CN206604018U - A kind of anti-degraded hydrophilic lubrication implant electrode wire - Google Patents
A kind of anti-degraded hydrophilic lubrication implant electrode wire Download PDFInfo
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- CN206604018U CN206604018U CN201621111993.0U CN201621111993U CN206604018U CN 206604018 U CN206604018 U CN 206604018U CN 201621111993 U CN201621111993 U CN 201621111993U CN 206604018 U CN206604018 U CN 206604018U
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- functional layer
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- electrode wire
- degraded
- hydrophilic lubrication
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Abstract
The utility model discloses a kind of anti-degraded hydrophilic lubrication implant electrode wire, implant electrode wire includes inner conducting layer and external insulation layer, external work ergosphere is provided with outside the external insulation layer, the outer functional layer is the functional layer containing base-material and vitamin E, and the thickness of the outer functional layer is 0.05mm to 1mm.The utility model prevents the degraded of external insulation layer, improves the physical and mechanical properties and safety in utilization of electrode cable by setting outer functional layer with the extexine of human contact；Due to also containing hydrophile copolymers in the functional layer, so as to improve lubricity, reduction wire implantation resistance, wire implantation is more smooth, safer, more reliable.
Description
Technical field
The utility model belongs to medical instruments field, is related to a kind of implant electrode wire, specifically a kind of anti-degraded parent
Water lubrication implant electrode wire.
Background technology
Pacemaker and electric cardioversion defibrillator be for heart can not one kind of patient of normal work long-term plant
Entering property medicine equipment, pacemaker is to be directed to Symptomatic bradycardia and the invalid patient of drug therapy；Electric cardioversion
Defibrillator is the patient for having ventricular fibrillation, ventricular flutter and other tachy-arrhythmias for another major class patient.Either
The pacemaker being chronically implanted, or electric cardioversion defibrillator, are required for intracardiac electrode wire electric pulse stimulation signal
Or shock energy reaches heart from pace-making generator or electrical conversion defibrillator.Intracardiac electrode wire sends into the chambers of the heart by vein, separately
One end is connected with pace-making generator or electrical conversion defibrillator, regular electric pulse or energy is reached heart, too slow or mistake
Fast heartbeat is adjusted to required frequency, so as to ensure normal heart action.
Brain pacemaker, also known as Deep brain stimulation (Deep brain stimulation (DBS)), it is specific in intracerebral
Nerve nucleus implant electrode, discharge high-frequency electrical stimulation, for treating various out of control nervous disorders, particularly for
Mitigate Parkinsonian symptoms.Three cardinal symptoms of Parkinson's are alleviated in treatment:Tremble, stiff and bradykinesia etc..Brain is paced
Device includes impulse generator, an electrode cable, and these parts implant.
Neuromodulation（Neuromodulation）It can be used to treat dyskinesia, spasm, epilepsy and Pain Syndrome,
Most common product is the spinal cord stimulation trial for treating back and lower limb pain, and the medical treatment device includes the nerve being chronically implanted
Stimulation instrument and electrode cable.
Although the illness of three major types product treatment above is different, the electrode cable of implantation is required for.
At present, the implant electrode wire external insulation layer used typically has two kinds of materials to be made, and one kind is that biological stability is good
But the poor silicone elastomer of physical and mechanical properties；Another is the excellent medical Polyurethane Elastomer of physical and mechanical properties,
But the polyether segment in polyurethane can slowly degrade in the presence of superoxide ion in vivo, cause medical polyurethane insulating properties
With the decline of physical and mechanical properties, the failure of electrode cable can be caused.
Patent No. CN99804383.4 Chinese patent discloses a kind of non-elastomeric polyurethane compsnss, with raising
Mechanical performance, transparency and anti-degradability, available for manufacture medical treatment device, product or implant, but said composition is main
It is, in order to improve mechanical performance and transparency, especially to require that high-impact, rigidity, heat distortion temperature are high and similar to poly- carbon
The application of the other structures strength character of acid esters, nylon and other engineered thermoplastics, for intracardiac electrode wire, implantable
Difference.
