• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Fastening system (1) for electrical stimulation generator (2), with a generator and an electrode, comprising a casing (4) to contain the generator (2) that has a first 5 and second openings (7.1, 7.2) equal, arranged on opposite sides; means for connecting the electrode (5) to the first or second opening (7.1, 7.2) of the housing (4) formed by a first connector (13) for the passage of the electrode, with a sealing element (14); a sealing element (10) arranged in the opening of the casing (4) opposite the one presenting the connection means of the electrode (5); a skin fixation device (6) of the electrode (5), and; means for securing the casing (4) to the patient's body (3). (Machine-translation by Google Translate, not legally binding)
    公开号:ES2804080A1
    申请号:ES201930723
    申请日:2019-08-02
    公开日:2021-02-03
    发明作者:Miralles Raimundo Vicente
    申请人:Fundacion Univ Miguel Hernandez de la Comunitat Valenciana；
    IPC主号:
    专利说明:

    [0002] Clamping system for electrical stimulation generator
    [0004] Technical field of the invention
    [0006] The present invention corresponds to the technical field of the industry dedicated to the manufacture of medical devices, specifically in the field of cardiac stimulation.
    [0008] Background of the Invention
    [0010] Cardiac pacing systems consist of devices whose function is to detect the electrical activity generated by the heart and in its absence, interpret it as an absence of a heartbeat and provide an electric shock that at a certain power achieves cardiac contraction.
    [0012] In detail, a cardiac pacing system is made up of circuits and processors, housed together with the battery in a metal casing, usually made of titanium, and designed to perform the function of detecting electrical activity and generating impulses.
    [0014] The system also has one, two or three electrodes, depending on the type of cardiac stimulation that is needed. These electrodes are connected to two ports of the generator located in a silicone head and from a central venous access of the patient they run to the desired cardiac cavity (right atrium or ventricle), remaining supported or fixed to the endocardium. If left ventricular stimulation is desired, via the coronary sinus, the electrode is directed to the desired location.
    [0016] The electrodes, made of metallic material covered with insulation, receive electrical information from the heart and conduct it to the processors in the housing. In the absence of electrical activity, an electrical discharge is emitted from the generator housed in the housing that is conducted to the endocardium (or epicardium at the coronary sinus electrodes), producing a cardiac contraction.
    [0018] These cardiac stimulation systems can be permanent or temporary, depending on how long we are going to maintain the stimulation therapy.
    [0019] Current definitive systems are made up of increasingly smaller generators, reaching up to 10 cm3 in volume and in which the generator is housed in the subcutaneous cellular tissue, usually of the patient's anterior pectoral region. In this case, the electrodes are introduced subclavian or in some cases internal jugular, towards the superior vena cava and up to the final location, which may be the right atrium, the right ventricle or the coronary venous network.
    [0021] In temporary cardiac pacing systems, the external generator that has traditionally been used and that contains all the necessary elements (battery, processors, electrode connection ports) can reach 15 cm in length and up to 1 kg in weight.
    [0023] On the other hand, the electrodes used with these devices for temporary stimulation usually lack any fixation system to the endocardium, remaining only supported on the internal cardiac surface.
    [0025] These two characteristics of the classical system of temporary cardiac pacing mean that the patient must remain in absolute rest and with continuous monitoring in an Intensive Care Unit (ICU). The electrode-endocardial contact and the size of the generator make the system unstable and impede patient mobility.
    [0027] This temporary stimulation seeks to obtain time to complete the study of the patient, which can lead to spontaneous recovery or the conclusion of the need for the implantation of a permanent pacemaker.
    [0029] Currently, materials from definitive pacing systems are being used for temporary cardiac pacing, due to the greater safety they provide. This technique consists of leaving the active fixation electrode externalized, connected to a permanent pacemaker generator. By using these components we have an electrode-endocardial junction with active fixation, more stable and safe, which allows the patient to be discharged from the ICU to continue his evolution in a hospitalization ward.
    [0031] Today there is no patient restraint system for this externalized generator and electrode, which provides the necessary safety. In some cases it is attached to the patient with dressings or sutured to the skin. This solution raises a series of problems since the systems can easily detach and the generator produces a traction on the electrode producing the disconnection generator-electrode, causing the cessation of the stimulation, or even a cardiac rupture could occur due to direct traction of the endocardium when the electrode is screwed to the same.
