CN1204244A

CN1204244A - Device. system and method for interstitial transvascular

Info

Publication number: CN1204244A
Application number: CN96198967A
Authority: CN
Inventors: J·马科韦
Original assignee: Transvascular Inc
Current assignee: Transvascular Inc
Priority date: 1995-10-13
Filing date: 1996-10-11
Publication date: 1999-01-06

Abstract

Method and apparatus for utilizing the vascular system as a conduit to reach other vascular and extravascular locations within the body. Included are methods for revascularization wherein the extravascular passageways are formed to permit blood flow between vascular locations. Also included are methods for performing transvascular interstitial surgery (TVIS) wherein extravascular passageways are formed from a blood vessel to another vascular or non-vascular intracorporeal location. Also disclosed are devices usable for forming extravascular passageways in accordance with the invention, or for modifying, valving, maintaining or closing such passageways.

Description

Device, system and method that interstitial transvascular is got involved

The bypass of background of invention percutaneous intravascular tremulous pulse

Atherosclerosis is a kind of owing to blockage has limited the PD that the blood flow in the arterial lumen causes, typical blockage is meant atherosclerotic plaque.The obstruction of heart and peripheral arterial can cause pain, dysfunction even death.In the past few years, a lot of methods are used to carry out reconstructing blood vessel in the tissue of the downstream of obstructing arterial.These methods comprise bypass graft using artificial, that original position vein or vein transplantation thing carry out, and angioplasty, atherosis speckle excision and nearest laser are through myocardium reconstructive vascular operation.It is extremely successful that bypass graft has been proved to be, but it needs consummate surgical operation skill.Recently, by Heartport, Inc. and Cardiothoracic Systems, Inc. adopt, and have shown the demand to light damaging arteria coronaria bypass method for building up such as the technology of upgrading through intrathoracic sight glass method etc.The extremely difficult enforcement of these methods, and can not be widely used.Through myocardium laser intravascular Reconstruction is the technology that gets out a plurality of apertures on heart wall, seems practical, but its method all do not accepted so far, and sets up on the passage still existing problems using laser energy.Reduce to potential minimum and that do not need the patient is placed cardiopulmonary bypass because this technology exists with damaging, therefore, the clinical position person is still extremely interested in this technology.

This century the seventies, several cardiovascular surgeons were once used the experiment that cardiac veins carries out reconstructing blood vessel.This method is used in the patient of the serious diffuse Narrowing of coronary vasodilator.This technology comprises that the aorta of using internal mammary artery or adhering to saphena is as graft.Graft is not to sew up with far-end coronarius, but is connected with arteria coronaria or venae cordis in same position.The ligation venous is entad held to prevent shunting, removes patient's cardiovascular shunt device, closes thorax.In this pattern, vein is allowed to carry venule and the blood capillary of the blood of oxygenation to heart in reverse mode by " tremulous pulseization ".The successful probability difference of this technology is huge, and the overwhelming majority is abandoned.Problem comprises thrombosis in the intracardiac hemorrhage and graft that the anastomosis is narrow, venule breaks causes.

The device of Ti Chuing, system and method have demonstrated a kind of new method of percutaneous reconstructing blood vessel in this disclosure.Here, venae cordis both can be tremulous pulseization, also can be only merely as bypass graft.This point does not still have document and shows trial to some extent.The original position bypass graft once had application in periphery, but still needed to cut to connect and the ligation vein end.There is some similarity in another method technology therewith, is called TIPS method-Portal system shunting in the jugular vein liver.In the method, a kind of stent is placed in the liver organization to connect portal vein and postcava.But this method percutaneous is finished, and tool is not that organ is rebuild blood vessel or set up the purpose of bypass for occluding vascular, does not allow blood back flow in any two blood vessels, does not follow the formation of thromboembolism, and needs to use stent.And the apparatus and method of using in the method are all too huge and can not be directly used in the little blood vessel of heart.Matter art between between the intravascular blood vessel

For many years, open surgery is near the unique channel of organizing and implementing surgical procedures always.Along with the arriving in optics epoch, multiple endoscopic procedures is developed.Beginning, these methods are utilized the natural mouth of pipe, as urethra, oral cavity, nasolacrimal duct and anus.Recently, use through abdomen with through the new technique of breast and be developed.These thoracoscopies or laparoscopic procedures be main bar-shaped, the flexible device of length of using in open operation.Need general anesthesia, the minor cut or wound that still has several places to heal.

