CN107921195A

CN107921195A - Right heart bypass

Info

Publication number: CN107921195A
Application number: CN201680046522.2A
Authority: CN
Inventors: D·伯克霍夫; R·C·法南
Original assignee: Heart Apparatus Ltd By Share Ltd
Current assignee: Heart Apparatus Ltd By Share Ltd; Heartware Inc
Priority date: 2015-08-07
Filing date: 2016-08-05
Publication date: 2018-04-17
Also published as: EP3331589A4; WO2017027414A1; EP3331589A1

Abstract

The present invention relates to blood is pumped into pulmonary artery so as to the apparatus and method for bypassing heart right ventricle from vena cave.The equipment includes pump and flows in and out intubation.In one embodiment, flow into intubation and outflow intubation is inserted into subclavian vein by single percutaneous opening and is advanced in vena cave.When outflow intubation is advanced in pulmonary artery, it is re-directed to pulmonary artery.The pump of the proximal end of bypass equipment is arranged in the cavity of body, such as near the thorax of patient.In operation, blood from vena cave is transported to pump by flowing into intubation, is then intubated and is pumped at least one in right pulmonary artery or left pulmonary artery by outflow.

Description

Right heart bypass

Cross reference to related applications

This application claims in the applying date of the U.S. Provisional Patent Application submitted the 62/202,484th on the 7th of August in 2015 Rights and interests, the disclosure of which is incorporated by reference herein in its entirety.

Technical field

This disclosure relates to for improving equipment, external member and method into the venous blood flow of pulmonary artery.

Background technology

The surgical procedures of referred to as Fontan programs is carried out to treat several complicated congenital cardiac anomalies, including tricuspid valve Locking, have the pulmonary atresia of complete ventricular septum, be hypoplastic left heart syndrome, hypoplastic right heart syndrome, double Other exceptions of entrance ventricle and pumpability on heart.The completion of surgical procedure cause systemic vein blood flow to lung without By right ventricle.

In general, Fontan programs are completed in two stages.First stage be related to the blood flow from upper body is rebooted it is logical Cross superior vena cava so that blood is transported to the atrium dextrum of pulmonary artery rather than heart by superior vena cava.In this stage, from cavity of resorption The venous blood of vein continues blood being transported to heart from the lower part of the body.In second stage, the blood from inferior caval vein is moved by lung Arteries and veins is redirected to lung.After the procedure is completed, the pressure in vein is depended on by the blood flow of lung, because blood is no longer Pumped by right ventricle.The formation of Fontan circulations is substantially palliative, in the patient with preferable haemodynamics In with good as a result, and with sizable morbidity and mortality in the bad patient of haemodynamics.Into into " the Fontan patient " in year is faced with uncertain future.

It is after performing the operation common problem encountered is that center due to by completing Fontan programs the burden brought to venous system The excessive rise of vein pressure.That is, the hyperpiesia in superior vena cava and inferior caval vein.Other complication of Fontan circulations include Movement do not tolerate, ventricular failure, atrium dextrum expansion and arrhythmia cordis, whole body and vena hepatica high pressure, portal hypertension, blood coagulation barrier Hinder, pulmonary arteriovenous malformation, venous shunt and lymphatic function obstacle be (for example, ascites, oedema, hydrops, protein losing enteropathy and fibre Tie up disposition bronchitis).Further detail below on Fontan programs can be in the The of such as Fredenburg et al. Fontan Procedure:Anatomy,Complications,and Manifestations of Failure, 31RADIOGRAPHICS 453, (2011) (Fontan programs：Dissection, complication and unsuccessfully show, 31《Irradiation image》453 (2011)) found in,.

At present, the patient for undergoing the Fontan programs of failure usually has two main selections：Carry out heart transplant or complete Artificial heart is implanted into.In most cases, Fontan patient is not the ideal candidate of any of the above-described kind of program, because so Patient due to big operation, especially open surgery and with bigger risk of injury.Further, since superior vena cava is with Vena cave anatomical structure changes, and when Fontan programs have been completed, heart transplant is not preferable solution.It is another Method is related to implantation left ventricular assist device (LVAD).However, such device can not be fully solved Fontan procedure failures The problem of.Therefore, it is necessary to for new solution the problem of generation by Fontan programs.

The content of the invention

The first aspect of the present invention provides a kind of medical treatment.The first step of this method, which is ideally related to, to be had There is the body that the pump for flowing into port and outflow port is connected to acceptor so that flow into port and at least one fluid in vena cave Connection, and flow out port and at least one fluid communication in left pulmonary artery or right pulmonary artery.The second step reason of this method It is related to pump operation with thinking, at least one at least some blood flows in vena cave is transported to left pulmonary artery or right lung moves It is at least one in arteries and veins.

In one embodiment of first aspect, patient is already subjected to Fontan programs before connection pumps so that chamber is quiet Arteries and veins is connected with pulmonary artery.In another embodiment, this method is further comprising the steps of：Measure and flow into or out intubation On or in the relevant property of blood；The signal related with the relevant property of blood is passed to the control for being connected to pump Device；And control pump in response to the signal.In yet another embodiment, pump is operable to transport at least some blood flows.Especially Ground, operation to pump can include blood being transported in pump from least one vena cave by flowing into intubation, and by blood By flowing out intubation from pump is transported at least one in left pulmonary artery or right pulmonary artery.In another embodiment, flow out Intubation is suitable for producing at least partly sealing or obstruction so that when outflow intubation is set in the blood vessel during the operation in pump, Prevent at least some blood backflows from outflow intubation outflow into vein.In another embodiment, by pump operation it It is preceding actuating be attached to outflow intubation sacculus carry out seal blood vessels so that sacculus seal at least in part outflow intubation outer surface with Space between peripheral vessels, is back in any one vena cave to prevent Hemostatic Oral Liquid.

