Training model for practicing a surgical procedure on the prostate using a holmium laser

Abstract

Training model (60) for training a surgical prostate procedure using a holmium laser, comprising: a representative model of a male urinary tract (48), the model (48) comprising: a first hollow body (42) representing a bladder, a second multi-layered body (44) representing a prostate, a tube (46) representing a urethra, wherein the second multi-layer body (44) has a continuous internal channel (44d), wherein the second multi-layer body (44) comprises an outer layer (44a) having a first texture, an inner layer (44b) having a second texture, and an intermediate layer (44c) having a third texture, wherein the intermediate layer (44c) separates the inner layer (44b) from the outer layer (44a), each texture having different physical properties, wherein, after assembly of the model of the urinary tract (48), the first hollow body (42) is connected to the second multi-layer body (44) such that the tube (46) is partially housed in the channel (44d) of the second multi-layer body (44) and is connected to the proximal opening of the first hollow body (42), wherein the tube (46) is designed to accommodate the surgical instrumentation used to perform enucleation and morcellation.

Description

TECHNICAL FIELD OF THE INVENTION

[0001] The invention relates to devices and systems for assisting in learning surgical techniques. In particular, it relates to a simulation device for prostate enucleation using a holmium laser and the intravesical morcellation of prostate tissue. STATE OF THE ART

[0002] Benign prostatic hyperplasia (BPH) is the most common prostate disease. It occurs in more than half of men over the age of 60 and in 80% of older men. The prostate is a male gland that surrounds the urethra. As it grows, it narrows it and causes the symptoms of BPH (see Fig. .

[0003] To treat this condition, a surgical technique called holmium laser prostatic enucleation (HOLEP) exists, which is beneficial for patients but technically challenging for surgeons. This method is performed transurethrally (i.e., through the male urethra) using specialized equipment and consists of two critical steps. The first step, called enucleation, requires transecting the mucous membrane of the prostatic urethra, locating a layer between the prostatic capsule and the prostatic adenoma. Subsequently, the surgeon proceeds retrogradely along the entire surface to the bladder neck, ultimately separating the prostatic adenoma from the prostatic capsule and floating freely within the bladder.In this second step, known as morcellation, the detached prostate adenoma is aspirated and crushed to remove it in tiny fragments through the urethra - without the need for an incision in the patient (see . Fig. Although this technique is recommended in European and American urological clinical guidelines, it is underrepresented in urology departments worldwide.

[0004] On the one hand, it requires laser technology and specialized instruments, which are associated with high acquisition costs. On the other hand, it is a technically highly complex method with a long learning curve to achieve optimal functional results, and there is no standardized training program that allows for progressive training.

[0005] To date, there is neither a regulated training program nor prior certification for the use of this type of laser. Likewise, there is no training model that allows for realistic practice of tissue morcellation or the combination of morcellation and enucleation. While virtual models (simulators or video games) and some physical prototypes exist that allow training of individual surgical steps with a limited degree of realism, none of them can convincingly replicate the tactile sensations of a real procedure. BRIEF DESCRIPTION OF THE INVENTION

[0006] In view of the above-described situation, the present invention is proposed according to the independent claims. In addition, advantageous embodiments are described in the dependent claims.

[0007] The present invention relates to a training model for practicing a surgical procedure on the prostate. The training model is designed to realistically recreate the behavior of the lower urinary tract (bladder, prostate, and urethra) as well as their anatomical features, enabling training of the key phases of the surgical technique. In particular, the training model is preferably intended for the surgical technique known as HOLEP: that is, the enucleation and morcellation of prostate tissue.

[0008] In general, the training model comprises a physical model representing a male urinary tract. This in turn includes: a first hollow body representing the urinary bladder and having a distal opening; a second multi-layered body simulating the prostate and having a continuous internal canal; and a tube representing the urethra. The second body comprises several layers: an outer layer with a first texture, an inner layer with a second texture, and an intermediate layer with a third texture. Each of these textures has different physical properties to realistically simulate the structure and behavior of a prostate during a surgical procedure. With the urinary tract model assembled, the first hollow body is connected to the second body so that the canal in the second body receives the tube and connects it to the opening of the first body.The proximal end of the tube is designed to accommodate medical instruments used to perform enucleation and morcellation.

