CN101415452A - Device and method for controlling in-vivo pressure - Google Patents

Abstract

A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particular in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation may be provided, to remotely activate the adjustable flow regulation mechanism.

Description

The apparatus and method that are used for the control volume internal pressure

Invention field

The present invention relates to be used for reduce or regulate blood circulation internal pressure, the apparatus and method of particularly regulating heart blood pressure.

Background of invention

Congestive heart failure (CHF) is considered to cause the most general reason of hospitalization and mortality in Western society, and it seriously influenced quality of life.CHF is perfusion of a kind of low system and the low disease of heart body.The reason of CHF can comprise owing to the myocardial damage that amyotrophy causes, cardiomyopathy and other disease.The physiopathologic mechanism directly related with CHF comprises that cardiac output reduces, and the full pressure of heart increases, the flow accumulation, and these for example can cause, pulmonary congestion and dyspnea.The damage of heart contraction function may cause poor left ventricular contraction and cardiac output to reduce, and these clinical symptoms that can produce comprise: endurance disease (effort intolerance) not, and dyspnea, the life-span reduces, edema (lung or body surface) and pain.The patient of heart contraction disorder has a bigger left ventricle usually, and this is because in order to keep enough stroke volumes the phenomenon of heart reconstruction to occur.This physiopathologic mechanism is relevant with increasing of atrial pressure and left ventricular filling pressure power.Follow the diastole parasthenia, owing to abnormal relaxation causes under normal pressure heart full insufficient, the left ventricle stiff and local obvious shortage compliance that may become.Under higher full pressure, to keep suitable heart to fill and to need to keep cardiac output.This for keeping heart enforceable filling pressure rising full and output can cause pulmonary venous hypertension and emphysema.

The method that is used for the treatment of CHF at present is divided into three kinds usually: (1) pharmacology, for example diuretic; (2) aid system, for example pump; And (3) operative treatment.About Drug therapy, vasodilation has been used to by reducing the workload that systemic vascular resistance reduces heart, utilizes diuretic to stop fluid accumulation and edema to take place, and reduces the full pressure of heart simultaneously.

The auxiliary facilities that is used for treating CHF can comprise, for example, and mechanical pump.Mechanical pump is by finishing the load that the pumping function of being done by heart under the normal condition has reduced heart whole or in part.At present, in the time of donation heart that mechanical pump for example is used to can to obtain being used to transplant as patient, patient is kept.Also have many pacemakers also to be used for treating CHF.Synchronously (Resysnchronization) pacemaker also has been used for treating CHF again.At last, also have three kinds of extreme invasives and complicated surgical method to be used for the treatment of heart failure at least: (1) heart transplantation; (2) dynamic cardiomyoplasty art; (3) Batista left ventricle local excision.

When extreme acute situations, the air bag in provisional supplementary instrument and the large artery trunks can be helpful.The implantation of heart transplantation and chronicity left ventricle auxiliary machine (LVAD) can be used as last-resort usually.Yet all supplementary instrument purposes of using all are to increase the heart pump capacity to reach with the increase cardiac output and the consistent state of normal life at present, reduce filling pressure and/or prevent to form edema.Finally, heart transplantation can be used to treat extreme cardiac dysfunction cases.Yet these means have very high invasive, and have been subjected to the restriction of donation heart availability.Machinery can allow to advance a large amount of blood (liter/minute), yet this also is their main limitation.To the needs of power supply, all these will consider sizable pump and haemolysis and infectious probability.

Description of drawings

Theme of the present invention is highlighted and clearly proposed opinion at the description conclusion part.Yet by the detailed description and the reference read accompanying drawing of project, structure of the present invention and operational approach two aspects and their characteristic and advantage can get the best understanding.Accompanying drawing is wherein:

Figure 1A has schematically illustrated according to the present invention one differential pressure regulation device (DPRD) of exemplary embodiments;

Figure 1B-1I has schematically illustrated other embodiment of differential pressure regulation device according to some embodiments of the invention (DPRD);

Fig. 1 J is the sketch map of an example of the description pressure curve of the exemplary embodiments according to the present invention, and this sketch map relates to the variation of pressure reduction between two inner chambers, flows through the flow of flow control mechanism and the relation between the orifice area;

Fig. 2 A and 2B have schematically illustrated according to the present invention the cross-sectional view and the side view of one exemplary embodiments adjustable shunt, pipe or other structure respectively;

Fig. 3 has schematically illustrated according to the present invention the isocon of another exemplary embodiments;

Fig. 4 has schematically illustrated according to the present invention the diverter that comprises flow control device (FRM) of one exemplary embodiments;

Fig. 5 has schematically illustrated according to the present invention the diverter among Fig. 4 of exemplary embodiments, and it is combined with the FRM of open mode;

Fig. 6 has schematically illustrated according to the present invention the FRM of another exemplary embodiments, its can be used for Fig. 1 for example in DPRD, the diverter among Fig. 2 A-2B, perhaps the diverter among Fig. 3 combines;

Fig. 7 has schematically illustrated according to the present invention the FRM of another exemplary embodiments, its can be used for Fig. 1 for example in DPRD, the diverter among Fig. 2 A-2B, perhaps the diverter among Fig. 3 combines;

Fig. 8 has schematically illustrated according to the present invention the FRM of another exemplary embodiments, its can be used for Fig. 1 for example in DPRD, the diverter among Fig. 2 A-2B, perhaps the diverter among Fig. 3 combines;

Fig. 9 has schematically illustrated according to the present invention the FRM in heart inside of another exemplary embodiments.

Figure 10 has schematically illustrated according to the present invention the FRM of another exemplary embodiments, its can be used for Fig. 1 for example in DPRD, the diverter among Fig. 2 A-2B, perhaps the diverter among Fig. 3 combines.

Figure 11 has schematically illustrated according to the present invention the FRM of another exemplary embodiments, its can be used for Fig. 1 for example in DPRD, the diverter among Fig. 2 A-2B, perhaps the diverter among Fig. 3 combines;

Figure 12 has schematically illustrated according to the present invention the FRM of another exemplary embodiments, its can be used for Fig. 1 for example in DPRD, the diverter among Fig. 2 A-2B, perhaps the diverter among Fig. 3 combines;

Figure 13 A has schematically illustrated the device that is used for remote control DPRD according to some embodiments of the present invention;

Figure 13 B-E has schematically illustrated the mechanism that is used for remote control DPRD according to some embodiments of the present invention;

Figure 14 has schematically illustrated according to some embodiments of the present invention and has been used to illustrate controlled pressure, for example the flow chart of the method for heart blood pressure.

It should be understood that the element shown in the figure there is no need ground and draws in proportion for simple and clearly explanation.For example, for the sake of clarity, some size of component have been exaggerated with respect to other element.Further, in suitable place, reference number can be reused in these accompanying drawings to represent corresponding or similar elements.

Summary of the invention

The present invention can provide the method and apparatus of control agent internal pressure.According to some embodiments of the present invention, differential pressure regulation device can comprise the diverter between two or more inner chambers in body, so that liquid can flow between these inner chambers, and a scalable flow governor motion that is set to optionally cover the diverter opening, pass diverter with adjusting with intracoelomic cavity between pressure reduction relevant liquid stream.

