Fastening system for an electrical stimulation generator

Abstract

A fastening system (1) for an electrostimulation generator (2), having a generator and electrodes, comprising a casing (4) for housing the generator (2), which has a first and a second opening (7.1, 7.2) of the same kind, provided on opposite sides of the casing; means for connecting the electrodes (5) to the casing (4) in the first or second opening (7.1, 7.2), said means being formed by a first connector (13) for the passage of the electrodes and having a hermetic valve (14) inside the first connector (13); a closing element (10) provided at the opening of the casing (4) and opposite the opening having the means for connecting the electrodes (5); means (6) for fixing the electrodes (5) to the skin; and means for fixing the casing (4) to the body of the patient (3).

Description

Technical Field

[0001] This invention relates to the technical field of manufacturing medical devices, particularly cardiac stimulation. Background Technology

[0002] The cardiac stimulation system consists of a device that detects the electrical activity generated by the heart and, when this activity is absent, interprets it as the absence of a heartbeat, then discharges electricity to cause the heart to contract with a certain power.

[0003] Specifically, the cardiac stimulation system consists of circuitry and a processor, encapsulated together with a battery in a metal casing, typically made of titanium, which performs the functions of detecting electrical activity and generating pulses.

[0004] Depending on the type of cardiac stimulation required, the system also provides one, two, or three electrodes. These electrodes are connected to the corresponding ports of the generator located in the silicone head, from the patient's central venous access to the desired right atrium or ventricle, and are supported or fixed to the endocardium. If stimulation of the left ventricle is to be performed through the coronary sinus, the electrodes are moved to the desired position.

[0005] The electrodes, formed of a metallic material covered with insulating elements, receive electrical signals from the heart and transmit them to a processor within the casing. In the absence of electrical activity, a generator housed within the casing emits a discharge that is directed to the epicardium in the endocardium or coronary sinus electrodes, causing the heart to contract.

[0006] These cardiac stimulation systems can be permanent or temporary, depending on the duration of the stimulation treatment.

[0007] Current permanent generator systems consist of increasingly smaller generators, with a volume reaching 10 cm². 3 The generator is implanted in subcutaneous tissue, typically in the patient's chest region. In this case, the electrode enters the superior vena cava via the subclavian artery, or in some cases via the internal jugular vein, and reaches its final location, which can be the right atrium, right ventricle, or coronary venous network.

[0008] Temporary cardiac stimulation systems typically use an external generator containing all necessary components, such as a battery, processor, and electrode connection ports, which can be up to 15 cm long and weigh up to 1 kg.

[0009] Furthermore, the electrodes used with these devices for temporary stimulation often lack a system for securing them to the endocardium, where the devices are simply supported on the inner surface of the heart.

[0010] These two characteristics of traditional temporary cardiac stimulation systems mean that patients must remain at absolute rest and undergo continuous monitoring in the intensive care unit (ICU). The contact between the electrodes and the endocardium, as well as the size of the generator, mean that the system is unstable and hinders patient movement.

[0011] The purpose of this temporary stimulation is to buy time to complete the study of the patient, which may lead to spontaneous recovery or the need for a permanent pacemaker.

[0012] Currently, permanent stimulation systems are being used for temporary cardiac stimulation due to the enhanced safety of their materials. This technology involves externally mounting active, immobilized electrodes connected to a permanent pacemaker. The use of these components provides an electrode-endocardial connection with safer and more stable active immobilization, allowing patients to be discharged from the ICU and continue treatment in their inpatient ward.

[0013] Currently, a secure fastening system that attaches this generator and external electrodes to the patient to provide the required safety is not available. In some cases, it is secured to the patient by dressings or sutures to the skin. Given that these systems can easily dislodge—the generator might pull on the electrodes, causing a generator-electrode disconnection and cessation of stimulation—or, because the electrodes are screwed onto the heart, directly pulling on the endocardium and potentially even causing cardiac rupture—this solution presents a range of problems.

[0014] Similarly, the entire external system is exposed to the medium, making it susceptible to bacterial colonization, which can then lead to infection in patients.

[0015] It would be desirable to provide an effective fastening system for all external components to improve patient safety, prevent accidental dislodgement, and prevent potential infections from the system being simply exposed to the environment or coming into contact with healthcare personnel.

[0016] There is currently no external fastening device for such a temporary cardiac electrical stimulation system with a permanent generator. Summary of the Invention

[0017] The fastening system for an electrical stimulation generator disclosed herein includes a generator for stimulating the heart and electrodes, the generator being, for example, a pacemaker, defibrillator, resynchronizer, neurostimulation device, or other similar generator disposed outside the patient's body, and the electrodes having a first end for connection to the patient's heart and a second end for connection to the generator.

