CN103584853A - Method of manufacturing mapping catheters with monophasic action potential - Google Patents

Abstract

The invention discloses a method of manufacturing far-end portions of a medical apparatus. The method includes providing one or more wire rods formed by conductive materials, each wire rod having a vertical axis; providing a houisng die with a first end and a second end; arranging the one or more wire rods inside the housing die, so that at least a part of each of the wire rods protrudes from the first end and the second end of the housing die; introducing biocompatible materials into the housing die; and providing a time for solidification of the biocompatible materials, so that a housing part wrapping and molded on the one or more wire rods is formed and the one or more wire rods are firmly fixed inside the housing part. The method of the invention can minimize the number of independent parts used for manufacturing MAP recording devices and help to optimize functions of all parts.

Description

The manufacture method of the mapping catheter of monophasic action potential

Technical field

The present invention relates to improved mapping and ablation of tissue device and system, and the method for manufacturing mapping and ablation member.The invention still further relates to the improved mapping device that comprises the ability of melting.In addition the invention still further relates to, the manufacture method of improved mapping and ablation catheter.

Background technology

There is multiple therapy to can be used to treat various cardiovascular diseasess such as arrhythmia, atrial fibrillation and other electric pulse pass through the erratic behavior of cardiac conduction.As a kind of alternative method to open heart operation, many therapys adopt Minimally Invasive Surgical Technology to carry out, and wherein one or more elongated medical devices are inserted in patient body by one or more little wounds.The method can comprise uses conduit or the probe with a plurality of sensors, electrode, or other measurement and treatment parts, in order to treat the affected areas of heart, vascular system or other tissue.Minimally invasive medical device is that various medical science and surgical operation application are needed, because they allow patient to fully recover within the time shorter than traditional surgery, and can accurately treat the discrete tissue in part that is difficult to arrival by other method.For example, conduit can easily insert and handle by blood vessel and tremulous pulse, permission with quite little damage Wicresoft arrive the region in health, simultaneously, the probe of other Wicresoft or instrument can insert in little opening, and be guided through the anatomical structure of target, for surrounding tissue, do not have a significant impact or destroy.

This type of example of minimally-invasive treatment comprises treatment arrhythmia or irregular heart beating, and to this, doctor uses cardiac diagnosis and therapy equipment special-purpose such as mapping and/or ablation catheter, in the hope of arriving the interior zone of patient body.Such device can comprise end electrodes or other ablation, in order to form, destroys or blocks by infringement or other anatomical effect of the electric pathway of destination organization.In ARR treatment, conventionally before treatment thereafter, first to identify heart tissue have abnormal electrical activity (for example, focus triggers, slowly conduction, too fastly polarize again, gradation electric scanning etc.) special area.This localization or identification can comprise the electric scanning figure of the monophasic action potential (" MAP ") that obtains heart special area.Monophasic action potential record has proved that local organization is unpolarizedly made a start, polarization process and total action potential morphology again.MAP signal can go on record the electrical activity of response by make selected to organize depolarization to obtain temporarily, 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.Accurately location heart tissue can reduce treatment abnormal electrical path required melt number of times, and melting of can making to carry out is more effective.In addition, MAP record can help to determine local organization activationary time, and when the standard of use intracardiac electrode records, this time is normally indefinite.

The precision of MAP signal measurement depends on the contact quality between one or more localizing electrodes and heart tissue to a great extent.For example, the motion artifact effect being caused by beating heart and inhomogeneous ventricular systole can make the MAP signal skew (distort) detecting significantly, because heart movement acts on the pressure (and therefore changing the contact between them) in heart tissue by changing localizing electrode.At present known mapping device can not be accurately and is surveyed reliably MAP signal.In addition, at present known mapping device is not only reliable not, and because the quantity cause of material therefor and used unit, their manufacturing cost is also very expensive.For example, 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, doctor uses cardiac diagnosis and therapy equipment special-purpose such as mapping and/or ablation catheter, in the hope of arriving the interior zone of patient body.Such device can comprise end electrodes or other ablation, in order to form, destroys or blocks by infringement or other anatomical effect of the electric pathway of destination organization.In ARR treatment, conventionally before treatment thereafter, first to identify heart tissue have abnormal electrical activity (for example, focus triggers, slowly conduction, too fastly polarize again, gradation electric scanning etc.) special area.The intracardiac catheter mapping electrode that has had standard, just can challenge resolution and the spatial resolution of this type of signal.Graded signal source is difficult to accurately identify, and this type of signal provides the information of few relevant lower myocardium disease state.In order to improve significantly lower myocardium electrical feature, this localization or identification can comprise the electric scanning figure of the monophasic action potential (MAP) that obtains special heart area.With regard to normal electrode, local organization is unpolarized makes a start for MAP record proof.In addition,, by determining the form of action potential, MAP record has characterized the myocyte under contact electrode and has polarized.Most importantly, the action potential duration (APD) of time myocardial cell determined in MAP record.MAP signal can obtain by the selected tissue of interim depolarization, 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.Accurately mapping heart tissue can reduce treatment abnormal electrical path required melt number of times, and melting of can making to carry out is more effective.In addition, MAP record can help to determine local organization activationary time, and when the standard of use intracardiac electrode records, this time is normally indefinite.By the MAP record that tissue contact depolarization is produced, will comprise a regularly upwards blow with accurate focal depolarization, and the catheter electrode of standard is affected by far field depolarization substantially can, and can show low revolution rate.This type of signal can not accurately indicate the time of focal depolarization.

