WO2020206562A1 - Implantable insulating device for leadless cardiac pacemakers and implantable leadless cardiac pacemaker including said insulating device - Google Patents

Implantable insulating device for leadless cardiac pacemakers and implantable leadless cardiac pacemaker including said insulating device Download PDF

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Publication number
WO2020206562A1
WO2020206562A1 PCT/CL2019/000014 CL2019000014W WO2020206562A1 WO 2020206562 A1 WO2020206562 A1 WO 2020206562A1 CL 2019000014 W CL2019000014 W CL 2019000014W WO 2020206562 A1 WO2020206562 A1 WO 2020206562A1
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WO
WIPO (PCT)
Prior art keywords
mcsc
tubular body
wall
implantable
isolating device
Prior art date
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PCT/CL2019/000014
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Spanish (es)
French (fr)
Inventor
Roberto Felipe MARRERO MEDEROS
Original Assignee
Marrero Mederos Roberto Felipe
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Application filed by Marrero Mederos Roberto Felipe filed Critical Marrero Mederos Roberto Felipe
Priority to PCT/CL2019/000014 priority Critical patent/WO2020206562A1/en
Publication of WO2020206562A1 publication Critical patent/WO2020206562A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings

Definitions

  • the present invention relates to the field of implantable cardiac pacing devices, more specifically cordless cardiac pacemakers and in particular provides an isolating device for a cordless cardiac pacemaker and a cordless cardiac pacemaker including such an isolating device.
  • Cardiac pacemakers such as cordless cardiac pacemakers, are used to electrically stimulate the heart and to detect the electrical signals emitted by the myocardium in patients with abnormal heart rhythm.
  • Such disturbances in heart rhythm include, but are not limited to, bradycardia, which consists of slow heartbeats, and tachycardia, which consists of rapid heartbeats.
  • MCSC cordless cardiac pacemaker
  • Such circumstances include: MCSC battery depletion, MCSC-related infection, and other medical conditions that make it necessary to remove said cardiac pacing device.
  • the outer surface of such leadless pacemakers is often covered by biological growth tissue.
  • This total or partial covering of the cardiac pacemaker without leads is known as epithelialization of the cardiac pacemaker without leads (MCSC).
  • MCSC cardiac pacemaker without leads
  • the aforementioned epithelialization can complicate the removal of an MCSC from the heart because the tissue that extends on the outer surface of the MCSC increases the degree of attachment of the MCSC to the wall of the cardiac chamber in which it has been implanted. Therefore, the aforementioned epithelialization phenomenon increases the complexity of the removal procedures of an MCSC and the probability of occurrence of complications during said procedures.
  • an implantable isolating device is required for cordless cardiac pacemakers, wherein said device avoids or decreases the degree of fixation produced by growth tissues on cordless cardiac pacemakers that have remained chronically implanted within a cardiac chamber.
  • the present invention provides an implantable isolating device for cardiac pacemakers without implantable leads, wherein said isolating device comprises: a tubular body that is arranged along a longitudinal axis, where said tubular body has an internal diameter that allows the insertion of at least a portion of the housing of a cordless cardiac pacemaker (MCSC), where said tubular body also has an impermeable wall configured to prevent biological tissues and substances present inside the body of a MCSC user coupled to said isolating device from passing through said wall of the tubular body, said tubular body further having a proximal end and a distal end.
  • MCSC cordless cardiac pacemaker
  • proximal end and said distal end having attachment means configured to allow attachment of said tubular body to the external surface of said MCSC; and where said proximal end and said distal end further possesses sealing means configured to allow a hermetic seal between said ends of the tubular body and portions of the outer surface of the housing of a leadless cardiac pacemaker that has been at least partially covered by said insulating device.
  • said tubular body additionally includes at least one electrical current conducting element that allows the conduction of electrical current between the external surface of the wall of the tubular body and the internal surface of the wall of said tubular body, in wherein said conductive element is configured to prevent electrical communication between the electrodes of the cordless cardiac pacemaker coupled to said insulating device from being interrupted.
  • the wall of said tubular body has a region of weakness or rupture that follows the path of a closed line around the longitudinal axis of the tubular body, where said region of weakness is configured to facilitate the rupture into two parts. of the tubular body when a pulling force is applied to said tubular body in a direction generally parallel to the direction of the longitudinal axis of said tubular body.
  • the wall of said tubular body is formed of one or more flexible materials that allow said wall to withstand a variety of deformations and bends, even 180 degree bends, without breaking or tearing into two or more parts.
  • the present invention further provides an implantable cordless cardiac pacemaker (MCSC), wherein said MCSC includes at least two electrodes, a generally cylindrical housing, and an isolating device, wherein said isolating device includes a tubular body disposed over and surrounding at least a portion of the external surface of revolution of the housing of said MCSC, said tubular body having a wall impermeable to tissues and substances present inside the body of a user of said MCSC, wherein said tubular body also has a proximal end and a distal end, wherein said proximal end and said distal end possess fixing means to the housing surface of said MCSC; and wherein said proximal end and said distal end further possess sealing means configured to allow a hermetic circumferential seal between said ends of the tubular body
  • FIG. 1 illustrates the epithelialization of two chronically implanted leadless cardiac pacemakers in a patient's heart.
  • the figure. 2 shows a schematic longitudinal sectional view of a first embodiment of the isolating device 1 coupled to a cardiac pacemaker without leads.
  • FIG. 3-5 illustrate the extraction sequence of a cordless cardiac pacemaker (MCSC) in which said MCSC has the isolating device exemplified in Figure 2.
  • FIG. 6 shows a schematic longitudinal sectional view of a second embodiment of the isolating device 1 coupled to a cardiac pacemaker without leads.
  • MCSC cordless cardiac pacemaker
  • FIG. 7-9 illustrate the extraction sequence of a cordless cardiac pacemaker (MCSC) wherein said MCSC has the isolating device exemplified in Figure 6.
  • MCSC cordless cardiac pacemaker
  • cordless cardiac pacemakers are implanted in some patients with heart rhythm disturbances to stimulate the heart to contract and to detect electrical signals from the heart muscle.
  • MCSC cordless cardiac pacemaker
  • the battery life of a cordless cardiac pacemaker (MCSC) expires or when some clinical circumstance of the patient requires it, the MCSC must be extracted from the heart. Consequently, when an MCSC must be removed for any of the reasons previously stated, it is often necessary to implement a new MCSC to replace the functions of the MCSC that has been removed.
  • the external surface of the MCSC is usually partially or totally covered by biological tissues with fibrous content (epithelialization) which significantly increases the degree of fixation of the MCSC to the wall of the heart chamber where the MCSC was implanted.
  • epithelialization biological tissues with fibrous content
  • procedures for the removal of MCSC commonly fail.
  • said MCSC is usually abandoned inside the cardiac chamber and a new MCSC is implanted in another region of said chamber that supplies the functions of the first.
  • the present invention provides an implantable isolating device 1 for cardiac pacemakers without leads 2, wherein said isolating device 1 comprises: a tubular body that is arranged along a longitudinal axis, wherein said tubular body It has an interior space or lumen that allows the insertion of at least a portion of the housing of an MCSC, where said tubular body also has an impermeable wall configured to prevent biological tissues and substances present inside the body of a user from an MCSC coupled with said isolation device traverses said tubular body wall, said tubular body also having a proximal end 3 and a distal end 4.
  • proximal end 3 and said distal end 4 having fixing means configured to allow fixation from said tubular body to the external surface of said MCSC 2; and wherein said proximal end and said distal end further possess sealing means configured to allow a hermetic seal between said ends of the tubular body and the outer surface portions (adjacent to said ends) of the MCSC housing coupled with said insulating device.
  • tubular body wall of the insulating device for leadless cardiac pacemakers is impermeable to biological tissues and substances present within the body of a user of a wireless cardiac pacemaker (MCSC) coupled to said isolation device, and because that the ends of said tubular body have sealing means configured to achieve a hermetic seal between said ends of the tubular body and the outer surface portions of the housing of said MCSC; biological tissue is prevented from proliferating directly on the outer surface of the MCSC isolated by the isolating device.
  • the biological tissue 9 would be spread on the outer surface of the isolating device 1 instead of on the outer surface portion of the MCSC housing covered by the isolating device. The foregoing would facilitate, as will be explained later, the extraction of a chronically implanted MCSC.
  • proximal and distal refer to the tool used by a specialist who performs the implantation or extraction of said MCSC percutaneously.
  • the proximal end 3 of the tubular body of the insulating device is the end closest to said tool, while the distal end 4 of said tubular body is the end furthest from said tool.
  • the longitudinal axis extends substantially parallel to the proximal-distal direction.
  • the terms interior and exterior should be understood as referring to the tubular body when it is normally in use, containing within it at least a portion of the housing of an MCSC.
  • an implantable cordless cardiac pacemaker possesses at least two electrodes, commonly referred to as anode and cathode, which are used to stimulate contraction of the heart by applying electrical current and to detect the electrical signals emitted by the cardiac muscle or myocardium 8.
  • the cardiac pacemakers without leads of the prior art have a housing with a generally cylindrical shape, whose outer surface or a portion of said outer surface is used as one of the electrodes of the MCSC, commonly the anode.
  • the other electrode or cathode, of prior art MCSCs is commonly located in a region of the distal end of the MCSC.
  • the wall of the tubular body of the insulating device is formed by at least one layer, without limiting the scope of the present invention.
  • at least one layer of the wall 5 of the tubular body is made of an impermeable material, to prevent the entry of biological substances and tissues into the space 6 formed between said tubular body and the portion of the MCSC housing that is intended. cover.
  • the interior surface of the tubular body wall could be configured to facilitate sliding of the MCSC during a medical procedure for removal of the MCSC.
  • the inner surface of the wall of the tubular body could be made of a Slip-on biocompatible material to decrease resistance during the MCSC removal procedure.
  • the inner surface of the wall of the tubular body could present protrusions or grooves that decrease the contact surface between the inner surface of the wall of the tubular body and the outer surface of the MCSC housing covered by the insulating device, thus reducing the resistance to sliding of the MCSC inside the insulating device during a procedure for its removal.
  • a space 6 limited by: the inner surface of the wall of the tubular body 5, the outer surface of the pacemaker housing that has been covered by the wall of the tubular body, and by means of sealing the ends of the tubular body.
  • said space is a communicated space in its entirety.
  • the insulating device can have any dimension without limiting the scope of the present invention.
  • the dimensions of said insulating device will depend among other factors and without limiting the scope of the present invention, on the dimensions and shapes of the portion of the MCSC housing to be insulated.
  • the thickness of the wall 5 of the tubular body of the insulating device 1 may have any dimension that avoids increasing in an inconvenient way the diameter of the MCSC + insulating device assembly.
  • the thickness of said wall 5 is of a magnitude that avoids excessively increasing the diameter of the sheaths and other tools used for percutaneous implantation and removal of an MCSC, provided that said selected thickness does not limit the scope of the present invention, for example, without being limited thereto, that it does not affect the waterproof characteristics of the wall.
  • the insulating device could have different lengths without limiting the scope of the present invention.
  • the length of the isolating device could be less than the length of the MCSC housing.
  • the length of said insulating device could be equal to the length of the MCSC housing and in a third embodiment the length of said insulating device could be greater than the length of the MCSC housing.
  • prior art MCSCs typically have two electrodes that constitute parts of the circuit responsible for electrically stimulating the heart and detecting electrical signals from the heart muscle.
  • the tubular body of the insulating device proposed in the present invention does not even cover one of the MCSC electrodes, allowing electrical communication between said electrodes.
