFFFAOYSA-N 8-[4-(dimethylamino)butan-2-ylamino]quinolin-6-ol Chemical compound C1=CN=C2C(NC(CCN(C)C)C)=CC(O)=CC2=C1 BSFODEXXVBBYOC-UHFFFAOYSA-N 0.000 description 1
- 241000252067 Megalops atlanticus Species 0.000 description 1
- 206010049816 Muscle tightness Diseases 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 208000007542 Paresis Diseases 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 241001122767 Theaceae Species 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 238000002583 angiography Methods 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 210000004883 areola Anatomy 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000001680 brushing effect Effects 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 150000001875 compounds Chemical group 0.000 description 1
- 230000001143 conditioned effect Effects 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 229920001821 foam rubber Polymers 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- -1 for example Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 210000002445 nipple Anatomy 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 208000012318 pareses Diseases 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000008447 perception Effects 0.000 description 1
- 230000004962 physiological condition Effects 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 230000003334 potential effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 229920002545 silicone oil Polymers 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
- 238000001931 thermography Methods 0.000 description 1
- KSBAEPSJVUENNK-UHFFFAOYSA-L tin(ii) 2-ethylhexanoate Chemical compound [Sn+2].CCCCC(CC)C([O-])=O.CCCCC(CC)C([O-])=O KSBAEPSJVUENNK-UHFFFAOYSA-L 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
- G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
- G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
- G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
- G09B23/30—Anatomical models
Abstract
BREAST CANCER DETECTION TRAINING SYSTEM
Abstract of the Disclosure A method, apparatus and a lifelike model of a human female breast form a breast cancer detection training system. The model closely simulates the feeling of the different tissues of the human breast and except for a tumor-free comparison model, contains at least one simulated tumor. When used in conjunction with the elec-tronic training apparatus, the model also contains a pressure sensing means. The apparatus and method compare signals initiated by the trainee with stored signals representative of the number of simulated tumors in the model, their location, and the pressure required to feel them and provide feedback information to the trainee so as to improve the trainee's examination technique.
Abstract of the Disclosure A method, apparatus and a lifelike model of a human female breast form a breast cancer detection training system. The model closely simulates the feeling of the different tissues of the human breast and except for a tumor-free comparison model, contains at least one simulated tumor. When used in conjunction with the elec-tronic training apparatus, the model also contains a pressure sensing means. The apparatus and method compare signals initiated by the trainee with stored signals representative of the number of simulated tumors in the model, their location, and the pressure required to feel them and provide feedback information to the trainee so as to improve the trainee's examination technique.
Description
zs~
1 Background of the Invention The present invention relates to a method, apparatus and a realistic model of a human female breast which are used to train doctors, nurses and other health professionals in the palpation method of breast examination, and is particularly useful in training women how to conduct breast self-examination.
Breast cancer is among the most common malignant tumors and is the leading cause of death from cancer among women in the United States. It is estimated that 1 out of every 15 American ~omen will develop the disease at some time during her life, and that 20% of deaths from cancer among women are attributable to breast cancer.
There has been no great reduction in the mortality rate of this disease in the past 35 yearsO
It is well recognized that early detection of breast cancer is the single most important variable in the successful cure and treatment of the cancer. Various methods for detecting breast can-cer include angiography, ultrasonography, isotope scanning, therm-ography, mammography and manual palpation. All of these techniques except for manual palpation are time consuming, expensive and require the interpretation of a trained specialist. In addition, recent studies suggest that mammography itself may be a cause of breast cancer.
Of all of these techniques for detecting breast cancer, the easiest and least expensive method is manual examination. The poten-tial effectiver.ess of manual examination, and particularly breast self-examination, in detecting small tumors relies on the effective-ness of manual palpation. Approximately 94~ of breast cancers are potentially palpable and are candidates for early manual detection.
It has been estimated that the expected death rate due to breast can-cer could be halved if the size of the detected tumors could be re-; l duced to less than about 2 cm. It has been indicated that further progress in breast cancer control is conditioned on progress in self-examination instruction, so that women are more comfortable and con-fident in performing breast self-examination.
The present invention is based upon the clinical and exper-imental evidence that a systematic approach to manual breast exami-nation can lead to the early detection of smaller tumors through training. See the following papers, the disclosures of which are hereby specifically incorporated herein by reference: C.K. Adams ; 10 et al., "Lump Detection In Simulated auman Breasts," Perception &Psychophysics, 20(3), pp. 163-167 (1976), D.C. Hall et al., "Progress In Manual Breast Examination," Cancer, Vol. 40, No. 1, July, 1977 `~ pp. 364-370.
The present invention comprises a realistic model of the human female breast and a method and apparatus for using a preferred ; form of the model to train persons how to systematically conduct a manual breast examination with a high degree of confidence. The present invention is clearly distinguishable from the following com-mercially available devices and patents, which are believed to be the closest prior art:
Ortho Pharmaceutical Corporation has been marketing a breast cancer teaching model in the form of a human female's torso having simulated tumors embedded in the breast. This model is of extremely limited value as an effective teaching tool in that it is made of foam rubber and not at all lifelike. There is no provision made in the model, sold under the trademark 'IBETSI'', for any means to simulate the different types of tissue found in the human breast.
In addition, the model is not adapted for use with any sort of means - for feeding back information to the trainee.
1 Spenco Medical Corporation markets a breast cancer teaching model comprising a plurality of simulated tumors within a gel-like substance shaped like a breast. The model comprises a gel-like sub-stance within a protective fabric cover, which serves as a "skin".
While this device is an improvement over "BETSI", it lacks the feel of a real breast. The gel-like substance does not have the complex-ity for simulating adipose, glandular and connective tissue which is ; found in the human female breast. Moreover, there are no means asso-ciated with the model to provide feedback information to the trainee.
U.S. Patent 3,742,935 of Baessler et al. relates to a method and apparatus used in teaching palpation techniques. A pres-sure transducer is in pressural engagement with the skin of a patient adjacent to an area of the body which generates changes in pressure, such as blood vessels, the heart, the larynx, etc. The transducer is connected through an amplifier to a master unit and a plurality of slave units. By monitoring the output of the transducer through the amplifier, a physician or other tea~her can instruct the students on the techniques of palpation by means of the slave units which re-produce the vibrations transmitted by the blood vessels, heart, larynx or other source. The method and apparatus described in this patent is of no use in teaching the palpation of passive areas of the body, such as breast tumors. Thus, while blood vessels, the heart and larynx all cause pressure displacements, such as pulses and voice vibrations, no such displacements are created by breast tumors.
U.S. Patent 3,942,516 of Glynn et al. discloses a system and method for use in training persons how to control various bio-logical functionæ, such as muscle activity, by means of monitoring electrical signals generated by the body, such as brain waves, dif-ferential skin temperature and muscle tension measurements. The system and method described in the patent require that electrodes 1 be attached to the patient/trainee to monitor his physiological con-dition. This patent does not teach or suggest the use of a model for training purposes and its interrelationship with a trainee.
U.S. Patent 3,681,787 of Perras discloses a breast pros-thesis to be implanted in a woman's chest. The prosthesis contains gels of different viscosities and densities to maintain the configur-ation of the prosthesis, and to retain the desired consistency and appearance. It is clear that the placement of the denser, more viscous gels in the patented prosthesis is not intended to simulate the feeling to the touch of real breast tissue. Rather, the differ-ent gels of the prosthesis are to maintain the shape and appearance of the prosthesis, and not to provide a realistic feel during palp-tion. Moreover, this patent neither teaches nor suggests the use of the prothesis as a model for breast cancer detection training.
S D ary of the Invention One portion of the present invention comprises a lifelike model of a human female breast comprising a membrane which simulates skin, first means having an irregular surface for simulating gland-ular, connective and/or skeletal tissue, the first means being con-nected to the membrane to define a chamber therebetween, second means for simulating adipose (fatty) tissue disposed within the ;~ chamber, and third means for simulating at least one tumor fixed within the chamber. When the model is used with the apparatus of the present invention, it is preferred that the model contain pres-sure sensing means.
The method according to the present invention of training ;
a person to detect breast tumors by palpating a model of a human breast which may be provided with one or more simulated tumors com-prises: (1) sele~tively applying pressure in a pattern to the model ~ 30 of the human breast; (2) automatically generating a set of signals :
5~
~' ; 1 representative of the pattern of pressure applied to the model; (3) storing reference information representative of a predetermined pat-tern of pressure which must be applied to the model to detect a sim-ulated tumor therein; (4) selectively generating a condition signal indicative of detection or lack of detection of a simulated tumor;
(5) comparing the stored reference information to the set of signals;
and (6) indicating whether the condition signal correctly indicates detection or lack of detection of a tumor as a function of step (5).
Apparatus in accordance with the present invention for ~ 10 training a person to detect breast tumors by applying pressure in a ; pattern to a model of a human breast provided with one or more simu-lated tumors comprises: first means for generating a set of signals representative of the pattern of pressure applied to the model;
second means for storing reference information representative of a predetermined pattern of pressure which must be applied to the model to detect a simulated tumor therein; third means for generating a condition signal indicative of detection or lack of detection of a simulated tumor; fourth means for comparing the stored reference information to the set of signals; and fifth means for indicating whether the condition signal correctly indicates detection or lack of detection of a tumor.
The system of the present invention is used to analyze a trainee's search pattern and provide the trainee with feedback on the effectiveness of the search. This will reinforce detection of the smallest palpable simulated tumors by delivering visual and/or auditory information for both successful and unsuccessful detections.
Information concerning breast, tumor and trainee variables will be considered by the system according to the present invention for increasing the accuracy and regularity of breast self-examination and decreasing the size of the tumor detected.
:~
1 Brief Description of the Drawings For the purpose of illustrating the invention, there is shown in the drawings a form which is presently preferred; it being understood, however, that this invention is not limited to the pre-cise arrangements and instrumentalities shown.
Figure 1 is a sectional view of one embodiment of a simple breast model according to the present invention.
Figure lA is a fragmentary sectional view of a breast model illustrating means for forming variable-sized simulated tumors.
Figure 2 is a sectional view of one embodiment of a breast model incorporating pressure sensing means in accordance with the present invention.
Figure 3 is a schematic representation of the system of the present invention.
Figure 4 is a schematic representation of the computer ~ interface circuit.
; Figures 5A and 5B are flow charts illustrating the opera- tion of the system according to the present invention.