Surface has the medical instruments of lubricity when being moistened disclosed in Publication No. US20110274918, by metal material
The substrate layer 1 of formation, and the compound that is at least one of, having multiple mercaptos by intramolecular of covering substrate layer 1 are formed
Intermediate layer 2, and the covering surface of intermediate layer 2, the surface lubrication that is formed by the hydrophilic macromolecule with reactive functional groups
Layer 3, wherein, by making the compound with mercapto be reacted with hydrophilic macromolecule, surface lubrication layer 3 is via the knot of intermediate layer 2
Close on substrate layer 1.Its anti-degradation effect does not reach requirement yet.
Patent No. CN1176966 Chinese invention patent discloses a kind of fluorine containing polyurethane material and preparation method thereof,
The composition of raw materials used by weight percentage for：PFPE dihydric alcohol 1~10%, makrolon or/and polyethers binary
Alcohol 30~70%, diisocyanate 20~50%, small molecule chain extender 3~25%, because PFPE dihydric alcohol surface can be low,
During hot-working or film forming can enrichment material surface so that reaching prevents oxide isolation and hydrolysis medium to body material
The purpose of material degraded, but the poor biocompatibility of the material, and degradation-resistant persistence is to be improved.
It is and for example a kind of with the mechanical performance, transparency, machinability that improve disclosed in Patent No. CN1299382
And/or the material of anti-degradability, described material includes polyurethane elastomeric compositions, and said composition includes being derived from least one
The soft chain segment of silicone glycol and at least one PTMEG and/or PCDL, the anti-degradability of described improvement
It is the resistance to free radical, oxidant, enzyme and/or hydrolytic process and/or the degraded when being implanted into as biomaterial, can be used in
On a variety of devices, heart heartstart or heart defibrillators, conduit, intubation, transplantable prosthese, heart assistance help device, the heart
Dirty valve, blood vessel graft, device outside, artificial organs, artificial or electronic heart pacemaker helical pitch, defibrillator helical pitch, blood pump, air pocket pump, A-V points
Stream device, biology sensor, cell envelope, drug delivery device, wound dressing, joint prosthesis, orthopedic implant or soft tissue are replaced
For thing.When above-mentioned composition is with electrode cable, the physical and mechanical properties of wire has been had a strong impact on, it is implanted into smooth degree
Difference, and difficulty of processing is big between wire insulating barrier itself.
In addition, United States Patent (USP) US 5589563, which further discloses a kind of used at polyurethane macromolecular two ends, has surface-active
The technology of molecule end-blocking improve the biological stability of polyurethane, wherein main sealed using single alkane hydroxyl polysiloxane
End.Because silicon surfactants are low, material surface is enriched in material processing, oxide isolation and acid can be hindered
Degraded of the property material to bulk material, therefore improve material biological stability.But polysiloxanes has lipophile, adsorbent
Inner lipid, makes material swelling set, therefore still suffer from definitely defect.
The content of the invention
In order to solve the above mentioned problem that existing implant electrode wire lead insulation material is present, the present invention provides a kind of anti-degraded
Hydrophilic lubrication implant electrode wire, by setting outer functional layer with the extexine of human contact, the functional layer contains natural anti-
Oxidant vitamin E, can prevent the oxidation scission of polyurethane polyethers segment, prevent the degraded of external insulation layer, improve electrode cable
Reliability；And the natural inhibitor has been widely used for human body, with nontoxic, bio-safety characteristic；Functional layer is also
Containing hydrophile copolymers, lubricity can be improved, reduction wire implantation resistance, wire implantation is more smooth, safer.
In order to achieve the above object, the present invention is adopted the following technical scheme that：A kind of anti-degraded hydrophilic lubrication implant electrode
External work ergosphere is provided with outside wire, including inner conducting layer and external insulation layer, the external insulation layer, the outer functional layer is to contain base
The functional layer of material and vitamin E, the thickness of the outer functional layer is 0.05mm to 2mm.