    [0033] Likewise, the entire external system is exposed to the environment in such a way that it can become colonized by bacteria and subsequently cause an infection to the patient.
    [0035] It would be desirable to have an effective securing system for all outsourced components, which increases the safety of these patients, avoiding accidental detachments and possible infections due to contamination due to the simple exposure of the system to the environment or contact with healthcare personnel in charge of the cares.
    [0037] There is no evidence of any external support device for this type of temporary cardiac electrical stimulation systems with definitive generators.
    [0039] Description of the invention
    [0041] The clamping system for electrical stimulation generator proposed here comprises a generator for cardiac stimulation, such as a pacemaker, a defibrillator, a resynchronizer; a neurostimulation mechanism or other similar generator arranged external to the patient's body, as well as an electrode that has a first connection end to the patient's heart and a second connection end to said generator.
    [0043] This system comprises a casing to contain the generator inside. This casing has first and second openings that are equal and arranged on opposite sides of the same.
    [0045] Likewise, the system comprises means for connecting the electrode to the first or second opening of the housing formed by a first through connector at the second end of the electrode. Said first connector has a sealing valve inside.
    [0046] Furthermore, the system has a sealing element that is arranged in the opening of the housing opposite to that which has the electrode connection means.
    [0048] The system in turn comprises a device for cutaneous fixation of the electrode with means of anchoring to said electrode and means of adherence to the torso of the patient. It also has means for fastening the casing to the patient's body.
    [0050] With the clamping system for electrical stimulation generator proposed here, a significant improvement in the state of the art is obtained.
    [0052] This is so because a clamping system is achieved with a very relevant improvement in terms of safety against possible detachments, which leads to a reduction in possible accidental disconnections of the electrode with respect to the generator or even in possible cardiac ruptures caused by tractions of the electrode in its connection to the endocardium.
    [0054] On the other hand, thanks to the tightness that is achieved in all the components of the system, it allows to significantly reduce the infections related to this type of intravascular systems, since it is possible to eliminate any possible route of entry of bacteria to the blood.
    [0056] Likewise, it is a system that allows it to be held in both the right and left half-body, thanks to the two openings in the casing arranged on both sides of the casing and between which the watertight closure element and the first connector, allowing the electrode to exit in both directions.
    [0058] Therefore, it is a system that allows solving the current drawbacks in temporary cardiac electrical stimulation systems with external definitive generators, in a simple and effective way.
    [0060] Brief description of the drawings
    [0062] In order to help a better understanding of the characteristics of the invention, according to a preferred example of a practical embodiment thereof, it is provided as part part of said description, a series of drawings where, by way of illustration and not limitation, the following has been represented:
    [0064] Figure 1.- Shows a perspective view of a fastening system for an electrical stimulation generator with the housing closed and attached to the neck of a patient, for a preferred embodiment of the invention.
    [0066] Figure 2.- Shows a perspective view of a fastening system for an electrical stimulation generator with the casing open and attached to the neck of a patient, for a preferred embodiment of the invention.
    [0068] Figure 3.- Shows a view of the housing of a clamping system for an electrical stimulation generator with the electrode connector and the sealing element, for a preferred embodiment of the invention.
    [0070] Figure 4.- Shows a side view of the housing of a fastening system for an electrical stimulation generator, for a preferred embodiment of the invention.
    [0072] Figure 5.- Shows a perspective view of the device for cutaneous fixation of the electrode, of a clamping system for an electrical stimulation generator, for a preferred embodiment of the invention.
    [0074] Figures 6.1 and 6.2.- Show perspective and section views respectively of the second connector of the electrode anchoring means of a fastening system for an electrical stimulation generator, for a preferred embodiment of the invention.
    [0076] Figure 7.- Shows a perspective view of the device for skin fixation of the electrode and the second connector at one end thereof, of a clamping system for an electrical stimulation generator, for a preferred embodiment of the invention.
    [0078] Figure 8.- Shows an exploded view of the first connector and the sealing valve of a clamping system for an electrical stimulation generator, for a preferred embodiment of the invention.
    [0079] Figure 9.- Shows a sectional view of the sealing valve of the first connector of a fastening system for an electrical stimulation generator, for a preferred embodiment of the invention.
