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WO2025177314A2 - Dispositif de simulation chirurgicale et son procédé de préparation - Google Patents

Dispositif de simulation chirurgicale et son procédé de préparation

Info

Publication number
WO2025177314A2
WO2025177314A2 PCT/IN2025/050272 IN2025050272W WO2025177314A2 WO 2025177314 A2 WO2025177314 A2 WO 2025177314A2 IN 2025050272 W IN2025050272 W IN 2025050272W WO 2025177314 A2 WO2025177314 A2 WO 2025177314A2
Authority
WO
WIPO (PCT)
Prior art keywords
organs
model
molecular weight
hwp
lwp
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.)
Pending
Application number
PCT/IN2025/050272
Other languages
English (en)
Other versions
WO2025177314A3 (fr
Inventor
Ashwini Kumar AGRAWAL
Shilpa Sharma
Jogender .
Manjeet Jassal
Gaurav SUNEJA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Incipient Materials Private Ltd
Original Assignee
Incipient Materials Private Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Incipient Materials Private Ltd filed Critical Incipient Materials Private Ltd
Publication of WO2025177314A2 publication Critical patent/WO2025177314A2/fr
Publication of WO2025177314A3 publication Critical patent/WO2025177314A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • G09B23/285—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
    • 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

Definitions

  • the common solvent selected from a group comprising water, aqueous NaOH, aqueous KOH, ionic liquids, tetrahydrofuran (THF), dimethyl formamide (DMF), dimethyl acetamide (DMAc), dimethyl sulphoxide (DMSO), acetone, CH2CI2, ethylene glycol, glycerol, methanol, ethanol, hexane, formic acid, acetic acid, benzene, toluene, m- cresol, n-methyl pyrrolidone (NMP), sulphuric acid and their compatible mixtures optionally with salts such as LiCl, NaCl, CaCh.
  • the present invention provides a composition for forming model organs for a surgical simulation device, wherein the LWP is selected from cellulose derivatives such as carboxymethyl cellulose (CMC), hexaethyl cellulose (HEC), guar gum, modified starch, siloxanes, maleic anhydride modified polyolefins, polyether, PEG (polyethylene glycol), polyols, polyvinyl alcohol, polyacrylic acid, polyacrylamide, or their copolymers, their functionalized derivatives, and mixtures thereof.
  • CMC carboxymethyl cellulose
  • HEC hexaethyl cellulose
  • guar gum modified starch
  • siloxanes maleic anhydride modified polyolefins
  • polyether polyether
  • PEG polyethylene glycol
  • polyols polyvinyl alcohol
  • polyacrylic acid polyacrylamide
  • copolymers their functionalized derivatives, and mixtures thereof.
  • the present invention provides a composition for forming model organs for a surgical simulation device, wherein, on weight basis, the high molecular weight polymer (HWP) is in a range of 70 - 99 wt%, low molecular weight polymer (LWP) is in a range of 1-30 wt% and the additive in a range of 0-10 wt%.
  • HWP high molecular weight polymer
  • LWP low molecular weight polymer
  • the present invention provides a composition for forming model organs for a surgical simulation device, wherein the HWP and the LWP is in a ratio of 99 to 2.33.
  • the present invention provides a composition for forming model organs for a surgical simulation device, the model organs are tubular and other internal organs selected from a group comprising organs of gastrointestinal system, circulatory system, endocrine system, urinary system, reproductive system, lymphatic system, nervous system and integumentary system.
  • the present invention provides a composition for forming model organs for a surgical simulation device wherein the organs of the gastrointestinal system, the circulatory system, the endocrine system, the urinary system, reproductive system, lymphatic system, nervous system and the integumentary system are selected from a group comprising arteries, veins, nerves, spinal cord capillaries, bronchi, bronchioles, alveolar ducts, ureters, liver, gallbladder, spleen, fallopian tubes, ovaries, uterus, scrotum, vas deferens, ejaculatory ducts, lymphatic vessels, esophagus, trachea, stomach, diaphragm, intestines, urinary bladder, urethra, kidney, lungs, umbilical cord, azygous vein, tracheoesophageal fistula, esophagus upper part, and oesophagus lower part.
  • the present invention provides a surgical simulation device, comprising: a) a plurality of model organs prepared from a composition disclosed herein; b) an outer shell (8) covering the plurality of model organs; c) a plurality of ports (Y1,Y2,Y3) on the outer shell for inserting thoracoscopic or laparoscopic instruments for simulation surgery; and d) a base plate (10) with a plurality of pegs (Q,R,S,T,U) adapted to mount the plurality of model organs.
  • the present invention provides a surgical simulation device, wherein the plurality of model organs are tubular and other internal organs selected from a group comprising organs of gastrointestinal system, circulatory system, endocrine system, urinary system, reproductive system, lymphatic system, nervous system and integumentary system.
  • the present invention provides a surgical simulation device, wherein the organs of the gastrointestinal system, the circulatory system, the endocrine system, the urinary system, reproductive system, lymphatic system, nervous system and the integumentary system are selected from a group comprising arteries, veins, nerves, spinal cord capillaries, bronchi, bronchioles, alveolar ducts, ureters, liver, gallbladder, spleen, fallopian tubes, ovaries, uterus, scrotum, vas deferens, ejaculatory ducts, lymphatic vessels, esophagus, trachea, stomach, diaphragm, intestines, urinary bladder, urethra, kidney, lungs, umbilical cord, azygous vein, tracheoesophageal fistula, esophagus upper part, and oesophagus lower part.
  • a group comprising arteries, veins, nerves, spinal cord
