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    • 专利摘要:
    Cadaver clinical simulator. The present invention relates to a composition comprising a humectant, a first antiseptic, a fixative, a thickener, a dye and water. The invention also relates to a corpse comprising a composition of the invention and/or at least one tag configured to communicate by radiofrequency and transmit a clinical information contained in the label to a device, as well as with its methods of obtaining and its uses. For medical training, learning or evaluation. Additionally, the invention is related to simulators and their uses for medical training, learning or evaluation. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2610032A1
    申请号:ES201531263
    申请日:2015-09-02
    公开日:2017-04-25
    发明作者:Francisco SÁNCHEZ DEL CAMPO；Marina SÁNCHEZ FERRER；Francisco SÁNCHEZ FERRER；María Luisa SÁNCHEZ FERRER
    申请人:Universidad de Murcia；Universidad Miguel Hernandez de Elche；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    5The present invention falls within the field of clinical simulators for themedical training, learning and evaluation. BACKGROUND OF THE INVENTION
    10 In medical education, simulators are demanded, as there are more and more models, some of them of high technology aimed at the learning of certain techniques by students.
    15 Most simulators are intended for specific functions, for example, there are simulators for cardiac massage or endotracheal intubation, spinal tap, or venocrisis. Therefore, it is necessary to have several simulators that are usually expensive and that sometimes fail to simulate the reality of a patient and are considered as a dummy.
    20 The use of animals as an alternative presents several problems, including large anatomical differences. In addition, the animal must be treated with minimal suffering so it must be anesthetized by an anesthetist with the consequent expenditure on resources and limitation of the intervention to a certain duration. The use of animals in addition,
    25 is a high cost since animals must be housed in extreme hygiene conditions.
    On the other hand, the use of frozen human corpses that are defrosted before use present the inconvenience of their danger to the user as they are
    30 corpses not treated with antiseptics while their use is closely linked to the duration of any test since once defrosted the decomposition period begins with the emission of unpleasant odors and the inability to freeze again because a second defrosting leaves the tissues without the right consistency to perform the surgery.


    Alternatively, the corpses preserved with the classic formolic or phenolic techniques cannot be used to perform some surgeries such as laparoscopic, since the stiffness of their tissues and the abdominal wall in particular prevents the abdominal wall from being distended by the action of the peritoneum distension essential to create a
    5 cavity enough to work with the right instruments.
    The bodies prepared with the Thiel method (Thiel, W. Annals of Anatomy (1992) 174: 185-195; (2002) 184: 267-269), have a disadvantage that the body cannot bleed, so it is not possible to monitor blood pressure, or perform hemostasis.
    10 Therefore, it is necessary to develop new clinical simulators that can be used to simulate different pathologies, of low cost and lasting over time, capable of simulating a live real human and allowing the testing of various techniques simultaneously. SUMMARY OF THE INVENTION
    In a first aspect, the invention relates to a composition comprising a humectant, a first antiseptic, a fixative, a thickener, a colorant and water.
    In a second aspect, the invention relates to a corpse comprising a composition of the invention in its vascular system.
    In a third aspect, the invention relates to a method of preserving a corpse comprising injecting a composition of the invention into a corpse.
    In a fourth aspect, the invention relates to the use of a corpse comprising a composition according to the invention in its vascular system for medical training, learning or evaluation.
    In a fifth aspect, the invention relates to a corpse comprising at least one tag configured to communicate by radio frequency and transmit clinical information contained in the tag to a device.
    In a sixth aspect, the invention relates to a method of obtaining a corpse according to the invention which comprises implanting at least one label in the corpse.


    configured to communicate by radio frequency and transmit clinical information contained in said label to a device.
    In a seventh aspect, the invention relates to the use of a corpse comprising
    5 at least one tag configured to communicate by radio frequency and transmit aclinical information contained on the label to a device for medical training,Learning or evaluation
    In an eighth aspect, the invention relates to a corpse comprising a
    The composition of the invention in its vascular system and which additionally comprises at least one tag configured to communicate by radiofrequency and transmit clinical information contained in said tag to a device.
    In a ninth aspect, the invention relates to the use of a corpse comprising
    A composition of the invention in its vascular system and additionally comprising at least one tag configured to communicate by radiofrequency and transmitting clinical information contained in said tag to a device for medical training, learning or evaluation.
    In a tenth aspect, the invention relates to a method of obtaining a clinical simulator comprising
    (i)  perfuse a corpse according to the invention, and
    (ii) implant at least one tag configured to communicate by radiofrequency and transmit clinical information contained in the tag to a device.
    In an eleventh aspect, the invention relates to a simulator comprising:
    (I)  a corpse according to the invention and
    (II) a reader configured to communicate by radiofrequency with the tag and display the clinical information of the tag visually or a reader configured to communicate
    30 by radiofrequency with the label and transmit the information to be displayed visually on another device.
    In a twelfth aspect, the invention relates to a simulator comprising a corpse comprising a composition of the invention and a peristaltic pump.