    [0081] Detailed description of a preferred embodiment of the invention
    [0083] In view of the figures provided, it can be seen how in a preferred embodiment of the invention, the fastening system (1) for the electrical stimulation generator (2), which comprises a generator (2) for cardiac stimulation, such as a pacemaker, defibrillator, resynchronizer; a neurostimulation mechanism or other similar generator arranged externally to the patient's body (3) and an electrode (5) that has a first end (5.1) for connection to the patient's heart (3) and a second end (5.2) of connection to said generator (2).
    [0085] This device comprises a casing (4) to contain said generator (2) inside it, some electrode connection means (5), a watertight closure element (10), a skin fixation device (6) of the electrode ( 5) and means of fastening the casing (4) to the patient's body (3).
    [0087] As shown in Figures 1 to 3, the casing (4) has first and second openings (7.1, 7.2) equal and arranged on opposite sides thereof.
    [0089] In this preferred embodiment of the invention, as can be seen in Figure 2, the casing (4) is formed by a rear part (8.1) in contact with the patient's body (3) and a front part (8.2), both joined by hinged means (9) and, comprises closing means at an end opposite the hinged means (9). These closing means consist in this embodiment, in the fitting of the first connector (13) in the first opening (7.1) of the housing (4) and the fitting of the closing element (10) in the second opening (7.2) Of the same. Said engagement of both allows to keep together both the rear and front parts (8.1, 8.2) of the casing (4).
    [0091] For its part, as shown in Figures 1 and 2, in this embodiment, the means for securing the casing (4) to the patient's body (3) are formed by a longitudinal and flexible tape (11) suitable for its placement as a collar around the patient's neck (3).
    [0092] In this way, as shown in Figure 4, the casing (4) comprises on the external surface of the rear part (8.1) an eye (12) suitable for hooking the longitudinal strap (11) therein. Thus, the tape (11) is passed through the eyelet (12) of the casing (4) and the latter remains securely attached to the neck of the patient (3).
    [0094] In this system (1), the connection means of the electrode (5) are formed by a first connector (13) for the passage of the second end (5.2) of the electrode (5), which has a sealing valve (14) in its inside.
    [0096] In this preferred embodiment of the invention, the electrode (5) is connected to the generator (2) through the first opening (7.1), whereby the first connector (13) is arranged in said first opening (7.1) , but in the case in which the connection had to be made in the opposite hemibody of the patient, the electrode (5) would be connected through the second opening (7.2).
    [0098] In this preferred embodiment of the invention, the electrode (5) comprises a covering sheath thereof, in the externalized part thereof, between the outlet thereof through the first opening (7.1) of the housing (4) in this case, up to the second connector (19) for anchoring it to the skin clamping device (6). In this case, moreover, the cover is preferably formed of a plastic material having shrinkable properties.
    [0100] As shown in Figures 8 and 9, the sealing valve (14) of the first connector (13) comprises internal discs (15) that allow the passage of the electrode (5) while providing sealing to said first opening ( 7.1), in this case.
    [0102] Since the electrode (5) is connected to the generator (2) through the first opening (7.1), it is the second opening (7.2) of the housing (4) that has a sealing element (10).
    [0104] On the other hand, the skin fixation device (6) of the electrode (5) has anchoring means to said electrode (5) and means of adherence to the patient's torso (3).
    [0106] In this preferred embodiment of the invention, as shown in Figures 1, 2, 5 and 7, the skin fixation device (6) has a tubular shape with a first and a second ends (6.1, 6.2) and at least one semicircular section (16) between them. In this specific embodiment, this skin fixation device (6) comprises two additional straight sections (17) between the semicircular section (16) and the first and second ends (6.1, 6.2) respectively of said skin fixation device ( 6), as can be seen in said figures.
    [0108] Figures 5 and 7 show that the skin fixation device (6) comprises a groove (18) that communicates the inside of the skin fixation device (6) with the outside along its entire length between the two first and second extremes (6.1, 6.2). The dimensions of said slot (18) are such that they allow the introduction of the electrode (5) into the entire tubular path of the skin fixation device (6) from the first end (6.1) to the second end (6.2) of the same.
    [0110] In this preferred embodiment of the invention, the means for anchoring the electrode (5) to the skin fixation device (6) are formed by a second connector (19), shown in Figures 6.1, 6.2 and 7, suitable for connection to the first or second end (6.1, 6.2) of said skin fixation device (6), in this case the first end (6.1) thereof.