[0018] The system includes a housing for accommodating the generator, the housing having identical first and second openings located on opposite sides of the housing.

[0019] Similarly, the system includes a component for connecting the electrode to a first or second opening in the housing, the component being formed by a first connector for allowing a second end of the electrode to pass through. The first connector contains an airtight valve.

[0020] In addition, the system has a sealing element disposed at the opening of the housing and opposite to the opening having a component for connecting the electrode.

[0021] The system also includes means for securing the electrodes to the skin, the means having components for anchoring the electrodes and means for adhering to the patient's torso. The invention also provides components for securing the housing to the patient's body.

[0022] The fastening system for an electrical stimulation generator provided in this disclosure represents a significant improvement over the prior art.

[0023] In other words, this fastening system represents a significant improvement in safety, preventing potential detachment and thus reducing the likelihood of accidental disconnection between the electrode and the generator, and even the possibility of cardiac rupture caused by the electrode being pulled when connected to the endocardium.

[0024] Furthermore, the airtightness of all system components can significantly reduce infections associated with the intravascular system, thereby eliminating any possible pathway for bacteria to enter the bloodstream.

[0025] Similarly, the system in this invention can be fixed to either the right or left side of the body because the two openings arranged on opposite sides of the housing, as well as the sealing element and the first connector between the two openings, are interchangeable, allowing the electrodes to emerge from both directions.

[0026] Therefore, this system can solve the shortcomings of current temporary cardiac electrical stimulation systems with permanent external generators in a simple and effective way. Attached Figure Description

[0027] To aid in a better understanding of the features of the invention according to preferred embodiments, accompanying drawings are provided as part of the specification, in which the following is described in an illustrative and non-limiting manner:

[0028] Figure 1 A perspective view of a fastening system for an electrical stimulation generator according to a preferred embodiment of the present invention is shown, wherein the housing is closed and secured to the patient's neck.

[0029] Figure 2 A perspective view of a fastening system for an electrical stimulation generator according to a preferred embodiment of the present invention is shown, wherein the housing is opened and secured to the patient's neck.

[0030] Figure 3 A view of a housing in a fastening system for an electrical stimulation generator according to a preferred embodiment of the present invention is shown, the fastening system having an electrode connector and a sealing element.

[0031] Figure 4 A side view of the housing in a fastening system for an electrical stimulation generator according to a preferred embodiment of the present invention is shown.

[0032] Figure 5 A perspective view of a device for securing electrodes to the skin in a fastening system for an electrical stimulation generator according to a preferred embodiment of the present invention is shown.

[0033] Figure 6.1 and Figure 6.2 A perspective view and a cross-sectional view of the second connector are shown, which is used to fix the electrodes of the fastening system for the electrical stimulation generator of the preferred embodiment of the present invention to the device.

[0034] Figure 7 A perspective view of the device and its end second connector is shown, the device being used to secure electrodes in a fastening system for an electrical stimulation generator according to a preferred embodiment of the invention to the skin.

[0035] Figure 8 An exploded view of the fastening system of the electrical stimulation generator according to a preferred embodiment of the present invention is shown, including the first connector and the airtight valve.

[0036] Figure 9 A cross-sectional view of the airtight valve of the first connector of the fastening system of the electrical stimulation generator according to a preferred embodiment of the present invention is shown. Detailed Implementation

[0037] With reference to the above figures, it can be observed that in a preferred embodiment of the invention, the fastening system 1 for the electrical stimulation generator 2 includes a generator 2 for stimulating the heart and an electrode 5. The generator 2 is, for example, a pacemaker, defibrillator, resynchronizer, neurostimulation device or other similar generator disposed outside the body of the patient 3. The electrode 5 has a first end 5.1 for connecting to the heart of the patient 3 and a second end 5.2 for connecting to the generator 2.

[0038] The system includes a housing 4 for housing the generator 2 inside, a component for connecting the electrode 5, a sealing element 10, a device 6 for fixing the electrode 5 to the skin, and a component for fixing the housing 4 to the body of the patient 3.

[0039] like Figures 1 to 3 As shown, the outer casing 4 has the same first opening 7.1 and second opening 7.2, which are respectively arranged on opposite sides of the outer casing.

[0040] In a preferred embodiment of the present invention, such as Figure 2 As shown, the outer casing 4 consists of a front portion 8.2 and a rear portion 8.1 that contacts the patient's body 3, connected by a hinge member 9, and includes a closing member disposed at one end opposite to the hinge member 9. In this embodiment, these closing members include fitting a first connector 13 into a first opening 7.1 of the outer casing 4 and fitting a sealing element 10 into a second opening 7.2 of the outer casing 4. The fitting of both allows the rear portion 8.1 and the front portion 8.2 of the outer casing 4 to remain connected to each other.