According to some embodiment, pressure-regulating device can comprise the diverter between the two or more inner chambers of heart, so that liquid can flow between these inner chambers, one is set to optionally cover the diverter opening, pass the scalable flow governor motion of the liquid stream of diverter with adjusting, and a controlling organization that links to each other with scalable flow governor motion, start this scalable flow governor motion with remote control.

A kind of method of control volume internal pressure is provided in another device, this method comprises a differential pressure regulation device is implanted, this pressure-regulating device comprises that one is positioned at the diverter of the two or more inner chambers of body, dispose a flow control device, and the setting of controlling flow control device according to the variation of pressure reduction between these inner chambers.

A kind of method of control volume internal pressure is provided in another embodiment of the present invention, this method comprises that controlling organization that employing has implanted controls the setting of a flow governor motion, this flow control device is placed on the differential pressure regulation device that comprises a diverter, this diverter for example, be placed between two or more inner chambers, between heart left atrium and right atrium.

The specific embodiment

In order intactly to understand the present invention, in following detailed description, a plurality of details have been set forth.Yet one of skill in the art will recognize that does not have these details can implement the present invention yet.In other example, may not specifically describe known method, process, parts and structure, in order to avoid obscure with the present invention.

Although should be appreciated that the purpose in order to illustrate, part is discussed and to be related to heart, chambers and/or atrium herein, and embodiment of the present invention is not limited to this respect, and it can be used for various other blood vessel, inner cavity chamber, organ or body part.For example embodiments of the invention can be included between the brain inner chamber, between the selected organ, between the blood vessel etc. (for example, between large artery trunks and interior caval vein), and/or between other the suitable inner chamber, such as, between the intravital band of body, inner chamber, organ, conduit, zone or area, regulate liquid and shift.

Some embodiments of the present invention comprise, and are for example a kind of by reducing or other mode is controlled two or more body parts, for example two of heart inner chambers (as, left atrium and right atrium) between pressure differential come the method and apparatus of control volume internal pressure.For example, such pressure control can fill the problem of increased pressure with the heart of patient of helping solve the diastole sexual disorder that has congestive heart failure and give prominence to, thereby helps to reduce or prevention pulmonary fluid accumulation, edema formation and clinical complaint of dyspnea as far as possible.Another example is that pressure is controlled and can be used for reducing left ventricular filling pressure.Some embodiments of the present invention can comprise differential pressure regulation device (DPRD), for example, comprise that diverter, pipe or other structure with aperture, pipe or opening connect two or more inner chambers with liquid ground, as connecting the left atrium of heart.According to some embodiments of the present invention, this DPRD can comprise an adjusting device or adjusting device, it can proofread and correct, change or otherwise regulate for example cross section in aperture, for example with first and second inner chambers between pressure differential change the cross section in relevant aperture, thereby increase and/or reduce velocity of blood flow between these two inner chambers.

Some embodiments of the present invention can be used to, and for example eliminate the extra filling pressure of congestive heart failure (CHF) patient left ventricle, and prevent potentially or reduce emophysematous generation.

Devices more of the present invention comprise that for example, two chambers, for example the wall between left atrium and the right atrium is implanted into an adjustable DPRD.This pressure-regulating device can, for example allow a selected blood flow volume from the left atrium flows towards right atrium, this is relevant with the pressure reduction between the left atrium.This pressure-regulating device for example can be regulated, with the size and the shape that optionally change opening, allow blood flow volume that flows through or the like.

In certain embodiments, this pressure-regulating device can be designed to keep between two or more inner chambers a continuous flow is for example arranged between the left atrium.And for example, a diverter, pipe or other structure can be connected to a lid, valve opening, valve rod, or other can be set to continuously on the half-open flow control device, so that selected minimal quantity of fluid two inner chambers in vivo for example continue to flow between two chambers.The described lid of scalable subsequently for example further opens or closes lid and controls amount of liquid between the inner chamber.The liquid that flows through DPRD can increase or reduce according to the variation of the pressure differential pressure between two inner chambers.For example, when the pressure of left atrium increased with respect to the pressure of right atrium or reduces, lid can be opened and/or close.In certain embodiments, DPRD can so design so that scuttle hatch does not directly contact with the opening of diverter so that to restorative help minimize or stop be organized on the port lid or port lid around growth.Such structure can make successive flow of liquid cross DPRD, and can stop or reduce the generation of blood clotting, biomembrane formation or other undesired growth.In certain embodiments, DPRD can be used to flushing or cleaning diverter and/or shunt cover etc.

Referring to Figure 1A, it schematically illustrates the DPRD101 in the exemplary embodiments implantation heart 109 according to the present invention.DPRD101 can implanted two or more intracoelomic cavities between, for example, implant between left atrium 102 and the right atrium 103.Adopt different chambers arrangement modes, DPRD101 can implant other chambers, and/or implanted other intracoelomic cavity in or be implanted between the intracoelomic cavity.Among some embodiment, use the perforation or otch instrument or other the suitable punching machine that for example are installed in distal end of catheter, can be in the wall between two intracoelomic cavities, for example, in the barrier film 105 between left atrium 102 and the right atrium 103, form an opening, perforation or other structure.With conduit or other conveyer device DPRD101 is positioned in the perforation then.In certain embodiments, one or more tissue fixation elements, for example, support arm 106 can be supported on DPRD101 and generate needed position in hole or the perforation.

DPRD101 can comprise, adjustable diverter for example, pipe or path 10 7, make liquid between two intracoelomic cavities, between the organ, flow between position or the zone etc., such as between left atrium 102 and right atrium 103, flowing.DPRD101 can comprise a flow regulator described herein (FRM) 108, for example fluid valve, lid, valve opening, valve rod or medicated cap, carry out selected change with parameter to isocon 107, for example, cross section by changing diverter 107 openings or diverter shape etc., thus regulate from the blood flow of left atrium 102 from right atrium 103.Can be set to continuous half-open position so that a continuous blood flow is arranged between the left atrium at some embodiment F RM108.For example, FRM108 can on purpose be in half-open so that a blood flow volume of selecting flows between chambers continuously.Subsequently can be by size and the shape that selectively changes perforate, blood allow throughflow, regulate FRM108, make the zone around diverter 107 openings and the FRM108 to be restricted and/or to expand, thereby influence effective circulation of diverter 107, can control the blood flow between each inner chamber simultaneously.DPRD101 can comprise one or more control appliances 110, and for example, lead, spring, rope etc. make FRM108 to be controlled passively or on one's own initiative.In one embodiment, for example, by the pulling force of being selected by prestrain one, spring can be used for making FRM108 move according to the variation of pressure reduction, responds the variation of one or more pressure thresholds with a controlled manner.

FRM108 can be set to respond selected pressure distribution, thereby a known pressure release profile is provided.For instance, FRM108 can preset, pre-calibration and/or pre-configured, changes its setting with the variation according to pressure differential between the left atrium, adjusts its configuration or position, and/or change its aperture width or flow etc.FRM108 can regulate continuously for for example continuous variable setting, for example in response to environmental condition and/or external control.In these modes at least, DPRD101 can provide that select, a predictable and/or guaranteed liquid stream between two or more intracoelomic cavities or zone.In certain embodiments, the static or default setting of FRM108, openings of sizes, traffic level or position can change by parameter and/or the remote-control gear that for example pre-sets.Continue in certain embodiments to open or half-open FRM108 can help to stop the obstruction of diverter 107.

