WO2022216259A1 - Enveloppe pour stimulateurs cardiaques implantables - Google Patents

Enveloppe pour stimulateurs cardiaques implantables Download PDF

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Publication number
WO2022216259A1
WO2022216259A1 PCT/TR2022/050299 TR2022050299W WO2022216259A1 WO 2022216259 A1 WO2022216259 A1 WO 2022216259A1 TR 2022050299 W TR2022050299 W TR 2022050299W WO 2022216259 A1 WO2022216259 A1 WO 2022216259A1
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WO
WIPO (PCT)
Prior art keywords
poly
methacrylate
envelope
acid
envelope according
Prior art date
Application number
PCT/TR2022/050299
Other languages
English (en)
Inventor
Bora GARIPCAN
Ahmet Ilker TEKKESIN
Sabra ROSTAMI
Original Assignee
Bogazici Universitesi
Istanbul Saglik Bilimleri Universitesi
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 Bogazici Universitesi, Istanbul Saglik Bilimleri Universitesi filed Critical Bogazici Universitesi
Publication of WO2022216259A1 publication Critical patent/WO2022216259A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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 invention relates to an envelope for implantable cardiac pacemakers, with high antimicrobial properties and not presenting any side effects for body by deriving from biocompatible components.
  • the subject matter of the invention relates to a sheath/envelope for implantable cardiac pacemakers and pertains to biomedical, bioengineering and biomaterial technical fields.
  • Heart is an organ that has the ability to generate and transmit electrical stimulation spontaneously, unlike many other organs. Although the performance of the electrical system of the heart changes depending on age, on average it provides 60-100 beats per minute at rest; and it is accelerated during physical activity or excitement. If the node of the heart’s electrical system (sinus node) fails to stimulate and/or there is a problem in the transmission of the stimulus in the specialized conduction system within the heart, very low pulses are generated which impairs the human health. Cardiac pacemakers are used in the treatment of this and similar cardiac conduction system problems.
  • ICD Implantable cardioverter-defibrillators
  • Implantable cardioverter-defibrillators are devices that can provide special maneuvers and shock therapy and are used in the treatment of life-threatening rhythm disorders.
  • the implantable cardioverter devices vary between about 30-50 cc and 60-90 g, although their sizes vary according to the brand and model.
  • Implantable cardioverter-defibrillators are usually implanted in the chest area under the skin. Complications associated with the cardiac pacemaker implantations are divided into four groups:
  • electrode displacement has the highest rate of incidence, followed by pocket-related infection and hematoma.
  • the risk of infection is between 0.5 and 1% for standard cardiac pacemaker patients within the first 12 months after surgery.
  • this rate is between 0.7-17% within the first 6 months after surgery. It is estimated to be 4.3% in the first 2.5 years of 3-chamber cardiac pacemaker CRT implantation. Therefore, most studies have focused on reducing these complications or alternative approaches for treatment thereof.
  • Cardiac pacemaker-related complications result in long hospital stay and therefore their economic costs are high. According to a statistical study conducted in the USA, 2.4 million patients underwent cardiac pacemaker implantation surgery and 369,000 patients underwent cardiac pacemaker replacement surgery between 1993 and 2006.
  • WO 2016/159885 numbered invention relates to a soft and elastic, biodegradable antibiotic socket (a sleeve or tape) providing controlled release, designed to securely hold CIEDs of different sizes.
  • Said socket is made of an elastic material having at least one opening. Once the device is inserted, the socket made of an elastomeric polymeric material is allowed to return to its original size, thereby securely holding the device inserted therein.
  • WO 2008/136856 numbered invention relates to pouches, coatings and such made from fully absorbable and biodegradable polymers, which can be converted into films, electrospinned membranes and bags, coatings, shells or other containers and such, as desired.
  • Said pouches of the invention contain one or more biodegradable polymers to deliver or control drug elution of certain profiles or other transient effects.
  • the polymer matrix of fully reabsorbable bags may contain one or more drugs.
  • WO 2012/064963 numbered invention is a fixation device comprising a mesh substrate attached to an implantable medical device, wherein the mesh substrate has a coating comprising a polymer and at least one active pharmaceutical ingredient (“API”).
  • the active pharmaceutical ingredient is selected from the group consisting of anesthetics, antibiotics, anti-inflammatory agents, procoagulant agents, anti-fibrosis agents, anti-wound agents, leukotriene inhibitors/antagonists, cell growth inhibitors, and mixtures thereof.
