MEDICAL DEVICE FOR AN INTRAPERITONEAL CHEMOTHERAPY PROCEDURE WITH PRESSURIZED DRUG

Description

DESCRIPTION The subject of this invention is a device 5 medical for performing a procedure intraperitoneal chemotherapy by pressurization of a chemotherapy drug. Intraperitoneal aerosol chemotherapy pressurized, called PIPAc (Pressurized IntraPeritoneal 10 Aerosolized Chemotherapy), is an oncology treatment experimental local-regional, that is, which allows the administration of a chemotherapy regimen in a given compartment of the organism (in this case the peritoneum of patients with carcinomatosis 15 peritoneal). The rationale for this procedure combines two principles: ensure effective distribution of chemotherapy drugs in the chosen compartment, severely limiting the systemic spread of drugs themselves, resulting in a reduction of the impact 20 systemic chemotherapy. PIPac is a recently introduced method, developed for the treatment of carcinomatosis peritoneal in patients on whom it is not possible intervene with cytoreductive surgery. The technique 25 allows the drug to be administered in the form nebulized, with a laparoscopic access, as well as performing biopsies for a study histological and aspiration of ascitic fluid if present. 5 PIPac is a technically simple procedure and has a duration of 30 minutes. It initially provides for bring the pressure to 12 mmHg and the temperature to 37°C inside the patient's peritoneal cavity; subsequently, a chemotherapy drug is 10 nebulized into the abdominal cavity for 30 minutes; the aerosol is then removed through a system of closed suction. In PIPac, the pressure gradient generated artificially with which the drug is nebulized 15 chemotherapy, overcomes fluid pressure interstitial tumors, which represent an obstacle in classical antitumor therapy. Furthermore, through the PIPac, the concentration at local level of the chemotherapy drug is much higher than 20 that would be achieved with the administration intravenous, but the concentration of the drug in the plasma chemotherapy remains low. With PIPac it is only 10% of the chemotherapy dosage was applied usually applied systemically in others 25 local-regional treatments such as HIPEC (chemotherapy hyperthermic intraperitoneal) with the great advantage that the typical side effects of chemotherapy systemic (alopecia, peripheral neurotoxicity, cardiotoxicity, nausea, myelosuppression) are not in 5 generally detected or are of slight severity. Precisely for this, PIPac treatment is a promising method, capable of inducing a regression of carcinomatosis peritoneal even in advanced stages and in pathologies apparently unresponsive to systemic therapy, 10 with limited side effects. Conventional PIPac provides multi-port access, that is, 2 / 3 peritoneal accesses are used, such as in the state of the art solution described in document EP 4 000 672. Considering that patients from 15 carcinosis have often been subjected to previous surgical interventions and have many adhesions parietal viscera, traditional access exposes more easily the patient at risk of visceral injuries and iatrogenic effects are often unrecognized. Furthermore, such access 20 traditional requires the placement of 2 / 3 trocars in different locations of the abdomen, with a non-existent risk negligible neoplastic seeding of the pathways same as trocars. A recently developed method involves a single 25 peritoneal access (single-port access), which allows to reduce or even eliminate the negative characteristics reported above in this regard to traditional multi-door access. With the single- port access to the peritoneal cavity is unique and 5 provides a wider opening (5 cm incision) performed on the midline. These characteristics allow access to the cavity peritoneal under vision thanks to a more wide, and to perform the lysis of any adhesions 10 minimizing the risk of iatrogenic injuries. Furthermore, in case of route disruption, this will happen located on the midline and therefore can be more easily removed in subsequent laparotomies. However, To date, there are few and inefficient devices 15 doctors for performing PIPac procedures with single-port access. It is described in two experimental works (Sa Hong Min, JGC, 2024 and Bachman Surg End, 2021) the possibility of use hyperthermia during the PIPac procedure, 20 in order to increase the effectiveness of this method local-regional therapy. In the medical field, heat is recognized to have an antineoplastic action, in as neoplastic tissues do not have the possibility, unlike other fabrics, to disperse heat 25 through vasodilation. Heat, therefore, is concentrates in neoplastic tissues and, in addition to having in itself an antitumor action, it is capable of enhance, through a synergistic effect, the effectiveness of certain commonly used anti-cancer drugs 5 in clinical practice. Hyperthermia is already used in oncology, both through external hyperthermia during systemic chemotherapy than in treatments loco-regional now entered into daily practice, such as HIPEC (Hyperthermic IntaPeritoneal 10 Chemotherapy). This treatment, used at the end of cytoreduction interventions, exploits the antineoplastic characteristics reported above, in treatment of primary and secondary tumors of the peritoneum and pleura. 