CN103584853B - The manufacture method of the mapping catheter of monophasic action potential - Google Patents
The manufacture method of the mapping catheter of monophasic action potential Download PDFInfo
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- CN103584853B CN103584853B CN201310360689.4A CN201310360689A CN103584853B CN 103584853 B CN103584853 B CN 103584853B CN 201310360689 A CN201310360689 A CN 201310360689A CN 103584853 B CN103584853 B CN 103584853B
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Abstract
Present invention is disclosed a kind of method manufacturing medical device distal end part, comprising: provide one or more wire rod be made up of conductive material, each wire rod has longitudinal axis; The outer casing mold with first end and the second end is provided; By one or more wire arrangement in outer casing mold, so that each go out from the first end of outer casing mold and the second distal process at least partially in one or more wire rod; And biocompatible material is incorporated in outer casing mold; And the time that biocompatible material is solidified is provided, to form the coated case member be molded on one or more wire rod, one or more wire rod is securely fixed in case member.Method of the present invention can reduce the number of components alone for the manufacture of MAP recording equipment as much as possible, and optimizes the function of all parts used.
Description
Technical field
The present invention relates to the mapping of improvement and tissue ablation device and system, and manufacture the method for mapping and ablation member.The invention still further relates to the mapping device comprising the ability of melting of improvement.In addition, the invention still further relates to the mapping of improvement and the manufacture method of ablation catheter.
Background technology
Multiple therapy is had to can be used to treat various such as arrhythmia, atrial fibrillation and other electric pulse cardiovascular diseases by the erratic behavior of cardiac conduction and so on.As a kind of alternative method to open heart operation, many therapys adopt Minimally Invasive Surgical Technology to perform, and wherein one or more elongated medical devices are inserted in patient body by one or more little wound.The method can comprise using and has multiple sensor, the conduit of electrode or probe, or other is measured and therapy component, in order to treat the affected areas of heart, vascular system or other tissue.Minimal invasion medical device is required for various medical science and surgical operation application, because they allow patient to fully recover within the time shorter than traditional surgery, and accurately can treat and is difficult to by other method the discrete tissue in local that arrives.Such as, conduit can easily insert and handle by blood vessel and tremulous pulse, allow to arrive region in health with quite little damage Wicresoft, simultaneously, the probe of other Wicresoft or instrument can insert in little opening, and be guided through the anatomical structure of target, surrounding tissue is not had a significant impact or destroys.
This type of example of minimally-invasive treatment comprises treatment arrhythmia or irregular heart beating, and to this, the cardiac diagnosis that doctor uses such as mapping and/or ablation catheter and so on special and therapy equipment, in the hope of arriving the interior zone of patient body.Such device can comprise end electrodes or other ablation, in order to form the infringement or other anatomical effect that destroy or block by the electric pathway of destination organization.In ARR treatment, usually before treatment thereafter, first to identify heart tissue have abnormal electrical activity (such as, focus trigger, slowly conduction, too fastly to polarize again, gradation electric scanning etc.) special area.This localization or identification can comprise the electric scanning figure of the monophasic action potential (" MAP ") obtaining heart special area.Monophasic action potential record demonstrates that local organization is unpolarizedly made a start, polarization process and total action potential morphology again.MAP signal is organized depolarization to obtain by making to select temporarily, the electrical activity of response is gone on record, or alternate manner monitors, to indicate focal depolarization's time and any abnormal electrical activity.After mapping and diagnosis abnormal structure, doctor can determine to treat patient by melting this tissue.Accurate location heart tissue can reduce and melts number of times needed for treatment abnormal electrical pathway, and melting of execution can be made more effective.In addition, MAP record can help to determine local organization activationary time, and when using standard intracardiac electrode record, this time is normally indefinite.
The precision of MAP signal measurement depends on the contact quality between one or more localizing electrode and heart tissue to a great extent.Such as, the motion artifact effect caused by beating heart and uneven ventricular systole can make the MAP signal skew (distort) detected significantly, because change localizing electrode is acted on the pressure (and the contact therefore changed between them) in heart tissue by heart movement.Mapping device known at present accurately and reliably can not detect MAP signal.In addition, mapping device known is at present not only reliable not, and because the quantity cause of material therefor and used unit, their manufacturing cost is also very expensive.Such as, normally used its effectiveness of Franz conduit is limited, and manufacturing cost is expensive and difficult.
This type of example of minimally-invasive treatment comprises treatment arrhythmia or irregular heart beating, and to this, the cardiac diagnosis that doctor uses such as mapping and/or ablation catheter and so on special and therapy equipment, in the hope of arriving the interior zone of patient body.Such device can comprise end electrodes or other ablation, in order to form the infringement or other anatomical effect that destroy or block by the electric pathway of destination organization.In ARR treatment, usually before treatment thereafter, first to identify heart tissue have abnormal electrical activity (such as, focus trigger, slowly conduction, too fastly to polarize again, gradation electric scanning etc.) special area.There is the intracardiac catheter mapping electrodes of standard, just can challenge resolution and the spatial resolution of this type of signal.Graded signal source is difficult to accurately identify, this type of signal provides seldom about the information of lower myocardium disease state.In order to improve the electrical feature of lower cardiac muscle significantly, this localization or identification can comprise the electric scanning figure of the monophasic action potential (MAP) obtaining special heart area.With regard to normal electrode, MAP record proves that local organization is unpolarized and makes a start.In addition, by determining the form of action potential, the myocyte that MAP record characterizes under contact electrode polarizes again.Most importantly, MAP record determines the action potential duration (APD) of lower myocardial cell.MAP signal obtains by the tissue that interim depolarization is selected, records the electrical activity of response, or alternate manner monitors in order to determine local APD and any abnormal electrical activity.After mapping and diagnosis abnormal structure, doctor can determine to treat patient by ablation tissue.Accurate mapping heart tissue can reduce and melts number of times needed for treatment abnormal electrical pathway, and melting of execution can be made more effective.In addition, MAP record can help to determine local organization activationary time, and when using standard intracardiac electrode record, this time is normally indefinite.The MAP record produced by making contact tissue depolarization, will comprise with accurate focal depolarization's timing upwards blow, and the catheter electrode of standard can be subject to far field depolarizing influences substantially, and can show low revolution rate.This type of signal accurately can not indicate the time of focal depolarization.
MAP recording equipment can comprise many parts alone, this make manufacture become difficulty and expensive.Such as, have a kind of device to have end electrodes design, this design comprises and is welded on circular platinum pole stock end or the spheroid be formed on this end.The manufacture method being used for producing these devices is in early days proved to be inconsistent and the electrode spheroid produced is not completely rounded.As a result, be difficult in the dome part of distal portion office electrode being seated to suitably device.When electrode spheroid is welded on wire rod, electrode also can become irregular in dome part, is eccentric on the point of electrode axis because wire rod is very easy to be attached to.In addition, due to the separating component partly wanting use cost expensive, so this type of MAP recording equipment manufactures very expensive.Use multiple parts also in use can be easier to fracture, this can cause hurting patient.Finally, current MAP recording equipment does not provide the ability of melting, and thus, needs additionally use ablating device.But, when detecting abnormal signal, with the identical position of MAP recording equipment in locate ablating device be very difficult, and be impossible sometimes.As a result, to melt or other process may far not reach the significant degree that will reach.