Another problem that this method exists is the evaluation of dissecting the concordance reference point.For accurate operation,, usually a support is invested patient's head so that this reference to be provided as performing the operation in the brain.Recently, a kind of " small rack " system is developed, and this system applies is equipped with the littler support of several light emitting diodes (LEDs).Use between these light emitting diodes that to be equipped in vertical three cameras interrelated.This helps to set up related between support and the boundary mark and the correct location of guaranteeing device.Though appearing to is preliminary trial, it has emphasized the importance of accurate arrival desired area.

Traditionally, the purpose of intravasation system only is in order to solve vascular problem.Angioplasty, atherosis speckle excision, stent, laser angioplasty, thrombolytic method, even intracardiac biopsy device all designs for using in the blood vessel.

Summary of the invention

Here provide and utilized vascular system, placed in the blood vessel wall inserting and outer a kind of device, system and method as conduit.According to an embodiment, will install one easily the entrance import vascular system, be directed into a particular target site then forward, the otch of performing an operation in this site, allow this device or other device by or enter space in the pipeline on every side at this mouth.In one embodiment, a kind of system is used as near certain space, but and the path of implementation and operation.This operation can be the freezing of tissue or part excision; Injection or drop are gone into medicine, material or material; Excision, operation or the reparation of tissue; The path of endoscope's close examination or diagnosis is provided; The arrangement of implantable or makeshift device; With the reconstructing blood vessel is the foundation of the substituting pipeline of target, and this pipeline can allow blood circulation; Perhaps can implement some other surgical procedures.In another embodiment, system is used to obtain another otch near the blood vessel first otch, circulates in the pipeline that this device is created to allow blood.This method is for creating substituting vascular access to provide substituting reconstructing blood vessel path very useful, as between heart coronary artery and venae cordis.Along with specific reinforcement, this system can be used to set up coronary artery bypass, cardiac veins arterialness or sections transplantation is provided.In addition, the stability of the blood vessel directional profile of anatomic landmark provides a kind of simple method for repeat to enter the peripheral blood vessel structure under image or other guiding.This organizes particularly usefully for entering brain, kidney, lungs, liver, spleen and other, and with respect to tissue mark location, external support or so-called " small rack " in-vitro directed apparatus system, has more shown its significant advantage.In the end in embodiment, system is used to do an otch at the entad end of blood vessel, by near the tissue the blood vessel, reenters blood vessel at the blood vessel far-end then.This is for provide a blood flow bypass to be highly profitable for circumvascular damage.

DESCRIPTION OF THE PREFERRED

The present invention utilizes vascular system as the perfect pipeline that arrives the health any part.Described device, system and method provide a kind of new route for matter position between operation arrival.The invention provides the system that arrives the health any part by the vascular system percutaneous, and provide to reaching the underlying instrument combination of several surgeries and medical effect.

The present invention provides a kind of percutaneous reconstructing blood vessel method for the organ of supply vessels generation pathological changes.According to another embodiment of the present invention, under the situation that need not open breast, general anesthesia or cardiovascular shunt, can finish the foundation of whole a plurality of coronary artery bypasses.

Understand in order to give to the invention provides more comprehensively, method of the present invention is discussed the application of reference unit together, and described device is used for percutaneous and sets up bypass at the heart coronary artery damage location.But for persons skilled in the art, can be understood as: conventional method of the present invention, system and device all can be used for the surgical procedures of all structures of arbitrary blood vessel equally.The present invention provides new ideas aspect minimum in that surgical operation damage is reduced to, and it is simple as arriving the passage of desiring operative site to be about to vascular system.After under suitably guiding, arriving operative site, utilize a kind of device to pass all zones of blood vessel and implement to perform the operation to allow the multiple instrument of insertion.The example of these methods can include but not limited to: intravascular enter intracranial and to multiple blood vessel week tumor, hemorrhage, apoplexy influence area and lesion region carry out interventional therapy or diagnosis; Intravascular is carried out brain, heart, kidney, liver, lung or osseous tissue biopsy; Intravascular implant, material or device are as sensor, radioactivity tubule, Armco magnetic iron granule, air bag, cell or genetic stocks.

With reference to figure 1, shown a typical coronary sinus guiding catheter 4, proceed to caval vein 7 and enter heart 1.Though do not show that guiding catheter 4 has arrived the coronary sinus that is positioned at heart 1 right atrium.This guiding catheter is a type well known in the art, comprises a rifle head that sufficient compliance and size are arranged, and inserts coronary sinus and a far-end air bag to guarantee atraumatic, allows reverse injection contrast agent, makes the cardiac veins system imaging.Matter art (TVIS) guiding catheter 5 inserts by guiding catheter between intravascular, inserts the vein 3 of uniting as one on guide wire 28, and the expectation site of arrival and coronary artery 2 vicinities.The figure illustrates TVIS probe 27 and draw before by TVIS guiding catheter 5, arrive the expectation site of coronary artery 2 by the operative incision on the venae cordis 3.

