WO2006115281A1 - Câblage pour stimulateurs cardiaques - Google Patents

Câblage pour stimulateurs cardiaques Download PDF

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Publication number
WO2006115281A1
WO2006115281A1 PCT/JP2006/308793 JP2006308793W WO2006115281A1 WO 2006115281 A1 WO2006115281 A1 WO 2006115281A1 JP 2006308793 W JP2006308793 W JP 2006308793W WO 2006115281 A1 WO2006115281 A1 WO 2006115281A1
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WO
WIPO (PCT)
Prior art keywords
adhesive layer
wire
patch
electrode
heart
Prior art date
Application number
PCT/JP2006/308793
Other languages
English (en)
Japanese (ja)
Inventor
Yukako Fukuhira
Eiichi Kitazono
Hiroaki Kaneko
Yoshihiko Sumi
Yuji Narita
Hideaki Kagami
Yuichi Ueda
Minoru Ueda
Original Assignee
Teijin Limited
National University Corporation Nagoya University
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 Teijin Limited, National University Corporation Nagoya University filed Critical Teijin Limited
Priority to JP2007514788A priority Critical patent/JP4889043B2/ja
Publication of WO2006115281A1 publication Critical patent/WO2006115281A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Definitions

  • the present invention relates to a temporary cardiac pacemaker wire. More specifically, the present invention relates to a heart pacemaker wire that can fix an electrode to heart tissue without sewing the electrode to heart tissue.
  • Implanting temporary pacemaker myocardial electrodes and leads after cardiac surgery is routinely performed as an effective means of diagnosing and treating arrhythmia during and after surgery, and to cope with unforeseen circumstances. ing.
  • the electrode is fixed by applying a sewing thread directly to the myocardium with a needle.
  • This temporary pacemaker myocardial electrode needs to be pulled out of the body after surgery after the patient's condition has stabilized.
  • the electrode is sewn to the myocardium with a coiled wire, it is rare, but when it is removed, the heart and blood vessels are damaged by the coil and the myocardium is cleaved by the suture thread. May cause fatal complications.
  • An object of the present invention is to provide a “wire for cardiac pacemaker” (hereinafter sometimes abbreviated as “wire”) capable of fixing an electrode to the surface of the heart without being sewn to the myocardium. It is an object of the present invention to provide a wire having good adhesion to the surface of the heart without adversely affecting the living body, and the present invention can be extracted without causing damage to the heart, blood vessels, etc. In addition, an object of the present invention is to provide a patch and a film used for the wire, and to provide a wire for a cardiac pacemaker. Another object of the present invention is to provide a heart basing method using a cardiac pacemaker wire.
  • the inventors found that a film mainly composed of a biodegradable polymer and having an uneven portion on one surface has good adhesion to the heart surface due to the action of the uneven portion, and completed the present invention. It was found that the biodegradable polymer was decomposed after a predetermined period of time after adhering to the heart surface, and the present invention was completed by finding that the electrode could be easily removed from the heart surface without damaging the tissue.
  • the present invention is a cardiac pacemaker wire comprising a patch having an adhesive layer and a lead having an electrode at its end,
  • the adhesive layer is a film mainly composed of a biodegradable polymer.
  • One surface is the adhesive surface (eight surfaces), and the A surface is concave and convex at a rate of 1 to 100% of the total surface area.
  • the electrode is a wire exposed on the A side of the adhesive layer.
  • the present invention is a patch for adhering an electrode to the surface of a heart, and has an adhesive layer, and the adhesive layer is a film mainly composed of a biodegradable polymer, and one surface has an adhesive surface (eight surfaces). And the A surface is a patch having uneven portions at a ratio of 1 to 100% of the total surface area.
  • the present invention is a film mainly composed of a biodegradable polymer, wherein at least one surface has an uneven structure in which pores having a pore diameter of 0.1 to 20 are arranged in a honeycomb shape for fixing an electrode to a heart surface It is a film.
  • the patch is applied to the heart surface with the side A of the adhesive layer facing the heart. And a method of installing the wire for the heart base maker.
  • the present invention also includes a method for pacing the heart using the above-mentioned cardiac pacemaker wire.
  • FIG. 1 is a schematic external view of an example of the wire of the present invention.
  • FIG. 2 is a schematic cross-sectional view of an example of the wire of the present invention.
  • FIG. 3 is a schematic cross-sectional view of an example of a wire according to the present invention.
  • FIG. 4 is a schematic cross-sectional view of an example of the wire of the present invention.