In certain embodiments, when being lower than a certain pressure differential pressure, valve or instrument can be closed fully; Yet in some other embodiment, when being lower than a certain pressure differential pressure, valve can not be closed fully or be in crack state.For example, valve can have a minimum to open yardstick.

In certain embodiments, one or more performances of DPRD, for example, the cross-sectional openings size of pressure-regulating device may depend on the blood pressure difference between the left atrium.Therefore, in certain embodiments, the blood flow between the left atrium may be subjected to the influence of change in blood pressure difference between the left atrium.

DPRD according to some embodiments of the invention can make the pressure of ventricle reduce by reducing atrial pressure.

In certain embodiments, DPRD can be used for heart film inflammation (ASD) patient, and for example those can not tolerate the people of complete uncontrolled atrium closure procedure, to close hole or the gap in the barrier film selectively.

In certain embodiments, DPRD can be used for liquid is moved on to right atrium from left atrium, for example gives first aid to the pulmonary hypertensive diseases people.In these examples, DPRD can be placed in the left atrium with FRM108.According to some embodiments of the present invention, FRM108 can be unidirectional or two-way.

In some devices, a plurality of DPRD can be implanted in a wall or other structure, for example, help to provide backup, with implantation the different instrument of scope is set and obtains higher levels of opening control, and/or can increase other instrument.When the DPRD of two or more more minor diameters can be transferred, implant the diameter that a plurality of DPRD can reduce delivery conduit.

In other embodiments, FRM108 can comprise lid, medicated cap or other suitable mechanism with various ways, so that FRM 108 can partially or completely close.Referring now to Figure 1B-1G.Among Figure 1B, FRM108 can comprise two or more arms 120, and above-mentioned arm can be set to keep crack continuously or consistently at opening 125 places of diverter 122.For instance, FRM108 can be set to keep continuously at least partly separating with diverter 107, has one to continue flow quantity between left atrium 102 and the right atrium 103 to allow.Arm 120 can respond the variation of the pressure reduction between chambers and open further and/or close.Arm 120 can be made of flexible polymer or other suitable material.Terminal 130 arm places 120 can have at arm, and are for example round-shaped, to help prevent blood stasis.

In Fig. 1 C, FRM108 can comprise diverter 122, and two or more flexible membrane 135, and this film can be set at opening 125 places half-open position consistently, so that blood can continue to flow through diverter 122.For example, here in the various embodiments of Tao Luning, an equipment can so be settled and make no matter the pressure differential pressure between the chambers is what, and the openings of sizes that minimum can be set maybe can produce flow.Film 135 can comprise at least one spring mechanism, with the variation of pressure reduction between the response chambers, helps to expand or shrink described film 135.

In Fig. 1 D, FRM 108 can comprise diverter 122, and one or more flexible or spring is medicated cap, film or the leaf 150 on basis, and it selectively links to each other with diverter 122 by spring or other suitable pressure sensitive mechanism 155.In one embodiment, pressure sensitive mechanism 155 can utilize a controlled manner to respond the variation of one or more pressure thresholds by prestrain.Medicated cap 150 can be set to continue at opening 125 places crack, makes blood can continue to flow through diverter 122.FRM 108 can comprise one or more elevated regions 160, and for example, the object of sour jujube shape thing or other suitable shape is to help stoping lid 150 to contact fully with diverter 122.

In Fig. 1 E, FRM108 can comprise diverter 122, and one or more angled flexible membrane or leaf 165, and it is set to continue at opening 125 places crack so that blood can continue to flow through diverter 122.In one embodiment, leaf 165 can be under selected tension force prestrain to respond the variation of one or more pressure thresholds with controlled manner.Leaf 165 can comprise that at least one spring mechanism or other suitable mechanism change with the pressure reduction between the response chambers, help to close and/or open leaf 165.Leaf 165 can comprise that at least one Magnet or electric magnet 170 or other suitable mechanism closes and/or open to help leaf 165 at a distance.Lead 172 or other suitable mechanism can be used for driving magnet or electric magnet 170.

In Fig. 1 F, FRM108 can comprise isocon 122 and cover, valve opening, valve rod or other flow regulation mechanism 175, and it is set to keep half-open at opening 125 places so that blood can continue to flow through diverter 122 always.Cover 175 can link together with spring 177 or other suitable pressure sensitive mechanism.In one embodiment, spring 177 can be under selected tension force prestrain to respond the variation of one or more pressure thresholds with a controlled manner.FRM 108 can comprise the motion limiter 179 of one or more covers.FRM 108 can comprise a fixed polarized magnet 181 and the solenoid 183 that has one or more conductors 185.Cover 175 can respond the variation of pressure reduction between the chambers, and/or opens and/or close by remote control driving magnet 181 and/or solenoid 183.For example, when Magnet 181 started, cover 175 can be opened further, and when coil 183 started, cover 175 can be closed further.

Shown in Fig. 1 G, FRM 108 can comprise diverter 122, and covers 175, and it is set to keep half-open at opening 125 places so that blood can continue to flow through pipeline 122 always.Cover 175 can be connected with diverter by linking arm 185.Cover 175 can comprise otch, slit, and groove or crack 187 etc. are so that blood can Continuous Flow be crossed diverter.Slit 187 can have different sizes, the degree of depth, width or density, and this can help to indicate the various zones of cover 175 is more solid relatively poor with pliability, still weak and more pliable and tougher, therefore can make differently according to the variation of pressure reduction between intracoelomic cavity and reacting.For instance, in zone with more or darker intrusion, this zone can be softer weak and have flexible, thereby cover 175 is opened the part at least, the blood flow stream that authorized pressure is low is relatively crossed diverter 122.In the zone with less or more shallow intrusion, can be solid relatively and lack pliability in this zone, cover 175 is opened the part at least, and the blood flow stream that authorized pressure is high is relatively crossed diverter 122.

Shown in Fig. 1 H and 1I, FRM108 can comprise diverter 122 and cover 175, and it can be set to keep half-open always state so that blood can Continuous Flow be crossed diverter 122 at opening 125 places.Cover 175 can be connected with spring 190 or other pressure sensitive mechanism that is fit to.Spring 190 can be connected with a piston or pump machanism 192 with cover 175.Shown in Fig. 1 I, cover 175 can be in response to the variation of pressure differential between the chambers, and/or activates springs 190 by piston 192, prolong and/or enlarge cover 175 and be opened and or close, thereby changed the size of opening 125.

According to some embodiments of the present invention, use DPRD101 can generate a pressure curve, this curve relates to the variation of pressure reduction between two inner chambers, flows through the flow of volume control device and the relation between the orifice area.Can adopt any required or selected design parameter.Referring now to Fig. 1 J, the figure shows an example of this pressure curve.Can see that in Fig. 1 J below 12 mmhg pressure differences, the size in opening or aperture can be relatively stable, and the main pressure differences of flow.When 20 millimetress of mercury were following more than pressure reduction rises to about 12 millimetress of mercury, flow can increase by a fair speed, and at this moment it both had been subjected to the influence that orifice area increases, also the influence of pressure difference growth.When pressure reduction rises to about 20 millimetress of mercury when above, because orifice area may reach its maximum cross section, so flow velocity is to increase the influence of the main pressure difference of flow than low velocity.Pressure reduction can be subjected to the influence of the linear and/or nonlinear change of orifice area.Can adopt other pressure reduction, flow and/or orifice area levels, various relations, and mutual relation, as other parameter, variable, minimum and maximum constraints etc.