In order to provide more effective and efficient therapeutic treatment, therefore, need to optimize and guarantee between mapping device with heart tissue evenly the operative installations contacted and method when recording MAP signal.Also need to have the conduit that not only monophasic action potential can be recorded but also melt local organization when needing thereafter.It would also be desirable to provide the manufacture not only simple but also effective positioner of cost.
In addition, in order to provide the method manufacturing the more effective and efficient method of mapping device and provide therapeutic treatment, therefore, needing to reduce the number of components alone for the manufacture of MAP recording equipment as much as possible, and optimizing the function of all parts used.It would also be desirable to provide a kind of device, it can either record the abnormal current source that MAP signal can melt again or alternate manner heat treatment identifies.
Summary of the invention
The present invention relates to for improvement of the methods, devices and systems of target tissue region mapping, a kind of not only can mapping but also the system that can be melted by common conduit, a kind of and method manufacturing this mapping and ablation member.The method of assembling mapping and ablation member can generally include a part of anodization making the tantalum/tantalum alloy being simultaneously used as conductor and attached electrode.Insulation and the anodization of corrosion resistant oxide deposition allow relative to adjacent structure electric insulation, reduce the size and sophistication of device simultaneously.
This system can generally include mapping structure, and it is designed to increase surface area and relative to the contact pressure of the tissue under it.This mapping device can generally include solid or deformable electrode shell, and multiple electrode be coupled on deformable electrode shell.Electrode shell can be made up of at least one in deformable polymer, expandable air bag, metal and fibre composites.
The present invention advantageously provides the method manufacturing mapping and/or ablating device distal portions, and parts and the manufacturing step of its needs are fewer than the quantity needed for device known at present.In one embodiment, the method can comprise: provide one or more wire rod be made up of conductive material, each wire rod has longitudinal axis; The outer casing mold with first end and the second end is provided; By one or more wire arrangement in outer casing mold, make going out from the first end of outer casing mold and the second distal process at least partially of each one or more wire rod; And biocompatible material is incorporated in outer casing mold, and allow this material cured, thus form the coated case member be molded on one or more wire rod.This one or more wire rod can be securely fixed in case member.Case member can form distal portions and proximal part, and distal portions can form the part of the one or more roundings be arranged on distal portions, such as, and three or more rounded portions.This rounded portion can be essentially hemispherical, and can the figure of radial symmetric be positioned on the distal portions of case member.In addition, the ledge of each one or more wire rod can be given prominence to from the exit point each one or more rounded portion.Then, the ledge of each one or more wire rod can be rived, to make the part of riving on the surface of one or more rounded portion and each one or more wire rod substantially coplanar.Then the surface of each one or more rounded portion can apply by layer of conductive material, and such as, conductive material is platinum-iridium.Conductive material layer in each hemisphere portion can be communicated with at least one electrode wires.
In a second embodiment, the method can comprise: provide electrode and electrode wires, and this electrode wires has longitudinal axis, near-end and far-end; Electrode wires is attached to electrode; The case member mould forming first end and the second end is provided; Electrode and electrode wires are arranged in case member mould, make going out from the second distal process of case member mould at least partially of electrode, giving prominence to from the first end of case member mould at least partially of electrode wires; Be incorporated into by biocompatible material in case member mould, and allow this biocompatible material solidify, form case member, and shift out case member from case member mould, case member is encapsulated and insulating electrode rigidly.Electrode can form the head of rounding, cervical region and shoulder, and this shoulder can form at least one plane surface.Electrode also can form distal portions and proximal part, and at least one plane surface of shoulder can comprise the plane surface of the close end office being positioned at electrode.In addition, the diameter that cervical region has is less than the diameter of each rounding head and shoulder.The far-end of electrode wires is attachable to the plane surface of electrode close end office.Alternatively, electrode also can be formed longitudinal axis and with coaxial recessed of electrode longitudinal axis, by by recessed in the far-end electrode insertion of electrode wires, electrode wires can be attached to electrode, like this, the longitudinal axis of electrode and the longitudinal axis of electrode wires substantially coaxial.Biocompatible material can be polyether-ether-ketone (PEEK), polyurethane or Polyetherimide.
In the third embodiment, the method can comprise: provide the wire rod be made up of conductive material, and this wire rod forms longitudinal axis, near-end and far-end; The outer casing mold with first end and the second end is provided; By wire arrangement in outer casing mold, the far-end of wire rod is given prominence to from the first end of outer casing mold, the near-end of wire rod goes out from the second distal process of outer casing mold; Make wire rod and biocompatible material coated molded; From outer casing mold, shift out case member, wire rod is attached in case member securely; The outstanding distal portions of removing wire rod; And layer of conductive material is coated to going up at least partially of case member, the wire rod in case member is communicated with this layer of conductive material.The method also can comprise: be arranged in outer casing mold by tractive wire rod, and this tractive wire rod has proximal part, goes out from the second distal process of outer casing mold to make the near-end of tractive wire rod.
According to the present invention, provide a kind of method manufacturing medical device distal end part, described method comprises: provide one or more wire rod be made up of conductive material, each wire rod has longitudinal axis; The outer casing mold with first end and the second end is provided; By described one or more wire arrangement in described outer casing mold, so that each go out from the first end of described outer casing mold and the second distal process at least partially in described one or more wire rod; And biocompatible material is incorporated in described outer casing mold; And the time that described biocompatible material is solidified is provided, to form the coated case member be molded on described one or more wire rod, described one or more wire rod is securely fixed in described case member.
Preferably, in the method for the invention, described case member forms distal portions and proximal part, and described distal portions forms one or more rounded portion.
Preferably, in the method for the invention, described one or more rounded portion comprises three or more rounded portions, and described three or more rounded portions are in roughly hemispherical.
Preferably, in the method for the invention, described three or more rounded portions are positioned on the distal portions of described case member with radial symmetric figure.
Preferably, in the method for the invention, when described case member takes out from described outer casing mold, giving prominence to from the distal portions of described case member at least partially of the described one or more wire rod given prominence to from the first end of described outer casing mold.
Preferably, in the method for the invention, described one or more wire rod aligns in described case member, so that the ledge of each in described one or more wire rod is given prominence to from the exit point in each described one or more rounded portion.
Preferably, in the method for the invention, the ledge of each in described one or more wire rod is rived, so that the surface of the part of riving of each in the surface of described one or more rounded portion and described one or more wire rod is roughly coplanar.
Preferably, in the method for the invention, the surface application layer of conductive material of described one or more rounded portion, the conductive material layer on described each rounded portion is communicated with one of them of at least one electrode wires.
Preferably, in the method for the invention, also comprise: by attaching electrodes to described one or more wire rod one of them on; And by electrode arrangement in described case member mould, so that the going out from the second distal process of described outer casing mold at least partially of described electrode; From described case member mould, shift out described case member, described case member is encapsulated and the described electrode that insulate rigidly.
Preferably, in the method for the invention, described electrode forms rounding head, cervical region and shoulder, and described shoulder forms at least one flat surfaces.
Preferably, in the method for the invention, described electrode also forms distal portions and proximal part, and at least one flat surfaces of described shoulder comprises the flat surfaces of the proximal part being positioned at described electrode.
Preferably, in the method for the invention, the diameter of described cervical region is less than the diameter of each rounding head and shoulder.
Preferably, in the method for the invention, the operation described electrode wires being attached to electrode comprises: by the flat surfaces of the distal attachment of described electrode wires to the close end office of described electrode.