  • FIG. 5 is a schematic cross-sectional view of an example of a wire according to the present invention.
  • FIG. 6 is a schematic cross-sectional view of an example of the wire of the present invention.
  • FIG. 7 is a photomicrograph of the concavo-convex portion of the adhesive layer produced in Example 1.
  • FIG. 8 is a micrograph of the uneven portion of the adhesive layer produced in Example 3.
  • Fig. 9 is a schematic diagram showing an 82-cam configuration.
  • FIG. 10 is a schematic diagram showing an 82-cam configuration.
  • FIG. 11 is a photomicrograph of the uneven part of the adhesive layer produced in Example 4.
  • FIG. 12 is a photomicrograph of the concavo-convex portion of the adhesive layer produced in Example 5.
  • the patch of the present invention is a patch for adhering an electrode to the heart surface, and has an adhesive layer, and the adhesive layer is a film mainly composed of a biodegradable polymer. Eight sides)
  • the A side is a patch having irregularities at a ratio of 1 to 100% of the total surface area.
  • Preferred embodiments of the patch include an embodiment having only an adhesive layer, an embodiment having an adhesive layer and a cover layer, and an embodiment having an adhesive layer, a holding layer and a cover layer.
  • the average total thickness of the patch is preferably 10 to 300 m, more preferably 10 to 200 m.
  • the adhesive layer is a film mainly composed of a biodegradable polymer.
  • the film preferably contains 80 to 100% by weight, more preferably 90 to 100% by weight of biodegradable polymer as a polymer component.
  • biodegradable polymers include aliphatic polyesters and aliphatic polycarbonates.
  • the aliphatic polyester include polylactic acid, lactic acid-glycolic acid copolymer, polyhydroxybutyric acid, poly strength prolactone, lactic acid-force prolactone copolymer, polyethylene adipate, and polybutylene adipate.
  • the aliphatic polycarbonate include polybutylene carbonate, polyethylene carbonate and the like. Moreover, these copolymers and a mixture may be sufficient. Of these, polylactic acid, lactic acid-glycolic acid copolymer, polystrength prolactone, and lactic acid-strength prolactone copolymer are preferable.
  • the copolymerization molar ratio (lactic acid glycolic acid) is preferably 1Z99 to 99Z1, more preferably 10Z90 to 90/10, and even more preferably 25 75 to 7525.
  • the copolymerization molar ratio (lactic acid Z force prolactone) is preferably 1Z99 to 99/1, more preferably 5/95 to 95Z5, and even more preferably 10 Z90 to 90 10 is there.
  • the film may contain a polymer other than the biodegradable polymer as a polymer component.
  • Other polymers include, for example, polystyrene, polyvinyl alcohol, poly (ethylene-covinyl acetate), poly (hydroxyethyl methacrylate). Rate), vinyl-based polymers and copolymers thereof, poly (carbonates), poly (urethanes), condensation polymers such as nylon, and biocompatible polymers such as these copolymers.
  • the film is preferably composed of 0 to 20% by weight, more preferably 0 to 10% by weight of biocompatible polymer.
  • the film may contain a phospholipid.
  • phospholipids those extracted from animal tissues or artificially synthesized can be used without regard to their origin.
  • the phospholipid is preferably at least one selected from the group consisting of phosphatidylethanolamine, phosphatidylcholine, phosphatidylserine, phosphatidylglycerol and derivatives thereof. More preferred are phosphatidylethanolamines, and more preferred is L- ⁇ -phosphatidylethanolamine monooleoyl.
  • the adhesive layer is preferably 0.1 to 100 parts by weight, more preferably 0.2 to 10 parts by weight, and still more preferably 0.5 to 2 parts by weight with respect to 100 parts by weight of the biodegradable polymer. It is preferred to contain an amount of phospholipid. Further, the film may contain other components such as a softening agent, an adhesion improver, and a drug as long as the object of the present invention is not impaired.
  • the adhesive layer has one surface as the adhesive surface (eight surfaces) and the other surface as the B surface.
  • the A surface has irregularities at a ratio of 1 to 100% with respect to the total surface area.
  • the proportion of the concavo-convex portion is preferably 10 to 100%, more preferably 20 to 100% with respect to the total surface area of the A surface. It is preferable that the peripheral part of A surface has an uneven part.
  • the concavo-convex portion preferably has pores having a pore diameter of 0.1 to 20 m, more preferably 0.5 to 18 m, and still more preferably 1 to 15. The pores are preferably arranged uniformly.
