CN100584286C - Energy based devices for treatment of patent foramen ovale - Google Patents

Abstract

A process, a device and a system for curing patent foramen oval (PFO) are disclosed. The process comprises advancing a pipe guide to one position in a heart which is convenient for curing the PFO, at least partially gathering tissues which are close to the PFO, exerting energy on the tissues, thereby basically rapidly closing the PFO. The pipe guide generally comprises an elongated pipe body, at least one tissue adherence component on the distal end or the vicinity of the distal end which is used to gather the tissues and at least one energy transport component on the distal end or the vicinity of the distal end which is used to exert energy on the tissues. The tissue adherence component also is used as the energy transport component in some examples. The energy which is exerted can be monopole radio frequency energy or bipolar radio frequency energy, or any other suitable energy such as laser, microwave, supersonic wave and resistance heating, etc.

Description

The device based on energy of treatment patent foramen ovale

Related application

The application requires the priority to following U.S. Provisional Patent Application: the Nos.60/458 that on March 27th, 2003 submitted to, 854 (attorney docket No.022128-000100US); The Nos.60/478 that on June 11st, 2003 submitted to, 035 (attorney docket No.022128-000110US); The Nos.60/490082 (attorney docket No.022128-000120US) that on July 24th, 2003 submitted to; The full content that this paper quotes them for your guidance.The application relates to following U.S. Patent application: the Nos.10/665974 (attorney docket No.022128-000300US) of JIUYUE in 2003 submission on the 16th; The Nos.10/679245 (attorney docket No.022128-000200US) that on October 2nd, 2003 submitted to; The Nos.10/787532 (attorney docket No.022128-000130US) that on February 25th, 2004 submitted to; And the Nos.10/_______ (attorney docket No.022128-000400US) that submits to simultaneously with the application, the full content that this paper quotes them is for your guidance.

Technical field

Relate generally to medical treatment device of the present invention and method.Specifically, the present invention relates to be used for the treatment of the device based on energy, the system and method for patent foramen ovale.

Background technology

The blood circulation of fetus has a great difference with adult's blood circulation.Because fetal blood relies on the Placenta Hominis oxygen supply, rather than by the lung oxygen supply of fetus, so blood usually keeps opening (promptly away from lung by a plurality of blood vessels with in the fetus life process, open) the tissue of all holes around being diverted to, the hole of patent just can be closed after birth soon usually.For example, fetal blood flows directly into left atrium from right atrium by elliptical aperture, and a part of blood that cycles through the pulmonary artery trunk flows to large artery trunks by ductus arteriosus.This circulation of fetus is shown in the accompanying drawing 1.

One new life begins to breathe during the fetus birth, and the blood pressure in the left atrium is higher than the blood pressure in the right atrium.In most of babies, organize skin graft to close elliptical aperture and also fully recover together.Baby in annual nearly 20,000 births of the U.S. lacks this skin graft of organizing, and therefore, the hole still stays open, and is called atrial septal defect (ASD).In higher percentage ratio population (estimation range is 5% to 20% of total man's mouth), have skin graft but do not have and fully recover together.This case is referred to as elliptical aperture patent (PFO).Blood pressure in each right atrium is higher than the blood pressure in the left atrium, and blood pressure can be pushed the elliptical aperture of this patent open, thereby allows blood to flow to left atrium from right atrium.

Because the elliptical aperture patent is very little for the common influence of the blood circulation of whole body, so be considered to a kind of benign relatively case always.Yet, recently since, find to result from PFO at least in part and can cause quite a lot of people's brain function to be lost suddenly.In some case, because the blood that PFO allows to contain [flows directly to arterial circulation and flows into the brain from venous circulation, rather than flow into that thrombosis can be trapped therein and gradually in the dissolved lung, so, can cause brain function to lose suddenly.In the other case, thrombosis can be formed in the open channels of PFO itself, and causes blood when right atrium flows to left atrium when blood pressure, and the thrombosis of formation can be by fuge.According to estimates, unexpected patient PFO who loses of agnogenic brain function having been taken place has 4% the other brain function risk of forfeiture suddenly takes place every year.

Further research just connects PFO and brain function forfeiture suddenly at present.At present, if the people of a certain PFO of suffering from is taken place twice or repeatedly brain function lose suddenly, then the health care system of the U.S. can repay surgery cost surgery or other intervention to close PFO definitely.Yet, obtain more preventative method probably and close PFO to prevent that in the future brain function taking place loses suddenly.Yet, owing to the sickness rate that causes because of PFO is relatively low, so the expense and the possible side effect and the complexity of such operation must be low.For example, in the patient of youth, PFO through closing voluntarily sometimes after a while and to health without any adverse effect.

Other is generally popular also relevant with PFO with weak case-chronic migraine one.Although reason is not also made explanations accurately, the closing of PFO demonstrates has eliminated in many patients or has reduced migraine significantly.Moreover, if the operation of relative Noninvasive can be provided, then can permit preventative PFO and close and treat chronic migraine.

At present, treat normally invasive relatively treatment and/or have potential shortcoming for the available intervention of PFO.A kind of strategy is to close PFO in the operation on heart process simply for opening of other purpose (such as heart valve surgery) enforcement.This by realizing once simple operation, for example, sews up a pin or two pins with the vascular stitching thread usually on PFO.Yet, purely for close an asymptomatic PFO or even a very little ASD and implement open heart surgery, be difficult to judge its reasonability.

People have proposed and have worked out many intervention devices via skin that are used to close PFO.Most of these devices are same or similar with the ASD shutoff device.They are the device of " Concha Meretricis Seu Cyclinae " or " two umbrella " shape usually, and they launch a biocompatible wire netting or fabric on each side of atrial septum (for example, ePTFE or Dacron) area is fixed together with a center axial member, closes PFO with this.Then, this umbrella heals in the atrial septum, utilizes the response of recovery from illness, forms a uniform tissue layer or " pannus " on this device.For example, such device is by such as Nitinol Medical Technologies, Inc. (Boston, Massachusetts) and AGA Medical, and the development of Inc. (White Bear Lake, the Minnesota State) two companies is produced.U.S. Patent No. 6,401,720 have described one is used for the interior method and apparatus of performing the operation of thoracoscope heart, and it can be used for the treatment of PFO.

Although the device that is provided can obtain using in some case well, they also face many challenges.For example, the result that complexity causes quite continually comprises: launch, install thromboembolism irrelevantly in circulation, and the device fracture etc.In some cases, a device of disposing does not fully heal in the septum wall, stays an exposure tissue that itself can become thrombotic focus.In addition, the device that can supply is usually complicated and make expensively at present, and it is infeasible that this makes that they are used for the prophylactic treatment of PFO.In addition, the device that provides is at present closed a PFO usually in this wise: place material on the either side in PFO tunnel, oppress and open shrilly the tunnel, on blood clotting is installing and till causing mobile stopping.

Organize the method for welding and the research of complex to carry out for many years to being used to.For example, in people's " the bipolar seal of vessel of the feedback control of high bursting strength " literary composition in Surg.Endosc. (1998) 12:876-878 such as Kennedy such research has been described.The technology of especially meaningfully being developed wherein by people such as McNally (as U.S. Patent No. 6,391, shown in 049) and Fusion Medical (as United States Patent(USP) Nos. 5,156,613,5,669,934,5,824,015 and 5,931,165).These technology all disclose the energy that is transferred to tissue bonding and patchery, so that conjunctive tissue and formation healing between tremulous pulse, intestines, nerve etc.What also have meaning is that a plurality of patents that proposed by inventor Sinofsky relate to laser stitching biomaterial (for example, United States Patent(USP) Nos. 5,725,522,5,569,239,5,540,677 and 5,071,417).Yet, do not have a technology to show in the invention of these announcements and be suitable for locating the PFO tissue so that weld or power transfer is arrived method or the device of PFO to be welded.