Preferably, in the method for the invention, described electrode also limit longitudinal axis and with coaxial recessed of the longitudinal axis of described electrode.
Preferably, in the method for the invention, the operation that described electrode wires is attached to electrode is comprised: during to be inserted into by the far-end of described electrode wires in described electrode recessed, the longitudinal axis of described electrode and the longitudinal axis of described electrode wires substantially coaxial.
Accompanying drawing explanation
Consider by reference to the accompanying drawings, with reference to the following detailed description, more easily will understand the more complete intension of the present invention and the advantage accompanied and feature, in accompanying drawing:
Fig. 1 shows the medical system comprising the conduit with mapping assembly;
Fig. 2 shows according to spherical wire rod of the present invention;
Fig. 3 shows for making the anodized example structure of spherical wire rod;
Fig. 4 shows the example constructions of wire rod spherical shown in Fig. 3 being given to further corrosion resistance;
Fig. 5 shows mapping assembly;
Fig. 6 shows the first embodiment of mapping assembly;
Fig. 7 shows the second embodiment of mapping assembly;
Fig. 8 shows the 3rd embodiment of mapping assembly;
Fig. 9 shows the 4th embodiment of mapping assembly;
Figure 10 shows the first electrode structure for improving the contact between mapping assembly and tissue;
Figure 11 shows the second electrode structure for improving the contact between mapping assembly and tissue.
Figure 12 shows the distal portions of medical treatment device, and it has and is combined to dome part part in case member and insulating element part;
Figure 13 A and 13B shows the distal portions of medical treatment device, and it has the coated case member be molded on end electrodes, electric wire and tractive wire rod;
Figure 14 shows medical device distal end part, and it has the coated case member be molded on electric wire material.Wire rod is rived in the position of overmolded resin and is polished, and the thin film deposition of platinum (or metalloid) is on outstanding protuberance;
Figure 15 shows the dome part of the distal portions of medical treatment device;
Figure 16 shows the first embodiment of recording electrode;
Figure 17 shows the second embodiment of recording electrode;
Figure 18 A-18C shows the embodiment of the insulating element of the distal portions of medical treatment device;
Figure 19 shows the system comprising the medical treatment device with mapping and ablation functionality;
Figure 20 A shows the first embodiment of the medical treatment device with mapping and ablation functionality;
Figure 20 B shows the second embodiment of the medical treatment device with mapping and ablation functionality, and this device comprises the temperature control capability based on thermocouple;
Figure 20 C shows the 3rd embodiment of the medical treatment device with mapping and ablation functionality, and this device comprises from the element of hypotube (hypotube) protrusion of surface and the temperature control capability based on thermocouple;
Figure 20 D shows the 4th embodiment of the medical treatment device with mapping and ablation functionality, and this device comprises the elbow in hypotube and the temperature control capability based on thermocouple;
Figure 21 A shows the 5th embodiment of the medical treatment device with mapping and ablation functionality, and this device comprises one or more graded areas of the metal surface of the transmitting direct current of exposure, and with blocking the region of radio frequency (RF) the conductive coatings coating that DC conducts;
Figure 21 B shows the medical treatment device with mapping and ablation functionality, and this device has the region of metal surface projection of the DC conduction that four expose, they by with block DC conduction the coating of RF conductive coatings four regions expose and separate.This class formation improves the ability recording MAP signal from this exposing metal surface contacted with myocardial cell; And
Figure 21 C shows the medical treatment device with mapping and ablation functionality, and this device has ducted three elbows, in order to improve localized contact and to improve the ability recording MAP signal from feature like this.Between this category feature, hypotube is coated with the RF conductive coatings of blocking DC conduction, therefore, improves the ability recording MAP signal from the exposing metal surface contacted with myocardial cell.This device also has the temperature control capability based on thermocouple.
Figure 22 shows the distal portions of medical treatment device, and it has and is combined to dome part part in case member and insulating element part;
Figure 23 shows the sectional view of the distal portions of medical treatment device, and it has the coated case member be molded on end electrodes, electric wire and tractive wire rod;
Figure 24 shows the flow chart of the first method manufacturing medical device distal end part, and it has and is combined to dome part part in case member and insulating element part;
Figure 25 shows the first embodiment of recording electrode;
Figure 26 shows the second embodiment of recording electrode;
Figure 27 shows the reduced graph of the case member in outer casing mold; And
Figure 28 A-28D shows the second method manufacturing medical device distal end part, and it has the coated case member be molded on electrode wire.Wire rod is rived, and polishes in the position of overmolded material, and platinum (or metalloid) thin film deposition is on the ledge of rounding.
Detailed description of the invention
Referring now to Fig. 1, there is shown the medical system with conduit and mapping assembly.This system always can comprise medical treatment device (such as conduit or surgical probe), and it is coupled on control station or other operating equipment.Conduit has mapping assembly, and it can be positioned on target tissue region or near target tissue region location.This conduit can have slender body, its inner chamber having proximal part, distal portions and formed between the ends.The distal portions of slender body can comprise one or more reference electrode, they and mapping assembly and control station electric connection.Slender body can be not only flexibility but also elastic, has enough post intensity so that with tissue stabilization contact, thus improve the in-house signal fidelity of mapping contact.Conduit also can have the handle be attached on slender body proximal part, and it can comprise one or more fluid intake and outlet port, actuator, adapter, and other controls and/or Connection Element.
Mapping assembly is coupled to the distal portions of slender body, and comprises one or more electrode, and each electrode comprises electrode head and electrode wires.This one or more electrode for good and all can be attached in (as shown in Figure 2-5 with described) on electrode assemblie shell.The operation of this mapping assembly at least for mapping target tissue region, but also can be used as processing components and operates.Such as, control station can comprise radio frequency (RF) generator with one or more electrode electric connection, so that mapping assembly also can be used for ablation targets tissue regions.Mapping assembly can comprise as concrete in Fig. 2-12 shown in and as described in one or more electrodes.Mapping assembly can be made up of height corrosion-resistant material, such as tantalum (Ta), particle stabilized tantalum (TaKS), tantalum pentoxide (Ta
2o
5), tungsten tantalum (TaW), capacitive character tantalum (TaK) or similar material.Tantalum compound is extremely corrosion-resistant, shows the characteristic of splendid cold ductility, high-melting-point (such as, the fusing point of Ta is 3,017 DEG C), outstanding water-resistance solution and metal molten, superconduction and biocompatibility highly.Such as, tantalum pentoxide has unique galvanic ability of obstruction, allows Guiding high frequency electric current simultaneously.In addition, TaKS is such as radiopaque, can be applicable to well to be positioned at patient body and the conduit handled by patient body.Tantalum and tantalum compound are even than MP35N(nickel-cobalt-chromium-molybdenum alloy, the material of the common armarium for such as conduit and so on, it is nonmagnetic, has high hot strength, good ductility and toughness, and splendid corrosion resistance) more durable, but cheap than platinum.Except embodiment as shown in Figure 1, mapping assembly can comprise unitary electrode, wherein, electrode at least partially by tantalum compound (such as, Ta
2o
5) composition, and it is at least partially by different materials (such as, gold or platinum) composition.Its result, the tantalum part of electrode can carry out ablation tissue (such as, kidney, liver, or prostata tissue) with RF energy, and the non-tantalum part of electrode can be used to provide unidirectional current to encourage, or record carrys out the unidirectional current of self-organizing.