15 The purpose of the present invention is to provide a medical device for performing a procedure PIPAc with single-port access allowing for optimal distribution of the drug in the peritoneal cavity, through the possibility of orienting, in multiple directions, 20 the insufflation nozzle, which in the known devices in trade is instead static and allows for insufflation in one direction only. The purpose of the present invention is also to provide a medical device that allows, if 25 the operator deems it appropriate to carry out the PIPac procedure not only in normothermia, but also in hyperthermia (IntraPeritoneal ChemoHyperthermia in Continuous Aerosol: CHyPAC). This purpose is achieved by a medical device in 5 agreement with claim 1. The claims employees describe preferred embodiments of the invention. The features and benefits of a device medical device for performing PIPac procedures with 10 single-port access will be evident from the description reported below, given as an example and non-limiting in accordance with the attached figures, in which: - Figure 1 shows a side view of a 15 medical device in accordance with this invention, in a first embodiment; - Figure 2 shows a side view of a portion of the device of figure 1, in particular the part distal, i.e. the cannula with a flexible portion; 20 - Figure 3 shows a sectional view of the cannula of figure 2; - figure 4 shows an axonometric view of the cannula of figure 2, during the movement of the flexible portion; 25 - Figures 5, 6 and 7 show a view respectively side, a sectional view and a front view of the nebulizing tip of the device in figure 1; - figure 8 shows an axonometric view of a 5 component of the spray tip of figure 6, and in particular a nozzle head; - Figure 9 shows an axonometric view of a portion of a medical device in accordance with the present invention, in a further example 10 realization of the distal part, that is, the cannula with flexible portion; - figure 10 shows an enlargement of the portion flexible cannula of figure 9; - figure 11 shows an axonometric view of the vehicles 15 of curvature of the flexible portion of the cannula, in a practical example; - figures 12 and 13 show a view respectively axonometric and a side view of a handle (partially removed for clarity) 20 associated with the means of curvature of figure 11 and hosting automatic control means; - figure 14 shows an axonometric view of the vehicles of curvature of the flexible portion of the cannula, in a further example of implementation; 25 - Figures 15 and 16 show a grip (partially removed in figure 15 and complete in figure 16) associated with the means of curvature of figure 14 with manual control means; - figures 17 and 18 show means of curvature of the 5 flexible portion of the cannula (partial in the figure) 17 and complete in figure 18), in a still further implementation example; - figure 19 shows a handle associated with the means of curvature of figure 18 with manual control means; 10 - Figure 20 shows a chemotherapy kit hyperthermic intraperitoneal (HIPEC), including the medical device of figure 1, a reservoir of liquid and heating and recirculation media liquid; 15 - Figure 21 shows an enlargement of the means of heating and recirculation of the liquid in figure 20. With reference to the attached figures, with the number of reference 1 has represented as a whole a medical device for performing a procedure 20 of intraperitoneal chemotherapy with aerosol pressurized (PIPAc) in accordance with this invention. The medical device 1 is suitable for nebulize a chemotherapy drug into the cavity abdominal of a patient to be treated by the 25 PIPAc procedure. The aerosol is obtained by nebulizing a chemotherapy drug through pressure. In the following discussion, conventionally established as a central point the doctor who performs the PIPac procedure, the terms proximal are defined 5 (i.e., closer to the doctor) and distal (i.e., more away from the doctor). The medical device 1 therefore comprises a distal portion, intended to be inserted at least partially into the abdominal cavity of a patient and 10 a proximal area closer to the doctor. Considering this reference system, the medical device 1 It includes a cannula 2 distally and proximally a handle 3 from which connectors branch off, as visible in figure 1. 