[0009] The proposed training model serves as an artificial physical support to non-virtually simulate the HOLEP technique. It can be used for both training and certification of medical professionals, typically urologists. BRIEF DESCRIPTION OF THE ILLUSTRATIONS

[0010] To complement the current description and to better understand the features of the invention, a set of drawings is attached as an integral part of this description, in which, for illustrative but non-limiting purposes, the following is shown: Fig. . Schematic representation of a normal prostate gland. Fig. : Schematic representation of a prostate gland with BPH. Fig. : Schematic representation of the steps of the HOLEP technique. Fig. . Insertion step of a cystoscope. Fig. : Step of prostate enucleation. Fig. : Step of morcellation of the prostate. Fig. : Schematic representation of three prostate volumes, designed from CT images of real patients: small ( Fig. , medium ( Fig. , large ( Fig. ). Fig. show two images from a 3D simulation of the lower urinary tract model, created based on CT images of real patients. Fig. : It schematically shows several artificial components and assembled models for simulating various aspects of the male lower urinary tract. Fig. : They show schematically several views of a training model. Fig. : Schematic structure of the layers of the prostate component of the urinary tract of the training model. DETAILED DESCRIPTION OF THE INVENTION

[0011] The Fig. show two images depicting a normal prostate (14) and a BPH prostate (14).

[0012] The Fig. schematically illustrate the three most important steps of a surgical procedure using the HOLEP technique.

[0013] The Fig. shows a section through the male urinary tract (18) illustrating the insertion of a cystoscope (22) through the urethra to gain access to the prostate (14), which is connected at its base to the bladder (12).

[0014] The Fig. shows another section through the male urinary tract (18), showing enucleation with a prostate adenoma (24) through the urethra to gain access to the prostate (14), as well as fragments of the enucleation entering the bladder (12).

[0015] The Fig. shows another section through the male urinary tract (18), illustrating morcellation with a morcellator (26) through the urethra to gain access to the bladder (12), which contains the fragments of the previously performed enucleation.

[0016] The Fig. show schematically three CAD-designed models of the prostate (44) with small, medium and large sizes (from left to right).

[0017] The Fig. schematically show two images of a 3D simulation of the model of the lower hamstring tract (48) (assembled), obtained from CT images of real patients. Fig. The grid model of a bilobular body (44) is visible, representing the prostate, and in dark color a globular body (42) representing the urinary bladder. Fig. The lattice model of the globular body (42), representing the urinary bladder, can be seen, as well as, in dark color, the bilobular body (44), representing the prostate. A tube (46), representing the male urethra, completes the model of the urinary tract (48), with one of its ends [the distal end (46b)] connected to the globular body (42). This is followed by a section of the tube (46) that traverses the bilobular body (44), while another section of the tube (46), enclosing its other end [the proximal end (46a)], is exposed to allow access for surgical instruments.

[0018] The Fig. schematically shows three models of the lower urinary tract (48) with different parts: a globular body (42), a bilobular body (44), and a duct (46) in various shapes and sizes. Also shown are three bilateral bodies (44) in small, medium, and large sizes, all of which can be interchangeably assembled to anatomically simulate various male lower urinary tracts.

[0019] The Fig. schematically show different views of an embodiment of the artificial training model (60) or simply training model representing the pelvic region for training a surgical procedure on the prostate in a non-virtual manner, preferably the HOLEP technique.

[0020] The Fig. shows the frontal external appearance of the training model (60) with a rear pelvic part (62) and a smaller front pelvic part (64) which is connected (e.g. snapped in) to the rear pelvic part (62).

[0021] The Fig. shows the external appearance of the training model (60) from the side with the rear pelvic part (62) and the smaller front pelvic part (64), which is connected to the rear pelvic part (62).

[0022] The Fig. shows a perspective view of the external appearance of the training model (60) with the rear pelvic part (62) and a smaller front pelvic part (64) attached to the rear pelvic part (62).

[0023] The Fig. shows the training model (60) from the front with the anterior pelvic part removed, whereby a cavity in the posterior pelvic part (62) is visible, in which the model of the lower urinary tract (48) is housed, with an upper globular body (42), a middle spheroid body (44) (in other versions it is bilobular) and its lower canal (46).

[0024] The Fig. shows the perspective of the training model (60) with the anterior pelvic part (64) as a lid or cover, which has been separated from the posterior pelvic part (62). Also shown is the model of the lower urinary tract (48) with an upper globular body (42), an intermediate spheroid body (44) (in other embodiments it is bilobular), and its lower canal (46).

[0025] The Fig. shows an embodiment of the bilobular body (44) representative of the prostate, which consists of three layers with different textures. An outer layer (44a), representing a capsule, is visible. Within the outer layer (44a), there is an inner layer (44b), representing an adenoma. Between the two layers (44a) and (44b) there is an intermediate layer (44c). The inner layer (44b) has a second texture with a lower hardness than the first texture to train the difference between the actual tissues for the capsule and the adenoma. The intermediate layer (44c) also has its own texture, a hair-like structure, to simulate a morphological feature that is important during surgery on a real prostate, thus increasing the degree of realism of the training.

