WO2008110005A1 - Dispositif cardiaque implantable - Google Patents

Dispositif cardiaque implantable Download PDF

Info

Publication number
WO2008110005A1
WO2008110005A1 PCT/CA2008/000484 CA2008000484W WO2008110005A1 WO 2008110005 A1 WO2008110005 A1 WO 2008110005A1 CA 2008000484 W CA2008000484 W CA 2008000484W WO 2008110005 A1 WO2008110005 A1 WO 2008110005A1
Authority
WO
WIPO (PCT)
Prior art keywords
cardiac device
implantable cardiac
housing
lead
header portion
Prior art date
Application number
PCT/CA2008/000484
Other languages
English (en)
Inventor
Klaus Witte
Robert A. Wald
John Parker
Original Assignee
Klaus Witte
Wald Robert A
John Parker
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Klaus Witte, Wald Robert A, John Parker filed Critical Klaus Witte
Publication of WO2008110005A1 publication Critical patent/WO2008110005A1/fr

Links

Classifications

    • 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
    • A61N1/3752—Details of casing-lead connections
    • 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
    • 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
    • A61N1/37512—Pacemakers

Definitions

  • the invention relates generally to implantable cardiac devices, and more particularly, to a housing for use in implantable cardiac devices.
  • the device In implantable cardiac devices such as cardiac pacemakers, cardiac defibrillators and heart- assist devices, the device usually includes a hermetically sealed metallic container joined to an external plastic header. Cardiac devices typically send electrical energy to the heart using thin, coated wires called leads. These leads are positioned inside or on the surface of the heart. The leads travelling to the heart are then connected via the header to the electronic pulse generation system of the cardiac device (also referred to as the circuitry) and battery.
  • the electronic pulse generation system of the cardiac device also referred to as the circuitry
  • U.S. Design Patent No. 338,731 shows a design of an implantable medical device which has a generally circular main housing and extending from the top of the housing, is a connector portion which has sharp edges.
  • Another type of implantable cardiac simulation system is shown in U.S. Patent No. 5,713,926.
  • the pulse generator housing for enclosing and containing the pulse generator defibrillation circuitry is generally of a rectangular box shape having rounded corners.
  • the connector portion which facilitates the delivery of the defibrillation energy to the heart is also of a rectangular shape such that the housing has protruding surfaces and varying contours when seen from each angle.
  • a cardiac pacemaker having top and bottom surface portions of generally circular configuration which meet through peripheral surface portions of convex outwardly curved shape.
  • this cardiac pacemaker there is a single electrode having a helically shaped portion which extends from the top surface to contact the neighbouring body tissue of the patient.
  • erosion may be caused by the single electrode extending from the top of the pacemaker to the body tissue.
  • this design only allows for a single electrode to be connected into the heart tissue.
  • a heart pacer or pacemaker is provided having a generally domical configuration with its casing having a flat, planar bottom.
  • the heart pacer also includes a catheter storage means such as a plurality of grooves for receiving a length of catheter.
  • the grooves are configured such that the catheter can be pulled to a number of different positions.
  • a large number of patients who receive pacemakers or defibrillators require two or more leads implanted therefrom such that each lead is coupled to a different portion of the patient's heart.
  • Pocket erosion if it occurs, usually leads to the extraction of the entire system. This procedure is of some risk and can require cardiac surgery.
  • the re-implant procedure usually in the contralateral shoulder exposes the patient to further risk.
  • the invention provides an implantable cardiac device comprising: a housing having a top surface and an opposed bottom surface, the housing configured to receive at least one of a power source, and a pulse generator, a portion of the top surface being configured to receive at least one lead, such that said at least one lead when received within the top surface cooperates with the top surface to form a substantially dome-shaped upper surface of the cardiac device that is substantially smooth and continuous.
  • the housing additionally comprises a cavity defined by the top surface and the housing further comprises a header portion configured to receive said at least one lead and is sized to be placed within at least a portion of the cavity.
  • the upper surface of the header portion conforms to the curvature of the curved top surface.
  • an implantable cardiac device kit comprising: at least one cardiac device lead; a housing having a substantially curved top surface and an opposed bottom surface, the housing having a cavity formed in the top surface.
  • a header portion is configured to be received in a portion of the cavity, the header portion is configured to receive said at least one lead.
  • a power source and a pulse generator are configured to be received within the housing and operable to be electrically coupled to the header portion.
  • the at least one lead extends into a remaining portion of the cavity when received within the header and cooperates with the curved top surface to form a substantially dome-shaped upper surface of the cardiac device that is substantially smooth and continuous.