Another aspect of the present invention provides a kind of method for being implanted into medical treatment equipment.The method for implantation ideally wraps Include following steps：At least one percutaneous slit is made in patient's body；It will simultaneously or sequentially flow into intubation and be inserted through institute State one at least one percutaneous slit and one be inserted through at least one percutaneous slit will be flowed out, make Intubation must be flowed into and outflow intubation all enters vein；Intubation will be flowed into be advanced in superior vena cava；And outflow intubation is promoted In at least one into right pulmonary artery or left pulmonary artery.It is all connected to pump in general, flowing in and out intubation so that in the behaviour of pump It is at least one by pumping and at least one stream in right pulmonary artery or left pulmonary artery in superior vena cava and inferior caval vein during work Body connects.

In one embodiment, patient is already subjected to Fontan programs before at least one percutaneous slit is made so that Vena cave is connected with pulmonary artery.This method can relate to seal wire being inserted through outflow intubation and activate seal wire, wherein to seal wire Actuating, which is repositioned, to be flowed into intubation and flows out at least one in intubation.In a variation of above-described embodiment, the second seal wire It is inserted through inflow intubation so that the actuating positioning outflow intubation of the first seal wire, and the actuating of the second seal wire is repositioned Flow into intubation.Identical percutaneous slit can be inserted through at the same time by flowing in and out intubation.In a variation, will flow into and Before outflow intubation is set also cross inserter sheath, inserter sheath is placed by percutaneous slit.In another reality Apply in example, intubation will be flowed out and be advanced at least one in right pulmonary artery or left pulmonary artery so that being moved in left pulmonary artery or right lung In arteries and veins it is at least one be disposed therein outflow intubation between formed at least one portion sealing.It is connected to outflow intubation Sacculus can be activated after it will flow out intubation and be advanced at least one in right pulmonary artery or left pulmonary artery.In this feelings Under condition, the actuating of sacculus can cause sacculus to seal at least in part in right pulmonary artery or left pulmonary artery around outflow intubation It is at least one.

On the other hand, the present invention relates to the external member of the blood flow for improving patient's body.The external member is ideally comprised pump And be suitably connected to pump flows in and out intubation.Intubation is flowed into may be adapted to be placed in superior vena cava or inferior caval vein extremely In few one, and flow out intubation and may be adapted to be placed at least one in right pulmonary artery or left pulmonary artery.

In one embodiment, flowing into intubation includes the length longer length than outflow intubation.In another embodiment In, one flowed into intubation and outflow intubation is disposed entirely within inflow intubation at least a portion of length for flowing into intubation In another in being intubated with outflow.In yet another embodiment, outflow intubation further includes the first outflow intubation and the second outflow Intubation.In one that first outflow intubation is suitable for being arranged in right pulmonary artery or left pulmonary artery, and the second outflow intubation is suitable for It is arranged in another in right pulmonary artery or left pulmonary artery.In another embodiment, pump is adapted for placement in patient body Portion so that the placement is under subcutaneous, muscle or in belly, chest or other body cavitys.

Brief description of the drawings

Fig. 1 is the side view of bypass equipment according to an embodiment of the invention.

Fig. 2 is that the bypass shown in Fig. 1 according to an embodiment of the invention during a stage of program is set Standby side view.

Fig. 3 is the partial sectional view of the bypass equipment shown in Fig. 1.

Fig. 4 is to show stereogram, shows the of the method for implantation bypass equipment according to an embodiment of the invention One step, it uses the equipment shown in Fig. 1.

Fig. 5 is the side view for another step for showing this method.

Fig. 6 is analogous to the view of Fig. 5, but shows another step in this method.

Fig. 7 A are the views similar with shown in Fig. 5, but depict the apparatus and method according to another embodiment.

Fig. 7 B are the partial sectional views of the inserter for being provided with being intubated shown in Fig. 7 A.

Fig. 8 is the side view of bypass equipment according to another embodiment of the invention.

Fig. 9 is the partial sectional view for flowing in and out intubation of the bypass equipment shown in Fig. 8.

Figure 10 is the side view of bypass equipment according to another embodiment of the invention.

Figure 11 is the partial sectional view for flowing in and out intubation of the bypass equipment shown in Figure 10.

Figure 12 is the side view of bypass equipment according to another embodiment of the invention.

Figure 13 is the side view for flowing in and out intubation according to another embodiment of the invention.

Figure 14 is the side view of bypass equipment according to another embodiment of the invention.

Figure 15 is the side view of bypass equipment according to an embodiment of the invention.

Figure 16 is the partial sectional view of the bypass equipment shown in Figure 15.

In whole attached drawing, unless otherwise stated, identical reference numeral and label are used to represent diagram embodiment Similar features, element, component or part.In addition, although the disclosure is described in detail referring now to attached drawing, it is done so that being Carry out, and do not limited by the specific embodiment shown in figure with reference to illustrative embodiment.

Embodiment

Various equipment, external member and the method for the present invention is intended to improve blood flow and/or reduces the vein pressure of patient.Retouch herein One particularly advantageous application of the embodiment stated is that the blood from vein is passed through pulmonary artery in Fontan patient after surgery Guide and accelerate to lung.

Used term " patient " of carrying throughout with used term " acceptor " of carrying throughout is interchangeable, and It is intended to refer to the people of the recipient of the equipment as the present invention.