MAP recording equipment can comprise many parts alone, and this makes to manufacture the difficulty and expensive that becomes.For example, have a kind of device to have end electrodes design, this design comprises and is welded on circular platinum pole stock end or is formed on the spheroid on this end.The manufacture method that is used in early days producing these devices is proved to be inconsistent and the electrode spheroid produced is not completely rounded.As a result, be difficult to electrode to be seated to suitably in the dome part of distal portion office of device.When electrode spheroid is welded on wire rod, electrode also can become irregular in dome part, because wire rod is very easy to be attached on the point that is eccentric in electrode axis.In addition, owing to partly wanting the separating component that use cost is expensive, so this type of MAP recording equipment manufactures very expensive.Use a plurality of parts also can in use be easier to fracture, this can cause hurting patient.Finally, current MAP recording equipment does not provide the ability of melting, thus, and use ablating device additionally.Yet, when detecting abnormal signal, with the identical position of MAP recording equipment in to locate ablating device be very difficult, and be impossible sometimes.As a result, melt or other processing may far not reach the significant degree that will reach.

For more effective and efficient therapeutic treatment is provided, therefore, need to optimize the more operative installations of even contact and the method guaranteed between mapping device and heart tissue when recording MAP signal.Also need to have the conduit that not only can record monophasic action potential but also melt local organization when needing thereafter.It would also be desirable to provide manufacture not only simply but also the effective positioner of cost.

In addition, for the method for manufacturing the more effective and efficient method of mapping device and therapeutic treatment being provided is provided, therefore, need to reduce as much as possible the number of components alone for the manufacture of MAP recording equipment, and optimize 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 system of not only can mapping but also can have been melted by common conduit, and a kind of method of manufacturing this mapping and ablation member.The method of assembling mapping and ablation member can generally include a part of anodization of the tantalum/tantalum alloy that makes to be simultaneously used as conductor and attached electrode.The anodization deposition of insulation and corrosion resistant oxide allows with respect to adjacent structure electric insulation, reduces the size and sophistication of device simultaneously.

This system can generally include mapping structure, and it is designed to increase surface area and with respect to the contact pressure of the tissue under it.This mapping device can generally include electrode shell solid or deformable, and a plurality of electrode being coupled on deformable electrode shell.Electrode shell can be in deformable polymer, expandable air bag, metal and fibre composites at least one form.

The present invention advantageously provides the method for manufacturing mapping and/or ablating device distal portions, and the parts that it needs and the manufacturing step quantity more required than current known device is few.In one embodiment, the method can comprise: one or more wire rods that are comprised of conductive material are provided, and each wire rod has longitudinal axis; The outer casing mold with first end and the second end is provided; One or more wire rods are arranged in outer casing mold, at least a portion of each one or more wire rods is gone out from first end and second distal process of outer casing mold; And biocompatible material is incorporated in outer casing mold, and allow this material cured, thus the coated case member on one or more wire rods that is molded in formed.These one or more wire rods can be securely fixed in case member.Case member can form distal portions and proximal part, and distal portions can form the part that is arranged on the one or more roundings on distal portions, for example, and three or more rounded portions.This rounded portion can be essentially hemispherical, and figure that can radial symmetric is positioned on the distal portions of case member.In addition, the ledge of each one or more wire rods can be given prominence to by the exit point from each one or more rounded portions.Then, the ledge of each one or more wire rods can be rived, so that the part of riving of the surface of one or more rounded portions and each one or more wire rods is substantially coplanar.The surface of each one or more rounded portions is available layer of conductive material coating then, and for example, 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: electrode and electrode wires are provided, and this electrode wires has longitudinal axis, near-end and far-end; Electrode wires is attached to electrode; The case member mould that forms first end and the second end is provided; Electrode and electrode wires are arranged in case member mould, at least a portion of electrode is gone out from the second distal process of case member mould, at least a portion of electrode wires is outstanding from the first end of case member mould; Biocompatible material is incorporated in case member mould, and allows this biocompatible material solidify, form case member, and shift out case member from case member mould, case member is sealed and insulating electrode rigidly.Electrode can form head, cervical region and the shoulder of rounding, 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 that is 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 form 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 are substantially coaxial.Biocompatible material can be polyether-ether-ketone (PEEK), polyurethane or Polyetherimide.

In the 3rd embodiment, the method can comprise: the wire rod consisting of conductive material is provided, 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; Wire rod is arranged in outer casing mold, makes the far-end of wire rod outstanding 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; Remove the outstanding distal portions of wire rod; And layer of conductive material is coated at least a portion of case member, the wire rod in case member is communicated with this layer of conductive material.The method also can comprise: tractive wire rod is arranged in outer casing mold, and this tractive wire rod has proximal part, so that the near-end of tractive wire rod goes out from the second distal process of outer casing mold.

According to the present invention, a kind of method of manufacturing medical treatment device distal portions is provided, described method comprises: one or more wire rods that consist of conductive material are provided, and each wire rod has longitudinal axis; The outer casing mold with first end and the second end is provided; Described one or more wire rods are arranged in described outer casing mold, so that at least a portion of each in described one or more wire rod goes out from first end and second distal process of described outer casing mold; And biocompatible material is incorporated in described outer casing mold; And the time that makes described biocompatible material curing is provided, and to form to be coated, being molded in the case member on described one or more wire rod, described one or more wire rods are 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 portions.

Preferably, in the method for the invention, described one or more rounded portions comprise three or more rounded portions, and described three or more rounded portions are 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, outstanding from the distal portions of described case member from least a portion of the outstanding described one or more wire rods of the first end of described outer casing mold.