  • the active pharmaceutical ingredient is an antibiotic.
  • the present invention relates to obtaining an envelope for implantable cardiac pacemakers, in order to eliminate the above-mentioned disadvantages and bring new advantages to the related technical field.
  • An object of the invention is to provide an envelope for cardiac pacemaker with high antimicrobial activity.
  • An object of the invention is to provide an envelope for cardiac pacemaker that will not present any side effects for body.
  • the present invention relates to a envelope for cardiac pacemakers with high antimicrobial properties.
  • the envelope obtained in the invention has a morphological surface topography similar to the sharkskin topography.
  • said envelope comprises of at least one of Chitosan, carboxymethyl chitosan, Polycaprolactone (PCL), Polyglycolic Acid (PGA), Poly-L-Lactic Acid (PLLA), Polylactic acid-glycolic Acid (PLGA), Polyhydroxyalkanoate [poly-3-hydroxybutyrate (P3HB), poly-4-hydroxybutyrate (P4HB), polyhydroxyvalerate (PHV), polyhydroxyhexanoate (PHH), polyhydroxoctanoate (PHO)], Collagen, Alginate, Cellulose, Polyvinylalcohol (PVA), Polyvinylchloride (PVC), Polyvinylpyrrolidone (PVP), Polyvinylidenefluoride (PVDF), Polysiloxanes [Poly(methylhydrosiloxan), Poly(dimethylsiloxane), Poly(methylphenylsiloxane),
  • said envelope comprises at least one additive component in addition to the biocompatible material.
  • said additive component contains at least one of components such as silver nanoparticles or salts, graphene, graphene oxide, antibiotic, antimicrobial, anti-inflammatory, antifungal agents and/or drugs, glycerol, PEG, hydroxyapatite, dextran, wound healing drugs, fibronectin, fibrinogen, collagen.
  • the additive component is present in the envelope in a ratio of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10% by weight.
  • said antimicrobial agent and/or drug is selected from the group of beta lactams, glycopeptides, fosfomycin, cycloserine, bacitracin, ristocetin, ramoplanin, mersacidin, moenomycin, macrolides, ketolides, lincosamides, streptogramins, chloramphenicol, oxazolidinones, aminoglycosides, tetracyclines, glycylcyclines, mupirocine, nitrofurantoin, quinolones, rifamycins, metronidazo, trimethoprim-sulfamethoxazole, paraamino, salicylic acid, bacitracin, gramicidin S, polymyxins, defensins, maganins, pyrocoricin, drododoin, apiadesin, daptomycin and pharmaceutically acceptable salts and mixtures
  • Said anti-inflammatory agent and/or drug in the possible embodiment of the invention is selected from the group of aspirin, amoxiprine, benorilate, choline magnesium salicylate, diflunisal, bromine, methyl salicylate, magnesium salicylate, salicyl salicylate (salsalate), ibuprofen, carprofen, fenbufen, fenoprofen, flurbiprofen, ketoprofen, loxoprofen, naproxen, thiaprofenic acid, suprofen, mefenamic acid, meclofenamic acid, piroxicam, meloxicam, tenoxicam, etoricoxib, parecoxib and pharmaceutically acceptable salts and mixtures thereof.
  • said antifungal agent and/or drug is selected from the group of azoles, morpholine, riseofulvin, haloprogin, butenafine, tolnaftate, nystatin, cyclohexamide, ciclopirox, flucytosine, terbinafine, amphotericin B and pharmaceutically acceptable salts and mixtures thereof.
  • FIGURE 1 A representative view of micro recesses-protrusions on the surface of the raw material of the envelope according to the invention is given in Figure 1.
  • the subject of the invention relates to an envelope for implantable cardiac pacemakers, with high antimicrobial properties and not presenting any side effects for body by deriving from biocompatible components and is only disclosed with non-limiting examples only for a better understanding of the subject.
  • the envelope to be obtained in the invention is selected from biocompatible natural and/or synthetic chemical materials to provide the desired properties in the related technical field.
  • additional morphological properties are provided during manufacturing of biocompatible chemical material as envelope.
  • the envelope according to the invention is aimed to be a biomaterial with superior properties for the related technical field, together with the selection of both its morphological properties and chemical components to comply with the implantable cardiac pacemaker.
  • the envelope obtained in the invention comprises chemical component or components that are completely biocompatible.