Figure 1 illustrates and can be used for the bypass equipment 10 of first embodiment according to the present invention as described below Improve the blood flow entered in lung after Fontan programs.The equipment includes blood pump 1.The pump can be known in the art any Type.In some variations, and as shown in Figure 1, blood pump 1 includes flowing into port 3 and outflow port 5.In other variations, pump Can simply it include an inlet and an outlet.Suitable blood pump for method described herein is implantable rotary blood pump, Such as some rotary blood pumps be disclosed in U.S. Patent No. 6,234,772, No. 7,699,586, No. 8,157,720, In 8,545, No. 380, the 8th, 512, No. 012 and the 8th, 882, No. 477, the patent is clearly incorporated herein by quoting.Other The use of the implantable pump of type is also advantageous in the present invention.Pump 1 is constructed such that it can be in the cavity in body In be arranged on patient's body.The non-limiting example placed is outside thoracic cavity or outside thorax.Placement can be subcutaneous or flesh Under meat.Other examples that pump is placed are included in the body cavity in such as abdominal cavity or thoracic cavity.It is also contemplated that it is placed on other body cavitys In.Alternatively, pump 1 can be placed in vitro.Pump 1 can also include alloing monitoring device and other equipment to be fixed on the spy pumped on 1 Sign portion.The position for flowing into port 3 and flowing out port 5 on pump 1 is as shown in Figure 1.Alternatively, port 3,5 can be located at appointing on pump 1 What suitable position, to be suitable for the anatomical structure of patient.

Equipment 10 further includes inflow intubation 9 and outflow is intubated 11, as shown in Figure 1, Figure 2 and Figure 3.The inflow intubation 9 of combination It is adapted for insertion into blood vessel with outflow intubation 11 and is also suitable for propulsion and passes through blood vessel.As shown in Figure 1, flow into intubation 9 and stream Go out intubation 11 to arrange with side-by-side configuration, and be attached to one another along a part of length of each intubation.In the configuration, farthest Part at end 21,22 is separated so that each intubation is extended in single blood vessel.

In shown configuration, flow into intubation 9 and outflow intubation 11 is fixed to one another by temporary attachment portion.Temporary attachment Portion, which is constructed and is manufactured into, to be promoted to flow into stripping of the intubation 9 from outflow intubation 11.Some examples of this configuration are included in two The indentation at the interface between intubation, or manufacture have the relatively thin material layer of the boundary between intubation so as to easily by it The intubation peeled away.

Flow into the relative positioning of intubation 9 and outflow intubation 11 and particularly in intubation comprising making the intubation can be from The characteristic that another intubation is peeled off, contributes to clinician to place.It is also helped by single entrance or notch single Both inflow intubation 9 and outflow intubation 11 are placed in operation sequence.As described in more detail below, clinician can separate or Two intubations are peeled off, enables them to separate and is placed in separated blood vessel.As Figure 2-3, intubation 9 is flowed into be constructed Into being placed in inferior caval vein, and flow out in one or two that intubation 11 is configured to be placed in pulmonary artery.

Intubation can be made of biocompatible materials, such as the biocompatible polymer with or without reinforcer Or the biocompatibility metal of such as Nitinol.Intubation 9 has the interior tube chamber 32A for being used for that blood to be conveyed from patient, and is intubated 11 With interior tube chamber 32B.In this embodiment, as shown in figure 3, flowing into intubation and outflow intubation has identical diameter and thickness, Wherein flowing into intubation 9 and outflow intubation 11 all has the internal diameter of about 5mm.Equally in figure 3, the outside diameter being each intubated is denoted as 6mm, so that the thickness of each cannula wall 13 is about 0.5mm.Alternatively, intubation can have greater or lesser diameter, Or there is different diameter and thickness, this depends on patient and the specific requirement determined by the anatomical structure of patient.Although such as This, intubation should have sufficiently small diameter, so as to be not totally blocked by the natural flowing of vascular system.

As shown in Fig. 2, it is longer than outflow intubation 11 to flow into intubation 9.In other embodiments, outflow intubation 11 can have with Flow into 9 identical or bigger length of intubation.Referring again to Fig. 2, flowing into intubation 9 includes opening 39, and opening 39 is from distal end 22 with big Cause equal be spaced apart away from distal end 22 about at 10cm.Opening 39 extends to tube chamber 32A from the outer surface for flowing into intubation 9 (Fig. 3).As shown in the figure, outflow intubation 11 includes sacculus 15 and inflation tube chamber 17, sacculus 15 is arranged on the distal end of outflow intubation 11 Near 21.As Fig. 2 and Fig. 3 are clearly shown that, the near-end 19 of inflation tube chamber 17 from outflow intubation 11 extends to sacculus 15 simultaneously Connected with sacculus 15.Especially, Fig. 3 shows inflation tube chamber 17 in the wall 13 of outflow intubation.In a variation, inflation Tube chamber can be placed on the outside of wall or the inside of wall 13.Sacculus 15 be configured to collapsed state and inflation or swelling state it Between activated.For example, in fig. 2, when outflow intubation 11 is pushed through subclavian vein 50 and superior vena cava 52, sacculus 15 In collapsed state.In contrast, Fig. 6 shows the sacculus 15 in swelling state, wherein outflow intubation 11 is in right pulmonary artery Desired position is in 56.

The near-end 19,20 of inflow intubation and outflow intubation is configured to have placement adapter 23 and 25 (Fig. 2) respectively, with Easy to which intubation is placed on patient's body.In an illustrated embodiment, the placement adapter at the near-end 19 of outflow intubation 11 25 have Y-shaped configuration.In the configuration, the near-end that Y shape places adapter 25 has two openings.Opening in the first accessory 27 Mouth is connected with the interior tube chamber 32B of outflow intubation 11, and is configured to receive seal wire 12B etc..Opening in second accessory 29 is with filling Tube expansion chamber 17 connects, and is configured to receive syringe (not shown), with via inflation 17 balloon inflation 15 of tube chamber.Inserted flowing into Placement adapter 23 at the near-end 20 of pipe 9 has accessory 24, and accessory 24 has opening and is configured to receive seal wire 12A. Each near-end placed adapter 23,25 and be connected to corresponding intubation 19,20 as depicted so that adapter and the tube chamber of intubation 32A, 32B are connected.Place adapter 23,25 to be configured to receive seal wire 12A, 12B etc., inserted with helping to flow into intubation 9 and outflow Propulsion and placement of the pipe 11 in patient's body.Be connected to pump 1 in order to which intubation 9 and outflow intubation 11 will be flowed into, place adapter 23, 25 include accessory 24,27 as shown in Figure 2, which is configured to be connected and formed close with ingress port 3 and outlet port 5 Envelope.Adapter is the pump for being also configured to be connectable to the type disposed in a program.