Preferably, in the method for the invention, described one or more wire rods align in described case member, so that the exit point in each from described one or more rounded portions of the ledge of each in described one or more wire rod is outstanding.

Preferably, in the method for the invention, the ledge of each in described one or more wire rods is rived, so that the surface of the part of riving of each in the surface of described one or more rounded portions and described one or more wire rod is roughly coplanar.

Preferably, in the method for the invention, the surface of described one or more rounded portions coating layer of conductive material, 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: electrode is attached in one of them of described one or more wire rods; And by electrode arrangement in described case member mould, so that at least a portion of described electrode goes out from the second distal process of described outer casing mold; From described case member mould, shift out described case member, described case member is sealed 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 that is 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 that described electrode wires is attached to electrode comprises: the flat surfaces by 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 comprises: the far-end of described electrode wires is inserted in recessed in described electrode, and the longitudinal axis of described electrode and the longitudinal axis of described electrode wires are substantially coaxial.

Accompanying drawing explanation

Consider by reference to the accompanying drawings, with reference to the following detailed description, will more easily understand the intension that the present invention is more complete and the advantage accompanying and feature, in accompanying drawing:

Fig. 1 shows the medical system that comprises 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 spherical wire rod 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 for the first electrode structure contacting between improving mapping assembly and organizing;

Figure 11 shows for the second electrode structure contacting between improving mapping assembly and organizing.

Figure 12 shows the distal portions of medical treatment device, and it has dome part part and the insulating element part being combined in case member;

Figure 13 A and 13B show the distal portions of medical treatment device, and it has the coated case member on end electrodes, electric wire and tractive wire rod that is molded in;

Figure 14 shows medical treatment device distal portions, and it has the coated case member on electric wire material that is molded into.Wire rod is rived and is polished in the position of overmolded resin, 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 insulating element of the distal portions of medical treatment device;

Figure 19 shows the system that comprises 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 element and the temperature control capability based on thermocouple of hypotube (hypotube) protrusion of surface;

Figure 20 D shows the 4th embodiment of the medical treatment device with mapping and ablation functionality, and this device comprises elbow and the temperature control capability based on thermocouple in hypotube;

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 metal surface of the transmitting direct current of exposure, and with the region of blocking radio frequency (RF) the conductive coatings coating of DC conduction;

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 of four exposures, and four regions that they are applied by the RF conductive coatings with blocking DC conduction are exposed and separate.This class formation has improved the ability that records MAP signal this exposing metal surface from contacting 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 local contact and improve the ability of MAP signal that records from feature like this.Between this category feature, hypotube is coated with the RF conductive coatings of blocking DC conduction, therefore, improves the ability of MAP signal that records from the exposing metal surface contacting 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 dome part part and the insulating element part being combined in case member;

Figure 23 shows the cutaway view of the distal portions of medical treatment device, and it has the coated case member on end electrodes, electric wire and tractive wire rod that is molded in;

Figure 24 shows the flow chart of the first method of manufacturing medical treatment device distal portions, and it has dome part part and the insulating element part being combined in case member;

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 of manufacturing medical treatment device distal portions, and it has the coated case member on electrode wire that is molded into.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.

The specific embodiment

Referring now to Fig. 1, there is shown the medical system with conduit and mapping assembly.This system can always 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, and it has proximal part, distal portions and is formed on the inner chamber between two ends.The distal portions of slender body can comprise one or more reference electrodes, 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 contact with organizing stably, thereby improve the in-house signal fidelity of mapping contact.Conduit also can have the handle being attached on slender body proximal part, and it can comprise one or more fluid intakes and export port, actuator, adapter, and other control and/or Connection Element.

Mapping assembly is coupled to the distal portions of slender body, and comprises one or more electrodes, and each electrode comprises electrode head and electrode wires.These one or more electrodes can for good and all 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, operates but also can be used as processing components.For example, control station can comprise radio frequency (RF) generator with one or more electrode electric connections, so that mapping assembly also can be used for ablation targets tissue regions.Mapping assembly can comprise as shown in Fig. 2-12 are concrete and as described in one or more electrodes.Mapping assembly can be comprised 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, has demonstrated the biocompatibility of characteristic, superconduction and the height of splendid cold ductility, high-melting-point (for example, the fusing point of Ta is 3,017 ℃), outstanding water-resistance solution and metal molten.For example, tantalum pentoxide has the galvanic ability of unique obstruction, allows conduction high frequency electric simultaneously.In addition, TaKS is for example radiopaque, can be applicable to be well positioned at patient body and handle by patient body's conduit.Tantalum and tantalum compound are even than MP35N(nickel-cobalt-chromium-molybdenum alloy, the common material for the armarium such as conduit, 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, and wherein, at least a portion of electrode for example, by tantalum compound (, Ta ₂o ₅) form, and its at least a portion for example, is comprised of different materials (, gold or platinum).Its result, the tantalum part of electrode can be carried out ablation tissue (for example, kidney, liver, or prostata tissue) with RF energy, and the non-tantalum of electrode partly can be used to provide unidirectional current excitation, 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 form at one end spherical or roughly spherical (being called " ball ").This ball will become electrode head (for example, as shown in Fig. 2-4 and as described in), so ball can be any size that is suitable for last mapping assembly.Have single-piece electrode head and electrode wires just without by electrode welding to wire rod.Two pieces type system is also feasible, but can increase cost and manufacturing time and complexity.The wire rod that comprises ball can be comprised of high corrosion resistance material, for example, such as tantalum or tantalum compound (, Ta ₂o ₅or TaKS).