  • the tubular body covers at least one of the electrodes of the MCSC but, in said embodiments, said body wall includes: one or more elements formed by an electrically conductive material, where said elements communicate electrically the outer medium of the tubular body and the electrode of the MCSC that remains covered by the wall of the tubular body, avoiding the interruption of the electrical circuit between the electrode covered by the insulating device and the electrode outside the insulating device.
  • this electrically conductive material can be a non-metallic material previously known in the state of the art that also complies with the condition of being a biocompatible material.
  • the electrically conductive material can be a known metal that also fulfills the condition of being a biocompatible material.
  • the previously referred electrically conductive material could be any biocompatible electrically conductive material recognizable and selectable by an expert in the field of such materials, provided that such selection does not limit the scope of the present invention.
  • the nature of the materials used to manufacture the insulating device for cordless cardiac pacemakers will depend on the dimensions and shapes of said cordless cardiac pacemakers, on the dimensions and shapes of the tubular body of the isolating device, the number of electrodes present in said cordless cardiac pacemakers and whether or not the isolating device covers any of said electrodes.
  • at least one layer of the wall of the tubular body of said insulating device must be constructed of a material that is impervious to biological substances and tissues present inside the body of a wearer. cardiac pacemaker without leads.
  • both the proximal end 3 of the tubular body and the distal end 4 of the tubular body include sealing means that allow a hermetic annular seal between each of the ends of the tubular body and the external surface of the MCSC housing that has been inserted. inside the isolating device, wherein said hermetic annular seal prevents biological substances and tissues present within the body of an MCSC user from coming into contact with the portion of the external surface of the MCSC housing that has been covered by the isolating device, thus preventing tissue proliferation on said external surface of the MCSC housing.
  • the wall of the tubular body of said insulating device is formed of one or more flexible materials to allow the wall of said tubular body to withstand multiple deformations and bends, even 180 degree bends, without breaking or fracturing in two. or more parts.
  • said tubular body has a proximal end 3 and a distal end 4, both ends having means of attachment to the housing of the cordless cardiac pacemaker (MCSC) that has been partially or totally covered by said tubular body.
  • the fixation means can be any suitable means that allows the fixation of said proximal and distal ends to the housing of said MCSC.
  • Said fixing means can be permanent, as exemplified in the Figures. 6-9, or said fixing means may be non-permanent, as exemplified in the Figures. 2-5.
  • An example of a permanent fixation means not limited to said example, it can be achieved with a biocompatible adhesive that does not lose its adhesive properties for at least the lifetime of the MCSC.
  • a different means of permanent fixation could be selected by a person skilled in the art, provided that such selection does not limit the scope of the present invention.
  • Some examples of non-permanent fixing means could be, without being limited to said examples, projections or protrusions and conical portions on the inner surfaces of the ends of the tubular body.
  • a different non-permanent fixing means could be selected by a person skilled in the art provided that such selection does not limit the scope of the present invention.
  • a region of weakness 10 is to be understood as an area of the tubular body that can easily break or tear when a pulling or twisting force is exerted on the tubular body while performing a medical procedure intended to removal of the cordless cardiac pacemaker (MCSC).
  • the objective of said region of weakness is that during said medical procedure aimed at the extraction of an epithelialized MCSC, the tubular body of the isolating device can be fractured into two parts, as illustrated in the Figure. 8, to facilitate the removal of said MCSC.
  • said region of weakness of the wall of the tubular body coincides with the path of a closed line that surrounds the longitudinal axis of the tubular body.
  • said region of weakness can be configured, for example and without limiting the scope of the present invention, as an annular region of the wall of the tubular body that it has a thickness significantly less than the thickness of the rest of the wall of said tubular cover.
  • said region of weakness can be obtained by means of a pre-cut, wherein said pre-cut does not go through the entire thickness of the wall of the tubular body so as not to affect the insulating properties of the wall of the tubular body.
  • said region of weakness is in a region near the proximal end of the tubular cover of said insulating device as illustrated in the Figure. 6.
  • a preferred location of this line of rupture of the tubular body, IF limited to said location, is a line of rupture that is less than 1 mm from the proximal end of the tubular body.
  • said tubular body has a proximal end 3 and a distal end 4 and said both proximal and distal ends present sealing means, wherein said sealing means prevent the fluids, substances and tissues present inside the body of an MCSC user coupled to said insulating device enter the space 6 created between the inner surface of the wall of the tubular body and the outer surface of the MCSC housing that has been covered by said wall of the tubular body, which prevents the proliferation of tissue on said outer surface of the MCSC housing.
  • Said sealing means can be any of the sealing means known in the state of the art, provided that said sealing means allows a hermetic surrounding seal between the ends of the tubular body of the insulating device and the portions of the outer surface of the MCSC adjacent to said ends, said sealing means must also be constructed of a biocompatible material and have a useful life time at least equal to the useful life of the MCSC on which the insulating device has been inserted.
  • said sealing means can be selected from the group formed by internal protrusions at the ends of the tubular body, O-rings, flat rings, o-rings, as well as combinations or variants thereof.
  • At least one of the ends of the tubular body of the insulating device is configured to allow a hermetic surrounding seal referred to above, and simultaneously, to allow the attachment of said end to the surface of the MCSC housing that the end would contact.
  • the aforementioned coincidence is achieved when at least one of the ends of the tubular body presents projections, protrusions or edges inside said end, which when in contact with the portion of the outer surface of the MCSC housing adjacent to said end allows: hermetic sealing between said end and the surface of the adjacent MCSC housing; and, fixing said end to the housing of said MCSC.
  • the present invention further provides an implantable leadless cardiac pacemaker (MCSC) comprising: at least two electrodes, a generally cylindrical housing, and an isolating device, wherein said isolating device includes a tubular body surrounding the minus a portion of the external surface of revolution of the MCSC housing, wherein said tubular body is arranged along a longitudinal axis that coincides with the longitudinal axis of the MCSC; wherein said tubular body also has a wall, said wall having at least one impermeable layer configured to prevent biological tissues and substances present inside the body of an MCSC user with said insulating device attached, from passing through said wall of the tubular body ; wherein said tubular body further has a proximal end and a distal end, wherein said proximal end and said distal end have both attachment means configured to allow attachment of said tubular body to the external surface of said housing; and wherein said proximal end and said distal end further possess both sealing means configured to allow a hermetic seal between said ends of the
  • FIG. 2 a longitudinal section of an insulating device 1 formed in a single piece surrounding the housing of an MCSC 2 is schematically shown, where said insulating device includes a tubular body, wherein said tubular body has a proximal end 3 and a distal end 4 , said both ends including non-permanent fixing means and sealing means. Therefore, said sealing means, allow the hermetic surrounding sealing between said ends of the tubular body and portions of the outer surface of the MCSC housing adjacent to said ends; and wherein said non-permanent fixing means, allow the fixing of the insulating device to the MCSC 2.
  • the tubular body has a wall 5 that has a length substantially equal to the length of the housing of the MCSC that has been outlined inside the insulating device .
  • annular space 6 is defined between the internal surface of said wall of the tubular body and the external surface of the housing covered by said wall of the tubular body, where said annular space is formed because the internal diameter of the tubular body is greater than the diameter external of the MCSC housing.
  • the existence of said annular space 6 makes it possible to reduce the resistance to movement of the MCSC inside the insulating device during a medical procedure intended to remove said MCSC. It should be understood that said annular space 6 constitutes only an example of an embodiment and that in different embodiments other designs or configurations could be used that also facilitate the sliding of the MCSC inside the insulating device during a procedure for the extraction of said MCSC.
  • Figure 3 shows the MCSC 2 housing covered by the insulating device 1 and said insulating device covered by epithelialization tissue 9.
  • Figure 3 also shows a removal loop 7 that will be attached to the proximal portion of the MCSC and on the which a pulling force will be applied.
  • the figure. 4 shows an MCSC partially removed from within the isolating device while a continuous pulling force is applied, through the loop, to the proximal end of the MCSC. Due to the fact that the fixing means of the ends of the isolating device, in this embodiment, are non-permanent fixing means, the MCSC has partially slid, proximally, inside the insulating device 1.
  • Figure. 5 shows the MCSC fully decoupled from the isolating device. Due to the presence of the isolating device 1, epithelialization 9 did not occur directly on the outer surface of the MCSC housing isolated by the isolating device and for that reason, the MCSC can be easily removed.
  • the MCSC can be removed from the heart but the isolating device is left within the heart chamber adhering to the surrounding epithelialization tissue.
  • FIG. 6 a longitudinal section of an insulating device formed in a single piece surrounding the housing of an MCSC is schematically shown, where said insulating device includes a tubular body, wherein said tubular body has a proximal end 3 and a distal end 4, including said both ends permanent fixing means and sealing means.
  • Said sealing means enables hermetic surrounding sealing between said ends of the tubular body and the portions of the outer surface of the MCSC housing adjacent to said ends; and said permanent fixing means allow the irreversible attachment of the ends of the tubular body to the MCSC 2.
  • the tubular body has a wall 5 having a length substantially equal to the length of the MCSC housing 2 which has been outlined inside the insulating device.
  • annular space 6 is defined between the internal surface of said wall of the tubular body and the external surface of the housing covered by said wall of the tubular body, where said annular space is formed because the internal diameter of the tubular body is greater than the diameter external of the MCSC housing.
  • the existence of said annular space 6 makes it possible, as in our first example of embodiment, to reduce the resistance to movement of the MCSC inside the insulating device during a medical procedure intended to remove said MCSC.
  • the wall of the tubular body breaks into two parts during the procedure for the extraction of the MCSC and in these circumstances, the blood that surrounds the insulating device and the MCSC penetrates inside the annular space 6 , wherein said amount of blood that penetrates into the annular space will serve as a lubricant during the proximal sliding of the MCSC, further facilitating the sliding of the MCSC inside the isolating device.
  • FIGs 7-9 three successive stages of an MCSC extraction procedure are outlined.
  • the figure. 7 shows the housing of an MCSC covered by the insulating device 1 and the external surface of said insulating device covered by epithelialization tissue 9.
  • Figure 7 also shows a removal loop 7 that will be coupled to the proximal portion of the MCSC 2 and on which a traction force will be applied.
  • the figure. 8 shows an MCSC partially removed from within the isolating device while a continuous pulling force is applied through loop 7, on the proximal end of the MCSC. Because the means of fixing the ends of the device Insulator are permanent means of fixation since the surface of the insulating device is trapped by the epithelialization tissue, the insulating device is divided into two parts through a tear line 10 configured near the proximal end 3 of the insulating device 1. In the Figure.
  • the figure. 9 shows the MCSC and the isolating device completely decoupled from the cardiac wall and epithelialization tissue 9.
  • the invagination of the distal end of the isolating device facilitates the detachment of said isolating device because the traction exerted on the MCSC is transmitted only to those annular portions 1 of the isolating device that progressively detach from the epithelialization tissue and invaginate into the space released by the MCSC.

Abstract

The invention relates to an implantable insulating device for a leadless cardiac pacemaker (LCP), which comprises a tubular body, the tubular body comprising: a lumen that allows at least a portion of the LCP casing to be accommodated; a proximal end and a distal end, both ends having attachment means configured to allow the insulating device to be attached to the surface of the LCP, and sealing means configured to allow hermetic sealing between the ends of the tubular body and the external surface of the LCP casing, the sealing means preventing biological tissue and substances inside the body of an LCP user from passing through the sealing means; and a wall that extends from the proximal end to the distal end, the wall including at least one layer impermeable to the biological tissues and substances inside the body of the LCP user. Also provided is an LCP that includes the insulating device.