  • Said chemical component comprises at least one of the materials such as Chitosan, carboxymethylchitosan, Polycaprolactone (PCL), Polyglycolic Acid (PGA), Poly-L-Lactic Acid (PLLA), Polylactic acid-glycolic Acid (PLGA), Polyhydroxyalkanoate [poly-3-hydroxybutyrate (P3HB), poly-4-hydroxybutyrate (P4HB), poly hydroxy valerate (PHV), polyhydroxyhexanoate (PHH), polyhydroxoctanoate (PHO)], Collagen, Alginate, Cellulose, Polyvinylalcohol (PVA), Polyvinylchloride (PVC), Polyvinylpyrrolidone (PVP), Polyvinylidenefluoride (PVDF), Polysiloxanes [Poly(methylhydrosiloxan), Poly(dimethylsiloxane), Poly(methylphenylsilox
  • the envelope obtained in the invention may contain at least one additive and/or coating material to improve its physicochemical, mechanical and biological properties, if preferred.
  • said additive component contains at least one of components selected from the group of silver nanoparticles or salts, graphene, graphene oxide, antibiotic, antimicrobial, anti inflammatory, antifungal agents and/or drugs, glycerol, PEG, hydroxyapatite, dextran, wound healing drugs, fibronectin, fibrinogen, collagen.
  • the envelope not only consists of said biocompatible chemical components, but also may comprise at least one additive and/or coating material.
  • Said additive and/or coating material may be present in the envelope in a ratio of 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10% by weight.
  • the envelope comprises at least one antimicrobial, anti-inflammatory, antifungal and/or antibiotic agent and/or drug.
  • Said anti-inflammatory agent and/or drug is selected from the group of aspirin, amoxiprine, benorilate, choline magnesium salicylate, diflunisal, bromine, methyl salicylate, magnesium salicylate, salicyl salicylate (salsalate), ibuprofen, carprofen, fenbufen, fenoprofen, flurbiprofen, ketoprofen, loxoprofen, naproxen, thiaprofenic acid, suprofen, mefenamic acid, meclofenamic acid, piroxicam, meloxicam, tenoxicam, etoricoxib, parecoxib and pharmaceutically acceptable salts and mixtures thereof.
  • Said antifungal agent and/or drug is selected from the group of azoles, morpholine, riseofulvin, haloprogin, butenafine, tolnaftate, nystatin, cyclohexamide, ciclopirox, flucytosine, terbinafine, amphotericin B and pharmaceutically acceptable salts and mixtures thereof.
  • Said antimicrobial agent and/or drug is selected from the group of beta lactams, glycopeptides, fosfomycin, cycloserine, bacitracin, ristocetin, ramoplanin, mersacidin, moenomycin, macrolides, ketolides, lincosamides, streptogramins, chloramphenicol, oxazolidinones, aminoglycosides, tetracyclines, glycylcyclines, mupirocine, nitrofurantoin, quinolones, rifamycins, metronidazo, trimethoprim-sulfamethoxazole, paraamino, salicylic acid, bacitracin, gramicidin S, polymyxins, defensins, maganins, pyrocoricin, drododoin, apiadesin, daptomycin and pharmaceutically acceptable salts and mixtures thereof.
  • the envelope according to the invention can be obtained as a composite material, if preferred.
  • as matrix component at least one of the components such as Chitosan, carboxymethylchitosan, Polycaprolactone (PCL), Polyglycolic Acid (PGA), Poly-L-Lactic Acid (PLLA), Polylactic acid-glycolic Acid (PLGA), Polyhydroxyalkanoate [poly-3-hydroxybutyrate (P3HB), poly-4-hydroxybutyrate (P4HB), poly hydroxy valerate (PHV), polyhydroxyhexanoate (PHH), polyhydroxoctanoate (PHO)], Collagen, Alginate, Cellulose, Polyvinylalcohol (PVA), Polyvinylchloride (PVC), Polyvinylpyrrolidone (PVP), Polyvinylidenefluoride (PVDF), Polysiloxanes [Poly(methylhydrosiloxan), Poly(dimethylsiloxane), Poly(methylpheny
  • the envelope to be obtained in the invention may contain additional components such as collagen, fibronectin or fibrinogen in certain weight ratios, if preferred. In this way, cell construction and growth can be achieved in order to reduce the effects of the operation that takes place during the insertion of the cardiac pacemaker into the body.
  • biocompatible raw materials are formed by using molding materials similar to sharkskin topography.
  • micro-sized recesses-protrusions are obtained on the surface of the biocompatible chemical material to be used in the manufacture of the envelope. Thanks to this biomimetic property, it is predicted that the biocompatible biomaterial will exhibit improvement in its antimicrobial properties and resistance in other mechanical strengths.
