Medical device for immobilizing a needle or catheter

Abstract

The present invention relates to a medical device (1) for immobilizing a needle or catheter during medical procedures, said device comprising a body (2), a retaining cover (3) and a drive cover (4), wherein said body (2) is arranged with a plurality of gripping blades (6), a locking join (7) and a rotating actuator (5), which is connected to said gripping blades (6). The retaining cover (3) is configured to axially retain the plurality of gripping blades (6) and the rotary actuator (5) inside the body (2). The drive cover (4) is arranged over the retaining cover (3) and connected to the rotary actuator (5) and is configured to apply different drive movements to the rotary actuator (5), which in turn generates either the opening or closing of the gripping blades (6).

Description

[0001] DESCRIPTION

[0002] "MEDICAL DEVICE FOR IMMOBILIZING NEEDLES OR CATHETER"

[0003] FIELD OF INVENTION

[0004] The present invention relates to a medical device (1) for immobilizing a needle or catheter, designed to assist medical professionals in procedures requiring the precise and controlled application of these instruments, such as paracentesis and other similar procedures. The invention has application in the technical field of medical instruments, more specifically medical instruments for immobilizing needles or catheters.

[0005] BACKGROUND OF THE INVENTION

[0006] In the medical field, there are several medical procedures that involve the insertion of needles or catheters into patients for diagnostic, therapeutic, or monitoring purposes. Some examples of these medical procedures include: diagnostic or therapeutic paracentesis, thoracentesis, image-guided biopsies, abscess drainage, central venous catheter insertion, cardiac catheterization, urinary catheter insertion, peripheral intravenous catheter insertion, epidural or intrathecal catheter insertion, hemodialysis catheter insertion, and lumbar puncture. These are just a few examples of the many medical procedures that involve the insertion of needles or catheters into patients.

[0007] Paracentesis is a medical procedure in which a needle or catheter is inserted into the abdominal region to drain fluid accumulated in the peritoneal cavity, the area between the abdominal walls and the internal organs. The main purpose of paracentesis is to relieve symptoms such as abdominal distension, discomfort, and difficulty breathing, which can occur due to the abnormal accumulation of fluid (ascites) in this region.

[0008] The paracentesis procedure is performed by a doctor in a hospital or outpatient setting and follows certain steps that are, in general, similar in all hospitals or private clinics and consist of:

[0009] 1. Patient preparation and positioning: The patient is typically placed in a reclining, semi-sitting, sitting, or fully recumbent position, with the abdominal region exposed.

[0010] 2. Asepsis and local anesthesia: the area where the needle or catheter will be inserted is prepared and cleaned with antiseptic solutions and local anesthesia is administered.

[0011] 3. Needle or catheter insertion: a needle and catheter are inserted through the abdominal wall into the peritoneal cavity; the needle is then removed and the catheter is left in place to guide the abdominal fluid out.

[0012] 4. Fluid Drainage: As the catheter advances, ascitic fluid begins to drain. A bottle is attached at a lower height than the patient to drain the ascitic fluid, allowing the fluid to flow passively. The procedure is also often monitored using imaging techniques, such as ultrasound, to guide insertion and monitor the amount of fluid drained. 5. Sample Collection (Optional): During paracentesis, ascitic fluid samples may be collected for laboratory analysis (if the procedure is diagnostic in nature). These samples can help determine the underlying cause of the fluid accumulation.

[0013] 6. Completion of the procedure: once the desired amount of fluid has been drained or the diagnostic or therapeutic purpose has been achieved, the needle or catheter is removed and a dressing is applied under sterile conditions to the procedure site.

[0014] In this paracentesis procedure described above, needle or catheter fixation is typically accomplished by one of the following means:

[0015] - medical tape or gauze: the needle or catheter is fixed to the patient's skin using medical tape or gauze, which will help keep the instrument in place to minimize the risk of unwanted movement.

[0016] - manual fixation: in some cases, a member of the medical team holds the needle or catheter to provide the necessary stability during the procedure.

[0017] - medical sutures: help to secure the needle or catheter in place. mechanical support devices: in some cases, special mechanical supports may be used to keep the needle or catheter stable during paracentesis, minimizing unwanted movements.