As shown in Figure 2-5, equipment includes two seal wires 12A, 12B according to this embodiment.Seal wire 12A, 12B are configured to The intubation for being configured to be placed into vascular system is placed on above seal wire or perhaps surrounds it.Seal wire 12A, 12B scribble biocompatible materials or perhaps are made of biocompatible materials, and are peaces during use in body Complete.Each seal wire 12A, 12B further include the flexural properties for reaching and bending required degree in vascular system when being pushed into. Seal wire 12A, 12B be able to can be turned in itself, and can be combined with general characteristics usually used in seal wire.

It is contemplated that the element of the said equipment can also be included in any combinations of element, to be used as external member.For example, External member in one embodiment of the present of invention can include pump, flow into intubation and outflow intubation.In certain embodiments, external member is also It can include attachment device, annex and/or instrument.For example, external member can include seal wire, guide pin, vessel dilator, guiding Device sheath, syringe, stopcock, scalpel and/or other devices, annex and the instrument used during surgical procedures.

Method according to another embodiment of the invention can complete Fontan journeys before this using bypass equipment 10 Implement with the patient of sequence.As shown in Figure 5 and Figure 6, after Fontan programs, superior vena cava 52 and inferior caval vein 54 are respectively controlled oneself Through being stapled pulmonary artery 56,58.In the case of not further mechanical assistance, which allows blood from epicoele Vein and inferior caval vein flow directly to right pulmonary artery, left pulmonary artery or both.The completion of Fontan programs by by blood from chamber Vein directly re-directs at least one pulmonary artery and by the right accessory pathway of patient's heart.According to patient and performed The type of Fontan programs, vena cave still can remain connected to right ventricle, and some blood flows can be after the procedure Continue the right side for entering heart from vena cave.

As shown in figure 4, method starts from the formation of patient's body percutaneous slit 51 according to this embodiment.Then by two Seal wire 12A, 12B are inserted through percutaneous slit 51 and enter superior vena cava 52.As shown in figure 5, a seal wire 12B is pushed into, make It is obtained to be directed into right pulmonary artery 56.Similarly, another seal wire 12A is pushed into so that it is directed into superior vena cava 52 In, towards inferior caval vein 54.

Flow into intubation 9 and outflow intubation 11 is produced with inserted into the patient.As Fig. 4-6 is discribed, clinician exists Place and flow into intubation 9 should separately how many with the distal end 21,22 for determining each to be intubated before outflow intubation 11.This determines part The position of branch of the ground based on irradiation image and relevant blood vessel.Flow into intubation 9 and outflow intubation 11 can be separated so that is every It is a to be intubated long enough to reside in the corresponding target blood of such as inferior caval vein and right pulmonary artery.In fig. 5 and fig., flow The separation entered in a part for the distal end of intubation and outflow intubation is visible.Before insertion flows in and out the combination of intubation Separation is carried out to determine.Then, as shown in figure 4, clinician that the distal end 21,22 of intubation is inserted into seal wire 12A, 12B is upper and pass through Percutaneous slit 51, the percutaneous slit 51 provide the surgical pathway for reaching subclavian vein 50.Established with the separation of each intubation, As shown in Figure 4 and Figure 5, flow into intubation 9 and outflow intubation 11 is placed on corresponding seal wire 12A, 12B at the same time, and via lock Vein 50 and/or venae brachiocephalicae enter in superior vena cava 52 under bone.It will be attached to mutual flow into and be intubated 9 and outflow intubation 11 At the same time inserted with beneficial to being inserted into and make the least risk of damage vascular system.Once reach superior vena cava (or inferior caval vein) and the right side Outflow intubation 11 is channeled out inflow using the seal wire 12B from outflow intubation 11 and inserted by the intersection of pulmonary artery, clinician Pipe 9, into pulmonary artery, as shown in Figure 5 and Figure 6.In other words, clinician activates seal wire.Clinician can be suitable by placing Orchestration 23,25 and corresponding accessory 24,27 aid in, and seal wire 12A, 12B match somebody with somebody accordingly at the near-end 19,20 of intubation through this Part 24,27.Flowing into intubation 9 will be advanced to and finally reside in inferior caval vein 54, and flow out intubation 11 and will reside in right lung In artery 56 (as shown in Figure 6) and/or left pulmonary artery 58.Once outflow intubation 11 is in desired position, it is possible to is passed through Balloon inflation 15 is carried out in the one end for the inflation tube chamber 17 being actuated at the second accessory 29 of the near-end 19 of neighbouring outflow intubation 11.One In a example, the actuating can by filled with brine or the syringe (not shown) of another acceptable liquid or gas come Realize.(referring to Fig. 2) and noted in the opening that syringe is inserted into the second accessory 29 for placing adapter 25 by clinician Emitter is activated with balloon inflation 15.The sacculus 15 of inflation will flow out intubation 11 and be secured in position and prevent fluid reflux.

Once flowing into intubation 9 and outflow intubation 11 positions as expected and sacculus 15 is inflated, clinician just will be neighbouring The accessory 24 for flowing into intubation 9 is fixed to the inflow port 3 pumped on 1, and the first accessory 27 that 11 are intubated adjacent to outflow is fixed to Outflow port 5 on pump 1.In order to complete the program, the pump 1 connected is placed on for example at or near the thorax of patient In subcutaneous pocket 53 below the skin 52 of patient (Fig. 6).According to the physical trait of patient, which can also be located at any chest External position or internal other positions.Once flowing into intubation and outflow intubation being completely fixed on pump, then vena cave passes through pump Port 3 and outflow port 5 is flowed into right pulmonary artery to be in fluid communication.