15 Preferably, the cannula 2 has a circular cross-section. The cannula 2 develops along a longitudinal axis and is made up of an external tubular body 211 with a central lumen 213 in which a core 212 is housed. Preferably, soul 212 is a full body. 20 The soul 212 is equipped, in correspondence with its external surface 214, of at least one groove 215 longitudinal, clearly visible in the section of figure 3. Preferably, the core 212 comprises a plurality of grooves 215. In one embodiment, the soul 25 212 comprises a pair of opposing grooves 215. In a further example, the 212 soul comprises two pairs of 215 opposite grooves, so that each groove is arranged at 45° to the other, thus marking the four cardinal points. 5 Between the internal surface 216 of the tubular body external 211 and the groove 215 a lumen is created tie rod 217 suitable for hosting a tie rod 17 for the curvature of a flexible portion of the cannula 2, which will be described later. 10 The soul 212 is equipped with a plurality of internal lights, or channels, clearly visible in the section of figure 3. The core 212 comprises at least one nozzle lumen 23 intended to house the duct of a nozzle 5 for nebulization of the drug inside the cavities 15 abdominal of a patient to be treated with PIPac. Preferably, the nozzle lumen 23 has a cross-section circular. Preferably, the nozzle lumen 23 is centrally located at the core 212. In an embodiment, where the device 20 medical 1 The object of this invention is usable to perform a procedure Continuous Aerosol Intraperitoneal ChemoHyperthermia (CHyPAC), the core 212 also comprises a plurality of heating lamps for a heated fluid suitable for 25 heat the flowing drug in turn nozzle duct 51 arranged in nozzle lumen 23. In this example, visible in figure 3, the soul 212 comprises at least one delivery port 241 and at least one return light 242. At least one of the delivery light 5 241 and the return lumen 242 is adjacent to the lumen nozzle 23 in order to allow heating for nozzle lumen conduction 23. Preferably, the medical device 1 comprises a delivery light 241 and a plurality of return lights 10 242, for example six or eight nozzles. In the example of figure 3, the delivery port 241 is arranged around the nozzle light 23, and the return lights 242 are uniformly distributed around the delivery lumen 241, forming a circular crown. 15 The cannula 2 extends between a distal outlet 21 and a proximal entrance 22, and also the internal lumens of the soul 212, as well as the grooves 215, are extend between the distal exit 21 and the entrance proximal 22. 20 At the distal exit 21 of the cannula 2, the medical device 1 is equipped with a nozzle 5 for the nebulization of the chemotherapy drug in the abdominal cavity of a patient to be treated by PIPAc. 25 The nozzle 5 comprises a cover 54, preferably with a dome-shaped tip, in which a head is housed nozzle 52 connected to a nozzle duct 51 which flows inside the cannula 2. Nozzle 5 has at least one atomizing outlet 5 53, preceded by a nebulization chamber 55 formed in the nozzle head 52. Preferably, the nebulizer outlet 53 has a shape funnel-shaped with the concavity facing outwards. The nebulization outlet 53 can be arranged 10 frontally, as in figure 10, or in any point of the cup-shaped tip that makes the nozzle 5, as in figure 5. Preferably, the nozzle 5 has a plurality of 53 nebulizer outlets, each preceded by a 15 nebulization chamber 55. For example, the outputs of nebulization 53 are uniformly arranged on the dome-shaped tip that makes the nozzle 5, as shown in figure 7. Preferably, the nebulization chamber 55 is in 20 auger shape and allows to expand and centrifuge the pressurized drug coming from the nozzle duct 51. The nozzle duct 51 is tubular and defines its inside a drug lumen 510 intended for injection of the 25 chemotherapy drug under pressure that will go to form the aerosol inside the nozzle head 52 to be nebulized inside the abdominal cavity of the patient. The drug lumen 510 terminates in a connector drug 512, which can be connected, for example, to a syringe 5 dosage. Preferably, the nozzle duct 51 is made of flexible plastic material. This solution allows to give the nozzle body 51 the curvature desired. 