    In a thirteenth aspect, the invention relates to the use of a simulator of the invention for medical training, learning or evaluation. BRIEF DESCRIPTION OF THE FIGURES
    5Figure 1. A. Carotid and jugular catheterization, B: Pseudo-blood recirculationby peristaltic pump interspersed between carotid and jugular.Figure 2. A and B. Image of a laparoscopic view of a blood vessel bleeding froma corpse reperfused with the pseudosangre
    10 Figure 3. A: NFC tag, B Introduction of the NFC tag in subcutaneous cell tissue. Figure 4. Representation of the operation of the simulator, the transducer reads the information contained in the NFC tag placed in different parts of the body and the corresponding image is displayed on the computer. A: The transducer is placed in the thoracic region and in the
    The computer displays a chest x-ray with explanatory text, or sounds of respiratory cardio auscultation. B .: The transducer placed on the wrist of the corpse allows an x-ray of the carpus to be reproduced. C: The transducer located in the neck reproduces a cervical CT. D: The transducer located in the abdomen of the body reproduces an abdominal CT scan in the computer DETAILED DESCRIPTION OF THE INVENTION
    The inventors of the present invention have developed a composition that exhibits a blood-like, pseudo-blood behavior (examples 1, 2 and 4) and have developed a
    25 optimal simulator for the practice of pre-acting medicine on living patients.
    The attainment of a blood recirculation by means of pseudosangre gives the laparo and thoracoscopy techniques an extreme realism where the surgeon is forced to perform preventive hemostasis or in cases of vascular injury to his clamping,
    30 aspiration and ligation or hemostasis with electric scalpel or other procedures.
    In addition, the implantation of NFC tags in the corpse allows the elaboration of practical evaluations by obtaining clinical information, such as images of or sounds contained in said tag (Examples 3 and 4).


    Composition of the invention.
    In a first aspect, the invention relates to a composition comprising a humectant, a first antiseptic, a fixative, a thickener, a colorant and water.
    Said composition is useful to be used in the recirculation of the vascular system in a5 corpse
    "Moisturizer" as used in the present invention, refers to a surfactant that, added to water, reduces its surface tension and promotes wetting by making water more easily penetrate another material or spread more easily over its surface There is a wide variety of wetting agents known to those skilled in the art. Preferably the wetting agents are selected from hydrophilic polymeric substances, such as anionic or non-ionic surfactants, such as, for example, monoethylineglycol, polyethylene glycol and polyethylene glycol derivatives (for example, polyethylene glycol alkyl ethers and oxyethylene polymers), polyols, acids
    15 ethoxylated fatty acids and siloxanes. Other humectants are glycerin, propylene glycol, sorbitol, lactic acid and urea.
    In a particular embodiment, the humectant is monoethylene glycol or polyethylene glycol. In a more particular embodiment the composition comprises monoethylene glycol or polypropylene glycol 2520 32% (v / v), more preferably 26.6-29.4% (v / v) and even more preferably 28% (v / v).
    By "monoethylene glycol" as used in the present invention, it refers to the compound with CAS number 107-21-1.
    "Polyethylene glycol," according to the invention known as Poly (oxy-1,2-ethynediyl), alpha-hydro-omegahydroxy, PEG, Carbowax, poly (ethylene oxide), polyoxyethylene, polyethylene oxide or Macrogol, corresponds to the compound with CAS number 25322-68-3.
    By "antiseptic" as used in the present invention, it refers to a substance
    30 antimicrobial that are applied to a biological tissue, reducing the possibility of infection, sepsis or putrefaction. Illustrative, non-limiting examples of antiseptics are 4-chloro-3 methylphenol, acetic acid, boric acid, ethyl alcohol, isopropyl alcohol, and formaldehyde.
    In a preferred embodiment the antiseptic is 4-chloro-3 methylphenol. In a preferred embodiment, the composition comprises 0.7M 4-chloro-3 methylphenol in ethylene glycol or


    0.075-0.090% (v / v) polypropylene glycol, more preferably 0.07885-0.08715% (v / v) and even more preferably 0.083% (v / v).
    "4-Chloro-3 methylphenol", also known as chlorocresol, parachlorometacresol or PCMC, corresponds to the compound with CAS number 59-50-7.
    "Fixer", as used in the present invention, refers to a substance capable of preserving the morphology and chemical composition of the cells of an organism, so that postmortem processes are stopped and the structures are preserved with a minimum of artifice, preparing them for further treatment. Illustrative, non-limiting examples of chemical fixatives are formalin, formaldehyde, gliozal, acrolein, glutaraldehyde, methanol, ethanol, paraldehyde, osmium tetroxide, chromic oxide, acetic acid, picric acid, mercury bichloride, potassium dichromate and acetone. In a particular embodiment, the fixing agent is formalin.
    In a particular embodiment, the composition comprises 2-4% (v / v) formalin, more particularly 2.25-2.75% (v / v) and even more particularly 2.5% (v / v).
    "Formalin," as used in the present invention, refers to 45% formalin in water. Formol corresponds to the compound with CAS number 50-00-0.
    By "thickener" as used in the present invention it refers to a compound that, when added to a mixture, increases its viscosity without substantially modifying other properties. Examples of thickeners are based on polysaccharides, such as starches or vegetable gums, proteins (egg yolk or collagen). Other thickeners are Agar-Agar, alginine, carrageenan, collagen, corn starch, gelatin, guar gum, locust bean gum, pectinapectin and xanthan gum. In a preferred embodiment the thickener is potato starch or corn starch. In an even more preferred embodiment, the thickener is cornstarch.
    In a preferred embodiment the composition comprises corn starch 0.1-0.3% (w / v), more preferably 0.19-0.21% (w / v) and even more preferably 0.20% (w / v).