In the case where bypass equipment 10 is fully-inserted, pump 1 is activated.As shown in fig. 6, blood is by flowing into intubation 9 Blood flow tube chamber 32A from inferior caval vein 54 and/or superior vena cava 52 be pumped through opening 39 enter flow into intubation 9 pump 1 in.Open It is along venacaval distribution of lengths that the longer distribution of mouth 39, which ensures to become a mandarin, so that is entered without single position with excessive Stream.This helps to prevent vena cave from inwardly collapsing and block blood flow completely.In other words, the distribution optimization being open on intubation is flowed into Suction flows into, and will cause venacaval wall by towards the suction for flowing into the magnitude that intubation attracts without causing.This holding passes through Venacaval nature blood flow.Then pump 1 in blood via outflow intubation 11 in blood flow tube chamber 32B back to pulmonary artery 56, In one or both of 58.As shown in fig. 6, blood returns to right pulmonary artery 56.The sacculus 15 being included in outflow intubation 11 The outside of blood along the outflow intubation 11 of outflow is prevented to double to return and enter inferior caval vein 54 and/or superior vena cava 52. In one variation, outflow intubation may include two or more sacculus.Should be enough by the blood flow of bypass equipment 10, with So that required pressure is provided in vena cave and right pulmonary artery and/or left pulmonary artery.For example, among the patients, when by blood When liquid pump enters single pulmonary artery, it is sufficient that the flow that about 2-3 per minute rises.Certainly, the definite stream needed for the Successful Operation of pump Amount changes the factor of the physical trait according to such as patient.Therefore, flow can be with the flow shown in above example It is dramatically different.Flow is ideally controlled to prevent the development of pulmonary edema or pulmonary hypertension.In addition, pump is ideally controlled, So that the average pressure in vena cave is maintained in desired scope, with prevent as described above with the pressure mistake in vena cave The development of high or too low relevant illness.Required pressure can be based on patient the extended duration (such as several weeks when Between section) in the pressure that is usually undergone.Certainly, the pressure that patient is usually subjected to can be because of patient and different.By pumping 1 as described above Operation, blood around the right heart of patient damage or lack part.The insertion and operation of bypass equipment 10 can be in response to for example Failure Fontan programs, as the supplementary procedure combined with Fontan programs or as interim after Fontan programs Measure.

As described above, the blood flow in Fontan circulations after Fontan programs may ultimately result in it is such as excessive in it is calm The complication of pulse pressure, and at least due to these reasons, methods herein is especially suitable for being involved in failure or failure The patient of Fontan programs.The method provides an additional bypass, it alleviates central venous pressure excessive in vena cave. That is, flow into intubation 9 to be used to shift blood from venous system by pump 1, and flow out intubation 11 and be used to blood recovery arriving patient's Pulmonary artery system, while bypass atrium dextrum and/or right ventricle.Other advantages of this method include increase lung blood flow, improve Internal oxygen uptake, reduces protein depletion, and reduces other serious secondary works related with Fontan procedure failures to greatest extent With.Increase pump to improve the blood flow inherently improvements over the prior art of the pulmonary artery of Fontan patient.In addition, retouched In the method stated, flowing into intubation 9 and outflow intubation 11 can be placed by identical entrance, i.e. percutaneous slit 51.Pass through The program is performed via single entrance, reduces the danger for the patient injury for living through Fontan programs in the past.As described above, When using Minimally Invasive Surgery, Fontan patient may be more preferable, because such patient is due to replacing the open surgery of heart or repairing Answer the prosthesis of existing Fontan programs and be easy to injured.

The above apparatus and method can change in many aspects.In one embodiment, bypass equipment 10 may include to be inserted into Device sheath 14, as shown in figures 7 a and 7b.Inserter sheath 14 is configured in vivo and particularly in vascular system Placement.In one example, inserter sheath is the stripping sheath that can be removed after implant procedure from body.Such as Fig. 7 B institutes Show, inserter sheath 14 is the tubular structure for having tube chamber 34, which is dimensioned to allow at least inflow intubation 9 It is inserted through wherein with outflow intubation 11.It scribbles biocompatible material or perhaps is made of biocompatible material.Inserter Sheath 14 is used to aid in the inserter for flowing into intubation and outflow intubation.After percutaneous slit 51 is made, inserter sheath 14 can It is inserted through notch 51 and is advanced to the position of connection vena cave 52,54 and pulmonary artery 56,58.Then it will flow into and be intubated 9 Hes Outflow intubation 11 is arranged in the tube chamber 34 of inserter sheath (Fig. 7 B), and will stream under the alignment guidance of inserter sheath 14 Enter intubation 9 and outflow intubation 11 is advanced in vascular system.In certain embodiments, thus it is possible to vary be intubated and be connected to intubation The structure of the element of pump.For example, intubation 9,11 can also be played with being intubated the structure for distinguishing but there is tube chamber, And can also as bypass equipment a part by including.In another example, the first intubation and the second intubation be able to can be slided It is connected to each other dynamicly, to improve ease for use.Other mechanism for temporary attachment between intubation include will eventually lead to intubation point From soluble polymer.More broadly, can use allows intubation separation, any material for separating or dismantling, intubation table Face shape or other processing.Alternatively or additionally, be arranged side by side it is a part of can be fixed completely and for good and all, as long as inserting The free end 21,22 of pipe can move freely relative to each other, so that each intubation can enter single blood vessel.In some realities Apply in example, place adapter and be removably attached to be intubated.In connection, pump adapter is enclosed in and is configured to by placement adapter In the intubation engaged with the entrance and exit of pump.In order to which intubation is fixed to pump, adapter will be placed and disengaged with intubation, and will pump Adapter is fixed to the entrance and exit of pump.Include connecting with the near-end of intubation via inflation tube chamber in one or more intubation Sacculus in the case of, pump adapter be configured to place adapter disengage when closure inflation tube chamber near-end.Pump adapter It can be configured to be connected with any kind of pump disposed in a program.Pump adapter allow intubation 9,11 and pump 1 it Between quick attachment.It is also contemplated that with differently placing adapter shown in Fig. 2.That is, it is envisioned that be constructed use Other electrical connectors of intubation are releasably or permanently connected at the near-end 19,20 in each intubation to be used as A part for the bypass equipment used in this method and by including.Such electrical connector can be configured to place seal wire And/or device (such as syringe), the actuating of Fluid pressure or other forms is applied in the tube chamber of intubation.

