CN109498867A

CN109498867A - Lead system for medical implant

Info

Publication number: CN109498867A
Application number: CN201810051055.3A
Authority: CN
Inventors: S·M·威尔德赫特; A·迈尔; R·沃尔法特; B·霍夫曼; H·德瓦尔
Original assignee: Adeyuko Co Ltd
Current assignee: Adeyuko Co Ltd; Adjucor GmbH
Priority date: 2017-09-15
Filing date: 2018-01-19
Publication date: 2019-03-22
Also published as: DE102017216424A1; WO2019052887A1

Abstract

The present invention relates to a kind of lead systems for medical implant.Lead system according to the present invention includes intracorporal lead section (100) and external lead section (200).There are flat cross-sectional profiles (11) in the remote area (114) of lead section (200) in the proximal end region (112) of the lead section (100) of the lead system (1) herein in vivo and in vitro.

Description

Lead system for medical implant

Technical field

The present invention relates to a kind of lead systems for medical implant.It is suitble to especially in accordance with lead system of the invention For cardiac assist devices, the cardiac assist devices are used for the blood-pumping function of accessory heart.

Background technique

The blood-pumping function of heart can be weakened due to disease, this is also referred to as cardiac insufficiency.Both from medical point or from warp From the point of view of angle of helping, the importance of cardiac insufficiency is great and increasingly increases.In this century the '20s, the whole world will have 23,000,000 people With cardiac insufficiency, annual neopathy rate will be 2,000,000 people.Only in the U.S., just there are about 5,000,000 people with heart function at present It is incomplete.Here, annual neopathy rate is about 550,000 people.At this during the decade only in the U.S., the number more than 50 years old has been doubled To a million people.This is also applied for Continental Europe.

The reason of cardiac insufficiency, may be the damage due to cardiac muscle and cause the contractility of heart impaired or fill It is full of.Raised blood pressure can cause to pump the increase of blood resistance, this can equally have a negative impact to the blood-pumping function of heart.The pump of heart Blood function may also can reduce due to not closed valve (such as not closed aorta petal or bicuspid valve).

Different types of cardiac insufficiency by drug therapy or can pass through operative treatment.In addition to other treatment method, The promising treatment method of a variety of causes of cardiac insufficiency, institute are across come the blood-pumping function of accessory heart by implantation material It states implantation material and mechanical pressure is applied to heart to improve it and pump hemorrhagic energy.

This implantation material usually requires lead system for its function, and the lead system and external supply unit connect It connects.In addition to ensuring that this lead system can also undertake additional functionality, such as function monitor except the operation of implantation material Data transmission.In general, this lead system includes the pneumatic or liquid for being supplied to the expansible unit at implantation material The lead of pressure and electrical lead for receiving ECG (electrocardiogram).

However, current lead system faces significant challenge in technology and medically, because its one side may cause trouble Person's complication, on the other hand may cause the system failure.The common complication of lead system may generate patient such as infection Lethal effect, therefore be also the restrictive factor for the treatment of method general effect.Similarly, in the supply in the lead of lead system Disconnected or Transmission will lead to thrashing, and bring the serious consequence in part, such as need surgical intervention, due to thrashing Patient's heart failure caused by capable of being lost with pump courage and uprightness is even dead.

It is very high in infection risk especially early stage after surgery.But also during other there are high infection risk, This is because the percutaneous lead system for implants in vivo enduringly stays in patient's body, and then skin exit opening is needed, So as to guide to external supply unit.Here, skin exit region is one of the region of most easy infection and tissue damage.It is right In for example strengthening antibiotic treatment or even surgical intervention, this frequently result in long-term inpatients and the patient that has left hospital it is frequent Readmission.

Summary of the invention

It is an object of the present invention to provide a kind of lead systems for medical implant, without known lead system The shortcomings that system, and increase patient's compatibility and system reliability.

The present invention relates to a kind of lead systems for medical implant.

Lead system according to the present invention in first scheme includes intracorporal lead section and external lead section. Here, the proximal end region of the lead section of lead system in vivo neutralizes in the remote area of lead section in vitro with flat Flat cross-sectional profiles.Thus generate following effects: lead system can be with flat in skin exit region under loading state Flat cross-sectional profiles leave.Therefore can the exit opening advantageously by lead system in patient skin remain it is small, and And it can reduce the infection risk at the exit site of lead system.Further, since lead system is being parallel to lead system cross Extension on the direction of section short side is smaller, so the drawing force being applied on patient skin is smaller.It therefore can be by flat Cross section skin exit site is mechanically depressurized.

It is parallel in addition, lead system can be surrounded more easily by the flat cross section in skin exit region The axis bending of lead system cross section long side, external lead section can extend closer to patient body as a result,.Therefore, It can improve and carry comfort level and daily practicability.Further, since the subsequent shifting of hook and lead system on lead system Position and caused by injury risk can be minimized.

In each design scheme, intracorporal lead section can have from flat cross-sectional profiles to non-flat transversal The transitional region of facial contour.Alternatively or additionally, external lead section can also have from flat cross-sectional profiles to The transitional region of non-flat cross-sectional profiles.Here, non-flat cross-sectional profiles can be preferably configured as it is generally square , circular or polygon cross-sectional profiles, the cross-sectional profiles for being particularly preferably configured to general triangular.

Therefore on the one hand obtain following effects: lead system can be adapted in corresponding transitional region, so that lead System can mutually be coordinated with the arbitrary cross section of interface.In the case where interface has flat cross section, corresponding section It may include other transitional region from non-flat region to flat region or even completely do not include transitional region. On the other hand, it therefore is capable of providing with the lead system for specially adapting to lead system corresponding region mechanical property.Institute as above It states, lead system can be optimized by flat cross section for skin exit region.It furthermore can in body interior Following cross-sectional profiles are for example generated by the transitional region of intracorporal lead section, the cross-sectional profiles are wanted about intracorporal (such as flexible, rigid and intracorporal storage) is asked to optimize.

In the design scheme that can be combined with all design schemes described so far, intracorporal lead section can be wrapped Include at least one and preferably three intraindividual anchoring sheaths.Here, intracorporal anchoring sheath is designed to, promote the length of tissue Enter.Thereby, it is ensured that: the tissue of patient can be connect with intracorporal anchoring sheath and therefore with intracorporal lead section.Pass through tissue Connection, intracorporal lead section can be stored and be fixed on patient's body.Therefore, lead system, especially intracorporal leading part The displacement risk of section is minimized, and system reliability and patient safety are all increased.Especially in skin outlet area In domain, since the routine of risk of injury and the mechanical force as caused by body kinematics to skin exit site caused by shifting can pass Passing property is reduced by the fixation of internal lead section, this causes the better healing of skin exit site and then causes to infect wind Danger becomes smaller.

In the design scheme that can be combined with design scheme before, intracorporal lead section includes the first, second He Third anchors sheath.First, second, and third anchoring sheath is proximally setting up drawing in vivo to the side of distal end herein In line section.By multiple anchoring sheaths, the bigger stability of intracorporal lead section can be realized in patient's body.This Outside, be applied to external force on lead system can than in the case where only one anchors sheath or absolutely not anchoring sheath more It is compensated well.

In the design scheme that can be combined with design scheme before, the transitional region of intracorporal lead section can be set It sets between the first and second anchoring sheaths.Because the first anchoring sheath is the anchoring sheath of most proximal end in three anchoring sheaths, So nearby distally anchoring sheath downstream, the cross-sectional profiles of lead system first after skin exit region Internal requirement more described above can be matched with.

In the design scheme that can be combined with aforementioned three design schemes, intracorporal anchoring sheath can be it is porous, Fiber or fabric structure.This design scheme by anchoring the structure of sheath provides following possibilities: tissue can It grows into anchoring sheath.In other words, tissue can be made preferably long by anchoring the configuration offer of this aperture of sheath The environment entered.Intracorporal anchoring sheath can be structure, such as hole or cavity herein, the hole or cavity have 40 μm extremely 2000 μm, preferably 50 μm to 1000 μm and more preferable 80 μm to 500 μm of size.Therefore it can grow into and be provided most preferably for tissue Size condition.

In the design scheme that can be combined with all design schemes described so far, lead system can include at least Two, preferably nine electrical leads.Alternatively or additionally, lead system can include at least two and preferably three pneumatic Lead.By at least two electrical lead, lead system can between feedway and medical implant transmission telecommunications number. For example, therefore the action potential of the voltage form at least two electrodes of heart can be transferred to feedway, and into And ECG signal can be calculated.Therefore it can directly feed back about the body function in implantation object area.That is, by drawing The special design scheme of linear system system, preferably can control and monitor medical implant.This causes system reliability and treatment The increase of success rate and the raising of patient safety.