Description of the Preferred ~mbodiments Referring to the drawings in detail, wherein like numerals indicate like elements, there is shown in Figure 1 one embodiment of a realistic, lifelife model of a human female breast 10. It is im-portant that the model have physical characteristics which closely simulate human tissue so that examination techniques will be learned through actual practice with realistic stimuli. It is preferred that models be available in several sizes with varying degrees of firm-ness so as to apply to a large cross-section of women.
The model is substantially hemispherical in shape and generally comprises a skin enclosing silicone gel or other means of simulating breast tissue and means for simulating tumors, except , sz :
l where a tumor-free model is desired for comparison purposes.
Skin 12 may be made of any material which closely simulates human skin. Presently preferred materials include elastomeric sili-cone resin polymers commercially available from General Electric Company and Dow Corning Corporation.
G.E.'s RTV 7100 silicone rubber compound forms a satisfac-tory membrane or skin for the model. A realistic skin results from mixing 1 part by weight of the curing agent to 50 parts by weight of the base and curing for 1 hour at 100C or 24 hours at room tempera-ture. The skin is formed by simply brushing a layer of the silicone elastomer onto a suitably shaped mold after applying a release agent, such as silicone oil, and allowing the polymer to cure. An areola region 14 and nipple 16 provide a realistic feel and a tactile refer-ence point for conducting the breast examination. Optional bottom skin 18 and optional membrane 34 may be made of the same type of material as skin 12 and may be formed in the same manner. The mem-branes are secured together by any ~uitable adhesive to provide a leak-proof membrane which contains gel 20, simulated tumors 28 and 30 which are fixed within the model by means of elastomeric silicone threads 22 and 24, for example, and means for simulating glandular, connective and/or skeletal tissue 32.
Gel 20 simulates adipose tissue and may be any gel which imparts a realistic feel to the model. A suitable gel is G.E.'s RTV
619 silicone gel containing about 6-8 parts by weight of curing agent to about 100 parts by weight of the base component. This material cures in 24 hours at room temperature, in about 30 minutes at 100C and in about 15 minutes at 150C.
The means 32 for simulating glandular tissue, connective tissue, such as muscles, tendons, etc., and skeletal tissue, such as the chest wall, is any substance which may be molded or otherwise ;: :
:
1 formed to have an irregular surface, density and feel of the firmer glandular, connective and skeletal tissue found in the breast. Means 32 need only be made of a material which is harder than gel 20, so as to accurately simulate the firmer tissue. Examples of suitable substances include G.E.'s RTV 619 gel containing about 8-10 parts by weight curing agent to about 100 parts by weight of the base compon-ent, and G.E.'s RTV-7 silicone rubber foam, containing about 5 parts by weight stannous octoate curing agent per 100 parts of base com-ponent. This material cures at room temperature in about 24 hours, but the cure may be accelerated by heating to about 100-150C.
It is not critical to use the particular materials sug-gested for forming the skin membranes, the gel representating the adipose tissue and the substance used to represent the glandular, connective and/or skeletal tissue. Rather, the only critical re-quirement is that the model have the complex feel of a real breast.
If desired, small particles of silica or other inert material may be added to the gel representing the adipose tissue to provide a granular feel to the model. Various pigments well known to those skilled in the art may be incorporated in the skin-simulating sub-stance to provide a good visual representation of a real breast. ; !
Except for a tumor-free model which is used as a basis for comparison with tumor containing models and to check for ~alse posi-tive responses, the models contain simulated tumors which simulate the types of tumors associated with breast cancer. The models pre~-erably contain more than one simulated tumor. The simulated tumors contained in the models may vary in size, shape, location and con-sistency, so long as they realistically simulate breast tumors.
~or convenience, tumors 28 and 30 are represented by stainless ball bearings. Other shapes and consistencies may easily be made from various other materials, for example, nylon, styrene and any other 92~
l material capable of realistically simulating breast tumors which is compatible with the other materials used in making the model.
As shown in Figure 1, simulated tumor 28 is encased in silicone membrane 26 which is supported within the model by silicone threads 22 and 24. The supporting threads should be as thin as pos-sible but of sufficient strength to support the simulated tumor in a fixed position within the model. The threads are shown greatly en-larged for purposes of illustration. Thread 24 is shown connected to membrane 34 which separates simulated adipose tissue 20 from the simulated glandular, connective and/or skeletal tissue 32. .~lthough membrane 34 may facilitate the secure fixation of the tumors within the model, membrane 34 is not necessary. In the absence of membrane 34, thread 24 would be directly connected to glandular, connective and/or skeletal tissue simulating means 32.
~ n alternative means for fixing a plurality of simulated tumors within a model is shown in Figure 2. Breast model 40 is shown as containing two simulated tumors 62 and 68. These simulated tumors are fixed within the model by means of silicone membranes 59 and 64 which encapsulate at 60 and 66 the tumors 62 and 68, re-spectively. Membranes 59 and 64 may comprise one or more layers of silicone or like material similar to that used in forming skin 12, threads 22 and 24 and membrane 34 as described with reference to Figure 1. Membranes 59 and 64 are substantially hemispherially shaped membranes to which the simulated tumors may be affi~ed by any convenient means, such as encapsulation or by means of suitable ad-hesives. Membranes 59 and 64 may be connected to optional bottom membrane 72 or may be connected directly to member 70 as desired.
It is preferable to provide several models wherein the simulated tumors are in different locations and are of different sizes and consistencies. Although it has been reported that breast _ g _ 1 tumors are palpable when they reach about 1-2 cm in approximate di-ameter, it has been found that people can be trained by using models according to the present invention to palpate simulated tumors be-tween about 1 and 2 mm in approximate diameter. By being able to detect such small tumors by palpation conducted by health special-ists or by women during regular self-breast examination, it will be possible to greatly reduce the catastrophic effects of breast cancer by early treatment and cure. One model that has been prepared and used by trainees contains three relatively large lumps 8.7, 11.1 and 12.7 mm in diameter. After working with this model for a while, another model containing five simulated tumors 1.6, 2.4, 3.2, 4.8 and 6.4 mm in diameter was given to the trainees. With practice, most trainees can detect even the smallest tumors.
A more advanced model containing a simulated tumor or tumors which are variable in size may be formed by modifying the model il-lustrated in Figure 1 as shown in Figure lA. Variable sized tumor 27 comprises a spherical portion 25 supported by thread 21 and tubular member 23 which passes through optional membrane 35, means for simu-lating glandular, connective and/or skeletal tissue 31 and optional bottom membrane 19. A syringe is inserted through plug 29 to add or remove gel or any other material which can be used to expand the walls of chamber 25 to or from simulated tumor 27 as indicated at 25' and 27'. Plug 29 can be made of any suitable self-sealing poly-meric material. By using this embodiment, one model may be adapted to contain simulated tumors which may be increased in size or de-cr~ased in size in the same relative location within the model to help the trainee compare the feel of different sized tumors in the same general location.
Model 40 shown in Figure 2 represents an advanced construc-tion of a lifelike human female breast particularly constructed for 1 use with the apparatus of the present invention.
Model 40 contains a different embodiment of means for simulating adipose, glandular, connective and/or skeletal tissue than the embodiment illustrated in Figure l. Adipose tissue is represented by gel 56 in the outer region of the model between membrane 59 and skin 42. Gel 57 between membranes 59 and 64 may be the same as or different than gel 56. It may be desirable to provide a firmer gel 57 for the intermediate portion of the model. The density and viscosity of the gel can readily be varied by adjusting the relative amounts of base material and curing agent. The consistency of gel 57 may be adjusted to simulate firmer glandular tissue found in the human breast.
Likewise, gel 58 may be the same aæ or different than gels 56 and 57. Preferably, gel 58 i8 firmer or harder than gels 56 and 57 to represent connective tissue found in the human breast. Base material 70 may be adapted to simulate the chest wall.
Model 40 is thus more complex than model 10. If desired, gels 56, 57 and 58 may be of the same general consistency and means 70 may represent glandular, connective and/or skeletal tissue similar to means 32. Of course, any number of simulated tumors of various sizes, shapes and consistencies may be affixed to any number of mem-branes corresponding to membranes 59 and 64 within the breast model.
Skin 42 of model 40 comprises several distinct layers as compared with skin 12 in model 10. Skin 42 comprises a silicone membrane 44 in which is embedded a plurality of flexible ele~trically conductive strips 46. An exploded view of the electrical components of skin 42 is shown in Figure 4. Electrical connecting means 47, which may be a wire, pin, plug or the like, is associated with each strip 46. Adjacent to membrane 44 and in contact with electrical strips 46 is a pressure conductive polymer layer 48 which conducts ~9~
~ 1 electricity when presaure is applied to the polymer as discussed - hereinafter in more detail. A plurality of flexible electrically conductive strips 50 (best seen in Figure 4) are adjacent to pressure conductive polymer layer 48 and are arranged substantially perpen-dicular to strips 46. Electrical connection means 51, which may be the same type as connection means 47, are associated with strips 50.
Strips 50 are embedded within membrane 52. Thus, ~kin 42 comprises laysrs 44, 46, 48, 50 and 52.
Skin 42 in Figure 2 need not be restricted to the particu-ular model shown in Figure 2 but may be used with a model constructed in accordance with Figure 1. Likewise, skin 12 of Figure 1 may con-tain the other components of the model illustrated in Figure 2. -~
Membranes 44 and 52 may be comprised of the same material used to form skin membrane 12 of model 10. Flexible electrical con-ductive strips 46 are preferably arranged parallel to each other and perpendicular to parallel flexible electrical conductive strips 50. The strips may be made of any good electrical conductor so long as it is flexible, such as metal foil. Electrical connecting means 47 and 51 may be attached to strips 46 and 50, respectively, in any suitable manner well known to those skilled in the art. ~-Because of the substantially perpendicular arrangement of strips 46 and 50, a grid or rnatrix will be formed in the skin of the model. Although any number of strips may be used in the model, generally, the more strips that are used, the more accurately the location of applied pressure can be determined. Strips 46 and 50 may be of any desired dimension in accordance with the degree of sensitivity desired for the particular trainee and the si~e of sim-ulated tumors contained within the model.
Pressure conductive polymer 48 has an electrical resistance perpendicular to its surface, and accordingly~ substantially perpen-. .