In other embodiments, for being inserted into bypass equipment the step of, can be unlike the embodiments above.For example, insertion journey Sequence can be carried out with single wire, or be carried out in other cases with three or more root seal wires.In some embodiments In, this method can be supplemented by placing valve and/or plugging device in one or more blood vessels, or can use another Device replaces the sacculus in outflow intubation to seal peripheral vessels.In addition, the diameter of the outflow intubation of bypass equipment can be to make When proper its is arranged in the blood vessel of such as right pulmonary artery, it forms the part or all of sealing of blood vessel.Flowing out intubation may also Obstruction is produced in the blood vessel.Therefore, because sealing and/or obstruction, it is therefore prevented that blood enters at least the one of venous system from blood vessel A little reflux or regurgitation.In certain embodiments, being intubated the method for insertion can change.For example, intubation be inserted into patient it Before be separated from each other in the case of, intubation can sequentially place and/or into single percutaneous slit.Can be by one or two Intubation insertion right internal jugular vein, right vena jugularis externa, right subclavian vein, in one in right axillary vein or right brachiocephalic vein.Insert Pipe can be advanced in superior vena cava from any one in these veins.In other examples, one or two can be intubated It is inserted into one in left jugular vein, left vena jugularis externa, left subclavian vein, left axillary vein or left brachiocephalic vein.Similarly, Intubation can be advanced in superior vena cava from any one in these veins.In other examples, two intubations can It is inserted into along the diverse location of vein length in any one above-mentioned with reference in vein.Some examples in the examples described above In, the distal end 22 for flowing into intubation 9 is only advanced in superior vena cava 52, and is not extended in inferior caval vein.In another example In, bypass equipment is inserted into percutaneous slit and is advanced to from notch in inferior caval vein, without advancing through first Vena cave.When bypass equipment is advanced in inferior caval vein from the latter half of venous system, it can be initially inserted to In right femoral vein or left femoral vein, and it is advanced therefrom in inferior caval vein.In other examples, insertion as described herein Method can be used and/or changed, for not undergoing in the vascular system of the patient of Fontan programs.In such case Under, leading to the vascular access of pulmonary artery must keep relatively unobstructed and can enter, for the best applications of methods described herein. In further embodiments, intubation 9,11 is inserted into so that the near-end of intubation extends through and stretches out the skin of patient.From exposure Intubation in, pump and fixed and positioned in vitro.When the desired use of bypass equipment is temporary transient, external place especially is fitted Close.It also has the advantages that to be easier adjustment to be connected with monitoring device.

In in the above-described embodiments any one, the operation of bypass equipment 10 can pump 1 or integrated with pump 1 with being connected to Device (Figure 15-16) and analytical equipment supplement, described device and analytical equipment are configured to measurement and are inserted in one or more Guan Zhong, such as pressure or flow in vascular system in pulmonary artery or vena cave with the relevant property of blood. Device for measuring blood properties can be sensor, and analytical equipment can be attached to the controller of pump.Including sensing In the case of device and controller, sensor is configured to communicate with being connected to the controller of pump.Sensor may be constructed such that prison Survey pressure and flow velocity in the blood vessel of such as vena cave and pulmonary artery, and other measurable properties.Measurement can be The one or more positions flowed into the length of intubation and outflow intubation carry out.Sensor is also structured to based on such as above-mentioned Those measurement results send signal to controller.The transmission of signal can be by inside the tube chamber in cannula wall or cannula wall or outer The optical cable and/or electric conductor in portion carry out.The specific example of sensor and transmission mechanism is including in differential manometer pressure sensor, tube chamber Fluid and fibre optic compression sensor.Moreover, the fluid in separated tube chamber can arrive the pressure transmission from cannula distal end External sensor.Controller is configured to monitor and analyzes the signal that receives.Controller can be monitored as signal and connect The various forms of energy received.By signal Analysis, controller can adjust the activity of bypass equipment.For example, in vena cave Pressure can be monitored (i.e. estimation in real time) and be adjusted by controller.In the discribed example of Figure 15-16, measurement sensing Device 672A, 672B are connected to controller 670 via pump 601.In discribed bypass equipment 610, sensor 672A, 672B warp By the optics being arranged in the corresponding wall 613 for flowing into intubation 609 and outflow intubation 611 or electric conductor 671A, 671B and control Device 670 communicates, as shown in figure 16.Described device and analytical equipment are also envisioned for and pump in vitro or the internal pump phase set It is compatible.In another variation, sensor can be communicated by wireless communication with controller.

Further embodiment is shown in Fig. 8-14.In the description of embodiment shown in the drawings, bypass equipment, which is in, to be inserted Enter position.Unless otherwise described, the bypass equipment for the embodiment otherwise described in Fig. 8-14 usually with above-mentioned bypass equipment class As mode operate.In one embodiment, bypass equipment 110 may include inflow intubation 109 completely separate from each other and outflow Intubation 111, as shown in Figure 8 and Figure 9.The structure in other respects can be identical with described in above-described embodiment.Describe in Fig. 9 Through the inflow intubation 9 of subclavian vein 150 and the sectional views of outflow intubation 11.In the insertion side using bypass equipment 110 In one embodiment of method, flowing into intubation 109 and outflow intubation 111, both can be inserted into single percutaneous slit, Huo Zheyi at the same time A intubation can be inserted into before another.In some variations, the first percutaneous slit can be inserted into by flowing into intubation 109 In, and flowing out intubation 111 can be inserted into the second percutaneous slit.In the case where making has two percutaneous slits, intubation 109th, 111 can simultaneously or sequentially be inserted into.The method of insertion in other respects can be as described above.