    [0112] This second connector (19) has first notches (20) on its inner surface, while the first and second ends (6.1, 6.2) of the skin fixation device (6) have second notches (21) suitable for for fitting to the first notches (20) of said second connector (19).
    [0114] In this preferred embodiment of the invention, the adhesion means of the skin fixation device (6) are formed by an emerging element (22) of the semicircular section (16) of said skin fixation device (6) with one face ( 22.1) opposite said semicircular section (16) and an adhesive on it.
    [0116] Likewise, this skin fixation device (6) comprises means for tying the electrode (5) thereto, to fix the electrode (5) to said device in an even more secure way. These tying means are formed by a silk thread or similar (not represented in the Figures), a third notch (23) around the contour of the central section of the semicircular section (16), and a through hole (24) arranged coincident with said third notch (23) between it and the emerging element (22) of the adhesion means.
    [0117] This third notch (23) is suitable for fitting said silk thread and tying it around the electrode (5).
    [0119] In this way, a silk thread is passed through the through hole (24) and is fitted into the third notch (23) so that when it is tied, the thread strangles the electrode (5), fixing it in its position inside the the groove (18) of the skin fixation device (6).
    [0121] In this preferred embodiment of the invention, the system (1) further comprises a padded element (25) on the inner surface of both front and rear parts (8.1, 8.2), to thereby damp the contact of the generator (2 ) with said front and rear parts (8.1, 8.2) of the casing (4).
    [0123] The described embodiment constitutes only an example of the present invention, therefore, the specific details, terms and phrases used in the present specification are not to be considered as limiting, but are to be understood only as a basis for the claims and as a representative basis that provides an understandable description as well as sufficient information to the person skilled in the art to apply the present invention.
    权利要求:
    Claims (1)
    [0001]
    1- Clamping system (1) for electrical stimulation generator (2), comprising a generator (2) for cardiac stimulation, such as a pacemaker, a defibrillator, a resynchronizer; a neurostimulation mechanism or other similar generator arranged externally to the patient's body (3) and an electrode (5) that has a first end (5.1) for connection to the patient's heart (3) and a second end (5.2) of connection to said generator (2), characterized in that it comprises
    - a casing (4) for containing the generator (2) inside, which has first and second openings (7.1, 7.2) equal and arranged on opposite sides thereof;
    - means for connecting the electrode (5) to the first or second opening (7.1, 7.2) of the housing (4) formed by a first connector (13) for the passage of the second end (5.2) of the electrode (5), which It has a sealing valve (14) inside it; - a watertight closure element (10) arranged in the opening of the casing (4) opposite that which has the means for connecting the electrode (5);
    - a device for skin fixation (6) of the electrode (5) having means of anchoring to said electrode (5) and means of adherence to the torso of the patient (3), and; - means of fastening the casing (4) to the patient's body (3).
    2- Clamping system (1) for electrical stimulation generator (2), according to claim 1, characterized in that the skin fixation device (6) has a tubular shape with first and second ends (6.1, 6.2) and at the less a semicircular section (16) between them, where the skin fixation device (6) comprises a groove (18) that communicates the inside of the skin fixation device (6) with the outside along its entire length between both first and second ends (6.1, 6.2), the dimensions of said slot (18) being such that it allows the fitting of the electrode (5) inside the skin fixation device (6) from the first end (6.1) to the second end (6.2) thereof.
    3- Clamping system (1) for electrical stimulation generator (2), according to claim 2, characterized in that the means for anchoring the electrode (5) to the skin fixation device (6) are formed by a second connector (19 ) suitable for connection at the first or second end (6.1, 6.2) of said skin fixation device (6), where the second connector (19) has first notches (20) on its inner surface and the first and second ends (6.1, 6.2) of said skin fixation device (6) has second notches (21) on its outer surface suitable for fitting into the first notches (20) of the second connector (19).
    4- Fastening system (1) for electrical stimulation generator (2), according to any of claims 2 and 3, characterized in that the adhesion means are formed by an emerging element (22) of the semicircular section (16) of the device skin fixation (6), with a face (22.1) opposite said semicircular section (16) and an adhesive on it.
    5- Fastening system (1) for the electrical stimulation generator (2), according to any of the preceding claims, characterized in that the skin fixation device (6) comprises means for tying the electrode (5) thereto.