1 dicular to the surface of the model, which is proportional to the applied pressure. The polymer is an insulator at rest but when prassure is applied it gradually becomes a conductor. When pressure is released, it returns to its original state as an insulator. An excellent property of the pressure conductive polymer is that current flow can be locali~ed. When pressure is applied to the surface of the polymer, only the area directLy beneath the pressure source be-comes conductive, with little or no lateral flow. The polymer covers an extremely wide range of resistance, for example from 100 megohms, which is fairly good insulator, to 0.1 ohm, which is a useful con-ductor. The polymer will handle up to 10 amps per square inch inter-mittently without failure~ but lower amperages are recommended. It will sustain up to 600-700 volts but optimum usage is with lower voltages since high voltage overloading will destroy conductivity.
Pressure conductive polymers havlng these characteristics are com-mercially available from Chomerics, Inc. of Woburn, Massachusetts and Dynacon Industries, Inc. of West Milford, New Jersey, for example.
Although the electronic circuitry and particular operation of the entire system will be discussed more fully hereinafter, the function of skin 42 will be described briefly. The application of ; pressure, such as that encountered during palpation as represented by arrow 49 in Figure 4, causes the resistance of the pressure con-ductive polymer in the vicinity of the applied pressure point to de-crease. When resistance decreases, electrical conductance increases so that there is an electrical connection between one of the strips 46 and one of the strips 50 at the location where pressure is ap-plied. Thus, the application of pressure at a particular point will generate an electrical signal proportional to the amount of applied pressure and representative of the location of the applied pressure.
A greater increase in conductivity would occur where greater pres-1 sures are formed on the skin of the model by palpation pressure against a simulated tumor.
A computer interfaces with the matrix formed by strips 46 and 50 via a resistance measuring circuit 76. Circuit 76 measures the voltages Vl and V2 which provide an indication of the resistance Rcp at each cross point of the matrix. See Figure 4. The computer calculates the ratio V2/Vl and multiplies the ratio by the value of a current measuring resistor Rst. The product is the value Rcp, the resistance at a cross point of the matrix. The resistance Rcp varies as a function of the pressure applied to model 40. The computer stores the value Rcp calculated for each cross point to form a map of the resistances at all points of the matrix. The map corresponds to the pattern of pressure applied to the model. As described more fully hereinafter, the smallest detectable simulated tumor, the elapsed time required to detect a simulated tumor and other informa-tion may be calculated based on the map.
The method of training a person to detect breast tumors in accordance with the present invention will now be described with reference to Figure 3.
Trainee 73 i5 instructed in baslc palpation techniques used in manual examination or self-examination for breast cancer.
For purposes of gaining familiarity with the technique and for basic instruction, a model without pressure sensing means adapted for con-nection to the apparatus of the present invention may be used. How-ever, to thoroughly train and maintain skill in breast examination, important manual aspectA of breast examination should be precisely measured by a system constructed to supply certain information.
This information includes the amount and duration of pressure exerted on a given location at a given time and the amount of breast area covered in the entire search. Precise measurement provides quanti-1 tative data for analysis of variations in search techniques and their effects on tumor detection and direct feedback can be continu-ously provided to the operator, teacher or trainee regarding the examination performance. The system of the present invention was developed to provide this information.
A breast model containing pressure sensing means, such as described hereinbefore with respect to model 40 may be placed on any suitabIe horizontal, vertical or obliquely inclined support for con-nection with the resistance measuring circuit 76 for eventual connec-tion with the computer data processor. Trainee console 74 comprises a number of switches to be activated by the trainee, including a positive detection switch to be activated when the trainee believes he or she has detected a simulated tumor; a negative detection switch to be activated when the trainee believes that there are no simulated tumors present in the model; a ~tart-stop switch to be activated at the beginning and the end of the palpation of a model; switches to be activated which correspond to various sizes of turnors, such as small, medium or large; and miscellaneous switches such as power on and off, pause, and the like.
Reference information correlated to each breast model is stored in the computer memory. This information includes the number of simulated tumors contained in the breast model, the location of the tumors (which may be expressed as coordinates relating to the electrical conductive strip matrix), the size of each simulated tumor, the amount of pressure (in terms of threshold resistance Rcp) required to detect each simulated tumor, and other variables such as the amount of time to be spent conducting the examination and so forth. The program for operating the computer in accordance with the invention may be stored in memory 80.
1 Upon receiving a signal from the operator to begin the examination, which may be communicated through operator console 82 to trainee display 84, the trainee begins the manual examination.
If the trainee detects a simulated tumor, he activates the positive detection switch. If the trainee does not detect a tumor, he acti-vates the negative detection switch. By means of resistance measur-ing circuit 76, the computer calculates the resistance Rcp at each cross point of the matrix for the model 40 and stores each calcula-tion in memory to form a map corresponding to the pattern of pressure applied to the model. The computer also compares the map with the stored reference information. The stored reference information re-lates to a predetermined pattern of pressure which must be applied to the particular model to detect the tumors therein. Based on the comparison, the computer determines whether the positive or negative detections are correct. The map of the pattern of pressure actually applied to the model is indicated to the trainee on display 84. An indication of the correctness of the positive or negative detection, for example, a visual or audible signal, may also be provided on the display. Both the map and the correctness of the detection may be stored for future reference in memory 80 to provide a running check of the progress of the trainee.
The trainee may also activate switches on console 7~ relat-ing to the detection of tumor size or other variables useful in teaching the art of palpation to detect breast cancer. Reference information relating to these variables may be stored in memory and accessed for purposes of comparison as previously indicated in con-nection with the detection of the location of a tumor.
Operation of the system is shown in further detail in Figures 5A and 5B.
z~
1 Initially, when power is applied to the computer 78 (or upon the operation of an initialization switch), the computer enters an initialization routine wherein the appropriate memory areas are cleared. See Figure 5A. The computer then enters a polling routine in which each of the cross points in the breast model matrix are sequentially activated and scanned via an address bus A0-A15. The least signiEicant byte of the address, bits ~0-A7, poll an analog switch 100 which sequentially energizes each of the conductive strips 46. See Figure 4. The analog switch 100 gates power from a power supply 102 to the strips 46 under control of the address byte A0-A7.
The most significant address byte, bits A8-A15, controls the sequence in which a second analog switch 104 scans the conductive strips 50 via conductors 51. Output current signals of varying am-plitudes flow through conductive strips 50 under application of pressure to the breast model. The amplitude of a particular output current signal is a function of the pattern of pressure applied to the model. The rate at which the bits of byte A8-Al5 vary to scan analog switch 104 is substantially greater than the rate at which the bits of byte A0-A7 vary to poll analog switch 100. During the period of time that a particular strip 46 is energized by analog ~ switch 100, analog switch 104 scans all of the conductive strips -~ 50 in sequence. By this technique, the resistance Rcp of the polymer 48 at each localized region at which a cross point of the matrix is located can be rapidly computed. The resistance Rcp provides a di-rect indication of the pressure applied to the model.
~ore specifically, there is a localized region of polymer 48 having a resistance Rcp associated with each cross point formed by the matrix of conductive strips. Each resistance Rcp is deter-mined by the pattern of pressure applied to the breast model. Each resistance Rcp decreases as the pressure applied to the associated 92~
1 localized region increases. To compute the value of each resistance Rcp, each cross point is energi2ed and scanned by analog switches 100 and 104 under control of computer addressing A0-A15 as previously described. Thus, the resistance Rcp associated with each cross point is electrically connected in sequence via analog switch 100 to power supply 102. In addition, the resistance Rcp is series connected in sequence via analog switch 104 to a reference or current measuring resistance Rst. The resistance Rst is connected to the return of the power supply 102. Accordingly, the resistance Rcp for any cross point is series connected in sequence with the resistance Rst across the power supply terminals. The analog switches 100 and 104 deter-mine which cross point resistance Rcp is connected in series with the resistance Rst at any given instant of time.
An A/D converter 106 senses the voltage developed across the resistance Rst. See Figure 4. An A/D converter 108 senses the voltage developed across the cross point resistance Rcp. Since the resistances Rst and Rcp are series connected across the power supply terminals, the same current flows through both resistances. Accord-ingly, the resistance Rcp can be computed as a function of the output voltages Vl and V2 of A/D converters 100 and 104 respectively as follows:
Rcp ~ Rst(V2/Vl~
The computer computes the resistance Rcp for each cross point and stores the computed value in RAM. See Figure 5A.
All of the cross point resistance Rcp are stored in RAM
to provide a map of the pattern of pressure actually applied to the breast model in terms of cross point resistances. The computer com-pares this map of cross point resistances to another map of cross point resistances (similarly obtained) stored in another area of the RAM. The latter map corresponds to an earlier pressure pattern 1 applied to the breast model. The computer compares the two maps to determine whether the current map differs from the earlier stored map by a predetermined "amount". The "amount" of difference between the maps may be measured by the difference in magnitudes between resistances Rcp for a particular cross point or it may be measured by the number of cross points for wh:ich a particular magnitude of ; variation in resistance Rcp is detected from map to map. Other criteria may be used for purposes of the comparison as appears from the following description of the computer control.
If the "amount" of difference between the maps does not exceed the predetermined criteria, it indicates that the pressure pattern currently applied to the breast model by the trainee does not differ sufficiently from the earlier applied pressure pattern to merit further inspection by the computer. Accordingly, the computer erases the earlier stored map of resistances and shifts the current map into the RAM area which had been occupied by the earlier map.
See Figure SA. The trainee must then apply a new pressure pattern to the breast model. The preceding operations are repeated by the computer until a sufficient "amount" of difference is detected be-tween the new map and the earlier map. This techniques ensures that the trainee will vary his pattern of searching for simulated tumors in the breast model.
If a sufficient amount of difference is detected between the current and earlier stored maps, the computer proceeds to process the current map to provide feedback information to the trainee. In particular, the computer scans the positive and negative detection switches to determine whether either switch has bsen depressed. If the positive switch has been depressed (indicating that the trainee has detected a tumor), the computer compares the current map of re-sistances Rcp to a reference map of threshold values of resistance 1 9~
1 corresponding to the cross points on the matrix. The reference map is stored in memory by operation of the operator console keyboard.
Alternatively, the reference map may be permanently stored in memory such as a ROM or equivalent memory. The threshold values in the reference map may vary from cross point to cross point. Each thres-hold value represents the pressure which should be applied by the trainee at the localized region to detect a particular simulated tumor.