  • a pore diameter means the diameter of the pore in the uneven
  • the pores are preferably arranged in a honeycomb shape.
  • the double cam-like arrangement means a structure in which regular hexagons are arranged adjacent to each other as shown in FIG. Therefore, the positional relationship between the pores of the concavo-convex portion corresponds to the positional relationship between regular hexagons shown in FIG. Therefore, six pores are arranged around one pore.
  • FIG. 10 shows a state in which circular pores are arranged in a honeycomb shape.
  • the pores are substantial Are preferably the same shape. Therefore, it is preferable that the plurality of pores have substantially the same shape, and six pores are arranged around one pore.
  • the shape of the pores is not limited but is preferably circular. If the radius of the pore is r and the distance between the centers of adjacent pores is a, then r and a are preferably expressed as 1 ⁇ a Z 2 r ⁇ 2.
  • the depth of the pores is preferably 0.1 to 20 m, more preferably 0.5 to 18 m, and still more preferably 1 to 15 m.
  • the concavo-convex portion may be formed of a projection such as a cilia shape, a columnar shape, a prismatic shape, or a flat plate shape.
  • the ratio (HZD) of the height (H) of the protrusion to the minimum thickness or the minimum diameter (D) of the protrusion is preferably larger than 1.
  • the minimum thickness or the minimum diameter is preferably 10 nm to 50 ⁇ m.
  • the height of the convex portion is preferably 10 nm to 100 m.
  • the thickness of the adhesive layer is preferably 10 to 300 / xm, and more preferably 10 to 200 / m.
  • the shape of the adhesive layer is preferably a circle, an ellipse, or a polygon.
  • the size is about 2-5 cm in diameter or major axis, and about 2-5 cm in diagonal length.
  • the film having an uneven portion constituting the adhesive layer of the present invention can be preferably produced by the following method. That is, the film
  • organic solvents such as chloroform and methylene chloride, aromatic hydrocarbons such as benzene, toluene and xylene, esters such as ethyl acetate and butyl acetate, and water-insoluble ketones such as methyl isobutyl ketone , Carbon dioxide, etc. these These organic solvents may be used alone or as a mixture of these solvents.
  • the solute concentration of one polymer component and phospholipid in the polymer solution is preferably
  • solute concentration 0.01 to 10% by weight, more preferably 0.05 to 5% by weight. If the solute concentration is lower than 0.01% by weight, the resulting film has insufficient mechanical strength, which is not desirable. On the other hand, if it exceeds 10% by weight, the solute concentration becomes too high, and a sufficient uneven structure may not be obtained.
  • the weight ratio of the polymer component to the phospholipid in the polymer solution is preferably 1: 1 to 1,000: 1.
  • the film preferably contains a phospholipid.
  • grooved part includes a casting process and an evaporation process.
  • the casting process is a process in which a polymer solution is cast on a substrate to obtain a liquid film. Such a process can be performed by pouring the polymer solution onto the substrate.
  • inorganic materials include glass, metal, and silicon wafers.
  • polymer include polypropylene, polyethylene, and polyether ketone.
  • liquid include water, liquid paraffin, and liquid polyether.
  • the evaporation process is a process in which water vapor with a relative humidity of 30 to 100% is sprayed on the liquid film to evaporate the organic solvent.
  • the relative humidity is preferably 50 to 95%, more preferably 50 to 90%.
  • a relative humidity of less than 30% is not preferable because condensation on the liquid film is insufficient.
  • the ambient temperature may be a temperature at which the organic solvent gradually evaporates, and is preferably 10 to 30 ° C., more preferably room temperature.
  • the organic solvent evaporates and water vapor condenses on the liquid film surface, forming water droplets. This takes away latent heat when the organic solvent evaporates, and the temperature of the liquid film surface This is because water vapor in the atmosphere is condensed on the liquid film surface.
  • the surface tension between the condensed water vapor and the organic solvent is reduced by the action of the hydrophilic group in the polymer, and the condensed water vapor aggregates into minute water droplets.
  • microscopic water droplets packed in a hexagonal arrangement are arranged on the liquid film surface.
  • the water droplets sink into the liquid film, and the surface of the liquid film has a structure in which the water droplets surrounded by the polymer are regularly arranged.
  • the organic solvent in the liquid film completely evaporates, Form a film.
  • the water droplets generated by condensation are evaporated.
  • the water droplets evaporate, leaving pores that are uniformly arranged on the polymer surface.