In the two pieces of patent applications (PCT publication Nos.WO99/18870 and WO99/18871) that propose by people such as Stambaugh, described patent foramen ovale has been caused thermal burn.Yet described apparatus and method cause burn to the PFO tissue, wish finally to form the incrustation tissue and close PFO.Use such apparatus and method, just PFO in fact still keeps patent after operation, and only certain hour is afterwards just closed (if it is closed completely).Therefore, the surgeon knows just whether treatment comes into force after the treatment operation has been done for a long time.Frequently, incrustation tissue may not form, or may not exclusively form and cause the PFO of patent still.

Therefore, advantageously need there be improved method and apparatus to be used for treating PFO.Be that such method and apparatus will be in implementing the treatment operation process, immediately or implement after the treatment operation in the near future to help sealing PFO ideally.Also for it is desirable to, such apparatus and method will not stay foreign body (or considerably less material) in heart of patient.In addition, such method and apparatus is preferably made and is used relative simply, therefore, gives prophylactic treatment PFO, for example, prevents the unexpected loss of function of brain, a kind of feasible selection.The present invention will satisfy above-mentioned at least some purpose.

Summary of the invention

The present invention usually provides the methods, devices and systems that are used for treating patent foramen ovale (PFO).As described in various embodiments, lump together and tissue is applied energy by the set of organizations of using a pipe guide will be close to patent foramen ovale at least in part, thereby can close a PFO basically sharp.So-called " basically " is meant that traversing PFO forms the stable tissue bridge that can bear physical stress.Yet a PFO who closes basically still can have one or more little gaps or opening, and they are closed by the recovery from illness process through behind the certain hour at least in some cases.So-called " sharp " is meant when closing and performs the operation when finishing that PFO closes basically.Therefore, close the embodiment that makes the following stated sharp and be different from existing technology, existing technology is based on by the tissue recovery from illness and is closed PFO with forming a scab retardation." sharp " do not refer to temporary transient implication for the purposes among the application, because the PFO that various embodiment provides usually permanent (or secular at least) closes.

Phrase " contiguous a PFO tissue ", or claim " PFO tissue " simply for the purposes among the application, means and can be used for or handle and help to close being positioned at PFO, centering on PFO or near any tissue of PFO of PFO.For example, the tissue that is close to a PFO comprises septum primum tissue, septum secundum tissue, is lateral to atrial septum tissue, the tissue in the PFO tunnel, the right atrium surface of atrial septum or the tissue on the left atrial surface etc. of septum primum or septum secundum.So-called " applying energy " is meant that energy can be transferred to the PFO tissue or transfers out from the PFO tissue.For example, if apply the low temperature energy, we can say that then heat energy transfers out tissue.In various embodiments, the energy transform device of any majority and form of energy can be used to the power transfer that provides such.For example, the kind of energy of employing can comprise radio frequency energy, low temperature energy, laser energy, ultrasonic wave energy, resistance heated energy, microwave energy etc.

Thereby tissue is applied energy PFO sharp basically, also can be referred to as " tissue welding " sometimes.Preferably, implement the welding method of organizing of the present invention, and not using-system conjugate or other foreign material.Yet, in certain embodiments, advantageously can use one or more welding materials.Various conjugates and other the welding material of organizing more intactly are described among the U.S. Patent application Nos.10/665974, and it was before quoted for your guidance.The tissue bonding that may be utilized or the example of binding agent include but not limited to: body blood, albumin, collagen, fibrin, cyanoacrylate adhesive, mussel byssus binding agent, polymer hot-melt adhesive etc.

Some embodiment described below provides the set of organizations with a contiguous PFO to lump together (or " adhering to " tissue).In various embodiments, can be before tissue being applied or removes energy, among and/or afterwards, implement tissue attachment.In general, energy applies or removes and will be used for making the in-house collagen modification of PFO.If before the modification and/or among adhering tissue, simultaneously, make the modification once more of in-house collagen, then in a single day isolating in-house collagen will bond together and gather tissue.Therefore, some embodiment comprise one or more before applying or removing energy, among and/or the device of set (and may keep) tissue afterwards.Basically close a PFO sharp by providing, device, system and method can prevent advantageously that brain from losing function, treatment migraine suddenly and/or preventing or treat other state of an illness medically that is caused or aggravated by PFO.

In one aspect of the invention, the method of one treatment PFO comprises that the pipe guide that advances is to the interior position of heart, so that treatment patent foramen ovale, lump together with the set of organizations that will be close to PFO with pipe guide at least in part, and tissue is applied energy, thereby close PFO sharp basically with pipe guide.In certain embodiments, before applying energy, set of organizations is lumped together.Alternative is that tissue can keep together, and applies energy simultaneously.In certain embodiments, also can after applying energy, tissue be kept together, to allow tissue cooling, modification again, to close PFO and/or operation like that.Alternative is that this method also is included in energy and applies afterwards cools tissue effectively.

In certain embodiments, after applying energy, pipe guide can move to different positions with respect to PFO, and tissue can gather together once more, and can apply energy once more.Some embodiment comprise repeatedly repeat to move, step that set and energy apply.In such embodiments, PFO can move by side to opposite side from one of PFO usually with pipe guide by moving and close basically along FPO, set of organizations is lumped together and repeatedly apply energy.A method like this can be referred to as " spot welding " of PFO tissue.In certain embodiments, the supravasal one or more bias component side of conduit that can be used to setover towards PFO.For example, the shape of catheter body, an expanding member, a silk thread of setovering etc. can help to urge the catheter to a side.Normally, conduit can traverse PFO and move, and in a plurality of positions set of organizations is lumped together and apply energy along this path.In one embodiment, for example, the tissue between tissue apposition member (it also can construct tissue the is applied energy) extruder member.When they were operated like this, they also can push the conduit of a shape between tissue, and when tissue pushed downwards, the shape of cross section of catheter body can make it be pushed to a new position.For example, catheter body can have a triangle, avette, diamond or other shape.After the primary importance place applied energy, tissue apposition member moved to the second position, and was squeezed in downwards once more on tissue and the catheter body, therefore, and pushing catheter body to the 3rd position or the like.

Also can conceive multiple other suitable technique traverses PFO and moves and " spot welding " tissue.In another embodiment, for example, a big immobilized positioning of electrode is in the right side or left atrium, and a less traveling electrode moves in another atrium and forms spot welding along PFO.In other embodiments, one or more electrodes can rotate around the circumference of PFO.

The pipe guide that advances can adopt any suitable technique to realize to the position in the heart so that treat PFO.In certain embodiments, for example, one first distal portions of conduit advances to the position in the right atrium, and this first distal portions is used for set of organizations is lumped together.In certain embodiments, one second distal portions may be advanced in the PFO or by PFO, and then, first and second distal portions are used for adhering tissue.In certain embodiments, second portion extends through PFO and enters in the left atrium, and like this, first is from right atrium side contacts tissue, and second portion is from left atrium side contacts tissue.In various embodiments, can handle one or two part then and between them, set of organizations is lumped together.For example, one or two part can move towards each other vertically.In certain embodiments, a part moves towards another part vertically, the latter partly keep static relatively and as one against " return to retaining " or the surface so that set of organizations is lumped together.Many such blocking means that return are described in the patent application, and it is numbered 60/458,854,60/478,035 and 60/490082, and they are quoted for your guidance hereinbefore.Alternatively be, no matter one still two parts also can be used to tissue is applied energy.