It, can will be at heart or the action potential of the intracorporal multiple electrodes of people is transferred to by large number of electrical lead Feed unit, and multiple ECG signals are calculated in turn.Furthermore it is possible to provide electric discontinuity of cable identification, and energy via electrical lead Enough realize electrical shielding.These preferred expedients schemes can further increase system reliability and success rate.Pass through Pneumatic lead is provided in lead system, pneumatic implantation material, for example expansible unit can be supplied with compressed air.It replaces Selection of land or additionally, can generate negative pressure in this expansible unit.Because lead system extends to skin with pneumatic lead Exit site it is external, so can by feedway be arranged in exterior.It must by eliminate internal feedway The property wanted can prevent other foreign matters from jeopardizing patient safety with this.

In the design scheme that can be combined with design scheme before, intracorporal lead section may include dispersion portion Section, the dispersion section are arranged at the distal end of lead section in vivo and can be realized the separation of lead.Here, point The proximal end for dissipating section can disperse the resolution element limit in section downstream by being proximally set up directly on.By dividing Scattered lead ensures: lead is respectively positioned at the particular locations of implantation material or can connect with the implantation material.By that will divide Scattered section, which is located on the distal end of intracorporal lead section, also ensures that each lead before its locality nearby Dispersed.Which ensure that the common conveying in the major part of the lead section of lead in vivo.Pass through lead section in vivo Major part on common conveying, by patient's minimum loads and resistance relative to mechanical load can be improved.Furthermore Can be reduced by conveying jointly can free close surface, reduce the chemical load due to caused by immune response whereby simultaneously And the durability of lead can be improved in turn.

In the design scheme that can be combined with the design scheme before two, at least one of electrical lead can draw It is helically wound at least one section of linear system system.Alternatively or additionally, at least one of electrical lead is in lead system At least one pneumatic wire wound can be helically surrounded at least one section of system.As an alternative, multiple electrical leads can Helically wind.As an alternative, multiple electrical leads can helically surround a pneumatic wire wound.As an alternative, at least one A electrical lead can helically surround a pneumatic wire wound respectively.

By spiral helicine coil, electrical lead is less susceptible to compared to the electrical lead not wound in implantation material and such as skin The influence of the distance between exit region variation.In the case where implantation material is as cardiac assist devices, such as heart can be passed through Expansion and contraction cause the distance between above-mentioned zone to change.The spiral helicine coil of electrical lead can be to a certain extent Uncompensation distance variation, similar to the telephone wire of winding.Furthermore it is possible to the wind for making electrical lead bend or disconnect by spiral coil Danger minimizes.This can increase the service life of electrical lead.Because can receive ECG by electrical lead, and electrical lead is used as implantation The control signal of object, so the fracture of electrical lead may result in the function loss of implantation material.Because this can generate patient Serious consequence, therefore such case is avoided anyway.By surrounding the winding of pneumatic lead, can reduce by lead system The volume of exclusion, and the cross section of lead system can be reduced, this has positive influences for patient's compatibility.In addition, gas Dynamic lead can be mechanically stable by the electrical lead of spiral wound on it.In other words, it can be mentioned by spiral wound High bending rigidity is and at the same time required flexibility remains unchanged.

In the design scheme that can be combined with the design scheme before three, at least one of electrical lead is in vivo It is not wound in the remote area of lead section in the proximal end region of lead section and in vitro.As an alternative, Duo Gehuo All electrical leads can be in this region not to be wound.Therefore ratio can be especially obtained in skin exit region in helical form Smaller cross section in the case where the electrical lead of winding.Therefore, as being more outlined above, lead system can be reduced Exit opening.

In the design scheme that can be combined with the design scheme before four, at least one of electrical lead can be integrated Into the sheath of at least one pneumatic lead.As an alternative, multiple or all electrical leads can be integrated at least one and pneumatically draw In the sheath of line.Thus on the one hand it is capable of providing more compact lead system.It on the other hand can be by integrating the electrical lead And enhances corresponding pneumatic lead and reduce the risk for resisting corresponding pneumatic wire kink.

In the design scheme that can be combined with the design scheme before five, at least one of pneumatic lead includes extremely A few restrictive coating, at least one of electrical lead are embedded in the restrictive coating.In addition, at least one of pneumatic lead can Including internal restrictive coating and external restrictive coating.As an alternative, multiple or all pneumatic leads include internal restrictive coating and outer The restrictive coating in portion.Internal restrictive coating can be made of herein the first material, and external restrictive coating can be by the second material It constitutes.First material can be elastic material herein, and the second material is the material smaller than the first elastic properties of materials.For example, the One material can be elastic material, especially silicone resin, and the second material is more mechanically stable material, especially polyurethane.It replaces Selection of land, the first and second materials can be also made of same material, such as be made of elastic material.

By these advantageous design schemes, the specific mechanical property of pneumatic lead can be set.

In the design scheme that can be combined with design scheme before, at least one of electrical lead is integrated into accordingly In the restrictive coating of the outside of pneumatic lead.As an alternative, multiple electrical leads can be integrated into the shield of the outside of corresponding pneumatic lead In jacket layer.As an alternative, all electrical leads can be integrated into the restrictive coating of the outside of pneumatic lead.This cause electrical lead safety and It is integrated reliably into corresponding pneumatic lead.If the second material is identical as the first material in this case, pneumatically draw Line may include the other restrictive coating around external restrictive coating.The other restrictive coating herein can be by with first and second The different material of material layer is constituted, and is preferably made of more mechanically stable material.

In the design scheme that can be combined with the design scheme before seven, pneumatic lead can material in locking manner each other Connection.Therefore the separation of each lead is prevented.It is of great significance in this lead section especially in vivo, because being separated herein Lead will lead to and endanger patient.Pneumatic lead herein can be mutual via the material for corresponding to the second material being set forth above Connection.Alternatively or additionally, pneumatic lead can be embedded in a common restrictive coating, and the restrictive coating surrounds all pneumatic Lead.Here, the restrictive coating can be made of the second material.If the second material is elastic material, restrictive coating also can It is enough to be made of more mechanically stable material.If being described above, intracorporal lead section can have dispersion section.Such as Fruit is such case, then material is not connected to each other pneumatic lead in locking manner in the region of dispersion section.

In the design scheme that can be combined with the design scheme before eight, at least one of pneumatic lead is corresponding Pneumatic lead sheath inner face on the protuberance at least one and preferably at least three web-likes.As an alternative, Duo Gehuo All pneumatic leads can have at least one and preferably at least three webs on the sheath inner face of corresponding pneumatic lead The protuberance of shape.Here, the protuberance of web-like can radially-inwardly be protruded into from the sheath inner face of internal restrictive coating.It is described advantageous Design scheme, which can be realized, prevents the pneumatic lead when hose is bent to be closed completely.Hose bending is closed completely with pneumatic lead Conjunction may result in: implantation material is maintained in the state of having a potential hazard for patient.It keeps pneumatically drawing in that case of ben The minimum volume of line can ensure promptly being vented and avoid precarious position for implantation material.

In the design scheme that can be combined with all design schemes described up to now, intracorporal lead section can Including stopping sheath.Here, stopping sheath that can be arranged in the proximal end of lead section in vivo.The edge from exit site The blocking sheath that distal direction extends has following effects: germ can be difficult to enter patient's body.Sheath is stopped to facilitate as a result, Reduce infection risk.Here, stopping sheath that can be designed as, promote the field planting of macrophage.In addition, stopping sheath that can have Porous or fiber structure.Stop sheath that there can be the structure of aperture herein.In addition, stop sheath that can have hole, Alternatively or additionally also there is cavity, the cavity is preferably directed towards at least side and is unlimited.The size in the hole, especially Each diameter can have 10 μm to 100 μm, preferably 20 μm to 60 μm and particularly preferred 30 μm to 50 μm of size herein.

Last feature provides realization and promotes the specified conditions of phagocyte field planting.Around skin exit region It is targetedly colonized phagocyte in environment and provides a kind of resist because of the sense caused by having just enter into the germ after patient's body The effective measures of dye.Thus, it is possible to prevent: germ deeper enters in vivo, and usually minimizes infection risk.Hole and The size of cavity is represented herein for targetedly growing into or the specific feature of resident macrophages.