Referring to Fig. 2 A and 2B, they have schematically illustrated cross-sectional view and the side view of scalable DPRD 201 according to an exemplary embodiment of the present invention respectively.DPRD 201 can comprise for example framework 220, this framework and one or more support arm, and for example, support arm 211-216 is connected.Framework 220 can comprise for example flexible fixation, ring or pipe.Framework 220 is by flexible material, flexible metal for example, and super flexible alloys, and/or shape-memory material makes, marmem adopts for example Nitinol (Nitinol) or other suitable material.

Although for the purpose of signal, DPRD201 has been described as six arms or appendage 211-216 here, device of the present invention is not subjected to this restriction, and can comprise the arm of varying number, for example an arm, two arms, ten arms or the like.

For the function that obtains to expect, arm or appendage 211-216 can be flexible and/or moulding in advance.For example, arm 211-216 can be folded in the time of for example in inserting a suitable carrier pipe during insertion.In certain embodiments, arm 211-216 can be by elastic material, and for example marmem (SMA) is made, this memorial alloy such as NiTi (NiTi) alloy.Other suitable material can comprise, for example, and metal, rustless steel, and/or other suitable material.To small part arm 211-216 or selected other DPRD201 element can be coated and/or be endowed certain structure, with the biocompatibility that increases them and/or increase the grade that these elements optionally become the endotheliocyte shape, as desired in some transplanting condition.

DPRD201 can comprise that for example, FRM 250, and for example, comprises a lid, valve port, valve rod, or other the flow that has one or more predeterminated positions adjusts equipment, the opening that causes with the expansion that covers selectively owing to DPRD201.FRM will be discussed in more detail below.

Shown in Fig. 2 B, DPRD201 can have two sides, refers to nearside 251 and distally 252 here respectively.For example DPRD201 can implanted heart 109 in, the nearside 251 of DPRD201 can be facing to right atrium 103 like this, and the distally 252 of DPRD201 can be facing to left atrium 102.The side 251 and 252 of other direction can be used, the side of other number can be used equally.

In some embodiments, the distally 252 of DPRD201 can link to each other with the one group of arm or the appendage of far-end, for example, and arm 211-213, and the nearside 251 of DPRD201 can link to each other with the one group of arm or the appendage of near-end, for example, arm 214-216.Therefore, when DPRD201 implanted heart 109, one group of arm 211-213 of far-end can enter the right side of Fig. 1 septation 105 at first for example decontroling in the left atrium 102, from patient's perspective view, DPRD201 is supported in the left side of barrier film 105.Then, along with finishing of DPRD201 insertion process, for example by regaining conduit or the carrier pipe of delivery DPRD201, one group of arm 214-216 of near-end decontrols in right atrium 103, for example enter the left side of Fig. 1 septation 105,, therefore support the right side of barrier film 105 from patient's perspective view.In this way, support arm 211-216 can be supported on the framework 220 of DPRD201 desired position between left atrium 102 and the right atrium 103.

Referring now to Fig. 3,, it has schematically illustrated according to another embodiment of the present invention DPRD301.DPRD301 can comprise that for example framework 302, and this framework is connected to one or more arms or appendage, for example arm 303 and 304.

Framework 302 can comprise, the flexible fixation that constitutes by flexible material for example, this flexible material such as flexible metal, this flexible metal for example be Nitinol as or nitinol wires.Framework 302 can have as shown in Figure 3 spiral-shaped usually, and can be one-body molded with framework 302 each terminal curved boom 303 and 304, as shown in Figure 3.Other suitable shape also can be used.Arm 303 and 304 can be flexible and can the moulding in advance function to realize wanting.For instance, arm 303 and 304 is in insertion process, for example can be folded in the suitable carrier pipe, so that decontrol subsequently framework 302 navigated in the aperture.According to some embodiments of the present invention, DPRD301 also comprises FRM305, such as the FRM that introduces in detail here.

Referring to Fig. 4, it has schematically illustrated the DPRD401 that comprises DPRD405 according to the embodiment of the invention equally.DPRD405 can be used as the example of FRM250 and FRM350.Although DPRD405 can be used in conjunction with DPRD301 or other suitable isocon or medical apparatus and instruments, for the purpose of illustrating, only showed that here DPRD405 combines with DPRD401, wherein DPRD401 can be similar to DPRD201.

DPRD405 for example can comprise that one is connected to dish 432 on the ring 431 by spring 433.Dish 432 can be by biocompatible materials, such as, form by RESEARCH OF PYROCARBON (Pyrolitic carbon) or rustless steel.Spring 433 can comprise one or more rotating springs, helical spring or any other flexible member, both sides as DPRD401, such as between the nearside 251 of DPRD201 among Fig. 2 B and the distally 252 not very during big pressure reduction, these springs will coils 432 holders and encircle 431 inside.

In response to the pressure reduction between the DPRD401 both sides, dish 432 can leave the higher relatively atrium of pressure, typically as left atrium, follows flexural spring 433, this can to coil 432 mobilely apply a counteracting force, thereby open and/or enlarge the inner cavity chamber that blood can therefrom flow through.The counteracting force that spring 433 is applied depends on the pressure reduction between the DPRD401 both sides, for example, an intraventricular pressure compresses when forcing spring 433, pressure reduction by DPRD401 is high more like this, then allows the opening by discharge this pressure reduction from the high side to low side flowing liquid just big more.By this way, the far-end of DPRD401 and the pressure reduction between the near-end can be controlled according to one or more selected levels.In certain embodiments, the various configuration tolerables of DPRD described herein along with pressure differential changing openings of sizes and flow velocity.

It being understood that does not have pressure reduction between the DPRD401 both sides substantially, and perhaps when suitable hour of pressure reduction, dish 432 may be closed fully, perhaps in addition can total blockage by DPRD450, such as by coiling 432 and encircle blood flow regional between 431.For instance, dish 432 is provided with the gap between can being chosen in ring 431 and coiling 432, coils 432 like this and can be used as leak valve and make blood flow through perforation constantly.It is passable that continuous free flow is crossed the fluid of DPRD401, for example stops inner and/or form blood clotting and/or thrombosis at dish 432 on every side.

In certain embodiments, ring 432 can be asymmetric, and for example it can have the top 451 of relative broad and the bottom 452 of relative narrower.Can allow like this, for example work as dish 432 during the pressure that increase have a down dip, blood is with relatively little flow velocity process, bend to above ring 431 upper parts up to dish 432, thereby provide a pressure differential pressure threshold value, open or begin at this threshold value lower valve and open, to increase blood flow cross section by blood vessel.Pressure threshold can be one group of pressure spot that (changes such as unlimited) continuously, at these pressure spots, and valve open or allow a baric flow according to this pressure.For example, before reaching a certain pressure, valve can remain closed or open slightly, when being higher than that pressure, constantly open then up to reaching a high pressure more, this more the high pressure lower valve open fully.Note according to embodiments of the invention, can use asymmetric ring 432 or other asymmetric parts to obtain and various FRMs DPRDs, the function that isocon and/or instrument are similar.

In certain embodiments, ring 431 can be formed by suitable metal.In certain embodiments, ring 431 can be combined in the framework 220, perhaps encircles 431 and can adopt whole ring-members of frame to realize with framework 220.Ring 431 and/or framework 220 can be made up of suitable line and pipe.Ring 431 and/or arm 211-216 can be made up of suitable line and pipe, for example, and identical line and pipe and/or identical materials.