At least in part set of organizations is lumped together and to adopt any multiple suitable method to be achieved.For example, just as described in just now, first and/or second distal portions of pipe guide can move towards each other and catch, clamps, clamps, catches or alternate manner adheres to two tissues between the parts.In another embodiment, set of organizations can be lumped together by expanding one or more expanding member.For example, expanding member can expand in the right side or left atrium and backup tissue and therefore they being gathered together.In another embodiment, an expanding member can expand in right atrium, and one second expansible elements expands in left atrium, and this expansion causes being organized between two parts and presses together.As mentioned above, parts can reach similar result by using an expanding member and " to return retaining ".Some embodiment also comprise move an expansible elements towards another so that further set of organizations is lumped together.For example, an expanding member can axially be slided towards another expanding member along pipe guide.Moreover, can use any suitable technique.

In the embodiment of other variation, set of organizations is lumped together to be included in expansion one swelling part in the PFO.The such swelling part of " fish mouth " shape parts such as two forks normally is arranged in the sheath, advances in the PFO simultaneously.Then, withdraw this sheath with allow two the fork open each other.Such expansion " fish mouth ", two fork part applicable shapes memory materials, spring add structures such as carrier material.By the PFO that between two forks, laterally scatters, be organized in two zones between the fork and gather together.In certain embodiments, one or more expanding member can be bonded together tissue so that further help with fork or pipe guide coupling.Alternatively be, this method also can comprise the distal portions contact septum primum that uses swelling part and at least one the left atrial surface in the septum secundum, and withdrawal swelling part and the set of organizations that will be close to PFO lumps together.For example, distal portions can contact septum primum and draw it towards the right side of heart and contact septum secundum.Swelling part is used for adhering to tissue some moment afterwards of contiguous PFO, can advantageously swelling part be withdrawn into the position in the pipe guide.In certain embodiments, for example, swelling part can be withdrawn before removing pipe guide.

In other embodiments, first distal portions of pipe guide and/or second distal portions may be advanced in the tissue of contiguous PFO.In other words, can cause one or more parts of pipe guide to penetrate in the PFO of adjacent tissue.For example, such embodiment can comprise the device that uses a jaw-like, makes first and second tissue apposition member comprise relative clamp.In one embodiment, for example, first distal portions advances in the septum secundum tissue.Alternative is that second distal portions can advance in the septum primum tissue.Then, first and second tissue apposition member can move together and set of organizations is lumped together.In another embodiment that also has, can use the device of a clamp-like, can puncture and organize the tissue that also can not puncture.Adopt anchor clamps, the part of anchor clamps can be from the right atrium contact tissue, and another part can be from the left atrium contact tissue.Moreover, can use any technology in a plurality of other suitable technique, wherein there are some technology more intactly to be described in U.S. Patent application Nos.60/458,854,60/478,035,60/490082,10/665974, and in 10/679245, they are all quoted for your guidance at above quilt.

In certain embodiments, pipe guide can advance on a guide wire.Guide wire extends through PFO usually and can comprise an extension along its length, so that extend in PFO.Alternatively be, guide wire may extend in the left atrium, this method selectively comprises: with at least one the left atrial surface in a distal portions of guide wire contact septum primum and the septum secundum, and withdrawal guide wire and the set of organizations that will be close to PFO lumps together.

The energy of any adequate types can be applied to the PFO tissue and close PFO sharp to provide.In certain embodiments, for example, can apply one pole or bipolar radio frequency energy, and in the embodiment of other variation, can apply low temperature, resistance heated, ultrasound wave, microwave or laser energy, be heat energy such as the such heating fluid form of saline etc.In various embodiments, by being switched on, the single conducting parts of pipe guide or a plurality of conducting parts apply energy.In general, can consider that any suitable device comes supplying energy.In one embodiment, tissue is applied energy comprise the fluid that energy is applied to a conduction, and the fluid of release conduction from pipe guide is with contact tissue.For example, can be incorporated into such as brinish conducting fluid in one or more expanding member of pipe guide, energy such as the radio frequency energy can be applied on the fluid, and then, this fluid discharges by at least one (preferably a plurality of) aperture on the expansible elements from expanding member.But the conducting fluid of energising is contact tissue and close PFO then.

Some embodiment of this method can comprise that also supervision is applied to the energy of tissue.For example, monitor that energy can comprise the temperature that monitors tissue, the impedance and/or the suchlike value of tissue.Such method also can comprise and determined when to tissue supply enough energy and close PFO sharp.Alternatively be that this method also can comprise stop to apply of energy when having applied enough energy.

Any above-mentioned method also can comprise: utilize with link coupled at least one visual device of pipe guide and directly watch PFO and contiguous tissue.Such visual device can comprise a fiber device, a ultrasonic unit or any other suitable visual device.

In another aspect of this invention, the method for the patent foramen ovale in the treatment heart comprises: the pipe guide that advances is to the interior position of heart, so that the treatment patent foramen ovale; The set of organizations of using pipe guide will be close to patent foramen ovale at least in part lumps together; With pipe guide tissue is applied energy, simultaneously, at least in part tissue is kept together; And the lasting time enough that after applying energy, at least in part tissue kept together, thereby close patent foramen ovale basically.Such method can comprise any feature of above-mentioned all embodiment.

In another aspect of this invention, one pipe guide of the patent foramen ovale in the treatment heart comprises an elongated catheter body, it has a near-end and a far-end, be positioned at the catheter body far-end or be used for to be close at least in part at least one tissue apposition member that the set of organizations of patent foramen ovale lumps together near it, and at least one is positioned at the energy transmission member of far-end or adjacent distal end, so that tissue is applied energy, thereby close PFO basically sharp.In certain embodiments, at least one tissue apposition member comprises one first tissue apposition member, is used for from the right atrium contact tissue of heart.Alternatively be, in various embodiments, can comprise one second tissue apposition member, be used for from right atrium or left atrium contact tissue.For example, in one embodiment, first and second parts can comprise one group of relative clamp, and they can be used in right atrium set of organizations be lumped together, and alternative is to advance by the tissue of one or more contiguous PFO.In certain embodiments, second portion can advance by PFO from the left atrium contact tissue.Can comprise the tissue apposition surface that any amount is different.

As mentioned above, for example, one or two in first and second tissue apposition member can comprise expanding member, and any one (or two) can slide toward each other vertically and set of organizations is combined between them.In other embodiments, can use an expanding member and a shape extensible " returning retaining " parts.For example, extensible parts can comprise a shape memory device, and it can advance in the left atrium and launch and contact tissue.One expandable air bag can launch and can axially move along conduit, so that set of organizations is combined between it and the unfolded time retaining.Any one or a plurality of such expansible elements also can comprise at least one aperture, so that allow conducting fluid to escape and contact tissue from expanding member.Some embodiment comprises a plurality of apertures, and some embodiment comprises two expanding member that have aperture.

In other embodiments, first and second tissue apposition member are configured to two arms of anchor clamps, and one of them arm is arranged in the right atrium, and another arm is arranged in the left atrium, so that with clamp tissue together.Also have other embodiment to comprise one group of relative clamp and a hook or clamp member, so that tissue is towards anchor clamps.In other embodiments, first and second section constructions are a clip, " hair clip " etc., and wherein, the relative shape of first and second attachment members presses against tissue together.For example, in one embodiment, one of all parts can be shaped as a hook or similar arc part, and from the left atrium contact tissue, and another parts can be straight relatively so that from the right atrium contact tissue so that hook on PFO.Therefore, tissue can be caught together between two parts, and they are gathered together, and it also is placed between two intermediate plates of a hair clip or the situation in the arc of paper clamp unlike article.