Fig. 2 has shown multiple function and the composition that TVIS guiding catheter 5 is included more meticulously.Here the TVIS guiding catheter 5 of Xian Shiing is to cause venae cordis 3 before on guide wire 28 and be positioned at wherein.TVIS guiding catheter 5 also provides air bag 21, its objective is for blocking blood flow, at tube chamber inner equilibrium conduit or expansion path.TVIS guiding catheter 5 also provides any or two in initiatively the directional detection instrument 23 and passive oriented prospecting tools 22.Persons skilled in the art can be recognized: passive oriented prospecting tools 22 can be used any cover known materials configuration, and this material can be taken pictures by radiation, perspective, magnetic or supersonic sounding position and TVIS guiding catheter 5 distal portions are located in vivo.These materials include but not limited to: any radiopaque material such as barium or steel; Any Armco magnetic iron material such as chalybeate; Or any material or the compositions that can fully interfere sound wave, as lockedin air space, impressed metal or several thin plates.Positive location prospecting tools 23 can carry out 360 ° of location to the distal site of the TVIS guiding catheter that is positioned at lumen of vessels, and in this example, lumen of vessels is a venae cordis 3.This positive location prospecting tools 23 can be used any one in the following technical method, but is not limited thereto: initiatively directional orientation tool 23 can be simple piezoelectricity line or silicon plate, can provide and received signal is surveyed the existence or the speed of blood flow in the adjacent blood vessel; This identical device can also be a series of receptors of getting in touch with mediator, and its purpose is to provide the image of surrounding tissue; This identical device can also be the guide wire 202 that can in this example, be arranged in coronary artery 2 send signals simple mediator-guide wire 202 can further be improved to comprise a little receptor/mediator 203 and wirning harness 204 here, just signal can be returned operator in case detect the signal that is sent by active directional orientation tool 23; Reverse system also can be used, and promptly sends signal by little receptor/mediator 203 to active directional orientation tool 23; Directional orientation tool 23 also can send a signal to any a series of known signal generator or receive its signal, comprises ultrasonic, electromagnetism, light or emission signal.Here the TVIS guiding catheter 5 that provides also has an additional opening, allows contrast agent or liquid selective injection blood vessel, and be venae cordis 3 in this example.In case confirmed the location of TVIS guiding catheter 5, TVIS probe 27 and TVIS sheath 26 just can pass the blood vessel wall of venae cordis 3, and a matter zone 29 and a coronary artery 2 are gone in preceding introduction.TVIS probe 27 and TVIS sheath 26 draw before there is no need simultaneously, and following orientation can be arranged: TVIS sheath 26 can be sharp or semi-stiff sleeve pipe, can be inserted tissue separately; TVIS probe 27 can insert tissue separately for hard relatively electric wire, antenna, photoconduction or energy guiding under the support of TVIS sheath 26; Perhaps in addition, TVIS probe 27 and TVIS sheath 26 can link together and operate, and promptly both are by the common tissue that inserts.TVIS probe 27 and/or TVIS sheath 26 provide two blood vessels, venae cordis 3 and coronary artery 2, between initial connection.In case it is appropriate that TVIS sheath 26 is settled, and can settle another softer guide wire by it, to allow inserting another tube chamber of desiring to enter with drawing before the other device.Perhaps, if implement dissimilar operations in order to enter a matter district, possible guide wire is just optional.This operation can be used to set up a bypass near the coronary artery 2 the coronary stricture 201, arrives venae cordis 3, at some example, also can return coronary artery 2.

Flow back into right atrium in order to prevent blood coronarius directly to divide by coronary sinus, one or more blocking blood flows are necessary in venae cordis.With reference to figure 3, in case duct formation, and determine that it is enough big, will use a kind of embolization device, as thromboembolism air bag 33, at the blood flow of blocking near anatomic passages 36 near zones in the venae cordis 3.This operation is guaranteed coronary flow 34 through anatomic passages 36, flows with arrow 35a and the unfavourable vein of 35b indicated direction.Thromboembolism air bag 33 is placed and suitably inflation by using thromboembolism conduit 31, breaks away from conduit by removable part 32.It will be understood by those skilled in the art that in several devices and the material any all can be used for the purpose of thromboembolism.These comprise detachable balloon, coil, generation blood coagulation strands of material, microfilament collagen, collagen sponge, cellulose gel or sponge such as Gelfoam (TM) or special stent.Fig. 3 has shown Venous system that how these devices to be used for connecting far-end tremulous pulseization again.By implement identical reverse operating in the appropriate location, downstream, it also is feasible that a bypass is provided merely but as shown in figure 12.It is to be noted: these embolization devices also can be used to block any not desire of telling from venae cordis and belong to the blood flow that props up.Fig. 4 and 9 will address at this paper rear portion.