  • the present invention provides a process of preparation of the surgical simulation device, the process comprising: a) obtaining dimensions of organs of a patient from DICOM images of the patient scans; b) preparing a plurality of model organs based on the dimensions of the patient scans from composition as disclosed herein; c) designing a base plate comprising a plurality of pegs to mount the plurality of model organs; d) arranging the plurality of model organs on the base plate based on patient anatomy to obtain the surgical simulation device.
  • the present invention provides a process for preparation of model organs for a surgical simulation device, wherein the model organs are prepared by casting, moulding, extrusion, solution spinning, melt spinning, compression or coating.
  • the present invention provides a process for preparation of model organs for a surgical simulation device, wherein the molds are prepared using casting, 3D printing, moulding, extrusion, compression or coating.
  • the present invention provides a process for preparation of model organs for a surgical simulation device, wherein the model organs are prepared by processes known in the art such as casting, 3D printing, moulding, extrusion, compression or coating.
  • the present invention provides a process for preparation of model organs for a surgical simulation device, wherein, on dry weight basis, the high molecular weight polymer (HWP) is in a range of 70 -99 wt%, low molecular weight polymer (LWP) is in a range of 1 -30 wt% and the additive in a range of 0-10wt%.
  • HWP high molecular weight polymer
  • LWP low molecular weight polymer
  • the high molecular weight polymer used in the preparation are the polymers having average molecular weight in the range of 30000 to 2,000,000 g/mol and is selected from the class of polymers
  • HWP is selected from polyolefins, polyurethane, polyacrylates, polyesters, polyamides, polyacrylonitrile, cellulose, cellulose acetate, triacetates, chitosan, collagen, alginate, polylactic acid, polycaprolactone, PMMA (polymethyl methacrylate), PVC (polyvinyl chloride), PTFE (polytetrafluoroethylene), acrylonitrile-butadiene-styrene (ABS) or their copolymers and mixtures thereof.
  • the low molecular weight polymer used in the preparation is having number average molecular weight in the range of 300 to 10000 g/mol and is selected from the class of polyether, PEG (polyethylene glycol), polyols, polyvinyl alcohol, poly aery lie acid
  • the abdominal cavities are formed using materials and the processing techniques known in the art. These cavity devices resemble structure and looks of a human body both from the outside and inside.
  • the devices of the present invention are fitted with ports in outer shell of the device appropriate for practicing thoracoscopic or laparoscopic surgical skills useful for treating both neonatal and adult patents.
  • the device uses several pegs on which various model organs are mounted to allow stability and limited movement to the various model organs simulating the real surgical situation.
  • the used model organs can be removed from the pegs and replaced with a new set on the same pegs to allow use of the surgical simulation device multiple times without degrading the surgical experience.
  • the surgical simulation device can be used for practicing any other operation involving abdominal cavity and tubular organs such as gastrointestinal system, circulatory system (including microsurgery of fine capillaries), endocrine system and urinary system.
  • tubular organs such as gastrointestinal system, circulatory system (including microsurgery of fine capillaries), endocrine system and urinary system.
  • the compositions of polymers and additives described herein can be used for developing other tubular model organs required for these systems and the abdominal cavity as described can be used to hold various organs belonging to gastrointestinal, circulatory, endocrine and urinary systems with positional change of pegs and changing dimensions of the cavity appropriately for adult, children and neonatal patients.
  • Tubular model organs of different diameters and lengths were made using various combinations of high molecular weight (HWP) and low molecular weight polymers (LWP). Some of the specific examples with observed properties are given below. The properties were evaluated both objectively using Universal Testing machine (UTM ) (for example mechanical strength, elasticity, modulus,) and subjectively by providing rating from surgeons (experts) on scale of 1 to 5 wherein 1 indicates as poor and 5 indicates as close to real situation.
  • UTM Universal Testing machine
  • Table 3 Mechanical properties of different compositions of HWP1, HWP2, HWP3, HWP4, HWP5 and LWP1, LWP2 with or without metal oxides (MO) for tubular organ replication.
  • MO metal oxides
  • LWP low molecular weight polymer
  • HWP high molecular weight polymer
  • HWP was used in different concentrations of the whole solution (more specifically ranging from 99% to 65%) and LWP in concentration range of 1% to 30% of the total solution in a compatible solvent as per Tables 3 and 4 where HWP1 is cellulose derivative, HWP2 is polyacrylates, HWP3 is polyamides, HWP4 is polyacrylonitrile, and HWP5 is polyurethane.
  • HWP1 is polyethylene glycol
  • LWP2 is polyvinyl alcohol
  • LWP3 is polyacrylic acid.
  • the solutions were cast into tubes of various sizes.
  • the solution cast tubes were heat treated at temperatures of 40-80 degree C for 30 minutes to 4 hours to allow evaporation of the solvent followed by controlled phase segregation, which results in final tubular membranes with properties as mentioned below.
  • the tubes were treated with warm water (50-90 degree C) for 1 min- 10 min as per leaching percentage to allow limited phase segregation. Without the physical or chemical treatment, the properties of tubular membrane were unstable and non-reproduceable.