    By "corn starch", corn starch or cornstarch as used in the present invention, refers to starch flour without containing that of the corn grain endosperm.
    "Dye", as used in the invention refers to a substance that is capable ofmodify or intensify the color, being able to be natural or artificial. In one embodimentPreferred the dye is a red dye. Illustrative, non-limiting examples of dyesreds are E-120 or carmic acid, E-121 or orcilla, E-122 azorubin, E-123 amaranth or redCarmine, E-124 GN Scarlet, E-126 Ponceau 6R, E-127 Erythrosine, E128 Red 2G.
    In a more preferred embodiment, the red dye is E-123.
    In a preferred embodiment, the composition comprises E-123 dye 0.2-0.4% (w / v), more preferably 0.27-0.33% (w / v) and even more preferably 0.30% ( p / v).
    "By E-123 dye" as used in the present invention refers to the compound with CAS number 915-67-3.
    In a preferred embodiment of the composition of the invention, the humectant is
    20 polypropylene glycol or monopropylene glycol, the antiseptic is 4-chloro-3-methylphenol, the fixative is formalin, the thickener is cornstarch and / or the dye is E-123 carmine red dye.
    The composition of the invention may additionally contain a second antiseptic, a buffering agent, a compound capable of maintaining tissue color, an oxidizing agent.
    25 hygroscopic and / or a preservative agent.
    By "buffering agent" is meant, in the context of the present invention, an agent capable of controlling the pH of the solution. Suitable buffer agents for the present invention are phosphate (monoacidic and diacidic), bicarbonate, sulfate, histidine, histidine-HCl, HEPES and
    30 citrate
    The term "pH" refers to the measure of the acidity or alkalinity of a solution. The pH typically ranges from 0 to 14 in aqueous solution, the solutions being acidic with pHs below 7 and alkaline those having pHs greater than 7. The pH = 7 indicates the neutrality of the solution, where the solvent is water. The pH determination of a solution can be done precisely by means of a potentiometer (or pH meter) and also


    approximated by indicators, by methods widely known in the state of the art. Since the pH value can vary with temperature, in the context of this invention the pH measurement is performed at 20 ° C. The compositions of the invention have a pH measured at 20 ° C between 6.5 and 8.5; preferably between 7.0 and
    5 7.5.
    In the composition of the invention the same compound can have more than one function. In a preferred embodiment, the second antiseptic and buffering agent is boric acid.
    In a preferred embodiment, the composition comprises 0.1-0.3% boric acid (w / v), more preferably 0.2375-0.2625% (w / v) and even more preferably 0.25% (w / / v).
    "Boric acid" or trioxoboric acid, as used in the present invention, refers to the compound with slightly acidic CAS number 10043-35-3 with antiseptic properties and buffering agent for pH regulation.
    By "compound capable of maintaining the color of tissues", as used in the present invention, it refers to a substance that added to a biological tissue allows to preserve the original coloration, specifically, to maintain the coloration of living tissues. The person skilled in the art knows techniques to identify compounds capable of maintaining tissue color, for example those compounds that inhibit enzymatic browning or inhibit some stages of the Maillard reaction. Illustrative non-limiting examples of compounds capable of maintaining tissue color are sulfur dioxide or E 220, sodium sulfite or E 221, sodium acid sulfite, sodium bisulfite or E 222, sodium metabisulfite or
    25 E 223, potassium metabisulfite or E 224, calcium sulphite or E 226, calcium acid sulfite or E 227 and potassium acid sulphite or E 228.
    In a preferred embodiment the compound capable of maintaining tissue color is sodium sulphite.
    In a more preferred embodiment the composition comprises 0.15-0.25% (w / v) sodium sulphite, more preferably 0.178-0.197% (w / v) and even more preferably 0.1875% (w / v).
    By "sodium sulphite" as used in the present invention refers to the compound with CAS number 7757-83-7.


    "Hygroscopic oxidizing agent" as used in the present invention refers to a chemical compound that oxidizes another substance in an electrochemical or reduction-oxidation reaction and that can absorb water. In a preferred embodiment the hygroscopic oxidizing agent is ammonium nitrate.
    In a preferred embodiment, the composition comprises 1.5-4% (w / v) ammonium nitrate, more preferably 3.04-3.36% (w / v), and even more preferably 3.2% (w / v)
    "Ammonium nitrate", as used in the invention refers to the salt formed by nitrate and ammonium ions, with CAS number 6484-52-2.
    "Preservative agent", as used in the present invention, refers to a compound that stops or inhibits the deterioration caused by the presence of different microorganisms in biological tissues. Illustrative, non-limiting examples of preservatives are sorbates,
    15 benzoates, sulphites, nitrites and nitrates. In a preferred embodiment the preservative is potassium nitrate.
    In another particular embodiment, the composition of the invention comprises potassium nitrate 2-5% (w / v), more preferably 3,952-4,368% (w / v) and even more preferably 4.16% (w / v).
    "Potassium nitrate" as used in the present invention refers to the compound with CAS number 7757-79-1.
    In a preferred embodiment of the composition, the second antiseptic and buffering agent is boric acid, the compound capable of maintaining tissue color is sodium sulphite, the hygroscopic oxidizing agent is ammonium nitrate and / or the preservative is potassium nitrate.
    In a more preferred embodiment, the composition of the invention comprises boric acid, monoethylene glycol or polyethylene glycol, ammonium nitrate, potassium nitrate, 4 chloro-3 methylphenol, sodium sulphite, formalin, corn starch, E-123 dye and water.
    In a preferred embodiment, the composition of the invention has a pH between 6.5 and 8.5; measured at 20 ° C.
    The term "osmolarity", in the context of the present invention, is a measure of the total concentration of substances in solution, defined as the number of osmoles of