10 Cannula 2 is rigid and includes distally, in proximity of the nozzle 5, a flexible portion 29. The flexible portion 29 is able to take at least a curvature, preferably a plurality of bends, by means of at least one tie rod 17, in order 15 to optimize the distribution of the nebulized drug from nozzle 5. In addition, managing the degree of traction of the tie rod 17 it is possible to manage the degree or radius of curvature of the flexible portion 29: a partial traction results in a partial curvature, a 20 full traction results in a camber that exceeds 45°, as shown in figure 4. The flexible portion 29 can be made directly on the external body 211, or it can be an insert applied to the outer body 211, as in 25 figure 10. In an example embodiment, shown in figures 1 and 4, the flexible portion 29 is obtained by means of the creation of a series of 219 openings, arranged parallel and staggered by 45°, in the external tubular body 5 211. In an example embodiment, shown in figures 9 and 10, the flexible portion 29 is obtained by means of a structure formed by a series of hinged joints, arranged parallel and staggered by 45°. 10 The cannula 2 is fixed integrally to the handle 3, preferably formed by two half-shells 31, in which the means of bending the portion are housed flexible 29. The cannula 2 in fact, and in particular the flexible portion 29, is able to switch from one 15 rectilinear configuration (figure 1) with a curved configuration (figure 4). The transition between the rectilinear configuration and curved configuration of the flexible portion 29 is controlled by means of curvature. 20 The bending means comprise at least one tie rod 17, housed inside the cannula 2. In the case of a single tie rod 17, the flexible portion 29 must be shape memory, in order to be able to return in the initial configuration, for example rectilinear, 25 while the tie rod 17 allows the passage to the curved configuration. Preferably, the bending means comprise a pair of tie rods 17, opposed, housed inside the cannula 2: a tie rod is used to 5 allow a bend to one side and the tie rod opposite is designed to allow a curvature towards the side opposite, as well as the return to the position rectilinear. In this example of implementation, it is not it is necessary that the flexible portion 29 is memorized 10 in shape. Preferably, the bending means comprise two pairs of 17 opposite tie rods, so that each tie rod is arranged at 45° to the other, marking so the four cardinal points. 15 In the example of embodiment shown in figures 11 and 12, the means of bending include 7 disc drive means. In this embodiment, the at least one tie rod 17 is fixed to a disc 710 supported by a frame 712 and tilting by means of a rotational cam 711. The 20 rotation of the disc 710 realizes the traction or the release of tie rod 17 and the consequent curvature and straightening of the flexible portion 29 of the cannula 2. Preferably, two pairs of 17 opposite tie rods, and the 17 tie rods are fixed at 45° 25 on the 710 disc, thus marking the four cardinal points. Preferably, the rotational cam 711 is driven from engine means 70 comprising an engine 713, preferably with gearmotor, powered by a battery 714 and controlled by a control circuit 5 715 operated by a 716 switch. As seen in figure 13, the bending means 7 and the motor means 70 are housed in the handle 3. In the example of embodiment shown in figures 14 and 15, the means of bending include 7 screw drive means. In 10 such an embodiment, the at least one tie rod 17 is fixed to a 720 worm screw supported by a frame 722 and rotatable by means of a wheel 723. The rotation of the wheel 723, and of the worm screw 720 in solidarity with it, carries out the traction or the 15 release of the tie rod 17 and the consequent curvature and straightening of the flexible portion 29 of the cannula 2. Preferably, as in the example in the figure 14, the bending means 7 comprise two pairs of 17 opposite tie rods, so that the tie rods of a pair 20 are fixed to a first worm screw 720 and the the second pair of tie rods are fixed to a second worm screw 720 rotated 45°, marking so the four cardinal points. In this context, with the expression worm screw refers to a 25 type of mechanism used to convert a motion rotary in a linear translational motion. In this example of implementation, the 723 knob is moved manually by the doctor. Alternatively, it is possible provide 70 engine means like those described above 5 for automatic rotation of the worm screw. In the example of embodiment shown in figures 17 and 18, the means of bending include 7 annular drive means. In this embodiment, the at least one tie rod 17 is fixed to a 730 support sliding along a frame 10 732 at least partially circular and rotatable by means of of a 733 selector. The rotation of the support realizes the traction or release of the tie rod 17 and the consequent curvature and straightening of the portion flexible 29 of cannula 2. Preferably, as 15 in the example of figure 18, the means of curvature 7 include two pairs of opposite tie rods 17, so that the tie rods of a pair are connected to a first frame 723 and the tie rods of the second pair are connected to a second frame 723; the two frames being 20 rotated 45° between them to form a spherical joint, the 723 tie rods mark the four cardinal points. In this example of implementation, the 