Above-mentioned technical proposal, by putting outer functional layer in external insulation layer peripheral hardware, can prevent degraded, in the base of outer functional layer
Vitamin E is added in material, anti-degradation is substantially increased, external insulation layer is protected, drastically increases the reliable of electrode cable
Property and security, extend electrode cable service life.
If the content of vitamin E is too low, do not reach degradation-resistant effect, it is too high if, the physical of wire can be influenceed
Can, and outer functional layer and the connection effect of external insulation layer are poor, increase and 1% is used in the difficulty of processing of outer functional layer, this programme
W to 40%W vitamin E, can both ensure anti-degradation effect, and small on other combination properties influence of wire.
Preferably, the outer functional layer is the functional layer containing polyurethane and vitamin E, the thickness of the outer functional layer
For 0.05mm to 2mm.
Preferably, the outer functional layer is the functional layer containing base-material, vitamin E and hydrophilic lubrication component, it is described outer
The thickness of functional layer is 0.05mm to 2mm.
Preferably, the vitamin E accounts for the 1%W to 40%W of the base-material.
Preferably, the hydrophilic lubrication component is while has the copolymer of the first segment and second of segment；Institute
The first segment is stated for hydrophilic molecule segment, including polyethylene glycol (polyethylene glycol, abbreviation PEG) and poly- second
Alkene pyrrolidone（Polyvinylpyrrolidone, abbreviation PVP）One or both of mixture, second of segment
Including at least one hydrophobic polymer segment.
Current electrode cable is in implantation, and smooth degree is poor, and the electrode cable blood vessel that can rub causes to rub than larger
Resistance is wiped, the feeding of electrode cable is influenceed, while causing unnecessary pain to patient, or even infection can be brought to injure；To electricity
Polar conductor is improved, and hydrophilic lubrication component is added in outer functional layer, lubricity can be substantially improved, and applicant is from numerous
Selected in hydrophilic material, but no matter be single use or be used in mixed way these hydrophilic high molecular materials, but lubrication
Effect is unsatisfactory, it may be possible to which these hydrophilic high molecular materials are easy to separate out from coating and migrated into blood, do not reach
The lubrication of long period.Also some lubricant coatings prepare complexity, costly.Applicant is by further studying hair
It is existing, hydrophilic material is polymerize to the copolymer to be formed with hydrophobic molecule segment as the principal component of lubricating layer, can be with one
Determine to improve lubricant effect in degree, relative cost is relatively low.PEG, the PVP selected in the application polymerize with hydrophobic molecule segment
The copolymer of formation, as the principal component of lubricating layer, its lubricant effect is the most notable, not only high lubricating effect, lasting lubrication
Performance can also reach the requirement of needs.
Preferably, the first described segment includes one or both of PEG and PVP mixture.
Preferably, the hydrophobic molecule segment is polyurethane（Polyurethane, abbreviation PU）, PPOX
（Polypropylene oxide, abbreviation PPO）In one or more.
The first segment, second of segment can be single-stranded section, such as PEG-PU or multiple segments, for example
PEG-PU-PEG-PU。
Preferably, the hydrophobic molecule segment is the one or more in polyurethane PU, PPOX PPO, this
After several molecule segments polymerize with PEG, PVP, lubricant effect is more preferable, more stable in intracardiac electrode conductive line surfaces, security
More preferably.
For example, the copolymer containing PEG（copolymer, PEG-CP）：CP segments in PEG-CP be it is hydrophobic, CP's
Hydrophobic performance can make PEG-CP be fixed on electrode with hydrophobic substrate molecule formation molecule winding, also mutual Van der Waals force
Conductive line surfaces.
If PEG is blended into polyurethane electrically insulating material, pure PEG is easy to that blood is separated out and be dissolved into from material
In liquid, so that the smooth effect in surface needed for not reaching electrode cable.The long-chain-segment of copolymer containing PEG and macromolecule electricity are exhausted
Edge wire substrate molecule mutually tangles and makes PEG-CP stable there is provided longer hydrophilic in electrode catheter polymer insulation layer surface
Lubrication.
Typical example is PEG-PPO-PEG copolymers, and hydrophilic PEG is stretched in blood, while hydrophobic PPO and dredging
The polyurethane of water plays fixed effect by Van der Waals force and molecule winding.