Referring now to Fig. 3, there is shown and use so that the anodized example constructions of spherical line material.Once the spherical wire rod shown in Fig. 1 forms, just make wire rod anodization to form thin oxide layer.For example, can be approximately 1 μ m thick for insulating barrier.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 at wire rod.This oxide layer also protects wire rod to resist corrosion, gives conductive barrier so that wire rod is electrically isolated with contiguous parts and structure.Many spherical wire rods can be a middle-jiao yang, function of the spleen and stomach polarization.Although entire infrastructure can carry out anodization, preferred embodiment only anodization is adjacent to the device region of other conductive structure, so that insulation barrier to be provided.

Referring now to Fig. 4, there is shown the example constructions of spherical wire rod shown in Fig. 3 being given to further corrosion resistance.After anodization, one or more deposition of materials to improve electric conductivity, provide additional corrosion resistance, or give other useful quality characteristic on spherical.For example, 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 processing is spherical, (for example, by electroplating or spray method), is placed on one or more wire rods in container, they are kept to suitable place.This container can be suitable for keeping any amount of wire rod, conventionally keeps wire rod, makes spherically on container top, just can take (as shown in Figure 3).Once wire rod is placed in position, just can process spherical.For example, electroplate such as the such one or more compounds of yttrium oxide or other suitable material.Additionally or alternatively, can adopt splash to deposit Ni-Ti alloy, gold, platinum or platinum base alloy or similar material.

Referring now to Fig. 5, the assembly of mapping shown in figure.For example, once one or more wire rods processed (, anodization and plating), place wire rod be bonded in electrode assemblie shell and (be also referred to as " mapping package shell ").For example, can use four spherical wire rods.At this stage (that is, in the time of in spherical wire rod is located in mapping package shell), spherical wire rod is known as electrode, and it comprises electrode head and electrode wires.Electrode and electrode assemblie shell are referred to as mapping assembly.Package shell comprises that one or more electrode heads can be 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 be used 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, so that electrode head and package shell electric insulation.This can utilize, and such as platinum or platinum alloy, (for example, 90Pt/10Ir) and so on material is realized, and to form package shell, or realizes by coating or the shell involucrum that is comprised of another material.This insulating barrier can be that oxide on electrode head is (such as Ta ₂o ₅), or such as the polymer thin coating of polyimides.Once after assembling, mapping assembly can be coupled to distal end of catheter and partly go up, and makes electrode wires that the electrical connection between mapping assembly and conduit and/or system is provided.Therefore, all mapping assembly can include as few as two parts (for example,, 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 that this can reduce costs and reduce built-up time, and higher reliability is provided simultaneously than the few parts of known mapping assembly.

Generally with reference to Fig. 6-9, there is shown several embodiment of mapping assembly.These embodiment usually comprise than the large surface area of 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 type electrode.Mapping assembly shown in Fig. 8 has a plurality of raised areas, and these regions form " muffin top " or " Brassica oleracea L. var. botrytis L. " shape.These raised areas increase surface area, therefore improve contact pressure and/or the contact force between mapping assembly and target tissue region.Each raised areas can be electrode head, and mapping package shell is configured to fix randomly a plurality of electrodes, or for forming the orderly structure of Brassica oleracea L. var. botrytis L. shape effect.In addition, the thin-material layers coating that electrode head and package shell can improve by conductivity, can protect corrosion, reduces the surface tension of mapping assembly, or gives foregoing other desirable feature.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 a plurality of raised areas and make by processing relatively large metal, or electrode can be molded and have a plurality of raised areas.The mapping assembly of Fig. 9 can comprise that (for example, electrode can comprise three, as shown in Figure 9) for the electrode of many.This structure can provide contact with destination organization separated to get depolarization.Described various embodiment can provide improved tissue contact under unique anatomical or procedure condition.For example, the embodiment in Fig. 9 can improve at conduit contact when place on the surface such as on heart epicardial surface.

Generally with reference to Figure 10 and 11, there is shown the electrode structure that improves contact between 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, to keep the contact between electrode head and target tissue region.In this case, package shell can comprise the inner chamber that allows each spring element motion.In addition, coiling region can, when conduit advances to target tissue region, help prevent because excessive contact masterpiece is used in cause in patient's vascular injured.

As shown in figure 11, mapping package shell can be comprised of deformable material, such as polymer, conducting polymer, aerating gasbag, gel, fibre composites etc., and this deformable material accords with irregular geometric form, meanwhile, guarantee the contact between electrode head and target tissue region.For example, when heartbeat, deformable shell is by absorption pressure, to keep the contact between electrode head and target tissue region.Alternatively, mapping package shell can be comprised of the rigid material more such as epoxy resin, or is comprised of the metal electrode material such as platinum/iridium alloy.

Referring now to Figure 12, there is shown for example, distal portions with the dome part of combination and the medical treatment device (, MAP recording equipment) of insulating element.Known MAP recording equipment has distal portions conventionally at present, and this distal portions comprises separated dome part and insulating element.In manufacture 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.Yet these parts can be removed, separated part just becomes thrombosis rapidly, thus patient is worked the mischief.In addition, it is very expensive adopting a plurality of parts, is not only the cost of material, and because manufacture difficulty large (for example, due to indivedual parts small-sized) and built-up time are long.With at present known recording equipment difference be that the device price with distal portions shown in Figure 12 is cheap, easy to manufacture, and has improved patient's safety.