In the design scheme that can be combined with all design schemes described, lead system can also include having the The connector system of one connector component and the second connector component.Drawing in vitro can be arranged in the first connector component In the proximal end of line section and preferably negatively constitute.The first connector component can be arranged in second connector component It proximal end and preferably positively constitutes.The lead of the lead of implantation material side and supply side can be decoupled by connector system. For example, in the case where the lead to feedway or existing supply side repairs, it is not necessary to remove entire implantation material side Lead, but the only part outside the mere body of removal system.Thus, it is possible to avoid surgical intervention and can be improved patient safety. By the negative design of the first connector component, can prevent from damaging connector pin on implantation material side.That is, if Connector system is damaged, it would be possible that being that the second connector component is damaged, the second connector component can be than the first grafting Device component obviously more simply and is for patients less jeopardously replaced.

In the design scheme that can be combined with design scheme before, lead system can also include being used for feedway Sub- lead section.Here, sub- lead section can proximally extend to feedway from the second connector component.

In the design scheme that can be combined with the design scheme before two, lead system can be in the first connector portion It include specified fracture location in the proximal end region of part.Specified fracture location is preferably able to that the region of the second connector component is arranged in In.As an alternative, there are sub- lead section, the remote area of sub- lead section can be arranged in specified fracture location In.

In the design scheme that can be combined with all design schemes described up to now, external lead section can Including lead fixing piece, the lead anchor designs are to apply on the skin.Alternatively or additionally, there are sub- leading parts In the case where section, the sub- lead section also can include lead fixing piece.Lead system is capable of fixing by lead fixing piece And ensures to prevent displacement or the transitivity for minimizing and being reduced in turn the mechanical force of skin exit site will be shifted.This Outside, lead system can be guided by lead fixing piece close to body.Therefore, improve patient carrying comfort level and will be injured And infection risk minimizes.

In the design scheme that can be combined with the design scheme before 14, flat cross-sectional profiles can have Perimeter more smaller than non-flat cross-sectional profiles.Therefore it can reduce exit opening and skin exit site is mechanically subtracted Pressure.It is furthermore possible to reduce infection risk.

In the design scheme that can be combined with the design scheme before 15, flat cross-sectional profiles are in the direction x On can have the flexible bigger than in y-direction.Alternatively or additionally, flat cross-sectional profiles in the direction x On axial Plane Rotation ratio of inertias in y-direction smaller.As above in conjunction with flat cross section description, body Outer lead section can be straight and easier flexible in the x direction or lesser axial Plane Rotation inertia It connects and is guided after being left from skin close to the body of patient.Therefore it can improve and carry comfort level and daily practicability.In addition, Risk of injury caused by subsequent displacement due to hook and lead system on lead system can be minimized.

In the design scheme that can be combined with the design scheme before 16, non-flat cross-sectional profiles can compare Flat cross-sectional profiles have bigger rigidity.Alternatively or additionally, non-flat cross-sectional profiles have radially side To substantially uniform flexible.Alternatively or additionally, non-flat cross-sectional profiles are in the x direction and in the side y There can be substantially uniform axial Plane Rotation inertia upwards.By these advantageous design schemes, can have The mechanical property of lead system is improved in the region of non-flat cross-sectional profiles for the region.For example, intracorporal leading part Section can be by the x direction and in y-direction with the non-flat cross of substantially uniform axial Plane Rotation inertia Cross section profile come meet about to a certain degree necessary flexible and rigidity internal requirement.

Can with it is all before in the design scheme that combines of the design scheme that describes, the medical implant can be the heart Dirty ancillary equipment.

Detailed description of the invention

Fig. 1 shows the isometric views of the first embodiment of lead system according to the present invention；

Fig. 2 a shows the different non-flat transversal of the lead system according to the present invention with electrical lead and pneumatic lead The viewgraph of cross-section of face shape；

Fig. 2 b shows the different flattened cross-sectionals of the lead system according to the present invention with electrical lead and pneumatic lead The viewgraph of cross-section of shape；

Fig. 3 a shows the isometric of the lead system according to the present invention with pneumatic lead and spirally-wound electrical lead View；

Fig. 3 b shows according to the present invention lead system of the tool there are two helical form around the electrical lead of pneumatic wire wound Isometric views；

Fig. 4 a, which is shown, to be had by the lead according to the present invention of the pneumatic lead of the sealed connection of material and the electrical lead of straight line The viewgraph of cross-section of the flat cross-sectional shape of system；

Fig. 4 b, which is shown, to be had by the lead according to the present invention of the pneumatic lead of the sealed connection of material and the electrical lead of straight line The viewgraph of cross-section of the non-flat cross-sectional shape of system；

Fig. 4 c shows the lead according to the present invention with the electrical lead being helically integrated into the sheath of pneumatic lead The viewgraph of cross-section of the non-flat cross-sectional shape of system；

The pneumatic lead that Fig. 4 d shows the integrated electrical lead with straight line of lead system according to the present invention is dispersing Viewgraph of cross-section in the region of section；

The pneumatic lead with the integrated electrical lead of winding that Fig. 4 e shows lead system according to the present invention is dispersing Viewgraph of cross-section in the region of section；

Fig. 4 f shows the viewgraph of cross-section of the pneumatic lead of the electrical lead with decoupling of connector system；

Fig. 5 shows the isometric views of the pneumatic lead according to the present invention with web-like protuberance；

Fig. 6 show with maintenance connector, sub- lead section and feedway lead system according to the present invention etc. Axonometric drawing.

Specific embodiment

Each embodiment of lead system 1 according to the present invention is described by attached drawing below.Within the scope of this invention, term " proximal end " is related to following regions or direction: the region or direction direction or close feedway or operator." remote area or Direction " is related to following regions and direction, and the region and direction are towards or close to medical implant.In other words, " proximal direction " Direction from implantation material to feed unit is described, and " distal direction " describes the direction from feed unit to implantation material." external " It describes the overwhelming majority under loading state or is fully located at the external whole components of patient, that is, be located at the close of skin exit site End.And " internal " description whole components that are most or being fully located at patient's body under loading state, it implies that positioned at skin The distal end of exit site.

With reference to Fig. 1, lead system 1 according to the present invention includes intracorporal lead section 100 and external lead section 200.The proximal end region 112 of lead section 100 in vivo neutralizes in the remote area 214 of lead section 200 in vitro, draws Linear system system 1 has flat cross-sectional profiles 11.Therefore obtain following effects: lead system 1 can be in skin under loading state It is left in skin exit region 6 with flat cross-sectional profiles 11.Therefore, the exit opening of lead system 1 is not shown herein Patient skin in advantageously narrowly keep.Further, since lead system 1 is in the short side for being parallel to lead system cross section 10 Smaller extension on direction (i.e. in the x-direction), lesser drawing force are applied on patient skin.Therefore, skin exit region It can be depressurized by the way that flat cross section 11 is mechanical.

In addition, lead system 1 can relatively easily be surrounded by flat cross section 11 in skin exit region 6 It is parallel to the axis bending of lead system cross section long side, external lead section 200 can prolong close to patient body as a result, It stretches.Therefore it can improve and carry comfort level and daily practicability.Furthermore it is possible to due to the hook on lead system 1 and will draw Risk of injury caused by the subsequent displacement of linear system system 1 minimizes.Here, skin exit region 6 indicates must being drawn for patient The epidermis and dermal zone that linear system system 1 punctures.Here, exit opening can be the necessary opening in patient skin, to make to draw Linear system system 1 can be directed across and related to the cross-sectional geometry 11 of lead system 1 in turn.It is also shown and draws in Fig. 1 The relative coordinate system 60 of linear system system 1.Here, the direction x 61, which limits, is parallel to the side that the short seamed edge of flat cross section 11 extends To.And the direction y 62 extends along the longitudinal edge of flat cross section 11.

As seen from Fig. 1, intracorporal lead section 100 has from flat cross-sectional profiles 11 to non-flat transversal The transitional region 113 of facial contour 12.In addition, external lead section 200 also has from flat cross-sectional profiles 11 to non-flat The transitional region 213 of flat cross-sectional profiles 12.In the embodiment illustrated in figure 1, intracorporal lead section 100 is non-flat Cross-sectional profiles 12 be configured to the cross-sectional profiles 12d of general triangular (referring to fig. 2 a).External lead section 200 it is non- Flat cross-sectional profiles 12 are configured to circular cross-sectional profiles 12b (referring to fig. 2 a).

In other embodiments, the non-flat cross section of intracorporal lead section 100 and external lead section 200 12 are also configured to other cross-sectional shapes.Fig. 2 a be exemplarily illustrated four different non-flat cross sections (12a, 12b, 12c,12d).Illustratively, non-flat cross section 12 can be configured to generally square 12a, circle 12b, polygon 12c or Triangle 12d.By " substantially " at this for example with following cross-sectional shape, the cross-sectional shape is mentioned shape The basic configuration of one of shape, but also have for example, by slight deviations caused by radius (see, for example, transversal in Fig. 2 a The dotted line of face shape 12d).