Some embodiment of device also comprises a guiding parts that is used for advancing by PFO, and pipe guide is slidably disposed on this guiding parts.For example, guiding parts can comprise a guiding catheter and be arranged at least one expanding member in the guiding catheter, wherein, guiding catheter regracting and expose expanding member, thus allow it in PFO, to expand.This expanding member can have any appropriate structures again, but in certain embodiments, it comprises that at least two inflatable parts of opening provide side force with the tissue to contiguous PFO, for example, and the expansible elements of " fish mouth " shape or two forks.When exposing, this expanding member also can provide dilatory force to the tissue of contiguous PFO.For expandable ability is provided, expanding member can be made by shape-memory material, and it can be the material of spring-loaded and/or state like that.

In the embodiment of other variation, guiding parts can comprise that one has along the guide wire of its length expandable portion.For example, expandable portion can be the part of dividing, and the part of this division comprises expandable shape-memory material.Alternatively be, guiding parts can comprise at least one end, and it is used for contacting the left atrial surface of the tissue of contiguous PFO.Such end can adapt to left atrial surface.Guiding parts can be withdrawn and be engaged at least one end and left atrial surface.In any one above-mentioned embodiment, one or more guiding parts, or the parts of guiding parts can be used as one or more energy transmission member.For example, in certain embodiments, a swelling part can be used as an one pole or bipolar radio-frequency electrode.

At least one energy transmission member of pipe guide can comprise any suitable energy transform device or the combination of various devices.For example, transmission part can transmit the energy that radio frequency energy, low temperature energy, resistance heated energy, ultrasonic wave energy, microwave energy, laser can or be used for the treatment of any other form of PFO tissue.In a preferred embodiment, energy transmission member comprises an one pole or two bipolar radio frequency transmission parts.For example, such transmission part can bend to the curvature that is similar to PFO.In other embodiments, can use the transmission part of straight transmission part, net or woollen yarn knitting, an a plurality of pin-transmission part etc.

In certain embodiments, one or more energy transmission member and one or more tissue apposition member coupling.In certain embodiments, for example, one or more energy transmission member just are used as tissue apposition member.In certain embodiments, energy transmission member can move along the circumferential section at least of at least one tissue apposition member.In the embodiment that changes, energy transmission member comprises a guiding parts that is used to advance by PFO, and wherein, pipe guide is slidably disposed on the guiding parts.Moreover guiding parts generally includes at least one expandable part, and the set of organizations that will be close to PFO in PFO so that expand at least in part lumps together, and in certain embodiments, expansible elements is used as energy transmission member.In also having some other embodiment, energy transmission member can with tissue apposition member and guiding parts/expansible elements coupling.

As mentioned above, in one embodiment, at least one energy transmission member comprises one or more energy transmission member that are arranged in the expansible elements, so that the fluid of a conduction is applied energy.Energy transmission member also comprises the fluid of one or more conduction, and they are incorporated in the expanding member, then, allows to escape from expanding member, escapes by a plurality of holes usually.In various embodiments, can comprise and have porous one, the fluid and the power transfer part of two or more expanding member, conduction.In one embodiment, radio frequency can be transferred to the saline solution as conducting fluid, but in the embodiment of other variation, can use the energy and/or the conducting fluid of other form.

Some embodiment of pipe guide also can comprise and link coupled at least one pick off of pipe guide, be used for detecting the energy size that is fed to tissue by at least one energy transmission member.For example, pick off can be infrared ray sensor, critesistor and thermocouple etc., but also can use any pick off.Alternatively be, a microprocessor can with at least one pick off coupling determine when the energy of supply has reached desired energy size so that handle detected data.

In another aspect of this invention, the system of the patent foramen ovale in the treatment heart comprises a pipe guide and is used for pipe guide is directed to a position so that at least one guiding parts of treatment patent foramen ovale.Pipe guide comprises an elongated catheter shaft, it has a near-end and a far-end, be positioned at the catheter body far-end or be used for to be close at least in part at least one tissue apposition member that the set of organizations of patent foramen ovale lumps together near it, and at least one is positioned at or the energy transmission member of adjacent distal end, so that tissue is applied energy, thereby close patent foramen ovale basically.Pipe guide can comprise above-mentioned any feature or variant.

In the following description with reference to the accompanying drawings, describe these in detail with other embodiment.

Brief description of drawings

Fig. 1 is the sketch map of fetal circulation;

Fig. 2 is the sketch map according to the pipe guide of one embodiment of the invention, and conduit passes through inner chamber vein and right atrium, and passes through PFO;

Fig. 3 is the axonometric chart of a distal portions that has the pipe guide of two expansible elements according to an embodiment of the invention;

Fig. 4 is the axonometric chart of a distal portions of the pipe guide with two expansible elements according to another embodiment of the present invention;

Fig. 5 is the axonometric chart of a distal portions of the pipe guide with an expansible elements according to another embodiment of the present invention;

Fig. 6 be according to another embodiment of the present invention have an expansible elements and-axonometric chart of a distal portions of the pipe guide of shape memory parts;

Fig. 7 is two axonometric charts of a distal portions with the pipe guide of two link coupled expansible elements of fork that have according to another embodiment of the present invention;

Fig. 8 is the axonometric chart of a distal portions of the pipe guide with an expansible elements and two forks according to another embodiment of the present invention;

Fig. 9 is the sectional view of a distal portions of the pipe guide with two tissue apposition member and a catheter body that is shaped according to another embodiment of the present invention;

Figure 10 is the axonometric chart of a distal portions of the pipe guide with two tissue apposition member and a catheter body that is shaped according to another embodiment of the present invention;

Figure 11 A-11C is the axonometric chart of a distal portions of a pipe guide, and the method that set of organizations is lumped together according to another embodiment of the present invention is shown;

Figure 12 A is the axonometric chart of a distal portions of the pipe guide with two relative clamps according to another embodiment of the present invention with 12B;

Figure 13 A is the axonometric chart of a distal portions of the pipe guide with two relative clamps according to another embodiment of the present invention with 13B;

Figure 14 is the axonometric chart of a distal portions of pipe guide of tissue apposition member that has two forks of vacuum that has according to another embodiment of the present invention;

Figure 15 A is the axonometric chart of a distal portions of the pipe guide with two relative clamps and an arc part according to another embodiment of the present invention with 15B;

Figure 16 A and 16B are the axonometric charts of a distal portions of the pipe guide with magnetic tissue apposition member according to another embodiment of the present invention;

Figure 17 is the axonometric chart of a distal portions of the pipe guide of the tissue apposition member with clamping according to another embodiment of the present invention;

Figure 18 is the right atrium figure of a PFO, and wherein, an immobilized energy transmission member is positioned at right atrium, and according to another embodiment of the present invention an a plurality of tissues welding;

Figure 19 is the axonometric chart of a distal portions of pipe guide that two expansible elements and extend through the guide wire of the right side of heart and left atrium that has according to another embodiment of the present invention; And

Figure 20 A-20C is the axonometric chart of a distal portions of the pipe guide with two isolating tissue apposition member according to another embodiment of the present invention.

The specific embodiment

Apparatus and method of the present invention are cured the elliptical aperture of patent (PFO) by applying energy usually.This method comprises that the pipe guide that advances to the interior position of heart, so that use conduit at least in part set of organizations to be lumped together, applies energy to the tissue that is close to a PFO, thereby cuts out PFO sharp basically.Device of the present invention generally includes a pipe guide, and it has a near-end and a far-end, at least one tissue apposition member, and at least one energy transmission member of adjacent distal end.

Fig. 1 is the sketch map of fetal circulation.Elliptical aperture shown in the figure, wherein, an arrow shows that blood flows to left atrium from the right atrium of fetus.After the baby due, if elliptical aperture fails to close (therefore, becoming a PFO), then blood can flow into left atrium from right atrium, vice versa, as mentioned above, causes brain function forfeiture suddenly, migraine and other may the risk of the disadvantageous state of an illness of health be increased.