[0018] Proper needle or catheter fixation is essential to ensure the accuracy and safety of paracentesis or any other similar medical procedure, with the primary goal of minimizing the risks associated with inadvertent movement during medical procedures. Keeping the needle or catheter stable is a primary concern for medical staff performing these procedures.

[0019] Current needle and catheter fixation methods present several drawbacks for both patients and healthcare professionals. One of the main drawbacks is that they provide poor stability and fixation against the patient's abdomen, which can lead to complications during medical procedures. Furthermore, for healthcare professionals, current fixation methods do not allow for the use of devices during medical procedures or the easy insertion and removal of needles or catheters without the use of non-invasive methods.

[0020] Document US5078688A refers to a paracentesis catheter system for removing fluids from a patient's abdominal cavity and administering medications into the abdominal cavity. As shown in Figure 1 of this document US5078688A, the system is divided into two main parts. The first part is understood to be the entire set of tubes and valves that guide the drained fluid (ascites) to the final collection or diagnostic container. In turn, the second part is where the described support device will operate, encompassing the set of equipment that allows access to the accumulated fluid inside the body through a puncture. This puncture is performed using a needle inserted inside a rigid catheter. The tip of the needle is left uncoated to allow better skin penetration.Once inserted into the cavity where the accumulated fluid is located, the needle is subsequently removed and the aforementioned catheter is left in its place, serving as a guide for the fluid to the tubing system. This type of system makes the procedure minimally invasive, using only a puncture as the only invasive means. However, a support system for the catheter itself is necessary, and currently a simple adhesive is used for its fixation.

[0021] As a support system, a set of invasive cutaneous systems are normally used, which are used in most cases. Document US 8454632B2 refers to one of these systems, describing an "anchor" that is inserted at the cutaneous level through penetrations between the adjacent skin layers, where the phalanges of the "anchor" interact with the most superficial layers of the tissue and the central region resides in the region where the cutaneous penetrations occurred.

[0022] The prior art describes different ways in which this anchoring can occur, such as in document US 8425539B2, in which the type of anchoring found, similar to the previous document, is performed in a first phase, with a puncture allowing the device to penetrate the skin followed by the release of the mechanism. In this case, the anchoring is performed through four arms that, upon penetrating the skin, extend and curve, creating a type of clamp anchoring in the outermost layers of the inner and outer part of the skin or the organ in question. Once fixed, the hollow stent in the center of the device allows the insertion of catheters or the passage of accumulated fluid in the region closest to the region where the device will have been placed.

[0023] There are also robotic arm systems used in more advanced procedures to precisely position needles or catheters. These systems provide a high degree of control, but they are complex, expensive, and not widely adopted in all types of medical procedures, being used only in surgical settings.

[0024] Although there are several approaches and devices available for immobilizing needles or catheters in medical procedures, many of them have limitations in terms of precision, fit, and support. Therefore, there is a need for innovation in this area to improve the efficacy and safety of non-invasive medical procedures involving the application of needles or catheters.

[0025] BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The invention is now described in detail with reference to the attached drawings, in which:

[0027] Fig. 1 illustrates the schematic exploded view of all the components of the medical device (1) for immobilizing a needle or catheter, according to the present invention, which comprises: the body (2), the retention cover (3), the actuation cap (4), the rotary actuator (5), the gripping blades (6) and the locking joint (7).

[0028] Fig. 2 is a schematic representation of the body (2) of the device, in which (21) refers to the side wall, (22) corresponds to the open top, (23) is the bottom, (24) is the through opening, (25) refers to the cavity, (26) corresponds to male-female type fitting means with the gripping blades (6) and (27) refers to male-female type fitting means with the retaining cover (3). Fig. 3 is a schematic representation of the retaining cover (3), where (31) represents the through hole and (32) corresponds to male-female type fitting means with the body (2).

[0029] Fig. 4 consists of a schematic representation of the drive cover (4), where (41) corresponds to the through hole.

[0030] Fig. 5 refers to the side view of the actuation cover (4) in which (42) corresponds to male-female fitting means with the rotary actuator (5).

[0031] Fig. 6 is the bottom view of the actuation cover (4), i.e. its base, where (41) corresponds to the through hole and (42) corresponds to male-female fitting means with the rotary actuator (5).