  • a biocompatible material suitable for said sharkskin topography in the invention For manufacturing a biocompatible material suitable for said sharkskin topography in the invention, the following process steps are followed: i. Preparing the solution containing the PDMS chemical compound, ii. Preparing the sharkskin as positive molding material, iii. Pouring the solution obtained in step (i) onto the positive molding material and preparing the negative molding material by soft lithography technique, iv. Preparing solution containing the biocompatible chemical component, v. Pouring the solution obtained in step (iv) onto the negative molding material and obtaining the biomaterial by solution casting method.
  • the solution mentioned in step (i) contains PDMS chemical compound, 184-silicone elastomer curing agent and a solvent.
  • the ratio of PDMS to 184-silicone elastomer curing agent is in the range of 10:1 to 15:1 in solution. Afterwards, the process of removing the air in the mixture is performed.
  • a number of processes are performed to produce a positive molding material containing said sharkskin in step (ii).
  • the sharkskin to be produced as the positive molding material is subjected to preliminary processes consisting essentially of six steps.
  • Said preliminary processes consist of processes such as fixing the sharkskin, cleaning the sharkskin, chemically treating the sharkskin, rinsing the sharkskin, dehydrating the sharkskin and drying the sharkskin.
  • Said shark is preferably selected from sharkskins of uniform thickness and of lengths of 40 cm. Sharkskins are completely removed from the dermis and subcutaneous tissues by means of a scalpel, and a sharkskin pattern is obtained. Deionized water is used to clean the sharkskin pattern. Said cleaning process is performed at least five times.
  • the sharkskin is cut into small pieces of plate without destroying its microstructure.
  • chemical treatment processes are applied to the shark.
  • Chemical treatment processes are carried out for a period of 1 to 5 hours.
  • the chemical solution to be used for chemical treatment is 2.5% by volume glutaraldehyde chemical compound.
  • Drying processes are applied to the sharkskins, to which chemical treatments are applied.
  • drying processes at first it is added to 30%, 50%, 75%, 80%, 95% and 100% ethanol solutions by volume, respectively.
  • Each process for immersion into the solution is carried out for a period of 15 to 30 minutes.
  • sharkskin taken from the solutions, is applied a drying process in a drying oven at a temperature between 60 to 65°C, as the last process. Said drying process is carried out for a period of 12 to 24 hours.
  • sharkskin can be used as a template as a positive pattern.
  • step (iii) The process of preparing the negative molding material by the soft lithography technique mentioned in step (iii) is carried out between the dried sharkskin samples obtained in step (ii) and the solution containing PDMS chemical compound obtained in step (i).
  • the solution obtained in step (i) is poured onto the sharkskin sample.
  • a hardening process by heating at temperatures between 60 to 65°C. Said hardening process is carried out for a period of 4 to 6 hours.
  • hardened PDMS polymer is allowed to separate from the sharkskin.
  • a negative molding material containing the PDMS polymer is obtained.
  • Said solution in step (iv) may contain at least one body-compatible and biocompatible polymer raw material and/or additive.
  • Obtaining the biomaterial by the solution casting method mentioned in step (v) is by pouring the polymer solution obtained in step (iv) onto the negative PDMS mold obtained in step (iii).
  • a drying process is performed at a temperature between 60 to 65°C. Said drying process continues for a period of 24 to 48 hours.
  • the innovative aspect of our invention as previously mentioned, relates to obtaining a biomimetic morphological envelope for cardiac pacemakers, made from biocompatible materials. Thus, it is ensured to obtain biomaterials suitable for the cardiac pacemaker, body conditions and with superior properties.
  • the envelope obtained in the invention has numerous advantages over other products in the related technical field.
  • Chemical compounds are selected, which are suitable for body conditions and cardiac pacemakers in the obtaining the envelope.
  • properties such as preventing the problems caused by the operations performed during the insertion of the cardiac pacemaker, stability of the envelope material during the duration of the cardiac pacemaker lifespan, and improving tissue regeneration are provided.
  • Another property of the envelope is that it has a biomimetic design.
  • the biomimetic property the morphological structure of a sharkskin is used.
  • the envelope is allowed to have a high level of antimicrobial properties due to this biomimetic property.
  • Providing an interface suitable for natural tissue formation on the outer surface of the envelope can reduce the likelihood of wound tissue formation around the generator.