Figure 10 A-10B and 11A-11B have shown that according to two other embolization device of the present invention they also can be used to finish closing of needing.

Figure 10 A shown and has been positioned at epitheca 102, the compression collagen sponge 101 that can carry by guide wire 51.Shown in Figure 10 B, in case guide wire 51 enters into the blood vessel that needs thromboembolism, epitheca 102 withdraws from along inner core 103, makes collagen sponge 101 at intravascular dilation.Finish in case carry, withdraw from guide wire 51 and duct assembly 102 and 103, sponge is stayed desired location.

Figure 11 A has shown an one-way valve graft fixed die 112.Place the film 111 in the graft fixed die 112,116 places are cylindrical at flank, at flank 113 places then to the formation one-way valve of self subsiding.As shown in major axis profile Figure 11 B, its allows blood to flow with the direction shown in the arrow 114, and inserts device in this direction; But stop blood to flow, and holdout device insert from this direction with the direction shown in the arrow 115.One-way valve graft fixed die 112 is easy to place desired area by conduit, and can be in this position expansion with the location.In a single day the internal transmission conduit is removed, and film 111 can subside, and forms a valve similar effect immediately.

As shown in Figure 4, in another embodiment, can not need embolization device.Graft fixed die 41 is inserted by anatomic passages 36, and its coronary artery segment 41a and vein segment 41b position are as shown in the figure.Graft fixed die 41 a kind of material that can be covered, fine and close mesh or cellular matrix, make coronary flow 34 graft fixed die 41 outer walls of can not flowing through easily, flow to stenosis 201, but path by setting up, flow into venae cordis 3 by graft fixed die 41, produce reverse venae cordis blood flow 35.In this figure, declare publicly the position of graft fixed die: the TVIS guiding catheter is placed in the coronary artery 2, and anatomic passages 36 is to set up from tremulous pulse to the venous direction.This allows the suitable location of guide wire and graft fixed die subsequently, allows the orientation of device from tremulous pulse to the vein direction.Clearly, also a similar graft fixed die can be placed downstream (for example, be equivalent to 1203 position at Figure 12, arrive through vein 3) with vein to the direction of tremulous pulse, set up a complete bypass in coronary artery 2 stenosis 201.Graft fixed die 41 must be processed to suitable size, makes its proximal part 41a and distal portions 41b be expanded to the fit closely shape of the blood vessel wall of inserting with it respectively.Perhaps, shown in Fig. 4 a, the inserting of graft fixed die 410, its proximal part 410a and distal portions 410b all do not hinder blood flow, only play the effect of keeping anatomic passages 36 sizes.

Fig. 5 has shown how to use the standard air bag 52 expansion anatomic passages 36 of inserting by guide wire 51, its objective is and guarantee that anatomic passages 36 has enough width of accepting blood flow.In addition, this step is being for inserting other device, stent 41 as seen in Figure 4, or the stent seen in Fig. 4 a 410, and before, the yardstick of right metric anatomic passages 36 is necessary.

If can remove or excise abundant material between coronary artery 2 and venae cordis 3, the stent of keeping anatomic passages 36 sizes is just non-essential.Fig. 6 has shown one by the slotting forward steam lead 63 that draws of guide wire 51.Here, energy 61 is sent to anatomic passages 36 by the distal portions 62 of steam lead 63, to set up being connected of suitable yardstick between tremulous pulse and vein.Those skilled in the art will recognize that this steam lead 63 also can be used to transmit heat energy, ablation energy, welding energy or the energy that condenses, method includes but not limited to: laser, bipolar or monopolar radio frequency (RF), microwave, ultrasonic, hot line or ray.

Stent shown in Fig. 4 and 4a for the size of control anatomic passages 36, prevents that it from expanding under pressure, or closes because of restenosis and to be absolutely necessary.Another kind of in healing with again in the moulding process, forever or temporarily keep the method for anatomic passages 36 sizes and see Fig. 7.Here the polymer stent 71 of Xian Shiing is coated on the wall of anatomic passages 36.This polymer stent 71 can balloon catheter inserts and expansion be settled by using, and perhaps uses several different methods foundation well known in the art and that put into practice for FOCAL (TM) company that is positioned at Massachusetts in position.71 pairs of restenosiss of this polymer stent or pseudoaneurysm form and can play the temporary protection effect, and can dissolve by after date in the time of one section, reduce the probability of any long-term tissue reaction effect.