  • pores having a pore diameter of 0.1 to 20 m are regularly formed in a honeycomb shape.
  • the pore diameter is preferably 0.5 to 18 / m, more preferably :! ⁇ 1 5 ⁇ .
  • the back surface that was in contact with the substrate is a flat surface with no pores.
  • the depth of the pores is preferably 0.1 to 20; iim, and more preferably 0.5 to 18 / zm.
  • the film thickness is thinner than the size of the water droplet, a film having fine pores is obtained.
  • Particularly suitable for fixing electrodes on the heart surface is a film mainly composed of the aforementioned biodegradable polymer, and at least one surface has pores having a pore diameter of 0.1 to 20 m in a honeycomb shape. It is a film which has the uneven structure arrange
  • the film having the concavo-convex portion constituting the adhesive layer can be produced by extrusion using a mold having concavo-convex, lithography, nanoimprinting after film formation, laser processing, or the like.
  • the adhesive layer preferably has an electrode window penetrating from the A surface to the B surface. An electrode is placed in the electrode window, and the electrode is brought into contact with the heart surface. Further, when the adhesive layer is manufactured, the adhesive layer and the conductor may be integrally formed so that the conductor is present in the liquid film and the electrode is exposed on the A surface side of the adhesive layer. When the electrodes are bipolar, the two electrodes may be exposed from the electrode window as long as both electrodes cannot be contacted, or an electrode window may be provided for each electrode. (Cover layer)
  • the patch of the present invention preferably has a cover layer on the B surface of the adhesive layer in order to prevent the electrode from being exposed to the outer surface of the patch.
  • the cover layer is preferably a film mainly composed of the aforementioned biodegradable polymer.
  • the cover layer and the adhesive layer may be the same polymer or different polymers.
  • the biodegradable polymer that forms the cover layer is preferably one that is more easily decomposed than the biodegradable polymer that forms the adhesive layer.
  • the cover layer is preferably formed of a lactic acid monodaricholic acid copolymer.
  • the cover layer may have uneven portions such as an adhesive layer, but may be a smooth film.
  • the conducting wire can be fixed by crimping the conducting wire between the cover layer and the adhesive layer.
  • the thickness of the cover layer is preferably 10 to 300 w m, and more preferably 20 to 200 / m.
  • the cover layer preferably has the same shape as the adhesive layer except that there is no electrode window.
  • the cover layer may be a single layer or a laminated layer.
  • a polymer solution containing a polymer component and an organic solvent is cast on a substrate and the solvent is removed, or an extrusion method such as an inflation extrusion method or a T-die extrusion method, a force render method, etc. Can be manufactured.
  • the polymer component and the organic solvent can be the same as those used for the production of the adhesive layer.
  • the solute concentration of the polymer solution is preferably 1 to 40% by weight, more preferably 5 to 30% by weight.
  • the holding layer is preferably a film mainly composed of the aforementioned biodegradable polymer.
  • the holding layer and the adhesive layer may be the same type of polymer or different types of polymers.
  • the holding layer may have uneven portions such as an adhesive layer, but may be a smooth film.
  • the lead wire can be fixed by pressing the lead wire between the holding layer and the adhesive layer.
  • the thickness of the holding layer is preferably 10 to 100 xm, more preferably 20 to 80. It is.
  • the holding layer preferably has the same shape as the adhesive layer.
  • the holding layer may be a single layer or a stacked layer.
  • the holding layer is a casting method in which a polymer solution containing a polymer component and an organic solvent is cast on a substrate and the solvent is removed, or an extrusion method such as an inflation extrusion method or a T-die extrusion method, a calendar method, etc. Can be manufactured.
  • the solute concentration of the polymer solution is preferably 1 to 40% by weight, more preferably 5 to 30% by weight.
  • the wire of this invention is comprised from the above-mentioned patch and conducting wire.
  • the lead has an electrode at a position far from the heart pacemaker main body side, and a connector on the heart pacemaker main body side.
  • the electrode is exposed on the A side of the adhesive layer.
  • the electrode contacts the heart surface and transmits the electrical signal from the heart base manufacturer to the heart muscle.
  • the electrode is made of a conductive metal material.
  • the electrode is preferably about the same diameter as the conductor and about 1 to 2 mm in length. This is because it is necessary to pull out the implanted cardiac wire outside the body without damaging human tissue after a predetermined period after cardiac surgery.