Description

DISPOSITIVO AISLANTE IMPLANTABLE PARA MARCAPASOS CARDÍACOS SIN CABLES Y MARCAPASO CARDÍACO SIN CABLES IMPLANTABLE QUE INCLUYE DICHO DISPOSITIVO AISLANTE IMPLANTABLE ISOLATING DEVICE FOR CORDLESS CARDIAC PACEMAKERS AND IMPLANTABLE CORDLESS CARDIAC PACEMAKER INCLUDING SUCH ISOLATING DEVICE
CAMPO TÉCNICO DE LA INVENCIÓN TECHNICAL FIELD OF THE INVENTION
La presente invención se relaciona con el campo de los dispositivos de estimulación cardíaca implantables, más específicamente con los marcapasos cardíacos sin cables y en particular proporciona un dispositivo aislante para un marcapaso cardíaco sin cables y un marcapaso cardíaco sin cables que incluye dicho dispositivo aislante. ANTECEDENTES DE LA INVENCIÓN The present invention relates to the field of implantable cardiac pacing devices, more specifically cordless cardiac pacemakers and in particular provides an isolating device for a cordless cardiac pacemaker and a cordless cardiac pacemaker including such an isolating device. BACKGROUND OF THE INVENTION
Los marcapasos cardíacos, tales como los marcapasos cardíacos sin cables son utilizados para estimular eléctricamente al corazón y para detectar las señales eléctricas emitidas por el miocardio en pacientes con alteraciones en el ritmo cardíaco. Dichas alteraciones en el ritmo cardíaco incluyen, sin limitarse a estas, bradicardia, que consiste en latidos cardíacos lentos, y taquicardia, que consiste en latidos cardíacos rápidos. En varias circunstancias, se hace necesario remover un marcapaso cardíaco sin cables (MCSC) previamente implantado en un paciente. Dichos circunstancias incluyen: el agotamiento de la batería del MCSC, una infección relacionada con el MCSC y otras situaciones médicas que hacen necesaria la extracción de dicho dispositivo de estimulación cardíaca. Cardiac pacemakers, such as cordless cardiac pacemakers, are used to electrically stimulate the heart and to detect the electrical signals emitted by the myocardium in patients with abnormal heart rhythm. Such disturbances in heart rhythm include, but are not limited to, bradycardia, which consists of slow heartbeats, and tachycardia, which consists of rapid heartbeats. In various circumstances, it is necessary to remove a previously implanted cordless cardiac pacemaker (MCSC) in a patient. Such circumstances include: MCSC battery depletion, MCSC-related infection, and other medical conditions that make it necessary to remove said cardiac pacing device.
Sin embargo, en los marcapasos cardíacos sin cables que han estado implantados crónicamente, comúnmente después de tres meses, la superficie exterior de dichos marcapasos sin cables suele ser recubierta por tejido biológico de crecimiento. Dicho recubrimiento total o parcial de los marcapasos cardíacos sin cables es conocido como epitelización del marcapaso cardíaco sin cables (MCSC). La mencionada epitelización puede complicar la remoción de un MCSC desde el corazón debido a que el tejido que se extiende sobre la superficie exterior del MCSC incrementa el grado de fijación del MCSC a la pared de la cavidad cardíaca en la cual ha sido implantado. Por lo tanto, el mencionado fenómeno de epitelización incrementa la complejidad de los procedimientos de remoción de un MCSC y la probabilidad de ocurrencia de complicaciones durante dichos procedimientos. However, in leadless cardiac pacemakers that have been chronically implanted, typically after three months, the outer surface of such leadless pacemakers is often covered by biological growth tissue. This total or partial covering of the cardiac pacemaker without leads is known as epithelialization of the cardiac pacemaker without leads (MCSC). The aforementioned epithelialization can complicate the removal of an MCSC from the heart because the tissue that extends on the outer surface of the MCSC increases the degree of attachment of the MCSC to the wall of the cardiac chamber in which it has been implanted. Therefore, the aforementioned epithelialization phenomenon increases the complexity of the removal procedures of an MCSC and the probability of occurrence of complications during said procedures.
En el estado de la técnica se conocen dispositivos que intentan resolver, en alguna medida, el problema técnico previamente descrito. Por ejemplo, el documento US 9,795,781 describe un MCSC que incluye un miembro de acoplamiento y una cubierta sobre dicho miembro de acoplamiento, la cual facilita el posterior acoplamiento con un dispositivo de extracción. El documento referido previamente, sin embargo no describe un dispositivo aislante para el alojamiento de dicho MCSC, por lo que no evita la adherencia del tejido sobre la superficie externa de dicho MCSC. Por otra parte, el documento WO 2017/173166 describe una herramienta para facilitar la extracción de marcapasos cardíacos sin cables que está diseñada para cortar o, rasgar el tejido biológico que ha proliferado sobre la superficie de dichos dispositivos de estimulación cardíaca, facilitando de este modo la posterior extracción. Sin embargo, si se corta solo una porción del tejido biológico que recubre a un marcapaso cardíaco sin cables, no se resuelve completamente el problema relacionado con la fijación (por tejido biológico) del MCSC a la pared de la cavidad cardíaca donde fue previamente implantado. In the state of the art, devices are known that attempt to solve, to some extent, the previously described technical problem. For example, US 9,795,781 describes an MCSC that includes a coupling member and a cover over said coupling member, which facilitates subsequent coupling with a removal device. The document referred to previously, however, does not describe an insulating device for the accommodation of said MCSC, therefore it does not prevent the adherence of the tissue on the external surface of said MCSC. On the other hand, document WO 2017/173166 describes a tool to facilitate the extraction of cardiac pacemakers without leads that is designed to cut or tear the biological tissue that has proliferated on the surface of said cardiac stimulation devices, thus facilitating subsequent removal. However, if only a portion of the biological tissue covering a cardiac pacemaker without leads is cut, the problem related to the fixation (by biological tissue) of the MCSC to the wall of the heart chamber where it was previously implanted is not completely solved.
En consecuencia, se requiere de un dispositivo aislante implantable para marcapasos cardíacos sin cables, en donde dicho dispositivo evite o disminuya el grado de fijación que producen los tejidos de crecimiento sobre los marcapasos cardíacos sin cables que han permanecido crónicamente implantados dentro de una cavidad cardíaca. Consequently, an implantable isolating device is required for cordless cardiac pacemakers, wherein said device avoids or decreases the degree of fixation produced by growth tissues on cordless cardiac pacemakers that have remained chronically implanted within a cardiac chamber.
SUMARIO DE LA INVENCIÓN SUMMARY OF THE INVENTION
La presente invención proporciona un dispositivo aislante implantable para marcapasos cardíacos sin cables implantables, donde dicho dispositivo aislante comprende: un cuerpo tubular que se dispone a lo largo de un eje longitudinal, donde dicho cuerpo tubular posee un diámetro interior que permite la inserción de al menos una porción del alojamiento de un marcapaso cardíaco sin cables (MCSC), donde dicho cuerpo tubular además posee una pared impermeable configurada para impedir que los tejidos biológicos y sustancias presentes en el interior del cuerpo de un usuario de MCSC acoplado a dicho dispositivo aislante atraviesen dicha pared del cuerpo tubular, dicho cuerpo tubular que además posee un extremo proximal y un extremo distal. Dicho extremo proximal y dicho extremo distal que poseen medios de fijación configurados para permitir la fijación de dicho cuerpo tubular a la superficie externa de dicho MCSC; y en donde dicho extremo proximal y dicho extremo distal además poseen medios de sellado configurados para permitir un sellado hermético entre dichos extremos del cuerpo tubular y las porciones de la superficie externa del alojamiento de un marcapaso cardíaco sin cables que haya sido al menos parcialmente cubierto por dicho dispositivo aislante. The present invention provides an implantable isolating device for cardiac pacemakers without implantable leads, wherein said isolating device comprises: a tubular body that is arranged along a longitudinal axis, where said tubular body has an internal diameter that allows the insertion of at least a portion of the housing of a cordless cardiac pacemaker (MCSC), where said tubular body also has an impermeable wall configured to prevent biological tissues and substances present inside the body of a MCSC user coupled to said isolating device from passing through said wall of the tubular body, said tubular body further having a proximal end and a distal end. Said proximal end and said distal end having attachment means configured to allow attachment of said tubular body to the external surface of said MCSC; and where said proximal end and said distal end further possesses sealing means configured to allow a hermetic seal between said ends of the tubular body and portions of the outer surface of the housing of a leadless cardiac pacemaker that has been at least partially covered by said insulating device.
En otra realización preferida, dicho cuerpo tubular incluye, adicionalmente, al menos un elemento conductor de corriente eléctrica que permite la conducción de corriente eléctrica entre la superficie externa de la pared del cuerpo tubular y la superficie interna de la pared de dicho cuerpo tubular, en donde dicho elemento conductor está configurado para impedir que se interrumpa la comunicación eléctrica entre los electrodos del marcapaso cardíaco sin cables acoplado a dicho dispositivo aislante. In another preferred embodiment, said tubular body additionally includes at least one electrical current conducting element that allows the conduction of electrical current between the external surface of the wall of the tubular body and the internal surface of the wall of said tubular body, in wherein said conductive element is configured to prevent electrical communication between the electrodes of the cordless cardiac pacemaker coupled to said insulating device from being interrupted.
En otra realización preferida, la pared del mencionado cuerpo tubular, presenta una región de debilitamiento o de ruptura que sigue el trayecto de una línea cerrada alrededor del eje longitudinal del cuerpo tubular, donde dicha región de debilitamiento es configurada para facilitar la ruptura en dos partes del cuerpo tubular cuando sobre dicho cuerpo tubular se aplique una fuerza de tracción en una dirección generalmente paralela a la dirección del eje longitudinal de dicho cuerpo tubular. In another preferred embodiment, the wall of said tubular body has a region of weakness or rupture that follows the path of a closed line around the longitudinal axis of the tubular body, where said region of weakness is configured to facilitate the rupture into two parts. of the tubular body when a pulling force is applied to said tubular body in a direction generally parallel to the direction of the longitudinal axis of said tubular body.
En otra realización también preferida, la pared del mencionado cuerpo tubular está formada por uno o más materiales flexibles que permiten que dicha pared soporte una variedad de deformaciones y flexiones, incluso, flexiones de 180 grados sin romperse o desgarrarse en dos o más partes. La presente invención, además proporciona un marcapaso cardíaco sin cables (MCSC) implantable, donde dicho MCSC incluye al menos dos electrodos, un alojamiento generalmente cilindrico, y un dispositivo aislante, en donde dicho dispositivo aislante incluye un cuerpo tubular dispuesto sobre y rodeando al menos una porción de la superficie de revolución externa del alojamiento de dicho MCSC, teniendo dicho cuerpo tubular una pared impermeable a los tejidos y sustancias presentes en el interior del cuerpo de un usuario de dicho MCSC, en donde dicho cuerpo tubular posee además un extremo proximal y un extremo distal, en donde dicho extremo proximal y dicho extremo distal poseen medios de fijación a la superficie del alojamiento de dicho MCSC; y en donde dicho extremo proximal y dicho extremo distal además poseen medios de sellado configurados para permitir un sellado circunferencial hermético entre dichos extremos del cuerpo tubular y las porciones de la superficie externa (adyacentes a dichos extremos) del alojamiento del MCSC. In another also preferred embodiment, the wall of said tubular body is formed of one or more flexible materials that allow said wall to withstand a variety of deformations and bends, even 180 degree bends, without breaking or tearing into two or more parts. The present invention further provides an implantable cordless cardiac pacemaker (MCSC), wherein said MCSC includes at least two electrodes, a generally cylindrical housing, and an isolating device, wherein said isolating device includes a tubular body disposed over and surrounding at least a portion of the external surface of revolution of the housing of said MCSC, said tubular body having a wall impermeable to tissues and substances present inside the body of a user of said MCSC, wherein said tubular body also has a proximal end and a distal end, wherein said proximal end and said distal end possess fixing means to the housing surface of said MCSC; and wherein said proximal end and said distal end further possess sealing means configured to allow a hermetic circumferential seal between said ends of the tubular body and the outer surface portions (adjacent to said ends) of the MCSC housing.