Referring to Fig. 5, it has schematically illustrated the DPRD401 that implants heart 109 according to the embodiment of the invention, and it is combined with the DPRD450 of open mode.One pressure reduction can be present between left atrium 102 and the right atrium 103, and for example the pressure of left atrium 102 is greater than the pressure of right ventricle 103.Pressure reduction can cause that described dish 432 moves and makes spring 433 bendings towards right atrium 103, thereby produces the opening of an expansion, can be from left atrium 102 flows towards right atrium 103 by the more blood of this opening.Along with blood flows towards right atrium 103, the pressure of left atrium 102 can reduce, simultaneously the pressure of right atrium 103 can raise, thereby has reduced the pressure reduction between left atrium 102 and the right atrium 103, and allow spring 433 towards closed or basically make position retract dish 432.Also can use other can make dish 432 equipment that move.

Fig. 6 schematically illustrates the DPRD650 according to another embodiment of the present invention.DPRD650 can be the example of FRM108, FRM250 or FRM350.DPRD650 can comprise, for example encircles 431 and moulding in advance line 634.Line 634 can comprise a flexible wire, and for example this metal wire is formed by Nitinol or other suitable material.Line 634 can be bent to the shape of a hoof, tongue shape or other shape that is fit in one embodiment.In certain embodiments, the end of line 634 can 431 be connected with ring, perhaps line 634 with encircle 431 and form by identical line, pipe or other suitable material.

Line 634 can by or the mode that is connected to a lid or plate 635 be capped, this lid or plate can comprise that for example, the flat board of a biological compatibility material, this material be the biological organization material for using with artificial valve disc sheet for example.Plate 635 for example can adopt one or many stitching thread 636 link to each other with line 634.

DPRD 650 is included among the DPRD 201 or DPRD 301 that implants in the heart.Between left atrium 102 and right atrium, there is a pressure reduction, such as, the pressure of left atrium 102 can be greater than right ventricle 103.Utilize the elasticity of line 634, this pressure reduction can cause that plate 635 moves, thereby forms an inner chamber, and blood can be by this inner chamber from left atrium 102 flows towards right atrium 103.When blood flows with this direction, the pressure of left atrium 102 can reduce, the pressure of right atrium 103 can increase simultaneously, thereby reduced the pressure reduction between left atrium 102 and the right atrium 103, and allowed plate 635 towards closing or closed position or move basically towards the position that plate 635 is opened on the limit.

Being noted that when between left atrium 102 and the right atrium 103 does not have pressure reduction, and perhaps pressure reduction is suitable hour, and plate 635 may pass DPRD650 by incomplete obstructions, for example pass around the plate 635, or plate 635 and encircle the blood flow in zone between 431.This can, for example stop within plate 635 or DPRD and/or form blood clotting and/or thrombosis on every side.Yet other configuration is the same as in this discussion, and in other embodiments, opening or valve can be closed under a certain pressure reduction fully.

Fig. 7 has schematically illustrated the FRM750 according to another embodiment of the present invention.FRM750 can comprise, the ring 431 that for example adopts one or more spring 738 to be connected with cone 737.Cone 737 can be placed in the ring 431, and can for example make by biocompatible materials, this biocompatible materials as, RESEARCH OF PYROCARBON or rustless steel.Cone 737 can have suitable shape, such as, rectangle, square, circular, oval, trapezoidal, taper or other suitable shape.

FRM750 can be included in the isocon of implanting in the heart 109, for example, and among DPRD201 or the DPRD301.Spring 738 can comprise one or more compression springs, and for example when not having pressure reduction substantially between left atrium 102 and the right atrium 103, cone 737 is remained in the ring 431.

Between left atrium 102 and right atrium 103, there is pressure reduction, such as, when the pressure of left atrium 102 during greater than right ventricle 103, FRM750 can allow blood to flow to right chamber 103 from left atrium 102.This pressure reduction can cause that cone 737 retreats to the opposite direction of spring 738, thereby opens or enlarged an inner chamber, and blood can pass this inner chamber from left atrium 102 flows towards right atrium 103.Along with blood flows in the direction, the pressure of left atrium 102 can reduce, and the pressure of right atrium 103 can increase simultaneously, thereby has reduced the pressure reduction between left atrium 102 and the right atrium 103, and allow cone 737 towards close or basically the closed position return.

Being noted that when between left atrium 102 and the right atrium 103 does not have pressure reduction, and perhaps pressure reduction is suitable hour, and cone 737 may be passed FRM750 by incomplete obstructions, for example pass around the FRM750, or the blood flow in zone between FRM750 and the ring 431.Like this can, for example stop within cone 737 or FRM750 and/or form blood clotting and/or thrombosis on every side.

Fig. 8 has schematically illustrated the FRM850 according to another embodiment of the present invention.FRM850 for example can comprise that one is connected with ring 431 and puts within it elastomeric valves 839.Valve 839 for example can be made by biocompatible materials, and for example this biocompatible materials is polyurethane or silicones.By for example bonding or sew up the bottom 840 of valve 839 in 431 at ring, valve 839 can with encircle 431 and be connected.Valve 839 can comprise one or more vanelets, and for example, vanelets 841 and 842 can move and set up or enlarge an opening 843.In certain embodiments, the size of opening 843 can be relevant with the pressure on being applied to vanelets 841 and 842.

FRM850 for example can be included in isocon, conduit or the pipeline implanted in the heart 109, among DPRD201 or the DPRD301.Between left atrium 102 and right atrium 103, there is pressure reduction, such as, when the pressure of left atrium 102 during greater than right ventricle 103, FRM850 can allow blood to flow to right chamber 103 from left atrium 102.This pressure reduction may extend, launches or promote blade 841 and/or 842, thereby increases the distance between them and enlarged opening 843, and blood can flow to right ventricle 103 from left ventricle 102 by this opening 843.Along with blood flows in the direction, the pressure of left atrium 102 can reduce, and the pressure of right atrium 103 can increase simultaneously, and allows blade 841 and/or 843 to return towards the position of closing or closing basically.

Being noted that between left atrium 102 and right atrium 103 does not have pressure reduction, and perhaps pressure reduction is suitable hour, and valve 839, blade 841 and 843 may pass FRM850 by incomplete obstruction, for example pass the blood flow of opening 843.Like this can, for example stop within valve 839 or FRM850 and/or form blood clotting and/or thrombosis on every side.

The DPRD950 that Fig. 9 has schematically illustrated according to a further embodiment of the invention in heart 109 inside.DPRD950 can comprise a large amount of air bag or liquid capsules that link to each other by one or more tube interiors, such as, one not compliant balloon 943 be connected with compliant balloon 945 by pipe 944.Compliant balloon 943 can not be placed in left atrium 102 and/or the acanthopore, and compliant balloon 945 can be placed in the right atrium 103.In certain embodiments, compliant balloon 943 and/or compliant balloon 945 are not connected to a ring (for example encircling 431).In certain embodiments, compliant balloon 943 and/or compliant balloon 945 do not contain liquid 920.