Owing to make the probability of complicated operationization very big such as restenosis or pseudoaneurysm, the anatomic passages of some establishments may no longer need.This problem can be used as Fig. 8, and 9,9a, 9b, 9c, 22, the method shown in the 22a and 23 is solved.

In Fig. 8, the welding conduit system of application comprises the welding conduit 81 and the distal end welding conduit 86 of proximal part.After matter district 29 sets up anatomic passages between between venae cordis 3 and the coronary artery 2, insert guide wire 51.Then, it is preposition along guide wire 51 that distal end is welded conduit 86, and far-end is inflated near air bag 89.Subsequently, it is preposition along far-end welding conduit 86 proximal part to be welded conduit 81.At this point, nearly the nearly air bag 82 of heart termination is inflated, and two air bags is pulled to the position of coronary artery 2 and the relative edge of venae cordis 3 openings.Can assemble with one or more following ingredients near air bag and welding conduit: interior welding electrode 83, offside face of weld 87 and 88, refurn electrode 85 and 84 and thermocouples 801.In this case, need not other mechanical auxiliary equipment, can two openings in blood vessels be welded together applying double pole RF energy.Energy or in transmission between offside face of weld 87 and 88 or between interior welding electrode 83 and refurn electrode 85 and 84.Which kind of situation no matter, in two openings and around the temperature of local organization will be by thermocouple 801 measurements, and rise to temperature required.This temperature will be kept a period of time, and during this period of time tissue merges.After the fusion, power-off, air bag deflation, device shifts out, and two openings of leaving over merge around it.

Fig. 9 has described application machine staple fixation and has connected two openings in blood vessels.Staple A/C 91 has epitheca 96,

optional heat coil

94 and 97, staple 95 and micromechanics staple nail holding device 93.Staple A/C 91 is preposition by anatomic passages 36, enters into coronary artery 2 well until device.The size of epitheca 96 external diameters should be that two intervascular anatomic passages 36 are slightly expanded.Epitheca 96 is pulled back, fully expose until the first half of staple 95.This point of pulling back is by the proximal part control of conduit.Staple 95 or by class spring material such as rustless steel perhaps is made of high elastic modulus alloy, so that can bend to the being seen position as Fig. 9 a.This effect can also be by using moulding memory material such as Nitinol and finishing by coil 97 heating.In case the first half of staple 95 has reached their case of bending, staple A/C 91 can be withdrawn from, shown in Fig. 9 B, make the tip of staple 95 pack into coronary artery 2 openings around.Epitheca 96 all can be withdrawn from (shown in Fig. 9 B) now, be made the latter half of staple 95 parameatal inner face of venae cordis of packing into.This effect also can passively be withdrawn from the heat energy of epitheca or active applications heater coil 94 and finish.Though passive method is simpler, active method can make the device counter-rotating by using the injection cool brine.When this point is not accurately finished inserting of staple 95, need do.At last, in case confirmed the position of staple, can be by micromechanics staple nail holding device 93 with its release, the result is shown in Fig. 9 C, and staple 95 makes anatomic passages 36 exist with open form.Those skilled in the art will recognize that, except using micromechanics, also have several method to can be used to discharge staple, comprise that hot material method such as scolder fuse, keep the thermal degradation of polymer or biomaterial, and mechanical means moves as the air bag expansion of the removal that keeps line, weak reserved materials or by the non-locking of staple A/C 91 of staple 95 decisions, and the latter only just can finish after appropriate in that staple is fixing.

Figure 22 has shown another embodiment that two openings with two blood vessels are fixed together.This embodiment has been used a far-end guiding catheter 2205 that inserts by guide wire 2206.A upper end Small clamp 2204 is fixed in far-end guiding catheter 2205 by near the subsided reservation unit 2207 that is positioned at it.This aggregation is preposition by anatomic passages 36, passes through fully until it.In this embodiment, reservation unit 2207 will assist to expand anatomic passages 36 because upper end Small clamp 2204 than the slightly larger in diameter of anatomic passages 36, therefore can subside.The near-end guiding catheter 2201 that has a bottom Small clamp 2202 on its top is preposition to anatomic passages 36 directions by far-end guiding catheter 2201.2204 and 2,202 two Small clamps are furthered each other, pass and lock the receiving opening 2209 that is positioned at bottom Small clamp 2202 until the prong 2208 of upper end Small clamp 2204.After success locked, the reservation unit 2207 that can subside subsided, and near-end and distal catheter are withdrawn from, and stay the Small clamp shown in Figure 22 a.Can subside keeps unit and can be, air bag for example, and the compression member or the electric wire safety pin that constitute by moulding memory material, and by the near-end control of conduit.