[0026] In the following, reference is made to the embodiments of the preceding figures, in particular to the Fig. as well as Fig. to explain various aspects of certain possible embodiments for better understanding.

[0027] As mentioned above, the surgical technique to be learned is delicate and complex, involving several critical steps that can lead to complications. This complication is usually due to the proximity of the urinary tract anatomy (especially the urinary sphincter) to the instruments. Therefore, the manikin (60) is key to realistic training prior to surgery on a real patient.

[0028] Inadequate enucleation may result in capsular perforations, sphincter lesions, or incomplete deobstruction, all of which may result in temporary or permanent urinary incontinence, or the symptoms that compelled the patient to undergo surgery due to incomplete deobstruction of the prostate may persist.

[0029] Lack of expertise in morcellation may result in bladder or bowel perforation or retention of intravesical fragments, which may require urgent reoperation, change of procedure, or acute insertion of a transurethral catheter.

[0030] As in the Fig. As can be seen, the training model (60) is an inanimate, anatomically realistic replica of the pelvic region that can be placed on an operating table to perform a surgical procedure using the HOLEP technique. However, the training model (60) can also be used to train other technical skills of urologists, as it enables the correct positioning of working instruments, correct hand movements, and tactile reactions such as the simulated resistance of artificial structures compared to that of human tissue.

[0031] The different textures simulated correspond to those that make up a urethra, a prostate, or a urinary bladder; they can be recreated using silicone gel as a material component. In particular, the urethra is artificially simulated as a tube (46), an elongated, hollow, tubular element that allows access through its lumen for working material and irrigating fluid.

[0032] As in Fig.As can be seen, the element simulating the prostate is generally a bilobular body (44) crossed longitudinally by a channel (44d) through whose lumen the tube (46) for assembly is introduced. The body (44) consists of two parts: an outer layer (44a), which represents a capsule and is harder, and an inner layer (44b), which represents an adenoma and is to be removed and is softer. The two are preferably separated by an intermediate layer (44c) with a hair-like texture, which allows the urologist to identify an intermediate plane between them - a key activity in real surgical technique. Thanks to these different characteristics and textures, a greater degree of realism can be achieved, closer to a real procedure.

[0033] The part simulating the bladder is generally a hollow, globular body (42) with an opening allowing one of the ends (46a) of the tube (46) to communicate with the interior and with sufficient filling capacity so that it can be expanded without easily bursting or perforating.

[0034] The training model (60) preferably has the shape of a scaled human pelvis and houses the model of the lower male urinary tract (48) or simply the model of the urinary tract, which comprises the unit formed by the globular body (42), the bilobular body (44), and the duct (46). The model of the urinary tract (48) is attached by means of an easily openable flange within the posterior pelvic part (62), together with the anterior pelvic part (64), which preferably has the external shape of a male genital organ. Materials and elaboration of a concrete example:

[0035] Regarding the materials used in the embodiments, a selection of silicones and additives specifically developed to replicate the texture and tactile sensation of human organs and skin is preferably used. Special silicone gels are used that are suitable for realistic modeling. These silicones guarantee high fidelity of the models and are ideal for realistic reproduction of anatomical structures for medical professionals and medical students.

[0036] Specifically, various gel types from the Feroca® brand are suitable, although gels from other manufacturers can also be used. These are generally platinum silicones with very low hardness, such as "EasyPlat Flesh," which are ideal for replicating skin textures, especially in combination with the additive deadener (a gelling agent / plasticizer for platinum silicone). "EasyPlat Flesh" is a two-component platinum catalyst silicone that can be translucent or, preferably, skin-colored. It has the property of crosslinking into an extremely soft and flexible elastomer. This material is suitable for the described embodiments and can be used multiple times without losing its properties.It exhibits excellent electrical properties, chemical stability, water resistance, and corrosion resistance. It is physiologically inert, non-toxic, and meets the requirements for mechanical strength despite its very low hardness. For component production, the material is mixed in a ratio of 100A:100B by weight or volume. At 25°C, the processing time is 30-40 minutes, and the demolding time is 3-4 hours. The tensile strength is >0.85 MPa, the tear strength is 2.4 kN / m, the mixed viscosity is 2800 mPa s, and the hardness is <0.1%.