Continuation is with reference to Figure 12, and 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.For example, case member can be comprised of polyimides or polyether-ether-ketone (PEEK).Therefore, case member can single, manufacture in not disliking complicated process, this manufacture process reduces costs, increases easily manufactured degree and improves the safety to patient.

Referring now to Figure 13, there is shown the distal portions of medical treatment device (for example, MAP recording equipment), it has the coated case member on end electrodes, electric wire and tractive wire rod that is molded in.Be similar to shown in Figure 12 and described medical treatment device distal portions, 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.Yet that the case member shown in Figure 13 can be coated is molded (both can single injection also can multiple injection) electrode, electric wire, tractive wire rod endways, and/or on device feature other inside or outside.Coated molded benefit is there is powerful combination between other device feature keeping in the time of can allowing case member and device to use, and without using binding agent.Coated another benefit being molded on electrode of case member is, electrode by do not need to be carefully seated in case member corresponding recessed in.As shown in Figure 15-17 and discuss, it can be very difficult electrode being properly positioned in the shell of device distal portions.Be coated molded another benefit that also has and be, tractive wire rod is anchored in case member, thus, reduces or eliminates adding the demand of tractive wire rod anchoring mechanism.

Figure 13 A shows the axonometric chart of the distal portions that comprises four electrodes, electrode wires and tractive wire rod.Figure 13 B shows the cutaway view of distal portions shown in Figure 13 A.Yet, by case member is coated and is molded in the medical treatment device distal portions of manufacturing on other device feature, can comprise electrode (it can work the function of note down electrode or ablating electrode), electrode wires, tractive wire rod and any other device feature of any quantity and structure.As limiting examples, each electrode can for example, by rounded portion (, having roughly hemispherical), cervical region and shoulder part (such as what describe in detail in Figure 16 and 17) composition.

Referring now to Figure 14, the distal portions of medical treatment device has the coated case member in electrode wires that is molded into.Identical with described distal portions with shown in Figure 13 A and 13B, the case member of the distal portions shown in Figure 14 can be coated and be molded on other device feature.Yet, be that the electrode shown in Figure 14 consists of electrode wires and the conductive layer being deposited on case member at least a portion outer surface with electrode difference shown in Figure 13 A and 13B.Total outward appearance of distal portions can be as shown in Figure 13 A-13B.That is, distal portions can comprise one or more arch sections (such as the roughly hemisphere portion of the electrode in Figure 13 A-13B), but these arch sections are parts of coated molded shape, therefore the material for case member, consist of.

In manufacture process, case member is coated to be molded in one or more electrode wires, and each electrode wires is outstanding from a part of case member.For example, the point that each electrode wires can be from the arch section of case member is outstanding.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, can place and cover cover or similar device contacts with distal portions, so that only have the part (or other surface area part that comprises the cross section that electrode wires exposes) of rounding not covered cover.Such as the such material of platinum-iridium (Pt-Ir) or other conductive material, then can be deposited on region exposure or that do not covered cover, to form the electrically conductive layer contacting 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.A kind of design of MAP recording equipment end electrodes (such as the design of the MAP4 device of Medtronic company) comprises welding or is formed on the spheroid of circular platinum filament end.This design is difficult to regenerate and need 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 exploitation shown in the shell shown in Figure 15 and Figure 16 and 17, when they use together in single device, are particularly advantageous.

Referring now to Figure 15, there is shown medical treatment device is the dome part of distal portions.This dome portion can be combined in the single case member with insulating element (as shown in Figure 12-14 and as described in), or can be used as separating component.In rear a kind of situation, dome part can be designed to join with dielectric member card (for example,, as shown in Figure 18 A-18C).In arbitrary situation, the dome portion shown in Figure 15 can be used 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; Yet, can use any amount of hole and electrode.Each hole of dome part is countersunk, and like this, each hole comprises vent stem part, and the electrode of at least a portion 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 part (for example, having hemispherical roughly), cervical region and the flat shoulder of rounding.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, not only allow electrode to be shelved on reliably in the vent stem part in dome part hole, and provide the attachment point (for example, wire rod can be received by Laser Welding or Resistance Welding the electrode proximal part at shoulder plane surface place) of electrode wires.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 using binding agent that electrode is bonded in dome part, 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 shown in Figure 16 and described electrode, and exception part is that the electrode shown in Figure 17 also comprises that the substantial cylindrical coaxial with the longitudinal axis of electrode is recessed.As unrestriced example, this is recessed has and is approximately the diameter of 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 recessed can extending in the rounded portion of electrode from shoulder.When electrode is attached in electrode wires, electrode wires can insertion and soldering or is welded in electrode recessed.Therefore, facilitate widely the suitable alignment between electrode and electrode wires.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.For example, when electrode wires is attached on the electrode at eccentric point place, there will be the difficulty being located in.Yet, use electrode as shown in figure 17, just can alleviate together or eliminate the inaccurate problem of alignment.

Referring now to Figure 18 A-18C, there is shown the embodiment of the insulating element of medical treatment device distal portions.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 the card that insulating element just can be used for being coupled in dome part is joined ridge.

Referring now to Figure 19, there is shown the medical system having with the medical treatment device of 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 between two ends, forms inner chamber.The distal portions of device comprises near the mapping assembly being positioned at target tissue region or region.The far-end of slender body also can comprise one or more reference electrodes, 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 contact with organizing stably, thereby improve the in-house signal fidelity of mapping contact.Conduit also can have the handle being attached on slender body proximal part, and it can comprise one or more fluid intakes and export port, actuator, adapter, and other control 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 electrodes 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 conductive material thin layer on mapping assembly at least a portion outer surface, all electrode wires and electrically conductive layers as shown in figure 14.In addition, the shell of mapping assembly can comprise the dome part that is bonded together and insulating element (for example, as shown in Figure 15 and 18 and as described in), or shell can comprise the case member (for example,, as shown in figure 12 with described) of single-piece.