[0032] Fig. 7 illustrates a schematic representation of the rotary actuator (5), where (51) represents the through hole and (52) corresponds to male-female fitting means with the actuation cover (4).

[0033] Fig. 8 consists of the bottom view of the rotary actuator (5), i.e. its base, in which (51) represents the through hole and (53) represents an eccentric pin-groove type connection with the gripping blades (6).

[0034] Fig. 9 is a schematic representation of the gripping blades (6), in which (61) represents an eccentric pin-groove type connection with the rotary actuator (5), and (62) refers to male-female type fitting means with the body (2). Fig. 10 is a schematic representation of the locking joint (7), in which (71) represents a through hole.

[0035] Fig. 11 shows a sectional view of the medical device (1).

[0036] SUMMARY OF THE INVENTION

[0037] The present invention relates to a medical device (1) for immobilizing a needle or catheter, which comprises a body (2), a retaining cover (3) and an actuating cap (4), in which the body (2) is delimited by a side wall (21), an open top (22) and a bottom (23) having a through opening (24), which jointly define a cavity (25) within which are arranged a plurality of gripping blades (6) and a rotary actuator (5), in which said actuator (5) comprises a through hole (51) and is connected to the gripping blades (6).

[0038] - the retaining cover (3), comprising a through hole (31), is arranged on said open top (22) of the body (2) and is configured to axially retain the plurality of gripping blades (6) and the rotary actuator (5) within the cavity (25) and

[0039] - the actuation cover (4) comprises a through hole (41) and is arranged on the retaining cover (3) and connected to the rotary actuator (5), wherein said actuation cover (4) is configured to, in use, provide alternative actuation movements to the rotary actuator (5), which, in turn, alternatively provides an opening or closing of the gripping blades (6).

[0040] In a preferred embodiment, said drive cover (4) is a rotary drive cover.

[0041] In another embodiment of the present invention, the medical device (1) further comprises a locking joint (7) arranged between the rotary actuator (5) and the side wall (21) of the body (2).

[0042] In one aspect, at least 3 gripping blades (6) are disposed within the cavity (25) of the body (2) of the device.

[0043] In another aspect, said drive cover (4) is connected to the rotary actuator (5) by connection means selected from the group consisting of threaded means, mechanical adhesive means, chemical adhesive means, magnetic attraction means, and snap-on means.

[0044] In yet another aspect of the invention, said actuation cover (4) is connected to the rotary actuator (5) by means of a male-female fitting, preferably of the pin-hole type.

[0045] In one aspect, said rotary actuator (5) is connected to the gripping blades (6) via an eccentric pin-groove type connection. In another aspect of the invention, said retaining cover (3) is connected to the body (2) by connecting means selected from the group consisting of threaded means, mechanical adhesive means, chemical adhesive means, magnetic attraction means, and snap-in means.

[0046] In yet another aspect, said retaining cover (3) is connected to the body (2) by male-female fitting means, preferably of the pin-hole type.

[0047] The present invention also relates to a medical puncture kit comprising the medical device (1) of the invention, a needle and a catheter.

[0048] The present invention also relates to a paracentesis kit comprising the medical device (1) of the invention and a paracentesis needle.

[0049] DETAILED DESCRIPTION OF THE INVENTION

[0050] The present invention relates to a medical device for immobilizing needles or catheters, designed to assist medical professionals in procedures that require the precise and controlled application of such instruments, such as paracentesis, thoracentesis, and other similar medical procedures. The present invention also relates to a medical puncture kit and a paracentesis kit that comprise the medical device disclosed herein. The invention has application in the technical field of medical instruments, more specifically, medical instruments for immobilizing needles or catheters.In the context of the present invention, the expression "grip blades" refers to elements of small thickness in relation to their axial dimensions that aim to act together, through a set of at least 3 blades, to grip or release a needle or catheter, thus contributing to the desired effect of immobilizing them, when the medical device is being used.

[0051] In turn, the expression "rotary actuator" refers to an intermediate element for actuating said blades. This element is directly connected to the blades on one of its faces, with the other face being connected to a drive cover of the medical device.

[0052] Furthermore, the expression "actuation cap" refers to an element with which the user of the medical device interacts manually to actuate said gripping blades.