Referring now to Fig. 2, there is shown according to electrode wires of the present invention.Tinsel can be manufactured or molded, to be formed at one end spherical or roughly spherical (being called " ball ").This ball will become electrode head (such as, as illustrated in figs. 2-4 with described), so ball can be any size being suitable for last mapping assembly.Have single-piece electrode head and electrode wires just without the need to by electrode welding on wire rod.Two pieces type system is also feasible, but can increase cost and manufacturing time and complexity.The wire rod comprising ball can be made up of high corrosion resistance material, such as tantalum or tantalum compound (such as, Ta
2o
5or TaKS).
Referring now to Fig. 3, there is shown to make the anodized example constructions of spherical wire rod.Once the spherical wire rod shown in Fig. 1 is formed, just make wire rod anodization to form thin oxide layer.Such as, insulating barrier can be approximately 1 μm thick.In anodizing process, wire rod (not comprising spherical) is placed on such as H
3pO
4, H
2sO
4, winestone acid amide etc. electrolyte in.Then, electric current (unidirectional current, alternating current or Pulse Electric), by solution, forms oxide layer around wire rod.This oxide layer also protects wire rod to resist corrosion, gives conductive barrier to completely cut off with making the parts of wire rod and vicinity and cubic.How spherical wire rod can polarize a middle-jiao yang, function of the spleen and stomach.Although entire infrastructure can carry out anodization, preferred embodiment only anodization is adjacent to the device region of other conductive structure, to provide insulation barrier.
Referring now to Fig. 4, there is shown the example constructions of wire rod spherical shown in Fig. 3 being given to further corrosion resistance.After anodising, one or more deposition of material to improve electric conductivity, provides additional corrosion resistance, or gives other beneficial qualities characteristic on spherical.Such as, yttrium oxide can be plated out on spherical wire rod, or Ni-Ti alloy can splash on spherical.Other material and technology also can adopt.Before process is spherical (such as, by plating or spray method), one or more wire rod is placed in container, so that they are kept at suitable place.This container can be suitable for keeping any amount of wire rod, usually keeps wire rod, makes spherically just can to take (as shown in Figure 3) on container top.Once wire rod is placed in position, just can process spherical.Such as, the such one or more compound of such as yttrium oxide or other suitable material is electroplated.Additionally or alternatively, splash can be adopted to deposit Ni-Ti alloy, gold, platinum or platinum base alloy or similar material.
Referring now to the assembly of mapping shown in Fig. 5, figure.Once one or more wire rod processed (such as, anodization and plating), wire rod is placed and is bonded in electrode assemblie shell and (be also referred to as " mapping package shell ").Such as, four spherical wire rods can be used.This stage (that is, when being located in mapping package shell when spherical wire rod), spherical wire rod is referred to as electrode, and it comprises electrode head and electrode wires.Electrode and electrode assemblie shell are referred to as mapping assembly.Package shell comprises one or more electrode head can from before wherein outstanding.Alternatively, electrode head can be arranged in package shell, and electrode head is flushed with before electrode shell substantially.Electrode can use binding agent, heat shrinkable plastic or other known technology to be attached to electrode assemblie shell.In addition, package shell can be used as ablating electrode, in this case, can include heat insulating lamina in, to make electrode head and package shell electric insulation.This can utilize such as platinum or platinum alloy (such as, 90Pt/10Ir) and so on material to realize, and to form package shell, or is realized by coating or the shell involucrum that is made up of another material.This insulating barrier can be oxide (the such as Ta on electrode head
2o
5), or the polymer thin coating of such as polyimides.Once after assembling, mapping assembly can be coupled on distal catheter portion, electrode wires is made to provide electrical connection between mapping assembly and conduit and/or system.Therefore, whole mapping assembly can include as few as two parts (such as, if use unitary electrode and mapping package shell).In non-limiting example, mapping assembly can comprise five parts: four electrodes and mapping package shell.This embodiment comprises the parts fewer than known mapping assembly, and this can reduce costs and reduce built-up time, provides higher reliability simultaneously.
Generally with reference to Fig. 6-9, there is shown several embodiments of mapping assembly.These embodiments usually comprise the surface area larger than known mapping assembly.Electrode structure becomes to improve the local contact force between mapping assembly and target tissue region, therefore, provides more reliable and accurate MAP signal record.Embodiment shown in Fig. 6-8 is single-piece electrode, and the embodiment shown in Fig. 9 is multi-piece electrode.Mapping assembly shown in Fig. 8 has multiple raised areas, and these regions form " muffin top " or " Brassica oleracea L. var. botrytis L. " shape.These raised areas increase surface area, therefore improve the contact pressure between mapping assembly and target tissue region and/or contact force.Each raised areas can be electrode head, and mapping package shell is configured to fix multiple electrode randomly, or for forming the organized architecture of Brassica oleracea L. var. botrytis L. shape effect.In addition, the thin-material layers coating that electrode head and package shell available conductive rate improve, can protect corrosion, reduce the surface tension of mapping assembly, or gives other desirable feature foregoing.Alternatively, the mapping assembly of Fig. 8 can comprise " Brassica oleracea L. var. botrytis L. " type electrode of single-piece, and it makes it have multiple raised areas by the relatively large metal of processing and makes, or electrode can be molded and have multiple raised areas.The mapping assembly of Fig. 9 can comprise the electrode of more than one piece, and (such as, electrode can comprise three, as shown in Figure 9).This structure can provide being separated of contacting with destination organization to get depolarization.That described various embodiments can provide unique anatomical or improve under procedure condition contact tissue.Such as, the embodiment in Fig. 9 can improve contact when conduit is placed along the surface on such as heart epicardial surface.
Generally with reference to Figure 10 and 11, there is shown the electrode structure of the Contact improving positioning catheter end and tissue.Figure 10 shows the electrode with spring-like electrode wires, and it absorbs the pressure of beating heart.When heart movement, the region of coiling of the cold formation of electrode wires will be expanded or shrink, with the contact between holding electrode head and target tissue region.In this case, package shell can comprise the inner chamber allowing the motion of each spring element.In addition, coiling region can when conduit proceeds to target tissue region, helps prevent because excessive contact masterpiece is used in patient's vascular causes injured.
As shown in figure 11, mapping package shell can be made up of deformable material, such as polymer, conducting polymer, aerating gasbag, gel, fibre composites etc., and this deformable material accords with irregular geometric form, meanwhile, the contact between electrode head and target tissue region is guaranteed.Such as, when heartbeat, deformable shell by absorption pressure, with the contact between holding electrode head and target tissue region.Alternatively, mapping package shell can be made up of the rigid material more of such as epoxy resin, or is made up of the metal electrode material of such as platinum/iridium alloy.
Referring now to Figure 12, there is shown the distal portions with the dome part of combination and the medical treatment device (such as, MAP recording equipment) of insulating element.MAP recording equipment known at present has distal portions usually, and this distal portions comprises dome part and the insulating element of separation.In the fabrication process, electrode is coupled to dome part, and then dome part is bonded to insulating element.This insulating element is then fused on catheter tip pipe.But these parts can be removed, the part of separation just becomes thrombosis rapidly, works the mischief thus to patient.In addition, adopt multiple parts to be very expensive, be not only the cost of material, and because manufacture difficulty large (such as, due to individual part small-sized) and built-up time long.That the device price with distal portions shown in Figure 12 is cheap, easy to manufacture, and improves the safety of patient with recording equipment difference known at present.