Another welder according to an embodiment of the invention sees Figure 23 for details.Here used the very proximate technology with Fig. 8, different is energy discharges nuclear 2301 by the center and is discharged into

blood vessel

2 and 3 relative opening.In this embodiment, make two openings relative by

air bag

89 and 81 after, the center is discharged the center that nuclear is prepended to

duct assembly

81 and 86, to the point midway of anatomic passages 36.Energy discharges nuclear by the center and discharges, and the local organization around device produces enough temperature, makes it to merge.This energy and release can be 360 degree emitted laser fibers, microwave or other electromagnetic antenna or local device produce ultransonic piezoquartz or laser release.Electroheat pair 801 can be used to define and control welding process.

Figure 12 has shown the final result after the coronary artery bypass program is finished.Normal coronary flow 34 is walked around stenosis 201, enters venae cordis 3 by anatomic passages 1202, comes back to coronary artery 2 by anatomic passages 1203 again.Here shown a common embolization device 1201, blocked the venae cordis upstream and downstream and belonged to the blood flow that props up vein 1204.If only desire so only needs the thromboembolism and the adnexa of proximal part with the cardiac veins tremulous pulseization here.

Figure 13 has shown a common TVIS inlet port 1301.The TVIS mouth has a protecting cover 130 and the inlet 138 that can import multiple device.Inlet 138 also has in conduit or when device inserts by it, keeps pressure or hemostatic function.Conduit 133 has a distal portions that constitutes the proximal part of protecting cover 130 and constitute rifle head 1302.TVIS inlet port 1301 also can provide visual indication thing 139 and the balance air bag 134 that is positioned at its distal site.In matter between TVIS guiding catheter shown in Figure 55 arrival and after staying guide wire, the far-end rifle head of TVIS inlet port 1301 is that percutaneous is inserted, by causing a matter position 138 before the guide wire.Confirm label 139 behind the outside of blood vessel 132, with air bag 134 inflations.The balance method that those of skill in the art will recognize that the rifle head also can comprise fixedly apperance support of lock-in line, expandable stent and expansible graft.In case all can inserting, TVIS inlet port fix in position, many other devices implement medical science or treatment intervention.These comprise endoscope 135, and operation tool 136 such as pin, sleeve pipe, conduit are cut, holder or biopsy device, and energy transform device 137 such as laser fibers, bipolar and one pole RF line, microwave antenna, ray transmission device and heat transfer apparatus.In case one or more TVIS inlet ports 1301 are settled and finished, multiple operative procedure all can be implemented in its surrounding tissue by vascular system.

Figure 14 has shown according to the present invention, another embodiment of TVIS guiding catheter 146.Here the TVIS guiding catheter 146 of Xian Shiing has a far-end rifle head 145 that can turn to flexibly.In this example, turning to of far-end rifle head 145 can be reached by the moulding memory material 142 that embeds this device far-end rifle head 145.When this material is heated coil 147 heating, can bend rapidly to required orientation.Service aisle 143 provides the preposition route of required TVIS device.Here the syringe needle 141 of Xian Shiing just injects blood vessel week tissue with medicine 140.As preceding discussion, TVIS guiding catheter 146 also can comprise a vascular homeostasis air bag 144 and passive visual indication thing 148.

Figure 15 has shown and has had supplementary element, the identical TVIS conduit 146 of the visual device 23 of foregoing active.Also in Figure 16, shown TVIS probe 27 and TVIS sheath 26 just withdraw from far-end rifle head 145 residing service aisles 143.Also show one in addition and flushed passage 150.

Figure 17 has shown according to one embodiment of the invention, creates the another kind of method of the accurate anatomic passages 36 of size.A reverse cutting tissue device duct assembly 173 is preposition by anatomic passages 36 along guide wire 51.This reverse cutting tissue device duct assembly 173 has a cylindrical blade 171 to link to each other with expansion rifle head 170.Rifle head 170 is preposition by anatomic passages 36, is positioned at the tremulous pulse 2 in opening distally until blade 171.In case it is this position is found,, relative with its proximal openings with a bigger basic conduit 172 preposition delivering in the vein 3.Pulled back in the edge of blade 171 and rifle head 170 relative organization's passages 36 then, when cylindrical blade 171 during to 172 extruding of basic conduit, the tissue of cutting-out stays within it.After aggregation 173 was withdrawn from, the size of anatomic passages 36 was the size of cylindrical blade 171 external diameters just.