  • an implantable cardiac device comprising: a housing having a top surface including a cavity therein and an opposed bottom surface.
  • the housing further comprises a header portion located adjacent to cavity, the header portion is configured to receive at least one lead.
  • a power source is received within the housing and a pulse generator is received within the housing and is configured for transmitting and receiving signals to and from a patient when the cardiac device is implanted in the patient.
  • the at least one lead when received within the header portion extends into the cavity and cooperates with the top surface to form a substantially dome-shaped upper surface of the cardiac device that is substantially smooth and continuous.
  • Fig. IA is a plan view of an implantable cardiac device, such as a pacemaker, according to one embodiment
  • Fig. IB is a side perspective view of the cardiac device of Fig. IA;
  • Fig. 1C is an alternative side perspective view of the cardiac device of Fig. IA;
  • Fig. ID is a side perspective view of the cardiac device of Fig. IA according to an alternative embodiment.
  • Fig. IE is a side perspective view of the cardiac device of Fig. IA according to an alternative embodiment.
  • Fig. IF is a cross-section of the cardiac device of Fig. IE.
  • the implantable cardiac device 10 may form a cardiac pacemaker or a cardiac defibrillator.
  • the cardiac device 10 includes a can or housing 20 having a substantially curved top surface 32 and an opposed bottom surface 34. It is noted that a person skilled in the art will understand that sometimes the term "can” is used in the art to describe a housing. Further the term housing will be used throughout the description but it will be understood that these terms are interchangeable.
  • the housing 20 is hermetically sealed.
  • the housing 20 includes a power source and a pulse generator (not shown). It will be understood by a person skilled in the art that any type of pulse generator and power source as is known in the field of implantable cardiac devices may be used. It will further be understood that the selected pulse generator and power source are sized to be received within the housing 20.
  • the cardiac device 10 comprises a header portion 24 adapted for receiving one or more leads.
  • the header portion 24 is integral with the housing 20 thereby forming a unitary construction therewith (as illustrated in Fig. 1C).
  • the header portion 24 is a separate component that is adapted to be received in at least a portion of a cavity defined by the housing 20 and is operable to connect to the housing 20 (as illustrated in Fig. ID).
  • the header portion 24 may be molded from a suitable medical grade plastic such as tecothane or other suitable material as will be understood by a person skilled in the art. Referring to Fig.
  • the housing 20 includes an integral header portion 24 located adjacent a cavity that is formed in the housing 20.
  • the cavity is formed in the curved top surface 32 and defined by a first exterior wall 36 and a second orthogonal exterior wall 38.
  • the first exterior wall 36 extends from the top surface 32 towards the bottom surface 34.
  • the second orthogonal exterior wall 38 meets the first exterior wall 36 at one end and extends at the other end along the general axis defined by the bottom surface 34 to meet the periphery of the top surface 32.
  • the cavity forms a cut-out within the curved top surface 32.
  • substantially curved top surface 32 discussed herein can refer to a generally curvilinear surface having one or more curved surfaces intersected by the cavity defined by the first exterior wall 36 and second exterior wall 38, on the curved top surface 32.
  • the top surface 32 and the bottom surface 34 may be formed of an epoxy or a metal such as titanium, or a combination thereof. It will also be understood that the cardiac device 10 is for use within the human body and the materials used for the cardiac device 10 must be compatible with the requirements of the human body.
  • the header portion 24 in the embodiment in which the header portion 24 is integral with and located in the housing 20, positioned adjacent the cavity the header portion 24 includes one or more apertures 26, each adapted for receiving a lead (not shown).
  • the one or more leads are typically thin, coated wires which are positioned inside or on the surface of the heart for sending electrical energy from the cardiac device 10 to the heart.
  • a proximal end of each lead is connected to the header portion 24 and received in one of the apertures 26 while the other distal end is implanted into one of the chambers of the heart.
  • the header portion 24 defines at least a portion of the first exterior wall 36, such that the apertures 26 located in the header portion 24 perforate the first exterior wall 36.
  • each of the leads is preferably a flexible insulated wire with a semi- rigid electrode tip portion at its proximal end.
  • the electrode tip for each of the leads is frictionally received in one of the apertures 26 and extends away from the first exterior wall 36 along the general axis defined by the second exterior wall 38.
  • the leads may be secured to the header portion 24 using screws inserted through screw openings 40 in the top surface 32, as illustrated in Fig. IA.
  • the screws extend into the openings 40 and clamp down the leads located in the header portion 24 such as to maintain electrical connectivity between the leads and the circuitry within the housing 20.
  • the screw openings 40 may include a rubber seal which allows a screwdriver to access the screws but seals the header portion 24 after removing the screwdriver.