Liquid 920 can be for example flows to air bag 945 or vice versa from air bag 943, and this is relevant with the pressure reduction between left atrium 102 and the right atrium 103.For example, when the pressure of left ventricle 102 is relatively large, liquid 920 can by pipe 944 never compliant balloon 943 flow to compliant balloon 945, thereby dwindled not the compliant balloon 943 and the air bag 945 that expanded.Be noted that compliant balloon 945 than compliant balloon 943 is more not soft, thereby allow compliant balloon 945 to control not dwindling of compliant balloon 943 as a spring assembly.

Figure 10 has schematically illustrated DPRD1050 in accordance with another embodiment of the present invention.DPRD1050 can comprise, for example encircles 431 and have a flexible disk 1046 in hole 1047.In certain embodiments, hole 1047 can be circular substantially and for example be positioned at the position at flexible disk 1046 centers substantially.Flexible disk 1046 can for example be formed by flexible polymeric material, for example silicone rubber or polyurethane.

DPRD1050 can implant heart 109, and hole 1047 can change diameter along with the pressure reduction between left atrium 102 and the right atrium 103.For example, pressure reduction can or stretch flexible disk 1046 to pusher, thereby expanded hole 1047 allows blood to pass big field flow orientation right atrium 103 from left atrium 102 simultaneously.

Being noted that between left atrium 102 and right atrium 103 does not have pressure reduction, and perhaps pressure reduction is suitable hour, and a quite little diameter can be opened and have in hole 1047 still, and flexible disk 1046 can not stop blood to pass through DPRD1050 fully.Like this can, for example stop within DPRD1050 and/or form blood clotting and/or thrombosis on every side.

Figure 11 has schematically illustrated DPRD1150 in accordance with another embodiment of the present invention.DPRD1150 can comprise, for example an air bag or liquid capsule 1148 are as if contain the not compliant balloon of liquid.Air bag 1148 can be placed on or be connected in the ring 1131, and it can comprise, for example is similar to the ring of ring 431 and/or framework.One pipe 1149 can be connected to air bag 1148 on the container 1155, and this container can comprise one or more piston 1151, and this piston can be resisted compression spring 1152 and move.Spring 1152 for example can be made of metal or suitable elastic materials.

In the DPRD1150 implantable cardiac 109, and the volume of air bag 1148 can change along with the pressure reduction between left atrium 102 and the right atrium 103.For example, this pressure reduction can promote or dwindle air bag 1148, thereby causes liquid 1120 to flow to container 1155 from air bag 1148.This can form or enlarge the opening in the ring 1131, and blood can flow to right atrium 103 from left atrium 102 by this opening.

Figure 12 has schematically illustrated DPRD1250 in accordance with another embodiment of the present invention.DPRD1250 can comprise that for example air bag 1148, as if contain the not compliant balloon of liquid.Air bag 1148 can be placed on or be connected in the ring 1131, and it can comprise, for example is similar to the ring of ring 431 and/or framework.One pipe 1149 can be connected to air bag 1148 on the container 1155, and this container can comprise one or more piston that can move 1151.This piston can move by using an electromotor 1153, and this electromotor can comprise a motor, as stepping motor or other suitable motor.Electromotor 1153 can move, pushes away or draw described piston 1151, thereby makes liquid 1120 flow to container 1155 from air bag 1148, and vice versa.This can change the volume of air bag 1148, thereby increases or reduce to encircle the size of the opening in 1131, can flow to right atrium 103 from left atrium 102 by this hole blood.

According to a further embodiment of the invention, can for example control DPRD1250 on one's own initiative by patient or health care provider.DPRD can adopt the outside and/or the instruction that manually provides is operated in one embodiment.For example, electromotor 1153 can be according to instruction running outside and/or that manually provide.By way of parenthesis or replacedly, electromotor 1153 can turn round according to the pressure reduction between left atrium 102 and the right atrium 103.For example can adopt the pressure-dependent closed loop 1260 that is combined with one or more pressure transducers 1254.This pressure transducer 1254 can be measured in one or more chambers, and for example the absolute pressure of left atrium 102 and right atrium 103 is perhaps measured between two chambers, for example the pressure differential between left atrium 102 and the right atrium 103.Based on this pressure information, electromotor 1153 can turn round and move, push away or draw described piston 1151.

Can adopt one or more motor drive mechanisms, mechanical mechanism, no line mechanism, pneumatic mechanism or other suitable remote manipulation DPRD of mechanism in another embodiment.For example a metal wire, line, spring, nail, cable, hook, pin, electromotor or Magnet can be connected to DPRD so that can be by patient and/or health care provider remote control DPRD.As shown in FIG. 13A, single line or pilot 1320 can be connected to DPRD1300 on the controlling organization 1310 of a control box for example at least.For example, pilot 1320 can come out from blood vessel 1330 by perforation or hole 1335.Controlling organization 1310 can comprise, for example a mechanical interface, electrical interface, draw/push away line, spring, Magnet or other suitable element or mechanism are so that DPRD1300 can be by remote control.

Controlling organization 1310 can be one can be placed on outside or inner micro mechanism, for example it can be put in the subcutaneous tissue of patient, think that health care provider provides an outer tunnel, perhaps it can internally be placed on approach most to make health care provider with minimum intrusion technology with regard to enterable position.

In one embodiment, DPRD1300 can be by controlling with outside " emission " unit wireless.For example control signal can adopt remote measurement outside the patient body, local wireless electricity frequency (RF) emission, local ultrasound emission, external magnetic field, local heat or other appropriate signal generating means.DPRD1300 can comprise one " reception " unit in such an embodiment.This receiving element can comprise an internal electric source (as battery), maybe can be from control signal or other reception activation power that transmits.This receiving element for example can be implanted plug via one and be connected to an external power, perhaps can be directly connected to the DPRD1300 (for example in doctor's office) of temporary base, but plug transfer instructions signal of being implanted and/or power supply is to start DPRD 1300.

Referring now to Figure 13 B,, its expression is disposed in the example of the controlling organization 1310 under the skin surface 1360.In an example, control line 1320 can be by adopting conventional needle or syringe 1365, for example enters patient and put into by making a little otch.Can be externally or internally control one or some control lines 1320 so that DPRD 1300 can be controlled.One in certain embodiments, (or some) line 1320 can be at pipe, for example operation in silicon pressure pipe 1370.Controlling organization 1310 can comprise that for example a remote valve opening/closing mechanism monitors DPRD function etc. so that can monitor cardiac pressure.In one embodiment, controlling organization 1310 position that can be used for responsive valves comes monitor blood flow to change.Controlling organization 1310 can make under the situation of clinical needs, can the artificially reduces the blood pressure in cardiac pressure or a certain inner chamber body or the heart.Controlling organization 1310 can wash or clean DPRD1300 by the mode that for example increases internal blood pressure or fluid pressure with at interval selected.Can adopt flushing or cleaning solution in another embodiment, for example under selected pressure, saline solution can enter control conduit 1320 and described aperture is cleaned or washed.This cleaning can help to reduce the undesired growth relevant with DPRD1300, infection etc.

Controlling organization 1310 can coat one or more materials in case tampon or other disease.DPRD1300 can comprise that point, thorn or other structure have only minimum the contact to avoid FRM and contact fully with diverter or to guarantee between FRM and the diverter.Controlling organization 1310 can make a plurality of parts of DPRD can be replaced at a distance, clean, keep in repair or carry out other operation.Controlling organization 1310 can make leak pre-configured or design be opened at a distance, to cut out according to clinical needs or carry out other change.Controlling organization 1310 can block hole or the inner chamber of DPRD, for example by laying thromboembolism at a distance to stop the effect of DPRD in the hole.One or more above-mentioned performances can make the function that public medical health services supplier can Long-distance Control DPRD1300.