According to one embodiment of the invention, Figure 18 has shown TVIS guiding catheter 182, and its far-end air bag 181 and proximal balloon 182 isolate one section tremulous pulse that will pass.This is of value to the application of TVIS guiding catheter 182 in high pressure blood vessel such as tremulous pulse.This conduit 182 can be used with the 5 basic similarly modes of conduit among Fig. 2.

According to one embodiment of the invention, be that the another kind of method that one section blood vessel is set up bypass is seen Figure 19 A and 19B.TVIS guiding catheter 146 shown in Figure 19 A is as described in Figure 14 and 15, and different is a far-end rifle head 145 that is made of moulding memory material 142 and can ACTIVE CONTROL here.The TVIS guiding catheter 146 here under the guiding of probe 27 and sheath 26, passes in the tissue around.At last, conduit 146 has been created a passage 190, shown in Figure 19 B, is used for allowing the blood of tremulous pulse 2 to flow to another point from a bit.

According to one embodiment of the invention, Figure 20,20A and 20B have shown the application through myocardium reconstructive vascular operation device.Figure 20 has shown how TVIS guiding catheter 5 inserts ventricle 2001.Here the TVIS probe 27 of Xian Shiing is created an elongate channel 2003 by cardiac muscle 2000.This passage makes between ventricle and the capillary bed in cardiac muscle 2000 direct contact.Figure 20 A has shown that TVIS guiding catheter 146 how to use another kind of Figure 19 A creates these elongate channel 2003 in heart.TVIS guiding catheter 146 in this example promptly has an air bag rifle head 2002 through further improvement, its objective is to cover passage 2003 in evaporation process; Air bag 2002 also helps to guarantee the insertion to ventricle wall 2004, and this point is to finish by the suction that 2002 distal openings from conduit 146 to air bag are provided.At last, Figure 20 B has shown the several channels 2003 that TVIS guiding catheter 5 intravascular are created, and makes blood directly flow into heart from blood vessel.

According to one embodiment of the invention, Figure 24 A has shown edge-to-edge's fistula stent 2400.This stent 2400 resembles the high different Herba Trifolii Pratentis of a strain leaf.Two

high leaves

2401 and 2403 and two

low leaves

2402 and 2404 are placed shown in Figure 24 B, make them be positioned at any one side of vessel boundary.Be positioned at the passage that the TVIS device is created with the vertical intervention part 2405 in Herba Trifolii Pratentis 2401-2404 plane.Device opens from the conduit 2407 that is positioned on the guide wire 2408, shown in Figure 24 C.Interior sheath 2409 is wrapping stent, make Herba Trifolii Pratentis 2401 and 2403 leaves be positioned at far-end, and 2402 and 2404 be positioned at near-end, when conduit 2407 when sheath 2409 moves, two pieces of far-end SANYE blades of

grass

2401 and 2403 are released, and backspace mechanism contacts with the distal vessels inner surface with 2403 until SANYE blade of grass 2401.Conduit 2407 relative sheaths 2409 are moved further then, and near-end SANYE blade of

grass

2402 and 2404 is discharged into the inner surface of near-end blood vessel, shown in Figure 24 E.

According to one embodiment of the invention, Figure 25 has shown in further detail can be by the preposition polytype device of TVIS conduit 146.Here dilator 2502 of Xian Shiing and sheath 2503 are just preposition by blood vessel wall 2504 on guide wire 2501.

Perhaps, an independently sheath as shown in figure 13 also can be preposition.Figure 26 A and 26B have shown the component of such system in further detail.Beginning, application TVIS conduit will lock guide wire 2602 and insert in the tissue.This guide wire has a very little locking knot 2604, its objective is when the device exchange guide wire to be anchored in the tissue.Then, it is preposition on locking guide wire 2602 that the TVIS mouth shown in Figure 26 A imports aggregation.This aggregation comprises a dilator 2601 that is positioned within the conduit 133.Conduit 133 also provides a kind of poising tool 134, is shown as air bag here.After conduit 133 was in place, poising tool 134 opened, and dilator 2601 and locking guide wire 2602 are removed.According to circumstances, valve can be equipped or do not adorned to protecting cover 1301, in case hemostasis liquid adverse current enters conduit 133.Subsequently, multiple device can insert conduit 133 as previously mentioned.