[0053] The term "locking joint" refers to an element arranged in the cavity of the device body, between the rotary actuator and the side wall of the same body. In addition to allowing the elimination of the clearance between the rotary actuator and the side wall of the same body, the locking joint prevents the free movement of the rotary actuator and, consequently, of the gripping blades, helping to fix the gripping blades in the closed position around the needle or catheter, which may have different thicknesses or diameters.

[0054] The term "retention cover" refers to an element intended to retain axillary the assembly of gripping blades, locking joint and rotary actuator inside the body of the device, the retention cover being arranged on the open top of the body of the medical device.

[0055] In the context of this description, the term "comprising" should be understood as "including, among others". As such, the said term should not be interpreted as "consisting only of".

[0056] The device provides a stable and safe platform for the precise insertion and manipulation of needles or catheters, minimizing the risks associated with involuntary movements and improving the efficiency and accuracy of medical procedures.

[0057] The said medical device can be applied to different areas of the body, namely the rib cage, lower back, abdomen, etc. and can be placed before or after insertion of the needle or catheter into the body.

[0058] The medical device of the present invention comprises several interconnected elements in which each one plays a specific role to ensure the objectives of immobilization, stability and support of needles or catheters during a given medical procedure.

[0059] In one embodiment of the present invention, the medical device of the present invention focuses on optimizing the paracentesis procedure, namely for better immobilization, support, and stabilization of the catheter, which is left in the patient's abdomen for continuous extraction of the fluid (ascites) present in the abdomen. Thus, in the case of the paracentesis medical procedure, the device of the present invention has the function of immobilizing the catheter after the needle has been inserted into the patient's abdomen. The device is placed under the surface of the skin, in the abdominal region of interest, and will allow, after the entire procedure, the immobilization and stabilization of the catheter in the patient's abdomen, which is left during the procedure for the removal of all the fluid accumulated in the abdomen.This procedure is, to date, carried out using gauze or adhesive to immobilize and stabilize the needle in the patient's abdomen, methods that have proven to be ineffective.

[0060] The medical device of the present invention is adaptable, since it can be applied in medical procedures similar to paracentesis, namely thoracentesis, which is based on a similar principle, the removal of pleural fluid.

[0061] The medical device of the present invention allows an improvement in the paracentesis procedure and other similar medical procedures, since it contributes to a reduction in complications and greater ease of application by the health professional. The medical device of the present invention makes the use of adhesive unnecessary, ensuring stability, immobilization and better fixation of the needle or catheter close to the abdomen or other region of the patient's body, reducing minor complications that may arise due to poor stability and immobilization of the needle or catheter, and allows the health professional to insert and remove the needle or catheter with greater ease and safety.

[0062] Thus, the objective of the present invention is to improve medical procedures that involve the application of needles or catheters into the patient's body, from a medical and technical point of view, contributing to a reduction in complications and greater ease of application by the health professional.

[0063] Contrary to the existing prior art, the medical device of the present invention promotes the safety of medical procedures involving medical puncture in a non-invasive manner, also allowing for the easy replacement of each component of the device, without the need to replace the device in its entirety, and allowing its reuse, requiring only its sterilization and disinfection. Another advantage of the medical device of the present invention is the possibility of its adaptation to different medical procedures in which there is a need for immobilization of needles or catheters.

[0064] As already mentioned above, the medical device of the present invention brings several advantages compared to what currently exists, with the following advantages also standing out:

[0065] • Reduction in the rate of complications associated with infection, ensuring ideal aseptic conditions;

[0066] • Allows greater adaptation of the equipment to the individual biotype of each patient, especially the characteristics of their abdominal wall;

[0067] • Acceleration of healing at the punctured site through a hypoallergenic adhesive that may contain, in its composition, an agent to aid healing;

[0068] • Facilitates the performance of paracentesis and similar medical procedures by health professionals, contributing to a user-friendly application; • Immobilization of the needle or catheter inserted in the abdomen, increasing the safety of the procedure itself;

[0069] • Allows greater adaptability of the device to different types of equipment;

[0070] • Produced in a material that allows sterilization by autoclaving and / or non-ionizing radiation (UV); and also

[0071] • Design that allows each element to be replaced individually in the event of damage or contact with bodily substances that make it impossible to reuse.