BREVE DESCRIPCIÓN DE LAS FIGURAS La Figura. 1 ilustra la epitelización de dos marcapasos cardíacos sin cables implantados crónicamente en el corazón de un paciente. BRIEF DESCRIPTION OF THE FIGURES Figure. 1 illustrates the epithelialization of two chronically implanted leadless cardiac pacemakers in a patient's heart.
La Figura. 2 muestra una vista de corte longitudinal esquemática de un primer ejemplo de realización del dispositivo aislante 1 acoplado a un marcapaso cardíaco sin cables. The figure. 2 shows a schematic longitudinal sectional view of a first embodiment of the isolating device 1 coupled to a cardiac pacemaker without leads.
Las Figuras. 3-5 ilustran la secuencia de extracción de un marcapaso cardíaco sin cables (MCSC) en donde dicho MCSC posee el dispositivo aislante ejemplificado en la Figura 2. La Figura. 6 muestra una vista de corte longitudinal esquemática de un segundo ejemplo de realización del dispositivo aislante 1 acoplado a un marcapaso cardíaco sin cables. The figures. 3-5 illustrate the extraction sequence of a cordless cardiac pacemaker (MCSC) in which said MCSC has the isolating device exemplified in Figure 2. The figure. 6 shows a schematic longitudinal sectional view of a second embodiment of the isolating device 1 coupled to a cardiac pacemaker without leads.
Las Figuras. 7-9 ilustran la secuencia de extracción de un marcapaso cardíaco sin cables (MCSC) en donde dicho MCSC posee el dispositivo aislante ejemplificado en la Figura 6. The figures. 7-9 illustrate the extraction sequence of a cordless cardiac pacemaker (MCSC) wherein said MCSC has the isolating device exemplified in Figure 6.
DESCRIPCIÓN DETALLADA DE LA PRESENTE INVENCIÓN DETAILED DESCRIPTION OF THE PRESENT INVENTION
Como se indicó previamente, los marcapasos cardíacos sin cables son implantados en algunos pacientes con alteraciones del ritmo cardíaco para estimular la contracción del corazón y para detectar las señales eléctricas provenientes del músculo cardíaco. Cuando finaliza la vida útil de la batería de un marcapaso cardíaco sin cables (MCSC) o cuando alguna circunstancia clínica del paciente así lo exige, el MCSC debe ser extraído desde el corazón. Consecuentemente, cuando un MCSC debe ser extraído por cualquiera de las razones expuestas previamente, suele hacerse necesario implantar un nuevo MCSC que sustituya las funciones del MCSC que ha sido extraído. Sin embargo, en los MCSC que han estado crónicamente implantados, típicamente después de los tres primeros meses posteriores al implante, la superficie externa del MCSC suele estar recubierta parcial o totalmente por tejidos biológicos con contenido fibroso (epitelización) lo cual incrementa notablemente el grado de fijación del MCSC a la pared de la cavidad cardíaca donde el MCSC fue implantado. En dichos MCSC que han sido englobados por la epitelización, los procedimientos destinados a la extracción del MCSC comúnmente fracasan. Y en dichos casos, en los que no puede realizarse la extracción del MCSC, dicho MCSC suele ser abandonado en el interior de la cavidad cardíaca y se implanta un nuevo MCSC en otra región de dicha cavidad que suple las funciones del primero. Consecuentemente, con el paso del tiempo y suponiendo que durante la vida de un paciente con marcapasos, este paciente requerirá el implante de varios MCSC, dichos marcapasos cardiacos sin cables se acumularían dentro de la cavidad cardíaca solo por el hecho de que ha sido imposible o considerada muy riesgosa su extracción. Para ayudar a resolver el problema anterior, la presente invención proporciona un dispositivo aislante implantable 1 para marcapasos cardíacos sin cables 2, en donde dicho dispositivo aislante 1 comprende: un cuerpo tubular que se dispone a lo largo de un eje longitudinal, donde dicho cuerpo tubular tiene un espacio interior o lumen que permite la inserción de al menos una porción del alojamiento de un MCSC, donde dicho cuerpo tubular además posee una pared 5 impermeable configurada para impedir que los tejidos biológicos y sustancias presentes en el interior del cuerpo de un usuario de un MCSC acoplado con dicho dispositivo de aislamiento atraviesen dicha pared del cuerpo tubular, dicho cuerpo tubular que además posee un extremo proximal 3 y un extremo distal 4. Dicho extremo proximal 3 y dicho extremo distal 4 que poseen medios de fijación configurados para permitir la fijación de dicho cuerpo tubular a la superficie externa de dicho MCSC 2; y en donde dicho extremo proximal y dicho extremo distal además poseen medios de sellado configurados para permitir un sellado hermético entre dichos extremos del cuerpo tubular y las porciones de la superficie externa (adyacentes a dichos extremos) del alojamiento del MCSC acoplado con dicho dispositivo aislante. Debido a que la pared del cuerpo tubular del dispositivo aislante para marcapasos cardíacos sin cables es impermeable a los tejidos biológicos y sustancias presentes en el interior del cuerpo de un usuario de marcapaso cardíaco sin cables (MCSC) acoplado a dicho dispositivo de aislamiento, y debido a que los extremos de dicho cuerpo tubular tienen medios de sellado configurados para conseguir un sellado hermético entre dichos extremos del cuerpo tubular y las porciones de la superficie externa del alojamiento de dicho MCSC; se impide que el tejido biológico prolifere directamente sobre la superficie externa del MCSC aislada por el dispositivo aislante . Como consecuencia de lo anteriormente expresado, el tejido biológico 9 se extendería sobre la superficie externa del dispositivo aislante 1 en vez de sobre la porción de superficie externa del alojamiento del MCSC cubierta por el dispositivo aislante. Lo anteriormente expresado facilitaría, como será explicado más adelante, la extracción de un MCSC implantado crónicamente. As previously noted, cordless cardiac pacemakers are implanted in some patients with heart rhythm disturbances to stimulate the heart to contract and to detect electrical signals from the heart muscle. When the battery life of a cordless cardiac pacemaker (MCSC) expires or when some clinical circumstance of the patient requires it, the MCSC must be extracted from the heart. Consequently, when an MCSC must be removed for any of the reasons previously stated, it is often necessary to implement a new MCSC to replace the functions of the MCSC that has been removed. However, in MCSCs that have been chronically implanted, typically after the first three months after implantation, the external surface of the MCSC is usually partially or totally covered by biological tissues with fibrous content (epithelialization) which significantly increases the degree of fixation of the MCSC to the wall of the heart chamber where the MCSC was implanted. In such MCSCs that have been engulfed by epithelialization, procedures for the removal of MCSC commonly fail. And in In such cases, in which the extraction of the MCSC cannot be performed, said MCSC is usually abandoned inside the cardiac chamber and a new MCSC is implanted in another region of said chamber that supplies the functions of the first. Consequently, with the passage of time and assuming that during the life of a patient with a pacemaker, this patient will require the implantation of several MCSCs, said cardiac pacemakers without leads would accumulate within the cardiac cavity just because it has been impossible or its extraction is considered very risky. To help solve the above problem, the present invention provides an implantable isolating device 1 for cardiac pacemakers without leads 2, wherein said isolating device 1 comprises: a tubular body that is arranged along a longitudinal axis, wherein said tubular body It has an interior space or lumen that allows the insertion of at least a portion of the housing of an MCSC, where said tubular body also has an impermeable wall configured to prevent biological tissues and substances present inside the body of a user from an MCSC coupled with said isolation device traverses said tubular body wall, said tubular body also having a proximal end 3 and a distal end 4. Said proximal end 3 and said distal end 4 having fixing means configured to allow fixation from said tubular body to the external surface of said MCSC 2; and wherein said proximal end and said distal end further possess sealing means configured to allow a hermetic seal between said ends of the tubular body and the outer surface portions (adjacent to said ends) of the MCSC housing coupled with said insulating device. Because the tubular body wall of the insulating device for leadless cardiac pacemakers is impermeable to biological tissues and substances present within the body of a user of a wireless cardiac pacemaker (MCSC) coupled to said isolation device, and because that the ends of said tubular body have sealing means configured to achieve a hermetic seal between said ends of the tubular body and the outer surface portions of the housing of said MCSC; biological tissue is prevented from proliferating directly on the outer surface of the MCSC isolated by the isolating device. As a consequence of the above, the biological tissue 9 would be spread on the outer surface of the isolating device 1 instead of on the outer surface portion of the MCSC housing covered by the isolating device. The foregoing would facilitate, as will be explained later, the extraction of a chronically implanted MCSC.
En el contexto de la presente invención, debe entenderse que los términos relativos tales como proximal y distal, están referidos a la herramienta utilizada por una persona especialista que realiza la implantación o extracción de dicho MCSC percutáneamente. En este sentido, el extremo proximal 3 del cuerpo tubular del dispositivo aislante es el extremo más cercano a dicha herramienta, mientras que el extremo distal 4 de dicho cuerpo tubular es el extremo más lejano a dicha herramienta. Del mismo modo, sin limitar el alcance de la presente invención, debe entenderse que el eje longitudinal se extiende sustancialmente paralelo a la dirección proximal-distal. Por otra parte, los términos interior y exterior deben entenderse como referidos al cuerpo tubular cuando el mismo se encuentra normalmente en uso, conteniendo en su interior al menos una porción del alojamiento de un MCSC. In the context of the present invention, it should be understood that the relative terms such as proximal and distal refer to the tool used by a specialist who performs the implantation or extraction of said MCSC percutaneously. In this sense, the proximal end 3 of the tubular body of the insulating device is the end closest to said tool, while the distal end 4 of said tubular body is the end furthest from said tool. Likewise, without limiting the scope of the present invention, it should be understood that the longitudinal axis extends substantially parallel to the proximal-distal direction. On the other hand, the terms interior and exterior should be understood as referring to the tubular body when it is normally in use, containing within it at least a portion of the housing of an MCSC.
Adicionaímente, en el contexto de la presente invención, debe entenderse que un marcapaso cardíaco sin cables (MCSC) implantable posee al menos dos electrodos, comúnmente denominados ánodo y cátodo, que se utilizan para estimular la contracción del corazón mediante la aplicación de corriente eléctrica y para detectar las señales eléctricas emitidas por el músculo cardíaco o miocardio 8. Los marcapasos cardíacos sin cables de la técnica anterior poseen un alojamiento con una forma generalmente cilindrica, cuya superficie exterior o una porción de dicha superficie exterior se utiliza como uno de los electrodos del MCSC, comúnmente el ánodo. El otro electrodo o cátodo, de los MCSC de la técnica anterior, comúnmente está localizado en una región del extremo distal del MCSC. Additionally, in the context of the present invention, it should be understood that an implantable cordless cardiac pacemaker (MCSC) possesses at least two electrodes, commonly referred to as anode and cathode, which are used to stimulate contraction of the heart by applying electrical current and to detect the electrical signals emitted by the cardiac muscle or myocardium 8. The cardiac pacemakers without leads of the prior art have a housing with a generally cylindrical shape, whose outer surface or a portion of said outer surface is used as one of the electrodes of the MCSC, commonly the anode. The other electrode or cathode, of prior art MCSCs, is commonly located in a region of the distal end of the MCSC.