With reference to Fig. 2, an embodiment of the pipe guide 10 of treatment PFO comprises a catheter body 12 and one or more tissue apposition member 14 suitably.Pipe guide 10 can advance to the position in the heart by a patient vascular system so that treat a PFO.For example, as shown in the figure, pipe guide 10 advances in the right atrium of heart by interior caval vein.In the embodiment that changes, pipe guide can advance and arrive left ventricle by large artery trunks, and then, the left atrium that enters into heart is interior with treatment PFO.In certain embodiments, two separating parts of one pipe guide may be advanced to right atrium and left atrium, in another embodiment, one guide wire or other parts of pipe guide can extend outside the patient body, arrive right atrium by vascular system, arrive left atrium by PFO, and withdraw from patient body to vascular system from one second side by large artery trunks.Therefore, various embodiment can utilize any suitable technology that enters that one pipe guide is arranged in the position so that treatment PFO.

Catheter body 12 generally includes an elongated flexible body with at least one inner chamber.Catheter body 12 can be made by the combination of materials of knowing in any suitable material or the microcatheter technology field, and this will be disclosed hereinafter, for example, and PTFE, other polymer etc.Catheter body 12 also can have any suitable dimensions, profile, diameter, shape etc.Alternatively be, catheter body 12 can be slidingly arranged on the guiding parts (not shown), for example, and a guiding catheter, guide wire etc.In certain embodiments, such guiding parts can comprise one or more swelling parts or be used for unfolded other similar device to help to adhere to adjacent tissue in PFO.In order to further describe such expandable guide members, can above quote this patent for your guidance with reference to U.S. Patent application No.10/679245.

Tissue apposition member 14 can comprise usually one arbitrarily, two or more device help will contiguous PFO set of organizations lump together.As shown in Figure 2, parts 14 can be arranged in the right atrium with from right atrium side contacts tissue (such as the septum secundum tissue), and another parts 14 can advance by PFO from the left atrium contact tissue.In certain embodiments, tissue apposition member 14 can preform and by manufacturings such as shape-memory material, spring rustless steels, and like this, when they discharged from catheter body 12, they were a shape, and this shape allows them that set of organizations is lumped together.

Pipe guide 10 also comprises at least one energy transmission member.In the embodiment shown, one or two tissue apposition member 14 also can be used as energy transmission member.In various embodiments, energy transmission member can lump together set of organizations, energy transmission member can with the tissue apposition member coupling, or energy transmission member can be separated with tissue apposition member and not with its coupling.Also in various embodiments, can use an energy transmission member,, can use two transmission parts,, maybe can use transmission part more than two so that bipolar RF energy is provided so that unipolar radio frequency energy (RF) is provided.

Referring now to Fig. 3, another embodiment of the pipe guide 20 of treatment PFO comprises that suitably a catheter body 22, has first expanding member 27 of one first energy transmission member 23, and second expanding member 28 with one second energy transmission member 25, make each expansible elements 27,28 comprise the hole 24 that a plurality of permission conducting fluids 26 pass through.Expanding member 27,28 can be located and is used for treating in right atrium (first parts 27) and left atrium (second parts 28), then, expand and the tissue of septum secundum SS and septum primum SP and/or the set of organizations of other contiguous PFO are lumped together.In certain embodiments, one or two expanding member 27,28 also can axially move along catheter body 22, for example, by sliding so that organize and be integrated into together between two expanding member 27,28.For example, second expansible elements 28 can be arranged on the catheter body 22 or the intravital independent catheter body of conduit on, axially slide to allow second parts 28 along catheter body 22 front and back ground.

Expanding member 27,28 can comprise any suitable material or the combination of existing known material, or the material of developing in the future.It is well-known being used for supravasal expandable airbag components, in various embodiment of the present invention, can use any suitable variant.Expanding member 27,28 can be made by the elastomeric material of being obedient to, polymer etc., and can have any suitable shape after expansion.

By introducing one or more conducting fluids such as saline solution etc. in expanding member 27,28, energy can be applied to tissue, energy (such as the RF energy) is applied to the fluid 26 of conduction by energy transmission member 25,23, then, allow fluid 26 from hole 24, to pass through and contact tissue.Therefore, fluid 26 can provide the energy that needs to close to cause PFO to tissue.After with near the tissue of power transfer PFO, the fluid 26 of conduction harmlessly dissipates in vivo.

In various embodiments, energy transmission member can comprise any in the multiple arrangement, and the energy that can transmit any adequate types is closed a PFO.For example, the energy of adoptable some type comprises radio frequency, low temperature, resistance heated, ultrasound wave, microwave and laser energy.Radio frequency can transmission part can be unipolar or bipolar, and unipolar pipe guide also can comprise a grounded parts.Energy transmission member also can have any appropriate structures, and wherein many structures will be described with reference to certain embodiments below.In certain embodiments, the coupling regularly of energy transmission member and tissue apposition member, and in other embodiments, energy transmission member can move in tissue apposition member, for example, can move around the circumference of PFO tissue and organize at a plurality of position welding PFO.In certain embodiments,, and do not allow such fluid to spread out of expanding member 27 and 28, can reach the supply of energy like this by fluid refrigerative at expanding member 27,28 internal recycle or heating.In these embodiments, hole 24 can be removed from design.

Energy transmission member 23,25 provides enough power transfer so that weld structure in time enough.For example, the time span of power transfer can be from about 0.5 second to about 15 minutes, is preferably, from about 30 seconds to about 5 minutes.In certain embodiments, power transfer can be from about 0.5 watt to about 100 watts, and preferably, from about 5 watts to about 50 watts.In various embodiments, also can adopt any other suitable energy and the combination of time.In an experimental example, a PFO who takes from the intravital heart tissue part of pig tests in a mobile saline, makes the PFO tissue apposition and applies the RF energy and continue 7 minutes for about 25 watts by applying suction force, then fixedly is closed.Then, stops the RF energy and apply, but tissue apposition continues to adhere to keep tissue to be in 1 minute again, simultaneously, cools tissue so that in-house collagen organize again and link together and form a stable tissue bridge.In the embodiment that changes, also can adopt other energy applied amount, energy application time, tissue apposition time etc.

Although can transmit the energy of any adequate types in various embodiments by energy transmission member, some embodiment will utilize one pole or bipolar radio frequency (RF) energy.For example, device can use the monopolar radio frequency energy, and wherein, energy side by side is applied to all transport elements, finishes circulation by the external ground pad that is attached to patient skin.Perhaps, bipolar energy can side by side be applied to all transport elements, is contained in the earth element that pipe guide goes up Anywhere by one and finishes circulation.Other embodiment can be included between two or more energy transmission member and apply bipolar energy, and energy transmission member is electrically insulation each other in pipe guide.

With energy transmission member or tissue apposition member is link coupled or otherwise be arranged on control system in the pipe guide, can detect the energy size that is fed to the PFO tissue, and alternatively, in case detect the variation of energy supply condition, then can automatically stop the energy supply, for example, if resistance in PFO tissue or the pipe guide or impedance increase, then the energy that obtains from pipe guide and/or suchlike device also increases.In certain embodiments, when the energy of supply reaches a level that requires, when being enough to close the energy of PFO basically, the energy supply then can automatically stop.Available any suitable method monitors the energy of supply, for example, monitors in-house temperature of PFO or impedance etc.In certain embodiments, can use one or more pick offs, they are coupled to tissue apposition member, energy transmission member, or any other parts of pipe guide, so that monitor such labelling.Examples of sensor includes but not limited to infrared ray sensor, critesistor and thermocouple.Alternative is that a control system also can comprise a microprocessor that is connected with pick off, to determine when the energy of supplying requirement and/or when automatically to stop power transfer.In the embodiment that changes, a microprocessor can be attached in the pipe guide, and it can detect, supervision and control energy supply, therefore, does not require independent pick off.