Refer to the two-dimentional shape of cross section 10 herein by term " flat cross section 11 " or " non-flat cross section 12 " Shape, wherein limiting value (flat) or height of the ratio lower than 0.5 of extension with the extension of longer size 64 of shorter size 63 In 0.5 limiting value (non-flat).In the case where flat cross section 11, the ratio can lower than preferably 0.4 and Particularly preferably 0.3 limiting value.In the case where non-flat cross section 12, the ratio can be higher than preferably 0.6 simultaneously And particularly preferably 0.7 ratio.About this, in order to better understand, cross-sectional shape 12a and 12b are shown in fig. 2 a Each shorter size (63a, 63b) and longer size (64a, 64b).It, herein should be by respective shapes in order to determine the ratio Minimum extend be used as shorter size 63, and by respective shapes along the maximum in the direction orthogonal with the direction of shorter size 63 Extend and is used as longer size 64.

By corresponding transitional region (113,213), lead system 1, which can match, is, so as to times with interface 10 phase of cross section of anticipating is coordinated.With the interface of flattened cross-sectional 11, corresponding section (100,200) can also be wrapped It includes from non-flat to the flat another transitional region being not shown herein.Even if when preferred form of implementation is shown in FIG. 1 When, corresponding lead system (100,200) also can not include completely in the embodiment of alternative transitional region (113, 213).In addition to interface compatibility, it is capable of providing special with the machinery for specially adapting to 1 corresponding region of lead system (113,213) The lead system 1 of property.As described above, lead system 1 can by flat cross section 11 for skin exit region 6 carry out it is excellent Change.In addition, can for example generate such as down cross-sectional wheel by the transitional region 113 of intracorporal lead section 100 in body interior Exterior feature 10, the cross-sectional profiles require (such as flexible, rigidity and storage in vivo) aspect to optimize in vivo.

As illustrated in detail below, lead system 1 also can include sub- lead section 300 (see Fig. 6).If this is Such case, as an alternative or other than external lead section 200, sub- lead section 300 also can include from flat Cross-sectional profiles 11 arrive the transitional region of non-flat cross-sectional profiles 12.

It is also known in Fig. 1, intracorporal lead section 100 includes multiple intracorporal anchoring sheaths 120.Specifically, Distally lead section in vivo is arranged in 4a with being sequentially distributed for first 120a, the 2nd 120b and the 3rd 120c anchoring sheath On 100.In the embodiment of alternative, intracorporal lead section 100 also can include being more or less than three anchoring sheaths 120.As being schematically shown in Fig. 1, intracorporal anchoring sheath (120；120a, 120b, 120c) with porous, fine Dimension or fabric structure 121.Following feasibilities are provided by the particularly advantageous design scheme of structure 121: being rich in collagen egg White connective tissue can be grown into anchoring sheath (120；120a, 120b, 120c) in.In the embodiment of alternative, in vivo Anchoring sheath (120；120a, 120b, 120c) also can differently it design, to promote growing into for connective tissue.

By anchoring sheath (120；120a, 120b, 120c) porous configuration provide connective tissue and can preferably grow Enter arrived ambient enviroment.Thereby, it is ensured that: the connective tissue of patient can with intracorporal anchoring sheath 120 and in turn and in vivo Lead section 100 connect.It is connected by connective tissue, intracorporal lead section 100 can support and be fixed on patient's body. Therefore by (especially intracorporal lead section 100) displacement risk minimization of lead system 1, and improve system reliability and Patient safety.It, will the machine caused by shifting by the intracorporal lead section 100 of fixation especially in skin exit region 6 The common transferability of tool power minimizes and reduces risk of injury in turn.Furthermore the healing of skin exit site is improved, Thus, it is possible to reduce risk of injury.Furthermore it is possible to the external force being applied on lead system 1 be better compensated for, because of the external force It can be via anchoring sheath (120；120a, 120b, 120c) it is absorbed by connective tissue.Pass through multiple anchoring sheaths 120, Neng Gouti For the higher stability of intracorporal lead section 100.Therefore most by the relative motion between lead system 1 and connective tissue Smallization.Corresponding anchoring sheath (120；120a, 120b, 120c) length 123 more particularly to according to intracorporal lead section Requirement flexible is matched in other words for 100 fixation and mobility.For example, passing through multiple shorter 120 energy of anchoring sheath It is enough that the multiple fixed points with lesser power absorbability are provided.Pass through small number of longer anchoring sheath 120, Neng Gouti For small number of fixed point, however the fixed point can absorb biggish power.Here, " length 123 " of anchoring sheath 120 It can be regarded as the size on the longitudinal direction of lead system 1.Anchor sheath (120；120a, 120b, 120c) length 123 exist This can be preferably placed in the range of 1cm to 10cm in the range of 0.5cm to 20cm, and particularly preferably be located at 3cm extremely In the range of 6cm.In a preferred form of implementation, sheath (120 is anchored；120a, 120b, 120c) length 123 be 5cm。

Here, intracorporal anchoring sheath 120 has structure, such as hole or intermediate space, the hole or intermediate space With 40 μm to 2000 μm, preferably 50 μm to 1000 μm, and particularly preferred 80 μm to 500 μm of size.Therefore it is capable of providing The optimum size condition grown into for connective tissue.It is capable of providing the structure, mode are as follows: intracorporal anchoring sheath 120 Such as by so-called " operation felt ", fabric or woven, braiding, spinning, felt or foamed products, preferably plastics production by other Product are made.The advantages of in addition to being already mentioned above, intracorporal anchoring sheath 120 help to improve the biocompatibility of lead system 1.This Outside, anchoring sheath 120 can also act as resisting the safeguard measure that intracorporal lead section 100 is bent.

The first 120a and the 2nd 120b is arranged in the transitional region 113 of intracorporal lead section 100 in the embodiment in figure 1 It anchors between sheath.In the embodiment of alternative, body can be also arranged in the transitional region 113 of intracorporal lead section 100 In other regions of interior lead section 100.The transitional region 113 being arranged by relatively close skin exit region 6, lead system The cross-sectional profiles 10 of system 1 can be matched with above-mentioned internal requirement on the distal direction 4a in the first anchoring downstream sheath 120a.

As especially in fig 1 and 2 it is appreciated that lead system according to the present invention 1 is in a preferred form of implementation It can include at least nine electrical leads 20 and at least three pneumatic leads (30a, 30b, 30c).But in other embodiments, Lead system also can include being more or less than nine electrical leads 20 and three pneumatic leads 30.In the embodiment illustrated, Every two electrical lead 20 is used for transmission the signal of the bipolar electrode of implantation material 2.In the preferred form of implementation, this is that have to use In three pairs of each two electrical leads of signal transmission.The signal for example can include believing for monitoring the simulation of vital functions Number, the especially ECG signal of patient.Two other electrical leads 20 are used for cable fault recognition, and another electrical lead 20 is used for Electrical shielding.The preferred advantageous design scheme can further increase system reliability and success rate.In other implementations In scheme, electrical lead 20 can also undertake the function different from representation function just now.Here, also can have more or less than nine A electrical lead 20.For example, lead system 1 also can only have electrical lead 20, the electrical lead is used for transmission ECG signal.

By at least two electrical lead 20, lead system 1 can be handed between feedway 3 and medical implant 2 Change electric signal.For example, therefore the action potential of the voltage form at least two electrodes of heart can be transferred to supply dress It sets and calculates ECG signal in turn.Therefore it can be realized the direct feedback about the body function in implantation object area.Therefore It can be realized the direct feedback of the cardiac function about body function, especially in 2 region of implantation material.This means, pass through lead system The special designing scheme of system 1, preferably can control and monitor medical implant 2.This causes system reliability and treats successfully The increase of rate and the raising for causing patient safety.It, can will be at heart or in human body by large number of electrical lead 20 Multiple electric signals, the especially action potential of multiple electrodes be transferred to feed unit and calculate multiple ECG signals.Institute as above It states, cable fault recognition can be improved via lead 20 and realizes electrical shielding.

By providing pneumatic lead 30 in lead system 1, can with compressed air to pneumatic implantation material, for example with The pneumatic implantation material of expansible unit is supplied.Here, implantation material 2 can be supplied with over-voltage.Alternatively or additionally, it plants Negative pressure feeding can be used by entering object 2.Therefore, in the implantation material with expansible unit, each expansible unit can be alternately Extension and compression.In the implantation material 2 for heart assistance, therefore the blood-pumping function of such as accessory heart.Because of lead system 1 The external of skin exit site is extended up to by pneumatic lead 30, so therefore feedway 3 can be arranged in patient Outside body.By cancelling the necessity of intracorporal feedway, therefore can prevent: other foreign matters endanger patient safety. In the embodiment of alternative, hydraulic lead also can be used instead of pneumatic lead.