These one or more electrodes can for good and all be attached on mapping package shell.For example, can be located in as shown in Figure 15-17 with described electrode as shown in FIG. 16 and 17 and as described in case member in and be attached to this parts.Example as an alternative, as shown in Figure 12-14 and as described in electrode can use the coated method of moulding as described in Figure 13 and 14 to be for good and all attached on mapping package shell.

The operation of mapping assembly, at least for localizing objects tissue regions, operates (it can be referred to as " location/processing components ") but also can be used as processing components.For example, device can comprise the hypotube electrode of the minor diameter of one or more strip electrodes and encirclement device distal portions.Control station can comprise radio frequency (RF) generator and saline solution source and/or the cryogen source being fluidly communicated with hypotube, with at RF, melt or pure cryoablation process in for the distal portions of chiller.Location/the ablation functionality of this combination is a much progress at present known device mapping device (such as MAP4 research conduit), and known devices can not provide RF energy safely.Hypotube is outstanding from device distal portions, like this, when distal portions becomes arbitrarily angled with respect to tissue surface, can contact with the tissue that surrounds location/processing components.Hypotube can be used as contact electrode (+), and strip electrode can be used as recording electrode (-), to produce MAP signal.Such device can be known as " sub-cooling monophasic action potential (HCMAP) conduit ".By the MAP contact electrode of a plurality of separation of demand is reduced to and only needs a contact electrode, this HCMAP conduit has also been simplified the design of current known MAP recording equipment.In addition the electrode that, by the ablation procedure of this device, the minimum saline of needs or cold-producing medium stream is carried out to cooling low thermal mass.In the situation of pure cryoablation pattern, conductive pipe supply refrigerant liquid from be connected to the freezing control station of device.This refrigerant liquid, the nitrous oxide such as compression, can be transported to hypotube by conduit axostylus axostyle,, allows liquid according to Joule-Thomson effect, expand and absorb heat there.Different from the HCMAP pattern of brine-cooled, in this case, can allow brine stream to go out hypotube and flow in blood flow, and be directed in conduit axostylus axostyle by the cold-producing medium of hypotube, by vacuum return path, get back to freezing control station.

Referring now to Figure 20 A, there is shown the detail drawing with the first embodiment of the distal portions of the device of mapping and ablation functionality.The distal portions of device comprises hypotube and a plurality of 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 and described in, this device can either be located and can be carried out ablation tissue with RF energy.

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 with the thermoelectricity distal portions of the HCMAP device of electro-hot regulator occasionally, and thermoelectricity occasionally electro-hot regulator is positioned to and hypotube electrode contact.One or more thermocouples can be positioned to contact with hypotube, with monitoring temperature.In unrestriced embodiment, hypotube is comprised of gold-plated pipe, so that thermal conductivity is very high.

Figure 20 C shows the distal portions with the HCMAP device of a plurality of elements, these elements are outstanding from hypotube surface, with the position contacting with each outstanding element, improve and contacting of organizing, therefore, by increasing structural local pressure below outstanding element, improve MAP signal record ability.Each outstanding element can extend from hypotube surface, for example, from hypotube periphery, extends.Although be shown as four outstanding elements in Figure 20 C, should be understood that, can improve the contact between HCMAP device and the tissue of concern with the outstanding element of any quantity.

Figure 20 D shows the distal portions with the HCMAP device of hypotube, and it can be crooked and comprise the elbow of one or more roughly angles.Each elbow can be outstanding from hypotube periphery, therefore around hypotube, forms outstanding position, in order to improve with contacting of organizing and to improve MAP signal record ability.Although Figure 20 D shows three outstanding positions, should be understood that, can comprise any amount of elbow, when being positioned at facing to heart wall any directed at device, improve MAP signal record ability.

Figure 21 A, 21B and 21C show and are similar to respectively the embodiment shown in Figure 20 B, 20C and 20D.Yet Figure 21 A-21C illustrated embodiment also comprises one or more graded areas of metal surface of the transmitting direct current of exposure, and with the region of blocking radio frequency (RF) the conductive coatings coating of DC conduction.By stoping the conduction in the part of low frequency heart signal between the DC conduction portion exposing, this RF conductive coatings can improve MAP signal record ability.The DC conduction portion of these exposures can be in the uncoated part of hypotube, maybe can be positioned on the prominent features of hypotube, further to improve MAP signal record ability.In addition, can use the hypotube (not shown) of additional a plurality of windings, make winding from the single far-end winding shown in Figure 20 A-21C towards near-end extend.A plurality of windings can apply the coating of RF conduction and DC obstruction substantially, are coated on whole near-end windings or most near-end winding, to improve the MAP signal record ability of far-end winding, allow when needed conduction RF energy simultaneously.

Referring now to Figure 22, there is shown for example, distal portions 10 with the dome part 12 of combination and the medical treatment device (, MAP recording equipment) of insulating element 14.Known MAP recording equipment has distal portions conventionally at present, and this distal portions comprises separated dome part and insulating element.In manufacture 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.Yet these parts can become and remove, separated part just becomes thrombosis rapidly, thus patient is worked the mischief.In addition, it is very expensive adopting a plurality of parts, is not only the cost of material, and because manufacture difficulty large (for example, due to indivedual parts small-sized) and built-up time are long.Different from present known recording equipment, the device price with distal portions is as shown in figure 22 cheap, easy to manufacture, and has improved patient's safety.