Fig. 4 illustrates the slightly different embodiment of a pipe guide 30, and it has a catheter body 32, one first expanding member 37 and one second expanding member 38, and it has the hole 34 that an energy transmission member 35 and a plurality of permission one conducting fluid 36 pass through.In this embodiment, first expanding member 37 can be used as a tissue apposition member and need not provide additional power transfer.

With reference to Fig. 5, another embodiment of the pipe guide 40 of treatment PFO comprises that a catheter body 42, has the expanding member 48 that a plurality of holes 44 allow fluid 46 to pass through, and an energy transmission member 45.In this embodiment, the expansion of expansible elements 48 can be enough to set of organizations is lumped together, or can be applied to expanding member 48 towards the power of near-end, for example, by being withdrawn on the catheter body 42 set of organizations is lumped together.

Referring now to Fig. 6, one embodiment of pipe guide 50 comprises a catheter body 52, an expanding member 57, it has one and is arranged on energy transmission member 53 wherein and is positioned at and be used for all holes 54 that conducting fluid 56 is passed through and a shaped distal portion 59 on its surface.Shaped distal portion 59 resides in the left atrium and is used as a surface or " returning retaining ", and like this, tissue can be integrated between shaped distal portion 59 and the expanding member 57.In an illustrated embodiment, shaped distal portion 59 is coils of a spiral, and it can be made by shape-memory material, spring rustless steel etc., like this, it has a straight relatively structure in the time of in it is arranged on catheter body 52, but is rendered as the structure of coil when it discharges.In other embodiments, can use other the blocking means that returns, such as at U.S. Patent application No.60/478, the device of more intactly describing in 035, this patent is quoted for your guidance hereinbefore.

Fig. 7 illustrates another embodiment of pipe guide 60, and it comprises the tissue apposition member 64 of a catheter body 62, a pair of fork, and is coupled to two expanding member 66 that are used to provide further tissue apposition on two forks 64.The fork of tissue apposition member 64 can comprise Nitinol, some other shape-memory material etc., and tissue apposition member 64 discharges from the catheter body in a PFO 62 usually and allows fork 64 to open.Therefore tissue between all forks gathers together, and flattens basically or is " fish mouth ".For further adhering tissue, expanding member 66 can expand, and alternatively is, can apply proximal force, for example by being withdrawn on the catheter body 62, with expanding member 66 tissue is pressed against together.All forks 64 are used as energy transmission member then so that tissue is applied energy.Normally, all forks 64 are bipolar RF energy transmission parts, but also can consider the embodiment that changes.

In an embodiment who changes, referring now to Fig. 8, a pipe guide 70 can comprise the tissue apposition member 74 of a catheter body 72, a pair of fork, and an isolating expanding member 76 that is used to improve tissue apposition.Moreover tissue apposition member 74 also can be used as energy transmission member.Additionally or change ground, a plurality of holes can be arranged in the expanding member 76 so that introduce fluid as the conduction of an energy supply system part.

Referring now to Fig. 9, in another embodiment, a pipe guide 80 comprises a catheter body 86, one first tissue apposition member 82 and one second tissue apposition member 84 suitably.As mentioned above, one or two tissue apposition member 82,84 can or can be used as energy transmission member with the energy transmission member coupling.In this embodiment, first tissue apposition member 82 is configured to from right atrium (such as septum secundum SS) contact tissue, and second tissue apposition member 84 is configured to from left atrium (such as septum primum SP) contact tissue.In contact with set of organizations is lumped together in the process of (arrow of terminal hollow), tissue apposition member 82,84 is also against catheter body 86 tissue is bonded together (or extrusion tissue).When power was applied on the catheter body 86, because its shape of cross section, it was pushed to a side (arrow of solid ends).In an illustrated embodiment, catheter body 86 has the triangular-section, but in the embodiment that changes, it can have other shape, for example, and avette, ellipsoid, diamond etc.When catheter body 86 was pushed to side, tissue apposition/energy transmission member 82,84 was used for the tissue at first position is applied energy.Tissue apposition member 82,84 is movable to side then and towards catheter body 86 adjacent tissue is gathered together, therefore, and further along PFO pushing catheter body 86.Then, can be again the tissue at second position be applied energy.Use such technology, can traverse a PFO and move pipe guide 80 from a side to opposite side, when device 80 moves, apply energy and close PFO.In other words, pipe guide is organized spot welding along PFO " walking " thereupon.

Figure 10 is the embodiment of a pipe guide 90, and it can be used for being similar in the described just now method.Device 90 comprises a catheter body 92, one first tissue apposition member 94, and one second tissue apposition member 96, and is shown as and is arranged on the guide wire 98.In this embodiment, tissue apposition member 94,96 is also as energy transmission member.First tissue apposition member 94 is spring-loaded clamps, and second tissue apposition member 96 is energy transmission member of a shape memory, for example, and an electrode.As mentioned above, when the set of organizations that will be close to PFO when tissue apposition member 94,96 lumped together, they made tissue gather together against catheter body 92, therefore, catheter body 92 were expressed on one side.After tissue was applied energy, tissue apposition member 94,96 can move towards catheter body 92 then once more, and is used for once more set of organizations being lumped together, and therefore, once more catheter body 92 was expressed on one side.In order to improve such technology, catheter body 92 can comprise one or more slick surfaces, more easily slides into side to allow it.Catheter body 92 also can comprise the coating, conjugate of a tissue welding substance etc., is extruded to side such as the albumin of partly wiping catheter body at every turn, therefore, improves the applying energy of tissue closed PFO.Catheter body 92 also can comprise one or more be used for guiding be positioned at the fluidic hole that energy applies the position, being used as a welding fluid, or alternate manner improves the welding of tissue.

In as Fig. 9 and 10 described embodiment and other embodiment, a pipe guide also can comprise a bias component, and its pipe guide that is used for setovering is towards the side of PFO and begin the operation of cutting out of a PFO.For example, an expanding member can with a catheter body coupling, usually on a side of catheter body, like this, in pipe guide is positioned at PFO and expanding member when expanding, pipe guide is pushed to the side of PFO.Then, set of organizations can be lumped together and weld on this side, expanding member can little by little be dwindled and be allowed pipe guide to move towards the opposite side of PFO, along with moving of it, set of organizations is lumped together and applies energy.The catheter body etc. that utilizes the silk thread, of a biasing to have a biasing shape can reach a similar result.

Referring now to Figure 11 A-11C, in another embodiment, a pipe guide 100 that is used for the treatment of PFO comprises a catheter body 106, one first tissue apposition member 104 and one second tissue apposition member 102.Tissue apposition member 102,104 comprises the energy transmission member of shape-memory material, and it is made by Nitinol or any other suitable shape memory material.In order to launch tissue apposition member 102,104, catheter body 106 at first advances by PFO (shown in Figure 11 A).Catheter body 106 is extracted out then/is recalled, and second tissue apposition member 102 is advanced (arrow of solid ends), so that second tissue apposition member 102 is from the far-end release of catheter body 106.Shown in Figure 11 B, therefore can advance an once more then surface of pushing second tissue apposition member 102 of catheter body 106, is opened attachment members (arrow of solid ends) and is engaged on the tissue (such as septum primum) of contiguous PFO.This technology type is similar to and expands two forks of opening a hair clip.Shown in Figure 11 C, placing second tissue apposition member 102 with after septum primum contact, the catheter body 106 of can withdrawing once more, and first tissue apposition member 104 can be preceding and then be exposed first parts 104.Then, all organizing is integrated between two tissue apposition member 102,104 together, and tissue apposition member 102,104 is used for tissue is applied energy and closes PFO.