In addition, intracorporal lead section 100 includes dispersion section 130.Disperse the lead section of the setting of section 130 in vivo On 100 distal end 115.It is arranged on the distal end 115 of lead section 100 in vivo due to dispersion section 130, thus Ensure: each lead (20,30) is only nearby separated before it determines place.This ensures each lead (20,30) in vivo It is conveyed jointly in the major part of lead section 100.It is conveyed jointly in major part by lead section 100 in vivo, it can By patient's minimum loads.In addition, the stability of lead therefore can be improved and then reduce the probability of disabler.In vitro In lead section 200, guided in addition in the case where selected connector embodiment, lead (20,30) is continuously common.? In the embodiment of alternative, lead (20,30) also can be in the partial region of lead system 1 or in entire lead system 1 In separately guide.For example, pneumatic lead 30 can separate guidance with electrical lead 20.As an alternative, every two or three electrical leads 20 can guide with a pneumatic lead 30 together respectively.

It is separated in the region of dispersion section 130 by dispersing section 130, electrical lead 20 and pneumatic lead 30.Fig. 1's In embodiment, distally 4a first separates three pneumatic leads 30.Furthermore distally 4a, will be each towards implantation material Electrical lead 20 is separated with corresponding pneumatic lead 30, and is guided on implantation material 2 on their specific position.In alternative In embodiment, each lead can guide jointly longlyer or shorter and distally 4a is separated early or late.Especially In the case where the electrical lead 20 of other quantity and/or pneumatic lead 30, dispersion section 130 can be configured differently.By dividing Ensure from the lead (20,30), lead (20,30) can be respectively positioned on the specific location of implantation material 2 or can be with The implantation material connection.The proximal end for dispersing section 130 is set up directly on dispersion 130 downstream of section by proximally 5a 150 limit of resolution element.In shown form of implementation, resolution element 150 anchors sheath 120c by third and realizes.? In the embodiment of alternative, resolution element 150 also can be other anchoring sheaths 120, such as the 4th anchor being not shown herein Solid protection set 120 or other elements.By resolution element 150, can be realized described in the distal direction 4a separation along resolution element 150 Lead and/or the separation for preventing the proximal direction 5a along dispersion section 130.

As schematically shown in fig. 3 a, electrical lead 20 can at least one section of lead system 1 spiral shell Wind to rotation shape.Electrical lead 20 can helically surround itself (see Fig. 3 a) herein or helically surround in pneumatic lead 30 At least one (see Fig. 3 b) winding.In the view of Fig. 3 b, electrical lead 20 is integrated into pneumatic lead 30 in a manner of winding In sheath.As an alternative, electrical lead 20 also can wind (being not shown here) around the sheath of pneumatic lead 30.It is preferred at one In embodiment, every three electrical leads 20 can be around the winding of one of three pneumatic leads (30a, 30b, 30c) (in Fig. 1 and 6 not It can be seen that).Here, the every two in three electrical leads 20 can be transmitted designed for the signal of bipolar electrode and can divide in turn It Xing Cheng not an electrical lead group (21a, 21b, 21c).Corresponding lead wire set (21a, 21b, 21c) medical implant specifically It is just guided in the close remote area for being in dispersion section 130 far from corresponding pneumatic lead (30a, 30b, 30c) simultaneously before point And it is separated (see Fig. 1 and 6).Corresponding other electrical leads 20 on pneumatic lead 30a and 30b are each one breaking identification lines (22a, 22b), the open circuit identification line is short-circuit in the region of resolution element 140 in the embodiment of Fig. 1 and 6 and is in turn It is sightless.Two breaking identification lines (22a, 22b) are provided and can be realized the two breaking identification line short circuits: by electrical zero The defect of line and electrical lead distinguishes.Third electrical lead 20 around pneumatic lead 30c winding is shielding line 23, the shielding line It is terminated in the region of resolution element 140.For the sake of clarity, the electrical lead of the winding described just now can not in Fig. 1 and 6 See.Fig. 4 b is exemplarily illustrated linearly extended breaking identification line (22a, 22b) and shielding line 23.In fig. 4b, electrical lead (22a, 22b, 23) is illustratively medially shown in cross section 12.As an alternative, but the electrical lead (22a, 22b, 23) Cross section (10 can be also set；11,12) in other positions.In the form of implementation of an alternative, more than three or institute There is electrical lead 20 that can also wind around pneumatic lead 30.In the embodiment of alternative, one or more electrical leads 20 also can Enough wound around all pneumatic leads 30.This is more particularly to being shielding line 23.In the embodiment of alternative, breaking identification line (22a, 22b) also can be towards the especially same electrode guidance and short-circuit at the position.Similarly, it is contemplated that drawing Short circuit at the other positions of linear system system 1.Ideally, the position of the short circuit of breaking identification line (22a, 22b) should position as far as possible In distal end, to cover the big region of lead system 1.It, can also be without using open circuit in the embodiment of other alternative Identification line 22 uses more than two open circuit identification line.This is similarly applicable for shielding line 23.Just now described about winding The embodiment of electrical lead 26 can also be applied similarly to the electrical lead 28 not wound, as long as the electrical lead is applicable 's.For example, do not wind, as substantially linearly extended breaking identification line (22a, 22b) corresponding pneumatically lead (30a, 30b) guidance nearby and the short circuit in the region of resolution element 140.

By spiral helicine coil 26, electrical lead 20 is less susceptible to compared to the electrical lead 28 not wound in implantation material 2 Such as the influence of the distance between skin exit region 6 variation.In the case where being used as implantation material 2 of cardiac assist devices, The distance for example between the region mentioned just now can be caused to change by the expansion and contraction of heart.The spiral of electrical lead 20 Shape coil 26 can be changed herein with uncompensation distance to a certain degree, similar to the telephone wire of winding.In addition, passing through spiral helicine line Circle 26, can be by the bending of electrical lead 20 or the risk minimization to fracture.Because ECG, the ECG can be received by electrical lead It is used as the control signal of implantation material 2 again, the function that the fracture of electrical lead 20 will lead to implantation material 2 is lost.Because this can be to patient It has serious consequences, so to be absolutely avoided.This can be improved the service life of electrical lead 20.By around pneumatic lead 30 Coil can reduce the volume squeezed by lead system 1 and the cross section 10 for reducing lead system 1, this is compatible to patient Property plays positive effect.In addition, pneumatic lead 30 can be able to machinery surely by the electrical lead 20 being helically wound about It is fixed.In other words, bending stiffness can be improved by spiral helicine coil 26 and at the same time required flexibility is remained unchanged.

In one form, the proximal end region 112 of the lead section 100 of electrical lead 20 in vivo neutralizes in vitro It is not wound in the remote area 214 of lead section 200.This means, electrical lead 20 in the region (112,214) substantially Linearly extend.About this, Fig. 4 a shows the flat cross-sectional profiles 11 of lead system 1, and the electricity with nine straight lines draws Line 20 and three pneumatic leads 30.Arrangement of the electrical lead 20 in the cross section of lead system 1 10 is herein for flat and non- Flat cross-sectional profiles (10；11,12) for can be also differently composed with the arrangement shown in fig.4.Fig. 4 b is shown The alternative arrangement of the electrical lead 20 of straight line in the non-flat cross-sectional profiles 12 of lead system 1.In the embodiment of alternative In, electrical lead can also lead system 1 other region or only linearly extend in other regions.As an alternative, Electrical lead 20 that can be only selected linearly extends in the specific region of lead system 1.By preferred form of implementation, especially It can be in skin exit region 6 than the smaller cross section of the acquisition lead system 1 in spirally-wound electrical lead 20 10.Thus, it is possible to the exit opening of lead system 1 is reduced as having been described above.