Continue with reference to Figure 12, the distal portions of medical treatment device comprises single case member, and it is substantially similar to the dome part of separating and the insulating element of current known devices.Such as, case member can be made up of polyimides or polyether-ether-ketone (PEEK).Therefore, case member can single, do not dislike in complicated process and manufacturing, this manufacture process reduces costs, the safety that increases easily manufactured degree and improve patient.
Referring now to Figure 13, there is shown the distal portions of medical treatment device (such as, MAP recording equipment), it has the coated case member be molded on end electrodes, electric wire and tractive wire rod.Be similar to medical device distal end part shown in Figure 12 He described, the distal portions of the medical treatment device shown in Figure 13 comprises single case member, and it is substantially similar to the dome part of separating and the insulating element of current well known device.But the case member shown in Figure 13 can coatedly be molded (both can single injection also can multiple injection) at end electrodes, electric wire, tractive wire rod, and/or other inside or outside device feature on.Coated molded benefit is, has powerful combination between other device feature kept when case member and device can be allowed to use, and without the need to using binding agent.Coated for case member another benefit be molded on electrode is, electrode by not need carefully to be seated in case member corresponding recessed in.As shown in Figure 15-17 and discuss, can be very difficult in shell electrode being properly positioned on device distal portions.Coated molded another benefit that also has is, tractive wire rod is anchored in case member, thus, reduces or eliminates the demand to additional tractive wire rod anchoring mechanism.
Figure 13 A shows the axonometric chart of the distal portions comprising four electrodes, electrode wires and tractive wire rod.Figure 13 B shows the sectional view of distal portions shown in Figure 13 A.But, by being molded in coated for case member the medical device distal end part that other device feature manufactures, the electrode (it can work the function of note down electrode or ablating electrode) of any quantity and structure, electrode wires, tractive wire rod and other device feature any can be comprised.As limiting examples, each electrode can by rounded portion (such as, having roughly hemispherical), cervical region and shoulder part (describing in detail in such as Figure 16 and 17) composition.
Referring now to Figure 14, the distal portions of medical treatment device has the coated case member be molded in electrode wires.Identical with the distal portions with described shown in Figure 13 A with 13B, the case member of the distal portions shown in Figure 14 can coatedly be molded on other device feature.But, be that the electrode shown in Figure 14 is by electrode wires and be deposited on the conductive layer of case member at least partially on outer surface and form with electrode difference shown in Figure 13 A and 13B.Total outward appearance of distal portions can be as shown in figs. 13 a-13b.That is, distal portions can comprise one or more arch section (the roughly hemisphere portion of the electrode in such as Figure 13 A-13B), but these arch sections are parts of coated molded shape, are therefore made up of the material for case member.
In the fabrication process, case member is coated to be molded in one or more electrode wires, and each electrode wires is outstanding from the case member of a part.Such as, each electrode wires can be outstanding from the point the arch section of case member.After coated molding process completes, the ledge of each wire rod can be rived in the surface of case member, allows the cross section of each electrode wires be exposed to the surface of case member, then polishes.Then, cover can be placed or similar device contacts with distal portions, to make only having the part of rounding (or comprising other surface area portions of the cross section that electrode wires exposes) not by cover.The material that such as platinum-iridium (Pt-Ir) is such or other conductive material then can be deposited on exposure or not by the region of cover, to form the electrically conductive layer contacted with electrode wires 20.The electrode of this simplification not only manufactures more cheap than traditional electrode, and relates to alignment minimum in case member.
Referring now to Figure 15-18, there is shown the embodiment of case member and electrode.One design (design of the MAP4 device of such as Medtronic company) of MAP recording equipment end electrodes comprises welding or is formed in the spheroid of circular platinum filament end.This design is difficult to regenerate and needs completely circular ball.This, when ball is not completely circular and is centered on attached wire rod, is difficult to electrode tip holder to drop in dome part.These shortcomings cause the electrode shown in the shell shown in Figure 15 and Figure 16 and 17 exploitation, when they use together in single device, are particularly advantageous.
Referring now to Figure 15, there is shown the dome part that medical treatment device is distal portions.This dome portion can be combined to (as noted in figs. 12-14 with described) in the single case member with insulating element, or can be used as separating component.In rear a kind of situation, dome part can be designed to join with dielectric member card (such as, as shown in Figure 18 A-18C).In arbitrary situation, the dome portion shown in Figure 15 can use in following situation, and wherein, case member is not coated being molded on record or ablating electrode, and electrode must be located in the enclosure, to be attached to medical treatment device.Dome part shown in Figure 15 comprises four circular ports, has wherein been located in four electrodes; But, any amount of hole and electrode can be used.Each hole of dome part is countersunk, and like this, each hole comprises vent stem part, and electrode at least partially can be located in thereon.
Referring now to Figure 16, there is shown the first embodiment of recording electrode.Electrode shown in Figure 16 comprises the part (such as, having hemispherical roughly) of rounding, cervical region and flat shoulder.The part of the cervical region peace of this rounding can be called " electrode head " together.The even shape of shoulder is positioned at the close end office of electrode, electrode is not only allowed reliably to be shelved in the vent stem part of circular top part piece bores, and the attachment point of electrode wires (such as, the weldering of wire rod available laser or Resistance Welding receive the electrode proximal part at shoulder plane surface place) is provided.The diameter that electrode cervical region has is less than the diameter of shoulder in radius branch.As unrestriced example, the diameter of rounded portion can be approximately 0.035 inch, and the diameter of shoulder can be approximately 0.024 inch, and the diameter of cervical region can be approximately 0.020 inch.When use binding agent by electrode adhesion to dome part time, binding agent will flow in the recessed region by neck formation, thus, for binding agent provides the surface area of increase, and forms bonding stronger between electrode and dome part.
Referring now to Figure 17, there is shown the second embodiment of recording electrode.This electrode is substantially similar to electrode shown in Figure 16 and described, and exception part is that it is recessed that the electrode shown in Figure 17 also comprises the substantial cylindrical coaxial with the longitudinal axis of electrode.As unrestriced example, this is recessed has the diameter that is approximately 0.008 inch and is approximately the degree of depth of 0.020 inch.Recessed mouth or opening can be positioned on the flat shoulder on electrode proximal part, and recessedly can extend in the rounded portion of electrode from shoulder.When on attaching electrodes to electrode wires, electrode wires can insert with soldering or be welded to electrode recessed on.Therefore, the suitable alignment between electrode and electrode wires is facilitated widely.As discussed in the text, one of prominent question of current known MAP recording equipment is that, when attempting electrode tip holder to fall in dome assembly, electrode is tending towards the tendency of misalignment.Such as, when on the electrode that electrode wires is attached to eccentric point place, there will be the difficulty be located in.But, use electrode as shown in figure 17, just can alleviate or eliminate the problem that alignment is inaccurate together.
Referring now to Figure 18 A-18C, there is shown the embodiment of the insulating element of medical device distal end part.As mentioned above, the dome part of Figure 15 can be configured to card and fits on insulating element.Figure 18 A-18C shows the embodiment of the various designs of insulating element, and insulating element just can be used for the card be coupled in dome part and joins ridge.