In another discribed embodiment of Figure 10 and Figure 11, flow into intubation 209 and outflow intubation 211 is put with one heart Put so that outflow intubation 211 is disposed entirely within least a portion of length for flowing into intubation in inflow intubation 209.Figure 11 The sectional view of intubation through subclavian vein 250 is shown.It can be seen that flowing into tube chamber 232A and effuser in same width figure The profile of chamber 232B.In a variation, flowing into intubation 209 can be at least a portion length of outflow intubation 211 completely It is arranged in outflow intubation 211.Each intubation is sealed so that there is no fluid communication between inflow intubation and outflow intubation. In one embodiment of this method, bypass equipment 210 is inserted into by single percutaneous slit so that and each intubation is inserted at the same time, It is also envisaged that other methods within the scope of the invention.

In fig. 12 in another shown embodiment, bypass equipment 310 includes being attached to three intubations of pump 301.One A intubation is to flow into intubation 309, as in the other embodiments.Two other is outflow intubation 311A, 311B.As Figure 12 is retouched Paint, each outlet cannula is derived from separated outlet port 305A, 305B.However, shown configuration is not limiting, and It is also contemplated that the connection of other forms.In some variations, the outlet of two outlet cannulas can be shared.In Figure 12 institutes In the implantation position of the bypass equipment shown, outflow intubation 311A is arranged in right pulmonary artery 356, and outflow intubation 311A is arranged on a left side In pulmonary artery 358.Outflow intubation 311A, 311B are shown as being positioned at the inflow intubation 309 that all three intubations interfix Opposite side.In a variation, two outflow intubations 311A, 311B can be adjacent to each other, and stream is attached on side Enter intubation 309.In other variations, only two attachments in three intubations.In other variations, three is separately and not attached Connect.It will also be appreciated that the other variation of other arrangements with intubation, including the adjustment arteries and veins as described in above-described embodiment The position of intubation in guard system.Certainly, when being attached any two intubation, attachment can be as described above interim or solid Fixed.As shown in figure 12, each outflow intubation is included in sacculus 315A, 315B of its distal end 321A, 321B nearside.By insertion During pipeline equipment 310, each outflow intubation 311A, 311B can place adapter 325A, 325B with as described above, it is wrapped Include the first opening for seal wire and the second opening for syringe.As in other embodiments, clinician can use Seal wire helps intubation being directed to desired position.

Figure 13 illustrates another embodiment in, bypass equipment 410 include outflow intubation 411A, it is from single The pump 401 of tube chamber extends to bifurcation site 414, and in the position, intubation 411A is divided into two outflow intubations 411B, 411C.Bifurcated Position 414 can include ring, accessory or other adapters, with separated intubation 411A.As shown in figure 13, in bifurcation site 414 Downstream, outflow intubation 411B are extended in right pulmonary artery 456, and outflow intubation 411C is extended in left pulmonary artery 458.For such as scheming Shown equipment, two seal wire (not shown) can be arranged in outflow intubation 411A.Can be correspondingly using the placement of modification Adapter.As shown in figure 13, each outflow intubation 411B, 411C further include the sacculus 415B towards the distal end being each intubated, 415C or valve.When in insertion position as depicted, the operation of bypass equipment 410 is similar to as described above three intubations Bypass equipment 310.

In another embodiment shown in Figure 14, the pump 501 of bypass equipment 510 is arranged in vascular system.Shown In the specific variants of embodiment, flow into intubation 509 and be arranged in superior vena cava 552, and extend to and be arranged in right pulmonary artery 556 Pump 501.Flowing into intubation 509 includes opening 539, and can also include being attached to the power lead 561 for flowing into intubation 509, As shown in the figure.Power lead 561 extends to the electric power source of such as percutaneous connection or transcutaneous energy transfer etc.Pump 501 quilts It is fixed between inflow intubation 509 and outflow intubation 511.One example of the pump that can be placed in vascular system can be in U.S. Found in state's patent the 5th, 399,499, which is incorporated by reference herein in its entirety.Outflow intubation 511 is in blood stream The free end in right pulmonary artery 556 is extended to from pump 501 on dynamic direction, and including sacculus 515 to prevent backflow, such as above-mentioned reality Apply described in example.Certainly, other examples of bypass equipment 510 include flowing into the arrangement that intubation 509 extends towards inferior caval vein 554 And/or pump 501 and outflow intubation 511 are arranged on the arrangement in left pulmonary artery 558 at its implantation position.In addition, pump 501 can be with It is arranged in one or two vena cave.Bypass equipment 510 can also include two outlet cannulas, right pulmonary artery and left pulmonary artery In each in be extended with one outlet intubation.For these and other node configurations, extra feature can be increased, such as Valve, add sacculus or other elements to strengthen function and improve security.Bypass equipment 510 can with above-described embodiment institute Similar mode is stated to be implanted into.For example, making percutaneous slit with patient, and inserter sheath is placed through it.Inserter Sheath is placed in vascular system enough distant places so that any object through its placement may be directed at least one lung Artery.It is partly because the diameter of pump closely, bypass equipment 510 can be inserted into venous system by inserter sheath, so Enter superior vena cava 552 afterwards.In operation, may be aided in by power lead 561, blood stream enters to flow into opening in intubation 509 Mouth 539, subsequently into pump 501, blood is pumped at least one pulmonary artery 556,558 by pump 501 by flowing out intubation 511. Sacculus 515 or valve prevent from being back to vena cave., can be by additional valve or plugging device in the variation of bypass equipment 510 It is attached to intubation or is otherwise placed into vascular system, blood flow is controlled with placement according to equipment component.