(for example, see Fig. 4 c) in preferred form of implementation, pneumatic lead 30 respectively include internal restrictive coating 31a and External restrictive coating 31b.Internal restrictive coating 31a is made of the first material 32a herein, and external restrictive coating 31b is by the Two material 32b are constituted.Each three electrical leads 20 are individually integrated into the restrictive coating 21b of the outside of corresponding pneumatic lead 30 herein In.This schematically shows in Fig. 4 c, wherein illustratively an electrical lead 20 is integrated into a pneumatic lead 30 by branch In.Furthermore it is seen that, pneumatic 30 material of lead is connected with each other in locking manner.If being described above, intracorporal leading part Section 100 includes dispersion section 130.In the region of dispersion section 130, material is not connected with each other pneumatic lead 30 in locking manner.Figure 4d and Fig. 4 e schematically shows independent one pneumatic lead 30, and the pneumatic lead, which has, is integrated into external restrictive coating 31b In electrical lead 20.Illustratively it is able to identification only one electrical lead 20.However it should be clear that can also by it is multiple, Especially three of them or four electrical leads 20 are integrated into external restrictive coating 31b.This for individual pneumatic lead 30 (see, for example, Fig. 4 d and Fig. 4 e) and material pneumatic lead 30 (see, for example, Fig. 4 c) interconnected is all applicable in locking manner.

Here, the first material 32a can be elastic material, and the second material 32b can be smaller than the first elastic properties of materials Material.For example, the first material 32a can be elastic material, especially silicone resin, and the second material 32b is mechanically stable Material, especially polyurethane.Here, the mechanically stable material for being related to that there is higher-strength, especially have higher anti-cut intensity, compared with High resistance against wear intensity and/or material with better tear-resistant characteristic.As an alternative, the first material 32a and the second material 32b Same material can be come from.By the elastic material of internal restrictive coating 31a, such as can will be made of mechanically stable material The risk minimization of external restrictive coating 31b being broken completely.In the embodiment of alternative, pneumatic lead 30 also can include Only one restrictive coating 31 or more than two restrictive coating 31.Especially when the second material 32b is material identical with the first material 32a When, pneumatic lead 30 can include another restrictive coating 31 around external restrictive coating 31b.The other restrictive coating herein can Come from the material identical or different with the first 31a and the second restrictive coating 31b, preferably comes from more mechanically stable than the first material 32a Material.

In restrictive coating 31b by the outside that one or more electrical leads 20 are integrated into pneumatic lead 30, one side energy Compact lead system 1 is enough provided.On the other hand, can be enhanced by integrated electrical lead 20 corresponding pneumatic lead 30 and Reduce corresponding pneumatic lead 30 and bends risk.When the mode that one or more electrical leads 20 spirally are wound is integrated into gas When in the restrictive coating 31b of the outside of dynamic lead 30, this then especially such case.In addition, electrical lead 20 is (winding or non- Winding) insertion causes: electrical lead 20 is simply and reliably integrated into corresponding pneumatic lead 30 by external restrictive coating 31b In.In the embodiment of alternative, one or more electrical leads 20 can also be wound around one or more pneumatic leads 30.? In the embodiment of alternative, electrical lead 20 can also be embedded in multiple restrictive coatings 31 of pneumatic lead 30 and/or be embedded into and gas In the restrictive coating 31b of the outside of dynamic lead 30 different restrictive coatings.Pass through these advantageous design schemes of different restrictive coatings The feasibility of feasibility and integrated electrical lead 20 can set the specific mechanical property of pneumatic lead.

By the sealed connection of material of each pneumatic lead 30, the separation of pneumatic lead 30 is prevented.This especially drawing in vivo It is important in line section 100, because isolated lead (20,30) can cause the injury to patient herein.Such as Fig. 4 a extremely As it can be seen that the sealed interconnecting piece 31c of material surrounds all leads (20,30) in Fig. 4 c.Here, the interconnecting piece 31c structure that material is sealed It makes as so that it is preferred that not generating the outside of the spill of lead system 1.In the embodiment of alternative, the sealed interconnecting piece of material 31c is also provided only between lead (20,30) (dotted line 65 in c referring to fig. 4).In the embodiment of other alternatives, pneumatically Lead 30 can be also pressed together in a contact fashion and only material is connected cohesively together (not shown) at contact site.? It is feasible outside the spill of lead system 1 in the case where finally referring to.One or more is not integrated into electrical lead 20 In form of implementation in pneumatic lead 30, electrical lead 20 can be directly integrated into (a referring to fig. 4 in the sealed interconnecting piece 31c of material With Fig. 4 b).Here, electrical lead 20 also includes spirally winding around wound upon themselves or around the sheath of pneumatic lead 30 Mode is integrated into (not shown) in the sealed interconnecting piece 31c of material.

In addition, the sealed interconnecting piece 31c of the material of pneumatic lead 30, which can be realized, ensures specific cross-sectional shape 10, example Such as the cross-sectional shape (11a, 11b, 11c, 12a, 12b, 12c, 12d) shown in Fig. 2 a and 2b.Here, 30 energy of pneumatic lead It is enough to be connected with each other via the material for corresponding to the second material 32b being set forth above.As an alternative, the sealed interconnecting piece 31c of material Also it can be made of the first material 32a.Alternatively or additionally, each pneumatic lead can be embedded in a common restrictive coating, The restrictive coating surrounds all pneumatic leads.The restrictive coating can be made of herein the second material.If the second material 32b is Elastic material, then restrictive coating can be also made of mechanical more stable material, such as by mechanical more stable thermosetting property or heat Plastic material or other materials are constituted.

In the embodiment of alternative, lead also can be connected with each other to form locking or force closure.

In the preferred form of implementation of one be shown in FIG. 5, sheath of the pneumatic lead 30 in the pneumatic lead 30 With the protuberance 33 of multiple web-likes on inner face 35.About this, Fig. 5 with sectional elevation show pneumatic lead 30 a section etc. Axonometric drawing.Even if the protuberance 33 of five web-likes is shown in FIG. 5, pneumatic lead 30 can also wrap in the form of implementation of alternative Include more or fewer web-like protuberances 33.Preferably, pneumatic lead 30 include at least one and it is three, five particularly preferred Or seven web-like protuberances 33.Here, web-like protuberance 33 from the sheath inner face 35 of internal restrictive coating 31a radially 34a is extended inwardly into.In the embodiment that pneumatic lead 30 includes the alternative of only one restrictive coating, the protuberance 33 of web-like is same It is radially extended inwardly into from sheath inner face.Here, the protuberance 33 of web-like is at least one section of pneumatic lead 30 34b extends in a longitudinal direction.Here, the protuberance 33 of web-like can continually or intermittently 34b extends along the longitudinal direction.? It is compartment arrangement shown in the embodiment of Fig. 5.When intermittently 34b extends the protuberance 33 of web-like along the longitudinal direction, This, the protuberance can be arranged in different location after one or many interruptions along ring circumferential direction 34c.The protuberance of web-like 33 help to stablize pneumatic lead 30 and can be realized to prevent being closed completely for pneumatic lead 30 in hose bending.Pneumatic Hose bending in the case of lead 30 is closed completely can cause: implantation material 2 is maintained at the state for patient there are potential danger Under.Keep the minimum diameter of pneumatic lead 30 that can ensure promptly being vented and avoid dangerous shape for implantation material in that case of ben State.It, can be rigid or soft to set to a certain degree by the abdomen 33 of compartment and/or the corresponding determining size of web 33 Property.Web 33 can be made of material identical with internal restrictive coating 31a, i.e., by material system identical with the first material 32a At.In the embodiment of alternative, web 33 can be made of the material different from the first material 32a.

Such as it is found that intracorporal lead section 100 further includes stopping sheath 140 especially from Fig. 1 and Fig. 6.Here, stopping shield In the proximal end 111 of the lead section 100 of 140 setting of set in vivo.Here, " proximal end 111 " can be regarded as it is intracorporal The region of the most proximal end of lead section 100.Here, stopping sheath 140 from the proximal end 111, distally 4a extends. Herein preferably, stop sheath 140 distally 4a in the range of 5mm to 35mm and particularly preferably in 10mm to 20mm Range in extend.Here, stopping sheath 140 to be configured to, so that the external side at least 5mm of its preferred distance epidermis.Especially Preferably, sheath 140 is stopped only to extend on the intracorporal side of epidermis under loading state.From exit site distally The blocking sheath 140 that 4a extends has following effects: germ can be difficult to enter patient's body.

As schematically shown in Fig. 1 and Fig. 6, stop sheath 140 that there is porous or fiber structure 141.By the particularly advantageous hatch frame 141, provide following feasibilities: especially macrophage, which can be colonized, is stopping sheath In 140.In the embodiment of alternative, stop sheath 140 that can also be designed differently to promote the field planting of macrophage.Macrophage Cell is used as the effective measures for preventing germ again.Sheath 140 is stopped to help to reduce infection risk as a result,.