Among the embodiment shown in Figure 13 C, controlling organization 1310 can comprise one or more push knob 1340 or other the suitable controller or the mechanism that can use finger or other suitable utensil control.For example, a plurality of push knobs 1340 can be separately, pressed down in DPRD1300, to reach desired effect simultaneously and/or with multiple other combination.Controlling organization 1310 can comprise in one embodiment, and for example one or more bars or electric conductor 1350 are to help control DPRD1300.Controlling organization 1310 can comprise in one embodiment, and for example one or more release mechanisms 1345 are added in the operation of DPRD1300 to help prevent unwanted change as lock-button.Controlling organization 1310 can comprise in another embodiment, for example one or more spring or other suitable controlling organizations that are connected with DPRD1300 with bar 1350.

Among the embodiment shown in Figure 13 D, controlling organization 1310 can be used for controlling DPRD1300, for example adopts selectively operation in pipe 1370 such as one or more bars or line 1375.DPRD1300 can comprise a lid 1377, and for example flexibility or inflexibility are covered, and it for example can keep constant crack, to form a gap 1379.In one embodiment, lid 1377 can and can rigid manner be assembled or be connected to a locking mechanism 1380 by constructed of rigid materials.Be fixed on select location in case cover 1377 by locking mechanism 1380, it just keeps stable so, for example is not subjected to the influence of blood pressure, reorientates up to lid 1377 always.In this case, lid 1377 can only be used controlling organization 1310, and as holding wire, or other suitable communication line is adjusted by conscious and in check action.

Locking mechanism 1380 can make with covering 1377 remote controls and be set on one or more positions.Locking mechanism 1380 can comprise, for example one or more springs, latch, control stick, recess, groove, hook, slide rail or other suitable locking mechanism.For example slot # 1 can be a lower position, for example in the grapple mechanism 1332 of this position hook 1325 shown in being fixed on; Slot # 2 can be a centre position, for example in the grapple mechanism 1333 of this position hook 1325 shown in being fixed on; Slot # 3 can be a higher position, for example in the grapple mechanism 1334 of this position hook 1325 shown in being fixed on.Also can adopt other setting, openings of sizes, mobile level, position and position number.Controlling organization 1310 can comprise for example safety component, starts DPRD1300 (as special tool(s) and Magnet, coded sequence, password etc.) to help prevent unauthorized persons.

Among the embodiment shown in Figure 13 E, controlling organization 1310 can be used for controlling DPRD1300, for example adopts auxiliary hydraulic system.Controlling organization 1310 for example can be connected to this hydraulic systems via one or more pipes 1390, and aforementioned tube can help to control the pressure and/or the flow velocity of the liquid of supplying with by DPRD1390.DPRD1390 can be connected to a hydraulic system when needed, perhaps can for good and all be connected to a hydraulic system.In one embodiment, pipe 1390 for example can increase the fluid pressure of DPRD1300, so that a significant power to be provided on diverter or in the diverter.Pipe 1390 can additionally or alternatively be used for " maintenance ", for example by forcing liquid as flowing through diverter via shunt base 1392, wash, clean and/or lubricated diverter and/or FRM1396, and/or discharge the moving component of EPRD so that keep DPRD1300 to be in required service condition or state.In one embodiment, pipe 1390 or therefrom extract as described in a kind of material (as saline solution) injectable advances, thereby with the pressure that changes bottom 1392 and make piston membrane 1394 activities.Caused that FRM1396 moves thereby piston membrane 1394 can stretch and/or enlarge, for example open and/or close FRM1396, flow through DPRD1300 to allow liquid selective ground.Pipe 1390 can be connected on the pipe 1320 (seeing Figure 13 A and 13B) and/or be suitable for puncturing that to enter patient skin continuous with pipe 1390 syringe needles that are connected 1366 or other apparatus.In one embodiment, hydraulic mechanism can use later in DPRD1300 is placed into body, for example checks the operability of DPRD1300.In another embodiment, hydraulic mechanism can use when checking the DPRD1300 operability back in DPRD1300 is placed into body.

It being understood that some embodiment of the present invention can adopt for example one or more threshold values, predefined parameter, condition and/or standard, to trigger that diverter, DPRD or FRM work or inoperative.

According to one embodiment of the invention, can adopt the suitable technique of a device of various implantation.According to some embodiment, can adopt the minimum operation of invading, the method that for example adopts the percutaneous importing is with in pressure-regulating device importing and the implant patient body.In such an embodiment, this device can be fixed on the conduit import system and via little otch and insert health.In case this device is positioned at intravital correct position, then it just can the person of being operated arrange, enlarges and be locked in correct position.Device by the conduit conduction can for example be retracted or be folded into small size, and this device can open when arranging certainly.This pressure regulation device can adopt the invasive surgical operation to be imported in another embodiment, and for example the surgeon makes big opening in vivo so that realize that the device implant site is more direct contacts with this.

In one embodiment of this invention, as submitting to April calendar year 2001, name is called the United States Patent (USP) 09/839643 of " method and apparatus that reduces the local blood circulation system pressure ", particularly described in Fig. 3-5, one group of diaphragm syringe needle can be pushed into right front atrial septum membranous wall (Right atrial septum).Can make an inlet from femoral vein, this device passes the lower inner cavity vein and advances and enter right atrium simultaneously.In case the diaphragm puncture is finished, then the commutative needle component of a guide line enters left atrium then.Mode with the diaphragm puncture is well known in the art with the method that conduit is fit into left atrium.After transseptal sheath is positioned left atrium, as mentioned above, can begin to place the diverter of doing according to embodiments of the invention.

Dilator and line can be drawn back from this sheath subsequently, and this sheath can be stretched from the inguinal femoral vein of patient entrance now and enter left atrium, passes femoral vein, iliac vein, lower inner cavity vein, right atrium and preceding atrial septum etc.Delivery conduit can pass this sheath under cryptoscope develops.Can on this conduit and sheath, provide radiopaque mark in order to locate some special points.Delivery conduit can advance carefully and lentamente, so the part farthest of left atrium retaining element is emitted and enter the inner cavity chamber of left atrium from the distal openings of conduit.This retaining element can be made of the material of spring-like and/or can be super-elastic shape memory alloy, and therefore when it broke away from the restriction of this delivery conduit interior zone, it just became the shape that is shaped fully that sets in advance.The assembly of sheath and delivery conduit can wholely lentamente be withdrawn so that draw back retaining element towards preceding atrial septum then.When developing by cryptoscope and knowing very much this retaining element when preceding atrial septum is fixed by tactile response, the doctor can stop this withdrawal.At that point, sheath can be contracted separately, exposes diverter and is located in preceding atrial septum in the established opening.Sheath can further be withdrawn then, allows the retaining element in right front room to become the shape that it is shaped fully.Whole diverter assembly can separate with delivery catheter system subsequently with DPRD.Inner this DPRD can control by long control line at delivery conduit, and this control line has independently to move at the conduit intra-zone to be controlled.This connection can constitute by any traditional method, and as welding or bonding, perhaps mechanically isolating similar fashion connects under the regulation tension level, and described tension level is exceeded in the process of firmly regaining this control line by the doctor.Other application process of DPRD and/or FRM also can adopt.