    solute per liter of solution, which indicates the possible variation of the osmotic pressure that will occur in the cells when the composition of the invention is introduced into the body. The osmolarity can be calculated from the value of the osmolality, the latter measured by an osmometer by methods known to those skilled in the art. Since the
    Osmolarity is temperature dependent, in the context of the present invention the calculation of osmolarity is performed at 20 ° C. The osmolarity of the composition of the invention, measured at 20 ° C, can be between 300 and 410 mOsm / L; preferably between 310 and 390 mOsm / L; more preferably between 320 and 360 mOsm / L.
    Ideally, the requirements that the composition of the invention must meet are:
    one. Have a bright red color similar to arterial blood
    2. Rheological behavior analogous to natural blood, which implies presenting the characteristics of a non-Newtonian fluid
    3. Its pigmentation and composition should not alter in any way the optics of
    15 endoscopes, laparoscopes, cystoscopes, hysteroscopes or arthroscopes. therefore, it must not permanently alter or stain the devices, or impregnate the tissues indelibly, but must disappear when aspirated with the surgical aspirator or prior washing with physiological serum.
    4. Its density and dynamic viscosity should allow vascular circulation
    20 5. Its characteristics should allow hemostasis performed not only by mechanical means, ligature by ligature and clip suture but also by mono or bipolar electric scalpel as well as by the most modern radiofrequency and ultrasound methods
    6. Chemical stability to be used indefinitely.
    25 7. Have antiseptic substances in order to prevent cadaveric decomposition as well as the protection of manipulators
    8. Adequate mineral salts and in the right proportion to achieve tissue turgidity.
    9. The texture, elasticity and friability of corpse tissues should not be altered by the composition of the invention.
    Thus, the various components of the composition of the invention may be in varying amounts, although preferably the composition of the invention comprises 0.1-0.3% boric acid (w / v); monoethylene glycol or polypropylene glycol 25-32% (v / v); Ammonium Nitrate 1.5-4% (w / v); potassium nitrate 2-5% (w / v); 0.7M 4-chloro-3 methylphenol in ethylene glycol or


    0.075-0.090% polypropylene glycol (v / v); sodium sulphite 0.15-0.25% (w / v); formalin 2-4% (v / v); 0.1-0.3% corn starch (w / v) and E-123 0.2-0.4% dye (w / v).
    The expressed ranges cover any intermediate value and the extremes.
    5In another more particular embodiment, the composition of the invention comprises boric acid.0.2375-0.2625% (w / v); monoethylene glycol or polypropylene glycol 26.6-29.4% (v / v); ammonium nitrate3.04-3.36% (w / v); potassium nitrate 3,952-4,368% (w / v); 0.7M 4-chloro-3 methylphenol inethylene glycol or polypropylene glycol 0.07885-0.08715% (v / v); sodium sulfite 0.178-0.197% (w / v);
    10 formalin 2.25-2.75% (v / v); corn starch 0.19-0.21% (w / v) and dye E-123 0.27-0.33% (w / v).
    In yet another embodiment the composition of the invention comprises 0.25% boric acid (w / v); monoethylene glycol or polypropylene glycol 28% (v / v); 3.2% ammonium nitrate (w / v); nitrate
    15 potassium 4.16% (w / v); 0.7M 4-chloro-3 methylphenol in ethylene glycol or 0.083% polypropylene glycol (v / v); 0.1875% (w / v) sodium sulphite; formalin 2.5% (v / v), corn starch 0.20% (p / v); dye E-123 0.30% (w / v).
    The percentages (w / v) or weight / volume and (v / v) or volume / volume refer to the weight 20 of the component by volume of water and volume of the component by volume of water respectively.
    First corpse
    In another aspect, the invention relates to a corpse (first corpse of the invention) comprising a composition of the invention in its vascular system.
    The first corpse of the invention, comprising a composition of the invention in its vascular system, has the characteristic of bleeding by damaging its blood vessels.
    "Corpse" as used in the present invention, refers to an animal body that has lost its life and to which its vital signs, such as pulsations or beats, are not recorded. The animal can be of any species, preferably a mammal and more preferably a human.
    35 The loss of life can be verified by identifying various signs of death, such as complete and permanent absence of conscience; permanent absence


    of spontaneous breathing; lack of perception and response to external stimuli; absence of cranial nerve reflexes and medullary reflexes; atony of all muscles; the term of physiological regulation of body temperature or irreversible cardiac arrest.
    5 By "vascular system", as used in the present invention, refers to the set of vessels that carry blood and lymph.
    The composition of the invention can be administered to the body preferably by
    10 perfusion with peristaltic pump. In this way, the composition of the invention is introduced through the circulatory system through which it accesses all cells thanks to the capillary network.
    Conservation method
    In another aspect, the invention relates to a method of preserving a corpse comprising injecting a composition of the invention into a corpse.
    By "preservation" or preservation of a corpse, as used herein
    The invention relates to stopping or slowing down the enzymatic action in human or animal tissue compared to untreated tissue, which prevents or slows the autocatalytic breakdown of this tissue, and / or that the tissues exhibit better resistance to external attacks. of the microorganisms that the untreated tissues, therefore avoiding or delaying the rapid deterioration of the tissues that occurs after death.
    "Injecting" or perfusing as used in the present invention refers to introducing a solution into a corpse. In a preferred embodiment, the perfusion is performed by arterial route. The composition of the invention enters through the carotid artery and exits through the jugular passes to the peristaltic pump and back to the closed circuit artery. In other
    In the previous embodiment an arteriovenous fistula is established between the femoral artery and the femoral vein. Another possibility consists of perfusion by the carotid and exit through the femoral artery, and can also be performed in a closed circuit by means of a peristaltic pump.
    35 As the person skilled in the art will understand, the ideal technique would be that prior to perfusion with the composition of the invention, the corpse is exanguinated, for which it is