  • the electrode may be monopolar or more than bipolar. In the case of bipolar or more, it can have two or more electrodes, a proximal electrode on the side closer to the heart pacemaker body and a distal electrode on the far side.
  • the connector is for connection to the heart pacemaker body. Since the wire of the present invention punctures the chest wall after cardiac surgery and connects it to the cardiac pacemaker body outside the body, it is preferable to provide a chest wall puncture needle at the end of the connector pin.
  • the diameter of the conducting wire is preferably less than 1 mm, more preferably 0.2 to 0.8 mm, and the outer surface is covered with an insulator.
  • the length is about 400 to 700 mm.
  • the wire 1 of the present invention will be described with reference to FIGS. 1 to 6 are schematic diagrams for explaining the appearance and cross-sectional structure of the wire of the present invention, and the scales of the conductors, electrodes, and layers are not unified.
  • FIG. 1 is an example of the appearance of the wire (monopolar) of the present invention.
  • One electrode (4) is installed in an electrode window provided in the center of the patch, and a connector pin and a chest wall puncture needle (8) are installed at the other end.
  • the patch is formed by an adhesive layer (1) and a cover layer (7).
  • FIG. 2 is a schematic illustration of an example of a cross section of a wire patch of the present invention.
  • the electrode (4) is crimped to the cover layer (7) and is opened on the electrode window (5) opened in the adhesive layer (1).
  • the conducting wire (3) is fixed by being pressed between the adhesive layer (1) and the cover layer (7).
  • the cover layer or the holding layer may be a single layer or a laminate as described above.
  • FIG. 3 is an embodiment in which the holding layer (6) is laminated between the B surface of the adhesive layer (1) and the cover layer (7) in the embodiment of FIG.
  • the conducting wire (3) is fixed by being pressed between the adhesive layer (1) and the holding layer (6).
  • the cover layer or the holding layer may be a single layer or a laminate as described above.
  • FIG. 4 shows an embodiment in which the holding layer (6) is laminated on the B surface of the adhesive layer (1), and a cover layer (7) is laminated on the holding layer (6).
  • the electrode (4) is crimped to the cover layer (7).
  • the conducting wire (3) is pressed and fixed between the holding layer (6) and the cover layer (7).
  • the cover layer or the holding layer may be a single layer or a laminate as described above.
  • FIG. 5 shows a state in which the conductor (3) is present when the adhesive layer (1) is manufactured, and the conductor is disposed in the adhesive layer (1).
  • FIG. 6 is an embodiment in which the cover layer (7) is laminated in the embodiment of FIG.
  • the cover layer may be a single layer or a laminate as described above.
  • the wire of the present invention performs a median sternotomy, and after reaching the heart, incises the pericardium and reaches the pericardium, and then attaches it to the surface of the left ventricle, left atrium, right ventricle, or right atrium. Can be used.
  • the present invention includes a method of installing a wire for a cardiac pacemaker, comprising attaching the patch to the heart surface with the side A of the adhesive layer facing the heart. It is preferable to apply the patch to the heart surface after the patch has been warmed to near the heart temperature. Warm The temperature is preferably from room temperature to the heart temperature. The patch can be heated in warm water or a thermostatic bath. By warming the patch to near the heart temperature, the adhesion of the patch to the heart surface is improved.
  • it is also preferable to apply a patch to the surface of the heart by applying an agent that enhances the adhesion to the heart surface to the side A of the adhesive layer.
  • a cardiac surgery method including the step of installing the cardiac pacemaker wire of the present invention.
  • the wire patch is applied to the heart surface with the side A of the adhesive layer facing the heart.
  • the wire for a cardiac pacemaker of the present invention can be used in a method for temporarily basing the heart during and after cardiac surgery. Therefore, according to the present invention, there is provided a heart basing method using the wire for a cardiac pacemaker of the present invention.
  • the operation can be performed, for example, by the following method.
  • median sternotomy and pericardium are opened to reach the pericardium, and extracorporeal circulation is established (extracorporeal circulation is not performed for heartbeat surgery).
  • extracorporeal circulation is not performed for heartbeat surgery.
  • the patch electrode of the present invention is applied to the heart surface.
  • This patch can be made more adhesive by warming it to near body temperature before use.
  • the patch electrode is preferably placed along the pericardium toward the left ventricle or on the diaphragm surface so as to be covered with the pericardium.
  • the patch electrode can be moved to another location if the base threshold is not good.
  • the end of the side connecting the pacemaker body with the other chest wall puncture needle penetrates the rectus abdominis muscle from the diaphragm surface and, after exiting the skin, cuts off the chest wall puncture sputum and connects it to the pacemaker body.