La pared del cuerpo tubular del dispositivo aislante está formada por al menos una capa, sin que esto limite el alcance de la presente invención. En particular, al menos una capa de la pared 5 del cuerpo tubular está constituida por un material impermeable, para evitar la entrada de sustancias y tejidos biológicos al interior del espacio 6 formado entre dicho cuerpo tubular y la porción del alojamiento del MCSC que se pretende cubrir. The wall of the tubular body of the insulating device is formed by at least one layer, without limiting the scope of the present invention. In particular, at least one layer of the wall 5 of the tubular body is made of an impermeable material, to prevent the entry of biological substances and tissues into the space 6 formed between said tubular body and the portion of the MCSC housing that is intended. cover.
Sin limitar el alcance de la presente invención, la superficie interior de la pared del cuerpo tubular podría estar configurada para facilitar el deslizamiento del MCSC durante un procedimiento médico destinado a la extracción del MCSC. En una realización preferida, la superficie interna de la pared del cuerpo tubular podría estar constituida de un material biocompatible deslizante para disminuir la resistencia durante el procedimiento de remoción del MCSC. En otra realización preferida, sin limitar el alcance de la presente invención, la superficie interna de la pared del cuerpo tubular, podría presentar protuberancias o estrías que disminuyen la superficie de contacto entre la superficie interna de la pared del cuerpo tubular y la superficie externa del alojamiento del MCSC cubierta por el dispositivo aislante, disminuyendo así la resistencia al deslizamiento del MCSC por el interior del dispositivo aislante durante un procedimiento destinado a su extracción. Without limiting the scope of the present invention, the interior surface of the tubular body wall could be configured to facilitate sliding of the MCSC during a medical procedure for removal of the MCSC. In a preferred embodiment, the inner surface of the wall of the tubular body could be made of a Slip-on biocompatible material to decrease resistance during the MCSC removal procedure. In another preferred embodiment, without limiting the scope of the present invention, the inner surface of the wall of the tubular body could present protrusions or grooves that decrease the contact surface between the inner surface of the wall of the tubular body and the outer surface of the MCSC housing covered by the insulating device, thus reducing the resistance to sliding of the MCSC inside the insulating device during a procedure for its removal.
En otro ejemplo de realización de la presente invención, sin limitar el alcance de la misma, podría existir un espacio 6 limitado por: la superficie interna de la pared del cuerpo tubular 5, la superficie externa del alojamiento del marcapaso que ha sido cubierto por la pared del cuerpo tubular, y por los medios de sellado de los extremos del cuerpo tubular. En dicha realización, debe entenderse que dicho espacio es un espacio comunicado en toda su extensión. In another embodiment of the present invention, without limiting its scope, there could be a space 6 limited by: the inner surface of the wall of the tubular body 5, the outer surface of the pacemaker housing that has been covered by the wall of the tubular body, and by means of sealing the ends of the tubular body. In said embodiment, it should be understood that said space is a communicated space in its entirety.
El dispositivo aislante puede tener cualquier dimensión sin limitar el alcance de la presente invención. Las dimensiones de dicho dispositivo aislante dependerán entre otros factores y sin limitar el alcance de la presente invención, de las dimensiones y formas de la porción del alojamiento de MCSC que se pretende aislar. The insulating device can have any dimension without limiting the scope of the present invention. The dimensions of said insulating device will depend among other factors and without limiting the scope of the present invention, on the dimensions and shapes of the portion of the MCSC housing to be insulated.
El espesor de la pared 5 del cuerpo tubular del dispositivo aislante 1 podrá tener cualquier dimensión que evite incrementar de una manera inconveniente el diámetro del conjunto MCSC + dispositivo aislante. En una realización preferida, el espesor de dicha pared 5 es de una magnitud que evita incrementar excesivamente el diámetro de las vainas y otras herramientas empleadas para el implante y extracción de un MCSC por vía percutánea, siempre que dicho espesor seleccionado no limite el alcance de la presente invención, por ejemplo, sin limitarse a esto, que no afecte las características impermeables de la pared. The thickness of the wall 5 of the tubular body of the insulating device 1 may have any dimension that avoids increasing in an inconvenient way the diameter of the MCSC + insulating device assembly. In a preferred embodiment, the thickness of said wall 5 is of a magnitude that avoids excessively increasing the diameter of the sheaths and other tools used for percutaneous implantation and removal of an MCSC, provided that said selected thickness does not limit the scope of the present invention, for example, without being limited thereto, that it does not affect the waterproof characteristics of the wall.
Adicionalmente, el dispositivo aislante podría tener diferentes longitudes sin que ello limite el alcance de la presente invención. En una realización preferida, la longitud del dispositivo aislante podría ser menor que la longitud del alojamiento del MCSC. En otro ejemplo de realización, la longitud de dicho dispositivo aislante podría ser igual a la longitud del alojamiento del MCSC y en un tercer ejemplo de realización la longitud de dicho dispositivo aislante podría ser mayor que la longitud del alojamiento del MCSC. Additionally, the insulating device could have different lengths without limiting the scope of the present invention. In a preferred embodiment, the length of the isolating device could be less than the length of the MCSC housing. In another embodiment, the length of said insulating device could be equal to the length of the MCSC housing and in a third embodiment the length of said insulating device could be greater than the length of the MCSC housing.
Como se explicó anteriormente, los MCSC de la técnica anterior presentan típicamente dos electrodos que constituyen partes del circuito encargado de estimular eléctricamente al corazón y de detectar las señales eléctricas provenientes del músculo cardíaco. En una realización preferida, sin limitar el alcance de la presente invención, el cuerpo tubular del dispositivo aislante propuesto en la presente invención ni siquiera cubre a uno de los electrodos del MCSC, permitiendo la comunicación eléctrica entre dichos electrodos. Sin embargo, en otras realizaciones también preferidas, el cuerpo tubular cubre al menos a uno de los electrodos del MCSC pero, en dichas realizaciones, la mencionada pared del cuerpo incluye: uno o más elementos formados por un material conductor eléctrico, donde dichos elementos comunican eléctricamente el medio exterior del cuerpo tubular y el electrodo del MCSC que permanece cubierto por la pared del cuerpo tubular, evitando la interrupción del circuito eléctrico entre el electrodo cubierto por el dispositivo aislante y el electrodo que se encuentra por fuera del dispositivo aislante. As explained above, prior art MCSCs typically have two electrodes that constitute parts of the circuit responsible for electrically stimulating the heart and detecting electrical signals from the heart muscle. In a preferred embodiment, without limiting the scope of the present invention, the tubular body of the insulating device proposed in the present invention does not even cover one of the MCSC electrodes, allowing electrical communication between said electrodes. However, in other also preferred embodiments, the tubular body covers at least one of the electrodes of the MCSC but, in said embodiments, said body wall includes: one or more elements formed by an electrically conductive material, where said elements communicate electrically the outer medium of the tubular body and the electrode of the MCSC that remains covered by the wall of the tubular body, avoiding the interruption of the electrical circuit between the electrode covered by the insulating device and the electrode outside the insulating device.
En los ejemplos de realizaciones mencionados, en donde la pared del cuerpo tubular del dispositivo aislante incluye uno o más elementos formados por un material conductor eléctrico, este material conductor eléctrico puede ser un material no metálico previamente conocido en el estado de la técnica que cumpla también la condición de ser un material biocompatible. En otro ejemplo de realización, sin afectar el alcance de la presente invención, el material conductor eléctrico puede ser un metal conocido que también cumpla con la condición de ser un material biocompatible. El material conductor eléctrico referido previamente podría ser cualquier material conductor eléctrico biocompatible reconocible y seleccionable por un experto en el campo de dichos materiales, siempre que dicha selección no limite el alcance de la presente invención. In the examples of embodiments mentioned, where the wall of the tubular body of the insulating device includes one or more elements formed by an electrically conductive material, this electrically conductive material can be a non-metallic material previously known in the state of the art that also complies with the condition of being a biocompatible material. In another embodiment, without affecting the scope of the present invention, the electrically conductive material can be a known metal that also fulfills the condition of being a biocompatible material. The previously referred electrically conductive material could be any biocompatible electrically conductive material recognizable and selectable by an expert in the field of such materials, provided that such selection does not limit the scope of the present invention.
La naturaleza de los materiales que se empleen para fabricar el dispositivo aislante para marcapasos cardíacos sin cables, sin limitar el alcance de la presente invención, dependerá de las dimensiones y formas de dichos marcapasos cardíacos sin cables, de las dimensiones y formas del cuerpo tubular del dispositivo aislante, del número de electrodos que presenten dichos marcapasos cardíacos sin cables y de si el dispositivo aislante cubre o no alguno de dichos electrodos. Sin embargo, para cumplir con el propósito de la presente invención, al menos una capa de la pared del cuerpo tubular de dicho dispositivo aislante debe ser construida de un material impermeable a las sustancias y tejidos biológicos presentes en el interior del cuerpo de un usuario de marcapaso cardíaco sin cables. En adición a lo anteriormente expresado, tanto el extremo proximal 3 del cuerpo tubular como el extremo distal 4 del cuerpo tubular incluyen medios de sellados que permiten un sellado anular hermético entre cada uno de los extremos del cuerpo tubular y la superficie externa del alojamiento del MCSC que ha sido insertado en el interior del dispositivo aislante, en donde dicho sellado anular hermético impide que las sustancias y tejidos biológicos presentes en el interior del cuerpo de un usuario de MCSC entren en contacto con la porción de la superficie externa del alojamiento del MCSC que ha sido cubierta por el dispositivo aislante, evitando así, la proliferación del tejido sobre dicha superficie externa del alojamiento del MCSC. The nature of the materials used to manufacture the insulating device for cordless cardiac pacemakers, without limiting the scope of the present invention, will depend on the dimensions and shapes of said cordless cardiac pacemakers, on the dimensions and shapes of the tubular body of the isolating device, the number of electrodes present in said cordless cardiac pacemakers and whether or not the isolating device covers any of said electrodes. However, to fulfill the purpose of the present invention, at least one layer of the wall of the tubular body of said insulating device must be constructed of a material that is impervious to biological substances and tissues present inside the body of a wearer. cardiac pacemaker without leads. In addition to As mentioned above, both the proximal end 3 of the tubular body and the distal end 4 of the tubular body include sealing means that allow a hermetic annular seal between each of the ends of the tubular body and the external surface of the MCSC housing that has been inserted. inside the isolating device, wherein said hermetic annular seal prevents biological substances and tissues present within the body of an MCSC user from coming into contact with the portion of the external surface of the MCSC housing that has been covered by the isolating device, thus preventing tissue proliferation on said external surface of the MCSC housing.
En otra realización preferida, la pared del cuerpo tubular de dicho dispositivo aislante está formada por uno o más materiales flexibles para permitir que la pared de dicho cuerpo tubular pueda soportar múltiples deformaciones y flexiones, incluso flexiones de 180 grados, sin romperse o fracturarse en dos o más partes. In another preferred embodiment, the wall of the tubular body of said insulating device is formed of one or more flexible materials to allow the wall of said tubular body to withstand multiple deformations and bends, even 180 degree bends, without breaking or fracturing in two. or more parts.