    6- Fastening system (1) for electrical stimulation generator (2), according to claims 4 and 5, characterized in that the means for tying the electrode (5) are formed by a silk thread or the like, a third notch ( 23) around the contour of a central section of the semicircular section (16), and a through hole (24) arranged coincident with said third notch (23), between it and the emerging element (22) of the means of adherence, and where the third notch (23) is suitable for fitting said silk thread and tying it around the electrode (5).
    7- Fastening system (1) for the electrical stimulation generator (2), according to any of claims 2 to 6, characterized in that the skin fixation device (6) comprises two additional straight sections (17) between the semicircular section ( 16) and the first and second ends (6.1, 6.2) respectively of said skin fixation device (6).
    8. Clamping system (1) for electrical stimulation generator (2), according to any of the preceding claims, characterized in that the sealing valve (14) of the first connector (13) comprises internal discs (15) that allow the electrode passage (5).
    9- Fastening system (1) for electrical stimulation generator (2), according to any of the preceding claims, characterized in that the casing (4) is formed by a rear part (8.1) in contact with the patient's body (3) and a front part (8.2), both joined by hinged means (9) and, comprises closing means at an end opposite to the hinged means ( 9), by fitting the first connector (13) and the closing element (10) in both the first and second openings (7.1, 7.2) of the housing (4), each one in one of them.
    10- Fastening system (1) for electrical stimulation generator (2), according to any of the preceding claims, characterized in that the means of fastening the casing (4) to the patient's body (3) are formed by a tape ( 11) longitudinal and flexible suitable for placement as a collar around the patient's neck (3).
    11- Fastening system (1) for electrical stimulation generator (2), according to claims 9 and 10, characterized in that the casing (4) comprises on the external surface of the rear (8.1) an eyelet (12) suitable for hooking the longitudinal strap (11) therein.
    12- Clamping system (1) for electrical stimulation generator (2), according to any of the preceding claims, characterized in that the electrode (5) comprises a covering sheath thereof from its exit from the casing (4) through the first connector (13) until its connection with the skin clamping device (6) through the second connector (19).
    13. Clamping system (1) for electrical stimulation generator (2), according to claim 12, characterized in that the cover is made of a plastic material and has shrink properties.
    14- Fastening system (1) for electrical stimulation generator (2), according to any of the preceding claims, characterized in that it comprises a padded element (25) on the inner surface of both front and rear parts (8.1, 8.2) of the housing (4).
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    同族专利:
    公开号 | 公开日
    ES2804080B2|2021-08-05|
    WO2021023901A1|2021-02-11|
    AU2020325726A1|2022-02-10|
    CA3145450A1|2021-02-11|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    EP0599567A2|1992-11-20|1994-06-01|Pacesetter, Inc.|System and method for stimulating a heart having undergone cardiac myoplasty using a single-chamber pacemaker|
    EP0948972A2|1998-04-07|1999-10-13|Lifecor, Inc.|Support garments for patient-worn energy delivery apparatus|
    US20140172056A1|2012-12-14|2014-06-19|Boston Scientific Neuromodulation Corporation|Systems and methods for making and using contact assemblies for leads of electrical stimulation systems|
    US20190160262A1|2016-07-29|2019-05-30|University Of Central Lancashire|A tube stabilising device|
    CN108671400A|2018-06-12|2018-10-19|李长寿|A kind of emergency pace-making device|
    法律状态:
    2021-02-03| BA2A| Patent application published|Ref document number: 2804080 Country of ref document: ES Kind code of ref document: A1 Effective date: 20210203 |
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    优先权:
    申请号 | 申请日 | 专利标题
    ES201930723A|ES2804080B2|2019-08-02|2019-08-02|Clamping system for electrical stimulation generator|ES201930723A| ES2804080B2|2019-08-02|2019-08-02|Clamping system for electrical stimulation generator|
    AU2020325726A| AU2020325726A1|2019-08-02|2020-07-17|Fastening system for an electrical stimulation generator|
    CA3145450A| CA3145450A1|2019-08-02|2020-07-17|Fastening system for an electrical stimulation generator|
    PCT/ES2020/070464| WO2021023901A1|2019-08-02|2020-07-17|Fastening system for an electrical stimulation generator|
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