If, based on the comparison of the current map to the reference map, the computer determines that the threshold pressure has in fact been applied to a localized region by the trainee, it stores this information in memory. This indicates that the trainee correctly detected a particular tumor. For each value of cross point resistance Rcp which is below as associated threshold value of resistance, the computer assigns a weight on a predetermined scale. For example, a 10 unit scale may be utilized. The computer operates the trainee display 84 to display the weighted value on ;~ a map. For example, the display may comprise a CRT screen, and the characters A-L may be uæed to identify the weight (representing resistance Rcp) assigned to a particular cross point on the map.
Thereafter, the weighted map, as displayed, is stored in storage means 80 and the entire process is repeated.
If the negative detection button is depressed (indicating that the trainee detected no tumor), the computer searches the cur-rent map for cross point resistances Rcp which are below their as-sociated threshold resistances. Thus, the computer comparas the current map of cross point resistances with the reference map of threshold values, as previously described, to determine which cross point resistance thresholds have been crossed. Thereafter, the com-puter weights each cross point resistance which has crossed a thres-~1~925Z
1 hold value according to a 10 unit scale. Each weighted resistance is then displayed on display 84 using a 0-9 numeric scale. The com-puter also determines whether the trainee correctly operated the de-tection switch. If sufficient pressure had been applied at a local-ized region in the breast model to detect a simulated tumor therein, but no detection had been indicated by the trainee, the computer stores this information in memory. This indicates that the trainee failed to detect a particular tumor. In addition, the computer stores the weighted map of cross point resistances Rcp as previously 10 described. Thereafter, the entire process is repeated.
The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof and, accordingly, reference should be made to the appended claims, rather than to the foregoing specification as indica~ing the scope of the invention. ~ -~
.''' ~, ,........................................................................ .
:~ .
, , .
~' ''
1 Background of the Invention The present invention relates to a method, apparatus and a realistic model of a human female breast which are used to train doctors, nurses and other health professionals in the palpation method of breast examination, and is particularly useful in training women how to conduct breast self-examination.
Breast cancer is among the most common malignant tumors and is the leading cause of death from cancer among women in the United States. It is estimated that 1 out of every 15 American ~omen will develop the disease at some time during her life, and that 20% of deaths from cancer among women are attributable to breast cancer.
There has been no great reduction in the mortality rate of this disease in the past 35 yearsO
It is well recognized that early detection of breast cancer is the single most important variable in the successful cure and treatment of the cancer. Various methods for detecting breast can-cer include angiography, ultrasonography, isotope scanning, therm-ography, mammography and manual palpation. All of these techniques except for manual palpation are time consuming, expensive and require the interpretation of a trained specialist. In addition, recent studies suggest that mammography itself may be a cause of breast cancer.
Of all of these techniques for detecting breast cancer, the easiest and least expensive method is manual examination. The poten-tial effectiver.ess of manual examination, and particularly breast self-examination, in detecting small tumors relies on the effective-ness of manual palpation. Approximately 94~ of breast cancers are potentially palpable and are candidates for early manual detection.
It has been estimated that the expected death rate due to breast can-cer could be halved if the size of the detected tumors could be re-; l duced to less than about 2 cm. It has been indicated that further progress in breast cancer control is conditioned on progress in self-examination instruction, so that women are more comfortable and con-fident in performing breast self-examination.
The present invention is based upon the clinical and exper-imental evidence that a systematic approach to manual breast exami-nation can lead to the early detection of smaller tumors through training. See the following papers, the disclosures of which are hereby specifically incorporated herein by reference: C.K. Adams ; 10 et al., "Lump Detection In Simulated auman Breasts," Perception &Psychophysics, 20(3), pp. 163-167 (1976), D.C. Hall et al., "Progress In Manual Breast Examination," Cancer, Vol. 40, No. 1, July, 1977 `~ pp. 364-370.
The present invention comprises a realistic model of the human female breast and a method and apparatus for using a preferred ; form of the model to train persons how to systematically conduct a manual breast examination with a high degree of confidence. The present invention is clearly distinguishable from the following com-mercially available devices and patents, which are believed to be the closest prior art:
Ortho Pharmaceutical Corporation has been marketing a breast cancer teaching model in the form of a human female's torso having simulated tumors embedded in the breast. This model is of extremely limited value as an effective teaching tool in that it is made of foam rubber and not at all lifelike. There is no provision made in the model, sold under the trademark 'IBETSI'', for any means to simulate the different types of tissue found in the human breast.
In addition, the model is not adapted for use with any sort of means - for feeding back information to the trainee.
1 Spenco Medical Corporation markets a breast cancer teaching model comprising a plurality of simulated tumors within a gel-like substance shaped like a breast. The model comprises a gel-like sub-stance within a protective fabric cover, which serves as a "skin".
While this device is an improvement over "BETSI", it lacks the feel of a real breast. The gel-like substance does not have the complex-ity for simulating adipose, glandular and connective tissue which is ; found in the human female breast. Moreover, there are no means asso-ciated with the model to provide feedback information to the trainee.
U.S. Patent 3,742,935 of Baessler et al. relates to a method and apparatus used in teaching palpation techniques. A pres-sure transducer is in pressural engagement with the skin of a patient adjacent to an area of the body which generates changes in pressure, such as blood vessels, the heart, the larynx, etc. The transducer is connected through an amplifier to a master unit and a plurality of slave units. By monitoring the output of the transducer through the amplifier, a physician or other tea~her can instruct the students on the techniques of palpation by means of the slave units which re-produce the vibrations transmitted by the blood vessels, heart, larynx or other source. The method and apparatus described in this patent is of no use in teaching the palpation of passive areas of the body, such as breast tumors. Thus, while blood vessels, the heart and larynx all cause pressure displacements, such as pulses and voice vibrations, no such displacements are created by breast tumors.
U.S. Patent 3,942,516 of Glynn et al. discloses a system and method for use in training persons how to control various bio-logical functionæ, such as muscle activity, by means of monitoring electrical signals generated by the body, such as brain waves, dif-ferential skin temperature and muscle tension measurements. The system and method described in the patent require that electrodes 1 be attached to the patient/trainee to monitor his physiological con-dition. This patent does not teach or suggest the use of a model for training purposes and its interrelationship with a trainee.
U.S. Patent 3,681,787 of Perras discloses a breast pros-thesis to be implanted in a woman's chest. The prosthesis contains gels of different viscosities and densities to maintain the configur-ation of the prosthesis, and to retain the desired consistency and appearance. It is clear that the placement of the denser, more viscous gels in the patented prosthesis is not intended to simulate the feeling to the touch of real breast tissue. Rather, the differ-ent gels of the prosthesis are to maintain the shape and appearance of the prosthesis, and not to provide a realistic feel during palp-tion. Moreover, this patent neither teaches nor suggests the use of the prothesis as a model for breast cancer detection training.
S D ary of the Invention One portion of the present invention comprises a lifelike model of a human female breast comprising a membrane which simulates skin, first means having an irregular surface for simulating gland-ular, connective and/or skeletal tissue, the first means being con-nected to the membrane to define a chamber therebetween, second means for simulating adipose (fatty) tissue disposed within the ;~ chamber, and third means for simulating at least one tumor fixed within the chamber. When the model is used with the apparatus of the present invention, it is preferred that the model contain pres-sure sensing means.
The method according to the present invention of training ;
a person to detect breast tumors by palpating a model of a human breast which may be provided with one or more simulated tumors com-prises: (1) sele~tively applying pressure in a pattern to the model ~ 30 of the human breast; (2) automatically generating a set of signals :
5~
~' ; 1 representative of the pattern of pressure applied to the model; (3) storing reference information representative of a predetermined pat-tern of pressure which must be applied to the model to detect a sim-ulated tumor therein; (4) selectively generating a condition signal indicative of detection or lack of detection of a simulated tumor;
(5) comparing the stored reference information to the set of signals;
and (6) indicating whether the condition signal correctly indicates detection or lack of detection of a tumor as a function of step (5).
Apparatus in accordance with the present invention for ~ 10 training a person to detect breast tumors by applying pressure in a ; pattern to a model of a human breast provided with one or more simu-lated tumors comprises: first means for generating a set of signals representative of the pattern of pressure applied to the model;
second means for storing reference information representative of a predetermined pattern of pressure which must be applied to the model to detect a simulated tumor therein; third means for generating a condition signal indicative of detection or lack of detection of a simulated tumor; fourth means for comparing the stored reference information to the set of signals; and fifth means for indicating whether the condition signal correctly indicates detection or lack of detection of a tumor.
The system of the present invention is used to analyze a trainee's search pattern and provide the trainee with feedback on the effectiveness of the search. This will reinforce detection of the smallest palpable simulated tumors by delivering visual and/or auditory information for both successful and unsuccessful detections.
Information concerning breast, tumor and trainee variables will be considered by the system according to the present invention for increasing the accuracy and regularity of breast self-examination and decreasing the size of the tumor detected.
:~
1 Brief Description of the Drawings For the purpose of illustrating the invention, there is shown in the drawings a form which is presently preferred; it being understood, however, that this invention is not limited to the pre-cise arrangements and instrumentalities shown.
Figure 1 is a sectional view of one embodiment of a simple breast model according to the present invention.
Figure lA is a fragmentary sectional view of a breast model illustrating means for forming variable-sized simulated tumors.
Figure 2 is a sectional view of one embodiment of a breast model incorporating pressure sensing means in accordance with the present invention.
Figure 3 is a schematic representation of the system of the present invention.
Figure 4 is a schematic representation of the computer ~ interface circuit.
; Figures 5A and 5B are flow charts illustrating the opera- tion of the system according to the present invention.
Description of the Preferred ~mbodiments Referring to the drawings in detail, wherein like numerals indicate like elements, there is shown in Figure 1 one embodiment of a realistic, lifelife model of a human female breast 10. It is im-portant that the model have physical characteristics which closely simulate human tissue so that examination techniques will be learned through actual practice with realistic stimuli. It is preferred that models be available in several sizes with varying degrees of firm-ness so as to apply to a large cross-section of women.
The model is substantially hemispherical in shape and generally comprises a skin enclosing silicone gel or other means of simulating breast tissue and means for simulating tumors, except , sz :
l where a tumor-free model is desired for comparison purposes.
Skin 12 may be made of any material which closely simulates human skin. Presently preferred materials include elastomeric sili-cone resin polymers commercially available from General Electric Company and Dow Corning Corporation.