  • the implanted cardiac wire should be removed within 2 weeks after the surgery.
  • the oil was mixed with PLCA at a ratio of 1 to 200 (by weight) to prepare a polymer solution.
  • the polymer solution was cast on a glass substrate to obtain a liquid film.
  • water vapor was sprayed on the liquid film at room temperature and humidity of 70% to gradually evaporate the solvent and to condense the water vapor on the surface of the liquid film to form water droplets, and then evaporate the water droplets to prepare a film.
  • the obtained film was a non-penetrating film having a concavo-convex portion in which pores having a pore diameter of about 5 // m were uniformly arranged in a honeycomb shape on the entire surface, the back surface was smooth, and the thickness was 10 / m. .
  • Fig. 7 shows a photomicrograph of the uneven part of the film. This film was heat-treated at 60 ° C. for 10 minutes, cut into a circle with a diameter of 4 cm, and the center with 6 mm biopsy.
  • a smooth film having a diameter of 4 cm was prepared in the same manner as the cover layer.
  • the film thickness was 52 ⁇ m.
  • the center was cut out with a 6 mm diameter biopsy to produce a window for the electrode.
  • the conductor was placed so that the electrode was in the center of the cover layer, and the conductor was pressed onto the cover layer with a cotton swab soaked in salted himethylene.
  • the holding layer was overlaid on the electrode side of the cover layer and again heat treated at 60 ° C for 10 minutes. Furthermore, an adhesive layer is placed on the upper surface of the holding layer so that the concavo-convex part becomes the outermost layer, heat-treated at 60 ° C. for 10 minutes, and shown in FIG. A wire having a cross-sectional structure was produced.
  • a film having a film thickness of 57 m was obtained using P L G A in the same manner as in Example 1. This film was cut into a circle with a diameter of 4 cm, stacked in two, and heat treated at 60 for 10 minutes to form a cover layer.
  • the adhesive layer produced in Example 1 was used.
  • a film having a thickness of 48 m was produced using PLCCA in the same manner as in Example 1, and the center portion was cut out with a biopsy having a diameter of 6 mm to form an electrode window.
  • Example 2 The same operation as in Example 1 was performed to manufacture a wire having the cross-sectional structure shown in FIG. 4 (the cover layer is a laminate).
  • Example 1 The same operation as in Example 1 was performed except that a dog (age 2 years 4 months, female, beagle) was used as the test animal.
  • the results are shown in Table 1. Slightly above the basing threshold Although there was a rise, it was confirmed that it was possible to drive without problems for 14 days. On the 14th day after the operation, the wire was pulled out and it was confirmed that it was pulled out without resistance. Arrhythmia did not occur when the wire was removed. Furthermore, after removal of the wire, no intracardiac hemorrhage was observed by cardiac ultrasonography, and no signs of cardiac tambonase, pericardial thickening or myocardial dilatation were observed.
  • a film having a thickness of 46 m was obtained using PLGA in the same manner as in Example 1. This film was cut into a circle with a diameter of 4 cm, stacked in two, and heat treated at 60 ° C for 10 minutes to form a cover layer.
  • the obtained film had uneven portions in which pores having a pore diameter of about 4/2 m were uniformly arranged in a honeycomb shape on the entire surface, the back surface was smooth, and a non-penetrating film having a thickness of 8 / m. It was.
  • Fig. 8 shows a photomicrograph of the film irregularities. This film was heat-treated at 60 ° C for 10 minutes, cut into a 4 cm diameter circle, and the center was cut out with 6 mm biopsy.
  • PLCA lactic acid monostrength prolactone copolymer
  • Example 1 The same operation as in Example 1 was performed to produce a wire having the cross-sectional structure shown in FIG. 4 (the cover layer is a laminate).
  • (Operation check) The same operation as in Example 1 was performed except that a dog (age 2 years 6 months, female, beagle) was used as a test animal. The results are shown in Table 1. A slight increase in the basing threshold was observed, but it was confirmed that the system could operate without any problems for 14 days. On the 14th day after the operation, the wire was pulled out and it was confirmed that it was pulled out without resistance. The results are shown in Table 1. Arrhythmia did not occur when the wire was removed. Furthermore, after removal of the wire, no echocardiogram was observed on echocardiography, and no signs of cardiac tambonase, pericardial thickening or myocardial dilatation were observed.