Although the present invention has been described in connection with the specified embodiments, it is to be understood that, these embodiments merely illustrate this hair Bright principle and application.It will thus be appreciated that the spirit and scope of the present invention that are defined by the following claims are not being departed from In the case of, many modifications can be made to exemplary embodiment and other arrangements can be found out.

Claims

1. a kind of medical treatment, including：

The body of acceptor will be connected to the pump for flowing into port and outflow port so that in the inflow port and vena cave At least one fluid communication, and the outflow port and at least one fluid communication in left pulmonary artery or right pulmonary artery；With

The pump is operated so that at least one at least some blood flows in the vena cave are transported to left pulmonary artery It is or at least one in right pulmonary artery.

2. according to the method described in claim 1, it is characterized in that, the patient is already subjected to before the pump is connected Fontan programs so that the vena cave is connected with the pulmonary artery.

3. according to the method described in claim 1, it is characterized in that, the method further includes：

Measurement and the relevant property of blood on or in the inflow and/or the outflow intubation；

The signal related with the relevant property of blood is passed to the controller for being connected to the pump；With

The pump is controlled in response to the signal.

4. according to the method described in claim 1, it is characterized in that, the operation pump is included blood with transporting at least some blood flows Liquid by flow into intubation from the vena cave it is described it is at least one be transported in the pump, and by blood by flow out insert Pipe from the pump be transported in left pulmonary artery or right pulmonary artery it is described it is at least one in.

5. according to the method described in claim 4, it is characterized in that, the outflow intubation is sealed suitable at least generation part or resistance Plug so that when the outflow intubation is set in the blood vessel during the operation in the pump, prevent from the outflow intubation stream At least some blood backflows gone out are into vein.

6. according to the method described in claim 4, it is characterized in that, further include：Actuating is attached to institute before the pump is operated State the sacculus of outflow intubation so that the sacculus seals between outer surface and the peripheral vessels of the outflow intubation at least in part Space, be back to prevent Hemostatic Oral Liquid in vein.

7. according to the method described in claim 4, it is characterized in that, operation it is described pump include by the vena cave extremely Blood one few is transported in the multiple openings for flowing into intubation and being spaced apart from each other.

8. a kind of method for being implanted into medical treatment equipment, including：

At least one percutaneous slit is made with patient；

It will simultaneously or sequentially flow into and be inserted through one at least one percutaneous slit and outflow is slotting Pipe is inserted through one at least one percutaneous slit so that intubation and the outflow intubation of flowing into is all into meditation Arteries and veins；

The inflow intubation is advanced in the superior vena cava；With

The outflow intubation is advanced at least one in the right pulmonary artery or left pulmonary artery,

Wherein, intubation and the outflow intubation of flowing into is all connected to pump so that during the operation of the pump, the epicoele At least one at least one fluid passed through in the pump and the right pulmonary artery or left pulmonary artery in vein and inferior caval vein Connection.

9. according to the method described in claim 8, it is characterized in that, the patient make at least one percutaneous slit it Before be already subjected to Fontan programs so that the vena cave is connected with the pulmonary artery.

10. according to the method described in claim 8, seal wire is inserted through the outflow intubation simultaneously it is characterized in that, further including Activate the seal wire, wherein, the actuating of the seal wire make it is described flow into intubation and the outflow intubation it is at least one again Positioning.

11. according to the method described in claim 10, inserted it is characterized in that, further include the second seal wire being inserted through described flow into Pipe so that the actuating of first seal wire repositions the outflow intubation, and the actuating of second seal wire make it is described Intubation is flowed into reposition.

12. according to the method described in claim 8, it is characterized in that, intubation and the outflow intubation of flowing into is inserted at the same time Through identical percutaneous slit.

13. according to the method for claim 12, it is characterised in that further include and inserter sheath is passed through into the percutaneous slit Place, and intubation and the outflow intubation of flowing into is set through the inserter sheath.

14. according to the method described in claim 8, it is characterized in that, by it is described outflow intubation be advanced to the right pulmonary artery or It is included at least one in the left pulmonary artery at least one with setting in the left pulmonary artery or the right pulmonary artery Partially sealed or obstruction is at least produced between outflow intubation wherein.

15. according to the method described in claim 8, the outflow intubation is advanced to the right side it is characterized in that, being additionally included in Actuating is connected to the sacculus of the outflow intubation after at least one in pulmonary artery or the left pulmonary artery, wherein, it is described Sealing is described in the right pulmonary artery or the left pulmonary artery of the outflow intubation at least in part for the actuating of sacculus It is at least one.

16. a kind of external member for being used to improve blood stream of patients, including：

Pump；With

Intubation and outflow intubation are flowed into, the inflow intubation and the outflow intubation are suitably connected to the pump,

Wherein, the intubation that flows into is adapted for placement at least one in superior vena cava or inferior caval vein, and

Wherein, the outflow intubation is adapted for placement at least one in right pulmonary artery or left pulmonary artery.

17. external member according to claim 16, it is characterised in that the intubation that flows into includes flowing out the long of intubation than described Spend longer length.

18. external member according to claim 17, it is characterised in that one flowed into intubation and the outflow intubation It is disposed entirely within least a portion of the length for flowing into intubation another in the inflow intubation and the outflow intubation In one.

19. external member according to claim 17, it is characterised in that the outflow intubation further includes the first outflow intubation and the Two outflow intubations, in one that the first outflow intubation is suitable for being arranged in the right pulmonary artery or the left pulmonary artery, and And the second outflow intubation be suitable for being arranged in the right pulmonary artery or the left pulmonary artery another in.

20. external member according to claim 16, it is characterised in that the pump is adapted for placement in the body of the patient Portion so that the placement is under subcutaneous, muscle or in belly, chest or other body cavitys.