G.E.'s RTV 7100 silicone rubber compound forms a satisfac-tory membrane or skin for the model. A realistic skin results from mixing 1 part by weight of the curing agent to 50 parts by weight of the base and curing for 1 hour at 100C or 24 hours at room tempera-ture. The skin is formed by simply brushing a layer of the silicone elastomer onto a suitably shaped mold after applying a release agent, such as silicone oil, and allowing the polymer to cure. An areola region 14 and nipple 16 provide a realistic feel and a tactile refer-ence point for conducting the breast examination. Optional bottom skin 18 and optional membrane 34 may be made of the same type of material as skin 12 and may be formed in the same manner. The mem-branes are secured together by any ~uitable adhesive to provide a leak-proof membrane which contains gel 20, simulated tumors 28 and 30 which are fixed within the model by means of elastomeric silicone threads 22 and 24, for example, and means for simulating glandular, connective and/or skeletal tissue 32.
Gel 20 simulates adipose tissue and may be any gel which imparts a realistic feel to the model. A suitable gel is G.E.'s RTV
619 silicone gel containing about 6-8 parts by weight of curing agent to about 100 parts by weight of the base component. This material cures in 24 hours at room temperature, in about 30 minutes at 100C and in about 15 minutes at 150C.
The means 32 for simulating glandular tissue, connective tissue, such as muscles, tendons, etc., and skeletal tissue, such as the chest wall, is any substance which may be molded or otherwise ;: :
:
1 formed to have an irregular surface, density and feel of the firmer glandular, connective and skeletal tissue found in the breast. Means 32 need only be made of a material which is harder than gel 20, so as to accurately simulate the firmer tissue. Examples of suitable substances include G.E.'s RTV 619 gel containing about 8-10 parts by weight curing agent to about 100 parts by weight of the base compon-ent, and G.E.'s RTV-7 silicone rubber foam, containing about 5 parts by weight stannous octoate curing agent per 100 parts of base com-ponent. This material cures at room temperature in about 24 hours, but the cure may be accelerated by heating to about 100-150C.
It is not critical to use the particular materials sug-gested for forming the skin membranes, the gel representating the adipose tissue and the substance used to represent the glandular, connective and/or skeletal tissue. Rather, the only critical re-quirement is that the model have the complex feel of a real breast.
If desired, small particles of silica or other inert material may be added to the gel representing the adipose tissue to provide a granular feel to the model. Various pigments well known to those skilled in the art may be incorporated in the skin-simulating sub-stance to provide a good visual representation of a real breast. ; !
Except for a tumor-free model which is used as a basis for comparison with tumor containing models and to check for ~alse posi-tive responses, the models contain simulated tumors which simulate the types of tumors associated with breast cancer. The models pre~-erably contain more than one simulated tumor. The simulated tumors contained in the models may vary in size, shape, location and con-sistency, so long as they realistically simulate breast tumors.
~or convenience, tumors 28 and 30 are represented by stainless ball bearings. Other shapes and consistencies may easily be made from various other materials, for example, nylon, styrene and any other 92~
l material capable of realistically simulating breast tumors which is compatible with the other materials used in making the model.
As shown in Figure 1, simulated tumor 28 is encased in silicone membrane 26 which is supported within the model by silicone threads 22 and 24. The supporting threads should be as thin as pos-sible but of sufficient strength to support the simulated tumor in a fixed position within the model. The threads are shown greatly en-larged for purposes of illustration. Thread 24 is shown connected to membrane 34 which separates simulated adipose tissue 20 from the simulated glandular, connective and/or skeletal tissue 32. .~lthough membrane 34 may facilitate the secure fixation of the tumors within the model, membrane 34 is not necessary. In the absence of membrane 34, thread 24 would be directly connected to glandular, connective and/or skeletal tissue simulating means 32.
~ n alternative means for fixing a plurality of simulated tumors within a model is shown in Figure 2. Breast model 40 is shown as containing two simulated tumors 62 and 68. These simulated tumors are fixed within the model by means of silicone membranes 59 and 64 which encapsulate at 60 and 66 the tumors 62 and 68, re-spectively. Membranes 59 and 64 may comprise one or more layers of silicone or like material similar to that used in forming skin 12, threads 22 and 24 and membrane 34 as described with reference to Figure 1. Membranes 59 and 64 are substantially hemispherially shaped membranes to which the simulated tumors may be affi~ed by any convenient means, such as encapsulation or by means of suitable ad-hesives. Membranes 59 and 64 may be connected to optional bottom membrane 72 or may be connected directly to member 70 as desired.
It is preferable to provide several models wherein the simulated tumors are in different locations and are of different sizes and consistencies. Although it has been reported that breast _ g _ 1 tumors are palpable when they reach about 1-2 cm in approximate di-ameter, it has been found that people can be trained by using models according to the present invention to palpate simulated tumors be-tween about 1 and 2 mm in approximate diameter. By being able to detect such small tumors by palpation conducted by health special-ists or by women during regular self-breast examination, it will be possible to greatly reduce the catastrophic effects of breast cancer by early treatment and cure. One model that has been prepared and used by trainees contains three relatively large lumps 8.7, 11.1 and 12.7 mm in diameter. After working with this model for a while, another model containing five simulated tumors 1.6, 2.4, 3.2, 4.8 and 6.4 mm in diameter was given to the trainees. With practice, most trainees can detect even the smallest tumors.
A more advanced model containing a simulated tumor or tumors which are variable in size may be formed by modifying the model il-lustrated in Figure 1 as shown in Figure lA. Variable sized tumor 27 comprises a spherical portion 25 supported by thread 21 and tubular member 23 which passes through optional membrane 35, means for simu-lating glandular, connective and/or skeletal tissue 31 and optional bottom membrane 19. A syringe is inserted through plug 29 to add or remove gel or any other material which can be used to expand the walls of chamber 25 to or from simulated tumor 27 as indicated at 25' and 27'. Plug 29 can be made of any suitable self-sealing poly-meric material. By using this embodiment, one model may be adapted to contain simulated tumors which may be increased in size or de-cr~ased in size in the same relative location within the model to help the trainee compare the feel of different sized tumors in the same general location.
Model 40 shown in Figure 2 represents an advanced construc-tion of a lifelike human female breast particularly constructed for 1 use with the apparatus of the present invention.
Model 40 contains a different embodiment of means for simulating adipose, glandular, connective and/or skeletal tissue than the embodiment illustrated in Figure l. Adipose tissue is represented by gel 56 in the outer region of the model between membrane 59 and skin 42. Gel 57 between membranes 59 and 64 may be the same as or different than gel 56. It may be desirable to provide a firmer gel 57 for the intermediate portion of the model. The density and viscosity of the gel can readily be varied by adjusting the relative amounts of base material and curing agent. The consistency of gel 57 may be adjusted to simulate firmer glandular tissue found in the human breast.
Likewise, gel 58 may be the same aæ or different than gels 56 and 57. Preferably, gel 58 i8 firmer or harder than gels 56 and 57 to represent connective tissue found in the human breast. Base material 70 may be adapted to simulate the chest wall.
Model 40 is thus more complex than model 10. If desired, gels 56, 57 and 58 may be of the same general consistency and means 70 may represent glandular, connective and/or skeletal tissue similar to means 32. Of course, any number of simulated tumors of various sizes, shapes and consistencies may be affixed to any number of mem-branes corresponding to membranes 59 and 64 within the breast model.
Skin 42 of model 40 comprises several distinct layers as compared with skin 12 in model 10. Skin 42 comprises a silicone membrane 44 in which is embedded a plurality of flexible ele~trically conductive strips 46. An exploded view of the electrical components of skin 42 is shown in Figure 4. Electrical connecting means 47, which may be a wire, pin, plug or the like, is associated with each strip 46. Adjacent to membrane 44 and in contact with electrical strips 46 is a pressure conductive polymer layer 48 which conducts ~9~
~ 1 electricity when presaure is applied to the polymer as discussed - hereinafter in more detail. A plurality of flexible electrically conductive strips 50 (best seen in Figure 4) are adjacent to pressure conductive polymer layer 48 and are arranged substantially perpen-dicular to strips 46. Electrical connection means 51, which may be the same type as connection means 47, are associated with strips 50.
Strips 50 are embedded within membrane 52. Thus, ~kin 42 comprises laysrs 44, 46, 48, 50 and 52.
Skin 42 in Figure 2 need not be restricted to the particu-ular model shown in Figure 2 but may be used with a model constructed in accordance with Figure 1. Likewise, skin 12 of Figure 1 may con-tain the other components of the model illustrated in Figure 2. -~
Membranes 44 and 52 may be comprised of the same material used to form skin membrane 12 of model 10. Flexible electrical con-ductive strips 46 are preferably arranged parallel to each other and perpendicular to parallel flexible electrical conductive strips 50. The strips may be made of any good electrical conductor so long as it is flexible, such as metal foil. Electrical connecting means 47 and 51 may be attached to strips 46 and 50, respectively, in any suitable manner well known to those skilled in the art. ~-Because of the substantially perpendicular arrangement of strips 46 and 50, a grid or rnatrix will be formed in the skin of the model. Although any number of strips may be used in the model, generally, the more strips that are used, the more accurately the location of applied pressure can be determined. Strips 46 and 50 may be of any desired dimension in accordance with the degree of sensitivity desired for the particular trainee and the si~e of sim-ulated tumors contained within the model.
Pressure conductive polymer 48 has an electrical resistance perpendicular to its surface, and accordingly~ substantially perpen-. .
1 dicular to the surface of the model, which is proportional to the applied pressure. The polymer is an insulator at rest but when prassure is applied it gradually becomes a conductor. When pressure is released, it returns to its original state as an insulator. An excellent property of the pressure conductive polymer is that current flow can be locali~ed. When pressure is applied to the surface of the polymer, only the area directLy beneath the pressure source be-comes conductive, with little or no lateral flow. The polymer covers an extremely wide range of resistance, for example from 100 megohms, which is fairly good insulator, to 0.1 ohm, which is a useful con-ductor. The polymer will handle up to 10 amps per square inch inter-mittently without failure~ but lower amperages are recommended. It will sustain up to 600-700 volts but optimum usage is with lower voltages since high voltage overloading will destroy conductivity.
Pressure conductive polymers havlng these characteristics are com-mercially available from Chomerics, Inc. of Woburn, Massachusetts and Dynacon Industries, Inc. of West Milford, New Jersey, for example.