    It is possible to perfuse with warm citrated physiological serum through the arterial route and drain the blood through a thick catheter introduced through the femoral vein to the right atrium. Later, after 24 hours, it is possible to perfuse with Thiel's solution (Thiel, W. Annals of Anatomy (1992) 174: 185-195; (2002) 184: 267-269). In a preferred embodiment the
    The infusion with Thiel's solution is performed systemically, endotracheally, rectally and in the superior longitudinal sinus.
    In another embodiment, the body has undergone an arteriovenous bypass.
    10 By “arteriovenous bypass”, it refers to the connection between arteries and veins, allowing an arteriovenous fistula. The person skilled in the art knows techniques for performing said arteriovenous bypass, for example it is possible by placing a 10 mm plastic tube between the artery and the femoral vein.
    15 Uses of the first corpse
    In another aspect, the invention relates to the use of the first corpse of the invention for medical training, learning or evaluation.
    Therefore, the first corpse of the invention makes it possible to replace reality with a simulated scenario in which medical students and professionals can train to acquire communication, psychomotor or teamwork skills.
    By "evaluation", in the present invention it is understood to evaluate communication skills and
    25 psychomotors of a medical student or a professional, for example in the so-called 'structured objective clinical examination' (ECOE).
    The terms and limitations described above are equally applicable to this aspect.
    30 Second corpse
    In another aspect, the invention relates to a corpse (second corpse of the invention) comprising at least one tag configured to communicate by radio frequency and
    35 transmitting clinical information contained in the label to a device.


    By "a label configured to communicate by radiofrequency and transmit clinical information contained in the label to a device", as used in the present invention, also known as a receiver, card or transponder, refers to a storage system and remote data recovery by a sender that recovers data stored in said receiver or tag wirelessly. Said label allows to transmit an identity request of an object from a reader by means of radio waves to said receiver, or label. The tags contain antennas to allow reception and response to such requests by radio frequency. Therefore, as the person skilled in the art will understand, the labels of the invention to be transmitted by
    10 radiofrequency clinical information, are configured to communicate by radiofrequency.
    By "radiofrequency," as used in the present invention, it refers to the least energetic portion of the electromagnetic spectrum, located between 3 hertz (Hz) and 300 gigahertz (GHz). Radio frequency includes an illustrative, non-limiting way of an electromagnetic wave, a light signal or a sound signal.
    "Clinical information", as used in the present invention, refers to sounds, paths or images of the normal or pathological human or animal being. By way of example 20 illustrative, not limiting, radiography image or CT scan, NMR, or scintigraphy.
    The operation of these labels, as well as how to include the clinical information and visualize it on a device such as a computer, are known in the state of the art, and can be done through the use of commercial kits, such as the NFC Solutions
    25 Identitive NFC Development Kit (SDK) containing NFC readers for use via desktop and USB, basic commands for communication between tags and readers in different programming languages such as VC ++, Delphi, C # or VB.Net, and software to reproduce the clinical information on a device.
    30 As the person skilled in the art will understand, the label configured to communicate by radiofrequency and transmit clinical information contained in the label to a device must be placed in the body so that it can communicate by radiofrequency.
    In a particular embodiment, the tag is located subcutaneously. For the implantation of said labels subcutaneously it is possible to section the skin and create a


    Small space in the subcutaneous tissue, place the label and close the incision using adhesives.
    As one skilled in the art will understand, the second corpse of the invention can5 contain a variable number of tags.
    In a preferred embodiment, the tag configured to communicate by radio frequency is an RFID tag.
    10 “RFID tags” can use different frequencies, but generally the most common frequencies are: Low frequency (Low Frequency or LF), High frequency (High Frequency or HF) and Ultra high frequency (Ultra High Frequency or UHF). Because radio waves behave differently according to their frequency, the appropriate band should be chosen according to the application in which the system is intended to be used. So, the
    The frequency segmentation of the systems according to each frequency band is as follows: RF Low frequency RFID (LF) systems: these systems work at frequencies emitted in a range of 120 KHz and 150 KHz.  High frequency (HF) RFID systems: these systems work at frequencies close to 13.56 MHz.  Ultra high frequency (UHF) RFID systems: these systems work at frequencies in a range between 860 and 960 MHz.
    In a particular embodiment, the RFID type tag is a high frequency tag and
    25 more particularly an NFC tag. High frequency labels are suitable for communication, including in the deep cavities of a corpse, since the range of the labels is about 20 cm.
    By "NFC label" (from Near English Faith Communication), as used herein
    The invention refers to a wireless communication label, short range and high frequency that allows the exchange of data between devices and communicates by induction in a magnetic field with a frequency of 13.56 MHz, where two antennas of spiral are placed within their respective near fields.
    35 Among the types of labels are:  passive labels, which do not need additional power, and


     active labels, which require additional power supply.
    In the case of passive systems, it is necessary to extract energy from the environment in which the reader system is located. In the case of active systems, energy is obtained from an energy source that generates energy independently, such as a battery or from the power grid.
    In a preferred embodiment the tag is of the passive type.
    10 The terms and limitations described above are equally applicable to this aspect.
    Second method
    In another aspect, the invention relates to a method of obtaining a corpse that
    15 comprises at least one tag configured to communicate by radiofrequency and transmit clinical information contained in the tag to a device (second corpse of the invention), which comprises implanting at least one tag configured in the corpse to communicate by radiofrequency and transmitting information clinic contained in said tag to a device.
    In a preferred embodiment, the label is implanted subcutaneously.
    In another preferred embodiment the tag is of the RFID type, more particularly of the NFC type. In another embodiment, the tag is of the passive type.
    25 The terms and limitations described above are equally applicable to this aspect.
    Second use
    In another aspect, the invention relates to the use of a corpse comprising at least one tag configured to communicate by radiofrequency and transmitting clinical information contained in the tag to a device (second corpse of the invention) for medical training, learning or evaluation.
    35 The terms and limitations described above are equally applicable to this aspect.