Referring now to Figure 19, there is shown the medical system of the medical treatment device with band mapping and ablation functionality.This system always comprises medical treatment device (such as mapping and/or ablation catheter), and it is coupled on control station or other operating equipment.This device can comprise slender body, and body has near-end, far-end and forms inner chamber between the ends.The distal portions of device comprises the mapping assembly being positioned at target tissue region or areas adjacent.The far-end of slender body also can comprise one or more reference electrode, they and mapping assembly and control station electric connection.Slender body can be not only flexibility but also elastic, has enough post intensity so that with tissue stabilization contact, thus improve the in-house signal fidelity of mapping contact.Conduit also can have the handle be attached on slender body proximal part, and it can comprise one or more fluid intake and outlet port, actuator, adapter, and other controls and/or Connection Element.Conduit can with control station fluidly and/or electric connection, this can comprise cold-producing medium and/or saline source, vacuum source, power generator, power source, and one or more display, computer, control station and user input apparatus.
Mapping assembly is coupled to the distal portions of slender body, and comprises one or more electrode and shell.Each electrode can comprise electrode head and electrode wires, all as shown in FIG. 16 and 17 with described electrode tip and electrode wires.Alternatively, each electrode can comprise electrode wires and be deposited on the thin layer of conductive material of mapping assembly at least partially on outer surface, all electrode wires as shown in figure 14 and electrically conductive layer.In addition, the shell of mapping assembly can comprise the dome part and insulating element (such as, as shown in figs. 15 and 18 with described) that are bonded together, or shell can comprise the case member (such as, as shown in figure 12 with described) of single-piece.
This one or more electrode can for good and all be attached on mapping package shell.Such as, can be located in described electrode as shown in FIG. 16 and 17 as seen in figs. 15-17 with described case member in and be attached to this parts.Example as an alternative, can use the coated method of moulding described in Figure 13 and 14 to be for good and all attached on mapping package shell as shown in figs. 12-14 with described electrode.
The operation of mapping assembly at least for localizing objects tissue regions, but also can be used as processing components and carries out operating (it can be referred to as " location/processing components ").Such as, device can comprise the hypotube electrode of the minor diameter of one or more strip electrode and encirclement device distal portions.Control station can comprise radio frequency (RF) generator and saline solution source and/or cryogen source that are fluidly communicated with hypotube, with melt at RF or in pure cryoablation process for the distal portions of chiller.Location/the ablation functionality of this combination is a much progress for device mapping device (such as MAP4 studies conduit) known at present, and known devices can not provide RF energy safely.Hypotube is given prominence to from device distal portions, like this, when distal portions becomes arbitrarily angled relative to tissue surface, can with surround locate/tissue of processing components contacts.Hypotube can be used as contact electrode (+), and strip electrode can be used as recording electrode (-), to produce MAP signal.Such device can be referred to as " monophasic action potential (HCMAP) conduit of sub-cooling ".Only need one to contact electrode by being reduced to by the MAP of multiple for demand separation contact electrode, this HCMAP conduit also simplify the design of current known MAP recording equipment.In addition, the ablation procedure of this device is used to need minimum saline or flow of refrigerant to cool the electrode of low thermal mass.In the situation of pure cryoablation pattern, conductive pipe supply refrigerant liquid from the freezing control station being connected to device.This refrigerant liquid, the nitrous oxide such as compressed, is transported to hypotube by conduit axostylus axostyle, allows liquid expand according to Joule-Thomson effect and absorb heat there.Different from the HCMAP pattern of brine-cooled, in this case, saline can be allowed to flow out hypotube and to flow in blood flow, and be directed in conduit axostylus axostyle by the cold-producing medium of hypotube, get back to freezing control station by vacuum return path.
Referring now to Figure 20 A, there is shown the detail drawing of the first embodiment of the distal portions of the device with mapping and ablation functionality.The distal portions of device comprises hypotube and multiple strip electrode.Hypotube can be coiled or be wrapped in around slender body distal portions, and hypotube is at least wound around about 360 ° (as shown in Figure 20 A-21C) around slender body distal portions.As shown in Figure 19 with described, this device can either be located and RF energy can be used to carry out ablation tissue.
Referring now to Figure 20 B-21C, there is shown the other embodiment of the medical treatment device with mapping and ablation functionality.Figure 20 B shows the distal portions with the thermoelectricity occasionally HCMAP device of electro-hot regulator, and thermoelectricity occasionally electro-hot regulator is positioned to and hypotube electrode contact.One or more thermocouple can be positioned to contact with hypotube, with monitoring temperature.In unrestriced embodiment, hypotube is made up of gold-plated pipe, to make thermal conductivity very high.
Figure 20 C shows the distal portions of the HCMAP device with multiple element, these elements are outstanding from hypotube surface, with at the position contacted with each outstanding element, improve the contact with tissue, therefore, by increasing structural local pressure below outstanding element, improve MAP signal record ability.Each outstanding element can extend from hypotube surface, such as, extends from hypotube periphery.Although be shown as four outstanding elements in Figure 20 C, should be understood that, any quantity can be used to give prominence to element to improve the contact between HCMAP device and the tissue of concern.
Figure 20 D shows the distal portions of the HCMAP device with hypotube, and it can bend and comprise the elbow of one or more roughly angle.Each elbow can be given prominence to from hypotube periphery, therefore forms outstanding position around hypotube, in order to improve with the contact of tissue and to improve MAP signal record ability.Although Figure 20 D shows three outstanding positions, should be understood that, any amount of elbow can be comprised, during to be positioned at any orientation facing to heart wall at device, improve MAP signal record ability.
Figure 21 A, 21B and 21C show and are similar to the embodiment shown in Figure 20 B, 20C and 20D respectively.But Figure 21 A-21C illustrated embodiment also comprises one or more graded areas of the metal surface of the transmitting direct current of exposure, and with blocking the region of radio frequency (RF) the conductive coatings coating that DC conducts.By stoping the conduction in the part of low frequency heart signal between the DC conduction portion exposed, this RF conductive coatings can improve MAP signal record ability.These DC conduction portions exposed can be in the uncoated portion of hypotube, maybe can be positioned on the prominent features of hypotube, to improve MAP signal record ability further.In addition, the hypotube (not shown) of additional multiple windings can being used, making winding from the single far-end winding shown in Figure 20 A-21C towards proximally extending.Multiple winding can apply the coating of RF conduction and DC obstruction substantially, is coated on whole near-end windings or most near-end winding, to improve the MAP signal record ability of far-end winding, allows conduct RF energy when needed simultaneously.
Referring now to Figure 22, there is shown the distal portions 10 with the dome part 12 of combination and the medical treatment device (such as, MAP recording equipment) of insulating element 14.MAP recording equipment known at present has distal portions usually, and this distal portions comprises dome part and the insulating element of separation.In the fabrication process, electrode is coupled to dome part, and then dome part is bonded to insulating element.This insulating element and being fused on catheter tip pipe.But these parts can become and remove, the part of separation just becomes thrombosis rapidly, works the mischief thus to patient.In addition, adopt multiple parts to be very expensive, be not only the cost of material, and because manufacture difficulty large (such as, due to individual part small-sized) and built-up time long.Different from recording equipment known at present, the device price with distal portions is as shown in figure 22 cheap, easy to manufacture, and improves the safety of patient.
Continue with reference to Figure 22, the distal portions 10 of medical treatment device comprises single case member 16, and it is substantially similar to the dome part 12 of separating and the insulating element 14 of current known devices.Whole case members 16 can be made up of the biocompatible material that such as polyether-ether-ketone (PEEK), polyurethane or Polyetherimide are such.Therefore, case member 16 can single, do not dislike in complicated process and manufacturing, this manufacture process reduces costs, increase easily manufactured degree and improve patient safety.