Although the electronic circuitry and particular operation of the entire system will be discussed more fully hereinafter, the function of skin 42 will be described briefly. The application of ; pressure, such as that encountered during palpation as represented by arrow 49 in Figure 4, causes the resistance of the pressure con-ductive polymer in the vicinity of the applied pressure point to de-crease. When resistance decreases, electrical conductance increases so that there is an electrical connection between one of the strips 46 and one of the strips 50 at the location where pressure is ap-plied. Thus, the application of pressure at a particular point will generate an electrical signal proportional to the amount of applied pressure and representative of the location of the applied pressure.
A greater increase in conductivity would occur where greater pres-1 sures are formed on the skin of the model by palpation pressure against a simulated tumor.
A computer interfaces with the matrix formed by strips 46 and 50 via a resistance measuring circuit 76. Circuit 76 measures the voltages Vl and V2 which provide an indication of the resistance Rcp at each cross point of the matrix. See Figure 4. The computer calculates the ratio V2/Vl and multiplies the ratio by the value of a current measuring resistor Rst. The product is the value Rcp, the resistance at a cross point of the matrix. The resistance Rcp varies as a function of the pressure applied to model 40. The computer stores the value Rcp calculated for each cross point to form a map of the resistances at all points of the matrix. The map corresponds to the pattern of pressure applied to the model. As described more fully hereinafter, the smallest detectable simulated tumor, the elapsed time required to detect a simulated tumor and other informa-tion may be calculated based on the map.
The method of training a person to detect breast tumors in accordance with the present invention will now be described with reference to Figure 3.
Trainee 73 i5 instructed in baslc palpation techniques used in manual examination or self-examination for breast cancer.
For purposes of gaining familiarity with the technique and for basic instruction, a model without pressure sensing means adapted for con-nection to the apparatus of the present invention may be used. How-ever, to thoroughly train and maintain skill in breast examination, important manual aspectA of breast examination should be precisely measured by a system constructed to supply certain information.
This information includes the amount and duration of pressure exerted on a given location at a given time and the amount of breast area covered in the entire search. Precise measurement provides quanti-1 tative data for analysis of variations in search techniques and their effects on tumor detection and direct feedback can be continu-ously provided to the operator, teacher or trainee regarding the examination performance. The system of the present invention was developed to provide this information.
A breast model containing pressure sensing means, such as described hereinbefore with respect to model 40 may be placed on any suitabIe horizontal, vertical or obliquely inclined support for con-nection with the resistance measuring circuit 76 for eventual connec-tion with the computer data processor. Trainee console 74 comprises a number of switches to be activated by the trainee, including a positive detection switch to be activated when the trainee believes he or she has detected a simulated tumor; a negative detection switch to be activated when the trainee believes that there are no simulated tumors present in the model; a ~tart-stop switch to be activated at the beginning and the end of the palpation of a model; switches to be activated which correspond to various sizes of turnors, such as small, medium or large; and miscellaneous switches such as power on and off, pause, and the like.
Reference information correlated to each breast model is stored in the computer memory. This information includes the number of simulated tumors contained in the breast model, the location of the tumors (which may be expressed as coordinates relating to the electrical conductive strip matrix), the size of each simulated tumor, the amount of pressure (in terms of threshold resistance Rcp) required to detect each simulated tumor, and other variables such as the amount of time to be spent conducting the examination and so forth. The program for operating the computer in accordance with the invention may be stored in memory 80.
1 Upon receiving a signal from the operator to begin the examination, which may be communicated through operator console 82 to trainee display 84, the trainee begins the manual examination.
If the trainee detects a simulated tumor, he activates the positive detection switch. If the trainee does not detect a tumor, he acti-vates the negative detection switch. By means of resistance measur-ing circuit 76, the computer calculates the resistance Rcp at each cross point of the matrix for the model 40 and stores each calcula-tion in memory to form a map corresponding to the pattern of pressure applied to the model. The computer also compares the map with the stored reference information. The stored reference information re-lates to a predetermined pattern of pressure which must be applied to the particular model to detect the tumors therein. Based on the comparison, the computer determines whether the positive or negative detections are correct. The map of the pattern of pressure actually applied to the model is indicated to the trainee on display 84. An indication of the correctness of the positive or negative detection, for example, a visual or audible signal, may also be provided on the display. Both the map and the correctness of the detection may be stored for future reference in memory 80 to provide a running check of the progress of the trainee.
The trainee may also activate switches on console 7~ relat-ing to the detection of tumor size or other variables useful in teaching the art of palpation to detect breast cancer. Reference information relating to these variables may be stored in memory and accessed for purposes of comparison as previously indicated in con-nection with the detection of the location of a tumor.
Operation of the system is shown in further detail in Figures 5A and 5B.
z~
1 Initially, when power is applied to the computer 78 (or upon the operation of an initialization switch), the computer enters an initialization routine wherein the appropriate memory areas are cleared. See Figure 5A. The computer then enters a polling routine in which each of the cross points in the breast model matrix are sequentially activated and scanned via an address bus A0-A15. The least signiEicant byte of the address, bits ~0-A7, poll an analog switch 100 which sequentially energizes each of the conductive strips 46. See Figure 4. The analog switch 100 gates power from a power supply 102 to the strips 46 under control of the address byte A0-A7.
The most significant address byte, bits A8-A15, controls the sequence in which a second analog switch 104 scans the conductive strips 50 via conductors 51. Output current signals of varying am-plitudes flow through conductive strips 50 under application of pressure to the breast model. The amplitude of a particular output current signal is a function of the pattern of pressure applied to the model. The rate at which the bits of byte A8-Al5 vary to scan analog switch 104 is substantially greater than the rate at which the bits of byte A0-A7 vary to poll analog switch 100. During the period of time that a particular strip 46 is energized by analog ~ switch 100, analog switch 104 scans all of the conductive strips -~ 50 in sequence. By this technique, the resistance Rcp of the polymer 48 at each localized region at which a cross point of the matrix is located can be rapidly computed. The resistance Rcp provides a di-rect indication of the pressure applied to the model.
~ore specifically, there is a localized region of polymer 48 having a resistance Rcp associated with each cross point formed by the matrix of conductive strips. Each resistance Rcp is deter-mined by the pattern of pressure applied to the breast model. Each resistance Rcp decreases as the pressure applied to the associated 92~
1 localized region increases. To compute the value of each resistance Rcp, each cross point is energi2ed and scanned by analog switches 100 and 104 under control of computer addressing A0-A15 as previously described. Thus, the resistance Rcp associated with each cross point is electrically connected in sequence via analog switch 100 to power supply 102. In addition, the resistance Rcp is series connected in sequence via analog switch 104 to a reference or current measuring resistance Rst. The resistance Rst is connected to the return of the power supply 102. Accordingly, the resistance Rcp for any cross point is series connected in sequence with the resistance Rst across the power supply terminals. The analog switches 100 and 104 deter-mine which cross point resistance Rcp is connected in series with the resistance Rst at any given instant of time.
An A/D converter 106 senses the voltage developed across the resistance Rst. See Figure 4. An A/D converter 108 senses the voltage developed across the cross point resistance Rcp. Since the resistances Rst and Rcp are series connected across the power supply terminals, the same current flows through both resistances. Accord-ingly, the resistance Rcp can be computed as a function of the output voltages Vl and V2 of A/D converters 100 and 104 respectively as follows:
Rcp ~ Rst(V2/Vl~
The computer computes the resistance Rcp for each cross point and stores the computed value in RAM. See Figure 5A.
All of the cross point resistance Rcp are stored in RAM
to provide a map of the pattern of pressure actually applied to the breast model in terms of cross point resistances. The computer com-pares this map of cross point resistances to another map of cross point resistances (similarly obtained) stored in another area of the RAM. The latter map corresponds to an earlier pressure pattern 1 applied to the breast model. The computer compares the two maps to determine whether the current map differs from the earlier stored map by a predetermined "amount". The "amount" of difference between the maps may be measured by the difference in magnitudes between resistances Rcp for a particular cross point or it may be measured by the number of cross points for wh:ich a particular magnitude of ; variation in resistance Rcp is detected from map to map. Other criteria may be used for purposes of the comparison as appears from the following description of the computer control.
If the "amount" of difference between the maps does not exceed the predetermined criteria, it indicates that the pressure pattern currently applied to the breast model by the trainee does not differ sufficiently from the earlier applied pressure pattern to merit further inspection by the computer. Accordingly, the computer erases the earlier stored map of resistances and shifts the current map into the RAM area which had been occupied by the earlier map.
See Figure SA. The trainee must then apply a new pressure pattern to the breast model. The preceding operations are repeated by the computer until a sufficient "amount" of difference is detected be-tween the new map and the earlier map. This techniques ensures that the trainee will vary his pattern of searching for simulated tumors in the breast model.
If a sufficient amount of difference is detected between the current and earlier stored maps, the computer proceeds to process the current map to provide feedback information to the trainee. In particular, the computer scans the positive and negative detection switches to determine whether either switch has bsen depressed. If the positive switch has been depressed (indicating that the trainee has detected a tumor), the computer compares the current map of re-sistances Rcp to a reference map of threshold values of resistance 1 9~
1 corresponding to the cross points on the matrix. The reference map is stored in memory by operation of the operator console keyboard.
Alternatively, the reference map may be permanently stored in memory such as a ROM or equivalent memory. The threshold values in the reference map may vary from cross point to cross point. Each thres-hold value represents the pressure which should be applied by the trainee at the localized region to detect a particular simulated tumor.
If, based on the comparison of the current map to the reference map, the computer determines that the threshold pressure has in fact been applied to a localized region by the trainee, it stores this information in memory. This indicates that the trainee correctly detected a particular tumor. For each value of cross point resistance Rcp which is below as associated threshold value of resistance, the computer assigns a weight on a predetermined scale. For example, a 10 unit scale may be utilized. The computer operates the trainee display 84 to display the weighted value on ;~ a map. For example, the display may comprise a CRT screen, and the characters A-L may be uæed to identify the weight (representing resistance Rcp) assigned to a particular cross point on the map.
Thereafter, the weighted map, as displayed, is stored in storage means 80 and the entire process is repeated.