  • An example of a horizontal cross-sectional view of the screw openings 40 for the cardiac device is illustrated in Fig. IF.
  • the curvature of each of the leads increases as it extends away from the first exterior wall 36 such that the leads bend towards the second exterior wall 38 as illustrated in Fig. ID.
  • the curvature of the leads combined with the curved top surface 32 cooperate to form a dome- shaped upper surface 22 of the cardiac device 10.
  • the cardiac device 10 when seen from above has a continuous and substantially smooth dome-shaped upper surface 22 formed by the top surface 32 of the housing 20 and the curvature of the one or more leads which fill the cavity portion.
  • the proximal end of each of the leads may be clamped down or otherwise secured with a fastening means to the second exterior wall 38 for maintaining the dome-shaped upper surface 22 and prevent any shifting of the proximal end of the leads outside the cavity portion.
  • the fastening means may include, but are not limited to, for example a screw, or other suitable bonding means as understood by a person skilled in the art.
  • the cavity defined by the first exterior wall 36 and the second exterior wall 38 is placed such that the cavity allows the one or more leads to extend along the outer peripheral edge of the top surface 32 towards the bottom surface 34.
  • the cavity is not isolated within the centre of the housing 20, rather the bottom surface 38 of the cavity is formed such that it extends to the peripheral edge of the top surface 32 and allows the one or more leads to form a domical upper surface 22 with the remaining curved portion of the top surface 32.
  • a pacemaker implanted in a patient may have two leads extruding therefrom such that one lead is connected to the right atrium of the heart and the other lead is connected to the right ventricle of the heart. Since each type of cardiac surgery may require a different number of leads, the number of apertures 26 and the spacing between them is designed to facilitate the different types of surgeries such that when the leads are placed within the apertures 26, the dome shape of the upper surface 22 is maintained.
  • the leads which are located closer to the second exterior wall 38 are received within apertures 26 having smaller depths than the leads which are vertically farther from the second exterior wall 38.
  • varying depths of apertures 26 may be envisaged as per the requirements by the surgeon/ cardiac device 10 manufacturer.
  • the apertures 26 may be identically sized and configured to receive the one or more leads.
  • the header portion 24 may be a part of the housing 20 and provided as a unitary construction with the housing 20.
  • the header portion 24 is a separate component that is received in the housing 20 and more specifically, within a portion of the cavity formed within the top surface 32 and is connected to the housing 20. The remaining portion of the cavity is then filled with the one or more leads which are received in the apertures 26 of the header portion 24 as described above.
  • the cavity is preferably sized larger than in the embodiment described above, to accommodate the header portion 24 as compared to when the header portion 24 is a unitary construction within the housing 20.
  • the header portion 24 is preferably shaped such that when it is received within said cavity, it conforms to the shape of the curved top surface 32 and maintains the curvature of the top surface 32, as clearly seen in Figure ID.
  • the one or more leads may be received within the apertures 26 of the header portion 24 and extend into the remaining portion of the cavity in such a way as to continue the curvature of the top surface 32 and form a substantially dome- shaped upper surface 22 of the cardiac device 10.
  • the upper surface 22 is a substantially smooth and continuous surface.
  • the header portion 24 may be fitted within the cavity in a number of ways.
  • the header portion 24 may include protruding members along one or more of its interior sides which are sized for fi ⁇ ctional engagement with channels formed on the first exterior wall 36 and the second exterior wall 38 that define the cavity.
  • Other means of placing the header portion 24 within the cavity of the top surface 32 will occur to those skilled in the art such that the header portion 24 is secured in place and connected to with the housing 20.
  • the header portion 24 may be sized differently to accommodate the number of leads such that the dome-shaped upper surface 22 is maintained. For example, if there are fewer leads that need to be placed, then the header portion 24 may be sized larger such that it covers a larger portion of the cavity. Further, the header portion 24 may cover portions of the first external surface 36 and the second external surface 38 in order to compensate for a smaller number of leads and to maintain the general domical structure of the upper surface 22. Further, although the header portion 24 has been illustrated in one shape it will be understood by a person skilled in the art that the header portion 24 is not limited to the illustrated shape and other shapes may be envisaged to meet the criteria of the present invention.
  • the header portion 24 described herein further comprises a connector or connector interface 42 shown in Fig. ID configured to provide electrical coupling and placed adjacent to the apertures 26 such that said at least one lead when received within the apertures 26 are electrically coupled to the pulse generator.