[0072] The medical device of the present invention will function during the period in which the needle or catheter is inserted into the abdominal region, or other region of the body where the medical procedure is being performed, serving as a guide between the liquid accumulated in the abdomen, or other region of the body, and the drainage system.

[0073] The construction and assembly of the device itself makes it possible to replace any of its parts without dismantling the entire device. This allows for the replacement of specific parts in the event of damage and / or contact with bodily fluids, although the device can be sterilized and disinfected.

[0074] Thus, with reference to Fig. 1 to 11, which represent a preferred and merely illustrative embodiment of the invention, the medical device (1) comprises a body (2), a retaining cover (3) and an actuating lid (4), in which the body (2) is delimited by a side wall (21), an open top (22) and a bottom (23) having a through opening (24), which together define a cavity (25) within which a plurality of gripping blades (6) are arranged, a rotary actuator (5), in which said actuator (5) comprises a through hole (51) and is connected to the gripping blades (6), and also a locking joint (7), arranged between the rotary actuator (5) and the side wall (21) of the body (2),

[0075] • the retaining cover (3), comprising a through hole (31), is arranged on said open top (22) of the body (2) and is configured to axially retain the plurality of gripping blades (6), the locking joint (7) and the rotary actuator (5) within the cavity (25) and

[0076] • the actuating cover (4) comprises a through hole (41) and is arranged on the retaining cover (3) and connected to the rotary actuator (5), and wherein said actuating cover (4) is configured to, in use, provide alternative actuating movements to the rotary actuator (5), which, in turn, alternatively provides an opening or closing of the gripping blades (6).

[0077] The aforementioned locking joint (7) has the function of eliminating the gap between the rotary actuator (5) and the side wall (21) of the body (2), as well as sealing and creating friction between the rotary actuator (5) and the side wall (21) of the body (2), allowing the gripping blades (6) to remain fixed through friction. Thus, the locking joint (7) fixes the rotary actuator (5) and, consequently, fixes the gripping blades (6), thus allowing the needle or catheter to be immobilized when the medical device is being used.

[0078] In one embodiment, the locking gasket (7) is in a rubber or silicone material or any other suitable material that creates friction between the rotary actuator (5) and the side wall (21) of the body (2), and a material that is sterilizable.

[0079] The aforementioned actuation cap (4) is a rotary actuation cap, being the part of the device (1) that the healthcare professional will actuate to immobilize the needle or catheter during the medical procedure. The actuation cap (4) corresponds to the upper part of the device (1), being the part that the healthcare professional will rotate and thus actuate the gripping blades (6), for closing or opening them and, consequently, immobilizing or not immobilizing the needle or catheter, respectively.

[0080] Furthermore, said actuating cover (4) is connected to the rotary actuator (5) by connecting means selected from the group consisting of threaded means, mechanical adhesive means, chemical adhesive means, magnetic attraction means and snap-in means.

[0081] In one embodiment, the drive cover (4) is connected to the rotary actuator (5) by male-female fitting means, preferably of the pin-hole type. In another embodiment, the drive cover (4) is connected to the rotary actuator (5) by means of at least two pin-hole assemblies.

[0082] In a preferred embodiment, the drive cover (4) is connected to the rotary actuator (5) by means of six pin-hole assemblies.

[0083] Said rotary actuator (5) is connected to the gripping blades (6) through an eccentric pin-groove connection, allowing the movement of the gripping blades (6), i.e., allowing the opening or closing of the gripping blades (6), for immobilization of the needle or catheter and adaptation of the device to the size of the needle or catheter.

[0084] In a preferred embodiment, the rotary actuator (5) is connected to the gripping blades (6) via an eccentric pin-groove connection. In this case, each blade has a pin that fits into a respective open groove in the actuator.

[0085] (5) rotary. This means that in the present preferred three-blade case, the rotary actuator comprises three slots.

[0086] In another embodiment, the medical device of the invention comprises six gripping blades (6).

[0087] Furthermore, said gripping blades (6) are connected to the device body (2) by means of male-female fitting means, preferably of the pin-hole type.

[0088] Since the rotary actuator (5) is connected to the blades

[0089] (6) gripping through an eccentric connection of the pin-groove type (61), it is possible to move the pins of each blade (6) after performing the rotary movement of the rotary actuator (5) (with the health professional acting on the actuation cover (4) with a rotary movement) for closing and opening the gripping blades (6).