Continuation is with reference to Figure 22, and the distal portions 10 of medical treatment device comprises single case member 16, and it is substantially similar to the dome part of separating 12 and the insulating element 14 of current known devices.Whole case members 16 can be by forming such as polyether-ether-ketone (PEEK), polyurethane or the such biocompatible material of Polyetherimide.Therefore, case member 16 can single, manufacture in not disliking complicated process, this manufacture process reduces costs, increases easily manufactured degree and improves patient safety.

Referring now to Figure 23, there is shown the cutaway view of the distal portions of medical treatment device (for example, MAP recording equipment), it has the coated case member on end electrodes, electric wire and tractive wire rod that is molded in.The cutaway view of Figure 23 shows the exemplary arrangement of the 16 interior all parts of case member 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 of separating 12 and the insulating element 14 of current known devices.In other words, case member 16 can hold electrodes and the electrode wires of 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.That the case member 16 of Figure 23 can be coated is molded (both can single injection also can multiple injection) electrode 18, electric wire 20, tractive wire rod 22 endways, and/or on device feature other inside or outside.Coated molded benefit is between other device feature keeping in the time of can allowing case member and device to use, have powerful combination, without using binding agent.Coated another benefit being molded on electrode of case member is, electrode by do not need to be carefully seated in case member corresponding recessed in.As shown in Figure 25 and 26 and discuss, it can be very difficult electrode being properly positioned in the shell of device distal portions.Be coated molded another benefit that also has and be, tractive wire rod 22 is anchored in case member 16, thus, reduces or eliminates adding the demand of tractive wire rod anchoring mechanism.By being molded in the medical treatment device distal portions 10 of manufacturing on other device feature by case member 16 is coated, 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 any other device feature.As limiting examples, each electrode 18 can by rounded portion 24(for example, have roughly hemispherical), cervical region 26 and shoulder part 28(be such as describing in detail in Figure 25 and 26) composition.

Referring now to Figure 24, there is shown the flow chart of the method for manufacturing medical treatment device distal portions, it has dome part part and the insulating element part being combined in case member.In step 1, one or more electrodes 18, one or more electrode wires 20 are provided, and alternatively, one or more other internal parts such as tractive wire rod 22.In step 2, each one or more electrode wires 20 are attached in one or more electrodes 18 one upper (for example, as shown in Figure 25 and 26 and as described in).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 forming for example case member as shown in Figure 22 and 23 16.In step 4, one or more electrodes 18, one or more electrode wires 20, and alternatively, one or more other internal parts (for example, tractive wire rod 22) be arranged in case member mould 29, so that at least a portion of each one or more electrodes 18 is outstanding from the second end 32 of case member mould 29, and each one or more electrode wires 20, and alternatively, the first end 31 from case member mould 29 at least a portion of one or more other internal parts is given prominence to (as shown in figure 27).In step 5, biocompatible material 30(for example, such as PEEK) coated molded (also referred to as inserted mode system) or injection-molded at least a portion once: one or more electrodes 18, one or more electrode wires 20, and alternatively, one or more other internal parts.In step 6, biocompatible material 30 is allowed to sclerosis, cooling or curing, thus, forms case member 16.In step 7, case member 16 is removed from case member mould 29.The case member 16 generating can have distal portions 33 and proximal part 34.The distal portions 33 of case member 16 can hold one or more electrodes 18, and the proximal part 34 of case member 16 can be attached on the body of medical treatment device afterwards, such as the slender body of mapping and/or ablation catheter.

Referring now to Figure 25, there is shown the first embodiment of record or ablating electrode.The head 24(that electrode shown in Figure 25 18 comprises rounding for example, 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 places of electrode 18, and the attachment point of electrode wires 20 is provided.For example, electrode wires 20 can be received by Laser Welding or Resistance Welding 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.In coated molded or injection-molded process, biocompatible material will flow in the recessed region being formed by cervical region 26, thus, for biocompatible material provides the surface area of increase, and between electrode 18 and case member 16, forms stronger connection.

Referring now to Figure 26, there is shown the second embodiment of record or ablating electrode.This electrode 18 is substantially similar to shown in Figure 25 and described electrode, 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 and be approximately the diameter of 0.008 inch and be approximately the degree of depth of 0.020 inch.Recessed 38 mouth 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 in any suitable manner electrode insertion 18 recessed 38 in, and soldering or be welded to this recessed on.Therefore, facilitate widely the suitable alignment between electrode 18 and electrode wires 20.

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 electrodes 18, one or more electrode wires 20, and alternatively, one or more other internal parts (for example, tractive wire rod 22) be aligned in case member mould 29, make at least a portion of each one or more electrodes 18 outstanding from the second end 32 of case member mould 29, and each one or more electrode wires 20, and alternatively, at least a portion in one or more other internal parts is from the first end 31 outstanding (as shown in Figure 27) of case member mould 29.For example, can be outstanding from case member mould 29 at least a portion of the head 24 of electrode rounding, and the cervical region 26 of electrode 18 and shoulder 28 can be in case member moulds 29.Yet, can use any size, shape or the structure of electrode, electrode to be not limited to shown in Figure 25 and 26 and described that electrode.In addition, electrode head 24 can be completely in mould 29, but only the electrode head 24 of a part can be coated molded with biocompatible material 30.Case member mould 29 shown in Figure 27 can be simplified widely, and at least a portion that only shows each electrode 18 is coated not molded with biocompatible material 30.