Here, stopping sheath 140 that there is structure, such as hole 142 or cavity.Here, the size in the hole 142, outstanding Its corresponding diameter can have 10 μm to 100 μm, preferably 20 μm to 60 μm and particularly preferred 30 μm to 50 μm of size. Therefore, it is capable of providing the optimum size condition for resident macrophages.The structure can be provided by following manner: be stopped Sheath 140 is for example made of the framework with porous structure or foam-like material.Last feature, which provides, can be realized and promote Into the specified conditions of the field planting of macrophage.Macrophage is this targeted in the ambient enviroment of skin exit region 6 Field planting be resistant to the effective measures because of the infection caused by having just enter into the germ after patient's body.Therefore it can prevent, disease Bacterium deeper enters in vivo, and usually minimizes infection risk.The size of hole 142 and cavity is represented herein for there is needle Property is grown into or the specific feature of resident macrophages.Stop sheath 140 thickness should at least with the hole that stops sheath 140 Size equally big (size for seeing above the middle hole 142 for stopping sheath 140) and thinner than 2mm, thinner than 1mm, especially It is thinner than 500 μm, to load skin barrier only on a small quantity.

As especially as can be seen from Fig. 6, furthermore lead system 1 includes connector system 40, and the connector system has the One connector component 41 and the second connector component 42.The close of lead section 200 in vitro is arranged in first connector component 41 It preferably constitutes on the end 211 of end and negatively.The proximal end of the first connector component 41 is arranged in simultaneously in second connector component 42 And it preferably positively constitutes.In addition, lead system 1 includes the sub- lead section 300 for feedway 3.Sub- lead section 300 Extend between feedway 3 and the second connector component 42.Sub- lead section 300 is directly connect with feedway 3 herein.? In the embodiment of alternative, sub- lead 300 can also be connect via another connector system with feedway 3.It is replaced in other In the embodiment of choosing, the second connector component 42 can be also integrated into feedway 3, and then feedway 3 is directly connected to Onto the first connector component 41.

In the form of implementation of Fig. 6, connector system 40 is configured to that there is the mixing of pneumatic lead 30 and electrical lead 20 to insert Connect device system.In the embodiment of alternative, connector system 40 also can include the connector of two separation, one of to use In pneumatic lead 30, and another is used for electrical lead 40.In the form of implementation of another alternative, connector system 40 also can Including the only one connector for electrical lead 20.In last-mentioned situation, pneumatic lead 30 is continuous.For this purpose, electric Lead 20 decouples in connector system 40 with pneumatic lead.This configuration is shown in Fig. 4 f.

In the embodiment of last-mentioned alternative, pneumatic lead 30 is separated under repair and passes through sleeve It is connect with new pneumatic lead member.Defective electrical lead 20 on the proximal lateral of connector system 40 can be via grafting The shutdown of device system 40 is replaced by new electrical lead 20 and is again connected in connector system.This configuration has following Advantage: it has than the smaller size of mixing connector system and in turn significant is conducive to patient comfort.

In general, the lead of the lead of implantation material side and supply side can be decoupled by connector system 40." implantation material side Lead " be interpreted as lead system 1 herein along the region of the distal direction 4a of connector system 40.In shown embodiment In, this is external lead section 200 and intracorporal lead section 100.For example, in maintenance feedway 3 or sub- lead section In the case where 300, it is not necessary to remove the lead of entire implantation material side, but only be supplied by the pure external component of system, i.e. It is removed to the lead of side.Here, " lead of supply side " can be regarded as proximal direction 5a of the lead system 1 along connector system 40 Region.In the embodiment illustrated, this is sub- lead section 300.

By decoupling feasibility, it can be avoided the surgical intervention under repair and can be improved patient safety. This is realized particularly by following manner: connector system 40 is arranged in as closely as possible at skin exit region 6.It is inserted by first The negative design scheme for connecing device component 41 can prevent damage of the connector pin to the lead of implantation material side.This means, if Connector system is damaged, it is then possible that the second connector component 42 is damaged, the second connector component is than first Connector component 41 significantly more simply and for patients less can be replaced jeopardously.

In addition, lead system 1 can include the specified fracture in the region of the proximal end 5a of the first connector component 41 Position 50.Specified fracture location 50 is preferably able in the region that the second connector component 42 is arranged in.As an alternative, specified fracture location 50 can be arranged in the remote area of sub- lead section 300.In the embodiment of other alternative, 40 energy of connector system Enough it is configured to specified fracture location 50.Illustratively, in Fig. 6, specified fracture location 50 is arranged in the second connector component 42 Region in.

External lead section 200 further includes lead fixing piece 270, and the lead anchor designs are that can be applied to skin On.Alternatively or additionally, sub- lead section 300 also can include lead fixing piece 370.By lead fixing piece (270, 370), lead system 1 is capable of fixing in region in vitro and is fixed against displacement or displacement is reduced to minimum journey Degree.In addition, lead system 1 can be guided by lead fixing piece (270,370) close to body.Therefore the carrying for improving patient is relaxed Risk of injury is minimized and reduces infection risk by reducing movement of the lead at skin exit site by appropriateness.

In the embodiment of alternative, lead system 1 can also include the fixation cream being all not shown in any attached drawing Medicine.Fixed plaster more particularly to be applied to patient in skin exit region 6 skin surface on.Fixed plaster may include protection Skin exit region 6 is with aseptic fungi-proofing region.In addition, fixed plaster can reduce the injury in skin exit region 6 Risk.In addition, exit site can be kept cleaning from pollution by fixed plaster, most by inflammation/injury of skin exit region 6 Smallization and the movement for helping to reduce lead system 1.

In the embodiment of alternative, flat cross-sectional profiles 11 can have than non-flat cross-sectional profiles 12 more Small perimeter.This is for example when the area utilization of flat cross-sectional profiles 11 is apparently higher than non-due to the suitably-arranged of lead It can be such case when the area utilization of flat cross-sectional profiles 12.Therefore it can reduce exit opening and skin is opened The decompression of oral area position machinery.It is furthermore possible to reduce infection risk.This is for example accomplished in the following manner, mode are as follows: flat cross The area availability of the cross section of cross section profile 11 due to pneumatic lead 30 and electrical lead 20 corresponding arrangement and with it is non-flat The area availability of the cross section of cross-sectional profiles 12 is compared to raising.

In the embodiment of alternative, flat cross-sectional profiles 11 can have in X-direction 61 than in the y-direction Bigger flexible.Alternatively or additionally, the Plane Rotation ratio of inertias on the direction x 61 of flat cross-sectional profiles 11 It is smaller on the direction y 62.As described above in conjunction with flat cross section 11, external lead section 200 can Lesser Plane Rotation inertia by easier flexible or in the x direction from skin directly after leaving close to trouble The body of person guides.Therefore it can improve and carry comfort level and daily practicability.Furthermore it is possible to by due on lead system Risk of injury caused by the subsequent displacement with lead system is hooked to minimize.

In the embodiment of alternative, non-flat cross-sectional profiles 12 can have more than flat cross-sectional profiles 11 Big rigidity.Alternatively or additionally, non-flat cross-sectional profiles 12, which have, is being orthogonal to intake line system longitudinal direction Direction on substantially uniform flexible.Alternatively or additionally, non-flat cross-sectional profiles 12 are on the direction x 61 And there can be substantially uniform Plane Rotation inertia on the direction y 62.Pass through these advantageous design schemes, Neng Gou The mechanical property of lead system 1 is improved in region with non-flat cross-sectional profiles 12 for the region.For example, intracorporal Lead section 100 can be by having substantially uniform axial Plane Rotation inertia on the direction x 61 and on the direction y 62 Non-flat cross-sectional profiles 12 come meet about necessary flexible and rigidity internal requirement.

In a preferred form of implementation, medical implant 2 is cardiac assist devices.In the form of implementation of alternative, The medical implant 2 is also possible to other equipment.

Although the present invention is described above and limits in the appended claims, it should be appreciated that are as follows: as an alternative The present invention can be limited according to following forms of implementation:

1. being used for the lead system of medical implant, comprising:

Intracorporal lead section, and

External lead section；

It is characterized in that,

The proximal end region of the lead section of the lead system in vivo neutralizes the remote area of lead section in vitro In have flat cross-sectional profiles.

2. according to lead system described in form of implementation 1, which is characterized in that intracorporal lead section and/or external draw Line section is respectively provided with the transitional region from flat cross-sectional profiles to non-flat cross-sectional profiles, especially described non-flat Cross-sectional profiles be generally square, circular or polygon cross-sectional profiles, especially general triangular is transversal Facial contour.

3. according to lead system described in form of implementation 2, which is characterized in that intracorporal lead section includes at least one body Interior anchoring sheath, the anchoring overwrap designs are that tissue is promoted to grow into.