  • a polymer solution was prepared by mixing at a ratio (weight) of 1 200 to PLCA. The polymer solution was cast on a glass substrate to obtain a liquid film.
  • the obtained film was a non-penetrating film having a concavo-convex portion in which pores having a pore diameter of about 9 were uniformly arranged in a honeycomb shape on the entire surface, the back surface was smooth, and the thickness was 15 m.
  • a photomicrograph of the film irregularities is shown in Fig. 11. This film was heat-treated at 60 ° C. for 10 minutes, cut into a circular shape with a diameter of .3 cm, and the center was cut with a 6 mm biopsy. (Holding layer)
  • a smooth film with a diameter of 3 cm was prepared using P L C A in the same manner as the cover layer.
  • the film thickness was 5 7 m.
  • the center was cut out with a 6 mm diameter biopsy to produce a window for the electrode.
  • the conductor was placed so that the electrode was at the center of the cover layer, and the conductor was pressed onto the cover layer with a cotton swab soaked in methylene chloride.
  • the holding layer was superimposed on the electrode side of the cover layer, and heat treatment was performed again at 60 for 10 minutes.
  • an adhesive layer is placed on the upper surface of the holding layer so that the uneven portion becomes the outermost layer, and heat treatment is performed at 60 ° C. for 10 minutes, and the adhesive layer, the holding layer, the cover layer, and the conductive wire are formed.
  • the dog '(age 10 months, male, beagle) was given general anesthesia, and then reached the chest cavity with the 4th intercostal thoracotomy in the lower left supine position.
  • the pericardium was incised to reach the pericardium, and the wire created above was applied to the left ventricle.
  • the chest wall was punctured, the connector pin was taken out of the body, the pericardium was sutured closed, the chest wall was closed, and the operation was completed. Wire one
  • the basing threshold was measured over time on the day of surgery, on the 1st, 3rd, 5th, 7th, and 14th days after surgery. The results are shown in Table 1. Although a slight increase in the pacing threshold was observed, it was confirmed that it could operate without any problems for 14 days. On the 4th day after surgery, the wire was pulled out and it was confirmed that it was pulled out without resistance. Arrhythmia did not occur when the wire was removed. Furthermore, after removal of the ear, no cardiac pericardial hemorrhage was observed by cardiac B ultrasound, and no signs of cardiac tambonase, pericardial thickening, or myocardial dilatation were observed.
  • PLCA lactic acid-strength prolactone copolymer
  • the obtained film had a concavo-convex portion in which pores having a pore diameter of about 4.5 were uniformly arranged in a honeycomb shape on the entire surface, the back surface was smooth, and a non-penetrating film having a thickness of 10 im.
  • Fig. 12 shows a photomicrograph of the uneven part of the film. This film was heat-treated at 60 at 10 minutes, cut into a 3 cm diameter circle, and the center was cut out with a 6 mm biopsy.
  • a smooth film having a diameter of 3 cm was produced in the same manner as the cover layer.
  • the film thickness was 42 im.
  • the center was cut out with a biopsy with a diameter of 6 mm to produce a window for the electrode.
  • the conductor was placed so that the electrode was at the center of the cover layer, and the conductor was pressed onto the cover layer with a cotton swab soaked in methylene chloride.
  • the holding layer was overlaid on the electrode side of the cover layer and again heat treated at 60 ° C for 10 minutes. Furthermore, an adhesive layer is placed on the upper surface of the holding layer so that the concavo-convex part becomes the outermost layer, and heat-treated at 60 ° C. for 10 minutes, and shown in FIG. A wire having a cross-sectional structure was produced.
  • Example 1 The same operation check operation as in Example 1 was performed except that Heart Wire (Model 6 4 92: Medtronic) was used as a test substance. Table 1 shows the results (average soil standard deviation for each measurement day for a total of 7 measurements). table 1
  • the wire patch of the present invention is a film mainly composed of a biodegradable polymer.
  • the electrode can be easily removed from the surface of the heart after a certain period of time has passed since it has broken down in the body. Therefore, according to the wire of the present invention, the incidence of complications can be reduced, and the patient's QOL (Quality of life) can be improved.
  • the wire of the present invention does not need to be sewn to the myocardium, it is extremely easy to install. Therefore, the stress of the surgeon during the operation can be reduced, and the operation time can be shortened.