Como se indicó previamente, dicho cuerpo tubular posee un extremo proximal 3 y un extremo distal 4, teniendo ambos extremos medios de fijación al alojamiento del marcapaso cardíaco sin cables (MCSC) que ha sido parcial o totalmente cubierto por dicho cuerpo tubular. En el contexto de la presente invención, debe entenderse que los medios de fijación puede ser cualquier medio apropiado que permita la fijación de dichos extremos proximal y distal al alojamiento de dicho MCSC. Dichos medios de fijación pueden ser permanentes, como los ejemplificados en las Figuras. 6-9, o dichos medios de fijación pueden ser no permanentes, como los ejemplificados en las Figuras. 2-5. Un ejemplo de medio de fijación permanente, sin limitarse a dicho ejemplo, puede lograrse con un adhesivo biocompatible que no pierda sus propiedades adhesivas durante al menos el tiempo de vida útil del MCSC. Otro medio de fijación permanente diferente, podría ser seleccionado por un experto en la materia, siempre que dicha selección no limite el alcance de la presente invención. Algunos ejemplos de medios de fijación no permanentes podrían ser, sin limitarse dichos ejemplos, proyecciones o protrusiones y porciones cónicas en las superficies internas de los extremos del cuerpo tubular. Igualmente, otro medio de fijación no permanente diferente podría ser seleccionado por un experto en la materia siempre que dicha selección no limite el alcance de la presente invención. As previously indicated, said tubular body has a proximal end 3 and a distal end 4, both ends having means of attachment to the housing of the cordless cardiac pacemaker (MCSC) that has been partially or totally covered by said tubular body. In the context of the present invention, it should be understood that the fixation means can be any suitable means that allows the fixation of said proximal and distal ends to the housing of said MCSC. Said fixing means can be permanent, as exemplified in the Figures. 6-9, or said fixing means may be non-permanent, as exemplified in the Figures. 2-5. An example of a permanent fixation means, not limited to said example, it can be achieved with a biocompatible adhesive that does not lose its adhesive properties for at least the lifetime of the MCSC. A different means of permanent fixation could be selected by a person skilled in the art, provided that such selection does not limit the scope of the present invention. Some examples of non-permanent fixing means could be, without being limited to said examples, projections or protrusions and conical portions on the inner surfaces of the ends of the tubular body. Similarly, a different non-permanent fixing means could be selected by a person skilled in the art provided that such selection does not limit the scope of the present invention.
En el contexto de la presente invención, debe entenderse que una región de debilitamiento 10 es una zona del cuerpo tubular que puede romperse o rasgarse fácilmente cuando se ejerce una fuerza de tracción o de torsión sobre el cuerpo tubular mientras se ejecuta un procedimiento médico destinado a la extracción del marcapaso cardíaco sin cables (MCSC). El objetivo de dicha región de debilitamiento es, que durante dicho procedimiento médico destinado a la extracción de un MCSC epitelizado, el cuerpo tubular del dispositivo aislante pueda fracturarse en dos partes, como se ilustra en la Figura. 8, para facilitar la extracción de dicho MCSC. In the context of the present invention, a region of weakness 10 is to be understood as an area of the tubular body that can easily break or tear when a pulling or twisting force is exerted on the tubular body while performing a medical procedure intended to removal of the cordless cardiac pacemaker (MCSC). The objective of said region of weakness is that during said medical procedure aimed at the extraction of an epithelialized MCSC, the tubular body of the isolating device can be fractured into two parts, as illustrated in the Figure. 8, to facilitate the removal of said MCSC.
En una realización preferida, dicha región de debilitamiento de la pared del cuerpo tubular coincide con el trayecto de una línea cerrada que rodea al eje longitudinal del cuerpo tubular. En una realización preferida de esta región de debilitamiento, dicha región de debilitamiento puede ser configurada, por ejemplo y sin limitar el alcance de la presente invención, como una región anular de la pared del cuerpo tubular que posee un espesor significativamente menor que el espesor del resto de la pared de dicho cobertor tubular. En otros ejemplos, dicha región de debilitamiento puede obtenerse mediante un pre-picado, en donde dicho pre-picado no atraviesa todo el espesor de la pared del cuerpo tubular para no afectar las propiedades aislantes de la pared del cuerpo tubular. En un ejemplo de realización preferido, dicha región de debilitamiento se encuentra en una región cercana al extremo proximal del cobertor tubular de dicho dispositivo aislante como se ilustra en la Figura. 6. Una localización preferida de esta línea de ruptura del cuerpo tubular, SÍ limitarse a dicha localización, es una línea de ruptura que se encuentra a menos de 1 mm del extremo proximal del cuerpo tubular. In a preferred embodiment, said region of weakness of the wall of the tubular body coincides with the path of a closed line that surrounds the longitudinal axis of the tubular body. In a preferred embodiment of this region of weakness, said region of weakness can be configured, for example and without limiting the scope of the present invention, as an annular region of the wall of the tubular body that it has a thickness significantly less than the thickness of the rest of the wall of said tubular cover. In other examples, said region of weakness can be obtained by means of a pre-cut, wherein said pre-cut does not go through the entire thickness of the wall of the tubular body so as not to affect the insulating properties of the wall of the tubular body. In a preferred embodiment, said region of weakness is in a region near the proximal end of the tubular cover of said insulating device as illustrated in the Figure. 6. A preferred location of this line of rupture of the tubular body, IF limited to said location, is a line of rupture that is less than 1 mm from the proximal end of the tubular body.
Como se indicó previamente, dicho cuerpo tubular posee un extremo proximal 3 y un extremo distal 4 y dichos ambos extremos proximal y distal presentan medios de sellado, en donde dichos medios de sellado evitan que los fluidos, sustancias y tejidos presentes en el interior del cuerpo de un usuario de MCSC acoplado a dicho dispositivo aislante entren al espacio 6 creado entre la superficie interna de la pared del cuerpo tubular y la superficie externa del alojamiento del MCSC que ha sido cubierto por dicha pared del cuerpo tubular, lo cual evita la proliferación de tejido sobre dicha superficie externa del alojamiento del MCSC. Dichos medios de sellado, sin limitar el alcance de la presente invención, pueden ser cualquiera de los medios de sellado conocidos en el estado de la técnica, siempre que dicho medio de sellado permita un sellado circundante hermético entre los extremos del cuerpo tubular del dispositivo aislante y las porciones de la superficie exterior del MCSC adyacentes a dichos extremos, dichos medios de sellado deben ser además construidos de un material biocompatible y poseer un tiempo de vida útil al menos igual que el tiempo de vida útil del MCSC sobre el cual ha sido insertado el dispositivo aislante. Por ejemplo, y sin que este ejemplo limite el alcance de la presente invención, dichos medios de sellado pueden seleccionarse del grupo formado por protrusiones internas en los extremos del cuerpo tubular, anillos tóricos, anillos planos, o-rings, así como combinaciones o variantes de los mismos. As previously indicated, said tubular body has a proximal end 3 and a distal end 4 and said both proximal and distal ends present sealing means, wherein said sealing means prevent the fluids, substances and tissues present inside the body of an MCSC user coupled to said insulating device enter the space 6 created between the inner surface of the wall of the tubular body and the outer surface of the MCSC housing that has been covered by said wall of the tubular body, which prevents the proliferation of tissue on said outer surface of the MCSC housing. Said sealing means, without limiting the scope of the present invention, can be any of the sealing means known in the state of the art, provided that said sealing means allows a hermetic surrounding seal between the ends of the tubular body of the insulating device and the portions of the outer surface of the MCSC adjacent to said ends, said sealing means must also be constructed of a biocompatible material and have a useful life time at least equal to the useful life of the MCSC on which the insulating device has been inserted. For example, and without this example limiting the scope of the present invention, said sealing means can be selected from the group formed by internal protrusions at the ends of the tubular body, O-rings, flat rings, o-rings, as well as combinations or variants thereof.
En una realización preferida, sin que esto limite el alcance de la presente invención, al menos uno de los extremos del cuerpo tubular del dispositivo aislante está configurado para permitir un sellado circundante hermético referido anteriormente, y simultáneamente, permitir la fijación de dicho extremo a la superficie del alojamiento del MCSC con la cual haría contacto dicho extremo. Por ejemplo, sin limitar el alcance de la presente invención, la coincidencia mencionada se logra cuando al menos uno de los extremos del cuerpo tubular presenta proyecciones, protuberancias o bordes en el interior de dicho extremo, las cuales al entrar en contacto con la porción de la superficie externa del alojamiento del MCSC adyacente a dicho extremo permiten: el sellado hermético entre dicho extremo y la superficie del alojamiento del MCSC adyacente; y, la fijación de dicho extremo al alojamiento de dicho MCSC. Esta última configuración preferida ofrece como ventaja que permite simplificar la construcción del dispositivo aislante propuesto por la presente invención y también ofrece la ventaja de que dicho dispositivo aislante podría ser construido en sola pieza. In a preferred embodiment, without limiting the scope of the present invention, at least one of the ends of the tubular body of the insulating device is configured to allow a hermetic surrounding seal referred to above, and simultaneously, to allow the attachment of said end to the surface of the MCSC housing that the end would contact. For example, without limiting the scope of the present invention, the aforementioned coincidence is achieved when at least one of the ends of the tubular body presents projections, protrusions or edges inside said end, which when in contact with the portion of the outer surface of the MCSC housing adjacent to said end allows: hermetic sealing between said end and the surface of the adjacent MCSC housing; and, fixing said end to the housing of said MCSC. This last preferred configuration offers the advantage that it allows to simplify the construction of the insulating device proposed by the present invention and also offers the advantage that said insulating device could be built in one piece.
La presente invención proporciona además, un marcapaso cardíaco sin cables (MCSC) implantable que comprende: al menos dos electrodos, un alojamiento generalmente cilindrico y un dispositivo aislante, en donde dicho dispositivo aislante incluye un cuerpo tubular que rodea al menos una porción de la superficie de revolución externa del alojamiento del MCSC, en donde dicho cuerpo tubular se dispone a lo largo de un eje longitudinal que coincide con el eje longitudinal del MCSC; donde dicho cuerpo tubular además posee una pared, teniendo dicha pared al menos una capa impermeable configurada para impedir que los tejidos biológicos y las sustancias presentes en el interior del cuerpo de un usuario de MCSC con dicho dispositivo aislante acoplado, atraviesen dicha pared del cuerpo tubular; en donde dicho cuerpo tubular además posee un extremo proximal y un extremo distal, en donde dicho extremo proximal y dicho extremo distal poseen ambos medios de fijación configurados para permitir la fijación de dicho cuerpo tubular a la superficie externa de dicho alojamiento; y en donde dicho extremo proximal y dicho extremo distal además poseen ambos, medios de sellado configurados para permitir un sellado hermético entre dichos extremos del cuerpo tubular y las porciones de la superficie externa del alojamiento del MCSC adyacentes a dichos extremos, en donde dichos medios de sellado son configurados para impedir que los tejidos biológicos y sustancias presentes en el interior de un usuario de MCSC con dicho dispositivo aislante acoplado, atraviesen dichos medios de sellado. The present invention further provides an implantable leadless cardiac pacemaker (MCSC) comprising: at least two electrodes, a generally cylindrical housing, and an isolating device, wherein said isolating device includes a tubular body surrounding the minus a portion of the external surface of revolution of the MCSC housing, wherein said tubular body is arranged along a longitudinal axis that coincides with the longitudinal axis of the MCSC; wherein said tubular body also has a wall, said wall having at least one impermeable layer configured to prevent biological tissues and substances present inside the body of an MCSC user with said insulating device attached, from passing through said wall of the tubular body ; wherein said tubular body further has a proximal end and a distal end, wherein said proximal end and said distal end have both attachment means configured to allow attachment of said tubular body to the external surface of said housing; and wherein said proximal end and said distal end further possess both sealing means configured to allow a hermetic seal between said ends of the tubular body and portions of the external surface of the MCSC housing adjacent to said ends, wherein said means of Seals are configured to prevent biological tissues and substances present within an MCSC user with said insulating device attached, from passing through said sealing means.