Figure 12 A and 12B illustrate another embodiment of a pipe guide 110 that is used for treating PFO, and it comprises a catheter body and a pair of relative clamp 114.Clamp 114 can be used to catch the tissue of contiguous PFO, such as the tissue of septum secundum SS and septum primum SP, carries out energy so that they are gathered together and applies and organize welding.Clamp 114 also can comprise energy transmission member, for example, and an electrode of two electrodes of a bipolar RF device, an one pole RF device and an energy Returning part etc.In certain embodiments, one or two clamp 114 can advance and organizes by (or in other words, thrusting) PFO.Here, indicated as dotted line, a clamp advances in the septum primum SP.Figure 12 A illustrates open clamp 114, and Figure 12 B illustrates and is withdrawn into together and tissue is pulled in together clamp 114.

With reference to Figure 13 A and 13B, pipe guide 110 is shown as the tissue that two clamps 114 thrust contiguous PFO.Moreover clamp 114 opens among Figure 13 A, and retract together in Figure 13 B tissue is moved to together.

Referring now to Figure 14, in one embodiment, a pipe guide 120 that is used for the treatment of PFO comprises " fish mouth " shape tissue apposition member 124 of a catheter body 122 and a pair of fork suitably, and it has a plurality of vacuum holes 126 and is used for applying vacuum power to improve tissue attachment.As mentioned above, tissue apposition prongs 124 can be launched in PFO and set of organizations is lumped together, and then, vacuum hole 126 can be used to further adhering tissue.Energy can apply by tissue apposition prongs 124 then, and in one embodiment, all tissue apposition prongs can comprise the bipolar RF energy transmission part.

With reference to Figure 15 A and 15B, another embodiment of pipe guide 130 comprises that suitably a catheter body 132, grasps tissue apposition member 134, and the tissue apposition member 136 of a shape memory.These tissue apposition member 134,136 can be used for then, being used for set of organizations is lumped together (shown in Figure 15 B) from the right side of PFO and left atrium side contacts tissue (shown in Figure 15 A).One or two tissue apposition member 134,136 also can be used as energy transmission member.

In Figure 16 A and 16B, a pipe guide 140 comprises a catheter body 142, one an anodal charged magnet 144 and a negative pole charged magnet 146.Magnet 144,146 is as the dual function of tissue apposition member and energy transmission member, shown in Figure 16 B, because the relative polarity of magnet is combined in set of organizations between them.

In another embodiment, as shown in figure 17, axonometric chart in the right atrium as seen, the tissue apposition member 150 that is used for treating the pipe guide of PFO can comprise anchor clamps, and it comprises that one is used for being positioned at first clip arm 152 and in the right atrium and is used for being positioned at second clip arm 154 in the left atrium.Then, two arms 152,154 gather together and set of organizations are lumped together.

In Figure 18, as seen the axonometric chart in the right atrium only illustrates an electrode 162 again.In an embodiment of device, a big relatively electrode 162 can be positioned in the right atrium and generally remains in the same position in the whole surgery process.One less electrode can be arranged on then in the left atrium and along the tissue of PFO move and the spot welding 164 of formative tissue to close PFO.Pressure and bipolar RF energy are between less electrode and bigger electrode 162, set of organizations is lumped together and apply energy and close PFO.

Referring now to Figure 19, in another embodiment, one conduit system 170 that is used for treating PFO can comprise second catheter body 174 that first catheter body 172, with one first expanding member 176 has one second expanding member 178, and a guide wire 179.In one embodiment, guide wire is from a patient entrance (such as a femoral vein) on one's body, caval vein IVC, right atrium RA, PFO and left atrium LA in extending through, then, by left ventricle, large artery trunks with finally pass femoral artery.Catheter body 172,174 can advance to position in the right side and the left atrium respectively along this guide wire.In the embodiment that changes, can adopt two guide wires, they can be coupled in the PFO or in the heart somewhere.

In another embodiment, shown in Figure 20 A-20C, a pipe guide 180 comprises a catheter body 182, a left atrial tissue apposition member 184 and an isolating right atrial tissue apposition member 186.Figure 20 A is from catheter body 182 shown in the right atrium view and left atrial member 184, makes left atrial member 184 hook on PFO and enter in the left atrium.Figure 20 B is the detail drawing that takes out the axonometric chart of far-end of left atrial member 184 in hooking left atrium.Figure 20 C illustrates left atrial member in place 184 and right atrial member 186, is used for adhering to the tissue of PFO.In one embodiment, left atrial member 184 can be rotated (curved arrow) and be moved the part of hooking along the left atrium of PFO, to apply energy at a plurality of positions.

Although it is accurate that above description is a complete sum, it has only described the embodiment of several demonstrations of the present invention.Without departing from the scope of the invention, can make various variations, interpolation, omission etc. to one or more embodiment of the present invention.In addition, different elements of the present invention can make up and reach any above-mentioned effect.Therefore, provide just purpose of above description, should not be construed as the scope of the present invention that its restriction is set forth by appended claims in order to demonstrate.

Claims (53)

1. the pipe guide of patent foramen ovale in the treatment heart, this pipe guide comprises:

One elongated catheter body can advance to the position in the heart through patient's vascular system, and with the treatment patent foramen ovale, described elongated catheter body has a near-end and a far-end;

At least one tissue apposition member is positioned near catheter body far-end or this far-end, lumps together so that will be close to the set of organizations of patent foramen ovale at least in part; And

At least one energy transmission member is positioned near catheter body far-end or this far-end, so that the tissue of described contiguous patent foramen ovale is applied energy, thereby closes patent foramen ovale sharp.

2. pipe guide as claimed in claim 1 is characterized in that at least one tissue apposition member comprises first tissue apposition member at least, so that contact the tissue of contiguous patent foramen ovale from the right atrium of heart.

3. pipe guide as claimed in claim 2 is characterized in that, at least one tissue apposition member also comprises second tissue apposition member at least, so that contact the tissue of contiguous patent foramen ovale from right atrium.

4. pipe guide as claimed in claim 3 is characterized in that first and second tissue apposition member comprise relative clamp, and wherein, at least one in first and second parts can be advanced by the tissue of contiguous patent foramen ovale.

5. pipe guide as claimed in claim 4 is characterized in that first attachment members advances by the septum secundum tissue, and second attachment members advances by the septum primum tissue.

6. pipe guide as claimed in claim 2 is characterized in that, at least one tissue apposition member also comprises second tissue apposition member at least, is used for advancing contacting the tissue of described contiguous patent foramen ovale with the left atrium from heart by patent foramen ovale.

7. pipe guide as claimed in claim 6 is characterized in that at least one in first and second tissue apposition member comprises an expansible elements.

8. pipe guide as claimed in claim 7, it is characterized in that both include expansible elements first and second tissue apposition member, wherein, at least one expansible elements is mounted slidably along catheter body, so that can move towards another expansible elements vertically.

9. pipe guide as claimed in claim 7 is characterized in that at least one expanding member comprises at least one hole, is used for discharging conducting fluid to contact the tissue of described contiguous patent foramen ovale.

10. pipe guide as claimed in claim 9 is characterized in that at least one expanding member comprises a plurality of apertures, is used for discharging conducting fluid.

11. pipe guide as claimed in claim 9, it is characterized in that, one in first and second tissue apposition member comprises an expansible elements, and in first and second tissue apposition member another comprises an extensible shaped portion, wherein, expansible elements and shaped portion gather together and lump together with the set of organizations with described contiguous patent foramen ovale.

12. pipe guide as claimed in claim 11 is characterized in that, extensible shaped portion comprises a shape-memory material, and when discharging from catheter body, it is from the unfolded shape of a not unfolded change of shape to.