  • HWP5 was kept constant in the range of 84-70%, while the percentage of LWP1 was varied between 16 and 30%. This improved the homogeneity of tubular model organs with a good collapsibility value; however, the suturing experience did not replicate that of actual organ. Collapsibility and flexibility should be in the desirable ranges (of 5 grade for collapsibility) and (4-5 grade for flexibility) (Table 4) for a better suturing experience. Therefore, the HWP5 percentage was reduced, with introduction of metal oxides (MO), with concentration up to (1-5%).
  • MO metal oxides
  • the tensile properties like modulus and tensile strength of different samples were measured using INSTRON 3365,.
  • Young’s modulus of HWP5( 100-94), LWPl(0-6), HWP5(93- 85) LWP1(7-15), HWP5(84-70) LWPl(16-30) were 11.58+1.98, 8.80+1.56 and 6.37+1.88 MPa and tensile strength values of 13.30+0.78, 9.48+0.62 and 5.95+0.56 MPa, respectively.
  • HWP and LWP A variety of other polymers with varying molecular weight ranges were tried as HWP and LWP, including polyurethane (ether-based), polyurethane (ester-based), PMMA (polymethyl methacrylate), PVC (polyvinyl chloride) as HWP, while PEG (polyethylene glycol), polyacrylic acid, polyethylene oxide (PEO), polyols as LWP.
  • Table 5 Mechanical properties of oesophagus and trachea for humans of age group 2-22 years.
  • the leaching rate of polymeric materials is significantly influenced by the concentration of LWP1 in the total polymer weight. Higher concentrations of LWP1 (18-22) result in a lower leaching percentage, typically ranging between 36% to 63%, whereas lower concentrations LWP1 (0-6) lead to increased leaching, ranging from 52% to 84%. Additionally, the duration of phase separation plays a crucial role in determining the final composition and leaching extent. A longer phase separation time, such as increasing from 1 minute to 5 minutes, results in a 30-40% increase in leaching as per Figure 9.
  • the storage duration before phase separation impacts leaching behaviour, with materials stored for one week exhibiting an increased leaching percentage by approximately 20-30% as per Figures 9 and 10.
  • MO metal oxides
  • the present invention provides a detailed description of a neonatal surgical simulation device created using tubular model organs made using the above compositions.
  • this complex medical disorder is defined by an improper connection between the trachea and the oesophagus. Food and air cannot move through this abnormality normally, which can cause serious digestive and respiratory issues. This frequently results from trauma, underlying medical disorders, extended intubation, or congenital abnormalities.
  • diagnostic procedures frequently entail imaging scans and endoscopic assessments. Surgical procedures and conservative approaches to management differ based on the underlying reasons and severity. To reduce risks and enhance patient outcomes, early detection and management are essential.
  • Medical model organs are crucial in helping physicians get the knowledge and abilities necessary to treat complicated diseases such as esophageal tracheal fistula. With the help of such realistic illustrations of anatomical structures and diseases, doctors can conduct a range of diagnostic and therapeutic techniques in a safe setting. Medical model organs instill confidence, competence, and decision-making skills in physicians by modeling the difficulties that arise in managing such abnormalities. They also provide a secure learning environment for trainees without endangering patient safety. In the end, the use of medical mode organs s promotes improved patient care by guaranteeing that medical professionals are suitably equipped to handle difficult clinical situations.
  • a base plate was prepared for efficient mounting of various organs, such as diaphragm, lungs, ribcage, trachea tube, azygos vein, oesophagus upper part and oesophagus lower part.
  • the tubular structures were made using the above examples to simulate their close to real life handling.
  • the base was created with dimensions (approx. 20-30 cm x 12-15 cm).
  • the base platform was tilted at an angle, with a mechanism that allowed angle to change in the range of 10-45 degree to simulate a real baby position during the surgery.
  • the model rib cage was about 7-11 cm wide as shown in Figure 3 which is the side view of the structure. All these parts were made using polymers such as polylactic acid and using known techniques such as 3D printing, moulding or/and machining.
  • This model rib cage is covered with model skin and outside body structure /outer shell of about (4-40 mm thick) made up of different materials like polyurethane, silicone, collagen, and polyvinylchloride. Skin and outside body structure can be created with different techniques like moulding and 3-D printing.
  • the surgical simulation device of the present invention has the needed collapsibility, tear strength and elasticity mimicking real tubular model organs such as trachea, esophageal tissue, and veins, etc.
  • the size of the simulated model organs (oesophagus and trachea, etc.) is same as in a newborn child thus giving the opportunity in a high- fidelity model.
  • the surgical simulation device of the present invention can be used as an open model and can be used as bigger cavity -based model by opening the model and placing in a laparoscopic simulator.
  • the surgical simulation device of the present invention can be used for practicing any other operation involving abdominal cavity and tubular organs such as gastrointestinal system, circulatory system, endocrine system and urinary system as the compositions described herein can be used for developing other tubular model organs and the model abdominal cavity as described can be used to hold various organs belonging to gastrointestinal, circulatory, endocrine and urinary systems with positional change of pegs and changing dimensions of the cavity appropriately.
  • EP3546499A1 Hydrogel Structure, Method of Manufacturing Hydrogel Structure, And Internal Organ Model, Saito Takuya