If the negative detection button is depressed (indicating that the trainee detected no tumor), the computer searches the cur-rent map for cross point resistances Rcp which are below their as-sociated threshold resistances. Thus, the computer comparas the current map of cross point resistances with the reference map of threshold values, as previously described, to determine which cross point resistance thresholds have been crossed. Thereafter, the com-puter weights each cross point resistance which has crossed a thres-~1~925Z
1 hold value according to a 10 unit scale. Each weighted resistance is then displayed on display 84 using a 0-9 numeric scale. The com-puter also determines whether the trainee correctly operated the de-tection switch. If sufficient pressure had been applied at a local-ized region in the breast model to detect a simulated tumor therein, but no detection had been indicated by the trainee, the computer stores this information in memory. This indicates that the trainee failed to detect a particular tumor. In addition, the computer stores the weighted map of cross point resistances Rcp as previously 10 described. Thereafter, the entire process is repeated.
The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof and, accordingly, reference should be made to the appended claims, rather than to the foregoing specification as indica~ing the scope of the invention. ~ -~
.''' ~, ,........................................................................ .
:~ .
, , .
~' ''
Claims (7)
1. A lifelike model of a human female breast comprising an elastomeric membrane, first means simulating glandular, connec-tive and/or skeletal tissue, the first means being connected to the membrane to define a chamber therebetween, second means simulating adipose tissue disposed within the chamber, the first means being harder than the second means and having an irregular surface within the chamber, and third means simulating at least one tumor fixed within the chamber.
2. A model according to claim 1 wherein a plurality of simulated tumors of different sizes are fixed within the chamber.
3. A model according to claim 1 wherein the simulated tumor is variable in size.
4. A model according to claim 1 wherein the simulated tumor is supported by a plurality of elastomeric threads.
5. A model according to claim 1 wherein the tumor is at-tached to a layer of elastomeric resin polymer fixed within the chamber.
6. A model according to claim 1 further comprising pres-sure sensing means within the model.
7. A model according to claim 6 wherein the pressure sensing means comprises a first series of electrical conductors ad-jacent to a polymer having an electrical conductivity substantially directly proportional to the amount of pressure applied thereto, and a second series of electrical conductors adjacent to the side of the polymer opposite the side adjacent to the first series, the second series arranged substantially perpendicular to the first series.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA000373213A CA1147951A (en) | 1977-10-11 | 1981-03-17 | Breast cancer detection training system |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US841,076 | 1977-10-11 | ||
US05/841,076 US4134218A (en) | 1977-10-11 | 1977-10-11 | Breast cancer detection training system |
Publications (1)
Publication Number | Publication Date |
---|---|
CA1109252A true CA1109252A (en) | 1981-09-22 |
Family
ID=25283956
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA312,932A Expired CA1109252A (en) | 1977-10-11 | 1978-10-10 | Breast cancer detection training system |
Country Status (5)
Country | Link |
---|---|
US (1) | US4134218A (en) |
JP (2) | JPS6024946B2 (en) |
CA (1) | CA1109252A (en) |
DE (2) | DE2844373C3 (en) |
GB (2) | GB2005894B (en) |
Families Citing this family (91)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4360345A (en) * | 1980-07-14 | 1982-11-23 | American Heart Association, Inc. | Health education system |
US4331428A (en) * | 1980-09-15 | 1982-05-25 | Chandler Eugene J | Model of the human knee suitable for teaching operative arthroscopy |
US4493653A (en) * | 1983-09-27 | 1985-01-15 | Technicare Corporation | Biopsiable ultrasound phantom |
JPS60120471U (en) * | 1984-01-25 | 1985-08-14 | 株式会社京都科学 | Breast mass palpation model |
JPS60176468U (en) * | 1984-04-28 | 1985-11-22 | 株式会社京都科学 | Breast pine surgery practice model |
EP0195718A1 (en) * | 1985-03-22 | 1986-09-24 | Commissariat A L'energie Atomique | Artificial skull, prosthetic head built up from the skull and process for producing them |
US4815977A (en) * | 1988-02-01 | 1989-03-28 | Peters Sheila N | Breast-feeding trainer |
US4867686A (en) * | 1989-02-09 | 1989-09-19 | Goldstein Mark K | Breast cancer detection model and method for using same |
US5020671A (en) * | 1989-09-19 | 1991-06-04 | Smith Raleigh A | Method and apparatus for optimum self-examination of breasts by users of birth control pills |
GB2241815A (en) * | 1990-03-07 | 1991-09-11 | Cancer Res Inst | Breast palpation teaching aid |
US5775916A (en) * | 1992-01-15 | 1998-07-07 | Limbs & Things Limited | Method of making a surgical and/or clinical apparatus |
US5207582A (en) * | 1992-02-03 | 1993-05-04 | B.S.E.-1.2.3., Inc. | Breast self-examination facilitator |
US5273435B1 (en) * | 1992-07-16 | 1995-12-05 | Wisconsin Med College Inc | Tumor localization phantom |
GB9309021D0 (en) * | 1993-04-30 | 1993-06-16 | Limbs & Things Ltd | Medical training apparatus |
US5833634A (en) * | 1995-11-09 | 1998-11-10 | Uromed Corporation | Tissue examination |
US7976312B2 (en) * | 1996-05-08 | 2011-07-12 | Gaumard Scientific Company, Inc. | Interactive education system for teaching patient care |
US8696362B2 (en) * | 1996-05-08 | 2014-04-15 | Gaumard Scientific Company, Inc. | Interactive education system for teaching patient care |
US7811090B2 (en) | 1996-05-08 | 2010-10-12 | Gaumard Scientific Company, Inc. | Interactive education system for teaching patient care |
US20090148822A1 (en) * | 2007-12-07 | 2009-06-11 | Gaumard Scientific Company, Inc. | Interactive Education System for Teaching Patient Care |
US8016598B2 (en) | 1996-05-08 | 2011-09-13 | Gaumard Scientific Company, Inc. | Interactive education system for teaching patient care |
US5989199A (en) * | 1996-11-27 | 1999-11-23 | Assurance Medical, Inc. | Tissue examination |
AU740919B2 (en) * | 1997-01-08 | 2001-11-15 | Eric Flam | Method and apparatus for testing the efficacy of patient support systems |
US6091981A (en) * | 1997-09-16 | 2000-07-18 | Assurance Medical Inc. | Clinical tissue examination |
US5916180A (en) * | 1997-10-03 | 1999-06-29 | Uromed Corporation | Calibrating pressure sensors |
US6063031A (en) * | 1997-10-14 | 2000-05-16 | Assurance Medical, Inc. | Diagnosis and treatment of tissue with instruments |
USD425980S (en) * | 1997-10-20 | 2000-05-30 | Assurance Medical, Inc. | Hand-held tissue examination device |
US6179790B1 (en) | 1997-10-20 | 2001-01-30 | Assurance Medical, Inc. | Layer of material for use with tissue examination device |
EP1051698B1 (en) * | 1998-01-28 | 2018-01-17 | Immersion Medical, Inc. | Interface device and method for interfacing instruments to vascular access simulation systems |
US5913686A (en) * | 1998-03-12 | 1999-06-22 | Vanwinkle; Tresa A. | Breast-mapping |
AU6028299A (en) * | 1998-09-08 | 2000-03-27 | Catholic University Of America, The | Method and system for tactile imaging for breast cancer examination and detection of prostate cancer |
US6669483B1 (en) * | 1998-09-24 | 2003-12-30 | West Virginia University | Instrumented breast model |
US20030031993A1 (en) * | 1999-08-30 | 2003-02-13 | Carla Pugh | Medical examination teaching and measurement system |
AU2001281064A1 (en) * | 2000-08-04 | 2002-02-18 | West Virginia University | Computer based instrumentation and sensing for physical examination training |
US7976313B2 (en) * | 2000-08-17 | 2011-07-12 | Gaumard Scientific Company, Inc. | Interactive education system for teaching patient care |
US6524246B1 (en) | 2000-10-13 | 2003-02-25 | Sonocine, Inc. | Ultrasonic cellular tissue screening tool |
US8556635B2 (en) | 2000-10-23 | 2013-10-15 | Christopher C. Toly | Physiological simulator for use as a brachial plexus nerve block trainer |
US7850454B2 (en) * | 2000-10-23 | 2010-12-14 | Toly Christopher C | Simulated anatomical structures incorporating an embedded image layer |
US7857626B2 (en) * | 2000-10-23 | 2010-12-28 | Toly Christopher C | Medical physiological simulator including a conductive elastomer layer |
US7665995B2 (en) * | 2000-10-23 | 2010-02-23 | Toly Christopher C | Medical training simulator including contact-less sensors |
GB0110847D0 (en) * | 2001-05-03 | 2001-06-27 | Haque Paulin | Breast cancer detection |
US20020172214A1 (en) * | 2001-05-16 | 2002-11-21 | Grantham Raymond Doyle | Double breast model in shape of football and method of using same |
US6485308B1 (en) | 2001-07-09 | 2002-11-26 | Mark K. Goldstein | Training aid for needle biopsy |
US6945783B2 (en) | 2002-05-21 | 2005-09-20 | The University Of Iowa Research Foundation | Interactive breast examination training model |
US6854976B1 (en) * | 2002-11-02 | 2005-02-15 | John S. Suhr | Breast model teaching aid and method |
US6817865B2 (en) * | 2003-03-11 | 2004-11-16 | Promotions Unlimited, Inc. | Training device for breast examination |
GB0308938D0 (en) * | 2003-04-17 | 2003-05-28 | Limbs And Things Ltd | Medical training system |
WO2004098404A2 (en) * | 2003-05-05 | 2004-11-18 | University Of Maryland, Baltimore | A system for detecting enlarged lymph nodes |
US7594815B2 (en) * | 2003-09-24 | 2009-09-29 | Toly Christopher C | Laparoscopic and endoscopic trainer including a digital camera |
US8007281B2 (en) * | 2003-09-24 | 2011-08-30 | Toly Christopher C | Laparoscopic and endoscopic trainer including a digital camera with multiple camera angles |
CA2544431A1 (en) * | 2003-10-29 | 2005-05-19 | John S. Suhr | Breast model teaching aid and method |