  • the connector may include one or more electrical contact members which electrically couple said at least one lead to the pulse generator and the power source for transmission of signals through said at least one lead to/from the heart of the patient.
  • Other types of suitable connectors may be used as will be understood by a person skilled in the art.
  • the connector is a unitary construction with the header portion 24 and in an alternate embodiment, the connector is a separate part from the header portion 24.
  • the header portion 24 may include connectors and corresponding circuitry such that during manufacture, the connectors can be attached to corresponding pins protruding from the sealed housing 20.
  • the pins serve to form an electrical connection between the housing 20 and the header portion 24.
  • the curved top surface 32 extends to and meets the bottom surface 34 in such a way that the housing 20 when seen from each side has curved sides.
  • each of the top surface 32, the bottom surface 34 and their joining surfaces are substantially smooth and continuous.
  • the bottom surface 34 is a substantially flat, and planar surface that is circular in shape such that the implantable cardiac device 10 is substantially smooth and without sharp edges (Fig. IE).
  • the bottom surface 34 sits on the chest wall of a patient when implanted therein. It is noted that Fig. IE further illustrates a cardiac device 10 having a three- port arrangement that may be used in, for example, a cardiac pacemaker.
  • the bottom surface 34 is contoured to conform to the chest wall of a patient when implanted therein.
  • the top surface 32 and the bottom surface 34 may be curved to deflect in a similar manner.
  • the top surface 32 is convex shaped and the bottom surface 34 is concave.
  • the bottom surface 34 may have a flat surface with a recess formed therein (i.e. a slight concavity on the bottom surface 34) to allow space for the chest wall.
  • the cardiac device 10 is placed in a pocket just under the skin tissue in the upper chest area near the collarbone and the bottom surface 34 rests firmly on the chest wall.
  • the bottom surface 34 extends away from the chest wall at its perimeter.
  • the shape of the bottom surface 34 allows the cardiac device 10 to adhere to the shape of the chest wall without tilting, rotating or shifting along the contacting tissue of the chest wall.
  • the dome-shaped upper surface 22 which is formed of the curved top surface 32 and the one or more leads, adheres closely to the skin tissue at its center and extends away from the skin tissue at its perimeter, thereby minimizing the pressure on the skin tissue and reducing the chance of erosion.
  • the top surface 32 is indented or notched such that the leads are received within the top surface 32 and extend into the space defined by the indentation, hi this case the top surface 32 includes a substantially curved portion which is intersected by the indentation or notch.
  • the cut-out or space formed by the notch or indentation may represent the cavity described above.
  • one the one or more leads may be received within the top surface 32, and the leads cooperate with the top surface 32 to form the substantially dome-shaped upper surface 22 of the cardiac device 10.
  • indentation or notches may be envisaged such as to achieve the overall dome-shaped upper surface 22 as formed by the leads in the top surface 32 cooperating with an upper boundary of the curved portion of the top surface 32.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un dispositif cardiaque implantable tel qu'un stimulateur cardiaque, qui comprend une source d'alimentation, un générateur d'impulsion et un corps, ce dernier comportant une surface supérieure incurvée et une surface inférieure opposée et servant à contenir la source d'alimentation et le générateur d'impulsion. Le corps permet de recevoir au moins un conducteur conçu pour relier, à l'utilisation, ledit corps au coeur d'un patient et transmettre au cœur une impulsion produite par le générateur d'impulsion. Le(s) conducteur(s), une fois installé(s) dans ledit corps, se déploient dans la cavité et coopère(nt) avec la surface supérieure incurvée du corps pour former une surface supérieure du dispositif cardiaque qui est sensiblement en forme de dôme et sensiblement lisse et continue.
PCT/CA2008/000484 2007-03-14 2008-03-12 Dispositif cardiaque implantable WO2008110005A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US90683207P 2007-03-14 2007-03-14
US60/906,832 2007-03-14

Publications (1)

Publication Number Publication Date
WO2008110005A1 true WO2008110005A1 (fr) 2008-09-18

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ID=39758957

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2008/000484 WO2008110005A1 (fr) 2007-03-14 2008-03-12 Dispositif cardiaque implantable

Country Status (1)

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WO (1) WO2008110005A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6212063B1 (en) * 1998-04-03 2001-04-03 Medtronic, Inc. Implantable medical device having flat electrolytic capacitor with connector block and sealed feedthroughs
US20070049975A1 (en) * 2005-09-01 2007-03-01 Cates Adam W Active can with dedicated defibrillation and sensing electrodes

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6212063B1 (en) * 1998-04-03 2001-04-03 Medtronic, Inc. Implantable medical device having flat electrolytic capacitor with connector block and sealed feedthroughs
US20070049975A1 (en) * 2005-09-01 2007-03-01 Cates Adam W Active can with dedicated defibrillation and sensing electrodes

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