Todas las opciones previamente expuestas para el dispositivo aislante implantable para marcapasos cardíacos sin cables, así como las combinaciones entre las mismas, son aplicables también al dispositivo aislante que fue caracterizado en el marcapaso cardíaco sin cables propuesto por la presente invención. All the options previously discussed for the implantable isolating device for cordless cardiac pacemakers, as well as the combinations between them, are also applicable to the isolating device that was characterized in the cordless cardiac pacemaker proposed by the present invention.
De acuerdo a la descripción detallada previa, es posible obtener un dispositivo aislante para marcapasos cardíacos sin cables implantables y un marcapaso cardíaco sin cables con un dispositivo aislante, en donde ambos facilitarían la extracción de un marcapaso cardíaco sin cables que haya permanecido crónicamente implantado en el corazón de un paciente y que haya sido parcial o totalmente englobado por tejido de epitelización. According to the previous detailed description, it is possible to obtain an isolating device for cardiac pacemakers without implantable leads. and a cordless cardiac pacemaker with an isolating device, both of which would facilitate the removal of a cordless cardiac pacemaker that has remained chronically implanted in a patient's heart and that has been partially or totally engulfed by epithelializing tissue.
Posteriormente se describirán dos ejemplos de realización de nuestra invención. Debe entenderse que el objetivo de dichos ejemplos es facilitar la comprensión de la presente invención pero sin que dichos ejemplos limiten el alcance de la misma. Two exemplary embodiments of our invention will be described later. It should be understood that the purpose of said examples is to facilitate an understanding of the present invention but without such examples limiting the scope thereof.
Los expertos en la materia reconocerán que los aspectos de la presente invención pueden manifestarse en una variedad de formas distintas de las realizaciones específicas descritas y contempladas en el presente documento. Por consiguiente, variantes diferentes de la forma y los detalles pueden ser consideradas sin apartarse del alcance y el espíritu de la presente invención, como se describe en las reivindicaciones adjuntas. Those skilled in the art will recognize that aspects of the present invention may manifest themselves in a variety of ways other than the specific embodiments described and contemplated herein. Accordingly, different variants of the shape and the details can be considered without departing from the scope and spirit of the present invention, as described in the appended claims.
Primer ejemplo de realización del dispositivo aislante para marcapasos cardíacos sin cables (MCSC) First embodiment of the isolating device for cordless cardiac pacemakers (MCSC)
En la Figura. 2, se muestra esquemáticamente una sección longitudinal de un dispositivo aislante 1 formado por una sola pieza rodeando el alojamiento de un MCSC 2, donde dicho dispositivo aislante incluye un cuerpo tubular, en donde dicho cuerpo tubular tiene un extremo proximal 3 y un extremo distal 4, incluyendo dichos ambos extremos medios de fijación no permanentes y medios de sellado. Por tanto, dichos medios de sellado, permiten el sellado circundante hermético entre dichos extremos del cuerpo tubular y las porciones de la superficie exterior del alojamiento del MCSC adyacentes a dichos extremos; y en donde dichos medios de fijación no permanentes, permiten la fijación del dispositivo aislante al MCSC 2. El cuerpo tubular posee una pared 5 que tiene una longitud sustancialmente igual a la longitud del alojamiento del MCSC que ha sido esbozado en el interior del dispositivo aislante. Entre la superficie interna de dicha pared del cuerpo tubular y la superficie externa del alojamiento cubierto por dicha pared del cuerpo tubular se define un espacio anular 6, donde dicho espacio anular se forma debido a que el diámetro interno del cuerpo tubular es mayor que el diámetro externo del alojamiento del MCSC. La existencia de dicho espacio anular 6 permite disminuir la resistencia al desplazamiento del MCSC por el interior del dispositivo aislante durante un procedimiento médico destinado a la extracción de dicho MCSC. Debe entenderse que dicho espacio anular 6 constituye solo un ejemplo de realización y que en realizaciones diferentes podrían emplearse otros diseños o configuraciones que también faciliten el deslizamiento del MCSC por el interior del dispositivo aislante durante un procedimiento destinado a la extracción de dicho MCSC. In Figure. 2, a longitudinal section of an insulating device 1 formed in a single piece surrounding the housing of an MCSC 2 is schematically shown, where said insulating device includes a tubular body, wherein said tubular body has a proximal end 3 and a distal end 4 , said both ends including non-permanent fixing means and sealing means. Therefore, said sealing means, allow the hermetic surrounding sealing between said ends of the tubular body and portions of the outer surface of the MCSC housing adjacent to said ends; and wherein said non-permanent fixing means, allow the fixing of the insulating device to the MCSC 2. The tubular body has a wall 5 that has a length substantially equal to the length of the housing of the MCSC that has been outlined inside the insulating device . An annular space 6 is defined between the internal surface of said wall of the tubular body and the external surface of the housing covered by said wall of the tubular body, where said annular space is formed because the internal diameter of the tubular body is greater than the diameter external of the MCSC housing. The existence of said annular space 6 makes it possible to reduce the resistance to movement of the MCSC inside the insulating device during a medical procedure intended to remove said MCSC. It should be understood that said annular space 6 constitutes only an example of an embodiment and that in different embodiments other designs or configurations could be used that also facilitate the sliding of the MCSC inside the insulating device during a procedure for the extraction of said MCSC.
En referencia ahora a las Figuras 3-5, se esbozan tres etapas sucesivas de un procedimiento de extracción del MCSC. La Figura 3, muestra el alojamiento del MCSC 2 cubierto por el dispositivo aislante 1 y dicho dispositivo aislante cubierto por tejido de epitelización 9. La Figura 3, muestra además un lazo de remoción 7 que se acoplará a la porción proximal del MCSC y sobre el cual se aplicará una fuerza de tracción. La Figura. 4, muestra un MCSC parcialmente removido desde el interior del dispositivo aislante mientras se aplica una fuerza de tracción continua, a través del lazo, sobre el extremo proximal del MCSC. Debido a que los medios de fijación de los extremos del dispositivo aislante, en este ejemplo de realización, son medios de fijación no permanentes, el MCSC se ha deslizado parcialmente, en sentido proximal, por el interior del dispositivo aislante 1. La Figura. 5, muestra el MCSC desacoplado totalmente del dispositivo aislante. Debido a la presencia del dispositivo aislante 1 , la epitelización 9 no ocurrió directamente sobre la superficie externa del alojamiento del MCSC aislada por el dispositivo aislante y por esa razón, el MCSC puede ser removido con facilidad. Referring now to Figures 3-5, three successive stages of an MCSC extraction procedure are outlined. Figure 3 shows the MCSC 2 housing covered by the insulating device 1 and said insulating device covered by epithelialization tissue 9. Figure 3 also shows a removal loop 7 that will be attached to the proximal portion of the MCSC and on the which a pulling force will be applied. The figure. 4 shows an MCSC partially removed from within the isolating device while a continuous pulling force is applied, through the loop, to the proximal end of the MCSC. Due to the fact that the fixing means of the ends of the isolating device, in this embodiment, are non-permanent fixing means, the MCSC has partially slid, proximally, inside the insulating device 1. Figure. 5 shows the MCSC fully decoupled from the isolating device. Due to the presence of the isolating device 1, epithelialization 9 did not occur directly on the outer surface of the MCSC housing isolated by the isolating device and for that reason, the MCSC can be easily removed.
En este ejemplo de realización del dispositivo aislante, el MCSC puede ser removido desde el corazón pero el dispositivo aislante queda abandonado en el interior de la cavidad cardíaca adherido al tejido de epitelización circundante. In this exemplary embodiment of the isolating device, the MCSC can be removed from the heart but the isolating device is left within the heart chamber adhering to the surrounding epithelialization tissue.
Segundo ejemplo de realización del dispositivo aislante para marcapasos cardíacos sin cables (MCSC) Second embodiment of the insulating device for cordless cardiac pacemakers (MCSC)
En la Figura. 6, se muestra esquemáticamente una sección longitudinal de un dispositivo aislante formado por una sola pieza rodeando el alojamiento de un MCSC, donde dicho dispositivo aislante incluye un cuerpo tubular, en donde dicho cuerpo tubular tiene un extremo proximal 3 y un extremo distal 4, incluyendo dichos ambos extremos medios de fijación permanentes y medios de sellado. Dichos medios de sellado permiten el sellado circundante hermético entre dichos extremos del cuerpo tubular y las porciones de la superficie exterior del alojamiento del MCSC adyacentes a dichos extremos; y dichos medios de fijación permanentes permiten la sujeción irreversible de los extremos del cuerpo tubular al MCSC 2. El cuerpo tubular posee una pared 5 que tiene una longitud sustancialmente igual a la longitud del alojamiento del MCSC 2 que ha sido esbozado en el interior del dispositivo aislante. Entre la superficie interna de dicha pared del cuerpo tubular y la superficie externa del alojamiento cubierto por dicha pared del cuerpo tubular se define un espacio anular 6, donde dicho espacio anular se forma debido a que el diámetro interno del cuerpo tubular es mayor que el diámetro externo del alojamiento del MCSC. La existencia de dicho espacio anular 6 permite, al igual que en nuestro primero ejemplo de realización, disminuir la resistencia al desplazamiento del MCSC por el interior del dispositivo aislante durante un procedimiento médico destinado a la extracción de dicho MCSC. Adicionalmente, en este ejemplo de realización, la pared del cuerpo tubular se rompe en dos partes durante el procedimiento destinado a la extracción del MCSC y en estas circunstancias, la sangre que circunda al dispositivo aislante y al MCSC penetra en el interior del espacio anular 6, en donde dicha cantidad de sangre que penetra en el espacio anular servirá como lubricante durante el deslizamiento proximal del MCSC, facilitando aún más el deslizamiento del MCSC por el interior del dispositivo aislante. En referencia ahora a las Figuras 7-9, se esbozan tres etapas sucesivas de un procedimiento de extracción del MCSC. La Figura. 7 muestra el alojamiento de un MCSC cubierto por el dispositivo aislante 1 y la superficie externa de dicho dispositivo aislante cubierta por tejido de epitelización 9. La Figura 7, muestra además un lazo de remoción 7 que se acoplará a la porción proximal del MCSC 2 y sobre la cual se aplicará una fuerza de tracción. La Figura. 8, muestra un MCSC parcialmente removido desde el interior del dispositivo aislante mientras se aplica una fuerza de tracción continua a través del lazo 7, sobre el extremo proximal del MCSC. Debido a que los medios de fijación de los extremos del dispositivo aislante son medios de fijación permanentes y a que la superficie del dispositivo aislante está atrapada por el tejido de epitelización, el dispositivo aislante se divide en dos partes a través de una línea de ruptura 10 configurada cerca del extremo proximal 3 del dispositivo aislante 1. En la Figura. 8, además se aprecia, que mientras el MCSC se desplaza proximalmente por el interior del dispositivo aislante, el extremo distal del alojamiento del MCSC transmite la tracción al extremo distal del dispositivo aislante 4, ocasionando una invaginación proximal del extremo distal de dicho dispositivo aislante y el desprendimiento progresivo del disjoositivo aislante desde el tejido de epitelización circundante. In Figure. 6, a longitudinal section of an insulating device formed in a single piece surrounding the housing of an MCSC is schematically shown, where said insulating device includes a tubular body, wherein said tubular body has a proximal end 3 and a distal end 4, including said both ends permanent fixing means and sealing means. Said sealing means enables hermetic surrounding sealing between said ends of the tubular body and the portions of the outer surface of the MCSC housing adjacent to said ends; and said permanent fixing means allow the irreversible attachment of the ends of the tubular body to the MCSC 2. The tubular body has a wall 5 having a length substantially equal to the length of the MCSC housing 2 which has been outlined inside the insulating device. An annular space 6 is defined between the internal surface of said wall of the tubular body and the external surface of the housing covered by said wall of the tubular body, where said annular space is formed because the internal diameter of the tubular body is greater than the diameter external of the MCSC housing. The existence of said annular space 6 makes it possible, as in our first example of embodiment, to reduce the resistance to movement of the MCSC inside the insulating device during a medical procedure intended to remove said MCSC. Additionally, in this exemplary embodiment, the wall of the tubular body breaks into two parts during the procedure for the extraction of the MCSC and in these circumstances, the blood that surrounds the insulating device and the MCSC penetrates inside the annular space 6 , wherein said amount of blood that penetrates into the annular space will serve as a lubricant during the proximal sliding of the MCSC, further facilitating the sliding of the MCSC inside the isolating device. Referring now to Figures 7-9, three successive stages of an MCSC extraction procedure are outlined. The figure. 7 shows the housing of an MCSC covered by the insulating device 1 and the external surface of said insulating device covered by epithelialization tissue 9. Figure 7 also shows a removal loop 7 that will be coupled to the proximal portion of the MCSC 2 and on which a traction force will be applied. The figure. 8 shows an MCSC partially removed from within the isolating device while a continuous pulling force is applied through loop 7, on the proximal end of the MCSC. Because the means of fixing the ends of the device Insulator are permanent means of fixation since the surface of the insulating device is trapped by the epithelialization tissue, the insulating device is divided into two parts through a tear line 10 configured near the proximal end 3 of the insulating device 1. In the Figure. 8, it can also be seen that while the MCSC moves proximally inside the insulating device, the distal end of the MCSC housing transmits the traction to the distal end of the insulating device 4, causing a proximal invagination of the distal end of said insulating device and the progressive detachment of the insulating disjoositivo from the surrounding epithelialization tissue.