    Third corpse
    In another aspect, the invention relates to a corpse comprising a composition
    5 of the invention in its vascular system and additionally comprising at least one tag configured to communicate by radiofrequency and transmitting clinical information contained in said tag to a device (third corpse of the invention).
    In a preferred embodiment, the tag is located subcutaneously.
    In another preferred embodiment the tag is of the RFID type, more particularly of the NFC type. In another embodiment, the tag is of the passive type.
    The terms and limitations described above are equally applicable to this aspect.
    Third use
    In another aspect, the invention relates to the use of a corpse comprising a
    The composition of the invention in its vascular system and additionally comprising at least one tag configured to communicate by radiofrequency and transmitting clinical information contained in said tag to a device for medical training, learning or evaluation.
    25 The terms and limitations described above are equally applicable to this aspect.
    Third method
    In another aspect, the invention relates to a method of obtaining a clinical simulator comprising
    (i)  perfuse a corpse with a composition of the invention, and
    (ii) implant at least one label configured to communicate by radiofrequency and
    transmit clinical information contained in the label to a device. 35


    "Clinical simulator", or simulator as used in the present invention, refers to a model that simulates the actual functioning of a live animal from a clinical point of view, that is, it can be used to identify and evaluate different pathological conditions. Additionally it can simulate various functions of a live animal such as circulation
    5 of the blood, and can be used in surgical and medical practice.
    In a preferred embodiment, the body has been previously perfused with Thiel solution.
    By "Thiel's solution", as used in the present invention, it refers to a solution 10 for the preservation of a corpse, as described in Thiel, W. Annals of Anatomy (1992) 174: 185- 195.
    In another embodiment the perfusion of the composition is carried out by arterial route, more particularly by carotid or femoral route. In another embodiment, the body has undergone an arteriovenous bypass.
    In another embodiment, the label implanted in step (ii) is implanted subcutaneously. In another embodiment, the tag is an RFID type tag, more particularly an NFC tag.
    In another embodiment the tag is of the passive type.
    The terms and limitations described above are equally applicable to this aspect.
    Simulator
    In another aspect, the invention relates to a simulator comprising: 30 (I) a corpse comprising at least one tag configured to communicate by radiofrequency and transmitting clinical information contained in the tag to a device
    or a corpse comprising a composition of the invention and additionally at least one tag configured to communicate by radio frequency and transmit clinical information contained in said tag to a device, and


    (II) a reader configured to communicate by radiofrequency with the tag and display the clinical information of the tag visually or a reader configured to communicate by radiofrequency with the tag and transmit the information to be displayed visually on another device.
    5According to the invention, the reader is configured to communicate byradio frequency, which implies transmitting at least one radio frequency signal, wheresaid signal is in the operating range of the at least one tagemployed in the invention, receiving at least one radio frequency signal from the at least one
    The tag, wherein said radio frequency signal additionally comprises information stored in said at least one tag, to process the clinical information contained in said at least one tag and to display the clinical information or to transmit said information to be displayed on another device.
    15 That is, the reader can send a radio frequency signal, receive another radio frequency signal and send the information to the computer to process it and display the information. Alternatively, the reader does all these integrated functions.
    The reader detects labels in a short distance by the use of a number of technologies
    20 radio frequencies available depending on the type of tag. In one embodiment the tag is of the RFID type. In another embodiment the tag is of the NFC type. In another embodiment the tag is of the passive type.
    In preferred embodiments, an NFC reader and passive NFC tags are used.
    25 The tag reader emits an electromagnetic wave at a specific frequency. The energy of the tag obtains energy from the wave using magnetic induction. The tag uses energy to power a small chip that transmits a new electromagnetic wave that encodes the unique identification number of the agreement tag
    30 with a predefined protocol. The tag reader then receives the encoded signal and relays the information to the calculation engine.
    To read the clinical information contained in the tag, a reader is required to detect the tag by radiofrequency in the specific electromagnetic wave. 35


    The clinical information contained in the label is displayed on the reader (for example a mobile phone) or on an additional device such as a computer.
    Additionally, it is possible to have an interface configured to interact with a5 user and select the information to be displayed as indicated by the user.
    In another embodiment, the simulator additionally comprises a peristaltic pump.
    "Peristaltic pump" as used in the present invention refers to a type of
    10 positive displacement hydraulic pump used to pump a variety of fluids, preferably blood.
    In another aspect, the invention relates to a simulator comprising a corpse comprising a composition of the invention in its vascular system and a pump
    15 peristaltic.
    The terms and limitations described above are equally applicable to this aspect.
    The invention is described below by the following examples, which should be considered as merely illustrative and in no case limiting the scope of the present invention. Materials and methods
    Example 1. Preparation of the pseudosangre
    For the preparation of the pseudo-blood composition the following components were added in the mentioned amounts:
    30 Boric acid ………………………………………………… 0´25 gr. Mono ethylene glycol ………………………………. …… .. …… .28´00 ml. Ammonium nitrate (0.2 g / ml) …………………………………… 16'00 ml. Potassium nitrate …………………………… .. …………. …… .. 4'16 gr 4-chloro-3 methylphenol (0.7 M in ethylene glycol or polypropylene glycol)… 0'83 ml.
    35 Sodium sulphite (0.0375 g / ml)) ………………………… .. ……… 5'00 ml. Formalin, (45% formalin) …………………………………… 2'50 ml.