[0041] Conversely, such as Figure 1 and Figure 2 As shown, in this embodiment, the component for securing the outer shell 4 to the patient 3's body is formed by a longitudinal, flexible strap 11, which is adapted to be placed around the patient 3's neck, like a necklace.

[0042] Therefore, as Figure 4 As shown, the housing 4 includes an eyelet 12 on the outer surface of the rear portion 8.1, which is adapted to secure a longitudinal strap 11 therein. Thus, the strap 11 passes through the eyelet 12 of the housing 4 and is securely fastened to the neck of the patient 3.

[0043] In system 1, the component for connecting electrode 5 is formed by a first connector 13 for allowing the second end 5.2 of electrode 5 to pass through, and the first connector 13 has an airtight valve 14.

[0044] In a preferred embodiment of the invention, the electrode 5 is connected to the generator 2 through a first opening 7.1, and thus the first connector 13 is disposed in the first opening 7.1. However, if the connection is to be made on the other side of the patient's body, the electrode 5 will be connected through a second opening 7.2.

[0045] In a preferred embodiment of the invention, the electrode 5 includes a sheath for covering the outer portion of the electrode, extending from the point where the electrode exits through the first opening 7.1 of the housing 4 until it is anchored to the second connector 19 on the device 6 for attachment to the skin. In this case, the sheath is further preferably formed of a plastic material with stretchable properties.

[0046] like Figure 8 and Figure 9 As shown, the airtight valve 14 of the first connector 13 includes an inner disc 15, which allows the electrode 5 to pass through while providing airtightness for the first opening 7.1 in this case.

[0047] Assuming that electrode 5 is connected to generator 2 through first opening 7.1, and the second opening 7.2 of housing 4 has an airtight sealing element 10.

[0048] In addition, the device 6 for fixing the electrode 5 to the skin has a component for anchoring the electrode 5 and a component for adhering to the torso of the patient 3.

[0049] In a preferred embodiment of the present invention, such as Figure 1 , Figure 2 , Figure 5 and Figure 7 As shown, the device 6 for attachment to the skin is tubular, having a first end 6.1 and a second end 6.2, and at least one semicircular segment 16 between them. In this specific embodiment, as shown, the device 6 for attachment to the skin includes two additional straight segments 17, respectively located between the semicircular segment 16 and the first end 6.1 and the second end 6.2 of the device 6 for attachment to the skin.

[0050] like Figure 5 and Figure 7 As shown, the device 6 for attachment to the skin includes a slot 18 that connects the interior and exterior of the device 6 for attachment to the skin over its entire length between a first end 6.1 and a second end 6.2. The size of the slot 18 allows the electrode 5 to be introduced into the entire tubular path of the device 6, mounting the electrode from the first end 6.1 to the second end 6.2 into the device 6 for attachment to the skin.

[0051] In a preferred embodiment of the invention, the component for anchoring the electrode 5 to the device 6 for fixation to the skin is formed by the second connector 19, such as... Figure 6.1 , Figure 6.2 and Figure 7 As shown, it is suitable to connect the second connector at either the first end 6.1 or the second end 6.2 of the device 6 for fixing to the skin, in this case the first end 6.1 of the device.

[0052] The inner surface of the second connector 19 has a first groove 20, and the outer surfaces of the first end 6.1 and the second end 6.2 of the device 6 for fixing to the skin have a second groove 21, which is used to mate with the first groove 20 of the second connector 19.

[0053] In a preferred embodiment of the invention, the component for adhering and fixing the device 6 to the skin is formed by a protruding element 22 that protrudes from a semicircular segment 16 of the device 6 for fixing to the skin, the protruding element having a surface opposite to the semicircular segment 16, and having an adhesive on the protruding element.

[0054] Similarly, the device 6 for attachment to the skin includes a component for securing the electrode 5 to the device, thereby more securely fixing the electrode 5 to the device. The component for securing includes a third groove 23 (not shown) surrounding the central portion of the semicircular segment 16, and a through-hole 24 disposed between the groove and a protruding element 22 for adhesion, the through-hole coinciding with the third groove 23. The third groove 23 is adapted to accommodate and secure the wire around the electrode 5.

[0055] Therefore, the thread can pass through the through hole 24 and be installed in the third groove 23, so that when it is tied, the thread will restrict the electrode 5 and fix it in the slot 18 of the device 6 so as to fix it to the skin.

[0056] In a preferred embodiment of the invention, the system 1 further includes a padding element 25 located on the inner surfaces of the front portion 8.2 and the rear portion 8.1, thereby preventing the generator 2 from contacting the front portion 8.2 and the rear portion 8.1 of the housing 4.