733 selector is manually moved by the doctor. Alternatively, it is It is possible to foresee 70 engine means like the ones above 25 described for automatic rotation of the selector. As anticipated above, in an example of implementation, the medical device 1 subject of this invention can be used to perform a procedure of Continuous Aerosol Intraperitoneal ChemoHyperthermia 5 (CHyPAC). In this example, the core 212 comprises at least a 241 flow port and at least one return port 242, sliding in the cannula 2 and ending in a fluid connector 513, connectable to a system heating and circulation 80 of a fluid, shown 10 in figure 20. The heating and circulation system 80 comprehends: - a system 83 connector, connectable to the connector fluid 513 of medical device 1; preferably, 15 the system 83 connector is of the two-way type, for allow both the flow and return of the fluid; - heating means 81, preferably of the type Peltier cells, used to heat the fluid intended for be sent to medical device 1; 20 - thrust means 82, preferably a pump peristaltic, which allow the circulation of the fluid in both the heating and circulation system 80 that in medical device 1; - a tank connector 84, connectable to a 25 fluid tank 89; - 85 circulation channels, suitable for connecting each other the elements of the heating and circulation system 80. An example of how to use it will now be described. 5 of the medical device for performing a PIPAc procedure with single-port access in accordance with the present invention. To the patient, in supine position and under anesthesia general, an incision of approximately 5 cm is prepared 10 on the midline, to ensure a type of access "open" to the peritoneal cavity limiting the probability of any intestinal lesions upon entry into the said cavity. Having gained access to the peritoneal cavity, if there are the conditions to proceed with the intervention, 15 a single-port type device is applied and induced pneumoperitoneum at 12 mm HG. The peritoneal cavity: if ascites is present it is aspirated; the extension and characteristics are measured of peritoneal carcinomatosis; some biopsies are performed 20 for histological evaluation. At this point introduces into the patient's abdominal cavity the medical device 1 through the single- port, and check that there are no gas leaks from access to the abdomen. After the correct 25 positioning / exposure of the nozzles 5, we proceed with the nebulization of the chemotherapy drug in pressure. The insufflation lasts 30 minutes. After this time interval, the drug residues chemotherapy are aspirated into a so-called 5 “closed system” to avoid environmental dispersion of the antiblastic drug. At this point, the medical device 1 from the peritoneal cavity. Yes then proceeds to induce pneumoperitoneum again, hemostasis occurs, the single-port is removed 10 used for insufflation and sutures the access to the peritoneum. Usually, no application of abdominal drains or nasogastric tube. Innovatively, a medical device for performing a single-access PIPAc procedure 15 ports in accordance with the present invention allows optimal distribution of the drug in the cavity peritoneal. Advantageously, the medical device which is the subject of the This invention is equipped with a single nozzle, which 20 allows for nebulization of the chemotherapy drug high pressure, easily directional 360°, then with a wide and homogeneous nebulization inside the peritoneal cavity. Advantageously, in the example implementation with four 25 tie rods, the flexible portion can be oriented of the cannula, and with it the nozzle, along the four main directions (north, south, west, east). This handling allows for a wide infusion into the cavity abdominal, with a substantially spherical covering 5 of the area to be treated. It is therefore possible to obtain an optimal and uniform distribution of the drug chemotherapy. Advantageously, the medical device 1 is equipped with a suitably 55 nebulization chamber 10 designed to allow optimal nebulization of the drug and its expansion during the release phase from the nozzle, contributing to optimal distribution of the chemotherapy drug. Advantageously, the medical device which is the subject of the 15 This invention can also be used to perform an intraperitoneal chemohyperthermia procedure in Continuous Aerosol (CHyPAC). Advantageously, the handle 3 has been designed to accommodate 7-act drive means inside it 20 to make the movement of the simple but precise flexible portion of the cannula, and with it of the nozzle, along the four main directions (north, south, west, east). It is clear that a technician in the sector could contribute 25 modifications to the medical device described above, all contained within the scope of protection as defined from the following claims.