    Corn Starch ……………………………………………… ... 0´20 gr.Carmine red dye E -123 …………………………… .... 0´30 gr.Distilled water …………………………. ………… (up to 100 ml)
    5 Alternatively, polypropylene glycol can be added in the same amount as themonoethylene glycol
    The dissolution of the components is carried out at room temperature and finally filtered through a filter paper.
    10 Example 2. Preparation of the corpse perfusing with the pseudosangre The corpses come from people who voluntarily ceded their bodies voluntarily for medical teaching and research, treated with great respect by the users and subsequently incinerated.
    15 24-hour corpses are subjected to catheter implantation by arterioctomy and venotomies of the femoral or jugular vessels, examination by infusion of citrated and hot physiological serum until the clean liquid flows through the catheter. It is then perfused with Thiel's solution systemically, endotracheally, rectally, and breast
    20 longitudinal upper.
    After 24 hours of infusion with the solution for the Thiel systemic route, a Ker tube is placed in the carotid, another in the jugular suturing the soft parts of the dissection, while a venous artery fistula is performed by a By- Pass with plastic tube
    25 of 10 mm between the femoral artery and vein (Figure 1 A), under these conditions and by means of a peristaltic pump, it is perfused with the pseudo-blood that enters by carotid and leaves by jugular, restoring circulation (Figure 1 B). Under these conditions the blood vessels bleed (Figure 2 A and B).
    30 If the capillary circulation is not sufficient, the femoral bypass is unblocked, ensuring that the recirculation of the vessels of intermediate size and in some cases is perfused by the carotid and the pseudosangre is collected by the femoral artery in a closed circuit, ensuring the blood pressure and recirculation being able to demand blood pressure as well as heartbeat frequency.


    This model allows conditions of perfect training in terms of various surgeries by laparoscopy, arthroscopy, thoracoscopy as well as endoscopy, arterial puncture implantation of central catheterization pathways etc. 5 Example 3. Preparation of the corpse with NFC tags.
    N.F.C tags equipped with antenna and microchips capable of being activated by radiofrequency, recognized by sensor and capable of being programmed are used (Figure 3A). An NFC tag is a small passive card (without battery) that contains
    10 a small microchip attached to a small frame antenna. When the tag is scanned by an NFC reader, such as a mobile phone and another reader, the information retrieval, such as a web address, text, image, graphic or a command for the application, is turned on and transferred wirelessly.
    15 These labels are implanted in the subcutaneous cellular tissue of the different regions through small incisions sutured by means of adhesives that make them practically unrecognizable, implanting a total of 22 in different regions (Figure 3B).
    20 Subsequently and by means of the “Tag SDK” program and once the label is recognized, it is numbered, identified and the program in order to claim a library of sounds, graphics and images previously implemented in the computer.
    The tags used can be RapidNFC, SonyTinsi, TecTiles and the NFC 25 Tag SDK, Identive Smartcard Comander, Task Laucher,
    The label is located by means of a reader connected through a USB port to the "PC" and is implemented by means of software suitable for reproducing on the computer sounds, paths or images of the human being.
    30 The multiprogramming of the "nfc" labels allows not only the obtaining of normal images, sounds or paths, but also of different pathologies, as well as the software to generate texts for answering questions aimed at the realization of the diverse clinical histories, so that the bodies monitored in this way, not only transform
    35 in elements of normal or pathological study of the individual, and training of the


    physical examination but also of evaluation elements type ECOE (structured objective clinical evaluation).
    If the label is multiprogrammed, by way of example, the label located on the
    5 point for right sternal will reproduce the auscultatory sound of the sigmoid valvepulmonary but if we simultaneously press on the keyboard 1 the radiography will be observedap. of the thorax or when pressing 1ª we will see the lateral one. If we press 2 we will see the TAC and ifpress 3 we will see the NMR and 4 the anatomical section of the region. If previouslypress the letter P we will see images or pathological sounds well on a known index or
    10 well by random selection. It is possible that the computer asks the diagnosis and indicates to the user in self-evaluation mode if his diagnosis has been correct and in evaluation mode ECOE will give a list of correct or failed answers and a qualification for the evaluator calculating the penalties for wrong answers.
    15 If over time the corpse deteriorates in excess the labels, even their low cost, can be recovered for reimplantation in a new corpse before incineration
    or without more problems than reimplanting them in the same region from which it came.
    20 It is possible to hear different heart tones at different points of auscultation, or perform ECG pulmonary auscultation. In other regions, conventional radiological images can be observed, as well as CT and 3D reconstructions. Example 4-Exploration of the corpse
    25 The results of the physical examination of the corpse perfused with the pseudosangre are optimal. The elasticity of its tissues allows the palpation of the different bone accidents or possible abdominal masses to be the depreciable walls, the good observation of the oropharynx as well as a correct rhinoscopy, colposcopy otoscopy and
    30 anoscopy and through the laryngoscope it is possible to observe the larynx and practice tracheal laryngeal intubation.
    Similarly, it is possible to explore joint mobility as well as the mobility of the head and neck and of the mandibular temporo joint, which allows the correct
    35 inspection of the mouth and other parts.