13. pipe guide as claimed in claim 6 is characterized in that, first and second tissue apposition member comprise that one is used for the clamp tissue anchor clamps together with described contiguous patent foramen ovale.

14. pipe guide as claimed in claim 6, it is characterized in that, first tissue apposition member has one first expansion shape, and second tissue apposition member has one second expansion shape, wherein, when contacting the organizing of described contiguous patent foramen ovale when expansion, first and second parts cause the set of organizations of described contiguous patent foramen ovale to lump together.

15. pipe guide as claimed in claim 14, it is characterized in that, first expansion shape roughly comprises arcual hook, be used on the edge of patent foramen ovale crooked, so that the tissue of described contiguous patent foramen ovale is applied power from left atrium, wherein, second expansion shape roughly comprises rectilinear shape, so that from right atrium the tissue of described contiguous patent foramen ovale is exerted pressure.

16. pipe guide as claimed in claim 6 is characterized in that, first and second tissue apposition member comprise the magnet with relative polarity.

17. pipe guide as claimed in claim 6, it is characterized in that, first tissue apposition member comprises a pair of relative clamp, so that from right atrium contact septum secundum, and second tissue apposition member comprise an arc part so that advance by patent foramen ovale from left atrium contact septum primum.

18. pipe guide as claimed in claim 1 is characterized in that, at least one tissue apposition member comprises:

At least two tissue apposition member are used for relative to each other moving and the set of organizations of described contiguous patent foramen ovale are combined between them; And

At least one bias component, first side of tissue apposition member towards patent foramen ovale is used for setovering.

19. pipe guide as claimed in claim 18 is characterized in that, tissue apposition member can be along patent foramen ovale from patent foramen ovale first moves by side to the second relative side.

20. pipe guide as claimed in claim 19, it is characterized in that, catheter body has such cross sectional shape, when the set of organizations with described contiguous patent foramen ovale was combined between two tissue apposition member, the tissue of described contiguous patent foramen ovale was shifted catheter body onto with respect to patent foramen ovale diverse location.

21. pipe guide as claimed in claim 20 is characterized in that, the cross sectional shape of described catheter body is selected from following cohort: triangle, avette, ellipse and diamond.

22. pipe guide as claimed in claim 20 is characterized in that, two tissue apposition member comprise:

A shape memory tissue apposition member; And

A clamp member.

23. pipe guide as claimed in claim 20 is characterized in that, comprises also that at least one is positioned to be used for discharging one or more fluidic holes on the catheter body, applies energy with the tissue that improves described contiguous patent foramen ovale, thereby closes patent foramen ovale.

24. pipe guide as claimed in claim 20 is characterized in that, also comprises the coating on the catheter body, when the tissue of described contiguous patent foramen ovale contacted catheter body, the tissue that this coating improves described contiguous patent foramen ovale applied energy.

25. pipe guide as claimed in claim 1, it is characterized in that, at least one tissue apposition member comprises and is arranged on the intravital expanding member of conduit releasedly, wherein, expansible elements is advanced protrude in the far-end of catheter body or catheter body is withdrawn with respect to expansible elements, in patent foramen ovale, expand to allow expansible elements.

26. pipe guide as claimed in claim 25 is characterized in that, expansible elements comprises two forks, and they open and provide side force to the tissue that is close to patent foramen ovale.

27. pipe guide as claimed in claim 26 is characterized in that, each described fork does not extend in the left atrium of heart.

28. pipe guide as claimed in claim 26 is characterized in that, each described fork is spring-loaded.

29. pipe guide as claimed in claim 26 is characterized in that, each described fork comprises a shape-memory material.

30. pipe guide as claimed in claim 26 is characterized in that, each described fork comprises at least one vacuum hole, is used for applying vacuum power further the set of organizations of described contiguous patent foramen ovale is lumped together.

31. the described pipe guide of any one in the claim is characterized in that as described above, also comprises a guiding parts that is used to advance by patent foramen ovale, wherein, pipe guide is slidably disposed on the guiding parts.

32. pipe guide as claimed in claim 31 is characterized in that, guiding parts comprises a guide wire that demarcates along the part of its length, comprises expandable shape-memory material by the part that demarcates the division that forms.

33. pipe guide as claimed in claim 31 is characterized in that, guiding parts comprises at least one end, is used for contacting the left atrial surface of the tissue of contiguous patent foramen ovale.

34. pipe guide as claimed in claim 33 is characterized in that, guiding parts regracting and at least one terminal is engaged with left atrial surface.

35. pipe guide as claimed in claim 31 is characterized in that, guiding parts comprises at least one energy transmission member.

36. pipe guide as claimed in claim 35 is characterized in that, guiding parts comprises an expansible elements so that expand in patent foramen ovale, and wherein, expansible elements comprises that at least one radio frequency can transmission part.

37. pipe guide as claimed in claim 1 is characterized in that, at least one energy in the following energy of at least one energy transmission member transmission: radio frequency energy, low temperature energy, resistance heated energy, ultrasonic wave energy, microwave energy and laser energy.

38. pipe guide as claimed in claim 37 is characterized in that, at least one energy transmission member can move with respect at least one tissue apposition member.

39. pipe guide as claimed in claim 37 is characterized in that, at least one energy transmission member and at least one tissue apposition member coupling connection.

40. pipe guide as claimed in claim 37 is characterized in that, at least one energy transmission member comprises this at least one tissue apposition member.

41. pipe guide as claimed in claim 37 is characterized in that, at least one energy transmission member comprises at least one monopolar radio frequency transmission part.

42. pipe guide as claimed in claim 37 is characterized in that, at least one energy transmission member comprises at least two bipolar radio frequency transmission parts.

43. pipe guide as claimed in claim 37 is characterized in that, at least one energy transmission member comprises:

At least one radio frequency transmission parts is arranged in the expansible elements, and this expansible elements comprises that at least one hole is used for release fluids and contacts the tissue of described contiguous patent foramen ovale; And

At least a conducting fluid is arranged in the expansible elements, and is exposed to the radio frequency transmission parts.

44. pipe guide as claimed in claim 37 is characterized in that, at least one energy transmission member comprises at least one arcual radio frequency transmission parts.

45. pipe guide as claimed in claim 37 is characterized in that, at least one energy transmission member comprises at least one in net materials and the knitted material.

46. pipe guide as claimed in claim 1 is characterized in that, at least one energy transmission member comprises a guiding parts, is used for advancing passing through patent foramen ovale.

47. pipe guide as claimed in claim 46 is characterized in that, guiding parts comprises at least one expandable portion, so that expand in patent foramen ovale, thereby the set of organizations that will be close to patent foramen ovale at least in part lumps together.

48. pipe guide as claimed in claim 1 is characterized in that, also comprises the pick off that at least one and pipe guide coupling join, so that detect the energy that is supplied to the tissue of described contiguous patent foramen ovale by at least one energy transmission member.

49. pipe guide as claimed in claim 48 is characterized in that, selects at least one pick off from following cohort: infrared ray sensor, critesistor and thermocouple.

50. pipe guide as claimed in claim 48 is characterized in that, also comprise one with the microprocessor of at least one pick off coupling connection determine when the energy of supplying has reached desired energy so that handle detected data.

51. pipe guide as claimed in claim 1 is characterized in that, also comprise one with the microprocessor of pipe guide coupling connection so as to detect and control by the energy of energy transmission member transmission.

52. one is used for treating the system of patent foramen ovale in the heart, this system comprises:

One pipe guide as claimed in claim 1; And

At least one guiding parts, be used for the guiding catheter device to a position in case the treatment patent foramen ovale.

53. the system of processing patent foramen ovale as claimed in claim 52 is characterized in that, also comprise one with the microprocessor of pipe guide coupling connection so as to detect and control by the energy of energy transmission member transmission.

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