[0090] Said retaining cover (3) is arranged on the open top (22) of the body (2) and is attached to said body (2) by means of threaded means, mechanical adhesive means, chemical adhesive means, magnetic attraction means and snap-in means.

[0091] In a preferred embodiment, the retaining cover (3) is fixed to the device body (2) by male-female fitting means, preferably of the pin-hole type.

[0092] Figs. 2 to 10 show the said elements (2) to (7) of the medical device (1) of the present invention, which together form the medical device for immobilizing needles or catheters during the paracentesis procedure or similar procedures.

[0093] The body (2) consists of the base structure of the device (1) that is positioned over the patient's area of ​​interest, providing a firm surface for immobilization. It is also adjustable and can be adapted to different sizes and anatomical positions, ensuring suitability for various patients and medical procedures.

[0094] In one aspect of the present invention, the construction and assembly of the device (1) allows the replacement of the elements (2) to (7) individually, without the need to replace the device (1) in its entirety.

[0095] With reference to Figs. 1 to 11, in a preferred embodiment, the order of assembly of each of said elements (2) to (7) of the medical device (1) is as described below:

[0096] - the body (2) serves as the base of the entire device (1) and is in direct contact with the skin;

[0097] - the gripping blades (6) are placed inside the cavity (25) of said body (2) by fitting the pin of the male-female type fitting means (62) into the hole in the body (2); each gripping blade (6) when placed in each hole of the male-female type fitting means (26) by means of its pin of the male-female type fitting means (62), in sequential order, will be superimposed on the gripping blade (6) placed previously, leaving exposed the pin of the eccentric connection (61) of the pin-groove type of each blade (6) for a subsequent fitting with the rotary actuator (5);

[0098] - in turn, the rotary actuator (5) is connected to the gripping blades (6) by fitting the pin of the eccentric connection (61) of the pin-groove type of each blade (6) into the grooves of the eccentric connection (53) of the pin-groove type of the rotary actuator (5);

[0099] - then, the locking joint (7) is arranged between the rotary actuator (5) and the side wall (21) of the body (2); the retaining cover (3) is arranged on the open top (22) of the body (2), being fixed to said body (2) by means of a pin-hole type fitting, that is, each pin of the male-female type fitting means (32) of the retaining cover (3) is placed in each hole of the male-female type fitting means (27) of the body (2);

[0100] - finally, the drive cover (4) is then placed under the retaining cover (3) and, since the pins of the male-female type of fitting means (52) of the rotary actuator (5) are exposed, said pins of the male-female type of fitting means (52) of the rotary actuator (5) are fitted into the holes of the male-female type of fitting means (42) of the drive cover (4).

[0101] With the above assembly, the device (1) of the present invention is obtained, which is based on a rotary locking and manual opening system from a rotary movement of the drive cover (4) counterclockwise / clockwise in relation to the body (2) of the device. Thus, when creating the rotary action in the drive cover (4), the rotary actuator (5) and the gripping blades (6) move together, which in turn will reduce the diameter of the through opening (24) and allow the fixation and immobilization of the needle or catheter.

[0102] Thus, to activate the rotary locking or opening system of the device (1), the user makes a rotary movement in the counterclockwise or clockwise direction on the actuation cover (4), respectively. With this movement, the rotary actuator (5) moves together with the actuation cover (4) and, consequently, the gripping blades (6) move, passing from the open position to the closed position with the counterclockwise movement and from the closed position to the open position with the clockwise movement.

[0103] The fixation of the medical device (1) to the patient's skin, specifically at the puncture site, is achieved through the use of an adhesive as a fixing agent, which is located at the base of the body (2) of the device (1). Furthermore, after the completion of the medical procedure, said adhesive may remain fixed to the patient's skin, in order to assist and promote better healing of the surgical insertion, reduce the rate of infection and reduce the material spent on post-operative treatment.

[0104] Since the device (1) of the present invention is for medical purposes, it is designed in a material whose composition allows sterilization to be performed without the device (1) losing its structural properties or becoming harmful to the user / patient. To this end, the device (1) is made of a material that is already used in hospital settings, such as polylactic acid (PLA) or polyethylene terephthalate (PET). These materials are already currently used in scalpel handles or plastic packaging, respectively, which facilitates the manufacturing process, since they are already implemented in various industries, including in the production of various medical devices.