Referring now to Figure 28 A-28D, there is shown the second manufacture method of medical treatment device distal portions, it has the coated case member in electrode wires that is molded in.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 be coated and be molded in one or more electrode wires 20.Yet, the medical treatment device distal portions 10 shown in Figure 28 C do not comprise as shown in Figure 26 and 27 and as described in ball electrode 18.On the contrary, electrode 18 is to adopt splash or other deposition process to form, and conductive material 44 is deposited at least a portion of case member 16, on rounding or ledge 46 such as case member 16.For example, the first step of method as shown in Figure 28 A, can provide the one or more wire rods 20 that are comprised of conductive material.Each wire rod can have longitudinal axis 48, proximal part 50 and distal portions 52.Although, shown in Figure 28 A-28D, can not comprise additional parts, such as one or more tractive wire rods.

At second step, roughly as shown in Figure 28 B, one or more wire rods 20 can be aligned in case member mould 29.Once wire rod 20 is aligned in case member mould 29, can be by biocompatible material 30(for example, PEEK) injection or other method are incorporated in mould 29, and wire segment is wrapped in case member mould 29.Then, allow biocompatible material 30 cooling, curing, and/or sclerosis.Case member mould 29 can be configured to define case member 16 as shown in figure 22; Yet, case member mould 29 can form such case member 16, it for example comprises one or more rounded portion 46(of being formed by bio-compatible overmolded material 30, roughly hemispheric protuberance), rather than form the wherein case member 16 of attached one or more spheric electrode 18.In addition, one or more wire rods 20 can be along central axis 54 alignment of case member, the distal portions 52 of each wire rod 20 can be given prominence to the first end 31 of crossing mould, and the proximal part 50 of each wire rod 20 can give prominence to cross mould the second end 32(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 rods 20 to exit case member 16 at point 57 places, substantially at rounded portion 46(for example puts 57, roughly hemispherical protuberance) center.Once allow biocompatible material 30 cooling and/or curing, can remove mould 29 from the case member 16 generating.

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, can place and cover cover or similar device contacts with the distal portions 33 of case member 16, so that only have rounding or hemisphere portion 46(or other surface area part of comprising the cross section that electrode wires exposes) do not covered cover.Such as the such material of platinum-iridium (Pt-Ir) or other conductive material 44, then can be deposited on region exposure or that do not covered cover, to form the electrically conductive layer 44 contacting 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 there is above contrary mentioning, otherwise, should be noted that, all accompanying drawings are not pro rata.For the above, can make various modifications 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 (15)

1. manufacture a method for medical treatment device distal portions, described method comprises:

One or more wire rods that consist of conductive material are provided, and each wire rod has longitudinal axis;

The outer casing mold with first end and the second end is provided;

Described one or more wire rods are arranged in described outer casing mold, so that at least a portion of each in described one or more wire rod goes out from first end and second distal process of described outer casing mold; And

Biocompatible material is incorporated in described outer casing mold; And

The time that makes described biocompatible material curing is provided, to form to be coated, is molded in the case member on described one or more wire rod, described one or more wire rods are securely fixed in described case member.

2. the method for claim 1, is characterized in that, described case member forms distal portions and proximal part, and described distal portions forms one or more rounded portions.

3. method as claimed in claim 2, is characterized in that, described one or more rounded portions comprise three or more rounded portions, and described three or more rounded portions are roughly hemispherical.

4. method as claimed in claim 3, is characterized in that, described three or more rounded portions are positioned on the distal portions of described case member with radial symmetric figure.

5. method as claimed in claim 2, it is characterized in that, when described case member takes out from described outer casing mold, outstanding from the distal portions of described case member from least a portion of the outstanding described one or more wire rods of the first end of described outer casing mold.

6. method as claimed in claim 5, it is characterized in that, described one or more wire rod aligns in described case member, so that the exit point in each from described one or more rounded portions of the ledge of each in described one or more wire rod is outstanding.

7. method as claimed in claim 6, 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 portions and described one or more wire rod is roughly coplanar.

8. method as claimed in claim 7, is characterized in that, the surface coating layer of conductive material of described one or more rounded portions, and the conductive material layer on described each rounded portion is communicated with one of them of at least one electrode wires.

9. the method for claim 1, is characterized in that, also comprises:

Electrode is attached in one of them of described one or more wire rods; And

By electrode arrangement in described case member mould, so that at least a portion of described electrode goes out from the second distal process of described outer casing mold;

From described case member mould, shift out described case member, described case member is sealed and the described electrode that insulate rigidly.

10. method as claimed in claim 9, is characterized in that, described electrode forms rounding head, cervical region and shoulder, and described shoulder forms at least one flat surfaces.

11. methods as claimed in claim 10, 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 that is positioned at described electrode.

12. methods as claimed in claim 11, is characterized in that, the diameter of described cervical region is less than the diameter of each rounding head and shoulder.

13. methods as claimed in claim 12, is characterized in that, the operation that described electrode wires is attached to electrode comprises: the flat surfaces by the distal attachment of described electrode wires to the close end office of described electrode.

14. methods as claimed in claim 12, is characterized in that, described electrode also limit longitudinal axis and with coaxial recessed of the longitudinal axis of described electrode.

15. methods as claimed in claim 14, it is characterized in that, the operation that described electrode wires is attached to electrode comprises: the far-end of described electrode wires is inserted in recessed in described electrode, and the longitudinal axis of described electrode and the longitudinal axis of described electrode wires are substantially coaxial.

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