  • the use of biocompatible chemical materials proposed in the invention in the form of coating material combined with sharkskin microtopography provides desired surface properties that can promote the wound tissue formation on the outer surface for cell attachment and growth to/on these surfaces.
  • the proposed envelope provides protection against possible infections around the cardiac pacemaker and prevents tissue necrosis, as a result of the slow release of loaded antimicrobial, antifungal and anti-inflammatory agents.
  • the envelope to be obtained in the invention is shown in Figure 2. Accordingly, there is an internal chamber (3) in the envelope for inserting the cardiac pacemaker. There is a cable output (2) for the cables to be attached to the necessary portions of the cardiac pacemaker inside the body.
  • the envelope has a very simple design and is provided at very low costs.
  • the envelope is manufactured from the raw materials derived from said chemical components with a structure suitable for the sharkskin topography in order to provide biomimetic properties.

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  • Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'enveloppe de l'invention est choisie parmi des matériaux chimiques naturels et/ou synthétiques biocompatibles pour conférer les propriétés souhaitées dans le domaine technique associé. De plus, pendant la production du matériau chimique biocompatible en tant qu'enveloppe, des applications sont réalisées pour améliorer topographiquement les propriétés antimicrobiennes. L'enveloppe selon l'invention est destinée à constituer un biomatériau présentant des propriétés supérieures pour le domaine technique associé, conjointement avec la sélection à la fois de ses propriétés morphologiques et de constituants chimiques en vue d'être conforme au stimulateur cardiaque implantable.
PCT/TR2022/050299 2021-04-09 2022-04-05 Enveloppe pour stimulateurs cardiaques implantables WO2022216259A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2021/006381 2021-04-09
TR202106381 2021-04-09

Publications (1)

Publication Number Publication Date
WO2022216259A1 true WO2022216259A1 (fr) 2022-10-13

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1874367A2 (fr) * 2005-04-26 2008-01-09 Arhus Universitet Matériau biocompatible pour implants chirurgicaux et surfaces de culture cellulaire de guidage de cellules
WO2008136856A2 (fr) * 2006-11-06 2008-11-13 Tyrx Pharma, Inc. Poches résorbables pour dispositifs médicaux implantables
US20100226943A1 (en) * 2004-02-17 2010-09-09 University Of Florida Surface topographies for non-toxic bioadhesion control
WO2012064963A1 (fr) * 2010-11-12 2012-05-18 Tyrx, Inc. Dispositifs d'ancrage comprenant un principe pharmaceutique actif
WO2016159885A1 (fr) * 2015-03-31 2016-10-06 Orchid Medical Pte Ltd Film antimicrobien élastique et douille formée à partir de celui-ci
CN109567881A (zh) * 2018-11-22 2019-04-05 创领心律管理医疗器械（上海）有限公司 抗菌制品及其制备方法

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100226943A1 (en) * 2004-02-17 2010-09-09 University Of Florida Surface topographies for non-toxic bioadhesion control
EP1874367A2 (fr) * 2005-04-26 2008-01-09 Arhus Universitet Matériau biocompatible pour implants chirurgicaux et surfaces de culture cellulaire de guidage de cellules
WO2008136856A2 (fr) * 2006-11-06 2008-11-13 Tyrx Pharma, Inc. Poches résorbables pour dispositifs médicaux implantables
WO2012064963A1 (fr) * 2010-11-12 2012-05-18 Tyrx, Inc. Dispositifs d'ancrage comprenant un principe pharmaceutique actif
WO2016159885A1 (fr) * 2015-03-31 2016-10-06 Orchid Medical Pte Ltd Film antimicrobien élastique et douille formée à partir de celui-ci
CN109567881A (zh) * 2018-11-22 2019-04-05 创领心律管理医疗器械（上海）有限公司 抗菌制品及其制备方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
S V V S NARAYANA P, S V V SRIHARI P: "Biofilm Resistant Surfaces and Coatings on Implants: A Review", MATERIALS TODAY: PROCEEDINGS, ELSEVIER, NL, vol. 18, 1 January 2019 (2019-01-01), NL , pages 4847 - 4853, XP055979030, ISSN: 2214-7853, DOI: 10.1016/j.matpr.2019.07.475 *
SABRA ROSTAMI ET AL.: "Bifunctional sharkskin mimicked chitosan/graphene oxide membranes: Reduced biofilm formation and improved cytocompatibility", APPLIED SURFACE SCIENCE, 2021, XP086493738, DOI: 10.1016/j.apsusc.2020.148828 *

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