Further preferably, it is to form PEG-PU on the electrode cable surface that external insulation layer is polyurethane（Polyurethane segment）Apply
Layer, PEG provides hydrophilicity, PU（Polyurethane segment）It is compatible to the polyurethane insulating material with similar structure to be formed well
Molecule is wound and Van der Waals force is so as to provide excellent fixation.Other similar copolymers include PEG-PU-PEG, PEG-
PU-PEG-PU, PEG-PU-PEG-PU-PEG etc..
The copolymer (PVP-CP) of other hydrophilic segments is PVP-PU, PVP-PU-PVP, PVP-PU-PVP-PU, PVP-PU-
PVP-PU-PVP etc..
Further preferably, external insulation layer is layer of polyurethane.
Preferably, the first chain segment molecular weight is 100 to 30000.
Preferably, second of chain segment molecular weight is 100 to 30000.
Further preferably, the first segment and second of chain segment molecular weight are 100 to 10000.
100-10000 models in the molecular size range influence polymerization effect of the first segment and second of segment, this programme
In enclosing, polymerization effect is good, and obtained performance of copolymer is stable, can meet hydrophilic and hydrophobic balance.
Preferably, the molecular weight of the copolymer is 200 to 100000.
Further preferably, the molecular weight of the copolymer is 300 to 50000, further preferred 500 to 20000.
The molecular weight of copolymer is too small, and lubrication is not obvious, and the effective time of lubrication is limited, in the scope of the program
Interior, the bigger effect of molecular weight is better, but when more than 100000, lubricant effect is no longer lifted, and cost also increases.
Preferably, the thickness of the outer functional layer is 0.005mm to 1mm.
Further preferably, the thickness of the outer functional layer is 0.05mm to 1mm.
Still more preferably, the thickness of the outer functional layer is 0.10mm to 0.50mm
By implementing above-mentioned technical proposal, the utility model by setting outer functional layer with the extexine of human contact,
The degraded of external insulation layer is prevented, and lubricity can be improved, reduction wire implantation resistance, wire implantation is more smooth, safer.
Brief description of the drawings
Accompanying drawing 1 is the cross section view of the embodiment of the utility model one；
Accompanying drawing 2 is the cross section view of another embodiment of the utility model.
Embodiment
Below by specific embodiment, the utility model is described in further detail.
Embodiment 1：
A kind of anti-degraded hydrophilic lubrication implant electrode wire, as shown in Figure 1, including inner conducting layer 1 and external insulation layer 2,
External work ergosphere 3 is provided with outside external insulation layer 2, the outer functional layer 3 is containing polyurethane base-material and added in the base-material
The functional layer of vitamin E, the vitamin E accounts for the 20%W of the base-material, and the thickness of the outer functional layer is 0.05mm.
Embodiment 2：
Set outside a kind of anti-degraded hydrophilic lubrication implant electrode wire, including inner conducting layer and external insulation layer, external insulation layer
There is outer functional layer, outer functional layer is the functional layer containing polyurethane He the vitamin E for the 5%W for accounting for polyurethane, the thickness of outer functional layer
Spend for 0.5mm.
Embodiment 3：
Set outside a kind of anti-degraded hydrophilic lubrication implant electrode wire, including inner conducting layer and external insulation layer, external insulation layer
There is outer functional layer, thickness is 0.6mm, outer functional layer is the functional layer containing polyurethane, vitamin E and hydrophilic lubrication component, institute
It is while having the copolymer of the first segment and second of segment, molecular weight is between 300-10000 to state hydrophilic lubrication component；
The first described segment is hydrophilic molecule segment, is PEG；Second of segment includes a kind of hydrophobic molecule segment, gathers
Urethane segment.