[0037] The additive "deadener," specifically "Smith's Prosthetics Deadener," enables the creation of gel prosthetic applications. By varying the amount of "deadener" added, different degrees of softness of the silicone gel can be achieved. A general rule is that adding 50% of the deadener by weight to an A+B silicone gel mixture results in a 1:1:1 deadener: part A: part B ratio (it is important to always add the deadener to part A before adding part B). To achieve the effect of skin in a prosthetic application (encapsulated silicone), an addition rate of approximately 180%-200% is required. When the deadener is added, the silicone loses its original consistency and becomes sticky to the touch. To create a prosthetic application, the deadener-added silicone must be encapsulated.This is done by depositing a thin layer of the resulting silicone gel into a mold previously coated with a so-called "bald cap" additive such as "key-cap plastic." This additive has also been used to produce softer components, such as the inner layer of the body (44) simulating the prostate.

[0038] For the intermediate layer (44c), which separates the inner layer (44b) from the outer layer (44a), a material with a hair-like texture is used. For example, flock fibers—a colored additive made of very fine polyamide fibers—can be used. A small amount of flock fibers is mixed into on-skin silicone, gelatin, or other transparent or semi-transparent carrier materials (such as Dragon Skin, EcoFlex, Platsil Gel) to create a fine, skin-like structure with visible vein texture. Dimensions of a preferred embodiment:

[0039] To better represent the variability of the male anatomy, the components can be manufactured in different sizes, shapes, and proportions. Preferred dimensions are given below as examples, each with a percentage to define a range around the preferred value that covers most anatomical conditions and is compatible with the previously described materials.

[0040] Tube (46) for simulating the urethra and body (44) for simulating the prostate: Inner diameter: - Proximal section (prostate): 15 mm + / - 20%; - Middle section 10 mm + / - 20%, - Distal section: 10 mm + / - 30%. Outer diameter: - Proximal section (prostate): 50 mm + / -20%; - Middle section: 20 mm + / - 20%; - Distal section: 20 mm + / - 30%. Length of inner duct section: 130 mm + / - 30%. Horizontal (transversal) circumference 20 cm + / - 20%. Vertical circumference (sagittal) 18 cm + / - 20%. Bilobular body 44, representing the prostate - Average thickness of the outer layer 5 mm + / - 20%, - Average thickness of the inner layer 15 mm + / - 25%, - Average thickness of the interlayer 1 mm + / - 15%.

[0041] The dimensions of the other components do not have any limitations that affect the training of a prostate surgery so much.

[0042] The above example serves as a guide and to complete the detailed description. It should be understood that selections with values ​​other than those mentioned above are also possible and still allow a professional user to conduct surgical training with sufficient realism.

[0043] Having sufficiently described various embodiments and examples of aspects of the invention, the following claims are presented.

Claims

[1] Training model (60) for training a surgical prostate procedure using a holmium laser, comprising: a representative model of a male urinary tract (48), the model (48) comprising: a first hollow body (42) representing a bladder, a second multi-layered body (44) representing a prostate, a tube (46) representing a urethra, wherein the second multi-layer body (44) has a continuous internal channel (44d), wherein the second multi-layer body (44) comprises an outer layer (44a) having a first texture, an inner layer (44b) having a second texture, and an intermediate layer (44c) having a third texture, wherein the intermediate layer (44c) separates the inner layer (44b) from the outer layer (44a), each texture having different physical properties, wherein, after assembly of the model of the urinary tract (48), the first hollow body (42) is connected to the second multi-layer body (44) such that the tube (46) is partially housed in the channel (44d) of the second multi-layer body (44) and is connected to the proximal opening of the first hollow body (42), wherein the tube (46) is designed to accommodate the surgical instrumentation used to perform enucleation and morcellation. [2] Training model (60) according to claim 1, wherein the first body (42) has a globular shape. [3] Training model (60) according to claim 1 or 2, wherein the second body (44) has a bilobular or spheroidal shape. [4] Training model (60) according to one of claims 1 to 3, having an external shape which anatomically corresponds to a pelvic region. [5] Training model (60) according to claim 4, wherein the pelvic region comprises a posterior pelvic part (62) and an anterior pelvic part (64), both parts (62, 64) being coupled together and defining a recess for receiving the representative model of a male urinary tract (48). [6] Training model (60) according to one of claims 1 to 5, wherein the intermediate layer (44c) of the bilobular body (44) has a hair-like texture. [7] Training model (60) according to one of claims 1 to 6, wherein to achieve a distinguishable texture, the first hollow body (42), the multi-layer second body (44) and the tube (46) are each made of a different silicone gel-based composition.

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