La Figura. 9, muestra al MCSC y al dispositivo aislante desacoplados totalmente de la pared cardíaca y del tejido de epitelización 9. La invaginación del extremo distal del dispositivo aislante facilita el desprendimiento de dicho dispositivo aislante debido a que la tracción ejercida sobre el MCSC se transmite solamente a aquellas porciones anulares í 1 del dispositivo aislante que progresivamente se van despegando del tejido de epitelización e invaginándose hacia el interior del espacio liberado por el MCSC. The figure. 9 shows the MCSC and the isolating device completely decoupled from the cardiac wall and epithelialization tissue 9. The invagination of the distal end of the isolating device facilitates the detachment of said isolating device because the traction exerted on the MCSC is transmitted only to those annular portions 1 of the isolating device that progressively detach from the epithelialization tissue and invaginate into the space released by the MCSC.

Claims

REIVINDICACIONES
1 . Dispositivo aislante implantable para marcapaso cardíaco sin cables (MCSC) implantable, dicho MCSC que incluye al menos dos electrodos y un alojamiento generalmente cilindrico, en donde dicho dispositivo aislante incluye un cuerpo tubular en el cual se define un eje longitudinal, en donde dicho cuerpo tubular comprende: un espacio interior o lumen que permite la inserción de al menos una porción del alojamiento de un MCSC; un extremo proximal y un extremo distal, en donde dichos ambos extremos poseen medios de fijación configurados para permitir la fijación del dispositivo aislante a la superficie externa del alojamiento de dicho MCSC, en donde dicho extremo proximal y dicho extremo distal del cuerpo tubular además poseen medios de sellado configurados para permitir un sellado circundante hermético entre dichos ambos extremos del cuerpo tubular y las porciones adyacentes de la superficie externa del alojamiento de dicho MCSC, dichos medios de sellados que impiden que las sustancias y tejidos biológicos presentes en el interior del cuerpo de un usuario de MCSC acoplado a dicho dispositivo aislante, atraviesen dichos medios de sellado; y una pared que se extiende entre dicho extremo proximal y dicho extremo distal del cuerpo tubular, en donde dicha pared incluye al menos una capa formada por un material aislante, dicho material aislante que impide que las sustancias y tejidos biológicos presentes en el interior del cuerpo de un usuario de MCSC acoplado a dicho dispositivo aislante, atraviesen dicha capa. one . Implantable isolating device for implantable leadless cardiac pacemaker (MCSC), said MCSC including at least two electrodes and a generally cylindrical housing, wherein said isolating device includes a tubular body in which a longitudinal axis is defined, wherein said tubular body It comprises: an interior space or lumen that allows the insertion of at least a portion of the housing of an MCSC; a proximal end and a distal end, wherein said both ends have fixing means configured to allow the fixing of the insulating device to the external surface of the housing of said MCSC, wherein said proximal end and said distal end of the tubular body also have means sealing devices configured to allow a hermetic surrounding seal between said both ends of the tubular body and the adjacent portions of the external surface of the housing of said MCSC, said sealing means that prevent biological substances and tissues present inside the body of a MCSC user coupled to said isolating device, pass through said sealing means; and a wall extending between said proximal end and said distal end of the tubular body, wherein said wall includes at least one layer formed by an insulating material, said insulating material that prevents biological substances and tissues present inside the body of an MCSC user coupled to said insulating device, from passing through said layer.
2. El dispositivo aislante implantable de la reivindicación 1 , en donde dicho cuerpo tubular esta además configurado con uno o más elementos conductores de corriente eléctrica. The implantable isolating device of claim 1, wherein said tubular body is further configured with one or more electrical current conducting elements.
3. El dispositivo aislante implantable de la reivindicación 2, en donde los elementos conductores de corriente eléctrica están configurados para permitir la comunicación eléctrica entre los electrodos del MCSC. The implantable isolating device of claim 2, wherein the electrical current conducting elements are configured to allow electrical communication between the electrodes of the MCSC.
4. El dispositivo aislante implantable de la reivindicación 3, en donde los elementos conductores de corriente eléctrica están formados por un material altamente conductor de corriente eléctrica. The implantable isolating device of claim 3, wherein the electrically conductive elements are formed of a highly electrically conductive material.
5. El dispositivo aislante implantable de la reivindicación 4, en donde el material altamente conductor es un material metálico. The implantable isolating device of claim 4, wherein the highly conductive material is a metallic material.
6. El dispositivo aislante implantable de la reivindicación 4, en donde el material altamente conductor es un material no metálico. 6. The implantable isolating device of claim 4, wherein the highly conductive material is a non-metallic material.
7. El dispositivo aislante implantable de la reivindicación 1 , en donde la pared del cuerpo tubular está formada además por uno o más materiales flexibles los cuales le confieren un grado de flexibilidad a dicha pared. The implantable isolating device of claim 1, wherein the wall of the tubular body is further formed by one or more flexible materials which give a degree of flexibility to said wall.
8. El dispositivo aislante implantable de la reivindicación 7, en donde la flexibilidad de la pared del cuerpo tubular le permite a dicha pared, soportar una variedad de deformaciones y flexiones de hasta 180 grados sin romperse o fragmentarse en dos o más partes. 8. The implantable isolating device of claim 7, wherein the flexibility of the wall of the tubular body allows said wall to withstand a variety of deformations and bends of up to 180 degrees without breaking or fragmenting into two or more parts.
9. El dispositivo aislante implantable de la reivindicación 1 , en donde la pared del cuerpo tubular está formada además por uno o más materiales resistentes a la tracción, los cuales le confieren un grado de resistencia a la tracción a dicha pared. The implantable isolating device of claim 1, wherein the wall of the tubular body is further formed of one or more tensile resistant materials, which confer a degree of tensile strength to said wall.
10. El dispositivo aislante implantable de la reivindicación 9, en donde la resistencia a la tracción que posee la pared es suficiente para soportar las tracciones producidas durante un procedimiento médico destinado a la extracción de un MCSC sin que dicha pared se rompa en dos o más partes. The implantable isolating device of claim 9, wherein the tensile strength of the wall is sufficient to withstand the tractions produced during a medical procedure for the removal of an MCSC without said wall breaking in two or more parts.
11. El dispositivo aislante implantable de la reivindicación 1 , en donde la pared del cuerpo tubular además posee una región de debilitamiento, en donde dicha región de debilitamiento sigue el trayecto de una línea cerrada alrededor del eje longitudinal de dicho cuerpo tubular. The implantable isolating device of claim 1, wherein the wall of the tubular body further possesses a region of weakness, wherein said region of weakness follows the path of a closed line around the longitudinal axis of said tubular body.
12. El dispositivo aislante implantable de la reivindicación 1 1 , en donde la región de debilitamiento consiste en una región anular de la pared del cuerpo tubular que tiene un grosor significativamente menor que el grosor que tiene dicha pared en cualquier otra región. 12. The implantable isolating device of claim 11, wherein the region of weakness consists of an annular region of the wall of the tubular body having a thickness significantly less than the thickness of that wall in any other region.
13. El dispositivo aislante implantable de la reivindicación 11 , en donde la región de debilitamiento de dicha pared está formada por uno o más materiales con baja resistencia a la tracción, para que dicha región de la pared se rompa fácilmente al ser sometida a una fuerza de tracción. The implantable isolating device of claim 11, wherein the weakening region of said wall is formed of one or more materials with low tensile strength, so that said region of the wall breaks easily when subjected to a force. traction.
14. Un marcapaso cardíaco sin cables (MCSC) implantable que incluye al menos dos electrodos, un alojamiento generalmente cilindrico en el cual se define un eje longitudinal y un dispositivo aislante; en donde dicho dispositivo aislante incluye un cuerpo tubular, dicho cuerpo tubular que se dispone sobre y rodeando al menos una porción de la superficie de revolución externa del alojamiento de dicho MCSC, en donde dicho cuerpo tubular comprende: 14. An implantable cordless cardiac pacemaker (MCSC) that includes at least two electrodes, a generally cylindrical housing in which a longitudinal axis is defined, and an isolating device; wherein said insulating device includes a tubular body, said tubular body that is arranged over and surrounding at least a portion of the external surface of revolution of the housing of said MCSC, wherein said tubular body comprises:
un extremo proximal y un extremo distal, en donde dichos ambos extremos tienen medios de fijación configurados para permitir la fijación del dispositivo aislante a la superficie del alojamiento del MCSC, en donde dichos extremos proximal y distal del cuerpo tubular tienen además medios de sellado configurados para permitir un sellado circunferencial hermético entre dichos extremos del cuerpo tubular y las porciones de la superficie externa del alojamiento del MCSC adyacentes a dichos extremos, dichos medios de sellados que impiden que las sustancias y tejidos biológicos presentes en el interior del cuerpo de un usuario de dicho MCSC atraviesen dichos medios de sellado; y a proximal end and a distal end, wherein said both ends have attachment means configured to allow attachment of the isolating device to the surface of the MCSC housing, wherein said proximal and distal ends of the tubular body further have sealing means configured to allow a hermetic circumferential seal between said ends of the tubular body and the portions of the external surface of the MCSC housing adjacent to said ends, said sealing means preventing biological substances and tissues present in the interior of the body of a user of said MCSC traverses said sealing means; Y
una pared que se extiende entre dicho extremo proximal y dicho extremo distal del cuerpo tubular, en donde dicha pared incluye al menos una capa formada por un material aislante, dicho material aislante que impide que las sustancias y tejidos biológicos presentes en el interior del cuerpo de un usuario de dicho MCSC atraviesen dicha capa. a wall that extends between said proximal end and said distal end of the tubular body, wherein said wall includes at least one layer formed by an insulating material, said insulating material that prevents biological substances and tissues present inside the body of a user of said MCSC traverses said layer.
PCT/CL2019/000014 2019-04-10 2019-04-10 Implantable insulating device for leadless cardiac pacemakers and implantable leadless cardiac pacemaker including said insulating device WO2020206562A1 (en)

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