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  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Mathematical Analysis (AREA)
  • Pure & Applied Mathematics (AREA)
  • Medical Informatics (AREA)
  • Algebra (AREA)
  • Computational Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Mathematical Optimization (AREA)
  • Mathematical Physics (AREA)
  • Medicinal Chemistry (AREA)
  • Business, Economics & Management (AREA)
  • Educational Administration (AREA)
  • Educational Technology (AREA)
  • Theoretical Computer Science (AREA)
  • Pulmonology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Materials For Medical Uses (AREA)
  • Instructional Devices (AREA)

Abstract

La présente invention concerne un dispositif de simulation haute fidélité pour simuler des opérations chirurgicales à proximité d'une partie tubulaire réelle et d'autres organes internes et un processus de préparation du dispositif de simulation chirurgicale. En particulier, la présente invention concerne une composition pour former des organes modèles pour un dispositif de simulation chirurgicale et un procédé de préparation d'organes modèles pour un dispositif de simulation chirurgicale. En outre, la présente invention concerne un dispositif de simulation chirurgicale haute fidélité pour fistule trachéo-oesophagienne.
PCT/IN2025/050272 2024-02-23 2025-02-22 Dispositif de simulation chirurgicale et son procédé de préparation Pending WO2025177314A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202411013232 2024-02-23
IN202411013232 2024-02-23

Publications (2)

Publication Number Publication Date
WO2025177314A2 true WO2025177314A2 (fr) 2025-08-28
WO2025177314A3 WO2025177314A3 (fr) 2025-10-02

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Application Number Title Priority Date Filing Date
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Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180126603A1 (en) * 2015-04-17 2018-05-10 Jsr Corporation Method for producing three-dimensional object
US20210139636A1 (en) * 2018-04-05 2021-05-13 Mitsui Chemicals, Inc. Polyurethane gel material, polyurethane gel, pseudo-biomaterial, and producing method of polyurethane gel
EP4051478A4 (fr) * 2019-11-01 2023-11-15 Resuture, Inc. Système chirurgical simulé, vaisseau simulé, et leurs procédés de fabrication et composants associés

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WO2025177314A3 (fr) 2025-10-02

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