According to another embodiment of the invention, the TVIS conduit can be as Figure 27 A and the being seen Unit 2704 of 27B.Here, TVIS conduit 2704 has a preformed bending, shown in Figure 27 A.When conduit was compressive state shown in Figure 27 B, it can keep linear position.When conduit 2704 was linear condition (Figure 27 B), guide wire 2701 withdrawed from from guiding spool 2709, and when conduit is replied its preformed shape (Figure 27 A) again, guide wire 2701 will withdraw from from lateral opening 2702.Shown TVIS probe 2703 is entering other passage, and can withdraw from from the device top in arbitrary position.Conduit 2704 can aforementioned other conduit form use, but it is advantageous that the top can required direction bending.

According to another embodiment of the invention, Figure 28 has shown TVIS conduit 2800.Here, two of blood vessel openings utilize evaporation energy bundle 2805 but not probe formation.This method applied energy guiding 2801, transmission of power is imported tissue with energy then successively to deflecting plates 2802.Operating time must accurately be set injury-free with the relative tube wall of guaranteeing blood vessel 2 with energy level.Also shown optional guide wire 2804 among the figure, this guide wire can be used to block or show the signal that laser energy passes.

According to one embodiment of the invention, Figure 29 has shown the another kind of mechanism of expansion or cut.Here, device is preposition by anatomic passages on guide wire 2903, and sheath 2904 is moved relative to centrosome 2902, makes 2901 expansions of the cutting wing.The cutting wing 2901 should be sharp, or use additional-energy, when device withdraws from from anatomic passages, enlarges otch.

Figure 16 and 21 has a mind to omit.

Claims

1. implement the method that the pathological changes arteries is rebuild, comprising:

A) form first opening at the contiguous vein of pathological changes tremulous pulse;

B) at pathological changes tremulous pulse and contiguous second opening of position formation of first opening; With

C) between first and second opening, provide blood flow path.

2. implement the method that the heart change arteries is rebuild, comprising:

A) first opening of the vascularization of certain point in the cardiac cycle system;

B) second opening of vascularization of another location in the cardiac cycle system; With

C) between first and second opening, provide blood flow path.

3. outside vessel lumen, organize and implement the device of operation, comprising:

A) have the conduit of near-end and far-end, far-end is fit to reach required operative site by vascular system, and near-end is fit to stay external, and allows to be controlled by operator;

B) directional orientation tool that provides of distal end of catheter allows operator to determine the axial position of rotation of tube chamber inner catheter; With

What c) distal end of catheter provided penetrates near instrument, can produce opening and extend out to the tube chamber external space.

4. blood is sent to the device of another section blood vessel from one section blood vessel by anatomic passages, comprises:

A) conduit member with proximal part, interlude part and distal portions;

B) proximal part can be the diameter of article one blood vessel;

C) the interlude part can be the diameter of anatomic passages; With

D) distal portions can be the diameter of second blood vessel.

5. expand the method for the anatomic passages that forms between two blood vessels, comprising:

A) pass through a guide wire through anatomic passages;

B) preposition one air bag with near-end and distal portions on guide wire;

C), its near-end and distal portions are stretched enter two vessel lumen with the air bag location; With

D) airbag aeration.

6. from first section blood vessel,,, create one and widen interval device, comprising to second section blood vessel through anatomic passages:

A) have near-end and far-end, can insert the conduit of vascular system; With

B) outlet is positioned at the energy guiding of distal end of catheter, power transfer can be gone into tissue, from a position formative tissue passage of vascular system.

7. allow first opening of article one blood vessel and second device that opening is connected of second blood vessel are comprised:

A) has first pinna rachis of near-end and far-end;

B) be positioned at first expanded part on first pinna rachis, can in article one blood vessel, enlarge;

C) have second pinna rachis of near-end and far-end;

D) be positioned on second pinna rachis second and can expand part, can in the second blood vessel, enlarge;

E) instrument that two enlarged are brought together produces first and second openings respect to one another, allows blood to flow between first and second blood vessels.

8. the device of one-way valve is provided in blood vessel, comprises:

A) has the tubular stent of near-end and far-end; With

B) diaphragm that can still keep the stent diameter at its far-end at its near-end providing of stent to self subsiding.

9. to provide matter between intravascular to be close to the inlet of purpose, comprising:

A) has the conduit of near-end and far-end and at least one tube chamber;

B) proximal part of conduit has protecting cover, allows multiple device to import conduit; With

C) distal portions of conduit be suitable for by blood vessel, by the opening intravasation tube chamber on the blood vessel wall outer between the matter zone.

10. enlarge the device that is positioned at passage between first opening of article one blood vessel and second opening of second blood vessel, comprising:

A) have first and second pinna rachis of near-end and distal portions;

B) be positioned at cylindrical blade on first pinna rachis, tissue part can be excised;

C) be positioned at second cylindrical blade container on the pinna rachis; With

D) instrument that causes cylindrical blade to contact with container.