Referring now to Figure 23, there is shown the sectional view of the distal portions of medical treatment device (such as, MAP recording equipment), it has the coated case member be molded on end electrodes, electric wire and tractive wire rod.The sectional view of Figure 23 shows the exemplary arrangement of all parts in case member 16 shown in Figure 22.The distal portions 10 of medical treatment device shown in Figure 23 comprises single case member 16, and it is substantially similar to the dome part 12 of separating and the insulating element 14 of current known devices.In other words, case member 16 can the electrode wires of hold electrodes and picture traditional round top part, and when distal portions is coupled on conduit, electrode wires also can make the remainder of electrode and catheter body insulate.The case member 16 of Figure 23 can coatedly be molded (both can single injection also can multiple injection) at end electrodes 18, electric wire 20, tractive wire rod 22, and/or other inside or outside device feature on.Coated molded benefit is, has powerful combination, without the need to use binding agent between other device feature kept when case member and device can be allowed to use.Coated for case member another benefit be molded on electrode is, electrode by not need carefully to be seated in case member corresponding recessed in.As shown in figures 25 and 26 with discussed, can be very difficult in shell electrode being properly positioned on device distal portions.Coated molded another benefit that also has is, tractive wire rod 22 is anchored in case member 16, thus, reduces or eliminates the demand to additional tractive wire rod anchoring mechanism.By being molded in coated for case member 16 the medical device distal end part 10 that other device feature manufactures, can comprise any quantity and structure electrode 18(its can work the function of note down electrode or ablating electrode), electrode wires 20, tractive wire rod 22 and other device feature any.As limiting examples, each electrode 18 by rounded portion 24(such as, can have roughly hemispherical), to describe in detail in cervical region 26 and shoulder part 28(such as Figure 25 and 26) composition.
Referring now to Figure 24, there is shown the flow chart of the method manufacturing medical device distal end part, it has and is combined to dome part part in case member and insulating element part.In step 1, provide one or more electrode 18, one or more electrode wires 20, and alternatively, other internal part of one or more such as tractive wire rod 22.In step 2, each one or more electrode wires 20 is attached to one upper (such as, as shown in figs. 25 and 26 with described) in one or more electrode 18.In step 3, provide the case member mould 29 with first end 31 and the second end 32.The size of this case member mould 29 and structure can be suitable for being formed such as case member 16 as depicted in figures 22 and 23.In step 4, one or more electrode 18, one or more electrode wires 20, and alternatively, other internal part one or more (such as, tractive wire rod 22) be arranged in case member mould 29, to make giving prominence to from the second end 32 of case member mould 29 at least partially of each one or more electrode 18, and each one or more electrode wires 20, and alternatively, the first end 31 outstanding (as shown in figure 27) gone up at least partially from case member mould 29 of other internal part one or more.In step 5, biocompatible material 30(such as, such as PEEK) coated molded (also referred to as inserted mode system) or injection-molded going up at least partially once: one or more electrode 18, one or more electrode wires 20, and alternatively, other internal part one or more.In step 6, biocompatible material 30 is allowed to sclerosis, cooling or solidification, thus, forms case member 16.In step 7, case member 16 is removed from case member mould 29.The case member 16 generated can have distal portions 33 and proximal part 34.The distal portions 33 of case member 16 can hold one or more electrode 18, and the proximal part 34 of case member 16 can be attached on the body of medical treatment device afterwards, the slender body of such as mapping and/or ablation catheter.
Referring now to Figure 25, there is shown the first embodiment of record or ablating electrode.Electrode 18 shown in Figure 25 comprises the head 24(of rounding such as, has hemispherical roughly), cervical region 26 and flat shoulder 28.This electrode can have proximal part 35 and distal portions 36.The even shape of shoulder 28 is positioned at proximal part 35 place of electrode 18, and provides the attachment point of electrode wires 20.Such as, the weldering of electrode wires 20 available laser or Resistance Welding receive the proximal part 35 of electrode 18, the plane surface place of the shoulder 28 as shown in the mixed and disorderly labelling in Figure 25.The diameter that the cervical region 26 of electrode 18 has is less than the diameter of rounding head 24 and shoulder 28.As unrestriced example, the diameter of rounding head 24 can be approximately 0.035 inch, and the diameter of shoulder 28 can be approximately 0.024 inch, and the diameter of cervical region 26 can be approximately 0.020 inch.Be molded coated or in injection-molded process, in the recessed region that inflow is formed by cervical region 26 by biocompatible material, thus, for biocompatible material provides the surface area of increase, and form stronger connection between electrode 18 and case member 16.
Referring now to Figure 26, there is shown the second embodiment of record or ablating electrode.This electrode 18 is substantially similar to electrode shown in Figure 25 and described, and exception part is that the electrode 18 of Figure 26 also comprises the substantial cylindrical coaxial with the longitudinal axis 40 of electrode 18 recessed 38.As unrestriced example, this recessed 38 can have the diameter that is approximately 0.008 inch and be approximately the degree of depth of 0.020 inch.The mouth of recessed 38 or opening 42 can be positioned on the flat shoulder 28 on the proximal part 35 of electrode 18, and recessed 38 can extend in the rounding head 24 of electrode 18 from shoulder 28.When electrode 18 is attached in electrode wires 20, electrode wires 20 can in any suitable manner electrode insertion 18 recessed 38 in, and soldering or be welded to this recessed on.Therefore, the suitable alignment between electrode 18 and electrode wires 20 is facilitated widely.
Referring now to Figure 27, there is shown the reduced graph of outer casing mold inside and outside shell parts.As described in Figure 24, one or more electrode 18, one or more electrode wires 20, and alternatively, other internal part one or more (such as, tractive wire rod 22) be aligned in case member mould 29, make giving prominence to from the second end 32 of case member mould 29 at least partially of each one or more electrode 18, and each one or more electrode wires 20, and alternatively, in other internal part one or more at least partially from the first end 31 outstanding (as shown in Figure 27) of case member mould 29.Such as, the going up at least partially of head 24 of electrode rounding can be given prominence to from case member mould 29, and the cervical region 26 of electrode 18 and shoulder 28 can in case member moulds 29.But can use any size of electrode, shape or structure, electrode is not limited to that electrode shown in Figure 25 and 26 He described.In addition, electrode head 24 can completely in mould 29, but only the electrode head 24 applicable biological compatible material 30 of a part is coated molded.Case member mould 29 shown in Figure 27 can simplify widely, illustrate only the coated not molded with biocompatible material 30 at least partially of each electrode 18.
Referring now to Figure 28 A-28D, there is shown the second manufacture method of medical device distal end part, it has the coated case member be molded in electrode wires.Identical with the method in Figure 24 with the case member 16 in Figure 22 and 23, the case member 16 of Figure 28 A-28D can coatedly be molded in one or more electrode wires 20.But, the medical device distal end part 10 shown in Figure 28 C not comprise as shown in Figure 26 and 27 and as described in ball electrode 18.On the contrary, electrode 18 adopts splash or other deposition process to be formed, and conductive material 44 is deposited on going up at least partially of case member 16, on the rounding of such as case member 16 or ledge 46.Such as, the first step of method as depicted in fig. 28 a, can provide the one or more wire rods 20 be made up of conductive material.Each wire rod can have longitudinal axis 48, proximal part 50 and distal portions 52.Although not shown in Figure 28 A-28D, additional parts can be comprised, such as one or more tractive wire rod.