4. according to lead system described in form of implementation 3, which is characterized in that intracorporal lead section includes first, second Sheath is anchored with third, it is each to anchor in the lead section that sheath is proximally arranged to distal end in vivo.

5. according to lead system described in form of implementation 4, which is characterized in that the transitional region of intracorporal lead section is located at institute It states between the first and second anchoring sheaths.

6. according to lead system described in one of above-mentioned form of implementation 3 to 5, which is characterized in that intracorporal anchoring sheath has Porous, fiber or fabric structure.

7. according to lead system described in one of above-mentioned form of implementation 3 to 6, which is characterized in that intracorporal anchoring sheath has Hole and/or cavity, the hole and/or cavity are with 40 μm to 1000 μm, preferably 50 μm to 800 μm and particularly preferred 200 μm to 500 μm of size.

8. the lead system according to one of above-mentioned form of implementation, which is characterized in that the lead system includes at least Two, preferably nine electrical leads and/or at least two, preferably three pneumatic leads.

9. according to lead system described in form of implementation 8, which is characterized in that intracorporal lead section includes dispersion section, The dispersion section is arranged at the distal end of lead section in vivo and can be realized the separation of each lead.

10. according to lead system described in form of implementation 9, which is characterized in that the proximal end of the dispersion section passes through Proximally it is set up directly on the resolution element limit in the dispersion section downstream.

11. according to lead system described in form of implementation 10, which is characterized in that the resolution element is anchoring sheath.

12. the lead system according to one of above-mentioned form of implementation 8 to 11, which is characterized in that in the electrical lead At least one helically winds at least one section of the lead system.

13. the lead system according to one of above-mentioned form of implementation 8 to 12, which is characterized in that in the electrical lead At least one is helically twined around at least one of described pneumatic lead at least one section of the lead system Around.

14. the lead system according to one of above-mentioned form of implementation 8 to 13, which is characterized in that in the electrical lead The proximal end region of at least one lead section in vivo neutralizes not to be wound in the remote area of lead section in vitro.

15. the lead system according to one of above-mentioned form of implementation 8 to 14, which is characterized in that in the electrical lead At least one is integrated into the sheath of at least one pneumatic lead.

16. the lead system according to one of above-mentioned form of implementation 8 to 15, which is characterized in that in the pneumatic lead At least one include at least one restrictive coating, at least one of described electrical lead is embedded in the restrictive coating.

17. the lead system according to one of above-mentioned form of implementation 8 to 16, which is characterized in that in the pneumatic lead At least one include internal restrictive coating and external restrictive coating.

18. according to lead system described in form of implementation 17, which is characterized in that internal restrictive coating is by the first material structure Constituted at, especially elastic material, and external restrictive coating is made of the second material, second material be elasticity it is lesser, Especially mechanical more stable material.

19. according to lead system described in form of implementation 17, which is characterized in that first and second material is by elastic material Material is constituted, and is especially made of silicone resin.

20. the lead system according to one of form of implementation 17 to 19, which is characterized in that in the electrical lead at least In the restrictive coating of one outside for being integrated at least one pneumatic lead.

21. the lead system according to one of form of implementation 8 to 20, which is characterized in that the pneumatic lead material lock It is connected to each other with closing.

22. the lead system according to one of above-mentioned form of implementation 8 to 21, which is characterized in that in the pneumatic lead At least one on the inner face of corresponding pneumatic lead with the protuberance of at least one and preferably at least three web-likes, it is described Protuberance is radially penetrated into corresponding pneumatic lead.

23. the lead system according to one of above-mentioned form of implementation, which is characterized in that intracorporal lead section includes resistance Sheath is kept off, the blocking sheath is arranged in the proximal end of lead section in vivo.

24. according to lead system described in form of implementation 23, which is characterized in that the blocking overwrap designs are to promote huge The field planting of phagocyte.

25. the lead system according to form of implementation 23 or 24, which is characterized in that the blocking sheath have it is porous or The structure of fiber.

26. the lead system according to one of above-mentioned form of implementation 23 to 25, which is characterized in that the blocking sheath tool There are hole and/or cavity, the hole and/or cavity have 20 μm to 60 μm and preferably 30 μm to 40 μm of size.

27. the lead system according to one of above-mentioned form of implementation, which is characterized in that the lead system further includes tool There is the connector system of the first connector component and the second connector component, wherein the first connector component is arranged in body It preferably constitutes in the proximal end of outer lead section and negatively, and the second connector component setting is inserted first It connects the proximal end of device component and preferably positively constitutes.

28. according to lead system described in form of implementation 27, which is characterized in that the lead system further includes for supplying The sub- lead section of device, the sub- lead section proximally extend to feedway from the second connector component.

29. according to lead system described in above-mentioned form of implementation 27 or 28, which is characterized in that the lead system is described It include specified fracture location in the remote area of sub- lead section, preferably in the region of the second connector component.

30. the lead system according to one of above-mentioned form of implementation, which is characterized in that the external lead section And/or sub- lead section includes lead fixing piece, the lead anchor designs are to be applied on skin.

31. the lead system according to one of above-mentioned form of implementation 2 to 30, which is characterized in that described flat transversal Facial contour has perimeter more smaller than non-flat cross-sectional profiles.

32. the lead system according to one of above-mentioned form of implementation 2 to 31, which is characterized in that described flat transversal Facial contour has the flexible bigger than in y-direction in the x direction.

33. the lead system according to one of above-mentioned form of implementation 2 to 32, which is characterized in that described flat transversal The axial Plane Rotation inertia of the axial Plane Rotation ratio of inertias in the x direction of facial contour in y-direction is smaller.

34. the lead system according to one of above-mentioned form of implementation 2 to 33, which is characterized in that the non-flat cross Cross section profile has bigger rigidity than the flat cross-sectional profiles.

35. the lead system according to one of above-mentioned form of implementation 2 to 34, which is characterized in that the non-flat cross Cross section profile has radially outside substantially uniform flexible.

36. the lead system according to one of above-mentioned form of implementation 2 to 34, which is characterized in that the non-flat cross Cross section profile has substantially uniform axial Plane Rotation inertia in the x direction and in y-direction.

37. the lead system according to one of above-mentioned form of implementation, wherein the medical implant is that heart assistance is set It is standby.

Claims

1. being used for the lead system (1) of medical implant (2), which includes:

Intracorporal lead section (100), and

External lead section (200)；

It is characterized in that,

The proximal end region (112) of the lead section (100) of the lead system (1) in vivo neutralizes lead section in vitro (200) there are flat cross-sectional profiles (11) in remote area (114).

2. lead system (1) according to claim 1, which is characterized in that the intracorporal lead section (100) and/or The external lead section (200) is respectively provided with from flat cross-sectional profiles (11) to non-flat cross-sectional profiles (12) Transitional region (113,213), especially: the non-flat cross-sectional profiles are generally square, circular or triangles The cross-sectional profiles (12a, 12b, 12c, 12d) of shape.

3. lead system according to claim 2, which is characterized in that the intracorporal lead section (100) includes at least One intraindividual anchoring sheath (120), the anchoring overwrap designs are that tissue is promoted to grow into.

4. lead system (1) according to claim 3, which is characterized in that intracorporal anchoring sheath (120) has porous , fiber or fabric structure (121).

5. lead system (1) according to one of the above claims, which is characterized in that the lead system (1) includes electricity Lead (20) and/or pneumatic lead (30).

6. lead system (1) according to claim 5, which is characterized in that at least one spiral shell in the electrical lead (20) With revolving shape around the winding of at least one of described pneumatic lead (30).

7. lead system (1) according to claim 5 or 6, which is characterized in that at least one of described electrical lead (20) It is integrated into the sheath of at least one pneumatic lead (30).

8. the lead system according to one of the claims 5 to 7 (1), which is characterized in that in the pneumatic lead (30) At least one on the inner face (35) of pneumatic lead (30) at least one web-like protuberance (33), it is described protuberance along diameter It is protruded into pneumatic lead (30) to (34a).

9. lead system according to one of the above claims, which is characterized in that intracorporal lead section (100) packet It includes and stops sheath (140), in the proximal end (111) for stopping the lead section (100) of sheath setting in vivo, wherein The blocking sheath (140) is designed as, and promotes the field planting of macrophage.

10. lead system (1) according to one of the above claims, which is characterized in that the lead system (1) further includes Connector system (40) with the first connector component (41) and the second connector component (42), wherein first grafting It preferably constitutes in the proximal end (211) of the lead section (200) of device component (41) setting in vitro and negatively, and it is described Second connector component (42) is arranged the proximal end in the first connector component (41) and preferably positively constitutes.