Claims

1. Medical device (1) for a procedure of 5 intraperitoneal drug chemotherapy pressurized, comprising: - a cannula (2) that develops along an axis longitudinal (X) and comprising: -- an external tubular body (211) with a central lumen 10 (213) defining an internal surface (216), and equipped distally of a flexible portion (29) capable of assume at least one curvature; -- a soul (212), housed in the central lumen (213) of the external tubular body (211), and equipped with a lumen 15 nozzle (23) and at least one groove (215) longitudinal; in which between said internal surface (216) of the external tubular body (211) and the groove (215) of the soul (212) a pulling light is created (217); 20 - at least one tie rod (17), housed in the tie rod lumen (217) and is capable of modifying the curvature of the portion flexible (29) of the cannula (2); - a nozzle (5) for nebulizing a drug placed at a distal end of the cannula (2), 25 said nozzle (5) having a nozzle head (52) connected to a nozzle duct (51), called nozzle duct (51) being placed in the nozzle lumen (23) of the cannula (2) and terminating in a drug connector (512); - a handle (3) integral with the cannula (2) and in which 5 are housed portion bending means flexible (29) connected to at least one tie rod (17).

2. Medical device (1) in accordance with the claim 1, wherein the core (212) comprises at least two opposite grooves (215), preferably four 10 grooves (215) arranged at 45° to each other; in each groove (215) of which houses a tie rod (17).

3. Medical device (1) in accordance with the claim 1 or 2, wherein the core (212) comprises at least one heating lumen for a fluid 15 heated, arranged adjacent to the nozzle lumen (23) and terminating in a fluid connector (513).

4. Medical device (1) in accordance with the claim 3, wherein the core (212) comprises at least a flow port (241) and at least one return port 20 (242), where the delivery port (241) is adjacent to the nozzle light (23).

5. Medical device (1) in accordance with a any of the preceding claims, where the nozzle (5) is equipped with at least one outlet 25 nebulization (53) funnel with concavity facing outwards.

6. Medical device (1) in accordance with the Claim 5, wherein the nebulization outlet (53) is preceded by a nebulization chamber (55) 5 auger formed in the nozzle head (52).

7. Medical device (1) in accordance with the claim 6, wherein the nozzle (5) is provided of a plurality of nebulization outlets (53), each preceded by a nebulization chamber 10 (55).

8. Medical device (1) in accordance with a any of the preceding claims, where: - the flexible portion (29) is obtained by means of a series of openings (219) made in the external body 15 (211) of the cannula (2); or - the flexible portion (29) is an insert applied to the external body (211), said insert being formed by a series of hinged joints.

9. Medical device (1) in accordance with a 20 any of the preceding claims, wherein the bending means include actuating means (7) disc-type, wherein the at least one tie rod (17) is fixed to a disc (710) supported by a frame (712) and tilting by means of a rotational cam (711), in which 25 the rotation of the disc (710) creates the traction or the release of the tie rod (17) and the consequent curvature and straightening of the flexible portion (29) of the cannula (2).

10. Medical device (1) in accordance with a 5 any of claims 1 to 8, wherein the means of bending include actuation means (7) to screw, wherein the at least one tie rod (17) is fixed to a worm screw (720) supported by a frame (722) and rotatable by means of a wheel (723), and in which the 10 rotation of the worm screw (720) realizes the traction or release of the tie rod (17) and the consequent curvature and straightening of the portion flexible (29) of the cannula (2).

11. Medical device (1) in accordance with a 15 any of claims 1 to 8, wherein the means of bending include means of actuation (7) annular, in which the at least one tie rod (17) is fixed to a support (730) sliding along a frame (732) at least partially circular and rotatable by means of 20 a selector (733), and in which the rotation of the support performs the traction or release of the tie rod (17) and the resulting curvature and straightening of the flexible portion (29) of the cannula (2).

12. Medical device (1) in accordance with a 25 any of the preceding claims, usable to perform a ChemoHyperthermia procedure intraPeritoneal Continuous Aerosol (CHyPAC), in which the soul (212) comprises at least one light of heating for a heated fluid, called lumen 5 heating being arranged adjacent to the nozzle lumen (23) and terminating in a fluid connector (513), and in which a heating and circulation system (80) is connected to the fluid connector (513); said system comprising the following components: 10 - a system connector (83), connected to the connector fluid (513); - heating means (81) for heating a fluid intended to be sent to the medical device (1) via the fluid connector (513); 15 - thrust means (82) for fluid circulation in the system; - a tank connector (84), connectable to a fluid reservoir (89); - circulation channels (85) to connect the 20 system components.

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