At second step, roughly as shown in Figure 28 B, one or more wire rod 20 can be aligned in case member mould 29.Once wire rod 20 is aligned in case member mould 29, then can by biocompatible material 30(such as, PEEK) to inject or other method is incorporated in mould 29, wire segment is wrapped in case member mould 29.Then, allow biocompatible material 30 to cool, solidify, and/or sclerosis.Case member mould 29 can be configured to define case member 16 as shown in figure 22; But, case member mould 29 can form such case member 16, it comprises one or more rounded portion 46(of being formed by bio-compatible overmolded material 30 such as, roughly hemispheric protuberance), instead of form the case member 16 of wherein attached one or more spheric electrode 18.In addition, one or more wire rod 20 can align along the central axis 54 of case member, the distal portions 52 of each wire rod 20 can project past the first end 31 of mould, and the proximal part 50 of each wire rod 20 can project past the second end 32(of mould as shown in Figure 28 B).The angle 56 of the flexible one-tenth off-axis of distal portions 52 of wire rod 20.As shown in Figure 28 B-28D, this elbow 56 allows wire rod 20 to exit case member 16 at point 57 place, point 57 substantially at rounded portion 46(such as, roughly hemispherical protuberance) center.Once allow biocompatible material 30 cool and/or solidify, then can remove mould 29 from the case member 16 generated.
After coated molding process completes, the ledge 58 of each wire rod 20 can be rived in the surface of case member 16, allows the cross section of each electrode wires 20 be exposed to the surface of case member 16.The expose portion of each electrode wires of then can polishing is to form the smooth surface of case member 16.Then, cover can be placed or similar device contacts with the distal portions 33 of case member 16, with make to only have rounding hemisphere portion 46(or comprise other surface area portions of the cross section that electrode wires exposes) not by cover.The material that such as platinum-iridium (Pt-Ir) is such or other conductive material 44 then can be deposited on exposure or not by the region of cover, to form the electrically conductive layer 44 contacted with electrode wires 20.The electrode of this simplification not only manufactures more cheap than traditional electrode, and relates to alignment minimum in case member.
Technical staff will recognize that in the art, and the present invention is not limited to the content of above special diagram and description.In addition, unless separately had contrary mentioning above, otherwise it should be noted that, all accompanying drawings are not pro rata.For the above, can make various amendment and change, and can not depart from the scope of the present invention and spirit, the scope of the invention is only limited by following claims.
Claims (13)
1. manufacture a method for medical device distal end part, described method comprises:
There is provided one or more wire rod be made up of conductive material, each wire rod has longitudinal axis;
The outer casing mold with first end and the second end is provided;
By described one or more wire arrangement in described outer casing mold, so that each go out from the first end of described outer casing mold and the second distal process at least partially in described one or more wire rod; And
Biocompatible material is incorporated in described outer casing mold;
The time that described biocompatible material is solidified is provided, to form the coated case member be molded on described one or more wire rod, described one or more wire rod is securely fixed in described case member, described case member forms distal portions and proximal part, described distal portions forms one or more rounded portion, and
When described case member takes out from described outer casing mold, giving prominence to from the distal portions of described case member at least partially of the described one or more wire rod given prominence to from the first end of described outer casing mold.
2. the method for claim 1, is characterized in that, described one or more rounded portion is in roughly hemispherical.
3. method as claimed in claim 2, it is characterized in that, one or more rounded portion described is positioned on the distal portions of described case member with radial symmetric figure.
4. the method for claim 1, is characterized in that, described one or more wire rod aligns in described case member.
5. method as claimed in claim 4, it is characterized in that, the ledge of each in described one or more wire rod is rived, so that the surface of the part of riving of each in the surface of described one or more rounded portion and described one or more wire rod is roughly coplanar.
6. method as claimed in claim 5, it is characterized in that, the surface application layer of conductive material of described one or more rounded portion, the conductive material layer on described each rounded portion is communicated with one of them of at least one electrode wires.
7. the method for claim 1, is characterized in that, also comprises:
By attaching electrodes to described one or more wire rod one of them on; And
By electrode arrangement in described case member mould, so that the going out from the second distal process of described outer casing mold at least partially of described electrode;
From described case member mould, shift out described case member, described case member is encapsulated and the described electrode that insulate rigidly.
8. method as claimed in claim 7, is characterized in that, described electrode forms rounding head, cervical region and shoulder, and described shoulder forms at least one flat surfaces.
9. method as claimed in claim 8, it is characterized in that, described electrode also forms distal portions and proximal part, and at least one flat surfaces of described shoulder comprises the flat surfaces of the proximal part being positioned at described electrode.
10. method as claimed in claim 9, it is characterized in that, the diameter of described cervical region is less than the diameter of each rounding head and shoulder.
11. methods as claimed in claim 10, is characterized in that, the operation that described electrode wires is attached to electrode comprised: by the flat surfaces of the distal attachment of described electrode wires to the close end office of described electrode.
12. methods as claimed in claim 10, is characterized in that, described electrode also limit longitudinal axis and with coaxial recessed of the longitudinal axis of described electrode.
13. methods as claimed in claim 12, it is characterized in that, the operation that described electrode wires is attached to electrode is comprised: during to be inserted into by the far-end of described electrode wires in described electrode recessed, the longitudinal axis of described electrode and the longitudinal axis of described electrode wires substantially coaxial.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
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| US201261684385P | 2012-08-17 | 2012-08-17 | |
| US61/684,385 | 2012-08-17 | ||
| US201261727163P | 2012-11-16 | 2012-11-16 | |
| US61/727,163 | 2012-11-16 | ||
| US13/750,561 US9757190B2 (en) | 2012-08-17 | 2013-01-25 | Methods of manufacturing monophasic action potential mapping catheters |
| US13/750,561 | 2013-01-25 |
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| CN103584853A CN103584853A (en) | 2014-02-19 |
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| CN201310360689.4A Active CN103584853B (en) | 2012-08-17 | 2013-08-16 | The manufacture method of the mapping catheter of monophasic action potential |
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| US10213856B2 (en) | 2015-10-19 | 2019-02-26 | Biosense Webster (Israel) Ltd. | Preparation of micro-electrodes |
| CN105078569B (en) * | 2014-05-22 | 2017-11-10 | 南京医科大学第一附属医院 | Sympathetic nerve mapping ablating device and system |
| WO2018006383A1 (en) * | 2016-07-07 | 2018-01-11 | 四川锦江电子科技有限公司 | Inter-electrode discharge ablation apparatus |
| CN106109059A (en) * | 2016-08-05 | 2016-11-16 | 北京爱康宜诚医疗器材有限公司 | Borrowed structure |
| CN109394211B (en) * | 2018-12-18 | 2021-08-06 | 新乡医学院 | Method for preparing in-vivo electrophysiological recording metal electrode |
| US20200345413A1 (en) * | 2019-05-02 | 2020-11-05 | Biosense Webster (Israel) Ltd. | Monophasic-enabled catheter with microelectrodes and method of using same for local detection of signals |
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| US8929969B2 (en) * | 2009-04-14 | 2015-01-06 | Medtronic Ablation Frontiers Llc | Catheter assembly and associated method |
| US8280477B2 (en) * | 2009-07-29 | 2012-10-02 | Medtronic Cryocath Lp | Mono-phasic action potential electrogram recording catheter, and method |
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