  • the wire of the present invention has an advantage that it can be used without considering the influence of the adhesive on the human body because the electrode can be fixed to the heart without using an adhesive or the like. Industrial applicability
  • the wire 1 of the present invention can fix the electrode to the heart tissue without sewing the electrode to the heart tissue, it is easy to change the fixing portion, and when the wire is removed, damage to the heart and blood vessels caused by the coil There is no myocardial dehiscence by sewing thread, and it is useful as a wire for cardiac pacemakers.

Abstract

L'invention a pour objet un câblage pour des stimulateurs cardiaques par lequel des électrodes peuvent être fixées à la surface cardiaque sans suturer sur le muscle cardiaque. L'invention concerne un câblage pour des stimulateurs cardiaques lequel comprend un timbre ayant une couche adhésive et un fil conducteur ayant une électrode à l'extrémité avant de celui-ci, a) la couche adhésive étant un film qui est principalement constitué d'un polymère biodégradable et qui a, sur une surface (face A) servant de face adhésive, des pics et des creux en proportion allant de 1 à 100 % du total de la surface de la face A et b) l'électrode distale étant exposée dans la couche adhésive du côté de la face A ; et un timbre et un film à utiliser dans le câblage.
PCT/JP2006/308793 2005-04-22 2006-04-20 Câblage pour stimulateurs cardiaques WO2006115281A1 (fr)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008149473A1 (fr) * 2007-06-07 2008-12-11 National University Corporation Kanazawa University Tampon myocardique
NL2001208C2 (nl) * 2008-01-23 2009-07-27 Medical Concepts Europ B V Werkwijze voor vervaardiging van een inrichting voor het positioneren en fixeren van elektroden op lichaamsorganen, inrichting en verzameling onderdelen.
WO2015170344A1 (fr) 2014-05-09 2015-11-12 Council Of Scientific & Industrial Research Électrode hors laboratoire sur puce polymère améliorée, de nouvelle génération
CN108721707A (zh) * 2017-04-25 2018-11-02 北京纳米能源与系统研究所 可降解导线及其制备方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0511881Y2 (fr) * 1988-10-28 1993-03-25
JPH07163650A (ja) * 1993-07-21 1995-06-27 Imedex 外科用の新規な接着剤組成物
JPH09508039A (ja) * 1994-01-21 1997-08-19 メドトロニック・インコーポレーテッド 医療用仮リード
JPH10174711A (ja) * 1996-09-23 1998-06-30 Focal Inc コンプライアントな組織シーラント
JP2795458B2 (ja) * 1989-05-26 1998-09-10 久光製薬株式会社 電気的経皮投薬用インタフェース
JP2002045345A (ja) * 2000-06-22 2002-02-12 Ethicon Inc 心臓装置のための電気コネクター

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4404273B2 (ja) * 1998-03-11 2010-01-27 多木化学株式会社 リード固定用樹脂組成物

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0511881Y2 (fr) * 1988-10-28 1993-03-25
JP2795458B2 (ja) * 1989-05-26 1998-09-10 久光製薬株式会社 電気的経皮投薬用インタフェース
JPH07163650A (ja) * 1993-07-21 1995-06-27 Imedex 外科用の新規な接着剤組成物
JPH09508039A (ja) * 1994-01-21 1997-08-19 メドトロニック・インコーポレーテッド 医療用仮リード
JPH10174711A (ja) * 1996-09-23 1998-06-30 Focal Inc コンプライアントな組織シーラント
JP2002045345A (ja) * 2000-06-22 2002-02-12 Ethicon Inc 心臓装置のための電気コネクター

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008149473A1 (fr) * 2007-06-07 2008-12-11 National University Corporation Kanazawa University Tampon myocardique
NL2001208C2 (nl) * 2008-01-23 2009-07-27 Medical Concepts Europ B V Werkwijze voor vervaardiging van een inrichting voor het positioneren en fixeren van elektroden op lichaamsorganen, inrichting en verzameling onderdelen.
WO2009093903A1 (fr) 2008-01-23 2009-07-30 European Custom Manufacturing B.V. Procédé de fabrication d'un dispositif de placement et de fixation d'électrodes sur des organes corporels, dispositif et kit de pièces
WO2015170344A1 (fr) 2014-05-09 2015-11-12 Council Of Scientific & Industrial Research Électrode hors laboratoire sur puce polymère améliorée, de nouvelle génération
CN108721707A (zh) * 2017-04-25 2018-11-02 北京纳米能源与系统研究所 可降解导线及其制备方法
CN108721707B (zh) * 2017-04-25 2021-04-09 北京纳米能源与系统研究所 可降解导线及其制备方法

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