    The corpse prepared with this technique allows the visualization of ultrasound images with practically the same definition as in vivo and being an eminently interactive technique it is essential that the explorer can observe the images to the movement of the probe in real time, which allows not only obtaining
    5 of ultrasound images, if not if the body is connected to recirculation, dynamic images can also be visualized with dopler effect, and also allows the realization of lumbar, epidural or subdural ultrasound punctures or infiltrations of ultrasound-guided nerve trunks.
    10 Using the implanted labels it is possible to observe with conventional radiographic imaging techniques TAC, NMR and anatomical sections of all body regions in normal mode or of different pathologies (Figure 4).
    Cardiopulmonary auscultation is possible and as for the cardiac it is possible to auscultate 15 independently the four classic foci in normal auscultation
    It is possible to practice venocrisis, the search for central pathways, as well as thoracocentesis or laparocentesis.
    20 As regards endoscopic techniques, bronchoscopy, esophagogastroscopy, pyloroplasty and trans duodenal papillotomy, as well as colonoscopy and polypectomy, as well as cystoscopy and hyteroscopy have been successfully tested.
    Arthroscopies of ATM, humeral scapulo, elbow Doll 25 (opening of the carpal tunnel), hip, knee and ankle have been successfully performed.
    As for laparoscopy, gastrectomies have been performed successfully in morbid obesity surgery, esophageal hiatus surgery, appendectomies, splenectomies, genioplasties, colostomies, prostatectomies, nephrectomies,
    30 annisectomy hysterectomies, as well as pelvic floor reconstructive surgery.
    Additionally, post-nasal approaches to the base of the brain have been tested, ventriculography approaches to the pontocerebellar angle and with septorrinoplasty, ethmoidectomies and approaches to the frontal and sphenoid maxillary sinuses have been tested.


    The use of corpses according to the invention with vascular recirculation prevents the slaughter of animals and offers greater possibilities of learning these techniques by a greater number of people.
    5 The possibility that the body of the invention can be physically explored by students with the possibility of cardiorespiratory auscultation, palpation, examination by real ultrasound and examined in real time with conventional radiographic techniques CT and MRI in all regions, is a optimization of resources with a reality factor that implies a change of attitude on the part of the student.
    10 The use in education would result in a clear economic saving with respect to the use of other types of simulators with clear advantages over their performance and replacement facilities.
    The simulators of the invention can be used to carry out practical evaluations where the evaluators can easily schedule the "Objective and Structured Clinical Evaluation" ECOE exam and where the answers given by the student through the computer can be processed in real time. with the consequent saving of time of the teaching staff.
    The corpses of the invention have advantages over other simulators that can be easily programmed by the teaching staff, depending on those aspects that in a moment of learning interest them most to highlight in practice and also reprogrammed for the performance of other functions.

    权利要求:
    Claims (1)
    [1]
    1-Composition comprising a humectant, a first antiseptic, a fixative, a thickener, a dye and water.
    52-Composition according to claim 1 wherein the humectant ispolypropylene glycol or monopropylene glycol, the antiseptic is 4-chloro-3-methylphenol, thefixative is formalin, the thickener is cornstarch and / or the dye iscarmine red dye E-123.
    Composition according to any one of claims 1 or 2, further comprising a second antiseptic, a buffering agent, a compound capable of maintaining tissue color, a hygroscopic oxidizing agent and / or a preservative agent.
    Composition according to claim 3, wherein the second antiseptic and buffering agent is boric acid, the compound capable of maintaining tissue color is sodium sulphite, the hygroscopic oxidizing agent is ammonium nitrate and / or the preservative is nitrate potassium
    Composition according to claim 4 comprising boric acid, monoethylene glycol or polyethylene glycol, ammonium nitrate, potassium nitrate, 4 chloro-3 methylphenol, sodium sulphite, formalin, corn starch, E-123 dye and water.
    Composition according to claim 5 comprising boric acid 0.1-0.3% (w / v), monoethylene glycol or polypropylene glycol 25-32% (v / v), ammonium nitrate 1.5-4% (w / v); potassium nitrate 2-5% (w / v), 4-chloro-3 methylphenol 0.7M in ethylene glycol or polypropylene glycol 0.075-0.090% (v / v), sodium sulphite 0.15-0.25% (w / v) , formalin 2-4% (v / v), corn starch 0.1-0.3% (w / v) and / or dye E-123 0.2-0.4% (w / v).
    Composition according to claim 6, which comprises 0.25% boric acid (w / v); monoethylene glycol or polypropylene glycol 28% (v / v), ammonium nitrate 3.2% (w / v), potassium nitrate 4.16%, 4-chloro-3 methylphenol 0.7M in ethylene glycol or polypropylene glycol 0.083% (v / v) , sodium sulphite 0.1875% (w / v), formalin 2.5%
    35 (v / v), corn starch 0.20% (w / v) and / or dye E-123 0.3% (w / v).

    8-A method of preserving a corpse comprising injecting a corpse with a composition according to any one of claims 1 to 7.
    Method 9 according to claim 8 wherein the body has previously been perfused with Thiel solution.
    10-Method according to claims 8 or 9 wherein perfusion of the composition is carried out by arterial route.
    Method 11 according to claim 10 wherein the arterial route is by carotid or femoral route.
    12-Method according to claims 8 to 11 wherein the body has been subjected to an arteriovenous bypass.

     FIGURES
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    同族专利:
    公开号 | 公开日
    ES2610032B1|2018-01-31|
    EP3345478A4|2019-04-10|
    EP3345478A1|2018-07-11|
    WO2017037323A1|2017-03-09|
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