[0057] The described embodiments constitute only examples of the present invention. Therefore, the specific details, terms and phrases used in this specification should not be regarded as limitations, but should only be understood as the basis of the claims and to provide an understandable representative basis for applying the present invention by those skilled in the art.

Claims

1. A fastening system (1) for an electrical stimulation generator (2), comprising a generator (2) for stimulating the heart and electrodes (5), said generator (2) being a pacemaker, defibrillator, resynchronizer, neurostimulation device or other similar generator disposed outside the body of a patient (3), said electrodes (5) having a first end (5.1) for connection to the heart of the patient (3) and a second end (5.2) for connection to said generator (2), characterized in that, The fastening system (1) also includes: - A housing (4) for accommodating the generator (2), the housing (4) having the same first opening and second opening (7.1, 7.2) on opposite sides of the housing. - A component for connecting the electrode (5) to a first opening or a second opening (7.1, 7.2) of the housing (4), the component being formed by a first connector (13) for allowing the second end (5.2) of the electrode (5) to pass through, wherein the first connector (13) has an airtight valve (14). - A sealing element (10) is provided at the opening of the housing (4) and opposite to the opening of the member having a connection for the electrode (5); - A device (6) for securing the electrode (5) to the skin, the device (6) having a component for anchoring the electrode (5) and a component for adhering to the torso of a patient (3); and - Components for securing the outer shell (4) to the patient's (3) body; The housing (4) is formed by a front portion (8.2) and a rear portion (8.1) that contacts the patient's body (3), the rear portion (8.1) and the front portion (8.2) being connected by a hinge member (9), the housing (4) including a closing member at one end of the hinge member (9), the closing member being formed by assembling the first connector (13) and the sealing element (10) in a first opening and a second opening (7.1, 7.2) of the housing (4), the first connector and the sealing element being disposed in one of the openings respectively.

2. The system according to claim 1, wherein, The device (6) for fixation to the skin is tubular and has a first end and a second end (6.1, 6.2) and at least one semicircular segment (16) between them, wherein the device (6) for fixation to the skin includes a slot (18) that connects the interior and exterior of the device (6) for fixation to the skin over its entire length between its first end and the second end (6.1, 6.2), the size of which allows the electrode (5) to be mounted inside the device (6) for fixation to the skin from its first end (6.1) to its second end (6.2).

3. The system according to claim 2, wherein, The component for anchoring the electrode (5) to the device for fixing to the skin (6) is formed by a second connector (19), which is adapted to connect at a first end or a second end (6.1, 6.2) of the device for fixing to the skin (6), wherein the inner surface of the second connector (19) has a first groove (20), and the outer surfaces of the first end and the second end (6.1, 6.2) of the device for fixing to the skin (6) have a second groove (21), which mates with the first groove (20) of the second connector (19).

4. The system according to claim 2, wherein, The component for adhesion is formed by a protruding element (22) that protrudes from a semicircular segment (16) of the device (6) for fixation to the skin, the protruding element (22) having a surface (22.1) opposite to the semicircular segment (16), and having an adhesive on the protruding element.

5. The system according to claim 4, wherein, The device (6) for fixing to the skin includes a component for securing the electrode (5) to the device.

6. The system according to claim 5, wherein, The component for binding the electrode (5) is formed by a wire or similar material, a third groove (23) surrounding the outline of the central portion of the semicircular segment (16), and a through hole (24) disposed between the third groove (23) and the protruding element (22) of the component for adhesion, the through hole coinciding with the third groove (23), and the third groove (23) being adapted to mount the wire and to bind the wire around the electrode (5).

7. The system according to claim 2, wherein, The device (6) for fixing to the skin includes two additional straight segments located between the semicircular segment (16) and the first and second ends (6.1, 6.2) of the device for fixing to the skin.

8. The system according to claim 1, wherein, The airtight valve (14) of the first connector (13) includes an inner disc (15) that allows the electrode (5) to pass through.

9. The system according to claim 1, wherein, The component for securing the outer shell (4) to the patient's (3) body is formed by a longitudinal, flexible strap (11) adapted to be placed around the patient's (3) neck like a necklace.

10. The system according to claim 9, wherein, The housing (4) includes eyelets (12) on the outer surface of the rear (8.1) for securing a longitudinal strap (11) inside.

11. The system according to claim 3, wherein, The electrode (5) includes a sheath for covering the electrode (5) between the electrode protruding from the housing (4) through the first connector (13) and the electrode being connected to the device (6) for securing it to the skin through the second connector (19).

12. The system according to claim 11, wherein, The sheath is made of plastic material and is stretchable.

13. The system according to claim 1, wherein, The fastening system also includes padding elements (25) located on the inner surfaces of the front and rear portions (8.1, 8.2) of the housing (4).

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