Embodiment 4：
A kind of anti-degraded hydrophilic lubrication implant electrode wire, including inner conducting layer and external insulation layer, external insulation layer is poly- ammonia
Ester layer, it is provided with external work ergosphere outside, and thickness is 0.2mm, and outer functional layer is to contain polyurethane, vitamin E and hydrophilic lubrication group
Point functional layer, hydrophilic lubrication component is the copolymer of PEG and PPOX PPO segments formation, molecular weight be 1000 to
20000。
Embodiment 5：
A kind of anti-degraded hydrophilic lubrication implant electrode wire, the present embodiment is by taking ICD electrode cables as an example, as shown in Figure 2,
Including cable 4 and external insulation layer 2, external insulation layer 2 uses polyurethane insulating material, and external insulation layer 2 contains 4 function passages 21,
Cable 4 is set in each function passage 21, the outer functional layer 3 that thickness is 1mm is provided with outside the external insulation layer 2, it is described
Outer functional layer 3 is the functional layer containing polyurethane base-material, vitamin E and hydrophilic lubrication component, the master of the hydrophilic lubrication component
Composition is PEG-PPO-PEG copolymers, and adds 80% polyurethane for accounting for the weight of outer functional layer 3, the molecular weight of copolymer
In 800-15000.
Claims (9)
1. a kind of anti-degraded hydrophilic lubrication implant electrode wire, including inner conducting layer and external insulation layer, it is characterised in that described outer
External work ergosphere is provided with outside insulating barrier, the outer functional layer is the functional layer containing base-material and vitamin E, the outer functional layer
Thickness is 0.05mm to 2mm.
2. according to claim 1 it is a kind of it is anti-degraded hydrophilic lubrication implant electrode wire, it is characterised in that the outer functional layer
For the functional layer containing polyurethane and vitamin E.
3. the anti-degraded hydrophilic lubrication implant electrode wire of one kind according to claim 1 or claim 2, it is characterised in that the external work
Ergosphere is the functional layer containing base-material, vitamin E and hydrophilic lubrication component, the thickness of the outer functional layer for 0.05mm extremely
2mm。
4. according to claim 1 it is a kind of it is anti-degraded hydrophilic lubrication implant electrode wire, it is characterised in that the vitamin E
Account for the 1%W to 40%W of the base-material.
5. according to claim 3 it is a kind of it is anti-degraded hydrophilic lubrication implant electrode wire, it is characterised in that the vitamin E
Account for the 1%W to 40%W of the base-material.
6. according to claim 3 it is a kind of it is anti-degraded hydrophilic lubrication implant electrode wire, it is characterised in that the hydrophilic lubrication
Component accounts for the 1%W to 40%W of the base-material.
7. according to claim 3 it is a kind of it is anti-degraded hydrophilic lubrication implant electrode wire, it is characterised in that the hydrophilic lubrication
Component is while has the copolymer of the first segment and second of segment；The first described segment is hydrophilic molecule segment；
Second of segment includes at least one hydrophobic molecule segment.
8. according to claim 7 it is a kind of it is anti-degraded hydrophilic lubrication implant electrode wire, it is characterised in that the copolymer by
PEG is formed with polyurethane segment and/or polypropylene oxide segments and/or silicon rubber segment copolymerization.
9. according to claim 7 it is a kind of it is anti-degraded hydrophilic lubrication implant electrode wire, it is characterised in that the copolymer by
PVP is formed with polyurethane segment and/or polypropylene oxide segments and/or silicon rubber segment copolymerization.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201621111993.0U CN206604018U (en) | 2016-10-11 | 2016-10-11 | A kind of anti-degraded hydrophilic lubrication implant electrode wire |
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| CN201621111993.0U CN206604018U (en) | 2016-10-11 | 2016-10-11 | A kind of anti-degraded hydrophilic lubrication implant electrode wire |
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| CN206604018U true CN206604018U (en) | 2017-11-03 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107913462A (en) * | 2016-10-11 | 2018-04-17 | 白龙腾 | A kind of anti-degraded hydrophilic lubrication implant electrode conducting wire and its preparation process |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107913462A (en) * | 2016-10-11 | 2018-04-17 | 白龙腾 | A kind of anti-degraded hydrophilic lubrication implant electrode conducting wire and its preparation process |
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| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20171103 Termination date: 20181011 |
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| CF01 | Termination of patent right due to non-payment of annual fee |