US8037102B2 (en) | 2004-02-09 | 2011-10-11 | Robert T. and Virginia T. Jenkins | Manipulating sets of hierarchical data |
US20050214726A1 (en) * | 2004-03-23 | 2005-09-29 | David Feygin | Vascular-access simulation system with receiver for an end effector |
US7625211B2 (en) * | 2004-03-23 | 2009-12-01 | Laerdal Dc | Vascular-access simulation system with skin-interaction features |
US20050214723A1 (en) * | 2004-03-23 | 2005-09-29 | David Feygin | Vascular-access simulation system with external end-effector |
US8403674B2 (en) * | 2004-03-23 | 2013-03-26 | Laerdal Medical As | Vascular-access simulation system with ergonomic features |
US9646107B2 (en) | 2004-05-28 | 2017-05-09 | Robert T. and Virginia T. Jenkins as Trustee of the Jenkins Family Trust | Method and/or system for simplifying tree expressions such as for query reduction |
US7620632B2 (en) * | 2004-06-30 | 2009-11-17 | Skyler Technology, Inc. | Method and/or system for performing tree matching |
US7731500B2 (en) * | 2004-07-08 | 2010-06-08 | Laerdal Medical Corporation | Vascular-access simulation system with three-dimensional modeling |
US7627591B2 (en) * | 2004-10-29 | 2009-12-01 | Skyler Technology, Inc. | Method and/or system for manipulating tree expressions |
US7801923B2 (en) | 2004-10-29 | 2010-09-21 | Robert T. and Virginia T. Jenkins as Trustees of the Jenkins Family Trust | Method and/or system for tagging trees |
US7630995B2 (en) | 2004-11-30 | 2009-12-08 | Skyler Technology, Inc. | Method and/or system for transmitting and/or receiving data |
US7636727B2 (en) | 2004-12-06 | 2009-12-22 | Skyler Technology, Inc. | Enumeration of trees from finite number of nodes |
US8316059B1 (en) | 2004-12-30 | 2012-11-20 | Robert T. and Virginia T. Jenkins | Enumeration of rooted partial subtrees |
US8615530B1 (en) | 2005-01-31 | 2013-12-24 | Robert T. and Virginia T. Jenkins as Trustees for the Jenkins Family Trust | Method and/or system for tree transformation |
US7681177B2 (en) | 2005-02-28 | 2010-03-16 | Skyler Technology, Inc. | Method and/or system for transforming between trees and strings |
US7727170B2 (en) * | 2005-03-17 | 2010-06-01 | Warner Michael J | Elastic hysteretic palpatory training apparatus and method of use thereof |
US8356040B2 (en) | 2005-03-31 | 2013-01-15 | Robert T. and Virginia T. Jenkins | Method and/or system for transforming between trees and arrays |
US7899821B1 (en) | 2005-04-29 | 2011-03-01 | Karl Schiffmann | Manipulation and/or analysis of hierarchical data |
US20060286525A1 (en) * | 2005-05-25 | 2006-12-21 | Haines Lindsay K | Wearable breast examination training apparatus |
US7575434B2 (en) * | 2006-08-01 | 2009-08-18 | Palakodeti Ratna K | Surgery practice kit |
US7419376B2 (en) * | 2006-08-14 | 2008-09-02 | Artahn Laboratories, Inc. | Human tissue phantoms and methods for manufacturing thereof |
EP2096615A3 (en) * | 2008-02-29 | 2014-01-01 | Laerdal Medical AS | Simulator for medical training with detachable self-sealing hollow member |
JP5424080B2 (en) * | 2008-08-25 | 2014-02-26 | 芳裕 小澤 | Safety evaluation dummy, safety evaluation artificial skin |
TW201016200A (en) * | 2008-10-31 | 2010-05-01 | Ind Tech Res Inst | A phantom and its manufacturing method |
US8063621B2 (en) * | 2008-11-05 | 2011-11-22 | Semiconductor Components Industries Llc | Current balancing circuit and method |
WO2010126018A1 (en) * | 2009-04-28 | 2010-11-04 | 有限会社聖和デンタル | Organ model |
US20110081636A1 (en) * | 2009-10-07 | 2011-04-07 | Lyle Ashley Wilkes | Dual gender cancer teaching kit |
US8500452B2 (en) * | 2010-02-19 | 2013-08-06 | Gaumard Scientific Company, Inc. | Interactive education system for teaching patient care |
US8740624B2 (en) | 2010-02-19 | 2014-06-03 | Gaumard Scientific Company, Inc. | Interactive education system with physiological modeling |
WO2011103489A2 (en) | 2010-02-19 | 2011-08-25 | Gaumard Scientific Company, Inc. | Ultrasound phantom models, materials, and methods |
US8673003B1 (en) * | 2010-07-20 | 2014-03-18 | Abdullah Khalid Al Rasheed | Method for improving the early detection of breast cancer and device therefor |
US8517740B2 (en) | 2011-02-18 | 2013-08-27 | Gaumard Scientific Company, Inc. | Lung compliance simulation system and associated methods |
US10037715B2 (en) | 2013-10-16 | 2018-07-31 | Simulab Corporation | Detecting insertion of needle into simulated vessel using a conductive fluid |
AU2015235994B2 (en) * | 2014-03-26 | 2019-11-21 | Applied Medical Resources Corporation | Simulated dissectible tissue |
EP2977977A1 (en) * | 2014-07-23 | 2016-01-27 | Sabanci Üniversitesi | A composite structure for medical training and production method thereof |
US10333696B2 (en) | 2015-01-12 | 2019-06-25 | X-Prime, Inc. | Systems and methods for implementing an efficient, scalable homomorphic transformation of encrypted data with minimal data expansion and improved processing efficiency |
WO2017089737A1 (en) * | 2015-11-24 | 2017-06-01 | Pemberton Ford Carrie | Cancer training aid device |
JP2021051244A (en) * | 2019-09-26 | 2021-04-01 | 株式会社エムシーピー | Breast model composed of silicone elastic body having pressure sensor and manufacturing method therefor |
CL2019003721A1 (en) | 2019-12-18 | 2021-09-20 | Univ Pontificia Catolica Chile | Device for training and direct practice of breast self-palpation techniques |
WO2022094476A1 (en) * | 2020-11-02 | 2022-05-05 | Sure, Inc. | Method and local and regional cloud infrastructure system for pressure elastography measurement devices |
CN113539039B (en) * | 2021-09-01 | 2023-01-31 | 山东柏新医疗制品有限公司 | Training device and method for drug application operation of male dilatation catheter |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3520071A (en) * | 1968-01-29 | 1970-07-14 | Aerojet General Co | Anesthesiological training simulator |
US3564729A (en) * | 1968-06-28 | 1971-02-23 | Singer General Precision | Medical training device |
US3662076A (en) * | 1970-04-22 | 1972-05-09 | Research Corp | Cardiac training mannikin |
US3742935A (en) * | 1971-01-22 | 1973-07-03 | Humetrics Corp | Palpation methods |
US3681787A (en) * | 1971-03-26 | 1972-08-08 | Moxness Products Inc | Implantable breast prosthesis filled with gels of different densities |
US3942516A (en) * | 1974-03-18 | 1976-03-09 | Cyborg Corporation | Biofeedback training method and system |
US4001951A (en) * | 1975-03-25 | 1977-01-11 | Fasse Wolfgang G | Breast cancer detection training device |
-
1977
- 1977-10-11 US US05/841,076 patent/US4134218A/en not_active Expired - Lifetime
-
1978
- 1978-10-02 GB GB7838922A patent/GB2005894B/en not_active Expired
- 1978-10-02 GB GB8108166A patent/GB2077017B/en not_active Expired
- 1978-10-10 CA CA312,932A patent/CA1109252A/en not_active Expired
- 1978-10-11 DE DE2844373A patent/DE2844373C3/en not_active Expired
- 1978-10-11 JP JP53124207A patent/JPS6024946B2/en not_active Expired
- 1978-10-11 DE DE2857496A patent/DE2857496C2/de not_active Expired
-
1984
- 1984-10-26 JP JP59224279A patent/JPS6042473B2/en not_active Expired
Also Published As
Publication number | Publication date |
---|---|
GB2077017A (en) | 1981-12-09 |
JPS6024946B2 (en) | 1985-06-15 |
DE2844373C3 (en) | 1982-03-25 |
GB2077017B (en) | 1982-10-13 |
JPS5493881A (en) | 1979-07-25 |
DE2844373A1 (en) | 1979-04-19 |
GB2005894A (en) | 1979-04-25 |
GB2005894B (en) | 1982-05-26 |
DE2844373B2 (en) | 1981-07-09 |
DE2857496C2 (en) | 1988-02-11 |
US4134218A (en) | 1979-01-16 |
JPS60121484A (en) | 1985-06-28 |
JPS6042473B2 (en) | 1985-09-21 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CA1109252A (en) | Breast cancer detection training system | |
US4867686A (en) | Breast cancer detection model and method for using same | |
CA2423513C (en) | Computer based instrumentation and sensing for physical examination training | |
US6854976B1 (en) | Breast model teaching aid and method | |
US6773263B2 (en) | Medical simulator | |
US7665995B2 (en) | Medical training simulator including contact-less sensors | |
Hall et al. | Progress in manual breast examination | |
US4605373A (en) | Training device for setting broken limbs | |
CA2058776A1 (en) | Electrode placement training system | |
JPH0951885A (en) | Improved device to obtain body inpedance data, using part impedance and plurality of frequency impedances | |
US20120171652A1 (en) | Pressure Ulcer Simulator and Related Methods | |
Adams et al. | Lump detection in simulated human breasts | |
CN108324554A (en) | A kind of dot matrix is wirelessly automatically positioned meridian point Chinese medicine diagnosis and therapy apparatus | |
US5719916A (en) | Anthropomorphic mammography and lung phantoms | |
US4592371A (en) | Muscle testing method | |
CN108577839A (en) | A kind of robot doctor diagnosis and treatment intelligence system and its working method | |
US6945783B2 (en) | Interactive breast examination training model | |
JP7343110B2 (en) | Method for simulating puncture needle insertion into the bone marrow of a human body part using a phantom for bone marrow aspiration training | |
WO2000013591A1 (en) | Method and system for tactile imaging for breast cancer examination and detection of prostate cancer | |
CA1147951A (en) | Breast cancer detection training system | |
Kumar et al. | A membrane-potentiometer-based palpation position sensor suitable for ophthalmic anesthesia training | |
Kalff et al. | Material surface detection on various body parts: a preliminary study for temperature substitution for upper arm amputees | |
Solanki et al. | Haptic based augmented reality simulator for training clinical breast examination | |
Murphy et al. | Temporomandibular-related pressure thresholds: a model for establishing baselines | |
Watson et al. | Equipment to evaluate the ability of physiotherapists to perform graded postero-anterior central vertebral pressure type passive movements of the spine by thumb pressure |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
MKEX | Expiry |