Referring now to Figure 14,, it shows according to some embodiments of the present invention, DPRD and/or FRM is transported in the body, for example the method for the heart diaphragm between left atrium and the right atrium.One equipment is implanted one or more in can comprising the following steps in the barrier film: a) the identification accurate position that is used to implant; B) this equipment is aimed at selected position; And c) guarantees accuracy and the integrity implanted.Ideal implantation position can be for example by medical practitioner by making the barrier film imaging and analyzing membranous anatomical structure (as using TEE) and select.The described position of the known means that will definitely comprise employing " drafting " diaphragm position being discerned this accurate equipment means of delivery.Label can be added to this means of delivery and equipment (as the label of gold).In case discerned this position and be configured this equipment, medical practitioner can be checked and test this equipment and install, and selectively carries out before fetching this induction system fully.For example, medical practitioner for example can adopt health to provoke the direct contact of (physically challenging) or draw entire equipment (as by gently drawing this equipment to guarantee grappling correctly).This grappling can be tested (as adopting magnetography, echo, X-line, using the angiography of radiography material etc.) by non-contact device.

At frame 140, for example can adopting, conduit implants DPRD between two or more chambers, inner chamber, organ, zone, the band etc.At frame 141, FRM configurable in for example selected position or position so that a successive liquid stream can be arranged between two or more inner chambers, and can be according to the variation of pressure differential between these inner chambers and optionally work or inoperative.At frame 142, FRM for example can be in response to the variation of pressure differential between these inner chambers controlled (as passively), but the variation of FRM response pressure is opened further and/or closed.Selectively, at frame 143, DPRD and/or FRM can be by remote control to help the liquid stream between these inner chambers of control.In certain embodiments, the remote control of DPRD and/or FRM can be cleaned DPRD and/or FRM, makes DPRD and/or FRM function stop, change the parts of DPRD and/or FRM etc.Combination in any in the above-mentioned steps can be implemented.Further, can adopt some other step or series of steps.

For the purpose of illustration and description, by the agency of foregoing these embodiment of the present invention.This does not also mean that and is exhaustive or limits the invention to accurate disclosed mode.Those skilled in the art will recognize that according to above-mentioned instruction and might have many improvement, distortion, substitute or variation and equivalent.Therefore it being understood that the appending claims intention comprises all such improvement and modification in true spirit of the present invention.

Claims (27)

1. differential pressure regulation device, this device comprises:

One diverter between two or more inner chambers, can flow liquid in body between described two inner chambers; With

One flow rate adjustable governor motion is set to optionally cover the opening of described diverter, with and described intracoelomic cavity between pressure differential regulate the liquid stream that flows through described diverter relatively.

2. pressure-regulating device as claimed in claim 1, wherein said flow control device allow between the described intracoelomic cavity continuous flow is arranged.

3. pressure-regulating device as claimed in claim 1, wherein said flow control device are continuously adjustable according at least one pressure threshold.

4. pressure-regulating device as claimed in claim 1, wherein said flow control device is continuously adjustable according to the variation of the pressure differential between described each inner chamber.

5. pressure-regulating device as claimed in claim 1 comprises the controlling organization of the described flow control device of a remote control.

6. pressure-regulating device as claimed in claim 5, wherein said controlling organization comprises one or more mechanisms that are selected from down group: metal wire, line, spring, nail, cable, Magnet, hook, pin, electrical mechanisms, pressure transducer, remote measurement mechanism, no line mechanism, pneumatic mechanism, and electromotor.

7. pressure-regulating device as claimed in claim 1, wherein said intracoelomic cavity are the chambeies of heart.

8. pressure-regulating device as claimed in claim 1, wherein said diverter are positioned in the heart diaphragm between heart left atrium and the right atrium.

9. pressure-regulating device as claimed in claim 1, wherein said flow control device is used to close the opening of described diverter.

10. pressure-regulating device as claimed in claim 1, wherein said flow control device comprise one or more mechanisms that are selected from down in the group: the annular valve that links to each other with curved spring; Preformed using flexible wire; The taperer that links to each other with the compression spring; Leaf valve; Have adjustable substantially in the flexible disk in the hole at center; In liquid is housed and is connected to first air bag of second air bag by a pipe; In liquid is housed and is connected to first air bag of a container by a pipe, this container has an opposing compression spring and the piston that moves; And in liquid is housed and is connected to first air bag of a container, the piston that this vessel with good grounds one controlled start-up system is moved by a pipe.

11. a differential pressure regulation device, this device comprises:

One diverter between two or more inner chambers of heart, can flow liquid between described two inner chambers;

One flow rate adjustable governor motion is set to optionally cover the opening of described diverter, flows through the liquid stream of described diverter with adjusting.

One controlling organization is connected to the described flow control device of described flow control device with remote startup.

12. pressure-regulating device as claim 11, wherein said controlling organization comprises one or more mechanisms that are selected from down group: one or more tinsels, line, spring, nail, cable, Magnet, hook, pin, electrical mechanisms, pressure transducer, no line mechanism, remote measurement mechanism, pneumatic mechanism, and electromotor.

13. as the pressure-regulating device of claim 11, wherein said intracoelomic cavity is the atrium.

14. as the pressure-regulating device of claim 11, wherein said diverter is positioned in the barrier film between left atrium and the right atrium.

15. as the pressure-regulating device of claim 11, wherein said flow control device is continuously adjustable according at least one pressure threshold.

16. as the pressure-regulating device of claim 11, wherein said flow control device is inflexible, described flow control device position is directly controlled by described controlling organization, thereby has determined the accurate dimension of described diverter opening basically.

17. a body internal pressure control method, this method comprises:

One differential pressure regulation device is implanted, and described pressure-regulating device comprises that one places the diverter between two or more inner chambers in the described body;

Dispose a flow governor motion; With

Control the setting of described flow control device according to the variation of pressure differential between described these inner chambers.

18., comprise the setting of the described flow control device of distant control as the compress control method of claim 17.

19., comprise the pressure differential that reduces between first inner chamber and second inner chamber as the compress control method of claim 17.

20., comprise that the described flow control device in location is so that can have a successive liquid stream between described these inner chambers as the compress control method of claim 17.

21., comprise that the described flow control device in location is to stop the liquid stream between the described inner chamber as the compress control method of claim 17.

22. as the compress control method of claim 17, wherein said implantation is to adopt percutaneous conveying and realization.

23. body internal pressure control method, this method comprises the mobile setting of adopting the interior controlling organization of being implanted of body to come the remote control flow control device, described flow control device is placed in the differential pressure regulation device inside that has a diverter, and this diverter is placed between the left atrium and right atrium of heart.

24., comprise that the described flow control device of employing reduces the pressure differential between left atrium and the right atrium as the compress control method of claim 23.

25. as the compress control method of claim 23, wherein said controlling organization is arranged under patient's the skin.

26. compress control method as claim 23, wherein adopt one or more mechanisms that are selected from following group to operate described controlling organization: tinsel, line, spring, nail, cable, Magnet, hook, pin, electrical mechanisms, pressure transducer, no line mechanism, pneumatic mechanism, and electromotor.

27. as the compress control method of claim 24, the minimizing of wherein said blood pressure is to reduce the left ventricle blood pressure.

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