[0105] The industrial production of the device (1) of the present invention, using the aforementioned materials, is based on molten plastic injection technology into a mold shaped like the desired part. This process allows for the production of thousands of units per day. As a medical device, post-production care, such as sterilization and vacuum packaging, are taken into consideration, and each country's regulatory standards are followed.

[0106] Thus, in view of the above, the device (1) of the present invention consists of an innovative solution that presents several significant advantages compared to conventional needle or catheter fixation techniques, namely, greater precision, reduced risk of complications arising from involuntary movements and provides a controlled environment for medical procedures. Furthermore, the adaptability of the device to different patients and medical procedures makes it a versatile and valuable tool for medical professionals in various specialties.

[0107] The device ( 1 ) is particularly useful in medical procedures such as paracentesis , image-guided biopsies , insertion of catheters for drainage and infusion , among others . Its applicability covers a variety of medical fields where precision in the application of needles or catheters is crucial .

[0108] In conclusion, the invention presents a notable advance in the area of ​​medical devices, providing an effective and efficient solution for the immobilization of needles or catheters during medical procedures, and its ability to improve the accuracy and safety of procedures has the potential to benefit both medical professionals and patients.

[0109] It should be noted that although the present invention has been described with reference to its preferred embodiments, many modifications and alternatives may be made by one skilled in the art without departing from the scope of the invention, which is defined by the claims.

Claims

CLAIMS 1. A medical device (1) for immobilizing a needle or catheter, the device (1) characterized in that it comprises a body (2), a retaining cover (3) and an actuating cap (4), wherein the body (2) is delimited by a side wall (21), an open top (22) and a bottom (23) having a through opening (24), which together define a cavity (25) within which are disposed a plurality of gripping blades (6), and a rotary actuator (5), wherein said actuator (5) comprises a through hole (51) and is connected to the gripping blades (6), - the retaining cover (3), comprising a through hole (31), is arranged on said open top (22) of the body (2) and is configured to axially retain the plurality of gripping blades (6) and the rotary actuator (5) within the cavity (25) and - the actuating cover (4) comprises a through hole (41) and is arranged on the retaining cover (3) and connected to the rotary actuator (5), wherein said actuating cover (4) is configured to, in use, provide alternative actuating movements to the rotary actuator (5), which, in turn, alternatively provides an opening or closing of the gripping blades (6).

2. The medical device (1) according to claim 1, characterized in that said actuating cap (4) is a rotary actuating cap.

3. Medical device (1) according to claim 1 or 2, characterized in that it further comprises a locking joint (7) arranged between the rotary actuator (5) and the side wall (21) of the body (2).

4. Medical device (1) according to any one of claims 1 to 3, characterized in that at least 3 gripping blades (6) are arranged within the cavity (25) of the body (2) of the device.

5. Medical device (1) according to any one of claims 1 to 4, characterized in that said drive cap (4) is connected to the rotary actuator (5) by connection means selected from the group consisting of threaded means, mechanical adhesive means, chemical adhesive means, magnetic attraction means and snap-on means.

6. Medical device (1) according to claim 5, characterized in that said actuating cap (4) is connected to the rotary actuator (5) by male-female fitting means, preferably of the pin-hole type.

7. Medical device (1) according to any one of the preceding claims 1 to 6, characterized in that the rotary actuator (5) is connected to the gripping blades (6) via an eccentric pin-groove connection.

8. Medical device (1) according to any one of claims 1 to 7, characterized in that said retaining cover (3) is connected to the body (2) by connection means selected from the group consisting of threaded means, mechanical adhesive means, chemical adhesive means, magnetic attraction means and snap-on means.

9. Medical device (1) according to claim 8, characterized in that said retention cover (3) is connected to the body (2) by male-female fitting means, preferably of the pin-hole type.

10. Medical puncture kit, characterized in that it comprises the medical device (1) claimed in any one of the preceding claims 1 to 9, a needle and a catheter.

11. Paracentesis kit characterized by comprising the medical device (1) claimed in any one of claims 1 to 9 and a paracentesis needle.

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